Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance

Article 1

Data requirements for active substances

The data requirements for the active substance provided for in Article 8(1)(b) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.

Article 2

Repeal

Regulation (EU) No 544/2011 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation

Article 3

Transitional measures as regards procedures concerning active substances

With respect to active substances, Regulation (EU) No 544/2011 shall continue to apply as regards the following:

(a) procedures concerning the approval of an active substance or an amendment to the approval of such a substance pursuant to Article 13 of Regulation (EC) No 1107/2009 for which the dossiers provided for in Article 8(1) and (2) thereof have been submitted by 31 December 2013;

(b) procedures concerning the renewal of approval of an active substance pursuant to Article 20 of Regulation (EC) No 1107/2009 for which the supplementary dossiers referred to in Article 9 of Commission Regulation (EU) No 1141/2010 (¹) have been submitted by 31 December 2013.

Article 4

Transitional measures as regards procedures concerning plant protection products

Article 5

Entry into force and date of application

As regards all other procedures, it shall apply from 1 January 2014.

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

ANNEX

INTRODUCTION

Information to be submitted, its generation and its presentation

A dossier shall be submitted in accordance with Part A if the active substance is:

(a) a chemical substance (including both semiochemicals and extracts from biological material), or

(b) a metabolite produced by a micro-organism where: — the metabolite is purified from the micro-organism; or — the metabolite is not purified from a producing micro-organism which is no longer capable of replication or of transferring genetic material.

A dossier shall be submitted in accordance with Part B if the active substance is:

(a) a micro-organism, either as a single strain or as a qualitatively defined combination of strains as they occur naturally or by manufacture, or

(b) a micro-organism, either as a single strain or as a qualitatively defined combination of strains as they occur naturally or by manufacture, and one or more metabolites produced by the micro-organism that are claimed to be part of the plant protection action (i.e. when the application of the metabolite(s) purified from the micro-organism would not cause the claimed plant protection action).

1.For the purposes of this Annex, the following definitions apply:

(1) ‘efficacy’ means a measure concerning the overall effect of the application of a plant protection product on the agricultural system in which it is used (i.e. which includes positive effects of treatment in performing the desired plant protection activity and negative effects such as development of resistance, phytotoxicity or reduction of qualitative or quantitative yield);

(2) ‘relevant impurity’ means a chemical impurity that is of concern for human health, animal health or the environment;

(3) ‘effectiveness’ means the capacity of the plant protection product to produce a positive effect regarding the desired plant protection activity;

(4) ‘toxicity’ means the degree of injury or damage in an organism caused by a toxin or a toxic substance;

(5) ‘toxin’ means a substance that is produced within living cells or organisms and is able to injure or cause damage in a living organism.

The information submitted shall meet the requirements set out in points 1.1 to 1.14.

1.1.The information shall be sufficient to evaluate the foreseeable risks, whether immediate or delayed, which the active substance may entail for humans, including vulnerable groups, animals and the environment and contain at least the information and results of the studies referred to in this Annex.

1.2.Any information including any known data on potentially harmful effects of the active substance, its metabolites and impurities on human and animal health or on their potential presence in groundwater shall be included.

1.3.Any information including any known data on potentially unacceptable effects of the active substance, its metabolites and impurities on the environment, plants and plant products shall be included.

1.4.The information shall include all relevant data from the scientific peer reviewed open literature on the active substance, relevant metabolites, and where relevant breakdown or reaction products and plant protection products containing the active substance and dealing with side-effects on human and animal health, the environment and non-target species. A summary of that data shall be provided.

1.5.The information shall include a full and unbiased report of the studies conducted as well as a full description of them. Such information shall not be required, where a justification is provided showing that:

(a) it is not necessary owing to the nature of the plant protection product or its proposed uses, or it is not scientifically necessary; or

(b) it is technically not possible to supply.

1.6.The simultaneous use of the active substance as a biocidal product or in veterinary medicine shall be reported. If the applicant for the application for the approval of the active substance in the plant protection product is identical to the one responsible for the notification of the active substance as a biocidal product or as a veterinary medicine, a summary of all relevant data submitted for approval of the biocidal product or the veterinary medicine shall be submitted. Where relevant, that summary shall include toxicological reference values and MRL proposals, taking into account any possible cumulative exposure due to different uses of the same substance based on scientific methods accepted by the competent authorities of the Union, together with information on residues, toxicology data and use of the plant protection product. If the applicant for the application for the approval of the active substance in the plant protection product is not identical to the one responsible for the notification of the active substance as a biocidal product or in veterinary medicine, a summary of all available data shall be submitted.

