Council of the
European Union
Brussels, 14 December 2022
(OR. en)
16031/22
Interinstitutional File:
2021/0170(COD)
LIMITE
CONSOM 340
MI 942
COMPET 1032
DIGIT 243
CYBER 403
CHIMIE 103
JAI 1680
CODEC 2015
NOTE
From:
Presidency
To:
Delegations
Subject:
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL on general product safety, amending Regulation (EU)
No 1025/2012 of the European Parliament and of the Council, and
repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the
European Parliament and of the Council
- 4-column table
Delegations find in the annex the
final four-column table containing the result of the political
agreement on the
General Product Safety Regulation and of the latest work done in the technical
meetings.
The text in square brackets will be finalised during the revision by the Lawyer Linguist as well as
ensure consistency in the terminology.
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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on general product
safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council
Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council (Text with EEA
relevance)
2021/0170(COD)
11469/22
Commission Proposal
EP Mandate
Draft Agreement
Council Mandate
Formula
2021/0170 (COD)
2021/0170 (COD)
2021/0170 (COD)
2021/0170 (COD)
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1
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Text Origin:
Commission Proposal
Proposal Title
Proposal for a
Proposal for a
Proposal for a
Proposal for a
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2
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REGULATION OF THE
REGULATION OF THE
REGULATION OF THE
REGULATION OF THE
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
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AND OF THE COUNCIL
AND OF THE COUNCIL
AND OF THE COUNCIL
AND OF THE COUNCIL
on general product safety,
on general product safety,
on general product safety,
on general product safety,
amending Regulation (EU) No
amending Regulation (EU) No
amending Regulation (EU) No
amending Regulation (EU) No
1025/2012 of the European
1025/2012 of the European
1025/2012 of the European
1025/2012 of the European
Parliament and of the Council,
Parliament and of the Council,
Parliament and of the Council,
Parliament and of the Council
and repealing Council Directive and repealing Council Directive and repealing Council Directive
and Directive (EU) 2020/1828
87/357/EEC and Directive
87/357/EEC and Directive
87/357/EEC and Directive
of the European Parliament
2001/95/EC of the European
2001/95/EC of the European
2001/95/EC of the European
and the Council, and repealing
Parliament and of the Council
Parliament and of the Council
Parliament and of the Council
Council Directive 87/357/EEC
and Directive 2001/95/EC of the
European Parliament and of the
(Text with EEA relevance)
(Text with EEA relevance)
(Text with EEA relevance)
Council
(Text with EEA relevance)
Text Origin:
Commission Proposal
Formula
THE EUROPEAN
THE EUROPEAN
THE EUROPEAN
THE EUROPEAN
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3
PARLIAMENT AND THE
PARLIAMENT AND THE
PARLIAMENT AND THE
PARLIAMENT AND THE
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COUNCIL OF THE
COUNCIL OF THE
COUNCIL OF THE
COUNCIL OF THE
EUROPEAN UNION,
EUROPEAN UNION,
EUROPEAN UNION,
EUROPEAN UNION,
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Text Origin:
Commission Proposal
Citation 1
Having regard to the Treaty on
Having regard to the Treaty on
Having regard to the Treaty on
Having regard to the Treaty on
the Functioning of the European the Functioning of the European the Functioning of the European the Functioning of the European
Union, and in particular Article
Union, and in particular Article
Union, and in particular Article
Union, and in particular Article
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4
114 thereof,
114 thereof,
114 thereof,
114 thereof,
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Text Origin:
Commission Proposal
Citation 2
Having regard to the proposal
Having regard to the proposal
Having regard to the proposal
Having regard to the proposal
from the European Commission, from the European Commission, from the European Commission, from the European Commission,
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Text Origin:
Commission Proposal
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Citation 3
After transmission of the draft
After transmission of the draft
After transmission of the draft
After transmission of the draft
legislative act to the national
legislative act to the national
legislative act to the national
legislative act to the national
parliaments,
parliaments,
parliaments,
parliaments,
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6
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Text Origin:
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Citation 4
Having regard to the opinion of
Having regard to the opinion of
Having regard to the opinion of
Having regard to the opinion of
the European Economic and
the European Economic and
the European Economic and
the European Economic and
Social Committee1,
Social Committee1,
Social Committee1,
Social Committee1,
_________
_________
_________
_________
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1. .OJ C , , p. .
1. .OJ C , , p. .
1. .OJ C , , p. .
1. .OJ C , , p. .
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Text Origin:
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Citation 5
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Acting in accordance with the
Acting in accordance with the
Acting in accordance with the
Acting in accordance with the
ordinary legislative procedure,
ordinary legislative procedure,
ordinary legislative procedure,
ordinary legislative procedure,
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Text Origin:
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Formula
Whereas:
Whereas:
Whereas:
Whereas:
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Text Origin:
Commission Proposal
Recital 1
(1) Directive 2001/95/EC of the (1) Directive 2001/95/EC of the (1) Directive 2001/95/EC of the (1) Directive 2001/95/EC of the
European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of the
G 10
Council1 lays down the
Council1 lays down the
Council1 lays down the
Council1 lays down the
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requirement that consumer
requirement that consumer
requirement that consumer
requirement that consumer
products must be safe and that
products must be safe and that
products must be safe and that
products must be safe and that
Member States' market
Member States' market
Member States' market
Member States' market
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surveillance authorities must
surveillance authorities must
surveillance authorities must
surveillance authorities must
take action against dangerous
take action against dangerous
take action against dangerous
take action against dangerous
products as well as exchange
products as well as exchange
products as well as exchange
products as well as exchange
information to that effect
information to that effect
information to that effect
information to that effect
through the “Union rapid
through the “Union rapid
through the "Union rapid
through the “Union rapid
information exchange system”,
information exchange system”,
information exchange system",
information exchange system”,
RAPEX.
RAPEX.
RAPEX.
RAPEX.
_________
_________
_________
_________
1. Directive 2001/95/EC of the
1. Directive 2001/95/EC of the
1. Directive 2001/95/EC of the
1. Directive 2001/95/EC of the
European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of the
Council on general product
Council on general product
Council on general product
Council on general product
safety (OJ L 11, 15.1.2002, p.
safety (OJ L 11, 15.1.2002, p.
safety (OJ L 11, 15.1.2002, p.
safety (OJ L 11, 15.1.2002, p.
4).
4).
4).
4).
Recital 2
(2) Directive 2001/95/EC needs (2) Directive 2001/95/EC needs (2) Directive 2001/95/EC needs (2) Directive 2001/95/EC needs
to be revised and updated in
to be revised and updated in
to be revised and updated in
to be revised and updated in
light of the developments
light of the developments
light of the developments
light of the developments
related to new technologies and related to new technologies and related to new technologies and related to new technologies and
G 11
online selling, to ensure
online selling, to ensure
online selling, to ensure
online selling, to ensure
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consistency with developments
consistency with developments
consistency with developments
consistency with developments
in the Union harmonisation
in the Union harmonisation
in the Union harmonisation
in the Union harmonisation
legislation and in the
legislation and in the
legislation and in the
legislation and in the
standardisation legislation, to
standardisation legislation, to
standardisation legislation, to
standardisation legislation, to
ensure a better functioning of
ensure a better functioning of
ensure a better functioning of
ensure a better functioning of
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the product recalls as well as to
the product recalls as well as to
the product recalls as well as to
the product recalls as well as to
ensure a clearer framework for
ensure a clearer framework for
ensure a clearer framework for
ensure a clearer framework for
food-imitating products so far
food-imitating products so far
food-imitating products so far
food-imitating products so far
regulated by Council Directive
regulated by Council Directive
regulated by Council Directive
regulated by Council Directive
87/357/EEC1. In the interest of
87/357/EEC1. In the interest of
87/357/EEC1. In the interest of
87/357/EEC1. In the interest of
clarity, Directive 2001/95/EC,
clarity, Directive 2001/95/EC,
clarity, Directive 2001/95/EC,
clarity, Directive 2001/95/EC,
as well as Directive
as well as Directive
as well as Directive
as well as Directive
87/357/EEC, should be repealed 87/357/EEC, should be repealed 87/357/EEC, should be repealed 87/357/EEC, should be repealed
and replaced by this Regulation. and replaced by this Regulation. and replaced by this Regulation.
and replaced by this Regulation.
_________
_________
_________
_________
1. Council Directive
1. Council Directive
1. Council Directive
1. Council Directive
87/357/EEC of 25 June on the
87/357/EEC of 25 June on the
87/357/EEC of 25 June on the
87/357/EEC of 25 June on the
approximation of the laws of the approximation of the laws of the approximation of the laws of the approximation of the laws of the
Member States concerning
Member States concerning
Member States concerning
Member States concerning
products which, appearing to be products which, appearing to be products which, appearing to be products which, appearing to be
other than they are, endanger
other than they are, endanger
other than they are, endanger
other than they are, endanger
the health or safety of
the health or safety of
the health or safety of
the health or safety of
consumers (OJ L 192, 11.7.
consumers (OJ L 192, 11.7.
consumers (OJ L 192, 11.7.
consumers (OJ L 192, 11.7.
1987, p. 49).
1987, p. 49).
1987, p. 49).
1987, p. 49).
Text Origin:
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Recital 3
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(3) A Regulation is the
(3) A Regulation is the
(3) A Regulation is the
(3) A Regulation is the
appropriate legal instrument as
appropriate legal instrument as
appropriate legal instrument as
appropriate legal instrument as
it imposes clear and detailed
it imposes clear and detailed
it imposes clear and detailed
it imposes clear and detailed
rules which do not give room
rules which do not give room
rules which do not give room
rules which do not give room
for divergent transposition by
for divergent transposition by
for divergent transposition by
for divergent transposition by
Member States. The choice of
Member States. The choice of
Member States. The choice of
Member States. The choice of
Regulation instead of Directive
Regulation instead of Directive
Regulation instead of Directive
Regulation instead of Directive
also allows to better deliver on
also allows to better deliver on
also allows to better deliver on
also allows to better deliver on
the objective to ensure
the objective to ensure
the objective to ensure
the objective to ensure
coherence with the market
coherence with the market
coherence with the market
coherence with the market
surveillance legislative
surveillance legislative
surveillance legislative
surveillance legislative
framework for products falling
framework for products falling
framework for products falling
framework for products falling
under the scope of Union
under the scope of Union
under the scope of Union
under the scope of Union
harmonisation legislation as set
harmonisation legislation as set
harmonisation legislation as set
harmonisation legislation as set
out in Regulation (EU)
out in Regulation (EU)
out in Regulation (EU)
out in Regulation (EU)
2019/1020, where the applicable 2019/1020, where the applicable 2019/1020, where the applicable 2019/1020, where the applicable
legal instrument is also of the
legal instrument is also of the
legal instrument is also of the
legal instrument is also of the
same type, namely Regulation
same type, namely Regulation
same type, namely Regulation
same type, namely Regulation
(EU) 2019/1020 of the
(EU) 2019/1020 of the
(EU) 2019/1020 of the
(EU) 2019/1020 of the
European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of the
Council1. Finally, such a choice Council1. Finally, such a choice Council1. Finally, such a choice Council1. Finally, such a choice
will further reduce the
will further reduce the
will further reduce the
will further reduce the
regulatory burden through a
regulatory burden through a
regulatory burden through a
regulatory burden through a
consistent application of product consistent application of product consistent application of product consistent application of product
safety rules across the Union.
safety rules across the Union.
safety rules across the Union.
safety rules across the Union.
_________
_________
_________
_________
1. Regulation (EU) 2019/1020
1. Regulation (EU) 2019/1020
1. Regulation (EU) 2019/1020
1. Regulation (EU) 2019/1020
of the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and
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of the Council of 20 June 2019
of the Council of 20 June 2019
of the Council of 20 June 2019
of the Council of 20 June 2019
on market surveillance and
on market surveillance and
on market surveillance and
on market surveillance and
compliance of products and
compliance of products and
compliance of products and
compliance of products and
amending Directive 2004/42/EC amending Directive 2004/42/EC amending Directive 2004/42/EC amending Directive 2004/42/EC
and Regulations (EC) No
and Regulations (EC) No
and Regulations (EC) No
and Regulations (EC) No
765/2008 and (EU) No
765/2008 and (EU) No
765/2008 and (EU) No
765/2008 and (EU) No
305/2011 (OJ L 169, 25.6.2019, 305/2011 (OJ L 169, 25.6.2019, 305/2011 (OJ L 169, 25.6.2019, 305/2011 (OJ L 169, 25.6.2019,
p. 1).
p. 1).
p. 1).
p. 1).
Text Origin:
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Recital 4
(4) The aim of this instrument
(4) The aim of this instrument
(4) The aim of this instrument
(4) The aim of this instrument
is to contribute to the attainment is to contribute to the attainment is to contribute to the attainment is to contribute to the attainment
of the objectives referred to in
of the objectives referred to in
of the objectives referred to in
of the objectives referred to in
Article 169 of the Treaty. In
Article 169 of the Treaty. In
Article 169 of the Treaty. In
Article 169 of the Treaty. In
particular, it should aim at
particular, it should aim at
particular, it should aim at
particular, it should aim at
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ensuring health and safety of
ensuring health and safety of
ensuring health and safety of
ensuring health and safety of
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consumers and the functioning
consumers and the functioning
consumers and the functioning
consumers and the functioning
of the internal market as regards of the internal market as regards of the internal market as regards of the internal market as regards
products intended for
products intended for
products intended for
products intended for
consumers.
consumers.
consumers.
consumers.
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Text Origin:
Commission Proposal
Recital 5
(5) This Regulation should aim (5) This Regulation should aim (5) This Regulation should aim (5) This Regulation should aim
at protecting consumers and
at protecting consumers and
at protecting consumers and
at protecting consumers and
their safety as one of the
their safety as one of the
their safety as one of the
their safety as one of the
fundamental principle of the EU fundamental principle of the EU fundamental principle of the EU fundamental principle of the EU
legal framework, enshrined in
legal framework, enshrined in
legal framework, enshrined in
legal framework, enshrined in
the EU Charter of fundamental
the EU Charter of fundamental
the EU Charter of fundamental
the EU Charter of fundamental
rights. Dangerous products can
rights. Dangerous products can
rights. Dangerous products can
rights. Dangerous products can
have very negative
have very negative
have very negative
have very negative
consequences on consumers and consequences on consumers and consequences on consumers and consequences on consumers and
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citizens. All consumers,
citizens. All consumers,
citizens. All consumers,
citizens. All consumers,
G
including the most vulnerable,
including the most vulnerable,
including the most vulnerable,
including the most vulnerable,
such as children, older persons
such as children, older persons
such as children, older persons
such as children, older persons
or persons with disabilities,
or persons with disabilities,
or persons with disabilities,
or persons with disabilities,
have the right to safe products.
have the right to safe products.
have the right to safe products.
have the right to safe products.
Consumers should have at their
Consumers should have at their
Consumers should have at their
Consumers should have at their
disposal sufficient means to
disposal sufficient means to
disposal sufficient means to
disposal sufficient means to
enforce such rights, and
enforce such rights, and
enforce such rights, and
enforce such rights, and
Member States adequate
Member States adequate
Member States adequate
Member States adequate
instruments and measures at
instruments and measures at
instruments and measures at
instruments and measures at
their disposal to enforce this
their disposal to enforce this
their disposal to enforce this
their disposal to enforce this
Regulation.
Regulation.
Regulation.
Regulation.
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Text Origin:
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Recital 6
(6) Despite the development of (6) Despite the development of (6) Despite the development of (6) Despite the development of
sector-specific Union
sector-specific Union
sector-specific Union
sector-specific Union
harmonisation legislation that
harmonisation legislation that
harmonisation legislation that
harmonisation legislation that
addresses safety aspects of
addresses safety aspects of
addresses safety aspects of
addresses safety aspects of
specific products or categories
specific products or categories
specific products or categories
specific products or categories
of products, it is practically
of products, it is practically
of products, it is practically
of products, it is practically
impossible to adopt Union
impossible to adopt Union
impossible to adopt Union
impossible to adopt Union
legislation for all consumer
legislation for all consumer
legislation for all consumer
legislation for all consumer
products that exist or may be
products that exist or may be
products that exist or may be
products that exist or may be
G 15
developed. There is therefore
developed. There is therefore
developed. There is therefore
developed. There is therefore ▌ G
still a need for a legislative
still a need for a
broad-based
still a need for a legislative
a need for a
broad-based
framework of a horizontal
legislative framework of a
framework of a horizontal
legislative framework of a
nature to fill gaps and ensure
horizontal nature to fill gaps and nature to fill gaps and ensure
horizontal nature to fill gaps and
consumer protection not
therefore to complement
consumer protection not
therefore to complement
otherwise ensured, in particular
provisions in existing or
otherwise ensured, in particular
provisions in existing or
with a view to achieving a high
forthcoming sector-specific
with a view to achieving a high
forthcoming sector-specific
level of protection of safety and
Union harmonisation
level of protection of safety and
Union harmonisation
health of consumers, as required
legislation and ensure consumer health of consumers, as required
legislation and ensure consumer
by Article 114 and Article 169
protection not otherwise ensured
by Article 114 and Article 169
protection not otherwise ensured
of the Treaty.
by that legislation, in particular of the Treaty.
by that legislation, in particular
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with a view to achieving a high
with a view to achieving a high
level of protection of safety and
level of protection of safety and
health of consumers, as required
health of consumers, as required
by Article 114 and Article 169
by Article 114 and Article 169
of the Treaty.
of the Treaty.
Recital 7
(7) At the same time, in respect (7) At the same time, in respect (7) At the same time, in respect (7) At the same time, in respect
of products subject to sector-
of products subject to sector-
of products subject to sector-
of products subject to sector-
specific Union harmonisation
specific Union harmonisation
specific Union harmonisation
specific Union harmonisation
legislation, the scope of
legislation, the scope of
legislation, the scope of
legislation, the scope of
application of the different parts application of the different parts application of the different parts application of the different parts
of this Regulation should be
of this Regulation should be
of this Regulation should be
of this Regulation should be
G 16
clearly set out to avoid
clearly set out to avoid
clearly set out to avoid
clearly set out to avoid
G
overlapping provisions and an
overlapping provisions and an
overlapping provisions and an
overlapping provisions and an
unclear legal framework.
unclear legal framework.
unclear legal framework.
unclear legal framework.
Text Origin:
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Recital 8
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(8) Whilst some of the
(8)
25Whilst some of the
(8) Whilst some of the
(8) Whilst some of the
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provisions such as those
provisions such as those
provisions such as those
provisions such as those
concerning most of the
concerning most of the
concerning most of the
concerning most of the
obligations of economic
obligations of economic
obligations of economic
obligations of economic
operators should not apply to
operators should not apply to
operators should not apply to
operators should not apply to
products covered by Union
products covered by Union
products covered by Union
products covered by Union
harmonisation legislation since
harmonisation legislation since
harmonisation legislation since
harmonisation legislation since
already covered in such
already covered in such
already covered in such
already covered in such
legislation, a certain number of
legislation, a certain number of
legislation, a certain number of
legislation, a certain number of
other provisions should apply in other provisions should apply in other provisions should apply in other provisions should apply in
order to complement Union
order to complement Union
order to complement Union
order to complement Union
harmonisation legislation. In
harmonisation legislation. In
harmonisation legislation. In
harmonisation legislation. In
particular the general product
particular the general product
particular the general product
particular the general product
safety requirement and related
safety requirement and related
safety requirement and related
safety requirement and related
provisions should be applicable
provisions should be applicable
provisions should be applicable
provisions should be applicable
to consumer products covered
to consumer products covered
to consumer
products covered
to consumer products covered
by Union harmonisation
by Union harmonisation
by Union harmonisation
by Union harmonisation
legislation when certain types of legislation when certain types of legislation when certain types of legislation when certain types of
risks are not covered by that
risks are not covered by that
risks are not covered by that
risks are not covered by that
legislation. The provisions of
legislation. The provisions of
legislation. The provisions of
legislation. The provisions of
this Regulation concerning the
this Regulation concerning the
this Regulation concerning the
this Regulation concerning the
obligations of online
obligations of online
obligations of online
obligations of
providers of
marketplaces, the obligations of marketplaces, the obligations of marketplaces, the obligations of online marketplaces, the
economic operators in case of
economic operators in case of
economic operators in case of
obligations of economic
accidents, the right of
accidents, the right of
accidents, the right of
operators in case of accidents,
information for consumers as
information
and remedy for
information for consumers as
the right of information
and
well as the recalls of consumer
consumers as well as the recalls well as the recalls of consumer
remedy for consumers as well as
products should apply to
of consumer products should
products should apply to
the recalls of consumer products
products covered by Union
apply to products covered by
products covered by Union
should apply to products
harmonisation legislation when
Union harmonisation legislation harmonisation legislation when
covered by Union
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Council Mandate
there are not specific provisions
whento the extent that there are there are not specific provisions harmonisation legislation
to the
with the same objective in such
not specific provisions with the
with the same objective in such
extent that there are not specific
legislation. Likewise RAPEX is same objective in such
legislation. Likewise RAPEX is provisions with the same
already used for the purposes of legislation. Likewise RAPEX is already used for the purposes of objective in such legislation.
Union harmonisation
already used for the purposes of Union harmonisation
Likewise RAPEX is already
legislation, as referred to in
Union harmonisation
legislation, as referred to in
used for the purposes of Union
Article 20 of Regulation (EU)
legislation, as referred to in
Article 20 of Regulation (EU)
harmonisation legislation, as
2019/1020 of the European
Article 20 of Regulation (EU)
2019/1020 of the European
referred to in Article 20 of
Parliament and of the Council1,
2019/1020 of the European
Parliament and of the Council1,
Regulation (EU) 2019/1020 of
therefore the provisions
Parliament and of the Council
125 therefore the provisions
the European Parliament and of
regulating the Safety Gate and
, therefore the provisions
regulating the Safety Gate and
the Council1, therefore the
its functioning contained in this regulating the Safety Gate and
its functioning contained in this provisions regulating the Safety
Regulation should be applicable its functioning contained in this Regulation should be applicable Gate and its functioning
to Union harmonisation
Regulation should be applicable to Union harmonisation
contained in this Regulation
legislation.
to Union harmonisation
legislation.
should be applicable to Union
_________
legislation.
_________
harmonisation legislation.
1. Regulation (EU) 2019/1020
_________
1. Regulation (EU) 2019/1020
_________
of the European Parliament and
25.
Regulation (EU) 2019/1020 of the European Parliament and 1. Regulation (EU) 2019/1020
of the Council of 20 June 2019
of the European Parliament
of the Council of 20 June 2019
of the European Parliament and
on market surveillance and
and of the Council of 20 June
on market surveillance and
of the Council of 20 June 2019
compliance of products and
2019 on market surveillance
compliance of products and
on market surveillance and
amending Directive 2004/42/EC
and compliance of products
amending Directive 2004/42/EC compliance of products and
and Regulations (EC) No
and amending Directive
and Regulations (EC) No
amending Directive 2004/42/EC
765/2008 and (EU) No
2004/42/EC and Regulations
765/2008 and (EU) No
and Regulations (EC) No
305/2011 (OJ L 169, 25.6.2019,
(EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, 765/2008 and (EU) No
p. 1).
305/2011 (OJ L 169, 25.6.2019, p. 1).
305/2011 (OJ L 169, 25.6.2019,
p. 1).
p. 1).
1.
Regulation (EU) 2019/1020
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of the European Parliament and
Text Origin:
of the Council of 20 June 2019
Commission Proposal
on market surveillance and
compliance of products and
amending Directive 2004/42/EC
and Regulations (EC) No
765/2008 and (EU) No
305/2011 (OJ L 169, 25.6.2019,
p. 1).
Recital 8a
(8a) Pursuant to Regulation
(8a) Pursuant to Regulation
(EU) 2013/952, products from (EU) 2013/952, products from
third countries intended to be third countries intended to be
made available on the Union
made available on the Union
market or intended for
market or intended for private
private use or consumption
use or consumption within the
G 17a
within the customs territory of customs territory of the Union
G
the Union are placed under
are placed under the customs
the customs procedure
procedure ‘release for free
‘release for free circulation’.
circulation’. This procedure
This procedure aims at
aims at completing the
completing the formalities laid formalities laid down in respect
down in respect of the import
of the import of the goods,
of the goods, including the
including the enforcement of
enforcement of the applicable
the applicable provisions of
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provisions of Union law, so
Union law, so that these goods
that these goods can be made
can be made available on the
available on the Union market Union market like any product
like any product made in the
made in the Union. As far as
Union. As far as consumer
consumer safety is concerned,
safety is concerned, these
these products are required to
products are required to
comply with this Regulation
comply with this Regulation
and, in particular, with the
and, in particular, with the
general safety requirement laid
general safety requirement
down in it.
laid down in it.
Text Origin: Council
Mandate
Recital 9
(9) The provisions of Chapter
(9) The provisions of Chapter
(9) The provisions of Chapter
(9) The provisions of Chapter
VII of Regulation (EU)
VII of Regulation (EU)
VII of Regulation (EU)
VII of Regulation (EU)
2019/1020, setting up the rules
2019/1020, setting up the rules
2019/1020, setting up the rules
2019/1020, setting up the rules
of controls on products entering of controls on products entering of controls on products entering of controls on products entering
G 18
the Union market, are already
the Union market, are already
the Union market, are already
the Union market, are already
G
directly applicable to products
directly applicable to products
directly applicable to products
directly applicable to products
covered by this Regulation and
covered by this Regulation
and
covered by this Regulation and
covered by this Regulation
. The
it is not the intention of this
it is not the intention of this
it is not the intention of this
authorities in charge of these
Regulation to modify such
Regulation to modify such
Regulation to modify such
controls
should perform them
provisions. The stability of the
provisions. The stability of the
provisions. The stability of the
on the basis of risk analysis as
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former is particularly important
former is particularly important former is particularly important
referred to in Articles 46 and 47
taking into account the fact that
taking into account the fact that taking into account the fact that
of Regulation (EU) No
the authorities in charge of these
the . The authorities in charge of the authorities in charge of these 952/2013 (the Union Customs
controls (which in almost all
these controls
(which in almost
controls (which in almost all
Code), the implementing
Member States are the customs
all Member States are the
Member States are the customs
legislation and corresponding
authorities) shall perform them
customs authorities)
authorities) shall perform them
guidance. This
Regulation
on the basis of risk analysis as
shallshould perform them on
on the basis of risk analysis as
therefore does not modify in
referred to in Articles 46 and 47 the basis of risk analysis as
referred to in Articles 46 and 47 any way Chapter VII of
of Regulation (EU) No
referred to in Articles 46 and 47 of Regulation (EU) No
Regulation 2019/1020
and the
952/2013 (the Union Customs
of Regulation (EU) No
952/2013 (the Union Customs
way the authorities in charge of
Code), the implementing
952/2013 (the Union Customs
Code), the implementing
controls on products entering
legislation and corresponding
Code), the implementing
legislation and corresponding
the Union market
organise
guidance. This risk-based
legislation and corresponding
guidance. This risk-based
themselves and perform their
approach is pivotal to customs
guidance. This
risk-based
approach is pivotal to customs
activities ▌ .
controls given the substantial
approach is pivotal to customs
controls given the substantial
volumes of goods coming into
controls given the substantial
volumes of goods coming into
and leaving the customs
volumes of goods coming into
and leaving the customs
territory and results in
and leaving the customs
territory and results in
application of concrete control
territory and results in
application of concrete control
measures depending on
application of concrete control
measures depending on
identified priorities. The fact
measures depending on
identified priorities. The fact
that the Regulation does not
identified priorities. The fact
that the Regulation does not
modify in any way Chapter VII
that the RegulationRegulation
modify in any way Chapter VII
of Regulation 2019/1020,
therefore does not modify in
of Regulation 2019/1020,
directly referring to the risk
any way Chapter VII of
directly referring to the risk
based approach laid down in the Regulation 2019/1020
, directly
based approach laid down in the
customs legislation, means in
referring to the risk based
customs legislation, means in
practice that the authorities in
approach laid down in the
practice that the authorities in
charge of controls on products
customs legislation, means in
charge of controls on products
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entering the Union market
practice that and the way the
entering the Union market
(including customs authorities)
authorities in charge of controls (including customs authorities)
should limit their controls to the on products entering the Union
should limit their controls to the
most risky products, depending
market
(including customs
most risky products, depending
on the likelihood and impact of
authorities) should limit their
on the likelihood and impact of
the risk, thereby ensuring
controls to the most risky
the risk, thereby ensuring
effectiveness and efficiency of
products, depending on the
effectiveness and efficiency of
their activities as well as
likelihood and impact of the
their activities as well as
protection of their capacity to
risk, thereby ensuring
protection of their capacity to
perform such controls.
effectiveness and efficiency
perform such controls.
oforganise themselves and
perform their activities
as well
as protection of their capacity to
perform such controls.
Recital 9a
(9a) The legal framework for
(9a) The legal framework for
market surveillance of products
market surveillance of products
covered by Union
covered by Union
harmonisation legislation and
harmonisation legislation and
G 18a
set out in Regulation (EU)
set out in Regulation (EU)
G
2019/1020 and the legal
2019/1020 and the legal
framework for market
framework for market
surveillance of products
surveillance of products
covered by this Regulation
covered by this Regulation
should be as coherent as
should be as coherent as
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possible. It is therefore
possible. It is therefore
necessary, as far as market
necessary, as far as market
surveillance activities,
surveillance activities,
obligations, powers, measures,
obligations, powers, measures,
and cooperation among market
and cooperation among market
surveillance authorities are
surveillance authorities are
concerned, to align the two sets
concerned, to align the two sets
of provisions. For that purpose
of provisions. For that purpose
Articles 10 to 16, Articles 18
[Articles 10 to 16, Articles 18
and 19 and Articles 21 to 24 of
and 19 and Articles 21 to 24] of
Regulation (EU) 2019/1020
Regulation (EU) 2019/1020
should be applicable also to
should be applicable also to
products covered by this
products covered by this
Regulation.
Regulation.
DLA, please align list in square
brackets with the article.
Recital 9b
(9b) Member States should
G 18b
also ensure that the authorities G
have sufficient expertise and
resources for all their
enforcement activities.
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moved from Recital 64a, row
73b.
Recital 10
(10) The precautionary
(10)
The precautionary
(10)
Technological changes
principle is a fundamental
principle is a fundamental
accompany new type of
deleted
principle for ensuring the safety
principle for ensuring the safety products as well as new or
of products and consumers and
of products and consumers and
emerging risks linked to a
should therefore be taken into
should therefore be taken into
high degree of scientific
no text here.
due account by all relevant
due account by all relevant
uncertainty. Especially, but
actors when applying this
actors when applying this
not only in these situations,
Regulation.
Regulation.
the precautionary principle is a
Text Origin:
Commission Proposal
fundamental principle for
G 19
ensuring the safety of products
G
and consumers and should
therefore be taken into due
account by all relevant actors
when applying this Regulation.
Where an activity or
substance poses a plausible
threat of harm but there is
insufficient scientific evidence,
or a lack of agreement as to
the nature or scale of the
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likely adverse effects, the
precautionary principle
should lead the different
actors in taking decisions. The
precautionary principle thus
expresses a need for caution
with regard to products or
action which are not based on
a high degree of scientific
certainty.
Recital 11
(11) Considering also the broad (11)
Considering also the
(11) Considering also the broad
scope given to the concept of
broad scope given to the
scope given to the concept of
deleted
health1, the environmental risk
concept of health1, the
health1, the environmental risk
posed by a product should be
environmental risk posed by a
posed by a product should be
taken into consideration in the
product should be taken into
taken into consideration in the
no text, moved to recital 23.
application of this Regulation
consideration in the application application of this Regulation
G 20
inasmuch as it can also
of this Regulation inasmuch as
inasmuch as it can also
G
ultimately result in a risk to the
it can also ultimately result in a ultimately result in a risk to the
Text Origin:
health and safety of consumers.
risk to the health and safety of
health and safety of consumers.
Commission Proposal
_________
consumers.
_________
1. European Environment
_________
1. European Environment
Agency, ‘Healthy environment,
1.
European Environment
Agency, ‘Healthy environment,
healthy lives: how the
Agency, ‘Healthy environment,
healthy lives: how the
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environment influences health
healthy lives: how the
environment influences health
and well-being in Europe’, EEA
environment influences health
and well-being in Europe’, EEA
report No 21/2019, 8 September
and well-being in Europe’, EEA report No 21/2019, 8 September
2020.
report No 21/2019, 8 September 2020.
2020.
Recital 12
(12) Products which are
(12) Products which are
(12) Products which are
(12) Products which are
designed exclusively for
designed exclusively for
designed exclusively for
designed exclusively for
professional use but which have professional use but which have professional use but which have professional use but which have
subsequently migrated to the
subsequently migrated to the
subsequently migrated to the
subsequently migrated to the
consumer market should be
consumer market should be
consumer market should be
consumer market should be
G 21
subject to this Regulation
subject to this Regulation
subject to this Regulation
subject to this Regulation
G
because they could pose risks to because they could pose risks to because they could pose risks to because they could pose risks to
the health and safety of
the health and safety of
the health and safety of
the health and safety of
consumers when used under
consumers when used under
consumers when used under
consumers when used under
reasonably foreseeable
reasonably foreseeable
reasonably foreseeable
reasonably foreseeable
conditions.
conditions.
conditions.
conditions.
Recital 12a
G 21a
(12a) Medicinal products are
(12a) Medicinal products are
G
subject to a pre-market
subject to a pre-market
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assessment that includes a
assessment that includes a
specific risk-benefit analysis.
specific risk-benefit analysis.
They should therefore be
They should therefore be
excluded from the scope of
excluded from the scope of this
this Regulation.
Regulation.
Text Origin: Council
Mandate
Recital 13
(13) Union legislation on food, (13) Union legislation on food, (13) Union legislation on food, (13) Union legislation on food,
feed and related areas sets up a
feed and related areas sets up a
feed and related areas sets up a
feed and related areas sets up a
specific system ensuring the
specific system ensuring the
specific system ensuring the
specific system ensuring the
safety of the products covered
safety of the products covered
safety of the products covered
safety of the products covered
by it. Therefore, food and feed
by it. Therefore, food and feed
by it.
Food products have
by it.
Food and feed products
should be excluded from the
should be excluded from the
indeed a specific legal
have indeed a specific legal
G 22
scope of this Regulation with
scope of this Regulation with
framework established, in
framework established, in
G
the exception of materials and
the exception of materials and
particular, by Regulation
particular, by Regulation (EC)
articles intended to come into
articles intended to come into
(EC) 178/2002. Furthermore,
178/2002. Furthermore, food
contact with food insofar as
contact with food insofar as
feed products are regulated by and feed products are regulated
risks are concerned that are not
risks are concerned that are not
Regulation (EC) 882/2004
by Regulation (EU) 2017/625
covered by Regulation (EC) No covered by Regulation (EC) No
ensuring a harmonised
ensuring a harmonised
1935/2004 of the European
1935/2004 of the European
approach with regard to
approach with regard to
Parliament and of the Council1
Parliament and of the Council1
official controls for verifying
official controls for verifying
or by other food specific
or by other food specific
compliance with feed and food compliance with feed and food
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legislation which only covers
legislation which only covers
law, animal health and animal law, animal health and animal
chemical and biological food-
chemical and biological food-
welfare rules. Therefore, food
welfare rules. Therefore, food
related risks.
related risks.
and feed should be excluded
and feed should be excluded
_________
_________
from the scope of this
from the scope of this
Regulation with the exception
Regulation with the exception
1. Regulation (EC) No
1. Regulation (EC) No
of materials and articles
of materials and articles
1935/2004 of the European
1935/2004 of the European
intended to come into contact
intended to come into contact
Parliament and of the Council of Parliament and of the Council of with food insofar as risks are
with food insofar as risks are
27 October 2004 on materials
27 October 2004 on materials
concerned that are not covered
concerned that are not covered
and articles on materials and
and articles on materials and
by Regulation (EC) No
by Regulation (EC) No
articles intended to come into
articles intended to come into
1935/2004 of the European
1935/2004 of the European
contact with food and repealing contact with food and repealing
Parliament and of the Council1
Parliament and of the Council1
Directives 80/590/EEC and
Directives 80/590/EEC and
or by other food specific
or by other food specific
89/109/EEC (OJ L 338,
89/109/EEC (OJ L 338,
legislation which only covers
legislation which only covers
13.11.2004, p. 4).
13.11.2004, p. 4).
chemical and biological food-
chemical and biological food-
related risks.
related risks.
_________
_________
1. Regulation (EC) No
1. Regulation (EC) No
1935/2004 of the European
1935/2004 of the European
Parliament and of the Council of Parliament and of the Council of
27 October 2004 on materials
27 October 2004 on materials
and articles on materials and
and articles on materials and
articles intended to come into
articles intended to come into
contact with food and repealing contact with food and repealing
Directives 80/590/EEC and
Directives 80/590/EEC and
89/109/EEC (OJ L 338,
89/109/EEC (OJ L 338,
13.11.2004, p. 4).
13.11.2004, p. 4).
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Recital 14
(14) Medicinal products are
(14) Medicinal products are
(14) Medicinal products are
subject to a pre-market
subject to a pre-market
subject to a pre-market
deleted
assessment that includes a
assessment that includes a
assessment that includes a
specific risk-benefit analysis.
specific risk-benefit analysis.
specific risk-benefit analysis.
G 23
They should therefore be
They should therefore be
They should therefore be
text in row 21a.
G
excluded from the scope of this
excluded from the scope of this
excluded from the scope of this
Regulation.
Regulation.
Regulation.
Text Origin:
Commission Proposal
Recital 14a
(14a) Living plants have a
(14a) Living plants have a
specific legal framework
specific legal framework
provided for, in particular, by provided for, in particular, by
G 23a
Regulation (EU) 2016/2031
Regulation (EU) 2016/2031
G
taking into consideration the
taking into consideration the
specificities to ensure the
specificities to ensure the safety
safety of these products.
of these products.
Recital 14b
G 23b
G
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(14b) Animal by-products are (14b) Animal by-products are
materials of animal origin that materials of animal origin that
people do not consume. These people do not consume. These
products, such as feed, are
products, such as feed, are very
very specific products which
specific products which have a
have a specific legal
specific legal framework, in
framework, in particular
particular Regulation (EC)
Regulation (EC) 1069/2009.
1069/2009.
Recital 14c
(14c) Plant protection
(14c) Plant protection
products, also referred as
products, also referred as
pesticides, have specific
pesticides, have specific
provisions for their
provisions for their
authorisation at national level, authorisation at national level,
G 23c
based on Regulation (EC) No
based on Regulation (EC) No
G
1107/2009, and should
1107/2009, and should
therefore be excluded as well
therefore be excluded as well
from the scope of application
from the scope of application of
of this Regulation.
this Regulation.
Recital 15
G 24
G
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(15) Aircraft referred to in
(15) Aircraft referred to in
(15) Aircraft referred to in
(15) Aircraft referred to in
Article 2(3) point (d) of
Article 2(3) point (d) of
Article 2(3) point (d) of
Article 2(3) point (d) of
Regulation (EU) 2018/11391 are Regulation (EU) 2018/11391 are Regulation (EU) 2018/11391 are Regulation (EU) 2018/11391 are
subject to the regulatory control subject to the regulatory control subject to the regulatory control subject to the regulatory control
of the Member States, in light of of the Member States, in light of of the Member States, in light of of the Member States, in light of
their limited risk to civil
their limited risk to civil
their limited risk to civil
their limited risk to civil
aviation safety. They should
aviation safety. They should
aviation safety. They should
aviation safety. They should
therefore be excluded from the
therefore be excluded from the
therefore be excluded from the
therefore be excluded from the
scope of this Regulation.
scope of this Regulation.
scope of this Regulation.
scope of this Regulation.
_________
_________
_________
_________
1. Regulation (EU) 2018/1139
1. Regulation (EU) 2018/1139
1. Regulation (EU) 2018/1139
1. Regulation (EU) 2018/1139
of the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and
of the Council of 4 July 2018 on of the Council of 4 July 2018 on of the Council of 4 July 2018 on of the Council of 4 July 2018 on
common rules in the field of
common rules in the field of
common rules in the field of
common rules in the field of
civil aviation and establishing a civil aviation and establishing a
civil aviation and establishing a civil aviation and establishing a
European Union Aviation
European Union Aviation
European Union Aviation
European Union Aviation
Safety Agency, and amending
Safety Agency, and amending
Safety Agency, and amending
Safety Agency, and amending
Regulations (EC) No
Regulations (EC) No
Regulations (EC) No
Regulations (EC) No
2111/2005, (EC) No 1008/2008, 2111/2005, (EC) No 1008/2008, 2111/2005, (EC) No 1008/2008, 2111/2005, (EC) No 1008/2008,
(EU) No 996/2010, (EU) No
(EU) No 996/2010, (EU) No
(EU) No 996/2010, (EU) No
(EU) No 996/2010, (EU) No
376/2014 and Directives
376/2014 and Directives
376/2014 and Directives
376/2014 and Directives
2014/30/EU and 2014/53/EU of 2014/30/EU and 2014/53/EU of 2014/30/EU and 2014/53/EU of 2014/30/EU and 2014/53/EU of
the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of
the Council, and repealing
the Council, and repealing
the Council, and repealing
the Council, and repealing
Regulations (EC) No 552/2004
Regulations (EC) No 552/2004
Regulations (EC) No 552/2004
Regulations (EC) No 552/2004
and (EC) No 216/2008 of the
and (EC) No 216/2008 of the
and (EC) No 216/2008 of the
and (EC) No 216/2008 of the
European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of the
Council and Council Regulation Council and Council Regulation Council and Council Regulation Council and Council Regulation
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(EEC) No 3922/91 (OJ L 212,
(EEC) No 3922/91 (OJ L 212,
(EEC) No 3922/91 (OJ L 212,
(EEC) No 3922/91 (OJ L 212,
22.8.2018, p. 1–122).
22.8.2018, p. 1–122).
22.8.2018, p. 1–122).
22.8.2018, p. 1–122).
Text Origin: EP
Mandate
Recital 16
(16) The requirements laid
(16) The requirements laid
(16) The requirements laid
(16) The requirements laid
down in this Regulation should
down in this Regulation should
down in this Regulation should
down in this Regulation should
apply to second hand products
apply to second hand products
apply to second hand products
apply to second hand products
or products that are repaired,
or products that are repaired,
or products that are repaired,
or products that are repaired,
refurbished or recycled that re-
refurbished or recycled that re-
refurbished
reconditioned or
reconditioned or recycled that
enter the supply chain in the
enter the supply chain in the
recycled that re-enter the supply re-enter the supply chain in the
course of a commercial activity, course of a commercial activity, chain in the course of a
course of a commercial activity,
except for those products for
except for those products for
commercial activity, except for
except for those products for
G 25
which the consumer cannot
which the consumer cannot
those products for which the
which the consumer cannot
G
reasonably expect that they
reasonably expect that they
consumer cannot reasonably
reasonably expect that they
fulfil state-of-the art safety
fulfil state-of-the art safety
expect that they fulfil state-of-
fulfil state-of-the art safety
standards, such as antiques or
standards, such as antiques or
the art safety standards, such as
standards, such as ▌ products
products which are presented as products which are
explicitly
antiques or products which are
which are
explicitly presented as
to be repaired or to be
presented as to be repaired or to presented as to be repaired or to to be repaired or to be
refurbished.
be refurbished
, or which are
be refurbished
reconditioned.
reconditioned, or which are
made available as collectible
made available as collectible
items of historical significance.
items of historical significance.
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Recital 17
(17) Directive 87/357/EEC on
(17) Directive 87/357/EEC on
(17) Directive 87/357/EEC on
(17) Directive 87/357/EEC on
consumer products which,
consumer products which,
consumer
products which,
▌
consumer products which,
although not foodstuff, resemble although not foodstuff, resemble although not foodstuff, resemble although not foodstuff, resemble
foodstuff and are likely to be
foodstuff and are likely to be
foodstuff and are likely to be
foodstuff and are likely to be
confused with foodstuff in a
confused with foodstuff in a
confused with foodstuff in a
confused with foodstuff in a
way that consumers, especially
way that consumers, especially
way that consumers, especially
way that consumers, especially
children, may place them in
children, may place them in
children, may place them in
children, may place them in
their mouths, suck or ingest
their mouths, suck or ingest
their mouths, suck or ingest
their mouths, suck or ingest
them and which might cause,
them and which might cause,
them and which might cause,
them and which might cause,
for example, suffocation,
for example, suffocation,
for example, suffocation,
for example, suffocation,
poisoning, the perforation or
poisoning, the perforation or
poisoning, the perforation or
poisoning, the perforation or
obstruction of the digestive
obstruction of the digestive
obstruction of the digestive
obstruction of the digestive
G 26
tract, has given rise to
tract, has given rise to
tract, has given rise to
tract, has given rise to
G
controversial interpretation.
controversial interpretation.
controversial interpretation.
controversial interpretation.
Furthermore it has been adopted Furthermore it has been adopted Furthermore it has been adopted Furthermore it has been adopted
at a time where the legal
at a time where the legal
at a time where the legal
at a time where the legal
framework for consumer
framework for consumer
framework for consumer
framework for consumer
product safety was very limited
product safety was very limited
product safety was very limited
product safety was very limited
in scope. For these reasons,
in scope. For these reasons,
in scope. For these reasons,
in scope. For these reasons,
Directive 87/357/EEC should be Directive 87/357/EEC should be Directive 87/357/EEC should be Directive 87/357/EEC should be
repealed.
repealed.
repealed
and replaced by
repealed
and replaced by
provisions of this Regulation,
provisions of this Regulation,
in particular those ensuring
in particular those ensuring
that, following risk
that, following risk assessment,
assessment, product which
product which can be harmful
can be harmful when placed
when placed in mouth, sucked
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in mouth, sucked or ingested
or ingested and which are
and which are likely to be
likely to be confused with
confused with foodstuff due to foodstuff due to their form,
their form, odour, colour,
odour, colour, appearance,
appearance, packaging,
packaging, labelling, volume,
labelling, volume, size or other size or other characteristics,
characteristics, should be
should be considered
considered dangerous. In
dangerous. In performing their
performing their evaluation,
evaluation, market surveillance
competent national authorities authorities should take into
should take into
consideration, among other
consideration, among other
elements, that as held by the
elements, that as held by the
Court of Justice of the
Court of Justice of the
European Union, it is not
European Union, it is not
necessary to demonstrate by
necessary to demonstrate by
objective and substantiated
objective and substantiated
data that placing in the mouth,
data that placing in the
sucking or ingesting food-
mouth, sucking or ingesting
imitating products may entail
food-imitating products may
risks such as suffocation,
entail risks such as
poisoning, or the perforation or
suffocation, poisoning, or the
obstruction of the digestive
perforation or obstruction of
tract. Nevertheless, the
the digestive tract.
competent national authorities
Nevertheless, the competent
must assess on a case-by-case
national authorities must
basis whether such products
assess on a case-by-case basis
are dangerous and justify their
whether such products are
assessment.
dangerous and justify their
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assessment.
Recital 18
(18) Services should not be
(18) Services should not be
(18) Services should not be
(18) Services should not be
covered by this Regulation.
covered by this Regulation.
covered by this Regulation.
covered by this Regulation.
