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1. This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of Article 6(1).

2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active substances. However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS. With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.

Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table. The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met. The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which is available on the website of the Agency.

The applicant shall initiate a pre-submission consultation with the prospective evaluating body. In addition to the obligation set out in Article 62(2), applicant may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out. The applicant shall document such pre-submission consultations and their outcomes and shall include the relevant documents in the application. Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).

3. A detailed and full description of the studies conducted or referred to and of the methods used shall be included. It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements. Evidence should also be provided to demonstrate that the active substance upon which the tests have been carried out is the same as the substance for which the application has been submitted.

4. The formats made available by the Agency must be used for submission of the dossiers. In addition, IUCLID must be used for those parts of the dossiers to which IUCLID applies. Formats and further guidance on data requirements and dossier preparation are available on the website of the Agency.

5. Tests submitted for the purpose of the approval of an active substance shall be conducted in accordance with the methods described in Commission Regulation (EC) No 440/2008 (), or any revised version of these methods not yet included in that Regulation. However, if a method is inappropriate or not described in Commission Regulation (EC) No 440/2008, other methods shall be used which are scientifically appropriate and their appropriateness shall be justified in the application. When test methods are applied to nano-materials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of these materials.

6. Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes () and in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in 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 application for tests on chemical substances () or other international standards recognised as being equivalent by the Commission or the Agency. Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards.

7. Where testing is done, a detailed description (specification) of the active substance used and its impurities must be provided. Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.

8. Where test data exist that have been generated before 1 September 2013 by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State concerned, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrates.

9. New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In-vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided. TITLE 1 CHEMICAL SUBSTANCES

Core data set and additional data set for active substances Information required to support the approval of an active substance is listed in the table below. Conditions for not requiring a specific test that are set out in the appropriate test methods in the Regulation (EC) No 440/2008 and are not repeated in column 3, also apply. TITLE 2 MICRO-ORGANISMS Core data set and additional data set for active substances Information required to support the approval of an active substance is listed in the table below. Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, also apply.