Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

CHAPTER I GENERAL PROVISIONS

Article 1

Subject matter and purpose

Article 2

Scope

• (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 reasons of hygiene 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 or a plant biostimulant;

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

• (d) destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;

• (e) checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.

These products are referred to as ‘plant protection products’.

• (a) substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants, referred to as ‘safeners’;

• (b) substances or preparations which, while showing no or only weak activity as referred to in paragraph 1, can give enhanced activity to the active substance(s) in a plant protection product, referred to as ‘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, referred to as ‘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 and which enhance its effectiveness or other pesticidal properties, referred to as ‘adjuvants’.

Article 3

Definitions

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

• 1. ‘residues’ means one or more substances present in or on plants or plant products, 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;

• 1. ‘substances’ means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;

• 1. ‘preparations’ means mixtures or solutions composed of two or more substances intended for use as a plant protection product or as an adjuvant;

• 1. ‘substance of concern’ means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concentration to present risks of such an effect. Such substances include, but are not limited to, substances meeting the criteria to be classified as hazardous in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures ([^E0001]), 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;

• 1. ‘plants’ means live plants and live parts of plants, including fresh fruit, vegetables and seeds;

• 1. ‘plant products’ means products of plant origin in an unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, but excluding plants;

• 1. ‘harmful organisms’ means any species, strain or biotype belonging to the animal kingdom or plant kingdom or pathogenic agent injurious to plants or plant products;

• 1. ‘non-chemical methods’ means alternative methods to chemical pesticides for plant protection and pest management, based on agronomic techniques such as those referred to in point 1 of Annex III to Directive 2009/128/EC, or physical, mechanical or biological pest control methods;

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

• 1. ‘authorisation of a plant protection product’ means an 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;

• 1. ‘producer’ means a person who manufactures plant protection products, active substances, safeners, synergists, co-formulants 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;

• 1. ‘letter of access’ means an original document by which the owner of data protected under this Regulation agrees to the use of such data under the specific terms and conditions 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;

• 1. ‘environment’ means 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;

• 1. ‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, the unborn, infants and children, the elderly and workers and residents subject to high pesticide exposure over the long term;

• 1. ‘micro-organisms’ means any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material;

• 1. ‘genetically modified organisms’ means 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 of 12 March 2001 on the deliberate release into the environment of genetically modified organisms ([^E0002]);

• 1. ‘zone’ means a group of Member States as defined in Annex I. For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment the zone means all zones defined in Annex I;

• 1. ‘good plant protection practice’ means a practice whereby the treatments with plant protection products applied to given plants or plant products, in conformity with the conditions of their authorised uses, 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;

• 1. ‘good laboratory practice’ means a practice as defined in point 2.1 of Annex I to Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances ([^E0003]);

• 1. ‘good experimental practice’ means a practice in accordance with the provisions of European and Mediterranean Plant Protection Organisation (EPPO) Guidelines 181 and 152;

• 1. ‘data protection’ means the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant;

• 1. ‘rapporteur Member State’ means the Member State which undertakes the task of evaluating an active substance, safener or synergist;

• 1. ‘tests and studies’ means investigations or experiments whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products;

• 1. ‘authorisation holder’ means any natural or legal person holding an authorisation of a plant protection product;

• 1. ‘professional user’ means a professional user as defined in Article 3(1) of Directive 2009/128/EC;

• 1. ‘minor use’ means use of a plant protection product in a particular Member State on plants or plant products which are:
• (a) not widely grown in that Member State; or
• (b) widely grown, to meet an exceptional plant protection need;

• 1. ‘greenhouse’ means a walk-in, static, closed place of crop production with a usually translucent outer shell, which allows controlled exchange of material and energy with the surroundings and prevents release of plant protection products into the environment. For the purpose of this Regulation, closed places of plant production where the outer shell is not translucent (for example, for production of mushrooms or witloof) are also considered as greenhouses;

• 1. ‘post-harvest treatment’ means treatment of plants or plant products after harvest in an isolated space where no run-off is possible, for example in a warehouse;

• 1. ‘biodiversity’ means variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this variability may include diversity within species, between species and of ecosystems;

• 1. ‘competent authority’ means any authority or authorities of a Member State responsible for carrying out the tasks established under this Regulation;

• 1. ‘advertisement’ means a means of promoting the sale or use of plant protection products (to anyone other than the authorisation holder, the person placing the plant protection product on the market and their agents) by printed or electronic media;

• 1. ‘metabolite’ means 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 intrinsic properties comparable to 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;

• 1. ‘impurity’ means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage);

• 1. ‘plant biostimulant’ means a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:
• (a) nutrient use efficiency;
• (b) tolerance to abiotic stress;
• (c) quality traits;
• (d) availability of confined nutrients in soil or rhizosphere.

