Esta es la versión HTML de un fichero adjunto a una solicitud de acceso a la información 'Limits for contaminants in fertilizers'.

12/12/2018
Post-trilogue version
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down rules on
the making available on the market of CE marked fertilising products and amending Regulations (EC)
No 1069/2009 and (EC) No 1107/2009
Note:
Differences between the EP's position and the Commission's proposal are in bold/italics. Differences between the Council's position and the
Commission's proposal are in bold and underlined. Deletions are in strike-through.
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1.
Proposal for a REGULATION
AM 1
Proposal for a REGULATION
Proposal for a REGULATION
OF THE EUROPEAN
OF THE EUROPEAN
OF THE EUROPEAN
PARLIAMENT AND OF THE
Proposal for a REGULATION
PARLIAMENT AND OF THE
PARLIAMENT AND OF THE
COUNCIL laying down rules on
OF THE EUROPEAN
COUNCIL laying down rules on
COUNCIL laying down rules on
the making available on the
PARLIAMENT AND OF THE
the making available on the
the making available on the
market of CE marked fertilising
COUNCIL laying down rules on
market of CE marked EU
market of EU fertilising products
products and amending
the making available on the
fertilising products and amending
and amending Regulations (EC)
Regulations (EC) No 1069/2009
market of CE marked plant
Regulations (EC) No 1069/2009
No 1069/2009 and (EC) No
and (EC) No 1107/2009
nutrition products and amending
and (EC) No 1107/2009
1107/2009
Regulations (EC) No 1069/2009
and (EC) No 1107/2009
(This amendment from
"fertilising products" to "plant
nutrition products" applies
throughout the text. Adopting it
will necessitate corresponding
changes throughout and,
consequently, adopted
amendments.)

2.
(Text with EEA relevance)
EC TEXT
3.
THE EUROPEAN
EC TEXT
PARLIAMENT AND THE
COUNCIL OF THE
EUROPEAN UNION,
4.
Having regard to the Treaty on
EC TEXT
the Functioning of the European
Union, and in particular Article
114 thereof,
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5.
Having regard to the proposal
EC TEXT
from the European Commission,
6.
After transmission of the draft
EC TEXT
legislative act to the national
parliaments,
7.
Having regard to the opinion of
EC TEXT
the European Economic and
Social Committee1,
1 OJ C , , p. .
8.
Acting in accordance with the
EC TEXT
ordinary legislative procedure,
9.
Whereas:
EC TEXT
10.
(1) The conditions for making
AM 2
(1) The conditions for making
fertilisers available on the
fertilisers available on the
internal market have been
(1) The conditions for making
internal market have been
partially harmonised through
fertilisers available on the
partially harmonised through
Regulation (EC) No 2003/2003
internal market have been
Regulation (EC) No 2003/2003
of the European Parliament and
partially harmonised through
of the European Parliament and
of the Council2, which almost
Regulation (EC) No 2003/2003
of the Council2, which almost
exclusively covers fertilisers
of the European Parliament and
exclusively covers fertilisers
from mined or chemically
of the Council2, which almost
from mined or chemically
produced, inorganic materials.
exclusively covers fertilisers
produced, mineral inorganic
There is also a need to make use
from mined or chemically
materials. There is also a need to
of recycled or organic materials
produced, mineral materials.
make use of recycled or organic
There is also a need to make use
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for fertilising purposes.
of recycled or organic materials
materials for fertilising purposes.
Harmonised conditions for
for fertilising purposes.
Harmonised conditions for
making fertilisers made from
Harmonised conditions for
making fertilisers made from
such recycled or organic
making fertilisers made from
such recycled or organic
materials available on the entire
such recycled or organic
materials available on the entire
internal market should be
materials available on the entire
internal market should be
established in order to provide an
internal market should be
established in order to provide an
important incentive for their
established in order to provide an
important incentive for their
further use. The scope of the
important incentive for their
further use. Promoting increased
harmonisation should therefore
further use. Promoting increased
use of recycled nutrients would
be extended in order to include
use of recycled nutrients would
further aid the development of
recycled and organic materials.
further aid the development of
the circular economy and allow
the circular economy and allow
a more resource-efficient
2 Regulation (EC) No 2003/2003
a more resource-efficient
general use of nutrients, while
of the European Parliament and
general use of nutrients, while
reducing Union dependency on
of the Council of 13 October
reducing Union dependency on
nutrients from third countries.
2003 relating to fertilisers (OJ L
nutrients from third countries.
The scope of the harmonisation
304, 21.11.2003, p. 1).
The scope of the harmonisation
should therefore be extended in
should therefore be extended in
order to include recycled and
order to include recycled and
organic materials.
organic materials.
2 Regulation (EC) No 2003/2003
2 Regulation (EC) No 2003/2003
of the European Parliament and
of the European Parliament and
of the Council of 13 October
of the Council of 13 October
2003 relating to fertilisers (OJ L
2003 relating to fertilisers (OJ L
304, 21.11.2003, p. 1).
304, 21.11.2003, p. 1).
(This amendment also covers a
horizontal technical amendment

on the term “inorganic” being
changed to “mineral”; adopting
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it will necessitate corresponding
changes of this term throughout
the text and, consequently,
adopted amendments.)

11.
(2) Certain products are being
EC TEXT
used in combination with
fertilisers for the purpose of
improving nutrition efficiency,
with the beneficial effect of
reducing the amount of fertilisers
used and hence their
environmental impact. In order to
facilitate their free movement on
the internal market, not only
fertilisers, i.e. products intended
to provide plants with nutrient,
but also products intended to
improve plants' nutrition
efficiency, should be covered by
the harmonisation.
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12.
AM 3
No amendment
(2a) Nutrients in food originate
from the soil; healthy and
nutritious soil results in healthy
and nutritious crops and food.
Farmers need a wide range of
fertilisers, organic and synthetic
to be available, in order to
enhance their soil. When soil
nutrients are missing, or
depleted, plants will be nutrient
deficient and may either stop
growing or not contain
nutritional value for human
consumption.

13.
(3) Regulation (EC) No 765/2008
(3) Regulation (EC) No 765/2008
CEU TEXT
of the European Parliament and
of the European Parliament and
of the Council3 lays down rules
of the Council3 lays down rules
on the accreditation of
on the accreditation of
conformity assessment bodies,
conformity assessment bodies,
provides a framework for the
provides a framework for the
market surveillance of products
market surveillance of products
and for controls on products from
and for controls on products from
third countries, and lays down the
third countries, and lays down
general principles of the CE
the general principles of the CE
marking. That Regulation should
marking. That Regulation should
be applicable to products covered
be applicable to products covered
by the scope of this Regulation in
by the scope of this Regulation in
order to ensure that products
order to ensure that products
benefiting from the free
benefiting from the free
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movement of goods within the
movement of goods within the
Union fulfil requirements
Union fulfil requirements
providing a high level of
providing a high level of
protection of public interests such
protection of public interests
as health and safety in general,
such as human, animal and
protection of consumers and
plant healthand safety in
protection of the environment.
general, protection of consumers
and protection of the
3 Regulation (EC) No 765/2008
environment.
of the European Parliament and
of the Council of 9 July 2008
3 Regulation (EC) No 765/2008
setting out the requirements for
of the European Parliament and
accreditation and market
of the Council of 9 July 2008
surveillance relating to the
setting out the requirements for
marketing of products and
accreditation and market
repealing Regulation (EEC) No
surveillance relating to the
339/93 (OJ L 218, 13.8.2008, p.
marketing of products and
30).
repealing Regulation (EEC) No
339/93 (OJ L 218, 13.8.2008, p.
30).
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14.
(4) Decision No 768/2008/EC of
EC TEXT
the European Parliament and of
the Council4 lays down common
principles and reference
provisions intended to apply
across sectoral legislation in
order to provide a coherent basis
for revision or recasts of that
legislation. Regulation (EC) No
2003/2003 should therefore be
replaced by a Regulation drafted
to the extent possible in
accordance with that Decision.
4 Decision No 768/2008/EC of
the European Parliament and of
the Council of 9 July 2008 on a
common framework for the
marketing of products, and
repealing Council Decision
93/465/EEC (OJ L 218,
13.8.2008, p. 82).
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15.
(5) Contrary to most other
EC TEXT
product harmonisation measures
in Union legislation, Regulation
(EC) No 2003/2003 does not
prevent non-harmonised
fertilisers from being made
available on the internal market
in accordance with national law
and the general free movement
rules of the Treaty. In view of the
very local nature of certain
product markets, this possibility
should remain. Compliance with
harmonised rules should
therefore remain optional, and
should be required only for
products, intended to provide
plants with nutrient or improve
plants' nutrition efficiency, which
are CE marked when made
available on the market. This
Regulation should therefore not
apply to products which are not
CE marked when made available
on the market.
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16.
AM 4
No amendment
(5a) To ensure effective use of
animal manure and on-farm
compost, farmers should use
those products which follow the
spirit of "responsible
agriculture", favouring local
distribution channels, good
agronomic and environmental
practice and in compliance with
the Union environmental law,
such as the Nitrates Directive or
the Water Framework Directive.
The preferential use of
fertilisers produced on-site and
in neighbouring agricultural
undertakings should be
encouraged.

17.
(6) Different product functions
(6) Different product functions
CEU TEXT
warrant different product safety
warrant different product safety
and quality requirements adapted
and quality requirements adapted
to their different intended uses.
to their different intended uses.
CE marked fertilising products
CE marked EU fertilising
should therefore be divided into
products should therefore be
different product function
divided into different product
categories, which should each be
function categories, which should
subject to specific safety and
each be subject to specific safety
quality requirements.
and quality requirements.
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18.
AM 5
(6a) An EU fertilising product
CEU TEXT
may have more than one of the
(6a) A CE marked fertilising
functions described in the
product might have more than
product function categories of
one of the functions described in
this Regulation. Where only
the product function categories
one of those functions is
of this Regulation. Where a
claimed, it should be sufficient
claim is made in respect of only
for the product to comply with
one of those functions, it should
the requirements of the
be sufficient for the product to
product function category
comply with the requirements of
describing that claimed
the product function category
function. By contrast, where
describing that claimed
more than one of those
function. By contrast, where a
functions are claimed, the EU
claim is made in respect of more
fertilising product should be
than one of those functions, the
regarded as a blend of two or
CE marked fertilising product in
more component fertilising
question should be regarded as a
products, and compliance
combination of two or more
should be required for each of
component fertilising products,
the component fertilising
and compliance should be
products with respect to its
required for each of the
function. A specific product
component fertilising products
function category should
with respect to its function.
therefore cover such blends.
Therefore, there should be a
specific product function
category to cover such
combinations.

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19.
AM 6
(6b) A manufacturer using one
CEU TEXT
or more EU fertilising products
(6b) A manufacturer using one
that have already been subject
or more CE marked fertilising
to a conformity assessment, by
products that have already been
that manufacturer or another
subject to a conformity
manufacturer, may wish to rely
assessment, carried out by that
on that conformity assessment.
manufacturer or another
For the purpose of reducing the
manufacturer, might wish to
administrative burden to a
rely on that conformity
minimum, the resulting EU
assessment. For the purpose of
fertilising product should also
reducing the administrative
be regarded as a blend of two
burden to a minimum, the
or more component fertilising
resulting CE marked fertilising
products, and the additional
product should also be regarded
conformity requirements for
as a combination of two or more
the blend should be reduced to
component fertilising products,
the aspects warranted by the
and the additional conformity
blending.
requirements for the
combination should be reduced
to the aspects warranted by the
mixing.

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20.
(7) Similarly, different
(7) Similarly, Different
CEU TEXT
component materials warrant
component materials warrant
different process requirements
different process requirements
and control mechanisms adapted
and control mechanisms adapted
to their different potential
to their different potential
hazardousness and variability.
hazardousness and variability.
Component materials for CE
Component materials for CE
marked fertilising products
marked EU fertilising products
should therefore be divided into
should therefore be divided into
different categories, which
different categories, which
should each be subject to specific
should each be subject to specific
process requirements and control
process requirements and control
mechanisms. It should be
mechanisms. It should be
possible to make available on the
possible to make available on the
market a CE marked fertilising
market a CE marked EU
product composed of several
fertilising product composed of
component materials from
several component materials
various component material
from various component material
categories, where each material
categories, where each material
complies with the requirements
complies with the requirements
of the category to which the
of the category to which the
material belongs.
material belongs.
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21.
(8) Contaminants in CE marked
AM 7
(8) Contaminants in CE marked
(8) Contaminants in CE marked
fertilising products, such as
EU fertilising products, such as
EU fertilising products, such as
cadmium, can potentially pose a
(8) Contaminants in CE marked
cadmium, can potentially pose a
cadmium, can potentially pose a
risk to human and animal health
fertilising products, if the latter
risk to human and animal health
risk to human and animal health
and the environment as they
are not used correctly, such as
and the environment as they
and the environment to human,
accumulate in the environment
cadmium, can potentially pose a
accumulate in the environment
animal or plant health, to
and enter the food chain. Their
risk to human and animal health
and enter the food chain. Their
safety or to the environment as
content should therefore be
and the environment as they
content should therefore be
they accumulate in the
limited in such products.
accumulate in the environment
limited in such products.
environment and enter the food
Furthermore, impurities in CE
and enter the food chain. Their
Furthermore, impurities in CE
chain. Their content should
marked fertilising products
content should therefore be
marked EU fertilising products
therefore be limited in such
derived from bio-waste, in
limited in such products.
derived from bio-waste, in
products. Furthermore, impurities
particular polymers but also
Furthermore, impurities in CE
particular polymers but also
in CE marked EU fertilising
metal and glass, should be either
marked fertilising products
metal and glass, should be either
products derived from bio-waste,
prevented or limited to the extent
derived from bio-waste, in
prevented or limited to the extent
in particular polymers but also
technically feasible by detection
particular polymers but also
technically feasible by detection
metal and glass, should be either
of such impurities in separately
metal and glass, should be either
of such impurities in separately
prevented or limited to the extent
collected bio-waste before
prevented or limited to the extent
collected bio-waste before
technically feasible by detection
processing.
technically feasible by detection
processing.
of such impurities in separately
of such impurities in separately
collected bio-waste before
collected bio-waste before
processing.
processing.
14

22.
AM 8
Several Member States have in
place national provisions limiting
(8a) Member States which
the content of cadmium in
already have more stringent
phosphate fertilisers on grounds
national limit values for
relating to the protection of
cadmium in fertilisers should be
human health and of the
allowed to maintain those limit
environment. Should a Member
values until the rest of the
State deem it necessary to
Union reaches an equivalent
maintain such provisions after
level of ambition.
the adoption of harmonised limits
through this Regulation, and until
the harmonised limits are equal
to or lower than the national
limits already in place, it should
notify them to the Commission
by virtue of Article 114(4) of the
Treaty on the Functioning of the
European Union. Furthermore,
based on the provision of Article
114(5) TFEU, should a Member
State deem it necessary to
introduce new national
provisions, such as limiting the
presence of cadmium in
phosphate fertilisers, based on
new scientific evidence relating
to the protection of the
environment or the working
environment on grounds of a
problem specific to that Member
State arising after the adoption of
this Regulation, it should notify
the Commission of the envisaged
provisions as well as the grounds
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for introducing them. In either
case, the Commission should
verify according to Article
114(6) of the Treaty whether or
not the notified provisions are a
means of arbitrary
discrimination, a disguised trade
restriction or an obstacle to the
functioning of the internal
market.
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23.
AM 9
(8b) In order to facilitate the
compliance of the phosphate
(8b) In order to facilitate the
fertilising products with the
compliance of the phosphate
requirements of this Regulation
fertilising products with the
and to boost innovation,
requirements of this Regulation
sufficient incentives should be
and to boost innovation, it is
provided for the development of
necessary to provide sufficient
relevant technologies,
incentives for the development
particularly decadmiation
of relevant technologies,
technology, and for the
particularly decadmiation
management of cadmium-rich
technology, and for the
hazardous waste by means of
management of cadmium-rich
relevant financial resources such
hazardous waste by means of the
as those available under Horizon
financial resources available
Europe, the Circular Economy
under Horizon 2020, LIFE
Finance Support Platform or
programmes, the Circular
through the European Investment
Economy Finance Support
Bank (EIB). Those incentives
Platform, through the European
should target cadmium removal
Investment Bank (EIB) and
solutions that will be
other financial instruments
economically viable on an
where relevant. The
industrial scale and allow
Commission should report
appropriate treatment of the
annually to the European
waste generated.
Parliament and the Council on
the incentives and the Union
funding provided for
decadmiation.

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24.
AM 395
No amendment
(8c) As from [Publications
Office, please insert the date of
application of this Regulation]
the Commission should establish
a mechanism further facilitating
access to finance for research
and innovation into
decadmiation technologies and
their implementation in the
production process in the Union
for all phosphate fertilisers, and
into possible cadmium removal
solutions that are economically
viable on an industrial scale and
allow the treatment of the waste
generated.

25.
(9) Products complying with all
AM 10
(9) An EU fertilising product
(9) An EU fertilising product
the requirements of this
Products complying with all the
Products complying with all the
Regulation should be allowed to
(9) CE marked fertilising
requirements of this Regulation
requirements of this Regulation
move freely on the internal
products complying with all the
should be allowed to move freely
should be allowed to move freely
market. Where one or more of
requirements of this Regulation
on the internal market. Where
on the internal market. Where
the component materials in a CE
should be allowed to move freely
one or more of the component
one or more of the component
marked fertilising product falls
on the internal market. Where
materials in a CE marked EU
materials in a CE marked EU
within the scope of Regulation
one or more of the component
fertilising product falls is a
fertilising product falls is a
(EC) No 1069/2009 of the
materials is a derived product
derived product within the
derived product within the
European Parliament and of the
within the scope of Regulation
scope of Regulation (EC) No
scope of Regulation (EC) No
Council5, but reaches a point in
(EC) No 1069/2009 of the
1069/2009 of the European
1069/2009 of the European
the manufacturing chain beyond
European Parliament and of the
Parliament and of the Council ,
Parliament and of the Council5,
which it no longer poses any
Council5, but has reached a point
but has reached reaches a point
but has reached reaches a point
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significant risk to public or
in the manufacturing chain
in the manufacturing chain
in the manufacturing chain
animal health (the 'end point in
beyond which it no longer poses
beyond which it no longer poses
beyond which it no longer poses
the manufacturing chain'), it
a risk to public or animal health
any significant risk to public or
any significant risk to public or
would represent an unnecessary
(the 'end point in the
animal health (the 'end point in
animal health (the 'end point in
administrative burden to continue
manufacturing chain'), it would
the manufacturing chain'), it
the manufacturing chain'), it
subjecting the product to the
represent an unnecessary
would represent an unnecessary
would represent an unnecessary
provisions of that Regulation.
administrative burden to continue
administrative burden to continue
administrative burden to continue
Such fertilising products should
subjecting the product to the
subjecting the product to the
subjecting the product to the
therefore be excluded from the
provisions of that Regulation.
provisions of that Regulation.
provisions of that Regulation.
requirements of that Regulation.
Such fertilising products should
Such fertilising products should
Such fertilising products should
Regulation (EC) No 1069/2009
therefore be excluded from the
therefore be excluded from the
therefore be excluded from the
should therefore be amended
requirements of that Regulation.
requirements of that Regulation.
requirements of that Regulation.
accordingly.
Regulation (EC) No 1069/2009
Regulation (EC) No 1069/2009
Regulation (EC) No 1069/2009
should therefore be amended
should therefore be amended
should therefore be amended
5 Regulation (EC) No 1069/2009
accordingly.
accordingly.
accordingly.
of the European Parliament and
of the Council of 21 October
5 Regulation (EC) No 1069/2009
5 Regulation (EC) No 1069/2009
2009 laying down health rules as
of the European Parliament and
of the European Parliament and
regards animal by-products and
of the Council of 21 October
of the Council of 21 October
derived products not intended for
2009 laying down health rules as
2009 laying down health rules as
human consumption and
regards animal by-products and
regards animal by-products and
repealing Regulation (EC) No
derived products not intended for
derived products not intended for
1774/2002 (Animal by-products
human consumption and
human consumption and
Regulation) (OJ L 300,
repealing Regulation (EC) No
repealing Regulation (EC) No
14.11.2009, p. 1).
1774/2002 (Animal by-products
1774/2002 (Animal by-products
Regulation) (OJ L 300,
Regulation) (OJ L 300,
14.11.2009, p. 1).
14.11.2009, p. 1).
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26.
(9a) Recalling that certain
CEU TEXT
Member States have been
granted derogations from
Article 5 of Regulation (EC) No
2003/2003 in accordance with
the Treaties relating to
cadmium content in phosphate
fertilisers on the grounds, inter
alia, of the protection of human
health and the environment in
the context of particular soil
and climactic conditions
prevailing in those Member
States, and noting that the
factual circumstances that led
to the granting of those
derogations by the Commission
remain valid, those Member
States should be able to
continue to apply their national
limit levels for cadmium
content in EU fertilising
products until such a point that
a harmonised limit level for
cadmium content which is
equal to or lower than that
limit level is applicable at
Union level.

27.
(10) The end point in the
AM 11
(10) For each component
(10) For each component
manufacturing chain should be
material category which
material category which
determined for each relevant
includes derived products
includes derived products
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component material containing
within the meaning of
within the meaning of
(10) For each component
animal by-products in accordance
Regulation (EC) No 1069/2009,
Regulation (EC) No 1069/2009,
material category which
with the procedures laid down in
tThe end point in the
tThe end point in the
includes derived products within
Regulation (EC) No 1069/2009.
manufacturing chain should be
manufacturing chain should be
the meaning of Regulation (EC)
Where a manufacturing process
determined for each relevant
determined for each relevant
No 1069/2009, the end point in
regulated under this Regulation
component material containing
component material containing
the manufacturing chain should
starts already before that end
animal by-products in accordance
animal by-products in accordance
be determined for each relevant
point has been reached, the
with the procedures laid down in
with the procedures laid down in
component material containing
process requirements of both
that Regulation (EC) No
that Regulation (EC) No
animal by-products in accordance
Regulation (EC) No 1069/2009
1069/2009. Where such an end
1069/2009. Where such an end
with the procedures laid down in
and this Regulation should apply
point is reached before the EU
point is reached before the EU
that Regulation. To take
cumulatively to CE marked
fertilising product is placed on
fertilising product is placed on
advantage of technical
fertilising products, which means
the market but after the
the market but after the
developments, create more
application of the stricter
manufacturing process
manufacturing process
opportunities for producers and
requirement in case both
regulated under this
regulated under this
businesses, and unlock the
Regulations regulate the same
Regulation has started, a
Regulation has started, a
potential to make more use of
parameter.
manufacturing process regulated
manufacturing process regulated
nutrients from animal by-
under this Regulation starts
under this Regulation starts
products such as animal
already before that end point has
already before that end point has
manure, the setting of
been reached, the process
been reached, the process
processing methods and
requirements of both Regulation
requirements of both Regulation
recovery rules for animal by-
(EC) No 1069/2009 and this
(EC) No 1069/2009 and this
products for which an end-point
Regulation should apply
Regulation should apply
in the manufacturing chain has
cumulatively to CE marked EU
cumulatively to CE marked EU
been determined should start
fertilising products, which means
fertilising products, which means
immediately after the entry into
application of the stricter
application of the stricter
force of this Regulation. When it
requirement in case both
requirement in case both
concerns fertilising products
Regulations regulate the same
Regulations regulate the same
containing or consisting of
parameter.
parameter.
processed animal manure end-
of-livestock-manure criteria
should be defined. In order to
expand or add component

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material categories to include
more animal by-products, the
power to adopt acts in
accordance with Article 290 of
the Treaty on the Functioning of
the European Union should be
delegated to the Commission.
Where such an end point is
reached before the CE marked
fertilising product is placed on
the market but after the
manufacturing process regulated
under this Regulation has
started
, the process requirements
of both Regulation (EC) No
1069/2009 and this Regulation
should apply cumulatively to CE
marked fertilising products,
which means application of the
stricter requirement in case both
Regulations regulate the same
parameter.
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28.
AM 12
(10a) Derived products referred
to in Article 3(2) of Regulation
(10a) For animal by-products
(EC) No 1069/2009  which are
already widely used in Member
already placed on the market and
States for the production of
used in the Union as organic
fertilisers the end point should
fertilisers and soil improvers in
be determined without undue
accordance with Article 32 of
delay, and at the latest one year
that Regulation constitute
after the date of entry into force
promising raw materials for the
of this Regulation.
production of innovative
fertilisers in a circular economy.
As soon as an end-point in the
manufacturing chain has been
determined for the respective
derived product, the fertilising
products containing such derived
products in accordance with this
Regulation should be granted
free movement on the single
market without being subject to
the requirements of Regulation
(EC) No 1069/2009. For this
purpose, the European
Commission should, without
undue delay, carry out a first
assessment to check whether an
end-point in the manufacturing
chain can be determined.
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29.
(11) In the event of risks to
(11) In the event of risks to
CEU text
public or animal health from CE
public or animal health from CE
marked fertilising products
marked EU fertilising products
derived from animal by-products,
derived from animal by-products,
recourse to safeguard measures in
recourse to safeguard measures
accordance with Regulation (EC)
in accordance with Regulation
No 178/2002 of the European
(EC) No 178/2002 of the
Parliament and of the Council6
European Parliament and of the
should be possible, as is the case
Council6 should be possible, as is
for other categories of products
the case for other categories of
derived from animal by-products.
products derived from animal by-
products.
6 Regulation (EC) No 178/2002
of the European Parliament and
6 Regulation (EC) No 178/2002
of the Council of 28 January
of the European Parliament and
2002 laying down the general
of the Council of 28 January
principles and requirements of
2002 laying down the general
food law, establishing the
principles and requirements of
European Food Safety Authority
food law, establishing the
and laying down procedures in
European Food Safety Authority
matters of food safety (OJ L 31,
and laying down procedures in
1.2.2002, p. 1).
matters of food safety (OJ L 31,
1.2.2002, p. 1).
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30.
(12) Where one or more of the
AM 13
(12) The making available on
(12) The making available on
component materials for a CE
the market of an animal by-
the market of an animal by-
marked fertilising product fall
(12) The making available on
product or a derived product
product or a derived product for
within the scope of Regulation
the market of an animal by-
for which no Where one or more
which no end point in the
(EC) No 1069/2009 and has not
product or a derived product for
of the component materials for a
manufacturing chain has been
reached the end point in the
which no end point in the
CE marked fertilising product
defined, or for which the defined
manufacturing chain, it would be
manufacturing chain has been
fall within the scope of
end point has not been reached
misleading to provide for the
defined, or for which the defined
Regulation (EC) No 1069/2009
at the time of making available
product's CE marking under this
end point has not been reached
and has not reached the end point
on the market, is subject to the
Regulation, since the making
at the time of making available
in the manufacturing chain has
requirements of Regulation
available on the market of such a
on the market, is subject to the
been defined, or for which the
(EC) No 1069/2009. Therefore,
product is subject to the
requirements of Regulation
defined end point has not been
it would be misleading to provide
requirements of Regulation (EC)
(EC) No 1069/2009. Therefore,
reached at the time of making
for the product's CE marking
No 1069/2009. Therefore, such
it would be misleading to provide
available on the market, it
under this Regulation. Any
products should be excluded
for the product's CE marking
would be misleading to provide
product containing or consisting
from the scope of this
under this Regulation. Any
for the product's CE marking
of such an animal by-product or
Regulation.
product containing or consisting
under this Regulation, since the
derived products should
of such an animal by-product or
making available on the market
therefore be excluded from the
derived products should
of such a product is subject to the
scope of this Regulation.
therefore be excluded from the
requirements of Regulation (EC)
scope of this Regulation.
No 1069/2009. Therefore, it
would be misleading to provide
for the product's CE marking
under this Regulation. Any
product containing or
consisting of 
such an animal by-
product or derived 
products
should therefore be excluded
from the scope of this
Regulation.
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31.
(13) For certain recovered wastes
AM 14
(13) For certain recovered wastes
(13) For certain recovered
within the meaning of Directive
within the meaning of Directive
wastes, such as struvite, biochar,
2008/98/EC of the European
(13) For certain recovered
2008/98/EC of the European
and ash-based products, within
Parliament and of the Council7, a
wastes, such as struvite, biochar,
Parliament and of the Council7, a
the meaning of Directive
market demand for their use as
and ash-based products, within
market demand for their use as
2008/98/EC of the European
fertilising products has been
the meaning of Directive
fertilising products has been
Parliament and of the Council7, a
identified. Furthermore, certain
2008/98/EC of the European
identified. Furthermore, certain
market demand for their use as
requirements are necessary for
Parliament and of the Council7 a
requirements are necessary for
fertilising products has been
the waste used as input in the
market demand for their use as
the waste used as input in the
identified. Furthermore, certain
recovery operation and for the
fertilising products has been
recovery operation and for the
requirements are necessary for
treatment processes and
identified. Furthermore, certain
treatment processes and
the waste used as input in the
techniques, as well as for
requirements are necessary for
techniques, as well as for
recovery operation and for the
fertilising products resulting from
the waste used as input in the
fertilising products resulting from
treatment processes and
the recovery operation, in order
recovery operation and for the
the recovery operation, in order
techniques, as well as for
to ensure that the use of those
treatment processes and
to ensure that the use of those
fertilising products resulting from
products does not lead to overall
techniques, as well as for
products does not lead to overall
the recovery operation, in order
adverse environmental or human
fertilising products resulting from
adverse environmental or human
to ensure that the use of those
health impacts. For CE marked
the recovery operation, in order
health impacts. For CE marked
products does not lead to overall
fertilising products, those
to ensure that the use of those
EU fertilising products, those
adverse environmental or human
requirements should be laid down
products does not lead to overall
requirements should be laid
health impacts. For CE marked
in this Regulation. Therefore, as
adverse environmental or human
down in this Regulation.
EU fertilising products, those
of the moment of compliance
health impacts. For CE marked
Therefore, as of the moment of
requirements should be laid
with all the requirements of this
fertilising products, those
compliance with all the
down in this Regulation.
Regulation, such products should
requirements should be laid
requirements of this Regulation,
Therefore, as of the moment of
cease to be regarded as waste
down in this Regulation.
such products should cease to be
compliance with all the
within the meaning of Directive
Therefore, as of the moment of
regarded as waste within the
requirements of this Regulation,
2008/98/EC.
compliance with all the
meaning of Directive
such products should cease to be
requirements of this Regulation,
2008/98/EC.
regarded as waste within the
7 Directive 2008/98/EC of the
such products should cease to be
meaning of Directive
European Parliament and of the
regarded as waste within the
7 Directive 2008/98/EC of the
2008/98/EC , and accordingly it
Council on waste and repealing
meaning of Directive
European Parliament and of the
should be possible for products
2008/98/EC, and accordingly it
Council on waste and repealing
containing or consisting of such
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certain Directives (OJ L 312,
should be possible for products
certain Directives (OJ L 312,
recovered waste materials to
22.11.2008, p. 3).
containing or consisting of such
22.11.2008, p. 3).
access the internal market. To
recovered waste materials to
ensure legal clarity, take
access the internal market. To
advantage of technical
ensure legal clarity, take
developments, and further
advantage of technical
stimulate the incentive among
developments, and further
producers to make more use of
stimulate the incentive among
valuable waste streams, the
producers to make more use of
scientific analyses and the
valuable waste streams, the
setting of recovery requirements
scientific analyses and the
at Union level for such products
setting of recovery requirements
should start immediately after
at Union level for such products
the entry into force of this
should start immediately after
Regulation. Accordingly, the
the entry into force of this
power to adopt acts in
Regulation. Accordingly, the
accordance with Article 290 of
power to adopt acts in
the Treaty on the Functioning of
accordance with Article 290 of
the European Union should be
the Treaty on the Functioning of
delegated to the Commission in
the European Union should be
respect of defining, without
delegated to the Commission in
unnecessary delay, larger or
respect of defining, without
additional categories of
unnecessary delay, larger or
component materials eligible for
additional categories of
use in the production of EU
component materials eligible for
fertilising products.
use in the production of CE
7
marked fertilising products.
Directive 2008/98/EC of the
European Parliament and of the
7 Directive 2008/98/EC of the
Council on waste and repealing
European Parliament and of the
certain Directives (OJ L 312,
Council of 19 November 2008 on
22.11.2008, p. 3).
waste and repealing certain
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Directives (OJ L 312,
22.11.2008, p. 3).
32.
AM 15
(13a) Certain by-products, within
the meaning of Directive
(13a) Certain industry by-
2008/98/EC are currently used by
products, co-products or
manufacturers as a component of
recycled products coming from
fertilising products, or can
specific industrial processes are
expected to be used in future
currently used by manufacturers
emerging markets. For such
as a component of a CE marked
components, specific
fertilising product. For
requirements should be laid
components of CE marked
down in this Regulation, in a
fertilising products,
separate component material
requirements related to
category in Annex II.
component material categories
should be laid down in this
Regulation. If applicable, as of
the moment of compliance with
all the requirements of this
Regulation, such products
should cease to be regarded as
waste within the meaning of
Directive 2008/98/EC.

