Common foodstuffs are governed by texts harmonized at European level which are applicable to all categories of foodstuffs, such as the following regulations:
- Regulation (EU) N ° 1169/2011 of 25 October 2011 governing consumer information on foodstuffs,
- Regulation (EC) N ° 1924/2006 of December 20, 2006 governing nutritional and health claims made on foodstuffs.
Common foodstuffs may also be governed by national and / or European texts specific to a product category, such as:
- National regulations for dairy products,
- Regulation (EU) No. 1308/2013 of December 17, 2013 on the common organization of the markets in agricultural products, which provides definitions and requirements applicable to certain agricultural products within the European Union.
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.
The UK has also developed regulatory changes following its exit from the EU. European regulations no longer apply to the UK and businesses are now required to adapt to UK legislation.
Many EU regulations have been retained by the UK, but food products must still undergo some changes before entering the UK market.
For the U.S., conventional food products are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act and other laws and regulations related to food safety and quality.
A substance that is reasonably expected to become a component of food is considered a food additive, and therefore must be authorized for use in food.
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…