Presidential Decree No. 205 concerning the authorisation and the placing on the market for use of biocidal products, in compliance with Directive 98/8/EC of the European Parliament and of the Council.

The present Decree aims at implementing EU Directive 98/8/EC concerning the authorisation and the placing on the market for use of biocidal products. Its provisions shall apply to biocidal products as defined in article 2(1)(a) but shall exclude products that are defined through previously issued instruments within the national legislative framework. Article 1 contains a list of such instruments. According to the provisions of article 3, biocidal products shall not be placed on the market and used in the national territory unless it has been authorised in accordance with the provisions of the present Decree. The Decree consists of 31 articles as follows: art.1, Scope and filed of application; art.2, Definitions; art.3, Authorisation for placing on the market of biocidal products; art.4, Mutual recognition of authorisations; art.5, Conditions for issue of an authorisation; art.6, Review of an authorisation; art.7, Cancellation or modification of an authorisation; art.8, Requirements for authorisation; art.9, Placing on the market of active substances; art.10, Inclusion of an active substance in Annexes I, IA or IB; art.11, Procedure for inclusion of an active substance in Annex I, IA or IB; art.12, Use of data held by competent authorities for other applicants; art.13, Cooperation in the use of data for second and subsequent applications for authorisation; art.14, New information; art.15, Derogation from the requirements; art.16, Transitional measures; art.17, Research and development; art.18, Information exchange; art.19, Confidentiality; art.20, Classification, packaging and labelling of biocidal products; art.21, Safety-data sheets; art.22, Advertising; art.23, Poison control; art.24, Compliance with requirements; art.25, Charges; art.26, Competent authorities; art.27, Safeguard clause; art.28, Sanctions; art.29, Civil and criminal liability; art.30, Annexes; art.31, Entry into force.