Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market - Preparation for the next trilogue - Hoofdinhoud

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• 1. 

  Following the trilogue held on 2 December and the meeting of the Working Party of Agricultural Counsellors/Attachés on 5 December 2008, a new draft mandate is presented in

the third column of the attached document.

• 2. 

  Although some fine-tuning is still necessary in the drafting of some of the compromise proposals, the Presidency has been able to agree on common views with the European

Parliament on the main issues which have arisen during these negotiations. In particular,

these areas concern the three-zones system for the authorisation of plant protection products,

the criteria for the approval of active substances and the candidates for substitution.

As regards the legal basis, the European Parliament is still reluctant to accept Article 95 as

one of the legal bases of the proposal.

• 3. 

  In addition, delegations have entered a number of reservations on the following amendments:

Amendment 1: DE, DK Amendment 6: DE on the words "under certain conditions" Amendment 13: UK as it can create additional administrative burdens Amendment 15: HU, UK, PT on the words "as a last resort" Amendment 17: DE, RO Amendment 23: UK, IT Amendment 26: HU, ES, RO Amendment 42: NL, HU, CZ, FI, DE, EL (would prefer the words available and agreed) Amendment 45: ES (on the last sentence of paragraph 3(e)(i) Amendment 46: IE, PT, AT concerning the phasing-out plan Amendment 53: DE would like to delete the words "relevant" and "non-target species" Amendment 66: UK (on the words "do not concern the protection of health or the

environment" DE, ES, IE, RO, SE (on the grace periods)

Amendment 77: BE, DE, IE (renewal period of the approval for candidates for substitution) Amendment 90: HU Amendment 93: DE Amendment 110: HU Amendment 128: UK (see amendment 66) Amendment 134: BE, DE, IE Amendment 160: EL and CZ on the use of the word "retailers". AT prefers the common

position. Amendment 174: ES, EL and HU on the words "acute or chronic".

• 4. 

  Coreper is invited to give its agreement to the revised mandate as set out in the Annex hereto in order to provide the Presidency with a mandate for the forthcoming negotiations with the

Parliament.

P R O P O S A L F O R A R E G U L A T I O N O F T H E E U R O P E A N P A R L I A M E N T A N D O F T H E T H E P L A C I N G O F P L A N T P R O T E C T I O N P R O D U C T S O N T H E M A R K E T

___

Common position Draft EP amendments Draft Council position Amendment 1

Citation 1

regard to the Treaty Having regard to the Treaty Accepted with modifications Having regard to the Treaty establishing the European Community, and in particular establishing the European Community, and in particular Articles 152(4)(b) and 175(1) thereof,

Articles 37(2),

152(4)(b) [...] thereof,

Amendment 2

Recital 10a (new)

(10a) To apply the 'polluter pays' principle, the Commission should examine how manufacturers of plant protection products or of the active substances they contain should be appropriately involved in dealing with or rectifying harm to human health or to the environment which may result from the use of plant protection products. Not accepted

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Amendment 3

Recital 10b (new)

(10b) In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort. This Regulation, and the legislation See AM 15 establishing data

requirements for active substances, plant protection products, safeners and synergists, should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and promote the use of nonanimal test methods and intelligent testing strategies. Existing results from tests on vertebrate animals should be shared in the process of developing new plant protection products. In accordance with Council Directive

86/609/EEC of 24 ovember 1986 on the approximation

of laws, regulations and administrative provisions of the Member

States regarding the protection of animals used for experimental and other scientific purposes

1

, tests on vertebrate animals

must also be replaced, restricted or refined.

Implementation of this

Regulation should where possible be based on the use of appropriate alternative testing methods. ot later

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*

than ... , the Commission should

review the rules on the data protection of results from tests on vertebrate

animals and where necessary change those rules.

1

OJ L 358, 18.12.1986, p. 1.

• * 

  Seven years after the entry into force of this Regulation.

Amendment 4

Recital 10c (new)

(10c) The development of non-animal in vitro (test tube) test methods should be promoted in order to produce safety data more relevant to humans than results of animal studies currently in use. Accepted with modifications Recital (38a) (10c) The development of non-animal [...] test methods should be promoted in order to produce safety data [...] relevant to humans and [...] to replace animal studies currently in use. Amendment 5

Recital 14

(14) In the interest of safety, the approval period for active substances should be limited in time. The approval period should be proportional to the possible risks inherent in the use of such substances. Experience gained from the actual use of plant protection products containing the substances concerned and any developments in

Accepted with modifications

(14) In the interest of safety, the approval period for active substances should be limited in time. The approval period should be proportional to the possible risks inherent in the use of such substances. Experience gained from the

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science and technology should be taken into account when any decision regarding the renewal of an approval is taken. After the first renewal, a regular review of substances should take place. actual use of plant protection products containing the substances concerned and any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. [...] The renewal of the approval should be for a period not exceeding fifteen years. Amendment 6

Recital 15

(15) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied, or where compliance with Directive 2000/60/EC Accepted with modifications (15) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied, or where

of the European Parliament and of the Council of 23 October

compliance with

2000 establishing a

2000/60/EC of the European framework for Community action in the field of water policy

Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy [...] is compromised, should be provided for under certain conditions.

1

and its

daughter directives may be compromised, should be provided for.

1 OJ L 327, 22.12.2000, p. 1. Amendment 7

Recital 18

(18) Some active substances with certain properties should be identified at Community level as candidates for Compromise package SUBSITUTION Accepted with modifications

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should be identified at substitution. Member States should regularly examine plant protection products (18) Some active substances with certain properties containing such active should be identified

substances with the aim of replacing them by plant protection products containing active substances which require significantly less or no risk mitigation or by alternative nonchemical agricultural practices and methods of crop protection. After a positive check, such active substances should be replaced swiftly. at Community level as candidates for substitution. Member States should regularly examine plant protection products containing such

substances with the aim of replacing them by plant protection products containing active substances which require [...] less [...] risk mitigation or by [...] non-chemical control or prevention methods [...].

Amendment 8

Recital 19a (new)

(19a) To encourage the development of Accepted with modifications Addition to Recital (16) Incentives should be given for placing on the market of low risk plant protection products plant protection products,

incentives should be established for placing on the market products with a low risk profile or a risk profile that is lower than that of products already on the market. Clear and objective criteria must be laid down to define which products may claim such a profile.

Amendment 9

Recital 20

(20) In addition to active substances, plant protection products may contain safeners or synergists for which similar legislation should be provided. The provisions necessary for the Not accepted See Article 26 and AM 80 should be provided. The

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review of such substances should be established on the basis of a legislative proposal from the Commission . Substances currently on

the market should only be reviewed after those provisions have been established.

Amendment 10

Recital 26b (new)

(26b) Good administrative Accepted with modifications (26b) Good administrative cooperation between Member States should be increased during all steps of the authorisation procedure [ ...] cooperation between Member States should be increased during all steps of the authorisation procedure and should be facilitated by a European Helpdesk.

Amendment 11

Recital 27

The principle of mutual (27) The principle of mutual Compromise package A ZONING recognition is one of the means of ensuring the free movement of goods within the Community. To avoid unnecessary duplication of work, to reduce the administrative burden for industry and for Member States and to facilitate more harmonised availability of

Accepted with modifications

(27) The principle of mutual recognition is one of the means of ensuring the free movement

products, authorisations plant protection products, of goods within

authorisations granted by one Member State should be notified to other Member States in which the applicant wishes to put the product on the market. Those Member States should Community. To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised are comparable. availability of

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be entitled to recognise an protection products, authorisations

into zones with such authorisation issued by another granted by one Member State should be accepted by

Member State, amend it or refrain from authorising the plant protection product in their territory, if justified because of specific agricultural or environmental circumstances, that may, but do not need to be limited to that Member State, or if the high level of protection of human or animal health or the environment set out in this Regulation can not be achieved, or to maintain a higher protection level in their territory in line with their other Member States where agricultural, plant health and environmental (including climatic) conditions environmental or are comparable. Therefore, the Community should be divided

into zones with comparable conditions in order to facilitate such mutual recognition. However,

environmental

agricultural circumstances specific to the territory of a Member State might require that, on application, Member States recognise an authorisation issued by another Member State, amend it or refrain from authorising the plant protection product in their territory, if justified because of specific environmental or agricultural circumstances or if the high level of protection of both human and animal health and the environment set out in this Regulation can not be achieved. Appropriate conditions may also be imposed with regard to the objectives laid down in the national action plan adopted in accordance with Directive 2008/.../EC

ational Pesticide Action Plan to

animal health and the reduce the risks associated with, and dependence on, the use of pesticides, adopted in accordance with Directive 2008/.../EC of the European Parliament and of the Council of ... [establishing

a framework for Community action to achieve a sustainable use of pesticides].

of the European Parliament and of the Council of ... [establishing

a framework

Community action to achieve a sustainable use of pesticides].