28

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33.
(14) Certain substances and
AM 16
(14) Certain substances and
(14) Certain substances and
mixtures, commonly referred to
mixtures, commonly referred to
mixtures, commonly referred to
as agronomic additives, improve
(14) Certain substances and
as inhibitors, improve the
as inhibitors, improve the
the nutrient release pattern of a
mixtures, referred to as
nutrient release pattern of a
nutrient release pattern of a
nutrient in a fertiliser. Substances
agronomic additives, improve the
nutrient in a fertiliser by
nutrient in a fertiliser by
and mixtures made available on
nutrient release pattern of a
delaying or stopping the
delaying or stopping the
the market with the intention of
nutrient in a fertiliser. Substances
activity of specific groups of
activity of specific groups of
them being added to CE marked
and mixtures made available on
micro-organisms or enzymes.
micro-organisms or enzymes.
fertilising products for that
the market with the intention of
Substances and mixtures made
Substances and mixtures made
purpose should fulfil certain
them being added to CE marked
available on the market with the
available on the market with the
efficacy criteria at the
fertilising products for that
intention of them being added to
intention of them being added to
responsibility of the
purpose should fulfil certain
CE marked fertilising products
CE marked fertilising products
manufacturer of those substances
efficacy, safety and
for that purpose should fulfil
for that purpose should fulfil
or mixtures, and should therefore
environmental criteria at the
certain efficacy criteria at the
certain efficacy, criteria at the
as such be considered as CE
responsibility of the
responsibility of the
responsibility of the
marked fertilising products under
manufacturer of those substances
manufacturer of those substances
manufacturer of those substances
this Regulation. Furthermore, CE
or mixtures, and should therefore
or mixtures, and should therefore
or mixtures, and should therefore
marked fertilising products
as such be considered as CE
as such be considered as CE
as such be considered as CE
containing such substances or
marked fertilising products under
marked EU fertilising products
marked EU fertilising products
mixtures should be subject to
this Regulation. Furthermore, CE
under this Regulation.
under this Regulation.
certain efficacy and safety
marked fertilising products
Furthermore, CE marked EU
Furthermore, CE marked EU
criteria. Such substances and
containing such substances or
fertilising products containing
fertilising products containing
mixtures should therefore also be
mixtures should be subject to
such substances or mixtures
such substances or mixtures
regulated as component materials
certain efficacysafety and
should be subject to certain
should be subject to certain
for CE marked fertilising
environmental criteria. Such
efficacy and safety criteria. Such
efficacy, safety and
products.
substances and mixtures should
substances and mixtures should
environmental criteria. Such
therefore also be regulated as
therefore also be regulated as
substances and mixtures should
component materials for CE
component materials for CE
therefore also be regulated as
marked fertilising products.
marked EU fertilising products.
component materials for CE
marked EU fertilising products.
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34.
AM 17
No amendment
(14a) As products made up of
substances and mixtures in
addition to the fertilising
elements are intended to be
added to soil and released in to
the environment, conformity
criteria should apply to all
materials in the product, in
particular where they are small
or break down into small
fragments that can be dispersed
throughout soil and into water
systems and carried to the wider
environment. Therefore
biodegradability criteria and
conformity testing should also
be under realistic in-vivo
conditions that take into
consideration differential rates
of decomposition under
anaerobic conditions, in aquatic
habitats or under water, in
waterlogged conditions or in
frozen soil.

35.
(15) Certain substances, mixtures
AM 18
(15) Certain substances, mixtures
(15) Certain substances, mixtures
and micro-organisms, commonly
and micro-organisms, commonly
and micro-organisms, referred to
referred to as plant biostimulants,
(15) Certain substances, mixtures
referred to as plant biostimulants,
as plant biostimulants, are not as
are not as such nutrients, but
and micro-organisms, referred to
are not as such nutrients, but
such inputs of nutrients, but
nevertheless stimulate plants'
as plant biostimulants, are not as
nevertheless stimulate plants'
nevertheless stimulate plants'
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nutrition processes. Where such
such inputs of nutrients, but
nutrition processes. Where such
natural nutrition processes.
products aim solely at improving
nevertheless stimulate plants'
products aim solely at improving
Where such products aim solely
the plants' nutrient use efficiency,
natural nutrition processes.
the plants' nutrient use efficiency,
at improving the plants' nutrient
tolerance to abiotic stress, or crop
Where such products aim solely
tolerance to abiotic stress, or crop
use efficiency, tolerance to
quality traits, they are by nature
at improving the plants' nutrient
quality traits, they are by nature
abiotic stress, or crop quality
more similar to fertilising
use efficiency, tolerance to
more similar to fertilising
traits, degradation of soil
products than to most categories
abiotic stress, or crop quality
products than to most categories
organic compounds, or
of plant protection products.
traits, degradation of soil
of plant protection products.
increasing the availability of
Such products should therefore
organic compounds, or
Such products should therefore
nutrients in the rhizosphere,
be eligible for CE marking under
increasing the availability of
be eligible for CE marking under
they are by nature more similar
this Regulation and excluded
nutrients in the rhizosphere,
this Regulation and excluded
to fertilising products than to
from the scope of Regulation
they are by nature more similar
from the scope of Regulation
most categories of plant
(EC) No 1107/2009 of the
to fertilising products than to
(EC) No 1107/2009 of the
protection products. They act in
European Parliament and of the
most categories of plant
European Parliament and of the
addition to fertilisers, with the
Council8. Regulation (EC) No
protection products. Therefore,
Council8. Regulation (EC) No
aim of optimising their
1107/2009 should therefore be
they act in addition to fertilisers,
1107/2009 should therefore be
efficiency and reducing the
amended accordingly.
with the aim of optimising their
amended accordingly.
nutrient application rates. Such
efficiency and reducing the
products should therefore be
8 Regulation (EC) No 1107/2009
8
nutrient application rates. Such
Regulation (EC) No 1107/2009
eligible for CE marking under
of the European Parliament and
products should therefore be
of the European Parliament and
this Regulation and excluded
of the Council of 21 October
eligible for CE marking under
of the Council of 21 October
from the scope of Regulation
2009 concerning the placing of
this Regulation and excluded
2009 concerning the placing of
(EC) No 1107/2009 of the
plant protection products on the
from the scope of Regulation
plant protection products on the
European Parliament and of the
market and repealing Council
(EC) No 1107/2009 of the
market and repealing Council
Council8. Regulation (EC) No
Directives 79/117/EEC and
European Parliament and of the
Directives 79/117/EEC and
1107/2009 should therefore be
91/414/EEC (OJ L 309,
Council8. Regulation (EC) No
91/414/EEC (OJ L 309,
amended accordingly.
24.11.2009, p. 1).
1107/2009 should therefore be
24.11.2009, p. 1).
8
amended accordingly.
Regulation (EC) No 1107/2009
of the European Parliament and
8 Regulation (EC) No 1107/2009
of the Council of 21 October
of the European Parliament and
2009 concerning the placing of
of the Council of 21 October
plant protection products on the
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14010/1/2017 REV 1
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2009 concerning the placing of
market and repealing Council
plant protection products on the
Directives 79/117/EEC and
market and repealing Council
91/414/EEC (OJ L 309,
Directives 79/117/EEC and
24.11.2009, p. 1).
91/414/EEC (OJ L 309,
24.11.2009, p. 1).
36.
AM 19
No amendment
(15a) For micro-organisms,
component material categories
should be expanded or added in
order to guarantee and enhance
the innovative potential
concerning the development and
discovery of new microbial plant
biostimulant products. In order
to stimulate innovation and to
create legal certainty for
producers concerning the
requirements which have to be
fulfilled for the use of micro-
organisms as component
materials for CE marked
fertilising products, harmonized
methods for the safety
evaluation of micro-organisms
have to be clearly identified. The
preparatory work for defining
these safety evaluation methods
should start immediately after
the entry into force of this

32

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Regulation. The power to adopt
acts in accordance with Article
290 of the Treaty should be
delegated to the Commission to
define, without any unnecessary
delay, the requirements which
producers have to comply with
when demonstrating the safety
of micro-organisms in order to
be used in CE marked fertilising
products.

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AGREEMENT
37.
(16) Products with one or more
AM 20
(16) Products with one or more
CEU text
functions, one of which is
functions, one of which is
covered by the scope of
(16) Products with one or more
covered by the scope of
Regulation (EC) No 1107/2009,
functions, one of which is
Regulation (EC) No 1107/2009,
should remain under the control
covered by the scope of
are plant protection products
tailored for such products and
Regulation (EC) No 1107/2009,
covered by the scope of that
provided for by that Regulation.
are plant protection products
Regulation. Those products
Where such products also have
covered by the scope of that
should remain under the control
the function of a fertilising
Regulation. Those products
tailored for such products and
product, it would be misleading
should remain under the control
provided for by that Regulation.
to provide for their CE marking
tailored for such products and
Where such products also have
under this Regulation, since the
provided for by that Regulation.
the function of a fertilising
making available on the market
Where such products also have
product, it would be misleading
of a plant protection product is
the function or the action of a
to provide for their CE marking
contingent on a product
fertilising product, it would be
under this Regulation, since the
authorisation valid in the
misleading to provide for their
making available on the market
Member State in question.
CE marking under this
of a plant protection product is
Therefore, such products should
Regulation, since the making
contingent on a product
be excluded from the scope of
available on the market of a plant
authorisation valid in the
this Regulation.
protection product is contingent
Member State in question.
on a product authorisation valid
Therefore, such products should
in the Member State in question.
be excluded from the scope of
Therefore, such products should
this Regulation.
be excluded from the scope of
this Regulation.
38.
(17) This Regulation should not
AM 21
(17) This Regulation should not
(17) This Regulation should not
prevent the application of
prevent the application of
prevent the application of
existing Union legislation
(17) Regardless the type of the
existing Union legislation
existing Union legislation
relating to aspects of protection
CE marked plant nutrition
relating to aspects of protection
relating to aspects of protection
of health, safety and the
product, this Regulation should
of health, safety and the
of health, safety and the
environment not covered by this
not prevent the application of
environment not covered by this
environment not covered by this
34

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COMMISSION PROPOSAL
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14010/1/2017 REV 1
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Regulation. This Regulation
existing Union legislation
Regulation. This Regulation
Regulation. This Regulation
should therefore apply without
relating to aspects of protection
should therefore apply without
should therefore apply without
prejudice to Council Directive
of health, safety and the
prejudice to Council Directive
prejudice to Council Directive
86/278/EEC9, Council Directive
environment not covered by this
86/278/EEC9, Council Directive
86/278/EEC9, Council Directive
89/391/EEC10, Regulation (EC)
Regulation. This Regulation
89/391/EEC10, Regulation (EC)
89/391/EEC10, Regulation (EC)
No 1907/2006 of the European
should therefore apply without
No 1907/2006 of the European
No 1907/2006 of the European
Parliament and of the Council11,
prejudice to Council Directive
Parliament and of the Council11,
Parliament and of the Council11,
Regulation (EC) No 1272/2008
86/278/EEC9 , Council Directive
Regulation (EC) No 1272/2008
Regulation (EC) No 1272/2008
of the European Parliament and
89/391/EEC10 , Regulation (EC)
of the European Parliament and
of the European Parliament and
of the Council12, Commission
No 1907/2006 of the European
of the Council12, Commission
of the Council12, Commission
Regulation (EC) No 1881/200613,
Parliament and of the Council11 ,
Regulation (EC) No 1881/200613,
Regulation (EC) No 1881/200613,
Council Directive 2000/29/EC14,
Regulation (EC) No 1272/2008
Council Directive 2000/29/EC14
Council Directive 2000/29/EC14
Regulation (EU) No 98/2013 of
of the European Parliament and
Regulation (EU) No 2031/2016,
Regulation (EU) No 2031/2016,
the European Parliament and of
of the Council12 , Commission
Regulation (EU) No 98/2013 of
Regulation (EU) No 98/2013 of
the Council15, and Regulation
Regulation (EC) No 1881/200613
the European Parliament and of
the European Parliament and of
(EU) No 1143/2014 of the
, Council Directive 2000/29/EC14
the Council15, and Regulation
the Council15, and Regulation
European Parliament and of the
, Regulation (EU) No 98/2013 of
(EU) No 1143/2014 of the
(EU) No 1143/2014 of the
Council16.
the European Parliament and of
European Parliament and of the
European Parliament and of the
the Council15 , Regulation (EU)
Council16, Directive
Council16, Council Directive
9 Council Directive 86/278/EEC
No 1143/2014 of the European
2004/852/EC, Directive
91/676/EEC16a, Directive
of 12 June 1986 on the protection
Parliament and of the Council16 ,
2016/2284/EC; Regulation (EC)
2000/60/EC16bRegulation
of the environment, and in
Council Directive
No. 882/2004/, and Regulation
2017/625/EC, Directive
particular of the soil, when
91/676/EEC16a, and Directive
(EC) No 834/2007.
2016/2284/EC16d, Regulation
sewage sludge is used in
2000/60/EC16b
(EC) No. 882/200416e,
agriculture (OJ L 181, 4.7.1986,
9 Council Directive 86/278/EEC
Regulation (EC) No 834/200716f
p. 6).
9 Council Directive 86/278/EEC
of 12 June 1986 on the protection
and Directive 2001/18/EC16g;
of 12 June 1986 on the protection
of the environment, and in
10 Council Directive 89/391/EEC
of the environment, and in
particular of the soil, when
9 Council Directive 86/278/EEC
of 12 June 1989 on the
particular of the soil, when
sewage sludge is used in
of 12 June 1986 on the protection
introduction of measures to
sewage sludge is used in
agriculture (OJ L 181, 4.7.1986,
of the environment, and in
encourage improvements in the
agriculture (OJ L 181, 4.7.1986,
p. 6).
particular of the soil, when
p. 6).
sewage sludge is used in
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safety and health of workers at
10
agriculture (OJ L 181, 4.7.1986,
Council Directive 89/391/EEC
10 Council Directive 89/391/EEC
work (OJ L 183, 29.6.1989, p. 1).
p. 6).
of 12 June 1989 on the
of 12 June 1989 on the
11
introduction of measures to
introduction of measures to
Regulation (EC) No 1907/2006
10 Council Directive 89/391/EEC
encourage improvements in the
encourage improvements in the
of the European Parliament and
of 12 June 1989 on the
safety and health of workers at
safety and health of workers at
of the Council of 18 December
introduction of measures to
work (OJ L 183, 29.6.1989, p. 1).
work (OJ L 183, 29.6.1989, p. 1).
2006 concerning the Registration,
encourage improvements in the
Evaluation, Authorisation and
11
safety and health of workers at
Regulation (EC) No 1907/2006
11 Regulation (EC) No 1907/2006
Restriction of Chemicals
work (OJ L 183, 29.6.1989, p. 1).
of the European Parliament and
of the European Parliament and
(REACH) (OJ L 396,
of the Council of 18 December
of the Council of 18 December
11
30.12.2006, p. 1).
Regulation (EC) No 1907/2006
2006 concerning the
2006 concerning the
of the European Parliament and
12
Registration, Evaluation,
Registration, Evaluation,
Regulation (EC) No 1272/2008
of the Council of 18 December
Authorisation and Restriction of
Authorisation and Restriction of
of the European Parliament and
2006 concerning the
Chemicals (REACH) (OJ L 396,
Chemicals (REACH) (OJ L 396,
of the Council of 16 December
Registration, Evaluation,
30.12.2006, p. 1).
30.12.2006, p. 1).
2008 on classification, labelling
Authorisation and Restriction of
and packaging of substances and
12
Chemicals (REACH) (OJ L 396,
Regulation (EC) No 1272/2008
12 Regulation (EC) No 1272/2008
mixtures (OJ L 353, 31.12.2008,
30.12.2006, p. 1).
of the European Parliament and
of the European Parliament and
p. 1).
of the Council of 16 December
of the Council of 16 December
12 Regulation (EC) No 1272/2008
13
2008 on classification, labelling
2008 on classification, labelling
Commission Regulation (EC)
of the European Parliament and
and packaging of substances and
and packaging of substances and
No 1881/2006 of 19 December
of the Council of 16 December
mixtures (OJ L 353, 31.12.2008,
mixtures (OJ L 353, 31.12.2008,
2006 setting maximum levels for
2008 on classification, labelling
p. 1).
p. 1).
certain contaminants in
and packaging of substances and
foodstuffs (OJ L 364,
13
mixtures (OJ L 353, 31.12.2008,
Commission Regulation (EC)
13 Commission Regulation (EC)
20.12.2006, p. 5).
p. 1).
No 1881/2006 of 19 December
No 1881/2006 of 19 December
14
2006 setting maximum levels for
2006 setting maximum levels for
Council Directive 2000/29/EC
13 Commission Regulation (EC)
certain contaminants in
certain contaminants in
of 8 May 2000 on protective
No 1881/2006 of 19 December
foodstuffs (OJ L 364,
foodstuffs (OJ L 364,
measures against the introduction
2006 setting maximum levels for
20.12.2006, p. 5).
20.12.2006, p. 5).
into the Community of organisms
certain contaminants in
harmful to plants or plant
products and against their spread
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within the Community (OJ L
14
foodstuffs (OJ L 364,
Council Directive 2000/29/EC
14 Council Directive 2000/29/EC
169, 10.7.2000, p. 1).
20.12.2006, p. 5).
of 8 May 2000 on protective
of 8 May 2000 on protective
15
measures against the introduction
measures against the introduction
Regulation (EU) No 98/2013
14 Council Directive 2000/29/EC
into the Community of organisms
into the Community of organisms
of the European Parliament and
of 8 May 2000 on protective
harmful to plants or plant
harmful to plants or plant
of the Council of 15 January
measures against the introduction
products and against their spread
products and against their spread
2013 on the marketing and use of
into the Community of organisms
within the Community (OJ L
within the Community (OJ L
explosives precursors (OJ L 39,
harmful to plants or plant
169, 10.7.2000, p. 1).
169, 10.7.2000, p. 1).
9.2.2013, p. 1).
products and against their spread
15
15
within the Community (OJ L
16
Regulation (EU) No 98/2013
Regulation (EU) No 98/2013
Regulation (EU) No 1143/2014
169, 10.7.2000, p. 1).
of the European Parliament and
of the European Parliament and
of the European Parliament and
of the Council of 15 January
of the Council of 15 January
of the Council of 22 October
15 Regulation (EU) No 98/2013
2013 on the marketing and use of
2013 on the marketing and use of
2014 on the prevention and
of the European Parliament and
explosives precursors (OJ L 39,
explosives precursors (OJ L 39,
management of the introduction
of the Council of 15 January
9.2.2013, p. 1).
9.2.2013, p. 1).
and spread of invasive alien
2013 on the marketing and use of
species (OJ L 317, 4.11.2014, p.
16
explosives precursors (OJ L 39,
Regulation (EU) No
16 Regulation (EU) No
35).
9.2.2013, p. 1).
1143/2014 of the European
1143/2014 of the European
Parliament and of the Council of
Parliament and of the Council of
16 Regulation (EU) No
22 October 2014 on the
22 October 2014 on the
1143/2014 of the European
prevention and management of
prevention and management of
Parliament and of the Council of
the introduction and spread of
the introduction and spread of
22 October 2014 on the
invasive alien species (OJ L 317,
invasive alien species (OJ L 317,
prevention and management of
4.11.2014, p. 35).
4.11.2014, p. 35).
the introduction and spread of
16a
invasive alien species (OJ L 317,
Council Directive 91/676/EEC
4.11.2014, p. 35).
of 12 December 1991
concerning the protection of

16aCouncil Directive 91/676/EEC
waters against pollution caused
of 12 December 1991
by nitrates from agricultural
concerning the protection of
sources (OJ L 375, 31.12.1991,
waters against pollution caused
p.1).
by nitrates from agricultural
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16b
sources (OJ L 375, 31.12.1991,
Directive 2000/60/EC of the
p.1).
European Parliament and of the
Council of 23 October 2000

16b Directive 2000/60/EC of the
establishing a framework for
European Parliament and of the
Community action in the field of
Council of 23 October 2000
water policy (OJ L 327,
establishing a framework for
22.12.2000, p. 1)
Community action in the field of
water policy (OJ L 327,
22.12.2000, p. 1).

16d Directive (EU) 2016/2284 of
the European Parliament and of
the Council of 14 December
2016 on the reduction of national
emissions of certain atmospheric
pollutants, amending Directive
2003/35/EC and repealing
Directive 2001/81/EC (OJ L 344,
17.12.2016, p. 1–31).
16e Regulation (EC) No 882/2004
of the European Parliament and
of the Council of 29 April 2004
on official controls performed to
ensure the verification of
compliance with feed and food
law, animal health and animal
welfare rules (OJ L 165,
30.4.2004, p. 1–141).
16f Council Regulation (EC) No
834/2007 of 28 June 2007 on
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organic production and labelling
of organic products and repealing
Regulation (EEC) No 2092/91
(OJ L 189, 20.7.2007, p. 1–23).
16g Directive 2001/18/EC of the
European Parliament and of the
Council of 12 March 2001 on the
deliberate release into the
environment of genetically
modified organisms and
repealing Council Directive
90/220/EEC - Commission
Declaration (OJ L 106,
17.4.2001, p. 1–39).
39.
AM 22
No amendment
(17a) The traceability of
products which are vulnerable
to organic pollution from
certain potentially problematic
sources (or perceived as such)
back to the source of the organic
material should be ensured. This
is necessary in order to secure
consumer confidence and to
limit damage if local
contamination occurs. As a
result, businesses which use
fertilising products containing
organic material from these
sources may be identified. This

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should be compulsory for
products containing material
from waste or from by-products
which have not undergone any
processing that destroys organic
pollutants, pathogens and
genetic material. The aim is not
only to reduce risks to health
and the environment but also to
reassure public opinion and
cater for the concerns of
farmers regarding pathogens,
organic pollutants and genetic
material. In order to protect
land owners against pollution
for which they themselves are
not to blame, Member States are
called upon to establish
appropriate liability rules.

40.
AM 23
(17b) Untreated animal by-
products of animal production

(17b) Untreated by-products of
should not be subject to this
animal production should not be
Regulation;
subject to this Regulation.
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40a
(17c) In line with common
practice, nitrogen (N),
phosphorus (P) and potassium
(K) should be referred to as
primary macronutrients, and
calcium (Ca) magnesium (Mg),
sodium (Na) and sulphur (S)
should be referred to as
secondary macronutrients. Also
in line with common practice,
fertilisers should be referred to as
straight when they contain either
only one macronutrient –
regardless whether it is primary
or secondary – or only one
primary macronutrient in
combination with one or more
secondary macronutrient. In line
with the same practice, fertilisers
should be referred to as
compound when they contain
either more than one primary
macronutrient – regardless
whether they also contain one or
more secondary macronutrients –
or contain no primary
macronutrient but more than one
secondary macronutrient.
41

41.
(18) Where a CE marked
(18) Where a CE marked EU
(18) Where a CE marked EU
fertilising product contains a
fertilising product contains a
fertilising product contains a
substance or mixture within the
substance or mixture within the
substance or mixture within the
meaning of Regulation (EC) No
meaning of Regulation (EC) No
meaning of Regulation (EC) No
1907/2006, the safety of its
1907/2006, the safety of its
1907/2006, the safety of its
constituent substances for the
constituent substances for the
constituent substances for the
intended use should be
intended use should be
intended use should be
established through registration
established through registration
established through registration
pursuant to that Regulation. The
pursuant to that Regulation. The
pursuant to that Regulation. The
information requirements should
information requirements should
information requirements should
ensure that the safety of the
ensure that the safety of the
ensure that the safety of the
intended use of the CE marked
intended use of the CE marked
intended use of the CE marked
fertilising product is
EU fertilising product is
EU fertilising product is
demonstrated in a manner
demonstrated in a manner
demonstrated in a manner
comparable to that achieved
comparable to that achieved
comparable to that achieved
through other regulatory regimes
through other regulatory regimes
through other regulatory regimes
for products intended for use on
for products intended for use on
for products intended for use on
arable soil or crops, notably
arable soil or crops, notably
arable soil or crops, notably
Member States' national fertiliser
Member States' national fertiliser
Member States' national fertiliser
legislation and Regulation (EC)
legislation and Regulation (EC)
legislation and Regulation (EC)
No 1107/2009. Therefore, where
No 1107/2009. Therefore, where
No 1107/2009. Therefore, where
the actual quantities placed on
the actual quantities placed on
the actual quantities placed on
the market are lower than 10
the market are lower than 10
the market are lower than 10
tonnes per company per year, the
tonnes per company per year, the
tonnes per company per year, the
information requirements
information requirements
information requirements
determined by Regulation (EC)
determined by Regulation (EC)
determined by Regulation (EC)
No 1907/2006 for the registration
No 1907/2006 for the registration
No 1907/2006 for the registration
of substances in quantities of 10
of substances in quantities of 10
of substances in quantities of 10
to 100 tonnes should
to 100 tonnes should
to 100 tonnes should
exceptionally apply as a
exceptionally apply as a
exceptionally apply as a
condition for making available
condition for use in EU
condition for use in EU
pursuant to this Regulation.
fertilising products making
fertilising products making
available pursuant to this
Regulation. Those information
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available pursuant to this
requirements should apply to
Regulation.
the actual substances contained
in the CE marked fertilising
product, as opposed to the
precursors used for the
manufacturing of those
substances. The precursors
themselves, such as sulphuric
acid used as a precursor for the
production of single
superphosphate (SSP), should
not be regulated as component
materials for the purpose of
this Regulation, since chemical
safety will be better ensured by
regulating as component
materials the substances
formed from the precursors
and actually contained in the
fertilising product. The
obligation to comply with all
the requirements of a
component material category

(‘CMC’) should therefore
apply to those substances.

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42.
(19) Where the actual quantities
(19) Where the actual quantities
CEU text
of substances in CE marked
of substances in CE marked EU
fertilising products regulated by
fertilising products regulated by
this Regulation are higher than
this Regulation are higher than
100 tonnes, the additional
100 tonnes, the additional
information requirements laid
information requirements laid
down in Regulation (EC) No
down in Regulation (EC) No
1907/2006 should apply directly
1907/2006 should apply directly
by virtue of that Regulation. The
by virtue of that Regulation. The
application of the other
application of the other
provisions of Regulation (EC) No
provisions of Regulation (EC)
1907/2006 should also remain
No 1907/2006 should also
unaffected by this Regulation.
remain unaffected by this
Regulation.
43.
AM 24
No amendment
(19a) In line with the circular
economy, certain industry by-
products or co-products from
specific industrial processes are
already used by manufacturers
as components of CE marked
fertilising products.
Requirements related to such
component material categories
should be laid down in Annex
II.

