The addition of vitamins, minerals and other active substances is regulated at European level.
However, maximum fortification limits as well as authorization of other active substances other than vitamins/minerals are not harmonized and national regulations vary across Member States.
Many EU regulations have been retained by the UK, but food products must still undergo some changes before entering the UK market.
FDA considers that the regulatory status of the overall food depends on the individual food ingredients, meaning that each ingredient must be assessed for compliance to determine the status of the finished product.
A specific ingredient may be authorized for use under existing regulations, but in certain cases, the ingredient may require new regulatory authorization, for example, through the Generally Recognized as Safe (GRAS) procedure.
Determining the regulatory status of an individual ingredient requires an understanding of the regulations and must consider the identity and specifications of the ingredient as well as the intended use and use levels.
Certain products may also be borderline between conventional food and dietary supplement categories, and the product classification can have important impacts for: ingredient authorization (for example GRAS vs. new dietary ingredient (NDI) notifications), labeling, and product claims. Therefore, determining the most appropriate regulatory status is an important first step in the strategy for your product.
- Assessment of the quality and conformity of raw materials such as nutrients and botanical extracts, and processing aids such as additives (excipients) and flavorings
- Product safety assessment
- Determination of the most appropriate regulatory status
- Compliance of the composition with applicable local or international regulations
- Determination of possible nutritional and health claims
- Quality audit in compliance with HACCP standards
Labeling and Communication
- Creation of product labeling (mandatory regulatory information: legal sales name, list of ingredients, etc.),
- Assessment of voluntary statements (nutritional and health claims, environmental claims, certifications, Organic Agriculture, etc.),
- Assessment of promotional content (labeling, website, advertisements, brochures etc.),
- Justification of health claims and substantiation for structure function claims.
- Drafting of authorization request files in accordance with the regulations in force (ingredients, final products, health claims)
- Monitoring and negotiating with competent authorities
- Submission of structure function claims to FDA or health claims under article 13.5 or 14 in Europe, FFC in Japan, Health foods in China…