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

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I. INTRODUCTION

1

• 1. 

  On 15 September the Council adopted a common position on the above proposal and forwarded it to the European Parliament.
• 2. 

  On 5 November, the European Parliament's Environment Committee adopted a draft recommendation for the second reading of the Council's common position including 177

amendments.

1

See 11119/8/08 REV 8.

• 3. 

  At its meeting on 12 November, Coreper took note of the progress made at working party level in the examination of the amendments proposed by the European Parliament

and agreed on a number of orientations, mainly in the areas of zonal authorisation of

plant protection products and the criteria for the approval of active substances.

• 4. 

  On the basis of these principles the Presidency held a first trialogue on 12 November and reported to Coreper on 14 November on the outcome of that meeting.
• 5. 

  Taking into consideration the positions expressed by the European Parliament, the Working Party on Agricultural Questions (Pesticides/Plant Protection Products)

completed the detailed examination of the amendments, at expert level, on 17 and 18

November. The text of the draft compromise proposals agreed at this meeting was

confirmed by the Working Party of Agricultural Counsellors/Attachés on 24 November

and is submitted to Coreper in the form of a table annexed to this report.

II. STATE OF PLAY

• 1. 

  There is broad agreement between delegations on the draft compromise proposals, in particular, on the following key areas:
• - 

  the system of mutual recognition of authorisations and the zonal division (amendments 11, 35, 96, 102, 105-115, 117-121, 123, 124, 127, 146, 166, 167):

the principle of compulsory mutual recognition of authorisations for plant

protection products in the context of the three-zones division is maintained

although some further flexibility is provided regarding the possibility of Member

States imposing additional risk mitigation measures or even refusing an

authorisation delivered by another Member State of the same zone. In this context,

DE objected to the deletion of the words "as a last resort" in the compromise text

for amendment 112. HU entered a reservation regarding the compromise proposal

for all these amendments.

• - 

  the criteria for the approval of active substances (amendments 4, 46, 132-135, 168-170, 174). For amendment 46 concerning the derogation from these criteria

for the approval of a substance in case of a serious danger for plant health, the

compromise text introduces, for Member States authorising pesticides with such

substances, a plan on how to control that danger by other means in the future. EL,

DE, IE, RO, PL and PT have entered a scrutiny reservation at this stage. In

particular, EL, PT and PL raised concerns concerning the implementation of the

plan.

Regarding substances with endocrine-disrupting properties, the compromise proposal for amendment 169 provides some examples of substances which may

be considered as such, pending the adoption of further scientific criteria by

committee procedure. IE, HU, RO and BG oppose the reference to carcinogen and

toxic for reproduction categories 3 substances.

ES has entered a reservation on amendment 174 (dangerous substances for bees) as it would considerably reduce the availability of insecticides.

• - 

  the substitution of dangerous substances with safer alternatives (amendments 7, 77, 132-135, 165) . SE, BE, DE and IE entered reservations on amendment 77 regarding the reduction, from 10 years as specified in the common position to 7

years, of the period for renewal of the approval of active substances which are

candidates for substitution.

• 2. 

  Some delegations maintained a general scrutiny reservation at this stage. Also, a number of delegations have entered reservations on the draft compromise text relating to the

following amendments:

• - 

  Amendments 1, 22, 50, 60, 61, 65, 69, 73, 76, 78, 80, 89, 109, 125, 144, 162, 163, 164 and 176) with legal connotations (mainly concerning the legal basis and comitology): DE, NL, SE, DK, PL, RO, IE and UK - Amendment 7: SE
• - 

  Amendment 12: UK and IE - Amendment 13: UK
• - 

  Amendment 34: DE and CZ - Amendment 41: SE and IE
• - 

  Amendment 45: ES, CZ, DE, UK, PL, NL, HU, SE and BE - Amendment 54: AT
• - 

  Amendments 55, 57 and 58: DE - Amendment 74: DE - Amendment 87: EE
• - 

  Amendment 88: EL, SE and DK - Amendment 91: DE
• - 

  Amendment 121: SE
• - 

  Amendment 140: DE, SE and DK - Amendment 160: DE and CZ

III. CONCLUSION

Coreper is invited to give its agreement to the draft compromise proposals set out in the

Annex hereto in order to provide the Presidency with a mandate for the forthcoming

discussions 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 Amendment 1

Citation 1

Having regard to the Treaty establishing the European Community, and in particular Articles 37(2) and 95 thereof, Having regard to the Treaty establishing the European Not accepted Community, and in particular Articles 152(4)(b) and 175(1) thereof,

Amendment 2

Recital 10a (new)

(10a) To apply the 'polluter pays' principle, the Commission Not accepted 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.

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 establishing data requirements for active substances, plant protection products, safeners and synergists, should ensure that testing on See AM 15

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vertebrate animals is minimised and that double-testing is avoided, and promote the use of non-animal 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 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.

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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 science and technology should be taken into account when any decision regarding the renewal of an approval is taken. (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 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. To be clarified

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Amendment 6

Recital 15

(15) The possibility of amending or (15) The possibility of amending or Accepted with modifications (15) withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied should be provided for. withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied, or where compliance with Directive The

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 of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy

1

and its 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. 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 may only be acceptable when extensive risk mitigation measures are taken. Such substances should be identified at Community level as candidates for substitution. Member States should regularly reexamine whether plant protection products containing such active substances can be replaced by plant protection products containing active substances which require less risk mitigation. (18) Some active substances with certain properties should be identified at Community level as candidates for substitution. Member States should regularly examine plant protection products containing such active 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 non-chemical agricultural practices and methods of crop protection. After a positive check, such active substances should be replaced swiftly. Compromise package C SUBSITUTION Accepted with modifications (18) Some active substances with certain properties should be identified at Community level as candidates for substitution. Member States should regularly examine plant protection products containing such active substances with the aim of considering their replacement plant protection products containing active substances which require [...] less [...] risk mitigation or by [...] non-chemical control or prevention methods [...].