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Amendment 12

Recital 30

(30) In exceptional cases, it should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production and ecosystems which cannot be contained by any other Accepted with modifications (30) In protection products not exceptional cases,

with the conditions Member States should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production [...] or ecosystems which cannot be contained by any other reasonable means. Such temporary authorisations should be reviewed at Community level. means. Such temporary authorisations should be reviewed at Community level

Amendment 13

Recital 33

(33) In order to ensure a high level of protection of human health and the environment, plant protection products should Accepted with modifications (33) In order to ensure a high level of protection of human health and the environment, plant protection products should be used properly, in accordance with their authorisation, having regard to the principles of integrated pest management and giving priority to non-chemical and natural alternatives wherever possible. The Council should include in the statutory management requirement referred to in Annex III of Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing be used properly, in

accordance with their authorisation, having regard to the principles of integrated pest management and giving priority to non-chemical and natural

alternatives wherever possible. The Council should include in

the statutory management

requirement referred to in Annex III of Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct

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support schemes under the common agricultural policy and establishing certain support schemes for farmers the principles of integrated pest management, including good plant protection practice and non-chemical methods of plant protection and pest and crop management. A transitional period should therefore be provided for to allow Member States to put in place the necessary structures to enable users of plant protection products to apply the principles of integrated pest management and nonchemical common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers, the principles of integrated pest management, including good plant protection practice and nonchemical methods of plant protection and pest and crop management [...]. alternatives to plant

protection and pest and crop management.

Amendment 14

Recital 37

represent a major (37) Studies represent a major Accepted with modifications (37) investment. This investment should be protected in order

in order to stimulate to stimulate

research. For this reason, studies, other than those involving tests on vertebrate animals and other studies that may prevent animal testing, lodged by one applicant with a Member State should be protected against use by another applicant. This protection should, however, be limited in time in order to allow competition. It should also be limited to studies Studies represent a investment. This investment should be protected in order to stimulate research. For this reason, studies, other than those involving tests on vertebrate animals,

which are subject

obligatory data sharing lodged by one applicant with a Member State should be protected against use by another applicant.

purposes, to avoid This protection

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which are genuinely necessary for regulatory however, be limited in time in order to allow competition. It should also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. purposes, to avoid

applicants artificially extending the period of protection by submitting new studies which are not necessary.

Amendment 15

Recital 38

(38) Rules should be laid down to avoid duplication of tests and studies. In particular, repetition of studies involving Accepted with modifications (38) The use of non-animal test methods and other risk assessment strategies vertebrates should be vertebrates should be

prohibited. In this context, there should be an obligation to allow access to studies on vertebrates and other studies that may prevent animal testing. In order to allow operators to know what studies have been carried out by others, Member States should forward to the Authority all should be promoted. Animal testing for the purposes of this

regulation should

minimised and tests on vertebrates should be undertaken as a last resort. In accordance with Council Directive 86/609/EEC...

regarding

such protection of animals used for experimental and other scientific purposes, tests on vertebrate animals must be replaced, restricted or refined. Therefore, rules should be laid down to studies even where they are not covered by the above system of compulsory access. The Authority should establish a central database for such studies.

avoid duplicative tests

duplication of tests on vertebrates should be prohibited. For the purpose of developing new plant protection products,

there should

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obligation to allow access to studies on vertebrates on reasonable terms and the results and the costs of tests and studies on animals should be shared. In order to allow operators to know what studies have been carried out by others, Member States should keep a list of such studies even where they are not covered by the above system of compulsory access.

Amendment 16

Recital 41

(41) To ensure that advertisements do not mislead users of plant protection products Accepted

or the public, it is appropriate to lay down rules on the advertising of those products.

Amendment 17

Recital 43a (new)

(43a) Operators must have the same opportunities in respect of market access, in particular so that small and medium-sized

Accepted with modifications

to be added to recital (37) Business operators, in particular small and medium sized enterprises, should have the same opportunities in respect of market access.

enterprises can

operate, in order to ensure that sufficient safe and effective plant protection products are available to farmers.

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Amendment 18

Recital 44a (new)

(44a) The bureaucratic burden on farmers should be as limited as possible Accepted with modifications To be added to recital (44)

Amendment 19

Recital 45

(45) The measures provided for in this Regulation should apply without prejudice to existing Accepted with modifications (45) The measures provided for in this Regulation with other Community Community

legislation, in particular Directive 2008/.../EC should apply

[establishing a prejudice to [...] other Community

on maximum framework for Community action to achieve legislation, in particular

a sustainable use of 2008/.../EC [establishing a framework for Community action to achieve a sustainable use of pesticides], Directive 2000/60/EC, pesticides], Directive 2000/60/EC, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residues levels of pesticides in or on food and feed of plant and animal

and with Community Regulation (EC)

396/2005 of the European Parliament and of the Council of 23 February 2005 on

maximum residues levels 2

origin and Community pesticides in or on food and feed of plant

legislation on the protection of workers and anyone concerned with the contained use and deliberate release and animal origin Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.

of genetically modified organisms.

+ OJ: please insert number + OJ: please insert number 2

OJ L 70, 16.3.2005, p. 1. Regulation as

2

OJ L 70, 16.3.2005, p. 1. Regulation as

amended by Commission Regulation (EC) o

amended by Commission Regulation (EC)

178/2006 (OJ L 29, 2.2.2006, p. 3). 178/2006 (OJ L 29, 2.2.2006, p. 3).

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Amendment 20

Recital 53

(53) In particular, the Commission should be empowered to approve active substances, to renew or review their approval, to adopt harmonised methods to determine the nature and quantity Accepted with modifications 53) In particular, the Commission should be empowered to adopt [...] harmonised methods to determine the nature concerning labelling

establishing a work

for safeners and of active substances, and quantity of

including their data safeners and synergists, and where appropriate of relevant impurities and co-formulants, to adopt detailed rules for allowing derogations from authorisation of plant protection products substances, safeners and synergists, and where appropriate of relevant impurities and co-formulants, [...], and to adopt Regulations concerning labelling requirements, controls and rules for adjuvants, establishing a work programme for safeners and synergists, including information requirements for for research and

development and the list of approved substances, and to adopt Regulations concerning labelling requirements, rules for adjuvants, postponing the expiry

their data requirements,

on uniform principles for postponing the expiry of the approval period, extending the date

of the approval period, provisional authorisations, setting the information requirements for parallel trade and on inclusion of co-formulants, as extending the date for provisional authorisations, setting the information requirements for parallel trade and on inclusion of co-formulants, as well as amendments to the Regulations on data requirements and on uniform principles

inter alia by well as amendments

Regulations on data requirements and on uniform principles for evaluation and authorisation and to the Annexes. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia by supplementing it with new nonessential elements, they must be adopted

for evaluation and

authorisation and to the Annexes. Since those measures are of general scope and are designed to amend nonessential elements of this Regulation, inter alia by supplementing it with new non-essential elements, they must

in accordance with regulatory procedure with scrutiny

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be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. provided for in Article 5a of Decision 1999/468/EC. Amendment 21

Recital 56

(56) It is also appropriate to use the advisory procedure to adopt some purely technical measures. Not accepted technical measures, in Amendment 22

Article 1

Subject matter Subject matter and purpose Accepted with modifications

• 1. 

  This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. 2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which

Subject matter and purpose

• 1. 

  This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. 2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and coformulants.

plant protection products

contain or consist of, and rules for adjuvants and co-formulants. 3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment.

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• 4. 

  This Regulation is based on the precautionary principle in order to ensure that substances or products placed on the market do not adversely affect 3. The purpose of this Regulation is to [...] harmonise the rules on the

placing on the market of plant protection products while ensuring a high level of protection of both human and animal health and the environment

human health or the

environment. 5. The purpose of this Regulation is furthermore to harmonise the rules on the placing on the market of plant protection products in order to harmonise the availability of plant protection products between farmers in different Member States. 6. Member States may not be prevented and improving agriculture production. 4. Its provisions are underpinned by the precautionary principle in order to ensure that substances or products placed on the market do not adversely affect human health or the environment.

from applying the

precautionary principle in restricting or prohibiting pesticides. 7. Member States may establish any pesticide-free

zones they deem necessary in order to safeguard drinking

water resources. Such pesticide-free zones may cover the entire Member State.

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Amendment 23

Article 2 ­ paragraph 2

This Regulation shall apply to 2. This Regulation shall apply to Cf. AM 162 substances, including micro-organisms and viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products,

hereinafter 'active

substances'. It shall, however, cease to apply to micro-organisms, viruses, pheromones and biological products once

a specific regulation on biological control products has been adopted.