44

44.
(20) A blend of different CE
AM 25
deleted
CEU text
marked fertilising products, each
of which has been subject to a
(20) A combination of products
successful assessment of
from different product function
conformity with the applicable
categories, each of which has
requirements for that material,
been subject to a successful
can itself be expected to be
assessment of conformity with
suitable for use as a CE marked
the applicable requirements for
fertilising product, subject only
that material, can itself be
to certain additional requirements
expected to be suitable for use as
warranted by the blending.
a CE marked fertilising product,
Therefore, in order to avoid an
subject only to certain additional
unnecessary administrative
requirements warranted by the
burden, such blends should
mixing. Therefore, in order to
belong to a separate category, for
avoid an unnecessary
which the conformity assessment
administrative burden, such
should be limited to the
combinations should belong to a
additional requirements
separate category, for which the
warranted by the blending.
conformity assessment should be
limited to the additional
requirements warranted by the
mixing.
(This amendment also covers a
horizontal amendment on the

term “blend” (in plural or
singular) being changed to

“combination” (in plural or
singular); adopting it will
necessitate corresponding
changes of these terms
throughout the text and,
consequently, adopted
amendments.)

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45.
(21) Economic operators should
(21) Economic operators should
(21) Economic operators should
be responsible for the compliance
be responsible for the compliance
be responsible for the compliance
of CE marked fertilising products
of CE marked EU fertilising
of CE marked EU fertilising
with this Regulation, in relation
products with this Regulation, in
products with this Regulation, in
to their respective roles in the
relation to their respective roles
relation to their respective roles
supply chain, so as to ensure a
in the supply chain, so as to
in the supply chain, so as to
high level of protection of the
ensure a high level of protection
ensure a high level of protection
aspects of public interest covered
of the aspects of public interest
of the aspects of public interest
by this Regulation, and also to
covered by this Regulation, and
covered by this Regulation, and
guarantee fair competition on the
also to guarantee fair competition
also to guarantee fair competition
internal market.
on the internal market.
on the internal market.
Whenever appropriate,
manufacturers and importers
should carry out sample testing
of EU fertilising products they
made available on the market,
in order to protect the health
and safety of consumers and the
environment
.
46.
(22) It is necessary to provide for
EC TEXT
a clear and proportionate
distribution of obligations which
correspond to the role of each
economic operator in the supply
and distribution chain.
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47.
(23) The manufacturer, having
(23) The manufacturer, having
CEU text
detailed knowledge of the design
detailed knowledge of the design
and production process, is best
and production process, is best
placed to carry out the
placed to carry out the
conformity assessment
conformity assessment
procedure. Conformity
procedure. Conformity
assessment of CE marked
assessment of CE marked EU
fertilising products should
fertilising products should
therefore remain solely the
therefore remain solely the
obligation of the manufacturer.
obligation of the manufacturer.
47

48.
(24) It is necessary to ensure that
(24) It is necessary to ensure that
(24) It is necessary to ensure that
CE marked fertilising products
CE marked EU fertilising
CE marked EU fertilising
from third countries that enter the
products from third countries that
products from third countries that
internal market comply with this
enter the internal market comply
enter the internal market comply
Regulation, and in particular that
with this Regulation, and in
with this Regulation, and in
the appropriate conformity
particular that the appropriate
particular that the appropriate
assessment procedures have been
conformity assessment
conformity assessment
carried out by manufacturers with
procedures have been carried out
procedures have been carried out
regard to those fertilising
by manufacturers with regard to
by manufacturers with regard to
products. Provision should
those fertilising products.
those fertilising products.
therefore be made for importers
Provision should therefore be
Provision should therefore be
to make sure that CE marked
made for importers to make sure
made for importers to make sure
fertilising products which they
that CE marked EU fertilising
that CE marked EU fertilising
place on the market comply with
products which they place on the
products which they place on the
the requirements of this
market comply with the
market comply with the
Regulation and that they do not
requirements of this Regulation
requirements of this Regulation
place on the market CE marked
and that they do not place on the
and that they do not place on the
fertilising products which do not
market CE marked EU fertilising
market CE marked EU fertilising
comply with such requirements
products which do not comply
products which do not comply
or present a risk to human,
with such requirements or
with such requirements or
animal or plant health, safety or
present a risk to human, animal
present a risk to human, animal
the environment. Provision
or plant health, safety or the
or plant health, safety or the
should also be made for such
environment. Provision should
environment. Provision should
importers to make sure that
also be made for such importers
also be made for such importers
conformity assessment
to make sure that conformity
to make sure that conformity
procedures have been carried out
assessment procedures have been
assessment procedures have been
and that marking of CE marked
carried out and that marking of
carried out and that marking of
fertilising products and
CE marked EU fertilising
CE marked EU fertilising
documentation drawn up by
products and documentation
products and documentation
manufacturers are available for
drawn up by manufacturers are
drawn up by manufacturers are
inspection by the competent
available for inspection by the
available for inspection by the
national authorities.
competent national authorities.
competent national authorities.
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49.
(25) When placing a CE marked
AM 26
(25) When placing a CE marked
CEU text
fertilising product on the market,
EU fertilising product on the
the importer should indicate on
(25) When placing a CE marked
market, the importer should
the packaging of the fertilising
product on the market, the
indicate on the packaging of the
product his or her name,
importer should indicate on the
fertilising product his or her
registered trade name or
packaging of the product his or
name, registered trade name or
registered trade mark and the
her name, registered trade name
registered trade mark and the
postal address at which he or she
or registered trade mark and the
postal address at which he or she
can be contacted, in order to
postal address at which he or she
can be contacted, in order to
enable market surveillance.
can be contacted, as well as the
enable market surveillance.
third-country manufacturer, in
order to enable market
surveillance.
50.
(26) Since the distributor makes a
(26) Since the distributor makes a
CEU text
CE marked fertilising product
CE marked EU fertilising
available on the market after it
product available on the market
has been placed on the market by
after it has been placed on the
the manufacturer or the importer,
market by the manufacturer or
he or she should act with due
the importer, he or she should act
care to ensure that his or her
with due care to ensure that his or
handling of the fertilising product
her handling of the fertilising
does not adversely affect the
product does not adversely affect
compliance of that product with
the compliance of that product
this Regulation.
with this Regulation.
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51.
(27) An economic operator who
(27) An economic operator who
CEU text
either places a CE marked
either places a CE marked EU
fertilising product on the market
fertilising product on the market
under his or her own name or
under his or her own name or
trade mark or modifies a CE
trade mark or modifies a CE
marked fertilising product in such
marked EU fertilising product in
a way that compliance with the
such a way that compliance with
provisions of this Regulation may
the provisions of this Regulation
be affected should be considered
may be affected should be
to be the manufacturer and
considered to be the
should assume the obligations of
manufacturer and should assume
the manufacturer.
the obligations of the
manufacturer. In other cases,
economic operators who only
package or repackage EU
fertilising products already
placed on the market by other
economic operators should be
able to prove that compliance
with the requirements set by
this Regulation have not been
affected, by indicating their
identity on the package and
keep a copy of the original
labelling information.

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52.
(28) Since distributors and
(28) Since distributors and
CEU text
importers are close to the market
importers are close to the market
place, they should be involved in
place, they should be involved in
market surveillance tasks carried
market surveillance tasks carried
out by competent national
out by competent national
authorities, and should be
authorities, and should be
required to participate actively
required to participate actively
and provide those authorities
and provide those authorities
with all necessary information
with all necessary information
relating to the CE marked
relating to the CE marked EU
fertilising product.
fertilising product.
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53.
(29) Ensuring traceability of a
(29) Ensuring traceability of a
CEU text
CE marked fertilising product
CE marked EU fertilising
throughout the whole supply
product throughout the whole
chain helps to make market
supply chain helps to make
surveillance simpler and more
market surveillance simpler and
efficient. An efficient traceability
more efficient. An efficient
system facilitates market
traceability system facilitates
surveillance authorities’ task of
market surveillance authorities’
tracing economic operators who
task of tracing economic
made non-compliant CE marked
operators who made non-
fertilising products available on
compliant CE marked EU
the market. When keeping the
fertilising products available on
information required for the
the market. When keeping the
identification of other economic
information required for the
operators, economic operators
identification of other economic
should not be required to update
operators, economic operators
such information in respect of
should not be required to update
other economic operators who
such information in respect of
have either supplied them with a
other economic operators who
CE marked fertilising product or
have either supplied them with a
to whom they have supplied a CE
CE marked EU fertilising
marked fertilising product, since
product or to whom they have
such updated information is
supplied a CE marked EU
normally not available to them.
fertilising product, since such
updated information is normally
not available to them.
52

54.
(30) In order to facilitate the
(30) In order to facilitate the
CEU text
assessment of conformity with
assessment of conformity with
safety and quality requirements it
safety and quality the
is necessary to provide for a
requirements of this Regulation
presumption of conformity for
it is necessary to provide for a
CE marked fertilising products
presumption of conformity for
which are in conformity with
CE marked EU fertilising
harmonised standards that are
products which are in conformity
adopted in accordance with
with harmonised standards that
Regulation (EU) No 1025/2012
are adopted in accordance with
of the European Parliament and
Regulation (EU) No 1025/2012
of the Council17.
of the European Parliament and
of the Council17.
17 Regulation (EU) No 1025/2012
of the European Parliament and
17 Regulation (EU) No
of the Council of 25 October
1025/2012 of the European
2012 on European
Parliament and of the Council of
standardisation, amending
25 October 2012 on European
Council Directives 89/686/EEC
standardisation, amending
and 93/15/EEC and Directives
Council Directives 89/686/EEC
94/9/EC, 94/25/EC, 95/16/EC,
and 93/15/EEC and Directives
97/23/EC, 98/34/EC,
94/9/EC, 94/25/EC, 95/16/EC,
2004/22/EC, 2007/23/EC,
97/23/EC, 98/34/EC,
2009/23/EC and 2009/105/EC of
2004/22/EC, 2007/23/EC,
the European Parliament and of
2009/23/EC and 2009/105/EC of
the Council and repealing
the European Parliament and of
Council Decision 87/95/EEC and
the Council and repealing
Decision No 1673/2006/EC of
Council Decision 87/95/EEC and
the European Parliament and of
Decision No 1673/2006/EC of
the Council (OJ L 316,
the European Parliament and of
14.11.2012, p. 12).
the Council (OJ L 316,
14.11.2012, p. 12).
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(31) Where harmonised standards
AM 27
(31) Where harmonised standards
(31) Where harmonised standards
have not been adopted, or do not
have not been adopted, or do not
have not been adopted, or do not
with sufficient detail cover all
(31) Where harmonised standards
with sufficient detail cover all
satisfy with sufficient detail
elements of the quality and safety
have not been adopted, or do not
elements of the quality and
cover all elements of the quality
requirements laid down in this
with sufficient detail cover all
satisfy the safety requirements
and safety the requirements laid
Regulation, uniform conditions
elements of the quality and safety
laid down in of this Regulation,
down in of this Regulation, or
for implementing those
requirements laid down in this
which they aim to cover,
where there are undue delays
requirements may be needed. The
Regulation, and where there are
uniform conditions for
in the process of adopting or
Commission should therefore be
undue delays in the process of
implementing those requirements
updating of these standards,
empowered to adopt
adopting or updating standards
may be needed. The Commission
uniform conditions for
implementing acts setting out
to reflect those requirements,
should therefore be empowered
implementing those requirements
those conditions in common
interim measures may be needed
to adopt implementing acts
may be needed. The Commission
specifications. For reasons of
to lay down uniform conditions
setting out those conditions in
should therefore be empowered
legal certainty, it should be
for implementing those
common specifications. For
to adopt implementing acts
clarified that CE marked
requirements. The Commission
reasons of legal certainty, it
setting out those conditions in
fertilising products must comply
should therefore be empowered
should be clarified that CE
common specifications. For
with such specifications even if
to adopt implementing acts
marked fertilising products must
reasons of legal certainty, it
they are considered to be in
setting out those conditions in
comply with such specifications
should be clarified that CE
conformity with harmonised
common specifications. For
even if they are considered to be
marked fertilising products must
standards.
reasons of legal certainty, it
in conformity with harmonised
comply with such specifications
should be clarified that CE
standards.
even if they are considered to be
marked fertilising products must
in conformity with harmonised
comply with such specifications
standards.
even if they are considered to be
in conformity with harmonised
standards.
54

56.
(32) In order to enable the
(32) In order to enable the
CEU text
economic operators to
economic operators to
demonstrate and the competent
demonstrate and the competent
authorities to verify that CE
authorities to verify that CE
marked fertilising products made
marked EU fertilising products
available on the market comply
made available on the market
with the requirements, it is
comply with the requirements, it
necessary to provide for
is necessary to provide for
conformity assessment
conformity assessment
procedures. Decision No
procedures. Decision No
768/2008/EC establishes modules
768/2008/EC establishes
for conformity assessment
modules for conformity
procedures, from the least to the
assessment procedures, from the
most stringent, in proportion to
least to the most stringent, in
the level of risk involved and the
proportion to the level of risk
level of safety required. In order
involved and the level of safety
to ensure inter-sectoral coherence
required. In order to ensure inter-
and to avoid ad-hoc variants,
sectoral coherence and to avoid
conformity assessment
ad-hoc variants, conformity
procedures should be chosen
assessment procedures should be
from among those modules.
chosen from among those
However, it is necessary to adapt
modules. It should be possible
those modules in order to reflect
for a manufacturer to choose a
specific aspects of fertilising
more stringent conformity
products. In particular, it is
assessment procedure for the
necessary to reinforce the quality
assessment of a product eligible
systems and the involvement of
for a less stringent procedure,
notified bodies for the conformity
since that possibility can allow
assessment of certain CE marked
the manufacturer to streamline
fertilising products derived from
his or her administration
recovered waste.
without jeopardising the
product's conformity. 
However,
Furthermore, it is necessary to
adapt the those modules
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established by Decision
No 786/2008/EC 
in order to
reflect specific aspects of
fertilising products. In particular,
it is necessary to reinforce the
quality systems and the
involvement of notified bodies
for the conformity assessment of
certain CE marked EU fertilising
products derived from recovered
waste.
57.
(33) In order to ensure that CE
EC text
marked ammonium nitrate
fertilisers of high nitrogen
content do not endanger safety,
and that such fertilisers are not
used for purposes other than
those for which they are
intended, for example as
explosives, such fertilisers should
be subject to specific
requirements relating to
detonation resistance testing and
to traceability.
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58.
(34) To ensure effective access to
(34) To ensure effective access to
CEU text
information for market
information for market
surveillance purposes,
surveillance purposes,
information regarding conformity
information regarding conformity
with all Union acts applicable to
with all Union acts applicable to
CE marked fertilising products
CE marked EU fertilising
should be given in the form of a
products should be given in the
single EU declaration of
form of a single EU declaration
conformity. In order to reduce the
of conformity. In order to reduce
administrative burden on
the administrative burden on
economic operators, that single
economic operators, that single
EU declaration of conformity
EU declaration of conformity
may be a dossier made up of
may be a dossier made up of
relevant individual declarations
relevant individual declarations
of conformity.
of conformity.
59.
(35) The CE marking, indicating
EC text
the conformity of a fertilising
product, is the visible
consequence of a whole process
comprising conformity
assessment in a broad sense.
General principles governing the
CE marking and its relationship
to other markings are set out in
Regulation (EC) No 765/2008.
Specific rules governing the
affixing of the CE marking in the
case of fertilising products should
be laid down.
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60.
(36) Certain conformity
EC text
assessment procedures set out in
this Regulation require the
intervention of conformity
assessment bodies, which are
notified by the Member States to
the Commission.
61.
(37) It is essential that all notified
EC text
bodies perform their functions to
the same level and under
conditions of fair competition.
That requires the setting of
obligatory requirements for
conformity assessment bodies
wishing to be notified in order to
provide conformity assessment
services.
62.
(38) If a conformity assessment
EC text
body demonstrates conformity
with the criteria laid down in
harmonised standards it should
be presumed to comply with the
corresponding requirements set
out in this Regulation.
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63.
(39) In order to ensure a
(39) In order to ensure a
CEU text
consistent level of quality in the
consistent level of quality in the
performance of conformity
performance of conformity
assessment of CE marked
assessment of CE marked EU
fertilising products, it is also
fertilising products, it is also
necessary to set requirements for
necessary to set requirements for
notifying authorities and other
notifying authorities and other
bodies involved in the
bodies involved in the
assessment, notification and
assessment, notification and
monitoring of notified bodies.
monitoring of notified bodies.
64.
(40) The system set out in this
EC text
Regulation should be
complemented by the
accreditation system provided for
in Regulation (EC) No 765/2008.
Since accreditation is an essential
means of verifying the
competence of conformity
assessment bodies, it should also
be used for the purposes of
notification.
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65.
(41) Due to the variable nature of
(41) Due to the variable nature of
CEU text
certain fertilising product
certain fertilising product
component materials, and the
component materials, and the
potentially irreversible nature of
potentially irreversible nature of
some of the damages to which
some of the damages to which
soil and crop exposure to
soil and crop exposure to
impurities could lead, transparent
impurities could lead, transparent
accreditation as provided for in
accreditation as provided for in
Regulation (EC) No 765/2008,
Regulation (EC) No 765/2008,
ensuring the necessary level of
ensuring the necessary level of
confidence in certificates of
confidence in certificates of
conformity of CE marked
conformity of CE marked EU
fertilising products containing
fertilising products containing
such components, should be the
such components, should be the
only means of demonstrating the
only means of demonstrating the
technical competence of
technical competence of
conformity assessment bodies.
conformity assessment bodies.
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66.
(42) Conformity assessment
(42) Conformity assessment
CEU text
bodies frequently subcontract
bodies frequently subcontract
parts of their activities linked to
parts of their activities linked to
the assessment of conformity or
the assessment of conformity or
have recourse to a subsidiary. In
have recourse to a subsidiary. In
order to safeguard the level of
order to safeguard the level of
protection required for CE
protection required for CE
marked fertilising products to be
marked EU fertilising products to
placed on the market, it is
be placed on the market, it is
essential that conformity
essential that conformity
assessment subcontractors and
assessment subcontractors and
subsidiaries fulfil the same
subsidiaries fulfil the same
requirements as notified bodies in
requirements as notified bodies
relation to the performance of
in relation to the performance of
conformity assessment tasks.
conformity assessment tasks.
Therefore, it is important that the
Therefore, it is important that the
assessment of the competence
assessment of the competence
and the performance of bodies to
and the performance of bodies to
be notified and the monitoring of
be notified and the monitoring of
bodies already notified cover also
bodies already notified cover also
activities carried out by
activities carried out by
subcontractors and subsidiaries.
subcontractors and subsidiaries.
67.
(43) It is necessary to provide for
EC TEXT
an efficient and transparent
notification procedure and, in
particular, to adapt it to new
technologies so as to enable
online notification.
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68.
(44) Since the services offered by
(44) Since the services offered by
CEU text
notified bodies may relate to CE
notified bodies may relate to CE
marked fertilising products made
marked EU fertilising products
available on the market
made available on the market
throughout the Union, it is
throughout the Union, it is
appropriate to give the other
appropriate to give the other
Member States and the
Member States and the
Commission the opportunity to
Commission the opportunity to
raise objections concerning a
raise objections concerning a
notified body. It is therefore
notified body. It is therefore
important to provide for a period
important to provide for a period
during which any doubts or
during which any doubts or
concerns as to the competence of
concerns as to the competence of
conformity assessment bodies
conformity assessment bodies
can be clarified before they start
can be clarified before they start
operating as notified bodies.
operating as notified bodies.
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69.
(45) In the interest of easing
EC text
market access, it is crucial that
notified bodies apply the
conformity assessment
procedures without creating
unnecessary burdens for
economic operators. For the same
reason, and to ensure equal
treatment of economic operators,
consistency in the technical
application of the conformity
assessment procedures needs to
be ensured. That can best be
achieved through appropriate
coordination and cooperation
between notified bodies.
70.
(46) In order to ensure legal
(46) In order to ensure legal
CEU text
certainty, it is necessary to clarify
certainty, it is necessary to clarify
that rules on internal market
that rules on internal market
surveillance and control of
surveillance and control of
products entering the internal
products entering the internal
market provided for in
market provided for in
Regulation (EC) No 765/2008
Regulation (EC) No 765/2008
apply to CE marked fertilising
apply to CE marked EU
products covered by this
fertilising products covered by
Regulation. This Regulation
this Regulation. This Regulation
should not prevent Member
should not prevent Member
States from choosing the
States from choosing the
competent authorities to carry out
competent authorities to carry out
those tasks.
those tasks.
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71.
(47) CE-marked fertilising
AM 28
(47) CE-marked EU fertilising
(47) CE-marked EU fertilising
products should be placed on the
products should be placed on the
products should be placed on the
market only if they are
(47) CE-marked fertilising
market only if they are
market only if they are
sufficiently effective and do not
products should be placed on the
sufficiently effective and do not
sufficiently effective and do not
present unacceptable risks to
market only if they are
present unacceptable risks to
present unacceptable a risks to
human, animal or plant health, to
sufficiently effective and do not
human, animal or plant health, to
human, animal or plant health,
safety or to the environment
present a risk to human, animal
safety or to the environment
to safety or to the environment
when properly stored and used
or plant health, to safety or to the
when properly stored and used
when properly stored and used
for their intended purpose, and
environment when properly
for their intended purpose, and
for their intended purpose, and
under conditions of use which
stored and used for their intended
under conditions of use which
under conditions of use which
can be reasonably foreseen, that
purpose, and under conditions of
can be reasonably foreseen, that
can be reasonably foreseen, that
is when such use could result
use which can be reasonably
is when such use could result
is when such use could result
from lawful and readily
foreseen, that is when such use
from lawful and readily
from lawful and readily
predictable human behaviour.
could result from lawful and
predictable human behaviour.
predictable human behaviour.
Therefore, requirements for
readily predictable human
Therefore, requirements for
Therefore, requirements for
safety and quality, as well as
behaviour. Therefore,
safety and quality, as well as
safety and quality, as well as
appropriate control mechanisms,
requirements for safety and
appropriate control mechanisms,
appropriate control mechanisms,
should be established.
quality, as well as appropriate
should be established.
should be established.
Furthermore, the intended use of
control mechanisms, should be
Furthermore, the intended use of
Furthermore, the intended use of
CE marked fertilising products
established. Furthermore, the
CE marked fertilising products
CE marked fertilising products
should not lead to food or feed
intended use of CE marked
should not lead to food or feed
should not lead to food or feed
becoming unsafe.
fertilising products should not
becoming unsafe.
becoming unsafe.
lead to food or feed becoming
unsafe.
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72.
(48) Regulation (EC) No
EC text
2003/2003 provides for a
safeguard procedure allowing the
Commission to examine the
justification for a measure taken
by a Member State against EC
fertilisers considered to constitute
a risk. In order to increase
transparency and to reduce
processing time, it is necessary to
improve the existing safeguard
procedure, with the view to
making it more efficient and
drawing on the expertise
available in Member States.
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73.
(49) The existing system should
AM 29
(49) The existing system should
(49) The existing system should
be supplemented by a procedure
be supplemented by a procedure
be supplemented by a procedure
under which interested parties are
(49) The existing system should
under which interested parties are
under which interested parties are
informed of measures intended to
be supplemented by a procedure
informed of measures intended to
informed of measures intended to
be taken with regard to CE
under which all interested
be taken with regard to CE
be taken with regard to CE
marked fertilising products
parties, including health and
marked EU fertilising products
marked EU fertilising products
presenting an unacceptable risk
consumers stakeholders, are
presenting an unacceptable risk
presenting an unacceptable risk
to human, animal or plant health,
informed of measures intended to
to human, animal or plant health,
to human, animal or plant
to safety or to the environment. It
be taken with regard to CE
to safety or to the environment. It
health, to safety or to the
should also allow market
marked fertilising products
should also allow market
environment. It should also
surveillance authorities, in
presenting risk to human,
surveillance authorities, in
allow market surveillance
cooperation with the relevant
animal or plant health, to safety
cooperation with the relevant
authorities, in cooperation with
economic operators, to act at an
or to the environment. It should
economic operators, to act at an
the relevant economic operators,
early stage in respect of such
also allow market surveillance
early stage in respect of such
to act at an early stage in respect
fertilising products.
authorities, in cooperation with
fertilising products.
of such fertilising products.
the relevant economic operators,
to act at an early stage in respect
of such fertilising products.
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74.
(49a) Market surveillance
CEU text
authorities' obligations under
this Regulation to require
economic operators to take
corrective actions should only
apply to products bearing the
CE marking when made
available on the market. That
obligation should therefore be
without prejudice to any
possibility existing under
national law to allow the
economic operator remove the
CE marking and legally place
the product on the market as a
product not covered by the
scope of this Regulation.

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75.
(50) Where the Member States
(50) Where the Member States
CEU text
and the Commission agree as to
and the Commission agree as to
the justification of a measure
the justification of a measure
taken by a Member State, further
taken by a Member State, further
involvement of the Commission
involvement of the Commission
should be required only where
should be required only where
non-compliance can be attributed
non-compliance can be attributed
to shortcomings of a harmonised
to shortcomings of in a
standard, in which case the
harmonised standard, in which
procedure of formal objection to
case the procedure of formal
harmonised standards laid down
objection to harmonised
in Regulation (EU) No
standards laid down in
1025/2012 should apply.
Regulation (EU) No 1025/2012
should apply, or to
shortcomings in a common
specification, in which case an
implementing act amending or
repealing the common
specification should be
adopted
.
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76.
(51) In order to ensure uniform
EC text
conditions for the
implementation of this
Regulation, implementing
powers should be conferred on
the Commission. Those powers
should be exercised in
accordance with Regulation (EU)
No 182/2011 of the European
Parliament and of the Council18.
18 Regulation (EU) No 182/2011
of the European Parliament and
of the Council of 16 February
2011 laying down the rules and
general principles concerning
mechanisms for control by
Member States of the
Commission’s exercise of
implementing powers (OJ L 55,
28.2.2011, p.13).
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77.
(52) The advisory procedure
EC text
should be used for the adoption
of implementing acts requiring
the notifying Member State to
take the necessary corrective
measures in respect of notified
bodies that do not meet or no
longer meet the requirements for
their notification, since such acts
do not fall within the ambit of
Article 2(2) of Regulation (EU)
No 182/2011.
78.
(53) The examination procedure
(53) The examination procedure
(53) The examination procedure
should be used for the adoption
should be used for the adoption
should be used for the adoption
of implementing acts with respect
of implementing acts with
of implementing acts with
to compliant CE marked
respect to compliant CE marked
respect to compliant CE marked
fertilising products which present
EU fertilising products which
EU fertilising products which
an unacceptable risk to human,
present an unacceptable risk to
present an unacceptable risk to
animal or plant health, to safety
human, animal or plant health, to
human, animal or plant health,
or to the environment, since such
safety or to the environment,
to safety or to the environment,
acts fall within the ambit of
since such acts fall within the
since such acts fall within the
Article 2(2) of Regulation (EU)
ambit of Article 2(2) of
ambit of Article 2(2) of
No 182/2011. For the same
Regulation (EU) No 182/2011.
Regulation (EU) No 182/2011.
reason, it should also be used for
For the same reason, it should
For the same reason, it should
the adoption, amendment or
also be used for the adoption,
also be used for the adoption,
repeal of common specifications.
amendment or repeal of common
amendment or repeal of common
specifications.
specifications.
79.
(54) The Commission should, by
(54) The Commission should, by
CEU text
means of implementing acts,
means of implementing acts,
determine whether measures
determine whether measures
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taken by Member States in
taken by Member States in
respect of non-compliant CE
respect of non-compliant CE
marked fertilising products are
marked EU fertilising products
justified or not. Since those acts
are justified or not. Since those
will relate to the question
acts will relate to the question
whether national measures are
whether national measures are
justified, there is no need for the
justified, there is no need for the
acts to be subject to control by
acts to be subject to control by
the Member States.
the Member States.
80.
(55) Promising technical progress
AM 30
(55) Promising technical progress
(55) Promising technical progress
is being made in the field of
is being made in the field of
is being made in the field of
recycling of waste, such as
(55) Promising technical progress
recycling of waste, such as
recycling of waste, such as
phosphorus recycling from
is being made in the field of
phosphorus recycling from
phosphorus recycling from
sewage sludge, and fertilising
recycling of waste, such as
sewage sludge, and fertilising
sewage sludge, and fertilising
product production from animal
phosphorus recycling from
product production from animal
product production from animal
by-products, such as biochar. It
sewage sludge, such as struvite,
by-products, such as biochar. It
by-products, such as biochar. It
should be possible for products
fertilising product production
should be possible for products
should be possible for products
containing or consisting of such
from animal by-products, such as
containing or consisting of such
containing or consisting of such
materials to access the internal
biochar, and phosphorus
materials to access the internal
materials to access the internal
market without unnecessary
recovery after incineration, such
market without unnecessary
market without unnecessary
delay when the manufacturing
as ash-based products. It should
delay when the manufacturing
delay when the manufacturing
processes have been scientifically
be possible for products
processes have been scientifically processes have been scientifically
analysed and process
containing or consisting of such
analysed and process
analysed and process
requirements have been
materials to access the internal
requirements have been
requirements have been
established at Union level. For
market without unnecessary
established at Union level. For
established at Union level. For
that purpose, the power to adopt
delay when the manufacturing
that purpose, the power to adopt
that purpose, the power to adopt
acts in accordance with Article
processes have been scientifically
acts in accordance with Article
acts in accordance with Article
290 of the Treaty on the
analysed and process
290 of the Treaty on the
290 of the Treaty on the
Functioning of the European
requirements have been
Functioning of the European
Functioning of the European
Union should be delegated to the
established at Union level. For
Union should be delegated to the
Union should be delegated to the
Commission in respect of
that purpose, the power to adopt
Commission in respect of
Commission in respect of
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defining larger or additional
acts in accordance with Article
defining and introducing larger
defining and introducing larger
categories of CE marked
290 of the Treaty on the
or additional categories of CE
or additional categories of CE
fertilising products or component
Functioning of the European
marked fertilising products or
marked fertilising products or
materials eligible for use in the
Union should be delegated to the
component materials eligible for
component materials eligible for
production of such products. For
Commission in respect of the
use in the production of EU
use in the production of EU
animal by-products, component
eligibility of such materials for
fertilising products and
fertilising products and
material categories should be
use in production. For products
corresponding contaminant
corresponding contaminant
expanded or added only to the
derived from animal by-products,
limits in such products. The
limits in such products. The
extent an end point in the
component material categories
empowerment should only
empowerment should only
manufacturing chain has been
should be expanded or added
apply to the extent justified by
apply to the extent justified by
determined in accordance with
only to the extent an end point in
technical progress established
technical progress established
the procedures laid down in
the manufacturing chain has been
after the adoption of this
after the adoption of this
Regulation (EC) No 1069/2009,
determined in accordance with
Regulation, and not for the
Regulation, and not for the
since animal by-products for
the procedures laid down in
purpose of amending any
purpose of amending any
which no such end point has been
Regulation (EC) No 1069/2009.
elements of this Regulation in
elements of this Regulation in
determined are in any event
the absence of new evidence of
the absence of new evidence of
excluded from the scope of this
such progress. In order to base
such progress. In order to base
Regulation.
the introduction of new
the introduction of new
contaminant limits in products
contaminant limits in products
on full consideration of direct
on full consideration of direct
and indirect impact on the food
and indirect impact on the food
and feed safety, a scientific
and feed safety, a scientific
opinion of European Food
opinion of European Food
Safety Authority should be
Safety Authority or other
requested prior to the adoption
European agencies or bodies
of new contaminant limits. For
should be requested prior to the
products derived from animal
adoption of new contaminant
by-products, component material
limits. For products derived
categories should be expanded or
from animal by-products,
added only to the extent an end
component material categories
point in the manufacturing chain
should be expanded or added
has been determined in
only to the extent an end point in
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accordance with the procedures
the manufacturing chain has been
laid down in Regulation (EC) No
determined in accordance with
1069/2009, since animal by-
the procedures laid down in
products for which no such end
Regulation (EC) No 1069/2009,
point has been determined are in
since animal by-products for
any event excluded from the
which no such end point has been
scope of this Regulation.
determined are in any event
excluded from the scope of this
Regulation.
73

81.
AM 31
(55a) A CE marked fertilising
product may contain other

(55a) A CE marked fertilising
polymers than nutrient
product may contain other
polymers, however this should
polymers than nutrient
be limited to the cases where the
polymers, however this should
purpose of the polymer is that of
be limited to the cases where the
controlling the release of
purpose of the polymer is that of
nutrients or increasing the water
controlling the release of
retention capacity of the CE
nutrients or increasing the water
marked fertilising product. It
retention capacity of the CE
should be possible for innovative
marked fertilising product. It
products containing such
should be possible for innovative
polymers to access the internal
products containing such
market. In order to minimise
polymers to access the internal
risks to human health, to safety
market. In order to minimise
or to the environment that may
risks to human health, to safety
be posed by other polymers than
or to the environment that may
nutrient polymers, the criteria
be posed by other polymers than
for their biodegradation so that
nutrient polymers, the criteria
they are capable of undergoing
for their biodegradation so that
physical and biological
they are capable of undergoing
decomposition should be
physical and biological
established. For that purpose,
decomposition should be
the power to adopt acts in
established. For that purpose,
accordance with Article 290 of
the power to adopt acts in
the Treaty on the Functioning of
accordance with Article 290 of
the European Union should be
the Treaty on the Functioning of
delegated to the Commission in
the European Union should be
respect of defining the criteria of
delegated to the Commission in
the conversion of polymeric
respect of defining the criteria of
carbon to be converted into
the conversion of polymeric
carbon dioxide (CO2) and a
carbon to be converted into
respective testing method for
carbon dioxide (CO2) and a
biodegradation. Polymers which
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respective testing method for
do not comply with these
biodegradation.
criteria should be prohibited
after a transitional period.

