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

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Delegations will find attached a revised text of the Commission's proposal. This revised text has

been drawn up by the Chair in the light of the negotiations that the Working Party carried out up to

20 June 2007.

All amendments have been made in track change mode.

The Presidency intends to use this document as a basis for the future discussions of the Working

Party.

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 12.7.2006 COM(2006) 388 final

2006/0136 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

concerning the placing of plant protection products on the market

(presented by the Commission)

{SEC(2006) 930} {SEC(2006) 931}

2006/0136 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

concerning the placing of plant protection products on the market

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37(2)

and 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee,

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

[Recitals omitted]

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

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.

Article 2

Scope

• 1. 

  This Regulation shall apply to products, in the form in which they are supplied to the user, 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, 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. These products are referred to hereinafter as `plant protection products'.

• 2. 

  This Regulation shall apply to 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'. 3. This Regulation shall apply to the following:

(a) substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the preparation on certain plants, hereinafter `safeners';

(b) substances or preparations which, while showing no or only weak activity in the sense of paragraph 1, can give enhanced activity to the active substance(s) in a plant protection product, hereinafter `synergists';

(c) 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, hereinafter `co-formulants';

(d) substances or preparations which consist of co-formulants or preparations containing one or more co-formulants, 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, hereinafter `adjuvants'. Article 3

Definitions

[Article 3 needs to be revised and completed taking into account consistency with the framework

directive. 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 of plant origin in unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, but excluding plants as defined in point (5);

(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) 'producer''

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;

(13) 'integrated pest management' [depending on definition in framework directive]

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;

(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 smallest amount practicable is placed into the environment;

(19) 'Good Laboratory Practice'

Practice as defined by Directive 2004/10/EC; a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

(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 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 framework directive: ....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,

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)' Probably necessary, see proposed amendment in Art. 29 (7).

(39) `Rapporteur Member State'

Member State, which agrees to undertake the task of evaluating an active substance, safener or synergist.

(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 directly 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 framework directive. Definition needed ???] (46) 'Advertising'

[is not defined in framework directive. 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

technical material (including originating from the manufacturing process or from

degradation during storage).

(50) Competent (responsible) authority in a Member State

Any state authority established at national level in charge of authorisation of plant

protection products.

CHAPTER II

Active substances, safeners, synergists and co-formulants

SECTION 1 ACTIVE SUBSTANCES

S UBSECTION 1

R EQUIREMENTS AND CONDITIONS FOR APPROVAL Article 4

Approval criteria for active substances

• 1. 

  An active substance shall be approved in accordance with Annex II, if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will fulfil the conditions provided for in paragraphs 2 and 3. The assessment of the active substance shall first establish whether the approval criteria set out in point 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of annex II are satisfied.

The assessment of plant protection products provided for in paragraphs 2 and 3 shall be based on the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6).

• 2. 

  The residues of the plant protection products, consequent on application consistent with good plant protection practice, shall meet the following requirements:

(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 when the methods to assess such effects are available, or on ground water; (b) they shall not have any unacceptable effect on the environment;

(c) for residues which are of toxicological, ecotoxicological or environmental relevance, there shall be methods in general use for measuring them. Analytical standards must be commercially available. 3. Plant protection products, consequent on application consistent with good plant protection practice and having regard to normal conditions of use, shall meet the following requirements: (a) it shall be sufficiently effective;

(b) The specification as mentioned in Article 29 must be supported by available data.

(c) it shall have no immediate or delayed harmful effect on human or animal health, directly or through drinking water, 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 available; or on groundwater; (d) it shall not have any unacceptable effects on plants or plant products;

(e) it shall not cause unnecessary suffering and pain to vertebrates to be controlled;

(f) it shall have no unacceptable effects on 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, , air and soil; (ii) its impact on non-target species;

(iii) its impact on biodiversity.

• 4. 

  For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.
• 5. 

  . Data from studies with human volunteers in which an active substance from a plant protection product or the plant protection product itself is intentionally administered into the human body without clinical grounds shall not be taken into consideration for the assessment in order to adjust the safety margins.
• 6. 

  'Current scientific and technical knowledge' referred to in Article 4 (1), 29 (1d) and elswhere in the regulation shall be defined, established, further developed and introduced in accordance with the procedure referred to in Article 76 (2) taking into account basic principles and criteria such as transparency, participation, predictability, proportionality and the precautionary principle. Article 5

First approval

First approval shall be for a period not exceeding ten years.

Article 6

Conditions and restrictions

Approval may be subject to conditions and restrictions including:

(a) the minimum degree of purity of the active substance; (b) the nature and maximum content of certain impurities;

(c) restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question; (d) type of preparation;

(e) manner of application;

(f) submission of further confirmatory information to Member States and to the European Food Safety Authority, hereinafter `the Authority', where new requirements are established during the evaluation process as a result of new scientific and technical knowledge; (g) designation of categories of users, such as professional and non-professional;

(h) ; designation of areas where the use of plant protection products containing the active substance may not be authorised. (i) the need to impose risk mitigation measures and monitoring after use;

(j) any other particular conditions that result from the evaluation of information made available in the context of this Regulation.

S UBSECTION 2

A PPROVAL PROCEDURE Article 7

Application

• 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 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.
• 2. 

  Within 14 days of receiving the application, the rapporteur Member State shall send the applicant a written acknowledgement, stating the date of receipt. 3. When submitting his application, the applicant may request certain information, as defined by Article 60 (3), to be kept confidential. The applicant shall physically separate the information to be kept confidential.
• 4. 

  When submitting his application the applicant shall at the same time submit any claims for data protection pursuant to Article 56. .

Article 8 Dossiers

• 1. 

  The summary dossier shall include the following:

(a) Data with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the requirements of Article 4 are met; where the data submitted do not cover all zones or concern a crop which is not widely grown, justification for this approach; (b) for each point of the data requirements for the active substance referred to in Article 75(1)(b), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies;

(c) for each point of the data requirements for the plant protection product referred to in Article 75(1)(b), the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria referred to in Article 4 for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that data gaps in the dossier, as provided for in paragraph 2 of this Article, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the approval; (d) a checklist demonstrating that the dossier provided for in paragraph 2 of this Article

is complete;

(e) the reasons why the test and study reports submitted are necessary for first approval of the active substance or for amendments to the conditions of the approval; (f) an application for a MRL as referred to in Article 7 of Regulation (EC) No. 396/2005 or a justification for not supplying such information; (g) an assessment of all information submitted.

• 2. 

  The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1. It shall not contain any reports from studies with human volunteers in which an active substance from a plant protection product or the plant protection product itself is intentionally administered into the human body without clinical grounds. 3. The format of the summary dossier and the complete dossier shall be established in accordance with the procedure referred to in Article 76(2).

The data requirements referred to in Article 8(1) and 8(2) shall be defined in Regulations adopted in accordance with the procedure referred to in Article 76(2), reflecting the requirements for active substances and plant protection products in Annexes II and III to Directive 91/414/EEC. Similar data requirements shall be defined for safeners and synergists within 5 years of the entry into force of this Regulation (see Article 26) in accordance with the procedure referred to in Article 76(3).

Article 9

Admissibility of the application

• 1. 

  Within 30 days of receiving the application, the rapporteur Member State shall check whether the dossier submitted with the application contain all the elements provided for in Article 8, using the checklist referred to in Article 8(1)(d). It shall also check the claims for confidentiality referred to in Article 7 (3). 2. Where one or more of the elements provided for in Article 8 are missing, the Member State shall inform the applicant, setting a time period for their submission, such time period shall be maximum six month. Where at the end of that period, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States that the application is inadmissible.

A new application for the same substance may be submitted at any time.

• 3. 

  Where the dossier submitted with the application contain all the elements provided for in Article 8, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and the Authority of the admissibility of the application and start assessing the active substance. After receiving that notification, the applicant shall immediately forward the complete dossier to the other Member States, the Authority and the Commission.

Article 10

Access to the summary dossier

The Authority shall without delay make the summary dossier referred to in Article 8(1) available to

the public, excluding any information which is confidential under Article 60 (3).

Article 11

Draft assessment report

• 1. 

  Within twelve months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Authority a report (hereafter called "draft assessment report") assessing whether the active substance can be expected to meet the requirements of Article 4.The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. If the assessment establishes that the approval criteria set out in point 3.7 of Annex II are not satisfied, the draft assessment report will be limited to cover only these parts of the assessment. The report shall also include where relevant, a proposal to set Maximum residue limits.

Where at the end of that period, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other member States that the application is inadmissible.

The rapporteur Member State may consult the Authority.

• 2. 

  Where the rapporteur Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-months period shall be extended by the additional time period granted by the rapporteur Member State. The additional time period shall be maximum 6 month and shall cease at the moment when the additional information is received by the rapporteur Member State. It shall inform the Commission and the Authority.
• 3. 

