COUNCIL OF
Brussels, 11 October 2011
THE EUROPEAN UNION
15137/11
Interinstitutional File:
2009/0076 (COD)
LIMITE
ENV
747
MI
475
AGRI
663
CHIMIE
64
CODEC 1614
NOTE
from:
General Secretariat
to:
Permanent Representatives Committee
No. prev. doc:
5032/2/11 ENV 4 MI 2 AGRI 2 CHIMIE 1 CODEC 2 PARLNAT 175 REV 2
No. Cion prop:
11063/09 ENV 440 MI 246 AGRI 267 CHIMIE 50 CODEC 849
Subject:
Proposal for a Regulation of the European Parliament and of the Council
concerning the placing on the market and use of biocidal products
- Preparation for the first informal trilogue
I.
INTRODUCTION
1.
The Commission submitted its proposal to the Council and the European Parliament on
12 June 2009.
2.
The European Economic and Social Committee adopted its opinion on 17 February 2010
1.
The Committee of the Regions decided not to deliver an opinion.
3.
The European Parliament adopted its position at first reading on 22 September 2010
2.
1
OJ C 347, 18.12.2010, p. 62.
2
doc. 13881/10.
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4.
The Council adopted its position at first reading on 21 June 2011.
5.
The Committee on the Environment, Public Health and Food Safety of the European
Parliament (ENVI), on 4 October 2011, adopted a draft recommendation
3, suggesting
179 amendments to the Council position at first reading, and notably a package of
compromise and consolidated amendments on the major political issues.
6.
The Presidency has been in informal contact with the European Parliament with the aim to
pave the way for a second reading agreement. The European Parliament has indicated its
willingness to enter into negotiations for such an agreement. The Commission has also
informally declared its readiness to facilitate such an agreement between the European
Parliament and the Council.
II.
EXAMINATION OF DRAFT AMENDMENTS
7.
Based on the examination of a number of ENVI amendments at the meeting of the Working
Party on the Environment, on 6 October 2011, the Presidency suggests that the first trilogue
identifies priority issues and sets the agenda for the negotiations. The Presidency intends to
follow the approach set out below:
·
On the main political issues, the Council confirms its position at first reading, namely in
relation to:
- the definition of biocidal products (AM 11),
- exclusion criteria (AM 25),
- derogations to mutual recognition (AM 82),
- the scope of Union authorisation (AM 83),
- derogations from Union authorisation (AM 87),
- treated Articles (AM 105),
- transitional measures (AM 4, 133 and 134) and
- the reinstatement of a list of approved active substances in "Annex -I" (AM 2, 23, 33,
34, 39, 40, 42, 44, 130 and 140).
3
See document A7-0336/2011.
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·
Other amendments could be already considered for negotiations based on the suggestions
for a Council position set out in the third column of Annex I to this note. In particular,
this concerns the amendments on:
- substitution criteria (AM 35 and 36),
- sustainable use of biocidal products (AM 49 and 127),
- comparative assessment (AM 58 and 59),
- simplified authorisation procedure (AM 61 and 62),
- data sharing and compensation arrangements (AM 107, 108, 110 and 111), and
- fees (AM 129).
8.
Given the large number of amendments on the table and the tight timeline for finalising the
negotiations, the first informal trilogue should furthermore agree to refer the examination of
more technical amendments to tripartite meetings at technical level. This group of
amendments, set out in Annex II, include those related to clarifications on fees, to the Register
for Biocidal products and to the Annexes of the Regulation.
9.
Additionally, for greater clarity, a full table with all the amendments voted by the ENVI
Committee will be established and will serve as basis for the negotiations.
III. CONCLUSION
10.
Based on the approach described above, the Permanent Representatives Committee is invited
to mandate the Presidency to enter into negotiations with the European Parliament with the
aim of reaching an agreement at second reading.
________________________
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ANNEX I
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 11
Article 3 – paragraph 1 – point a
(a) ‘biocidal product’ means any
(a) ‘biocidal product’ means any
Not acceptable
substance, mixture or article, in the
substance, mixture or article, in the
form in which it is supplied to the
form in which it is supplied to the
user, consisting of, containing or
user, consisting of, containing or
generating one or more active
generating one or more active
substances, with the
primary
substances, with the intention of
intention of destroying, deterring,
destroying, deterring, rendering
rendering harmless, preventing the
harmless, preventing the action of,
action of, or otherwise exerting a
or otherwise exerting a controlling
controlling effect on, any harmful
effect on, any harmful organism by
organism by any means other than
any means other than mere physical
mere physical or mechanical action; or mechanical action;
A treated article that has a primary
biocidal function shall be
considered a biocidal product.
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 25
Article 5
1. Subject to paragraph 2, the
1. Subject to paragraph 2, the
Not acceptable
following active substances shall
following active substances shall
not be approved:
not be approved:
(a) active substances which have
(a) active substances which have
been classified in accordance with
been classified in accordance with
Regulation (EC) No 1272/2008 as,
Regulation (EC) No 1272/2008 as,
or which meet the criteria to be
or which meet the criteria to be
classified as, carcinogen
classified as, carcinogen
category 1A or 1B;
category 1A or 1B;
(b) active substances which have
(b) active substances which have
been classified in accordance with
been classified in accordance with
Regulation (EC) No 1272/2008 as,
Regulation (EC) No 1272/2008 as,
or which meet the criteria to be
or which meet the criteria to be
classified as, mutagen category 1A
classified as, mutagen category 1A
or 1B;
or 1B;
(c) active substances which have
(c) active substances which have
been classified in accordance with
been classified in accordance with
Regulation (EC) No 1272/2008 as,
Regulation (EC) No 1272/2008 as,
or which meet the criteria to be
or which meet the criteria to be
classified as, toxic for reproduction
classified as, toxic for reproduction
category 1A or 1B;
category 1A or 1B;
(d) active substances identified in
(d) active substances
which, on the
accordance with Articles 57(f) and
basis of the assessment of Union
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
59(1) of Regulation (EC) No
or internationally agreed test
1907/2006 as having endocrine
guidelines or other peer-reviewed
disrupting properties
;
scientific data and information,
including a review of the scientific
literature, reviewed by the Agency,
are considered as having
endocrine-disrupting properties
that may cause adverse effect in
humans, or which are identified in
accordance with Articles 57(f) and
59(1) of Regulation (EC) No
1907/2006 as having endocrine
disrupting properties
.
