Governmental Decree No. HG344/2020 validating Sanitary Regulation on the placing on the market and the use of biocidal products.

The scope of this Regulation is to improve the functioning of the internal market through the harmonization of norms for the placement and use of biocidal products, while ensuring a high level of protection of human health, animal health and environment. The provisions of this Regulation are based on the principle of precaution, the purpose of which is to ensure the protection of human health, animal health, as well as environmental protection. This Regulation lays down rules relating to: (a) use of the List of active substances that can be used in biocidal products established at the level of the European Union, which is adopted by order of the Minister of Health, Labor and Social Protection; (b) procedures for registration of biocidal products prior to their placing on the market; (c) placing on the market products treated with biocides; and (d) mutual recognition of permits issued in one of the countries of the European Union. This Regulation applies to biocidal products and articles treated with biocides. List of groups and types of biocidal products that are included in the scope of this Regulation are set out in Appendix No. 1. This Regulation shall not be applicable to the following items: (a) veterinary drugs; (b) feed additives; (c) food additives; (d) hygiene of foodstuffs; (e) phytosanitary means; and (f) repellents. Placing on the market shall be intended any supply of a biocidal product or treated products for sale or use in trading activities, on a paid or free basis. Biocidal products are allowed to be placed on the market or used only upon their registration in accordance with this Regulation. The certificate of registration of a biocide is issued for a period not exceeding 10 years. Biocidal products must be used in accordance with the terms and conditions of registration and the labelling and packaging requirements set out in this Regulation.