However, in order to secure the
However, in order to secure the
However, in order to secure the
However, in order to secure the
attainment of the protection of
attainment of the protection of
attainment of the protection of
attainment of the protection of
health and safety of consumers,
health and safety of consumers,
health and safety of consumers,
health and safety of consumers,
products that are supplied or
products that are supplied or
products that are supplied or
products that are supplied or
made available to consumers in
made available to consumers in
made available to consumers in
made available to consumers in
the context of the provision of
the context of the provision of
the context of the provision of
the context of the provision of
services, including products to
services, including products to
services, including products to
services, including products to
which consumers are directly
which consumers are directly
which consumers are directly
which consumers are directly
G 27
exposed during a service
exposed during a service
exposed during a service
exposed during a service
G
provision, should fall within the provision, should fall within the provision, should fall within the provision, should fall within the
scope of this Regulation.
scope of this Regulation.
scope of this Regulation.
scope of this Regulation.
Equipment on which consumers
However, equipment on which
Equipment on which consumers
However, equipment on which
ride or travel which is operated
consumers ride or travel
, when
ride or travel
but which is
consumers ride or travel
, when
by a service provider should be
it is directly which is operated
operated
driven by a service
it is directly operated by a
excluded from the scope of this
by a service provider
within the provider should be excluded
service provider
within the
Regulation since it has to be
context of a transport service,
from the scope of this
context of a transport service,
dealt with in conjunction with
should be excluded from the
Regulation since it has to be
should be excluded from the
the safety of the service
scope of this Regulation since it dealt with in conjunction with
scope of this Regulation since it
provided.
has to be dealt with in
the safety of the service
has to be dealt with in
conjunction with the safety of
provided.
conjunction with the safety of
the service provided.
the service provided.
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Text Origin: EP
Mandate
Recital 18a
(18a) Works of art, collectors’ (18a) Works of art, collectors’
items and antiques are specific items and antiques are specific
categories of products which
categories of products which
cannot be expected to meet the cannot be expected to meet the
safety requirements laid down safety requirements laid down
by the present Regulation, and by the present Regulation, and
they should therefore be
they should therefore be
excluded from its scope.
excluded from its scope.
However, in order to prevent
However, in order to prevent
G 27a
other products from being
other products from being
G
mistakenly considered as
mistakenly considered as
belonging to these categories,
belonging to these categories, it
it should be necessary to take
should be necessary to take into
into account that works of art account that works of art
should only be products
should only be products created
created solely for artistic
solely for artistic purposes, that
purposes, that collector’s
collector’s items should be of
items should be of sufficient
sufficient rarity and historical
rarity and historical or
or scientific interest to justify
scientific interest to justify
their collection and
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their collection and
preservation, and that antiques,
preservation, and that
if they do not already fall in the
antiques, if they do not
first two above-mentioned
already fall in the first two
categories, should be of an out
above-mentioned categories,
of the ordinary age. When
should be of an out of the
assessing a product as a work
ordinary age.
of art, collector's item or
antique, Annex IX of Directive
2006/112/EC on the common
system of value added tax could
be taken into account.
Recital 18b
(18b) Given the potential risk of digital items the
no text here.
Commission should be
encouraged to provide
G 27b
economic operators and
G
market surveillance
authorities with guidance on
this issue.
Recital 18c
G 27c
G
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(18c) According to the
(18c) According to the general
general safety requirement
safety requirement laid down in
laid down in this Regulation,
this Regulation, economic
economic operators are
operators are obliged to place
obliged to place only safe
only safe products on the
products on the market. Such
market. Such a high level of
a high level of safety should be safety should be primarily
primarily achieved by design
achieved by design and the
and the features of the
features of the product, taking
product, taking into account
into account the intended and
the intended and foreseeable
foreseeable use and conditions
use and conditions of use of
of use of the product. The
the product. The remaining
remaining risks, if any, should
risks, if any, should be
be alleviated with certain
alleviated with certain
safeguards, such as warnings
safeguards, such as warnings
and instructions.
and instructions. In
determining whether a
product is safe, the different
actors should also take into
consideration the possibility
that the product is misused,
that is to say used in a way
that was not necessarily
intended, in case such a
misuse is reasonably
foreseeable. In any case, the
reasonably foreseeable misuse
of the product should not
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include reckless, malevolent
or criminal behaviour by the
consumer.
Recital 19
(19) Items which connect to
(19) Items which connect to
(19) Items which connect to
(19) Items which connect to
other items or non-embedded
other items or non-embedded
other items or non-embedded
other items or non-embedded
items which influence the way
items which influence the way
items which influence the way
items which influence the way
another item works can present
another item works can present
another item works can present
another item works can present
a risk for the safety of the
a risk for the safety of the
a risk for the safety of the
a risk for the safety of the
product. That aspect should be
product. That aspect should be
product. That aspect should be
product. That aspect should be
taken into due consideration as a taken into due consideration as a taken into due consideration as a taken into due consideration as a
potential risk. The connections
potential risk. The connections
potential risk. The
potential risk. The connections
G 28
and interrelation that an item
and interrelation that an item
interconnections and
and interrelation that an item
G
might have with external items
might have with external items
interrelation , and therefore
might have with external items
should not jeopardise its safety.
should not jeopardise its safety.
the possibility to digitally or
should not jeopardise its safety.
physically interact with
another item, connections and
interrelation that an item might
Text Origin:
have with external items should Commission Proposal
not jeopardise its safety.
Recital 20
G 29
G
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(20) New technologies also
(20) New technologies
might
(20) New technologies also
(20) New technologies
might
cause new risks to consumers’
also cause new risks to
cause new risks to consumers’
also pose new risks to
health and safety or change the
consumers’ health and safety or health and safety or change the
consumers’ health and safety or
way the existing risks could
change the way the existing
way the existing risks could
change the way the existing
materialise, such as an external
risks could materialise, such as
materialise, such as an external
risks could materialise, such as
intervention hacking the product an external intervention hacking intervention hacking the product an external intervention hacking
or changing its characteristics.
the product or changing its
or changing its characteristics.
the product or changing its
characteristics.
New
characteristics.
New
technologies, such as through
technologies, such as through
software updates, may
software updates, may
substantially modify the
substantially modify the
original product, which could
original product, which could
then be submitted to a new risk
then be submitted to a new risk
assessment if that substantial
assessment if that substantial
modification has an impact on
modification has an impact on
the safety of the product.
the safety of the product.
Recital 21
(21) The World Health
(21) The World Health
(21) The World Health
(21) The World Health
Organisation defines ‘health’ as Organisation defines ‘health’ as Organisation defines ‘health’ as Organisation defines ‘health’ as
a state of complete physical,
a state of complete physical,
a state of complete physical,
a state of complete physical,
G 30
mental and social well-being
mental and social well-being
mental and social well-being
mental and social well-being
G
and not merely the absence of
and not merely the absence of
and not merely the absence of
and not merely the absence of
disease or infirmity. This
disease or infirmity.
This
disease or infirmity. This
disease or infirmity. ▌
definition supports the fact that
definition supports the fact that
definition supports the fact that
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the development of new
the development of new
the development of new
Text Origin: EP
technologies might bring new
technologies might bring new
technologies might bring new
Mandate
health risks to consumers, such
health risks to consumers, such
health risks to consumers, such
as psychological risk,
as psychological risk,
as psychological risk,
development risks, in particular
development risks, in particular development risks, in particular
for children, mental risks,
for children, mental risks,
for children, mental risks,
depression, loss of sleep, or
depression, loss of sleep, or
depression, loss of sleep, or
altered brain function.
altered brain function.
altered brain function.
Recital 22
(22) Specific cybersecurity
(22) Specific cybersecurity
(22) Specific cybersecurity
(22) Specific cybersecurity
risks affecting the safety of
risks affecting the safety of
risks affecting the safety of
risks affecting the safety of
consumers as well as protocols
consumers as well as protocols
consumers as well as protocols
consumers as well as protocols
and certifications can be dealt
and certifications can be dealt
and certifications can be dealt
and certifications can be dealt
with by sectorial legislation.
with by sectorial legislation.
with by sectorial legislation.
with by sectorial legislation.
However, it should be ensured,
However, it should be ensured
However, it should be ensured,
However, it should be ensured
in case of gaps in the sectorial
that, in cases where, in case of
in case of gaps in the sectorial
that, in cases where the
G 31
legislation, that the relevant
gaps in the sectorial legislation
, legislation, that the relevant
sectorial legislation
does not
G
economic operators and national
that cannot be applied, the
economic operators and national
apply, the relevant economic
authorities take into
relevant economic operators and authorities take into
operators and national
consideration risks linked to
national authorities take into
consideration risks linked to
authorities take into
new technologies, respectively
consideration risks linked to
new technologies, respectively
consideration risks linked to
when designing the products
new technologies, respectively
when designing the products
new technologies, respectively
and assessing them, in order to
when designing the products
and assessing them, in order to
when designing the products
ensure that changes introduced
and assessing them, in order to
ensure that changes introduced
and assessing them, in order to
in the product do not jeopardise ensure that changes introduced
in the product do not jeopardise ensure that changes introduced
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its safety.
in the product do not jeopardise its safety.
in the product do not jeopardise
its safety.
its safety.
Recital 23
(23) The safety of products
(23) The safety of products
(23) The safety of products
(23) The safety of products
should be assessed taking into
should be assessed taking into
should be assessed taking into
should be assessed taking into
account all the relevant aspects, account all the relevant aspects, account all the relevant aspects, account all the relevant aspects,
notably their characteristics and notably their characteristics
,
notably their characteristics and notably their characteristics
,
presentation as well as the
such as physical, mechanical
presentation as well as the
such as physical, mechanical
specific needs and risks for
and chemical characteristics,
specific needs and risks for
and chemical characteristics,
categories of consumers who
and presentation as well as the
categories of consumers who
and presentation as well as the
are likely to use the products, in specific needs and risks
, which
are likely to use the products, in specific needs and risks
, which
particular children, older
may also include
particular children, older
may also include
persons and persons with
environmental risk inasmuch
persons and persons with
environmental risk inasmuch
G 32
disabilities. Therefore, if
as it poses a risk to the health
disabilities. Therefore, if
as it poses a risk to the health
G
specific information is
and safety of consumers, for
specific information is
and safety of consumers, for
necessary to make products safe categories of consumers who
necessary to make products safe categories of consumers who
toward a given category of
are likely to use the products, in toward a given category of
are likely to use the products, in
persons, the assessment of the
particular children, older
persons, the assessment of the
particular children, older
safety of the products should
persons and persons with
safety of the products should
persons and persons with
take into consideration also the
disabilities.
That assessment
take into consideration also the
disabilities.
That assessment
presence of this information and
should take into account the
presence of this information and
should take into account the
its accessibility. The safety of
health risk posed by digital
its accessibility. The safety of
health risk posed by digital
products should be assessed
connected products, including
products should be assessed
connected products, including
taking into consideration the
on mental health, especially on taking into consideration the
on mental health, especially on
need for the product to be safe
vulnerable consumers such as
need for the product to be safe
vulnerable consumers, in
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over its entire lifespan.
children. Therefore,
when
over its entire lifespan.
particular children. Therefore,
assessing the safety of digital
when assessing the safety of
connected products likely to
digital connected products
have an impact on children,
likely to have an impact on
manufacturers should ensure
children, manufacturers should
that the products they make
ensure that the products they
available on the market meet
make available on the market
the highest standards of safety,
meet the highest standards of
security and privacy by design
safety, security and privacy by
in the best interests of children.
design in the best interests of
Furthermore, if specific
children. Furthermore, if
information is necessary to
specific information is
make products safe toward a
necessary to make products safe
given category of persons, the
toward a given category of
assessment of the safety of the
persons, the assessment of the
products should take into
safety of the products should
consideration also the presence
take into consideration also the
of this information and its
presence of this information and
accessibility. The safety of
all
its accessibility. The safety of
products should be assessed
all products should be assessed
taking into consideration the
taking into consideration the
need for the product to be safe
need for the product to be safe
over its entire lifespan.
over its entire lifespan.
Recital 24
G 33
G
(24) Economic operators
(24) Economic operators
(24) Economic operators
(24) Economic operators
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should have obligations
should have
proportionate
should have obligations
should have
proportionate
concerning the safety of
obligations concerning the
concerning the safety of
obligations concerning the
products, in relation to their
safety of products, in relation to products, in relation to their
safety of products, in relation to
respective roles in the supply
their respective roles in the
respective roles in the supply
their respective roles in the
chain, so as to ensure a high
supply chain, so as to ensure a
chain, so as to ensure a high
supply chain, so as to ensure a
level of protection of the health
high level of protection of the
level of protection of the health
high level of protection of the
and safety of consumers. All
health and safety of consumers
,
and safety of consumers. All
health and safety of consumers
,
economic operators intervening
while also ensuring efficient
economic operators intervening
while also ensuring efficient
in the supply and distribution
functioning of the internal
in the supply and distribution
functioning of the internal
chain should take appropriate
market. All economic operators chain should take appropriate
market. All economic operators
measures to ensure that they
intervening in the supply and
measures to ensure that they
intervening in the supply and
only make available on the
distribution chain should take
only make available on the
distribution chain should take
market products, which are safe appropriate measures to ensure
market products, which are safe appropriate measures to ensure
and in conformity with this
that they only make available on and in conformity with this
that they only make available on
Regulation. It is necessary to
the market products, which are
Regulation. It is necessary to
the market products, which are
provide for a clear and
safe and in conformity with this provide for a clear and
safe and in conformity with this
proportionate distribution of
Regulation. It is necessary to
proportionate distribution of
Regulation. It is necessary to
obligations corresponding to the provide for a clear and
obligations corresponding to the provide for a clear and
role of each operator in the
proportionate distribution of
role of each operator in the
proportionate distribution of
supply and distribution process. obligations corresponding to the supply and distribution process.
obligations corresponding to the
role of each operator in the
For example, when it comes to role of each operator in the
supply and distribution process.
the verification of whether the supply and distribution process.
In order to balance
manufacturer and, where
For example, when it comes to
administrative burdens, digital
relevant, importer complied
the verification of whether the
consumer information tools
with their obligations,
manufacturer and, where
should be allowed to provide
distributors should only be
relevant, importer complied
information in a sustainable
required to perform factual
with their obligations,
and accessible way over time.
verifications and not an
distributors should only be
Within that context, it is
assessment of the information required to perform factual
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important to ensure that the
provided by them.
verifications and not an
contact information of all
assessment of the information
economic operators intervening
provided by them. The
in the supply and distribution
information about the
chain is easily accessible to
identification of the product, of
consumers and market
the economic operators and
surveillance authorities and
instructions and safety
that products are accompanied
information could be
with the relevant
additionally provided by the
documentation. That
economic operators in a digital
information could be
form by means of electronic
additionally provided by the
solutions, such as a QR or data
economic operators in a digital
matrix code.
form by means of electronic
solutions, such as a QR or data
matrix code.
Recital 24a
(24a) The manufacturer has a central role in the supply
no text here
chain and therefore in
G 33a
ensuring the safety of its
G
products. It has data and
information on the products,
and should primarily ensure
that the products have been
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designed and manufactured in
accordance with the general
safety requirement. A certain
number of obligations should
derive from its role, such as
the obligation to provide data
and technical documentation
of the product, as well as the
obligation to inform market
surveillance authorities and
consumers in case it considers
or has reason to believe that a
product it placed on the
market is dangerous.
Importers and distributors
should check that some of
these obligations have been
complied with by the
manufacturer before placing
or making a product available
on the market. In particular,
as concerns the obligation to
inform market surveillance
authorities and consumers in
case of dangerous products,
importers and distributors
should inform the
manufacturer and verify that
the obligation to inform
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market surveillance
authorities and consumers has
been complied with by the
manufacturer. In case this
obligation has not been
complied with, they should
have the obligation to provide
such information according to
their respective role.
Recital 24a
(24a) In order for economic
(24b) In order for economic
operators that are SMEs and
operators that are SMEs and
micro-businesses to be able to
micro-businesses to be able to
cope with the new obligations
cope with the new obligations
imposed by this Regulation, the
imposed by this Regulation, the
Commission should provide
Commission should provide
G 33b
them with practical guidelines
practical guidelines and
G
and tailored guidance, for
tailored guidance, for example,
example, a direct channel to
a direct channel to connect to
connect to experts in case of
experts in case of questions,
questions, taking into account
taking into account the need to
the need to simplify and limit
simplify and limit their
the administrative burdens.
administrative burdens.
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Mandate
Recital 24b
(24b) A product should be
deemed in conformity or
no text.
compliant with the provisions
of this Regulation when
G 33c
economic operators have
G
complied with the safety
requirements and the
obligations set out in relation
to this product.
Recital 24c
(24c) In order to prevent the
(24d) In order to prevent the
placing on the market of
placing on the market of
G 33d
dangerous products, it should dangerous products, it should
G
be compulsory for economic
be compulsory for economic
operators to introduce into
operators to introduce into
their production or marketing their production or marketing
activities internal processes
activities internal processes
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ensuring compliance with this ensuring compliance with the
Regulation. Such processes –
relevant requirements of this
which can be based, for
Regulation. Such processes –
example, upon organisational
which can be based, for
procedures, guidelines,
example, upon organisational
standards or ad hoc manager
procedures, guidelines,
– should be determined by
standards or ad hoc manager –
economic operators
should be determined by
themselves in relation to their economic operators themselves
role in the supply chain and
in relation to their role in the
the type of products
supply chain and the type of
concerned.
products concerned.
Establishment and the format
of the internal processes
remains under the sole
responsibility of relevant
economic operators while their
objective being to allow
economic operators to comply
with relevant requirements
provided for them by this
Regulation.
Recital 24d
G 33e
G
(24d) Cooperation from all
(24d) Cooperation from all
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economic operators with
economic operators and
market surveillance
providers of online
authorities in order to
marketplaces with market
eliminate or mitigate risks for surveillance authorities in
the relevant products made
order to eliminate or mitigate
available on the market is
risks for the relevant products
essential. However, the
made available on the market is
requests made to them by
essential. However, the
market surveillance
requests made to them by
authorities should be tailored
market surveillance authorities
to the role they play in the
should be tailored to the role
supply chain and with regards they play in the supply chain
to their respective legal
and with regards to their
obligations.
respective legal obligations.
Text Origin: Council
Mandate
Recital 25
(25) Distance selling, including (25) Distance selling, including (25) Distance selling, including (25) Distance selling, including
online selling, should also fall
online selling, should also fall
online selling, should also fall
online selling, should also fall
G 34
within the scope of this
within the scope of this
within the scope of this
within the scope of this
G
Regulation. Online selling has
Regulation. Online selling has
Regulation. Online selling has
Regulation. Online selling has
grown consistently and steadily, grown consistently and steadily, grown consistently and steadily, grown consistently and steadily,
creating new business models
creating new business models
,
creating new business models
creating new business models
,
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and new actors in the market
new challenges regarding
and new actors in the market
new challenges regarding
such as the online marketplaces.
product safety and new actors in such as the online marketplaces.
product safety and new actors in
the market such as the online
the market such as the
providers
marketplaces.
of online marketplaces.
Recital 25a
(25a) Union product safety
legislation also applies to cases see row below
where online traders based
outside the Union target
consumers within the Union.
Therefore it should be
established whether the offer
from the online seller based
outside the Union targets
G 34a
consumers within the Union in
G
order to assess whether a
product is placed on the Union
market. On the basis of the
Court of Justice of the
European Union case-law, the
assessment should be done on
a case-by-case basis. The
following aspects should in
particular be considered: the
international nature of the
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activity, the use of a language
and currency of the Member
States, a domain name
registered in one of the
Member States, and the
geographical areas to which
dispatch is possible. If an
online operator delivers to
adresses in the Union, accepts
currencies used in the
Member States as payment
for the product from
consumers within the Union
and uses any Union official
language, it can be considered
that the operator has directed
its activites to Union
consumers within the Union.
The physical fulfilment to
consumers within the Union of
an order for a product from a
given online seller based
outside the Union, including
by a fulfilment service
provider regardless of
whether it is based within or
outside the Union, should give
confirmation that a product is
placed on the Union market.
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Therefore, if the
manufacturers or distributors
are based outside the Union
and direct their offers of
products for sale online to the
Union market, they should
comply with the requirements
set out in this Regulation.
Recital 25a
(25a) In the case of a product
(25b) In the case of a product
offered for sale through
offered for sale online or
distance sales, the product
through other means of
should be considered to have
distance sales, the product
been made available on the
should be considered to have
market if the offer for sale is
been made available on the
directed at consumers in the
market if the offer for sale is
G 34b
Union. In accordance with the
targeted at consumers in the
G
applicable Union rules on
Union. In line with the
private international law, a
applicable Union rules on
case-by-case analysis should be
private international law, a
carried out in order to establish
case-by-case analysis should be
whether an offer is directed at
carried out in order to establish
consumers in the Union. An
whether an offer is targeted at
offer for sale should be
consumers in the Union. An
considered to be directed at
offer for sale should be
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consumers in the Union if the
considered to be targeted at
relevant economic operator
consumers in the Union if the
directs, by any means, its
relevant economic operator
activities to a Member State.
directs, by any means, its
For the case-by-case analyses,
activities to a Member State.
relevant factors, such as the
For the case-by-case analyses,
geographical areas to which
relevant factors, such as the
dispatch is possible, the
geographical areas to which
languages available, used for
dispatch is possible, the
the offer or for ordering, or
languages available, used for
means of payment, need to be
the offer or for ordering,
taken into consideration. In the
means of payment, the use of
case of online sales, the mere
currency of the Member State
fact that the economic
or a domain name registered in
operators' or the
one of the Member States need
intermediaries' website is
to be taken into consideration.
accessible in the Member State
In the case of online sales, the
in which the consumer is
mere fact that the economic
domiciled is insufficient.
operators' or the providers of
online marketplaces' interface
is accessible in the Member
State in which the consumer is
established or domiciled is
insufficient.
Recital 26
G 35
G
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(26) Online marketplaces play a (26) Online marketplaces play a (26) Online marketplaces play a (26)
Providers of online
crucial role in the supply chain - crucial role in the supply chain - crucial role in the supply chain - marketplaces play a crucial role
allowing economic operators to
allowing economic operators to
allowing economic operators to
in the supply chain - allowing
reach an indefinite number of
reach an indefinite number of
reach an indefinite number of
economic operators to reach an
consumers - and therefore also
consumers - and therefore also
consumers - and therefore also
indefinite number of consumers
in the product safety system.
in the product safety system.
in the product safety system.
- and therefore also in the
Online marketplaces,
product safety system.
depending on their business
model and their role and
involvement in a supply chain,
Text Origin:
could also be considered as
Commission Proposal
manufacturer, importer
distributor, fulfilment service
provider or authorised
representative and, in that case,
should be subject to the legal
obligations and responsibilities
applicable to those actors as
laid down in this Regulation or
in relevant Union
harmonisation legislation. For
example, if an online
marketplace presents itself as
the manufacturer by affixing to
the product its name, trade
mark or other distinctive mark,
or if it reconditions it or if its
activity affects the safety
properties of the product, it
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should be considered as a
manufacturer and should have
the obligations thereof.
Recital 26a
(26a) Under the new complex (26a) Under the new complex
business models linked to
business models linked to
online sales, the same entity
online sales, the same entity
can provide a variety of
can provide a variety of
services. Depending on the
services. Depending on the
nature of the services
nature of the services provided
provided for a given product,
for a given product, the same
the same entity may fall
entity may fall within different
within different categories of
categories of business models
G 35a
business models under this
under this Regulation. When
G
Regulation. When an entity
an entity provides only online
provides only online
intermediation services for a
intermediation services for a
given product, then it qualifies
given product, then it qualifies only as a provider of an online
only as a provider of an online marketplace for this product.
marketplace for this product.
In case the same entity provides
In case the same entity
both online marketplace
provides both online
services for the sale of a
marketplace services for the
particular product and also
sale of a particular product
acts as an economic operator in
and also acts as an economic
this Regulation, it would
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operator in this Regulation, it
qualify also as the relevant
would qualify also as the
economic operator. In such a
relevant economic operator.
case, the entity in question
In such a case, the entity in
would therefore have to comply
question would therefore have with those obligations
to comply with those
prescribed for the given
obligations prescribed for the
economic operator in question.
given economic operator in
For instance, if the provider of
question. For instance, if the
the online market place also
provider of the online market
distributes a product, then, with
place also distributes a
respect to the sale of the
product, then, with respect to
distributed product, it would be
the sale of the distributed
considered to be a distributor.
product, it would be
Similarly, if the entity in
considered to be a distributor. question sells its own branded
Similarly, if the entity in
products, it would act as a
question sells its own branded manufacturer and would thus
products, it would act as a
need to comply with the
manufacturer and would thus applicable requirements for
need to comply with the
manufacturers. Also some
applicable requirements for
entities can qualify as
manufacturers. Also some
fulfilment service providers if
entities can qualify as
they offer fulfilment services.
fulfilment service providers if
Such cases would thus need to
they offer fulfilment services.
be assessed on a case-by-case
Such cases would thus need to basis. be assessed on a case-by-case
basis.
Text Origin: Council
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Mandate
Recital 27
(27) Given the important role
(27) Given the important role
(27) Given the important role
(27) Given the important role
played by online marketplaces
played by online marketplaces
played by online marketplaces
played by
providers of online
when intermediating the sale of
when intermediating the sale of
when intermediating the sale of
marketplaces when
products between traders and
products between traders and
products between traders and
intermediating the sale of
consumers, such actors should
consumers, such actors should
consumers, such actors should
products between traders and
have more responsibilities in
have more responsibilities in
have more responsibilities in
consumers, such actors should
tackling the sale of dangerous
tackling the sale of dangerous
tackling the sale of dangerous
have more responsibilities in
products online. Directive
products online. Directive
products online. Directive
tackling the sale of dangerous
2000/31/EC of the European
2000/31/EC of the European
2000/31/EC of the European
products online. Directive
Parliament and of the Council1
Parliament and of the Council1
Parliament and of the Council1
2000/31/EC of the European
G 36
provides the general framework provides the general framework provides the general framework Parliament and of the Council1
G
for e-commerce and lays down
for e-commerce and lays down
for e-commerce and lays down
provides the general framework
certain obligations for online
certain obligations for online
certain obligations for online
for e-commerce and lays down
platforms. Regulation […/…]
platforms. Regulation […/…]
platforms. Regulation […/…]
certain obligations for online
on a Single Market for Digital
on a Single Market for Digital
on a Single Market for Digital
platforms. Regulation […/…]
Services (Digital Services Act)
Services (Digital Services Act)
Services (Digital Services Act)
on a Single Market for Digital
and amending Directive
and amending Directive
and amending Directive
Services (Digital Services Act)
2000/31/EC2 regulates the
2000/31/EC2 regulates the
2000/31/EC2 regulates the
and amending Directive
responsibility and accountability responsibility and accountability responsibility and accountability 2000/31/EC2 regulates the
of providers of intermediary
of providers of intermediary
of providers of intermediary
responsibility and accountability
services online with regard to
services online with regard to
services online with regard to
of providers of intermediary
illegal contents, including
illegal contents, including
illegal contents, including
services online with regard to
unsafe products. That
unsafe products. That
unsafe
dangerous products.
illegal contents, including
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Regulation applies without
Regulation applies without
That Regulation applies without
dangerous products. That
prejudice to the rules laid down
prejudice to the rules laid down
prejudice to the rules laid down
Regulation applies without
by Union law on consumer
by Union law on consumer
by
other Union legal acts
prejudice to the rules laid down
protection and product safety.
protection and product safety.
regulating other aspects of the by Union law on consumer
Accordingly, building on the
Accordingly, building on the
provision of intermediary
protection and product safety.
horizontal legal framework
horizontal legal framework
services in the internal market Accordingly, building on the
provided by that Regulation,
provided by that Regulation,
or specifying and
horizontal legal framework
specific requirements essential
specific requirements essential
complementing that
provided by that Regulation,
to effectively tackle the sale of
to effectively tackle the sale of
Regulation, in particular
specific requirements essential
dangerous products online
dangerous products online
Union law on consumer
to effectively tackle the sale of
should be introduced, in line
should be introduced, in line
protection and product safety.
dangerous products online
with Article [1(5), point (h)] of
with Article [1(5), point (h)] of
Accordingly, building on the
should be introduced, in line
that Regulation.
that Regulation.
horizontal legal framework
with Article
2(4), point
(f) of
_________
_________
provided by that Regulation,
that Regulation.
To the extent
specific
and complementary
that this Regulation specifies
1. Directive 2000/31/EC of the
1. Directive 2000/31/EC of the
requirements essential to
the requirements, in relation to
European Parliament and of the European Parliament and of the effectively tackle the sale of
product safety, with which
Council of 8 June 2000 on
Council of 8 June 2000 on
dangerous products online
providers of online
certain legal aspects of
certain legal aspects of
should be introduced, in line
marketplaces must comply in
information society services, in
information society services, in
with Article [1(5)
1a (3), point
order to ensure compliance
particular electronic commerce, particular electronic commerce, (h)
(f)] of that Regulation.
with certain provisions of
in the Internal Market
in the Internal Market
Regulation (EU) 2022/2065
('Directive on electronic
('Directive on electronic
_________
[the DSA], those requirements
commerce') - OJ L 178,
commerce') - OJ L 178,
1. Directive 2000/31/EC of the
should not affect the
17.7.2000, p. 1–16.
17.7.2000, p. 1–16.
European Parliament and of the
application of Regulation
2. Regulation […/…] on a
2. Regulation […/…] on a
Council of 8 June 2000 on
2022/2065, which continues to
Single Market for Digital
Single Market for Digital
certain legal aspects of
apply to those providers.
Services (Digital Services Act)
Services (Digital Services Act)
information society services, in
_________
and amending Directive
and amending Directive
particular electronic commerce,
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2000/31/EC.
2000/31/EC.
in the Internal Market
1. Directive 2000/31/EC of the
('Directive on electronic
European Parliament and of the
commerce') - OJ L 178,
Council of 8 June 2000 on
17.7.2000, p. 1–16.
certain legal aspects of
2. Regulation […/…] on a
information society services, in
Single Market for Digital
particular electronic commerce,
Services (Digital Services Act)
in the Internal Market
and amending Directive
('Directive on electronic
2000/31/EC.
commerce') - OJ L 178,
17.7.2000, p. 1–16.
2. Regulation […/…] on a
Single Market for Digital
Services (Digital Services Act)
and amending Directive
2000/31/EC.
Recital 27a
G 36a
G
deleted
Recital 28
G 37
G
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(28) The Product Safety
(28) The Product Safety
(28) The Product Safety
(28) The Product Safety
Pledge, signed in 2018 and
Pledge, signed in 2018 and
Pledge, signed in 2018 and
Pledge, signed in 2018 and
joined by a number of
joined by a number of
joined by a number of
joined by a number of
marketplaces since then,
marketplaces since then,
marketplaces since then,
marketplaces since then,
provides for a number of
provides for a number of
provides for a number of
provides for a number of
voluntary commitments on
voluntary commitments on
voluntary commitments on
voluntary commitments on
product safety. The Product
product safety
. The Product
product safety. The Product
product safety. The Product
Safety Pledge has proved its
Safety Pledge has proved its
Safety Pledge has proved its
Safety Pledge has proved its
rationale in enhancing the
rationale in with the aim of
rationale in enhancing the
rationale in enhancing the
protection of consumers against enhancing the protection of
protection of consumers against protection of consumers against
dangerous products sold online. consumers against dangerous
dangerous products sold online. dangerous products sold online.
Nonetheless, its voluntary
products sold online.
Nonetheless, its voluntary
In order to strengthen the
nature and the voluntary
Nonetheless, its voluntary
nature and the voluntary
protection of consumers by
participation by a limited
nature and the voluntary
participation by a limited
avoiding damage to their life,
number of online marketplaces
participation by a limited
number of online marketplaces
health and safety and to ensure
reduces its effectiveness and
number of online marketplaces
reduces its effectiveness and
fair competition in the internal
cannot ensure a level-playing
reduceshave indicated a lack of cannot ensure a level-playing
market, providers of online
field.
progress in some of the
field.
Therefore, this
market places are encouraged
voluntary commitments
Regulation should lay down
to take those voluntary
reducing its effectiveness
with
the specific and
commitments to prevent the re-
regard to consumer protection
complementary obligations of appearance of listings of
and cannot ensure a level-
providers of online
dangerous products already
playing field.
marketplaces in relation to
withdrawn. The use of
product safety.
technologies and digital
processes and the
improvements in alert systems,
in particular Safety Gate, can
allow the automatic
identification and
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communication of notified
dangerous products and to
carry out automated random
checks against the Safety Gate.
Recital 28a
(28a) This Regulation should
(28a) This Regulation should
also lay down provisions
also lay down provisions
encouraging online
encouraging economic
marketplaces to enter into
operators and providers of
voluntary memoranda of
online marketplaces to enter
understanding with market
into voluntary memoranda of
surveillance authorities or
understanding with competent
G 37a
organisations representing
authorities, the Commission or G
consumers to undertake
organisations representing
voluntary commitments with
consumers or economic
regard to the products sold
operators to undertake product
online that go beyond the legal
safety related voluntary
obligations laid down in Union
commitments that go beyond
law.
the legal obligations laid down
in Union law.
Recital 29
G 38
G
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(29) Online marketplaces
(29) Online marketplaces
(29) Online marketplaces
(29)
Providers of online
should act with due care in
should act with due care in
should act with due care in
marketplaces should act with
relation to the content hosted on relation to the content hosted on relation to the content hosted on due care in relation to the
their online interfaces that
their online interfaces that
their online interfaces that
content hosted on their online
concerns safety of products, in
concerns safety of products, in
concerns safety of products, in
interfaces that concerns safety
accordance with the specific
accordance with the specific
accordance with the specific
of products, in accordance with
obligations laid down in this
obligations laid down in this
obligations laid down in this
the specific obligations laid
Regulation. Accordingly, due
Regulation. Accordingly, due
Regulation. Accordingly, due
down in this Regulation.
diligence obligations for all
diligence obligations for all
diligence obligations for all
Accordingly, due diligence
online marketplaces should be
online marketplaces should be
online marketplaces should be
obligations for all
providers of
established in relation to the
established in relation to the
established in relation to the
online marketplaces should be
content hosted on their online
content hosted on their online
content hosted on their online
established in relation to the
interfaces that concerns safety
interfaces that concerns safety
interfaces that concerns safety
content hosted on their online
of products.
of products.
of products.
interfaces that concerns safety
of products.
Recital 30
(30) Moreover, for the purposes (30) Moreover, for the purposes (30) Moreover, for the purposes (30) Moreover, for the purposes
of effective market surveillance, of effective market surveillance, of effective market surveillance, of effective market surveillance,
online marketplaces should
online marketplaces should
online marketplaces should
providers of online
G 39
register in the Safety Gate portal register in the Safety Gate portal register in the Safety Gate portal marketplaces should register in
G
and indicate, in the same portal, and indicate, in the same portal, and indicate, in the same portal, the Safety Gate portal and
the information concerning their the information concerning their the information concerning their indicate, in the same portal, the
single contact points for the
single contact points for the
single contact points for the
information concerning their
facilitation of communication of facilitation of communication of facilitation of communication of single contact points for the
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information on product safety
information on product safety
information on product safety
facilitation of communication of
issues. The single point of
issues. The single point of
issues. The single point of
information on product safety
contact under this Regulation
contact under this Regulation
contact under this Regulation
issues. The
Commission should
might be the same as the point
might be the same as the point
might be the same as the point
ensure that the registration is
of contact under [Article 10] of
of contact under [Article 10] of
of contact under [Article 10] of
easy and user-friendly. The
Regulation (EU) …/…[the
Regulation (EU) …/…[the
Regulation (EU) …/…[the
single point of contact under
Digital Services Act], without
Digital Services Act], without
Digital Services Act], without
this Regulation might be the
endangering the objective of
endangering the objective of
endangering the objective of
same as the point of contact
treating issues linked to product treating issues linked to product treating issues linked to product under ▌ Article
11 of
safety in a swift and specific
safety in a swift and specific
safety in a swift and specific
Regulation (EU) …/…[the
manner.
manner.
manner.
Digital Services Act], without
endangering the objective of
treating issues linked to product
safety in a swift and specific
manner.
Recital 30a
(30a) The online marketplaces
(30a) The providers of online
should designate a single point
marketplaces should designate
of contact for consumers to
a single point of contact for
G 39a
serve as a single window for
consumers to serve as a single
G
consumer communications on
window for consumer
product safety issues, which
communications on product
may then be redirected to the
safety issues, which may then
proper service unit of an online
be redirected to the proper
marketplace. This should not
service unit of an online
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prevent additional points of
marketplace. This should not
contact for specific services
prevent additional points of
being made available to
contact for specific services
consumers.
being made available to
consumers. The single point of
contact under this Regulation
might be the same as the point
of contact under Article 12 of
Regulation (EU) …/…[the
Digital Services Act].
Text Origin: EP
Mandate
Recital 31
(31) In order to be able to
(31) In order to be able to
(31) In order to be able to
(31) In order to be able to
comply with their obligations
comply with their obligations
comply with their obligations
comply with their obligations
under this Regulation, in
under this Regulation, in
under this Regulation, in
under this Regulation, in
particular in respect of timely
particular in respect of timely
particular in respect of timely
particular in respect of timely
G 40
and effective compliance with
and effective compliance with
and effective compliance with
and effective compliance with
G
the orders of public authorities,
the orders of public authorities,
the orders of public authorities,
the orders of public authorities,
processing of notices of other
processing of notices of other
processing of notices of other
processing of notices of other
third parties and cooperating
third parties and cooperating
third parties and cooperating
third parties and cooperating
with market surveillance
with market surveillance
with market surveillance
with market surveillance
authorities in the context of
authorities in the context of
authorities in the context of
authorities in the context of
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corrective measures upon
corrective measures upon
corrective measures upon
corrective measures upon
request, online marketplaces
request, online marketplaces
request, online marketplaces
request,
providers of online
should have in place an internal should have in place an internal should have in place an internal marketplaces should have in
mechanism for handling product mechanism for handling product mechanism for handling product place an internal mechanism for
safety-related issues.
safety-related issues.
safety-related issues.
handling product safety-related
issues.
Text Origin:
Commission Proposal
Recital 32
(32) The obligations imposed
(32) The obligations imposed
(32) The obligations imposed
(32) The obligations imposed
by this Regulation on online
by this Regulation on online
by this Regulation on online
by this Regulation on
providers
marketplaces should neither
marketplaces should neither
marketplaces should neither
of online marketplaces should
amount to a general obligation
amount to a general obligation
amount to a general obligation
neither amount to a general
to monitor the information
to monitor the information
to monitor the information
obligation to monitor the
which they transmit or store, nor which they transmit or store, nor which they transmit or store, nor information which they transmit
G 41
to actively seek facts or
to actively seek facts or
to actively seek facts or
or store, nor to actively seek
G
circumstances indicating illegal
circumstances indicating illegal
circumstances indicating illegal
facts or circumstances
activity, such as the sale of
activity, such as the sale of
activity, such as the sale of
indicating illegal activity, such
dangerous products online.
dangerous products online.
dangerous products online.
as the sale of dangerous
Online marketplaces should,
Online marketplaces should,
Online marketplaces should,
products online.
Providers of
nonetheless, expeditiously
nonetheless, expeditiously
nonetheless, expeditiously
online marketplaces should,
remove content referring to
remove content referring to
remove content referring to
an
nonetheless, expeditiously
dangerous products from their
dangerous products from their
offer of dangerous products
remove content referring to
an
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online interfaces, upon
online interfaces, upon
from their online interfaces,
offer of dangerous products
obtaining actual knowledge or,
obtaining actual knowledge or,
upon obtaining actual
from their online interfaces,
in the case of claims for
in the case of claims for
knowledge or, in the case of
upon obtaining actual
damages, awareness of the
damages, awareness of the
claims for damages, awareness
knowledge or, in the case of
illegal content, in particular in
illegal content, in particular in
of the
content referring to an
claims for damages, awareness
cases where the online
cases where the online
offer of dangerous products
of the
content referring to an
marketplace has been made
marketplace has been made
illegal content, in particular in
offer of dangerous products, in
aware of facts or circumstances
aware of facts or circumstances
cases where the online
particular in cases where the
on the basis of which a diligent
on the basis of which a diligent
marketplace has been made
provider of online marketplace
economic operator should have
economic operator should have
aware of facts or circumstances
has been made aware of facts or
identified the illegality in
identified the illegality in
on the basis of which a diligent
circumstances on the basis of
question, in order to benefit
question, in order to benefit
economic operator should have
which a diligent economic
from the exemption from
from the exemption from
identified the illegality in
operator should have identified
liability for hosting services
liability for hosting services
question, in order to benefit
the illegality in question, in
under the 'Directive on
under the 'Directive on
from the exemption from
order to benefit from the
electronic commerce' and the
electronic commerce' and the
liability for hosting services
exemption from liability for
[Digital Services Act]. Online
[Digital Services Act]. Online
under the 'Directive on
hosting services under the
marketplaces should process
marketplaces should process
electronic commerce' and the
'Directive on electronic
notices concerning content
notices concerning content
[Digital Services Act]. Online
commerce' and the [Digital
referring to unsafe products,
referring to unsafe products,
marketplaces should process
Services Act]. Online
received in accordance with
received in accordance with
orders and notices concerning
marketplaces should process
[Article 14] of Regulation (EU) [Article 14] of Regulation (EU)
content referring to unsafe
an
notices concerning content
…/…[the Digital Services Act], …/…[the Digital Services Act],
offer of dangerous products,
referring to
an offer of
within the additional timeframes within the additional timeframes received in accordance with
dangerous products, received in
established by this Regulation.
established by this Regulation.
[Article 14] of
Regulation
accordance with [Article 14] of
In addition, online
(EU) …/…
[the Digital Services Regulation (EU) …/…[the
marketplaces are strongly
Act], within the additional
Digital Services Act], within the
encouraged to check products
timeframes established by this
additional timeframes
with Safety Gate before placing Regulation.
established by this Regulation.
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them on their website.
In addition, providers of online
marketplaces are encouraged
to check products with Safety
Gate Portal before placing
them on their interface.
Recital 33
(33) Article 14(4) of Regulation (33) Article 14(4) of Regulation (33) Article 14(4) of Regulation (33) Article 14(4) of Regulation
(EU) 2019/1020 provides
(EU) 2019/1020 provides
(EU) 2019/1020 provides
(EU) 2019/1020 provides
market surveillance authorities
market surveillance authorities
market surveillance
relevant
market surveillance authorities
with the power, where no other
with the power, where no other
national authorities with the
with the power, where no other
effective means are available to effective means are available to power, where no other effective effective means are available to
eliminate a serious risk, to
eliminate a serious risk, to
means are available to eliminate eliminate a serious risk, to
require the removal of content
require the removal of content
a serious risk, to require the
require the removal of content
referring to the related products referring to the related products
removal of content referring to
referring to the related products
G 42
from an online interface or to
from an online interface or to
the related products from an
from an online interface or to
G
require the explicit display of a
require the explicit display of a
online interface or to require the require the explicit display of a
warning to end users when they warning to end users when they explicit display of a warning to
warning to end users when they
access an online interface. The
access an online interface. The
end users
consumers when
access an online interface. The
powers entrusted to market
powers entrusted to market
they access an online interface.
powers entrusted to market
surveillance authorities by
surveillance authorities by
The powers entrusted to market surveillance authorities by
Article 14(4) of Regulation
Article 14(4) of Regulation
surveillance
these authorities
Article 14(4) of Regulation
(EU) 2019/1020 should also
(EU) 2019/1020 should also
by Article 14(4) of Regulation
(EU) 2019/1020 should also
apply to this Regulation. For
apply to this Regulation. For
(EU) 2019/1020 should also
apply to this Regulation. For
effective market surveillance
effective market surveillance
apply to this Regulation. For
effective market surveillance
under this Regulation and to
under this Regulation and to
effective market surveillance
under this Regulation and to
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avoid dangerous products being avoid dangerous products being under this Regulation and to
avoid dangerous products being
present on the Union market,
present on the Union market,
avoid dangerous products being present on the Union market,
this power should apply in all
this power should apply in all
present on the Union market,
this power should apply in all
necessary and proportionate
necessary and proportionate
this power should apply in all
necessary and proportionate
cases and also for products
cases and also for products
necessary and proportionate
cases and also for products
presenting a less than serious
presenting a less than serious
cases and also for products
presenting a less than serious
risk. It is essential that online
risk. It is essential that online
presenting a less than serious
risk. It is essential that
providers
marketplaces comply with such
marketplaces comply with such
risk. It is essential that online
of online marketplaces comply
orders as a matter of urgency.
orders as a matter of urgency.
marketplaces comply with such
with such orders as a matter of
Therefore, this Regulation
Therefore, this Regulation
orders as a matter of urgency.
urgency. Therefore, this
introduces binding time limits in introduces binding time limits in Therefore, this Regulation
Regulation introduces binding
this respect, without prejudice to this respect
, without prejudice to introduces binding time limits in time limits in this respect ▌ .
the possibility for a shorter time
the possibility for a shorter time this respect, without prejudice to This power should be exercised
limit to be laid down in the
limit to be laid down in the
the possibility for a shorter time in accordance with ▌ Article
9
order itself. This power should
order itself. This power should
limit to be laid down in the
of the Digital Services Act.
be exercised in accordance with be exercised in accordance with order itself. This power should
[Article 8] of the Digital
[Article 8] of the Digital
be exercised in accordance with
Services Act.
Services Act.
[Article 8] of
Regulation (EU)
Text Origin: EP
Mandate
…/… [the Digital Services Act
]
.
Recital 33a
(33a) When such orders also
(33a) Orders which also
G 42a
require the provider of an
require the provider of an
G
online marketplace to remove online marketplace to remove
from its online interface all
from its online interface all
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identical content referring to
identical content referring to
the offer of a dangerous
the offer of a dangerous
product specified in the order, product specified in the order,
in order to determine such
should identify the elements
content the provider of online that will determine and allow
marketplace should take into
the provider of online
account the identification of
marketplace to remove
the product specified in the
identical offers, based on the
order as well as the minimum
information displayed by the
traceability and product
traders, to the extent that it
safety information displayed
does not require the provider of
by the traders.
online marketplace to carry out
an independent assessment of
that content.
Recital 34
(34) Even where the
(34) Even where the
(34) Even Where the
(34) ▌ Where the information
information from the Safety
information from the Safety
information from the Safety
from the Safety Gate
Rapid
Gate does not contain an exact
Gate does not contain an exact
Gate
Rapid Alert System does
Alert System does not contain
uniform resource locator (URL) uniform resource locator (URL) not contain an exact uniform
an exact uniform resource
G 43
and, where necessary, additional and, where necessary, additional resource locator (URL) and,
locator (URL) and, where
G
information enabling the
information enabling the
where necessary, additional
necessary, additional
identification of the illegal
identification of the illegal
information enabling the
information enabling the
content concerned, online
content concerned, online
identification of the
content
identification of the ▌ content
marketplaces should
marketplaces should
referring to an offer of
referring to an offer of
nevertheless take into account
nevertheless take into account
dangerous products illegal
dangerous products,
providers
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the transmitted information,
the transmitted information,
content concerned, online
of online marketplaces should
such as product identifiers,
such as product identifiers,
marketplaces should
nevertheless take into account
when available, and other
when available, and other
nevertheless take into account
the transmitted information,
traceability information, in the
traceability information, in the
the transmitted information,
such as product identifiers,
context of any measures
context of any measures
such as product identifiers,
when available, and other
adopted by online marketplaces adopted by online marketplaces when available, and other
traceability information, in the
on their own initiative aiming at on their own initiative aiming at traceability information, in the
context of any measures
detecting, identifying, removing detecting, identifying, removing context of any measures
adopted by
providers of online
or disabling access to dangerous or disabling access to dangerous adopted by online marketplaces marketplaces on their own
products offered on their
products offered on their
on their own initiative aiming at initiative aiming at detecting,
marketplace, where applicable.
marketplace, where applicable.
detecting, identifying, removing identifying, removing or
Nonetheless, the Safety Gate
or disabling access to dangerous disabling access to
such offers
should be modernised and
products offered
such offers of
of dangerous products ▌ on
updated in order to make it
dangerous products on their
their marketplace, where
easier for online marketplaces
marketplace, where applicable.
applicable.