(e) active substances which fulfil
(e) active substances which fulfil
the criteria for being persistent, bio-
the criteria for being persistent, bio-
accumulative and toxic (PBT) or
accumulative and toxic (PBT) or
very persistent and very bio-
very persistent and very bio-
accumulative (vPvB) according to
accumulative (vPvB) according to
Annex XIII to Regulation (EC) No
Annex XIII to Regulation (EC) No
1907/2006.
1907/2006.
2. Without prejudice to Article 4(1), 2. Without prejudice to Article 4(1),
active substances referred to in
active substances referred to in
paragraph 1 of this Article may be
paragraph 1 of this Article may be
approved if it is shown that at least
approved if it is shown that at least
one of the following conditions is
one of the following conditions is
met:
met:
(a) the
risk to humans or the
(a) the
exposure of humans or the
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
environment
from exposure to the
environment to the active substance
active substance in a biocidal
in
question in a biocidal product,
product, under
realistic worst case
under
normal conditions of use, is
conditions of use, is negligible,
in
negligible,
meaning that the
particular where the product is
product is used in closed systems or
used in closed systems or
strictly
under other conditions
excluding
controlled conditions;
contact with humans;
(b) the active substance is
essential
(b)
it is shown by evidence that the
to prevent or
to control a serious
active substance is
necessary to
danger to public or animal health or prevent or control a serious danger
the environment
; or
to public or animal health or
to the
environment
, to food and feed
safety, or
to the public interest and
that there are no effective
alternative substances or
technologies available.
The use of any biocidal product
containing active substances
included in Annex -I pursuant to
this paragraph shall be subject to
appropriate risk mitigation
measures to ensure that exposure
of humans and the environment is
minimised.
Member State authorising a
biocidal product containing an
active substance included in
Annex I pursuant to this
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
paragraph shall draw up a
substitution plan concerning the
control of the serious danger by
other means including non-
chemical methods, which are as
effective as the biocidal product
concerned and shall without delay
transmit that plan to the
Commission. The use of the
biocidal product with the active
substance concerned shall be
restricted to those Member States
where the serious danger has to be
prevented or, if it occurs,
controlled.
(c) not approving the active
substance would cause
disproportionate negative impacts
for society when compared with
the risk to human health or the
environment arising from the use
of the substance.
When deciding whether an active
substance may be approved in
accordance with the first
subparagraph, the availability of
suitable and sufficient alternative
substances or technologies shall
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Draft EP Recommendation at
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EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
also be taken into account.
3.
The Commission shall
be
3.
No later than 13 December
empowered to adopt delegated acts
2013, the Commission shall adopt
in accordance with Article 82
delegated acts in accordance with
specifying scientific criteria for the
Article 82 specifying scientific
determination of endocrine
criteria for the determination of
disrupting properties.
endocrine disrupting properties.
Pending the adoption of those
Pending the adoption of those
criteria, active substances that are
criteria, active substances that are
classified in accordance with the
classified in accordance with the
provisions of Regulation (EC) No
provisions of Regulation (EC) No
1272/2008 as, or meet the criteria to 1272/2008 as, or meet the criteria to
be classified as, carcinogen
be classified as, carcinogen
category 2 and toxic for
category 2 and toxic for
reproduction category 2, shall be
reproduction category 2, shall be
considered as having endocrine-
considered as having endocrine-
disrupting properties.
disrupting properties.
Substances such as those that are
Substances such as those that are
classified in accordance with the
classified in accordance with the
provisions of Regulation (EC) No
provisions of Regulation (EC) No
1272/2008 as, or that meet the
1272/2008 as, or that meet the
criteria to be classified as, toxic for
criteria to be classified as, toxic for
reproduction category 2 and that
reproduction category 2 and that
have toxic effects on the endocrine
have toxic effects on the endocrine
organs, may be considered as
organs, may be considered as
having endocrine-disrupting
having endocrine-disrupting
properties.
properties.
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 82
Article 36 paragraphs 1 and 2
1. By way of derogation from
1. By way of derogation from
Not acceptable
Article 31(2), any of the Member
Article 31(2), any of the Member
States concerned may
propose to
States concerned may refuse to
refuse to grant an authorisation or
grant an authorisation or adjust the
to adjust the terms and conditions
terms and conditions of the
of the authorisation to be granted,
authorisation to be granted,
provided that such a measure can be provided that such a measure can be
justified on grounds of:
justified on grounds of:
(a) the protection of the
(a) the protection of the
environment;
environment;
(b) public policy or public security;
(b) public policy or public security;
(c) the protection of health and life
(c) the protection of health and life
of humans, animals or plants;
of humans,
particularly of
vulnerable groups, or of animals or
plants;
(d) the protection of national
(d) the protection of national
treasures possessing artistic,
treasures possessing artistic,
historic or archaeological value; or
historic or archaeological value; or
(e) the target organisms not being
(e) the target organisms not being
present in harmful quantities.
present in harmful quantities.
(ea) implementation of other
Union legislation, and in
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
particular Directive 98/83/EC.