  The format of the draft assessment report shall be established in accordance with the procedure referred to in Article 76(2). Article 12

Conclusion by the Authority

• 1. 

  The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant, the other Member States and the Commission at the latest 30 days after its receipt. It shall make it available to the public, after giving the applicant two weeks to request, pursuant to Article 60, that certain parts of the draft assessment report be kept confidential.

The Authority shall allow a period of ninety days for the submission of written comments.

Where appropriate, the Authority shall organise a consultation of experts, including experts from the rapporteur Member State.

• 2. 

  The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 4 within ninety days of the end of the period provided for in paragraph 1 of this Article and communicate it to the applicant, the Member States and the Commission and make it available to the public. Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.
• 3. 

  Where the Authority needs additional information, it shall set a time period of maximum ninety days for the applicant to supply it to the authority and the rapporteur Member State. It shall inform the Commission and the Member States.

The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within sixty days after the receipt of the additional information. In that case the ninety-day period provided for in paragraph 2 shall be extended by an additional period which shall cease at the moment when the additional assessment is received by the Authority.

The Authority may ask the Commission to consult a Community reference laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and meets the requirements of Article 29(1)(f) of this Regulation. The

applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards.

• 4. 

  The conclusion of the Authority shall include details on the procedure of the evaluation and the properties of the active substance concerned. The format for the conclusion of the Authority shall be established in accordance with the procedure referred to in Article 76 (3). Article 13

Approval Regulation

• 1. 

  Within six months of receiving the conclusion provided for in Article 12(2) 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 76(1), taking into account the conclusion of the Authority under Article 12. The applicant shall be given the possibility to submit comments on the review report.
• 2. 

  In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health or the environment is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of protection of health and the environment chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.

Measures adopted on this basis shall be proportionate and no more restrictive of trade than is required to achieve the high level of protection of health and the environment chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.

[copied from Art. 7 of Regulation 178/2002 with respect to the precautionary principle]

• 3. 

  On the basis of the review report provided for in paragraph 1, other factors legitimate to the matter under consideration and the precautionary principle referred to in paragraph (2) (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 procedure referred to in Article 76(3), providing that: (a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate; (b) an active substance is not approved; or

(c) the conditions of the approval are amended.

• 4. 

  The Commission shall maintain a list of approved active substances.

S UBSECTION 3

R ENEWAL AND REVIEW Article 14

Renewal of approval

• 1. 

  On application the approval of an active substance shall be renewed where it is established that the criteria referred to in Article 4 are satisfied.

Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.

Such renewal of the approval may include conditions and restrictions, as referred to in Article 6.

• 2. 

  . The approval may be renewed once or more for a period not exceeding ten years. Article 15

Application for renewal

• 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.
• 2. 

  When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable on first approval of the active substance or because his request is for an amended approval. He shall at the same time submit a timetable of any new and ongoing studies. The applicant shall identify, giving reasons, the parts of the information submitted that are to be kept confidential in accordance with Article 60.

Article 16

Access to the application for renewal

The Authority shall, without delay, make available to the public the information provided by the applicant under Article 15, excluding any information declared confidential under Article 60.

Article17

Extension of approval period for the duration of the procedure

Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a Regulation shall be adopted in accordance with the procedure referred to in Article 76(3), postponing the expiry for a period sufficient to examine the

application. In particular, such a Regulation shall be adopted where applicants could not give the three years' notice required under Article 15(1) because the active substance was included in Annex I to Directive 91/414/EEC for a duration which expired less than three years after the date of application of this Regulation.

The length of that period shall be established on the basis of the following:

(a) the time needed to provide the information requested; (b) the time needed to complete the procedure;

(c) the need to ensure the establishment of a coherent programme of work, as provided for in Article 18.

Article 18

Programme of work

The Commission may establish a programme of work grouping together similar active substances. This programme may require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a period provided for in the programme.

The programme shall include the following:

(a) the procedures concerning the submission and assessment of applications for renewal of approvals;

(b) the necessary data to be submitted;

(c) the time periods for submission of such data; (d) rules on the submission of new information;

(e) rules on requests for confidentiality in accordance with Article 60. (f) time period for assessment and decision making Article 19

Implementing measures

A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set out the provisions necessary for the implementation of the renewal, including, where relevant, the implementation of a programme of work, as provided for in Article 18.

Article 20

Renewal Regulation

• 1. 

  A Regulation shall be adopted in accordance with the procedure referred to in Article 76(3), providing that:

(a) the approval of an active substance is renewed, where appropriate, subject to conditions and restrictions; or (b) the approval of an active substance is not renewed.

• 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 for a maximum of 2 years (2 vegetation periods) for the disposal, storage, and use of existing stocks of the plant protection products concerned. The grace period shall not interfere with the normal period of use of the plant protection product. 3. Article 13 (4) shall apply. Article 21

Review of approval

• 1. 

  The Commission, acting on its own initiative or at the request of a Member State, may review the approval of an active substance at any time.

Where it considers that there are indications that the substance no longer satisfies the criteria provided for in Article 4, or further information required in accordance with point (f) of Article 6 has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a time period for the producer to submit its comments.

• 2. 

  The Commission may ask the Authority and the other Member States for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.
• 3. 

  Where the Commission concludes that the criteria referred to 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 procedure referred to in Article 76(3). Article 20(2) shall apply.
• 4. 

  Article 13 (4) shall apply.
• 5. 

  A Regulation, adopted in accordance with the procedure referred to in Article 76 (3) shall set out the provisions necessary for the implementation of the review procedure.

S UBSECTION 4 D EROGATIONS 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. 

  An active substance is considered as a low risk active substance if it 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.

Further criteria may be adopted in accordance with the procedure referred to in Article 76 (3).

Article 23

Approval criteria for basic substances

• 1. 

  Basic substances shall be approved in accordance with paragraphs 2 to 6. By way of derogation from Article 5, the approval shall be for an unlimited period of time. For the purpose of those paragraphs, a basic substance is an active substance which (a) is not a substance of concern,

(b) is not predominantly used for plant protection purposes but

(c) nevertheless is useful in plant protection, either directly or in a product consisting of the substance and a simple diluent, (d) is not placed on the market as a plant protection product.

• 2. 

  A Regulation, adopted in accordance with the procedure referred to in Article 76 (3) may establish criteria for an active substance to be considered as a basic substance.
• 3. 

  Active substances considered to be basic substances shall be included in a separate list.
• 4. 

  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. 5. An application for the approval of a basic substance shall be submitted by any interested party or by a Member State to the Commission. The application shall be accompanied by the following information:

(a) any evaluations of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance; or (b) other relevant information on its possible effects on human or animal health or the environment.

• 6. 

  The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request. 7. Articles 6 and 13 shall apply.
• 8. 

  The Commission, acting on its own initiative or at the request of a Member State, may review the approval of a basic substance at any time.

Where it considers that there are indications that the substance no longer satisfies the criteria provided for in paragraphs 1 and 2 it shall inform the Member States, the Authority and the interested party, setting a time period for their comments to be submitted.

The Commission shall ask the Authority and the other Member States for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.

Where the Commission concludes that the criteria referred to in paragraph 1 are no longer satisfied, a Regulation to withdraw or amend the approval shall be adopted in accordance with the procedure referred to in Article 76(3).

Article 24

Approval criteria for candidates for substitution

• 1. 

  By way of derogation from Article 5 and Article 14(2), an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding seven years, where other already approved active substances are significantly less toxic for consumers or operators or present significantly fewer risks for the environment. The assessment shall take account of the criteria laid down in point 4 of Annex II. Such a substance is referred to hereinafter as a `candidate for substitution'.
• 2. 

  Article 4 and Articles 6 to 21 shall apply.

SECTION 2

S AFENERS AND SYNERGISTS Article 25

Approval of safeners and synergists

• 1. 

  A safener or synergist shall be approved, where it complies with Article 4.
• 2. 

  By way of derogation of Article 4 (4) for approval of a safener or synergist, paragraphs 1, 2 and 3 of Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of the safener or synergist with at least one plant protection product. 3. Articles 5 to 21 shall apply. Article 26

Safeners and synergists already on the market

Within 5 years of the entry into force of this Regulation, a Regulation shall be adopted in accordance with the procedure referred to in Article 76(3) establishing a programme of work for the gradual review of synergists and safeners on the market when that Regulation enters into force. The regulation shall include notification, evaluation, assessment and decision-making procedures. It shall require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a specified time period.

SECTION 3

U NACCEPTABLE CO - FORMULANTS Article 27

Prohibition

• 1. 