82.
(56) Furthermore, it should be
AM 32
(56) Furthermore, it should be
CEU TEXT
possible to react immediately to
possible to react immediately to
new findings regarding the
(56) Furthermore, it should be
new findings regarding the
conditions for CE marked
possible to react immediately to
conditions for CE marked EU
fertilising products to be
new findings regarding the
fertilising products to be
sufficiently effective and to new
conditions for CE marked
sufficiently effective and to new
risk assessments regarding
fertilising products to be
risk assessments regarding
human, animal or plant health,
sufficiently effective and to new
human, animal or plant health,
safety or the environment. For
risk assessments regarding
safety or the environment. For
that purpose, the power to adopt
human, animal or plant health,
that purpose, the power to adopt
acts in accordance with Article
safety or the environment, taking
acts in accordance with Article
290 of the Treaty should be
into account assessments made
290 of the Treaty should be
delegated to the Commission to
by or in cooperation with
delegated to the Commission to
amend the requirements
authorities in the Member
amend the requirements
applicable to various categories
States. For that purpose, the
applicable to various categories
of CE marked fertilising
power to adopt acts in
of CE marked EU fertilising
products.
accordance with Article 290 of
products.
the Treaty should be delegated to
the Commission to amend the
requirements applicable to
various categories of CE marked
fertilising products.
75

83.
(57) In exercising those powers,
AM 33
(57) In order to achieve the
CEU text
it is of particular importance that
objectives of this Regulation,
the Commission carry out
(57) When adopting delegated
the power to adopt acts in
appropriate consultations during
acts provided for in this
accordance with Article 290 of
its preparatory work, including at
Regulation, it is of particular
the Treaty on the Functioning
expert level. The Commission,
importance that the Commission
of the European Union should
when preparing and drawing up
carry out appropriate
be delegated to the Commission
delegated acts, should ensure a
consultations during its
in respect of the adaptation to
simultaneous, timely and
preparatory work, including at
technical progress, in
appropriate transmission of
expert level, and that those
particular in the field of
relevant documents to the
consultations be conducted in
fertilising product production
European Parliament and to the
accordance with the principles
from animal by-products, of
Council.
laid down in the
waste recovery, in the
Interinstitutional Agreement of
agricultural sector and the
13 April 2016on Better Law-
agro-food industry. It is of
Making. In particular, to ensure
particular importance that the
equal participation in the
Commission carry out
preparation of delegated acts,
appropriate consultations
the European Parliament and
during its preparatory work,
the Council receive all
including at expert level, and
documents at the same time as
that those consultations be
Member States' experts, and
conducted in accordance with
their experts systematically have
the principles laid down in the
access to meetings of
Interinstitutional Agreement
Commission expert groups
on Better Law-Making of 2016.
dealing with the preparation of
In particular, to ensure equal
delegated acts.
participation in the
preparation of delegated acts,
the European Parliament and
the Council receive all
documents at the same time as
Member States' experts, and
their experts systematically
have access to meetings of

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Commission expert groups
dealing with the preparation of
delegated acts. 
In exercising
those powers, it is of particular
importance that the Commission
carry out appropriate
consultations during its
preparatory work, including at
expert level. The Commission,
when preparing and drawing up
delegated acts, should ensure a
simultaneous, timely and
appropriate transmission of
relevant documents to the
European Parliament and to the
Council.
84.
(58) Member States should lay
EC text
down rules on penalties
applicable to infringements of
this Regulation and ensure that
those rules are enforced. The
penalties provided for should be
effective, proportionate and
dissuasive.
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85.
(58a) Since micro-organisms
CEU TEXT
are not subject to registration
under Regulation (EC) No
1907/2006, or any other general
legislation requiring
manufacturers to demonstrate
that the intended use is safe,
they should be eligible as
component materials for
fertilising products only to the
extent that they have been
clearly identified and
supported by data
demonstrating that their use is
safe, and indicated in an
exhaustive list adopted on this
basis. The same criteria should
apply to the Commission's
delegation of power to add new
micro-organisms to that
exhaustive list.

86.
(58b) In view of the need to
CEU TEXT
ensure a high level of
environmental protection, and
in view of the need to take into
account new developments
based on scientific facts, a
review clause is needed in
relation to limit levels for
cadmium content.

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87.
(59) It is necessary to provide for
EC text
transitional arrangements that
allow the making available on the
market of EC fertilisers that have
been placed on the market in
accordance with Regulation (EC)
No 2003/2003 before the date of
application of this Regulation
without those products having to
comply with further product
requirements. Distributors should
therefore be able to supply EC
fertilisers that have been placed
on the market, namely stock that
is already in the distribution
chain, before the date of
application of this Regulation.
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88.
AM 34
No amendment
(59a) Due to the high level of
dependency on phosphate rock
imports in the Union, the
Commission has classified that
material as a critical raw
material. It is therefore
necessary to monitor the impact
of this Regulation on access to
raw material supplies in general,
on the availability of phosphate
rock in particular, and, in both
cases, on prices. After such
evaluation, and in the case of
negative impact, the
Commission should take any
measures that it deems to be
appropriate in order to remedy
those disturbances to trade.

89.
(60) It is necessary to provide for
EC text
sufficient time for economic
operators to comply with their
obligations under this Regulation,
and for Member States to set up
the administrative infrastructure
necessary for its application. The
application should therefore be
deferred to a date where those
preparations can reasonably be
finalised.
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90.
(61) Since the objective of this
(61) Since the objective of this
CEU text
Regulation, namely to guarantee
Regulation, namely to guarantee
the functioning of the internal
the functioning of the internal
market while ensuring that CE
market while ensuring that CE
marked fertilising products on the
marked EU fertilising products
market fulfil the requirements
on the market fulfil the
providing for a high level of
requirements providing for a high
protection of human, animal, and
level of protection of human,
plant health, safety and the
animal, and plant health, safety
environment, cannot be
and the environment, cannot be
sufficiently achieved by the
sufficiently achieved by the
Member States but can rather, by
Member States but can rather, by
reason of its scale and effects, be
reason of its scale and effects, be
better achieved at Union level,
better achieved at Union level,
the Union may adopt measures,
the Union may adopt measures,
in accordance with the principle
in accordance with the principle
of subsidiarity as set out in
of subsidiarity as set out in
Article 5 of the Treaty on
Article 5 of the Treaty on
European Union. In accordance
European Union. In accordance
with the principle of
with the principle of
proportionality, as set out in that
proportionality, as set out in that
Article, this Regulation does not
Article, this Regulation does not
go beyond what is necessary in
go beyond what is necessary in
order to achieve that objective,
order to achieve that objective,
91.
HAVE ADOPTED THIS
EC TEXT
REGULATION:
92.
CHAPTER 1
EC TEXT
GENERAL PROVISIONS
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Article 1
EC TEXT
Scope
94.
1. This Regulation shall apply to
1. This Regulation shall apply to
CEU TEXT
CE marked fertilising products.
CE marked EU fertilising
products.
95.
However, this Regulation shall
EC TEXT
not apply to the following
products:
96.
AM 35
(a) animal by-products or
(a) animal by-products or
derived products which are
derived products which are
(a) animal by-products which are
(a) animal by-products or derived
made available on the market
made available on the market
subject to the requirements of
products which are made
subject to the requirements of
subject to the requirements of
Regulation (EC) No 1069/2009,
available on the market subject
Regulation (EC) No 1069/2009,
Regulation (EC) No 1069/2009,
to the requirements of Regulation
(EC) No 1069/2009,
97.
(b) plant protection products
EC TEXT
covered by the scope of
Regulation (EC) No 1107/2009.
98.
2. This Regulation shall not
EC TEXT
affect the application of the
following acts:
99.
(a) Directive 86/278/EEC;
EC TEXT
100.
(b) Directive 89/391/EEC;
EC TEXT
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AM 36
(ba) Directive 91/676/EEC;
(ba) Directive 91/676/EEC;
102.
AM 37
(bb) Directive 2000/60/EC;
(bb) Directive 2000/60/EC;
103.
(c) Regulation (EC) No
EC TEXT
1907/2006;
104.
(d) Regulation (EC) No
EC TEXT
1272/2008;
105.
(e) Regulation (EC) No
EC TEXT
1881/2006;
106.
(f) Directive 2000/29/EC;
(f) Directive 2000/29/EC;
(f) Directive 2000/29/EC;
Regulation (EU) No 2031/2016
Regulation (EU) 2016/2031;
107.
(g) Regulation (EU) No 98/2013;
EC TEXT
108.
(h) Regulation (EU) No
EC TEXT
1143/2014.
109.
(ha) Directive 2004/852/EC;
(ha) Regulation (EC) No
852/2004;

110.
(haa) Directive 2016/2284/EC;
(hb) Directive 2016/2284/EC;
111.
(hb) Regulation (EC) No
CEU TEXT
882/2004;
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(hbc) Regulation (EU) 2017/625
CEU TEXT
(from 15 December 2019 on)
113.
(hc) Regulation (EC) No
(hc) Regulation (EC) No
834/2007.
834/2007;
114.
(hd) Directive 2001/18/EC
(hd) Directive 2001/18/EC.
115.
Article 2
EC TEXT
Definitions
116.
For the purposes of this
EC TEXT
Regulation, the following
definitions shall apply:
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117.
(1) ‘fertilising product’ means a
AM 38
(1) ‘fertilising product’ means a
(1) ‘fertilising product’ means a
substance, mixture, micro-
substance, mixture, micro
substance, mixture, micro
organism or any other material,
(1) ‘plant nutrition product’
organism or any other material,
organism or any other material,
applied or intended to be applied,
means a substance, mixture,
applied or intended to be applied
applied or intended to be applied
either on its own or mixed with
micro-organism or any other
either on its own or mixed with
either on its own or mixed with
another material, on plants or
material, applied or intended to
another material on plants or
another material on plants or
their rhizosphere for the purpose
be applied, either on its own or
their rhizosphere or on
their rhizosphere or on
of providing plants with nutrient
mixed with another material, on
mushrooms or their
mushrooms or their
or improving their nutrition
fungi or their mycosphere or on
mycosphereor intended to
mycosphereor intended to
efficiency;
plants at any growth stage,
constitute the rhizosphere or
constitute the rhizosphere or
including seeds, and/or
mycosphere, either on its own
mycosphere, either on its own
rhizosphere, for the purpose of
or mixed with another
or mixed with another
providing  plants or fungi with
material, for the purpose of
material, for the purpose of
nutrientor of improving their
providing the plants or
providing the plants or
physical or biological growth
mushrooms with nutrient or
mushrooms with nutrient or
conditions or their general
improving their nutrition
improving their nutrition
vigour, yields and quality,
efficiency;
efficiency;
including by increasing the
ability of the plant to take up
nutrients (with the exception of
plant protection products
covered by Regulation (EC) No
1107/2009)
;
118.
(2) ‘CE marked fertilising
(2) ‘CE marked EU fertilising
CEU TEXT
product’ means a fertilising
product’ means a fertilising
product which is CE marked
product which is CE marked
when made available on the
when made available on the
market;
market;
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119.
(2a) ‘Presenting a risk’ means
No amendment
having the potential to affect
adversely human, animal or
plant health, safety or the
environment to a degree which
goes beyond that considered
reasonable and acceptable in
relation to the intended
purpose or under the normal
or reasonably foreseeable
conditions of use;

120.
AM 39
EC TEXT
(3) ‘substance’ means a
(3) 'substance' means a chemical
substance within the meaning of
element and its compounds in
Article 3(1) of Regulation (EC)
the natural state or obtained by
No 1907/2006;
any manufacturing process,
including any additive necessary
to preserve its stability and any
impurity deriving from the
process used, but excluding any
solvent which may be separated
without affecting the stability of
the substance or changing its
composition
;
121.
(4) ‘mixture’ means a mixture
EC TEXT
within the meaning of Article
3(2) of Regulation (EC) No
1907/2006;
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122.
(5) 'micro-organism' means a
EC TEXT
micro-organism within the
meaning of Article 3(15) of
Regulation (EC) No 1107/2009;
123.
(5a) 'liquid form' means a
(5a) 'liquid form' means a
suspension or a solution, where
suspension or a solution, where
a suspension is a two-phase
a suspension is a two-phase
dispersion in which solid
dispersion in which solid
particles are maintained in
particles are maintained in
suspension in the liquid phase,
suspension in the liquid phase,
and a solution is a liquid that is
and a solution is a liquid that is
free of solid particles, or a gel;
free of solid particles, or a gel,
and includes pastes;

124.
(5b) 'solid form' means form
(5b) 'solid form' means form
characterized by structural
characterised by structural
rigidity and resistance to
rigidity and resistance to
changes of shape or volume
changes of shape or volume
and in which the atoms are
and in which the atoms are
tightly bound to each other,
tightly bound to each other,
either in a regular geometric
either in a regular geometric
lattice (crystalline solids) or
lattice (crystalline solids) or
irregularly (an amorphous
irregularly (an amorphous
solid), and includes pastes.
solid);
125.
(5c) '% by mass' means a
CEU TEXT
percentage of the mass of the
entire fertilising product in the
form in which it is made
available on the market;

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126.
(6) ‘making available on the
(6) ‘making available on the
CEU TEXT
market’ means any supply of a
market’ means any supply of a
CE marked fertilising product for
CE marked EU fertilising
distribution or use on the Union
product for distribution or use on
market in the course of a
the Union market in the course of
commercial activity, whether in
a commercial activity, whether in
return for payment or free of
return for payment or free of
charge;
charge;
127.
(7) ‘placing on the market’
(7) ‘placing on the market’
CEU TEXT
means the first making available
means the first making available
of a CE marked fertilising
of a CE marked EU fertilising
product on the Union market;
product on the Union market
128.
(8) ‘manufacturer’ means a
(8) ‘manufacturer’ means any a
CEU TEXT
natural or legal person who
natural or legal person who
manufactures a CE marked
manufactures a CE marked EU
fertilising product or has a CE
fertilising product or has a CE
marked fertilising product
marked EU fertilising product
designed or manufactured, and
designed or manufactured, and
markets that fertilising product
markets that fertilising product
under his or her name or
under his or her name or
trademark;
trademark;
129.
(9) ‘authorised representative’
EC TEXT
means a natural or legal person
established within the Union who
has received a written mandate
from a manufacturer to act on his
or her behalf in relation to
specified tasks;
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(10) ‘importer’ means any natural
(10) ‘importer’ means any
CEU TEXT
or legal person established within
natural or legal person
the Union who places a CE
established within the Union who
marked fertilising product from a
places a CE marked EU
third country on the Union
fertilising product from a third
market;
country on the Union market;
131.
(11) ‘distributor’ means any
(11) ‘distributor’ means any
CEU TEXT
natural or legal person in the
natural or legal person in the
supply chain, other than the
supply chain, other than the
manufacturer or the importer,
manufacturer or the importer,
who makes a CE marked
who makes a CE marked EU
fertilising product available on
fertilising product available on
the market;
the market;
132.
(12) ‘economic operators’ means
EC TEXT
manufacturers, authorised
representatives, importers and
distributors;
133.
(13) 'technical specification'
AM 40
(13) 'technical specification'
CEU TEXT
means a document that prescribes
means a document that prescribes
technical requirements to be
(13) 'technical specification'
technical requirements to be
fulfilled by a CE marked
means a document that prescribes
fulfilled by a CE marked EU
fertilising product;
technical requirements to be
fertilising product, by its
fulfilled by a CE marked
production process or by the
fertilising product or by its
methods for its sampling and
production process;
analysis;
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134.
(14) ‘harmonised standard’
EC TEXT
means harmonised standard as
defined in Article 2(1)(c) of
Regulation (EU) No 1025/2012;
135.
(15) ‘accreditation’ means
EC TEXT
accreditation as defined in Article
2(10) of Regulation (EC) No
765/2008;
136.
(16) ‘national accreditation body’
EC TEXT
means national accreditation
body as defined in Article 2(11)
of Regulation (EC) No 765/2008;
137.
(17) ‘conformity assessment’
(17) ‘conformity assessment’
CEU TEXT
means the process demonstrating
means the process demonstrating
whether the requirements
whether the requirements
provided in this Regulation
provided in this Regulation
relating to a CE marked
relating to a CE marked EU
fertilising product have been
fertilising product have been
fulfilled;
fulfilled;
138.
(18) ‘conformity assessment
EC TEXT
body’ means a body that
performs conformity assessment
activities including testing,
certification and inspection;
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139.
(19) ‘recall’ means any measure
(19) ‘recall’ means any measure
CEU TEXT
aimed at achieving the return of a
aimed at achieving the return of a
CE marked fertilising product
CE marked EU fertilising
that has already been made
product that has already been
available to the end-user;
made available to the end-user;
140.
(20) ‘withdrawal’ means any
(20) ‘withdrawal’ means any
CEU TEXT
measure aimed at preventing a
measure aimed at preventing a
CE marked fertilising product in
CE marked EU fertilising
the supply chain from being
product in the supply chain from
made available on the market;
being made available on the
market;
141.
(21) ‘CE marking’ means a
EC TEXT
marking by which the
manufacturer indicates that the
fertilising product is in
conformity with the applicable
requirements set out in Union
harmonisation legislation
providing for its affixing;
142.
(22) ‘Union harmonisation
EC TEXT
legislation’ means any Union
legislation harmonising the
conditions for the marketing of
products.
143.
Article 3
EC TEXT
Free movement
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144.
Member States shall not impede
AM 41
(1) Member States shall not, for
1. Member States shall not, for
the making available on the
reasons relating to
reasons relating to
market of CE marked fertilising
Member States shall not impede,
composition, labelling or other
composition, labelling or other
products which comply with this
for the aspects and risks covered
aspects covered by this
aspects covered by this
Regulation.
by this Regulation, the making
Regulation, impede the making
Regulation, impede the making
available on the market of CE
available on the market of CE
available on the market of CE
marked fertilising products which
marked EU fertilising products
marked EU fertilising products
comply with this Regulation.
which comply with this
which comply with this
Regulation.
Regulation.
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(1a) By derogation from
CEU TEXT
paragraph 1, those Member
States which, on [please insert
the date one day before the
entry into force of this
Regulation] benefit from a
derogation from Article 5 of
Regulation (EC) No 2003/2003
in relation to cadmium content
in fertilising products granted
in accordance with Article
114(4) TFEU may continue to
apply the national limit level
for cadmium content in
phosphate fertilisers which is
applicable in that Member
State on [please insert the date
one day before the entry into
force of this Regulation] to EU
fertilising products until such a
point that a harmonised limit
level for cadmium content in
phosphate fertilisers which is
equal to or lower than the limit
level applicable in the Member
State concerned on [please
insert the date one day before
the entry into force of this
Regulation] is applicable at
Union level.

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AM 42
(2) This Regulation shall not
CEU TEXT
prevent Member States from
This Regulation does not
maintaining or adopting
prevent Member States from
provisions, which are in
maintaining or adopting
compliance with the Treaties,
provisions which are in
concerning the use of EU
compliance with the Treaties,
fertilising products for the
concerning the use of CE
purpose of protecting human
marked fertilising products for
health and the environment,
the purpose of protecting human
provided that those provisions
health and the environment,
do not require modification of
provided that those provisions
EU fertilising products which
do not require modification of
are in compliance with this
CE marked fertilising products
Regulation and do not
which are in compliance with
influence the conditions for
this Regulation and provided
making them available on the
that they do not influence the
market.
conditions for making them
available on the market.

147.
Article 4
EC TEXT
Product requirements
148.
1. A CE marked fertilising
1. A CE marked EU fertilising
CEU TEXT
product shall
product shall
149.
(a) meet the requirements set out
EC TEXT
in Annex I for the relevant
product function category;
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(b) meet the requirements set out
EC TEXT
in Annex II for the relevant
component material category or
categories;
151.
(c) be labelled in accordance with
EC TEXT
the labelling requirements set out
in Annex III.
152.
2. For any aspects not covered by
2a. For any aspects not covered
2. For any aspects not covered
Annex I or II, CE marked
by Annex I or II, EU fertilising
by Annex I or II, EU fertilising
fertilising products shall meet the
products shall not present a
products shall not present a risk
requirement that their use, as
risk as defined in Article 2 (2a).
to human, animal or plant
specified in the use instructions,
health, to satety or to the
does not lead to food or feed of
environment.
plant origin becoming unsafe
within the meaning of Articles 14
and 15 of Regulation (EC) No
178/2002, respectively.
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AM 44
2a. The Commission shall, by …
[Publications office, please

2a. Commission shall
insert the date 1 year after the
simultaneously with the
date of entry into force], publish
publication of this Regulation in
a guidance document giving
the Official Journal of the
clear information and examples
European Union publish a
to manufacturers and market
guidance document giving clear
surveillance authorities about
information and examples to
what the label should look like.
manufacturers and market
surveillance authorities about
how the label should look like.
This guidance document shall
also specify other relevant
information as referred to in
point (d) of paragraph 2 of Part
1 of Annex III.

154.
Article 5
EC TEXT
Making available on the market
155.
CE marked fertilising products
CE marked EU fertilising
CEU TEXT
may be made available on the
products may be made available
market only if they satisfy the
on the market only if they satisfy
requirements of the present
the requirements of this the
Regulation.
present Regulation.
156.
CHAPTER 2
EC TEXT
OBLIGATIONS OF
ECONOMIC OPERATORS
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Article 6
EC TEXT
Obligations of manufacturers
158.
1. When placing CE marked
1. When placing CE marked EU
CEU TEXT
fertilising products on the
fertilising products on the
market, manufacturers shall
market, manufacturers shall
ensure that they have been
ensure that they have been
designed and manufactured in
designed and manufactured in
accordance with the requirements
accordance with the requirements
set out in Annex I for the relevant
set out in Annex I for the relevant
product function category and the
product function category and the
requirements set out in Annex II
requirements set out in Annex II
for the relevant component
for the relevant component
material category or categories.
material category or categories.
97

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159.
2. Before placing CE marked
2. Before placing CE marked EU
2. Before placing CE marked EU
fertilising products on the
fertilising products on the
fertilising products on the
market, manufacturers shall draw
market, manufacturers shall draw
market, manufacturers shall draw
up the technical documentation
up the technical documentation
up the technical documentation
and carry out the relevant
and carry out the relevant
and carry out the relevant
conformity assessment procedure
conformity assessment procedure
conformity assessment procedure
referred to in Article 14, or have
referred to in Article 14, or have
referred to in Article 14, or have
it carried out. Where compliance
it carried out. Where compliance
it carried out. Where compliance
of such a fertilising product with
of such a fertilising product with
of such a fertilising product with
the applicable requirements laid
the applicable requirements laid
the applicable requirements laid
down in this Regulation has been
down in this Regulation has been
down in this Regulation has been
demonstrated by that procedure,
demonstrated by that procedure,
demonstrated by that procedure,
manufacturers shall affix the CE
manufacturers shall affix the CE
manufacturers shall affix the CE
marking, draw up an EU
marking, and draw up an EU
marking, and draw up an EU
declaration of conformity and
declaration of conformity and
declaration of conformity and
ensure that the declaration
ensure that the declaration
ensure that the declaration
accompanies the fertilising
accompanies the fertilising
accompanies the fertilising
product when placed on the
product when placed on the
product when placed on the
market.
market.
market.
98

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160.
AM 45
3. Manufacturers shall keep the
3. Manufacturers shall keep the
technical documentation and the
technical documentation and the
3. Manufacturers shall keep the
3. Manufacturers shall keep the
EU declaration of conformity for
EU declaration of conformity for
technical documentation and the
technical documentation and the
10 years after the CE marked
10 years after the CE marked
EU declaration of conformity for
EU declaration of conformity for
EU fertilising product covered by
EU fertilising product covered by
10 years after the CE marked
five years after the CE marked
those documents has been placed
those documents has been placed
fertilising product covered by
fertilising product covered by
on the market.
on the market.
those documents has been placed
those documents has been placed
on the market.
on the market.
Manufacturers shall, upon
On request, manufacturers shall
request, make available a copy
make a copy of the EU
(This is a horizontal amendment
of the EU declaration of
declaration of conformity
on the term for keeping all the
conformity to other economic
available to other economic
technical documentation;
operators.
operators.
adopting it will necessitate
corresponding changes
throughout the text and,
consequently, adopted
amendments)

99

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161.
4. Manufacturers shall ensure
AM 46
4. Manufacturers shall ensure
4. Manufacturers shall ensure
that procedures are in place for
that procedures are in place for
that procedures are in place for
CE marked fertilising products
4. Manufacturers shall ensure
CE marked EU fertilising
CE marked EU fertilising
that are part of a series
that procedures are in place for
products that are part of a series
products that are part of a series
production to remain in
CE marked fertilising products
production to remain in
production to remain in
conformity with this Regulation.
that are part of a series
conformity with this Regulation.
conformity with this Regulation.
Changes in production method or
production to remain in
Changes in production method or
Changes in production method or
characteristics of those fertilising
conformity with this Regulation.
characteristics of those fertilising
characteristics of those fertilising
products and changes in the
Changes in the characteristics of
products and changes in the
products and changes in the
harmonised standards, common
those fertilising products and
harmonised standards, common
harmonised standards, common
specifications referred to in
changes in the harmonised
specifications referred to in
specifications referred to in
Article 13 or other technical
standards, common specifications
Article 13 or other technical
Article 13 or other technical
specifications by reference to
referred to in Article 13 or other
specifications by reference to
specifications by reference to
which conformity of a CE
technical specifications by
which conformity of a CE
which conformity of a CE
marked fertilising product is
reference to which conformity of
marked EU fertilising product is
marked EU fertilising product is
declared shall be adequately
a CE marked fertilising product
declared or verified shall be
declared or verified shall be
taken into account.
is declared shall be adequately
adequately taken into account.
adequately taken into account.
taken into account.
100

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162.
When deemed appropriate with
AM 47
When deemed appropriate with
When deemed appropriate with
regard to the performance of, or
regard to the performance of, or
regard to the performance of, or
the risks presented by, a CE
When deemed appropriate with
the risks presented by, a CE
the risks presented by, a CE
marked fertilising product,
regard to the performance of, or
marked EU fertilising product,
marked EU fertilising product,
manufacturers shall carry out
the risks presented by, a CE
manufacturers shall carry out
manufacturers shall carry out
sample testing of such fertilising
marked fertilising product,
sample testing of such fertilising
sample testing of such fertilising
products made available on the
manufacturers shall, to protect
products made available on the
products made available on the
market, investigate, and, if
the health and safety of
market, investigate, and, if
market, investigate, and, if
necessary, keep a register of
consumers and the
necessary, keep a register of
necessary, keep a register of
complaints, of non-conforming
environment, carry out sample
complaints, of non-conforming
complaints, of non-conforming
CE marked fertilising products
testing of such fertilising
CE marked EU fertilising
CE marked EU fertilising
and recalls of such products, and
products made available on the
products and recalls of such
products and recalls of such
shall keep distributors informed
market, investigate, and keep a
products, and shall keep
products, and shall keep
of any such monitoring.
register of complaints, of non-
distributors informed of any such
distributors informed of any such
conforming CE marked
monitoring.
monitoring.
fertilising products and recalls of
such products, and shall keep
distributors and market
surveillance authorities
informed of any such monitoring.
101