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Amendment 8

Recital 19a (new)

(19a) To encourage the development of 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. Accepted with modifications Addition to Recital (16) Incentives should be given for placing on the market of low risk plant protection products. Amendment 9

Recital 20

(20) In addition to active substances, plant protection products may contain safeners or synergists for which similar rules should be provided. The technical rules necessary for the evaluation of such substances should be established. Substances currently on the market should only be evaluated after those provisions have been established. (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 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. Not accepted See Article 26 and AM 80 Amendment 10

Recital 26b (new)

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

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Amendment 11

Recital 27

(27) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable. Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition. However, environmental or 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 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. (27) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To avoid unnecessary Compromise package A ZONING Accepted with modifications (27) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health duplication of work, to reduce the

administrative burden for industry and for Member

States and to facilitate more

harmonised availability of plant protection products, 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 be entitled to 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

and

climatic)

agricultural or environmental Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition. However, environmental or 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 agricultural circumstances or if the high level of protection of both human and animal health and the environment set out in this 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 ational Pesticide Action Plan to 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

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pesticides]. 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 of the European Parliament and of the Council of ... [establishing a framework for Community action to achieve a sustainable use of pesticides]. Amendment 12

Recital 30

(30) In exceptional cases, 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 which cannot be combatted by any other means. Such authorisations should be reviewed at Community level. (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 means. Such temporary authorisations should be reviewed at Community level. Accepted with modifications (30) In exceptional cases, [...] 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.

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Amendment 13

Recital 33

(33) In order to ensure a high level of protection of human health and the environment, plant protection products should be used properly having regard to the principles of integrated pest management. The Council should include in the statutory management requirement referred to in Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing 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. (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 nonchemical 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 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 non-chemical alternatives to plant protection and pest and crop management. 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 nonchemical and natural 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 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 [...].

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Amendment 14

Recital 37

(37) Studies represent a major investment. This investment should be protected in order to stimulate research. For this reason, studies 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 which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. (37) Studies represent a major investment. This investment should be protected in order 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 which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. Not accepted Amendment 15

Recital 38

(38) Rules should be laid down to avoid duplication of tests and studies. In particular, repetition of studies involving vertebrates should be prohibited. In this context, there should be an obligation to allow access to studies on vertebrates on reasonable terms. 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. (38) Rules should be laid down to avoid duplication of tests and studies. In particular, repetition of studies involving 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 such studies even where they are not covered by the above system of compulsory access. The Authority should Accepted with modifications (38) The use of non-animal test methods and other risk assessment strategies should be promoted. Animal testing for the purposes of this regulation should be minimised and tests on vertebrates should be undertaken as a last resort. In accordance with Council Directive 86/609/EEC... regarding the protection of animals used for experimental and other scientific purposes, tests on vertebrate animals must be replaced, restricted or

15978/08 PVG/re ANNEX DG B II

establish a central database for such studies . refined. Therefore, rules should be laid down to avoid duplicative tests on animals and duplication of tests on vertebrates should be prohibited. For the purpose of developing new plant protection products, there should be an 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, it is appropriate to lay down rules on the advertising of those products. (41) To ensure that advertisements do not mislead users of plant protection products or the public, it is appropriate to lay down rules on the advertising of those products. Accepted Amendment 17

Recital 43a (new)

(43a) Operators must have the same To be clarified opportunities in respect of market access, in particular so that small and medium-sized 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) Close coordination should be ensured with other Community legislation, in particular Regulation (EC) No 396/2005 of the European Parliament (45) The measures provided for in this Regulation should apply without prejudice to existing Community legislation, in particular Directive Accepted with modifications (45) The measures provided for in this Regulation should apply without prejudice to [...] other Community legislation, in particular Directive and of the Council of 2008/.../EC [establishing a

23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, and with Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms. framework for Community action to achieve a sustainable use of 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 origin framework for Community action to achieve a sustainable use of 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 origin

2

and Community legislation on

the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.

the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.

+ OJ: please insert number 2 OJ L 70, 16.3.2005, p. 1. Regulation as amended by Commission Regulation (EC) o 178/2006 (OJ L 29,

+ OJ: please insert number 2.2.2006, p. 3). 2

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

Commission Regulation (EC)

2.2.2006, p. 3).

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Amendment 20

Recital 53

(53) In particular, the Commission should be empowered to adopt Regulations concerning labelling requirements, controls and rules for adjuvants, establishing a work programme for safeners and synergists, including their data requirements, postponing the expiry of the approval period, extending the date for provisional (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 of active substances, safeners and synergists, and where appropriate of relevant impurities and co-formulants, to adopt detailed rules Accepted with modifications 53) In particular, the Commission should be empowered to adopt [...] harmonised methods to determine the nature and quantity of active substances, safeners and synergists, and where appropriate of relevant impurities and coformulants, [...], and to adopt Regulations concerning labelling requirements, controls and rules for adjuvants, establishing a work programme authorisations, setting the for allowing derogations from

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 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 non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. authorisation of plant protection products for research and development and the list of approved substances, and to adopt Regulations concerning labelling requirements, rules for adjuvants, postponing the expiry of the approval period, extending the date for provisional authorisations, including their data requirements, postponing the expiry of the approval period, 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 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 non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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 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 non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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Amendment 21

Recital 56

(56) It is also appropriate to use the advisory procedure to adopt some purely technical measures, in particular technical guidelines in view of their non-binding character (56) It is also appropriate to use the advisory procedure to adopt some purely technical measures. Not accepted .

