Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market

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1.

Tekst

COUNCIL OF THE EUROPEAN UNION

Brussels, 27 September 2007

11209

Interinstitutional File: 2006/0136 (COD)

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AGRILEG 93

ENV 361 CODEC 722

OUTCOME OF PROCEEDINGS from : dated :

Working Party on Agricultural Questions (Pesticides/Plant Protection Products) 20 June 2007

No. prev. doc. : 7007/07

No. Cion prop. : 11755/06 + ADD 1-12

Subject :

Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market

I.

INTRODUCTION

The Council Working Party on Agricultural Questions (Pesticides/Plant Protection Products) met on 20 June 2007 to continue its examination of the above proposal. Discussions were based on a revised version drawn up by the Presidency in the light of comments expressed by delegations (cf. Annex A).

The Group also heard a presentation by the German delegation on the outcome of the workshop on mutual recognition which took place in Braunschweig (Germany) on 14 and 15 June 2007.

At the end of the meeting, a brief debate was held on co-operation between Member States and EFSA.

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II. RESULTS ON THE MAIN ITEMS DISCUSSED

  • 1. 
    Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market

i)

Article 3: Definitions

Delegations welcomed the revised draft of this Article which groups the definitions scattered throughout the text of the proposal and clarifies a number of new terms. This draft will be completed with those definitions which are currently in the Framework Directive but concern both proposals, once discussions are more advanced.

  • ii) 
    Article 49a: Parallel trade

Although a number of topics still need further discussion, Delegations also welcomed the new text presented by the Presidency. It reflects the concerns voiced by delegations and also the results of informal talks with the Commission aimed at reconciling the different positions.

The following questions were raised on certain paragraphs by delegations:

  • • 
    Paragraph 2:
  • - 
    The UK delegation asked about the reasons for using the word "permit" instead of "authorisation". The Presidency answered that it was essential to respect the jurisprudence of the ECJ and that the idea was not to create a new authorisation procedure.
  • - 
    Another delegation (IT) suggested inserting a definition of parallel trade . The Presidency explained that they had favoured a description of the procedure rather than a definition.

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  • - 
    Regarding the deadline for the granting of a parallel trade permit, a majority of delegations preferred to keep the 90 working days instead of the 45 working days supported by some delegations and the Commission. As for the time limit for Member States to provide each other with the necessary information to assess identicality, it was agreed to reduce this from 20 to 10 days.
  • - 
    One delegation (EE) called for a definition of "competent authority" similar to the one in REACH, but the Presidency considered that it was sufficient for Member States to inform each other about their contact points.
  • - 
    The FR delegation pointed out the it would have to be clarified whether the permit was granted for one or several persons.
  • • 
    Paragraph 3

The reference to safeners and synergists was questioned by the SE delegation because of the workload entailed. In reply, the Commission representative explained that, given that safeners and synergists were within the scope of the Regulation, it was logical that they should be mentioned in the provisions for parallel trade.

  • • 
    Paragraph 7

The Commission wondered whether it was necessary to ask for the name and address of a contact person in the Member State of introduction in the case that the applicant was not established there and the FR delegation suggested adding the original label to the list.

  • • 
    Paragraph 8

The SE delegation asked to use the word "shall" instead of "may", but other delegations opposed this because the applicant might not have the necessary information to demonstrate that the product was identical to the reference one.

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  • • 
    Paragraph 9

The Commission representative supported by one delegation (SE) expressed reservation about the possibility of setting out additional requirements for the product to be introduced. The Presidency explained that the idea behind these words was to make sure that the holder of the parallel trade permit should share some of the obligations with the first applicant and she undertook to reword this paragraph. Three delegations (IE, SI, DE) were in favour of the Presidency's position.

  • • 
    Paragraph 11

The IE delegation, supported by others (IT, BE), called for the inclusion of Article 56. The Commission representative and two delegations (DE, UK) warned against this because it would be very complicated to apply data protection to parallel trade.

  • • 
    Paragraph 13

One delegation (SE) considered paragraph 13 superfluous and asked for it to be deleted. Nevertheless, no support was received from the rest of the delegations.

The FR delegation raised the question of repackaging and undertook to organise a special meeting to discuss this further. The Presidency agreed that this issue had not yet been solved and that such a debate would be useful. The Commission representative underlined that the question of repackaging would have to be considered on a case by case basis and that aspects such as intellectual property rights would have to be taken into account.