  The Commission, acting on ist own initiative or at the request of a member State, may review co-formulants at any time. A co-formulant shall not be accepted for inclusion in a plant protection product where it has been established that: (a) its residues, consequent on application consistent with good plant protection practice, 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 regard to realistic normal 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 procedure referred to in Article 76(3).

CHAPTER III

Plant protection products

S ECTION 1

A UTHORISATION S UBSECTION 1

R EQUIREMENTS AND CONTENTS Article 28

Authorisation for placing on the market and use

• 1. 

  A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation. 2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases: (a) use of products containing exclusively one or more basic substances; (b) placing on the market and use of plant protection products for research or

development purposes in accordance with Article 51;

(c) production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory (d) introducing, placing on the market and use of plant protection products for which has been granted a parallel trade permit according Article 49a. Article 29

Requirements

• 1. 

  Without prejudice to Article 48 a plant protection product shall only be authorised where it complies with the following requirements: (a) its active substances, safeners and synergists have been approved;

(b) where its active substance, safener or synergist is produced in a different source compared to the source which was approved for substance, safener or synergist, the active substance, safener or synergist contained in the plant protection product does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist and has no more harmful effects within the

meaning of Article 4(2) and (3), due to its impurities, than if it had been produced in accordance with the manufacturing process specified in that dossier;

[A general reference should be made to Article 37 where the procedure to assess the equivalence of the technical material according to SANCO/10597/2003 (Guidance Document on the assessment of the equivalence of technical material of substances regulated under Council Directive 91 /414/EEC) is described. ,,Decisions according to Article 37 may be followed." (in the case that no commenting by Member States is forseen in Article 37).]

(c) its co-formulants are not included in the list of Annex III;

(d) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);

(e) the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants can be determined by appropriate methods; (f) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental significance, can be determined by appropriate methods in general use; (g) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;

(h) for feed and food crops, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005.

• 2. 

  By way of derogation from point (a) of paragraph 1, a Member State may, during a period of 5 years following the adoption of the programme of work referred to in Article 26 authorise the placing on the market in its territory of plant protection products containing synergists and safeners which are not approved, but which are included in that programme. 3. The applicant shall demonstrate that the requirements provided for in paragraph 1(a) to (g) are met.
• 4. 

  Compliance with the requirements set out in point (b) and points (d) to (g) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out by official or officially recognised units under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. 5. With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the procedure referred to in Article 76(3).
• 6. 

  Uniform principles for evaluation and authorisation of plant protection products shall be defined in Regulations adopted in accordance with the procedure referred to in Article 76(3), reflecting the requirements in Annex VI to Directive 91/414/EEC.
• 7. 

  In case that the decision on approval could not be finalised within a time period of 2 years and 6 months due only to procedural reasons than by way of derogation from paragraph 1 Member States may authorise for a provisional period not exceeding three years period, the placing on the market of plant protection products containing an active substance not yet approved, provided that a) following application of Article 9 it is found that the dossier on the active substance is

admissable in relation to the projected uses;

• b) 

  the Member State establishes that the active substance can satisfy the requirements of

Article 4 (2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29 (b) to (g); and

• c) 

  the Member State has made application in accordance with Articles 6 and 7 of

Regulation (EC) No 396/2005 to establish a maximum residue limit for the feed and feed products to which application is to be made.

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 authorization, giving at least the information provided for in Article 54 (1).

[Proposal: The necessity of the provisions under Article 29 (7) might be reexamined after 5 years of experience. An introduction of a respective revision clause in Article 29 should therefore be considered. Alternatively this could also be included in the recitals.]

Article 30

Contents of authorisations

• 1. 

  The authorisation shall define the plants, crops and non-agricultural areas (e. g. railways, public areas, storage rooms, equipments, package materials) on which and the purposes for which the plant protection pro duct may be used.
• 2. 

  The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall include the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists. The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC and the approved label. 3. The requirements referred to in paragraph 2 may include:

(a) a restriction of the product 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 and workers concerned; (b) the obligation before the product is used to inform any neighbours who could be exposed to the spray drift before the product is used and who have requested to be informed. (c) designation of categories of uses, such as professional and non-professional.

Article 31

Duration

• 1. 

  The period of authorisation shall be laid down in the authorisation. The maximum period for authorisation shall not exceed 10 years and shall be withdrawn when the approval period of any active substance, safener or synergist contained in the plant protection product expires. 2. Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 48.
• 3. 

  After renewal of the approval of an active substance, safener or synergist contained in the plant protection product, an additional authorisation period of nine months shall be granted to allow the examination as provided for in Article 42 to be carried out.

S UBSECTION 2 P ROCEDURE Article 32

Application for authorisation or amendment of an authorisation

• 1. 

  A person who wishes to place a plant protection product on the market shall apply for an authorisation, by themselves or via a representative, to each Member State where the plant protection product is intended to be placed on the market. 2. The application shall include the following:

(a) a list of intended uses of the zones and the Member States where the applicant has made or intends to make an application;

(b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned; in case of an application for use in greenhouses or as postharvest treatment or for treatment of empty storage rooms, only one Member State shall be proposed, who evaluates the application considering all zones; (c) a certified copy of any authorisations already granted for that plant protection product in a Member State; (d) a copy of any conclusion of the rapporteur Member State as referred to in Article 37 (2). 3. The application shall be accompanied by the following:

(a) for the plant protection product concerned, a complete dossier for each point of the data requirements of the plant protection product;

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

(d) the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation; (e) an application for a MRL as referred to in Article 7 of Regulation (EC) No. 396/2005 or a justification for not supplying such information;

(f) an assessment of all information submitted according to Art. 8 (1) g, including where relevant an assessment of the equivalence as referred to in Article 29 (1) (b); (g) a draft label.

• 4. 

  When submitting his application, the applicant shall, pursuant to Article 60 (3), physically separate the information to be kept confidential. He shall at the same time submit any claims for data protection pursuant to Article 56(3).

.

• 5. 

  Where requested by the Member State the applicant shall submit his application in the national or official languages of that Member State or one of those languages. 6. On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients.
• 7. 

  The provisions of paragraphs (1) to (6) apply also where a person who has been granted an authorisation for a plant protection product wishes to apply for an amendment of the authorisation. Article 33

Exemption

• 1. 

  Applicants shall be exempted from supplying the test and study reports referred to in Article 32(3) where the Member State to which an application is made has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 56, 58 or 59 or that any data protection period has expired. 2. However, applicants to whom paragraph 1 applies shall provide the following information: (a) the complete composition of the plant protection product;

(b) the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with Article 29(1)(b), where appropriate;

(c) the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data. (d) all necessary data for the identification of the plant protection product as well as a declaration, that no prohibited co-formulants are used. Article 34

Member State examining the application

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. 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 .

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.

Article 35

Examination

• 1. 

  The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. It may consult other Member States in the zone.

It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish whether the plant protection product meets the requirements provided for in Article 29, where used in accordance with Article 52, and under all realistic normal conditions of use, and the consequences of its use under the authorised conditions prevailing in the zone where the product is intended to be used.

The Member State examining the application shall make available its assessment to the other Member States within the same zone to which an application has been made. The format of the assessment report shall be established in accordance with the procedure referred to in Article 76 (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 30 and 31. The Member States shall authorise the plant protection product concerned, taking into account national conditions and risk mitigation options, including classification for the purpose of Directive 1999/45/EC, as the Member State examining the application.

[Question to Commission: Is the zonal authorisation intended to be mandatory for the Member States concerned? What happens if one Member State disagrees with the conclusion of the examining Member State?]

• 3. 

  Paragraph 2 shall not apply to plant protection products containing a candidate for substitution.
• 4. 

  By way of derogation from paragraph 2 and subject to Community law, additional conditions may be imposed with respect to the requirements referred to in Article 30(3).

Article 36

Time period for examination

• 1. 

  The Member State examining the application shall decide within twelve months of receiving it whether the requirements for authorisation are met.

Where the Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-month period shall be extended by the additional time period granted by the Member State. The additional time period shall be at maximum 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.

• 2. 

  The time-limits provided for in paragraph 1 shall be suspended while applying the procedure set out in Article 37.
• 3. 

  For an application for authorisation of a plant protection product containing an active substance not yet approved, the Member State examining the application shall start the evaluation as soon as it has received the draft assessment report referred to in Article 12(1). In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8 the Member State shall decide on the application at the latest within six months of the active substance being approved as referred to in Article 35(2). 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 and lay down the corresponding risk mitigation measures taking into account national conditions.

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 [or by a Member State which received the

application of equivalence]. 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. 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 within 90 days 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). The 90-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State that it does not agree with the conclusion of the latter, in accordance with paragraph 3. 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 38

Reporting and exchange of information on applications for authorisation

• 1. 