Amendment 22

Article 1

Subject matter Subject matter and purpose Accepted with modifications

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. 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 co-formulants. 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 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. 4. 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 co-formulants. 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

This Regulation is based on the precautionary principle in order to ensure that substances or products placed on the market do not adversely affect human health or the environment.

and

environment and improving agriculture

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• 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 from applying the precautionary principle in restricting or prohibiting pesticides. 7. Member States may establish any pesticidefree zones they deem necessary in order to safeguard drinking water resources. Such pesticide-free zones may cover the entire Member State. 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. Amendment 23

Article 2 ­ paragraph 2

• 2. 

  This Regulation shall apply to substances, 2. This Regulation shall apply to substances, Not accepted

including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, hereinafter referred to as "active 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 microorganisms, viruses, pheromones and biological products once a specific regulation on biological control products has been adopted.

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Amendment 24

Article 3 ­ point 2a (new)

(2a) "active substances" Substances, 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; Not accepted. Amendment 25

Article 3 ­ point 3

• 3) 

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

Mixtures composed of two or more substances intended for use as a plant protection product or as an adjuvant; 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

Amendment 26

Article 3 ­ point 4

• 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 and is present or is produced in a plant protection product in sufficient concentration to present risks of such an effect. Such substances include, but are not limited to, substances meeting the criteria to be classified as dangerous in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation 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 of laws, regulations and substances, and regarded as

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administrative provisions relating to the classification, packaging and labelling of dangerous substances, and present in the plant protection product at a concentration leading the product to be dangerous within the meaning of Article 3 of Directive 1999/45/EC. Any substance that has or potentially has either carcinogenic, mutagenic, endocrine disrupting, regarded as dangerous within

the meaning of Article 3 of Directive 1999/45/EC; neurotoxic, immunotoxic, reprotoxic or genotoxic capabilities should be regarded as a substance of concern;

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

• 5) 

  "plants" 5) "plants" Not accepted

Live plants and live parts of plants, including fresh fruit, vegetables and seeds; 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;

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Amendment 29

Article 3 ­ point 8

• 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 shall constitute placing on the market for the purposes of this Regulation; 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; 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 conditions of Directive 91/414/EEC; Not accepted

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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 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 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; 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;

15978/08 PVG/re ANNEX DG B II

Amendment 35

Article 3 ­ point 15

• 15) 

  "zone" Group of Member States as defined in Annex I; For the purpose of use in greenhouses, as postharvest treatment, for treatment of empty storage rooms and for seed treatment the zone means all zones defined in Annex I; deleted Compromise package A ZONING Not accepted Amendment 36

Article 3 ­ point 15a (new)

(15a) "integrated pest management" Careful consideration of all available pest 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; Not accepted

15978/08 PVG/re ANNEX DG B II

Amendment 37

Article 3 ­ point 15b (new)

(15b) "non-chemical methods of plant Not accepted 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 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 the provisions of European and Mediterranean Plant Protection Organisation (EPPO) Guidelines 181 and 152; 18) `good experimental practice' Practice Not accepted Directive 2004/10/EC relates to the application of the principles of good laboratory practices. in accordance with Directive 2004/10/EC;

Amendment 39

Article 3 ­ point 19

• 19) 

  "data protection" The temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant; 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

15978/08 PVG/re ANNEX DG B II

Amendment 40

Article 3 ­ point 19a (new)

(19a) "rapporteur Member State" Accepted with modifications The Member State which agrees to assume the responsibility (19a) "rapporteur Member State"

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

substances, or safeners, or synergists. It is required to carry out this task in a professional manner and to publish an impact 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, including vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the methods to assess such effects are agreed, or on groundwater; (a) they shall not have any harmful effects on human health, in particular that of users who are in direct contact with 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; Not accepted

15978/08 PVG/re ANNEX DG B II

Amendment 43

Article 4 ­ paragraph 2 ­ point b

(b) they shall not have any unacceptable effect on the environment. (b) they shall not have any unacceptable effect on the 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. Not accepted. Amendment 44

Article 4 ­ paragraph 3 ­ point b

(b) it shall have no immediate or delayed harmful effect on human 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 effects where the methods to assess such effects are agreed; or on groundwater; (b) it shall have no immediate or delayed harmful effect on human health, in particular that of residents and bystanders and vulnerable 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 Accepted with modifications (b) it shall have no immediate or delayed harmful effect on human health, including [...] 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 effects, where the methods to assess such effects are agreed; or on [...] groundwater; 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;

15978/08 PVG/re ANNEX DG B II

Amendment 45

Article 4 ­ paragraph 3 ­ point e

(e) it shall have no unacceptable effects on (e) it shall have no unacceptable effects on Accepted with modifications (e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the methods to assess such effects are agreed: (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, [...] groundwater, air and soil [...]; (ii) its impact on non-target species, including on the behaviour of those species; (iii) its impact on biodiversity and the ecosystem; [...] the environment, having particular regard to the following considerations: (i) the environment, having particular regard to the following considerations: (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, drinking water, groundwater, air and soil, taking into account locations distant from its use following long-range 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. its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil; (ii) its impact on non-target species; (iii) its impact on biodiversity.

Amendment 46

Article 4 ­paragraph 7

• 7. 

