FOOD SUPPLEMENT AUTHORIZATION in THE UK

The UK is in the process of establishing and implementing its own regulations for food supplements in the post-Brexit period. Despite having left the EU, a system based on and largely similar to the EU's Food Supplements Directive 2002/46/EC is currently in effect. However, there are some important differences, and further changes are expected in the future.

Current Situation:

• Main Legal Framework: In the UK, food supplements are regulated by national legislation, such as the Food Supplements Regulations 2003 and the Food Supplements Regulations (England) 2003 (and equivalent regulations for Scotland and Wales) for Great Britain. These regulations are largely based on the EU's Directive 2002/46/EC. Northern Ireland continues to follow EU rules.

• Definition and Scope: 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.).

• Permitted Ingredients: The list of vitamins and minerals that are permitted for use in food supplements, as well as their permitted forms, are listed in the annexes of the relevant regulations.

• Labeling Requirements: There are mandatory requirements such as labeling products as "food supplements," stating the recommended daily dose, and including warnings that they should not be used as a substitute for a varied diet.

• Notification System: In the UK, there is a mandatory requirement to notify the Food Standards Agency (FSA) before placing food supplements on the market. This notification includes information on the product's composition, labeling information, and manufacturer/importer details.

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

The Role of the FSA:

The Food Standards Agency (FSA) has the following responsibilities regarding food supplements in the UK:

• Policy Development: Develops policies and legislation related to food supplements.

• Receipt of Notifications: Receives and evaluates food supplement notifications.

• Inspection and Enforcement: Inspects food supplements on the market and takes enforcement action in cases of non-compliance.

• Consumer Information: Provides information to consumers about food supplements.

• Risk Assessment: Conducts risk assessments on specific ingredients in food supplements.

• Manufacturer and Importer Responsibilities:
  
  

  • Safety and Compliance: They are responsible for ensuring that the food supplements placed on the market are safe and comply with applicable UK legislation.

  • Labeling: They must ensure that products are labeled accurately and completely.

  • Notification: They must notify the FSA before placing food supplements on the market.

  • Record Keeping: They must keep records related to production, ingredients, analysis, and distribution processes.

  • Good Manufacturing Practices (GMP): They are expected to comply with general food safety principles regarding hygiene and quality control.