  • iii) 
    Article 37: Assessment of equivalence

The new version of this article raised no objections except for the UK delegation. The Commission representative expressed satisfaction that the rapporteur Member State was to carry out the assessment and that EFSA should not be involved systematically but he pointed out that the 90 days deadline should be reintroduced.

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  • iv) 
    Article 39, 40 and 41: Mutual recognition, authorisation and procedure

Regarding Article 39, the Commission representative gave a positive reaction to the new paragraph 1(b) which provides for mutual voluntary recognition between bordering countries and agreed with the inclusion of the treatment of empty storage rooms in paragraph 1(c).

Delegations expressed no objections to the changes made to paragraph 1 of Article 40 in order to take account of national conditions and be able to apply risk mitigation measures. The NL delegation welcomed the new paragraph 3 in Article 40 set out by the Presidency because it introduced some flexibility in the compulsory mutual recognition system proposed by the Commission. However, the AT delegation entered a general reservation on this paragraph and two delegations (UK, IT) expressed scrutiny reservations. The Commission representative voiced support for the obligatory mutual recognition within a zone. Other rewording suggestions were made in order to establish an adequate link between paragraphs 1 and 3.

  • v) 
    Article 22: Low risk active substances

The UK delegation asked for a definition of carcinogenic and mutagenic. In reply, the Commission representative mentioned the reference made to Directive 67/548/EEC in Annex II. The Commission also wondered whether it was preferable or not to delete the last two bullet points. The Presidency agreed to reflect on this again and pointed out that further criteria could be added to the list following the comitology procedure.

  • vi) 
    Articles 56 and 57: Data protection and list of test and study reports

The Group agreed to add a reference to safeners and synergists in paragraphs 1 and 3 of Article 56 and subparagraph 2(a) of Article 57.

At the end of the discussion, the Presidency undertook to present a new version of the text of the proposal before the end of June in the light of the comments made by delegations.

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  • 2. 
    Symposium on mutual recognition (Braunschweig (Germany), 14-15 June 2007)

A note drawn up by the Presidency setting out the main results of the two day symposium on mutual recognition, zonal authorisation and possibilities of improving co-operation was presented to the working group. It outlined the main advantages and drawbacks of the system of mutual recognition and identified some alternatives and improvements.

The Commission representative expressed his satisfaction with this workshop which had made it possible to discuss problems and possible solutions in detail. He undertook to reflect on the new ideas put forward by the participants.

One delegation drew attention to the need to streamline assessment procedures between Member States in order to make the system work.

  • 3. 
    Cooperation between Member States and EFSA

On the basis of written contributions sent by Member States, a brief debate on the possibilities to simplify procedures and improve cooperation with EFSA took place. The Presidency concluded that the idea presented by delegations of creating a permanent or an ad hoc group to facilitate the dialogue with EFSA should be further examined. One delegation expressed the view that this dialogue should remain within the Council working group forum.

III. CONCLUSION

During the course of the meeting, the Portuguese delegation took the floor to explain briefly her programme for the incoming Presidency. She explained that the new document prepared by the German Presidency would be a good working base for future work of the group.

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ANNEX A

Article 3 Definitions

[Article 3 needs to be revised and completed. An alphabetical order should be discussed.

For the purposes of this Regulation, the following definitions shall apply:

(1)         'residues'

One or more substances present in or on plants or products of plant origin, edible animal products, drinking water or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites, breakdown or reaction products;

(2)         'substances'

Chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;

(3)         'preparations'

Substances or mixtures (composed of two or more substances) intended for use as a plant protection product or as an adjuvant;

(4)         'substance of concern'

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 classified as dangerous in accordance with Directive 67/548/EEC, and present in the plant protection product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC;

(5)         'crops' [alternatively 'plants and/or crops']

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

(6)         'plant products'

Products in unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, derived from plants, but excluding plants as defined in point (5);

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(7)         'harmful organisms'

Any species, strain or biotype belonging to the animal kingdom or plant kingdom or pathogenic agent injurious to plants or plant products;

(8)         'placing on the market'

The holding of a plant protection product 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. Release for free circulation of a plant protection product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Regulation;

(9)         'authorisation of a plant protection product'

Administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory;

