Annex 9

(Art. 14 para. 2 let. d)

Application for authorisation AN

1 Documents concerning the applicant, the manufacturer and the product

1.1 General

The application documents must contain the following details:

1. name and address of the applicant;
2. name and address of the manufacturer of the biocidal product and the active substances;
3. trade name of the biocidal product;
4. full composition of the biocidal product;
5. list of the active substances contained in the biocidal product;
6. information on physical and chemical properties, and toxicology and ecotoxicology data;
7. information about certain active substances (Number 2);
8. assignment of the biocidal product to product type and field of use;
9. categories of users;
10. proposals and justification for classification and labelling, as well as information concerning the packaging, in accordance with Articles 35, 36 and 38;
11. if required, proposals for the safety data sheet in accordance with Article 40;
12. information concerning disposal;
13. for disinfectants and wood preservatives: evidence that the biocidal product is sufficiently effective for the intended uses.

1.2 Additional requirements

¹An authorisation ANshall only be granted if the persons supplying the active substances contained in the biocidal product are included in the list specified in Article 95 paragraph 1 of Regulation (EU) No 528/2012¹or if the following documents are submitted:

1. a copy of the decision by the ECHA concerning the inclusion in the above-mentioned list of the persons supplying the active substances contained in the biocidal product;
2. documents complying with Annex II to Regulation (EU) No 528/2012 or with Annex IIA or IVA and, where relevant, IIIA to Directive 98/8/EC²;
3. a letter of access to active substance data as referred to in letter b; or
4. a reference to data for which the protection period specified in Article 28 has expired.

²For data on existing active substances listed in combination with a product type in Annex II to Regulation (EC) No 1062/2014³– including data not involving tests on vertebrates –Article 29a applies.

³Paragraphs 1 and 2 do not apply to biocidal products containing only active substances listed in Annex 1 in categories 1–5 and 7.

2 Additional documents

¹The Notification Authority may ask the applicant to provide the following additional documents:

1. test reports, scientific opinions or publications or other papers which support the information specified in Number 1;
2. information specified in Annex II to Regulation (EC) No 1896/2000⁴;
3. in justified cases, information on exposure levels for the public and the operator or for the environment;
4. samples of packaging, drafts for labelling and for leaflets, as well as a draft label.

²The documents must include a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to those methods.

3 Methods of detection and identification

3.1 Prescribed methods of detection and identification

¹As a general rule, detection and identification must be carried out using the methods described in Regulation (EC) No 440/2008⁵.

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/EU⁶; and
2. in compliance with the principles and requirements of Good Laboratory Practice specified in Article 43 paragraphs 4 and 5 of the ChemO⁷.

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

3.2 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/EEC⁸, the adequacy of such data for the purposes of this Ordinance, or the need to conduct new detection and identification tests in accordance with Regulation (EC) 440/2008, must be determined on a case‑by‑case basis.

²Testing on vertebrates must be minimised.