Decree No 8 of 22 January 2018 adopting the Regulation on the form and content of documents necessary for the issuance of marketing authorization for biocides or a group of biocides under article 18 of the Law on the protection against the harmful impact of chemical substances and preparations.

This Decree proclaims the adoption of the Regulation on the form and content of documents necessary for the issuance of marketing authorization for biocide or a group of biocides, as defined by the provisions of the article 18 of the Bulgarian Law on the protection against the harmful impact of chemical substances and preparations.
Important compliance document indicated in the text of this Decree is the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocide products; also a technical dossier and safety data sheet will be prepared as indicated in the Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation, authorization and restriction of chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
The Annex is also part of this publication (administrative forms; technical dossier of biocide product or group of biocide products with active substance).