(10)       'applicant'

A person who manufactures active substances, safeners, synergists, co-formulants, plant protection products or adjuvants on his own, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation;

(11)       'letter of access'

An original document, with notarised signature by which the owner of data protected under this Regulation agrees to the use of such data by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another applicant;

(12)       'environment'

Waters (including ground, surface, transitional ,coastal,and marine), sediment, soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms;

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(13)       'integrated pest management'

[Careful consideration of all available plant protection methods and subsequent integration of appropriate measures that discourage the development of the populations of harmful organisms and keep the use of plant protection products and other forms of intervention to levels that are economically 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 and encourages natural pest control mechanisms;] (depending on def. in Directive)

(14)       'micro-organisms'

Microscopic organisms, including bacteria, viruses, protozoa, certain algae and fungi, cellular or non-cellular, capable of replication or of transferring genetic material;

(15)       'genetically modified micro-organisms'

Micro-organisms in which the genetic material has been altered within the meaning of Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council;

(16)       'zone'

Group of Member States, as defined in Annex I, ;

(17)       'Good Plant Protection Practice'

Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses (timing, dosage and application method), are selected, dosed and timed to ensure acceptable efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control;

(18)       'Good Environmental Practice'

Practice in plant protection which includes the handling, application and disposal of plant protection products and their containers, in conformity with the conditions of their authorised uses (timing, dosage and application method), in a way which only the smalles amount practicable is placed into the environment;

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(19)       'Good Laboratory Practice'

Practice as defined by Directive 2004/10/EC,

(20)       'Data protection'

The temporary right of the owner of a test or study report to prevent it being used for the benefit of another person for the purpose of obtaining an authorisation of a plant protection product or an approval of an active substance, synergist or safener;

(21)       'Low risk substance'

[Definition and proposals for the simplification of procedures should be discussed together in relation to Articles 22, 23 and 46]

(22)       'Basic substance'

[Definition and proposals for the simplification of procedures should be discussed together in relation to Articles 22, 23 and 46]

(23)       'Low-risk products'

[Definition and proposals for the simplification of procedures should be discussed together in relation to Articles 22, 23 and 46]

(24)       'Authorisation holder' Any person or legal entity holding a valid authorisation of a plant protection product.

(25)       ‘Active substances’

Substances or micro-organisms including viruses, having general or specific action:

– against harmful organisms; or

– on plants, parts of plants or plant products.

Generally the ISO common name should be followed.

(26)       ‘Relevant metabolite’

Any metabolite or a degradation product of an active substance, safener or synergist, formed either in organisms or in the environment. A metabolite is deemed relevant if there is a reason to assume that it has comparable intrinsic properties as the parent substance in

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terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable. Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures.

[A general reference should be made to SANCO 221/2000 (Guidance Document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council Directive 91/414/EEC)]

(27)       'Use of plant protection products' No proposal for text

(28)       'Professional user'

Any natural or legal person, who carries out the application of pesticides in his professional activity, including operators, technicians, employers, self-employed people in the farming or the non-farming sector.

[Definition in Art. 3(b) of the Thematic Strategy: ....means any natural or legal person who uses pesticides in the course of their professional activities, including operators, technicians, employers and self-employed people, both in farming and other sectors]

(29)       'Non-professional user' Not necessary to define, compare to professional user.

(30)       'Candidate for substitution' [Definition needed]

(31) 'Plant protection products'

Products, in the form in which they are supplied to the user, which are not acting by solely physical means, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:

(a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for hygiene reasons rather than for the protection of plants or plant products;

(b) influencing the life processes of plants, such as substances influencing their growth,

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other than as a nutrient;

(c) preserving plant products, insofar as such substances or products are not subject to special Community provisions on preservatives;

(d) destroying undesired plants or parts of plants, except algae;

(e) checking or preventing undesired growth of plants, except algae.

(32)       'Minor use'

Use of a plant protection product on a crop, which is not widely grown in a particular Member State or on a widely grown crop to meet an exceptional need.

(33)       'Safener'

Substances which are added to a plant protection product to eliminate or reduce phytotoxic effects of the preparation on certain plants.

(34)       'Synergists'

Substances which, while showing no or only weak activity as plant protection products, can give enhanced activity to the active substance(s) in a plant protection product.

(35)       'Co-formulants'

Substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists.