Amendment 24

Article 3 ­ point 2a (new)

(2a) "active substances" Substances, Not accepted. including their

metabolites present in the use phase, micro-organisms and viruses, having general or specific action against target organisms or on plants, parts of plants or plant products;

Amendment 25

Article 3 ­ point 3

"preparations" 3) "preparations" Accepted with modifications 3)

Mixtures or solutions composed of two or more substances, at least one of which is an active substance, intended for use as a plant protection product or as an adjuvant; "preparations" Mixtures or solutions composed of two or more substances [...] intended for use as a plant protection product or as an adjuvant

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Amendment 26

Article 3 ­ point 4

"substance of concern" (4) "substance of concern" Not accepted

Any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment. Such substances include, but are not limited to, substances classified as dangerous in accordance with Council Directive 67/548/EEC of 27 June 1967 on

the approximation of laws, regulations and administrative

provisions relating to the

classification, packaging and labelling of dangerous substances, and regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC. Any substance that has or potentially has either carcinogenic, mutagenic, endocrine

classification, packaging and disrupting, neurotoxic,

immunotoxic, reprotoxic or genotoxic capabilities should be regarded as a substance of concern;

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Amendment 27

Article 3 ­ point 4a (new)

(4a) "article" An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition; Not accepted Amendment 28

Article 3 ­ point 5

"plants" 5) "plants" Not accepted

Live plants and live parts of plants, together with seeds for sowing, in particular: fresh fruit, vegetables, flowers, leaves, shoots, living pollen, seedlings, bulbs and roots;

Amendment 29

Article 3 ­ point 8

"placing on the market" 8) "placing on the market" Not accepted

The holding for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves, but not the return to the previous seller. Release for free circulation into the territory of the Community, as well as imports, shall constitute placing on the market for the purposes of this Regulation;

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Amendment 30

Article 3 ­ point 8a (new)

(8a) "parallel trade" The import of a plant protection product from a Member State where the product has been authorised under the conditions of Directive 91/414/EEC or this Regulation with the intention of placing it on the market in the importing Member State where the plant protection product or an identical reference product has been authorised under the Not accepted conditions of Directive 91/414/EEC;

Amendment 31

Article 3 ­ point 8b (new)

(8b) "importer" A person importing plant protection products for commercial purposes Not accepted Amendment 32

Article 3 ­ point 10a (new)

(10a) "low risk" Of a nature considered inherently unlikely to cause an adverse effect on humans, animals or the environment Not accepted

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Amendment 33

Artcile 3 ­ point 12a (new)

(12a) "health" A state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity Not accepted Amendment 34

Article 3 ­ point 12b (new)

(12b) "vulnerable groups" Persons Accepted with modifications (12b) "vulnerable groups" Persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, [...] unborns, infants and children, the elderly [...] and workers and residents subject to high pesticide exposure over the long term; needing specific

consideration when assessing the acute and chronic health effects of plant protection products. These include

pregnant and nursing

women, embryos and foetuses, infants and children, the elderly, people who are ill and those taking medication,

and workers and residents subject to high pesticide exposure over the long term;

Amendment 35

Article 3 ­ point 15

deleted Compromise package A ZONING Not accepted

the purpose of use in as post-harvest

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Amendment 36

Article 3 ­ point 15a (new)

(15a) "integrated pest management" Careful consideration of all available pest Not accepted control techniques and subsequent integration of appropriate measures

that discourage the

development of pest populations and keep plant protection products and other forms of intervention to levels that

are economically and

ecologically justified and reduce or minimise risks to human health and the environment. Integrated pest management emphasises the growth of a healthy crop with the least possible

disruption to agro-

ecosystems by giving priority to preventive crop-growing measures and the use of adapted varieties and of non-chemical methods of plant protection

and pest and crop management;

Amendment 37

Article 3 ­ point 15b (new)

(15b) "non-chemical methods of Not accepted plant protection and pest and crop management" The use of pest control and management techniques that do not have

chemical properties. on chemical methods of plant protection

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and pest and crop management include

rotation, physical and mechanical control and natural predator management;

Amendment 38

Article 3 ­ point 18

• 18) 

  `good experimental practice' Practice in accordance with Directive 2004/10/EC; Not accepted Directive 2004/10/EC relates to the application of the principles of good laboratory practices. of European and Plant Protection Amendment 39

Article 3 ­ point 19

• 19) 

  "data protection" A test or study report, other than those involving tests on vertebrate animals and other tests or studies that may prevent animal testing, is covered by data protection where its owner has the right to prevent it being used for the benefit of another person; Not accepted Amendment 40

Article 3 ­ point 19a (new)

(19a) "rapporteur Member State" Accepted with modifications

The Member State which agrees to assume (19a) "rapporteur Member State" the responsibility for

The Member State which undertakes the task of evaluating an active substance, or safener, or synergist. [...];

assessing the active substances, or safeners, or synergists. It is required to carry out this task in a professional manner and to publish an impact

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assessment report within a specified period;

Amendment 41

Article 3 ­ point 19b (new)

(19b) "tests and studies" Investigations or experiments whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products; Accepted Amendment 42

Article 4 ­ paragraph 2 ­ point a

(a) they shall not have any harmful effects on human health, in particular that of users who are in direct contact with

Accepted with modifications

(a) they shall not have any harmful effects on human health, [...] including vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the established scientific

the products, residents,

bystanders and vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the methods to assess such effects are available, or on groundwater;

methods to assess

such effects are available, or on groundwater;

Amendment 43

Article 4 ­ paragraph 2 ­ point b

they shall not have any (b) they shall not have any Not accepted. effect on the unacceptable effect on the

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environment, taking into account cumulative and synergistic effects and all relevant exposure routes to organisms in the environment; methods to assess such effects will be presented by the Authority

.

Amendment 44

Article 4 ­ paragraph 3 ­ point b

(b) it shall have no immediate or delayed harmful effect on human health, in particular that of residents and Accepted with modifications (b) it shall have no immediate or delayed harmful effect on human health, including for [...] vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, [...] or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic bystanders and vulnerable

resulting from water groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, including in locations distant from its use following long-range

transportation, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects, where the methods to assess such effects are available; or on surface water or groundwater;

effects, where

established scientific methods to assess such effects are available; or on [...] groundwater;

Amendment 45

Article 4 ­ paragraph 3 ­ point e

it shall have no unacceptable (e) it shall have no unacceptable Accepted with modifications (e) it shall have no unacceptable effects on the environment, having effects on the environment, having particular regard to the following considerations:

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its fate and distribution in the (i) its fate and distribution in the environment, particular regard to the following considerations where the established scientific methods to assess such effects are agreed available: (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters [...] groundwater, air and soil [...] taking into account locations particularly particularly

of surface waters, contamination of surface waters, including estuarine and coastal waters, drinking water, groundwater, air and soil, taking into account locations distant from its use following longrange environmental transportation ;

(ii) its impact on non-target species, including on the behaviour of those species; (iii) its impact on biodiversity and the ecosystem; (iiia) its destructive impact on species threatened with extinction.

distant from

following long-range environmental transportation; (ii) its impact on non-target species, including on the ongoing behaviour of those species; (iii) its impact on biodiversity and the ecosystem; [...]

Amendment 46

Article 4 ­paragraph 7

• 7. 

  By way of derogation from paragraph 1, where a) it is proven by the applicant on the basis of documented evidence that an active substance is necessary to control a serious danger to plant health in a Member State which cannot be contained by other available means, including non-chemical means; and Compromise package B CUT OFFS evidence an active Accepted with modifications
• 7. 

  By way of derogation from paragraph 1, where [...] on the basis of documented evidence included in the application an active substance is necessary to control a serious danger to

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• b) 

  there is a public interest in controlling that danger, such plant health [...] which cannot be contained by other available means including non-chemical means, [...] such active substance may be approved for a time limited period necessary to control that serious danger but not exceeding five years [...] even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans active substance may be approved for a time limited period necessary to control that serious danger but

not exceeding four years

in that Member State even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised, and that a substitution plan on how to control the serious danger in two years time by other means,

and the environment

minimised. [...]. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. This derogation shall not apply to active substances which are or have to be classified in accordance with Directive 67/548/EEC, as carcinogenic category 1, carcinogenic category 2 without a threshold, or toxic for reproduction category 1. [...] Members States may authorise plant protection products containing active substances approved in accordance with this paragraph when it is necessary to control that serious danger to plant health in their

including non-chemical

methods, is presented by the

applicant. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. This derogation shall not apply to active substances which are or have to be classified in accordance with Directive 67/548/EEC, as carcinogenic category 1, carcinogenic category 2 without a threshold, or toxic for reproduction category 1. If an applicant applies for a derogation under this paragraph, the timelines set out in Articles 12 and 13

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shall be halved. territory. They shall elaborate a phasing out plan on how to control the serious danger by other means, including non-chemical methods, and shall inform the Commission thereof.

Amendment 47

Article 4a (new)

Article 4a

Accepted with modifications

Animal testing

In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. The use To be added to Article 62, new first paragraph [...] Testing on vertebrate animals for the purposes of this Regulation shall be undertaken [...] only where no other methods are available. Repetition of tests and studies involving vertebrates undertaken for the purposes of this regulation shall be avoided in accordance with paragraphs 1 to 4. of non-animal tests and intelligent testing strategies shall be promoted, and duplicate vertebrate animal testing shall be prohibited.

Amendment 48

Article 6 ­ point (ia) (new)

(ia) restrictions or prohibitions for uses not compatible with integrated pest management schemes, or even detrimental to these schemes such as chemical soil treatment;

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Amendment 49

Article 7 ­ paragraph 1

• 1. 

  The Authority shall be responsible for Not accepted

coordinating the approval

procedure. In doing so, the Authority shall rely on the competent authorities of Member States. An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to the Authority together with a complete and a summary dossier, as provided for in Article 8(1) and (2), or a letter of access

"rapporteur Member State",

parts of those dossiers, to such dossiers or a

scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4. The Authority shall inform the competent authorities of the Member States of the applications it has received. A Member State may choose an active substance for which an application for approval has been received by the Authority, with the aim of becoming the rapporteur Member State.

