Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, 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 plant protection products

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

Article 2

Repeal

Regulation (EU) No 545/2011 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation.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 545/2011 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

Regulation (EU) No 545/2011 shall continue to apply as regards procedures concerning the renewal of authorisations of plant protection product pursuant to Article 43(2) of Regulation (EC) No 1107/2009, following the renewal of an active substance carried out pursuant to Regulation (EU) No 1141/2010.

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

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

(1) ‘storage stability’ means the capacity of a plant protection product to maintain the initial properties and the specified content during the storage period under established storage conditions;

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

(3) ‘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);

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

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

(6) ‘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 1.15.

1.1.The information shall be sufficient to evaluate efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product 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 plant protection product on human and animal health or on groundwater shall be included as well as known and expected cumulative and synergistic effects.

1.3.Any information including any known data on potentially unacceptable effects of the plant protection product on the environment, plants and plant products shall be included as well as known and expected cumulative and synergistic effects.

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

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

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

1.8.Where relevant, the information shall be generated in accordance with Directive 2010/63/EU of the European Parliament and of the Council (²).

1.9.The information shall include a list of endpoints for the plant protection product where relevant.

1.10.The information shall include the proposed classification and labelling of the plant protection product in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (³), where relevant.

1.11.Information as provided for in Commission Regulation (EU) No 283/2013 (⁴) may be required by the competent authorities on co-formulants. Before requiring additional studies to be performed, the competent authorities shall assess all available information provided in accordance with other Union legislation.

1.12.The information provided for the plant protection product and that provided for the active substance, shall be sufficient to:

(a) decide whether or not the plant protection product is to be authorised;

(b) specify conditions or restrictions to be associated with any authorisation;

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

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

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

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

(g) 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;

(h) predict the distribution, fate and behaviour in the environment, as well as the time courses involved;

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

(j) permit an assessment of the impact of the plant protection product on non-target species;

(k) identify measures necessary to minimise contamination of the environment and impact on non-target species;

(l) classify the plant protection product as to hazard in accordance with Regulation (EC) No 1272/2008;

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

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

1.14.Exposure calculations shall refer to scientific methods accepted by the European Food Safety Authority, when available. The use of additional methods shall be justified.

1.15.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 (⁵) 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, tests and analyses, required under Section 6 of Part A and Section 6 of Part B, may be conducted by official or officially recognised testing facilities or organisations, which satisfy at least the following requirements:

(a) they have at their disposal sufficient scientific and technical staff having the necessary education, training, technical knowledge and experience for their assigned functions;

(b) they have at their disposal suitable equipment required for correct performance of the tests and measurements which they claim to be competent to carry out; that equipment is properly maintained and calibrated, where appropriate, before being put into service and thereafter in accordance with an established programme;

(c) they have at their disposal appropriate experimental fields and, where necessary, greenhouses, growth cabinets or storage rooms; they ensure that environment in which the tests are undertaken does not invalidate their results or adversely affect the required accuracy of measurement;

(d) they make available to all relevant personnel operating procedures and protocols used for the trials;

(e) they make available, where requested by the competent authority, prior to the commencement of a test, information on its location and on the tested plant protection products;

(f) they ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose;

(g) they maintain records of all observations, calculations and derived data and calibrations records and final test report as long as the plant protection product concerned is authorised in a Member State.

3.3.Officially recognised testing facilities and organisations, and, where requested by the competent authorities, official facilities and organisations shall:

(a) report to the relevant national authority all information necessary to demonstrate that they can satisfy the requirements set out in point 3.2,

(b) permit at any time the inspections, which each Member State shall regularly organise on its territory in order to verify the compliance with point 3.2.

3.4.By way of derogation from point 3.1:

(a) For active substances that are micro-organisms, tests and analyses performed 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 specified in points 3.2 and 3.3.

(b) Studies conducted before the application of this Regulation, although not fully compliant with GLP principles or with current test methods, shall be considered for the assessment if carried out in accordance with the recognised international test guidelines in place at the time of conduction of the studies and/or scientifically valid, thereby avoiding repeating animal tests, especially for carcinogenicity and reprotoxicity studies. This derogation shall apply in particular to studies with vertebrate species.

