FOOD SUPPLEMENT AUTHORIZATION in EUROPE

In the European Union (EU), as in the United States, food supplements are not subject to a strict pre-market approval system like pharmaceuticals. Instead, the EU has specific directives and regulations governing the safety and labeling of food supplements. These regulations are overseen and enforced by the European Food Safety Authority (EFSA) and the European Commission.

Key Regulations:

The primary legal framework governing food supplements in Europe is the Food Supplements Directive 2002/46/EC. This directive:

• Defines food supplements: Food supplements are defined as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients such as vitamins and minerals or other substances with a nutritional or physiological effect, marketed in dose form (e.g., capsules, tablets, pastilles, liquid ampoules, etc.).

• Establishes a list of permitted vitamins and minerals: Annex I provides a list of vitamins and minerals that are permitted for use in food supplements.

• Specifies the forms in which these vitamins and minerals can be used: Annex II provides a list of permitted forms of vitamins and minerals.

• Sets labeling requirements: It mandates that products be labeled as "food supplements," specify the recommended daily dose, and include warnings that they should not be used as a substitute for a varied diet, among other requirements.
  
  

Other Relevant Regulations:

• Regulation (EC) No 1924/2006 on Nutrition and Health Claims: This regulation governs nutrition and health claims made on foods, including food supplements. Health claims must be scientifically evaluated and authorized by EFSA.

• Regulation (EC) No 1925/2006 on the Addition of Vitamins and Minerals and of Certain Other Substances to Foods: This regulation sets out rules for the addition of vitamins and minerals to foods other than food supplements.

• Regulation (EU) 2015/2283 on Novel Foods: This regulation provides for a safety assessment and authorization process for food ingredients that were not consumed to a significant degree in the EU market before May 15, 1997. A new ingredient to be used in a food supplement may be considered a "novel food" and must be authorized before being placed on the market.

• Regulation (EC) No 178/2002, the General Food Law: This regulation lays down food safety requirements and places primary responsibility for food safety on food business operators.

Manufacturer and Importer Responsibilities:

• Safety: Manufacturers and importers are responsible for ensuring that the food supplements they place on the market are safe and comply with applicable EU legislation.

• Labeling: Products must be labeled in accordance with Directive 2002/46/EC and other relevant regulations.

• Notification: Some member states may require notification to national competent authorities before food supplements are placed on the market.

• Record Keeping: Manufacturers and importers are required to keep records related to production, ingredients, analysis, and distribution processes.

• Good Manufacturing Practices (GMP): Although there are no specific GMP rules for food supplements, manufacturers are expected to comply with general food safety principles regarding hygiene and quality control.
  
  

The Role of EFSA:

The European Food Safety Authority (EFSA) has the following responsibilities regarding food supplements:

• Scientific Advice: Provides scientific advice to the European Commission and Member States on the safety and nutritional aspects of food supplements.

• Evaluation of Health Claims: Scientifically evaluates health claims intended for use on food supplements and provides opinions to the European Commission for their authorization.

• Evaluation of Novel Food Applications: Conducts safety assessments of novel food ingredients proposed for use in food supplements.

• Risk Assessment: Conducts risk assessments on specific ingredients in food supplements and issues warnings when necessary.