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In cases where two or more Member States have expressed an interest in becoming the rapporteur Member State and they cannot agree who should be the competent authority, the rapporteur Member State shall be determined in accordance with the regulatory procedure referred to in Article 79(3). The decision shall be based on objective criteria such as geographic, agricultural and climatic conditions, especially with regard to the target organisms, the performance and impartiality

of the competent

authority and the reference laboratory, and the absence of interests linked to the producing companies.

Amendment 50

Article 7 ­ paragraph 1a (new)

1a. A natural or legal person established outside the Community who submits an application shall appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on producers under this Regulation. Not accepted

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Amendment 51

Article 7 ­ paragraph 1b (new)

1b. Assessment of an application may be performed by a number of Member States together under the corapporteur system. Accepted with modifications 1b. Assessment of an application may be performed by a number of Member States together under a [...] corapporteur system. Amendment 52

Article 8 ­ paragraph 1 ­ point ca (new)

(ca) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals; Accepted Amendment 53

Article 8 ­ paragraph 4a (new)

4a. All scientific peer-reviewed open literature on the active substance and its metabolites regarding negative side-effects

Accepted with modifications

4a. [...] Scientific peer-reviewed open literature, as determined by the Authority, on the active substance and its relevant metabolites dealing with [...] side-effects on health, and the environment and non-target species [...] and published within the last five ten years before the date of dossier submission shall be added by the applicant to the dossier.

on health, the environment and non-target species shall be added by the applicant to the dossier.

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Amendment 54

Article 11 ­ paragraph 1

• 1. 

  The rapporteur Member State may start the evaluation of test and study reports as soon as they are submitted by the applicant, including before the date of the notification provided for in the first subparagraph of Article 9(3). Within twelve months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report (hereinafter referred to as "draft assessment report") assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4. Not accepted Amendment 55

Article 11 ­ paragraph 2

• 2. 

  The draft assessment report shall also include where relevant, a proposal to set maximum residue levels. Accepted evaluation report and the o

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Amendment 56

Article 12 ­ paragraph 2 ­ sub-paragraph 2

Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public. Where a consultation as provided for in the subparagraph above is organised, the 120- day period shall be extended by 60 days. Accepted with modifications Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public. Where a consultation as provided for in the subparagraph above is organised, the 120- day period shall be extended by [...] 30 days. Amendment 57

Article 12 ­ paragraph 6a (new)

6a. Where the conclusion of the Authority is adopted within the time limit set out in paragraph 2 of this Article, extended by any additional time period set in paragraph 3, the provisions of Article 11 of Regulation (EC) °396/2005 shall not apply and Accepted

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the provisions of Article 14 of that Regulation shall apply without delay.

Amendment 58

Article 12 ­ paragraph 6b (new)

6b. Where the conclusions of the Authority are not adopted within the time limit set out in paragraph 2 of this Article, extended by any additional time period set in paragraph 3, the provisions of Article 11 and 14 of Regulation (EC) Accepted °396/2005 shall apply without delay

Amendment 59

Article 13 ­ paragraph 1 ­ sub-paragraph 1

• 1. 

  Within three months of receiving the conclusion from the Authority, the Commission shall present a report, (hereinafter referred to as "the review report"), and a draft Regulation to the Committee referred to in Article 79(1), taking into account the draft assessment report by the rapporteur Member State and the conclusion of the Authority. Not accepted Amendment 60

Article 13 ­ paragraph 2 ­ introduction et point (a)

• 2. 

  On the basis of the review report, other factors legitimate to the matter under Not accepted

consideration and the consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are

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relevant, a Regulation with due justification

shall be adopted in

accordance with the regulatory

procedure with scrutiny referred to in Article 79(4), providing that: (a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate, and included in Annex IIa;

Amendment 61

Article 13 ­ paragraph 4

• 4. 

  The Commission shall maintain an updated list of approved active substances in Annex IIa and publish this list on the Internet. Not accepted approved active substances Amendment 62

Article 14 ­ paragraph 2

• 2. 

  The approval may be renewed once or repeatedly for a period not exceeding 10 years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding four years. Not accepted Amendment 63

Article 15 ­ paragraph 1

• 1. 

  The application provided for in Article 14 shall be submitted by a Not accepted

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producer of the active substance to the Member State concerned, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the first approval.

Amendment 64

Article 18 ­ point b

(b) the necessary data to be submitted including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies; Accepted Amendment 65

Article 20 ­ paragraph 1 ­ introduction

• 1. 

  A Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4), providing that: Not accepted with the regulatory Amendment 66

Article 20 ­ paragraph 2

• 2. 

  Where the reasons for not renewing the approval do not concern the protection Accepted with modifications 2. Where the reasons for not renewing the approval do not concern the protection

of health or the

environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding one year for using up stocks of the plant protection products concerned. Past this period, producers shall ensure

of health

environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding [...] six months for the sale and distribution, but in

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the removal and safe disposal of the remaining stocks any case such that it does not interfere with the normal period of use of the plant protection product, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. [...] In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately. .

In the case of a withdrawal of the approval or if the approval is not renewed because of concerns for human health or animal health or the environment, the plant protection products

from the market

concerned shall be

withdrawn from the market immediately.

Amendment 67

Article 21 ­ paragraph 1 ­ sub-paragraph 1

The Commission may review the 1. The Commission may review the approval of an active substance at any time and shall give due consideration to requests for review from a Member State, the European Parliament or other stakeholders, based on current scientific and technical knowledge and monitoring data. Accepted with modifications

1.

The Commission may review the

approval of an active substance at any time. [...] It may shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where after the review of the authorisations pursuant to article 44 (1), there are indications that the achievement of the

objectives established accordance with Article 4(1)(a)(iv)

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and (b)(i) and Article 7(2) and (3) of Directive

2000/60/EC

compromised.

Amendment 68

Article 21 ­ paragraph 1 ­ sub-paragraph 2a (new)

The Commission shall review the approval of an active substance where there are indications that the achievement See AM 67 of the objectives

established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may be compromised.

Amendment 69

Article 21 ­ paragraph 3 ­ sub-paragraph 1

• 3. 

  Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with point (f) of Article 6 has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). Not accepted

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Amendment 70

Article 21 ­ paragraph 3a (new)

3a. Where the Commission concludes that the objectives of reducing pollution from priority substances established Not accepted in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC

cannot be met, a Regulation to withdraw or amend the approval

shall be adopted in

accordance with the regulatory procedure with scrutiny referred to in Article 79(4) of this Regulation.

Amendment 71

Article 22 ­ paragraph 1 ­ sub-paragraph 1a (new)

This derogation shall not apply to any active Accepted with modifications Add "chemicals" in Annex II.5, first paragraph, 4 substance classified in

accordance with Directive th

67/548/EEC as: indent.

­ carcinogenic, ­ mutagenic, ­ toxic to reproduction, ­ sensitising chemicals, - sensitising chemicals, or to substances that are qualified as:

­ persistent with a half-life of

more than 60 days,

­ endocrine disrupters appearing on the EU list of suspected

endocrine

disrupters,

­ toxic,

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­ bioaccumulative and non-

readily degradable.

o later than ...*, the Commission

shall review and if necessary specify the criteria for treating an active substance as a low risk substance and, if appropriate, submit proposals.

• * 

  One year after the entry into force of this

Regulation. Amendment 72

Article 22 ­ paragraph 1a (new)

1a. otwithstanding Article 5, active substances Not accepted based on biological

control agents which comply with the criteria of Article 4 shall be given approval for a period not exceeding 15 years where plant protection products containing such biological control agents are expected to present only a low risk to human and animal health and the environment as defined in Article 47(1).

Amendment 73

Article 22 ­ paragraph 2

• 2. 

  Articles 4 and 6 to 21 and Section 5 of Annex II shall apply. Low-risk active substances shall be listed separately in Annex Iia. Not accepted

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Amendment 74

Article 23 ­ paragraph 1 - sub-paragraph 2a (new)

For the purpose of this Regulation, an active substance which fulfils the criteria of a 'foodstuff' as defined in Article 2 of Regulation (EC) Accepted o

178/2002 shall be considered as a basic substance.

Amendment 75

Article 23 ­ paragraph 2

• 2. 

  A basic substance shall be approved in accordance with Article 4 and where Not accepted any relevant evaluations,

in accordance with other carried out in accordance with other Community legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment, provided that each point of the data requirements for active substances contained in plant protection products is given and the same decision-making procedures apply. Amendment 76

Article 23 ­ paragraph 5

• 5. 

  Articles 6 and 13 shall apply. Basic substances shall be listed separately in Not accepted

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Annex Iia.

Amendment 77

Article 24 ­ paragraph 1

• 1. 

  An active substance complying with the criteria provided for in Article 4 shall be approved as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for a period not exceeding five years. Compromise package SUBSTITUTION

Accepted with modifications

• 1. 

  An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for a period not exceeding seven years.

Amendment 78

Article 24 ­ paragraph 2

• 2. 

  Without prejudice to paragraph 1, Articles Not accepted

4 to 21 shall apply.

substitution shall be listed Candidates for substitution shall be listed separately in Annex Iia. Amendment 79

Article 25 ­ paragraph 1a (new)

1a. For approval of a safener or synergist, paragraph 1 shall be deemed Not accepted to be satisfied where

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compliance with Article 4 has been established with respect to one or more representative uses of at least one plant protection product for every different active substance the safener or synergist is combined with.