Any of the Member States
Any of the Member States
concerned may, in particular,
concerned may, in particular, in
propose in accordance with the first accordance with the first
subparagraph
to refuse to grant an
subparagraph
, refuse to grant an
authorisation or
to adjust the terms
authorisation or adjust the terms
and conditions of the authorisation
and conditions of the authorisation
to be granted for a biocidal product
to be granted for a biocidal product
containing an active substance to
containing an active substance to
which Article 5(2) or 10(1) applies.
which Article 5(2) or 10(1) applies.
2. The Member State concerned
2. The Member State concerned
shall communicate to the applicant
shall communicate to the applicant
a detailed statement of the grounds
a detailed statement of the grounds
for seeking a derogation pursuant to for seeking a derogation pursuant to
paragraph 1 and shall seek to reach
paragraph 1 and shall seek to reach
an agreement with the applicant on
an agreement with the applicant on
the proposed derogation.
the proposed derogation.
If the Member State concerned is
If the Member State concerned is
unable to reach agreement with the
unable to reach agreement with the
applicant or receives no reply from
applicant or receives no reply from
the applicant within 60 days of that
the applicant within 60 days of that
communication it shall inform the
communication it shall
without
Commission.
In that case, the
delay inform
other Member States
Commission:
and the Commission
of any
decision taken in this respect and
its justification.
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EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
(a) may ask the Agency for an
opinion on scientific or technical
questions raised by the applicant
or the Member State concerned;
(b) shall adopt a decision on the
derogation in accordance with the
examination procedure referred to
in Article 81(3).
The Commission's decision shall
be addressed to the Member State
concerned and the Commission
shall inform the applicant thereof.
The Member State concerned shall
take necessary measures to comply
with the Commission's decision
within 30 days of its notification.
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 83
Article 41
1. Applicants may apply for Union
1. Applicants may apply for Union
Not acceptable
authorisation for biocidal products
authorisation for biocidal products
which have similar conditions of
which have similar conditions of
use across the Union
and which fall use across the Union
with the
within the following categories of
exception of biocidal products that
biocidal products:
contain active substances that fall
under Article 5:
(a) biocidal products of product-
a) from 2013 the Union
types 6, 7, 9, 10, 12, 13 and 22; and authorisation may be granted to
biocidal products containing one
or more new active substances;
(b) with effect from 1 January
b) from 2017 the Union
2020, all other biocidal products
authorisation may be granted to all
except for those of product-types
categories of biocidal products.
14, 15, 17, 20 and 21.
2. The Commission shall report to
No later than 31 December 2012,
the European Parliament and the
the Commission shall adopt
Council on the application of this
delegated acts in accordance with
Article by 31 December 2017. It
Article 82 concerning the
shall, if appropriate, accompany its definition of "similar conditions of
report with relevant proposals for
use across the Union".
adoption in accordance with the
ordinary legislative procedure.
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 87
Article 43 – paragraph 3a (new) and 4
3a. Within 30 days of the
Not acceptable
submission of its opinion to the
Commission, the Agency shall
transmit, in all the official
languages of the European Union,
the draft summary of the biocidal
product characteristics, as referred
to in Article 21(2), as applicable;
4. On receipt of the opinion of the
4. On receipt of the opinion of the
Agency, the Commission shall
Agency, the Commission shall
adopt, by means of implementing
adopt a decision on the Union
acts, a decision on the Union
authorisation of the biocidal
authorisation of the biocidal
product in accordance with the
product. Those implementing acts
examination procedure referred to
shall be adopted in accordance with in Article 81(3).
the examination procedure referred
to in Article 81(3).
As soon as the
Commission has taken a decision
to grant a Union authorisation, it
shall enter the information
referred to in Article 29(4) in the
Register for Biocidal Products.
The Commission may, at the
A Member State
shall inform the
request of a Member State
, decide
Commission if it decides to adjust
to adjust certain conditions of a
certain conditions of a Union
Union authorisation specifically for authorisation specifically for the
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(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
the territory of that Member State
territory of that Member State or
or
decide that a Union authorisation
decides that a Union authorisation
shall not apply in the territory of
shall not apply in the territory of
that Member State, provided that
that Member State, provided that
such a
request can be justified on
such a
decision can be justified on
one or more of the grounds referred one or more of the grounds referred
to in Article 36(1).
to in Article 36(1).
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Council position at first reading
Draft EP Recommendation at
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EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 105
Article 57 – paragraph 3-5
3. Where
the release of the active
3. Where a treated article
contains
Not acceptable
substances contained in the
a biocidal product, the person
biocidal products with which a
responsible for the placing on the
treated article
was treated or which market of that treated article shall
it incorporates, is intended or
ensure that the label provides the
expected under normal or
following information:
reasonably foreseeable conditions
of use, the person responsible for
the placing on the market of that
treated article shall ensure that the
label provides the following
information:
(a) a statement that the treated
(a) a statement that the treated
article incorporates biocidal
article incorporates biocidal
products;
products;
(b) where substantiated, the biocidal (b) where substantiated, the biocidal
property attributed to the treated
property attributed to the treated
article;
article;
(c) without prejudice to Article 24
(c) without prejudice to Article 24
of Regulation (EC) No 1272/2008,
of Regulation (EC) No 1272/2008,
the name of all active substances
the name of all active substances
contained in the biocidal products;
contained in the biocidal products;
(ca) the name of all nanomaterials,
followed by the word "nano" in
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second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
brackets;
(d) any relevant instructions for use, (d) any relevant instructions for use,
including any precautions to be
including any precautions to be
taken because of the biocidal
taken because of the biocidal
products
with which a treated
products which a treated article
article
was treated or which it
incorporates.
incorporates.
4. Where the release of the active
This paragraph shall not apply
substances contained in the
where at least equivalent labelling
biocidal products with which a
requirements for biocidal products
treated article was treated or which in treated articles to meet
it incorporates, is not intended or
information requirements
expected under normal or
concerning those active substances
reasonably foreseeable conditions
already exist under sector-specific
of use, the person responsible for
legislation.
the placing on the market of the
treated article shall ensure that the
label provides the
following information:
(a) a statement that the treated
article was treated with biocidal
products; and
(b) the address of a website
containing the name of all active
substances used for the treatment,
without prejudice to Article 24 of
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EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Regulation (EC) No 1272/2008.
