Order No. OMAIA186/2025 of the Ministry of Agriculture and Food Industry validating the List of novel food.

The Order of the Minister of Agriculture and Food Industry approves the List of novel foods. It mandates publication in the Official Gazette and assigns responsibility for enforcement to the Minister. The annexed List is a detailed technical schedule specifying which novel foods are authorized on the national market, under what conditions, and with which labelling and data protection requirements. The List is structured as a table of authorized novel foods, each entry identifying the substance or ingredient (for example N acetyl D neuraminic acid, various plant extracts, microbial preparations, algae oils, fortified yeasts, novel carbohydrates and sweeteners, mineral and vitamin forms, and numerous other ingredients). For each novel food, the table sets out: the specific food categories in which it may be used (such as infant formulae, foods for special medical purposes, cereal based foods for infants and young children, total diet replacements for weight control, milk and dairy analogues, beverages, confectionery, food additives and others); the maximum permitted levels (expressed per litre, kilogram, portion or per day, as appropriate); and any additional compositional specifications. Many entries include detailed age group or population restrictions (e.g. exclusion of infants, young children, pregnant or lactating women) and cross references to existing national sanitary regulations on foods for infants and young children, foods for special medical purposes, food additives, fortified foods and gluten free foods. The Order also prescribes specific labelling requirements for each novel food, typically mandating the exact name to be used on the label and, where relevant, mandatory warning statements (for example, not to be consumed by certain age groups, not to be used concurrently with other additives containing the same substance, or potential allergen cross reactions). A number of entries establish time limited data protection and exclusive marketing rights for named companies. These clauses allow only the specified operator to place the novel food on the national market until a stated expiry date, unless a later applicant obtains authorization without relying on the protected scientific data or with the right holder’s consent. The annex further includes extensive technical specifications for many of the novel foods (purity criteria, compositional ranges, contaminant limits and microbiological criteria), thereby integrating EU derived safety and quality standards into the national food legislation.