3. Compositional Aspects
- 3 Mins to read
- DarkLight
3. Compositional Aspects
- 3 Mins to read
- DarkLight
Article summary
Did you find this summary helpful?
Thank you for your feedback
Dietary Supplements
United Kingdom (UK)
This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.
3.1 Composition Requirements
The UK does not have any national legislation setting maximum levels for vitamins and minerals and vitamin and mineral substances that may be used in the manufacture of food supplements. However, there is a voluntary guideline for safe upper levels which is based upon a report issued in 2003 by the Expert Group on Vitamins and Minerals (EVM) [1].
Botanicals
The UK is not proactive in setting maximum levels for inclusion of botanicals but depends instead upon the general requirements in EU Regulation 178/2002 [2] that food manufacturers must ensure the foods they sell are safe. Hence, the amount used in a dietary supplement should be based on the GMP (Good Manufacturing Practice) principle at a level sufficient to meet the intended benefits and ensure safety for consumption following the recommended daily dosage of the supplement.
In principle, the onus does not rest with the Government to prove a product is unsafe. It is for the manufacturer/FBO to prove their product is safe and this can be done through validated risk assessments. As a guideline, the UK has developed Guidance on Food Traceability, Withdrawals and Recalls [3] which basically set out the legal requirements of Regulation (EC) No. 178/2002 and also best practices.
Products containing botanical substances may fall under a medicinal product depending on the substance, its form, and its claims. The Medicines and Healthcare Products Regulatory Agency (MHRA) has produced a guide to what is a medicinal product (March 2020) [4]. If it is not clear whether a product containing botanical substances should be regulated as a food supplement or as a medicinal product, the manufacturer may contact the Medicines Borderline Section at MHRA (email: borderline_medicine@mhra.gsi.gov.uk).
3.2 Raw Material Requirements
Only vitamins and minerals listed in the Annexes to the Food Supplement Directive may be used. A consolidated list is available on the European Commission's website [5].
For other substances such as essential fatty acids, amino acids, or other nutrients or botanicals, there are currently no positive lists and these continue to be available in food supplements. However, all substances are required to adhere to the generic areas of the legislation concerning safety.
3.3 Fortification
N/A
3.4 Other Permitted Ingredients
Please refer to Section 3.4 of the "General Foods" guidebook for the UK.
3.5 Permitted Additives
Please refer to Section 3.5 of the "General Foods" guidebook for the UK.
3.6 Permitted Flavors and Colors
Please refer to Section 3.6 of the "General Foods" guidebook for the UK.
3.7 Permitted Processing Aids
The category of "Food Supplements" follows the same requirements for processing aids as outlined in Section 3.7 of the "General Foods" guidebook for the UK. Additionally, the below applies:
Extraction solvents used for the preparation of botanical extracts and any solvent residual limits must be fully compliant with the legislation on extraction solvents for use in foods.
3.8 Additional Notes
Please refer to Section 3.8 of the "General Foods" guidebook for the UK. Additionally, the below applies:
Prohibited Substances and Controlled Substances at National UK level – Food Supplements
Presently there are two substances that are either prohibited or controlled at the national UK level for food supplements (i.e. the Kava-kava in food (England) regulations 2002 [6] and the Tryptophan in food (England) regulation 2005 [7], including their equivalent legislations in Scotland, Wales and Northern Ireland.
There is also a list of banned and restricted list of herbal ingredients published on 18 December 2014, which includes the legislation around the species Senecio [8]. It is illegal to sell 2,4-dinitrophenol (DNP) for human consumption in the UK. Previously it has been sold as a diet pill for weight loss; however, it is a highly toxic industrial chemical and is not fit for human consumption.
3.9 References
1. Safe Upper Levels
https://cot.food.gov.uk/sites/default/files/vitmin2003.pdf
2. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down general principles and requirements of the food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety
https://www.legislation.gov.uk/eur/2002/178/introduction
3. Guidance on Food Traceability, Withdrawals and recalls within the UK Food Industry
4. A Guide to What is a Medicinal Product (March 2020) (MHRA)
5. Levels of vitamins and minerals
https://food.ec.europa.eu/saftey/labelling-and-nutrition/food-supplements_en
6. Kava-kava in Food (England) Regulation 2002.
https://www.legislation.gov.uk/uksi/2002/3169/contents/made
7. The Tryptophan in Food (England) Regulations 2005
https://www.legislation.gov.uk/uksi/2005/2630/contents/made
8. Banned and restricted herbal ingredients 2014
Was this article helpful?