  Member States shall compile a file on each application. Each file shall contain the following: (a) a copy of the application;

(b) a report containing information on the evaluation of and decision on the plant protection product; the format of the report shall be established in accordance with the procedure referred to in Article 76 (3); (c) a record of the administrative decisions taken by the Member State concerning the application and the documentation provided for in Article 32(3) together with a summary of the latter.

(d) the approved label (see art 30)

• 2. 

  On request, Member States shall, without delay, make available to the other Member States, the Authority and the Commission a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1. 3. On request, applicants shall provide a copy of the documentation to be submitted with an application pursuant to Article 32(2) and Article 33 to Member States, the Authority and the Commission. 4. Detailed rules for the implementation of paragraphs 2 to 3 may be established in accordance with the procedure referred to in Article 76 (3).

S UBSECTION 3

M UTUAL RECOGNITION OF AUTHORISATIONS 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 postharvest 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 authorise the plant protection product taking into account national conditions and laying down the corresponding risk mitigation measures and include classifications for the purpose of Directive 1999/45/EC, as the reference Member State.
• 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 according to Article 40 (1) 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 76 (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. The Member State to which an application under Article 39 is submitted shall decide on the application within 90 days.

• 3. 

  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.

S UBSECTION 4

A MENDMENT , R ENEWAL AND WITHDRAWAL Article 42

Renewal of authorisation

• 1. 

  An authorisation shall be renewed upon application by the authorisation holder, provided that the conditions provided for in Article 29 are still satisfied.

The application shall be submitted at the latest one year before the expiry of the authorisation except where applicants cannot comply with this deadline because the active substance in question was included in Annex I to Directive 91/414/EEC for a duration which expired less than a year after the date of application of this Regulation.

• 2. 

  The application shall be accompanied by the following information: (a) a copy of the authorisation of the plant protection product,

(b) a report on the results of monitoring, where the authorisation was subject to monitoring.

• 3. 

  Within three months of renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information: (a) any new information required as a result of amendments in data requirements or criteria;

(b) justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted;

(c) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained in it; (d) a report on the results of monitoring, where the authorisation was subject to monitoring.

• 4. 

  Member States shall check that all plant protection products containing the active substance, safener or synergist concerned comply with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20. One Member State within each zone shall coordinate performance of the compliance check and assessment of the results for all Member States within that zone. The compliance check shall be performed within the time period set in the Regulation on the renewal of the approval.
• 5. 

  Guidelines on the organisation of compliance checks may be established in accordance with the procedure referred to in Article 76(2).
• 6. 

  Member States shall decide on the renewal of the authorisation at the latest nine months after the renewal of the approval of the active substance, safener or synergist contained in it.
• 7. 

  Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal. Article 43

Withdrawal or amendment of an authorisation

• 1. 

  Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.
• 2. 

  Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments. The Member State may ask the authorisation holder to submit further information.
• 3. 

  The Member State shall withdraw or amend the authorisation, as appropriate, where: (a) the requirements referred to in Article 29 are not or are no longer satisfied;

(b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted; (c) a condition included in the authorisation has not been met.

(d) the authorisation holder fails to comply with his obligations resulting from this Regulation. 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 Authority and the Commission. The other Member States belonging to the same

zone shall withdraw or amend the authorisation accordingly. Article 45 shall apply where

appropriate.

Article 44

Withdrawal or amendment of an authorisation at the request of the authorisation holder

• 1. 

  An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request. 2. Amendments may only be granted where it is established that the requirements of Article 29 continue to be satisfied.
• 3. 

  Where a Member State withdraws or amends an authorisation in accordance with paragraph 1 or 2, it shall immediately inform the holder of the authorisation, the other

Member States, and the Commission. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly if the conditions in Article 29 are no longer satisfied. Article 45 shall apply where appropriate.

Article 45

Grace period

Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.

Where the reasons for withdrawal, amendment or not renewing the authorisation do not concern the protection of health or the environment, grace periods for using up stocks of the plant protection products concerned shall be such that they do not interfere with the normal period of use of the plant protection product.

The grace period shall be limited and not exceed one year for the placing on the market and a maximum of two years (two vegetation periods) for the disposal, storage, and use of existing stocks of the plant protection products concerned.

S UBSECTION 5 S PECIAL CASES

Article 46

Placing on the market and use of low-risk plant protection products

• 1. 

  Where all the active substances contained in a plant protection product are substances as referred to in Article 22 (`low-risk active substances'), that product shall, by way of derogation from Article 29, be authorised as a low-risk plant protection product provided it meets the following requirements: (a) the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II; (b) it does not contain a substance of concern; (c) it is sufficiently effective;

(d) it does not cause unnecessary pain and suffering to vertebrates to be controlled; (e) it complies with Article 29(1)(b), (c) and (e) to (h). These products are referred to hereinafter as `low-risk plant protection products'.

• 2. 

  An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall accompany the application with a complete and summary dossier for each point of the data requirements of the active substance and the plant protection product.
• 3. 

  The Member State shall decide within 120 days on whether to approve an application for authorisation of a low-risk plant protection product.

Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the period specified 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. Article 47

Placing on the market and use of plant protection products containing

a genetically modified micro-organism

• 1. 

  A plant protection product which contains a micro-organism falling within the scope of Directive 2001/18/EC shall be examined in respect of the genetic modification in accordance with that Directive, in addition to the assessment under this Chapter. An authorisation under this Regulation shall not be granted for such a plant protection product unless written consent, as referred to in Article 19 of Directive 2001/18/EC, has been granted for it.
• 2. 

  Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. Article 48

Comparative assessment of plant protection products containing candidates for substitution

• 1. 

  Member States shall not authorise a plant protection product containing a candidate for substitution where they have performed a comparative assessment weighing up the risks and benefits, as set out in Annex IV, which demonstrates that: (a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment; and (b) the 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 minimise the occurrence of resistance in the target organism.
• 2. 

  By way of derogation from paragraph 1, a plant protection product containing a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice. Such authorisations shall be granted for a period not exceeding three years.
• 3. 

  Member States shall repeat the comparative assessment provided for in paragraph 1 regularly and at the latest four years after authorisation or renewal of the authorisation was granted.

Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation.

• 4. 

  Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 3, that withdrawal or amendment shall take effect seven 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. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. Article 49

Extension of authorisations for minor uses

• 1. 

  For the purpose of this Article, minor use of a plant protection product in a particular Member State means the use of that product on a crop which is not widely grown in that Member State or on a widely grown crop for a pest organism of only local distribution or if pest only occurs erratically within longer time periods.
• 2. 

  The authorisation holder, official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation. 3. Member States shall extend the authorisation provided that: (a) the intended use is minor in nature;

(b) the conditions referred to in Article 4(3) and Article 29(1)(h) are satisfied; (c) the extension is in the public interest;

(d) the documentation and information to support an extension of use has been submitted by the persons or bodies referred to in paragraph 2. The tests and studies necessary to grant the extension of authorisation have to be added to the request. Especially data on the magnitude of residues and where necessary on operator safety including worker and bystander safety are needed. 4. The extension may take the form of an amendment to the existing authorisation or may be a separate authorisation, according to the administrative procedures of the Member State concerned 5. 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. Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website.

• 6. 

  Member States shall establish and regularly update a list of minor uses.
• 7. 

  Article 39(1) shall only apply if the intended use is minor in nature also in the Member State that has to apply mutual recognition. 8. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. Article 49a

Parallel trade

• 1. 

  A plant protection product that is authorised in one Member State (Member State of origin) may, subject to an application for a parallel trade permit, be introduced, placed on the market and used in another Member State (Member State of introduction), if this Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in the Member State of introduction (reference product). The application shall be submitted to the regulatory authority in the Member State of introduction (competent authority). 2. From receiving a complete application a parallel trade permit shall be granted within 90 working days. Member States shall on request provide each other with the information necessary to assess identicality within 10 working days of receiving the request. The procedure for granting a parallel trade permit is interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority. 3. Member States shall grant in a simplified procedure a parallel trade permit if the plant protection product to be introduced is identical to the reference product in specification and content of the active substances, safeners and synergists, in type of the formulation and in composition of the plant protection product. 4. Active substances, safeners and synergists shall be considered as identical in terms of paragraph 3 if: a) they have been manufactured by the same company or by an associated undertaking or

under licence according to the same manufacturing process; or

• b) 

  they have either the same specification or specifications approved to be equivalent

under the procedure referred to in Article 37.

• 5. 

  The plant protection product to be introduced and the reference product are identical in composition in terms of paragraph 3 if: a) the co-formulants are identical in all respects; or
• b) 

  varying co-formulants have no more harmfull effects within the meaning of Article 4 (3) with due regard, in particular, to differences which may exist in conditions relating to agriculture, plant health and the environment, in particular climatic conditions, relevant to the use of the product. 6. The criteria and the procedures for evaluating to what extent the compositions are identical

may be described in detail in accordance with the procedure referred to in Article 76 (3).

