Governmental Decision No. 617 on the establishment of the institutional framework and measures for the implementation of Regulation (EU) no. 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and use of biocidal products.

This Governmental Decision designates as authorities responsible for carrying out official controls for compliance with the requirements of this Regulation as follows: (a) Ministry of Health through the public health directorates; (b) Ministry of Environment and Climate Change through the National Environmental Guard; (c) National Sanitary Veterinary and Food Safety Authority through the sanitary-veterinary directorates and for safety of the local food and the municipality of Bucharest. The attributions of the personnel empowered to carry out official controls shall be approved, in accordance with the acting legislation, by order of the Minister of Health, the Minister of Environment and Climate Change and the President of the National Sanitary Veterinary and Food Safety Authority, within 60 days from the date of entry into force of this decision. The National Commission for Biocidal Products, a specialized body, without legal personality, operating under the Ministry of Health, fulfills the attributions regarding the approval for placing on the market and use of biocidal products in Romania, respectively: (a) approval of active substances; (b) renewal and review of the approval of an active substance; (c) authorization and simplified authorization of biocidal products; (d) national authorization of biocidal products; (e) cancellation, review and modification of authorization; (f) mutual recognition of authorizations; (g) authorization of parallel trade; (h) approval of research or development experiments involving a biocidal product; and (i) data protection and sharing. The biocidal products are placed on the market and used on the Romanian territory only if: (a) they are authorized according to the provisions of this Regulation; and (b) have labels and the safety data sheet in Romanian language. All documents required for the authorization of a biocidal product shall be submitted in Romanian and in English.