  By way of derogation from paragraph 1, where on the basis of documented evidence an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means, such active substance may be approved for a time limited period 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 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 b) there is a public interest in controlling that Compromise package B CUT OFFS 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 plant health [...] which cannot be contained by other available

15978/08 PVG/re ANNEX DG B II

mitigation measures to ensure that exposure of humans and the environment is 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 danger, such 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, including non-chemical methods, is presented by the applicant 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 and the environment is 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 category 1 or toxic for reproduction category 1.

.

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 shall be halved.

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 authorising plant protection products

approved in accordance with this paragraph 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.

15978/08 PVG/re ANNEX DG B II

Amendment 47

Article 4a (new)

Article 4a Not accepted 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 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; Accepted with modifications Addition to article 6 (h) (h) designation of areas where the use of plant protection products including soil treatment products containing the active substance may not be authorised or where the use may be authorised under specific conditions;

15978/08 PVG/re ANNEX DG B II

Amendment 49

Article 7 ­ paragraph 1

• 1. 

  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 a Member State, hereinafter referred to as "rapporteur Member State", together with a summary and a complete dossier as provided for in Article 8(1) and (2) 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. A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation. The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it. 1. The Authority shall be responsible for 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 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. 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, Not accepted

15978/08 PVG/re ANNEX DG B II

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. To be clarified Amendment 51

Article 7 ­ paragraph 1b (new)

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

15978/08 PVG/re ANNEX DG B II

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 on health, the environment and non-target species shall be added by the applicant to the dossier. Accepted with modifications 4a. [...]

literature, as determined by the Authority, on the

active

metabolites dealing with [...] side-effects on health and the environment [...] and published within the last five years before the date of dossier submission shall be added by the applicant to the dossier.

15978/08 PVG/re ANNEX DG B II

Amendment 54

Article 11 ­ paragraph 1

• 1. 

  Within twelve months of the date of the notification 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 Not accepted 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.

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.

Amendment 55

Article 11 ­ paragraph 2

• 2. 

  The draft assessment report shall also include where relevant, a proposal to set maximum residue levels. In such a case the rapporteur Member State shall forward the application, the evaluation report and the supporting dossier referred to in Article 9 of Regulation (EC) o 396/2005 to the Commission no later than six months after the date of the notification 2. The draft assessment report shall also include where relevant, a proposal to set maximum residue levels. Accepted provided for in the first

subparagraph of Article 9(3) of this Regulation.

15978/08 PVG/re ANNEX DG B II

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. 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 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 60 days.

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) Accepted °396/2005 shall not apply and the provisions

of Article 14 of that Regulation shall apply without delay.

15978/08 PVG/re ANNEX DG B II

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) °396/2005 shall apply without delay. Accepted Amendment 59

Article 13 ­ paragraph 1 ­ sub-paragraph 1

• 1. 

  Within six 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. 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

15978/08 PVG/re ANNEX DG B II

Amendment 60

Article 13 ­ paragraph 2 ­ introduction et point (a)

• 2. 

  On the basis of the review report, other factors 2. On the basis of the review report, other factors Not accepted

legitimate to the matter under legitimate to the matter under

consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that: (a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate; consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are 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. 

  Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved. The Commission shall maintain a list of approved active substances electronically available to the public. 4. The Commission shall maintain an updated list of approved active substances in Annex IIa and publish this list on the Internet. Not accepted

15978/08 PVG/re ANNEX DG B II

Amendment 62

Article 14 ­ paragraph 2

• 2. 

  The renewal of the approval shall be for a period not exceeding fifteen years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years. 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 producer of the active substance to a Member State, 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. 1. The application provided for in Article 14 shall be submitted by a 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. Not accepted Amendment 64

Article 18 ­ point b

(b) the necessary data to be submitted; (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 shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that: 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

15978/08 PVG/re ANNEX DG B II

Amendment 66

Article 20 ­ paragraph 2

• 2. 

  Where the reasons for not renewing the approval permit it, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding one year for the placing on the market 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. 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 the removal and safe disposal of the remaining stocks. 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 concerned shall be withdrawn from the market immediately. Not accepted Amendment 67

Article 21 ­ paragraph 1 ­ sub-paragraph 1

• 1. 

  The Commission may review the approval 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. of an active substance at any time. It may take into account the request of a Member State to review the approval of an active substance.

The Commission may review the approval

of an active substance at any time. [...] It may 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.

15978/08 PVG/re ANNEX DG B II

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 of the objectives established Accepted with modifications Such review may also be carried out, following information transmitted by the Member States, [...] where there are indications that the achievement 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, after the review of the authorisations pursuant to article 44. 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 referred to in Article 79(3). 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

15978/08 PVG/re ANNEX DG B II

Amendment 70

Article 21 ­ paragraph 3a (new)

3a. Where the Commission concludes that the objectives of reducing pollution from priority substances established 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. Not accepted Amendment 71

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

This derogation shall not apply to any active substance classified in accordance with Directive 67/548/EEC as: Accepted with modifications Add "chemicals" in Annex II.5, first paragraph, 4 ­ carcinogenic, ­ mutagenic, ­ toxic to reproduction, ­ sensitising chemicals,

th

indent.

• - 

  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, ­ bioaccumulative

and non-readily degradable.

o later than ...*, the Commission shall review

15978/08 PVG/re ANNEX DG B II

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 Not accepted

substances 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 the Regulation referred to in Article 13(4). 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 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.

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Amendment 75

Article 23 ­ paragraph 2

• 2. 

  By way of derogation from Article 4, a basic substance shall be approved where any relevant evaluations, 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. 2. A basic substance shall be approved in accordance with Article 4 and where any relevant evaluations, 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. Not accepted Amendment 76

Article 23 ­ paragraph 5

• 5. 