• 7. 

  The application for a parallel trade permit shall include the following: Member State of origin

-

name and address of the applicant

-

the name and address of a contact person in the Member State of introduction, if the applicant is not established there

-

name to be given to the plant protection product to be distributed in the Member State of introduction

-

name and registration number of the plant protection product in the Member State of origin

-

name and address of the authorisation holder in the Member State of origin

-

original instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority. The competent authority may require a translation of the relevant parts of the original instructions for use.

-

name and registration number of the reference product

-

name and address of the authorisation holder of the reference product

-

a draft label for the product intended to be placed on the market

-

a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority

-

• 8. 

  The applicant for a parallel trade permit may demonstrate by means of all available and accessible information that the plant protection product intended to be introduced is identical in terms of paragraph 3, 4 and 5 to the reference product.
• 9. 

  A plant protection product for which a parallel trade permit has been issued is to be placed on the market and used in accordance with the provisions of the authorisation of the reference product. To meet the requirements of Article 29 and to facilitate monitoring and controls in terms of Article 65 the competent authority may set out additional requirements for the product to be introduced.
• 10. 

  The parallel trade permit is valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 44 (1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit will expire by the date on which the authorisation of the reference product would normally have expired. 11. Without prejudice to specific provisions in this Article, Articles 43-45, 52,53 (4) and Chapter VI ­ X shall apply to parallel traded plant protection products correspondingly. 12. Without prejudice to Article 43 a parallel trade permit may be withdrawn if

the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons

-

the parallel trade permit is misused by the applicant to introduce or place on the market plant protection products which are not authorised in any Member State.

-

• 13. 

  Where, with regard to the criteria provided for in paragraphs 3, 4 and 5 the assessment carried out by the Member State of introduction shows that the product intended to be introduced is not identical in terms of paragraph 3, 4 or 5 to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 28. 14. The provisions of this Article do not apply to plant protection products which are authorised in the Member State of origin according Article 50 or 51.

S UBSECTION 6 D EROGATIONS Article 50

Exceptional situations in plant protection

• 1. 

  By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety.
• 2. 

  The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within one month of the request.
• 3. 

  A decision shall be taken, in accordance with the procedure referred to in Article 76(3), (a) when the treated crop may not be safely marketed, and (b) when and under what conditions the Member State

(i) may not extend the duration of the measure or repeat it; or (ii) shall withdraw or amend its measure.

Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified micro-organisms. Article 51

Research and development

• 1. 

  By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted an authorisation for trial purposes. The authorisation may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005. The Member State may authorise a programme of experiments or tests in advance or require an authorisation for each experiment or test.
• 2. 

  An application shall be submitted to the Member State in whose territory the experiment or test is to be conducted, together with a dossier containing all the available data to permit an assessment of possible effects on human or animal health or the possible impact on the environment. 3. An authorisation for trial purposes shall not be granted for experiments or tests involving the release into environment of a genetically modified micro-organism unless such release has been accepted under Directive 2001/18/EC.
• 4. 

  Paragraphs 2 and 3 shall not apply if the Member State has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken.
• 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 procedure referred to in Article 76(3).

S ECTION 2

U SE AND INFORMATION Article 52

Use of plant protection products

Plant protection products shall be used properly.

Proper use shall include compliance with the conditions established in accordance with Article 30

and specified on the labelling, and application of the principles of good plant protection practice as well as, whenever possible, the principles of integrated pest management and good environmental practice.

At the latest by 1 January 2014 proper use of plant protection products shall comply with the principles of integrated pest management, including good plant protection practice and good environmental practise.

Detailed rules for the application of this Article including minimum requirements for these principles may be adopted in accordance with the procedure referred to in Article 76(2).

Article 53

Information on potentially unacceptable effects

• 1. 

  The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, or an active substance, safener, synergist or co-formulant contained in the plant protection product, which suggests that the plant protection product has harmful effects which might mean that the plant protection product or the active substance, safener or synergist no longer complies with the criteria set out in Articles 29 and 4 respectively. In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, safener, synergist or co-formulant contained in it, on human or animal health or on groundwater, or their potentially unacceptable effects on plants or plant products or the environment shall be notified.

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.

The obligation to notify shall include relevant information on decisions or assessments by international organisations or by public bodies which authorise plant protection products or active substances in third countries.

• 2. 

  The notification shall include an assessment of whether and how the new information means that the plant protection product or the active substance, safener, synergist or coformulant no longer comply with the requirements set out in Article 29 and Article 4 respectively. 3. The first Member State which 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 43.

It shall inform the other Member States and the Commission where it considers that the conditions of the approval of the active substance, safener, synergist or co-formulant contained in the plant protection product are no longer fulfilled and propose that the approval be withdrawn or the conditions amended.

• 4. 

  The holder of an authorisation for a plant protection product shall report annually to the competent authority of the Member State which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment.

Article 54

Obligation to keep information available

• 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: (a) the name or business name of the holder of the authorisation and the authorisation number, (b) the trade name of the product, (c) the type of preparation,

(d) the name and amount of each active substance, safener or synergist which it contains, (e) the use or uses for which it isauthorised,

(f) where relevant, the reasons for withdrawal of an authorisation if they are related to safety concerns.

• 2. 

  The information referred to in paragraph 1 shall be readily accessible and updated at least once every three months.
• 3. 

  In accordance with the procedure referred to in Article 76(3), a standardised information system may be set up to facilitate the application of paragraphs 1 and 2.

CHAPTER IV

ADJUVANTS

Article 55

Placing on the market and use of adjuvants

An adjuvant shall not be placed on the market or used if it contains a co-formulant which has not been accepted for inclusion in plant protection products in accordance with Article 27.

CHAPTER V

DATA PROTECTION AND DATA SHARING

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, safener or synergist 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 , safener or synergist 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 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, safener or synergist 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. Article 58

General rules on avoidance of duplicative testing

• 1. 

  Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, enquire of the competent authority of the Member State to which they intend to make an application whether an authorisation has already been granted in that Member State for a plant protection product containing the same active substance, safener or synergist. Such enquiry shall include consultation of the information available pursuant to Article 54. The prospective applicant shall submit all data regarding the identity and impurities of the active substance he proposes to use and the composition of the plant protection product for which it intends to apply for an authorisation.
• 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.
• 3. 

  The prospective applicant for the 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 56 that are required by the applicant for authorisation of a plant protection product. Article 59

Sharing of tests and studies involving vertebrate animals

• 1. 

  Tests and studies involving vertebrate animals shall not be repeated for the purposes of this Regulation. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated.
• 2. 

  The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.
• 3. 

  Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State. [The two parties shall nevertheless agree which courts have jurisdiction for the purpose of the second subparagraph.] The failure to reach agreement, as provided in paragraph 2, shall not prevent the competent authority of the Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant. However the competent authority of the Member State may request proof that the prospective applicant has paid to the holder or holders of the relevant authorisation for the test and study reports a share of the costs.
• 4. 

  The holder or holders of the relevant authorisation shall have a claim on the prospective applicant for an equal share of the costs incurred by him, which shall be settled [enforceable] before arbitration boards or courts of the Member States.,[ as designated by the parties under the first subparagraph.] Those boards or courts shall have regard to the principles determined in paragraph 2.

CHAPTER VI

PUBLIC ACCESS TO INFORMATION

Article 60

Confidentiality

• 1. 

  Regulation (EC) No. 1049/2001 shall apply to documents held by the authority.
• 2. 

  A person claiming under Articles 7(3), 12(1), 15(2), 16 or 32(4) that information submitted by that person under this Regulation is to be treated as confidential shall provide a verifiable justification to show that the disclosure of the information might undermine his commercial interests, as referred to in the first indent of Article 4(2) of Regulation (EC) No 1049/2001 of the European Parliament and of the Council 1

, or any interest protected by

Article 4(1) of that Regulation.

3 Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person.: (a) the method of manufacture;

(b) all data regarding identity, maximum content, toxicological and ecotoxicological properties of impurities and additives of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant; (c) results of production batches of the active substance including impurities and additives;

(d) methods of analysis for impurities and additives in the active substance except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant; (e) links between a manufacturer or importer and his distributors;

(f) information on the complete composition of a plant protection product

• 3. 

  This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council.

1

OJ L 145, 31.5.2001, p. 43.

CHAPTER VII

PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS Article 61

Packaging and presentation

• 1. 

  Plant protection products and adjuvants that may be mistaken for food, drink or feed shall be packaged in such a way as to minimise the likelihood of such a mistake being made.
• 2. 

  Plant protection products and adjuvants available to the general public that may be mistaken for food, drink or feed shall contain components to discourage or prevent their consumption.
• 3. 

