Joint Order No. 1,321 of the Ministry of Public Health, the Ministry of Environment and Water Management, and National Sanitary Veterinary and Food Safety Authority validating the Methodological Norms for the application of Government Decision no. 956/2005 regarding the placing on the market of biocidal products.

Methodological Norms for the application of Government Decision no. 956/2005 regarding the placing on the market of biocidal products (contained in the Annex I) shall be applicable to the products that have already been placed on the Romanian market; the product whose source of active substance is changed from an initial supplier to a supplier that holds a complete dossier of the active substance; new biocidal that was not placed on the Romanian market on the date of inclusion of its active substance in Annex I. Legal entities that intend to continue the commercialization of an existing biocidal product on Romanian territory must submit to the Technical Secretariat of the National Commission for Biocidal Products the following documentation: (a) request for authorization; or (b) request for mutual recognition. Legal entities may apply for the first authorization in any of the EU member states. The placing on the Romanian market of new biocidal products is carried out after obtaining the authorization or after its mutual recognition, according to the provisions of the present Methodological Norms. The files must contain a detailed and complete description of the studies carried out and the methods used or a bibliographic reference to these methods. The information provided in the files in must be sufficient for the evaluation of the effects and properties of biocidal products. Information that is not necessarily due to the nature of the biocidal product or the proposed uses should not be provided. The evaluation of biocidal products and low-risk biocidal products for authorization and registration is done in terms of: effects on human health, effects on animal health, effects on the environment, effectiveness, physico-chemical properties. If Romania, as the reference member state, reaches the conclusion that the authorization for placing biocidal products on the market cannot be issued following the evaluation of a biocidal product for which there are requests for mutual recognition of the authorization, informs, through the National Commission for Biocidal Products, the member states in question within 5 working days, before taking the final decision. As the case may be, before taking the final decision, the National Commission for Biocide Products consults with the competent authorities of the member states in question on these reasons.