CHAPTER II ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS

SECTION 1 Active substances

Subsection 1 Requirements and conditions for approval

Article 4

Approval criteria for active substances

The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 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.

• (a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available, or on groundwater;

• (b) they shall not have any unacceptable effect on the environment.

For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them. Analytical standards shall be commonly available.

• (a) it shall be sufficiently effective;

• (b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available; or on groundwater;

• (c) it shall not have any unacceptable effects on plants or plant products;

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

• (e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available:
• (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation;
• (ii) its impact on non-target species, including on the ongoing behaviour of those species;
• (iii) its impact on biodiversity and the ecosystem.

This derogation shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A.

Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control that serious danger to plant health in their territory.

At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission.

Article 5

First approval

First approval shall be for a period not exceeding 10 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 and conditions of application;

• (f) submission of further confirmatory information to Member States, the Commission and the European Food Safety Authority, (the Authority), where new requirements are established during the evaluation process or 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, including soil treatment products, containing the active substance may not be authorised or where the use may be authorised under specific conditions;

• (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.

Subsection 2 Approval procedure

Article 7

Application

A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.

The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it.

Member States shall assess the confidentiality requests. After consultation with the Authority, the rapporteur Member States shall decide what information is to be treated as confidential, in accordance with Article 63.

The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.

Article 8

Dossiers

• (a) information 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 approval criteria provided for in Article 4 are met; where the information submitted does 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, 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, 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 provided for in Article 4(2) and (3) 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) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals;

• (e) a checklist demonstrating that the dossier provided for in paragraph 2 of this Article is complete in view of the uses applied for;

• (f) 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;

• (g) where relevant, a copy of an application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;

• (h) an assessment of all information submitted.

Article 9

Admissibility of the application

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

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

After receiving that notification, the applicant shall immediately forward the dossiers as provided for in Article 8 to the other Member States, the Commission and the Authority, including the information about those parts of the dossiers in respect of which confidentiality has been requested as referred to in Article 7(3).

Article 10

Public access to the dossiers

The Authority shall without delay make the dossiers referred to in Article 8, including any supplementary information supplied by the applicant, available to the public, with the exception of any information to which the rapporteur Member State has granted confidential treatment pursuant to Article 63.

Article 11

Draft assessment report

The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge.

Where, pursuant to Article 4(1), the assessment establishes that the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are not satisfied, the draft assessment report shall be limited to those parts of the assessment.

Where at the end of the additional period, the applicant has not submitted the additional studies or information, the rapporteur Member State shall inform the applicant, the Commission and the Authority and shall state the missing elements in the assessment included in the draft assessment report.

Article 12

Conclusion by the Authority

The Authority shall make the draft assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63, that certain parts of the draft assessment report be kept confidential.

The Authority shall allow a period of 60 days for the submission of written comments.

Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public. In the event of a consultation as provided for in this paragraph, the 120-day period shall be extended by 30 days.

Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.

The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after receipt of the additional information. In that case the 120-day period provided for in paragraph 2 shall be extended by a 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 in Article 29(1)(g) of this Regulation. The applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards.

Article 13

Approval Regulation

The applicant shall be given the possibility to submit comments on the review report.

• (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.

The rapporteur Member State shall assess the additional information and submit its assessment to the other Member States, the Commission and the Authority without delay and at the latest six months after the receipt of the additional information.

Subsection 3 Renewal and review

Article 14

Renewal of approval

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.

Article 15

Application for renewal

The applicant shall identify, giving reasons, the parts of the information submitted that he requests to be kept confidential in accordance with Article 63 and at the same time any data protection claims pursuant to Article 59.

Article 16

Public access to the information for renewal

The Authority shall assess, without delay, any confidentiality request and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and granted by the Authority pursuant to Article 63.

The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.

Article 17

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 decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application.

A Regulation postponing the expiry for a period sufficient to examine the application shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(5) where an applicant 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 before 14 June 2014.

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

Article 18

Work programme

The Commission may establish a work programme grouping together similar active substances setting priorities on the basis of safety concerns for human and animal health or the environment and taking into account, as far as possible, the need for an effective control and resistance management of target pest. The programme may require interested parties to submit all the necessary data to the Member States, the Commission and the Authority 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, including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies;

• (c) the periods for submission of such data;

• (d) rules on the submission of new information;

• (e) period for assessment and decision making;

• (f) the allocation of evaluation of active substances to Member States, taking into account a balance in the responsibilities and work to be done among Member States acting as rapporteurs.

Article 19

Implementing measures

A Regulation, adopted in accordance with the regulatory procedure referred to in Article 79(3), shall set out the provisions necessary for the implementation of the renewal procedure, including, where relevant, the implementation of a work programme, as provided for in Article 18.