Amendment 80

Article 26

By ...*, a Regulation shall be adopted in accordance with the procedure referred to in Article 251 of the Treaty establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force. The Regulation Accepted with modifications By ...*, a Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in [...] Article 79(4) establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force. The Regulation shall include the establishment of data requirements, including Regulation shall include shall include the establishment of data requirements, including measures to minimise animal

testing, notification,

evaluation, assessment and decisionmaking procedures. It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified time period.

measures to

animal testing, notification, evaluation, assessment

and decision-making

procedures. It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified time period.

• * 

  Note to OJ: 24 months from the date of

entry into force of this Regulation.

• * 

  Note to OJ: [...] 60 months from the date of entry into force of this Regulation.

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Amendment 81

Article 27 ­ titre et paragraphs 1 et 2

Approval of co-formulants 1. A co-formulant shall be approved where it has been established that: (a) the co-formulant or its residues, consequent on application consistent with good plant protection practice, and Not accepted its residues, consequent on having regard to realistic conditions of use, do not have a harmful effect on human or animal health or on groundwater or an unacceptable

effect on the

effect on the environment; and (b) its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, does not have a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the

environment. 2. Co-formulants approved pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

product pursuant to

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Amendment 82

Article 27 ­ paragraph 2a (new)

2a. Where a co-formulant is used in a plant protection product authorised under this Regulation, its specific use in plant protection products shall be considered as being registered in accordance with Article 15 (1) of Regulation (EC) o 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning Not accepted the Registration,

Evaluation, Authorisation and 1

Restriction of Chemicals (REACH) . ____________

1 OJ L 396, 30.12.2006, p. 1. Corrected in OJ L 136, 29.5.2007, p. 3. Amendment 83

Article 28 ­ paragraph 2 ­ point b

placing on the market and use (b) use of plant protection products for research or development purposes in accordance with Article 54; Not accepted Amendment 84

Article 29 ­ paragraph 1 ­ point c

its co-formulants are not (c) its co-formulants have been approved under Article 27; Not accepted

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Amendment 85

Article 29 ­ paragraph 1 ­ point ca (new)

(ca) its (technical) formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product; Accepted Amendment 86

Article 29 ­ paragraph 1 ­ point ea (new)

(ea) all metabolites of the active substance(s) present in the use-phase have been determined and comply with criteria of the uniform principles referred to in paragraph 6; Not accepted Amendment 87

Article 29 ­ paragraph 1 ­ point f

its residues, resulting from (f) its residues, resulting from Accepted with modifications (f) authorised uses, can be determined by standardised methods in general use in all Member States, which are sufficiently sensitive with respect to any technically detectable levels that could

ecotoxicological or its residues, resulting authorised uses, and which are of toxicological,

ecotoxicological

environmental relevance, can be determined

be present in any by [...] appropriate

environmental and biological media. The residues shall be detectable with the common multi-residue methods as applied by Community reference laboratories; methods in general use in all Member States, with appropriate limits of determination on relevant samples [...];

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Amendment 88

Article 29 ­ paragraph 1 ­ point ha (new)

(ha) its authorisation does not counteract Not accepted the national plans developed under Directive 2008/.../EC [establishing

a framework for Community action to achieve a sustainable use of pesticides]*.

• * 

  ote to OJ: please insert number. Amendment 89

Article 29 ­ paragraph 4

• 4. 

  With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). Accepted Amendment 90

Article 29 ­ paragraph 6 - sub-paragraph 1a (new)

The uniform principles shall take due account of the interaction between the

Accepted with modifications

Addition to point 6. Following these principles interaction between

active substance, safeners, synergists and co-formulants.

the active substance,

safeners, synergists and

formulants shall be taken into account in the evaluation of plant protection products.

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Amendment 91

Article 30 ­ paragraph 1 ­ point a

The decision on approval could not be finalised within a time period of 30 months from the date of admissibility of the application, extended with any additional Accepted with modifications The decision on approval could not be finalised within a time period of 30 months from the date of admissibility of the application, extended with any additional time period set in accordance with article 9 [...] (2), article 11 (3) or article 12 (2) or (3); and time period set in time period set in accordance with article 92 (2), article 11 (3) or article 12 (2) or (3); and

Amendment 92

Article 30 ­ paragraph 2

• 2. 

  In such cases the Member State may start its evaluation regarding a provisional authorisation as soon as there is evidence that the deadlines for the substance authorisation will not be met and shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57 (1). Not accepted Amendment 93

Article 31 ­ paragraph 2 ­ sub-paragraph 1a (new)

These requirements shall also Accepted with modifications Paragraph 2a (new) include: a) the maximum dose per hectare in each application;

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• b) 

  the period between the last application and harvest; c) the number of applications per year. 2a. These requirements shall also include where applicable: a) the maximum dose per hectare in each application; b) the period between the last application and harvest; c) the number of applications per year.

Amendment 94

Article 31 ­ paragraph 2 - sub-paragraph 2

The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC. Member States may provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with Directive 1999/45/EC. In such case, they shall immediately inform the competent authority thereof. Not accepted Amendment 95

Article 31 ­ paragraph 2 - sub-paragraphs 2a et 2b (new)

The authorisation shall include indications Accepted with modifications Article 31 ­ paragraph 3 (ba) (new) (ba) [...] indications for proper use according for proper use in accordance with the principles of integrated

pest management as defined in Article 3, to apply from 2012 onwards;

to the principles

integrated pest management [...] as referred to in article 13 and in Annex III to the Directive 2008/.../EC

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establishing a framework Community action to achieve a sustainable use of pesticides;

Amendment 96

Article 31 ­ paragraph 3 ­ point a

(a) a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents and workers concerned and consumers or animal health or the environment, taking into consideration requirements imposed by other Community provisions; such restriction shall be indicated on the label; Compromise package A ZONING Accepted with modifications (a) a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents, [...] consumers and workers concerned, [...] or the environment, taking into consideration requirements product taking into concerned and the imposed by

Community provisions; such restriction shall be indicated on the label;

Amendment 97

Article 31 ­ paragraph 3 ­ point ba (new)

(ba) any restrictions or prohibitions of pesticide use in and around areas used by the general public or by vulnerable Not accepted groups, such as

residential areas, parks, public gardens, sports grounds, school grounds, children's playgrounds;

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Amendment 98

Article 31 ­ paragraph 3 ­ point bb (new)

(bb) other restrictions or conditions relevant Not accepted

to the issue of an

authorisation and to the use of the plant protection product, particularly where these are intended to protect the health of distributors, users, workers, residents, bystanders and consumers or animal health or the environment;

Amendment 99

Article 31 ­ paragraph 3 ­ point (e)

the maximum dose per hectare deleted Accepted Amendment 100

Article 31 ­ paragraph 3 ­ point (f)

the maximum number of deleted Accepted Amendment 101

Article 31 ­ paragraph 3 ­ point (h)

deleted Accepted Amendment 102

Art. 33, paragraph 2, points a and b

(a) a list of intended uses and the Member States where the applicant has made or intends to make an application; Compromise package A ZONING Not accepted

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as post-harvest

which evaluates the Amendment 103

Article 33 ­ paragraph 3 ­ point b

(b) for each active substance, safener and synergist, co-formulant and adjuvant contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist, coformulant and adjuvant, as well as a complete and a summary dossier on the combined effect of the active substance(s), Not accepted safener(s) and

synergist(s), co-formulant(s) and adjuvant(s) contained in the plant protection product;

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Amendment 104

Article 33 ­ paragraph 3 ­ point c

(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals; Accepted Amendment 105

Art. 33, paragraph 6a (new)

6a. On request, the applicant shall provide any other Member States with the complete dossier referred to in paragraph 3(a). Compromise package A ZONING Not accepted Amendment 106

Article 33 ­ paragraph 6b (new)

6b. Application forms shall be standard in all Member States. Compromise package A ZONING Not accepted Amendment 107

Article 35

The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it. The Member State which will examine the application shall inform the applicant. At the request of the Member State examining the application, the other Member States shall cooperate to Compromise package A ZONING Not accepted

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ensure a fair division of the workload. Member

shall cooperate to ensure a States evaluating the

application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions.

shall refrain from Member States

Amendment 108

Article 35a (new)

Article 35 a Compromise package A ZONING Not accepted Database of the Authority

Upon being informed which Member State will examine the application, the

applicant shall immediately

forward to the Authority the complete and the summary dossiers referred to in Article 33(3)(a) and (b) and the information referred to in Article 33(3)(c). The Authority shall without delay make available to the public the

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summary dossiers, excluding any information which is confidential under Article 63, and the information referred to in Article 33(3)(c).

Amendment 109

Art. 36, paragraph 1

• 1. 

  The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application. It shall give all Member States the opportunity to submit comments to be considered in the assessment. It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product Compromise package A ZONING Not accepted in the same zone the meets the requirements

provided for in Article 29, where used in accordance with Article 55, and under realistic conditions of use. The Member State examining the application shall make available its assessment to the other Member States. The format of the assessment report

shall be established in

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assessment report shall be accordance with the regulatory procedure referred to in Article 79(3).

procedure referred to in .