Nonetheless, the
to detect unsafe products and,
Safety Gate Portal should be
with that aim, it should be
modernised and updated in
possible to implement the
order to make it easier for
provisions on the removal of
providers of online
illegal content referring to
marketplaces to detect unsafe
dangerous products from
products and, with that aim, it
online marketplaces by means
should be possible to
of a Union notification system
implement the provisions on
designed and developed within
the removal of content
the Safety Gate.
referring to an offer of
dangerous products from
online interfaces by means of a
notification system designed
and developed within the Safety
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Gate.
Recital 35
(35) For the purposes of
(35) For the purposes of
(35) For the purposes of
(35) For the purposes of ▌
[Article 19] of Regulation (EU) [Article 19] of Regulation (EU)
[Article 19] of Regulation (EU) Article
22 of Regulation (EU)
…/…[the Digital Services Act], …/…[the Digital Services Act], …/…[
the Digital Services
…/…[the Digital Services Act],
and concerning the safety of
and concerning the safety of
Actthe Digital Services Act],
and concerning the safety of
products sold online, the Digital products sold online, the Digital and concerning the safety of
products sold online, the Digital
Services Coordinator should
Services Coordinator should
products sold online, the Digital Services Coordinator should
consider in particular consumer
consider in particular consumer
Services Coordinator should
consider in particular consumer
G 44
organisations and associations
organisations and associations
consider in particular consumer
organisations and associations
G
representing consumers’
representing consumers’ interest
organisations and associations
representing consumers’ interest
interest, upon their request, as
and other relevant
representing consumers’
and other relevant
trusted flaggers, provided that
stakeholders, upon their
interest, upon their request, as
stakeholders, upon their
the conditions set out in that
request, as trusted flaggers,
trusted flaggers, provided that
request, as trusted flaggers,
article have been met.
provided that the conditions set
the conditions set out in that
provided that the conditions set
out in that article have been met. Article have been met.
out in that article have been met.
Recital 36
G 45
(36) Product traceability is
(36) Product traceability is
(36) Product traceability is
(36) Product traceability is
G
fundamental for effective
fundamental for effective
fundamental for effective
fundamental for effective
market surveillance of
market surveillance of
market surveillance of
market surveillance of
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dangerous products and
dangerous products and
dangerous products and
dangerous products and
corrective measures. Consumers corrective measures. Consumers corrective measures. Consumers corrective measures. Consumers
should also be protected against should also be protected against should also be protected against should also be protected against
dangerous products in the same
dangerous products in the same
dangerous products in the same
dangerous products in the same
way in the offline and online
way in the offline and online
way in the offline and online
way in the offline and online
sales channels, including when
sales channels, including when
sales channels, including when
sales channels, including when
purchasing products on online
purchasing products on online
purchasing products on online
purchasing products on online
marketplaces. Building on the
marketplaces. Building on the
marketplaces. Building on the
marketplaces. Building on the
provisions of Regulation (EU)
provisions of Regulation (EU)
provisions of Regulation (EU)
provisions of Regulation (EU)
…/…[the Digital Services
…/…[the Digital Services
…/…
[the Digital Services Act]
…/…[the Digital Services
Act]concerning the traceability
Act]concerning the traceability
concerning the traceability of
Act]concerning the traceability
of traders, online marketplaces
of traders, online marketplaces
traders,
providers of online
of traders,
providers of online
should not allow listings on
should not allow listings on
marketplaces should not allow
marketplaces should not allow
a
their platforms unless the trader their platforms unless the trader
a specific product offer being
specific product offer being
provided all information related provided all information related
listed listings on their platforms
listed on their platforms unless
to product safety and
to product safety and
unless the trader provided all
the trader provided all
traceability as detailed in this
traceability as detailed in this
information related to product
information related to product
Regulation. Such information
Regulation. Such information
safety and traceability as
safety and traceability as
should be displayed together
should be displayed together
detailed in this Regulation. Such detailed in this Regulation. Such
with the product listing so that
with the product listing so that
information should be displayed information should be displayed
consumers can benefit from the
consumers can benefit from the
together with the product listing together with the product listing
same information made
same information made
so that consumers can benefit
so that consumers can benefit
available online and offline.
available online and offline.
from the same information
from the same information
However, the online
However, the online
made available online and
made available online and
marketplace should not be
marketplace should not be
offline. However, the
provider
offline. However, the
providers
responsible for verifying the
responsible for verifying the
of an online marketplace should
of an online marketplace should
completeness, correctness and
completeness, correctness and
not be responsible for verifying
not be responsible for verifying
the accuracy of the information
the accuracy of the information
the completeness, correctness
the completeness, correctness
itself, as the obligation to ensure
itself, as the obligation to
and the accuracy of the
and the accuracy of the
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the traceability of products
ensure the traceability of
information itself, as the
information itself, as the
remains with the trader.
products remains with the
obligation to ensure the
obligation to ensure the
trader.
traceability of products remains traceability of products remains
with the
relevant trader.
with the
relevant trader.
Recital 37
(37) It is also important that
(37) It is also important that
(37) It is also important that
(37) It is also important that
online marketplaces closely
online marketplaces closely
providers of online
providers of online
cooperate with the market
cooperate with the market
marketplaces closely cooperate
marketplaces closely cooperate
surveillance authorities, law
surveillance authorities, law
with the market surveillance
with the market surveillance
enforcement authorities and
enforcement authorities and
authorities, law enforcement
authorities,
with traders and
with relevant economic
with relevant economic
authorities
with traders and
with relevant economic
operators on the safety of
operators on the safety of
with relevant economic
operators on the safety of
products. An obligation of
products. An obligation of
operators on the safety of
products. An obligation of
cooperation with market
cooperation with market
products. An obligation of
cooperation with market
G 46
surveillance authorities is
surveillance authorities is
cooperation with market
surveillance authorities is
G
imposed on information society imposed on information society surveillance authorities is
imposed on information society
service providers under Article
service providers under Article
imposed on information society service providers under Article
7(2) of Regulation (EU)
7(2) of Regulation (EU)
service providers under Article
7(2) of Regulation (EU)
2019/1020 in relation to
2019/1020 in relation to
7(2) of Regulation (EU)
2019/1020 in relation to
products covered by that
products covered by that
2019/1020 in relation to
products covered by that
Regulation and should therefore Regulation and should therefore products covered by that
Regulation and should therefore
be extended to all consumer
be extended to all consumer
Regulation and should therefore be extended to all consumer
products. For instance, market
products. For instance, market
be extended to all consumer
products. For instance, market
surveillance authorities are
surveillance authorities are
products. For instance, market
surveillance authorities are
constantly improving the
constantly improving the
surveillance authorities are
constantly improving the
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technological tools they use for
technological tools they use for
constantly improving the
technological tools they use for
the online market surveillance
the online market surveillance
technological tools they use for
the online market surveillance
to identify dangerous products
to identify dangerous products
the online market surveillance
to identify dangerous products
sold online. For these tools to be sold online. For these tools to be to identify dangerous products
sold online. For these tools to be
operational, online marketplaces operational, online marketplaces sold online. For these tools to be operational,
providers of online
should grant access to their
should grant access to their
operational, online marketplaces marketplaces should grant
interfaces. Moreover, for the
interfaces. Moreover,
only for
should grant access to their
access to their interfaces.
purpose of product safety,
the purpose of product safety,
interfaces. Moreover, for the
Moreover, for the purpose of
market surveillance authorities
market surveillance authorities
purpose of product safety,
product safety, market
may also need to scrape data
and other competent
market surveillance authorities
surveillance authorities may
from the online marketplaces.
authorities, upon specific
may also need to scrape data
also need to scrape data from
an
request, may also need to scrape from the online marketplaces.
online interface upon reasoned
data from the online
Providers of online
request in case of technical
marketplaces.
marketplaces should also
obstacles put in place by
cooperate on product recalls
providers of online
and on accident reporting.
marketplaces
or online sellers.
Providers of online
marketplaces should also
cooperate on product recalls
and on accident reporting.
Recital 38
(38) Direct selling by economic (38) Direct selling by economic (38) Direct selling by economic (38) Direct selling by economic
G 47
operators established outside the operators established outside the operators established outside the operators established outside the G
Union through online channels
Union through online channels
Union through online channels
Union through online channels
hinders the work of market
hinders the work of market
hinders the work of market
hinders the work of market
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surveillance authorities when
surveillance authorities when
surveillance authorities when
surveillance authorities when
tackling dangerous products in
tackling dangerous products in
tackling dangerous products in
tackling dangerous products in
the Union, as in many instances the Union, as in many instances the Union, as in many instances the Union, as in many instances
economic operators may not be
economic operators may not be
economic operators may not be
economic operators may not be
established nor have a legal
established nor have a legal
established nor have a legal
established nor have a legal
representative in the Union. It is representative in the Union. It is representative in the Union. It is representative in the Union. It is
therefore necessary to ensure
therefore necessary to ensure
therefore necessary to ensure
therefore necessary to ensure
that market surveillance
that market surveillance
that market surveillance
that market surveillance
authorities have adequate
authorities have adequate
authorities have adequate
authorities have adequate
powers and means to effectively powers and means to effectively powers and means to effectively powers and means to effectively
tackle the sale of dangerous
tackle the sale of dangerous
tackle the sale of dangerous
tackle the sale of dangerous
products online. In order to
products online. In order to
products online. In order to
products online. In order to
ensure an effective enforcement ensure an effective enforcement ensure an effective enforcement ensure an effective enforcement
of this Regulation, the
of this Regulation, the
of this Regulation, the
of this Regulation, the
obligation set out in Article
obligation set out in Article
obligation set out in Article
obligation set out in Article
4(1), (2) and (3) of Regulation
4(1), (2) and (3) of Regulation
4(1), (2) and (3) of Regulation
4(1), (2) and (3) of Regulation
2019/1020 should be extended
2019/1020 should be extended
2019/1020 should be extended
2019/1020 should be extended
also to products falling outside
also to products falling outside
also to products falling outside
also to products falling outside
the scope of the Union
the scope of the Union
the scope of the Union
the scope of the Union
harmonisation legislation to
harmonisation legislation to
harmonisation legislation to
harmonisation legislation to
ensure that there is a responsible ensure that there is a responsible ensure that there is a responsible ensure that there is a responsible
economic operator established
economic operator established
economic operator established
economic operator established
in the Union, which is entrusted in the Union, which is entrusted in the Union, which is entrusted in the Union, which is entrusted
with tasks regarding such
with tasks regarding such
with tasks regarding such
with tasks regarding such
products, providing market
products, providing market
products, providing market
products, providing market
surveillance authorities with an
surveillance authorities with an
surveillance authorities with an
surveillance authorities with an
interlocutor and performing
interlocutor and performing
interlocutor and performing
interlocutor and
, where
specific tasks in a timely
specific tasks in a timely
specific tasks in a timely
appropriate with regard to the
manner.
manner.
manner.
possible risks related to a
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product, performing specific
tasks in a timely manner
to
ensure that the products are
safe.
Those specific tasks
should include regular checks
with regard to the compliance
with the technical
documentation, product and
manufacturer information,
instruction and safety
information.
Recital 39
(39) Contact information of the (39) Contact information of the (39) Contact information of the (39) Contact information of the
economic operator, established
economic operator, established
economic operator, established
economic operator, established
in the Union and responsible for in the Union and responsible for in the Union and responsible for in the Union and responsible for
products falling under the scope products falling under the scope products falling under the scope products falling under the scope
G 48
of application of this Regulation of application of this Regulation of application of this Regulation of application of this Regulation G
should be indicated with the
should be indicated with the
should be indicated with the
should be indicated with the
product in order to facilitate
product in order to facilitate
product in order to facilitate
product in order to facilitate
checks throughout the supply
checks throughout the supply
checks throughout the supply
checks throughout the supply
chain.
chain.
chain.
chain.
Recital 39a
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(39a) To verify that the
products placed or made
no text here. see row 47.
available on the market are
safe, all products need to be
subject to appropriate and
regular checks by the
responsible person to ensure
that they comply with the
description provided for in the
technical documentation, that
the solutions adopted to
G 48a
eliminate or mitigate the risks
G
remain in place and effective,
and that they comply with the
requirements regarding
technical documentation,
identification and instructions.
The responsible person may
choose to perform such
verifications through
representative random sample
testing.
Recital 39a
G 48b
G
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(39a) The precautionary
principle is a fundamental
no text here.
principle for ensuring the
safety of products and
consumers and should
therefore be taken into due
account in a proportionate
manner by market surveillance
authorities when applying this
Regulation.
Recital 40
(40) Where economic operators (40) Where economic operators (40) Where economic operators
or market surveillance
or market surveillance
or market surveillance
deleted
authorities face a choice of
authorities face a choice of
authorities face a choice of
various corrective measures, the various corrective measures, the various corrective measures, the
most sustainable action resulting most sustainable action resulting most sustainable action resulting
no text. Recital deleted.
G 49
in the lowest environmental
in the lowest environmental
in the lowest environmental
G
impact, such as the repair of the impact, such as the repair of the impact, such as the repair of the
product, should be preferred,
product, should be preferred,
product, should be preferred,
Text Origin:
provided that it does not result
provided that it does not result
provided that it does not result
Commission Proposal
in a lesser level of safety.
in a lesser level of safety
or
in a lesser level of safety.
affects consumers’ rights under Provided that safety is not
other relevant Union
reduced, economic operators
legislation.
should consequently give
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preference to the most
sustainable solution and
inform the consumers
concerned accordingly, in
particular in case of recalls.
Recital 41
(41) Any economic operator
(41) Any economic operator
(41) Any
natural or legal
(41) Any
natural or legal
that either places a product on
that either places a product on
person economic operator that
person that either places a
the market under their own
the market under their own
either places a product on the
product on the market under
name or trademark or modifies a name or trademark or modifies a market under their own name or their own name or trademark or
product in such a way that
product in such a way that
trademark or modifies a product
substantially modifies a product
conformity with the
conformity with the
in such a way that conformity
in such a way that conformity
requirements of this Regulation
requirements of this Regulation
with the requirements of this
with the requirements of this
G 50
may be affected, should be
may be affected, should be
Regulation may be affected,
Regulation may be affected,
G
considered to be the
considered to be the
should be considered to be the
should be considered to be the
manufacturer and should
manufacturer and should
manufacturer and should
manufacturer and should
assume the obligations of the
assume the obligations of the
assume the obligations of the
assume the obligations of the
manufacturer.
manufacturer.
manufacturer.
manufacturer.
Text Origin: Council
Mandate
Recital 41a
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(41a) Modification, by
(41a) Modification, by physical
physical or digital means, to a or digital means, to a product
product might have
might have consequences on
consequences on the nature
the nature and characteristics
and characteristics of the
of the product in a way, which
product in a way which was
was not foreseen in the initial
not foreseen in the initial risk
risk assessment of the product
assesment of the product and
and may jeopardize the safety
may jeopardize the safety of
of the product. It should
the product. It should
therefore be considered as a
therefore be considered as a
substantial modification and,
substantial modification and,
when not done by the consumer
G 50a
when not done by the
or on his behalf, it should lead
G
consumer or on his behalf, it
to consider that it is a new
should lead to consider that it
product from a different
is a new product from a
manufacturer. In order to
different manufacturer. In
ensure the compliance with the
order to ensure the
general safety requirement, the
compliance with the general
person that carries out the
safety requirement, the person substantial modification should
that carries out the substantial be considered as the
modification should be
manufacturer and subject to
considered as the
the same obligations. That
manufacturer and subject to
requirement should only apply
the same obligations. That
with respect to the modified
requirement should only
part of the product, provided
apply with respect to the
that the modification does not
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modified part of the product,
affect the product as a whole.
provided that the modification In order to avoid an
does not affect the product as
unnecessary and
a whole. In order to avoid an
disproportionate burden, the
unnecessary and
person carrying out the
disproportionate burden, the
substantial modification should
person carrying out the
not be required to repeat tests
substantial modification
and produce new
should not be required to
documentation in relation to
repeat tests and produce new
aspects of the product that are
documentation in relation to
not impacted by the
aspects of the product that are modification. It should be up to
not impacted by the
the person who carries out the
modification. It should be up
substantial modification to
to the person who carries out
demonstrate that the
the substantial modification to modification does not have an
demonstrate that the
impact on the product as a
modification does not have an whole. impact on the product as a
whole.
Recital 42
(42) Internal conformity
(42) Internal conformity
(42) Internal conformity
(42) Internal conformity
G 51
procedures through which
procedures through which
procedures through which
procedures through which
G
economic operators ensure,
economic operators ensure,
economic operators ensure,
economic operators ensure,
internally, the effective and
internally, the effective and
internally, the effective and
internally, the effective and
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swift performance of their
swift performance of their
swift performance of their
swift performance of their
obligation as well as the
obligation as well as the
obligation as well as the
obligation as well as the
conditions to react timely in
conditions to react timely in
conditions to react timely in
conditions to react timely in
case of a dangerous product,
case of a dangerous product,
case of a dangerous product,
case of a dangerous product,
should be put in place by the
should be put in place by the
should be put in place by the
should be put in place by the
economic operators themselves. economic operators themselves. economic operators themselves. economic operators themselves.
Text Origin:
Commission Proposal
Recital 43
(43) When making products
(43)
When making products
(43) When making products
available on the market,
available on the market,
available on the market,
deleted
economic operators should
economic operators should
economic operators should
provide minimum information
provide minimum information
provide minimum information
on product safety and
on product safety and
on product safety and
no text, see recital 44.
traceability as part of the
traceability as part of the
traceability as part of the
G 52
relevant offer. This should be
relevant offer. This should be
relevant offer. This should be
G
without prejudice to the
without prejudice to the
without prejudice to the
Text Origin:
information requirements laid
information requirements laid
information requirements laid
Commission Proposal
down by Directive 2011/83/EU
down by Directive 2011/83/EU
down by Directive 2011/83/EU
of the European Parliament and
of the European Parliament and of the European Parliament and
of the Council1, such as on the
of the Council1, such as on the
of the Council1, such as on the
main characteristics of the
main characteristics of the
main characteristics of the
goods, to the extent appropriate
goods, to the extent appropriate goods, to the extent appropriate
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to the medium and to the goods.
to the medium and to the goods. to the medium and to the goods.
_________
_________
_________
1. Directive 2011/83/EU of the
1.
Directive 2011/83/EU of the
1. Directive 2011/83/EU of the
European Parliament and of the
European Parliament and of the European Parliament and of the
Council of 25 October 2011 on
Council of 25 October 2011 on
Council of 25 October 2011 on
consumer rights, amending
consumer rights, amending
consumer rights, amending
Council Directive 93/13/EEC
Council Directive 93/13/EEC
Council Directive 93/13/EEC
and Directive 1999/44/EC of the
and Directive 1999/44/EC of the and Directive 1999/44/EC of the
European Parliament and of the
European Parliament and of the European Parliament and of the
Council and repealing Council
Council and repealing Council
Council and repealing Council
Directive 85/577/EEC and
Directive 85/577/EEC and
Directive 85/577/EEC and
Directive 97/7/EC of the
Directive 97/7/EC of the
Directive 97/7/EC of the
European Parliament and of the
European Parliament and of the European Parliament and of the
Council (OJ L 304, 22.11.2011,
Council (OJ L 304, 22.11.2011, Council (OJ L 304, 22.11.2011,
p. 64).
p. 64).
p. 64).
Recital 44
(44) Ensuring product
(44) Ensuring product
(44) Ensuring product
(44) Ensuring product
identification and the
identification
1aand information identification and the
identification
1aand information
traceability of products
on the manufacturer and other traceability of products
on the manufacturer and other
G 53
throughout the entire supply
relevant economic
throughout the entire supply
relevant economic operators
G
chain helps to identify economic
operatorsand the traceability of chain helps to identify economic throughout the entire supply
operators and to take effective
products throughout the entire
operators and to take effective
chain helps to identify economic
corrective measures against
supply chain helps to identify
corrective measures against
operators and
, where
dangerous products, such as
economic operators and
, where
dangerous products, such as
applicable, to take effective
and
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targeted recalls. Product
applicable, to take effective
and targeted recalls. Product
proportionate corrective
identification and traceability
proportionate corrective
identification and traceability
measures against dangerous
thus ensures that consumers and measures against dangerous
thus ensures that consumers and products, such as targeted
economic operators obtain
products, such as targeted
economic operators obtain
recalls. Product identification
accurate information regarding
recalls. Product identification
accurate information regarding
and
information on the
dangerous products which
and
traceabilityinformation on
dangerous products which
manufacturer and other
enhances confidence in the
the manufacturer and other
enhances confidence in the
relevant economic operators
market and avoids unnecessary
relevant economic operators
market and avoids unnecessary
thus ensures that consumers
,
disruption of trade. Products
thus ensures that consumers
,
disruption of trade. Products
including persons with
should therefore bear
including persons with
should therefore bear
disabilities, and market
information allowing their
disabilities, and market
information allowing their
surveillance authorities obtain
identification and the
surveillance authorities and
identification and the
accurate information regarding
identification of the
economic operators obtain
identification of the
dangerous products which
manufacturer and, if applicable, accurate information regarding
manufacturer and, if applicable, enhances confidence in the
of the importer. Such
dangerous products which
of the importer. Such
market and avoids unnecessary
traceability requirements could
enhances confidence in the
traceability requirements could
disruption of trade. Products
be made stricter for certain
market and avoids unnecessary
be made stricter for certain
should therefore bear
kinds of products.
disruption of trade. Products
kinds of products.
information allowing their
Manufacturers should also
should therefore bear
Manufacturers should also
identification and the
establish technical
information allowing their
establish technical
identification of the
documentations regarding their
identification and the
documentations regarding their
manufacturer and,
as applicable,
products, which should contain
identification of the
products, which should contain
of the importer
and other
the necessary information to
manufacturer and,
ifas
the necessary information to
relevant economic operators.
prove that their product is safe.
applicable, of the importer
and
prove that their product is safe.
Such ▌ requirements could be
other relevant economic
made stricter for certain kinds of
operators. Such
traceability
products
, susceptible to bear a
requirements could be made
serious risk to health and safety
stricter for certain kinds of
of consumers, by a system of
products
, susceptible to bear a
collection and storage of data
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serious risk to health and safety
enabling, besides the
of consumers, by a system of
identification of the product,
collection and storage of data
the identification of its
enabling, besides the
components or of the economic
identification of the product,
operators involved in its supply
the identification of its
chain. This should
be without
components or of the economic
prejudice to the information
operators involved in its supply
requirements laid down by
chain. This. Manufacturers
Directive 2011/83/EU1a of the
should
also establish technical
European Parliament and of
documentations regarding their
the Council, such as on the
products, which should contain
main characteristics of the
the necessary information to
goods, to the extent appropriate
prove that their product is
to the medium and to the
safebe without prejudice to the
goods. A picture should be
information requirements laid
considered as a photograph,
down by Directive
illustration or other
2011/83/EU1a of the European
pictographic element, which
Parliament and of the Council,
easily allows the identification
such as on the main
of a product
or potential
characteristics of the goods, to
product.
the extent appropriate to the
_________
medium and to the goods.
1a.
Directive 2011/83/EU of the
_________
European Parliament and of
1a.
Directive 2011/83/EU of the
the Council of 25 October 2011
European Parliament and of
on consumer rights, amending
the Council of 25 October 2011
Council Directive 93/13/EEC
on consumer rights, amending
and Directive 1999/44/EC of
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Council Directive 93/13/EEC
the European Parliament and
and Directive 1999/44/EC of
of the Council and repealing
the European Parliament and
Council Directive 85/577/EEC
of the Council and repealing
and Directive 97/7/EC of the
Council Directive 85/577/EEC
European Parliament and of
and Directive 97/7/EC of the
the Council (OJ L 304,
European Parliament and of
22.11.2011, p. 64).
the Council (OJ L 304,
22.11.2011, p. 64).
Text Origin: EP
Mandate
Recital 44a
(44a) Manufacturers should
Manufacturers should draw
also establish technical
up technical documentations
documentation regarding the
regarding the products they
products they place on the
place on the market, which
market, which should contain should contain the necessary
G 53a
the necessary information to
information to prove that these G
prove that these products are
products are safe. The
safe. In particular,
technical documentation
manufacturers should provide should be based on an internal
a general description of the
risk analysis carried out by the
product with the elements
manufacturer. The amount of
necessary to assess its safety as information to be provided in
well as the possible risks and
the technical documentation
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the solutions adopted to
should be proportionate to the
eliminate or mitigate such
complexity of the product and
risks. The amount of
possible risks identified by the
information and analysis to be manufacturer. In particular,
provided should be
manufacturers should provide
proportional to the complexity a general description of the
and possible risks identified
product and the elements
by the manufacturer. For
necessary to assess its safety. In
products not presenting
the case of complex products or
specific and particular risks,
products presenting possible
the information to be
risks, the information to be
provided in the technical
provided might need a more
documentation could be short extensive description of the
and limited to a generic
product. In such cases, also an
description of the product and analysis of those risks and the
to well established practices to technical means adopted to
eliminate or mitigate possible
mitigate or eliminate the risks
risks. On the other hand, the
should be included. In case the
information to be provided in
product complies with
case of complex products or
European standards or other
products presenting higher
elements applied to meet the
risks should include a more
general safety requirement, the
extensive description of the
list of the relevant European
product and of the technical
standards or the other elements
means adopted to face the
should also be indicated.
risks. In case the product
complies with European
standards or other elements
applied to meet the general
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safety requirement, the list of
these elements should also be
indicated.
Recital 44a
(44a) Manufacturers should
also establish technical
documentations regarding their
products, which should contain
no text here see row 53a.
the necessary information to
prove that their product is safe.
The amount of information to
be provided should be
proportionate to the complexity
G 53b
of the product and possible
G
risks. In particular,
manufacturers should provide
a general description of the
product and of its essential
properties relevant for
assessing its safety. In the case
of complex products or
products presenting higher
risks, the information to be
provided might need a more
extensive description of the
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product, including an analysis
of possible risks and the
technical means adopted to
mitigate or eliminate the risks.
In such cases if the product
complies with European
standards or other elements
applied to meet the general
safety requirement, the list of
those elements should also be
indicated.
Recital 45
(45) The legal framework for
(45)
The legal framework for
(45) The legal framework for
market surveillance of products
market surveillance of products market surveillance of products
deleted
covered by Union
covered by Union
covered by Union
harmonisation legislation and
harmonisation legislation and
harmonisation legislation and
set out in Regulation (EU)
set out in Regulation (EU)
set out in Regulation (EU)
no text here see row 18a.
G 54
2019/1020 and the legal
2019/1020 and the legal
2019/1020 and the legal
G
framework for market
framework for market
framework for market
surveillance of products covered
surveillance of products covered surveillance of products covered
Text Origin:
by this Regulation should be as
by this Regulation should be as
by this Regulation should be as
Commission Proposal
coherent as possible. It is
coherent as possible. It is
coherent as possible. It is
therefore necessary, as far as
therefore necessary, as far as
therefore necessary, as far as
market surveillance activities,
market surveillance activities,
market surveillance activities,
obligations, powers, measures,
obligations, powers, measures,
obligations, powers, measures,
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and cooperation among market
and cooperation among market
and cooperation among market
surveillance authorities are
surveillance authorities are
surveillance authorities are
concerned, to close the gap
concerned, to close the gap
concerned, to close the gap
between the two sets of
between the two sets of
between the two sets of
provisions. For that purpose
provisions. For that purpose
provisions. For that purpose
Articles 10 to 16, Articles 18
Articles 10 to 16, Articles 18
Articles 10 to 16, Articles 18
and 19 and Articles 21 to 24 of
and 19 and Articles 21 to 24 of
and 19 and Articles 21 to 24 of
Regulation (EU) 2019/1020
Regulation (EU) 2019/1020
Regulation (EU) 2019/1020
should be applicable also to
should be applicable also to
should be applicable also to
products covered by this
products covered by this
products covered by this
Regulation.
Regulation.
Regulation.
Recital 46
(46) To preserve the coherence (46) To preserve the coherence (46) To preserve the coherence (46) To preserve the coherence
of the market surveillance legal
of the market surveillance legal
of the market surveillance legal
of the market surveillance legal
framework and, at the same
framework and, at the same
framework and, at the same
framework and, at the same
time, ensure an effective
time, ensure an effective
time, ensure an effective
time, ensure an effective
cooperation between the
cooperation between the
cooperation between the
cooperation between the
G 55
European network of the
European network of the
European network of the
European network of the
G
Member States’ authorities
Member States’ authorities
Member States’ authorities
Member States’ authorities
competent for product safety
competent for product safety
competent for product safety
competent for product safety
(‘Consumer Safety Network’)
(‘Consumer Safety Network’)
(‘Consumer Safety Network’)
(‘Consumer Safety Network’)
provided for by this Regulation
provided for by this Regulation
provided for by this Regulation
provided for by this Regulation
and the Union Product
and the Union Product
and the Union Product
and the Union Product
Compliance Network aimed at
Compliance Network aimed at
Compliance Network aimed at
Compliance Network aimed at
structured coordination and
structured coordination and
structured coordination and
structured coordination and
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cooperation between Member
cooperation between Member
cooperation between Member
cooperation between Member
States’ enforcement authorities
States’ enforcement authorities
States’ enforcement authorities
States’ enforcement authorities
and the Commission provided
and the Commission provided
and the Commission provided
and the Commission provided
for by Regulation (EU)
for by Regulation (EU)
for by Regulation (EU)
for by Regulation (EU)
2019/1020, it is necessary to
2019/1020, it is necessary to
2019/1020, it is necessary to
2019/1020, it is necessary to
associate the Consumer Safety
associate the Consumer Safety
associate the Consumer Safety
associate the Consumer Safety
Network to the Union Product
Network to the Union Product
Network to the Union Product
Network to the Union Product
Compliance Network in the
Compliance Network in the
Compliance Network in the
Compliance Network in the
activities referred to in Articles
activities referred to in Articles
activities referred to in Articles
activities referred to in Articles
11, 12, 13 and 21 of Regulation 11, 12, 13 and 21 of Regulation 11, 12, 13 and 21 of Regulation 11, 12, 13 and 21 of Regulation
(EU) 2019/1020.
(EU) 2019/1020.
(EU) 2019/1020.
(EU) 2019/1020.
Text Origin:
Commission Proposal
Recital 46a
(46a) MemberStates should
ensure that any measure taken
by their competent authorities
G 55a
under this Regulation are
G
subject to effective judicial
remedies in accordance with
Article 47 of the Charter of
Fundamental Rights of the
European Union.
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Recital 47
(47) National authorities should (47) National authorities should (47) National authorities should (47) National authorities should
be enabled to complement the
be enabled to complement the
be enabled to complement the
be enabled to complement the
traditional market surveillance
traditional market surveillance
traditional market surveillance
traditional market surveillance
activities focused on safety of
activities focused on safety of
activities focused on safety of
activities focused on safety of
products with market
products with market
products with market
products with market
surveillance activities focusing
surveillance activities focusing
surveillance activities focusing
surveillance activities focusing
on the internal conformity
on the internal conformity
on the internal conformity
on the internal conformity
procedures set up by economic
procedures set up by economic
procedures set up by economic
procedures set up by economic
operators to ensure product
operators to ensure product
operators to ensure product
operators to ensure product
safety. Market surveillance
safety. Market surveillance
safety. Market surveillance
safety. Market surveillance
authorities should be able to
authorities should be able to
authorities should be able to
authorities should be able to
G 56
require the manufacturer to
require the manufacturer to
require the manufacturer to
require the manufacturer to
G
indicate which other products -
indicate which other products -
indicate which other products -
indicate which other products -
produced with the same
produced with the same
produced with the same
produced with the same
procedure, or containing the
procedure, or containing the
procedure, or containing the
procedure, or containing the
same components considered to same components considered to same components considered to same components considered to
present a risk or that are part of
present a risk or that are part of
present a risk or that are part of
present a risk or that are part of
the same production batch - are
the same production batch - are
the same production batch - are
the same production batch - are
affected by the same risk.
affected by the same risk.
affected by the same risk.
affected by the same risk.
Text Origin:
Commission Proposal
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Recital 47a
(47a) Market surveillance
authorities should conduct
redrafted and moved to 58a.
inspections on products
acquired under a cover identity
on a regular basis, in
G 56a
particular on those products
G
made available on online
marketplaces and products that
are most frequently notified on
the Safety Gate.
Recital 48
(48) An exchange of
(48) An exchange of
(48) An exchange of
(48) An exchange of
information between Member
information between Member
information between Member
information between Member
States and the Commission
States and the Commission
States and the Commission
States and the Commission
concerning the implementation
concerning the
concerning the implementation
concerning the
application of
G 57
of this Regulation should be
implementationapplication of
of this Regulation should be
this Regulation should be
G
established on the basis of
this Regulation should be
established on the basis of
established on the basis of
output indicators which would
established on the basis of
output indicators which would
output indicators which would
allow measuring and comparing output indicators which would
allow measuring and comparing allow measuring
the
Member States’ effectiveness in allow measuring
and comparing Member States’ effectiveness in effectiveness
of Union product
implementing Union product
Member States’the effectiveness implementing Union product
safety legislation.
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safety legislation.
in implementingof Union
safety legislation.
product safety legislation.
Recital 49
(49) There should be effective,
(49) There should be effective,
(49) There should be effective,
(49) There should be effective,
speedy and accurate exchange
speedy and accurate exchange
speedy and accurate exchange
speedy and accurate exchange
of information concerning
of information concerning
of information concerning
of information concerning
dangerous products.
dangerous products
to ensure
dangerous products.
dangerous products
to ensure
G 58
G
that appropriate measures are
that appropriate measures are
taken in relation to those
taken in relation to those
products and to protect
products and to protect
consumers fully.
consumers safety.
Recital 50
(50) The Union rapid
(50) The Union rapid
(50) The Union rapid
(50) The Union rapid
information system (RAPEX)
information system (RAPEX)
information system (RAPEX)
information system (RAPEX)
has proved its effectiveness and
has proved its effectiveness and has proved its effectiveness and
should be modernised to enable
G 59
efficiency. It enables corrective
efficiency. It enablesshould be
efficiency. It enables corrective
more efficient corrective
G
measures to be taken across the
modernised to enable more
measures to be taken across the
measures to be taken across the
Union in relation to products
efficient corrective measures to
Union in relation to products
Union in relation to products
that present a risk beyond the
be taken across the Union in
that present a risk beyond the
that present a risk beyond the
territory of a single Member
relation to products that present territory of a single Member
territory of a single Member
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State. It is opportune, though, to a risk beyond the territory of a
State. It is opportune, though, to State. It is opportune, though, to
change the used abbreviated
single Member State. It is
change the used abbreviated
change the used abbreviated
name from RAPEX to Safety
opportune, though, to change
name from RAPEX to Safety
name from RAPEX to Safety
Gate for greater clarity and
the used abbreviated name from Gate
Rapid Alert System for
Gate for greater clarity and
better outreach to consumers.
RAPEX to Safety Gate for
greater clarity and better
better outreach to consumers.
Safety Gate comprises a rapid
greater clarity and better
outreach to consumers. Safety
Safety Gate comprises
three
alert system on dangerous non-
outreach to consumers. Safety
Gate
Rapid Alert System
elements: first, a rapid alert
food products whereby national Gate comprises a rapid alert
comprises a rapid alert system
system on dangerous non-food
authorities and the Commission system on dangerous non-food
on dangerous non-food products products whereby national
can exchange information on
products whereby national
whereby national authorities and authorities and the Commission
such products, a web portal to
authorities and the Commission the Commission can exchange
can exchange information on
inform the public (Safety Gate
can exchange information on
information on such products
such products
(Safety Gate
portal) and an interface to
such products, a web portal to
(Safety Gate Rapid Alert
Rapid Alert System), second, a
enable businesses to comply
inform the public (Safety Gate
System), a web portal to inform web portal to inform the public
with their obligation to inform
portal) and an interface to
the public (Safety Gate portal)
and enable them to submit
authorities and consumers of
enable businesses to comply
and an interface to enable
complaints (Safety Gate portal)
dangerous products (Safety
with their obligation to inform
businesses to comply with their
and
third an interface to enable
Business Gateway).
authorities and consumers of
obligation to inform authorities
businesses to comply with their
dangerous products (Safety
and consumers of dangerous
obligation to inform authorities
Business Gateway).
In addition, products (Safety Business
and consumers of dangerous
the Commission should develop Gateway).
products
and accidents (Safety
an interoperable interface to
Business Gateway).
enable online marketplaces to
Interfaces must exist between
link their interfaces with the
the different Safety Gate
Safety Gate in an easy, quick
elements.
and reliable way.
The Safety Gate Rapid Alert
System is the internal system
through which authorities and
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the Commission exchange
information on measures
concerning dangerous
products, and it may contain
confidential information. An
extract of alerts should be
published on the Safety Gate
portal in order to inform the
public about dangerous
products. The Safety Business
Gateway is the web portal
through which businesses
inform market surveillance
authorities of the Member
States about dangerous
products and about accidents.
The Commission should
develop a technical solution to
ensure that the information
encoded by businesses in the
Safety Business Gateway that is
meant to alert consumers can
be made available to
consumers on the Safety Gate
Portal without undue delay. In
addition, the Commission
should develop an
interoperable interface to
enable providers of online
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marketplaces to link their
interfaces with the Safety Gate
Portal in an easy, quick and
reliable way.
Recital 51
(51) Member States should
(51) Member States should
(51) Member States should
(51) Member States should
notify in the Safety Gate both
notify in the Safety Gate both
notify in the Safety Gate
Rapid notify in the Safety Gate
Rapid
compulsory and voluntary
compulsory and voluntary
Alert System both compulsory
Alert System both compulsory
corrective measures that
corrective measures that
and voluntary corrective
and voluntary corrective
prevent, restrict or impose
prevent, restrict or impose
measures that prevent, restrict or measures that prevent, restrict or
specific conditions on the
specific conditions on the
impose specific conditions on
impose specific conditions on
possible marketing of a product possible marketing of a product
the possible marketing of a
the possible marketing of a
because of a serious risk to the
because of a serious risk to the
product because of a serious risk product because of a serious risk
G 60
health and safety of consumers
health and safety of consumers
to the health and safety of
to the health and safety of
G
or, in case of products covered
or, in case of products covered
consumers or, in case of
consumers or, in case of
by Regulation (EU) No
by Regulation (EU) No
products covered by Regulation products covered by Regulation
2019/1020, also to other
2019/1020, also to other
(EU) No 2019/1020, also to
(EU) No 2019/1020, also to
relevant public interests of the
relevant public interests of the
other relevant public interests of other relevant public interests of
end-users.
end-users.
the end-users.
▌ end-users.
Text Origin: Council
Mandate
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Recital 52
(52) Under Article 34 of
(52) Under Article 34 of
(52) Under Article 34 of
(52) Under Article 34 of
Regulation (EU) No 2019/1020, Regulation (EU)
No
Regulation (EU) No 2019/1020, Regulation (EU)
2019/1020,
Member States authorities are to
2019/10202019/1020, Member
Member States authorities are to Member States authorities are to
notify measures adopted against States authorities are to notify
notify measures adopted against notify measures adopted against
products covered by that
measures adopted against
products covered by that
products covered by that
Regulation, presenting a less
products covered by that
Regulation, presenting a less
Regulation, presenting a less
than serious risk, through the
Regulation, presenting a less
than serious risk, through the
than serious risk, through the
information and communication than serious risk, through the
information and communication information and communication
system referred to in the same
information and communication system referred to in the same
system referred to in the same
article, while corrective
system referred to in the same
article, while corrective
article, while corrective
measures adopted against
article, while corrective
measures adopted against
measures adopted against
products covered by this
measures adopted against
products covered by this
products covered by this
G 61
Regulation presenting a less
products covered by this
Regulation presenting a less
Regulation presenting a less
G
than serious risk should be
Regulation presenting a less
than serious risk should be
than serious risk
could also be
notified in the Safety Gate.
than serious risk should be
notified in the Safety Gate
notified in the Safety Gate
Member States and the
notified in the Safety Gate.
Rapid Alert System. Member
Rapid Alert System. Member
Commission should make
Member States and the
States and the Commission
States and the Commission
available to the public
Commission should make
should make available to the
should make available to the
information relating to risks to
available to the public
public information relating to
public information relating to
the health and safety of
information relating to risks to
risks to the health and safety of
serious risks to the health and
consumers posed by products. It the health and safety of
consumers posed by products. It safety of consumers posed by
is opportune for consumers and
consumers posed by products. It is opportune for consumers and
products. It is opportune for
businesses that all information
is opportune for consumers and
businesses that all information
consumers and businesses that
on corrective measures adopted
businesses that all information
on corrective measures adopted
all information on corrective
against products posing a risk
on corrective measures adopted
against products posing a risk
measures adopted against
are contained in the Safety Gate, against products posing a risk
are contained in the Safety Gate
products posing a
serious risk
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allowing relevant information
are contained in the Safety Gate,
Rapid Alert System, allowing
are contained in the Safety Gate
on dangerous products to be
allowing relevant information
relevant information on
Rapid Alert System, allowing
made available to the public
on dangerous products to be
dangerous products to be made
relevant information on
through the Safety Gate portal.
made available to the public
available to the public through
dangerous products to be made
Member States are therefore
through the Safety Gate portal.
the Safety Gate portal. Member
available to the public through
encouraged to notify in the
It is important to ensure that
States are therefore encouraged
the Safety Gate portal
. It is
Safety Gate all corrective
all of that information is
to notify in the Safety Gate all
important to ensure that all of
measures on products posing a
available in the official
corrective measures on products
that information is available in
risk to the health and safety of
language(s) of the consumer’s
posing a risk to the health and
the official language(s) of the
consumers.
Member State of residence and safety of consumers.
consumer’s Member State of
that it is written in clear and
residence and that it is written
understandable language.
in clear and understandable
Member States are therefore
language. Member States are
encouraged to notify in the
therefore encouraged to notify
Safety Gate all corrective
in the Safety Gate all corrective
measures on products posing a
measures on products posing a
risk to the health and safety of
risk to the health and safety of
consumers.
The database and
consumers.
website of the Safety Gate
should be accessible to persons
with disabilities.
Recital 53
G 62
(53) In case the information has (53) In case the information has (53) In case the information has (53) In case the information has G
to be notified in the information to be notified in the information to be notified in the information to be notified in the information
and communication system
and communication system
and communication system
and communication system
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according to Regulation (EU)
according to Regulation (EU)
according to Regulation (EU)
according to Regulation (EU)
2019/1020, there is the
2019/1020, there is the
2019/1020, there is the
2019/1020, there is the
possibility, for such
possibility, for such
possibility, for such
possibility, for such
notifications, to be submitted
notifications, to be submitted
notifications, to be submitted
notifications, to be submitted
directly in the Safety Gate or, to directly in the Safety Gate or, to directly in the Safety Gate
directly in the Safety Gate
be generated from within the
be generated from within the
Rapid Alert System or, to be
Rapid Alert System or, to be
information and communication information and communication generated from within the
generated from within the
system for market surveillance
system for market surveillance
information and communication information and communication
provided for in Article 34 of
provided for in Article 34 of
system for market surveillance
system for market surveillance
Regulation (EU) 2019/1020. For Regulation (EU) 2019/1020. For provided for in Article 34 of
provided for in Article 34 of
this purpose, the Commission
this purpose, the Commission
Regulation (EU) 2019/1020. For Regulation (EU) 2019/1020. For
should maintain and further
should maintain and further
this purpose, the Commission
this purpose, the Commission
develop the interface that has
develop the interface that has
should maintain and further
should maintain and further
been set up for the transfer of
been set up for the transfer of
develop the interface that has
develop the interface that has
information between the
information between the
been set up for the transfer of
been set up for the transfer of
information and communication information and communication information between the
information between the
system and the Safety Gate, in
system and the Safety Gate, in
information and communication information and communication
order to avoid double data entry order to avoid double data entry system and the Safety Gate
system and the Safety Gate
and facilitate such transfer.
and facilitate such transfer.
Rapid Alert System, in order to
Rapid Alert System, in order to
avoid double data entry and
avoid double data entry and
facilitate such transfer.
facilitate such transfer.
Recital 54
G 63
(54) The Commission should
(54) The Commission should
(54) The Commission should
(54) The Commission should
G
maintain and further develop the maintain and further develop the maintain and further develop the maintain and further develop the
Safety Business Gateway web
Safety Business Gateway web
Safety Business Gateway web
Safety Business Gateway web
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portal, enabling economic
portal, enabling economic
portal, enabling economic
portal, enabling economic
operators to comply with their
operators to comply with their
operators to comply with their
operators to comply with their
obligations to inform market
obligations to inform market
obligations to inform market
obligations to inform market
surveillance authorities and
surveillance authorities and
surveillance authorities and
surveillance authorities and
consumers of dangerous
consumers of dangerous
consumers of dangerous
consumers of dangerous
products they have placed or
products they have
placed or
products they have placed or
products they have ▌
made
made available on the market.
made available on the market.
made available on the market.
available on the market. ▌
It
This tool should also enable
This tool should also enable
This tool should also enable
should enable quick and
economic operators to inform
economic operators to inform
economic operators to inform
efficient information exchange
market surveillance authorities
market surveillance authorities
market surveillance authorities
between economic operators
of accidents caused by products of accidents caused by products of accidents caused by products and national authorities, and
they have placed or made
they have
placed or made
they have placed or made
facilitate information to
available on the market. It
available on the market.
available on the market. It
consumers from economic
should enable quick and
ItEconomic operators should
should enable quick and
operators.
efficient information exchange
enable quick and efficientaim to efficient information exchange
between economic operators
investigate complaints and
between economic operators
and national authorities, and
information
exchange between
and national authorities, and
facilitate information to
economic operators andon
facilitate information to
consumers from economic
accidents from consumers as
consumers from economic
operators.
quickly as possible in order to
operators.
ensure timely and efficient
information exchange with national authorities, and
facilitate information to
consumers from economic
operators.
Recital 54a
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(54a) Ensuring that
manufacturers notify accidents
that are caused by a product
they made available on the
market will improve the
information available to market
surveillance authorities and
allow for a better identification
of potentially dangerous
categories of products. Rules
on product liability of
G 63a
economic operators for
G
defective products are laid
down in specific Union
legislation and such
notification and collection of
data should not therefore be
considered as an admission of
liability for a defective product
nor as confirmation of liability
under the relevant Union or
national legislation.
Recital 54b
G 63b
G
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(54b) In order to be able to
detect early emerging new risks
and other product safety
related market trends, all
interested parties, including
consumer or business
organisations, should be
encouraged to signal to market
surveillance authorities and to
the Commission information
available to them to detect and
investigate infringements of
this Regulation.
