Order No. OMS1186/2025 of the Ministry of Health “On the establishment of the Specialized Commission for the Registration of Biocidal Products and the approval of the regulation on its organization and functioning”.

This Ministerial Order establishes a permanent Specialized Commission for the registration of biocidal products and approves its Rules of Organization and Functioning. The Order defines the composition of the Commission, placed alongside the National Agency for Public Health (ANSP), and links its work to the existing sanitary regulatory framework on biocides. It also provides for publication in the Official Gazette and assigns responsibility for implementation to the Commission members and the Director of ANSP. The Regulation annexed to the order details the Commission’s structure, mandate, and procedures. The Commission is composed of ten members representing ANSP, the National Food Safety Agency, the Environment Agency, and the State University of Medicine and Pharmacy. It operates without legal personality and is assisted by a technical Secretariat within ANSP’s Directorate for sanitary expertise and authorization, as well as by expert groups designated by ANSP, the National Food Safety Agency and the Environment Agency. The Regulation sets out the Commission’s responsibilities, including examining evaluation reports for registration of biocidal products, analyzing summaries of minor and major modifications to existing registration certificates, deciding on registration (primary, by recognition, or by modification), suspension for additional information, rejection, and cancellation of certificates, and handling complaints. It also requires annual confidentiality and interest declarations from members, Secretariat staff and experts. Detailed operational provisions govern the Secretariat’s tasks (administrative verification and validation of applications, allocation of dossiers to experts, preparation of agendas, minutes, and certificates, management of the National Register of biocidal products, archiving, and issuing extracts) and the experts’ obligations (evaluation of specific product types, preparation of reports and summaries within fixed deadlines, and responsibility for data accuracy). The Regulation further specifies how Commission meetings are convened, quorum and voting rules, documentation to be circulated in advance, and the form and signing of minutes and responses. Standardized templates are annexed for confidentiality and interest declarations, evaluation reports, summaries of modifications to certificates, and the State registration certificate for biocidal products, including an annex describing product characteristics, composition, use, labelling, user categories, and risk-related recommendations.