Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (Text with EEA relevance) (repealed)
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ANNEX IIIRequirements for the complete dossier and the summary dossier
(a)The complete dossier must include the original test and study reports for each point of Annex IIA and IIB, or Annex IVA and IVB, to Directive 98/8/EC, and where specified the relevant parts of Annex IIIA and IIIB thereto, together with the summary dossier referred to in Article 11(1)(b) of that Directive.
(b)The summary dossier must include the following:
in the case of a collective dossier, the name of all participants concerned and a person designated by them as being responsible for the collective dossier and the processing of the dossier in accordance with this Regulation,
for each point of Annex IIA and IIB, or Annex IVA and IVB, to Directive 98/8/EC, and where specified the relevant parts of Annex IIIA and IIIB to the Directive, the summaries and results of studies and trials,
list of references used,
risk assessment,
overall summary and assessment,
a check by the participant or, where appropriate, by the person designated as responsible for a collective dossier of the completeness of the dossier.
(c)The formats made available by the Commission must be used for submission of the dossiers. In addition, the special software package (IUCLID) made available by the Commission 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 ECB homepage http://ecb.jrc.it/biocides
(d)For existing active substances that have been or are being evaluated under the review programme for plant protection products in accordance with Article 8(2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(), the required format for an application for inclusion in Annex I thereto may be used for the preparation of the dossier for inclusion of the existing active substance in Annex I, IA or IB to Directive 98/8/EC, taking into account relevant differences in the dossier requirements. A summary of the dossier must be entered in IUCLID. Additional information related to the biocidal use must be submitted in accordance with the requirements of this Regulation.
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