Recital 55
(55) There might be cases
(55) There might be cases
(55) There might be cases
(55) There might be cases
where it is necessary to deal
where it is necessary to deal
where it is necessary to deal
where it is necessary to deal
with a serious risk at the Union
with a serious risk at the Union
with a serious risk at the Union
with a serious risk at the Union
level where the risk cannot be
level where the risk cannot be
level where the risk cannot be
level where the risk cannot be
G 64
contained satisfactorily by
contained satisfactorily by
contained satisfactorily by
contained satisfactorily by
G
means of measures taken by the means of measures taken by the means of measures taken by the means of measures taken by the
Member State concerned or by
Member State concerned or by
Member State concerned or by
Member State concerned or by
any other procedure under
any other procedure under
any other procedure under
any other procedure under
Union legislation. This could
Union legislation. This could
Union legislation. This could
Union legislation. This could
notably be the case of new
notably be the case of new
notably be the case of new
notably be the case of new
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emerging risks or those
emerging risks or those
emerging risks or those
emerging risks or those
impacting vulnerable
impacting vulnerable
impacting vulnerable
impacting vulnerable
consumers. For that reason the
consumers. For that reason the
consumers. For that reason the
consumers. For that reason the
Commission can adopt
Commission can adopt
Commission can adopt
Commission can adopt
measures either on its own
measures either on its own
measures either on its own
measures either on its own
initiative or upon request of the
initiative or upon request of the
initiative or upon request of the
initiative or upon request of the
Member States. Such measures
Member States
or relevant
Member States. Such measures
Member States. Such measures
should be adapted to the gravity
interested parties. Such
should be adapted to the gravity should be adapted to the gravity
and urgency of the situation. It
measures should be adapted to
and urgency of the situation. It
and urgency of the situation. It
is furthermore necessary to
the gravity and urgency of the
is furthermore necessary to
is furthermore necessary to
provide for an adequate
situation. It is furthermore
provide for an adequate
provide for an adequate
mechanism whereby the
necessary to provide for an
mechanism whereby the
mechanism whereby the
Commission could adopt
adequate mechanism whereby
Commission could adopt
Commission could adopt
immediately applicable interim
the Commission could adopt
immediately applicable interim
immediately applicable interim
measures.
immediately applicable interim
measures.
measures.
measures.
see recital 54b, row 63
Recital 56
(56) The determination of the
(56) The determination of the
(56) The determination of the
(56) The determination of the
risk concerning a product and its risk concerning a product and its risk concerning a product and its risk concerning a product and its
G 65
level is based on a risk
level is based on a risk
level is based on a risk
level is based on a risk
G
assessment performed by the
assessment performed by the
assessment performed by the
assessment performed by the
relevant actors. Member States,
relevant actors. Member States,
relevant actors. Member States,
relevant actors. Member States,
in performing risk assessment,
in performing risk assessment,
in performing risk assessment,
in performing risk assessment,
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might reach different results as
might reach different results as
might reach different results as
might reach different results as
far as the presence of a risk or
far as the presence of a risk or
far as the presence of a risk or
far as the presence of a risk or
its level is concerned. This
its level is concerned. This
its level is concerned. This
its level is concerned. This
could jeopardise the correct
could jeopardise the correct
could jeopardise the correct
could jeopardise the correct
functioning of the single market functioning of the single market functioning of the single market functioning of the single market
and the level playing field for
and the level playing field for
and the level playing field for
and the level playing field for
both consumers and economic
both consumers and economic
both consumers and economic
both consumers and economic
operators. An arbitration
operators. An arbitration
operators. An arbitration
operators.
A mechanism should
mechanism should therefore be
mechanism should therefore be
mechanism should therefore be
therefore be
established to
made available to Member
made available to Member
made available to Member
allow the Commission ▌ to
States, on a voluntary basis,
States, on a voluntary basis,
States, on a voluntary basis,
provide an opinion on the issue
which would allow the
which would established to
which would allow the
in dispute.
Commission, to provide an
allow the Commission
, to
Commission, to provide an
opinion on the issue in dispute.
provide an opinion on the issue
opinion on the issue in dispute.
in dispute.
Recital 56a
(56a) The Commission should
(56a) The Commission should
draw up a periodic report on
draw up a periodic report on
the application of the
the application of the
G 65a
arbitration mechanism for risk
mechanism under Article 27 ,
G
assessments, which should be
which should be presented to
presented to the Consumer
the Consumer Safety Network.
Safety Network. That report
That report should identify the
should identify the main
main criteria applied by the
criteria applied by the Member
Member States for risk
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States for risk assessment and
assessment and their impact on
their impact on the internal
the internal market and on an
market and on an equal level of
equal level of consumer
consumer protection, with the
protection, with the aim of
aim of enabling Member States
enabling Member States and
and the Commission to
the Commission to harmonise
harmonise the approaches and
the approaches and criteria for
criteria for risk assessment.
risk assessment.
Recital 57
(57) The Consumer Safety
(57) The Consumer Safety
(57) The Consumer Safety
(57) The Consumer Safety
Network enhances the
Network enhances the
Network enhances the
Network enhances the
cooperation on product safety
cooperation on product safety
cooperation on product safety
cooperation on product safety
enforcement between Member
enforcement between Member
enforcement between Member
enforcement between Member
States. In particular, it facilitates States. In particular, it facilitates States. In particular, it facilitates States. In particular, it facilitates
the activities of exchange of
the activities of exchange of
the activities of exchange of
the activities of exchange of
information, the organisation of information, the organisation of information, the organisation of information, the organisation of
G 66
joint market surveillance
joint market surveillance
joint market surveillance
joint market surveillance
G
activities, the exchange of
activities, the exchange of
activities, the exchange of
activities, the exchange of
expertise and best practices. The expertise and best practices.
It
expertise and best practices. The expertise and best practices.
It
Consumer Safety Network
should also contribute to
Consumer Safety Network
should also contribute to
should be duly represented and
harmonisation of the
should be duly represented and
harmonisation of the
participate in the coordination
methodologies to collect data
participate in the coordination
methodologies to collect data
and cooperation activities of the
on product safety, as well as to
and cooperation activities of the
on product safety, as well as to
Union Product Compliance
an increase in the
Union Product Compliance
an increase in the
Network provided for in
interoperability between
Network provided for in
interoperability between
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Regulation (EU) 2019/1020
regional, sectorial, national
Regulation (EU) 2019/1020
regional, sectorial, national
whenever coordination of
and European information
whenever coordination of
and European information
activities falling under the scope
systems for product safety. The activities falling under the scope
systems for product safety. The
of application of both
Consumer Safety Network
of application of both
Consumer Safety Network
Regulations is necessary to
should be duly represented and
Regulations is necessary to
should be duly represented and
ensure their effectiveness.
participate in the coordination
ensure their effectiveness.
participate in the coordination
and cooperation activities of the
and cooperation activities of the
Union Product Compliance
Union Product Compliance
Network provided for in
Network provided for in
Regulation (EU) 2019/1020
Regulation (EU) 2019/1020
whenever coordination of
whenever coordination of
activities falling under the scope
activities falling under the scope
of application of both
of application of both
Regulations is necessary to
Regulations is necessary to
ensure their effectiveness.
ensure their effectiveness.
Recital 58
(58) Market surveillance
(58) Market surveillance
(58) Market surveillance
(58) Market surveillance
authorities might carry out joint authorities
mightshould carry
authorities might carry out joint authorities
should carry out
activities with other authorities
out joint activities with other
activities with other authorities
joint activities with other
G 67
or organisations representing
authorities or organisations
or organisations representing
authorities or organisations
G
economic operators or end
representing economic operators economic operators or end users
representing economic operators
users, with a view to promoting or end users, with a view to
consumers, with a view to
or
consumers, with a view to
safety of products and
promoting safety of products
promoting safety of products
promoting safety of products
identifying dangerous products, and identifying dangerous
and identifying dangerous
and identifying dangerous
including those that are offered
products, including those that
products, including those that
products, including those that
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for sale online. In doing so the
are offered for sale online. In
are offered for sale online. In
are offered for sale online. In
market surveillance authorities
doing so the market surveillance doing so the market surveillance doing so the market surveillance
and the Commission, as
authorities and the Commission, authorities and the Commission, authorities and the Commission,
appropriate, should ensure that
as appropriate, should ensure
as appropriate, should ensure
as appropriate, should ensure
the choice of products and
that the choice of products and
that the choice of products and
that the choice of products and
producers as well as the
producers as well as the
producers as well as the
producers as well as the
activities performed does not
activities performed does not
activities performed does not
activities performed does not
create situation which might
create
situationsituations, which create situation which might
create
situations, which might
distort competition or affect the might distort competition or
distort competition or affect the distort competition or affect the
objectivity, independence and
affect the objectivity,
objectivity, independence and
objectivity, independence and
impartiality of the parties.
independence and impartiality
impartiality of the parties.
The
impartiality of the parties.
The
of the parties.
market surveillance
market surveillance authorities
authorities should make
should make available to the
available to the public the
public the agreements on joint
agreements on joint activities
activities as soon as possible,
as soon as possible, providing
providing such publication
such publication does not
does not jeopardise the
jeopardise the effectiveness of effectiveness of the activities to
the activities to be
be undertaken.
undertaken.
Recital 58a
(58a) The Commission should
G 67a
organise on regular basis a
G
joint activity whereby market
surveillance authorities should
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conduct inspections on
products acquired under a
cover identity online or offline,
in particular on those products
that are most frequently
notified within the Safety Gate.
Recital 59
(59) Simultaneous coordinated
(59) Simultaneous coordinated
(59) Simultaneous coordinated
(59) Simultaneous coordinated
control actions (‘sweeps’) are
control actions (‘sweeps’) are
control actions (‘sweeps’) are
control actions (‘sweeps’) are
specific enforcement actions
specific enforcement actions
specific enforcement actions
specific enforcement actions
that can further enhance product that can further enhance product that can further enhance product that
could further enhance
safety. In particular, sweeps
safety
. and therefore should be safety. In particular, sweeps
product safety
and therefore
should be conducted where
conducted on a regular basis to should be conducted where
should be conducted to detect
market trends, consumer
detect online and offline
market trends, consumer
online and offline
G 68
complaints or other indications
infringements to this
complaints or other indications
infringements to this
G
suggest that certain product
Regulation, In particular,
suggest that certain product
Regulation, In particular,
categories are often found to
sweeps should be conducted
categories are often found to
sweeps should be conducted
present a serious risk.
where market trends, consumer
present a serious risk.
where market trends, consumer
complaints or other indications
complaints or other indications
suggest that certain product
suggest that certain
products or
categories are often found to
product categories are often
present a serious risk.
found to present a serious risk.
Recital 60
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(60) The public interface of the (60) The public interface of the (60) The public interface of the (60) The public interface of the
Safety Gate, the Safety Gate
Safety Gate, the Safety Gate
Safety Gate
Rapid Alert
Safety Gate
Rapid Alert System,
portal, allows the general
portal, allows the general
System, the Safety Gate portal,
the Safety Gate portal, allows
public, including consumers,
public, including consumers,
allows the general public,
the general public, including
economic operators and online
economic operators and online
including consumers, economic consumers, economic operators
marketplaces, to be informed
marketplaces, to be informed
operators and online
and
providers of online
about corrective measures taken about corrective measures taken marketplaces, to be informed
marketplaces, to be informed
against dangerous products
against dangerous products
about corrective measures taken about corrective measures taken
present on the Union market. A
present on the Union market. A
against dangerous products
against dangerous products
separate section of the Safety
separate section of the Safety
present on the Union market. A
present on the Union market. A
Gate portal enables consumers
Gate portal enables consumers
separate section of the Safety
separate section of the Safety
to inform the Commission of
to inform the Commission of
Gate portal enables consumers
Gate portal enables consumers
G 69
products presenting a risk to
products presenting a risk to
to inform the Commission of
to inform the Commission of
G
consumer health and safety
consumer health and safety
products presenting a risk to
products presenting a risk to
found in the market. Where
found in the market. Where
consumer health and safety
consumer health and safety
relevant, the Commission
relevant, the Commission
found in the market. Where
found in the market. Where
should provide adequate follow- should provide adequate follow- relevant, the Commission
relevant, the Commission
up, notably by transmitting such up, notably by transmitting such should provide adequate follow- should provide adequate follow-
information to the concerned
information to the concerned
up, notably by transmitting such up, notably by transmitting such
national authorities.
national authorities.
The
information to the concerned
information to the concerned
database and website of the
national authorities.
national authorities.
The
Safety Gate should be easily
database and website of the
accessible for persons with
Safety Gate should be easily
disabilities.
accessible for persons with
disabilities.
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Recital 60a
(60a) After verification of
accuracy of information
received from consumers and
other interested parties, the
Commission should ensure an
appropriate follow up. In
particular, it should forward
the information to the relevant
G 69a
Member States so that the
G
competent market surveillance
authority can proceed as
appropriate and needed. It is
important that consumers and
other interested parties are
properly informed of the
Commission action.
Recital 61
(61) In making available
(61)
Public access to the
(61) In making available
(61)
Public access to the
G 70
information on product safety to
information available to the
information on product safety to
information available to the
G
the public, professional secrecy,
authorities on product safety
the public, professional secrecy,
authorities on product safety
as referred to in Article 339 of
should, as a general rule, be
as referred to in Article 339 of
should, as a general rule, be
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the Treaty, should be protected
ensured. However, in making
the Treaty, should be protected
ensured. However, in making
in a way which is compatible
available information on
in a way which is compatible
available information on
with the need to ensure the
product safety to the public,
with the need to ensure the
product safety to the public,
effectiveness of market
professional secrecy, as referred effectiveness of market
professional secrecy, as referred
surveillance activities and of
to in Article 339 of the Treaty,
surveillance activities and of
to in Article 339 of the Treaty,
protection measures.
should be protected in a way
protection measures.
should be protected in a way
which is compatible with the
which is compatible with the
need to ensure the effectiveness
need to ensure the effectiveness
of market surveillance activities
of market surveillance activities
and of protection measures.
and of protection measures.
Recital 61a
(61a) Complaints are
(61a) Complaints are
important to raise awareness
important to raise awareness
on national authorities about
on national authorities about
safety and effectiveness of
safety and effectiveness of
surveillance and control
surveillance and control
activities on dangerous
activities on dangerous
G 70a
products. Member States
products. Member States
G
should therefore give to
should therefore give to
consumers and other
consumers and other interested
interested parties such as
parties such as consumer
consumer associations and
associations and economic
economic operators the
operators the possibility to
possibility to submit
submit complaints in this
complaints in this respect.
respect.
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Recital 62
(62) When a product already
(62) When a product already
(62) When a product already
(62) When a product already
sold to consumers turns out to
sold to consumers turns out to
sold to consumers turns out to
sold to consumers turns out to
be dangerous, it may need to be be dangerous, it may need to be be dangerous, it may need to be be dangerous, it may need to be
recalled to protect consumers in recalled to protect consumers in recalled to protect consumers in recalled to protect consumers in
the Union. Consumers might not the Union. Consumers might not the Union. Consumers might not the Union. Consumers might not
be aware that they own a
be aware that they own a
be aware that they own a
be aware that they own a
recalled product. In order to
recalled product. In order to
recalled product. In order to
recalled product. In order to
increase recall effectiveness, it
increase recall effectiveness, it
increase recall effectiveness, it
increase recall effectiveness, it
is therefore important to better
is therefore important to better
is therefore important to better
is therefore important to better
reach consumers concerned.
reach consumers concerned.
reach consumers concerned.
reach consumers concerned.
Direct contact is the most
Direct contact is the most
Direct contact is the most
Direct contact is the most
G 71
effective method to increase
effective method to increase
effective method to increase
effective method to increase
G
consumers’ awareness of recalls consumers’ awareness of recalls consumers’ awareness of recalls consumers’ awareness of recalls
and encourage action. It is also
and encourage action. It is also
and encourage action. It is also
and encourage action. It is also
the preferred communication
the preferred communication
the preferred communication
the preferred communication
channel across all groups of
channel across all groups of
channel across all groups of
channel across all groups of
consumers. In order to ensure
consumers. In order to ensure
consumers. In order to ensure
consumers. In order to ensure
the safety of the consumers, it is the safety of the consumers, it is the safety of the consumers, it is the safety of the consumers, it is
important that they are informed important that they are informed important that they are informed important that they are informed
in a quick and reliable way.
in a quick and reliable way.
in a quick and reliable way.
in a quick and reliable way.
Economic operators should
Economic operators
and, where Economic operators should
Economic operators
and, where
therefore use the customer data
applicable, online marketplaces therefore
ensure that all
applicable, providers of online
at their disposal to inform
should therefore use the
customers affected by a recall marketplaces should therefore
consumers of recalls and safety
customer data at their disposal
or a safety warning that can
use the customer data at their
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warnings linked to products
to inform consumers of recalls
be identified are notified
disposal to inform consumers of
they have purchased. Therefore, and safety warnings linked to
directly. Such information can recalls and safety warnings
a legal obligation is needed to
products they have purchased.
be provided either directly by linked to products they have
require economic operators to
Therefore, a legal obligation is
economic operators using use
purchased. Therefore, a legal
use any customer data already at needed to require economic
the customer data at their
obligation is needed to require
their disposal to inform
operators
and online
disposal
, or through third
economic operators
and
consumers of recalls and safety
marketplaces to use any
parties having access to data
providers of online
warnings. In this respect,
customer data already at their
identifying to inform
marketplaces to use any
economic operators will make
disposal to inform consumers of consumers of recalls
customer data already at their
sure to include the possibility to recalls and safety warnings. In
and
affected by a recall or a
disposal to inform consumers of
directly contact customers in the this respect, economic operators
safety warnings linked to
recalls and safety warnings. In
case of a recall or safety
and online marketplaces will
products they have
this respect, economic operators
warning affecting them in
make sure to include the
purchased
warning, such as
and providers of online
existing customer loyalty
possibility to directly contact
insurance or banking
marketplaces will make sure to
programmes and product
customers in the case of a recall
institutions. Therefore, a legal
include the possibility to
registration systems, through
or safety warning affecting them obligation is needed to require
directly contact customers in the
which customers are asked, after in existing customer loyalty
economic operators to use any
case of a recall or safety
having purchased a product, to
programmes and product
customer data already at their
warning affecting them in
communicate to the
registration systems, through
disposal to inform consumers of existing customer loyalty
manufacturer on a voluntary
which customers are asked, after recalls and safety warnings. In
programmes and product
basis some information such as
having purchased a product, to
this respect, economic operators registration systems, through
their name, contact information, communicate to the
will
should also make sure to
which customers are asked, after
the product model or serial
manufacturer on a voluntary
include the possibility to
having purchased a product, to
number.
basis some information such as
directly contact customers in the communicate to the
their name, contact information, case of a recall or safety
manufacturer on a voluntary
the product model or serial
warning affecting them in
basis some information such as
number.
existing customer loyalty
their name, contact information,
programmes
enabling the
the product model or serial
identification of products
number.
The mere fact that
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bought by consumers and
recalls are targeted to
product registration systems,
consumers should not prevent
through which customers are
economic operators and
asked, after having purchased a
providers of online
product, to communicate to the
marketplaces from making all
manufacturer on a voluntary
customers aware of a product
basis some information such as
recall notice nor from offering
their name, contact information,
remedies to other end-users.
the product model or serial
Economic operators and
number.
providers of online market
places should be encouraged to
take such actions, especially in
the case of micro- and small
enterprises acting like
consumers.
Recital 62a
(62a) Consumers should be
encouraged to register products
in order to receive information
G 71a
about recalls and safety
G
warnings. The Commission
should be empowered to adopt
implementing acts in order to
specify that for some specific
products or categories of
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products, consumers should
always have the possibility to
register a product they have
purchased in order to be
directly notified about a recall
or a safety warning related to
this product. In determining
the specific products or
categories or products subject
to this requirement, due
consideration should be given
to the lifecycle of the products
or categories of products at
stake, as well as to the risks the
products pose, the frequency of
recalls and the category of
users of the products, in
particular vulnerable
consumers.
Recital 63
(63) A third of consumers
(63) A third of consumers
(63) A third of consumers
(63) A third of consumers
G 72
continue using dangerous
continue using dangerous
continue using dangerous
continue using dangerous
G
products despite seeing a recall
products despite seeing a recall
products despite seeing a recall
products despite seeing a recall
notice, notably because recall
notice, notably because recall
notice, notably because recall
notice, notably because recall
notices are drafted in a complex notices are drafted in a complex notices are drafted in a complex notices are drafted in a complex
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way or minimise the risk at
way or minimise the risk at
way or minimise the risk at
way or minimise the risk at
stake. The recall notice should
stake. The recall notice should
stake. The recall notice should
stake. The recall notice should
therefore be clear, transparent
therefore be clear, transparent
therefore be clear, transparent
therefore be clear, transparent
and clearly describe the risk at
and clearly describe the risk at
and clearly describe the risk at
and clearly describe the risk at
stake, avoiding any terms,
stake, avoiding any terms,
stake, avoiding any terms,
stake, avoiding any terms,
expressions or other elements
expressions or other elements
expressions or other elements
expressions or other elements
that may decrease consumers'
that may decrease consumers'
that may decrease consumers'
that may decrease consumers'
perception of risk. Consumers
perception of risk. Consumers
perception of risk. Consumers
perception of risk. Consumers
should also be able to get more
should also be able to get more
should also be able to get more
should also be able to get more
information, if needed, via a
information, if needed, via a
information, if needed, via a
information, if needed, via a
toll-free telephone number or
toll-free telephone number or
toll-free telephone number or
toll-free telephone number or
other interactive instrument.
other interactive instrument.
other interactive instrument.
other interactive instrument.
Recital 64
(64) To encourage consumer
(64) To encourage consumer
(64) To encourage consumer
(64) To encourage consumer
response to recalls it is also
response to recalls it is also
response to recalls it is also
response to recalls it is also
important that the action
important that the action
important that the action
important that the action
required from consumers be as
required from consumers be as
required from consumers be as
required from consumers be as
simple as possible and that the
simple as possible and that the
simple as possible and that the
simple as possible and that the
G 73
remedies offered be effective,
remedies offered be effective,
remedies offered be effective,
remedies offered be effective,
G
cost-free and timely. Directive
cost-free and timely. Directive
cost-free and timely. Directive
cost-free and timely. Directive
(EU) 2019/771 of the European (EU) 2019/771 of the European
(EU) 2019/771 of the European (EU) 2019/771 of the European
Parliament and of the Council1
Parliament and of the Council1
Parliament and of the Council1
Parliament and of the Council
1
provides the consumers with the provides the consumers with the provides the consumers with the provides the consumers with the
contractual remedies for a lack
contractual remedies for a lack
contractual remedies for a lack
contractual remedies for a lack
of conformity of goods that
of conformity of goods that
of conformity of goods that
of conformity of
physical goods
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existed at the time of delivery
existed at the time of delivery
existed at the time of delivery
that existed at the time of
and became apparent within the and became apparent within the and became apparent within the delivery and became apparent
liability period. The economic
liability period. The economic
liability period
laid down by
within the liability period
laid
operator responsible for the
operator responsible for the
the Member States in
down by the Member States in
recall should provide similar
recall should provide similar
accordance with Article 10(3)
accordance with Article 10(3)
remedies to the consumer.
remedies to the consumer.
of that Directive.
However,
of that Directive. Article 14 of
_________
_________
situations where dangerous
Directive (EU) 2019/770 of the
products are recalled from the European Parliament and of
1. Directive (EU) 2019/771 of
1. Directive (EU) 2019/771 of
market justify having a
the Council x also applies in
the European Parliament and of the European Parliament and of
specific set of rules that should terms of the tangible medium,
the Council of 20 May 2019 on
the Council of 20 May 2019 on
be applied without prejudice
such as DVDs, CDs, USB sticks
certain aspects concerning
certain aspects concerning
to contractual remedies
and memory cards, used to
contracts for the sale of goods,
contracts for the sale of goods,
because their objectives are
carry a digital content.
amending Regulation (EU)
amending Regulation (EU)
different. Whereas
However, situations where
2017/2394 and Directive
2017/2394 and Directive
contractual remedies serve the dangerous products are
2009/22/EC, and repealing
2009/22/EC, and repealing
purpose to remedy the lack of recalled from the market justify
Directive 1999/44/EC (OJ L
Directive 1999/44/EC (OJ L
conformity of the goods with
having a specific set of rules
136, 22. 5. 2019, p. 28).
136, 22. 5. 2019, p. 28).
the contract, the remedies in
that should be applied without
case of a recall serve both to
prejudice to contractual
ensure elimination of
remedies because their
dangerous products from the
objectives are different.
market and an adequate
Whereas contractual remedies
remedy The economic operator
serve the purpose to remedy the
responsible for the
consumer.
lack of conformity of the goods
As a consequence, there are
with the contract, the remedies
major differences between the in case of a recall serve both to
two sets of remedies: firstly, in ensure elimination of
case of a product recall
dangerous products from the
according to this Regulation,
market and an adequate
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there should provide similar
be
remedy for the
consumer. As a
no time limitation to activate
consequence, there are major
the remedies
; secondly, the
differences between the two
consumer should be entitled to sets of potential remedies:
ask remedies from the
firstly, in case of a product
relevant economic operator,
recall
according to this
not necessarily from the
Regulation, there should
be no
trader. Moreover, in case of a
time limitation to activate the
recall, to the consumer
does
remedies
; secondly, the
not have to prove the product
consumer should be entitled to
to be dangerous (not
ask remedies from the relevant
conforming the safety
economic operator, not
requirements).
necessarily from the trader.
_________
Moreover, in case of a recall,
the consumer
does not have to
1. Directive (EU) 2019/771 of
prove the product to be
the European Parliament and of
dangerous.
the Council of 20 May 2019 on
certain aspects concerning
contracts for the sale of goods,
amending Regulation (EU)
2017/2394 and Directive
2009/22/EC, and repealing
Directive 1999/44/EC (OJ L
136, 22. 5. 2019, p. 28).
Recital 64a
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(64a) Given the different
(64a) Given the different
objectives of remedies
objectives of remedies provided
provided in case of a recall of
in case of a recall of a
a dangerous product and
dangerous
remedies for non-comformity
product and remedies for non-
of goods with the contract,
conformity of goods with the
consumers should use the
contract, consumers
system corresponding to the
relevant situation. For
should use the system
example, if the consumer
corresponding to the relevant
receives a recall notice with
situation. For example, if the
G 73a
description of the remedies
consumer receives a recall
G
available to the consumer, the notice with description of the
consumer should act
remedies available to the
according to the instructions
consumer, the consumer
in the recall notice.
should act according to the
Nevertheless, he or she should instructions in the recall notice.
not be deprived of the
Nevertheless, he or she should
possibility to ask for remedies not be deprived of the
from the seller based on non-
possibility to ask for remedies
conformity of the dangerous
from the seller based on non-
goods with the contract.
conformity of the dangerous
goods with the contract.
Recital 64a
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(64a) The Commission should
publish guidance to market
surveillance authorities to
ensure more uniform
No text here, the following text
enforcement when dealing with
"Member States should also
G 73b
recalls. Member States should
ensure that the authorities have G
also ensure that the authorities
sufficient expertise and
have sufficient expertise and
resources for all their
resources for all their
enforcement activities." moved
enforcement activities.
to Recital 9b new
Recital 64b
(64b) Once the consumer was (64c) Once the consumer was
remedied as a follow up of a
remedied as a follow up of a
recall, the consumer could not recall, the consumer could not
be entitled to a remedy for
be entitled to
non-conformity of the good
a remedy for non-conformity of
G 73c
with the contract for reasons
the good with the contract for
G
connected with the fact that
reasons connected with the fact
the product was dangerous
that the product was dangerous
because the non-conformity
because the non-conformity
does not exist any more.
does not exist anymore.
Similarly, in case the
Similarly, in case the consumer
consumer invokes its rights to
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remedy under Directive (EU)
invokes its rights to remedy
2019/771 or Directive (EU)
under Directive (EU) 2019/771
2019/770, the consumer is not
or Directive (EU) 2019/770, the
entitled to a remedy under
consumer is not entitled to a
this Regulation for the same
remedy under this Regulation
safety isssue. However, if
for the same safety issue.
other requirements for
However, if other requirements
conformity regarding the
for conformity regarding the
same good are not fulfilled,
same good are not fulfilled, the
the seller would remain liable
seller would remain liable for
for such non-conformity of the such non-conformity of the
good with the contract even if
good
there has been a remedy
with the contract even if there
provided to the consumer
has been a remedy provided to
following a recall of a
the consumer
dangerous product.
following a recall of a
dangerous product.
Recital 64c
(64c) Economic operators
(64d) Economic operators
initiating a product recall
initiating a product recall
G 73d
should offer consumers, under should offer consumers at least G
the control of the national
two options between repair,
competent authorities, at least replacement, or adequate
two options between repair,
refund of the value of the
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replacement, or adequate
recalled
refund of the value of the
product, except where
recalled product, except
impossible or disproportionate.
where impossible or
Offering consumers a choice
disproportionate. Offering
between remedies can improve
consumers a choice between
the effectiveness of a recall. In
remedies can improve the
addition, incentives to motivate
effectiveness of a recall. In
consumers to participate in a
addition, incentives to
recall, such as discounts or
motivate consumers to
vouchers, should be
participate in a recall, such as encouraged in order to
discounts or vouchers, should
increase the effectiveness of
be encouraged in order to
recalls. The repair of the
increase the effectiveness of
product should only be
recalls. The repair of the
considered a possible remedy if
product should only be
the safety of the repaired
considered a possible remedy
product can be ensured. The
if the safety of the repaired
amount of the refund should be
product can be ensured. The
at least equal to the price paid
amount of the refund should
by the consumer, without
be at least equal to the price
prejudice to a further
paid by the consumer, without compensation as provided for
prejudice to a further
in national laws. Where no
compensation as provided for
proof of the price paid is
in national laws. In case of
available, an adequate refund
recalls of digital products in
of the value of the recalled
the meaning of Article 2(1) of
product should still be
Directive (EU) 2019/770, the
provided. In case of recalls of
refund should cover all sums
the tangible medium of digital
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paid by the consumer under
products in the meaning of
the contract, as provided for
Article 2(1) of Directive (EU)
by Article 16(1) of that
2019/770, the refund
Directive. Any remedy should should cover all sums paid by
be without prejudice to the
the consumer under the
consumers’ right to damages
contract, as provided for
according to national laws.
by Article 16(1) of that
Directive. Any remedy should
be without prejudice to the
consumers’ right to damages
according to national laws.
Recital 64d
(64d) Remedies offered in
(64e) Remedies offered in case
case of a product safety recall
of a product safety recall
should not place an excessive
should not place an excessive
burden on consumers nor
burden on consumers nor place
place them at risk. If the
them at risk. If the remedy also
G 73e
remedy also entails the
entails the disposal of the
G
disposal of the recalled
recalled product, such disposal
product, such disposal should
should be carried out with due
be carried out with due
consideration of the
consideration of the
environmental and sustainable
environmental and
objectives set at Union and
sustainable objectives set at
national levels. In addition,
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Union and national levels. In
repair by consumers should
addition, self-repair by
only be considered as a possible
consumers should only be
remedy if it can be carried out
considered as a possible
easily and safely by the
remedy if it can be carried out consumer, for instance through
easily and safely by the
the replacement of a battery or
consumer, for instance
by cutting excessively long
through the replacement of a
drawstrings on a children’s
battery or by cutting
garment when provided for in
excessively long drawstrings
the recall notice. Moreover, the
on a children’s garment when repair by the consumer should
provided for in the recall
be without prejudice to
notice. Moreover, the self-
consumers rights under
repair should be without
Directive (EU) 2019/771 and
prejudice to consumers rights Directive (EU) 2019/770.
under Directive (EU)
Therefore, in such situations,
2019/771. Therefore, in such
economic operators should not
situations, economic operators oblige consumers to repair a
should not oblige consumers
dangerous product.
to self-repair a dangerous
product.
Recital 64f
G 73f
(64f) Consumers should be
G
entitled to enforce their rights
in relation to the obligations
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imposed on economic operators
or providers of online
marketplaces under this
Regulation through
representative actions in
accordance with Directive (EU)
2020/1828 of the European
Parliament and of the Council.
For that purpose, this
Regulation should provide that
Directive (EU) 2020/1828 is
applicable to the representative
actions concerning
infringements of the provisions
of this Regulation that harm or
can harm the collective
interests of consumers. The
Annex to that Directive should
therefore be amended
accordingly. It is for the
Member States to ensure that
that amendment is reflected in
their transposition measures
adopted in accordance with
Directive (EU) 2020/1828,
although the adoption of
national transposition
measures in this regard is not a
condition for the applicability
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of that Directive to those
representative actions. The
applicability of Directive (EU)
2020/1828 to the representative
actions brought against
infringements by economic
operators or providers of online
marketplaces of provisions of
this Regulation that harm or
can harm the collective
interests of consumers should
start from the date of
application of this Regulation.
Until that date consumers
should be able to rely on the
applicability of Directive (EU)
2020/1828 in line with point 8
of Annex I of that Directive.
Recital 65
(65) In order to facilitate the
(65) In order to facilitate the
(65) In order to facilitate the
(65) In order to facilitate the
effective and consistent
effective and consistent
effective and consistent
effective and consistent
G 74
application of the general safety application of the general safety application of the general safety application of the general safety G
requirement set out in this
requirement set out in this
requirement set out in this
requirement set out in this
Regulation, it is important to
Regulation, it is important to
Regulation, it is important to
Regulation, it is important to
make use of European standards make use of European standards make use of European standards make use of European standards
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covering certain products and
covering certain products and
covering certain products and
covering certain products and
risks in such a way that a
risks
. European standards, the
risks in such a way that a
risks
. European standards, the
product which conforms to such
references of which have been
product which conforms to such
references of which have been
a European standard, the
published in accordance with
a European standard, the
published in accordance with
reference of which is published
Directive 2001/95/EC, should
reference of which is published
Directive 2001/95/EC, should
in the Official Journal of the
be considered as European in
in the Official Journal of the
continue providing a
European Union, is presumed to
such a way that a product
which European Union, is presumed to
presumption of conformity with
be in compliance with that
conforms to such a European
be in compliance with that
the general safety requirement
requirement.
standard, the reference of which requirement.
In case different
set out in this Regulation.
is published in the Official
risks or risk categories are
Standardisation requests issued
Journal of the European Union, covered by the same standard, by the Commission in
is presumed
safety standards
the conformity of a product
accordance with Directive
and should provide a
with the part of the standard
2001/95/EC should be deemed
presumption of conformity with covering the relevant risk or
standardisation requests issued
the general safety requirement
risk category would also give
in accordance with this
set out in this Regulation.
to the product itself
Regulation. In case different
Standardisation requests issued presumption of safety as far as risks or risk categories are
by the Commission in
the relevant risk or risk
covered by the same standard,
accordance with Directive
category is concerned.
the conformity of a product
2001/95/EC should be deemed
with the part of the
standard
to be
standardisation requests
covering the relevant risk or
issued in accordance with this
risk category would also give to
Regulationin compliance with
the product itself presumption
that requirement.
of safety as far as the relevant
risk or risk category is
concerned.
Recital 66
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(66) Where the Commission
(66) Where the Commission
(66) Where the Commission
(66) Where the Commission
identifies a need for a European identifies a need for a European identifies a need for a European identifies a need for a European
standard ensuring compliance of standard ensuring compliance of standard ensuring compliance of standard ensuring compliance of
certain products with the
certain products with the
certain products with the
certain products with the
general safety requirement
general safety requirement
general safety requirement
general safety requirement
under this Regulation, it should
under this Regulation, it should
under this Regulation, it should
under this Regulation, it should
apply the relevant provisions of apply the relevant provisions of apply the relevant provisions of apply the relevant provisions of
Regulation (EU) No 1025/2012
Regulation (EU) No 1025/2012
Regulation (EU) No 1025/2012
Regulation (EU) No 1025/2012
of the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and
of the Council1 to request one or of the Council1 to request one or of the Council1 to request one or of the Council1 to request one or
several European
several European
several European
several European
standardisation organisations to standardisation organisations to standardisation organisations to standardisation organisations to
G 75
either draft or identify a
either draft or identify a
either draft or identify a
either draft or identify a
G
standard which is suitable to
standard which is suitable to
standard which is suitable to
standard which is suitable to
ensure that products which
ensure that products which
ensure that products which
ensure that products which
conform to it are presumed to be conform to it are presumed to be conform to it are presumed to be conform to it are presumed to be
safe.
safe.
safe.
safe.
_________
_________
_________
_________
1. Regulation (EU) No
1. Regulation (EU) No
1. Regulation (EU) No
1. Regulation (EU) No
1025/2012 of the European
1025/2012 of the European
1025/2012 of the European
1025/2012 of the European
Parliament and of the Council of Parliament and of the Council of Parliament and of the Council of Parliament and of the Council of
25 October 2012 on European
25 October 2012 on European
25 October 2012 on European
25 October 2012 on European
standardisation, amending
standardisation, amending
standardisation, amending
standardisation, amending
Council Directives 89/686/EEC Council Directives 89/686/EEC Council Directives 89/686/EEC Council Directives 89/686/EEC
and 93/15/EEC and Directives
and 93/15/EEC and Directives
and 93/15/EEC and Directives
and 93/15/EEC and Directives
94/9/EC, 94/25/EC, 95/16/EC,
94/9/EC, 94/25/EC, 95/16/EC,
94/9/EC, 94/25/EC, 95/16/EC,
94/9/EC, 94/25/EC, 95/16/EC,
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97/23/EC, 98/34/EC,
97/23/EC, 98/34/EC,
97/23/EC, 98/34/EC,
97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC,
2004/22/EC, 2007/23/EC,
2004/22/EC, 2007/23/EC,
2004/22/EC, 2007/23/EC,
2009/23/EC and 2009/105/EC
2009/23/EC and 2009/105/EC
2009/23/EC and 2009/105/EC
2009/23/EC and 2009/105/EC
of the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and
of the Council and repealing
of the Council and repealing
of the Council and repealing
of the Council and repealing
Council Decision 87/95/EEC
Council Decision 87/95/EEC
Council Decision 87/95/EEC
Council Decision 87/95/EEC
and Decision No 1673/2006/EC and Decision No 1673/2006/EC and Decision No 1673/2006/EC and Decision No 1673/2006/EC
of the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and
of the Council (OJ L 316, 14.
of the Council (OJ L 316, 14.
of the Council (OJ L 316, 14.
of the Council (OJ L 316, 14.
11. 2012, p. 12).
11. 2012, p. 12).
11. 2012, p. 12).
11. 2012, p. 12).
Text Origin:
Commission Proposal
Recital 66a
(66a) Products could present
(66a) Products could present
different risks for different
different risks for different
genders and standardisation
genders and standardisation
activities should take this into
activities should take this into
G 75a
account to avoid discrepancies
account to avoid discrepancies
G
in terms of safety and therefore
in terms of safety and therefore
a gender safety gap. The
a gender safety gap. The
Gender Responsive Standards
Gender Responsive Standards
Declaration outlines several
Declaration outlines several
actions that national standards
actions that national standards
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bodies and standards
bodies and standards
developing organisations
developing organisations
should include in their gender
should include in their gender
action plan for gender
action plan for gender
responsive standards and
responsive standards and
standards development, in
standards development, in
order to achieve gender
order to achieve gender
balanced, representative and
balanced, representative and
inclusive standards.
inclusive standards.
Recital 67
(67) Certain provisions of
(67) Certain provisions of
(67) Certain provisions of
(67) Certain provisions of
Regulation (EU) 1025/2012
Regulation (EU) 1025/2012
Regulation (EU) 1025/2012
Regulation (EU) 1025/2012
should be amended to take the
should be amended to take the
should be amended to take the
should be amended to take the
specificities of this Regulation
specificities of this Regulation
specificities of this Regulation
specificities of this Regulation
into account, and in particular
into account, and in particular
into account, and in particular
into account, and in particular
the need to define the specific
the need to define the specific
the need to define the specific
the need to define the specific
G 76
safety requirements under this
safety requirements under this
safety requirements under this
safety requirements under this
G
Regulation before launching the Regulation before launching the Regulation before launching the Regulation before launching the
request to the European
request to the European
request to the European
request to the European
standardisation organisation.
standardisation organisation.
standardisation organisation.
standardisation organisation.
Standardisation requests
issued by the Commission in
accordance with Directive
2001/95/EC should be deemed
standardisation requests
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issued in accordance with this
Regulation.
Recital 68
(68) Together with the
(68) Together with the
(68) Together with the
(68) Together with the
adaptation of Regulation (EU)
adaptation of Regulation (EU)
adaptation of Regulation (EU)
adaptation of Regulation (EU)
1025/2012, a specific procedure 1025/2012, a specific procedure 1025/2012, a specific procedure 1025/2012, a specific procedure
for the adoption of the specific
for the adoption of the specific
for the adoption of the specific
for the adoption of the specific
safety requirements with the
safety requirements with the
safety requirements with the
safety requirements with the
assistance of the specialised
assistance of the specialised
assistance of the specialised
assistance of the specialised
G 77
Committee provided for by this
Committee provided for by this
Committee provided for by this
Committee provided for by this
G
Regulation should be
Regulation should be
Regulation should be
Regulation should be
introduced.
introduced.
introduced.
introduced.
Text Origin:
Commission Proposal
Recital 69
(69) European standards, the
(69)
European standards, the
(69) European standards, the
G 78
references of which have been
references of which have been
references of which have been
deleted
G
published in accordance with
published in accordance with
published in accordance with
Directive 2001/95/EC, should
Directive 2001/95/EC, should
Directive 2001/95/EC, should
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continue providing a
continue providing a
continue providing a
deleted, see rows above.
presumption of conformity with
presumption of conformity with
presumption of conformity with
the general safety requirement
the general safety requirement
the general safety requirement
set out in this Regulation.
set out in this Regulation.
set out in this Regulation.
Text Origin:
Standardisation requests issued
Standardisation requests issued Standardisation requests issued
Commission Proposal
by the Commission in
by the Commission in
by the Commission in
accordance with Directive
accordance with Directive
accordance with Directive
2001/95/EC should be deemed
2001/95/EC should be deemed
2001/95/EC should be deemed
standardisation requests issued
standardisation requests issued
standardisation requests issued
in accordance with this
in accordance with this
in accordance with this
Regulation.
Regulation.
Regulation.
Recital 69a
(69a) In the absence of
(69a) In the absence of
European standards, the law
European standards, the law of
of the Member State where
the Member State where the
the product is made available
product is made available on
on the market laying down
the market laying down health
G 78a
health and safety
and safety requirements should G
requirements should comply
comply with Union law, in
with Union law, in particular
particular Articles 34 and 36 of
Articles 34 and 36 of the
the TFEU.
TFEU.
Recital 70
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(70) The Union should be able
(70) The Union should be able
(70) The Union should be able
(70) The Union should be able
to cooperate and to exchange
to cooperate and to exchange
to cooperate and to exchange
to cooperate and to exchange
information related to product
information related to product
information related to product
information related to product
safety with regulatory
safety with regulatory
safety with regulatory
safety with regulatory
authorities of third countries or
authorities of third countries or
authorities of third countries or
authorities of third countries or
international organisations
international organisations
international organisations
international organisations
within the framework of
within the framework of
within the framework of
within the framework of
agreements concluded between
agreements concluded between
agreements
arrangements
agreements concluded between
the Commission and third
the Commission and third
concluded between the
the
Union and third countries
countries or international
countries or international
Commission and third countries
or international organisations
organisations. Such cooperation organisations
, also with a view
or international organisations.
or of arrangements concluded
and exchange of information
to preventing the circulation of Such cooperation and exchange
between the Commission and
G 79
should respect confidentiality
dangerous products on the
of information should respect
authorities of third countries or G
and personal data protection
Union market. Such
confidentiality and personal data international organisations
, also
rules of the Union.
cooperation and exchange of
protection rules of the Union.
with a view to preventing the
information should respect
Personal data should only be
circulation of dangerous
confidentiality and personal data
transferred to the extent that
products on the Union market.
protection rules of the Union.
such exchange is necessary for Such cooperation and exchange
the sole purpose of the
of information should respect
protection of consumers’
confidentiality and personal data
health or safety.
protection rules of the Union.
Personal data should only be
transferred to the extent that
such exchange is necessary for
the sole purpose of the
protection of consumers’
health or safety.
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Recital 70a
(70a) Systematic exchange of
(70a) Systematic exchange of
information between the
information between the
Commission and third
Commission and third
countries or international
countries or international
organisations on the safety of
organisations on the safety of
consumer products and on
consumer products and on
preventive, restrictive and
preventive, restrictive and
corrective measures should be corrective measures should be
based on reciprocity, which
based on reciprocity, which
entails an equivalent but not
entails an equivalent but not
necessarily identical exchange necessarily identical exchange
G 79a
of information for mutual
of information for mutual
G
benefit. An exchange of
benefit. An exchange of
information with a country
information with a country
producing goods destined to
producing goods destined to the
the Union market might
Union market might consist in
consist in the Commission
the Commission sending
sending selected information
selected information from the
from the Safety Gate Rapid
Safety Gate Rapid Alert System
Alert System related to
related to products originating
products originating from this from this partner country. In
partner country. In exchange, exchange, this third country
this third country might send
might send information on the
information on the follow-up
follow-up measures taken on
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measures taken on the basis of the basis of the notifications
the notifications received.
received. Such cooperation
Such cooperation might
might contribute to the
contribute to the objective of
objective of stopping dangerous
stopping dangerous products
products at the source and
at the source and preventing
preventing them from reaching
them from reaching the Union the Union market. market.
Recital 71
(71) In order to play a
(71) In order to play a
(71) In order to play a
(71) In order to play a
significant deterrent effect for
significant deterrent effect for
significant deterrent effect for
significant deterrent effect for
economic operators and online
economic operators and
, where
economic operators and online
economic operators and
, where
marketplaces to prevent the
applicable, online marketplaces marketplaces to prevent the
applicable, providers of online
placing of dangerous products
to prevent the placing of
placing of dangerous products
marketplaces to prevent the
on the market, penalties should
dangerous products on the
on the market, penalties should
placing of dangerous products
be adequate to the type of
market, penalties should be
be adequate to the type of
on the market, penalties should
G 80
infringement, to the possible
adequate to the type of
infringement, to the possible
be adequate to the type of
G
advantage for the economic
infringement, to the possible
advantage for the economic
infringement, to the possible
operator or online marketplace
advantage for the economic
operator or online marketplace
advantage for the economic
and to the type and gravity of
operator or online marketplace
and to the type and gravity of
operator or
providers online
the injury suffered by the
and to the type and gravity of
the injury suffered by the
marketplace and to the type and
consumer. Furthermore an
the injury suffered by the
consumer. Furthermore an
gravity of the injury suffered by
homogenous level of penalties
consumer. Furthermore an
homogenous level of penalties
the consumer. ▌ Penalties
is important to ensure a level
homogenous level of penalties
is important to ensure a level
should be effective,
playing field, avoiding that
is important to ensure a level
playing field, avoiding that
proportionate and dissuasive.
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Council Mandate
economic operators or online
playing field, avoiding that
economic operators or online
marketplaces concentrate their
economic operators or online
marketplaces concentrate their
activities in territories where the marketplaces concentrate their
activities in territories where the
level of penalties is lower.
activities in territories where the level of penalties is lower
In
level of penalties is lower.
particular, infringements of
provisons applicable to
providers of online
marketplaces, for example on
the internal processes that
they have to put in place,
should be subject to effective,
proportionate and disuassive
penalties.
Recital 71a
(71a) The Commission should
carry out an evaluation on the
implementation of the penalties
laid down under this
G 80a
Regulation as to their
G
effectiveness and deterrent
effects, and, if appropriate
adopt a legislative proposal as
to their enforcement.
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Recital 72
(72) When imposing penalties,
(72) When imposing penalties,
(72) When imposing penalties,
(72) When imposing penalties,
due regard should be given to
due regard should be given to
due regard should be given to
due regard should be given to
the nature, gravity and duration
the nature, gravity and duration
the nature, gravity and duration
the nature, gravity and duration
of the infringement in question.
of the infringement in question.
of the infringement in question.
of the infringement in question.