(36)       'Adjuvants'

Substances or preparations containing no active substance, safener and/or synergist in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product for the purpose of changing its properties or effects.

(38)       'National provisional authorization (NPA)'

Not mentioned in the Regulation.

(39)       ‘Rapporteur Member State’

Member State, which agrees to undertake the task of evaluating an active substance, safener or synergist. Rapporteur Member State delivers the Draft Assessment Report within the specified deadlines.

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(40)       'Greenhouse'

A greenhouse is defined as a walk-in, static, closed place of crop production with a transparent outer shell. The type of transparent materials used (glass, plastic, plastic film, etc.), the kind of floor (concrete, plastic film or existing soil) and the exchange of air between the greenhouse and its surroundings via ventilation are not significant in this regard.

(41)       'Widely grown crop'

A crop which is nationally or regionally important.

(42)       'Post-harvest treatment'

Treatment of plants or plant products in an isolated space where no run-off is possible, for example in a warehouse.

(43)       'Neighbour'

Natural or legal person, whose residence or estate is connected to the residence or estate of another natural or legal person's.

(44)       'Good Experimental Practice'

Efficacy tests for plant protection products are to be performed by official or officially recognized organizations in accordance with the provisions of EPPO Guidelines 181 and 152.

(45)       'Application area'

[is not defined in Thematic Strategy. Definition needed ???]

(46)       'Advertising'

[is not defined in Thematic Strategy. Definition needed ???]

 

(47)

'Biodiversity'
 

[Definition needed]

(48)

'Review Report'
 

[Definition needed ???]

(49) Impurities

Any component other than the pure active substance and/or variant which is present in the

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technical material (including originating from the manufacturing process or from degradation during storage).

Article 22 Low risk active substances

  • 1. 
    By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment, as provided for in Article 46(1).
  • 2. 
    Article 4 and Articles 6 to 21 shall apply.
  • 3. 
    The following criteria may be adopted for an active substance to be considered as a low risk active substance in accordance with the procedure referred to in Article 76 (3): The active substance is
  • - 
    not carcinogenic;
  • - 
    not mutagenic;
  • - 
    not toxic to reproduction;
  • - 
    not sensitising;
  • - 
    not persistent [(half life of less than 60 days)], not bioaccumulative and readily biodegradable;
  • - 
    [no endocrine disruptor appearing on the EU list of suspected endocrine disrupters;]
  • - 
    [of low toxicity].

Article 37 Assessment of equivalence under Article 29(1)(b)

  • 1. 
    Where it is necessary to establish whether a different source for an active substance complies with Article 29(1)(b), this shall be assessed by the Member State which acted as rapporteur for the active substance, safener or synergist as referred to in Article 7(1), hereafter called the rapporteur Member State. The applicant shall submit all necessary data to that Member State.
  • 2. 
    After giving the applicant the opportunity to submit his comments, which the applicant shall also communicate to the Member State examining the application, the rapporteur Member State shall prepare a report on equivalence and shall communicate the report to the Commission, the other Member States and the applicant.

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  • 3. 
    Where a Member State examining the report on equivalence does not agree with the conclusion of the rapporteur Member State, it shall inform the applicant, the other Member States and the Commission stating its reasons.

The concerned Member States and the rapporteur Member State shall try to reach agreement on whether Article 29(1)(b) is complied with. They shall provide the applicant with an opportunity to submit his comments.

  • 4. 
    Where the Member States concerned do not reach agreement the Member State examining the application for authorisation shall submit the matter to the Commission. A decision on whether the conditions referred to in Article 29(1)(b) are complied with shall be adopted in accordance with the procedure referred to in Article 76(2).

Before such a decision is adopted, the Commission may ask the Authority for an opinion, or for scientific or technical assistance which shall be provided within three months of the request.

  • 5. 
    Detailed rules for the implementation of paragraphs 1 to 4 may be established in accordance with the procedure referred to in Article 76(3), after consultation of the Authority.

Article 39 Mutual recognition

  • 1. 
    The holder of an authorisation may apply for an authorisation for the same plant protection product and for the same use 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;

(b)    the authorisation was granted by a Member State (reference Member State) which belongs to a different zone, but which shares a common border with the Member State to which the application is made;

(c)     the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty storage rooms, regardless of the zone to which the reference Member State belongs.

