Annex 5

(Art. 14 para. 2 let. a)

Application for authorisation AL or AnL

1 Documents concerning the product and the active substances

The following must be submitted to the Notification Authority together with the application for authorisation:

1. the documents concerning the biocidal product;
2. the documents concerning each active substance.

2 Dossier requirements

2.1 General provisions

¹The documents must be presented to the Notification Authority in the form of technical dossiers.

²The requirements of the Annexes to Regulation (EU) No 528/2012¹must be met in accordance with the latest scientific and technical developments.

2.2 Quantitative and qualitative requirements

¹The technical dossiers must contain the information specified in the following Annexes to Regulation (EU) No 528/2012:

1. concerning the product: as specified in Annex III; adaptation of the data requirements, and the statement of reasons for such adaptation, is subject to the rules set out in Annex IV;
2. concerning the active substances: as specified in Annex II; adaptation of the data requirements is subject to the rules set out in Annex IV.

²Where Annexes II and III to Regulation (EU) No 528/2012 refer to other EC law for classification and labelling, Articles 35 and 38 of the present Ordinance apply.

³If an active substance meets the exclusion criteria specified in Article 5 paragraph 1 of Regulation (EU) No 528/2012, evidence must be provided that the provisions concerning exceptions specified in Article 5 paragraph 2 of Regulation (EU) No 528/2012 are applicable.

⁴For biocidal products, a summary of the product characteristics must be presented in accordance with Article 20 paragraph 1 letter a point ii of Regulation (EU) No 528/2012.

⁵Apart from the information specified in Article 17 paragraph 6, the Notification Authority may ask the applicant to provide the following documents:

1. the summary of the biocidal product characteristics, from the EU or EFTA authorities, in accordance with Article 22 paragraph 2 of Regulation (EU) No 528/2012 and the assessment report with the authority’s conclusions in accordance with Article 30 paragraph 3 of Regulation (EU) No 528/2012, or, for active substances, in accordance with Article 8 paragraph 1 of Regulation (EU) No 528/2012, insofar as they are accessible to the applicant;
2. samples of packaging, drafts for labelling and for leaflets, as well as a draft label.

⁶The dossiers must include a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to those methods.

⁷They must be sufficient to permit an evaluation of the effects and properties referred to in Article 11.

2.3 Prescribed methods of detection and identification

¹Detection and identification must be carried out using the methods described in Regulation (EC) No 440/2008².

²If a method is inappropriate or is not described, internationally recognised methods should be used as far as possible; these must be justified.

³Detection and identification must be carried out, if applicable:

1. in accordance with Directive 2010/63/EU³; and
2. in compliance with the principles and requirements of Good Laboratory Practice specified in Article 43 paragraphs 4 and 5 of the ChemO⁴.

⁴Paragraph 3 does not apply to detection and identification tests which were started before 1 March 2000.

2.4 Other methods of detection and identification

¹Where detection and identification data exist that were generated before the commencement of this Ordinance by methods other than those laid down in Annex V to Directive 67/548/EEC⁵, the adequacy of such data for the purposes of this Ordinance, or the need to conduct new detection and identification tests in accordance with to Regulation (EC) 440/2008, must be determined on a case‑by‑case basis.

²Testing on vertebrates must be minimised.

3 Letter of access and reference

If the Notification Authority is already in possession of the complete documentation specified in Numbers 1 and 2, the applicant may:

1. submit a letter of access; or
2. if the data protection period specified in Article 28 has expired: make reference to the documentation.

4 Assessment and conclusions of an EU or EFTA Member State

With regard to a biocidal product containing an active substance not listed in Annex 1 or 2 or included in the list of notified active substances, the applicant may enclose the summary of the biocidal product characteristics in accordance with Article 22 paragraph 2 of Regulation (EU) No 528/2012 and the assessment report with the conclusions in accordance with Article 30 paragraph 3 of Regulation (EU) No 528/2012, or, for active substances, in accordance with Article 8 paragraph 1 of Regulation (EU) No 528/2012, from the competent authority of an EU or EFTA Member State.