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163.
5. Manufacturers shall ensure
5. Manufacturers shall ensure
5. Manufacturers shall ensure
that the packaging of the CE
that the packaging of the CE
that the packaging of the CE
marked fertilising products which
marked EU fertilising products
marked EU fertilising products
they have placed on the market
which they have placed on the
which they have placed on the
bears a type, batch or serial
market bears a type, batch or
market bears a type, batch or
number or other element
serial number or other element
serial number or other element
allowing their identification or,
allowing their identification or,
allowing their identification or,
where the fertilising products are
where the fertilising products are
where the fertilising products are
supplied without packaging, that
supplied without packaging, that
supplied without packaging, that
the required information is
the required information is
the required information is
provided in a document
provided in a document
provided in a document
accompanying each fertilising
accompanying each fertilising
accompanying each fertilising
product.
product.
product.
102

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164.
6. Manufacturers shall indicate
AM 48
6. Manufacturers shall indicate
6. Manufacturers shall indicate
their name, registered trade name
their name, registered trade name
their name, registered trade name
or registered trade mark and the
6. Manufacturers shall indicate
or registered trade mark and the
or registered trade mark and the
postal address at which they can
their name, registered trade name
postal address at which they can
postal address at which they can
be contacted on the packaging of
or registered trade mark and the
be contacted on the packaging of
be contacted on the packaging of
the CE marked fertilising product
postal address at which they can
the CE marked EU fertilising
the CE marked EU fertilising
or, where the fertilising product
be contacted on the packaging of
product or, where the fertilising
product or, where the fertilising
is supplied without packaging, in
the CE marked fertilising product
product is supplied without
product is supplied without
a document accompanying the
or, where the fertilising product
packaging, in a document
packaging, in a document
fertilising product. The postal
is supplied without packaging, in
accompanying the fertilising
accompanying the fertilising
address shall indicate a single
a document accompanying the
product. The postal address shall
product. The postal address shall
point at which the manufacturer
fertilising product. The postal
indicate a single point at which
indicate a single point at which
can be contacted. The contact
address shall indicate a single
the manufacturer can be
the manufacturer can be
details shall be in a language
point at which the manufacturer
contacted. The contact details
contacted. Such information
easily understood by end-users
can be contacted. Such
shall be in a language easily
shall be in a language easily
and market surveillance
information shall be in a
understood by end-users and
understood by end-users and
authorities.
language easily understood by
market surveillance authorities.
market surveillance authorities
end-users and market
and shall be clear,
surveillance authorities as
understandable and legible.
determined by the Member State
concerned, and shall be clear,
understandable and legible
.
165.
7. Manufacturers shall ensure
AM 49
7. Manufacturers shall ensure
7. Manufacturers shall ensure
that CE marked fertilising
that CE marked EU fertilising
that CE marked EU fertilising
products are labelled in
7. Manufacturers shall ensure
products are accompanied by
products are accompanied by
accordance with Annex III, or
that CE marked fertilising
the information required under
the information required under
where the fertilising product is
product is labelled in accordance
labelled in accordance with
labelled in accordance with
supplied without packaging, that
with Annex III, or where the
Annex III,. Where the fertilising
Annex III,. Where the fertilising
the labelling statements are
package is too small for the
product is supplied in a
product is supplied in a
provided in a document
label to contain all the
package the information shall
package, the information shall
accompanying the fertilising
information, or where the CE
appear on a label, which is
appear on a label, which is
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product and accessible for
marked fertilising product is
affixed to the package.
affixed to the package.
inspection purposes when the
supplied without packaging, that
However, where the package is
However, where the package is
product is placed on the market.
the required information is
too small to contain all the
too small to contain all the
The labelling statement shall be
provided in a document
information, some information
information, the remaining
in a language which can be easily
accompanying the CE marked
shall be provided in a separate
information shall be provided
understood by end-users, as
fertilising product. The
leaflet accompanying the
in a separate leaflet
determined by the Member State
information required in
package. Such a leaflet shall be
accompanying the package.
concerned, and shall be clear,
accordance with Annex III shall
regarded as part of the label. or
Such a leaflet shall be regarded
understandable and intelligible.
be in a language which can be
wWhere the fertilising product is
as part of the label. or wWhere
easily understood by end-users,
supplied without packaging, that
the fertilising product is supplied
as determined by the Member
all the labelling statements are
without packaging, that all the
State concerned, and shall be
information shall be provided in
labelling statements are
clear, understandable and
such leaflet document
information shall be provided in
intelligible.
accompanying the fertilising
such leaflet. document
product and accessible for
accompanying the fertilising
inspection purposes when the
product and The label and the
product is placed on the market.
leaflet shall be accessible for
The labelling statement
inspection purposes when the
information shall be in a
product is made available on the
language which can be easily
market. The labelling statement
understood by end-users, as
information shall be in a
determined by the Member State
language which can be easily
concerned, and shall be clear,
understood by end-users, as
understandable and intelligible.
determined by the Member State
concerned, and shall be clear,
understandable and intelligible.
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166.
8. Manufacturers who consider or
8. Manufacturers who consider or
CEU TEXT
have reason to believe that a CE
have reason to believe that a CE
marked fertilising product which
marked EU fertilising product
they have placed on the market is
which they have placed on the
not in conformity with this
market is not in conformity with
Regulation shall immediately
this Regulation shall immediately
take the corrective measures
take the corrective measures
necessary to bring that fertilising
necessary to bring that fertilising
product into conformity, to
product into conformity, to
withdraw it or to recall it, if
withdraw it or to recall it, if
appropriate.
appropriate.
167.
Furthermore, where
Furthermore, where
Furthermore, where
manufacturers consider or have
manufacturers consider or have
manufacturers consider or have
reason to believe that CE marked
reason to believe that CE marked
reason to believe that CE marked
fertilising products which they
EU fertilising products which
EU fertilising products which
have placed on the market
they have placed on the market
they have placed on the market
present an unacceptable risk to
present an unacceptable risk to
present an unacceptable risk to
human, animal or plant health, to
human, animal or plant health, to
human, animal or plant health, to
safety or to the environment, they
safety or to the environment, they
safety or to the environment, they
shall immediately inform the
shall immediately inform the
shall immediately inform the
competent national authorities of
competent national authorities of
competent national authorities of
the Member States in which they
the Member States in which they
the Member States in which they
made the fertilising products
made the fertilising products
made the fertilising products
available on the market to that
available on the market to that
available on the market to that
effect, giving details, in
effect, giving details, in
effect, giving details, in
particular, of any non-compliance
particular, of any non-
particular, of any non-
and of any corrective measures
compliance and of any corrective
compliance and of any corrective
taken.
measures taken.
measures taken.
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168.
9. Manufacturers shall, further to
9. Manufacturers shall, further to
CEU TEXT
a reasoned request from a
a reasoned request from a
competent national authority,
competent national authority,
provide it with all the
provide it with all the
information and documentation,
information and documentation,
in paper or electronic form,
in paper or electronic form,
necessary to demonstrate the
necessary to demonstrate the
conformity of the CE marked
conformity of the CE marked EU
fertilising product with this
fertilising product with this
Regulation, in a language which
Regulation, in a language which
can be easily understood by that
can be easily understood by that
authority. They shall cooperate
authority. They shall cooperate
with that authority, at its request,
with that authority, at its request,
on any action taken to eliminate
on any action taken to eliminate
the risks posed by CE marked
the risks posed by CE marked
fertilising products which they
EU fertilising products which
have placed on the market.
they have placed on the market.
169.
10. The manufacturer shall
AM 50
deleted
CEU TEXT
submit to the competent authority
of the Member State of
10. The manufacturer shall
destination a report of the
submit to the competent authority
detonation resistance test
of the Member State of
prescribed in Annex IV for the
destination a report of the
following CE marked fertilising
detonation resistance test
products:
prescribed in Annex IV, and
guarantee that 
the following CE
marked fertilising products are
capable of passing that test
:
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170.
(a) straight or compound solid
deleted
CEU TEXT
inorganic macronutrient
ammonium nitrate fertilisers of
high nitrogen content, as
specified in product function
category 1(C)(I)(a)(i-ii)(A) in
Annex I;
171.
(b) fertilising product blends, as
AM 51
deleted
CEU TEXT
specified in product function
category 7 in Annex I, containing
(b) combinations from different
a fertiliser referred to in point (a).
product function categories, as
specified in product function
category 7 in Annex I, containing
a fertiliser referred to in point (a).
172.
The report shall be submitted at
AM 52
deleted
CEU TEXT
least five days in advance of
placing those products on the
The report shall be submitted at
market.
least five working days in
advance of placing those
products on the market. The list
of the competent authorities of
Member States shall be provided
by the Commission on its
website.

173.
Article 7
EC TEXT
Authorised representative
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174.
1. A manufacturer may, by a
EC TEXT
written mandate, appoint an
authorised representative.
175.
The obligations laid down in
EC TEXT
Article 6(1) and the obligation to
draw up technical documentation
referred to in Article 6(2) shall
not form part of the authorised
representative's mandate.
176.
2. An authorised representative
EC TEXT
shall perform the tasks specified
in the mandate received from the
manufacturer. The mandate shall
allow the authorised
representative to do at least the
following:
177.
(a) keep the EU declaration of
(a) keep the EU declaration of
(a) keep the EU declaration of
conformity and the technical
conformity and the technical
conformity and the technical
documentation at the disposal of
documentation at the disposal of
documentation at the disposal of
national market surveillance
national market surveillance
national market surveillance
authorities for 10 years after the
authorities for 10 years after
authorities for 10 years after
CE marked fertilising product
the CE marked EU fertilising
the CE marked EU fertilising
covered by those documents has
product covered by those
product covered by those
been placed on the market;
documents has been placed on
documents has been placed on
the market;
the market;
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178.
(b) further to a reasoned request
(b) further to a reasoned request
CEU TEXT
from a competent national
from a competent national
authority, provide that authority
authority, provide that authority
with all the information and
with all the information and
documentation necessary to
documentation necessary to
demonstrate the conformity of a
demonstrate the conformity of a
CE marked fertilising product;
CE marked EU fertilising
product;
179.
(c) cooperate with the competent
(c) cooperate with the competent
CEU TEXT
national authorities, at their
national authorities, at their
request, on any action taken to
request, on any action taken to
eliminate the risks posed by CE
eliminate the risks posed by CE
marked fertilising products
marked EU fertilising products
covered by the authorised
covered by the authorised
representative's mandate.
representative's mandate;
180.
Article 8
EC TEXT
Obligations of importers
181.
1. Importers shall place only
AM 53
1. Importers shall place only
1. Importers shall place only
compliant CE marked fertilising
compliant CE marked EU
compliant CE marked EU
products on the market.
1. Only compliant CE marked
fertilising products on the
fertilising products on the
fertilising products can be
market.
market.
imported into the Union and
placed 
on the Union market.
182.
2. Before placing a CE marked
AM 54
2. Before placing a CE marked
2. Before placing a CE marked
fertilising product on the market
EU fertilising product on the
EU fertilising product on the
importers shall ensure that the
2. Before placing a CE marked
market importers shall ensure
market importers shall ensure
appropriate conformity
fertilising product on the market
that the appropriate conformity
that the appropriate conformity
assessment procedure referred to
importers shall ensure that the
assessment procedure referred to
assessment procedure referred to
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in Article 14 has been carried out
appropriate conformity
in Article 14 has been carried out
in Article 14 has been carried out
by the manufacturer. They shall
assessment procedure referred to
by the manufacturer. They shall
by the manufacturer. They shall
ensure that the manufacturer has
in Article 14 has been carried out
ensure that the manufacturer has
ensure that the manufacturer has
drawn up the technical
by the manufacturer. They shall
drawn up the technical
drawn up the technical
documentation, that the CE
ensure that the manufacturer has
documentation, that the CE
documentation, that the CE
marked fertilising product is
drawn up the technical
marked EU fertilising product is
marked EU fertilising product is
accompanied by the EU
documentation, that the CE
accompanied by the EU
accompanied by the EU
declaration of conformity and the
marked fertilising product is
declaration of conformity and the
declaration of conformity and the
required documents, and that the
accompanied by the EU
required documents, and that the
required documents, and that the
manufacturer has complied with
declaration of conformity and the
manufacturer has complied with
manufacturer has complied with
the requirements set out in
required documents, and that the
the requirements set out in
the requirements set out in
Article 6(5) and (6). Where an
manufacturer has complied with
Article 6(5) and (6). Where an
Article 6(5) and (6). Where an
importer considers or has reason
the requirements set out in
importer considers or has reason
importer considers or has reason
to believe that a CE marked
Article 6(5) and (6). Where an
to believe that a CE marked EU
to believe that a CE marked EU
fertilising product is not in
importer considers or has reason
fertilising product is not in
fertilising product is not in
conformity with the applicable
to believe that a CE marked
conformity with the applicable
conformity with the applicable
requirements set out in Annex I,
fertilising product is not in
requirements set out in Annex I,
requirements set out in Annex I,
Annex II or Annex III, he or she
conformity with the applicable
Annex II or Annex III this
Annex II or Annex III this
shall not place the fertilising
requirements of this Regulation,
Regulation, he or she shall not
Regulation, he or she shall not
product on the market until it has
he or she shall not place the
place the fertilising product on
place the fertilising product on
been brought into conformity.
fertilising product on the market
the market until it has been
the market until it has been
Furthermore, where the CE
until it has been brought into
brought into conformity.
brought into conformity.
marked fertilising product
conformity. Furthermore, where
Furthermore, where the CE
Furthermore, where the CE
presents an unacceptable risk to
the CE marked fertilising product
marked EU fertilising product
marked EU fertilising product
human, animal or plant health, to
presents an unacceptable risk to
presents an unacceptable risk to
presents an unacceptable risk to
safety or to the environment, the
human, animal or plant health, to
human, animal or plant health, to
human, animal or plant health, to
importer shall inform the
safety or to the environment, the
safety or to the environment, the
safety or to the environment, the
manufacturer and the market
importer shall inform the
importer shall inform the
importer shall inform the
surveillance authorities to that
manufacturer and the market
manufacturer and the market
manufacturer and the market
effect.
surveillance authorities to that
surveillance authorities to that
surveillance authorities to that
effect.
effect.
effect.
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183.
3. Importers shall indicate their
AM 55
3. Importers shall indicate their
3. Importers shall indicate their
name, registered trade name or
name, registered trade name or
name, registered trade name or
registered trade mark and the
3. Importers shall indicate their
registered trade mark and the
registered trade mark and the
postal address at which they can
name, registered trade name or
postal address at which they can
postal address at which they can
be contacted on the packaging of
registered trade mark and the
be contacted on the packaging of
be contacted on the packaging of
the CE marked fertilising product
postal address at which they can
the CE marked EU fertilising
the CE marked EU fertilising
or, where the CE marked
be contacted as well as the third-
product or, where the CE marked
product or, where the CE marked
fertilising product is supplied
country manufacturers, on the
EU fertilising product is supplied
EU fertilising product is supplied
without packaging, in a
packaging of the CE marked
without packaging, in a
without packaging, in a
document accompanying the
fertilising product or, where the
document accompanying the
document accompanying the
fertilising product. The contact
CE marked fertilising product is
fertilising product. The contact
fertilising product. The contact
details shall be in a language
supplied without packaging, in a
details shall be in a language
details shall be in a language
easily understood by end-users
document accompanying the
easily understood by end-users
easily understood by end-users
and market surveillance
fertilising product. The contact
and market surveillance
and market surveillance
authorities.
details shall be in a language
authorities.
authorities.
easily understood by end-users
and market surveillance
authorities.
184.
4. Importers shall ensure that the
AM 56
4. Importers shall ensure that CE
4. Importers shall ensure that CE
CE marked fertilising product is
marked EU fertilising products
marked EU fertilising products
labelled in accordance with
4. Importers shall ensure that the
are accompanied by the
are accompanied by the
Annex III in a language which
CE-marked fertilising product is
information required under
information required under
can be easily understood by end-
labelled in accordance with
labelled in accordance with
labelled in accordance with
users, as determined by the
Annex III, or where the package
Annex III,. Where the fertilising
Annex III,. Where the fertilising
Member State concerned.
is too small for the label to
product is supplied in a
product is supplied in a
contain all the information, or
package the information shall
package, the information shall
where the CE marked fertilising
appear on a label, which is
appear on a label, which is
product is supplied without
affixed to the package.
affixed to the package.
packaging, that the required
However, where the package is
However, where the package is
information is provided in a
too small to contain all the
too small to contain all the
document accompanying the CE
information, some information
information, the remaining
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marked fertilising product. The
shall be provided in a separate
information shall be provided
information required in
leaflet accompanying the
in a separate leaflet
accordance with Annex III shall
package. Such a leaflet shall be
accompanying the package.
be in a language which can be
regarded as part of the label. or
Such a leaflet shall be regarded
easily understood by end-users,
wWhere the fertilising product is
as part of the label. or wWhere
as determined by the Member
supplied without packaging, that
the fertilising product is supplied
State concerned.
all the labelling statements are
without packaging, that all the
information shall be provided in
labelling statements are
such leaflet document
information shall be provided in
accompanying the fertilising
such leaflet. document
product and accessible for
accompanying the fertilising
inspection purposes when the
product and The label and the
product is placed on the market.
leaflet shall be accessible for
The labelling statement
inspection purposes when the
information shall be in a
product is made available on the
language which can be easily
market. The labelling statement
understood by end-users, as
information shall be in a
determined by the Member State
language which can be easily
concerned.
understood by end-users, as
determined by the Member State
concerned.
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185.
5. Importers shall ensure that,
5. Importers shall ensure that,
5. Importers shall ensure that,
while a CE marked fertilising
while a CE marked EU fertilising
while a CE marked EU fertilising
product is under their
product is under their
product is under their
responsibility, its storage or
responsibility, its storage or
responsibility, its storage or
transport conditions do not
transport conditions do not
transport conditions do not
jeopardise its compliance with
jeopardise its compliance with
jeopardise its compliance with
the safety and quality
the safety and quality
the safety and quality
requirements set out in Annex I
requirements set out in Annexes I
requirements set out in Annexes I
or with the labelling requirements
or with the labelling
or with the labelling
set out in Annex III.
requirements set out in Annex
requirements set out in Annex
III.
III.
186.
6. When deemed appropriate
AM 57
6. When deemed appropriate
6. When deemed appropriate
with regard to the performance of
with regard to the performance of
with regard to the performance
or the risks presented by a CE
6. When deemed appropriate
or the risks presented by a CE
of, or the risks presented by a CE
marked fertilising product,
with regard to the performance of
marked EU fertilising product,
marked EU fertilising product,
importers shall carry out sample
or the risks presented by a CE
importers shall carry out sample
importers shall carry out sample
testing of such fertilising
marked fertilising product,
testing of such fertilising
testing of such fertilising
products made available on the
importers shall, to protect the
products made available on the
products made available on the
market, investigate, and, if
health and safety of consumers
market, investigate, and, if
market, investigate, and, if
necessary, keep a register of
and the environment, carry out
necessary, keep a register of
necessary, keep a register of
complaints, of non-conforming
sample testing of such fertilising
complaints, of non-conforming
complaints, of non-conforming
CE marked fertilising products
products made available on the
CE marked EU fertilising
CE marked EU fertilising
and recalls of such products, and
market, investigate, and keep a
products and recalls of such
products and recalls of such
shall keep distributors informed
register of complaints, of non-
products, and shall keep
products, and shall keep
of any such monitoring.
conforming CE marked
distributors informed of any such
distributors informed of any such
fertilising products and recalls of
monitoring.
monitoring.
such products, and shall keep
distributors informed of any such
monitoring.
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187.
7. Importers who consider or
7. Importers who consider or
CEU TEXT
have reason to believe that a CE
have reason to believe that a CE
marked fertilising product which
marked EU fertilising product
they have placed on the market is
which they have placed on the
not in conformity with this
market is not in conformity with
Regulation shall immediately
this Regulation shall immediately
take the corrective measures
take the corrective measures
necessary to bring that fertilising
necessary to bring that fertilising
product into conformity, to
product into conformity, to
withdraw it or to recall it, if
withdraw it or to recall it, if
appropriate.
appropriate.
188.
Furthermore, where importers
Furthermore, where importers
Furthermore, where importers
consider or have reason to
consider or have reason to
consider or have reason to
believe that CE marked fertilising
believe that CE marked EU
believe that CE marked EU
products which they have placed
fertilising products which they
fertilising products which they
on the market present an
have placed on the market
have placed on the market
unacceptable risk to human,
present an unacceptable risk to
present an unacceptable risk to
animal or plant health, to safety
human, animal or plant health, to
human, animal or plant health, to
or to the environment, they shall
safety or to the environment, they
safety or to the environment, they
immediately inform the
shall immediately inform the
shall immediately inform the
competent national authorities of
competent national authorities of
competent national authorities of
the Member States in which they
the Member States in which they
the Member States in which they
made the fertilising product
made the fertilising product
made the fertilising product
available on the market to that
available on the market to that
available on the market to that
effect, giving details, in
effect, giving details, in
effect, giving details, in
particular, of any non-compliance
particular, of any non-
particular, of any non-
and of any corrective measures
compliance and of any corrective
compliance and of any corrective
taken.
measures taken.
measures taken.
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189.
8. Importers shall, for 10 years
AM 58
8. Importers shall, for 10 years
8. Importers shall, for 10 years
after the CE marked fertilising
after the CE marked EU
after the CE marked EU
product has been placed on the
8. Importers shall, for five years
fertilising product has been
fertilising product has been
market, keep a copy of the EU
after the CE marked fertilising
placed on the market, keep a
placed on the market, keep a
declaration of conformity at the
product has been placed on the
copy of the EU declaration of
copy of the EU declaration of
disposal of the market
market, keep a copy of the EU
conformity at the disposal of the
conformity at the disposal of the
surveillance authorities and
declaration of conformity at the
market surveillance authorities
market surveillance authorities
ensure that the technical
disposal of the market
and ensure that the technical
and ensure that the technical
documentation can be made
surveillance authorities and
documentation can be made
documentation can be made
available to those authorities,
ensure that the technical
available to those authorities,
available to those authorities,
upon request.
documentation can be made
upon request.
upon request.
available to those authorities,
upon request. On request,
Importers shall, upon request,
On request, importers shall
importers shall make a copy of
make available a copy of the
make a copy of the EU
the EU declaration of
EU declaration of conformity
declaration of conformity
conformity available to other
to other economic operators.
available to other economic
economic operators concerned.
operators.
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190.
9. Importers shall, further to a
9. Importers shall, further to a
CEU TEXT
reasoned request from a
reasoned request from a
competent national authority,
competent national authority,
provide it with all the
provide it with all the
information and documentation,
information and documentation,
in paper or electronic form,
in paper or electronic form,
necessary to demonstrate the
necessary to demonstrate the
conformity of the CE marked
conformity of the CE marked EU
fertilising product in a language
fertilising product in a language
which can be easily understood
which can be easily understood
by that authority. They shall
by that authority. They shall
cooperate with that authority, at
cooperate with that authority, at
its request, on any action taken to
its request, on any action taken to
eliminate the risks posed by CE
eliminate the risks posed by CE
marked fertilising products which
marked EU fertilising products
they have placed on the market.
which they have placed on the
market.
191.
10. The importer shall submit to
deleted
CEU TEXT
the competent authority of the
Member State of destination a
report of the detonation
resistance test prescribed in
Annex IV for the following CE
marked fertilising products:
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192.
(a) straight or compound solid
deleted
CEU TEXT
inorganic macronutrient
ammonium nitrate fertilisers of
high nitrogen content, as
specified in product function
category 1(C)(I)(a)(i-ii)(A) in
Annex I;
193.
(b) fertilising product blends, as
deleted
CEU TEXT
specified in product function
category 7 in Annex I, containing
a fertiliser referred to in point (a).
194.
The report shall be submitted at
deleted
CEU TEXT
least five days in advance of
placing those products on the
market.
195.
Article 9
EC TEXT
Obligations of distributors
196.
1. When making a CE marked
1. When making a CE marked
CEU TEXT
fertilising product available on
EU fertilising product available
the market distributors shall act
on the market distributors shall
with due care in relation to the
act with due care in relation to
requirements of this Regulation.
the requirements of this
Regulation.
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197.
2. Before making a CE marked
AM 59
2. Before making a CE marked
2. Before making a CE marked
fertilising product available on
EU fertilising product available
EU fertilising product available
the market distributors shall
Before making a CE marked
on the market distributors shall
on the marketdistributors shall
verify that it is accompanied by
fertilising product available on
verify that it is accompanied by
verify that it is accompanied by
the EU declaration of conformity
the market distributors shall
the EU declaration of conformity
the EU declaration of conformity
and by the required documents,
verify that it is accompanied by
and by the required documents,
and by the required documents,
that it is labelled in accordance
the required documents, that it is
including the information
including the information
with Annex III in a language
labelled in accordance with
referred to in Article 6(7)
referred to in Article 6(7) or
which can be easily understood
Annex III in a language which
provided as specified therein,
Article 8(4) provided as
by end-users in the Member State
can be easily understood by end-
that it is labelled in accordance
specified therein,, that it is
in which the CE marked
users in the Member State in
with Annex III and in a language
labelled in accordance with
fertilising product is to be made
which the CE marked fertilising
which can be easily understood
Annex III and in a language
available on the market, and that
product is to be made available
by end-users in the Member State
which can be easily understood
the manufacturer and the
on the market, and that the
in which the CE marked EU
by end-users in the Member State
importer have complied with the
manufacturer and the importer
fertilising product is to be made
in which the CE marked EU
requirements set out in Article
have complied with the
available on the market, and that
fertilising product is to be made
6(5) and (6) and Article 8(3)
requirements set out in Article
the manufacturer and the
available on the market, and that
respectively.
6(5) and (6) and Article 8(3)
importer have complied with the
the manufacturer and the
respectively. Where the package
requirements set out in Article
importer have complied with the
is too small for the label to
6(5) and (6) and Article 8(3)
requirements set out in Article
contain all the information, or
respectively.
6(5) and (6) and Article 8(3)
where the CE marked fertilising
respectively.
product is supplied without
packaging, market distributors
shall verify that the required
information is provided in a
document accompanying the CE
marked fertilising product.