  For each plant protection product and adjuvant the suitability of the packaging including the seals, i.e. their stability, impermeability, transportability and handling safety, must be examined in accordance with the methods of the "Accord européen relatif au transport international des marchandises Dangereuses par Route". 4. Article 9 of Directive 1999/45/EC shall also apply to plant protection products and adjuvants not covered by that Directive. Article 62

Labelling

• 1. 

  The labelling of plant protection products shall comply with the requirements set out in a Regulation adopted in accordance with the procedure referred to in Article 76(2).

That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC. It shall reflect the text of Article 16 and the text of the Annexes IV and V to Directive 91/414/EEC.

• 2. 

  Member States may require samples or mock-ups of the packaging and drafts of labels and leaflets to be submitted before the authorisation is granted.
• 3. 

  Where a Member State considers that additional phrases are necessary to protect human or animal health or the environment, it shall notify the other Member States and the Commission forthwith and shall forward the additional phrase or phrases and the reasons for these requirements. Such phrases shall be considered for inclusion in the Regulation referred to in paragraph 1.

Pending that inclusion, the Member State may require the use of the additional phrase or phrases.

Article 63

Advertising

• 1. 

  Every advertisement for a plant protection product shall be accompanied by the sentences `Use plant protection products safely. Always read the label and product information before use'. These sentences shall be clearly distinguishable in relation to the whole advertisement. The words `plant protection products' may be replaced by a more precise description of the product-type, such as fungicide, insecticide or herbicide. 2. The advertisement shall not include information which could be misleading as regards possible risks to human or animal health or to the environment, such as the terms `low risk', `non-toxic' or `harmless'.

CHAPTER VIII

CONTROLS

Article 64

Record keeping

• 1. 

  Producers, suppliers, distributors and professional users of plant protection products shall keep records of the plant protection products they produce, store, use or place on the market.

They shall make the relevant information contained in these records available to the competent authority on request. They shall also keep this information available for neighbours or the drinking water industry who request access to it.

• 2. 

  Authorisation holders shall provide the competent authorities of the Member States with all data relating to the volume of sales of plant protection products.
• 3. 

  Implementing measures to ensure the uniform application of paragraphs 1 and 2 may be adopted in accordance with the procedure referred to in Article 76(3). Article 65

Monitoring and controls

Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission, a report on the scope and the results of these controls within six months of the end of the year to which the reports relate.

Commission experts shall carry out general and specific audits in the Member States for purposes of verifying the official controls carried out by the Member States.

A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set out provisions for the controls on the production, packaging, labelling, storage, transport, marketing, formulation and use of plant protection products. That Regulation shall contain provisions equivalent to Articles 1 to 13, 26, 27 (1), 27(4)(a) and (b) and 27(5) to (12), 28, 29, 32 to 45, 51, 53, 54, 66 and to Annexes I, II, III, VI, and VII to Regulation (EC) No 882/2004. It shall also contain provisions concerning the collection of information and reporting on suspected poisonings.

CHAPTER IX EMERGENCIES

Article 66

Emergency measures

Where it is clear that an approved substance, safener, synergist or co-formulant or a plant protection product which has been authorised in accordance with this Regulation is likely to constitute a serious risk to human or animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of that substance or product shall be taken immediately in accordance with the procedure referred to in Article 76(3), either at the own initiative of the Commission or at the request of a Member State. Before taking such measures the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided.

Article 67

Emergency measures in cases of extreme urgency

By way of derogation from Article 66, the Commission may provisionally adopt the measures referred to in Article 66 after consulting the Member State or Member States concerned and informing the other Member States.

As soon as possible, and at the latest after 10 working days, those measures shall be confirmed, amended, revoked or extended in accordance with the procedure referred to in Article 76 (3).

Article 68

Other emergency measures

• 1. 

  Where a Member State officially informs the Commission of the need to take emergency measures, and no action has been taken in accordance with Articles 66 or 67, the Member State may adopt interim protective measures. In this event, it shall immediately inform the other Member States and the Commission. 2. Within 30 working days, the Commission shall put the matter before the Committee referred to in Article 76(1) in accordance with the procedure provided for in Article 76(3) with a view to the extension, amendment or abrogation of the national interim protective measure. 3. The Member State may maintain its national interim protective measures until Community measures have been adopted.

CHAPTER X

ADMINISTRATIVE AND FINANCIAL PROVISIONS

Article 69

Penalties

The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

The Member States shall notify those rules and any subsequent amendment to the Commission without delay.

Article 70

Civil and criminal liability

The granting of authorisation and any other measures in conformity with this Regulation shall be without prejudice to general civil and criminal liability in the Member States of the producer and, where applicable, of the person responsible for placing the plant protection product on the market or using it.

Article 71

Fees and charges

• 1. 

  Member States may recover the costs associated with any work they carry out arising from obligations under this Regulation, by means of fees or charges. 2. Member States shall ensure that the fee or charge referred to in paragraph 1: (a) is established in a transparent manner; and

(b) corresponds to the actual cost of the work involved.

The fee or charge may include a scale of fixed charges based on average costs for the work referred to in paragraph 1.

Article 72

Member State authority

• 1. 

  Each Member State shall designate a competent authority or authorities to carry out the obligations of the Member States as defined in this Regulation.
• 2. 

  Each Member State shall designate a coordinating national authority to coordinate and ensure all the necessary contacts with applicants, other Member States, the Commission and the Authority.
• 3. 

  The competent authority or authorities shall ensure thea they have a sufficient number of suitable qualified and experienced staff so the the obligation as defined in this Regulation shall be carried out efficiently and effectively.
• 4. 

  Each Member State shall give the details concerning its national competent authority or authorities to the Commission, the Authority and the coordinating national authorities of the other Member States and inform them of any modifications thereof. 5. The Commission shall publish and keep updated on its website a list of the authorities referred to in paragraphs 1 and 2. Article 73

Expenditure by the Commission

• 1. 

  The Commission may incur expenditure for activities contributing to the aims of this Regulation including the organisation of the following:

(a) development of a harmonised system, including an appropriate database, for gathering and storing all information concerning active substances, safeners, synergists, co-formulants, plant protection products and adjuvants and for making such information available to the Member States, producers and other interested parties; (b) performance of studies needed to prepare and develop further legislation on the placing on the market and use of plant protection products and adjuvants; (c) performance of studies needed to harmonise procedures, decision-making criteria and data requirements;

(d) coordination, if necessary by electronic means, of cooperation between Member States, the Authority and the Commission and measures to facilitate work sharing;

(e) development and maintenance of a coordinated electronic submission and evaluation system aimed at promoting electronic document exchange and work sharing between the applicants, the Member States, the Authority and the Commission; (f) development of guidance to facilitate the day-to-day implementation of this Regulation;

(g) travel and subsistence expenses that Member States' experts incur as a result of the Commission appointing them to assist its experts in the framework of control activities laid down under Article 65; (h) training of control staff;

(i) financing of other measures needed to ensure application of the Regulation adopted under Article 65.

• 2. 

  The appropriations required under paragraph 1 shall be subject to authorisation by the budgetary authority each financial year Article 74

Guidance documents

The Commission may, in accordance with the procedure referred to in Article 76(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.

Article 75

Amendments and implementing measures

• 1. 

  The following shall be adopted in accordance with the procedure referred to in Article 76(3): (a) amendments to the Annexes, taking into account current scientific and technical knowledge;

(b) amendments to the Regulations on data requirements for active substances and for plant protection products, as referred to in Article 8(1)(b) and (c), taking into account scientific and technical knowledge; (c) amendments to the Regulation on uniform principles for evaluation and authorisation of plant protection products, as referred to in Article 29(6), taking into account scientific and technical knowledge; (d) amendments to the Regulation containing the requirements of the labelling of plant protection products as referred to in Article 62(1); (e) the measures needed to implement this Regulation.

• 2. 

  In accordance with the procedure referred to in Article 76(2), a Regulation shall be adopted containing the list of active substances included in Annex I to Directive 91/414/EEC. Those substances shall be deemed to have been approved under this Regulation.

Article 76

Committee

• 1. 

  The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, as established by Article 58 of Regulation (EC) No 178/2002, hereinafter referred to as "the Committee". 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
• 4. 

  The Committee shall adopt its Rules of Procedure.

Chapter XI

Transitional and final provisions

Article 77

Transitional measures

• 1. 

  Directive 91/414/EEC ("the Directive") shall continue to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before the date of application of this Regulation. On the basis of the examination carried out under the Directive, a Regulation on the approval of such a substance shall be adopted in accordance with Article 13(2) of this Regulation.
• 2. 