4. Test material

4.1.Due to the influence that impurities and other components can have on toxicological and ecotoxicological behaviour, a detailed description (specification) of the test material used shall be provided for each study submitted. Studies shall be conducted using the plant protection product to be authorised or bridging principles may be applied, for example, by using a study on a plant protection product with a comparable/equivalent composition. A detailed description of the composition used shall be provided.

4.2.Where radio-labelled test material 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 investigation of the distribution of the active substance and of its metabolites, breakdown and reaction products.

4.3.Whenever a study implies the use of different doses, the relationship between the dose and the adverse effect shall be reported.

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 an 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 harmonisation, the list of test methods and guidance documents referred to in this Annex shall be published in the Official Journal of the European Union. That list shall be regularly updated.

PART A

CHEMICAL PLANT PROTECTION PRODUCTS

SECTION 1

Identity of the plant protection product

The information provided shall be sufficient to precisely identify the plant protection product and define it in terms of its specification and nature.

The name and address of the applicant shall be provided, as well as the name, position, telephone, e-mail address and telefax number of a contact point.

The name and address of the producer of the plant protection product and of each active substance in the plant protection product shall be provided, as well as the name and address of each manufacturing plant in which the plant protection product and active substance are manufactured. A contact point (name, telephone, e-mail address and telefax number) shall be provided.

If the active substance originates from a producer from which data in accordance with Regulation (EU) No 283/2013 have not been submitted previously, data to address those requirements shall be provided in order to establish equivalence of the active substance.

All former and current trade names and proposed trade names and development code numbers of the plant protection product shall be provided. Where trade names and code numbers referred to, relate to similar but different plant protection products, full details of the differences shall be provided. The proposed trade name shall be such that it does not give rise to confusion with the trade name of already authorised plant protection products. Each code number shall be specific to a unique plant protection product.

For plant protection products the following information shall be reported:

— the content of the technical active substances (based on the specified minimum purity) and the declared content of pure active substances and, where relevant, the corresponding content of the variant (such as salts and esters) of the active substances,

— the content of safeners, synergists and co-formulants,

— the maximum content of relevant impurities, where appropriate.

In addition to the total active substance content, for slow or controlled release plant protection products (such as capsule suspension, CS) the free (non-encapsulated) and encapsulated active substance content and the release rate shall be given. Where possible, appropriate Collaborative International Pesticides Analytical Council (CIPAC) methods shall be used. If an alternative method is used this shall be justified by the applicant and a detailed description of the methodology used shall be given.

The concentration of each active substance shall be expressed as follows:

— for solids, aerosols, volatile liquids (maximum boiling point 50 °C) or viscous liquids (lower limit 1 Pa s at 20 °C), as % w/w and g/kg,

— for other liquids/gel formulations, as % w/w and g/l,

— for gases, as % v/v and % w/w.

For active substances their International Organisation for Standardisation (ISO) common names or proposed ISO common names, their CIPAC numbers, and, where available, the European Commission (EC) numbers shall be provided. Where relevant, it shall be stated which salt, ester, anion or cation is present.

Safeners, synergists and co-formulants shall, where possible, be identified both by their chemical name as given in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council or, if not included in that Regulation, in accordance with both the International Union of Pure and Applied Chemistry (IUPAC) and Chemical Abstracts (CA) nomenclature. Their structural formula shall be provided. For each component of the safeners, synergists and co-formulants the relevant EC number and Chemical Abstracts Service (CAS) number, where they exist, shall be provided. For co-formulants which are mixtures, the composition shall be provided. Where the information provided does not fully identify the safener, synergist or co-formulant, an appropriate specification shall be provided. The trade name, where available, shall also be provided. Safety data sheets pursuant to Article 31 of Regulation (EC) No 1907/2006 (^*1) shall be provided. They shall be up to date and in accordance with other Union legislation.

For co-formulants the function shall be specified from among the following:

(a) adhesive (sticker);

(b) antifoaming agent;

(c) antifreeze;

(d) binder;

(e) buffer;

(f) carrier;

(g) deodorant;

(h) dispersing agent;

(i) dye;

(j) emetic;

(k) emulsifier;

(l) fertiliser;

(m) preservative;

(n) odourant;

(o) perfume;

(p) propellant;