  • 2. 
    Mutual recognition shall not apply to plant protection products containing a candidate for substitution.

Article 40 Authorisation

  • 1. 
    The Member State to which an application under Article 39 is submitted shall take into

account national conditions and shall lay down the corresponding risk mitigation measures when authorising the plant protection product concerned , including classification for the purpose of Directive 1999/45/EC, as the reference Member State.

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  • 2. 
    By way of derogation from paragraph 1 and subject to Community law, additional conditions may be imposed with respect to the requirements referred to in Article 30(3).
  • 3. 
    Where a Member State has valid reasons to consider that a product which it has authorized or is bound to authorize under Article 39 (1b) constitutes a risk to human or animal health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision. A decision shall be taken on the matter within three months in accordance with the procedure laid down in Article 72 (2).

Article 41 Procedure

1.

The application shall be accompanied by:

(a)     a certified copy of the authorisation granted by the reference Member State; as well as a certified translation of the authorisation into the official language of the Member State receiving the application;

(b)    a formal statement that the plant protection product is identical to that authorised by the reference Member State;

(c)     a formal statement of the reference Member State, that the authorisation was granted according to the requirements of this Regulation;

(d)    a complete dossier as required in Article 32(3);

(e)     a report of the reference Member State containing information on the evaluation and decision on the plant protection product. Detailed rules for the content and format of the report may be established in accordance with the procedure referred to in Article 76 (3);

(f)     proposals for instructions of use, taking into account specific conditions in the Member State to which the application is made;

(g)    a justification for the comparability of the uses and of the agricultural, plant health and environmental conditions as well as of the operator and consumer safety as mentioned with those of the reference Member State

2.

3.

The Member State to which an application under Article 39 is submitted shall decide on the application within 90 days.

When requested by the Member State the applicant shall submit his application in the national or official languages of that member State or one of these languages.

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Article 56 Data protection

  • 1. 
    Test and study reports shall benefit from data protection under the conditions laid down in this Article.

The protection shall apply to test and study reports concerning the active substance and the plant protection product as referred to Article 8(2) when they are submitted to a Member State by an applicant for authorisation under this Regulation (hereinafter called ‘the first applicant’), provided that those test and study reports were

(a)     necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop, and

(b)    certified as compliant with the principles of Good Laboratory Practice or Good Experimental Practice. Good Experimental Practice is defined in [accordance with] the data requirements for plant protection products referred to in Article 8(1)(c).

Where a report is protected, it may not be used, by the Member State which received it, to grant an authorisation to [for the benefit of] other applicants for plant protection products, except as provided in paragraph 2, in Article 59 or in Article 77.

The period of data protection is ten years starting at the date of first authorisation in that Member State, except as provided in paragraph 2or in Article 59. That period is extended to 13 years for plant protection products covered by Article 46.

Those periods are extended by three months for each authorisation for a minor use as defined in Article 49 (1) if the application for such an authorisation is made by the authorisation holder at the latest 5 years after the date of the first authorisation in that Member State. The total period of data protection may in no case exceed 13 years. For plant protection products covered by Article 46 the total period of data protection may in no case exceed 15 years.

The period of data protection is 10 years starting at the date of the amendment of an authorisation in a Member State except as provided in paragraph 2 or in Article 59. That period is extended to thirteen years for plant protection products covered by Article 46.

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 five years. The first to fourth subparagraphs shall apply mutatis mutandis.

  • 2. 
    Paragraph 1 shall not apply:

(a)     to test and study reports for which the applicant has submitted a letter of access; or

(b)    where any period of data protection granted for the test and study reports concerned has expired.

  • 3. 
    Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection for test and study reports concerning the active substance and the plant protection product at the time of submitting the dossier and has provided to the Member State concerned for each test or study report the information referred to

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the Article 8(1)(i) and Article 32(3)(d) confirmation that any period of data protection granted for the test or study report has not expired.

Article 57 List of test and study reports

  • 1. 
    For each active substance, safener and synergist, 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 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 56 and any reasons submitted in accordance with that Article.

  • 3. 
    The lists provided for in paragraphs 1 and 2 shall include information on whether those test and study reports were certified as compliant with the principles of Good Laboratory Practice or with the principles of Good Experimental Practice.

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2.

Originele weergave

afbeelding document
 
 

3.

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