The imposition of penalties
The imposition of penalties
The imposition of penalties
The imposition of penalties
should be proportionate and
should be
effective,
should be proportionate and
should be proportionate and
should comply with Union and
proportionate
and dissuasive
should comply with Union and
should comply with Union and
national law, including with
and should comply with Union
national law, including with
national law, including with
applicable procedural
and national law, including with applicable procedural
applicable procedural
safeguards and with the
applicable procedural
safeguards and with the
safeguards and with the
G 81
principles of the Charter of
safeguards and with the
principles of the Charter of
principles of the Charter of
G
fundamental rights.
principles of the Charter of
fundamental rights.
However, it fundamental rights.
fundamental rights.
should remain a matter for
the Member States to choose
the types of penalties to be
imposed and to lay down in
their national law the relevant
procedures for the imposition
of penalties in the event of
infringements of this
Regulation.
Recital 73
G 82
G
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(73) In order to facilitate the
(73) In order to facilitate the
(73) In order to facilitate the
more consistent application of
more consistent application of
more consistent application of
deleted
penalties, common non-
penalties, common non-
penalties, common non-
exhaustive and indicative
exhaustive and indicative
exhaustive and indicative
criteria for the application of
criteria for the application of
criteria for the application of
deleted.
penalties should be included.
penalties should be included.
penalties should be included.
Those criteria should include
Those criteria should include
Those criteria should include
the duration or temporal effects
the duration or temporal effects
the duration or temporal effects
Text Origin:
of the infringement, as well as
of the infringement, as well as
of the infringement, as well as
Commission Proposal
its nature and gravity, in
its nature and gravity, in
its nature and gravity, in
particular the level of risk
particular the level of risk
particular the level of risk
incurred by the consumer.
incurred by the consumer.
incurred by the consumer.
Repeated infringement by the
Repeated infringement by the
Repeated infringement by the
same perpetrator shows a
same perpetrator shows a
same perpetrator shows a
propensity to commit such
propensity to commit such
propensity to commit such
infringements and is therefore a infringements and is therefore a infringements and is therefore a
significant indication of the
significant indication of the
significant indication of the
gravity of the conduct and,
gravity of the conduct and,
gravity of the conduct and,
accordingly, of the need to
accordingly, of the need to
accordingly, of the need to
increase the level of the penalty increase the level of the penalty increase the level of the penalty
to achieve effective deterrence.
to achieve effective deterrence.
to achieve effective deterrence.
The financial benefits gained, or The financial benefits gained, or The financial benefits gained, or
losses avoided, because of the
losses avoided, because of the
losses avoided, because of the
infringement should be taken
infringement should be taken
infringement should be taken
into account, if the relevant data into account, if the relevant data into account, if the relevant data
are available. Other aggravating are available. Other aggravating are available. Other aggravating
or mitigating factors applicable
or mitigating factors applicable
or mitigating factors applicable
to the circumstances of the case to the circumstances of the case to the circumstances of the case
should also be taken into
should also be taken into
should also be taken into
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account.
account.
account.
Recital 74
(74) In order to ensure more
(74)
In order to ensure more
(74) In order to ensure more
consistency, a list of those types
consistency, a list of those types consistency, a list of those types
deleted
of infringements that should be
of infringements that should be
of infringements that should be
subject to penalties should be
subject to penalties should be
subject to penalties should be
G 83
included.
included.
included.
deleted
G
Text Origin:
Commission Proposal
Recital 75
(75) The deterrent effect of
(75) The deterrent effect of
(75) The deterrent effect of
penalties should be reinforced
penalties should be reinforced
penalties should be reinforced
deleted
by the possibility to publish the
by the possibility to publish the
by the possibility to publish the
G 84
information related to the
information related to the
information related to the
G
penalties imposed by Member
penalties imposed by Member
penalties imposed by Member
deleted
States. Where these penalties
States.
Where these penalties
States. Where these penalties
are issued against natural
are issued against natural
are issued against natural
persons or include personal
persons or include personal
persons or include personal
Text Origin:
Commission Proposal
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data, they may be published in a
data, they may be published in a data, they may be published in a
manner that complies with the
manner that complies with the
manner that complies with the
data protection requirements as
data protection requirements as data protection requirements as
set out in Regulation (EU)
set out in Regulation (EU)
set out in Regulation (EU)
2016/679 of the European
2016/679 of the European
2016/679 of the European
Parliament and of the Council1
Parliament and of the Council1
Parliament and of the Council1
and Regulation (EU) 2018/1725
and Regulation (EU) 2018/1725 and Regulation (EU) 2018/1725
of the European Parliament and
of the European Parliament and of the European Parliament and
of the Council2. The annual
of the Council2. The annual
of the Council2. The annual
report on the penalties imposed
report on the penalties imposed
report on the penalties imposed
by the Member States should
by the Member States should
by the Member States should
contribute to the level playing
contribute to the level playing
contribute to the level playing
field and to prevent repeated
field and to prevent repeated
field and to prevent repeated
infringements. For reasons of
infringements.
For reasons of
infringements. For reasons of
legal certainty and in
legal certainty and in
legal certainty and in
accordance with the principle of
accordance with the principle of accordance with the principle of
proportionality, it should be
proportionality, it should be
proportionality, it should be
specified in which situations a
specified in which situations a
specified in which situations a
publication should not take
publication should not take
publication should not take
place. As far as natural persons
place. As far as natural persons place. As far as natural persons
are concerned, personal data
are concerned, personal data
are concerned, personal data
should only be published in
should only be published in
should only be published in
exceptional circumstances
exceptional circumstances
exceptional circumstances
justified by the seriousness of
justified by the seriousness of
justified by the seriousness of
the infringement, for instance
the infringement, for instance
the infringement, for instance
when a penalty has been
when a penalty has been
when a penalty has been
imposed to an economic
imposed to an economic
imposed to an economic
operator whose name identifies
operator whose name identifies
operator whose name identifies
a natural person and such
a natural person and such
a natural person and such
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economic operator has
economic operator has
economic operator has
repeatedly failed to comply with
repeatedly failed to comply with repeatedly failed to comply with
the general product safety
the general product safety
the general product safety
requirement.
requirement.
requirement.
_________
_________
_________
1. Regulation (EU) 2016/679 of
1.
Regulation (EU) 2016/679 of 1. Regulation (EU) 2016/679 of
the European Parliament and of
the European Parliament and of the European Parliament and of
the Council of 27 April 2016 on
the Council of 27 April 2016 on the Council of 27 April 2016 on
the protection of natural persons
the protection of natural
the protection of natural persons
with regard to the processing of
persons with regard to the
with regard to the processing of
personal data and on the free
processing of personal data and personal data and on the free
movement of such data, and
on the free movement of such
movement of such data, and
repealing Directive 95/46/EC
data, and repealing Directive
repealing Directive 95/46/EC
(General Data Protection
95/46/EC (General Data
(General Data Protection
Regulation) (OJ L 119,
Protection Regulation) (OJ L
Regulation) (OJ L 119,
4.5.2016, p. 1).
119, 4.5.2016, p. 1).
4.5.2016, p. 1).
2. Regulation (EU) 2018/1725
2.
Regulation (EU) 2018/1725
2. Regulation (EU) 2018/1725
of the European Parliament and
of the European Parliament and of the European Parliament and
of the Council of 23 October
of the Council of 23 October
of the Council of 23 October
2018 on the protection of
2018 on the protection of
2018 on the protection of
natural persons with regard to
natural persons with regard to
natural persons with regard to
the processing of personal data
the processing of personal data
the processing of personal data
by the Union institutions,
by the Union institutions,
by the Union institutions,
bodies, offices and agencies and
bodies, offices and agencies and bodies, offices and agencies and
on the free movement of such
on the free movement of such
on the free movement of such
data, and repealing Regulation
data, and repealing Regulation
data, and repealing Regulation
(EC) No 45/2001 and Decision
(EC) No 45/2001 and Decision
(EC) No 45/2001 and Decision
No 1247/2002/EC (OJ L 295,
No 1247/2002/EC (OJ L 295,
No 1247/2002/EC (OJ L 295,
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Council Mandate
21.11.2018, p. 39).
21.11.2018, p. 39).
21.11.2018, p. 39).
Recital 76
(76) In order to ensure uniform (76) In order to ensure uniform (76) In order to ensure uniform (76) In order to ensure uniform
conditions for the
conditions for the
conditions for the
conditions for the
implementation of this
implementation of this
implementation of this
implementation of this
Regulation, implementing
Regulation, implementing
Regulation, implementing
Regulation, implementing
powers should be conferred on
powers should be conferred on
powers should be conferred on
powers should be conferred on
the Commission to adopt the
the Commission to adopt the
the Commission to adopt the
the Commission to adopt the
specific safety requirements, to
specific safety requirements, to
specific safety requirements, to
specific safety requirements, to
determine the output indicators
determine the output indicators
determine the output indicators
determine the output indicators
on the basis of which Member
on the basis of which Member
on the basis of which Member
on the basis of which Member
States have to communicate
States have to communicate
States have to communicate
States have to communicate
G 85
data concerning the
data concerning the
data concerning the
data concerning the
G
implementation of this
implementation of this
implementation
of this
implementation
of this
Regulation, to adopt the
Regulation, to adopt the
Regulation, to adopt the
Regulation, to ▌ take measures
modalities and procedures for
modalities and procedures for
modalities and procedures for
as regards
Union action against
the exchange of information
the exchange of information
the exchange of information
products presenting a serious
regarding measures
regarding measures
regarding measures
risk, to adopt the modalities for
communicated through the
communicated through the
communicated through the
the sending of information by
Safety Gate and criteria to
Safety Gate and criteria to
Safety Gate
Rapid Alert
consumers in the Safety Gate
assess the level of risk, to take
assess the level of risk, to take
System and criteria to assess the portal, to set out the
measures as regards the
measures as regards the
level of risk, to take measures as requirements for registration of
products presenting a serious
products presenting a serious
regards the products presenting
products for recall purposes and
risk, to adopt the modalities for
risk, to adopt the modalities for
a serious risk, to adopt the
to adopt the template for a recall
the sending of information by
the sending of information by
modalities for the sending of
notice. Those powers should be
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consumers in the Safety Gate
consumers in the Safety Gate
information by consumers in the exercised in accordance with
portal, to set out the
portal, to set out the
Safety Gate portal, to set out the Regulation (EU) No 182/2011
requirements for registration of
requirements for registration of
requirements for registration of
of the European Parliament and
products for recall purposes and products for recall purposes and products for recall purposes and of the Council1.
to adopt the template for a recall to adopt the template for a recall to adopt the template for a recall _________
notice. Those powers should be
notice. Those powers should be
notice. Those powers should be
exercised in accordance with
exercised in accordance with
exercised in accordance with
1. Regulation (EU) No
Regulation (EU) No 182/2011
Regulation (EU) No 182/2011
Regulation (EU) No 182/2011
182/2011 of the European
of the European Parliament and of the European Parliament and of the European Parliament and Parliament and of the Council of
of the Council1.
of the Council1.
of the Council1.
16 February 2011 laying down
the rules and general principles
_________
_________
_________
concerning mechanisms for
1. Regulation (EU) No
1. Regulation (EU) No
1. Regulation (EU) No
control by the Member States of
182/2011 of the European
182/2011 of the European
182/2011 of the European
the Commission's exercise of
Parliament and of the Council of Parliament and of the Council of Parliament and of the Council of implementing powers (OJ L 55,
16 February 2011 laying down
16 February 2011 laying down
16 February 2011 laying down
28.2.2011, p. 13).
the rules and general principles
the rules and general principles
the rules and general principles
concerning mechanisms for
concerning mechanisms for
concerning mechanisms for
control by the Member States of control by the Member States of control by the Member States of Text Origin: Council
the Commission's exercise of
the Commission's exercise of
the Commission's exercise of
Mandate
implementing powers (OJ L 55, implementing powers (OJ L 55, implementing powers (OJ L 55,
28.2.2011, p. 13).
28.2.2011, p. 13).
28.2.2011, p. 13).
Recital 77
G 86
(77) The Commission should
(77) The Commission should
(77) The Commission should
(77) The Commission should
G
adopt immediately applicable
adopt immediately applicable
adopt immediately applicable
adopt immediately applicable
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implementing acts where, in
implementing acts where, in
implementing acts where, in
implementing acts where, in
duly justified cases relating to
duly justified cases relating to
duly justified cases relating to
duly justified cases relating to
the health and safety of
the health and safety of
the health and safety of
the health and safety of
consumers, imperative grounds
consumers, imperative grounds
consumers
, , imperative grounds consumers, imperative grounds
of urgency so require.
of urgency so require.
of urgency so require.
of urgency so require.
Text Origin:
Commission Proposal
Recital 78
(78) In order to maintain a high (78) In order to maintain a high (78) In order to maintain a high (78) In order to maintain a high
level of health and safety of
level of health and safety of
level of health and safety of
level of health and safety of
consumers, the power to adopt
consumers, the power to adopt
consumers, the power to adopt
consumers, the power to adopt
acts in accordance with Article
acts in accordance with Article
acts in accordance with Article
acts in accordance with Article
290 of the Treaty should be
290 of the Treaty should be
290 of the Treaty should be
290 of the Treaty should be
delegated to the Commission in delegated to the Commission in delegated to the Commission in delegated to the Commission in
G 87
respect of the identification and respect of the identification
of
respect of the identification and respect of the identification and G
traceability of products bearing
the products, categories or
traceability of products bearing
traceability of products bearing
a potential serious risk to health
groups of products for which
a potential serious risk to health a potential serious risk to health
and safety. It is of particular
checks should be carried out by and safety. 52)It is of particular
and safety
and of the
importance that the Commission
the responsible person
importance that the Commission
functioning of the Safety Gate
carries out appropriate
established in the Union, and
carries out appropriate
Rapid Alert System, in
consultations during its
the identification and
consultations during its
particular to adopt the
preparatory work, including at
traceability of products bearing
preparatory work, including at
modalities and procedures for
expert level and that those
a potential serious risk to health expert level and that those
the exchange of information
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consultations be conducted in
and safety. It is of particular
consultations be conducted in
regarding measures
accordance with the principles
importance that the Commission accordance with the principles
communicated through the
laid down in the
carries out appropriate
laid down in the
Safety Gate Rapid Alert System
Interinstitutional Agreement of
consultations during its
Interinstitutional Agreement of
and criteria to assess the level
13 April 2016 on Better Law-
preparatory work, including at
13 April 2016 on Better Law-
of risk. It is of particular
Making1. In particular, to ensure expert level and that those
Making1. In particular, to ensure importance that the Commission
equal participation in the
consultations be conducted in
equal participation in the
carries out appropriate
preparation of delegated acts,
accordance with the principles
preparation of delegated acts,
consultations during its
the European Parliament and the laid down in the
the European Parliament and the preparatory work, including at
Council receive all documents
Interinstitutional Agreement of
Council receive all documents
expert level and that those
at the same time as Member
13 April 2016 on Better Law-
at the same time as Member
consultations be conducted in
States' experts, and their experts Making
137. In particular, to
States' experts, and their experts accordance with the principles
systematically have access to
ensure equal participation in the systematically have access to
laid down in the
meetings of Commission expert preparation of delegated acts,
meetings of Commission expert Interinstitutional Agreement of
groups dealing with the
the European Parliament and the groups dealing with the
13 April 2016 on Better Law-
preparation of delegated acts.
Council receive all documents
preparation of delegated acts.
Making1. In particular, to ensure
_________
at the same time as Member
_________
equal participation in the
States' experts, and their experts
preparation of delegated acts,
1. OJ L 123, 12.5.2016, p. 1.
systematically have access to
1. OJ L 123, 12.5.2016, p. 1.
the European Parliament and the
meetings of Commission expert
Council receive all documents
groups dealing with the
at the same time as Member
preparation of delegated acts.
States' experts, and their experts
_________
systematically have access to
meetings of Commission expert
1.
OJ L 123, 12.5.2016, p. 1.
groups dealing with the
37.
OJ L 123, 12.5.2016, p. 1.
preparation of delegated acts.
_________
1. OJ L 123, 12.5.2016, p. 1.
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Recital 78a
(78a) In order to allow
economic operators and
providers of online
marketplaces, sufficient time to
adapt to the requirements of
this Regulation, including
information requirements, it is
necessary to provide for a
sufficient transitional period
after the entry into force of this
G 87a
regulation during which
G
products covered by Directive
2001/95/EC which are in
conformity with that Directive
may still be placed on the
market. Member States should
therefore not impede the
making available on the market
of such products, including
offers for sale.
Recital 79
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(79) Since the objectives of this (79) Since the objectives of this (79) Since the objectives of this (79) Since the objectives of this
Regulation, namely to ensure a
Regulation, namely to ensure a
Regulation, namely to ensure a
Regulation, namely to ensure a
consistent, high level of
consistent, high level of
consistent, high level of
consistent, high level of
consumer health and safety
consumer health and safety
consumer health and safety
consumer health and safety
protection while preserving the
protection while preserving the
protection while preserving the
protection while preserving the
unity of the Single market,
unity of the Single market,
unity of the Single market,
unity of the Single market,
cannot be sufficiently achieved
cannot be sufficiently achieved
cannot be sufficiently achieved
cannot be sufficiently achieved
by the Member States given the by the Member States given the by the Member States given the by the Member States given the
need for a high degree of
need for a high degree of
need for a high degree of
need for a high degree of
collaboration and coherent
collaboration and coherent
collaboration and coherent
collaboration and coherent
action between Member States’
action between Member States’
action between Member States’
action between Member States’
competent authorities and for a
competent authorities and for a
competent authorities and for a
competent authorities and for a
G 88
mechanism to quickly and
mechanism to quickly and
mechanism to quickly and
mechanism to quickly and
G
efficiently exchange
efficiently exchange
efficiently exchange
efficiently exchange
information on dangerous
information on dangerous
information on dangerous
information on dangerous
products in the Union but can
products in the Union but can
products in the Union but can
products in the Union but can
rather, by reason of the Union-
rather, by reason of the Union-
rather, by reason of the Union-
rather, by reason of the Union-
wide character of the problem,
wide character of the problem,
wide character of the problem,
wide character of the problem,
be better achieved at Union
be better achieved at Union
be better achieved at Union
be better achieved at Union
level, the Union may adopt
level, the Union may adopt
level, the Union may adopt
level, the Union may adopt
measures, in accordance with
measures, in accordance with
measures, in accordance with
measures, in accordance with
the principle of subsidiarity as
the principle of subsidiarity as
the principle of subsidiarity as
the principle of subsidiarity as
set out in Article 5 of the Treaty set out in Article 5 of the Treaty set out in Article 5 of the Treaty set out in Article 5 of the Treaty
on European Union. In
on European Union. In
on European Union. In
on European Union. In
accordance with the principle of accordance with the principle of accordance with the principle of accordance with the principle of
proportionality, as set out in that proportionality, as set out in that proportionality, as set out in that proportionality, as set out in that
Article, this Regulation does not Article, this Regulation does not Article, this Regulation does not Article, this Regulation does not
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go beyond what is necessary in
go beyond what is necessary in
go beyond what is necessary in
go beyond what is necessary in
order to achieve those
order to achieve those
order to achieve those
order to achieve those
objectives.
objectives.
objectives.
objectives.
Text Origin:
Commission Proposal
Recital 80
(80) Any processing of
(80)
Any processing of personal (80) Any processing of
(80)
Where, for the purposes
personal data for the purpose of
data for the purpose of this
personal data for the purpose of
of this Regulation, it is
this Regulation should be in
RegulationWhere, for the
this Regulation should be in
necessary to process personal
compliance with Regulations
purposes of this Regulation, it
compliance with Regulations
data, such processing should be
(EU) 2016/679 and (EU)
is necessary to process personal (EU) 2016/679 and (EU)
carried out in accordance with
2018/1725. When consumers
data, such processing should be 2018/1725. When consumers
Union law on the protection of
report a product in the Safety
carried out in accordance with
report a product in the Safety
personal data. Any processing
G 89
Gate, only those personal data
Union law on the protection of
Gate, only those personal data
of personal data under this
G
will be stored that are necessary
personal data. Any processing
will be stored that are necessary
Regulation is subject to
to report the dangerous product
of personal data under this
to report the dangerous product
Regulation (EU) 2016/679
,
and for a period not exceeding
Regulation is subject to
and for a period not exceeding
Regulation (EU) 2018/1725
five years after such data have
Regulationin compliance with
five years after such data have
and Directive 2002/58/EC, as
been encoded. Manufacturers
Regulations (EU) 2016/679
,
been encoded. Manufacturers
applicable. When consumers
and importers should hold the
Regulation and (EU) 2018/1725
and importers should hold the
report a product in the Safety
register of consumer complaints
and Directive 2002/58/EC, as
register of consumer complaints Gate, only those personal data
only as long as it is necessary
applicable. When consumers
only as long as it is necessary
will be stored that are necessary
for the purpose of this
report a product in the Safety
for the purpose of this
to report the dangerous product
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Council Mandate
Regulation. Manufacturers and
Gate, only those personal data
Regulation. Manufacturers and
and for a period not exceeding
importers, when they are natural will be stored that are necessary importers, when they are natural five years after such data have
persons should disclose their
to report the dangerous product
persons should disclose their
been encoded. Manufacturers
names to ensure that the
and for a period not exceeding
names to ensure that the
and importers should hold the
consumer is able to identify the
five years after such data have
consumer is able to identify the
register of consumer complaints
product for purpose of
been encoded. Manufacturers
product for purpose of
only as long as it is necessary
traceability.
and importers should hold the
traceability.
for the purpose of this
register of consumer complaints
Regulation. Manufacturers and
only as long as it is necessary
importers, when they are natural
for the purpose of this
persons should disclose their
Regulation. Manufacturers and
names to ensure that the
importers, when they are natural
consumer is able to identify the
persons should disclose their
product for purpose of
names to ensure that the
traceability.
consumer is able to identify the
product for purpose of
traceability.
Recital 81
(81) The European Data
(81) The European Data
(81) The European Data
(81) The European Data
Protection Supervisor was
Protection Supervisor was
Protection Supervisor was
Protection Supervisor was
G 90
consulted in accordance with
consulted in accordance with
consulted in accordance with
consulted in accordance with
G
Article 42 of Regulation (EU)
Article 42 of Regulation (EU)
Article 42 of Regulation (EU)
Article 42 of Regulation (EU)
2018/1725 and delivered an
2018/1725 and delivered an
2018/1725 and delivered an
2018/1725 and delivered an
opinion on XX XXXX.1
opinion on XX XXXX.1
opinion on XX XXXX.1
opinion on XX XXXX.1
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_________
_________
_________
_________
1. …
1. …
1.
…
1. …
Text Origin:
Commission Proposal
Formula
HAVE ADOPTED THIS
HAVE ADOPTED THIS
HAVE ADOPTED THIS
HAVE ADOPTED THIS
REGULATION:
REGULATION:
REGULATION:
REGULATION:
G 91
G
Text Origin:
Commission Proposal
CHAPTER I
CHAPTER I
CHAPTER I
CHAPTER I
CHAPTER I
General provisions
General provisions
General provisions
General provisions
G 92
G
Text Origin:
Commission Proposal
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Article 1
Article 1
Article 1
Article 1
Article 1
G 93
G
Subject matter
Subject matter
and objective
Subject matter
Subject matter
Article 1, first paragraph
This Regulation lays down
The objective of this Regulation This Regulation lays down
1. The objective of this
essential rules on the safety of
laysis to improve the
essential rules on the safety of
Regulation is to improve the
consumer products placed or
functioning of the internal
consumer
products placed or
functioning of the internal
made available on the market.
market and maintain a high
made available on the market.
market while providing for a
level of health, safety and
high level of consumer
G 94
consumer protection by laying
protection.
G
down essential rules
onto
ensure the safety of consumer
products
placed or made
2. This Regulation lays down
available on the
Union market.
essential rules on the safety of
consumer products placed or
made available on the market.
Article 2
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Council Mandate
Article 2
Article 2
Article 2
Article 2
G 95
G
Scope
Scope
Scope
Scope
Article 2(1), first subparagraph
1. This Regulation shall apply
1. This Regulation shall apply
1. This Regulation shall apply
1. This Regulation shall apply
to products defined in Article
to products defined in Article
to products defined in Article
to products defined in Article
3(1), placed or made available
3(1),
placed or made available
3(1), placed or made available
3(1), placed or made available
on the market in so far as there
on the market in so far as there
on the market in so far as there
on the market in so far as there
G 96
are no specific provisions with
are no specific provisions with
are no specific provisions with
are no specific provisions with
G
the same objective in rules of
the same objective in rules of
the same objective in rules of
the same objective in rules of
Union law which regulate the
Union law which regulate the
Union law which regulate the
Union law which regulate the
safety of the products
safety of the products
safety of the products
safety of the products
concerned.
concerned.
concerned.
concerned.
Article 2(1), second subparagraph
Where products are subject to
Where products are subject to
Where products are subject to
Where products are subject to
G 97
specific safety requirements
specific safety requirements
specific safety requirements
specific safety requirements
G
imposed by Union legislation,
imposed by Union legislation,
imposed by Union legislation,
imposed by Union legislation,
this Regulation shall apply only this Regulation shall apply only this Regulation shall apply only this Regulation shall apply only
to the aspects and risks or
to the aspects and risks or
to the aspects and risks or
to the aspects and risks or
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categories of risks not covered
categories of risks not covered
categories of risks not covered
categories of risks not covered
by those requirements.
by those requirements.
by those requirements.
by those requirements.
Article 2(1), third subparagraph, introductory part
In particular, as regards
In particular, as regards
In
regard to particular, as
In
regard to products subject to
products subject to specific
products subject to specific
regards products subject to
specific requirements imposed
requirements imposed by Union requirements imposed by Union specific requirements imposed
by Union harmonisation
G 98
harmonisation legislation as
harmonisation legislation as
by Union harmonisation
legislation as defined in Article
G
defined in Article 3(25),
defined in Article 3(25),
legislation as defined in Article
3(25),
3(25),
Article 2(1), third subparagraph, point (a)
(a) Chapter II shall not apply
(a) Chapter II shall not apply
(a) Chapter II shall not apply
(a) Chapter II shall not apply
insofar as the risks or categories insofar as the risks or categories insofar as the risks or categories insofar as the risks or categories
G 99
of risks covered by Union
of risks covered by Union
of risks covered by Union
of risks covered by Union
G
harmonisation legislation are
harmonisation legislation are
harmonisation legislation are
harmonisation legislation are
concerned;
concerned;
concerned;
concerned;
Article 2(1), third subparagraph, point (b)
G 100
G
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(b) Chapter III, Section 1,
(b) Chapter III, Section 1,
(b) Chapter III, Section 1,
(b) Chapter III, Section 1,
Chapters V and VII, Chapters
Chapters V and VII, Chapters
Chapters V and VII, Chapters
Chapters V and VII, Chapters
IX to XI shall not apply.
IX to XI shall not apply.
IX to XI shall not apply.
IX to XI shall not apply.
Article 2(2), introductory part
2. This Regulation shall not
2. This Regulation shall not
2. This Regulation shall not
2. This Regulation shall not
G 101
apply to:
apply to:
apply to:
apply to:
G
Article 2(2), point (a)
(a) medicinal products for
(a) medicinal products for
(a) medicinal products for
(a) medicinal products for
G 102
human or veterinary use;
human or veterinary use;
human or veterinary use;
human or veterinary use;
G
Article 2(2), point (b)
G 103
(b) food;
(b) food;
(b) food;
(b) food;
G
Article 2(2), point (c)
G 104
G
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(c) feed;
(c) feed;
(c) feed;
(c) feed;
Article 2(2), point (d)
(d) living plants and animals,
(d) living plants and animals,
(d) living plants and animals,
(d) living plants and animals,
genetically modified organisms
genetically modified organisms
genetically modified organisms
genetically modified organisms
and genetically modified
and genetically modified
and genetically modified
and genetically modified
microorganisms in contained
microorganisms in contained
microorganisms in contained
microorganisms in contained
G 105
use, as well as products of
use, as well as products of
use, as well as products of
use, as well as products of
G
plants and animals relating
plants and animals relating
plants and animals relating
plants and animals relating
directly to their future
directly to their future
directly to their future
directly to their future
reproduction;
reproduction;
reproduction;
reproduction;
Article 2(2), point (e)
(e) animal by-products and
(e) animal by-products and
(e) animal by-products and
(e) animal by-products and
G 106
derived products;
derived products;
derived products;
derived products;
G
Article 2(2), point (f)
G 107
G
(f) plant protection products;
(f) plant protection products;
(f) plant protection products;
(f) plant protection products;
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Article 2(2), point (g)
(g) equipment on which
(g) equipment on which
(g) equipment on which
(g) equipment on which
consumers ride or travel which
consumers ride or travel
which
consumers ride or travel
but
consumers ride or travel
when
is operated by a service provider
is when that equipment is
which is operated
or driven by
that equipment is directly
within the context of a service
directly operated by a service
a service provider within the
operated by a service provider
G 108
provided to consumers;
provider within the context of a
context of a service provided to
within the context of a
transport G
transport service provided to
consumers;
service provided to consumers
consumers
and not operated by
and not operated by the
the consumers themselves;
consumers themselves;
Article 2(2), point (h)
(h) aircraft referred to in point
(h) aircraft referred to in point
(h) aircraft referred to in point
(h) aircraft referred to in point
G 109
(d) of Article 2(3) of Regulation (d) of Article 2(3) of Regulation (d) of Article 2(3) of Regulation (d) of Article 2(3) of Regulation G
2018/1139;
2018/1139;
2018/1139;
2018/1139;
Article 2(2), point (i)
G 110
(i) antiques.
(i) antiques.
(i)
works of art, collectors’
(i) antiques.
G
items and antiques
, as referred
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to in Annex IX of Directive
2006/112/EC on the common
system of value added tax.
Article 2(3)
3. This Regulation shall apply
3. This Regulation shall apply
3. This Regulation shall apply
3. This Regulation shall apply
to products placed or made
to products
placed or made
to products placed or made
to products
[placed or
] made
available on the market whether available on the market whether available on the market whether available on the market whether
new, used, repaired or
new, used, repaired or
new, used, repaired or
new, used, repaired or
reconditioned. It shall not apply reconditioned. It shall not apply reconditioned. It shall not apply reconditioned. It shall not apply
to products to be repaired or
to products to be repaired or
to products to be repaired or
to products to be repaired or
reconditioned prior to being
reconditioned prior to being
reconditioned prior to being
reconditioned prior to being
G 111
G
used where those products are
used where those products are
used where those products are
used where those products are
made available on the market as made available on the market as made available on the market as made available on the market
such.
such.
such
and the supplier clearly
and clearly marked as such.
informs the person whom he
supplies the product to.
Subject to legal check on
placed/made available
Article 2(4)
G 112
G
4. This Regulation is without
4. This Regulation is without
4. This Regulation is without
4. This Regulation is without
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prejudice to the rules laid down
prejudice to the rules laid down
prejudice to the rules laid down
prejudice to the rules laid down
by Union law on consumer
by Union law on consumer
by Union law on consumer
by Union law on consumer
protection.
protection.
protection.
protection.
Article 2(5)
5. This Regulation shall be
5.
This Regulation shall be
5. This Regulation shall be
5.
This Regulation shall be
applied taking due account of
applied taking due account of
applied taking due account of
implemented taking due
G 113
the precautionary principle.
the precautionary principle.
the precautionary principle.
account of the precautionary
G
principle.▌
Article 3
Article 3
Article 3
Article 3
Article 3
G 114
G
Definitions
Definitions
Definitions
Definitions
Article 3, first paragraph, introductory part
G 115
For the purposes of this
For the purposes of this
For the purposes of this
For the purposes of this
G
Regulation the following
Regulation the following
Regulation the following
Regulation the following
definitions apply:
definitions apply:
definitions apply:
definitions apply:
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Article 3, first paragraph, point (1)
1. ‘product’ means any item,
1. ‘product’ means any item,
1. ‘product’ means any item,
1. ‘product’ means any item,
interconnected or not to other
interconnected or not to other
interconnected or not to other
interconnected or not to other
items, supplied or made
items, supplied or made
items, supplied
placed or made
items ▌ supplied or made
available, whether for
available, whether for
available
on the market,
available, whether for
consideration or not, in the
consideration or not, in the
whether for consideration or
consideration or not, ▌
course of a commercial activity
course of a commercial activity
not, in the course of a
including in the context of
including in the context of
including in the context of
commercial activity
including
providing a service – which is
G 116
providing a service – which is
providing a service – which is
in the context of providing a
intended for consumers or
is
G
intended for consumers or can,
intended for consumers or
canis service –
, which is intended for
likely, under reasonably
under reasonably foreseeable
likely, under reasonably
consumers or can, under
foreseeable conditions,
to be
conditions, be used by
foreseeable conditions,
to be
reasonably foreseeable
used by consumers even if not
consumers even if not intended
used by consumers even if not
conditions, be used by
intended for them;
for them;
intended for them;
consumers even if not intended
for them;
Article 3, first paragraph, point (2)
2. ‘safe product’ means any
2.
‘safe product’ means any
2. ‘safe product’ means any
2. ▌ ‘safe product’ means any
G 117
product which, under normal or product which, under normal or product which, under normal or product which, under normal or G
reasonably foreseeable
reasonably foreseeable
reasonably foreseeable
reasonably foreseeable
conditions of use or misuse,
conditions of use
or misuse,
conditions of use or misuse,
conditions of use ▌ , including
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including the actual duration of
including the actual duration of
including the actual duration of
the actual duration of use, does
use, does not present any risk or use, does not present any risk or use, does not present any risk or not present any risk or only the
only the minimum risks
only the minimum risks
only the minimum risks
minimum risks compatible with
compatible with the product's
compatible with the product's
compatible with the product's
the product's use, considered
use, considered acceptable and
use, considered acceptable and
use, considered acceptable and
acceptable and consistent with a
consistent with a high level of
consistent with a high level of
consistent with a high level of
high level of protection of
protection of health and safety
protection of health and safety
protection of health and safety
health and safety of consumers;
of consumers;
of consumers;
of consumers;
Article 3, first paragraph, point (3)
3. ‘dangerous product’ means
3. ‘dangerous product’ means
3. ‘dangerous product’ means
3. ‘dangerous product’ means
any product which does not
any product which does not
any product which does not
any product which does not
G 118
conform to the definition of
conform to the definition of
conform to the definition of
conform to the definition of
G
‘safe product’;
‘safe product’;
‘safe product’;
‘safe product’;
Article 3, first paragraph, point (4)
4. ‘risk’ means the combination 4. ‘risk’ means the combination 4. ‘risk’ means the combination 4. ‘risk’ means the combination
of the probability of an
of the probability of an
of the probability of an
of the probability of an
G 119
occurrence of a hazard causing
occurrence of a hazard causing
occurrence of a hazard causing
occurrence of a hazard causing
G
harm and the degree of severity
harm and the degree of severity
harm and the degree of severity
harm and the degree of severity
of that harm;
of that harm;
of that harm;
of that harm;
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Article 3, first paragraph, point (5)
5. ‘serious risk’ means a risk
5. ‘serious risk’ means a risk
5. ‘serious risk’ means a risk
5. ‘serious risk’ means a risk ▌
for which, based on a risk
for which, based on a risk
for
which, based on a risk
which, based on a risk
assessment and taking into
assessment and taking into
assessment and taking into
assessment and taking into
account the normal and
account the normal and
account the normal and
account the normal and
foreseeable use of the product,
foreseeable use of the product,
foreseeable use of the product,
foreseeable use of the product,
the combination of the
the combination of the
the combination of the
▌
is considered to require
probability of occurrence of a
probability of occurrence of a
probability of occurrence of a
rapid intervention by the market
G 120
hazard causing harm and the
hazard causing harm and the
hazard causing harm and the
surveillance authorities,
G
degree of severity of the harm is degree of severity of the harm is degree of severity of the harm
including cases where the
considered to require rapid
considered to require rapid
is considered to require rapid
effects of the risk are not
intervention by the market
intervention by the market
intervention by the market
immediate;
surveillance authorities,
surveillance authorities,
surveillance authorities,
including cases where the
including cases where the
including cases where the
effects of the risk are not
effects of the risk are not
effects of the risk are not
immediate;
immediate;
immediate;
Article 3, first paragraph, point (5a)
(5a) ‘accident’ means an
G 120a
occurrence associated with the no text here.
G
use of a product that resulted
or may reasonably have been
expected to result in an
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individual’s death or in
serious adverse effects on
their health and safety,
permanent or temporary,
including injuries, other
damages to the body, illnesses
and chronic health effects;
Article 3, first paragraph, point (6)
6. ‘making available on the
6. ‘making available on the
6. ‘making available on the
6. ‘making available on the
market’ means any supply of a
market’ means any supply of a
market’ means any supply of a
market’ means any supply of a
product for distribution,
product for distribution,
product for distribution,
product for distribution,
consumption or use on the
consumption or use on the
consumption or use on the
consumption or use on the
G 121
Union market in the course of a Union market in the course of a
Union market in the course of a Union market in the course of a G
commercial activity, whether in commercial activity, whether in commercial activity, whether in commercial activity, whether in
return for payment or free of
return for payment or free of
return for payment or free of
return for payment or free of
charge;
charge;
charge;
charge;
Article 3, first paragraph, point (7)
G 122
7. ‘placing on the market’
7. ‘placing on the market’
7. ‘placing on the market’
7. ‘placing on the market’
G
means the first making available means the first making available means the first making available means the first making available
of a product on the Union
of a product on the Union
of a product on the Union
of a product on the Union
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market;
market;
market;
market;
Article 3, first paragraph, point (8)
8. ‘manufacturer’ means any
8. ‘manufacturer’ means any
8. ‘manufacturer’ means any
8. ‘manufacturer’ means any
natural or legal person who
natural or legal person who
natural or legal person who
natural or legal person who
manufactures a product or has a manufactures a product or has a manufactures a product or has a manufactures a product or has a
G 123
product designed or
product designed or
product designed or
product designed or
G
manufactured, and markets that
manufactured, and markets that
manufactured, and markets that
manufactured, and markets that
product under its name or
product under its name or
product under its name or
product under its name or
trademark;
trademark;
trademark;
trademark;
Article 3, first paragraph, point (9)
9. ‘authorised representative’
9. ‘authorised representative’
9. ‘authorised representative’
9. ‘authorised representative’
means any natural or legal
means any natural or legal
means any natural or legal
means any natural or legal
person established within the
person established within the
person established within the
person established within the
Union who has received a
Union who has received a
Union who has received a
Union who has received a
G 124
written mandate from a
written mandate from a
written mandate from a
written mandate from a
G
manufacturer to act on his or her manufacturer to act on
his or
manufacturer to act on his or her manufacturer to act on his or her
behalf in relation to specified
herthat manufacturer’s behalf
behalf in relation to specified
behalf in relation to specified
tasks;
in relation to specified tasks;
tasks
with regard to the
tasks
with regard to the
manufacturer’s obligations
manufacturer’s obligations
under this Regulation;
under this Regulation;
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Article 3, first paragraph, point (10)
10. ‘importer’ means any
10. ‘importer’ means any
10. ‘importer’ means any
10. ‘importer’ means any
natural or legal person
natural or legal person
natural or legal person
natural or legal person
established within the Union
established within the Union
established within the Union
established within the Union
G 125
who places a product from a
who places a product from a
who places a product from a
who places a product from a
G
third country on the Union
third country on the Union
third country on the Union
third country on the Union
market;
market;
market;
market;
Article 3, first paragraph, point (11)
11. ‘distributor’ means any
11. ‘distributor’ means any
11. ‘distributor’ means any
11. ‘distributor’ means any
natural or legal person in the
natural or legal person in the
natural or legal person in the
natural or legal person in the
supply chain, other than the
supply chain, other than the
supply chain, other than the
supply chain, other than the
G 126
manufacturer or the importer,
manufacturer or the importer,
manufacturer or the importer,
manufacturer or the importer,
G
who makes a product available
who makes a product available
who makes a product available
who makes a product available
on the market;
on the market;
on the market;
on the market;
Article 3, first paragraph, point (12)
G 127
G
12. ‘fulfilment service
12. ‘fulfilment service
12. ‘fulfilment service
12. ‘fulfilment service
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provider’ means any natural or
provider’ means any natural or
provider’ means any natural or
provider’ means any natural or
legal person offering, in the
legal person offering, in the
legal person offering, in the
legal person offering, in the
course of commercial activity,
course of commercial activity,
course of commercial activity,
course of commercial activity,
at least two of the following
at least two of the following
at least two of the following
at least two of the following
services: warehousing,
services: warehousing,
services: warehousing,
services: warehousing,
packaging, addressing and
packaging, addressing and
packaging, addressing and
packaging, addressing and
dispatching, without having
dispatching, without having
dispatching, without having
dispatching, without having
ownership of the products
ownership of the products
ownership of the products
ownership of the products
involved, excluding postal
involved, excluding postal
involved, excluding postal
involved, excluding postal
services as defined in Article 2,
services as defined in Article 2,
services as defined in Article 2,
services as defined in Article 2,
point 1 of Directive 97/67/EC of point 1 of Directive 97/67/EC of point 1 of Directive 97/67/EC of point 1 of Directive 97/67/EC of
the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of
the Council1, parcel delivery
the Council1, parcel delivery
the Council1, parcel delivery
the Council1, parcel delivery
services as defined in Article 2,
services as defined in Article 2,
services as defined in Article 2,
services as defined in Article 2,
point 2 of Regulation (EU)
point 2 of Regulation (EU)
point 2 of Regulation (EU)
point 2 of Regulation (EU)
2018/644 of the European
2018/644 of the European
2018/644 of the European
2018/644 of the European
Parliament and of the Council2,
Parliament and of the Council2,
Parliament and of the Council2,
Parliament and of the Council2,
and any other postal services or
and any other postal services or
and any other postal services or
and any other postal services or
freight transport services;
freight transport services;
freight transport services;
freight transport services;
_________
_________
_________
_________
1. Directive 97/67/EC of the
1. Directive 97/67/EC of the
1. Directive 97/67/EC of the
1. Directive 97/67/EC of the
European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of the
Council of 15 December 1997
Council of 15 December 1997
Council of 15 December 1997
Council of 15 December 1997
on common rules for the
on common rules for the
on common rules for the
on common rules for the
development of the internal
development of the internal
development of the internal
development of the internal
market of Community postal
market of Community postal
market of Community postal
market of Community postal
services and the improvement of services and the improvement of services and the improvement of services and the improvement of
quality of service (OJ L 15, 21.
quality of service (OJ L 15, 21.
quality of service (OJ L 15, 21.
quality of service (OJ L 15, 21.
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1. 1998, p. 14).
1. 1998, p. 14).
1. 1998, p. 14).
1. 1998, p. 14).
2. Regulation (EU) 2018/644 of 2. Regulation (EU) 2018/644 of 2. Regulation (EU) 2018/644 of 2. Regulation (EU) 2018/644 of
the European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of
the Council of 18 April 2018 on the Council of 18 April 2018 on the Council of 18 April 2018 on the Council of 18 April 2018 on
cross-border parcel delivery
cross-border parcel delivery
cross-border parcel delivery
cross-border parcel delivery
services (OJ L 112, 2. 5. 2018,
services (OJ L 112, 2. 5. 2018,
services (OJ L 112, 2. 5. 2018,
services (OJ L 112, 2. 5. 2018,
p. 19).
p. 19).
p. 19).
p. 19).
Article 3, first paragraph, point (13)
13. ‘economic operator’ means 13. ‘economic operator’ means 13. ‘economic operator’ means 13. ‘economic operator’ means
the manufacturer, the authorized the manufacturer, the authorized the manufacturer, the
the manufacturer, the
representative, the importer, the representative, the importer, the authorized
authorised
authorised representative, the
distributor, the fulfilment
distributor, the fulfilment
representative, the importer, the importer, the distributor, the
service provider or any other
service provider or any other
distributor, the fulfilment
fulfilment service provider or
natural or legal person who is
natural or legal person who is
service provider or any other
any other natural or legal person
G 128
subject to obligations in relation subject to obligations in relation natural or legal person who is
who is subject to obligations in
G
to the manufacture of products,
to the manufacture of products,
subject to obligations in relation relation to the manufacture of
making them available on the
making them available on the
to the manufacture of products,
products, making them available
market in accordance with this
market in accordance with this
making them available on the
on the market in accordance
Regulation;
Regulation;
market in accordance with this
with this Regulation;
Regulation;
Article 3, first paragraph, point (14)
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14. ‘online marketplace’ means 14. ‘online marketplace’ means 14. ‘
provider of an online
14.
’provider of an online
a provider of an intermediary
a provider of an intermediary
marketplace’ means a provider
marketplace’ means a provider
service using software,
service using
software,
of an intermediary service using of an intermediary service using
including a website, part of a
including a website, part of a
software, including a website,
an online interface, which
website or an application,
website or an application,
part of a website or an
allows consumers to conclude
operated by or on behalf of a
operated by or on behalf of a
application, operated by or on
distance contracts with ▌
trader, which allows consumers
trader, whichan online
behalf of a trader, which allows traders ▌ for the sale of
G 129
to conclude distance contracts
interface, which gives
consumers to conclude distance products
.