Article 20

Renewal Regulation

• (a) the approval of an active substance is renewed, subject to conditions and restrictions where appropriate; or

• (b) the approval of an active substance is not renewed.

In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.

Article 21

Review of approval

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

Article 13 (4) and Article 20(2) shall apply.

Subsection 4 Derogations

Article 22

Low-risk active substances

Article 23

Approval criteria for basic substances

For the purpose of paragraphs 2 to 6, a basic substance is an active substance which:

• (a) is not a substance of concern; and

• (b) does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and

• (c) is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and

• (d) is not placed on the market as a plant protection product.

For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance.

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; and

• (b) other relevant information on its possible effects on human or animal health or the environment.

Where the Commission considers that there are indications that the substance no longer satisfies the criteria provided for in paragraphs 1 to 3 it shall inform the Member States, the Authority and the interested party, setting a period for their comments to be submitted.

The Commission shall 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 three months of the date 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 regulatory procedure referred to in Article 79(3).

Article 24

Candidates for substitution

SECTION 2 Safeners and synergists

Article 25

Approval of safeners and synergists

Article 26

Safeners and synergists already on the market

By 14 December 2014, a Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4) establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force. The Regulation shall include the establishment of data requirements, including measures to minimise animal testing, notification, evaluation, assessment and decision-making procedures. It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified period.

SECTION 3 Unacceptable co-formulants

Article 27

Co-formulants

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

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

CHAPTER III PLANT PROTECTION PRODUCTS

SECTION 1 Authorisation

Subsection 1 Requirements and contents

Article 28

Authorisation for placing on the market and use

• (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 54;

• (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) production, storage or movement of a plant protection product intended for use in a third country provided that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is exported from its territory;

• (e) placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52.

Article 29

Requirements for the authorisation for placing on the market

• (a) its active substances, safeners and synergists have been approved;

• (b) where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location:
• (i) the specification, pursuant to Article 38, does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist; and
• (ii) the active substance, safener or synergist 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 the dossier that supported the approval;

• (c) its co-formulants are not included in Annex III;

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

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

• (f) the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods;

• (g) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in all Member States, with appropriate limits of determination on relevant samples;

• (h) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;

• (i) for plants or plant products to be used as feed or food, 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.

Following these principles, interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products.

Article 30

Provisional authorisations

• (a) the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and

• (b) pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and

• (c) the Member State concludes 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(1)(b) to (h); and

• (d) maximum residue levels have been established in accordance with Regulation (EC) No 396/2005.

Article 31

Contents of authorisations

The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC. Member States may provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with Directive 1999/45/EC. In such cases, they shall immediately inform the competent authority thereof.

• (a) the maximum dose per hectare in each application;

• (b) the period between the last application and harvest;

• (c) the maximum number of applications per year.

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

• (b) the obligation before the product is used to inform any neighbours who could be exposed to the spray drift and who have requested to be informed;

• (c) indications for proper use according to the principles of Integrated Pest Management referred to in Article 14 of and Annex III to Directive 2009/128/EC;

• (d) designation of categories of users, such as professional and non-professional;

• (e) the approved label;

• (f) the interval between applications;

• (g) the period between the last application and consumption of the plant product where applicable;

• (h) the re-entry interval;

• (i) the packaging size and material.

Article 32

Duration

Without prejudice to Article 44, the duration of an authorisation shall be set for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved.

This period shall allow the examination as provided for in Article 43 to be carried out.

Subsection 2 Procedure

Article 33

Application for authorisation or amendment of an authorisation

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

• (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request;

• (c) where relevant, a copy of any authorisations already granted for that plant protection product in a Member State;

• (d) where relevant, a copy of any conclusion of the Member State assessing equivalence as referred to in Article 38(2).

• (a) for the plant protection product concerned, a complete and a summary 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;

• (c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals;

• (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) where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;

• (f) where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1);

• (g) a draft label.

The applicant shall at the same time submit the complete list of studies submitted pursuant to Article 8(2) and a list of test and study reports for which any claims for data protection pursuant to Article 59 are requested.

Upon a request for access to information the Member State examining the application shall decide what information is to be kept confidential.

Article 34

Exemption from the submission of studies

• (a) all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that no unacceptable co-formulants are used;

• (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 point (b) of Article 29(1), where appropriate;

• (c) on the request of the concerned Member State, 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.

Article 35

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.

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.

Where 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.

Article 36

Examination for authorisation

It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone, where used in accordance with Article 55, and under realistic conditions of use.

The Member State examining the application shall make available its assessment to the other Member States within the same zone. The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).

Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment.

That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor.

Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal.

Article 37

Period for examination

Where the Member State needs additional information, it shall set a period for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the Member State. That additional period shall be a maximum of 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.

Article 38

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