The label of such a treated article
shall not lay claim to any biocidal
property.
5. The labelling shall be clearly
5. The labelling shall be clearly
visible, easily legible and
visible, easily legible and
appropriately durable. Where
appropriately durable. Where
necessary because of the size or the necessary because of the size or the
function of the treated article, the
function of the treated article, the
labelling shall be printed on the
labelling shall be printed on the
packaging, on the instructions for
packaging, on the instructions for
use or on the warranty.
use or on the warranty
in the
national language or languages of
the Member State on whose market
the treated article is to be placed. In
the case of treated goods which are
not produced as part of a series, but
rather designed and manufactured
to meet a specific order, the
manufacturer may agree other
methods of providing the customer
with the relevant information.
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second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 4
Recital 65
(65)
It is appropriate to provide for
(65)
To ensure a smooth
Not acceptable
a deferred application of this
transition, it is appropriate to
Regulation so as to facilitate the
provide for
procedures so that the
smooth transition to the new
applications submitted for the
systems for the approval of active
approval of active substances and
substances and authorisation of
authorisation of biocidal products
biocidal products.
before the application of this
Regulation are assessed against
the requirements of this
Regulation.
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EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 133
Article 89 – paragraph 2 – subparagraph 1
Dossiers submitted for the purposes Dossiers submitted for the purposes
Not acceptable
of Directive 98/8/EC for which the
of Directive 98/8/EC for which the
evaluation has not been completed
evaluation has not been completed
by …* shall
continue to be
by …* shall be evaluated by the
evaluated by the competent
competent authorities in accordance
authorities in accordance with the
with the provisions of
this
provisions of
Directive 98/8/EC
Regulation and, where relevant,
and, where relevant, Regulation
Regulation (EC) No 1451/2007.
(EC) No 1451/2007.
To ensure a smooth transition, the
Commission shall, no later than ...
*, adopt a delegated act in
accordance with Article 82
regarding the evaluation of
dossiers submitted in accordance
with Directive 98/8/EC.
This delegated act shall be based
on the following principles:
1) the evaluation shall be carried
out on the basis of the information
provided in the dossier as
submitted under Directive
98/8/EC;
2) where the evaluation identifies
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second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
concerns arising from the
application of provisions of the
present Regulation, which were
not included in Directive 98/8/EC,
the applicant shall be given the
opportunity to provide additional
information;
3) every effort shall be made to
avoid additional testing on
vertebrate animals;
4) every effort shall be made to
avoid causing delays to the review
programme laid down in
Regulation (EC) No 1451/2007 as
a result of these transitional
arrangements.
* OJ: Insert the date - the day of
* OJ: Insert the date - the day of
application of this Regulation
application of this Regulation
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ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 134
Article 89 a (new)
Transitional measures concerning Not acceptable
applications for biocidal product
authorisations submitted under
Directive 98/8/EC
Dossiers submitted for the
purposes of Directive 98/8/EC for
which the evaluation has not been
completed by …*shall be evaluated
by the competent authorities in
accordance with this Regulation.
To ensure a smooth transition, the
Commission shall, no later than ...
*, adopt a delegated act in
accordance with Article 82
regarding the evaluation of
dossiers submitted in accordance
with Directive 98/8/EC. This
delegated act shall be based on the
following principles:
1) the evaluation shall be carried
out on the basis of the information
provided in the dossier as
submitted under Directive
98/8/EC;
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22
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
2) where the evaluation identifies
concerns arising from the
application of provisions of the
present Regulation, which were
not included in Directive 98/8/EC,
the applicant shall be given the
opportunity to provide additional
information;
3) every effort shall be made to
avoid additional testing on
vertebrate animals.
* OJ: Insert the date - the day of
application of this Regulation
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23
ANNEX I
DG I 1A
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 2
Recital 10
(10) In order to ensure legal
(10) In order to ensure legal
Not acceptable
certainty, it is necessary to establish
certainty
and transparency, it is
a Union list of active substances
necessary
to maintain, within this
approved for use in biocidal
Regulation, a Union list of active
products. A procedure should be
substances
which are approved for
laid down for assessing whether or
use in biocidal products. A
not an active substance can be
procedure should be laid down for
entered in that list. The information assessing whether or not an active
that interested parties should submit substance can be entered in that list.
in support of an application for
The information that interested
approval of an active substance and parties should submit in support of
its inclusion in the list should be
an application for approval of an
specified.
active substance and its inclusion in
the list should be specified.
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24
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 23
Article 4 – paragraph 1
1. An active substance shall be
1. An active substance shall be
Not acceptable
approved for an initial period not
included in Annex -I for an initial
exceeding 10 years if at least one
period not exceeding 10 years if at
biocidal product containing that
least one biocidal product
active substance
may be expected to containing that active substance
meet the
criteria laid down in point
fulfils the
conditions laid down in
(b) of Article 18(1) taking into
point (b) of Article 18(1) taking
account the factors set out in Article into account the factors set out in
18(2) and (5).
Article 18(2) and (5).
An active
substance referred to in Article 5
may only be included in Annex -I
for an initial period of 5 years.
(Note: This amendment applies
throughout the text. If adopted,
reference to "approval of an active
substance" is to be replaced by
reference to "inclusion of an active
substance in Annex -I", reference to
"approval" by "inclusion in Annex -
I", reference to "approved" by
"included in Annex -I" etc.
throughout the text.)