G
with other traders or consumers
consumers access to traders’
contracts with other traders or
for the sale of products covered
products and allows consumers consumers
for the sale of
by this Regulation;
to conclude distance contracts
products covered by this
with
otherthose traders
or
Regulation;
consumers for the sale of
products covered by this
Regulation;
Article 3, first paragraph, point (15)
15. ‘online interface’ means
15. ‘online interface’ means
15. ‘online interface’ means
15. ‘online interface’ means
any software, including a
any software, including a
any software, including a
any software, including a
G 130
website, part of a website or an
website, part of a website or an
website, part of a website or an
website, part of a website or an
G
application, that is operated by
application,
that is operated by
application, that is operated by
application,
including mobile
or on behalf of an economic
or on behalf of an economic
or on behalf of an economic
applications;
operator, and which serves to
operator, and which serves to
operator, and which serves to
give end users access to the
give end users access to the
give end users
consumers
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economic operator's products;
economic operator's
access to the economic
productsincluding mobile
operator's products;
applications;
Article 3, first paragraph, point (15a)
(15a) ‘distance contract’
(15a) ‘distance contract’
means a distance contract as
means a distance contract as
G 130a
defined in Article 2, point (7),
defined in Article 2, point (7),
G
of Directive 2011/83/EU;
of Directive 2011/83/EU;
Article 3, first paragraph, point (15a)
(15a) ‘consumer’ means any
(15a) ‘consumer’ means any
natural person who acts for
natural person who acts for
G 130b
purposes which are outside
purposes which are outside that G
that person’s trade, business,
person’s trade, business, craft
craft or profession;
or profession;
Article 3, first paragraph, point (15b)
G 130c
G
(15b) ‘trader’ means any
(15c) ‘trader’ means any
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natural person, or any legal
natural person, or any legal
person irrespective of whether person irrespective of whether
privately or publicly owned,
privately or publicly owned,
who is acting, including
who is acting, including
through any person acting in
through any person acting in
his or her name or on his or
his or her name or on his or
her behalf, for purposes
her behalf, for purposes
relating to his or her trade,
relating to his or her trade,
business, craft or profession;
business, craft or profession;
Article 3, first paragraph, point (16)
16. ‘end user’ means any
16. ‘end user’ means any
16. ‘end user’ means any
natural or legal person residing
natural or legal person residing
natural or legal person residing
deleted
or established in the Union, to
or established in the Union, to
or established in the Union, to
whom a product has been made
whom a product has been made
whom a product has been made
available either as a consumer
available either as a consumer
available either as a consumer
G 131
outside of any trade, business,
outside of any trade, business,
outside of any trade, business,
G
craft or profession or as a
craft or profession or as a
craft or profession or as a
professional end user in the
professional end user in the
professional end user in the
course of its industrial or
course of its industrial or
course of its industrial or
professional activities;
professional activities;
professional activities;
Article 3, first paragraph, point (17)
G 132
G
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17. ‘European standard’ means 17. ‘European standard’ means 17. ‘European standard’ means 17. ‘European standard’ means
a European standard as defined
a European standard as defined
a European standard as defined
a European standard as defined
in Article 2(1), point (b) of
in Article 2(1), point (b) of
in Article 2(1), point (b) of
in Article 2(1), point (b) of
Regulation (EU) No 1025/2012; Regulation (EU) No 1025/2012; Regulation (EU) No 1025/2012; Regulation (EU) No 1025/2012;
Article 3, first paragraph, point (18)
18. ‘International standard’
18. ‘International standard’
18. ‘International standard’
18. ‘International standard’
means an international standard means an international standard means an international standard means an international standard
G 133
as defined in Article 2(1), point
as defined in Article 2(1), point
as defined in Article 2(1), point
as defined in Article 2(1), point
G
(a) of Regulation (EU) No
(a) of Regulation (EU) No
(a) of Regulation (EU) No
(a) of Regulation (EU) No
1025/2012;
1025/2012;
1025/2012;
1025/2012;
Article 3, first paragraph, point (19)
19. ‘National standard’ means a 19. ‘National standard’ means a 19. ‘National standard’ means a 19. ‘National standard’ means a
national standard as defined in
national standard as defined in
national standard as defined in
national standard as defined in
G 134
Article 2(1), point (d) of
Article 2(1), point (d) of
Article 2(1), point (d) of
Article 2(1), point (d) of
G
Regulation (EU) No 1025/2012; Regulation (EU) No 1025/2012; Regulation (EU) No 1025/2012; Regulation (EU) No 1025/2012;
Article 3, first paragraph, point (20)
G 135
G
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20. ‘European standardisation
20. ‘European standardisation
20. ‘European standardisation
20. ‘European standardisation
organisation’ means a European organisation’ means a European organisation’ means a European organisation’ means a European
standardisation organisation as
standardisation organisation as
standardisation organisation as
standardisation organisation as
listed in Annex 1 to Regulation
listed in Annex 1 to Regulation
listed in Annex 1 to Regulation
listed in Annex 1 to Regulation
(EU) No 1025/2012;
(EU) No 1025/2012;
(EU) No 1025/2012;
(EU) No 1025/2012;
Article 3, first paragraph, point (21)
21. ‘market surveillance’ means 21. ‘market surveillance’ means 21. ‘market surveillance’ means 21. ‘market surveillance’ means
the activities carried out and
the activities carried out and
the activities carried out and
the activities carried out and
measures taken by market
measures taken by market
measures taken by market
measures taken by market
G 136
surveillance authorities to
surveillance authorities to
surveillance authorities to
surveillance authorities to
G
ensure that products comply
ensure that products comply
ensure that products comply
ensure that products comply
with the requirements set out in
with the requirements set out in
with the requirements set out in
with the requirements set out in
this Regulation;
this Regulation;
this Regulation;
this Regulation;
Article 3, first paragraph, point (22)
22. ‘market surveillance
22. ‘market surveillance
22. ‘market surveillance
22. ‘market surveillance
authority’ means an authority
authority’ means an authority
authority’ means an authority
authority’ means an authority
G 137
designated by a Member State
designated by a Member State
designated by a Member State
designated by a Member State
G
under Article 10 of Regulation
under Article 10 of Regulation
under Article 10 of Regulation
under Article 10 of Regulation
(EU) 2019/1020 as responsible
(EU) 2019/1020 as responsible
(EU) 2019/1020
or competent
(EU) 2019/1020 as responsible
for organising and carrying out
for organising and carrying out
for the enforcement of this
for organising and carrying out
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market surveillance in the
market surveillance in the
Regulation as responsible for
market surveillance in the
territory of that Member State;
territory of that Member State;
organising and carrying out
territory of that Member State;
market surveillance in the
territory of that Member State;
Article 3, first paragraph, point (23)
23. ‘recall’ means any measure 23. ‘recall’ means any measure 23. ‘recall’ means any measure 23. ‘recall’ means any measure
aimed at achieving the return of aimed at achieving the return of aimed at achieving the return of aimed at achieving the return of
G 138
a product that has already been
a product that has already been
a product that has already been
a product that has already been
G
made available to the consumer; made available to the
made available to the consumer; made available to the consumer;
consumerend-user;
Article 3, first paragraph, point (24)
24. ‘withdrawal’ means any
24. ‘withdrawal’ means any
24. ‘withdrawal’ means any
24. ‘withdrawal’ means any
measure aimed at preventing a
measure aimed at preventing a
measure aimed at preventing a
measure aimed at preventing a
G 139
product in the supply chain from product in the supply chain from product in the supply chain from product in the supply chain from G
being made available on the
being made available on the
being made available on the
being made available on the
market;
market;
market;
market;
Article 3, first paragraph, point (25)
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25. ‘Union harmonisation
25. ‘Union harmonisation
25. ‘Union harmonisation
25. ‘Union harmonisation
legislation’ means Union
legislation’ means Union
legislation’ means Union
legislation’ means Union
legislation listed in Annex I to
legislation listed in Annex I to
legislation listed in Annex I to
legislation listed in Annex I to
Regulation (EU) 2019/1020 and Regulation (EU) 2019/1020 and Regulation (EU) 2019/1020 and Regulation (EU) 2019/1020 and
G 140
any other Union legislation
any other Union legislation
any other Union legislation
any other Union legislation
G
harmonising the conditions for
harmonising the conditions for
harmonising the conditions for
harmonising the conditions for
the marketing of products to
the marketing of products to
the marketing of products to
the marketing of products to
which that Regulation applies.
which that Regulation applies.
which that Regulation applies.
which that Regulation applies.
Article 3, first paragraph, point (25a)
(25a) ‘antiques’ means
(25a) ‘antiques’ means
products, such as collectible
products, such as collectible
objects and works of art, in
objects and works of art, in
G 140a
relation to which consumers
relation to which consumers
G
cannot reasonably expect that
cannot reasonably expect that
they fulfil state-of-the-art safety
they fulfil state-of-the-art safety
standards.
standards.
Article 4
G 141
G
Article 4
Article 4
Article 4
Article 4
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Distance sales
Distance sales
Distance sales
Distance sales
Article 4(1)
1. Products offered for sale
1. Products offered for sale
1. Products offered for sale
1. Products offered for sale
online or through other means
online or through other means
online or through other means
online or through other means
of distance sales shall be
of distance sales shall be
of distance sales shall be
of distance sales shall be
deemed to be made available on deemed to be made available on deemed to be made available on deemed to be made available on
the market if the offer is
the market if the offer is
the market if the offer is
the market if the offer is
targeted at consumers in the
targeteddirected at consumers
targeted at consumers in the
targeted at consumers in the
Union. An offer for sale shall be in the Union. An offer for sale
Union. An offer for sale shall be Union. An offer for sale shall be
considered to be targeted at
shall be considered to be
considered to be targeted at
considered to be targeted at
G 142
consumers in the Union if the
targeteddirected at consumers
consumers in the Union if the
consumers in the Union if the
G
relevant economic operator
in the Union if the relevant
relevant economic operator
relevant economic operator
directs, by any means, its
economic operator directs, by
directs, by any means, its
directs, by any means, its
activities to one or several
any means, its activities to one
activities to one or several
activities to one or several
Member State(s).
or several Member State(s).
Member State(s).
Member State(s).
This article shall also apply to products offered free of
charge.
Article 4(2), introductory part
G 143
G
2. For the purpose of
2.
For the purpose of
2. For the purpose of
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determining whether an offer is
determining whether an offer is
determining whether an offer is
deleted
targeted at consumers in the
targeted at consumers in the
targeted at consumers in the
Union, the following non-
Union, the following non-
Union, the following non-
exhaustive criteria shall be
exhaustive criteria shall be
exhaustive criteria shall be
deleted
taken into account:
taken into account:
taken into account:
Text Origin:
Commission Proposal
Article 4(2), point (a)
(a) the use of an official
(a)
the use of an official
(a) the use of an official
language or currency of the
language or currency of the
language or currency of the
deleted
Member States,
Member States,
Member States,
G 144
deleted
G
Text Origin:
Commission Proposal
Article 4(2), point (b)
G 145
(b) a domain name registered in (b)
a domain name registered
(b) a domain name registered in
G
one of the Member States,
in one of the Member States,
one of the Member States,
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deleted
deleted
Text Origin:
Commission Proposal
Article 4(2), point (c)
(c) the geographical areas to
(c)
the geographical areas to
(c) the geographical areas to
which the products can be
which the products can be
which the products can be
deleted
dispatched.
dispatched.
dispatched.
G 146
deleted
G
Text Origin:
Commission Proposal
CHAPTER II
G 147
G
CHAPTER II
CHAPTER II
CHAPTER II
CHAPTER II
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Safety requirements
Safety requirements
Safety requirements
Safety requirements
Article 5
Article 5
Article 5
Article 5
Article 5
G 148
G
General safety requirement
General safety requirement
General safety requirement
General safety requirement
Article 5, first paragraph
Economic operators shall place
Economic operators shall
place
Economic operators shall place
Economic operators shall
[place
or make available on the Union
or make available on the Union
or make available on the Union
or
] make available on the Union
market only safe products.
market only safe products.
market only safe products.
market only safe products.
G 149
G
Subject to legal check on
placed/made available
Article 5a
G 149a
Article 5a
Aspects
Article 5a
G
Aspects for assessing the safety for assessing the safety of
Aspects for assessing the safety
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of products
products
of products
(Moved for easy of
reading only)
Same title, same position as line
156.
Article 5a(1), introductory part
1. When assessing whether a
1. When assessing whether a
1. When assessing whether a
product is safe, the following
product is safe, the following
product is safe, the following
aspects shall be taken in
aspects shall at least be taken
aspects shall be taken in
particular into account:
into account :
particular into account:
G 149b
G
(Moved for easy of
See row 157.
reading only)
Article 5a(1), point (a)
(a) the characteristics of the
(a) the characteristics of the
(a) the characteristics of the
product, including its design,
product, including its design,
product, including its design,
G 149c
technical features,
technical features,
technical features,
G
composition, packaging,
composition, packaging,
composition, packaging,
instructions for assembly and,
instructions for assembly and, instructions for assembly and,
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where applicable, for
where applicable, for
where applicable, for
installation, use and
installation and maintenance; installation, use and
maintenance;
maintenance;
(Moved for easy of
reading only)
See row 158.
Article 5a(1), point (b)
(b) the effect on other
(b) the effect on other
(b) the effect on other
products, where it is reasonably products, where it is
products, where it is reasonably
foreseeable that it will be used
reasonably foreseeable that it
foreseeable that it will be used
with other products, including
will be
with other products, including
the interconnection of products
the interconnection of products
G 149d
used with other products,
among them;
G
including the interconnection
among them;
of products among them;
(Moved for easy of
See row 159.
reading only)
Article 5a(1), point (c)
G 149e
(c) the effect that other
(c) the effect that other
(c) the effect that other
G
products might have on the
products might have on the
products might have on the
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product to be assessed, where it product to be assessed,
product to be assessed, where it
is reasonably foreseeable that
including the effect of non-
is reasonably foreseeable that
other products will be used with embedded items that are
other products will be used with
that product, including the
meant to determine, change or that product, including the
effect of non-embedded items
complete the way the product
effect of non-embedded items
that are meant to determine,
to be assessed works;
that are meant to determine,
change or complete the way
change or complete the way the
another product falling under
product to be assessed works,
the scope of this Regulation
(Moved for easy of reading
which has to be taken into
works, which have to be taken
only)
consideration when assessing
into consideration in assessing
the safety of the product to be
the safety of that other product;
assessed;
Article 5a(1), point (d)
(d) the presentation of the
(d) the presentation of the
(d) the presentation of the
product, the labelling,
product, the labelling, any
product, the labelling,
including the labelling
warnings and instructions for
including the labelling
regarding age suitability for
its items;
regarding age suitability for
children, any warnings and
children, any warnings and
G 149f
instructions for its safe use and
instructions for its safe use and G
disposal, and any other
(Moved for easy of reading
disposal, and any other
indication or information
only)
indication or information
regarding the product;
regarding the product;
See 161 Council.
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Article 5a(1), point (e)
(e) the categories of consumers (e) the categories of
(e) the categories of consumers
at risk when using the product, consumers using the product,
using the product, in particular
in particular by assessing the
in particular vulnerable
by assessing the risk for
risk for vulnerable consumers
consumers such as children,
vulnerable consumers such as
G 149g
such as children, older people
older people and persons with children, older people and
G
and persons with disabilities, as disabilities;
persons with disabilities, as
well as the different impact on
well as the impact of gender
health and safety of different
differences on health and
genders;
(Moved for easy of reading
safety;
only)
Article 5a(1), point (f)
(f) the appearance of the
(f) the appearance of the
(f) the appearance of the
product and in particular
product where it is likely to
product where it is likely to
where a product, although not
make consumers use the
make consumers use the
G 149h
foodstuff, resembles foodstuff
product in a way different
product in a way different from G
and is likely to be confused
from what it was designed for, what it was designed for, and in
with foodstuff due to its form,
and in particular:
particular:
odour, colour, appearance,
(i) where a product, although
packaging, labelling, volume,
not foodstuff, resembles
size or other characteristics
(Row 163a)
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and may therefore be placed in (i) where a product, although foodstuff and is likely to be
the mouth, sucked or ingested
not foodstuff, resembles
confused with foodstuff due to
by the consumer, especially by
foodstuff and is likely to be
its form, odour, colour,
children;
confused with foodstuff due to appearance, packaging,
its form, odour, colour,
labelling, volume, size or other
appearance, packaging,
characteristics and may
labelling, volume, size or other therefore be placed in the
characteristics;
mouth, sucked or ingested by
the consumer, especially by
children;
(Moved for easy of reading
(ii) where a product, although
only)
not designed or not intended
for use by children, is likely to
be used by children or
resembles an object commonly
recognized as appealing to or
intended for use by children ,
because of its design,
packaging and characteristics;
See 149i EP, 163, 163a, 163b
Council.
Article 5a(1), point (g)
G 149i
G
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(g) the fact that although not
(g) (Row 163b)
designed or not intended for
No text here. See rows 149h
use by children, the product is
likely to be used by children or
(ii) where a product, although above and 164 Council.
resembles an object or a
not designed or not intended
product commonly recognised
for use by children, resembles
as appealing to or intended for
an object commonly
use by children, because of its
recognized as appealing to or
design, packaging and
intended for use by children,
characteristics;
because of its design,
packaging and characteristics;
(Moved for easy of reading
only)
Article 5a(1), point (h)
(h) when required by the
(h) the appropriate
(h) when required by the
nature of product, the
cybersecurity features
nature of product, the
appropriate cybersecurity
necessary to protect the
appropriate cybersecurity
G 149j
features necessary to protect
product against external
features necessary to protect
G
the product against external
influences, including malicious the product against external
influences, including malicious third parties, when such an
influences, including malicious
third parties, when such an
influence might have an
third parties, when such an
influence may have an impact
impact on the safety of the
influence may have an impact
on the safety of the product,
product;
on the safety of the product,
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including the possible loss of
including the possible loss of
interconnection;
interconnection;
(moved for easy of reading
only)
See row 165 Council.
Article 5a(1), point (i)
(i) the evolving, learning and
(i) the evolving, learning and
(i) when required by the
predictive functionalities of a
predictive functionalities of a
nature of the product, the
product when such
product.
evolving, learning and
functionalities have an impact
predictive functionalities of a
G 149k
G
on the safety of the product.
product.
(Moved for easy of
reading only)
See row 166 Council.
Article 5a(2)
2. The feasibility of obtaining
2. 2. The feasibility of
2. The feasibility of obtaining
higher levels of safety or the
obtaining higher levels of
higher levels of safety or the
G 149l
availability of other products
safety or the availability of
availability of other products
G
presenting a lesser degree of
other products presenting a
presenting a lesser degree of
risk shall not constitute
lesser degree of risk shall not
risk shall not constitute
grounds for considering a
constitute grounds for
grounds for considering a
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product not to be safe.
considering a product not to
product not to be safe.
be safe.
See row 167 Council
(Moved for easy of reading
only)
Text Origin: EP
Mandate
Article 6
Article 6
Article 6
Article 6
Article 6
Presumption of safety
Presumption of
conformity with
Presumption of safety
Presumption of
conformity with
G 150
the general safety
requirement
the general safety
requirement G
[moved to new Art. 7a with
changes]
See row 178a Council.
Article 6(1), introductory part
1. For the purpose of this
1. For the purpose of this
1. For the purpose of this
1. For the purpose of this
G 151
Regulation, a product shall be
Regulation, a product shall be
Regulation, a product shall be
Regulation, a product shall be
G
presumed to be in conformity
presumed to be in conformity
presumed to be in conformity
presumed to be in conformity
with the general safety
with the general safety
with the general safety
with the general safety
requirement laid down in
requirement laid down in
requirement laid down in
requirement laid down in
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Article 5 in the following cases: Article 5 in the following cases: Article 5 in the following cases: Article 5 in the following cases:
See row 178b Council
Text Origin:
Commission Proposal
Article 6(1), point (a)
(a) if it conforms to relevant
(a) if it conforms to relevant
(a) if it conforms to relevant
(a) if it conforms to relevant
European standards or parts
European
product safety
European standards or parts
European standards or parts
thereof as far as the risks and
standards or parts thereof as far
thereof as far as the risks and
thereof as far as the risks and
risk categories covered are
as the risks and risk categories
risk categories covered are
risk categories covered
by those
concerned, the references of
covered
by those standards are
concerned, the references of
standards are concerned, the
which have been published in
concerned, the references of
which have been published in
references of which have been
the Official Journal of the
which have been published in
the Official Journal of the
published in the Official Journal
G 152
G
European Union in accordance
the Official Journal of the
European Union in accordance
of the European Union in
with Article 10(7) of Regulation European Union in accordance
with Article 10(7) of Regulation accordance with Article 10(7) of
(EU) 1025/2012;
with Article 10(7) of Regulation (EU) 1025/2012;
Regulation (EU)
No 1025/2012;
(EU)
1025/2012No 1025/2012;
or
or
See row 178c Council.
Article 6(1), point (b)
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(b) in the absence of European
(b) in the absence of European
(b) in the absence of European
(b) in the absence of
the
standards referred to in point
standards referred to in point (a)
standards referred to in point
European standards referred to
(a), as regards the risks covered
of this paragraph, as regards
(a), as regards the risks covered in point (a),
if the product
by health and safety
the risks
and risk categories
by health and safety
conforms to national
requirements laid down in the
covered by health and safety
requirements laid down in the
requirements, as regards the
law of the Member State where
requirements laid down in the
law of the Member State where
risks
and risk categories
the product is made available on law of the Member State where
the product is made available on covered by health and safety
G 153
the market, if it conforms to
the product is made available on the market, if it conforms to
requirements laid down in the
G
such national requirements.
the market
, such requirements
such national requirements.
law of the Member State
it is
being in conformity with the
made available on the market,
Treaties, and in particular with
provided that such law is in
Articles 34 and 36 of the Treaty
compliance with Union law.
on the Functioning of the
European Union, if it conforms
to such national requirements.
See row 178d Council.
Article 6(2)
2. The Commission shall adopt 2. The Commission shall adopt 2. The Commission shall adopt 2. The Commission shall adopt
implementing acts determining
implementing acts determining
implementing acts determining
implementing acts determining
G 154
the specific safety requirements the specific safety requirements the specific safety requirements the specific safety requirements G
necessary to ensure that
necessary to ensure that
necessary to ensure that
to be covered by European
products which conform to the
products which conform to the
products which conform to the
standards in order to ensure
European standards satisfy the
European
product safety
European standards satisfy the
that products which conform to
general safety requirement laid
standards satisfy the general
general safety requirement laid
these European standards satisfy
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down in Article 5. Those
safety requirement laid down in down in Article 5. Those
the general safety requirement
implementing acts shall be
Article 5. Those implementing
implementing acts shall be
laid down in Article 5. Those
adopted in accordance with the
acts shall be adopted in
adopted in accordance with the
implementing acts shall be
examination procedure referred
accordance with the
examination procedure referred
adopted in accordance with the
to in Article 42(3).
examination procedure referred
to in Article 42(3).
examination procedure referred
to in Article 42(3).
to in Article 42(3).
See 178e Council.
Article 6(3)
3. However, presumption of
3. However, presumption of
3. However, presumption of
3. However, presumption of
safety under paragraph 1 shall
conformity with the general
safety under paragraph 1 shall
conformity with the general
not prevent market surveillance
safety
requirement under
not prevent market surveillance
safety
requirement under
authorities from taking action
paragraph 1 shall not prevent
authorities from taking action
paragraph 1 shall not prevent
under this Regulation where
market surveillance authorities
under this Regulation where
market surveillance authorities
there is evidence that, despite
from taking
actionall
there is evidence that, despite
from taking
all appropriate
G 155
such conformity, the product is
appropriate measures under
such conformity, the product is
measures under this Regulation G
dangerous.
this Regulation where there is
dangerous.
where there is evidence that,
evidence that, despite such
despite such
presumption, the
conformity, the product is
product is dangerous.
dangerous.
See row 178f Council.
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Article 7
Article 7
Article 7
Article 7
Article 7
G 156
Aspects for assessing the safety
AspectsAdditional elements for Aspects for assessing the safety
Additional elements to be taken G
of products
assessing the safety of products
of products
into account for assessing the
safety of products
Article 7(1), introductory part
1. Where the presumption of
1.
Where the presumption of
1. Where the presumption of
safety laid down in Article 5
safety laid down in Article 5
safety laid down in Article 5
deleted
does not apply, the following
does not apply, the following
does not apply
When assessing
aspects shall be taken into
aspects shall be taken into
whether a product is safe, the
G 157
account in particular when
account in particular when
following aspects shall
at least
G
see above.
assessing whether a product is
assessing whether a product is
be taken into account in
safe:
safe:
particular when assessing
whether a product is safe:
Article 7(1), point (a)
G 158
(a) the characteristics of the
(a)
the characteristics of the
(a) the characteristics of the
G
product, including its design,
product, including its design,
product, including its design,
deleted
technical features, composition,
technical features, composition, technical features, composition,
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packaging, instructions for
packaging, instructions for
packaging, instructions for
assembly and, where applicable,
assembly and, where applicable, assembly and, where applicable,
for installation and
for installation and
for installation and
see above
maintenance;
maintenance;
maintenance;
Article 7(1), point (b)
(b) the effect on other products, (b)
the effect on other products, (b) the effect on other products,
where it is reasonably
where it is reasonably
where it is reasonably
deleted
foreseeable that it will be used
foreseeable that it will be used
foreseeable that it will be used
G 159
with other products, including
with other products, including
with other products, including
G
the interconnection of products
the interconnection of products
the interconnection of products
see above.
among them;
among them;
among them;
Article 7(1), point (c)
(c) the effect that other
(c)
the effect that other
(c) the effect that other
products might have on the
products might have on the
products might have on the
deleted
product to be assessed,
product to be assessed,
product to be assessed,
G 160
including the effect of non-
including the effect of non-
including the effect of non-
G
embedded items that are meant
embedded items that are meant
embedded items that are meant
see above.
to determine, change or
to determine, change or
to determine, change or
complete the way another
complete the way another
complete the way another
product falling under the scope
product falling under the scope
product falling under the scope
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of this Regulation works, which
of this Regulation works, which
of this Regulation works, which
have to be taken into
have to be taken into
have
the product to be taken
consideration in assessing the
consideration in assessing the
into consideration in assessing
safety of that other product;
safety of that other product;
the safety of that other
product
assessed works;
Article 7(1), point (d)
(d) the presentation of the
(d)
the presentation of the
(d) the presentation of the
product, the labelling, any
product, the labelling, any
product, the labelling, any
deleted
warnings and instructions for its
warnings and instructions for its warnings and instructions for its
G 161
safe use and disposal, and any
safe use and disposal, and any
safe use and disposal, and any
G
other indication or information
other indication or information
other indication or information
see above.
regarding the product;
regarding the product;
regarding the product;
items;
Article 7(1), point (e)
(e) the categories of consumers (e)
the categories of consumers (e) the categories of consumers
at risk when using the product,
at risk when using the product,
at risk when
using the product,
deleted
in particular vulnerable
in particular vulnerable
in particular vulnerable
G 162
consumers such as children,
consumers such as children,
consumers such as children,
G
older people and persons with
older people and persons with
older people and persons with
see above.
disabilities;
disabilities;
disabilities;
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Article 7(1), point (f)
(f) the appearance of the
(f)
the appearance of the
(f) the appearance of the
product and in particular where
product and in particular where product and in particular where
deleted
a product, although not
a product, although not
a product, although not
foodstuff, resembles foodstuff
foodstuff, resembles foodstuff
foodstuff, resembles foodstuff
and is likely to be confused with
and is likely to be confused with and
it is likely to be confused
see above.
foodstuff due to its form, odour,
foodstuff due to its form, odour, with foodstuff due to its form,
colour, appearance, packaging,
colour, appearance, packaging, odour, colour, appearance,
G 163
labelling, volume, size or other
labelling, volume, size or other
packaging, labelling, volume,
G
characteristics;
characteristics;
size or other
characteristics;
make
consumers use the product in
a way different from what it
was designed for, and in
particular:
Article 7(1), point (f)(i)
(i) where a product, although
not foodstuff, resembles
deleted
G 163a
foodstuff and is likely to be
G
confused with foodstuff due to
its form, odour, colour,
no text here. see above.
appearance, packaging,
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labelling, volume, size or other
characteristics;
Article 7(1), point (f)(ii)
(ii) where a product, although
not designed or not intended
deleted
for use by children, resembles
an object commonly
G 163b
recognized as appealing to or
G
no text here. see above.
intended for use by children,
because of its design,
packaging and characteristics;
Article 7(1), point (g)
(g) the fact that although not
(g)
the fact that although not
(g) the fact that although not
designed or not intended for use
designed or not intended for use designed or not intended for use
deleted
by children, the product
by children, the product
by children, the product
G 164
resembles an object commonly
resembles an object commonly
resembles an object commonly
G
recognized as appealing to or
recognized as appealing to or
recognized as appealing to or
see above.
intended for use by children,
intended for use by children,
intended for use by children,
because of its design, packaging
because of its design, packaging because of its design, packaging
and characteristics;
and characteristics;
and characteristics;
[moved to
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changes]
Article 7(1), point (h)
(h) the appropriate
(h)
the appropriate
(h) the appropriate
cybersecurity features necessary
cybersecurity features necessary cybersecurity features necessary
deleted
to protect the product against
to protect the product against
to protect the product against
external influences, including
external influences, including
external influences, including
G 165
malicious third parties, when
malicious third parties, when
malicious third parties, when
G
see above.
such an influence might have an
such an influence might have an such an influence might have an
impact on the safety of the
impact on the safety of the
impact on the safety of the
product;
product;
product;
Article 7(1), point (i)
(i) the evolving, learning and
(i)
the evolving, learning and
(i) the evolving, learning and
predictive functionalities of a
predictive functionalities of a
predictive functionalities of a
deleted
G 166
product.
product.
product.
G
see above row 149k.
Article 7(2)
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2. The feasibility of obtaining
2.
The feasibility of obtaining
2. The feasibility of obtaining
higher levels of safety or the
higher levels of safety or the
higher levels of safety or the
deleted
availability of other products
availability of other products
availability of other products
G 167
presenting a lesser degree of
presenting a lesser degree of
presenting a lesser degree of
G
risk shall not constitute grounds
risk shall not constitute grounds risk shall not constitute grounds
see above row 149l.
for considering a product not to
for considering a product not to for considering a product not to
be safe.
be safe.
be safe.
Article 7(3), introductory part
3. For the purpose of paragraph 3. For the purpose of
3. For the purpose of paragraph
1. For the purpose of
Article 5a
1, when assessing whether a
paragraph 1Article 5a and
1,
and without prejudice to
and where the presumption of
product is safe, the following
where the presumption of
the application of Article 7a,
safety under Article 6 does not
elements, when available, shall
safety under Article 6 does not
when assessing whether a
apply, when assessing whether a
G 168
be taken into account, in
apply, when assessing whether a product is safe, the following
product is safe, the following
G
particular:
product is safe, the following
elements, when available, shall
elements ▌ shall be taken
in
elements, when available, shall
shall at least be taken into
particular into account,
when
be taken
in particular into
account, in particular
when
available:
account
, in particular:
available:
Article 7(3), point (a)
G 169
G
(a) European standards other
(a) European standards other
(a) European standards other
(a) European standards other
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than those the references of
than those the references of
than those the references of
than those the references of
which have been published in
which have been published in
which have been published in
which have been published in
the Official Journal of the
the Official Journal of the
the Official Journal of the
the Official Journal of the
European Union in accordance
European Union in accordance
European Union in accordance
European Union in accordance
with Article 10(7) of Regulation with Article 10(7) of Regulation with Article 10(7) of Regulation with Article 10(7) of Regulation
(EU) 1025/2012;
(EU) 1025/2012;
(EU) 1025/2012;
(EU) 1025/2012;
Article 7(3), point (b)
G 170
(b) international standards;
(b) international standards;
(b) international standards;
(b) international standards;
G
Article 7(3), point (c)
G 171
(c) international agreements;
(c) international agreements;
(c) international agreements;
(c) international agreements;
G
Article 7(3), point (d)
(d) voluntary certification
(d) voluntary certification
(d) voluntary certification
(d) voluntary certification
G 172
schemes or similar third-party
schemes or similar third-party
schemes or similar third-party
schemes or similar third-party
G
conformity assessment
conformity assessment
conformity assessment
conformity assessment
frameworks, in particular those
frameworks, in particular those
frameworks, in particular those
frameworks, in particular those
conceived to support Union
conceived to support Union
conceived to support Union
conceived to support Union
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legislation;
legislation;
legislation;
legislation;
Article 7(3), point (e)
(e) Commission
(e) Commission
(e) Commission
(e) Commission
recommendations or guidelines
recommendations or guidelines
recommendations or guidelines
recommendations or guidelines
G 173
on product safety assessment;
on product safety assessment;
on product safety assessment
on product safety assessment;
G
from the Commission or other
Union institutions or agencies;
Article 7(3), point (f)
(f) national standards drawn up (f) national standards drawn up (f) national standards drawn up (f) national standards drawn up
G 174
in the Member State in which
in the Member State in which
in the Member State in which
in the Member State in which
G
the product is made available;
the product is made available;
the product is made available;
the product is made available;
Article 7(3), point (g)
(g) the state of the art and
(g) the state of the art and
(g) the state of the art and
(g) the state of the art and
G 175
technology, including the
technology, including the
technology, including the
technology, including the
G
opinion of recognized scientific opinion of recognized scientific opinion of recognized scientific opinion of recognized scientific
bodies and expert committees;
bodies and expert committees;
bodies and expert committees;
bodies and expert committees;
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Article 7(3), point (h)
(h) product safety codes of
(h) product safety codes of
(h) product safety codes of
(h) product safety codes of
G 176
good practice in force in the
good practice in force in the
good practice in force in the
good practice in force in the
G
sector concerned;
sector concerned;
sector concerned;
sector concerned;
Article 7(3), point (i)
(i) reasonable consumer
(i) reasonable consumer
(i) reasonable consumer
(i) reasonable consumer
G 177
expectations concerning safety;
expectations concerning safety;
expectations concerning safety;
expectations concerning safety;
G
Article 7(3), point (j)
(j) safety requirements adopted (j) safety requirements adopted (j) safety requirements adopted (j) safety requirements adopted
G 178
in accordance with Article 6(2). in accordance with Article 6(2). in accordance with Article 6(2)
in accordance with Article 6(2). G
7a(2).
Article 7a
G 178a
G
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Article 7a
Presumption of safety
no text here.
[moved from Art. 6 with
changes]
[moved from Art. 6 with
changes]
Article 7a(1), introductory part
1. For the purpose of this
Regulation, a product shall be no text here.
presumed to be in conformity
G 178b
with the general safety
G
requirement laid down in
Article 5 in the following
cases:
Article 7a(1), point (a)
G 178c
(a) if it conforms to relevant
G
European standards drawn up no text here. see above
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in support of this Regulation
or parts thereof for the risks
and risk categories covered by
those standards, the
references of which have been
published in the Official
Journal of the European
Union in accordance with
Article 10(7) of Regulation
(EU) 1025/2012;
Article 7a(1), point (b)
(b) in the absence of the
European standards referred
no text here. see above
to in point (a), if the product
conforms to national
requirements, as regards the
risks covered by health and
G 178d
safety requirements laid down
G
in the law of the Member
State it is made available on
the market, provided that
such law is in compliance with
Union law.
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Article 7a(2)
2. The Commission shall
adopt implementing acts
no text here. see above.
determining the specific safety
requirements to be covered by European standards in order
to ensure that products which
conform to these European
G 178e
standards satisfy the general
G
safety requirement laid down
in Article 5. Those
implementing acts shall be
adopted in accordance with
the examination procedure
referred to in Article 42(3).
Article 7a(3)
3. However, presumption of
safety under paragraph 1
G 178f
no text here. see above.
shall not prevent market
G
surveillance authorities from
taking action under this
Regulation where, despite
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such presumption, there is
evidence that the product is
dangerous.
CHAPTER III
CHAPTER III
CHAPTER III
CHAPTER III
CHAPTER III
G 179
Obligations of economic
Obligations of economic
Obligations of economic
Obligations of economic
G
operators
operators
operators
operators
Section 1
G 180
Section 1
Section 1
Section 1
Section 1
G
Article 8
Article 8
Article 8
Article 8
Article 8
G 181
G
Obligations of manufacturers
Obligations of manufacturers
Obligations of manufacturers
Obligations of manufacturers
Article 8(1)
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1. When placing their products
1. When placing their products
1. When placing their products
1. When placing their products
on the market, manufacturers
on the market, manufacturers
on the market, manufacturers
on the market, manufacturers
shall ensure that these products
shall ensure that these products
shall ensure that these products
shall ensure that these products
have been designed and
have been designed and
have been designed and
have been designed and
G 182
manufactured in accordance
manufactured in accordance
manufactured in accordance
manufactured in accordance
G
with the general safety
with the general safety
with the general safety
with the general safety
requirement laid down in
requirement laid down in
requirement laid down in
requirement laid down in
Article 5.
Article 5.
Article 5.
Article 5.
Article 8(2), first subparagraph
2. Manufacturers shall
2.
Manufacturers shall
2. Manufacturers shall
investigate the complaints
investigate the complaints
investigate the complaints
deleted
received that concern products
received that concern products
received that concern products
they made available on the
they made available on the
they made available on the
G 183
market, and which have been
market, and which have been
market, and which have been
G
identified as dangerous by the
identified as dangerous by the
identified as dangerous by the
complainant, and shall keep a
complainant, and shall keep a
complainant, and shall keep a
register of these complaints as
register of these complaints as
register of these complaints as
well as of product recalls.
well as of product recalls.
well as of product recalls.
Article 8(2), second subparagraph
G 184
G
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Manufacturers shall make
Manufacturers shall make
Manufacturers shall make
publicly available to consumers,
publicly available to consumers, publicly available to consumers,
deleted
communication channels such
communication channels such
communication channels such
as telephone number, electronic
as telephone number, electronic as telephone number, electronic
address or dedicated section of
address or dedicated section of
address or dedicated section of
their website, allowing the
their website, allowing the
their website, allowing the
consumers to file complaints
consumers to file complaints
consumers to file complaints
and to inform them of any
and to inform them of any
and to inform them of any
accident or safety issue they
accident or safety issue they
accident or safety issue they
have experienced with the
have experienced with the
have experienced with the
product.
product.
product.
Article 8(2), third subparagraph
Personal data stored in the
Personal data stored in the
Personal data stored in the
register of complaints shall only
register of complaints shall only register of complaints shall only
deleted
be those personal data that are
be those personal data that are
be those personal data that are
necessary for the manufacturer
necessary for the manufacturer
necessary for the manufacturer
to investigate the complaint
to investigate the complaint
to investigate the complaint
G 185
about an alleged dangerous
about an alleged dangerous
about an alleged dangerous
G
product. Such data shall only be
product. Such data shall only be product. Such data shall only be
kept as long as it is necessary
kept as long as it is necessary
kept as long as it is necessary
for the purpose of investigation
for the purpose of investigation
for the purpose of investigation
and no longer than five years
and no longer than five years
and no longer than five years
after they have been encoded.
after they have been encoded.
after they have been encoded.
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Article 8(3)
3. Manufacturers shall keep
3.
Manufacturers shall keep
3. Manufacturers shall keep
distributors, importers and
distributors, importers and
distributors, importers and
deleted
online marketplaces in the
online marketplaces in the
online marketplaces in the
G 186
concerned supply chain
concerned supply chain
concerned supply chain
G
informed of any safety issue that
informed of any safety issue that informed of any safety issue that
they have identified.
they have identified.
they have identified.
Article 8(4), first subparagraph, introductory part
4. Manufacturers shall draw up 4.
Before placing a product on 4. Manufacturers shall draw up 4.
Before placing a product on
technical documentation of the
the market, manufacturers shall technical documentation of the
the market, manufacturers
product. The technical
draw up
a technical
product. The technical
shall carry out an internal risk
documentation shall contain, as
documentation
containing at
documentation shall contain, as
analysis and draw up a
appropriate:
least a general description of
appropriate:
technical documentation
the product
and its essential
containing at least a general
G 187
properties relevant for
description of the product and
G
assessing its safety.
its essential properties relevant
Where deemed appropriate
for assessing its safety.
with regard to the risks
Where appropriate with regard
presented by a product, the
to possible risks related to the
technical documentation
shall
product, the technical
contain, as appropriatereferred
documentation referred to in
to in the first subparagraph
the first subparagraph shall
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shall also contain:
also contain, as applicable:
(a) [deleted]
(b) an analysis of the possible
risks related to the product and
the solutions adopted to
eliminate or mitigate such
risks, including the outcome of
any reports related to tests
conducted by the manufacturer
or by another party on their
behalf;
(c) the list of the European
standards referred to in Article
6(1) point a, or the other
elements referred to in 6(1)
point b or Article 7, applied to
meet the general safety
requirement laid down in
Article 5.▌
Article 8(4), first subparagraph, point (a)
(a) a general description of the
(a)
a general description of the (a) a general description of the
G 188
product and its essential
product and its essential
product and its essential
deleted
G
properties relevant for assessing
properties relevant for assessing properties relevant for assessing
the product's safety;
the product's safety;
the product's safety;
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see text above.
Article 8(4), first subparagraph, point (b)
(b) an analysis of the possible
(b) an analysis of the possible
(b) an analysis of the possible
risks related to the product and
risks related to the product and
risks related to the product and
deleted
the solutions adopted to
the solutions adopted to
the solutions adopted to
eliminate or mitigate such risks, eliminate or mitigate such risks, eliminate or mitigate such risks,
G 189
including the outcome of any
including the outcome of any
including the outcome of any
see text above
G
tests conducted by the
tests conducted by the
reports related to tests
manufacturer or by another
manufacturer or by another
conducted by the manufacturer
party on their behalf;
party on their behalf;
or by another party on their
behalf;
Article 8(4), first subparagraph, point (c)
(c) the list of the European
(c) the list of the European
(c) the list of the European
standards referred to in Article
standards referred to in Article
standards referred to in Article
deleted
6(1) point a, or the other
6(1) point a, or the other
6(1) point a, or the other
G 190
elements referred to in Article
elements referred to in
6(1)
elements referred to in Article
G
7(3), applied to meet the general
point b or Article
7(3)7, applied 7(3), applied to meet the general
see text above
safety requirement laid down in to meet the general safety
safety requirement laid down in
Article 5.
requirement laid down in
Article 5.
Article 5.
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Article 8(4), second subparagraph
Where any of the European
Where any of the European
Where any of the European
Where any of the European
standards, health and safety
standards, health and safety
standards, health and safety
standards, health and safety
requirements or elements
requirements or elements
requirements or elements
requirements or elements
G 191
referred to in Article 7(3) have
referred to in Article
7(3)6(1) or referred to in Article 7(3) have
referred to in Article
6(1) or
G
been only partly applied, the
Article 7 have been only partly
been only partly applied, the
Article 7 have been only partly
parts which have been applied
applied, the parts which have
parts which have been applied
applied, the parts which have
shall be identified.
been applied shall be identified. shall be identified
and justified. been applied shall be identified.
Article 8(5)
5. Manufacturers shall keep the 5. Manufacturers shall
5. Manufacturers shall keep the 5. Manufacturers shall
ensure
technical documentation, for a
keepensure that the technical
technical documentation,
that the technical
period of ten years after the
documentation
, referred to in
referred to in paragraph 4 for documentation
referred to in
product has been placed on the
paragraph 4 is up to date. They a period of ten years after the
paragraph 4 is up to date. They
market and make it available to
shall keep it for a period of ten
product has been placed on the
shall keep it for a period of ten
G 192
the market surveillance
years after the product has been market and make it available to
years after the product has been G
authorities, upon request.
placed on the market
and make
the market surveillance
placed on the market
at the
it available toat the disposal of
authorities, upon request.
disposal of the market
the market surveillance
surveillance authorities, upon
authorities, upon request.
request.
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Article 8(5a)
5a. Manufacturers shall
5a. Manufacturers shall
ensure that procedures are in
ensure that procedures are in
place for products produced
place for products produced in
G 192a
in series to remain in
series to remain in conformity
G
conformity with the general
with the general safety
safety requirement laid down
requirement laid down in
in Article 5.
Article 5.
Article 8(5a)
5a. Manufacturers shall
ensure that procedures are in
no text here. see above.
place for series production to
G 192b
remain in conformity with the
G
general safety requirement laid
down in Article 5.
Article 8(6)
G 193
6. Manufacturers shall ensure
6. Manufacturers shall ensure
6. Manufacturers shall ensure
6. Manufacturers shall ensure
G
that their products bear a type,
that their products bear a type,
that their products bear a type,
that their products bear a type,
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batch or serial number or other
batch or serial number or other
batch or serial number or other
batch or serial number or other
element allowing the
element allowing the
element allowing the
element allowing the
identification of the product
identification of the product
identification of the product
identification of the product
which is easily visible and
which is easily visible and
adequate information
which is easily visible and
legible for consumers, or, where legible for consumers, or, where
allowing the identification of
legible for consumers, or, where
the size or nature of the product the size or nature of the product
the product, such as a type
the size or nature of the product
does not allow it, that the
does not allow it, that the
reference, batch or serial
does not allow it, that the
required information is provided required information is provided
number, which is easily visible required information is provided
on the packaging or in a
on the packaging or in a
and legible for consumers, or,
on the packaging or in a
document accompanying the
document accompanying the
where the size or nature of the
document accompanying the
product.
product.
product does not allow it, that
product.
the required information is
provided on the packaging or in
a document accompanying the
product.
Article 8(7)
7. Manufacturers shall indicate
7. Manufacturers shall indicate
7. Manufacturers shall indicate
7. Manufacturers shall indicate
their name, registered trade
their name, registered trade
their name,
their registered
their name,
their registered
name or registered trade mark
name or registered trade mark
,
trade name or registered trade
trade name or registered trade
G 194
and the postal and electronic
the postal address and the
mark
, their postal and
mark
, their postal and
G
address at which they can be
postal andwebsite or electronic
electronic address and, where electronic address and, where
contacted on the product or,
address at which they can be
different, and the postal and
or different, the postal
or
where that is not possible, on its contacted on the product or,
electronic address
of the single
electronic address
of the single
packaging or in a document
where that is not possible, on its
contact point at which they can
contact point at which they can
accompanying the product. The packaging or in a document
be contacted
. This information be contacted
. This information
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address shall indicate a single
accompanying the product. The
shall be placed on the product
shall be placed on the product
contact point at which the
address shall indicate a single
or, where that is not possible, on or, where that is not possible, on
manufacturer can be contacted.
contact point at which the
its packaging or in a document
its packaging or in a document
manufacturer can be contacted.
accompanying the product. The accompanying the product. ▌
address shall indicate a single
contact point at which the
manufacturer can be contacted.
Article 8(8)
8. Manufacturers shall ensure
8. Manufacturers shall ensure
8. Manufacturers shall ensure
8. Manufacturers shall ensure
that their product is
that their product is
that their product is
that their product is
accompanied by instructions
accompanied by instructions
accompanied by
clear
accompanied by
clear
and safety information in a
and safety information in a
instructions and safety
instructions and safety
language which can be easily
language which can be easily
information in a language which information in a language which
understood by consumers, as
understood by consumers, as
can be easily understood by
can be easily understood by
determined by the Member
determined by the Member
consumers, as determined by the consumers, as determined by the
G 195
State in which the product is
State in which the product is
Member State in which the
Member State in which the
G
made available. This
made available. This
product is made available. This
product is made available. This
requirement shall not apply
requirement shall not apply
requirement shall not apply
requirement shall not apply
where the product can be used
where the product can be used
where
there is no doubt that
where the product can be used
safely and as intended by the
safely and as intended by the
the product can be used safely
safely and as intended by the
manufacturer without such
manufacturer without such
and as intended by the
manufacturer without such
instructions and safety
instructions and safety
manufacturer
under reasonably instructions and safety
information.
information.
foreseeable conditions, without information.
such instructions and safety
information.
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Article 8(9)
9. Manufacturers shall ensure
9.
Manufacturers shall ensure
9. Manufacturers shall ensure
that procedures are in place for
that procedures are in place for that procedures are in place for
deleted
series production to remain in
series production to remain in
series production to remain in
G 196
conformity with the general
conformity with the general
conformity with the general
G
safety requirement laid down in
safety requirement laid down in safety requirement laid down in
Article 5.
Article 5.
Article 5.
Article 8(10)
10. Manufacturers who
10. Manufacturers who
10. Manufacturers who
10. Manufacturers who
consider or have reason to
consider or have reason to
consider or have reason to
consider or have reason to
believe, on the basis of the
believe, on the basis of the
believe, on the basis of the
believe, on the basis of ▌
information in their possession,
information in their possession,
information in their possession,
the information in their
that a product which they have
that a product which they have
that a product which they have
possession, that a product which
G 197
placed on the market is not safe, placed on the market is not safe, placed on the market is not
in
they have placed on ▌
G
shall immediately take the
shall immediately take the
conformity with this
corrective measures necessary
corrective measures necessary
Regulation safe, shall
the market is
a dangerous
to bring the product into
to
effectively bring the product
immediately take the corrective
product, shall immediately take
conformity, including a
into conformity, including a
measures necessary to bring the the corrective ▌
withdrawal or recall, as
withdrawal or recall, as
product into conformity,
measures necessary to
appropriate.
appropriate.
Where the product including a withdrawal or recall,
effectively bring the product ▌
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poses a risk to the health and
as appropriate.
into conformity, including a
safety of consumers,
withdrawal or recall, as
manufacturers shall
appropriate.
immediately alert them thereof
in accordance with Article 33
and, via the Safety Business
Gateway referred to in Article
25, immediately inform the
market surveillance authorities
of the Member States in which
the product has been made
available to that effect, giving
details, in particular, of the risk
to health and safety of
consumers and of any
corrective measure already
taken, and if available of the
quantity by Member State of
products still circulating in the
market.