Amendment 110

Art. 36, paragraph 2

• 2. 

  Within 180 days, the Member States concerned shall grant or refuse authorisations on the basis of the conclusions of the assessment of the Member Compromise package A ZONING Not accepted See AM 112 "...on the basis of a related assessment..." State examining the

application as provided for in Articles 31 and 32, and on the basis of any additional assessments, tests, and studies related to specific conditions in the Member States. The 180-day period cannot be extended.

Amendment 111

Art. 36, paragraph 2a (new)

2a (new) A Member State may refuse authorisation of the plant protection product in its territory only if, due to specific Compromise package A ZONING Not accepted environmental or

agricultural circumstances, it has substantiated reasons to consider that the product in question poses a risk to human or animal health or the environment

Amendment 112

Art. 36, paragraph 3

• 3. 

  By way of derogation from paragraph 2 and subject to Community Compromise package A ZONING

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law, Member States may impose appropriate conditions with respect to the requirements referred to in Article 31(3) and other risk mitigation measures Accepted with modifications 3. By way of derogation from paragraph 2 and subject to Community law, [...] appropriate conditions may be imposed with respect to the requirements referred to in Article 31 (2a) and (3) and other risk mitigation measures deriving from specific conditions of use. Where the concerns of a Member State related to human or animal health or the environment cannot be controlled by the establishment of national risk mitigation measures referred to in the first subparagraph, a with respect to the deriving from specific

conditions of use. It shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefore. Member States shall provide for a possibility to challenge a decision accepting or

Member State may

authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances on the basis of a related

assessment it

substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. It

refusing the authorisation

of such product by any stakeholder before the national courts or other instances of appeal.

shall immediately inform

to challenge decision applicant and the Commission of its decision and provide a technical or scientific justification therefore.

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Member States shall provide for a possibility to challenge [...] decision [...]

refusing the authorisation of such

product [...] before the national courts or other instances of appeal.

Amendment 113

Article 37 ­ paragraph 4

The other Member States Deleted Compromise package A ZONING Not accepted Article 37 paragraph 4 modified as such : 4. and the copy of the The other Member

concerned shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(2) and (3).

Amendment 114

Article 39 ­ paragraph 4- sub-paragraph 1a (new)

ot later than ...*, the Commission Compromise package A ZONING Not accepted shall present a proposal introducing a

standardised format for the documentation provided for in points (a), (b) and (c).

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_____ * 12 months after the entry into force of this

Regulation. Amendment 115

Article 39 ­ paragraph 1a (new)

1a. Member States shall, without delay, make available to the Authority a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1. The Authority shall maintain a register in which all authorisations Compromise package A ZONING Not accepted in the different Member States are registered.

Amendment 116

Article 39 ­ paragraph 2a (new)

2a. Within 12 weeks of a decision on the Not accepted

authorisation of a plant

protection product, Member States shall make available a record of the administrative decision as referred to in point (c) of paragraph 1 on a public website.

Amendment 117

Art. 40, paragraph 1

• 1. 

  The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural Compromise package A ZONING Not accepted practices in another practices in another Member State under the mutual

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recognition procedure provided for in this subsection.

of empty rooms or Amendment 118

Art. 41, paragraph 1

• 1. 

  The Member State to which an application under Article 40 is submitted Compromise package A ZONING Not accepted under Article 40 is shall examine the

assessment undertaken by the Member State where the

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authorisation was granted (reference Member See AM 112 "...on the basis of a related assessment..."

Article 36(3) applies. State) against the circumstances in its own territory and shall

within 180 days authorise the

plant protection product concerned under the same conditions as the Member

State examining the application or apply Article 36(2a) or (3).

Amendment 119

Art. 41, paragraph 1ba (new)

1ba. Where a Member State refuses the Compromise package A ZONING Not accepted authorisation of a plant

protection product in accordance with article 36 (2a), it shall notify the Commission, the other Member States and the applicant within 15 days

of its decision and its substantiated reasons therefore.

Amendment 120

Art. 41, paragraph 2

By way of derogation from paragraph 1, the Member State may authorise the plant protection product where: (a) it contains a candidate of substitution; (b) Article 30 has been applied; or (c) Compromise package A ZONING Not accepted it contains a substance approved in

accordance with Article 4(7).

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it contains a substance approved in

Amendment 121

Article 41 ­ paragraph 2a (new)

2a. A Member State may also refuse authorisation of the plant protection product in its territory if it has substantiated Compromise package ZONING Not accepted reasons that the authorisation of this product would counteract the objectives of its

ational Action Plan.

Amendment 122

Article 42 ­ paragraph 1 (a)

a copy of the authorisation (a) a copy of the authorisation Not accepted granted by the reference Member State as well as, where requested, a translation of the authorisation into an official or national language of the Member

State receiving the application;

Amendment 123

Article 42 ­ paragraph 2

The Member State to which an 2. The Member State to which an application under Article 40 is submitted Compromise package A ZONING Accepted with modifications 2. The Member State to which an application under Article 40 is

shall decide on the shall decide on the application within 180 days.

under Article

submitted shall decide application within 120 days

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Amendment 124

Art. 43, paragraph 2 - sub-paragraph 2

The Member State referred to in Article 35 shall coordinate the compliance check and assessment of the information submitted to all Member States that received an application. Compromise package A ZONING Not accepted of the information Amendment 125

Article 43 ­ paragraph 4

• 4. 

  Guidelines on the authorisation of compliance checks may be established in accordance with the regulatory procedure referred to in Article 79(3). Not accepted Amendment 126

Article 44 ­ paragraph 3 ­ point ca (new)

(ca) on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified; Accepted Amendment 127

Article 44 ­ paragraph 4

• 4. 

  Where a Member State withdraws or Compromise package A ZONING Not accepted

amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation,

other Member States, the the other Member States, the Commission and the Authority. The other Member States shall

withdraw or amend the authorisation accordingly taking into

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account national conditions and risk mitigation measures except for cases where Article 36(2a) has been applied. Article 46 shall apply where appropriate.

where second to fourth

Amendment 128

Article 46 ­ paragraph 2

Where the reasons for withdrawal, amendment or not renewing the authorisation are not related to the protection of human and animal health or the environment, grace periods for using up stocks of the plant protection products concerned shall be granted for a period not longer than one season. If the reasons for withdrawal, amendment or not renewing the authorisation are related to the protection of human and Accepted with modifications

Where the reasons for withdrawal, amendment or not renewing the authorisation are not related to the protection of human and animal health or the environment, [...] the grace period shall be limited and not exceed six months for the sale and the distribution

and an additional

animal health or the maximum of one year for the disposal, storage, and use of existing stocks

environment then there shall be no time period for using up stocks of the plant protection products concerned and all sales and use of such products shall cease with immediate effect once the decision of withdrawal or non-renewal has been taken.

of the plant protection products concerned.

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Amendment 129

Article 46a (new)

Article 46 a Not accepted Disposal and destruction of

unauthorised plant protection

products

otwithstanding the provisions of

Article 46, stocks of unauthorised plant protection products shall be safely disposed of and destroyed under the responsibility of the former authorisation holder.

Amendment 130

Article 46b (new)

Article 46b Not accepted Imports

Imported non-food materials or

articles shall not contain residues of active substances that have not been

approved in accordance with the

provisions of this Regulation

Amendment 131

Article 47a (new)

Article 47a Not accepted Placing on the market and use of

reduced-risk plant protection

products

• 1. 

  otwithstanding Article 29, a plant protection

product shall be authorised as a reduced-risk product if

it meets the following requirements:

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(a) at least one of the active substances that it contains is a substance as defined in Article 22; (b) all the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II; (c) it entails, in the light of scientific or technical knowledge, considerably fewer risks to human or animal health or the environment than a comparable plant protection product that is already authorised; (d) it is sufficiently effective; (e) it complies with points (b), (c) and (e) to (h) of Article 29(1). 2. Applicants for authorisation of a reduced-risk plant protection product shall

demonstrate that the

requirements set out in paragraph 1 are met and shall accompany the application with a complete and a summary dossier for each point of the data requirements of the active substance and the plant protection product.

Amendment 132

Article 50 ­ paragraph 1 - introduction and points (a) and (b)

• 1. 

  A comparative assessment shall be performed by Member States when evaluating Compromise package SUBSTITUTION

an application for an application for

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authorisation for a plant protection product containing an active substance approved Accepted with modifications 1. A comparative assessment shall be performed by Member States when evaluating

as a candidate for as a candidate for

substitution. Member States shall not authorise or shall restrict the use of a plant protection product for use in a given crop containing a candidate for substitution where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that: (a) for the uses specified in the application an application

authorisation for a plant protection product containing an active substance approved as a candidate for substitution. Member States shall not authorise or shall restrict the use of a plant protection product [...] containing a candidate for substitution for use on a given crop where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that: (a) for the uses specified in the application

an authorised plant an authorised plant

protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment; and (b) the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages; and (c) the chemical diversity of the active substances,

an authorised

protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment; and (b) the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a)

where relevant, or does not present significant

methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and economic or practical disadvantages; and (c) the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in

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the target organism; and

Amendment 133

Article 50 ­ paragraph 3 ­ sub-paragraph 2

Such authorisations shall be granted for a period not exceeding three years. Compromise package C SUBSTITUTION Accepted with modifications Such authorisations shall be once granted for a period not exceeding five [...] years. Amendment 134

Article 50 ­ paragraph 4 ­ sub-paragraph 1

• 4. 