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198.
Where a distributor considers or
AM 60
Where a distributor considers or
Where a distributor considers or
has reason to believe that a CE
has reason to believe that a CE
has reason to believe that a CE
marked fertilising product is not
Where a distributor considers or
marked EU fertilising product is
marked EU fertilising product is
in conformity with the applicable
has reason to believe that a CE
not in conformity with the
not in conformity with the
requirements set out in Annex I,
marked fertilising product is not
applicable requirements set out in
applicable requirements set out in
Annex II or Annex III, he or she
in conformity with the applicable
Annex I, Annex II or Annex III
Annex I, Annex II or Annex III
shall not make the fertilising
requirements of this Regulation,
this Regulation, he or she shall
this Regulation, he or she shall
product available on the market
he or she shall not make the
not make the fertilising product
not make the fertilising product
until it has been brought into
fertilising product available on
available on the market until it
available on the market until it
conformity. Furthermore, where
the market until it has been
has been brought into
has been brought into
the CE marked fertilising product
brought into conformity.
conformity. Furthermore, where
conformity. Furthermore, where
presents an unacceptable risk to
Furthermore, where the CE
the CE marked EU fertilising
the CE marked EU fertilising
human, animal or plant health, to
marked fertilising product
product presents an unacceptable
product presents an unacceptable
safety or to the environment, the
presents an unacceptable risk to
risk to human, animal or plant
risk to human, animal or plant
distributor shall inform the
human, animal or plant health, to
health, to safety or to the
health, to safety or to the
manufacturer or the importer to
safety or to the environment, the
environment, the distributor shall
environment, the distributor shall
that effect as well as the market
distributor shall inform the
inform the manufacturer or the
inform the manufacturer or the
surveillance authorities.
manufacturer or the importer to
importer to that effect as well as
importer to that effect as well as
that effect as well as the market
the market surveillance
the market surveillance
surveillance authorities.
authorities.
authorities.
199.
3. Distributors shall ensure that,
3. Distributors shall ensure that,
3. Distributors shall ensure that,
while a CE marked fertilising
while a CE marked EU fertilising
while a CE marked EU fertilising
product is under their
product is under their
product is under their
responsibility, its storage or
responsibility, its storage or
responsibility, its storage or
transport conditions do not
transport conditions do not
transport conditions do not
jeopardise its compliance with
jeopardise its compliance with
jeopardise its compliance with
the safety and quality
the safety and quality
the safety and quality
requirements set out in Annex I
requirements set out in Annexes I
requirements set out in Annexes I
or the labelling requirements set
or the labelling requirements set
or the labelling requirements set
out in Annex III.
out in Annex III.
out in Annex III.
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200.
4. Distributors who consider or
4. Distributors who consider or
CEU TEXT
have reason to believe that a CE
have reason to believe that a CE
marked fertilising product which
marked EU fertilising product
they have made available on the
which they have made available
market is not in conformity with
on the market is not in
this Regulation shall make sure
conformity with this Regulation
that the corrective measures
shall make sure that the
necessary to bring that fertilising
corrective measures necessary to
product into conformity, to
bring that fertilising product into
withdraw it or to recall it, if
conformity, to withdraw it or to
appropriate, are taken.
recall it, if appropriate, are taken.
201.
Furthermore, where distributors
Furthermore, where distributors
Furthermore, where distributors
consider or have reason to
consider or have reason to
consider or have reason to
believe that CE marked fertilising
believe that CE marked EU
believe that CE marked EU
products which they have made
fertilising products which they
fertilising products which they
available on the market presents
have made available on the
have made available on the
an unacceptable risk to human,
market presents an unacceptable
market presents an unacceptable
animal or plant health, to safety
risk to human, animal or plant
risk to human, animal or plant
or to the environment, they shall
health, to safety or to the
health, to safety or to the
immediately inform the
environment, they shall
environment, they shall
competent national authorities of
immediately inform the
immediately inform the
the Member States in which they
competent national authorities of
competent national authorities of
made the CE marked fertilising
the Member States in which they
the Member States in which they
product available on the market
made the CE marked EU
made the CE marked EU
to that effect, giving details, in
fertilising product available on
fertilising product available on
particular, of any non-compliance
the market to that effect, giving
the market to that effect, giving
and of any corrective measures
details, in particular, of any non-
details, in particular, of any non-
taken.
compliance and of any corrective
compliance and of any corrective
measures taken.
measures taken.
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5. Distributors shall, further to a
5. Distributors shall, further to a
CEU TEXT
reasoned request from a
reasoned request from a
competent national authority,
competent national authority,
provide it with all the
provide it with all the
information and documentation,
information and documentation,
in paper or electronic form,
in paper or electronic form,
necessary to demonstrate the
necessary to demonstrate the
conformity of the CE marked
conformity of the CE marked EU
fertilising product. They shall
fertilising product. They shall
cooperate with that authority, at
cooperate with that authority, at
its request, on any action taken to
its request, on any action taken to
eliminate the risks posed by CE
eliminate the risks posed by CE
marked fertilising products which
marked EU fertilising products
they have made available on the
which they have made available
market.
on the market.
203.
Article 10
EC TEXT
Cases in which obligations of
manufacturers apply to importers
and distributors
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204.
An importer or distributor shall
An importer or distributor shall
CEU TEXT
be considered a manufacturer for
be considered a manufacturer for
the purposes of this Regulation,
the purposes of this Regulation,
and shall be subject to the
and shall be subject to the
obligations of the manufacturer
obligations of the manufacturer
under Article 6, where he or she
under Article 6, where he or she
places a CE marked fertilising
places a CE marked EU
product on the market under his
fertilising product on the market
or her name or trademark or
under his or her name or
modifies a CE marked fertilising
trademark or modifies a CE
product already placed on the
marked EU fertilising product
market in such a way that
already placed on the market in
compliance with this Regulation
such a way that compliance with
may be affected.
this Regulation may be affected.
205.
Article 10a
CEU TEXT
Repackaging by importers and
distributors

206.
Where an importer or
Where an importer or
distributor packages or
distributor packages or
repackages an EU fertilising
repackages an EU fertilising
product and is not considered a
product and is not considered a
manufacturer pursuant to
manufacturer pursuant to
Article 10, he or she shall
Article 10, he or she shall:
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1. ensure that the packaging
CEU TEXT
bears his or her name,
registered trade name or
registered trade mark and
postal address preceded by the

words ‘packaged by’ or
‘repackaged by’; and
208.
2. keep a specimen of the
2. keep a specimen of the
original information referred
original information referred
to in Article 6(7) at the disposal
to in Article 6(7) or Article 8(4)
of the market surveillance
at the disposal of the market
authorities for 5 years after
surveillance authorities for 5
having made the EU fertilising
years after having made the EU
product available on the
fertilising product available on
market.
the market.
209.
Article 11
EC TEXT
Identification of economic
operators
210.
1. Economic operators shall, on
EC TEXT
request, identify the following to
the market surveillance
authorities:
211.
(a) any economic operator who
(a) any economic operator who
CEU TEXT
has supplied them with a CE
has supplied them with a CE
marked fertilising product;
marked EU fertilising product;
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(b) any economic operator to
(b) any economic operator to
CEU TEXT
whom they have supplied a CE
whom they have supplied a CE
marked fertilising product.
marked EU fertilising product.
213.
2. The economic operators shall
2. The economic operators shall
2. The economic operators shall
be able to present the information
be able to present the information
be able to present the information
referred to in the first paragraph
referred to in the first paragraph
referred to in the first paragraph
for 10 years after they have been
for 10 years after they have
for 10 years after they have
supplied with the CE marked
been supplied with the CE
been supplied with the CE
fertilising product and for 10
marked EU fertilising product
marked EU fertilising product
years after they have supplied the
and for 10 years after they have
and for 10 years after they have
CE marked fertilising product.
supplied the CE marked EU
supplied the CE marked EU
fertilising product.
fertilising product.
214.
CHAPTER 3
CHAPTER 3
CEU TEXT
CONFORMITY OF CE
CONFORMITY OF CE
MARKED FERTILISING
MARKED EU FERTILISING
PRODUCTS
PRODUCTS
215.
Article 12
EC TEXT
Presumption of conformity
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216.
Without prejudice to the common
AM 61
Without prejudice to the common
1. Without prejudice to the
specifications referred to in
specifications referred to in
common specifications referred
Article 13, CE marked fertilising
CE marked fertilising products
Article 13, CE marked EU
to in Article 13, CE marked EU
products which are in conformity
which are in conformity with, or
fertilising products which are in
fertilising products which are in
with harmonised standards or
have been tested in conformity
conformity with harmonised
conformity with harmonised
parts thereof the references of
withharmonised standards or
standards or parts thereofthe
standards or parts thereofthe
which have been published in the
parts thereof the references of
references of which have been
references of which have been
Official Journal of the European
which have been published in the
published in the Official Journal
published in the Official Journal
Union shall be presumed to be in
Official Journal of the European
of the European Unionshall be
of the European Unionshall be
conformity with the requirements
Union shall be presumed to be in
presumed to be in conformity
presumed to be in conformity
set out in Annexes I, II and III
conformity with the respective
with the requirements set out in
with the requirements set out in
covered by those standards or
requirements set out in Annexes
Annexes I, II and III covered by
Annexes I, II and III covered by
parts thereof.
I, II and III covered by those
those standards or parts thereof.
those standards or parts thereof.
standards or parts thereof.
217.
Tests for verifying conformity
2. Tests for verifying
of EU fertilising products with
conformity of EU fertilising
the requirements set out in
products with the requirements
Annexes I, II and III shall be
set out in Annexes I, II and III
performed in a reliable and
shall be performed in a reliable
reproducible manner. Tests
and reproducible manner.
which are in conformity with
Tests which are in conformity
harmonised standards or parts
with harmonised standards or
thereof, the references of which
parts thereof, the references of
have been published in the
which have been published in
Official Journal of the
the Official Journal of the
European Union, shall be
European Union, shall be
presumed to be reliable and
presumed to be reliable and
reproducible.
reproducible to the extent that
the tests are covered by those
standards or parts thereof.

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218.
Article 13
EC TEXT
Common specifications
126

219.
The Commission may adopt
AM 62
Where a requirement set out in
Where a requirement set out in
implementing acts laying down
Annexes I, II or III, or a test
Annexes I, II or III, or a test
common specifications, the
Where a requirement set out in
referred to in Article 12, is not
referred to in Article 12, is not
compliance with which shall
Annexes I, II or III is not
covered by harmonised
covered by harmonised standards
ensure conformity with the
covered by harmonised
standards or parts thereof the
or parts thereof the references of
requirements set out in Annexes
standards or parts thereof, the
references of which have been
which have been published in the
I, II and III covered by those
references of which have been
published in the Official
Official Journal of the European
specifications or parts thereof.
published in the Official
Journal of the European
Union, or where
Those implementing acts shall be
Journal of the European Union,
Union, or where the
(i) the Commission observes
adopted in accordance with the
and where following a request to
Commission has initiated a
undue delays in the adoption of
examination procedure referred
one or several European
procedure in accordance with
requested standards, or
to in Article 41(3).
standardisation organisations to
Article 11(5) of Regulation
(ii) where the Commission has
draft harmonised standards for
(EU) No 1025/2012 for
initiated a procedure in
that requirement the
maintaining with restriction or
accordance with the procedure
Commission observes undue
withdrawing the references to
referred to in Article 11(5) of
delays in the adoption of that
the harmonised standards or
Regulation (EU) No 1025/2012
standard, the Commission may
parts thereof by which that
has decided to for maintaining
adopt implementing acts laying
requirement or that test is
with restriction or to
down common specifications for
covered, the Commission may
withdrawing the references to the
that requirement. Those
adopt implementing acts laying
harmonised standards or parts
implementing acts shall be
down common specifications for
thereof by which that
adopted in accordance with the
that requirement or that test,
requirement or that test is
examination procedure referred
the compliance with which shall
covered,
to in Article 41(3).
ensure conformity with the
the Commission may adopt
requirements set out in Annexes
implementing acts laying down
I, II and III covered by those
common specifications for that
specifications or parts thereof.
requirement or that test. Those
Those implementing acts shall be
implementing acts shall be
adopted in accordance with the
adopted in accordance with the
examination procedure referred
examination procedure referred
to in Article 41(3).
to in Article 41(3).
Fertilizing products, which are in
conformity with common
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specifications or parts thereof,
shall be presumed to be in
conformity with the requirements
set out in Annexes I, II, III
covered by those common
specifications or parts thereof.
Tests for verifying conformity of
EU fertilizing products with the
requirements set out in Annexes
I, II, III which are in conformity
with common specifications or
parts thereof shall be presumed to
be reliable and reproducible to
the extent that the tests are
covered by those common
specifications or parts thereof.

220.
Article 14
EC TEXT
Conformity assessment
procedures
221.
1. Conformity assessment of a
1. Conformity assessment of a
1. Conformity assessment of a
CE marked fertilising product
CE marked EU fertilising
CE marked EU fertilising
with the requirements in this
product with the requirements in
product with the requirements in
Regulation shall be carried out by
this Regulation shall be carried
this Regulation shall be carried
applying the conformity
out by applying the applicable
out by applying the applicable
assessment procedure specified
conformity assessment procedure
conformity assessment procedure
in Annex IV.
specified in accordance with
specified in accordance with
Annex IV.
Annex IV.
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2. Records and correspondence
EC TEXT
relating to conformity assessment
procedures shall be drawn up in
the official language(s) of the
Member State where the notified
body carrying out the conformity
assessment procedures is
established, or in a language
accepted by that body.
223.
Article 15
EC TEXT
EU declaration of conformity
224.
1. The EU declaration of
1. The EU declaration of
CEU TEXT
conformity shall state that the
conformity shall state that the
fulfilment of the requirements set
fulfilment of the requirements set
out in Annexes I, II and III has
out in Annexes I, II and III this
been demonstrated.
Regulation has been
demonstrated.
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2. The EU declaration of
2. The EU declaration of
CEU TEXT
conformity shall have the model
conformity shall have the model
structure set out in Annex V,
structure set out in Annex V,
shall contain the elements
shall contain the elements
specified in the relevant modules
specified in the relevant modules
set out in Annex IV and shall be
set out in Annex IV and shall be
continuously updated. It shall be
continuously updated. It shall be
translated into the language or
translated into the language or
languages required by the
languages required by the
Member State in which the CE
Member State in which the CE
marked fertilising product is
marked EU fertilising product is
placed or made available on the
placed or made available on the
market.
market.
226.
3. Where a CE marked fertilising
3. Where a CE marked EU
CEU TEXT
product is subject to more than
fertilising product is subject to
one Union act requiring an EU
more than one Union act
declaration of conformity, a
requiring an EU declaration of
single EU declaration of
conformity, a single EU
conformity shall be drawn up in
declaration of conformity shall
respect of all such Union acts.
be drawn up in respect of all such
That declaration shall state the
Union acts. That declaration shall
Union acts concerned and their
state the Union acts concerned
publication references. It may be
and their publication references.
a dossier made up of relevant
It may be a dossier made up of
individual declarations of
relevant individual declarations
conformity.
of conformity.
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4. By drawing up the EU
4. By drawing up the EU
CEU TEXT
declaration of conformity, the
declaration of conformity, the
manufacturer shall assume
manufacturer shall assume
responsibility for the compliance
responsibility for the compliance
of the CE marked fertilising
of the CE marked EU fertilising
product with the requirements
product with the requirements
laid down in this Regulation.
laid down in this Regulation.
228.
Article 16
EC TEXT
General principles of CE marking
229.
The CE marking shall be subject
EC TEXT
to the general principles set out in
Article 30 of Regulation (EC) No
765/2008.
230.
Article 17
EC TEXT
Rules and conditions for affixing
the CE marking
231.
1. The CE marking shall be
AM 63
1. The CE marking shall be
1. The CE marking shall be
affixed visibly, legibly and
affixed visibly, legibly and
affixed visibly, legibly and
indelibly to the accompanying
1. The CE marking shall be
indelibly to the packaging of the
indelibly to the packaging of the
documents and, where the CE
affixed visibly, legibly and
EU fertilising product or, where
EU fertilising product or,
marked fertilising product is
indelibly to the packaging of the
the EU fertilising product is
where the EU fertilising
supplied in a packaged form, to
CE marked fertilising product
supplied without packaging, in
product is supplied without
the packaging.
or, where the CE marked
a document accompanying
packaging, to a document
fertilising product is supplied
documents and, where the CE
accompanying documents and,
without packaging, to the
marked EU fertilising product is
where the CE marked EU
documents accompanying the
supplied in a packaged form, to
fertilising product is supplied in a
CE marked fertilising product.
the packaging.
packaged form, to the packaging.
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232.
2. The CE marking shall be
2. The CE marking shall be
CEU TEXT
affixed before the CE marked
affixed before the CE marked EU
fertilising product is placed on
fertilising product is placed on
the market.
the market.
233.
3. The CE marking shall be
AM 64
3. The CE marking shall be
3. The CE marking shall be
followed by the identification
followed by the identification
followed by the identification
number of the notified body
The CE marking shall be
number of the notified body,
number of the notified body,
involved in the conformity
followed by the identification
where required by involved in
where required by involved in
assessment referred to in Annex
number of the notified body,
the conformity assessment
the conformity assessment
IV, Module D1.
where required by Annex IV.
referred to in Annex IV, Module
referred to in Annex IV, Module
D1.
D1.
234.
The identification number of the
EC TEXT
notified body shall be affixed by
the body itself or, under its
instructions, by the manufacturer
or his or her authorised
representative.
235.
4. Member States shall build
EC TEXT
upon existing mechanisms to
ensure correct application of the
regime governing the CE
marking and shall take
appropriate action in the event of
improper use of that marking.
236.
Article 18
EC TEXT
End-of-waste status
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237.
A CE marked fertilising product
AM 65
A CE marked fertilising product
This Regulation lays down
that has undergone a recovery
that has undergone a recovery
criteria according to which
operation and complies with the
Where a material that was waste
operation and complies with the
material that constitutes waste
requirements laid down in this
has undergone a recovery
requirements laid down in this
as defined in Directive
Regulation shall be considered to
operation and a CE marked
Regulation shall be considered to
2008/98/EC can cease to be
comply with the conditions laid
fertilising product compliant
comply with the conditions laid
waste if contained in a
down in Article 6(1) of Directive
with this Regulation contains or
down in Article 6(1) of Directive
compliant EU fertilising
2008/98/EC and shall, therefore,
consists of that material, the
2008/98/EC and shall, therefore,
product. In such cases, the
be considered as having ceased to
material shall be considered to
be considered as having ceased to
recovery operation in
be waste.
comply with the conditions laid
be waste.
accordance with this
down in Article 6(1) of Directive
Regulation shall be performed
2008/98/EC and shall, therefore,
Where a material that was
before the material ceases to be
be considered as having ceased to
waste has undergone a
waste, and the material shall be
be waste from the moment the
recovery operation in
considered to comply with the
EU declaration of conformity is
accordance with this
conditions laid down in Article
drawn up.
Regulation and a compliant EU
6 of that Directive and
fertilising product contains or
therefore be considered as
consists of that material, the
having ceased to be waste from
material shall be considered to
the moment the EU declaration
comply with the conditions laid
of conformity is drawn up.
down in Article 6(1) of
Directive 2008/98/EC and shall,
therefore, be considered as
having ceased to be waste from
the moment the EU declaration
of conformity is drawn up.

238.
CHAPTER 4
EC TEXT
NOTIFICATION OF
CONFORMITY ASSESSMENT
BODIES
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239.
Article 19
EC TEXT
Notification
240.
Member States shall notify the
EC TEXT
Commission and the other
Member States of bodies
authorised to carry out third-party
conformity assessment tasks
under this Regulation.
241.
Article 20
EC TEXT
Notifying authorities
242.
1. Member States shall designate
EC TEXT
a notifying authority that shall be
responsible for setting up and
carrying out the necessary
procedures for the assessment
and notification of conformity
assessment bodies and the
monitoring of notified bodies,
including compliance with
Article 25.
243.
2. Member States may decide
EC TEXT
that the assessment and
monitoring referred to in
paragraph 1 shall be carried out
by a national accreditation body
within the meaning of and in
accordance with Regulation (EC)
No 765/2008.
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244.
3. Where the notifying authority
EC TEXT
delegates or otherwise entrusts
the assessment, notification or
monitoring referred to in
paragraph 1 to a body which is
not a governmental entity, that
body shall be a legal entity and
shall comply mutatis mutandis
with the requirements laid down
in Article 21. In addition it shall
have arrangements to cover
liabilities arising out of its
activities.
245.
4. The notifying authority shall
EC TEXT
take full responsibility for the
tasks performed by the body
referred to in paragraph 3.
246.
Article 21
EC TEXT
Requirements relating to
notifying authorities
247.
1. A notifying authority shall be
EC TEXT
established in such a way that no
conflict of interest with
conformity assessment bodies
occurs.
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248.
2. A notifying authority shall be
EC TEXT
organised and operated so as to
safeguard the objectivity and
impartiality of its activities.
249.
3. A notifying authority shall be
EC TEXT
organised in such a way that each
decision relating to notification
of a conformity assessment body
is taken by competent persons
different from those who carried
out the assessment.
250.
4. A notifying authority shall not
EC TEXT
offer or provide any activities
that conformity assessment
bodies or consultancy services
perform on a commercial or
competitive basis.
251.
5. A notifying authority shall
EC TEXT
safeguard the confidentiality of
the information it obtains.
252.
6. A notifying authority shall
EC TEXT
have a sufficient number of
competent personnel at its
disposal for the proper
performance of its tasks.
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253.
Article 22
EC TEXT
Information obligation on
notifying authorities
254.
Member States shall inform the
EC TEXT
Commission of their procedures
for the assessment and
notification of conformity
assessment bodies and the
monitoring of notified bodies,
and of any changes thereto.
255.
The Commission shall make that
EC TEXT
information publicly available.
256.
Article 23
EC TEXT
Requirements relating to notified
bodies
257.
1. For the purposes of
EC TEXT
notification, a conformity
assessment body shall meet the
requirements laid down in
paragraphs 2 to 11.
258.
2. A conformity assessment body
EC TEXT
shall be established under the
national law of a Member State
and have legal personality.
137

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259.
3. A conformity assessment body
3. A conformity assessment body
CEU TEXT
shall be a third-party body
shall be a third-party body
independent of the organisation
independent of the organisation
or the CE marked fertilising
or the CE marked EU fertilising
products it assesses.
products it assesses.
260.
A body belonging to a business
deleted
CEU TEXT
association or professional
federation representing
undertakings involved in the
design, manufacturing, provision,
or use of CE marked fertilising
products which it assesses, may,
on condition that its
independence and the absence of
any conflict of interest are
demonstrated, be considered such
a body.
138

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261.
4. A conformity assessment
EC TEXT
body, its top level management
and the personnel responsible for
carrying out the conformity
assessment tasks shall not be the
designer, manufacturer, supplier,
purchaser, owner, or user of
fertilising products nor the
representative of any of those
parties. This shall not preclude
the use of fertilising products that
are necessary for the operations
of the conformity assessment
body or the use of fertilising
products for personal purposes.
139

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262.
A conformity assessment body,
EC TEXT
its top level management and the
personnel responsible for
carrying out the conformity
assessment tasks shall not be
directly involved in the design,
manufacture, marketing, or use of
fertilising products or represent
the parties engaged in those
activities. They shall not engage
in any activity that may conflict
with their independence of
judgement or integrity in relation
to conformity assessment
activities for which they are
notified. This shall in particular
apply to consultancy services.
263.
Conformity assessment bodies
EC TEXT
shall ensure that the activities of
their subsidiaries or
subcontractors do not affect the
confidentiality, objectivity or
impartiality of their conformity
assessment activities.
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264.
5. Conformity assessment bodies
EC TEXT
and their personnel shall carry
out the conformity assessment
activities with the highest degree
of professional integrity and the
requisite technical competence in
the specific field and shall be free
from all pressures and
inducements, particularly
financial, which might influence
their judgement or the results of
their conformity assessment
activities, especially as regards
persons or groups of persons with
an interest in the results of those
activities.
265.
6. A conformity assessment body
EC TEXT
shall be capable of carrying out
all the conformity assessment
tasks assigned to it by Annex IV
and in relation to which it has
been notified, whether those
tasks are carried out by the
conformity assessment body
itself or on its behalf and under
its responsibility.
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266.
At all times and for each
At all times and for each
CEU TEXT
conformity assessment procedure
conformity assessment procedure
and each kind or category of CE
and each kind or category of CE
marked fertilising products in
marked EU fertilising products in
relation to which it has been
relation to which it has been
notified, a conformity assessment
notified, a conformity assessment
body shall have at its disposal the
body shall have at its disposal the
necessary:
necessary:
267.
(a) personnel with technical
EC TEXT
knowledge and sufficient and
appropriate experience to
perform the conformity
assessment tasks;
268.
(b) descriptions of procedures in
EC TEXT
accordance with which
conformity assessment is carried
out, ensuring the transparency
and the ability of reproduction of
those procedures. It shall have
appropriate policies and
procedures in place that
distinguish between tasks it
carries out as a notified body and
other activities;
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269.
(c) procedures for the
EC TEXT
performance of activities which
take due account of the size of an
undertaking, the sector in which
it operates, its structure, the
degree of complexity of the
product technology in question
and the mass or serial nature of
the production process.
270.
A conformity assessment body
EC TEXT
shall have the means necessary to
perform the technical and
administrative tasks connected
with the conformity assessment
activities in an appropriate
manner and shall have access to
all necessary equipment or
facilities.
271.
7. The personnel responsible for
EC TEXT
carrying out the conformity
assessment tasks shall have the
following:
272.
(a) sound technical and
EC TEXT
vocational training covering all
the conformity assessment
activities in relation to which the
conformity assessment body has
been notified;
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273.
(b) satisfactory knowledge of the
EC TEXT
requirements of the assessments
they carry out and adequate
authority to carry out those
assessments;
274.
(c) appropriate knowledge and
(c) appropriate knowledge and
CEU TEXT
understanding of the
understanding of the
requirements set out in Annex I,
requirements set out in Annex I,
Annex II and Annex III, of the
Annex II and Annex III, of the
applicable harmonised standards
applicable harmonised standards
and of the relevant provisions of
referred to in Article 12 and
Union harmonisation legislation
common specifications referred
and of national legislation;
to in Article 13 and of the
relevant provisions of Union
harmonisation legislation and of
national legislation;
275.
(d) the ability to draw up
EC TEXT
certificates, records and reports
demonstrating that assessments
have been carried out.
276.
8. The impartiality of the
EC TEXT
conformity assessment bodies,
their top level management and
of the personnel responsible for
carrying out the conformity
assessment tasks shall be
guaranteed.
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277.
The remuneration of the top level
EC TEXT
management and personnel
responsible for carrying out the
conformity assessment tasks of a
conformity assessment body shall
not depend on the number of
assessments carried out or on the
results of those assessments.
278.
9. Conformity assessment bodies
EC TEXT
shall take out liability insurance
unless liability is assumed by the
State in accordance with national
law, or the Member State itself is
directly responsible for the
conformity assessment.
279.
10. The personnel of a
EC TEXT
conformity assessment body shall
observe professional secrecy with
regard to all information obtained
in carrying out their tasks under
Annex IV, except in relation to
the competent authorities of the
Member State in which its
activities are carried out.
Proprietary rights shall be
protected.
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280.
11. Conformity assessment
EC TEXT
bodies shall participate in, or
ensure that their personnel
responsible for carrying out the
conformity assessment tasks are
informed of, the relevant
standardisation activities and the
activities of the notified body
coordination group established
under Article 35 and shall apply
as general guidance the
administrative decisions and
documents produced as a result
of the work of that group.
281.
Article 24
EC TEXT
Presumption of conformity of
notified bodies
282.
Where a conformity assessment
EC TEXT
body demonstrates its conformity
with the criteria laid down in the
relevant harmonised standards or
parts thereof the references of
which have been published in the
Official Journal of the European
Union it shall be presumed to
comply with the requirements set
out in Article 23 in so far as the
applicable harmonised standards
cover those requirements.
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283.
Article 25
EC TEXT
Subsidiaries of and
subcontracting by notified bodies
284.
1. Where a notified body
EC TEXT
subcontracts specific tasks
connected with conformity
assessment or has recourse to a
subsidiary, it shall ensure that the
subcontractor or the subsidiary
meets the requirements set out in
Article 23 and shall inform the
notifying authority accordingly.
285.
2. Notified bodies shall take full
EC TEXT
responsibility for the tasks
performed by subcontractors or
subsidiaries wherever these are
established.
286.
3. Activities may be
EC TEXT
subcontracted or carried out by a
subsidiary only with the
agreement of the client.
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287.
4. Notified bodies shall keep at
EC TEXT
the disposal of the notifying
authority the relevant documents
concerning the assessment of the
qualifications of the
subcontractor or the subsidiary
and the work carried out by them
under Annex IV.
288.
Article 26
EC TEXT
Application for notification
289.
1. A conformity assessment body
EC TEXT
shall submit an application for
notification to the notifying
authority of the Member State in
which it is established.
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290.
2. The application for notification
2. The application for notification
CEU TEXT
shall be accompanied by a
shall be accompanied by a
description of the conformity
description of the conformity
assessment activities, the
assessment activities, the
conformity assessment module or
conformity assessment module or
modules and the CE marked
modules and the CE marked EU
fertilising product or products for
fertilising product or products for
which that body claims to be
which that body claims to be
competent, as well as by an
competent, as well as by an
accreditation certificate issued by
accreditation certificate issued by
a national accreditation body
a national accreditation body
attesting that the conformity
attesting that the conformity
assessment body fulfils the
assessment body fulfils the
requirements laid down in Article
requirements laid down in Article
23.
23.
291.
Article 27
EC TEXT
Notification procedure
292.
1. Notifying authorities may
EC TEXT
notify only conformity
assessment bodies which have
satisfied the requirements laid
down in Article 23.
293.
2. They shall notify the
EC TEXT
Commission and the other
Member States using the
electronic notification tool
developed and managed by the
Commission.
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3. The notification shall include
3. The notification shall include
CEU TEXT
full details of the conformity
full details of the conformity
assessment activities, the
assessment activities, the
conformity assessment module or
conformity assessment module or
modules and CE marked
modules and CE marked EU
fertilising product or products
fertilising product or products
concerned and the accreditation
concerned and the accreditation
certificate referred to in Article
certificate referred to in Article
26(2).
26(2).
295.
4. The body concerned may
EC TEXT
perform the activities of a
notified body only where no
objections are raised by the
Commission or the other Member
States within two weeks of a
notification.
296.
Only such a body shall be
EC TEXT
considered a notified body for the
purposes of this Regulation.
297.
5. The notifying authority shall
EC TEXT
notify the Commission and the
other Member States of any
subsequent relevant changes to
the notification.
298.
Article 28
EC TEXT
Identification numbers and lists
of notified bodies
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299.
1. The Commission shall assign
EC TEXT
an identification number to a
notified body.
300.
It shall assign a single such
EC TEXT
number even where the body is
notified under several Union acts.
301.
2. The Commission shall make
EC TEXT
publicly available the list of the
bodies notified under this
Regulation, including the
identification numbers that have
been assigned to them and the
activities for which they have
been notified.
302.
The Commission shall ensure
EC TEXT
that the list is kept up to date.
303.
Article 29
EC TEXT
Changes to notifications
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304.
1. Where a notifying authority
EC TEXT
has ascertained or has been
informed that a notified body no
longer meets the requirements
laid down in Article 23 or that it
is failing to fulfil its obligations,
the notifying authority shall
restrict, suspend or withdraw
notification as appropriate,
depending on the seriousness of
the failure to meet those
requirements or fulfil those
obligations. It shall immediately
inform the Commission and the
other Member States accordingly.
305.
2. In the event of restriction,
EC TEXT
suspension or withdrawal of
notification, or where the notified
body has ceased its activity, the
notifying Member State shall
take appropriate steps to ensure
that the files of that body are
either processed by another
notified body or kept available
for the responsible notifying and
market surveillance authorities at
their request.
306.
Article 30
EC TEXT
Challenge of the competence of
notified bodies
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307.
1. The Commission shall
EC TEXT
investigate all cases where it
doubts, or doubt is brought to its
attention regarding, the
competence of a notified body or
the continued fulfilment by a
notified body of the requirements
and responsibilities to which it is
subject.
308.
AM 66
EC TEXT
2. The notifying Member State
2. The notifying authorities shall
shall provide the Commission, on
provide the Commission, on
request, with all information
request, with all information
relating to the basis for the
relating to the basis for the
notification or the maintenance of
notification or the maintenance
the competence of the notified
of the competence of the notified
body concerned.
body concerned.
309.
3. The Commission shall ensure
EC TEXT
that all sensitive information
obtained in the course of its
investigations is treated
confidentially.
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310.
4. Where the Commission
EC TEXT
ascertains that a notified body
does not meet or no longer meets
the requirements for its
notification, it shall adopt an
implementing act requiring the
notifying Member State to take
the necessary corrective
measures, including withdrawal
of notification if necessary.
311.
That implementing act shall be
EC TEXT
adopted in accordance with the
advisory procedure referred to in
Article 41(2).
312.
Article 31
EC TEXT
Operational obligations of
notified bodies
313.
1. Notified bodies shall carry out
EC TEXT
conformity assessments in
accordance with the conformity
assessment procedures provided
for in Annex IV.
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314.
2. Conformity assessments shall
EC TEXT
be carried out in a proportionate
manner, avoiding unnecessary
burdens for economic operators.
Notified bodies shall perform
their activities taking due account
of the size of an undertaking, the
sector in which it operates, its
structure, the degree of
complexity of the product
technology in question and the
mass or serial nature of the
production process.
315.
In so doing they shall
In so doing they shall
CEU TEXT
nevertheless respect the degree of
nevertheless respect the degree of
rigour and the level of protection
rigour and the level of protection
required for the compliance of
required for the compliance of
the CE marked fertilising product
the CE marked EU fertilising
with this Regulation.
product with this Regulation.
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316.
3. Where a notified body finds
AM 67
3. Where a notified body finds
CEU TEXT
that the requirements set out in
that the requirements set out in
Annex I, Annex II or Annex III,
3. Where a notified body finds
Annex I, Annex II or Annex III,
or corresponding harmonised
that the requirements set out in
or corresponding harmonised
standards, common specifications
Annex I, Annex II or Annex III,
standards, common specifications
referred to in Article 13 or other
or corresponding harmonised
referred to in Article 13 or other
technical specifications, have not
standards, or common
technical specifications, have not
been met by a manufacturer, it
specifications referred to in
been met by a manufacturer, it
shall require that manufacturer to
Article 13, have not been met by
shall require that manufacturer to
take appropriate corrective
a manufacturer, it shall require
take appropriate corrective
measures and shall not issue a
that manufacturer to take
measures and shall not issue a
certificate.
appropriate corrective measures
certificate or approval decision.
and shall not issue a conformity
certificate or approval decision.
317.
4. Where, in the course of the
AM 68
4. Where, in the course of the
4. Where, in the course of the
monitoring of conformity
monitoring of conformity
monitoring of conformity
following the issue of a
4. Where, in the course of the
following the issue of a
following the issue of a
certificate, a notified body finds
monitoring of conformity
certificate or approval decision,
certificate or approval decision,
that a CE marked fertilising
following the issue of a
a notified body finds that a CE
a notified body finds that a CE
product no longer complies, it
certificate or approval decision,
marked EU fertilising product no
marked EU fertilising product no
shall require the manufacturer to
a notified body finds that a CE
longer complies, it shall require
longer complies, it shall require
take appropriate corrective
marked fertilising product no
the manufacturer to take
the manufacturer to take
measures and shall suspend or
longer complies, it shall require
appropriate corrective measures
appropriate corrective measures
withdraw the certificate if
the manufacturer to take
and shall suspend or withdraw
and shall suspend or withdraw
necessary.
appropriate corrective measures
the certificate or approval
the certificate or approval
and shall suspend or withdraw
decision, if necessary.
decision, if necessary.
the certificate or approval
decision 
if necessary.
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318.
5. Where corrective measures are
AM 69
5. Where corrective measures are
CEU TEXT
not taken or do not have the
not taken or do not have the
required effect, the notified body
5. Where corrective measures are
required effect, the notified body
shall restrict, suspend or
not taken or do not have the
shall restrict, suspend or
withdraw any certificates, as
required effect and a CE marked
withdraw any certificates or
appropriate.
fertilising product thus remains
approval decisions, as
non-compliant with the
appropriate.
requirements of this Regulation,
the notified body shall restrict,
suspend or withdraw any
certificates or approval
decisions
, as appropriate.
319.
Article 32
EC TEXT
Appeal against decisions of
notified bodies
320.
Member States shall ensure that
EC TEXT
an appeal procedure against
decisions of the notified bodies is
available.
321.
Article 33
EC TEXT
Information obligation on
notified bodies
322.
1. Notified bodies shall inform
EC TEXT
the notifying authority of the
following:
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(a) any refusal, restriction,
AM 70
(a) any refusal, restriction,
(a) any refusal, restriction,
suspension or withdrawal of a
suspension or withdrawal of a
suspension or withdrawal of a
certificate;
(a) any refusal, restriction,
certificate or approval decision;
certificate or approval decision;
suspension or withdrawal of a
certificate or approval decision;
324.
(b) any circumstances affecting
EC TEXT
the scope of or conditions for
notification;
325.
(c) any request for information
EC TEXT
which they have received from
market surveillance authorities
regarding conformity assessment
activities;
326.
(d) on request, conformity
EC TEXT
assessment activities performed
within the scope of their
notification and any other activity
performed, including cross-
border activities and
subcontracting.
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327.
2. Notified bodies shall provide
2. Notified bodies shall provide
CEU TEXT
the other bodies notified under
the other bodies notified under
this Regulation carrying out
this Regulation carrying out
similar conformity assessment
similar conformity assessment
activities covering the same CE
activities covering the same CE
marked fertilising products with
marked EU fertilising products
relevant information on issues
with relevant information on
relating to negative and, on
issues relating to negative and,
request, positive conformity
on request, positive conformity
assessment results.
assessment results.
328.
Article 34
EC TEXT
Exchange of experience
329.
The Commission shall provide
EC TEXT
for the organisation of exchange
of experience between the
Member States' national
authorities responsible for
notification policy.
330.
Article 35
EC TEXT
Coordination of notified bodies
331.
The Commission shall ensure
EC TEXT
that appropriate coordination and
cooperation between bodies
notified under this Regulation are
put in place and properly
operated in the form of a sectoral
group of notified bodies.
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332.
Member States shall ensure that
Notified bodies shall Member
CEU TEXT
the bodies notified by them
States shall ensure that the bodies
participate in the work of that
notified by them participate in
group, directly or by means of
the work of that group, directly
designated representatives.
or by means of designated
representatives.
333.
CHAPTER 5
CHAPTER 5
CEU TEXT
UNION MARKET
UNION MARKET
SURVEILLANCE, CONTROL
SURVEILLANCE, CONTROL
OF CE MARKED
OF CE MARKED EU
FERTILISING PRODUCTS
FERTILISING PRODUCTS
ENTERING THE UNION
ENTERING THE UNION
MARKET AND UNION
MARKET AND UNION
SAFEGUARD PROCEDURE
SAFEGUARD PROCEDURE
334.
Article 36
Article 36
CEU TEXT
Union market surveillance and
Union market surveillance and
control of CE marked fertilising
control of CE marked EU
products entering the Union
fertilising products entering the
market
Union market
335.
Articles 16 to 29 of Regulation
Articles 16 to 29 of Regulation
CEU TEXT
(EC) No 765/2008 shall apply to
(EC) No 765/2008 shall apply to
CE marked fertilising products.
CE marked EU fertilising
products.
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336.
Article 37
AM 71
Article 37
Article 37
Procedure for dealing with CE
Procedure at national level for
Procedure at national level for
marked fertilising products
Article 37
dealing with CE marked EU
dealing with CE marked EU
presenting a risk at national level
Procedure at national level for
fertilising products presenting a
fertilising products presenting a
dealing with CE marked
risk at national level
risk at national level
fertilising products presenting a
risk
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337.
1. Where the market surveillance
AM 72
1. Where the market surveillance
1. Where the market surveillance
authorities of one Member State
authorities of one Member State
authorities of one Member State
have sufficient reason to believe
Where the market surveillance
have sufficient reason to believe
have sufficient reason to believe
that a CE marked fertilising
authorities of one Member State
that a CE marked EU fertilising
that a CE marked EU fertilising
product presents an unacceptable
have sufficient reason to believe
product presents an unacceptable
product presents an unacceptable
risk to human, animal or plant
that a CE marked fertilising
risk to human, animal or plant
risk to human, animal or plant
health, to safety or to the
product presents risk to human,
health, to safety or to the
health, to safety or to the
environment, they shall carry out
animal or plant health, to safety
environment, they shall carry out
environment, they shall carry out
an evaluation in relation to the
or to the environment or to other
an evaluation in relation to the
an evaluation in relation to the
fertilising product concerned
aspects of public interest
fertilising product concerned
fertilising product concerned
covering the requirements laid
protection covered by this
covering all relevant the
covering all relevant the
down in this Regulation. The
Regulation, they shall carry out
requirements laid down in this
requirements laid down in this
relevant economic operators shall
an evaluation in relation to the
Regulation. The relevant
Regulation. The relevant
cooperate as necessary with the
fertilising product concerned
economic operators shall
economic operators shall
market surveillance authorities
covering all the requirements laid
cooperate as necessary with the
cooperate as necessary with the
for that purpose.
down in this Regulation. The
market surveillance authorities
market surveillance authorities
relevant economic operators shall
for that purpose.
for that purpose.
cooperate as necessary with the
market surveillance authorities
for that purpose.
(This amendment also covers a
horizontal amendment on the