Article 8(10a)
10a. When the product
10a. When the product
G 197a
referred to in paragraph 10 is referred to in paragraph 10 is
G
dangerous, manufacturers
dangerous, manufacturers
shall, via the Safety Business
shall immediately inform
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Gateway referred to in Article consumers, in accordance with
25, immediately inform the
Articles 33 or 34.
market surveillance
Manufacturers shall, via the
authorities of the Member
Safety Business Gateway
States in which the product
referred to in Article 25,
has been made available. They immediately inform the market
shall give details, in
surveillance authorities of the
particular, of the risk to
Member States in which the
health and safety of
product has been made
consumers, of the number of
available on the market. They
products involved and of any
shall give details, in particular,
corrective measure already
of the risk to health and safety
taken.
of consumers and of any
corrective measure already
taken, and if available, of the
quantity, by Member State, of
products still circulating in the
market.
Article 8(11)
11. Manufacturers shall, via the 11.
Manufacturers shall, via the 11. Manufacturers shall, via the
Safety Business Gateway
Safety Business Gateway
Safety Business Gateway
When
deleted
G 198
referred to in Article 25,
referred to in Article 25,
the product referred to in
G
immediately alert consumers of
immediately alert consumers of
Article 25, immediately alert
the risk to their health and
the risk to their health and
consumers of the risk to their
deleted, see above.
safety presented by a product
safety presented by a product
health and safety presented by a
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they manufacture and
they manufacture and
product they manufacture and
immediately inform the market
immediately inform the market
immediately inform the market
surveillance authorities of the
surveillance authorities of the
surveillance authorities of the
Member States in which the
Member States in which the
Member States in which the
product has been made available
product has been made
product has been made available
to that effect, giving details, in
available to that effect, giving
to that effect, giving details, in
particular, of the risk to health
details, in particular, of the risk particular,
paragraph 10 is
and safety of consumers and of
to health and safety of
dangerous, and without
any corrective measure already
consumers and of any corrective prejudice to the obligations
taken.
measure already taken.
laid down by Articles 33 and
34, manufacturers shall,
through the Safety Business
Gateway referred to in Article
25, immediately alert
consumers of the risk to
their health and safety of consumers
and of any corrective measure
already taken
presented by a
product they manufacture.
Article 8(11a)
The Commission shall ensure 11a. The Commission shall
G 198a
that the information meant to ensure that the information
G
alert consumers can be
meant to alert consumers can
provided by manufacturers
be provided by manufacturers
via the Safety Business
via the Safety Business
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Gateway referred to in Article Gateway referred to in Article
25 and is made available to
25 and is made available to
consumers on the Safety Gate consumers on the Safety Gate
Portal without undue delay.
Portal without undue delay.
Article 8(11a)
11a. Manufacturers shall
11.b Manufacturers shall
inform distributors, importers
ensure that other economic
and, where relevant,
operators, responsible persons,
responsible persons, fulfilment
and providers of online
service providers and online
marketplaces in the concerned
marketplaces in the supply
supply chain are kept informed
chain concerned of any safety
in a timely manner of any
issue that they have identified.
safety issue that they have
identified.
G 198b
G
11c. Manufacturers shall make
publicly available
communication channels such
as a telephone number,
electronic address or dedicated
section of their website, taking
into account accessibility needs
for persons with disabilities,
allowing consumers to file
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complaints and to inform them
of any accident or safety issue
they have experienced with the
product.
see row 198g.
Article 8(11b)
11b. Manufacturers shall
12. Manufacturers shall
11d. Manufacturers shall
investigate the complaints and
investigate the complaints
investigate complaints and
information on accidents
received that concern the
information on accidents
received that concern products
safety of products they made
received that concern the safety
which have been
available on the market, and
of products they [placed or]
shall keep a register of these
made available on the market
identified as dangerous by the
complaints as well as of
and which have been alleged as
complainant, and shall keep an
G 198c
corrective measures necessary dangerous by the complainant,
internal register
G
to bring the product into
and shall keep an internal
of those complaints as well as
conformity with this
register of those complaints as
of product recalls.
Regulation, including recalls.
well as of product recalls and
any corrective measures taken
to bring the product into
(Moved here for easy reading
conformity.
from row 198d second
suparagraph EP text.)
Subject to legal check on
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placed/made available
Article 8(11b)
11b. Manufacturers shall
11b. Manufacturers shall
make publicly available
make publicly available to
no text here, see above.
communication channels such
consumers communication
as a telephone number,
channels such as telephone
electronic address or dedicated number, electronic address or
section of their website, taking
dedicated section of their
into account accessibility needs website, allowing the
for persons with disabilities,
consumers to file complaints
allowing consumers to file
and to inform them of any
complaints that concern
accident or safety issue they
G 198d
products which manufacturers have experienced with the
G
have made available on the
product.
market and enabling
manufacturers to be informed
of any accident or safety issue
(moved here for easy reading)
consumers have experienced
with those products.
Manufacturers shall
investigate the complaints and
information on accidents
received that concern products
which have been identified as
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dangerous by the complainant,
and shall keep an internal
register of those complaints as
well as of product recalls.
Personal data stored in the
register of complaints shall
only be those personal data that
are necessary for the
manufacturer to investigate the
complaint about an alleged
dangerous product. Such data
shall only be kept for as long as
is necessary for the purpose of
investigation and in any event
for no longer than five years
after they have been encoded.
Article 8(11c)
Manufacturers shall make
publicly available to
no text here. see above
G 198e
consumers communication
channels such as telephone
G
number, electronic address or
dedicated section of their
website, allowing the
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consumers to file complaints
and to inform them of any
accident or safety issue they
have experienced with the
product.
Article 8(11d)
Personal data stored in the
Personal data stored in the
11e. Personal data stored in
register of complaints
register of complaints shall
the internal register of
shall only be those personal
only be those personal data
complaints shall only be those
data that are necessary for the
that are necessary for the
personal data that are
manufacturer to
manufacturer to investigate
necessary for the manufacturer
the complaint about an
to investigate the complaint
investigate the complaint about alleged dangerous product.
about an alleged dangerous
an alleged dangerous product.
Such data shall only be kept
product. Such data shall only
G 198f
Such data shall
as long as it is necessary for
be kept as long as it is
G
only be kept for as long as is
the purpose of investigation
necessary for the purpose of
necessary for the purpose of
and no longer than five years
investigation and no longer
investigation and in
after they have been encoded.
than five years after they have
any event for no longer than
been encoded.
five years after they have been
encoded.
(Moved here for easy reading,
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see row 198e, third
subparagraph EP text)
Article 8(11e)
Manufacturers shall
13. Manufacturers shall
inform distributors, importers
ensure that other economic
no text here, see above.
and, where relevant,
operators and providers of
responsible persons,
online marketplaces in the
concerned supply chain are
fulfilment service providers and kept informed of any safety
G 198g
online marketplaces in the
issue that they have identified.
G
supply chain
concerned of any safety issue
that they have identified.
(Moved here for easy reading)
Article 9
Article 9
Article 9
Article 9
Article 9
G 199
G
Obligations of authorised
Obligations of authorised
Obligations of authorised
Obligations of authorised
representatives
representatives
representatives
representatives
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Text Origin:
Commission Proposal
Article 9(1)
1. A manufacturer may, by a
1. A manufacturer may, by a
1. A manufacturer may, by a
1. A manufacturer may, by a
written mandate, appoint an
written mandate, appoint an
written mandate
specifying the
written mandate, appoint an
authorised representative.
authorised representative.
products covered, appoint an
authorised representative.
G 200
authorised representative.
This
G
mandate shall be provided to
market surveillance
authorities upon request.
Article 9(2), introductory part
2. An authorised representative 2. An authorised representative 2. An authorised representative 2. An authorised representative
shall perform the tasks specified shall perform the tasks specified shall perform the tasks specified shall perform the tasks specified
in the mandate received from
in the mandate received from
in the mandate received from
in the mandate received from
G 201
the manufacturer. The mandate
the manufacturer.
It shall
the manufacturer. The mandate
the manufacturer.
It shall
G
shall allow the authorised
provide a copy of the mandate
These tasks shall allow the
provide a copy of the mandate
representative to perform at
to the market surveillance
authorised representative to
to the market surveillance
least the following tasks:
authorities upon request. The
perform
include at least the
authorities upon request. The
mandate shall allow the
following tasks:
mandate shall allow the
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authorised representative to
authorised representative to
perform at least the following
perform at least the following
tasks:
tasks:
Article 9(2), point (a)
(a) provide a market
(a) provide a market
(a) provide
providing a market (a)
providing a market
surveillance authority, upon its
surveillance authority, upon its
surveillance authority, upon its
surveillance authority, upon its
reasoned request, with all
reasoned request, with all
reasoned request, with all
reasoned request, with all
information and documentation
information and documentation
information and documentation
information and documentation
G 202
necessary to demonstrate the
necessary to demonstrate the
necessary to demonstrate the
necessary to demonstrate the
G
safety of the product in an
safety of the product in an
safety of the product in an
safety of the product in an
official language which can be
official language which can be
official language which can be
official language which can be
understood by that authority;
understood by that authority;
understood by that authority;
understood by that authority;
Article 9(2), point (b)
(b) where they have a reason to (b) where they have a reason to (b) where
the authorised
(b) where
the authorised
believe that a product in
believe that a product in
representative has they have a
representative has a reason to
question presents a risk, inform
question
presents a riskis not
reason to believe that a product
believe that a product in
G 203
the manufacturer;
safe, inform the manufacturer;
in question presents a risk,
question
is dangerous,
G
inform
informing the
informing the manufacturer;
manufacturer;
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Article 9(2), point (ba)
(ba) informing the competent (ba) informing the competent
national authorities about any national authorities about any
action taken to eliminate the
action taken to eliminate the
risks posed by products
risks posed by products covered
covered by their mandate
by their mandate through a
through a notification in the
notification in the Safety
G 203a
Safety Business Gateway
Business Gateway referred to
G
referred to in Article 25, in
in Article 25, in case that the
case that the information has
information has not been
not been already provided by
already provided by the
the manufacturer or upon
manufacturer or upon
instruction of the
instruction of the
manufacturer;
manufacturer;
Article 9(2), point (c)
(c) cooperate with the
(c) cooperate with the
(c) cooperate
cooperating with (c)
cooperating with the
competent national authorities,
competent national authorities,
the competent national
competent national authorities,
at their request, on any action
at their request, on any action
authorities, at their request, on
at their request, on any action
G 204
taken to eliminate the risks
taken to
effectively eliminate the any action taken to eliminate the taken to
effectively eliminate the G
posed by products covered by
risks posed by products covered risks posed by products covered risks posed by products covered
their mandate.
by their mandate.
by their mandate.
by their mandate.
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Article 10
Article 10
Article 10
Article 10
Article 10
Obligations of importers
Obligations of importers
Obligations of importers
Obligations of importers
G 205
G
Text Origin:
Commission Proposal
Article 10(1)
1. Before placing a product on
1. Before placing a product on
1. Before placing a product on
1. Before placing a product on
the market importers shall
the market importers shall
the market importers shall
the market importers shall
ensure that the product is
ensure that the product is
ensure that the product is
ensure that the product is
compliant with the general
compliant with the general
compliant with the general
compliant with the general
safety requirement laid down in safety requirement laid down in safety requirement laid down in safety requirement laid down in
Article 5 and that the
Article 5 and that the
Article 5 and that the
Article 5 and that the
G 206
manufacturer has complied with manufacturer has complied with manufacturer has complied with manufacturer has complied with G
the requirements set out in
the requirements set out in
the requirements set out in
the requirements set out in
Article 8 (4), (6) and (7).
Article 8 (4), (6) and (7).
Article 8 (4)
8(4), (6) and (7).
Article
8(4), (6) and (7).
Text Origin: Council
Mandate
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Article 10(2)
2. Where an importer considers 2. Where an importer considers 2. Where an importer considers 2. Where an importer considers
or has reason to believe that a
or has reason to believe that a
or has
Importers who consider or has reason to believe
, on the
product is not in conformity
product is not in conformity
or have reason to believe
, on
basis of the information in
with Article 5 and Article 8(4),
with Article 5 and Article 8(4),
the basis of the information in their possession, that a product
(6) and (7), he or she shall not
(6) and (7), he or she shall not
their possession, that a product is not in conformity with Article
place the product on the market
place the product on the market
is not in conformity with Article 5 and Article 8(4), (6) and (7),
until it has been brought into
until it has been brought into
5 and Article 8(4), (6) and (7),
the importer shall not place the
conformity. Furthermore, where conformity. Furthermore, where he or she
shall not place the
product on the market until it
the product is not safe, the
the product is not safe, the
product on the market until it
has been brought into
importer shall inform the
importer shall inform the
has been brought into
conformity. Furthermore, where
G 207
manufacturer and ensure that
manufacturer and ensure that
conformity. Furthermore, where the product is
dangerous, the
G
the market surveillance
the market surveillance
the product is not safe
importer shall
immediately
authorities are informed.
authorities are informed
without dangerous, the importer shall
inform the manufacturer and
undue delay.
immediately inform the
ensure that the market
manufacturer and ensure that
surveillance authorities are
the market surveillance
informed
through the Safety
authorities are informed
Business Gateway referred to
through the Safety Business
in Article 25.
Gateway referred to in Article
25.
Article 10(3)
G 208
G
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3. Importers shall indicate their 3. Importers shall indicate their 3. Importers shall indicate their 3. Importers shall indicate their
name, registered trade name or
name, registered trade name or
name,
their registered trade
name,
their registered trade
registered trade mark, the postal registered trade mark, the postal name or registered trade mark,
name or registered trade mark,
and electronic address at which
address and the website orand
their postal and electronic
their postal and electronic
they can be contacted on the
electronic address at which they
address and, where different,
address and, where different,
product or, where that is not
can be contacted on the product the postal and
or electronic
the postal
or electronic address
possible, on its packaging or in
or, where that is not possible, on address
of the single contact
of the single contact point at
a document accompanying the
its packaging or in a document
point at which they can be
which they can be contacted
.
product. They shall ensure that
accompanying the product.
contacted
. This information
This information shall be
any additional label does not
They shall ensure that any
shall be placed on the product
placed on the product or, where
obscure any information on the
additional label does not
or, where that is not possible, on that is not possible, on its
label provided by the
obscure any information on the
its packaging or in a document
packaging or in a document
manufacturer.
label provided by the
accompanying the product.
accompanying the product.
manufacturer.
They shall ensure that any
They shall ensure that any
additional label does not
additional label does not
obscure any information on the
obscure any information on the
label provided by the
label provided by the
manufacturer.
manufacturer.
Article 10(4)
4. Importers shall ensure that
4. Importers shall ensure that
4. Importers shall ensure that
4. Importers shall ensure that
G 209
the product they imported is
the product they imported is
the product they imported is
the product they imported is
G
accompanied by instructions
accompanied by instructions
accompanied by
clear
accompanied by
clear
and safety information in a
and safety information in a
instructions and safety
instructions and safety
language which can be easily
language which can be easily
information in a language which information in a language which
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understood by consumers, as
understood by consumers, as
can be easily understood by
can be easily understood by
determined by the Member
determined by the Member
consumers, as determined by the consumers, as determined by the
State in which the product is
State in which the product is
Member State in which the
Member State in which the
made available, except where
made available, except where
product is made available,
product is made available,
the product can be used safely
the product can be used safely
except
. This requirement shall except where the product can be
and as intended by the
and as intended by the
not apply where
there is no
used safely and as intended by
manufacturer without such
manufacturer without such
doubt that the product can be
the manufacturer without such
instructions and safety
instructions and safety
used safely and as intended by
instructions and safety
information.
information.
the manufacturer
under
information.
reasonably foreseeable
conditions, without such
instructions and safety
information.
Article 10(5)
5. Importers shall ensure that,
5. Importers shall ensure that,
5. Importers shall ensure that,
5. Importers shall ensure that,
while a product is under their
while a product is under their
while a product is under their
while a product is under their
responsibility, storage or
responsibility, storage or
responsibility, storage or
responsibility, storage or
transport conditions do not
transport conditions do not
transport conditions do not
transport conditions do not
G 210
jeopardize its conformity with
jeopardize its conformity with
jeopardize its conformity with
jeopardize its conformity with
G
the general safety requirement
the general safety requirement
the general safety requirement
the general safety requirement
laid down in Article 5 and its
laid down in Article 5 and its
laid down in Article 5 and its
laid down in Article 5 and its
conformity with Article 8 (6)
conformity with Article 8 (6)
conformity with Article 8
conformity with Article
8(6)
and (7).
and (7).
(6)
8(6) and (7).
and (7).
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Text Origin: Council
Mandate
Article 10(6), first subparagraph
6. Importers shall investigate
6. Importers shall investigate
complaints related to products
Moved to row 212a
complaints related to products
deleted
they made available on the
they made available on the
market and file these
market and file these
complaints, as well as products
complaints, as well as products
no text here.
recalls, in the register referred to
recalls, in the register referred to
G 211
in Article 8(2), first
in Article 8(2), first
G
subparagraph, or in their own
subparagraph, or in their own
Text Origin:
register. Importers shall keep
register. Importers shall keep
Commission Proposal
the manufacturer and
the manufacturer and
distributors informed of the
distributors informed of the
investigation performed and of
investigation performed and of
the results of the investigation.
the results of the investigation.
Article 10(6), second subparagraph
G 212
Importers shall ensure that the
Importers shall
ensureverify
Importers shall ensure that the
Importers shall
verify whether
G
communication channels
whether that the communication communication channels
the communication channels
referred to in Article 8(2),
channels referred to in Article
referred to in Article 8(2),
referred to in Article
8(11c),
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second subparagraph, are
8(2), second8(11b), first
second subparagraph, are
second subparagraph, are
available to consumers allowing subparagraph, are
publicly
available to consumers allowing
publicly available to consumers
them to present complaints and
available
to consumers allowing them to present complaints and
allowing them to present
communicate any accident or
them to presentand allow
communicate any accident or
complaints and communicate
safety issue they have
presentation of complaints and
safety issue they have
any accident or safety issue they
experienced with the product. If
communicatecommunication of experienced with the product. If have experienced with the
such channels are not available
any accident or safety issue
such channels are not available
product. If such channels are not
the importer shall provide for
theyconsumers have
the importer shall provide for
available the importer shall
them.
experienced with the product
,
them.
provide for them
, taking into
taking into account
account accessibility needs for
accessibility needs for persons
persons with disabilities.
with disabilities. If such
channels are not available the
importer shall provide for them.
Article 10(6), first subparagraph
6. Importers shall investigate
6. Importers shall investigate
6. Importers
Importers shall investigate
complaints related to products
complaints
and information on shall investigate complaints
complaints
and information on
they made available on the
accidents related to products
related to
received that concern accidents received that concern
market and file these
they made available on the
the safety of products they
the safety of products they made
G 212a
complaints, as well as products
market
, which have been
available on the market
, which
G
recalls, in the register referred to
identified as dangerous by the
made available on the market
have been alleged as dangerous
in Article 8(2), first
complainant, and file
and file these complaints, as
by the complainant, and file
subparagraph, or in their own
thesethose complaints, as well
well as products
those complaints, as well as
register. Importers shall keep
as products recalls, in the
recalls
corrective
products recalls
and any
the manufacturer and
register referred to in Article
measures necessary to bring
corrective measures taken to
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distributors informed of the
8(2), first8(11b), second
the product into conformity,
bring the product into
investigation performed and of
subparagraph,
orand in their
in the register
conformity, in the register
the results of the investigation.
own
internal register. Importers referred to in Article 8(2)
8(12), referred to in Article
8(11b),
shall keep the manufacturer
,
first subparagraph, or in their
second subparagraph, or in their
distributors and, where
own
internal register. Importers
Moved reference text
own register.
relevant, fulfilment service
shall keep the manufacturer
,
providers and online
Importers shall keep the
distributors and, where
marketplaces and distributors
manufacturer and distributors
relevant, fulfilment service
informed of the investigation
informed
in a timely
providers and providers of
performed and of the results of
manner of the investigation
online marketplaces informed
the investigation.
performed and of the results of
in a timely manner of the
the investigation.
investigation performed and of
the results of the investigation.
Moved from row 211
(moved
for easy of reading only)
Article 10(6), third subparagraph
Personal data stored in the
Personal data stored in the
Personal data stored in the
register of complaints shall only register of complaints shall only register of complaints shall only
deleted
be those personal data that are
be those personal data that are
be those personal data that are
G 213
necessary for the importer to
necessary for the importer to
necessary for the importer to
G
investigate the complaint about
investigate the complaint about
investigate the complaint about
no text here
an alleged dangerous product.
an alleged dangerous product.
an alleged dangerous product.
Such data shall only be kept as
Such data shall only be kept as
Such data shall only be kept as
Text Origin:
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long as it is necessary for the
long as it is necessary for the
long as it is necessary for the
Commission Proposal
purpose of investigation and no
purpose of investigation and no
purpose of investigation and no
longer than five years after they longer than five years after they longer than five years after they
have been encoded.
have been encoded.
have been encoded.
Article 10(7)
7. Importers shall cooperate
7. Importers shall cooperate
7. Importers shall cooperate
7. Importers shall cooperate
with market surveillance
with market surveillance
with market surveillance
with market surveillance
authorities and the manufacturer authorities and the manufacturer authorities and the manufacturer authorities and the manufacturer
G 214
to ensure that a product is safe.
to ensure that a product is safe.
to ensure that a product is
in
to ensure that a product is safe.
G
conformity with this
Regulation safe.
Article 10(8)
8. Importers who consider or
8. Importers who consider or
8. Importers who consider or
8. Importers who consider or
have reason to believe, on the
have reason to believe, on the
have reason to believe, on the
have reason to believe, on the
basis of the information in their
basis of the information in their
basis of the information in their
basis of the information in their
G 215
possession, that a product which possession, that a product which possession, that a product which possession, that a product which G
they have placed on the market
they have placed on the market
they have placed on the market
they have placed on the market
is not safe shall immediately
is not safe shall immediately
is not
in conformity with this
is
dangerous shall immediately
inform the manufacturer and
inform the manufacturer and
Regulation safe shall
inform the manufacturer and
ensure that the corrective
ensure that the corrective
immediately inform the
ensure that the corrective
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measures necessary to bring the measures necessary to
manufacturer and ensure that
measures necessary to bring
product into conformity are
effectively bring the product
the corrective measures
effectively the product into
adopted including withdrawal or into conformity are adopted
necessary to bring the product
conformity are adopted
recall, as appropriate. In case
including withdrawal or recall,
into conformity are adopted
including withdrawal or recall,
such measures have not been
as appropriate. In case such
including withdrawal or recall,
as appropriate. In case such
adopted, the importer shall
measures have not been
as appropriate. In case such
measures have not been
adopt them. Importers shall
adopted, the importer shall
measures have not been
adopted, the importer shall
ensure that, through the Safety
adopt them.
Importers shall
adopted, the importer shall
immediately adopt them. ▌
Business Gateway referred to in
ensure that, through the Where
adopt them. Importers shall
Article 25, consumers are
the product poses a risk to the
ensure that, through the Safety
immediately and effectively
health and safety
Business
Business Gateway referred to in
alerted of the risk where
Gateway referred to in Article
Article 25, consumers are
applicable and that market
25, consumersof consumers,
immediately and effectively
surveillance authorities of the
importers shall ensure that they alerted of the risk where
Member States in which they
are immediately
and effectively
applicable and that market
made the product available to
alerted
of the risk where
surveillance authorities of the
that effect be immediately
applicablethereof in
Member States in which they
informed, giving details, in
accordance with Article 33 and made the product available to
particular, of the risk to health
that market surveillance
that effect be immediately
and safety of consumers and of
authorities of the Member States informed, giving details, in
any corrective measure already
in which they made the product
particular, of the risk to health
taken.
available
are immediately
and safety of consumers and of
informed to that effect
be
any corrective measure already
immediately informedthrough
taken.
without delay.
the Safety Business Gateway
referred to in Article 25, giving
details, in particular, of the risk
to health and safety of
consumers and of any corrective
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measure already taken
, and if
available of the quantity by
Member State of products still
circulating in the market.
Article 10(8a)
8a. When the product
8a. Where the product is
referred to in paragraph 8 is
dangerous, importers shall
dangerous, importers shall
ensure that consumers are
ensure that the market
immediately informed thereof
surveillance authorities of the
in accordance with Article 33
Member States in which the
or 34. Importers shall, via the
product has been made
Safety Business Gateway
available are immediately
referred to in Article 25,
informed, via the Safety
immediately inform the market
G 215a
Business Gateway referred to
surveillance authorities of the
G
in Article 25, with the
Member States in which the
appropriate details of the risk product has been made
to health and safety of
available on the market. They
consumers, of the number of
shall give details, in particular,
products involved and of any
of the risk to health and safety
corrective measure already
of consumers and of any
taken.
corrective measure already
taken, and if available of the
quantity, by Member State, of
products still circulating in the
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market.
Text Origin: Council
Mandate
Article 10(8b), introductory part
8b. When the product
referred to in paragraph 8 is
no text here
dangerous, and without
prejudice to the obligations
laid down by Articles 33 and
G 215b
34, importers shall ensure that
G
consumers are immediately
alerted of the risk through the
Safety Business Gateway
referred to in Article 25.
Article 10(8b), a
The Commission shall ensure
G 215c
that the information meant to
G
no text here
alert consumers can be
provided by importers via the
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Safety Business Gateway
referred to in Article 25 and is
made available to consumers
on the Safety Gate Portal
without undue delay.
Article 10(8c), introductory part
8c. Importers shall investigate complaints received that
concern the safety of products
they made available on the
no text here.
market and file these
complaints, as well as
corrective measures necessary
to bring the product into
G 215d
conformity, in the register
G
referred to in Article 8(12),
first subparagraph, or in their
own register. Importers shall
keep the manufacturer and
distributors informed in a
timely manner of the
investigation performed and
of the results of the
investigation.
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Article 10(8c), a
Importers shall ensure that
the communication channels
no text here.
referred to in Article 8(12),
second subparagraph, are
available to consumers
allowing them to present
G 215e
complaints and communicate
G
any accident or safety issue
they have experienced with
the product. If such channels
are not available the importer
shall provide for them.
Article 10(8c), b
Personal data stored in the
register of complaints shall
G 215f
no text here, see below.
only be those personal data
G
that are necessary for the
importer to investigate the
complaint about an alleged
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dangerous product. Such data
shall only be kept as long as it
is necessary for the purpose of
investigation and no longer
than five years after they have
been encoded.
Article 10(9)
9. Importers shall keep the
9. Importers shall keep the
copy 9. Importers shall keep the
▌
9. Importers shall keep the
technical documentation
of technical documentation
technical documentation
copy of technical documentation
referred to in Article 8(4) for a
referred to in Article 8(4)
, first
referred to in Article 8(4) for a
referred to in Article 8(4)
, first
period of 10 years after they
subparagraph, for a period of
period of 10
ten years after
subparagraph, for a period of
have placed the product on the
10 years after they have placed
they have placed the product on 10 years after they have placed
market and make it available to
the product on the market
and
the market and make it available the product on the market
at the
the market surveillance
make it available toat the
to the market surveillance
disposal of the market
authorities, upon request.
disposal of the market
authorities, upon request.
surveillance authorities
and
G 216
G
surveillance
authorities and
ensure that the documents
ensure that the documents
referred to in Article 8(4), as
referred to in Article 8(4),
applicable, can be made
second subparagraph, points
available to those authorities,
(a) and (b), where applicable,
upon request.
can be made available to those
authorities, upon request.
9a. Personal data stored in the
register of complaints shall
only be those personal data that
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are necessary for the importer
to investigate the complaint
about an alleged dangerous
product. Such data shall only
be kept as long as it is
necessary for the purpose of
investigation and no longer
than five years after they have
been encoded.
Text Origin: EP
Mandate
Article 11
Article 11
Article 11
Article 11
Article 11
Obligations of distributors
Obligations of distributors
Obligations of distributors
Obligations of distributors
G 217
G
Text Origin:
Commission Proposal
Article 11(1)
G 218
G
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1. Before making a product
1. Before making a product
1. Before making a product
1. Before making a product
available on the market,
available on the market,
available on the market,
available on the market,
distributors shall verify that the
distributors shall verify that the
distributors shall verify that the
distributors shall verify that the
manufacturer and the importer
manufacturer and the importer
manufacturer and
, where
manufacturer and
, where
have complied with the
have complied with the
appropriate, the importer have
applicable, the importer have
requirements set out in Article
requirements set out in Article
complied with the requirements complied with the requirements
8(6), (7) and (8) and Article
8(6), (7) and (8) and Article
set out in Article 8(6), (7) and
set out in Article 8(6), (7) and
10(3) and (4), as applicable.
10(3) and (4), as applicable.
(8) and Article 10(3) and (4), as (8) and Article 10(3) and (4), as
applicable.
applicable.
Text Origin: Council
Mandate
Article 11(2)
2. Distributors shall ensure that, 2. Distributors shall ensure that, 2. Distributors shall ensure that, 2. Distributors shall ensure that,
while a product is under their
while a product is under their
while a product is under their
while a product is under their
responsibility, storage or
responsibility, storage or
responsibility, storage or
responsibility, storage or
transport conditions do not
transport conditions do not
transport conditions do not
transport conditions do not
G 219
jeopardize its conformity with
jeopardize its conformity with
jeopardize its conformity with
jeopardize its conformity with
G
the general safety requirement
the general safety requirement
the general safety requirement
the general safety requirement
laid down in Article 5 and its
laid down in Article 5 and its
laid down in Article 5 and its
laid down in Article 5 and its
conformity with Article 8(6), (7) conformity with Article 8(6), (7) conformity with Article 8(6), (7) conformity with Article 8(6), (7)
and (8) and Article 10(3) and
and (8) and Article 10(3) and
and (8) and Article 10(3) and
and (8) and Article 10(3) and
(4), as applicable.
(4), as applicable.
(4), as applicable.
(4), as applicable.
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Text Origin:
Commission Proposal
Article 11(3)
3. Distributors who consider or 3. Distributors who consider or 3. Distributors who consider or 3. Distributors who consider or
have reason to believe, on the
have reason to believe
, on the
have reason to believe, on the
have reason to believe, on the
basis of the information in their
basis of the information in their basis of the information in their
basis of the information in their
possession, that a product is not
possession, that a product is not possession, that a product is not possession, that a product is not
in conformity with the
in conformity with the
in conformity with
Article 5,
in conformity with
Article 5,
provisions referred to in
provisions referred to in
Article 8(6) to (8), and Article Article 8(6) to (8), and Article
paragraph 2, shall not make the
paragraph 2, shall not make the
10(3) and (4) the provisions
10(3) and (4), shall not make
product available on the market product available on the market referred to in paragraph 2, shall
the product available on the
until it has been brought into
until it has been brought into
not make the product available
market
unless it has been
G 220
conformity. Furthermore, where conformity. Furthermore, where on the market until
unless it has brought into conformity.
G
the product is not safe, the
the product is not safe, the
been brought into conformity.
Furthermore, where the product
distributor shall immediately
distributor shall immediately
Furthermore, where the product is
dangerous, the distributor
inform the manufacturer or the
inform the manufacturer or the
is not safe
dangerous, the
shall immediately inform the
importer, as applicable, to that
importer, as applicable, to that
distributor shall immediately
manufacturer or the importer, as
effect and shall make sure that,
effect and shall make sure that,
inform the manufacturer or the
applicable,
and ensure that,
via
through the Safety Business
through the Safety Business
importer, as applicable, to that
the Safety Business Gateway
Gateway referred to in Article
Gateway referred to in Article
effect and shall make sure
and referred to in Article 25, the
25, the market surveillance
25, the market surveillance
ensure that, through the Safety
market surveillance authorities
authorities are informed.
authorities are informed.
Business Gateway referred to in are informed.
Article 25, the market
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surveillance authorities are
informed.
Article 11(4)
4. Distributors who consider or 4. Distributors who consider or 4. Distributors who consider or 4. Distributors who consider or
have reason to believe, on the
have reason to believe, on the
have reason to believe, on the
have reason to believe, on the
basis of the information in their
basis of the information in their
basis of the information in their
basis of the information in their
possession, that a product which possession, that a product which possession, that a product which possession, that a product which
they have made available on the they have made available on the they have made available on the they have made available on the
market is not safe or is not in
market is not safe or is not in
market is not safe
dangerous
market is
dangerous or is not in
conformity with Article 8(6), (7) conformity with Article 8(6), (7) or is not in conformity with
conformity with Article 8(6), (7)
and (8) and Article 10(3) and
and (8) and Article 10(3) and
Article 8(6), (7) and (8) and
and (8) and Article 10(3) and
(4), as applicable, shall ensure
(4), as applicable, shall ensure
Article 10(3) and (4), as
(4), as applicable, shall ensure
that the corrective measures
that the corrective measures
applicable, shall ensure that the
that the corrective measures
G 221
necessary to bring the product
necessary to bring
effectively
corrective measures necessary
necessary to bring
effectively
G
into conformity are adopted,
the product into conformity are
to bring the product into
the product into conformity are
including withdrawal or recall,
adopted, including withdrawal
conformity are adopted,
adopted, including withdrawal
as appropriate. Furthermore,
or recall, as appropriate.
including withdrawal or recall,
or recall, as appropriate. ▌
where the product is not safe,
Furthermore, where the product as appropriate. Furthermore,
distributors shall immediately
is not safe, distributors shall
where the product is not safe,
inform the manufacturer or the
immediately inform the
distributors shall immediately
importer, as applicable, to that
manufacturer or the importer, as inform the manufacturer or the
effect and shall make sure that,
applicable, to that effect and
importer, as applicable, to that
through the Safety Business
shall make sure that, through the effect and shall make sure that,
Gateway referred to in Article
Safety Business Gateway
through the Safety Business
25, the market surveillance
referred to in Article 25, the
Gateway referred to in Article
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authorities of the Member State market surveillance authorities
25, the market surveillance
in which they made the product
of the Member State in which
authorities of the Member State
available to that effect are
they made the product available in which they made the product
informed giving details, in
to that effect are informed
available to that effect are
particular, of the risk to health
giving details, in particular, of
informed giving details, in
and safety and of any corrective the risk to health and safety and particular, of the risk to health
measure taken.
of any corrective measure taken. and safety and of any corrective
measure taken.
Article 11(4a)
4a. When the product
4a. When the product referred
referred to in paragraph 4 is
to in paragraph 4 is dangerous,
dangerous, distributors shall
distributors shall immediately
immediately inform the
inform the manufacturer or the
manufacturer or the importer, importer, as applicable, and
as applicable, and shall ensure shall ensure that the market
that the market surveillance
surveillance authorities of the
G 221a
authorities of the Member
Member States in which the
G
States in which the product
product has been made
has been made available are
available are immediately
immediately informed, via the informed, via the Safety
Safety Business Gateway
Business Gateway referred to
referred to in Article 25, with
in Article 25, with the
the appropriate details
appropriate details available to
available to them of the risk to them of the risk to health and
health and safety of
safety of consumers, of the
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consumers, of the number of
number of products involved
products involved and of any
and of any corrective measure
corrective measure already
already taken.
taken.
Article 11(4b)
4b. When the product
referred to in paragraph 4 is
no text here
dangerous, and without
prejudice to the obligations
laid down by Articles 33 and
G 221b
34, distributors shall ensure
G
that, through the Safety
Business Gateway referred to
in Article 25, consumers are
immediately alerted of the
risk.
Article 11(4c)
The Commission shall ensure
G 221c
that the information meant to
G
no text here.
alert consumers can be
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provided by distributors via
the Safety Business Gateway
referred to in Article 25 and is
made available to consumers
on the Safety Gate Portal
without undue delay.
Article 12
Article 12
Article 12
Article 12
Article 12
Cases in which obligations of
Cases in which obligations of
Cases in which obligations of
Cases in which obligations of
manufacturers apply to other
manufacturers apply to other
manufacturers apply to other
manufacturers apply to other
G 222
economic operators
economic operators
economic operators
persons
persons
G
Text Origin: Council
Mandate
Article 12(-1)
-1. A natural or legal person
G 222a
shall be considered a
G
text below.
manufacturer for the
purposes of this Regulation
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and shall be subject to the
obligations of the
manufacturer set out in
Article 8 where it places a
product on the market under
its name or trademark.
Article 12(-1)
-1. A natural or legal person
-1a. A natural or legal person
shall be considered to be a
shall be considered to be a
manufacturer for the purposes
manufacturer for the purposes
of this Regulation and shall be
of this Regulation and shall be
subject to the obligations of the
subject to the obligations of the
manufacturer set out in Article
manufacturer set out in Article
8 where that natural or legal
8 where that natural or legal
G 222b
person places a product on the
person places a product on the
G
market under the natural or
market under the natural or
legal person’s name or
legal person’s name or
trademark.
trademark.
Text Origin: EP
Mandate
Article 12(1)
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1. A natural or legal person,
1. A natural or legal person,
1. A natural or legal person,
1. A natural or legal person,
other than the manufacturer, that other than the manufacturer, that other than the manufacturer, that other than the manufacturer, that
substantially modifies the
substantially modifies the
substantially modifies the
substantially modifies the
product, shall be considered a
product, shall be considered a
product, shall be considered a
product, shall be considered a
manufacturer for the purposes
manufacturer for the purposes
manufacturer for the purposes
manufacturer for the purposes
of this Regulation and shall be
of this Regulation and shall be
of this Regulation and shall be
of this Regulation and shall be
subject to the obligations of the
subject to the obligations of the
subject to the obligations of the
subject to the obligations of the
manufacturer set out in Article 8 manufacturer set out in Article 8 manufacturer set out in Article 8 manufacturer set out in Article 8
G 223
for the part of the product
for the part of the product
for the part of the product
for the part of the product
G
affected by the modification or
affected by the modification or
affected by the modification or
affected by the modification or
for the entire product if the
for the entire product if the
for the entire product if the
for the entire product if the
substantial modification has an
substantial modification has an
substantial modification has an
substantial modification has an
impact on its safety.
impact on its safety.
impact on its safety.
impact on its safety.
Text Origin:
Commission Proposal
Article 12(2), introductory part
2. A modification shall be
2. A modification shall be
2. A modification
of a product, 2. A modification
of a product,
deemed to be substantial where
deemed to be substantial where
by physical or digital means,
by physical or digital means,
G 224
the three following criteria are
the three following criteria are
shall be deemed to be
shall be deemed to be
G
met:
met:
substantial where the three
substantial where
it has an
following criteria are met:
impact on the safety of the
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product and the three following
criteria are met:
Article 12(2), point (a)
(a) the modification changes
(a) the modification changes
(a) the modification changes
(a) the modification changes ▌
the intended functions, type or
the intended functions, type or
the intended functions, type or
the product in a manner which
performance of the product in a
performance of the product in a
performance of
the product in
was not foreseen in the initial
G 225
manner which was not foreseen manner which was not foreseen
a manner which was not
risk assessment of the product;
G
in the initial risk assessment of
in the initial risk assessment of
foreseen in the initial risk
the product;
the product;
assessment of the product;
Article 12(2), point (b)
(b) the nature of the hazard has (b) the nature of the hazard has (b) the nature of the hazard has (b) the nature of the hazard has
changed or the level of risk has
changed or the level of risk has
changed
, a new hazard has
changed
, a new hazard has
increased because of the
increased because of the
been created or the level of risk
been created or the level of risk
modification;
modification;
has increased because of the
has increased because of the
G 226
modification;
modification;
G
Text Origin: Council
Mandate
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Article 12(2), point (c)
(c) the changes have not been
(c) the changes have not been
(c) the changes have not been
(c) the changes have not been
made by the consumer for their
made by the consumer for their
made by the
consumers
made by the
consumers
own use.
own use
. or are performed
themselves or on their behalf
themselves or on their behalf
G 227
G
upon specific request by the
consumer for their own use.
for their own use.
consumer on the essential
safety features of the product
Article 13
Article 13
Article 13
Article 13
Article 13
Internal processes for product
Internal processes for product
Internal processes for product
Internal processes for product
safety
safety
safety
safety
G 228
G
Text Origin:
Commission Proposal
Article 13, first paragraph
G 229
The economic operators shall
The economic operators shall
The Economic operators shall
The economic operators shall
G
ensure that they have internal
ensure that they have internal
ensure that they have internal
ensure that they have internal
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processes for product safety in
processes for product safety in
processes for product safety in
processes for product safety in
place, allowing them to respect
place, allowing them to respect
place, allowing them to respect
place, allowing them to comply
the general safety requirement
the general safety requirement
the general safety requirement
with the relevant requirements
laid down in Article 5.
laid down in Article 5.
laid down in Article 5
comply
of this Regulation.▌
with this Regulation.
Article 14
Article 14
Article 14
Article 14
Article 14
Cooperation of economic
Cooperation of economic
Cooperation of economic
Cooperation of economic
operators with market
operators with market
operators with market
operators with market
G 230
surveillance authorities
surveillance authorities
surveillance authorities
surveillance authorities
G
Text Origin:
Commission Proposal
Article 14(1)
1. Economic operators shall
1. Economic operators shall
1. Economic operators shall
1. Economic operators shall
G 231
cooperate with market
cooperate with market
cooperate with market
cooperate with market
G
surveillance authorities
surveillance authorities
surveillance authorities
surveillance authorities
regarding actions which could
regarding actions which could
regarding actions which could
regarding actions which could
eliminate or mitigate risks that
eliminate or mitigate risks that
eliminate or mitigate risks that
eliminate or mitigate risks that
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are presented by products made are presented by products made are presented by
the relevant
are presented by
the relevant
available on the market by those available on the market by those products made available on the
products made available on the
operators.
operators.
market by those operators.
market ▌ .
Article 14(2), introductory part
2. On request of a market
2. On request of a market
2. On request of a market
2. On request of a market
surveillance authority, the
surveillance authority, the
surveillance authority, the
surveillance authority, the
economic operator shall provide economic operator shall provide economic operator shall provide economic operator shall provide
all necessary information, and in all necessary information, and in all necessary information, and in all necessary information, and in
G 232
particular:
particular:
particular:
particular:
G
Text Origin:
Commission Proposal
Article 14(2), point (-a)
(-a) a detailed description of
the product and its
G 232a
characteristics, the available
G
documentation and the
no text to be added here.
number of products placed on
the market of each Member
State concerned;
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Article 14(2), point (a)
(a) a full description of the risk (a) a full description of the risk (a) a full description of the risk (a) a full description of the risk
presented by the product;
presented by the product;
presented by the product
,
presented by the product
,
G 233
G
related complaints and known related complaints and known
accidents;
accidents;
Article 14(2), point (b)
(b) a description of any
(b) a description of any
(b) a description of any
(b) a description of any
G 234
corrective measure undertaken
corrective measure undertaken
corrective measure undertaken
corrective measure undertaken
G
to address the risk.
to address the risk.
to address the risk.
to address the risk.
Article 14(3), introductory part
3. On request, the economic
3. On request, the economic
3. On request, the
economic
3. On request, the economic
operators shall also identify and operators shall also identify and operators shall also identify and operators shall also identify and
G 235
communicate the following
communicate the following
communicate the
relevant
communicate the following
G
information:
information:
traceability following
relevant traceability
information
for the product,
information
for the product:
including at least:
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Article 14(3), point (a)
(a) any economic operator who (a) any economic operator who (a) any economic operator who (a) any economic operator who
has supplied them with the
has supplied them with the
has supplied them with the
has supplied them with the
G 236
product;
product;
product
, or with a part, a
product
, or with a part, a
G
component or any software
component or any software
embedded into the product;
embedded into the product;
Article 14(3), point (b)
(b) any economic operator to
(b) any economic operator to
(b) any economic operator to
(b) any economic operator to
whom they have supplied the
whom they have supplied the
whom they have supplied the
whom they have supplied the
product.
product.
product.
product.
G 237
G
Text Origin:
Commission Proposal
Article 14(4)
G 238
G
4. Economic operators shall be
4. Economic operators shall be
4. Economic operators shall be
4. Economic operators shall be
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able to present the information
able to present the information
able to present the information
able to present the information
referred to in paragraph 2 for a
referred to in paragraph 2 for a
referred to in paragraph 2
referred to in ▌
paragraph 2 for
period of ten years after they
period of ten years after they
paragraphs 2 and 3 for a
a period of ten years after they
have been supplied with the
have been supplied with the
period of ten years after they
have been supplied with the
product and for a period of ten
product and for a period of ten
have been supplied with the
product and for a period of ten
years after they have supplied
years after they have supplied
product and for a period of ten
years after they have supplied
the product, where relevant.
the product, where relevant.
years after they have supplied
the product, where relevant.
the product, where relevant.
4a. Economic operators shall
be able to present the
information referred to in
paragraph 3 for a period of six
years after they have been
supplied with the product and
for a period of six years after
they have supplied the product,
where relevant.
Text Origin: Council
Mandate
Article 14(5)
G 239
5. Economic operators shall
5.
Economic operators shall
5. Economic operators shall
5. ▌ Market surveillance
G
ensure that the corrective
ensure that the corrective
ensure that the corrective
authorities may request the
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measure undertaken is effective
measure undertaken is effective
measure undertaken is effective economic operators to submit
in eliminating or mitigating the
in eliminating or mitigating the
in eliminating or mitigating the
regular progress reports and
risks. Market surveillance
risks. Market surveillance
risks. Market surveillance
may decide whether or when the
authorities may request the
authorities may request the
authorities may request the
corrective measure can be
economic operators to submit
economic operators to submit
economic operators to submit
considered completed.
regular progress reports and
regular progress reports and
regular progress reports and
decide whether or when the
decide whether or when the
may decide whether or when
corrective measure can be
corrective measure can be
the corrective measure can be
considered completed.
considered completed.
considered completed.
Article 15
Article 15
Article 15
Article 15
Article 15
Responsible person for products Responsible person for products Responsible person for products Responsible person for products
placed on the Union market
placed on the Union market
placed on the Union market
placed on the Union market
G 240
G
Text Origin:
Commission Proposal
Article 15(1)
G 241
1. Article 4(1), (2) and (3) of
1. Article 4(1), (2) and (3) of
1.
A product covered by this
1.
A product covered by this
G
Regulation (EU) 2019/1020
Regulation (EU) 2019/1020
Regulation may be placed on
Regulation may be placed on
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shall also apply to products
shall also apply to products
the market only if there is an
the market only if there is an
covered by this Regulation. For
covered by this Regulation. For
economic operator established economic operator established
the purposes of this Regulation, the purposes of this Regulation,
in the Union who is
in the Union who is responsible
references to “Union
references to “Union
responsible for the tasks set
for the tasks set out in Article
harmonisation legislation” in
harmonisation legislation” in
out in Article 4(1), (2)
4(3) of
4(3) of Regulation (EU)
Article 4(1), (2) and (3) of
Article 4(1), (2) and (3) of
Regulation (EU) 2019/1020 in
2019/1020 in respect to that
Regulation (EU) 2019/1020
Regulation (EU) 2019/1020
respect to that product.
product. Article 4(2) and (3) of
shall be read as “Regulation
shall be read as “Regulation
Article 4(2) and (3) of
Regulation (EU) 2019/1020
[…]”.
[…]”.
