Joint Order No. 280 of the Ministry of Public Health, the Ministry of Environment and Water Management and the National Sanitary Veterinary and Food Safety Authority validating the Methodological Rules for the application of Government Decision no. 956/2005 regarding the placing on the market of biocidal products (updated until August 13, 2012*).

Methodological Rules for the application of Government Decision no. 956/2005 regarding the placing on the market of biocidal products establish the procedure for placing biocidal products on the market in Romania. The competent authority for regulating the regime of biocidal products in Romania is the Ministry of Health, the competent authority for authorization and registration of biocidal products on the territory of Romania, is the National Commission for Biocidal Products, a specialized body, without legal personality, which operates under the Ministry of Health. Biocidal products are placed on the market and used on the territory of Romania only if they are authorized in accordance with the provisions of these Methodological Rules. The placing on the market and the use of basic substances for biocidal purposes are prohibited. The placing on the market and the use of basic substances for biocidal purposes are prohibited, if they have not been included in the "List of basic substances approved by the European Community". It is prohibited to place on the market biocidal products containing active substances that are not included in Annex 3. It is prohibited to place on the market biocidal products containing active substances that are not included in the type/types of biocidal products inserted in Annex 4. It is prohibited to place on market unauthorized biocidal substance or product, except for cases of provided scientific research and development information and data. Applications for biocidal products that require authorization are resolved by the competent authority within one year, after the presentation of complete documentation. Applications for biocidal products that require registration are resolved by the competent authority within 60 days from the presentation of the complete documentation. The authorization, renewable, is granted for a maximum period of 10 years, depending on the type of biocidal product and without exceeding the deadline specified for the active substance in the "List of active substances approved by the European Community, admitted as part of biocidal products" or in the "List of active substances approved by the European Community, admitted as part of low-risk biocidal products". A biocidal product that is already authorized in a member state of the European Community is also authorized in Romania within 120 days from the receipt of the request, provided that the active substance in the biocidal product is included in the "List of active substances approved by the European Community, admitted as part of biocidal products", and the requirements of this decision are met. In this case, the Mutual Recognition Authorization is issued. A biocidal product that is already registered in a member state of the European Community is also registered in Romania within 60 days of receiving the request, provided that the active substance of the biocidal product to be included in the "List of active substances approved by the European Community, admitted in the component of biocidal products with low risk", and the requirements of this decision to be met. If other legal provisions impose certain requirements regarding the conditions for issuing authorization for use of the biocidal products, especially when they have the role of protecting the health of distributors, users, workers and consumers, animal health or environmental protection, the competent authority takes them into account when issuing an authorization and establishing terms and conditions for the use thereof, and, if necessary, authorizes release of such biocidal products, only if these requirements are fulfilled. The applicant may indicate to the competent authority the information which he considers to be commercially sensitive and the dissemination of which may prejudice him from an industrial and commercial point of view and which he wishes to keep secret from all other persons, except the competent authority and the European Commission. In this situation, full justifications are presented for each case. At the request of the applicant, the competent authority takes the necessary measures to ensure the confidentiality of all ingredients in the composition of a biocidal product. Biocidal products must be packaged so that they are not confused with food, beverages or animal feed. Biocidal products accessible to the population, which can be confused with food, beverages or with animal feed, must contain warning information on the packaging to discourage their consumption.