term “unacceptable risk” (in
plural or singular) being

changed to “risk” (in singular);
adopting it will necessitate
corresponding changes of these
terms throughout the text and,
consequently, adopted
amendments.)

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338.
Where, in the course of the
AM 73
Where, in the course of the
Where, in the course of the
evaluation, the market
evaluation referred to in the
evaluation referred to in the
surveillance authorities find that
Where, in the course of the
first subparagraph, the market
first subparagraph, the market
the CE market fertilising product
evaluation, the market
surveillance authorities find that
surveillance authorities find that
does not comply with the
surveillance authorities find that
the CE market EU fertilising
the CE market EU fertilising
requirements laid down in this
the CE market fertilising product
product does not comply with the
product does not comply with the
Regulation, they shall without
does not comply with the
requirements laid down in this
requirements laid down in this
delay require the economic
requirements laid down in this
Regulation, they shall without
Regulation, they shall without
operator to take all appropriate
Regulation, they shall without
delay require the economic
delay require the economic
corrective actions within a
delay require the economic
operator to take all appropriate
operator to take all appropriate
reasonable period to bring the
operator to take all appropriate
corrective actions within a
corrective actionswithin a
fertilising product into
corrective actions to bring the
reasonable period to bring the
reasonable period prescribed by
compliance with those
fertilising product into
fertilising product into
the market surveillance
requirements, to withdraw the
compliance with those
compliance with those
authorities and commensurate
fertilising product from the
requirements, to withdraw the
requirements, to withdraw the
with the nature of the risk, to
market, to recall it, or to remove
fertilising product from the
fertilising product from the
bring the fertilising product into
the CE marking.
market or to recall it within a
market, or to recall it, or, to
compliance with those
reasonable period,
remove the CE marking.
requirements, to withdraw the
commensurate with the nature
fertilising product from the
of the risk, as they may
market, or to recall it, or, to
prescribe, and to remove the CE
remove the CE marking.
marking.
339.
Market surveillance
No amendment
authorities' obligations in this
respect shall be without
prejudice to Member States'
possibility to regulate fertilising
products which are not CE
marked when made available
on the market.

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340.
The market surveillance
EC TEXT
authorities shall inform the
relevant notified body
accordingly.
341.
Article 21 of Regulation (EC) No
EC TEXT
765/2008 shall apply to the
measures referred to in the
second subparagraph.
342.
2. Where the market surveillance
EC TEXT
authorities consider that non-
compliance is not restricted to
their national territory, they shall
inform the Commission and the
other Member States of the
results of the evaluation and of
the actions which they have
required the economic operator to
take.
343.
3. The economic operator shall
3. The economic operator shall
CEU TEXT
ensure that all appropriate
ensure that all appropriate
corrective action is taken in
corrective action is taken in
respect of all the CE marked
respect of all the CE marked EU
fertilising products concerned
fertilising products concerned
that it has made available on the
that it has made available on the
market throughout the Union.
market throughout the Union.
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344.
4. Where the relevant economic
AM 74
4. Where the relevant economic
4. Where the relevant economic
operator does not take adequate
operator does not take adequate
operator does not take adequate
corrective action within the
Where the relevant economic
corrective action within the
corrective action within the
period referred to in the second
operator does not take adequate
period referred to in the second
period referred to in the second
subparagraph of paragraph 1, the
corrective action within the
subparagraph of paragraph 1, the
subparagraph of paragraph 1, the
market surveillance authorities
period referred to in the second
market surveillance authorities
market surveillance authorities
shall take all appropriate
subparagraph of paragraph 1, the
shall take all appropriate
shall take all appropriate
provisional measures to prohibit
market surveillance authorities
provisional measures to prohibit
provisional measures to prohibit
or restrict the CE marked
shall take all appropriate
or restrict the CE marked EU
or restrict the CE marked EU
fertilising product being made
provisional measures to prohibit
fertilising product being made
fertilising product being made
available on their national
or restrict the CE marked
available on their national
available on their national
market, to withdraw the
fertilising product being made
market, to withdraw the
market, to withdraw the
fertilising product from that
available on their national
fertilising product from that
fertilising product from that
market or to recall it.
market, to withdraw the
market or to recall it.
market or to recall it.
fertilising product from that
market or to recall it. Market
surveillance authorities'
obligations in this respect shall
be without prejudice to Member
States' possibility to regulate
fertilising products which are
not CE marked when made
available on the market.

345.
The market surveillance
EC TEXT
authorities shall inform the
Commission and the other
Member States, without delay, of
those measures.
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5. The information referred to in
5. The information referred to in
CEU TEXT
the second subparagraph of
the second subparagraph of
paragraph 4 shall include all
paragraph 4 shall include all
available details, in particular the
available details, in particular the
data necessary for the
data necessary for the
identification of the non-
identification of the non-
compliant CE marked fertilising
compliant CE marked EU
product, the origin of that
fertilising product, the origin of
fertilising product, the nature of
that fertilising product, the nature
the non-compliance alleged and
of the non-compliance alleged
the risk involved, the nature and
and the risk involved, the nature
duration of the national measures
and duration of the national
taken and the arguments put
measures taken and the
forward by the relevant economic
arguments put forward by the
operator. In particular, the market
relevant economic operator. In
surveillance authorities shall
particular, the market
indicate whether the non-
surveillance authorities shall
compliance is due to either of the
indicate whether the non-
following:
compliance is due to either of the
following:
347.
(a) failure of the CE marked
(a) failure of the CE marked EU
CEU TEXT
fertilising product to meet the
fertilising product to meet the
requirements set out in Annexes
requirements set out in Annexes
I, II or III
I, II or III
348.
(b) shortcomings in the
AM 75
(b) shortcomings in the
(b) shortcomings in the
harmonised standards referred to
harmonised standards referred to
harmonised standards referred to
in Article 12 conferring a
(b) shortcomings in the
in Article 12 conferring a
in Article 12;
presumption of conformity.
harmonised standards referred to
presumption of conformity;
in Article 12;
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349.
AM 76
(ba) shortcomings in the
(ba) shortcomings in the
common specifications referred
common specifications referred
(ba) shortcomings in the
to in Article 13
to in Article 13.
common specifications referred
to in Article 13.

350.
6. Member States other than the
6. Member States other than the
CEU TEXT
Member State initiating the
Member State initiating the
procedure under this Article shall
procedure under this Article shall
without delay inform the
without delay inform the
Commission and the other
Commission and the other
Member States of any measures
Member States of any measures
adopted and of any additional
adopted and of any additional
information at their disposal
information at their disposal
relating to the non-compliance of
relating to the non-compliance of
the CE marked fertilising product
the CE marked EU fertilising
concerned, and, in the event of
product concerned, and, in the
disagreement with the adopted
event of disagreement with the
national measure, of their
adopted national measure, of
objections.
their objections.
351.
7. Where, within three months of
EC TEXT
receipt of the information
referred to in the second
subparagraph of paragraph 4, no
objection has been raised by
either a Member State or the
Commission in respect of a
provisional measure taken by a
Member State, that measure shall
be deemed justified.
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352.
8. Member States shall ensure
8. Member States shall ensure
CEU TEXT
that appropriate restrictive
that appropriate restrictive
measures, such as withdrawal,
measures, such as withdrawal,
are taken without delay in respect
are taken without delay in respect
of the CE marked fertilising
of the CE marked EU fertilising
product concerned.
product concerned.
352a.
8a. Market surveillance
authorities' obligations under
this Article 
shall be without
prejudice to Member States'
possibility to regulate fertilising
products which are not CE
marked when made available
on the market.

353.
Article 38
EC TEXT
Union safeguard procedure
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354.
1. Where, on completion of the
EC TEXT
procedure set out in Article 37(3)
and (4), objections are raised
against a measure taken by a
Member State, or where the
Commission considers a national
measure to be contrary to Union
legislation, the Commission shall
without delay enter into
consultation with the Member
States and the relevant economic
operator or operators and shall
evaluate the national measure.
On the basis of the results of that
evaluation, the Commission shall
adopt an implementing act in the
form of a decision determining
whether the national measure is
justified or not.
355.
If the national measure is
If the national measure is
CEU TEXT
considered justified, the decision
considered justified, the decision
shall order all Member States to
shall order all Member States to
take the necessary measures to
take the necessary measures to
ensure that the non-compliant CE
ensure that the non-compliant CE
marked fertilising product is
marked EU fertilising product is
withdrawn from their market, and
withdrawn from their market, and
to inform the Commission
to inform the Commission
accordingly.
accordingly.
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356.
If the national measure is
EC TEXT
considered unjustified, the
decision shall order the Member
State concerned to withdraw that
measure.
357.
The Commission shall address its
EC TEXT
decision to all Member States
and shall immediately
communicate it to them and the
relevant economic operator or
operators.
358.
2. Where the national measure is
2. Where the national measure is
CEU TEXT
considered justified and the non-
considered justified and the non-
compliance of the CE marked
compliance of the CE marked
fertilising product is attributed to
EU fertilising product is
shortcomings in the harmonised
attributed to shortcomings in the
standards referred to in point (b)
harmonised standards referred to
of Article 37(5), the Commission
in point (b) of Article 37(5), the
shall apply the procedure
Commission shall apply the
provided for in Article 11 of
procedure provided for in Article
Regulation (EU) No 1025/2012.
11 of Regulation (EU) No
1025/2012.
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359.
AM 77
2a.Where the national measure
2a. Where the national measure
is considered justified and the
is considered to be justified and
2a. Where the national measure
non-compliance of the EU
the non-compliance of the EU
is considered to be justified and
fertilising product is attributed
fertilising product is attributed
the non-compliance of the CE
to shortcomings in the common
to shortcomings in the common
marked fertilising product is
specifications referred to in
specifications referred to in
attributed to shortcomings in the
point (c) of Article 37(5), the
point (ba) of Article 37(5), the
common specifications referred
Commission shall, without
Commission shall, without
to in point (ba) of Article 37(5),
delay, adopt an implementing
delay, adopt implementing acts
the Commission shall, without
act amending or repealing the
amending or repealing the
delay, adopt implementing acts
common specification
common specifications
amending or repealing the
concerned. The implementing
concerned. Those implementing
common specification
act shall be adopted in
acts shall be adopted in
concerned. Those implementing
accordance with the
accordance with the
acts shall be adopted in
examination procedure
examination procedure referred
accordance with the
referred to in Article 41(3).
to in Article 41(3).
examination procedure referred
to in Article 41(3).

360.
Article 39
Article 39
CEU TEXT
Compliant CE marked fertilising
Compliant CE marked EU
products which present a risk
fertilising products which present
a risk
361.
1. Where, having carried out an
AM 78
1. Where, having carried out an
1. Where, having carried out an
evaluation under Article 37(1), a
evaluation under Article 37(1), a
evaluation under Article 37(1), a
Member State finds that although
1. Where, having carried out an
Member State finds that although
Member State finds that,
a CE marked fertilising product
evaluation under Article 37(1), a
a CE marked EU fertilising
although a CE marked EU
is in compliance with this
Member State finds that although
product is in compliance with
fertilising product is in
Regulation it presents an
a CE marked fertilising product
this Regulation it presents an
compliance with this Regulation,
unacceptable risk to human,
is in compliance with this
unacceptable risk to human,
it presents an unacceptable risk to
animal or plant health, to safety
Regulation it  presents risk to
animal or plant health, to safety
human, animal or plant health, to
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or to the environment, it shall
human, animal or plant health, to
or to the environment, it shall
safety or to the environment, it
require the relevant economic
safety or to the environment or to
require the relevant economic
shall without delay require the
operator to take all appropriate
other aspects of public interest
operator to take all appropriate
relevant economic operator to
measures within a reasonable
protection covered by this
measures within a reasonable
take all appropriate measures,
period to ensure that the
Regulation, it shall without delay
period to ensure that the
within a reasonable period
fertilising product concerned,
require the relevant economic
fertilising product concerned,
prescribed by the market
when placed on the market, no
operator to take all appropriate
when placed on the market, no
surveillance authority and
longer presents that risk, to
measures, within a reasonable
longer presents that risk, to
commensurate with the nature
withdraw the fertilising product
period prescribed by the market
withdraw the fertilising product
of the risk, to ensure that the
from the market or to recall it.
surveillance authority and
from the market or to recall it.
fertilising product concerned,
commensurate with the nature
when made available on the
of the risk, to ensure that the
market, no longer presents that
fertilising product concerned,
risk, to withdraw the fertilising
when made available on the
product from the market or to
market, no longer presents that
recall it.
risk, to withdraw the fertilising
product from the market or to
recall it.
362.
2. The economic operator shall
2. The economic operator shall
CEU TEXT
ensure that corrective action is
ensure that corrective action is
taken in respect of all the CE
taken in respect of all the CE
marked fertilising products
marked EU fertilising products
concerned that he or she has
concerned that he or she has
made available on the market
made available on the market
throughout the Union.
throughout the Union.
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363.
3. The Member State shall
3. The Member State shall
CEU TEXT
immediately inform the
immediately inform the
Commission and the other
Commission and the other
Member States. That information
Member States. That information
shall include all available details,
shall include all available details,
in particular the data necessary
in particular the data necessary
for the identification of the CE
for the identification of the CE
marked fertilising product
marked EU fertilising product
concerned, the origin and the
concerned, the origin and the
supply chain of that fertilising
supply chain of that fertilising
product, the nature of the risk
product, the nature of the risk
involved and the nature and
involved and the nature and
duration of the national measures
duration of the national measures
taken.
taken.
364.
4. The Commission shall without
EC TEXT
delay enter into consultation with
the Member States and the
relevant economic operator or
operators and shall evaluate the
national measures taken. On the
basis of the results of that
evaluation, the Commission shall
adopt an implementing act in the
form of a decision determining
whether the national measure is
justified or not, and where
necessary, ordering appropriate
measures.
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365.
Those implementing acts shall be
EC TEXT
adopted in accordance with the
examination procedure referred
to in Article 41(3).
366.
On duly justified imperative
EC TEXT
grounds of urgency relating to
the protection of human, animal
or plant health, safety or the
environment, the Commission
shall adopt immediately
applicable implementing acts in
accordance with the procedure
referred to in Article 41(4).
367.
5. The Commission shall address
EC TEXT
its decision to all Member States
and shall immediately
communicate it to them and the
relevant economic operator or
operators.
368.
Article 40
EC TEXT
Formal non-compliance
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369.
1. Without prejudice to Article
1. Without prejudice to Article
CEU TEXT
37, where a Member State makes
37, where a Member State makes
one of the following findings on
one of the following findings on
a CE marked fertilising product,
a CE marked EU fertilising
it shall require the relevant
product, it shall require the
economic operator to put an end
relevant economic operator to put
to the non-compliance
an end to the non-compliance
concerned:
concerned:
370.
(a) the CE marking has been
EC TEXT
affixed in violation of Article 30
of Regulation (EC) No 765/2008
or of Article 17 of this
Regulation;
371.
(b) the identification number of
EC TEXT
the notified body has been
affixed in violation of Article 17
or has not been affixed, where
required by Article 17;
372.
(c) the EU declaration of
AM 79
(c) the EU declaration of
(c) the EU declaration of
conformity does not accompany
conformity does not accompany
conformity has not been drawn
the CE marked fertilising
(c) the EU declaration of
the CE marked fertilising
up does not accompany the CE
product;
conformity has not been drawn
product;
marked fertilising product;
up;
(ca) the EU declaration of
conformity has not been drawn
up

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373.
(d) the EU declaration of
EC TEXT
conformity has not been drawn
up correctly;
374.
(e) technical documentation is
(e) the technical documentation
CEU TEXT
either not available or not
is either not available or not
complete;
complete;
375.
(f) the information referred to in
EC TEXT
Article 6(6) or Article 8(3) is
absent, false or incomplete;
376.
(g) any other administrative
EC TEXT
requirement provided for in
Article 6 or Article 8 is not
fulfilled.
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377.
2. Where the non-compliance
2. Where the non-compliance
2. Where the non-compliance
referred to in paragraph 1
referred to in paragraph 1
referred to in paragraph 1
persists, the Member State
persists, the Member State
persists, the Member State
concerned shall take all
concerned shall take all
concerned shall take all
appropriate measures to restrict
appropriate measures to restrict
appropriate measures to restrict
or prohibit the CE marked
or prohibit the CE marked EU
or prohibit the CE marked EU
fertilising product being made
fertilising product being made
fertilising product being made
available on the market or ensure
available on the market or ensure
available on the market or ensure
that it is recalled or withdrawn
that it is recalled or withdrawn
that it is recalled or withdrawn
from the market or that the CE
from the market or, that the CE
from the market or, that the CE
marking is removed.
marking is removed.
marking is removed.
Member States' obligations in
Member States' obligations in
this respect shall be without
this respect shall be without
prejudice to their possibility to
prejudice to their possibility to
regulate fertilising products
regulate fertilising products
which are not CE marked
which are not CE marked
when made available on the
when made available on the
market.
market.
378.
CHAPTER 6
EC TEXT
COMMITTEE AND
DELEGATED ACTS
379.
Article 41
EC TEXT
Committee procedure
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380.
1. The Commission shall be
EC TEXT
assisted by the Committee on
Fertilising products. That
committee shall be a committee
within the meaning of Regulation
(EU) No 182/2011.
381.
2. Where reference is made to
EC TEXT
this paragraph, Article 4 of
Regulation (EU) No 182/2011
shall apply.
382.
3. Where reference is made to
EC TEXT
this paragraph, Article 5 of
Regulation (EU) No 182/2011
shall apply.
383.
4. Where reference is made to
EC TEXT
this paragraph, Article 8 of
Regulation (EU) No 182/2011, in
conjunction with Article 5
thereof, shall apply.
384.
Article 42
EC TEXT
Amendments of Annexes
178

385.
AM 80
1. The Commission shall be
1. The Commission shall be
empowered to adopt delegated
empowered to adopt delegated
1. The Commission shall be
1. The Commission shall be
acts in accordance with Article
acts in accordance with Article
empowered to adopt delegated
empowered to adopt delegated
43 to amend Annexes I II to IV
43 to amend Annex I, with the
acts in accordance with Article
acts in accordance with Article
for the purposes of adapting them
exception of cadmium (Cd)
43 to amend Annexes I to IV for
43 to amend Annexes I to IV for
to technical progress established
limit values and the definitions,
the purposes of adapting them to
the purposes of adapting them to
after the adoption of this
or other elements relating to
technical progress and facilitating
technical progress, taking into
regulation, in particular in the
scope, of product function
internal market access and free
account products and materials
field of fertilising product
categories, and Annexes II, III
movement for CE marked
already authorised in Member
production from animal by-
and IV for the purposes of
fertilising products
States, and in particular in the
products, of waste recovery, in
adapting them to technical
fields of fertilising product
the agricultural sector and the
progress and of facilitating
production from animal by-
agro-food industry, and for
internal market access and free
products and waste recovery,
facilitating internal market access
movement for EU fertilising
and for the purpose of
and free movement for CE
products:
facilitating internal market access
marked EU fertilising products,
and free movement for CE
marked fertilising products:
Council position modified by CRP
Mandate 16/03:

1. The Commission shall be
empowered to adopt delegated
acts in accordance with
Article 43 to amend Annexes I II
to IV for the purposes of
adapting them to technical
progress established after the
adoption of this regulation, in
particular in the field of
fertilising product production
from animal by-products, other
by-products, or recovered
waste, in the agricultural sector
and in the agro-food industry,

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and for facilitating internal
market access and free
movement for CE marked EU
fertilising products
386.
(a) which are likely to be subject
(a) which have the potential to
EP TEXT
of significant trade on the
be subject of significant trade on
internal market, and
the internal market, and
387.
(b) for which there is scientific
(b) for which there is scientific
(b) for which there is scientific
(b) for which there is scientific
evidence that the they do not
evidence that the they do not
evidence that the they do not
evidence that the they do not
present an unacceptable risk to
present risk to human, animal
present an unacceptable risk to
present a risk to human, animal
human, animal or plant health, to
or plant health, to safety or to the
human, animal or plant health, to
or plant health, to safety or to the
safety or to the environment, and
environment, and that they are
safety or to the environment, and
environment, and that they are
that they are sufficiently
sufficiently effective.
that they are sufficiently
sufficiently effective ensure
effective.
effective.
agronomic efficiency, taking
into account in particular

Council position modified by CRP
products and materials already
Mandate 16/03:
authorised in Member States.
(b) for which there is scientific
evidence that the they do not
present an unacceptable risk to
human, animal or plant health, to
safety or to the environment, and
that they are sufficiently effective
ensure agronomic efficiency.
388.
Those delegated acts may also
Where the Commission adopts
introduce contaminant limits in
delegated acts in order to add
Annex I which are necessary as
or review component material
a consequence of the addition
categories so as to include
materials that can be

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of component materials in
considered as recovered waste
Annex II.
or as by-products within the
meaning of Directive

Council position modified by CRP
2008/98/EC, those delegated
Mandate 16/03:
acts shall explicitly exclude
such materials from

Where the Commission adopts
Component Material
delegated acts in order to add
Categories 1 and 12.
or review component material
categories so as to include

When adopting those delegated
materials that can be
acts, the Commission shall
considered as recovered waste
prioritise in particular animal
within the meaning of Directive
by-products, by-products
2008/98/EC, those delegated
within the meaning of Directive
acts shall explicitly excluded
2008/98/EC, and recovered
such materials from
waste, in particular from the
Component Material Category
agricultural sector and the
1.
agro-food industry, as well as
materials and products already

Where the Commission adopts
lawfully placed on the market
delegated acts in order to add
in one or more Member States.
or review component material
categories so as to include
materials that can be
considered as by-products
within the meaning of Directive
2008/98/EC, those delegated
acts shall explicitly excluded
such materials from
Component Material Category
12.

