Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 8 Requirements for authorisation

1. Application for authorisation shall be made by, or on behalf of, the person who will be responsible for the first placing on the market of a biocidal product in a particular Member State and shall be to the competent authority of that Member State. Every applicant shall be required to have a permanent office within the Community.

2. Member States shall require that an applicant for authorisation of a biocidal product shall submit to the competent authority:

(a) a dossier or a letter of access for the biocidal product satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex IIB and, where specified, the relevant parts of Annex IIIB, and

(b) for each active substance in the biocidal product, a dossier or a letter of access satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex IIA and, where specified, the relevant parts of Annex IIIA.

3. By way of derogating from paragraph 2(a), Member States shall require a dossier comprising the following data for a low-risk biocidal product:

(i)

applicant:

1.1.

name and address,

1.2.

manufacturers of the biocidal product and the active substances,

(names and addresses including location of manufacturer of the active substance)

1.3.

where appropriate, a letter of access to any relevant data needed,

(ii)

identity of the biocidal product:

2.1.

trade name,

2.2.

full composition of the biocidal product,

2.3.

physical and chemical properties as referred to in Article 5(1)(d),

(iii)

intended uses:

3.1.

product type (Annex V) and field of use,

3.2.

category of users,

3.3.

method of use,

(iv)

efficacy data,

(v)

analytical methods,

(vi)

classification, packaging and labelling, including a draft label, according to Article 20,

(vii)

safety data sheet prepared in accordance with Article 10 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances(1), or Article 27 of Directive 67/548/EEC.

4. The dossiers shall include a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to those methods. The information in the dossiers supplied in accordance with Article 8(2) shall be sufficient for an evaluation to be made of the effects and properties referred to in Article 5(1)(b), (c) and (d). It shall be submitted to the competent authority in the form of technical dossiers, containing the information and results of the studies referred to in Annexes IIA and IIB and, where specified, the relevant parts of Annexes IIIA and IIIB.

5. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation which the applicant has the right to access.

6. If the evaluation of the dossier shows that further information, including data and results from further testing, is necessary to evaluate the risks of the biocidal product, the competent authority shall ask the applicant to submit such information. The time period for the evaluation of the dossier shall start only after the dossier is complete.

7. The name of an active substance must be given as registered in the list contained in Annex I to Directive 67/548/EEC or, if the name is not included therein, as given in the European Inventory of Existing Chemical Substances (Einecs), or, if the name is not included therein, the active substance must be given its International Standards Organisation (ISO) common name. If the latter is not available, the substance must be designated by its chemical designation according to International Union of Pure and Applied Chemistry (IUPAC) rules.

8. As a general principle, tests must be conducted according to the methods described in Annex V to Directive 67/548/EEC. In the event of a method being inappropriate or not described, other methods used should, whenever possible, be internationally recognised and must be justified. Where appropriate, tests must be conducted in accordance with the provisions laid down in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(2) and Council Directive 87/18/EEC of 18 December 1986 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 applications for tests on chemical substances(3).

9. Where test data exist that have been generated before the adoption of this Directive by methods other than those laid down in Annex V to Directive 67/548/EEC, the adequacy of such data for the purposes of this Directive and the need to conduct new tests according to Annex V must be decided on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrate animals.

10. Competent authorities as referred to within the meaning of Article 26 shall ensure that a file is compiled on each application. Each file shall contain at least a copy of the application, a record of the administrative decisions taken by the Member State concerning the application and concerning the dossiers submitted in accordance with paragraph 2, together with a summary of the latter. On request, Member States shall make available to the other competent authorities and to the Commission the files provided for in this paragraph; they shall supply to them, on request, all information necessary for full comprehension of applications and shall, where requested, ensure that applicants provide a copy of the technical documentation laid down in paragraph 2.

11. Member States my require that samples of the preparation and of its ingredients be provided.

12. Member States may require that applications for authorisation be submitted in their national or official languages or one of these languages.

(1)

OJ L 187, 16.7.1988, p. 14. Directive as amended by Directive 93/18/EEC (OJ L 104, 29.4.1993, p. 46).

(2)

OJ L 358, 18.12.1986, p. 1.

(3)

OJ L 15, 17.1.1987, p. 29.