Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 3 U.K. Authorisation for placing on the market of biocidal products

1. Member States shall prescribe that a biocidal product shall not be placed on the market and used in their territory unless it has been authorised in accordance with this Directive.

2. By way of derogation from paragraph 1:

(i)

Member States shall, subject to registration, allow the placing on the market and use of a low-risk biocidal product, provided that a dossier in accordance with Article 8(3) has been submitted and verified by the competent authorities.

Unless otherwise specified, all provisions relating to authorisation under this Directive shall also apply to registration.

(ii)

Member States shall allow the placing on the market and use of commodity substances for biocidal purposes once they have been entered in Annex IB.

(i)

Every application for authorisation shall be decided on without undue delay.

(ii)

For applications for biocidal products that require registration, the competent authority shall take a decision within a period of 60 days.

4. Member States shall, on request, or may, on their own initiative, and where relevant, establish a frame-formulation and communicate it to the applicant when issuing an authorisation for a particular biocidal product.

Without prejudice to Articles 8 and 12 and providing that the applicant has a right of access to the frame-formulation in the form of a letter of access, when a subsequent application for authorisation for a new biocidal product is based on this frame-formulation, the competent authority shall take a decision with regard to this application within a period of 60 days.

5. Member States shall prescribe that biocidal products are to be classified, packaged and labelled in accordance with the provisions of this Directive.

6. Without prejudice to Article 7(1), authorisations shall be granted for a maximum period of 10 years from the date of first or renewed inclusion of the active substance in Annex I or I A for the product type, without exceeding the deadline specified for the active substance in Annex I or I A; they may be renewed after verification that the conditions imposed in Article 5(1) and (2) are still satisfied. Renewal may, where necessary, be granted only for the period necessary to allow the competent authorities of the Member States to make such verification, where an application for renewal has been made.

7. Member States shall prescribe that biocidal products are to be properly used. Proper use shall include compliance with conditions established pursuant to Article 5 and specified under the labelling provisions of this Directive. Proper use shall also involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary. Where biocidal products are used at work, use shall also be in accordance with the requirements of Directives for the protection of workers.