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25
ANNEX I
DG I 1A
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 33
Article 9 – paragraph 1
1. The Commission shall, on receipt 1. The Commission shall, on receipt
Not acceptable
of the opinion of the Agency
of the opinion of the Agency
referred to in Article 8(4),
either:
referred to in Article 8(4),
adopt, by
means of delegated acts in
(a) adopt an implementing
accordance with Article 82, a
Regulation providing that an
decision on the inclusion of the
active substance is approved, and
active substance in Annex -I,
under which conditions, including including the conditions of the
the dates of approval and of expiry inclusion, the dates of inclusion
of the approval; or
and of expiry of inclusion, or on
the non-inclusion of the active
(b) in cases where the
substance in Annex I.
requirements of Article 4(1) or,
where applicable, Article 5(2), are
not satisfied or where the requisite
information and data have not
been submitted within the
prescribed period, adopt an
implementing decision that an
active substance is not approved.
Those implementing acts shall be
adopted in accordance with the
examination procedure referred to
in Article 81(3).
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26
ANNEX I
DG I 1A
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 34
Article 9 – paragraph 2
2. Approved active substances shall deleted
Not acceptable
be included in a Union list of
authorised active substances. The
(Note: This amendment applies
Commission shall keep the list up
throughout the text. If adopted, any
to date and make it electronically
reference to Article 9(2) is to be
available to the public.
deleted, and any reference to "the
list drawn up in accordance with
Article 9(2)" or the "list referred to
in Article 9(2)" is to be replaced by
a reference to "Annex -I".)
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27
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 39
Article 14 – paragraph 4
4. The Commission shall, on receipt 4. The Commission shall, on receipt
Not acceptable
of the opinion of the Agency,
of the opinion of the Agency, adopt
,
adopt
:
by means of delegated acts in
accordance with Article 82, a
(a) an implementing Regulation
decision on the renewal of the
providing that the approval of an
inclusion of the active substance in
active substance is renewed for one Annex -I for one or more product-
or more product-types, and under
types, or of the non-renewal of
which conditions; or
inclusion. In the event that the
inclusion is renewed, the decision
(b) an implementing decision that
shall state the conditions of
the approval of an active substance renewal and the dates of renewal
is not renewed.
and of expiry of inclusion.
Those implementing acts shall be
adopted in accordance with the
examination procedure referred to
in Article 81(3).
Article 9(2) shall apply.
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28
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 40
Article 14 – paragraph 6
6. Where the Commission decides
6. Where the Commission decides
Not acceptable
not to renew the
approval of an
not to renew
or to amend the
active substance for one or more
inclusion of an active substance
in
product-types
it may grant a period Annex -I for one or more product-
of grace for the disposal, making
types
, the Member States or, in the
available on the market and use of case of a Union authorisation, the
existing stocks of biocidal products
Commission shall cancel or, where
of the product-type(s) concerned
appropriate, amend the
containing that active substance.
authorisations of biocidal products
of the product-type(s) concerned
containing that active substance.
Article 51 shall apply accordingly.
The period of grace shall not
exceed 180 days for making
available on the market and an
additional maximum of 180 days
for disposal and use of existing
stocks of biocidal products of the
product-type(s) concerned
containing that active substance.
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29
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 42
Article 15 – paragraph 1 - subparagraph 2
Where those indications are
Where those indications are
Not acceptable
confirmed the Commission shall
confirmed the Commission shall
adopt
an implementing Regulation adopt
delegated acts in accordance
amending the conditions of
with Article 82 amending the
approval of an active substance or
conditions of
inclusion of an active
cancelling its
approval.
That
substance
in Annex -I or cancelling
implementing Regulation shall be
its
inclusion. The Commission shall
adopted in accordance with the
inform the initial applicant(s) for
examination procedure referred to the
inclusion in Annex -I that it is
in Article 81(3). Article 9(2) shall
carrying out a review and shall
apply. The Commission shall
provide an opportunity for the
inform the initial applicant(s) for
applicant to submit comments. The
the
approval accordingly.
Commission shall take due
account of those comments in its
review.
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30
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 44
Article 15 – paragraph 3 a (new)
3a. Where the Commission decides Not acceptable
to cancel or amend the inclusion
of an active substance in Annex -I
for one or more product-types, the
Member States or, in the case of a
Union authorisation, the
Commission shall cancel or, where
appropriate, amend the
authorisations of biocidal products
of the product-type(s) concerned
containing that active substance.
Article 29 and Article 43, as
appropriate, shall apply mutatis
mutandis.
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31
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 130
Article 88 – paragraph 1 – subparagraph 3
In order to facilitate a smooth
The Commission shall adopt
, by
Not acceptable
transition from Directive 98/8/EC
means of delegated acts in
to this Regulation, during the work accordance with Article 82,
programme the Commission shall
decisions on the inclusion of an
adopt
either implementing
active substance in Annex -I,
regulations providing that an
including the conditions of the
active substance is approved, and
inclusion, the dates of inclusion
under which conditions, or, in
and of expiry of inclusion, or on
cases where the requirements of
the non-inclusion of the active
Article 4(1) or, where applicable,
substance in Annex -I. In cases
5(2), are not satisfied or where the
where the requirements of
requisite information and data have Article 4(1) or, where applicable,
not been submitted within the
5(2), are not satisfied or where the
prescribed period,
implementing
requisite information and data have
decisions stating that an active
not been submitted within the
substance is not approved. Those
prescribed period,
the active
implementing acts shall be adopted substance shall not be included in
in accordance with the
Annex -I.
examination procedure referred to
in Article 81(3). Regulations
approving an active substance
shall specify the date of approval.
Article 9(2) shall apply.
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32
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 140
Annex -I (new)
Annex -I
Not acceptable
List of active substances with
requirements for inclusion in
biocidal products
(The full text of Annex I of
Parliament's Position at first
reading (EP-PW-TC1-
COD(2009)0076) shall be re-
inserted as Annex -I (new).)
