GOrder No. OMS1185/2025 of the Ministry of Health validating the Regulation on the Specialized Commission for the Registration of Food Additives and the Regulation on its organization and functioning thereof.

This Ministerial Order establishes a permanent Specialized Commission for the Registration of Food Additives under the National Agency for Public Health (ANSP) and approves its rules of organization and functioning. The text defines the composition of the Commission (eight members from ANSP, the State University of Medicine and Pharmacy, the National Food Safety Agency, the Medicines and Medical Devices Agency, and the National Anti-Doping Agency) and the duration and renewal of mandates. It sets out the Commission’s core responsibilities: examining evaluation reports for registration of food additives, deciding on approval or refusal of registration, handling complaints from applicants or other persons, and examining proposals to delete previously registered additives from the State Register. A technical Secretariat within ANSP’s Directorate for sanitary expertise and authorization is tasked with receiving and administratively verifying applications and documentation via the national services portal, distributing technical dossiers to experts, organizing meetings, drafting minutes, issuing registration certificates or refusal decisions, maintaining and updating the National Register of food additives, archiving dossiers for 25 years, and issuing extracts and other acts to law enforcement bodies. The Regulation further details the role of designated experts, who must evaluate dossiers and prepare evaluation reports within 30 working days, and may seek opinions from other competent institutions. It regulates the convening and conduct of Commission meetings (frequency, quorum, agenda, presentation of evaluation reports, and recording of decisions). Annexes provide standard forms: a confidentiality declaration, a declaration of interests (including detailed instructions on what constitutes an interest in the food additives industry), a model evaluation report for registration of food additives, and a model State registration certificate. These annexes emphasize confidentiality, avoidance of conflicts of interest, and the prohibition of health claims on packaging or leaflets that attribute disease prevention, treatment, or cure properties to food additives. Any modification of identification data of a registered additive automatically leads to cancellation of the registration certificate.