Government Decision No. HG165/2025 validating the Novel Food Regulation.

This Regulation establishes the legal framework for placing novel foods on the national market, with the stated objective of enabling their marketing while ensuring a high level of protection of human health and consumer interests. It clarifies that the instrument does not apply to genetically modified foods, nor to foods used as food enzymes, food additives, flavourings, or extraction solvents, which are regulated separately under existing national sanitary regulations. The text incorporates and adapts EU concepts such as novel food, traditional food from another country, history of safe food use, applicant, and manufactured nanomaterial. The Regulation provides a detailed definition of novel food as any food not used for human consumption to a significant degree in Moldova before 15 May 1997 and falling into specified categories. These include foods with a new or intentionally modified molecular structure; foods based on microorganisms, fungi, algae, mineral materials, plants, animals, or their parts; foods derived from cell or tissue cultures; foods obtained by new production processes that significantly change composition or structure; foods containing or based on manufactured nanomaterials; certain vitamins, minerals and other substances produced by new processes or involving nanomaterials; and foods previously used only in food additives when proposed for use in other foods. The Regulation also defines traditional foods from other countries with a documented safe history of use over at least 25 years in the normal diet of a significant number of people in at least one country. The Decision establishes that only novel foods included in a national List of novel foods, approved and regularly updated by order of the Minister of Agriculture and Food Industry in line with the EU list, may be placed on the national market. Food business operators must verify whether their products are on this list and provide all necessary information to determine whether a product falls within the scope of the Regulation. Novel foods already on the list may be marketed on the basis of a prior notification to the National Food Safety Agency (ANSA), submitted at least 10 working days before placing on the market and including a notification form, product specifications confirmed by laboratory investigations, description of production processes, and information on conditions of use and labelling. ANSA has 15 working days to verify completeness and conformity of documentation, register notifications, and inform applicants; if ANSA neither registers nor refuses within the deadline, operators may place the novel food on the market. Operators remain responsible for label compliance, ensuring that products do not pose risks to public health, and providing additional information upon ANSA’s request. They must also notify ANSA within 10 working days of any changes to composition or production processes or of new information affecting safety, enabling ANSA to update records and take consumer protection measures. ANSA must respect confidentiality of trade secrets, except where disclosure is required to protect public health. The Ministry of Agriculture and Food Industry is tasked with updating the national list in accordance with EU changes, while ANSA conducts supervision and control of novel foods on the market under the general food safety law. Placing novel foods on the market without prior notification to ANSA is subject to contravention sanctions.