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33
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 35
Article 10 – paragraph 1 – point a a (new)
(a a) it meets the criteria to be Acceptable
classified, in accordance with
Regulation (EC) No 1272/2008, as
a respiratory sensitiser;
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34
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 36
Article 10 – paragraph 1 – point d
(d) there are reasons for concern
(d) there are reasons for concern
Not acceptable
linked to the nature of the critical
linked to the nature of the critical
effects which, in combination with
effects
, in particular
Already covered by Council text
the use patterns, amount to use that
developmental neurotoxic or
could still cause concern, such as
immunotoxic effects which, in
high potential of risk to
combination with the use patterns,
groundwater, even with very
amount to use that could still cause
restrictive risk management
concern, such as high potential of
measures;
risk to groundwater, even with very
restrictive risk management
measures;
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35
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 49
Article 17 a (new)
Measures geared to the sustainable Not acceptable / further
use of biocidal products
clarification required
Member States shall establish and
implement mandatory measures on
the basis of a Union framework
directive in order to achieve the
sustainable professional use of
biocidal products, including the
introduction of National Action
Plans, integrated pest
management, risk reduction
measures and the promotion of
alternatives.
By ...*, the Commission shall
submit a legislative proposal for
the framework directive referred to
in paragraph 1 to the European
Parliament and the Council.
_____________
* Please insert date two years after
adoption of this Regulation.
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36
ANNEX I
DG I 1A
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 127
Article 75 – paragraph 1 – point j a (new)
(ja) providing guidance and tools
Not acceptable
for the use phase, particularly:
- measures for integrated pest
management, for specified vermin,
- monitoring biocidal product use,
- best practice of biocidal product
use to limit use of such products to
the minimum necessary dose,
- pest management in sensitive
areas like schools, workplaces,
kindergartens, public spaces,
lakes, canals, riversides and
geriatric care centres,
- technical equipment for biocidal
product application and its
inspection.
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37
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 58
Article 22 – paragraph 3 a (new)
3a. The Commission shall be
Not acceptable
empowered to adopt delegated acts
in accordance with Article 82
defining the criteria and
algorithms to be used in the
comparative assessments referred
to in paragraph 3, in order to
ensure that there is a uniform
application throughout the Union.
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38
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 59
Article 22 – paragraph 7
7. Where it is decided not to
7. Where it is decided not to
To be discussed
authorise or to restrict the use of a
authorise or to restrict the use of a
biocidal product pursuant to
biocidal product pursuant to
paragraph 3, that cancellation or
paragraph 3, that cancellation or
amendment of the authorisation
amendment of the authorisation
shall take effect
five years after that shall take effect
three years after
decision. However, where the
that decision. However, where the
approval of the active substance
approval of the active substance
which is a candidate for substitution which is a candidate for substitution
expires on an earlier date, the
expires on an earlier date, the
cancellation of the authorisation
cancellation of the authorisation
shall take effect on that earlier date.
shall take effect on that earlier date.
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39
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 61
Article 24 – paragraph 1 – point b a (new)
(b a) the biocidal product does not
Acceptable
contain a nanomaterial;
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40
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 62
Article 24 – point c a (new)
(ca) the biocidal product meets the Not acceptable
criteria laid down in Article
18(1)(b)(ii) to (iv); and
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41
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 107
Article 58 – paragraph 1 – introductory part
1. Without prejudice to Articles 61
1. Without prejudice to Articles 61
Acceptable
and 62, data submitted for the
and 62, data submitted for the
purposes of this Regulation shall
purposes of
Directive 98/8/EC or of
not be used by competent
this Regulation shall not be used by
authorities or the Agency for the
competent authorities or the
benefit of a subsequent applicant,
Agency for the benefit of a
except where:
subsequent applicant, except where:
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42
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 108
Article 58 – paragraph 1 – point a
(a) the subsequent applicant has a (a) the subsequent applicant has
Acceptable
letter of access; or
and submits a letter of access; or
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43
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 110
Article 61 – paragraph 2
Partly acceptable. The text should
read:
2. Any person intending to perform 2. Any person intending to perform 2. Any person intending to perform
tests or studies involving vertebrate tests or studies involving vertebrate tests or studies involving vertebrate
animals or non-vertebrate animals
animals or non-vertebrate animals,
animals or non-vertebrate animals,
("the prospective applicant") shall
("the prospective applicant"), shall
("the prospective applicant"), shall
ask the Agency whether such tests
submit a written request to the
submit a written request to the
or studies have already been
Agency to determine whether such Agency to determine whether such
submitted in connection with a
tests or studies have already been
tests or studies have already been
previous application under this
submitted to the Agency, or to a
submitted to the Agency, or to a
Regulation or Directive 98/8/EC.
competent authority in connection competent authority in connection
with a previous application under
with a previous application under
this Regulation or
this Regulation or
Directive 98/8/EC for an identical
Directive 98/8/EC
for an identical
or technically equivalent product.
or technically equivalent product.
The request shall be accompanied
The request shall be accompanied
by fees in accordance with Article
by fees in accordance with Article
79(1). If the applicant fails to pay
79(1). If the applicant fails to pay
the fees, the Agency shall not
the fees, the Agency shall not
consider the request.
consider the request.
The
competent authority or the
The Agency shall verify whether
The Agency shall verify whether
Agency shall verify whether such
such tests or studies have already
such tests or studies have already
tests or studies have already been
been submitted.
been submitted.
submitted.
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44
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Where such tests or studies have
Where such tests or studies have
Where such tests or studies have
already been submitted in
already been submitted
to the
already been submitted to the
connection with a previous
Agency, or to a competent
Agency, or to a competent authority
application, under this Regulation
authority in connection with a
in connection with a previous
or Directive 98/8/EC,
the
previous application, under this
application, under this Regulation
competent authority or the Agency Regulation or Directive 98/8/EC,
or Directive 98/8/EC, the Agency
shall, without delay, communicate
the Agency shall, without delay,
shall, without delay, communicate
the name and contact details of the
communicate the name and contact
the name and contact details of the
data
owner to the prospective
details of the data
submitter(s) to
data
submitter(s) and data owners
applicant.
the prospective applicant.
to the prospective applicant.
