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1. This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of Article 6(1) and the dossier accompanying an application for the authorisation of a biocidal product in accordance with point (a) of Article 20(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 biocidal products. With regard to the ADS, the data elements to be provided for a specific biocidal product 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 product, existing data, information which is part of the CDS and the types of products 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 III table. The general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.

For some of the information requirements set out in this Annex, it may be possible to satisfy these requirements based on available information of the properties of the active substance(s) contained in the product and the properties of non-active substance(s) included in the product. For non-active substances, applicants shall use the information provided to them in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and the information made available by the Agency in accordance with point (e) of Article 77(2) of that Regulation. However, the information may be not sufficient or adequate to determine whether a non-active substance contained in a biocidal product has hazardous properties and the evaluating body may conclude that further data are required. The relevant calculation methods used for the classification of mixtures as laid down in Regulation (EC) No 1272/2008 shall, where appropriate, be applied in the hazard assessment of the biocidal product. Such calculation methods shall not be used if, in relation to a particular hazard, synergistic and antagonistic effects between the different substances contained in the product are considered likely.

Detailed technical guidance regarding the application of this Annex and the preparation of the dossier 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), the 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 necessary to carry out the evaluation as indicated in Article 29(3) or Article 44(2). The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria in Article 19(1)(b) are met.

3. A detailed and full description of studies conducted 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.

4. The formats made available by the Agency shall be used for submission of the dossiers. In addition, IUCLID shall 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 Agency homepage.

5. Tests submitted for the purpose of authorisation 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 and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC 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 quantitative and qualitative description (specification) of the product used for each test and its impurities must be provided.

8. Where test data exist that have been generated before 17 July 2012 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, on a case-by-case basis, taking into account, among other factors, the need to avoid unnecessary testing.

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 PRODUCTS Core data set and additional data set for chemical products Information required to support the authorisation of a biocidal product is listed in the table below. For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply. TITLE 2 MICRO-ORGANISMS Core data set and additional data set Information required to support the authorisation of a biocidal product is listed in the table below. For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.