  For plant protection products containing a candidate for substitution Member States shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest four years after authorisation or renewal of the authorisation was granted. Compromise package C SUBSTITUTION Not accepted See AM 77 = 7 years Amendment 135

Article 50 ­ paragraph 5

• 5. 

  Where a Member State decides to withdraw or amend an authorisation pursuant Compromise package C SUBSTITUTION Accepted with modifications 5. Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect [...] to paragraph 4, that to paragraph 4, that withdrawal or amendment shall take effect two years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends

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earlier. three years after the decision of the

Member State or at the end of the approval period of the candidate for substitution where that period ends earlier.

Amendment 136

Article 51 ­ paragraph 2a (new)

• 2. 

  Member States may, after authorisation by the Commission, adopt specific measures to facilitate the submission of applications to extend the authorisation for and the submission of applications relating to minor uses. Accepted with modifications 2a. Member States may [...] take measures to facilitate or encourage the submission of applications [...] to extend the authorisation of already authorised plant protection products to minor uses. Amendment 137

Article 51 ­ paragraph 4 ­ sub-paragraph 1

• 4. 

  When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder, who shall change the labelling accordingly. Not accepted Amendment 138

Article 51 ­ paragraph 4a (new)

Extensions on the basis of this Article shall be separately identified and separate reference shall be made to liability restrictions. Accepted Amendment 139

Article 51 ­ paragraph 6

• 6. 

  Member States shall establish and regularly update a list of minor uses. Accepted with modifications Article 57, 1st paragraph, h) (new)

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This list shall be made available to the public through official websites of the Member State and of the Commission h) The list of minor uses as referred to in Article 51, paragraph 6 .

Amendment 140

Article 51 ­ paragraph 6a (new)

*

6a. ot later than ... , the Accepted in principle Commission shall present a proposal to the European Parliament and the Council for establishing a European promotion fund for minor uses. The Fund shall also be entitled to finance additional residue tests for minor uses.

________

• * 

  One year after the entry into force of this Regulation. Amendment 141

Article 52 ­ paragraph 3 ­ points b et c

they are identical in (b) they have either the same specification, Not accepted or specifications

assessed as equivalent under the procedure referred to in Article 38.

they are either the same or

in the co-formulants

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Amendment 142

Article 52 ­ paragraph 3 ­ sub-paragraph 1a (new)

Plant protection products which do not comply with the condition referred to in subparagraph (a) but which do comply with the all the other conditions referred to in this paragraph shall be deemed to be identical to the reference product if a comparative Not accepted

assessment by a

laboratory officially recognised in accordance with the Principles of Good Laboratory Practice, which is submitted to the competent authority of the importing Member State by the applicant,

or a comparative

assessment by the competent

authority, confirms that the plant protection product in respect of which an import permit is requested is, in substance, identical to the reference product and that the following requirements are met: (a) the requirements of subparagraph 1, points (b) and (c), (b) the plant protection product in respect of which an import permit is requested does not contain a coformulant

or a co-formulant substance which has not been assessed, (c) no co-formulant substances with

16947/08 PVG/prk ANNEX DG B II

essential functions are lacking, (d) the product does not feature different nominal concentrations of co-formulants

with essential

functions or co-formulant substances which are more toxic or ecotoxic than the reference product or are less favourable from the point of view of effectiveness or stability than those of the reference product, (e) no co-formulants are absent which serve to protect users or third parties.

Amendment 143

Article 52 ­ paragraph 10a (new)

10a. Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits Accepted Amendment 144

Article 54 ­ paragraph 5

• 5. 

  Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that Not accepted

may be released during may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance

with the regulatory with the regulatory procedure with scrutiny referred to in Article 79(4).

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Amendment 145

Article 56 ­ paragraph 1 ­ sub-paragraph 3

To this end the authorisation holder shall record and report all suspected adverse reactions in humans, in animals and the environment related to the use of the plant protection product. Accepted Amendment 146

Article 56 ­ paragraph 3 ­ sub-paragraph 1

• 3. 

  The Member State receiving such notification shall immediately pass it on to the other Member States. Without prejudice to the right of Member States to adopt interim protective measures, the Member State which granted an authorisation shall evaluate the information received and inform the other Member States, where it decides to withdraw or amend the authorisation under Article 44. Compromise package A ZONING Not accepted where it decides to

Amendment 147

Article 57 ­ paragraph 1 ­ introduction

Member States shall keep 1.Member States shall forward to the Authority, Not accepted who shall make electronically available to the public, information

on plant protection

products authorised or withdrawn in accordance with this Regulation, containing at least:

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Amendment 148

Article 59 ­ paragraph 1 ­ sub-paragraph 7

A study shall not be protected if it was necessary for the renewal or review of an authorisation. Not accepted The first to fourth Amendment 149 Article 60 ­ paragraphs 1 et 2

• 1. 

  For each active substance, safener and synergist and adjuvant, rapporteur Member States shall forward to the Authority, who shall make available to the public at the moment of publishing the draft assessment report in accordance with Article 12, a list of the test and study reports necessary Not accepted for first approval,

amendment of approval conditions or renewal of the approval and a summary of the results of the test and study reports to establish the efficacy of the substance and its harmlessness to humans, animals, plants and the environment. 2. For each plant protection product which they authorise, Member States shall forward to the Authority, who shall make available to the public, at the moment of publishing the draft

the active substance,

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assessment report in accordance with Article 12: (a) a list of the test and study reports concerning the

active substance,

safener or synergist, adjuvant and the plant protection product necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and (b) a list of test and study reports for which the applicant claimed data protection under Article 59 and any reasons submitted in accordance with that Article. (ba) a summary of the results of the test and study reports to establish the efficacy of the product and its harmlessness to humans, animals, plants and the environment.

Amendment 150

Article 61 ­ paragraph -1 (new)

-1. Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the database referred to in Articles 35a and 57. Not accepted Amendment 151

Article 61 ­ paragraph 2

• 2. 

  The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or Accepted

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review thereof, shall provide him with the name and address of the holder or holders

of previous relevant

authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.

Amendment 152

Article 61 ­ paragraph 3

• 3. 

  The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 59 that are required by the applicant for the authorisation, or the renewal or review thereof, of a plant protection Accepted with modifications 3. The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing, of any test and study reports protected under Article 59, in a fair, transparent and non-discriminatory way. product. Such an

agreement may be replaced by submission of the matter to an arbitration board and acceptance of the

arbitration order. In an endeavour to ensure that the costs of sharing

the information are determined in a fair, transparent and non-discriminatory

way, the

Commission may, in accordance with the regulatory procedure referred to in Article 79(3), adopt cost-sharing guidelines based on those principles.

16947/08 PVG/prk ANNEX DG B II

Amendment 153

Article 61 ­ paragraph 3a (new)

3a. Where the Member State Not accepted considers that a monopoly might be created, and the prospective applicant and the holder or holders of the authorisations for plant protection products containing the same active substance,

safener, or synergist

cannot reach agreement on the sharing of any tests and studies involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State to that effect. The two parties shall nevertheless agree which courts and tribunals have jurisdiction for the purposes of Article 62(4).

Amendment 154

Article 62 ­ paragraph 2

• 2. 

  The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is required to share in the costs that accrue during the full process of generating the information he is Not accepted

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required to submit to meet the authorisation requirements.

Amendment 155

Article 62 ­ paragraph 3a (new)

3a. ot later than ...*, the Not accepted

Commission shall carry out a review of the provisions in this Regulation concerning data protection for tests and studies involving vertebrate animals. The Commission shall submit this assessment, and any proposed amendments for limiting the data protection with regard to animal experiments, to the European Parliament and the Council.

______________________

• * 

  Seven years after the entry into force of this

Regulation. Amendment 156

Article 63 ­ paragraph 2

Disclosure of the following 2. Disclosure of the following Not accepted information shall be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned:

integrity of the individuals Amendment 157

Article 63 ­ paragraph 2a (new)

2a. For test data, including study reports, which have been provided by an applicant to support a decision to Not accepted

16947/08 PVG/prk ANNEX DG B II

authorise or amend a plant protection product under this Regulation, such data may be viewed by interested parties in specific locations identified by the Commission, the Authority or the Member States. Such data shall not be made public through the provision of copies or through any other means of publication (including electronic publication).

Amendment 158

Article 65 ­ paragraph 3a (new)

3a. Food products which do not comply Not accepted

with the provisions of

Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children

1

shall be

labelled "not suitable for infants and young children".

1 OJ L 339, 6.12.2006, p. 16.

Amendment 159

Article 66 ­ paragraph 2a (new)

2a. Member States may prohibit or restrict the advertising of plant protection products in certain media. Accepted with modification 2a. Member States may prohibit or restrict the advertising of plant protection products in certain media subject to Community law.

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Amendment 160

Article 67 - paragraph 1

• 1. 