  Articles 6 and 13 shall apply. Basic substances shall be listed separately in the Regulation referred to in Article 13(4). 5. Articles 6 and 13 shall apply. Basic substances shall be listed separately in Annex IIa. Not accepted

15978/08 PVG/re ANNEX DG B II

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 ten years. 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 C SUBSTITUTION Accepted with modifications 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 seven years. Amendment 78

Article 24 ­ paragraph 2

• 2. 

  Without prejudice to paragraph 1, Articles 4 to 21 shall apply. Candidates for substitution shall be listed separately in the Regulation referred to in Article 13(4). 2. Without prejudice to paragraph 1, Articles 4 to 21 shall apply. Candidates for substitution shall be listed separately in Annex IIa. Not accepted Amendment 79

Article 25 ­ paragraph 1a (new)

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

15978/08 PVG/re ANNEX DG B II

Amendment 80

Article 26

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 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 shall include the establishment of data requirements, including measures to minimise animal testing, notification, Not accepted include 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.

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: 60 months from the date of entry into force of this Regulation.
• * 

  Note to OJ: 24 months from the date of entry into force of this Regulation.

Amendment 81

Article 27 ­ titre et paragraphs 1 et 2

Co-formulants 1. A co-formulant shall not be accepted for inclusion in a plant protection product where it has been established that: (a) 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 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 environment; and (b) its use, consequent on application consistent with good plant protection practice and having Not accepted its residues, consequent on application

consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or (b) its use, consequent on application consistent with good plant protection practice and having

15978/08 PVG/re ANNEX DG B II

regard to realistic conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment. 2. Co-formulants which shall not be accepted for inclusion in a plant protection product pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). 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).

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) Not accepted o 1907/2006 of the

European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

1

.

____________

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

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

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Amendment 84

Article 29 ­ paragraph 1 ­ point c

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

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

(f) its residues, resulting from authorised uses, and (f) its residues, resulting from 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 be present in any environmental and biological media. The residues shall be detectable with the common multi-residue methods as applied by Community reference laboratories; Accepted with modifications (f) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use;

which

ecotoxicological or environmental relevance, can be determined by [...] appropriate 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 the national plans developed under Directive 2008/.../EC [establishing a framework for Community action to achieve a sustainable use of pesticides]*. Not accepted * 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 referred to in Article 79(3). 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 active substance, safeners, synergists and co-formulants. Not accepted 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 time period set in accordance with article 92 (2), article 11 (3) or article 12 (3); and 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 92 (2), article 11 (3) or article 12 (2) or (3); and 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

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Amendment 92

Article 30 ­ paragraph 2

• 2. 

  In such cases the Member State 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). 2. In such cases the Member State may start its evaluation Not accepted 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).

Amendment 93

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

These requirements shall also include: 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. Not accepted 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 The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC. Member States shall 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 Not accepted

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competent authority thereof. competent authority thereof. Amendment 95

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

The authorisation shall include indications for proper use in accordance with the principles of integrated pest management as defined in Article 3, to apply from 2012 onwards; Accepted with modifications Article 31 ­ paragraph 3 (ba) (new) (ba) [...] indications for proper use according to the

management [...] as referred to in article 13 and in Annex III to the Directive 2008/.../EC establishing a framework for 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 taking into consideration requirements imposed by other community provisions in order to protect the health of the distributors, users, bystanders and workers concerned and the environment; such restriction shall be indicated on the label; (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, Compromise package A ZONING Not accepted taking into consideration

requirements imposed by other Community provisions; such restriction shall be indicated on the label;

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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 groups, such as residential areas, parks, public gardens, sports grounds, school grounds, children's playgrounds; Not accepted Amendment 98

Article 31 ­ paragraph 3 ­ point bb (new)

(bb) other restrictions or conditions relevant 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; Not accepted Amendment 99

Article 31 ­ paragraph 3 ­ point (e)

(e) the maximum dose per hectare in each deleted Not accepted application;

Amendment 100

Article 31 ­ paragraph 3 ­ point (f)

(f) the maximum number of applications per Deleted Not accepted year and interval between applications;

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Amendment 101

Article 31 ­ paragraph 3 ­ point (h)

(h) the pre-harvest interval, where deleted ZONING Not accepted applicable;

Amendment 102

Art. 33, paragraph 2, points a and b

(a) a list of intended uses in each zone as indicated in Annex I and the Member States where the applicant has made or intends to make an application; (b) a proposal as to which Member State the (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

applicant expects to evaluate the

application in the zone concerned. In case of an application for use in greenhouses, as postharvest treatment, for treatment of empty storage rooms and for seed treatment only one Member State shall be proposed, which evaluates the application considering all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request;

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Amendment 103

Article 33 ­ paragraph 3 ­ point b

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

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Amendment 107

Article 35

The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone 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 in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload. The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application. In case an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions. 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 ensure a fair division of the workload. Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions. Compromise package A ZONING Not accepted

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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 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 in the same zone 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 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 Compromise package A ZONING Not accepted

15978/08 PVG/re ANNEX DG B II

the plant protection product meets the requirements provided for in Article 29 in the same zone protection product 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 accordance with the regulatory procedure referred to in Article 79(3). , 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 within the same zone. The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).

Amendment 110 Art. 36, paragraph 2

• 2. 

