Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 19 Confidentiality

1. Without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(1), an applicant may indicate to the competent authority the information which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially and which he therefore wishes to be kept confidential from all persons other than the competent authorities and the Commission. Full justification will be required in each case. Without prejudice to the information referred to in paragraph 3 and the provisions of Directives 67/548/EEC and 88/379/EEC, Member States shall take the necessary steps to ensure the confidentiality of the full composition of product formulations if requested by the applicant.

2. The competent authority receiving the application shall decide, on the basis of documentary evidence produced by the applicant, which information shall be confidential within the terms of paragraph 1.

Information accepted as being confidential by the receiving competent authority shall be treated as being confidential by the other competent authorities, Member States and the Commission.

3. After the authorisation has been granted, confidentiality shall not in any case apply to:

(a) the name and address of the applicant;

(b) the name and address of the biocidal product manufacturer;

(c) the name and address of the active substance manufacturer;

(d) the names and content of the active substance or substances in the biocidal product and the name of the biocidal product;

(e) the names of other substances which are regarded as dangerous within the meaning of Directive 67/548/EEC and contribute to the classification of the product;

(f) physical and chemical data concerning the active substance and biocidal product;

(g) any ways of rendering the active substance or biocidal product harmless;

(h) a summary of the results of the tests required pursuant to Article 8 to establish the substance's or product's efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;

(i) recommended methods and precautions to reduce dangers from handling, storage, transport and use as well as from fire or other hazards;

(j) safety data sheets;

(k) methods of analysis referred to in Article 5(1)(c);

(l) methods of disposal of the product and of its packaging;

(m) procedures to be followed and measures to be taken in the case of spillage or leakage;

(n) first aid and medical advice to be given in the case of injury to persons.

If the applicant or manufacturer or importer of the biocidal product or active substance should later disclose previously confidential information, the competent authority shall be informed accordingly.

4. The detailed provisions and format for making information publicly available and for implementing this Article shall be decided in accordance with the procedures set out in Article 28(2).

(1)

OJ L 158, 6.10.1990, p. 40.