  Producers, suppliers, distributors, importers, exporters and professional users of plant protection products shall keep records of the plant protection products they produce, import, export, store, use or place on the market for at least ten years after the end of production or use. They shall make the information contained in these records available to the competent authority. They shall also keep this information available for Compromise package INFORMATION Accepted with modifications 1. Producers, suppliers, distributors, importers, and exporters [...] of plant protection products shall keep records of the plant protection products they produce, import, export, store, or place on the market for at least five years [...]. Professional users of plant protection

shall make the relevant products shall

records of the plant protection products they use for at least three years. They

to this information by neighbours and residents,

retailers or the drinking water industry who request direct access to it. The information on all applications of plant protection products on a given agricultural product shall be provided to retailers and wholesalers using a standardised format. The standardised format for the provision of the information referred to in the subparagraph above shall be established in accordance with the advisory procedure referred to in Article 79(2).

shall make the

information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information

by addressing competent authority. [...]

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Amendment 161

Article 67 ­ paragraph 1a (new)

1a. Producers of plant protection products Accepted with modifications 1a. Producers of plant protection products shall undertake post-

registration monitoring. They shall notify the competent authorities of any relevant information and keep the information available to relevant stakeholders on request.

shall undertake

registration monitoring on request of the competent authorities. They shall notify the competent authorities of [...] the relevant results.

Amendment of the Council

Article 74 ­ paragraph 2

(b) correspond to the actual total cost of the work involved except if it is in public interest to lower the fees or charges Amendment 162

Article 77

The Commission may, in accordance with Accepted with modifications The Commission may, in accordance with the [...] advisory procedure referred to in Article 79 [...] (2), adopt or amend technical and other guidance documents such as explanatory notes or guidance documents on the content of the application concerning micro-organisms, pheromones and biological products once a specific regulation on biological control products, for the implementation of this Regulation. The Commission may ask the the regulatory procedure

referred to in Article 79(3), adopt or amend technical and other guidance documents for the implementation of this Regulation. The Commission may ask the Authority to prepare or to contribute to such guidance documents. The Authority may initiate the preparation or revision of guidance documents for the risk assessment of active substances.

and other guidance

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Authority to prepare or to contribute to such guidance documents. [...]

Amendment 163

Article 78 ­ paragraph 1 ­ point f

Deleted Not accepted For consistency with AM 89, addition of a new point : (fa) (new) adoption of the harmonised methods as referred to in Article 29(4) Amendment 164

Article 78 ­ paragraph 3

• 3. 

  In accordance with the regulatory procedure with scrutiny referred to in Article 79(4), a Regulation shall be adopted incorporating the list of active substances included in Annex I to Directive 91/414/EEC into Annex IIa Not accepted Regulation shall be adopted in Annex I to Those

of this Regulation . Those substances shall be deemed to have been approved under this Regulation.

Amendment 165

Article 80 ­ paragraph 7

• 7. 

  By ...*, the Commission shall establish a list of substances included in Annex I of Directive 91/414/EEC which satisfy the criteria set out in point 4 of Annex II to this Regulation and to which the provisions of Article Compromise package SUBSTITUTION Accepted with modifications 7. By ...*, the Commission shall

16947/08 PVG/prk ANNEX DG B II

50 of this Regulation shall apply. establish a list of substances included in Annex I of Directive 91/414/EEC which satisfy the criteria set out in point 4 of Annex II to this Regulation and to which the provisions of Article 50 of this Regulation shall apply.

Note to OJ: 78 months from the date of Note to OJ: 36 months from the date of entry into force of this Regulation.

Note to OJ: 48 months from the date of entry into force of this Regulation. Amendment 166

Article 82

By ...*, the Commission shall present a report to the European Parliament and the Council on the functioning of mutual recognition of authorisations and in particular on the application by the Member States of the provisions referred to in Article 36(2a) and (3) and Article 50(2) and on the application of the criteria for the approval of active substances, safeners and synergists as set out in Annex II and the impact thereof on the diversification and competitiveness of agriculture, including on food prices, as well as on human health and on the environment. The report may be accompanied, if necessary, by the appropriate legislative proposals to amend those provisions. Compromise package A ZONING Not accepted

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Amendment 167

Annexe I

Deleted Compromise package A ZONING Not accepted Luxembourg, Hungary,

etherlands, Austria, Poland, Amendment 168

Annex II - point 3.6.1

3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing Compromise package B CUT OFFS Accepted with modifications 3.6.1 Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be such values an

appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects, possible combination effects and the vulnerability of vulnerable

16947/08 PVG/prk ANNEX DG B II

groups. ensured taking into account the type and severity of effects [...] and the vulnerability of specific groups of the population. When the critical effect is judged of particular significance such as developmental neurotoxic or immunotoxic effects, an increased margin of safety may shall be considered and applied if necessary. Amendment 169

Annex II - point 3.6.5

3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information including a review of the scientific literature, reviewed by the Authority, it is not considered, taking Compromise package B CUT OFFS Accepted with modifications 3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information including a review of the scientific literature, reviewed by the Authority, it is not considered [...] to have endocrine disrupting properties that may cause adverse effect in humans, [...] unless the exposure of humans to that active substance, safener or synergist in a plant protection product, due account of likely

combination effects, to have

endocrine disrupting properties that may cause adverse effect in humans, so that, for example, it is not or does not have to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic to reproduction category 3, unless the exposure of humans to that active substance, safener or synergist in a plant

conditions of use, is under realistic

conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with

protection product, under realistic proposed conditions of use, is

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negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. Further specific scientific criteria for the humans and where residues of the active substance, safener or

concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. [...]

Within 5 years from the entry into force

of this Regulation,

Commission shall present to the Committee referred to in Article 79 (1) a draft of the measures concerning specific scientific criteria for the determination

determination of endocrine

disrupting properties shall be adopted by ... * in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). *

of endocrine

disrupting properties [...] to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). Pending the

ote to OJ: 18 months from the

date of entry into force of this Regulation"

adoption of these

substances, such as those that are or have to be classified, in accordance with the provisions of Directive 67/548/EEC, as

• - 

  toxic for reproduction carcinogen category 3, or
• - 

  toxic for reproduction category 3 , and which have adverse effects on the endocrine organs, may be considered to have such endocrine disrupting properties.

16947/08 PVG/prk ANNEX DG B II

Amendment 170

Annex II - point 3.6.5a (new)

3.6. Impact on human health 3.6.5a. An active substance, safener or synergist shall only be approved if, on the basis of an assessment or other available data and information including a review of the scientific literature, it is not considered to cause a significant risk (affecting one in Compromise package B CUT OFFS See AM 168 a million citizens) of developmental neurotoxic or

immunotoxic properties in humans, taking into account exposure during embryonic/foetal life and/or during childhood

as well as likely

combination effects, unless the exposure of humans to that active substance, safener or synergist in a plant

protection product, under

realistic proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1)

of Regulation (EC) o 396/2005.

16947/08 PVG/prk ANNEX DG B II

Amendment 171

Annexe II ­ point 3.7.2 ­ introduction ­ sub-paragraph 1

3.7.2. An active substance, safener or synergist shall only be approved if it, and its transformation products or residues, are not considered to be persistent, bioaccumulative and toxic (PBT) substances. Not accepted Amendment 172

Annexe II ­ point 3.7.3 ­ introduction ­ sub-paragraph 1

3.7.3. An active substance, safener or synergist shall only be approved if it or its transformation products or residues, are not considered to be very persistent and very bioaccumulative substances (vPvB). Not accepted Amendment 173

Annexe II ­ point 3.7.3.2 ­sub-paragraph 1a (new)

It also fulfils the very Not accepted bioaccumulative criterion when there is

evidence of very high

bioaccumulation in other species, or monitoring data in biota indicate that the bioaccumulation potential of the chemical is sufficient to be of concern.

Amendment 174

Annex II - point 3.8.2. a (new)

3.8.2a. An active substance, safener or synergist shall not be approved Compromise package B CUT OFFS

16947/08 PVG/prk ANNEX DG B II

unless it is established that under realistic proposed conditions of use: - the direct or indirect exposure of honeybees to that active substance in a Accepted with modifications 3.8.2a. An active substance, safener or synergist shall be approved only if it is established following an appropriate risk assessment on the basis of Community or internationally agreed test guidelines, that the use under the proposed conditions of use of plant protection products containing this active substance, safener or synergist : - will result in a negligible exposure of honeybees [...], or - [...] there are no unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae, honeybee behaviour. plant protection product is

negligible, or - it is clearly established through an appropriate risk assessment that there are no unacceptable acute or chronic, lethal

or sublethal effects on honeybee larvae, honeybee behaviour, or colony survival and development.

Amendment 175

Annexe II ­ point 3.9b (new)

3.9b. Exclusion of priority hazardous substances Substances on the list of priority hazardous substances for water policy Non Accepted annexed to Directive 2000/60/EC, should not be approved.

16947/08 PVG/prk ANNEX DG B II

Amendment 176

Annexe Iia (new)

Annex II a Not accepted

List of active substances approved for inclusion in plant protection products

Amendment 177

Annexe IV ­ point 3 ­ sub-paragraph 2a (new)

The comparative assessment shall take authorised minor uses into account. Accepted

____________________

16947/08 PVG/prk ANNEX DG B II

• 12 jul '06
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