Regulation (EU) 2019/1020
shall ▌
apply to products
shall also
apply to products
covered by this Regulation. For
covered by this Regulation. For
the purposes of this Regulation,
the purposes of this Regulation, references to "Union
references to "Union
harmonisation legislation"
and
harmonisation legislation"
and
"applicable Union
"applicable Union
harmonisation legislation" in
harmonisation legislation" in
Article 4(3) of Regulation (EU)
Article 4(1), (2) and (3)
4(3) and 2019/1020 shall be read as "
this
(4) of Regulation (EU)
Regulation ▌ ".
2019/1020 shall be read as "
this
Regulation […]".
Article 15(2)
2. In addition to the tasks
2. In addition to the tasks
2. In addition to the tasks
2.
Without prejudice to any
G 242
referred to in Article 4(3) of
referred to in Article 4(3) of
referred to in Article 4(3) of
obligations of economic
G
Regulation (EU) 2019/1020, the Regulation (EU) 2019/1020,
the Regulation (EU) 2019/1020, the
operators under this economic operator referred to in
economic operator referred to
Without prejudice to any
Regulation
, in addition to the
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Article 4(1) of Regulation (EU)
in Article 4(1) of Regulation
obligations of economic
tasks referred to in Article
4(3)
2019/1020 shall periodically
(EU) 2019/1020 shall
operator referred to in Article
of Regulation (EU) 2019/1020
,
carry out sample testing of
periodically carry out sample
4(1) of
operators under this
and to ensure the safety of the
randomly chosen products made
testing of randomly chosen for
Regulation (EU) 2019/1020
product it is responsible for,
available on the market. When
the products, categories or
shall periodically carry out
where appropriate with regard
the products made available on
groups of products
made
sample testing of randomly
to the possible risks related to a
the market have been subject to
available on the market. When
chosen products made available
product, the economic operator
a Commission decision adopted
the products made available on
on the market. When the
referred to in
paragraph 1 shall
under Article 26(1) of this
the market have been subject to
products made available on the
regularly check:
Regulation, the economic
a Commission
market have been subject to a
operator referred to in Article
decisionestablished by a
Commission decision adopted
4(1) of Regulation (EU)
delegated act adopted
under
under Article 26(1) of this
agreed in trilogue
2019/1020 shall carry out, at
Article 26(1) of this
Regulation, the economic
least once a year, for the entire
Regulationin accordance with
operator
, in addition to the
duration of the decision,
paragraph 3, the economic
tasks referred to in Article
representative sample testing of operator referred to in
Article
4(1)
4(3) of Regulation (EU)
products made available on the
4(1) of Regulation (EU)
2019/1020 shall carry out, at
market chosen under the control
2019/1020paragraph 1 shall
least once a year, for the entire
of a judicial officer or any
periodically carry out
, at least
duration
, and to ensure the
qualified person designated by
once a year, for the entire
safety of the decision,
the Member State where the
duration of the decision,
representative sample testing of
economic operator is situated.
representative sample testing of products made available on the
checks of randomly chosen
market chosen under the control
products made available on the
of a judicial officer or any
market
chosen under the control qualified person designated by
of a judicial officer or any
the Member State where the
qualified person designated by
economic operator is
the Member State where the
situated.
product it is
economic operator is situated.
responsible for, the economic
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operator referred to in
paragraph 1 shall regularly
check:
Article 15(2), point (a)
(a) that the product complies
(a) that the product complies
with the description provided
with the technical
for in the technical
documentation in accordance
G 242a
documentation and that the
with Article 8 (4);
G
solutions adopted to eliminate
or mitigate the risks are still
in place and effective;
Article 15(2), point (b)
(b) that the product complies
(b) that the product complies
with the requirements
with the requirements provided
G 242b
provided for in Article 8 (6) to for in Article 8 (6) to (8).
G
(8).
Article 15(2), point (c)
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The economic operator
The economic operator
referred to in paragraph (1)
referred to in paragraph (1)
shall provide, upon request of shall provide, upon request of
G 242c
the market surveillance
the market surveillance
G
authorities, documented
authorities, documented
evidence of the checks
evidence of the checks
performed.
performed.
Article 15(2a)
2a. By ... [six months before
the date of application of this
no text here
Regulation] the Commission
shall adopt a delegated act in
accordance with Article 41 to
supplement this Regulation by
establishing the list of products,
G 242d
categories or groups of
G
products for which the
obligations referred to in
paragraph 2 of this Article
shall apply.
The Commission is empowered
to adopt delegated acts in
accordance with Article 41 to
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amend the list of products,
categories or groups of
products set out in accordance
with the first subparagraph.
In preparing the delegated acts
referred to in the first and
second subparagraphs, the
Commission shall take into
account the potential risk to the
health and safety of consumers
caused by the products
concerned, based on the
information from the Safety
Gate, related in particular to
the products most frequently
listed in it, and other relevant
evidence.
Article 15(3)
3. The name, registered trade
3. The name, registered trade
3. The name, registered trade
3. The name, registered trade
name or registered trade mark,
name or registered trade mark,
name or registered trade mark,
name or registered trade mark,
G 243
and contact details, including
and contact details, including
and contact details, including
and contact details, including
G
the postal and electronic
the postal
address and the
the postal and electronic
the postal and electronic
address, of the economic
website orand electronic
address, of the economic
address, of the economic
operator referred to in Article
address, of the economic
operator referred to in Article
operator referred to in
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4(1) of Regulation (EU)
operator referred to in Article
4(1) of Regulation (EU)
paragraph 1 shall be indicated
2019/1020 shall be indicated on 4(1) of Regulation (EU)
2019/1020
paragraph 1 shall
on the product or on its
the product or on its packaging, 2019/1020 shall be indicated on be indicated on the product or
packaging, the parcel or an
the parcel or an accompanying
the product or on its packaging,
on its packaging, the parcel or
accompanying document.
document.
the parcel or an accompanying
an accompanying document.
document.
Article 16
Article 16
Article 16
Article 16
Article 16
Information to economic
Information to economic
Information to economic
Information to economic
operators
operators
operators
operators
G 244
G
Text Origin:
Commission Proposal
Article 16, first paragraph -a
1. The Commission shall
1. The Commission shall
G 244a
provide economic operators,
provide economic operators,
G
free of charge, with general
free of charge, with general
information with respect to
information with respect to this
this Regulation.
Regulation.
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Article 16, first paragraph
Member States shall put in place Member States shall put in place
2. Member States shall put in
2. Member States shall
provide
procedures for providing
procedures for providing
place procedures for providing
economic operators, at their
economic operators, at their
economic operators, at their
provide economic operators, at
request and free of charge, with
request and free of charge, with request and free of charge, with
their request and free of charge,
specific information with
information with respect to the
information with respect to the
with
specific information with
respect to the implementation of
implementation of this
implementation of this
respect to the implementation of this Regulation
at national level
G 245
Regulation.
Regulation
and national rules
this Regulation
at national
and national rules on product
G
on product safety applicable to
level.
safety applicable to products
products covered by this
covered by this Regulation. For
Regulation. For that purpose,
that purpose, Article 9(1) and
Article 9(1) and (4) of
(4) of Regulation (EU)
Regulation (EU) 2019/515
2019/515 shall apply.
shall apply.
Article 16, first paragraph a
The Commission shall adopt
The Commission shall adopt
G 245a
specific guidelines for
specific guidelines for
G
economic operators,
economic operators, with
particularly those that qualify
particular regard to the needs
as SMEs, including micro-
of those that qualify as SMEs,
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enterprises, on how to fulfil the
including micro-enterprises, on
obligations laid down in this
how to fulfil the obligations
Regulation. In particular they
laid down in this Regulation.
shall aim to simplify and limit
the administrative burden for
smaller businesses while
ensuring the effective and
consistent application in
accordance with the general
objective of ensuring product
safety and consumer
protection.
Article 17
Article 17
Article 17
Article 17
Article 17
Traceability of products
Traceability of products
Specific traceability
Specific traceability
G 246
of
requirements for certain
requirements for certain
G
products
, product categories or products, categories or groups
product groups
of products
Article 17(1)
G 247
G
1. For certain products,
1. For certain products,
1. For certain products,
1. For certain products,
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categories or groups of
categories or groups of
product categories or
product
categories or groups of
products, which are susceptible
products, which are susceptible
groups of products, which are
products, which are susceptible
to bear a serious risk to health
to bear a serious risk to health
susceptible to bear a serious risk to bear a serious risk to health
and safety of consumers, based
and safety of consumers, based
to health and safety of
and safety of consumers, based
on accidents registered in the
on accidents registered in the
consumers, based on accidents
on accidents registered in the
Safety Business Gateway, the
Safety Business Gateway, the
registered in the Safety Business Safety Business Gateway, the
Safety Gate statistics, the results Safety Gate statistics, the results Gateway, the Safety Gate
Safety Gate statistics, the results
of the joint activities on product of the joint activities on product statistics, the results of the joint of the joint activities on product
safety and other relevant
safety and other relevant
activities on product safety and
safety and other relevant
indicators or evidence, the
indicators or evidence,
and after other relevant indicators or
indicators or evidence,
and after
Commission may require
consulting the Consumer
evidence, the Commission may
consulting the Consumer
economic operators who place
Safety Network referred to in
require economic operators who
Safety Network referred to in
and make available those
Article 28, relevant expert
place and make available those
Article 28, relevant expert
products on the market to
groups and relevant
products on the market to
groups and relevant
establish or adhere to a system
stakeholders, the Commission
establish or adhere to a system
stakeholders, the Commission
of traceability.
may
requireset up a system of
of traceability.
may
set up a system of
traceability to which economic
traceability to which economic
operators who
place and make
operators who ▌ make
available those products on the
available those products on the
market
to establish orshall
market
shall adhere ▌ .
adhere
to a system of
traceability.
Article 17(2)
G 248
2. The system of traceability
2. The system of traceability
2. The system of traceability
2. The system of traceability
G
shall consist in the collection
shall consist in the collection
shall consist in the collection
shall consist in the collection
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and storage of data, including
and storage of data, including
and storage of data, including
and storage of data, including
by electronic means, enabling
by electronic means, enabling
by electronic means, enabling
by electronic means, enabling
the identification of the product, the identification of the product, the identification of the product, the identification of the product,
its components or of the
its components or of the
its components or of the
its components or of the
economic operators involved in
economic operators involved in
economic operators involved in
economic operators involved in
its supply chain, as well as in
its supply chain, as well as in
its supply chain, as well as in
its supply chain, as well as in
modalities to display and to
modalities to display and to
modalities to display and to
modalities to display and to ▌
access that data, including
allow public access
thatto those access that data, including
access
those data, including
placement of a data carrier on
data, including placement of a
placement of a data carrier on
placement of a data carrier on
the product, its packaging or
data carrier on the product, its
the product, its packaging or
the product, its packaging or
accompanying documents.
packaging or accompanying
accompanying documents.
accompanying documents.
documents.
Article 17(3), introductory part
3. The Commission is
3. The Commission is
3. The Commission is
3. The Commission is
empowered to adopt delegated
empowered to adopt delegated
empowered to adopt delegated
empowered to adopt delegated
acts in accordance with Article
acts in accordance with Article
acts in accordance with Article
acts in accordance with Article
41 to supplement this
41 to supplement this
41 to supplement this
41 to supplement this
G 249
Regulation by:
Regulation by:
Regulation by:
Regulation by:
G
Text Origin:
Commission Proposal
Article 17(3), point (a)
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(a) determining the products,
(a) determining the products,
(a) determining the products,
(a) determining the products,
categories or groups of products categories or groups of products
product categories or
product
categories or groups of products
or components susceptible to
or components susceptible to
groups of products or
or components susceptible to
bear a serious risk to health and bear a serious risk to health and components susceptible to bear
bear a serious risk to health and
safety of persons as referred to
safety of persons as referred to
a serious risk to health and
safety of persons as referred to
in paragraph 1. The
in paragraph 1. The
safety of persons as referred to
in paragraph 1. The
Commission shall state in the
Commission shall state in the
in paragraph 1. The
Commission shall state in the
delegated acts concerned if it
delegated acts concerned if it
Commission shall state in the
delegated acts concerned if it
has used the risk analysis
has used the risk analysis
delegated acts concerned if it
has used the risk analysis
methodology provided for in
methodology provided for in
has used the risk analysis
methodology provided for in
Commission Decision (EU)
Commission Decision (EU)
methodology provided for in
Commission Decision (EU)
2019/4171 or, if that
2019/4171 or, if that
Commission Decision (EU)
2019/4171 or, if that
G 250
methodology is not appropriate
methodology is not appropriate
2019/4171 or, if that
methodology is not appropriate
G
for the product concerned, it
for the product concerned, it
methodology is not appropriate
for the product concerned, it
shall give a detailed description shall give a detailed description for the product concerned, it
shall give a detailed description
of the methodology used;
of the methodology used;
shall give a detailed description of the methodology used;
_________
_________
of the methodology used;
_________
1. Commission Implementing
1. Commission Implementing
_________
1. Commission Implementing
Decision (EU) 2019/417 of 8
Decision (EU) 2019/417 of 8
1. Commission Implementing
Decision (EU) 2019/417 of 8
November 2018 laying down
November 2018 laying down
Decision (EU) 2019/417 of 8
November 2018 laying down
guidelines for the management
guidelines for the management
November 2018 laying down
guidelines for the management
of the European Union Rapid
of the European Union Rapid
guidelines for the management
of the European Union Rapid
Information System ‘RAPEX’
Information System ‘RAPEX’
of the European Union Rapid
Information System ‘RAPEX’
established under Article 12 of
established under Article 12 of
Information System ‘RAPEX’
established under Article 12 of
Directive 2001/95/EC on
Directive 2001/95/EC on
established under Article 12 of
Directive 2001/95/EC on
general product safety and its
general product safety and its
Directive 2001/95/EC on
general product safety and its
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notification system (OJ L 73,
notification system (OJ L 73,
general product safety and its
notification system (OJ L 73,
15.3.2019, p. 121).
15.3.2019, p. 121).
notification system (OJ L 73,
15.3.2019, p. 121).
15.3.2019, p. 121).
Article 17(3), point (b)
(b) specifying the type of data,
(b) specifying the type of data,
(b) specifying the type of data,
(b) specifying the type of data,
which economic operators shall which economic operators shall which economic operators shall which economic operators shall
collect and store by means of
collect and store by means of
collect and store by means of
collect and store by means of
the traceability system referred
the traceability system referred
the traceability system referred
the traceability system referred
G 251
to in paragraph 2;
to in paragraph 2;
to in paragraph 2;
to in paragraph 2;
G
Text Origin:
Commission Proposal
Article 17(3), point (c)
(c) the modalities to display
(c) the modalities to display
(c) the modalities to display
,
(c)
specifying the modalities to
and to access data, including
and to
allow public access
to
both for offline and distance
display and to access data,
G 252
placement of a data carrier on
data, including placement of a
sales, and to access data,
including placement of a data
G
the product, its packaging or
data carrier on the product, its
including placement of a data
carrier on the product, its
accompanying documents as
packaging or accompanying
carrier on the product, its
packaging or accompanying
referred to in paragraph 2.
documents as referred to in
packaging or accompanying
documents as referred to in
paragraph 2.
documents as referred to in
paragraph 2.
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paragraph 2.
d) specifying the actors that
shall have access to the data
referred to in point (b) and to
what data they shall have
access, including consumers,
economic operators, providers
of online marketplaces,
competent national authorities,
the Commission, and public
interest organisations, or any
organisation acting on their
behalf.
Text Origin:
Commission Proposal
Article 17(3a)
3a. Market surveillance
authorities, consumers,
G 252a
economic operators and other
G
relevant actors shall have free
access to the data referred to in
paragraph 3 based on their
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respective access rights set out
in the applicable delegated act
adopted pursuant to paragraph
3, point (d).
Article 17(4), introductory part
4. When adopting the measures 4. When adopting the measures 4. When adopting the measures 4. When adopting the measures
referred to in paragraph 3, the
referred to in paragraph 3, the
referred to in paragraph 3, the
referred to in paragraph 3, the
Commission shall take into
Commission shall take into
Commission shall take into
Commission shall take into
G 253
account:
account:
account:
account:
G
Text Origin:
Commission Proposal
Article 17(4), point (a)
(a) the cost-effectiveness of the (a) the cost-effectiveness of the (a) the cost-effectiveness of the (a) the cost-effectiveness of the
measures, including their impact measures, including their impact measures, including their impact measures, including their impact
G 254
on businesses, in particular
on businesses, in particular
on businesses, in particular
on businesses, in particular
G
small and medium-sized
small and medium-sized
small and medium-sized
small and medium-sized
enterprises;
enterprises;
enterprises;
enterprises;
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Text Origin:
Commission Proposal
Article 17(4), point (aa)
(aa) an adequate delay in
(aa) an adequate delay in
G 254a
order for economic operators
order for economic operators to G
to prepare for these measures; prepare for these measures;
Article 17(4), point (b)
(b) the compatibility with
(b) the compatibility
and
(b) the compatibility with
(b) the compatibility
and
traceability systems available at
interoperability with other
traceability systems available at
interoperability with other
Union or at international level.
product with traceability
Union or at international level.
product traceability systems
G 255
G
systems
availablealready set up
already set up at Union or at
at Union or at international
international level.
level.
Section 2
G 256
G
Section 2
Section 2
Section 2
Section 2
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Article 18
Article 18
Article 18
Article 18
Article 18
G 257
Obligations of economic
Obligations of economic
Obligations of economic
Obligations of economic
G
operators in case of distance
operators in case of distance
operators in case of distance
operators in case of distance
sales
sales
sales
sales
Article 18, first paragraph, introductory part
Where products are made
Where products are made
Where products are made
Where products are made
available on the market online
available on the market online
available on the market online
available on the market online
or through other means of
or through other means of
or through other means of
or through other means of
distance sales by the relevant
distance sales by the relevant
distance sales by the relevant
distance sales by ▌ economic
G 258
economic operators, the relevant economic operators, the relevant economic operators, the relevant operators, the relevant offer of
G
offer of the product shall clearly offer of the product shall clearly offer of the product shall clearly the product shall clearly and
and visibly indicate at least the
and visibly indicate at least the
and visibly indicate at least the
visibly indicate at least the
following information:
following information:
following information:
following information:
Article 18, first paragraph, point (a)
G 259
G
(a) name, registered trade name (a) name, registered trade name (a) name, registered trade name (a) name, registered trade name
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or registered trade mark of the
or registered trade mark of the
or registered trade mark of the
or registered trade mark of the
manufacturer, as well as the
manufacturer, as well as the
manufacturer, as well as the
manufacturer, as well as the
postal or electronic address at
postal
address and the website
postal or
and electronic address postal
and electronic address at
which they can be contacted;
or electronic address at which
at which they can be contacted;
which they can be contacted;
they can be contacted;
Article 18, first paragraph, point (b)
(b) in case the manufacturer is
(b) in case the manufacturer is
(b) in case the manufacturer is
(b) in case the manufacturer is
not established in the Union, the not established in the Union, the not established in the Union, the not established in the Union, the
name, address, telephone
name, address,
telephone
name, address, telephone
name,
postal and electronic
number and electronic address
number andand the website or
number and electronic address
address of the responsible
G 260
of the responsible person within electronic address of the
of the responsible person within person within the meaning of
G
the meaning of Article 15(1);
responsible person within the
the meaning of Article 15(1)
of
Article 15(1)
of this Regulation
meaning of Article 15(1);
this Regulation or Article 4(1) or Article 4(1) of Regulation
of Regulation (EU) 2019/1020;
(EU) 2019/1020;
Article 18, first paragraph, point (c)
(c) information to identify the
(c)
pictures and other
(c) information
allowing the
(c) information
allowing the
product, including its type and,
information
to identifythat allow unequivocal identification of
identification of the product,
G 261
when available, batch or serial
identification of the product,
to identify the product,
including
a picture of it, its type G
number and any other product
including its type
and, when
including
a picture of it, its
and any other product identifier;
identifier;
available, batch or serial
type and, when
easily accesible
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number and any other product
and/or available, batch or serial Note to LL for translation of
identifier;
number and any other product
picture (not to be limited to
identifier;
"photo").
Article 18, first paragraph, point (d)
(d) any warning or safety
(d) any warning or safety
(d) any warning or safety
(d) any warning or safety
information that is to be affixed information that is to be affixed information that is to be affixed information that is to be affixed
on the product or to accompany on the product or
on the
on the product or to accompany on the product or
on the
it in accordance with this
packaging or to accompany it in it in accordance with this
packaging or an accompanying
G 262
Regulation or the applicable
accordance with this Regulation Regulation or the applicable
document in accordance with
G
Union harmonisation legislation or the applicable Union
Union harmonisation legislation this Regulation or the applicable
in a language which can be
harmonisation legislation in a
in a language which can be
Union harmonisation legislation
easily understood by consumers. language which can be easily
easily understood by consumers. in a language which can be
understood by consumers.
easily understood by consumers.
Article 19
Article 19
Article 19
Article 19
Article 19
G 263
Obligations of economic
Obligations of economic
Obligations of economic
Obligations of economic
G
operators in case of accidents or
operators in case of accidents
operators in case of accidents or
operators in case of accidents
safety issues related to products
orrelated to safety
issues
safety issues
related to
related to safety
of products ▌
related toof products
products
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agreed in trilogue.
Article 19(1)
1. The manufacturer shall
1. The manufacturer shall
1. The manufacturer shall
1. The manufacturer shall
ensure that, through the Safety
ensure that, through the Safety
ensure that, through the Safety
ensure that, through the Safety
Business Gateway referred to in Business Gateway referred to in Business Gateway referred to in Business Gateway referred to in
Article 25, an accident caused
Article 25, an accident
directly
Article 25, an accident
related
Article 25, an accident caused
by a product placed or made
caused by a product
placed or
to caused by a product placed or by a product
[placed or
] made
available on the market is
made available on the market is made available on the market is available on the market is
notified, within two working
notified
, within two working
notified, within two
three
notified,
without undue delay
days from the moment it knows
days from the moment it knows
working days from the moment
from the moment it knows about
about the accident, to the
immediately after it knows
it knows about the accident, to
the accident, to the competent
competent authorities of the
about the accident in
the competent authorities of the authorities of the Member State
G 264
Member State where the
accordance with Article 8(10)
Member State where the
where the accident has occurred. G
accident has occurred. The
or about the
accidentresults of
accident has occurred. The
The notification shall include
notification shall include the
the investigation referred to in
notification shall include the
the type and identification
type and identification number
Article 8(11b), as applicable, to type and identification number
number of the product as well as
of the product as well as the
the competent authorities of the of the product as well as the
the circumstances of the
circumstances of the accident, if Member State where the
circumstances of the accident, if accident, if known. The
known. The manufacturer shall
accident has occurred. The
known. The manufacturer shall
manufacturer shall notify, upon
notify, upon request, to the
notification shall include the
notify, upon request, to the
request, to the competent
competent authorities any other
type and identification number
competent authorities any other
authorities any other relevant
relevant information.
of the product as well as the
relevant information.
information.
circumstances of the accident, if
known. The manufacturer shall
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notify, upon request, to the
competent authorities any other
relevant information.
Article 19(1a)
1a. For the purpose of
paragraph 1, the manufacturer
shall notify the occurrences
associated with the use of a
product that resulted in an
individual’s death or in serious
G 264a
adverse effects on their health
G
and safety, permanent or
temporary, including injuries,
other damages to the body,
illnesses and chronic health
effects.
Article 19(2)
G 265
2. The importers and the
2. The importers and the
2. The importers and the
2. The importers and the
G
distributors which have
distributors which have
distributors which have
distributors which have
knowledge of an accident
knowledge of an accident
knowledge of
such an accident
knowledge of an accident
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caused by a product that they
caused by a product that they
caused by a product that they
caused by a product that they
placed or made available on the placed or made available on the placed or made available on the placed or made available on the
market shall inform the
market shall
immediately
market
shall inform the
market shall
without undue
manufacturer, which can
inform the manufacturer, which manufacturer, which can
delay inform the manufacturer,
instruct the importer or one of
can
proceed to the notification
instruct the importer or one of
which can
proceed to the
the distributors to proceed to the
in accordance with paragraph
the distributors to proceed to
notification in accordance with
notification.
1 or instruct the importer or one
will be responsible for the
paragraph 1 or instruct the
of the distributors to proceed to
notification.
importer or one of the
thesuch notification.
distributors to proceed to
such
notification.
Article 19(2a)
3. Where the manufacturer of 3. Where the manufacturer of
the product is not established
the product is not established in
in the Union, the responsible
the Union, the responsible
person within the meaning of
person within the meaning of
Article 15(1) of this
Article 15(1) of this Regulation
G 265a
Regulation or Article 4(1) of
or Article 4(1) of Regulation
G
Regulation (EU) 2019/1020
(EU) 2019/1020 which has
shall ensure that the
knowledge of an accident shall
notification is done.
ensure that the notification is
done.
Article 19a
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Article 19a
Article 19a
G 265b
Information requirements in
Information in electronic
G
electronic format
format
Article 19a(1)
1. Without prejudice to
1. 1. Without prejudice to
Articles 8(6), (7) and (8),
Articles 8(6), (7) and (8),
Article 10(3) and Article 15(3),
Article 10(3) and Article 15(3),
economic operators may
and the relevant provisions in
additionally make the
the Union harmonisation
information referred to in those
legislation, economic operators
Articles available in a digital
may additionally make the
format by means of electronic
information referred to in those
G 265c
solutions, such as a non-
Articles available in a digital
G
removable QR or matrix code,
format by means of electronic
clearly visible on the product
technical solutions clearly
or, where that is not possible,
visible on the product or, where
on its packaging or in a
that is not possible, on its
document accompanying the
packaging or in a document
product. That information shall
accompanying the product.
be in a language which can be
That information shall be in a
easily understood by
language which can be easily
consumers, as determined by
understood by consumers, as
the Member State in which the
determined by the Member
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product is made available, and
State in which the product is
in accessible formats for
made available, and in
persons with disabilities.
accessible formats for persons
with disabilities.
CHAPTER IV
CHAPTER IV
CHAPTER IV
CHAPTER IV
CHAPTER IV
Online marketplaces
Online marketplaces
Online marketplaces
Online marketplaces
G 266
G
Text Origin:
Commission Proposal
Article 20
Article 20
Article 20
Article 20
Article 20
Specific obligations of online
Specific obligations of online
Specific obligations of
Specific obligations of
marketplaces related to product
marketplaces related to product
providers of online
providers of online
G 267
safety
safety
marketplaces related to product
marketplaces related to product G
safety
safety
Text Origin: Council
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Mandate
Article 20(1), first subparagraph
1. Online marketplaces shall
1.
Without prejudice to the
1.
Providers of online
1.
Without prejudice to the
establish a single contact point
general obligations provided
marketplaces shall establish
general obligations provided
allowing for direct
for in [Article 10 of Regulation designate a single contact point
for in Article 11 of Regulation
communication with Member
(EU) […/…]] on a Single
allowing for direct
(EU) […/…] on a Single
States’ market surveillance
Market for Digital Services
communication
, by electronic
Market for Digital Services
authorities in relation to product
(Digital Services Act) and
means, with Member States’
(Digital Services Act) and
safety issues, in particular for
amending Directive
market surveillance authorities
amending Directive
orders concerning offers of
2000/31/EC, online
in relation to product safety
2000/31/EC, providers of online
dangerous products.
marketplaces shall
issues, in particular for orders
marketplaces shall
designate a
G 268
establishdesignate a single
concerning offers of dangerous
single
point of contact allowing G
point of contact
point allowing
products
the purpose of
for direct communication
, by
for
swift direct communication
notifying orders issued
electronic means, with Member
with Member States’ market
pursuant to paragraph 2.
States’ market surveillance
surveillance authorities
and
authorities in relation to product
other competent authorities in
safety issues, in particular for
relation to product safety issues,
the purpose of notifying orders
in particular for orders
issued pursuant to paragraph
concerning offers of dangerous
2. ▌
products.
Article 20(1), second subparagraph
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Online marketplaces shall
Online marketplaces shall
easily Providers of online
Providers of online
register with the Safety Gate
register with the Safety Gate
marketplaces shall register with marketplaces shall register with
portal and indicate on the portal portal and indicate on the portal the Safety Gate portal and
the Safety Gate portal and
the information concerning their the information concerning their indicate on the portal the
indicate on the portal the
single contact point.
single contact point.
information concerning their
information concerning their
Online marketplaces shall
single contact point.
single contact point.
make use of the single point of
contact designated in
accordance with [Article 10a of
Regulation (EU) […/…]] on a
1a. Without prejudice to the
Single Market for Digital
general obligations provided
Services (Digital Services Act)
for in Article 12 of Regulation
G 269
and amending Directive
(EU) […/…] on a Single
G
2000/31/EC, to enable
Market for Digital Services
consumers to communicate
(Digital Services Act) and
directly and swiftly with them.
amending Directive
2000/31/EC, providers of
online marketplaces shall
designate a single point of
contact to enable consumers to
communicate directly and
rapidly with them in relation to
product safety issues.
1b. Providers of online
marketplaces shall ensure that
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they have internal processes for
product safety in place in order
to comply with the relevant
requirements of this Regulation
without undue delay.
Text Origin: Council
Mandate
Article 20(2), first subparagraph -a
1a. Providers of online
marketplaces shall ensure that
they have internal processes
G 269a
for product safety in place in
G
order to comply with this
Regulation without undue
delay.
Article 20(2), first subparagraph
G 270
2. As far as powers conferred
2. As
far asregards powers
2. As far as powers conferred
2. As
regards powers conferred G
by Member States in accordance conferred by Member States in
by Member States in accordance by Member States in accordance
to Article 14 of Regulation (EU) accordance to Article 14 of
to Article 14 of Regulation (EU) to Article 14 of Regulation (EU)
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2019/1020 are concerned,
Regulation (EU) 2019/1020
are 2019/1020 are concerned,
2019/1020 are concerned,
Member States shall confer on
concerned, Member States shall Member States shall confer on
Member States shall confer on
their market surveillance
confer on their market
their market surveillance
their market surveillance
authorities the power, for all
surveillance authorities the
authorities the
necessary power, authorities the
necessary power
products covered by this
power, for all products covered
for all products covered by this
to impose on the providers of
Regulation, to order an online
by this Regulation, to
order
Regulation, to order an
to
online
marketplaces the
marketplace to remove specific
anissue orders in accordance
impose on the providers of
removal of specific ▌
content
illegal content referring to a
with the conditions set out in
online marketplace to remove
referring to
an offer of a
dangerous product from its
[Article 8(2)] of Regulation
marketplaces the removal of
dangerous product from
their
online interface, to disable
[DSA…/…] to online
specific illegal
content
online interface, to disable
access to it or to display an
marketplacemarketplaces to
referring to
an offer of a
access to it or to display an
explicit warning to end users
remove specific illegal content
dangerous product from its
explicit warning ▌ . Such
when they access it. Such orders referring to a dangerous product
their online interface, to disable orders shall
be issued in
shall contain a statement of
from its online interface, to
access to it or to display an
accordance with the minimum
reasons and specify one or more disable access to it or to display explicit warning to end users
conditions set out in Article
exact uniform resource locators
an explicit warning to end users when they access it. Such orders
9(2) of Regulation (EU) […/…]
and, where necessary, additional when they access it.
Such orders shall contain a statement of
on a Single Market for Digital
information enabling the
shall contain a statement of
reasons and specify one or more
Services (Digital Services Act)
identification of the illegal
reasons and specify one or more exact uniform resource locators
and amending Directive
content concerned. They may be
exact uniform resource locators and, where necessary, additional
2000/31/EC.
transmitted by means of the
and, where necessary,
information enabling the
Safety Gate portal.
additional information enabling identification of the illegal
the identification of the illegal
content concerned. They may be
content concerned. They may be transmitted by means of the
transmitted by means of the
Safety Gate portal
clear
Safety Gate portal.
information enabling the
provider of the online
marketplace to identify and
locate the content concerned,
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such as one or more exact
uniform resource locators
(URL), and, where necessary,
additional information .
Article 20(2), second subparagraph
Online marketplaces shall take
Online marketplaces shall take
Providers of online
Providers of online
the necessary measures to
the necessary measures to
marketplaces shall take the
marketplaces shall take the
receive and process the orders
receive and process the orders
necessary measures to receive
necessary measures to receive
issued in accordance with this
issued in accordance with this
and process the orders
actions
and process the orders issued
paragraph. They shall act upon
paragraph. They shall act upon
imposed by the order issued in
pursuant to this paragraph
and
receipt of the order issued
receipt of the order issued
accordance with
pursuant to
they shall act ▌ without undue
without undue delay, and in any
without undue delay, and in any this paragraph. They shall act
delay, and in any event within
event within two working days
eventexpeditiously. If the
upon receipt of the order issued
two working days ▌ from
in the Member State where the
information provided by the
without undue delay
within the receipt of the order. They shall
G 271
online marketplace operates,
market surveillance authorities time limit indicated therein,
inform the issuing market
G
from receipt of the order. They
is sufficiently precise to enable and in any event within
by two
surveillance authority of the
shall inform the issuing market
the immediate identification
working days in the Member
effect given to the order by
surveillance authority of the
and location of the illegal
State where the online
electronic means using the
effect given to the order by
content referring to a
marketplace operates, from
contacts of the market
using the contacts of the market
dangerous product, the online
from the receipt of the order.
surveillance authority published
surveillance authority published
marketplaces shall act within
They shall inform the issuing
in the Safety Gate
Portal.
in the Safety Gate.
twoone working
days in the
market surveillance authority of
Member State where the day
how they applied the order
from the receipt of the order. If including the actions taken
online
marketplace operates,
further the effect given to the
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marketplaces have to carry out order by using the contacts of
additional research in order to
the market surveillance
identify the product, they shall
authority published in the Safety
act within two working days
Gate
Portal.
from receipt of the order. They
shall inform the issuing market
surveillance authority of the
effect given to the order by
using the contacts of the market
surveillance authority published
in the Safety Gate.
For that
purpose, the market
surveillance authorities shall
allow communication by e-mail
or other electronic means.
Article 20(2a)
2a. Orders issued pursuant to
paragraph 2 may require the
provider of online
G 271a
marketplace to remove from
G
its online interface all
identical content referring to
offers of a dangerous product,
to disable access to it or to
display an explicit warning,
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provided that the search for
the content concerned is
limited to the information
identified in the order and
does not require the provider
to carry out an independent
assessment of that content,
and that it can be carried out
by reliable automated search
tools.
Article 20(2a)
2a. Online marketplaces shall
inform, where possible, the
relevant economic operator of
G 271b
the decision to remove or
G
disable access to the illegal
content.
Article 20(2b)
G 271c
2b. Orders issued pursuant to
G
paragraph 2 may require,
moved to 271a.
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during the period indicated in
the order, the provider of
online marketplace to remove
from its online interface all
identical illegal content
referring to the dangerous
product in question, to disable
access to it or to display an
explicit warning to end users,
provided that the search for the
content concerned is limited to
the information identified in
the order and does not require
the provider to carry out an
independent assessment of that
content, and that it can be
carried out by reliable and
proportionate automated
search tools.
Article 20(2c)
2c. In the event that a provider
G 271d
of online marketplaces refuses
no text here.
G
to allow a trader to use its
service pursuant to paragraphs
2b, the trader concerned shall
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have the right to lodge a
complaint as provided for in
Article 4 of Regulation (EU)
2019/1150 and [Articles 17 of
... DSA Regulation].
Article 20(2c)
2c. Orders issued pursuant to
paragraph 2 may require,
during the period indicated in
the order, the provider of
online marketplace to remove
from its online interface all
identical content referring to
an offer of the dangerous
271e
product in question, to disable
access to it or to display an
explicit warning, provided that
the search for the content
concerned is limited to the
information identified in the
order and does not require the
provider to carry out an
independent assessment of that
content, and that the search
and the removal can be carried
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out in a proportionate manner
by reliable automated tools.
Article 20(2d)
2d. After allowing the offering
of the product or service by the
no text here. see row 272a
trader, online marketplaces
shall make reasonable efforts
to check randomly whether the
products offered have been
G 271f
identified as being dangerous
G
products in any official, freely
accessible and machine-
readable online database or
online interface, in particular
the Safety Gate Portal.
Article 20(3)
3. Online marketplaces shall
3. Online marketplaces shall
3. Online marketplaces shall
▌
3. Providers of online
G 272
take into account regular
take into account regular
take into account regular
marketplaces shall take into
G
information on dangerous
information on dangerous
information on dangerous
account regular information on
products notified by the market
products notified by the market
products notified by the market
dangerous products notified by
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surveillance authorities in line
surveillance authorities in line
surveillance authorities in line
the market surveillance
with Article 24, received via the with Article 24, received via the with Article 24, received via the authorities in line with Article
Safety Gate portal, for the
Safety Gate portal, for the
Safety Gate portal, for the
24, received via the Safety Gate
purpose of applying their
purpose of applying their
purpose of applying their
Portal, for the purpose of
voluntary measures aimed at
voluntary measures aimed at
voluntary measures aimed at
applying their voluntary
detecting, identifying, removing detecting, identifying, removing detecting, identifying, removing measures aimed at detecting,
or disabling access to the illegal or disabling access to the illegal or disabling access to the illegal
identifying, removing or
content referring to dangerous
content referring to dangerous
content referring to dangerous
disabling access to the ▌
products offered on their
products offered on their
products offered
offers of
content referring to
offers of
marketplace, where applicable.
marketplace, where applicable
,
dangerous products on their
dangerous products ▌
on their
They shall inform the authority
also by making use of the
marketplace, where applicable.
marketplace, where applicable
,
that made the notification to the
interoperable interface to the
They shall inform the authority
also by making use of the
Safety Gate of any action taken
Safety Gate developed in
that made the notification to the
interoperable interface to the
by using the contacts of the
accordance with Article 23.
Safety Gate of any action taken
Safety Gate Portal in
market surveillance authority
They shall inform the authority
by using the contacts of the
accordance with Article 23.
published in the Safety Gate.
that made the notification to the market surveillance authority
They shall inform the authority
Safety Gate of any action taken
published in the Safety Gate.
that made the notification to the
by using the contacts of the
Safety Gate of any action taken
market surveillance authority
by using the contacts of the
published in the Safety Gate.
market surveillance authority
published in the Safety Gate
Portal.
Article 20(3a)
G 272a
3a. For the purpose of
G
compliance with Article 31(3)
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of Regulation (EU) […/…] on
a Single Market for Digital
Services (Digital Services Act),
regarding product safety,
providers of online
marketplaces shall use at least
the Safety Gate Portal.
see row 271e and 278b.
Article 20(4)
4. Online marketplaces shall
4. Online marketplaces shall
4.
Providers of online
4.
Providers of online
give an appropriate answer
give an appropriate answer
marketplaces shall give an
marketplaces shall ▌ without
without undue delay, and in any without undue delay, and in any appropriate answer
without
undue delay, and in any event
event within five working days, event within
fivethree working
undue delay, and in any event
within
three working days
in the Member State where the
days
, in the Member State
within five
three working days,
process notices related to
online marketplace operates, to
where the online marketplace
in the Member State where the
product safety issues with
G 273
notices related to product safety
operates, to notices related to
online marketplace operates, to
regard to the product offered
G
issues and dangerous products
product safety issues and
process notices related to
for sale online through their
received in accordance with
dangerous products process
product safety issues and
services, received in accordance
[Article 14] of Regulation (EU)
notices related to product safety dangerous products received in
with ▌ Article
16 of Regulation
[…/…] on a Single Market for
issues with regard to the
accordance with [Article 14] of
(EU) […/…] on a Single Market
Digital Services (Digital Service
product offered for sale online
Regulation (EU) […/…] on a
for Digital Services (Digital
Act) and amending Directive
through their services, received Single Market for Digital
Service Act) and amending
2000/31/EC.
in accordance with [Article 14]
Services (Digital Service Act)
Directive 2000/31/EC.
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of Regulation (EU) […/…] on a and amending Directive
Single Market for Digital
2000/31/EC.
Services (Digital Service Act)
and amending Directive
2000/31/EC.
Article 20(5), introductory part
5. For the purpose of the
5. For the purpose of the
5. For the purpose of
5. For the purpose of
requirements of Article 22(7) of requirements of
[Article
compliance with the
compliance with the
Regulation (EU) […/…] on a
22(7)24(c) of Regulation (EU)
requirements of Article 22(7)
requirements of Article
31(1)
Single Market for Digital
[…/…]
] on a Single Market for
24c of Regulation (EU) […/…]
and (2) of Regulation (EU)
Services (Digital Services Act)
Digital Services (Digital
on a Single Market for Digital
[…/…] on a Single Market for
and amending Directive
Services Act) and amending
Services (Digital Services Act)
Digital Services (Digital
2000/31/EC, online
Directive 2000/31/EC, online
and amending Directive
Services Act) and amending
marketplaces shall design and
marketplaces shall design and
2000/31/EC
as regards
Directive 2000/31/EC
as
G 274
organise their online interface in organise their online interface in
product safety information,
regards product safety
G
a way that enables traders to
a way that enables traders
using providers of online
information, providers of
provide the following
their services to comply with
marketplaces shall design and
online marketplaces shall design
information for each product
this Regulation.
organise their online interface in and organise their online
offered and ensures that it is
Online marketplaces shall
a way that enables
requires
interface in a way that enables
displayed or otherwise made
ensure thatto provide the
traders
offering the product to
traders
offering the product to
easily accessible by consumers
following information
provided provide
at least the following
provide
at least the following
on the product listing:
by the traders for each product
information for each product
information for each product
offered
and ensures that it isis
offered and ensures that it is
offered and ensures that it is
clearly and visibly displayed or
displayed or otherwise made
displayed or otherwise made
easily accessible by consumers
easily accessible by consumers
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otherwise made easily
on the product listing:
on the product listing:
accessible by consumers on the
product listing:
Article 20(5), point (a)
(a) name, registered trade name (a) name, registered trade name (a) name, registered trade name (a) name, registered trade name
or registered trade mark of the
or registered trade mark of the
or registered trade mark of the
or registered trade mark of the
manufacturer, as well as the
manufacturer, as well as the
manufacturer, as well as the
manufacturer, as well as the
G 275
postal or electronic address at
postal
address and the website
postal or
and electronic address postal
and electronic address at
G
which they can be contacted;
or electronic address at which
at which they can be contacted;
which
the manufacturer can be
theythe manufacturer can be
contacted;
contacted;
Article 20(5), point (b)
(b) where the manufacturer is
(b) where the manufacturer is
(b) where the manufacturer is
(b) where the manufacturer is
not established in the Union, the not established in the Union, the not established in the Union, the not established in the Union, the
name, address, telephone
name, address
, telephone
name, address, telephone
name,
postal and electronic
G 276
number and electronic address
number and and the website or
number and electronic address
address of the responsible
G
of the responsible person within electronic address of the
of the responsible person within person within the meaning of
the meaning of Article 15 (1);
responsible person
within the
the meaning of Article 15
Article
15(1) of this Regulation
meaning ofin accordance with
(1)
15(1) of this Regulation or
or Article 4(1) of Regulation
Article 15 (1);
Article 4(1) of Regulation
(EU) 2019/1020;
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(EU) 2019/1020;
Article 20(5), point (c)
(c) information to identify the
(c) information to identify the
(c) information
allowing the
(c) information
allowing the
product, including its type and,
product, including its type and
,
unequivocal identification of
identification of the product,
when available, batch or serial
when available, batch or serial
to identify the product,
including
a picture of it, its type
number and any other product
number and any other product
including
a picture of it, its
and any other product identifier;
G 277
identifier;
identifier;
type and, when
easily accesible
G
and/or available, available,
batch or serial number and any
other product identifier;
Article 20(5), point (d)
(d) any warning or safety
(d) any warning or safety
(d) any warning or safety
(d) any warning or safety
information that is to be affixed information that is to be affixed information that is to be affixed information that is to be affixed
on the product or to accompany on the product or to accompany on the product or to accompany on the product or to accompany
it in accordance with this
it in accordance with this
it in accordance with this
it in accordance with this
G 278
Regulation or the applicable
Regulation or the applicable
Regulation or the applicable
Regulation or the applicable
G
Union harmonisation legislation Union harmonisation legislation Union harmonisation legislation Union harmonisation legislation
in a language which can be
in a language which can be
in a language which can be
in a language which can be
easily understood by consumers. easily understood by consumers. easily understood by consumers. easily understood by consumers.
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Article 20(5a)
5-a. For the purpose of
5a. The internal processes
compliance with Article 24c of referred to in paragraph 1b
Regulation (EU) […/…] on a
shall include mechanisms
Single Market for Digital
which enable traders to
Services (Digital Services Act) provide:
and paragraph 5 of this
(a) information in accordance
Article, the internal processes with paragraph 5 of this Article
referred to in paragraph 1a
including information on the
shall include mechanisms
manufacturer established in
which enable providers of
the Union or, where applicable,
online marketplaces to obtain
the responsible person, and
G 278a
information from the trader
G
on its self-certification
(b) their self-certification
committing to only offer
committing to only offer
products that comply with this products that comply with this
Regulation and on the
Regulation and additional
existence of an economic
identification information, in
operator established in the
accordance with Article 30(1)
Union or a responsible person of the DSA, where applicable. for products offered or any
other relevant information on
the identification of the
trader.
Article 20(5b)
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5a. For the purpose of
compliance with Article
no text here. see text in row
24d(3) of Regulation (EU)
272a.
[…/…] on a Single Market for
Digital Services (Digital
Services Act), regarding
product safety, providers of
G 278b
online marketplaces shall use
G
the Safety Gate Portal in
addition to any other official,
freely accessible and machine-
readable online database or
online interface reporting
dangerous product or product
safety recalls.
Article 20(5c)
5b. For the purpose of
5b. For the purpose of
compliance with Article 20 of
compliance with Article 20 of
G 278c
Regulation (EU) […/…] on a
Regulation (EU) […/…] on a
G
Single Market for Digital
Single Market for Digital
Services (Digital Services Act), Services (Digital Services Act),
regarding product safety,
regarding product safety,
providers of online
providers of online
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marketplaces shall suspend,
marketplaces shall suspend, for
for a reasonable period of
a reasonable period of time and
time and after having issued a after having issued a prior
prior warning, the provision
warning, the provision of their
of their services to traders
services to traders that
that frequently offer products frequently offer products which
which are non-compliant with are non-compliant with this
this Regulation.
Regulation
Article 20(6), introductory part
6. Online marketplaces shall
6. Online marketplaces shall
6.
Providers of online
6.
Providers of online
cooperate with the market
cooperate with the market
marketplaces shall cooperate
marketplaces shall cooperate
surveillance authorities and with surveillance authorities and with with the market surveillance
with the market surveillance
relevant economic operators to
relevant economic operators to
authorities
, with traders and
authorities
, with traders and
facilitate any action taken to
facilitate any action taken to
with relevant economic
with relevant economic
eliminate or, if that is not
eliminate or, if that is not
operators to facilitate any action operators to facilitate any action
possible, to mitigate the risks
possible, to mitigate the risks
taken to eliminate or, if that is
taken to eliminate or, if that is
G 279
presented by a product that is or presented by a product that is or not possible, to mitigate the
not possible, to mitigate the
G
was offered for sale online
was offered for sale online
risks presented by a product that risks presented by a product that
through their services. That
through their services.
is or was offered for sale
is or was offered ▌ online
cooperation shall include in
In particular, online
online through their services.
through their services.
particular:
marketplaces That cooperation
The actions taken by the
In particular, providers of
shall
include in particular:
providers of online
online marketplaces shall:
marketplaces in the context of
that cooperation shall include in
particular:
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Article 20(6), point (-a), introductory part
(-a) ensuring that, they
(-a) ensure that, they provide
provide appropriate and 