The data submitter(s) shall where
The data submitter(s) shall, where
relevant, facilitate contacts
relevant, facilitate contacts between
between the prospective applicant
the prospective applicant and the
and the data owner(s)
data owner(s).
Where the data acquired under
Where the data acquired under
Where the data acquired under
those tests or studies are still
those tests or studies are still
those tests or studies are still
protected under Article 59, the
protected under Article 59, the
protected under Article 59, the
prospective applicant:
prospective applicant:
prospective applicant:
(a) shall, in the case of data
(a) shall, in the case of data
(a) shall, in the case of data
involving tests on vertebrate
involving tests on vertebrate
involving tests on vertebrate
animals,
request from the data
animals; and
animals; and
owner the right to refer to those
tests or studies; and
(b) may, in the case of data not
(b) may, in the case of data not
(b) may, in the case of data not
involving tests on vertebrate
involving tests on vertebrate
involving tests on vertebrate
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45
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
animals, request from the
data
animals, request from the
data
animals, request from the data
owner the right to refer to those
owner(s) all the scientific and
owner(s) all the scientific and
tests or studies.
technical data related to the tests
technical data related to the tests
and studies
concerned as well as
and studies concerned as well as the
the right to refer to these data
right to refer to these data when
when submitting applications
submitting applications within the
within the framework of this
framework of this Regulation.
Regulation.
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46
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 111
Article 62 - paragraphs 1-3
Partly acceptable; (Clarification
required for the reference in
paragraph 1)
The text should read:
1. Where a request has been made
1. Where a request has been made
1. Where a request has been made
in accordance with Article 61(2),
in accordance with
the sixth
in accordance with Article 61(2),
the prospective applicant and the
subparagraph of Article 61(2), the
the prospective applicant and the
data owner shall make every effort
prospective applicant and the data
data owner shall make every effort
to reach an agreement on the
owner shall make every effort to
to reach an agreement on the
sharing of the results of the tests or
reach an agreement on the sharing
sharing of the results of the tests or
studies requested by the prospective of the results of the tests or studies
studies requested by the prospective
applicant. Such an agreement may
requested by the prospective
applicant. Such an agreement may
be replaced by submission of the
applicant. Such an agreement may
be replaced by submission of the
matter to an arbitration body and a
be replaced by submission of the
matter to an arbitration body and a
commitment to accept the
matter to an arbitration body and a
commitment to accept the
arbitration order.
commitment to accept the
arbitration order.
arbitration order.
2. Where such agreement is
2. Where such agreement is
2. Where such agreement is
reached, the data owner shall make
reached, the data owner shall make
reached, the data owner
(s) shall
the data available to the prospective
all the
scientific and technical data make all the scientific and technical
applicant
and shall give the
related to the tests and studies
data related to the tests and studies
prospective applicant permission to
concerned available to the
concerned available to the
refer to the data owner's tests or
prospective applicant
or shall give
prospective applicant or shall give
studies.
the prospective applicant
the prospective applicant
permission to refer to the data
permission to refer to the data
owner's tests or studies
where
owner's tests or studies where
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ANNEX I
DG I 1A
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
submitting applications under this
submitting applications under this
Regulation.
Regulation.
3. Where no
such agreement is
3. Where no agreement is reached
3. Where no agreement is reached
reached
within 60 days of a request with respect to tests
and studies
with respect to
data concerning
made according to Article 61(2)
involving
vertebrate animals, the
tests and studies involving
with respect to
data involving tests
prospective applicant shall inform
vertebrate animals, the prospective
on vertebrate animals, the
the Agency and the
data owner(s)
applicant shall inform the Agency
prospective applicant shall
, without thereof at the earliest one month
and the data owner(s) thereof at the
delay, inform the Agency
,
after receipt, from the Agency, of
earliest one month after receipt,
competent authority and the
data
the name and address of the data
from the Agency, of the name and
owner accordingly. Within 60 days
submitter(s).
address of the data submitter(s).
of being informed
about the failure
to reach an agreement, the Agency Within 60 days of being informed,
Within 60 days of being informed,
shall give the prospective applicant
the Agency shall give the
the Agency shall give the
the right to refer to
those tests
or
prospective applicant
permission to prospective applicant permission to
studies.
Where the prospective
refer to
the requested tests
and
refer to the requested tests and
applicant and data owner cannot
studies
involving vertebrate
studies involving vertebrate animals
agree, national courts shall decide animals provided that the
provided that the prospective
on the proportionate share of the
prospective applicant demonstrates applicant demonstrates that it has
cost
that the prospective applicant
that it has paid the data owner(s)
paid the data owner(s) for these
shall pay to the data owner.
for these tests and studies a share
tests and studies a share of cost
of cost incurred, and that every
incurred, and that every effort has
effort has been made to reach an
been made to reach an agreement
agreement on the sharing of these
on the sharing of these tests and
tests and studies. The data
studies. The data owner(s) shall
owner(s) shall have a claim on the have a claim on the prospective
prospective applicant for a
applicant for a proportionate share
proportionate share of the cost
of the cost incurred by it.
Where
incurred by it.
the prospective applicant and data
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ANNEX I
DG I 1A
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
owners cannot agree, national
courts shall decide on the
proportionate share of the cost that
the prospective applicant shall pay
to the data owners.
