UK

I. FOOD SUPPLEMENTS

Food supplements are regulated by legislation made in each of the countries of the United Kingdom. These still refer to the Annexes of Directive 2002/46/EC for rules for vitamins and minerals used in food supplements. As of 1st January 2021, the responsibility for the regulation of food supplements was transferred from EU institutions to the appropriate authorities and bodies in Great Britain and reflected in the Protocol on Ireland/Northern Ireland.

The definition of food supplement is harmonised between the four countries:

“food supplement” means any food the purpose of which is to supplement the normal diet and which—

• is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and
• is sold in dose form.

II. FOOD SUPPLEMENT REGISTRATION IN THE UNITED KINGDOM

To be able to sell food supplements in the UK, one must be registered as a Food Business Operator (FBO). FBOs are required to guarantee the safety of food products before placing them on the UK’s market, and since Brexit, no pre-market authorization is needed. The Food Standards Agency checks with post-market controls that the food supplement marketed is compliant regarding composition, labelling and safety.

III. CONTENT AND COMPOSITION OF FOOD SUPPLEMENTS IN THE UNITED KINGDOM

Food supplements can be composed of various ingredients, including (but not limited to):

• vitamins;
• minerals;
• amino acids;
• essential fatty acids;
• fiber;
• various plants and herbal extracts.

IV. MANDATORY LABELLING REQUIREMENTS OF FOOD SUPPLEMENTS IN THE UNITED KINGDOM

Pursuant to Regulation 6 of the Food Supplement Regulations 2003, the product must be labelled as “Food Supplement” and not “Dietary Supplement”, and it must include:

• The business name and address, which can be placed either on the product label or product packaging. This must be either:
  • The name of the business whose name the food is marketed under; or
  • The address of the business that has imported the food.
• A list of ingredients, including common allergens (which must be emphasized).
• Conditions for use, including information on the recommended daily dosage and a warning not to exceed it.
• Storage instructions including a statement that the product should be stored out of the reach of young children.
• A ‘use by’ or ‘best before’ date.
• A nutritional declaration containing the names and amounts of the vitamins, minerals and/or other substances (amino acids, fatty acids, plant extracts etc.) that form the primary part of the product.
• A statement that food supplements should not be used as a substitute for a varied diet.

This information must be either on:

• The packaging.
• A label attached to the packaging.
• A label which is clearly visible through the packaging.

Note that Food supplements sold in Northern Ireland must include a NI or EU address for the food business. If the food business is not in NI or EU, they must include the address of the importer, based in NI or the EU. Food businesses can continue to use an EU, GB or NI address for the FBO on food supplements sold in GB until 30 September 2022. From 1 October 2022, food supplements sold in GB must include a UK, Channel Islands or the Isle of Man address for the food business. If the food business is not in GB, they must include the address of the importer, based in the UK, Channel Islands or the Isle of Man. 

V. NUTRITION AND HEALTH CLAIMS

Nutrition and health claims in the United Kingdom are regulated by Regulation (EC) 1924/2006 and its amending regulations (‘The Nutrition (Amendment etc.) (EU Exit) Regulations 2019’ and ‘The Nutrition (Amendment etc.) (EU Exit) Regulations 2020’) which transferred responsibilities from EU organisations involved in the risk assessment and risk management processes covered by nutrition legislation to bodies in Great Britain (GB).

The Regulation requires that nutrition and health claims made on foods are authorised before being used in Europe. The EU register of authorised claims is on the European Commission’s website. Other key requirements of the Regulation are that:

• Claims must comply with the general rules which include not being false, ambiguous, or misleading; not encouraging or condoning excess consumption of a food; and not implying that a balanced diet cannot provide necessary nutrients.
• If a claim is made, it is obligatory to provide nutrition labelling in most cases.
• Only nutrition claims in the EU Register can be made and only if a product meets with the specific conditions of use for that claim. For example, “low fat” can only be made on a product containing no more than 3g of fat / 100g (for a solid) or no more than 1.5g fat / 100ml (for a liquid).
• Health claims must be authorised and included in the list of authorised health claims in the EU Register before they can be used.
• With limited exceptions, claims must not be made on alcoholic beverages containing more than 1.2% by volume of alcohol.
• Health claims which suggest that health could be affected by not consuming a food cannot be made.
• Health claims which refer to the rate or amount of weight loss cannot be made.
• Health claims which refer to recommendations of individual doctors or health professionals cannot be made on food.