  The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32. 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 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. Compromise package A ZONING Not accepted

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Amendment 111

Art. 36, paragraph 2a (new)

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

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 3. By way of derogation from paragraph 2 and subject to Community law, Member States may impose appropriate conditions with respect to the requirements referred to in Article 31(3) and other risk mitigation measures deriving from specific conditions of use. Compromise package A ZONING 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(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 to Community law, appropriate

conditions may be imposed with respect to the requirements referred to in points (a) and (b) of Article 31(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 Member State may as a last resort refuse authorisation of the plant protection product in its territory if, due to

its very specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question poses a serious risk to human or animal health or the environment.

subparagraph, a Member State may refuse authorisation of the plant protection product

15978/08 PVG/re ANNEX DG B II

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 decision refusing the authorisation of such product before the national courts or other instances of appeal. 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 refusing the authorisation in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. 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 [...] decision [...] refusing the authorisation of such product [...] before the national courts or other instances of appeal. of such product by any stakeholder before the national courts or other instances of appeal.

Amendment 113

Article 37 ­ paragraph 4

• 4. 

  The other Member States concerned shall at the latest within 90 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). deleted Compromise package A ZONING Not accepted Amendment 114

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

ot later than ...*, the Commission shall Compromise package A ZONING Not accepted present a proposal introducing a standardised format for the documentation provided for in points (a), (b) and (c).

_____ * 12 months after the entry into force of this Regulation.

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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 in the different Member States are registered. Compromise package A ZONING Not accepted Amendment 116

Article 39 ­ paragraph 2a (new)

2a. Within 12 weeks of a decision on the 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. Not accepted 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 practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone; 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 practices in another Member State under Compromise package A ZONING Not accepted the mutual recognition procedure provided for in this subsection.

15978/08 PVG/re ANNEX DG B II

(b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone; (c) the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs.

Amendment 118

Art. 41, paragraph 1

• 1. 

  The Member State to which an application under Article 40 is submitted shall authorise the plant protection product concerned under the same conditions as the Member State examining the application except where Article 36(3) applies. 1. The Member State to which an application under Article 40 is submitted shall examine the assessment undertaken by the Member State where the authorisation was granted (reference Member 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). Compromise package A ZONING Not accepted

15978/08 PVG/re ANNEX DG B II

Amendment 119

Art. 41, paragraph 1ba (new)

1ba. Where a Member State refuses the 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. Compromise package A ZONING Not accepted Amendment 120

Art. 41, paragraph 2

By way of derogation from paragraph 1, the Member State may authorise the plant protection product where: (a) an authorisation under point (b) of Article 40(1) was applied for; (b) it contains a candidate of substitution; (c) Article 30 has been applied; or (d) it contains a substance approved in accordance with Article 4(7). 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) it contains a substance approved in accordance with Article 4(7). Compromise package A ZONING Not accepted 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 reasons that the authorisation of this product would counteract the objectives of its ational Action Plan. Compromise package ZONING Not accepted

15978/08 PVG/re ANNEX DG B II

Amendment 122

Article 42 ­ paragraph 1 (a)

(a) a copy of the authorisation granted by the (a) a copy of the authorisation granted by the Not accepted

reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application; 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

• 2. 

  The Member State to which an application 2. The Member State to which an application under Article 40 is submitted shall decide on the application within 180 days. Compromise package A ZONING Not accepted under Article 40 is submitted shall decide on the application within 90 days.

Amendment 124

Art. 43, paragraph 2 - sub-paragraph 2

The Member State referred to in Article 35 within 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 each zone shall coordinate the

compliance check and assessment of the information submitted for all Member States within that zone.

Amendment 125

Article 43 ­ paragraph 4

• 4. 

  Guidelines on the authorisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2). 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

15978/08 PVG/re ANNEX DG B II

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 amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for 4. Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority. The other Member States shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where Article 36(2a) has been applied. Compromise package A ZONING Not accepted cases where second to fourth Article 46 shall apply where subparagraphs of Article 36(3) have been applied. appropriate.

Article 46 shall apply where appropriate.

Amendment 128

Article 46 ­ paragraph 2

Where the reasons for withdrawal, amendment or not renewing the authorisation permit it the grace period shall be limited and not exceed six months for the placing on the market and an additional maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. 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 Not accepted

15978/08 PVG/re ANNEX DG B II

authorisation are related to the protection of human and animal health or the 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 nonrenewal has been taken.

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.

15978/08 PVG/re ANNEX DG B II

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: (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 reducedrisk 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.

15978/08 PVG/re ANNEX DG B II

• 3. 

  The Member State shall decide within 120 days on whether to approve an application for authorisation

of a reduced-risk plant

protection product. The period shall be 90 days where an authorisation has already been granted for the same reduced-risk plant protection product by another Member State. Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case the period of 120 days shall be extended by the additional time limit granted by the Member State. 4. Unless otherwise specified, all provisions relating

to authorisations under this Regulation shall apply.

Amendment 132

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

• 1. 

  A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection 1. A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection Compromise package C SUBSTITUTION Accepted with modifications 1. A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active 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 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 protection product, or a nonchemical control or prevention method, already substance approved 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 authorised plant protection product, or a nonchemical control or prevention method, already 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,

15978/08 PVG/re ANNEX DG B II

exists which is significantly safer for human or animal health or the environment; and (b) the plant protection product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages; and (c) the chemical diversity of the active substances is adequate to minimize the occurrence of resistance in the target organism; and 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, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and demonstrates that: (a) for the uses specified in the application an authorised plant protection product, or a nonchemical 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, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and Amendment 133

Article 50 ­ paragraph 3 ­ sub-paragraph 2

Such authorisations shall be granted for a period not exceeding five years. Such authorisations shall be granted for a period not exceeding three years. Compromise package C SUBSTITUTION Not accepted 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 at renewal or amendment of the authorisation. 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

15978/08 PVG/re ANNEX DG B II

Amendment 135

Article 50 ­ paragraph 5

• 5. 

  Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect five 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. 5. Where a Member State decides to withdraw or amend an authorisation pursuant 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 earlier. Compromise package C SUBSTITUTION Not accepted 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 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. the authorisation for and the submission of applications relating 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 if necessary the authorisation holder and request him to change the labelling accordingly. 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

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Amendment 139

Article 51 ­ paragraph 6

• 6. 

  Member States shall establish and regularly update a list of minor uses. 6. Member States shall establish and regularly update a list of minor uses. This list shall be made available to the public through official websites of the Member State and of the Commission. Accepted with modifications Article 57, 1st paragraph, h) (new) h) The list of minor uses as referred to in Article 51, paragraph 6 Amendment 140

Article 51 ­ paragraph 6a (new)

• * 

  Accepted in principle

6a. ot later than ... , the 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

(b) they are identical in specification and (b) they have either the same specification, or specifications assessed as equivalent under the procedure referred to in Article 38. Not accepted content of the active substances, safeners and synergists, and in the type of formulation; and (c)

they are either the same or equivalent in

the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.

15978/08 PVG/re ANNEX DG B II

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

15978/08 PVG/re ANNEX DG B II

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 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 procedure referred to in Article 79(3). 5. Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that 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 procedure with scrutiny referred to in Article 79(4). Not accepted 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 related to the use of the plant protection product. 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

15978/08 PVG/re ANNEX DG B II

Amendment 146

Article 56 ­ paragraph 3 ­ sub-paragraph 1

• 3. 

  Without prejudice to the right of Member States to adopt interim protective measures the Member 3. The Member State receiving such Compromise package A ZONING Not accepted 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.

State which first granted an

authorisation within each zone shall evaluate the information received and inform the other Member States, belonging to the same zone, where it decides to withdraw or amend the authorisation under Article 44.

Amendment 147

Article 57 ­ paragraph 1 - introduction

• 1. 

  Member States shall keep information electronically available to the public on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least: 1.Member States shall forward to the Authority, who shall make electronically available to the public, information on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least: Not accepted Amendment 148

Article 59 ­ paragraph 1 ­ sub-paragraph 7

A study shall also be protected if it was necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months. The first to fourth subparagraphs shall apply with due changes. A study shall not be protected if it was necessary for the renewal or review of an authorisation. Not accepted

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Amendment 149

Article 60 ­ paragraphs 1 et 2

• 1. 

  For each active substance, safener and synergist and adjuvant, rapporteur Member States shall prepare a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and make it available to the Member States and the Commission. 2. For each plant protection product which they authorise, Member States shall keep and make available to any interested party upon request: (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. 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 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 Not accepted 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 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.

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

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Amendment 152

Article 61 ­ paragraph 3

• 3. 

  The prospective applicant for the 3. The prospective applicant for the Not accepted

authorisation 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 authorisation of a plant protection product. 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 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 nondiscriminatory way, the Commission may, in accordance with the regulatory procedure referred to in Article 79(3), adopt cost-sharing guidelines based on those principles. Amendment 153

Article 61 ­ paragraph 3a (new)

3a. Where the Member State considers that a monopoly Not accepted

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

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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 nondiscriminatory way. The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements. 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 nondiscriminatory way. The prospective applicant is required to share in the costs that accrue during the full process of generating the information he is required to submit to meet the authorisation requirements. Not accepted Amendment 155

Article 62 ­ paragraph 3a (new)

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

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.

15978/08 PVG/re ANNEX DG B II

Amendment 156

Article 63 ­ paragraph 2

• 2. 

  Disclosure of the following information 2. Disclosure of the following information Not accepted

shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned: shall be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned: 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 authorise or amend a plant protection product under this Regulation, such data may be viewed by interested parties in Not accepted 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 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 Not accepted

1

shall be labelled "not

suitable for infants and young children".

1 OJ L 339, 6.12.2006, p. 16.

15978/08 PVG/re ANNEX DG B II

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. 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 three years. They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as 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 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 Compromise package D INFORMATION Accepted with modifications 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 five years [...]. They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry may request access to this information by addressing the competent authority. [...] the drinking water industry may request

access to this information by addressing the competent authority.

retailers and wholesalers using a standardised format. The standardised format for the provision of

15978/08 PVG/re ANNEX DG B II

the information referred to in the subparagraph above shall be established in accordance with the advisory procedure referred to in Article 79(2).

Amendment 161

Article 67 ­ paragraph 1a (new)

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. Accepted with modifications 1a. Producers of plant protection products shall undertake post-registration monitoring on request of the competent authorities shall notify the competent authorities of [...] the relevant results.

Amendment 162

Article 77

The Commission may, in accordance with the advisory procedure referred to in Article 79(2), 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 Commission may, in accordance with 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. Not accepted

15978/08 PVG/re ANNEX DG B II

Amendment 163

Article 78 ­ paragraph 1 ­ point f

(f) a Regulation establishing a work program for safeners and synergists referred to in Article 26; 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 advisory procedure referred to in Article 79(2), a Regulation shall be adopted containing the list of active substances 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 of this Regulation. Those substances shall be deemed to have been approved under this Regulation. Not accepted included in Annex I to Directive 91/414/EEC. 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 50 of this Regulation shall apply. 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 50 of this Regulation shall apply. Compromise package C SUBSTITUTION Not accepted Note to OJ: 78 months from the date of entry into Note to OJ: 36 months from the date of entry into force of this Regulation. force of this Regulation.