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
Amendment 129
Article 79
1. The Commission shall adopt, on
1. The Commission shall adopt, on
Partly acceptable: last sentence of
the basis of the principles set out in
the basis of the principles set out in
paragraph 1 subparagraph 4 to be
paragraph 3,
an implementing
paragraph 3,
delegated acts
discussed; paragraph 3 point f
Regulation specifying:
pursuant to Article 82 specifying:
acceptable
(a) the fees payable to the Agency,
(a) the fees payable to the Agency,
including an annual fee;
including an annual
and a
submission fee;
(b) the rules defining conditions for (b) the rules defining conditions for
reduced fees, fee waivers and the
reduced fees, fee waivers and the
reimbursement of the member of
reimbursement of the member of
the Biocidal Products Committee
the Biocidal Products Committee
who acts as a rapporteur; and
who acts as a rapporteur; and
(c) conditions of payments.
(c) conditions of payments.
That implementing Regulation
These delegated acts shall apply
shall be adopted in accordance
only with respect to fees paid to
with the examination procedure
the Agency.
referred to in Article 81(3). It shall
apply only with respect to fees paid
to the Agency.
The Agency may collect charges for The Agency may collect charges for
other services it provides.
other services it provides.
The fees payable
to the Agency
The fees payable shall be set at such
shall be set at such a level as to
a level as to ensure that the revenue
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50
ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
ensure that the revenue derived
derived from the fees, when
from the fees, when combined with combined with other sources of the
other sources of the Agency's
Agency's
and competent
revenue pursuant to this Regulation,
authorities’ revenue pursuant to
is sufficient to cover the cost of the
this Regulation, is sufficient to
services delivered.
cover the cost of the services
delivered.
The fees payable shall
be published by the Agency.
2. Member States shall directly
2. Member States shall directly
charge applicants fees for services
charge applicants fees for services
that they provide with respect to the that they provide with respect to the
procedures under this Regulation,
procedures under this Regulation,
including the services undertaken
including the services undertaken
by Member States' competent
by Member States' competent
authorities when acting as
authorities when acting as
evaluating competent authority.
evaluating competent authority.
Based on the principles set out in
Based on the principles set out in
paragraph 3, the Commission
may
paragraph 3, the Commission
shall
issue guidance concerning a
issue guidance concerning a
harmonised structure of fees.
harmonised structure of fees.
Member States may levy annual
Member States shall set and publish
fees with respect to biocidal
the amount of fees payable to their
products made available on
competent authorities.
their markets.
Member States may collect charges
for other services they provide.
Member States shall set and publish
the amount of fees payable to their
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ANNEX I
DG I 1A
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Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
competent authorities.
3. Both the
implementing
3. Both the
delegated acts referred
Regulation referred to in paragraph to in paragraph 1 and Member
1 and Member States' own rules
States' own rules concerning fees
concerning fees shall respect the
shall respect the following
following principles:
principles:
(a) fees shall be set at such a level
(a) fees shall be set at such a level
as to ensure that the revenue
as to ensure that the revenue
derived from the fees is, in
derived from the fees is, in
principle, sufficient to cover the
principle, sufficient to cover the
cost of the services delivered and
cost of the services delivered and
shall not exceed what is necessary
shall not exceed what is necessary
to cover those costs;
to cover those costs
, The level
should also reflect the fact that
(the funding of) the evaluation and
authorisation procedure shall not
be entirely financed by these fees;
(b) partial reimbursement of the fee (b) partial reimbursement of the fee
if the applicant fails to submit the
if the applicant fails to submit the
information requested within the
information requested within the
specified time limit;
specified time limit;
(c) the specific needs of
SMEs shall (c) the specific needs of
small and
be taken into account, as
medium sized enterprises shall be
appropriate;
taken into account,
with respect to a
fee payment system, as appropriate;
this shall have no bearing on the
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ANNEX I
DG I 1A
LIMITE EN
Council position at first reading
Draft EP Recommendation at
Draft Council position on draft
EP position
(adopted on 21 June 2011)
second reading (voted by ENVI
EP recommendation
Committee
on 4 October 2011)
responsibility of the relevant
competent authority to carry out a
careful assessment in accordance
with the provisions of this
Regulation;
(d) the structure and amount of fees (d) the structure and amount of fees
shall take into account whether
shall take into account whether
information has been submitted
information has been submitted
jointly or separately;
jointly or separately;
(e) in duly justified circumstances,
(e) in duly justified circumstances,
and where it is accepted by the
and where it is accepted by the
Agency or the competent authority, Agency or the competent authority,
the whole fee or a part of it may be
the whole fee or a part of it may be
waived; and
waived; and
(f)
as regards Member States' rules (f) the deadlines for the payment of
only, the deadlines for the payment
fees shall be fixed taking due
of fees
to competent authorities
account of the deadlines of the
shall be fixed taking due account of procedures provided for in this
the deadlines of the procedures
Regulation.
provided for in this Regulation.
____________
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ANNEX II
Amendments for examination by tripartite meetings at technical level
Fees (clarification related to Article 79 paragraphs 1 and 2):
AM 28, 29, 30, 38, 64, 65, 71, 72, 74, 84, 85, 88, 94, 98 and 99
Register for Biocidal Products – AM 63, 66, 69, 73, 87 (partly), 89, 92, 93, 97, 103 (partly), 126
Reporting: 114, 115, 116, 117, 118, 119, 120
Electronic public access: 121, 122, 123, 124, 128, 131, 132, 138
Annex I: 141, 142, 143
Annex II+III: AM 144 - 170
Annex V: 171, 172, 173
Annex VI: AM 174 - 179
AM 3, 10, 12, 13, 14, 15, 16, 17, 18, 20, 21, 24 (partly), 26, 31, 32, 40 (partly), 41, 42 (partly)
, 44
(partly), 45 (partly), 47, 48, 51, 52, 54 (partly), 56, 57, 60, 67, 68, 70, 90, 95, 96 (partly), 100, 101,
104, 106, 109, 112, 113, 135, 137, 139
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ANNEX II
DG I 1A
LIMITE EN