  Article 13 (1) to (4) of the Directive and Annexes II and III to the Directive shall continue to apply with respect to active substances included in Annex I to the Directive and to active substances approved in accordance with paragraph 1: ­ For a period of five years from the date of their inclusion or approval, for active substances covered by Article 8(2) of the Directive.

­ For a period of ten years from the date of their inclusion or approval, for active substances which were not on the market two years after the date of notification of the Directive.

­ For a period of five years from the date of the renewal of the inclusion or renewal of the approval, for active substances whose inclusion in Annex I to the Directive expires at the latest two years after the date of publication of this Regulation. This provision shall only apply to data necessary for the renewal of the approval and which were certified as compliant with the principles of Good Laboratory practice at the latest two years after the publication of Regulation. 3. Where Article 13 of the Directive applies by virtue of paragraph 1 or paragraph 2, it shall be subject to any special rules concerning the Directive laid down in the Act of Accession by which a Member State joined the Community.

• 4. 

  For active substances for which the first approval expires at the latest 3 years after the entry into force of this Regulation, 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 two years before the expiry of the first approval. 5. Applications for authorisations of plant protection products under Article 4 of the Directive which are pending in the Member States on the date of application of this Regulation shall be decided on the basis of national law in force on that date. After that decision, this Regulation shall apply.
• 6. 

  Products labelled in accordance with Article 16 of the Directive may continue to be placed on the market for four years from the date of application of this Regulation.

Article 78

Derogation for safeners and synergists

By way of derogation from Article 28(1), a Member State may, for a period of five years following the adoption of the programme referred to in Article 26 authorise the placing on the market in its territory of plant protection products containing safeners and synergists which have not been approved, where they are included in that programme.

Article 79

Repeal

Without prejudice to Article 77, Directives 79/117/EEC and 91/414/EEC, as amended by the acts listed in Annex V, are repealed with effect from the date of application of this Regulation, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in that Annex.

References to the repealed Directives shall be construed as references to this Regulation. In particular, references in other Community legislation, such as Regulation 1782/2003 [give full title an OJ reference], to Article 3 of Directive 91/414/EEC shall be construed as references to Article 52 of this Regulation.

Article 80

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The Commission shall within 18 months after its entry into force adopt the following Regulations:

­ A Regulation containing the list of the active substances already approved at the moment of publication of that Regulation ­ A Regulation on data requirements for active substances, as referred to in Article 8(1)(b)

­ A Regulation on data requirements for plant protection products, as referred to in Article 8(1)(c)

­ A Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 35 ­ A Regulation containing the requirements of the labelling of plant protection products as referred to in Article 62(1).

It shall apply from 18 months from that date on which it enters into force. [OFFICE OF

PUBLICATIONS: INSERT DATE ... AFTER PUBLICATION]

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council The President The President

ANNEX I

Definition of zones for the authorisation of plant protection products

Zone A ­ North

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, Luxemburg, Hungary, Netherlands, 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

ANNEX II

Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II

• 1. 

  Evaluation

1.1. During the process of evaluation and decision-making provided for in Articles 4 to

21, the rapporteur Member State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for the evaluation of the dossier, including information to eliminate the need for a restriction of the approval, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Regulation.

1.2. The evaluation by the Authority and the rapporteur Member State must be based on

scientific principles and be made with the benefit of expert advice.

1.3. During the process of evaluation and decision-making provided for in Articles 4 to

21, Member States and the Authority shall take into consideration any further guidance developed in the framework of the Standing Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk assessments.

• 2. 

  General decision-making criteria

2.1. Article 7(1) shall only be considered as complied with, where, on the basis of the

dossier submitted, authorisation in at least one Member State is expected to be possible for at least one plant protection product containing that active substance for at least one of the representative uses.

2.2. Submission of further information

In principle an active substance shall only be approved where a complete dossier is submitted.

In exceptional cases an active substance may be approved even though certain information is still to be submitted where: (a) the data requirements have been amended or refined after the submission of the dossier or;

(b) the information is considered to be confirmatory in nature, as required to increase the confidence in the decision.

In such cases the additional information shall be submitted to the rapporteur Member State for evaluation within a deadline set by the Commission. The Member State shall report to the Commission on the results of the assessment.

2.3. Restrictions on approval

Restrictions on approval, where necessary, may be linked to:

­ identification of unacceptable risks under particular conditions

­ gaps in the risk assessment resulting from the limited range of representative uses and preparations notified by the applicant.

Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed. 3. Criteria for the approval of an active substance 3.1. Dossier

The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD).

In the case of an active substance for which the limited range of representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1) shall contain the information necessary to carry out a risk assessment and for enforcement purposes. The dossier shall in particular:

(a) permit any residue of concern to be defined;

(b) reliably predict the residues in food and feed, including succeeding crops;

(c) reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing;

(d) permit a Maximum Residue Level (MRL) to be defined for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals; (e) permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined;

The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species. 3.2. Efficacy

An active substance shall only be approved where it has been established for a limited range of representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic normal conditions of use is sufficiently effective. This requirement shall be

evaluated in the light of the uniform principles for evaluation and authorisation of plant protection products referred to in the second paragraph of Article 35.

3.3. Toxic relevance of breakdown products

Where the limited range of representative uses includes use on food or feed crops, the documentation submitted shall be sufficient to permit the establishment of the toxicological relevance of breakdown products that were not present in the animals used in the test or studies performed on the active substance but which are formed in or on treated plants, as a result of processing or are found in studies performed on livestock animals. 3.4. Composition of the active substance

3.4.1. The specification shall define the minimum degree of purity, the identity and

maximum content of impurities, and where relevant of isomers / diastereoisomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.

3.4.2. The specification shall be in compliance with the relevant FAO specification

where such specification exists. However where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted.

3.5. Methods of analysis

3.5.1. The methods of analysis of the active substance as manufactured and of

determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance as manufactured, shall have been validated and shown to be sufficiently specific, linear, accurate and precise.

3.5.2. The method of analysis in environmental matrices, as appropriate, shall have

been validated and shown to be sufficiently sensitive with respect to the levels of concern.

3.5.3. The evaluation has been carried out in accordance with the uniform principles

for evaluation and authorisation of plant protection products referred to in Article 35.

3.6. Impact on human health

3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When

establishing such values a sufficient safety margin shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population.

3.6.2. An active substance shall only be approved, if, on the basis of assessment of

higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not classified, in accordance with the provisions of Directive 67/548/EEC, as mutagen category 1or 2 unless the

exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.

3.6.3. An active substance shall only be approved, if, on the basis of assessment of

carcinogenicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.

3.6.4. An active substance shall only be approved, if, on the basis of assessment of

reproductive toxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.

3.6.5. An active substance shall only be approved, if, on the basis of the assessment

of Community or internationally agreed test guidelines it is not considered to have endocrine disrupting properties that may be of toxicological significance in humans unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible.

3.7. Fate and behaviour in the environment

3.7.1. An active substance shall only be approved where it is not considered to be a

persistent organic pollutant.

A persistent organic pollutant is defined as follows: (a) Persistence:

(i) Evidence that its DT50 in water is greater than two months, or that its DT50 in soil is greater than six months, or that its DT50 in sediment is greater than six months; and (b) Bio-accumulation:

(i) Evidence that its bio-concentration factor or bio accumulation factor in aquatic species is greater than 5,000 or, in the absence of such data, that the log Ko/w is greater than 5; (ii) Evidence that a chemical presents other reasons for concern, such

as high bio-accumulation in other non-target species, high toxicity or ecotoxicity; and

(c) Potential for long-range environmental transport:

(i) Measured levels of the active substance in locations distant from the sources of its release that are of potential concern; (ii) Monitoring data showing that long-range environmental transport

of the active substance, with the potential for transfer to a receiving environment, may have occurred via air, water or migratory species; or

(iii) Environmental fate properties and/or model results that demonstrate that

the active substance has a potential for long-range environmental transport through air, water or migratory species, with the potential for transfer to a receiving environment in locations distant from the sources of its release. For an active substance that migrates significantly through the air, its DT50 in air should be greater than two days.

3.7.2. An active substance shall only be approved if it is not considered to be a

persistent, bioaccumulating and toxic (PBT) substance.

A substance that fulfils all three of the criteria of the sections below is a PBT substance. 3.7.2.1. Persistence

An active substance fulfils the persistence criterion where: ­ the half-life in marine water is higher than 60 days, or

­ the half-life in fresh or estuarine water is higher than 40 days, or ­ the half-life in marine sediment is higher than 180 days, or

­ the half-life in fresh or estuarine water sediment is higher than 120 days, or ­ the half-life in soil is higher than 120 days.

Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant.

3.7.2.2. Bioaccumulation

An active substance fulfils the bioaccumulation criterion where the bioconcentration factor (BCF) is higher than 2000.

Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used. 3.7.2.3. Toxicity

An active substance fulfils the toxicity criterion where:

­ the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/l, or

­ the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or

­ there is other evidence of chronic toxicity, as identified by the classifications: T, R48 or Xn, R48 pursuant to Directive 67/548/EEC. 3.7.3. An active substance shall not be considered as complying with Article 4 where

it is very persistent, very bioaccumulating (vPvB).

A substance that fulfils both of the criteria of the sections below is a vPvB substance. 3.7.3.1. Persistence

An active substance fulfils the very persistence criterion where:

­ the half-life in marine, fresh- or estuarine water is higher than 60 days, or ­ the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or ­ the half-life in soil is higher than 180. 3.7.3.2. Bioaccumulation

An active substance fulfils the very bioaccumulative criterion where the bioconcentration factor is greater than 5000. 3.8. Ecotoxicology

3.8.1. An active substance shall only be considered as complying with Article 4 if the

risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 35 under realistic proposed conditions of use of a plant protection product containing the active substance. The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance is expected to affect adversely by the intended use.

3.8.2. An active substance shall only be considered as complying with Article 4 if, on

the basis of the assessment of Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may be of toxicological significance on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.

3.9. Residue definition

An active substance shall only be approved if, where relevant, a residue definition can be established for the purposes of risk assessment and for enforcement purposes. 4. Criteria for approval as a candidate for substitution

An active substance shall be approved as a candidate for substitution pursuant to Article 24 where:

­ its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances; ­ it meets two of the criteria to be considered as a PBT substance;

­ there are reasons for concern linked to the nature of the critical effects which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, even with very restrictive risk management measures(such as extensive personal protective equipment or very large buffer zones); ­ it contains a significant proportion of non-active isomers

ANNEX III

List of co-formulants which are not accepted for inclusion in plant protection products

ANNEX IV

Comparative assessment pursuant to Article 48

• 1. 

  Conditions for comparative assessment

A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution.

Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product is considered (hereinafter `substitution'), the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment. An assessment of the alternative plant protection product shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not.

Further conditions for refusal or withdrawal of an authorisation are:

(a) substitution shall be applied only where the chemical diversity of the active substances is sufficient to minimise the occurrence of resistance in the target organism;

(b) substitution shall be applied only to active substances which, where used in authorised plant protection products, present a significantly higher level of risk to human health or the environment; (c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from use in practice, where not already available. 2. Significant difference in risk

A significant difference in risk shall be identified on a case-by-case basis by the competent authorities. The properties of the active substance, and the possibility of exposure of different population subgroups (professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, drinking water or the environment shall be taken into account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment must also be considered.

For the environment, a factor of at least 10 between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) ratios of different active substances is considered a significant difference in risk.

• 3. 

  Significant practical or economic disadvantages

Significant practical or economic disadvantage to the user is defined as a major quantifiable impairment of working practices or business activity leading to inability to maintain sufficient control of the target organism. Such a major impairment might be, for example, where no technical facilities for the use of the alternative substance(s) are available or economically feasible.

Where a comparative assessment indicates that restrictions/prohibitions of use of a plant protection product could cause such disadvantage, then this will be taken into account in the decision-making process. This situation must be substantiated.

ANNEX V

Repealed Directives and their successive amendments

A. Directive 91/414/EEC

Acts amending Directive 91/414/EEC Deadline for transposition Directive 93/71/EEC 3 August 1994 Directive 94/37/EC 31 July 1995

Directive 94/79/EC 31 January 1996 Directive 95/35/EC 30 June 1996

Directive 95/36/EC 30 April 1996 Directive 96/12/EC 31 March 1997 Directive 96/46/EC 30 April 1997

Directive 96/68/EC 30 November 1997 Directive 97/57/EC 1 October 1997 Directive 2000/80/EC 1 July 2002 Directive 2001/21/EC 1 July 2002

Directive 2001/28/EC 1 August 2001 Directive 2001/36/EC 1 May 2002

Directive 2001/47/EC 31 December 2001 Directive 2001/49/EC 31 December 2001 Directive 2001/87/EC 31 March 2002

Directive 2001/99/EC 1 January 2003 Directive 2001/103/EC 1 April 2003 Directive 2002/18/EC 30 June 2003

Directive 2002/37/EC 31 August 2003

Directive 2002/48/EC 31 December 2002 Directive 2002/64/EC 31 March 2003 Directive 2002/81/EC 30 June 2003 Directive 2003/5/EC 30 April 2004

Directive 2003/23/EC 31 December 2003 Directive 2003/31/EC 30 June 2004

Directive 2003/39/EC 30 September 2004 Directive 2003/68/EC 31 March 2004

Directive 2003/70/EC 30 November 2004 Directive 2003/79/EC 30 June 2004

Directive 2003/81/EC 31 January 2005 Directive 2003/82/EC 30 July 2004 Directive 2003/84/EC 30 June 2004

Directive 2003/112/EC 30 April 2005

Directive 2003/119/EC 30 September 2004 Regulation 806/2003 -

Directive 2004/20/EC 31 July 2005

Directive 2004/30/EC 30 November 2004 Directive 2004/58/EC 31 August 2005

Directive 2004/60/EC 28 February 2005 Directive 2004/62/EC 31 March 2005 Directive 2004/66/EC 1 May 2004

Directive 2004/71/EC 31 March 2005 Directive 2004/99/EC 30 June 2005

Directive 2005/2/EC 30 September 2005

Directive 2005/3/EC 30 September 2005 Directive 2005/25/EC 28 May 2006

Directive 2005/34/EC 30 November 2005 Directive 2005/53/EC 31 August 2006 Directive 2005/54/EC 31 August 2006

Directive 2005/57/EC 31 October 2006 Directive 2005/58/EC 31 May 2006

Directive 2005/72/EC 31 December 2006 Directive 2006/5/EC 31 March 2007 Directive 2006/6/EC 31 March 2007

Directive 2006/10/EC 30 September 2006 Directive 2006/16/EC 31 January 2007

Directive 2006/19/EC 30 September 2006 Directive 2006/39/EC 31 July 2007

B. Directive 79/117/EEC

Acts amending Directive 79/117/EEC Deadline for transposition Directive 83/131/EEC 1 October 1984 Directive 85/298/EEC 1 January 1986 Directive 86/214/EEC -

Directive 86/355/EEC 1 July 1987

Directive 87/181/EEC 1 January 1988 and 1 January 1989 Directive 87/477/EEC 1 January 1988

Directive 89/365/EEC 31 December 1989 Directive 90/335/EEC 1 January 1991

Directive 90/533/EEC 31 December 1990 and 30 September 1990 Directive 91/118/EEC 31 March 1992 Regulation 807/2003 - Regulation 850/2004 -

• 12 jul '06
  COM(2006)388 - Op de markt brengen van gewasbeschermingsmiddelen
  
  
  
• 4 mrt '04
  COM(2004)148 - Aanpassing van de Richtlijnen 1999/45/EG, 2002/83/EG, 2003/37/EG en 2003/59/EG van het Europees Parlement en de Raad en de Richtlijnen 77/388/EEG, 91/414/EEG, 96/26/EG, 2003/48/EG en 2003/49/EG, op het gebied van vrij verkeer van goederen, vrijheid van dienstverlening, landbouw, vervoer en belastingen, in verband met de toetreding van Tsjechië, Estland, Cyprus, Letland, Litouwen, Hongarije, Malta, Polen, Slovenië en Slowakije
  
  
  
• 22 dec '03
  COM(2003)814 - Wijziging van bijlage VI bij Richtlijn 91/414/EEG ten aanzien van gewasbeschermingsmiddelen die micro-organismen bevatten
  
  
  
• 12 jun '03
  COM(2003)333 - Persistente organische verontreinigende stoffen en tot wijziging van de Richtlijnen 79/117/EEG en 96/59/EG
  
  
  
• 14 mrt '03
  COM(2003)117 - Maximumgehalten aan bestrijdingsmiddelenresiduen in producten van plantaardige en van dierlijke oorsprong
  
  
  
• 5 feb '03
  COM(2003)52 - Officiële controles van diervoeders en levensmiddelen
  
  
  
• 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
  
  
  
• 27 dec '01
  COM(2001)789 - Aanpassing van de bepalingen betreffende de comités die de Commissie bijstaan in de uitoefening van haar uitvoeringsbevoegden die zijn vastgelegd in volgens de raadplegingsprocedure (gekwalificeerde meerderheid) goedgekeurde besluiten van de Raad
  
  
  
• 27 dec '01
  COM(2001)789 - Aanpassing van de bepalingen betreffende de comités die de Commissie bijstaan in de uitoefening van haar uitvoeringsbevoegden die zijn vastgelegd in volgens de raadplegingsprocedure (unanimiteit) goedgekeurde besluiten van de Raad