15978/08 PVG/re ANNEX DG B II

Amendment 166

Article 82

By ...*, the Commission shall present a report to the European Parliament and the Council on the functioning By ...*, the Commission shall present a report to the European Parliament and the Council on the functioning Compromise package A ZONING Not accepted of mutual recognition of of mutual recognition of

authorisations and in particular on the application by the Member States of the provisions referred to in Article 36(3) and Article 50(2), the division of the Community into three zones 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 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. 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.

15978/08 PVG/re ANNEX DG B II

Amendment 167

Annexe I

Annex I Zone A ­ orth The following Member States belong to this zone: Denmark, Estonia, Latvia, Lithuania, Finland, Sweden Zone B ­ Centre The following Member States belong to this zone: Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Deleted Compromise package A ZONING Not accepted etherlands, Austria,

Poland, Romania, Slovenia, Slovakia, United Kingdom Zone C ­ South The following Member States belong to this zone: Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal

15978/08 PVG/re ANNEX DG B II

Amendment 168

Annex II - point 3.6.1

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 ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population. 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 ensured taking into account the type and severity of effects, possible combination effects and the vulnerability of vulnerable groups. 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 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

developmental neurotoxic or immunotoxic effects, an increased margin of safety may be considered 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 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, under realistic proposed 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 due account of likely combination 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 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

15978/08 PVG/re ANNEX DG B II

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) No 396/2005. 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 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) No 396/2005. Further specific scientific criteria for the determination properties that may cause adverse effect in humans, [...] unless the exposure of humans to that active substance, safener or synergist in a plant protection

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) No 396/2005. [...]

Pending the adoption of further

of endocrine disrupting scientific criteria for the determination of endocrine

properties shall be adopted by ... * in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). * ote to OJ: 18 months from the date of entry into force of this Regulation"

accordance with the regulatory procedure with scrutiny referred to in Article 79(4), substances that are or have to be classified, in accordance with the provisions of Directive 67/548/EEC, as

• - 

  toxic for reproduction and carcinogen category 3, or
• - 

  toxic for reproduction category 3 and having toxic effects on the endocrine organs,

may be considered to have such endocrine disrupting properties.

15978/08 PVG/re ANNEX DG B II

Amendment 170

Annex II - point 3.6.5a (new)

3.6. Impact on human health 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 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 Compromise package B CUT OFFS See AM 168 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.

15978/08 PVG/re 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 is not considered to be a persistent, bioaccumulative and toxic (PBT) substance. 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 is not considered to be a very persistent and very bioaccumulative substance (vPvB). 3.7.3. An active substance, safener or synergist shall Not accepted only be approved if it or its transformation products or residues, are not considered to be very persistent and very bioaccumulative substances (vPvB).

Amendment 173

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

It also fulfils the very bioaccumulative criterion when there is evidence of very high bioaccumulation Not accepted in other species, or monitoring data in biota indicate that the bioaccumulation potential of the chemical is sufficient to be of concern.

15978/08 PVG/re ANNEX DG B II

Amendment 174

Annex II - point 3.8.2. a (new)

3.8.2a. An active substance, safener or synergist shall not be approved unless it is established that under realistic proposed conditions of use: - the direct or indirect exposure of honeybees to that active substance in a 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. Compromise package B CUT OFFS 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 effects on colony survival and development, taking into account effects on honeybee larvae, honeybee behaviour.

15978/08 PVG/re ANNEX DG B II

Amendment 175

Annexe II ­ point 3.9b (new)

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

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 Accepted authorised minor uses into account.

____________________

15978/08 PVG/re ANNEX DG B II

• 12 jul '06
  Op de markt brengen van gewasbeschermingsmiddelen
  
  
  
• 12 jul '06
  COM(2006)388 - Op de markt brengen van gewasbeschermingsmiddelen
  
  
  
• 14 mrt '03
  COM(2003)117 - Maximumgehalten aan bestrijdingsmiddelenresiduen in producten van plantaardige en van dierlijke oorsprong
  
  
  
• 21 jan '03
  COM(2003)23 - Gemeenschappelijke voorschriften voor regelingen inzake rechtstreekse steunverlening in het kader van het gemeenschappelijk landbouwbeleid en tot vaststelling van steunregelingen voor producenten van bepaalde gewassen
  
  
  
• 26 sep '02
  COM(2002)530 - Voorstel voor een Richtkijn van het Europees Parlement en de Raad betreffende de harmonisatie van nationale wetgevinginzake de toepassing van de beginselen van goede laboratoriumpraktijken en het toezicht op de toepassing ervan voor tests op chemische stoffen
  
  
  
• 8 nov '00
  COM(2000)716 - Algemene beginselen en vereisten van de levensmiddelenwetgeving, tot oprichting van een Europese Voedselautoriteit en tot vaststelling van procedures voor voedselveiligheidsaangelegenheden
  
  
  
• 24 jun '98
  COM(1998)380 - Voorwaarden voor de uitoefening van de aan de Commissie verleende uitvoeringsbevoegdheden
  
  
  
• 26 feb '97
  COM(1997)49; - Kader voor gemeenschappelijke maatregelen betreffende het waterbeleid
  
  
  
• 18 jul '96
  COM(1996)347 - Harmonisatie van nationale wetgevingvan de lid - staten inzake de indeling, de verpakking en het kenmerken van gevaarlijke preparaten
  
  
  
• 18 dec '85
  COM(1985)637 - Bescherming van dieren die voor experimentele en andere wetenschappelijke doeleinden worden gebruikt