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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 environmentor
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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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)
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 
subparagraphrefuse 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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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)
(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 
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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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)
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
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 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 
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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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)
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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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)
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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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 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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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 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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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)
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
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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 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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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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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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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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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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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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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 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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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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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 approvalThat 
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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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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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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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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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 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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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 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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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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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 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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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
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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 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
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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 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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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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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)
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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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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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 
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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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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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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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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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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