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389.
AM 81
1a. Without undue delay after
[date of the entry into force of

1a. Without undue delay after
this Regulation], the
… [date of the entry into force
Commission shall assess
of this Regulation], the
struvite, biochar, and ash-based
Commission shall adopt
products, and if the assessment
delegated acts, in accordance
concludes that the criteria in
with paragraph 1, to amend the
point b of paragraph 1 are
component material categories
fulfilled adopt delegated acts in
set out in Annex II to add in
accordance with that paragraph
particular animal by-products
to include those materials in
for which the end-point has
Annex II.
been determined, struvite,
biochar and ash-based products

When adopting delegated acts
to those component material
in accordance with paragraph
categories, as well as to lay
1, the Commission may amend
down the requirements for the
the component material
inclusion of those products in
categories set out in Annex II
those categories. When adopting
in order to include materials
those delegated acts, the
that cease to be waste following
Commission shall specifically
a recovery operation only if
take into account technological
recovery rules in that Annex,
progress in the recovery of
adopted no later than the
nutrients.
inclusion, ensure that the
materials comply with the
conditions laid down in
Article 6 of Directive
2008/98/EC.

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390.
AM 345
No amendment
1b. The Commission shall be
empowered to adopt delegated
acts in accordance with Article
43 to extend the date of entry
into force of the 20mg/kg limit
referred to in Annex I, part II,
PFC1(B), point 3, point (a),
point 2 and Annex I, part II,
PFC1(C)I, point 2, point (a),
point 2, if, based on a thorough
impact assessment, it has
evidence to consider that the
introduction of a stricter limit
would seriously jeopardise the
supply of fertilising products to
the Union.

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391.
AM 82
2. Where the Commission
amends Annex II in order to add
2. Where the Commission
2. Where the Commission
2. Where the Commission
new micro-organisms or strains
amends Annex II in order to add
amends Annex II in order to add
amends Annex II in order to add
of microorganisms, or
new micro-organisms to the
new strains of micro-organisms
new micro-organisms or strains
additional processing methods,
component material category for
to the component material
of microorganisms to the
to the component material
such organisms pursuant to
category for such organisms, it
component material category for
category for such organisms
paragraph 1, it shall do so on the
shall do so, after verifying that
such organisms pursuant to
pursuant to paragraph 1, it shall
basis of the following data:
all concerned strains of the
paragraph 1, it shall do so, after
do so, after having verified
additional microorganism
having verified which strains of
which strains of the additional
comply with the requirements in
the additional microorganism
microorganism fulfil the
point (b) of paragraph 1 of this
are fulfilling the provisions of
requirements of paragraph
Article, on the basis of the
paragraph 1 (b), on the basis of
1(b), on the basis of the
following data:
the following data:
following data:
392.
AM 83
EC TEXT
(a) name of the micro-organism;
(a) name of the micro-organism
at strain level;
393.
(b) taxonomic classification of
(b) taxonomic classification of
CEU TEXT
the micro-organism;
the micro-organism: genus,
species, strain and
procurement method
;
394.
AM 84
CEU TEXT
(c) historical data of safe
(c) scientific literature reporting
(c) historical data of scientific
production and use of the micro-
about safe production and use of
literature reporting about safe
organism
the micro-organism
production, conservation and
use of the micro-organism
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395.
AM 85
CEU TEXT
(d) taxonomic relation to micro-
(d) taxonomic relation to micro-
(d) taxonomic relation to micro-
organism species fulfilling the
organism species fulfilling the
organism species fulfilling the
requirements for a Qualified
requirements for a Qualified
requirements for a Qualified
Presumption of Safety as
Presumption of Safety as
Presumption of Safety as
established by the European Food
established by the European
established by the European
Safety Agency;
Food Safety Authority, or
Food Safety Authority Agency;
reference of declared conformity
to the relevant harmonised
standards on safety of micro-
organisms used which have
been published in the Official
Journal of the European Union,
or conformity with the
requirements for the safety
evaluation of micro-organisms
as adopted by the Commission if
such harmonised standards are
not in place
;
396.
(e) information on residue levels
deleted
CEU TEXT
of toxins;
397.
(f) information on the production
(f) information on the production
process; and
process, including, where
relevant, processing methods
such as spray dying, fluid-bed
dying, static dying,
centrifugation, deactivation by
heat, filtration and grinding; and
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398.
(g) information on the identity of
(g) information on the identity
CEU TEXT
residual intermediates or
and residue levels of residual
microbial metabolites in the
intermediates, toxins or
component material.
microbial metabolites in the
component material.;
399.
(ga) natural occurrence,
CEU TEXT
survival and mobility in the
environment.

400.
AM 86
No amendment
To reflect the rapid
technological progress in that
field, the Commission shall, by

… [one year after the date of
entry into force of this
Regulation], adopt delegated
acts in accordance with Article
43 to define criteria for the
evaluation of micro-organisms
that may be used in plant
nutrition products without being
inscribed nominally in a positive
list.

401.
3. When adopting delegated acts
3. When adopting delegated acts
3. The Commission may adopt
in accordance with paragraph 1,
in accordance with paragraph
delegated acts in accordance with
the Commission may amend the
1,the Commission may amend
paragraph 1 to amend the
component material categories
the component material
component material categories
set out in Annex II in order to
categories set out in Annex II in
set out in Annex II in order to
add animal by-products within
order to add products derived
add derived products within the
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the meaning of Regulation (EC)
from animal by-products within
meaning of Regulation (EC)
No 1069/2009 only where an end
the meaning of Regulation (EC)
No 1069/2009 only where an end
point in the manufacturing chain
No 1069/2009 only where an end
point in the manufacturing chain
has been determined for such
point in the manufacturing chain
has been determined in
products in accordance with the
has been determined for such
accordance with Article 5(2) of
procedures laid down in that
products in accordance with the
that Regulation.
Regulation.
procedures laid down in that
Regulation.
The Commisison shall assess
such derived products with
respect to relevant aspects not
taken into account for the
purpose of defining an end point
in accordance with Regulation
(EC) No 1069/2009, and shall, if
the assessment concludes that
the criteria in point b of
paragraph 1 are fulfilled, adopt
delegated acts in accordance
with paragraph 1 to include
those materials in Annex II
without undue delay whenever
such an end point is determined.

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402.
AM 87
No amendment
By … [six months after the date
of entry into force of this
Regulation], the Commission
shall adopt delegated acts in
accordance with Article 43 to
amend Annex II in order to
insert the end-points in the
manufacturing chain that have
been determined in accordance
with the second subparagraph of
Article 5(2) of Regulation (EC)
No 1069/2009,with regard to the
animal by-products listed in
CMC 11 of Annex II.

403.
AM 88
The Commission shall by …
[five years after the date of entry

3a. When adopting delegated
into force of this Regulation]
acts referred to in paragraph 1,
assess biodegradation criteria
the Commission shall amend the
for polymers referred to in
component material category
point 2 of CMC 10 and test
setting the requirement for
methods to verify the
polymers other than nutrient
compliance with those criteria
polymers in Annex II in order to
and, where appropriate, adopt a
reflect the latest scientific
delegated act in accordance with
evidence and technological
paragraph 1 which lays down
development, and by … [three
those criteria. The criteria shall
years after the date of
ensure that the polymer is
application of this Regulation]
capable of undergoing physical
shall define the criteria of the
and biological decomposition in
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conversion of polymeric carbon
natural soil conditions and
to be converted into carbon
aquatic environments across the
dioxide (CO2) and a respective
EU, such that it ultimately
testing method for
decomposes only into carbon
biodegradation.
dioxide (CO2), biomass and
water. They shall ensure that the
polymer has at least 90% of the
organic carbon converted into
CO2 in a maximum period of 48
months after the end of the
claimed functionality period of
the fertilising product indicated
on the label, and as compared to
an appropriate standard in the
biodegradation test. Those
criteria shall ensure that the use
of polymers does not lead to
accumulation of plastics in the
environment.

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404.
AM 89
3b. By … [Publications office,
please insert the date 3 years
3b. When adopting delegated
after the date of entry into force],
acts referred to in paragraph 1,
the Commission shall adopt
the Commission shall amend the
delegated acts in accordance with
component material category
Article 43 to supplement point 3
setting the criteria for other
of CMC 12 in Annex II by laying
industry by-products in Annex
down criteria on agronomic
II in order to reflect the present
efficiency and safety for the use
product manufacturing
of by-products within the
practices, technological
meaning of Directive
development and the latest
2008/98/EC in EU fertilising
scientific evidence, and by …
products.
[one year after the date of entry
into force of this Regulation]

The criteria shall reflect present
shall define the criteria for
product manufacturing practices,
industrial by-products for their
technological developments and
inclusion to the component
the latest scientific evidence.
material category.
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405.
3a. When adopting delegated
No amendment
acts in accordance with
paragraph 1, the Commission
may amend the component
material categories set out in
Annex II in order to include
materials that have ceased to
be waste following a recovery
operation only if recovery rules
in that Annex, adopted no later
than the inclusion, ensure that
the materials comply with the
conditions laid down in Article
6(1) of Directive 2008/98/EC.

405a.
Council position modified by CRP
No amendment
Mandate 16/03:
3b.
By … [Publications
office, please insert the date 3
years after the date of entry
into force] the Commission
shall adopt delegated acts in
accordance with Article 43 to
supplement point 3 of CMC 12
in Annex II in the light of the
latest scientific evidence by
laying down the criteria on
agronomic efficiency and safety
for the use of by-products in
EU fertilising products.

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406.
4. The Commission shall also be
4. The Commission shall also be
4. The Commission shall also be
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
43 to amend Annexes I to IV in
43 to amend Annexes I, with the
43 to amend Annex I, with the
the light of new scientific
exception of cadmium (Cd)
exception of cadmium (Cd)
evidence. The Commission shall
limit values, and Annexes II,
limit values, and Annexes II,
use this empowerment where,
III and to IV in the light of new
III and to IV in the light of new
based on a risk assessment, an
scientific evidence. The
scientific evidence. The
amendment proves necessary to
Commission shall use this
Commission shall use this
ensure that any CE marked
empowerment where, based on a
empowerment where, based on a
fertilising product complying
risk assessment, an amendment
risk assessment, an amendment
with the requirements of this
proves necessary to ensure that
proves necessary to ensure that
Regulation does not, under
any CE marked EU fertilising
any CE marked EU fertilising
normal conditions of use, present
product complying with the
product complying with the
an unacceptable risk to human,
requirements of this Regulation
requirements of this Regulation
animal, or plant health, to safety
does not, under normal
does not, under normal
or to the environment.
conditions of use, present an
conditions of use, present an
unacceptable risk to human,
unacceptable risk to human,
animal, or plant health, to safety
animal or plant health, to safety
or to the environment.
or to the environment.
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407.
4a. By (Publication office
No amendment
please insert the date occurring
five years after the date of
entry-into-force of this
Regulation) the Commission
shall adopt delegated acts in
accordance with Article 43 to
supplement point 2 of CMC 10
in Annex II in the light of the
latest scientific evidence by
laying down the exact
biodegradability criteria and
the testing method for
biodegradation that ensure that
as a result of physical and
biological decomposition
polymers ultimately decompose
into carbon dioxide (CO2),
biomass and water. Those
criteria shall ensure that the
use of polymers does not lead
to accumulation of plastics in
the environment.

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408.
4b. Prior to the adoption of
Delegated acts introducing new
delegated acts introducing new
contaminant limits in Annex I
contaminant limits in Annex I
in accordance with paragraph
in accordance with paragraph
1 shall take into account
1, the Commission shall request
scientific opinions of the
the scientific advice of the
European Food Safety
European Food Safety
Authority, the European
Authority provided under
Chemicals Agency, or the
Article 22 of Regulation (EC)
Commission’s Joint Research
No 178/2002 of the European
Centre, as relevant.
Parliament and of the Council
of 28 January 2002 laying
down the general principles
and requirements of food law,
establishing the European Food
Safety Authority and laying
down procedures in matters of
food safety.

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409.
Article 42a
When exercising its power to
Separate delegated acts for
adopt delegated acts pursuant
separate Component Material
to Article 42, the Commission
Categories
shall adopt a separate
delegated act in respect of each

When exercising its power to
Component Material Category
adopt delegated acts pursuant
in Annex II, including any
to Article 42, the Commission
amendments in Annexes I, III
shall adopt a separate
and IV which are necessary as
delegated act in respect of each
a consequence of the
Component Material Category
amendment of Annex II.
in Annex II, including the
introduction of any
contaminant limits in Annex I
which are necessary as a
consequence of the addition of
component materials in Annex
II.

410.
Article 43
EC TEXT
Exercise of the delegation
411.
1. The power to adopt delegated
EC TEXT
acts is conferred on the
Commission subject to the
conditions laid down in this
Article.
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2. The power to adopt delegated
2. The power to adopt delegated
CEU TEXT
acts referred to in Article 42 shall
acts referred to in Article 42 shall
be conferred on the Commission
be conferred on the Commission
for five years from [Publications
for a period of five years from
office, please insert the date of
[Publications office, please insert
entry into force of this
the date of entry into force of this
Regulation]. The Commission
Regulation]. The Commission
shall draw up a report in respect
shall draw up a report in respect
of the delegation of power not
of the delegation of power not
later than nine months before the
later than nine months before the
end of the five-year period. The
end of the five-year period. The
delegation of power shall be
delegation of power shall be
tacitly extended for periods of an
tacitly extended for periods of an
identical duration, unless the
identical duration, unless the
European Parliament or the
European Parliament or the
Council opposes such extension
Council opposes such extension
not later than three months before
not later than three months before
the end of each period.
the end of each period.
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413.
3. The delegation of power
EC TEXT
referred to in Article 42 may be
revoked at any time by the
European Parliament or by the
Council. A decision to revoke
shall put an end to the delegation
of the power specified in that
decision. It shall take effect the
day following the publication of
the decision in the Official
Journal of the European Union or
at a later date specified therein. It
shall not affect the validity of any
delegated acts already in force.
414.
AM 91
3a. Before adopting a delegated
EP TEXT
act, the Commission shall
3a. Before adopting a delegated
consult experts designated by
act, the Commission shall
each Member State in
consult experts designated by
accordance with the principles
each Member State in
laid down in the
accordance with the principles
Interinstitutional Agreement
laid down in the
on Better Law-Making of 13
Interinstitutional Agreement of
April 2016.
13 April 2016 on Better Law-
Making.

415.
4. As soon as it adopts a
EC TEXT
delegated act, the Commission
shall notify it simultaneously to
the European Parliament and to
the Council.
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416.
5. A delegated act adopted
5. A delegated act adopted
CEU TEXT
pursuant to Article 42 shall enter
pursuant to Article 42 shall enter
into force only if no objection has
into force only if no objection
been expressed either by the
has been expressed either by the
European Parliament or the
European Parliament or the
Council within a period of two
Council within a period of two
months of notification of that act
three months of notification of
to the European Parliament and
that act to the European
the Council or if, before the
Parliament and the Council or if,
expiry of that period, the
before the expiry of that period,
European Parliament and the
the European Parliament and the
Council have both informed the
Council have both informed the
Commission that they will not
Commission that they will not
object. That period shall be
object. That period shall be
extended by two months at the
extended by two three months at
initiative of the European
the initiative of the European
Parliament or of the Council.
Parliament or of the Council.
417.
CHAPTER 7
EC TEXT
TRANSITIONAL AND FINAL
PROVISIONS
418.
Article 44
EC TEXT
Penalties
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419.
Member States shall lay down
AM 92
Member States shall lay down
EC TEXT
rules on penalties applicable to
rules on penalties applicable to
infringements of this Regulation
Member States shall lay down
infringements by economic
and shall take all measures
rules on penalties applicable to
operators of this Regulation and
necessary to ensure that they are
infringements of this Regulation
shall take all measures necessary
implemented. The penalties
and shall take all measures
to ensure that they are
provided for shall be effective,
necessary to ensure that they are
implemented. The penalties
proportionate and dissuasive.
implemented. The penalties
provided for shall be effective,
Member States shall, without
provided for shall be effective,
proportionate and dissuasive.
delay, notify the Commission of
proportionate and dissuasive.
Member States shall, without
those rules and of those measures
Member States shall, without
delay, notify the Commission of
and shall notify it, without delay,
delay, notify the Commission of
those rules and of those measures
of any subsequent amendment
those rules and of those measures
and shall notify it, without delay,
affecting them.
and shall notify it, without delay,
of any subsequent amendment
of any subsequent amendment
affecting them.
affecting them. Member States
shall take all measures
necessary to ensure that their
rules on penalties are enforced.

420.
Article 45
EC TEXT
Amendments to Regulation (EC)
No 1069/2009
421.
In Regulation (EC) No
Regulation (EC) No 1069/2009 is
1069/2009, Article 5 is amended
amended as follows:
as follows:
422.
(1) in paragraph 2, the first
(1) in Article 5, paragraphs 2 and
subparagraph is replaced by the
3 are replaced by the following:
following:
199

423.
"For derived products referred to
“2. For derived products referred
in Articles 32, 35 and 36 which
to in Articles 32, 35 and 36
no longer pose any significant
which no longer pose any
risk to public or animal health, an
significant risk to public or
end point in the manufacturing
animal health, an end point in the
chain may be determined, beyond
manufacturing chain may be
which they are no longer subject
determined, beyond which they
to the requirements of this
are no longer subject to the
Regulation.";
requirements of this Regulation.
Those derived products may
subsequently be placed on the
market without restrictions under
this Regulation and shall no
longer be subject to official
controls in accordance with this
Regulation.
The Commission is empowered
to adopt delegated acts in
accordance with Article 51a
supplementing this Regulation by
determining an end point in the
manufacturing chain, beyond
which derived products referred
to in this paragraph are no longer
subject to the requirements of
this Regulation.
3. In the event of risks to public
or animal health, Articles 53 and
54 of Regulation (EC) No
178/2002 concerning emergency
health measures shall apply
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mutatis mutandis to the derived
products referred to in Articles
32, 33 and 36 of this
Regulation.”;
201

424.
AM 93
(1a) in Article 5, the following
new paragraph is added:
(1a) in paragraph 2, the
following subparagraph is

“3a. Within six months after
inserted after the first
[date of entry into force of FPR],
subparagraph:
the Commission shall initiate a
first assessment of derived
“For derived products falling
products referred to in Article 32
under the scope of Article 32
that are already widely used in
that are already widely used in
the Union as organic fertilisers
Member States for the
and soil improvers. This
production of fertilisers, the
assessment shall cover at least
Commission shall determine
the following products: meat
such an end-point by … [six
meal, bone meal, meat-and-bone
months after the date of entry
meal, hydrolysed proteins of
into force of the Fertilisers
Category 3 materials, processed
Regulation]".
manure, compost, biogas
digestion residues, feather meal,
glycerine and other products of
Category 2 and 3 materials
derived from biodiesel and
renewable fuels production, as
well as petfood, feed and dog
chews that have been refused for
commercial reasons or technical
failures, and derived products
from blood of animals, hides and
skins, hoofs and horns, guano of
bats and birds, wool and hair,
feather and downs, and pig
bristles. Where the assessment
concludes that those derived
products no longer pose any
significant risk to public or
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animal health, the Commission
shall determine an end point in
the manufacturing chain pursuant
to paragraph 2 without undue
delay and in any case no later
than six  months after the
assessment is finalised.”;
425.
(2) paragraph 3 is replaced by the
(2) the following article is
following:
inserted:
203

426.
“3. In the event of risks to public
“Article 51a
or animal health, Articles 53 and
Exercise of the delegation
54 of Regulation (EC) No
178/2002 concerning emergency
1. The power to adopt delegated
health measures shall apply
acts is conferred on the
mutatis mutandis to the derived
Commission subject to the
products referred to in Articles
conditions laid down in this
32, 33 and 36 of this Regulation.”
Article.
2. The power to adopt delegated
acts referred to in Article 5(2)
shall be conferred on the
Commission for a period of five
years from ... [date of entry into
force of the Fertilisers
Regulation]. The Commission
shall draw up a report in respect
of the delegation of power not
later than nine months before the
end of the five-year period. The
delegation of power shall be
tacitly extended for periods of an
identical duration, unless the
European Parliament or the
Council opposes such extension
not later than three months before
the end of each period.
3. The delegation of power
referred to in Article 5(2) may be
revoked at any time by the
European Parliament or by the
Council. A decision to revoke
shall put an end to the delegation
204

of the power specified in that
decision. It shall take effect the
day following the publication of
the decision in the Official
Journal of the European Union or
at a later date specified therein. It
shall not affect the validity of any
delegated acts already in force.
4. Before adopting a delegated
act, the Commission shall consult
experts designated by each
Member State in accordance with
the principles laid down in the
Interinstitutional Agreement on
Better Law-Making of 13 April
2016*.
5. As soon as it adopts a
delegated act, the Commission
shall notify it simultaneously to
the European Parliament and to
the Council.
6. A delegated act adopted
pursuant to Article 5(2) shall
enter into force only if no
objection has been expressed
either by the European
Parliament or by the Council
within a period of two months of
notification of that act to the
European Parliament and the
Council or if, before the expiry of
that period, the European
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Parliament and the Council have
both informed the Commission
that they will not object. That
period shall be extended by two
months at the initiative of the
European Parliament or of the
Council.
__________________
* OJ L 123, 12.5.2016, p.1.”.
427.
Article 46
EC TEXT
Amendments to Regulation (EC)
No 1107/2009
428.
Regulation (EC) No 1107/2009 is
EC TEXT
amended as follows:
429.
(1) Article 2(1) (b) is replaced by
EC TEXT
the following:
430.
"(b) influencing the life processes
EC TEXT
of plants, such as substances
influencing their growth, other
than as a nutrient or a plant
biostimulant;"
431.
(2) in Article 3, the following
EC TEXT
point is added:
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432.
(3) "34. "plant biostimulant"
AM 94
(3) "34. "plant biostimulant"
(3) "34. "plant biostimulant"
means a product stimulating plant
means a product stimulating
means a product stimulating
nutrition processes independently
“34. "plant biostimulant’ means a
plant nutrition processes
plant nutrition processes
of the product's nutrient content
product containing any
independently of the product's
independently of the product's
with the sole aim of improving
substance or micro-organism
nutrient content with the sole aim
nutrient content with the sole aim
one or more of the following
stimulating plant nutrition
of improving one or more of the
of improving one or more of the
characteristics of the plant:
processes independently of its
following characteristics of the
following characteristics of the
nutrient content, or any
plant:
plant or the plant rhizosphere:
combination of such substances
and/or micro-organisms, 
with
the sole aim of improving one or
more of the following
characteristics of the plant or the
plant rhizosphere
:
433.
(a) nutrient use efficiency;
EC TEXT
434.
(b) tolerance to abiotic stress;
EC TEXT
435.
AM 95
(c) crop quality traits."
CEU TEXT
(c) crop quality traits."
(c) crop quality.
436.
AM 96
EP TEXT
(ca) availability of confined
nutrients in soil or rhizosphere;

437.
AM 97
No amendment
(cb) degradation of organic
compounds in the soil;

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438.
AM 98
No amendment
(cc) humification;
439.
(2a) in Article 80, the following
CEU TEXT
new paragraph is added:
"8. To a product which was
granted an authorisation under
Article 32(1) based on an
application submitted before
[Please insert the date of entry
into force of the Regulation on
the making available on the
market of EU fertilising
products], and which after that
date falls under the definition
in point 34 of Article 3, this
Regulation shall continue to
apply for the duration
provided in the authorisation."

440.
Article 47
EC TEXT
Repeal of Regulation (EC) No
2003/2003
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441.
Regulation (EC) No 2003/2003 is
Regulation (EC) No 2003/2003 is
Regulation (EC) No 2003/2003 is
repealed with effect from the date
repealed with effect from the date
repealed with effect from the date
referred to in the second
referred to in the second
referred to in the second
paragraph of Article 49.
paragraph of Article 49
paragraph of Article 49
[Publications office, please
[Publications office, please
insert the date 3 years after the
insert the date 3 years after the
date of entry into force].
date of entry into force].
442.
References to the repealed
EC TEXT
Regulation shall be construed as
references to this Regulation.
209

443.
Article 47a
Article 47a
Review
Review
By [Publication office, please
By ….[Publication office, please
insert the date 16 years after
insert the date seven years after
the entry into force of this
the entry into force of this
Regulation], the Commission
regulation], the Commission
shall carry out a review of limit
shall submit to the European
values for cadmium content in
Parliament and to the Council a
phosphate fertilisers. This
report assessing the application
review shall be accompanied, if
of this Regulation and its overall
necessary, by a legislative
impact as to the attainment of its
proposal.
objectives, including the impact
on SMEs. That report shall
include:

(a) an assessment of the
functioning of the internal
market for fertilising products,
including conformity assessment
and market surveillance
effectiveness, an analysis of the
effects of optional
harmonization on production,
market share and trade flows of
EU fertilising products and
fertilising products placed on
the market under national rules;

(b) a review of limit values for
cadmium content in phosphate
fertilisers, with a view to
assessing the feasibility of
reducing those limit values to a
210

lower appropriate level on the
basis of available technologies
and scientific evidence on
cadmium exposure and
accumulation in the environment,
taking into account
environmental factors, in
particular in the context of soil
and climatic conditions, health
factors, as well as socio-
economic factors, including
considerations of security of
supply;
(c) an assessment of application
of restrictions on levels of
contaminants as laid out in
Annex I of this Regulation, any
new relevant scientific
information as regards the
toxicity and carcinogenicity of
contaminants if it becomes
available, including the risks
from uranium contamination in
fertilising products.

The report shall take due
account of technological
progress and innovation as well
as standardisation processes
affecting production and use of
fertilising products. It shall be
accompanied, if appropriate, by
a legislative proposal.

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444.
Article 48
AM 99
EC TEXT
Transitional provisions
Article 48
Transitional provisions,
reporting and review

445.
Member States shall not impede
AM 100
Member States shall not impede
CEU TEXT
the making available on the
the making available on the
market of products which were
Member States shall not impede
market of products which were
placed on the market as fertilisers
the making available on the
placed on the market as fertilisers
designated "EC fertiliser" in
market of products which were
designated "EC fertiliser" in
conformity with Regulation (EC)
placed on the market as fertilisers
conformity with Regulation (EC)
No 2003/2003 before
designated "EC fertiliser" in
No 2003/2003 before
[Publications office, please insert
conformity with Regulation (EC)
[Publications office, please insert
the date of application of this
No 2003/2003 before ... [twelve
the date of application three
Regulation]. However, Chapter 5
months after the date of
years after the entry-into-force
shall apply mutatis mutandis to
application of this Regulation].
of this Regulation]. However,
such products.
However, Chapter 5 shall apply
Chapter 5 shall apply mutatis
mutatis mutandis to such
mutandis to such products.
products.
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446.
AM 101
No amendment
1a. Member States which have
already implemented a lower
limit for cadmium (Cd) content
in organo-mineral fertilisers and
inorganic fertilisers, set out in
PFC 1 (B)(3)(a) and PFC 1
(C)(I)(2)(a) of Part II of Annex
I may maintain that stricter limit
until the limit established
according to this Regulation is
equal or lower. Member States
shall notify such existing
national measures to the
Commission by ... [six months
after the date of entry into force
of this Regulation].

447.
AM 102
No amendment
1b. By … [42 months after the
date of application of this
Regulation], the Commission
shall submit to the European
Parliament and to the Council a
report assessing the application
of this Regulation and its overall
impact as to the attainment of its
objectives, including the impact
on SMEs. That report shall in
particular include:

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(a) an assessment of the
functioning of the internal
market for fertilising products,
including the conformity
assessment and market
surveillance effectiveness, an
analysis of the effects of partial
harmonization on production,
use patterns and trade flows of
CE marked fertilising products
and fertilising products placed
on the market under national
rules;

(b) an assessment of application
of restrictions on levels of
contaminants as laid out in
Annex I of this Regulation, any
new relevant scientific
information as regards the
toxicity and carcinogenicity of
contaminants if it becomes
available, including the risks
from uranium contamination in
fertilising products;

(c) an assessment of the
developments in decadmiation
technologies and their impact,
scale and costs across the value
chain, as well as related

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cadmium waste management;
and

(d) an assessment of the impacts
on trade in raw material
sourcing, including the
availability of phosphate rock.

The report shall take due
account of technological
progress and innovation as well
as standardisation processes
affecting production and use of
fertilising products. It shall be
accompanied, if necessary, by a

legislative proposal by … [five
years after the date of
application of this Regulation].

By ...[12 months after the entry
into force of this Regulation] the
Commission shall submit an
evaluation of the scientific data
to set the agronomic and
environmental criteria to define
end-of-livestock-manure criteria
in order to qualify the
performance of products that
contain or consist of processed
livestock manure.

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448.
AM 103
No amendment
1c. By … [five years after the
date of entry into force of this
Regulation], the Commission
shall carry out a review of the
conformity assessment
procedure of micro-organisms.

448a
By … [five years after the date of
entry into force of this
Regulation], the Commission
shall carry out a review in order
assess the possibility of
determining biodegrability
criteria of mulch films, and the
possibility of incorporating them
into CMC 10.
449.
Article 49
EC TEXT
Entry into force and application
450.
This Regulation shall enter into
EC TEXT
force on the twentieth day
following that of its publication
in the Official Journal of the
European Union.
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451.
It shall apply from 1 January
AM 104
It shall apply from 1 January
It shall apply from 1 January
2018.
2018 [Publications office,
2018 [Publications office,
It shall apply from … [two years
please insert the date three
please insert the date three
after the date of entry into force
years after the date of entry
years after the date of entry
of this Regulation], with the
into force of this Regulation],
into force of this Regulation],
exception of Articles 19 to 35,
with the exception of:
with the exception of:
which shall apply from … [one
year after the date of entry into

(a) Articles 19 to 35, which
(a) Articles 19 to 35, which
force of this Regulation] and
shall apply from [Publications
shall apply from [Publications
Articles 13, 41, 42, 43 and 45,
office, please insert the date
office, please insert the date
which shall apply from … [the
nine months after the date of
nine months after the date of
date of entry into force of this
entry into force] and
entry into force] and
Regulation].
(b) Articles 13, 41, 42, 43, 45
(b) Articles 4(2a), 13, 41, 42, 43,
and 46, which shall apply from
45 and 46, which shall apply
[Publications office, please
from [Publications office,
insert the date of entry into
please insert the date of entry
force].
into force].
452.
This Regulation shall be binding
EC TEXT
in its entirety and directly
applicable in all Member States.
217