1.7.Where relevant, the information shall be generated using test methods, which are included in the list referred to in Section 6.

In the absence of suitable internationally or nationally validated test guidelines, test protocol discussed with and accepted by the competent authorities of the Union shall be used. Any deviations from test guidelines shall be described and justified.

1.8.The information shall include a full description of the test methods used.

1.9.The information shall include a list of endpoints for the active substance, where relevant.

1.10.Where relevant, the information shall be generated in accordance with Directive 2010/63/EU of the European Parliament and of the Council (³).

1.11.The information on the active substance, taken together with the information concerning one or more plant protection products containing the active substance and together, if appropriate, with the information concerning safeners and synergists and other components of the plant protection product, shall be sufficient to:

(a) permit an assessment of the risks for humans, associated with handling and use of plant protection products containing the active substance;

(b) for chemical active substances: permit an assessment of the risks for human and animal health, arising from residues of the active substance and its relevant metabolites, impurities and, where relevant, breakdown and reaction products remaining in water, air, food and feed;

(c) for active substances that are micro-organisms: permit an assessment of the risks for human and animal health, arising from residues of the metabolites of concern in water, air, food and feed;

(d) for chemical active substances: predict the distribution, fate and behaviour in the environment of the active substance and metabolites, breakdown and reaction products where they are of toxicological, or environmental significance, as well as the time courses involved;

(e) permit an assessment of the impact on non-target species (flora and fauna), including the impact on their behaviour, which are likely to be exposed to the active substance, its relevant metabolites and, where relevant, breakdown and reaction products, where they are of toxicological, pathogenic or environmental significance. Impact can result from single, prolonged or repeated exposure and can be direct or, where relevant, indirect, reversible or irreversible;

(f) evaluate the impact on biodiversity and the ecosystem;

(g) identify non-target species and populations for which risks arise because of potential exposure;

(h) permit an evaluation of short and long-term risks for non-target species - populations, communities and processes;

(i) classify the chemical active substance as to hazard in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (⁴);

(j) specify the pictograms, the signal words and relevant hazard and precautionary statements for the protection of human and animal health, non-target species and the environment, which are to be used for labelling;

(k) establish, where relevant, an acceptable daily intake (ADI) level for humans;

(l) establish, where relevant, acceptable operator exposure levels (AOEL);

(m) establish, where relevant, an acute reference dose (ARfD) for humans;

(n) identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning or infection in humans;

(o) for chemical active substances: establish the isomeric composition and the possible metabolic conversion of the isomers, where relevant;

(p) establish residues definitions appropriate for risk assessment, where relevant;

(q) establish residues definitions appropriate for monitoring and enforcement purposes, where relevant;

(r) permit a risk assessment of consumer exposure, including, where relevant, a cumulative risk assessment deriving from exposure to more than one active substance;

(s) permit an estimation of the exposure of operators, workers, residents and bystanders including, where relevant, the cumulative exposure to more than one active substance;

(t) establish, where relevant, maximum residue levels and concentration/dilution factors in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council (⁵);

(u) permit an evaluation to be made as to the nature and extent of the risks for humans, animals (species normally fed and kept by humans or food-producing animals) and of the risks for other non-target vertebrate species;

(v) identify measures necessary to mitigate the risks identified for human and animal health, the environment and/or non-target species;

(w) for chemical active substances: decide whether or not the active substance has to be considered as persistent organic pollutant (POP), persistent, bio accumulative and toxic (PBT) or very persistent and very bio accumulative (vPvB) in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009;

(x) decide whether or not the active substance is to be approved;

(y) for chemical active substances: decide whether or not the active substance has to be considered as a candidate for substitution in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009;

(z) decide whether or not the active substance has to be considered as a low-risk active substance in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009;

(aa) specify conditions or restrictions to be associated with any approval.

1.12.Where relevant, tests shall be designed and data analysed using appropriate statistical methods. Details of the statistical analysis shall be reported transparently.

1.13.Exposure calculations shall refer to scientific methods accepted by the European Food Safety Authority, where available. Additional methods, when used, shall be justified.

1.14.For each section of this Annex, a summary of all data, information and evaluation made shall be submitted. This shall include a detailed and critical assessment in accordance with Article 4 of Regulation (EC) No 1107/2009.

2.The requirements set out in this Annex constitute the minimum set of data to be submitted. Member States may set out additional requirements at national level to address specific circumstances, specific exposure scenarios and specific patterns of use other than those taken into account for approval. The applicant shall pay careful attention to environmental, climatic and agronomic conditions when tests are set up subject to the approval by the Member State where the application has been submitted.

