This Law establishes the legal framework for food supplements, marketed as food and presented as such. Ministry of Health is the competent authority for food additives: (a) vitamins, minerals; (b) mixtures of vitamins and/or minerals; (c) substances with nutritional or physiological effect other than vitamins and minerals; (d) mixtures of vitamins and/or minerals with substances having a nutritional or physiological effect other than vitamins and minerals; (e) mixtures of vitamins and/or minerals with plant extracts and/or extracts of animal origin; and (f) mixtures of vitamins and/or minerals with plant extracts and/or extracts of animal origin, with substances having a nutritional or physiological effect other than vitamins and minerals. Food supplements shall require mandatory authorization and certification issued by the Ministry of Health for their circulation and trade on the national territory. Labelling of food additives must not contain any indication of the attribution of the properties of prevention, treatment or cure of a human disease or reference to such properties. To ensure strict safety standards, the Law establishes a rigorous commercial notification procedure that manufacturers, importers, or distributors must complete before placing any food supplement on the Romanian market. This process requires the submission of detailed technical dossiers—including qualitative and quantitative formulations, raw material origins, and laboratory analysis certificates—to the National Institute of Public Health or regional authorities. The Law explicitly penalizes non-compliance, granting regulatory bodies the power to issue substantial administrative fines, seize unauthorized products, or temporarily suspend a company's trading privileges if a supplement fails to match its registered chemical composition or poses a threat to public health. Furthermore, this Law aligns Romania’s domestic market controls with wider European Union food safety directives. It institutes mandatory labelling requirements that dictate the exact formatting of nutritional tables, maximum recommended daily allowances, and explicit precautionary warnings against exceeding stated dosages.
Roumanie · 2021-03-31