3. Good laboratory practice (GLP)

3.1.Tests and analyses shall be conducted in accordance with the principles laid down in Directive 2004/10/EC of the European Parliament and of the Council (⁶) where testing is done to obtain data on the properties or safety with respect to human or animal health or the environment.

3.2.By way of derogation from point 3.1:

(a) for active substances that are micro-organisms, tests and analyses done to obtain data on their properties and safety with respect to other aspects than human health may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements set out in points 3.2 and 3.3 of the Introduction of the Annex to Commission Regulation (EU) No 284/2013 (⁷);

(b) for tests and analyses made to obtain data for minor crops required under points 6.3 and 6.5.2 of Part A: — the field phase may have been conducted by official or officially recognised testing facilities or organisations which satisfy the requirements as laid down in points 3.2 and 3.3 of the Introduction of the Annex to Regulation (EU) No 284/2013; — the analytical phase, if not realised in accordance with the principles of good laboratory practice (‘GLP principles’), shall be conducted by laboratories accredited for the relevant method in accordance with the European standard EN ISO/IEC 17025 ‘General requirements for the competence of testing and calibration laboratories’;

(c) studies conducted before the application of this Regulation, although not fully compliant with GLP principles or with current test methods, may be integrated into the assessment if carried out in accordance with scientifically validated test guidelines, thereby avoiding repeating animal tests, especially for carcinogenicity and reprotoxicity studies. This derogation from point 3.1 shall apply in particular to studies with vertebrate species.

4. Test material

4.1.A detailed description (specification) of the test material used shall be provided. Where tests are done using the active substance, the test material used shall comply with the specification that will be used in the manufacture of plant protection products to be authorised, except for radio-labelled chemicals or the purified chemical active substance.

4.2.Where studies are conducted using an active substance manufactured in the laboratory or in a pilot plant production system, the studies shall be repeated using the active substance as manufactured, unless the applicant shows that the test material used is essentially the same, for the purposes of toxicological, pathological, ecotoxicological, environmental and residue testing and assessment. In cases of uncertainty, bridging studies shall be submitted to serve as a basis for a decision as to the possible need for repetition of the studies.

4.3.Where studies are conducted using an active substance of different purity or which contains different impurities or different levels of impurities to the technical specification or where the active substance is a mixture of components, the significance of the differences shall be addressed either by data or scientific case. In cases of uncertainty, appropriate studies using the active substance as manufactured for commercial production shall be submitted to serve as a basis for a decision.

4.4.In the case of studies in which dosing extends over a certain period (for example, repeated dose studies), the same batch of active substance shall be used, if stability permits. Whenever a study implies the use of different doses, the relationship between dose and adverse effect shall be reported.

4.5.For chemical active substances, when tests are conducted using a purified chemical active substance (≥ 980 g/kg) of stated specification, the purity of such test material shall be as high as can be achieved using the best available technology and shall be reported. A justification shall be provided in cases where the degree of purity achieved is less than 980 g/kg. Such justification shall demonstrate that all technically feasible and reasonable possibilities for the production of the purified chemical active substance have been exhausted.

4.6.For chemical active substances, where radio-labelled test material of the chemical active substance is used, radio-labels shall be positioned at sites (one or more as necessary) to facilitate elucidation of metabolic and transformation pathways and to facilitate the investigation of the distribution of the active substance and of its metabolites, reaction and breakdown products.

5. Tests on vertebrate animals

5.1.Tests on vertebrate animals shall be undertaken only where no other validated methods are available. Alternative methods shall include in vitro methods or in silico methods. Reduction and refinement methods for in vivo testing shall also be encouraged to keep the number of animals used in testing to a minimum.

5.2.The principles of replacement, reduction and refinement of the use of vertebrate animals shall be taken into account in the design of the test methods, in particular when appropriate validated methods become available to replace, reduce or refine animal testing.

5.3.Study designs shall be carefully considered from ethical point of view, taking into account the scope for reduction, refinement and replacement of animal tests. For example, by including one or more additional dose groups or time points for blood sampling in one study, it may be possible to avoid the need for another study.

6.For purposes of information and of harmonisation the list of test methods and guidance documents relevant to the implementation of this Regulation shall be published in the Official Journal of the European Union. That list shall be regularly updated.

PART A

CHEMICAL ACTIVE SUBSTANCES

SECTION 1

Identity of the active substance

The information provided shall be sufficient to precisely identify each active substance and define it in terms of its specification and nature.