8. Safety Parameters

Dietary Supplements
United Kingdom (UK)

This section provides the safety parameters (microbiological, contaminants, heavy metals, pesticides, veterinary residues, and food contact materials).

8.1 Microbiological Standards

Microbiological Testing [1]

There are no specific microbiological criteria for food supplements in the UK. The guidance from legislation (EC) 2073/2005 [1] should be followed.

Testing should be carried out on food supplements which are syrups, tonics or emulsions, and other formulations having a high moisture content. Such testing should be carried out over the shelf life period of the product. Microbiological testing should also be carried out as part of the ‘in use’ trials and if necessary as a challenge test to prove preservative efficacy in new formulations. Microbiological testing should also be considered where it is known that raw materials carry a high microbial load.

When microbiological testing is carried out on tablets or capsules, it is probably only necessary to conduct this at the start and end of the shelf life period, due to the low risk associated with these presentations.

8.2 Contaminants and Heavy Metals

The Contaminants in Food (England) Regulations 2013 [2], makes provision for enactment and enforcement of retained UK law in GB, which sets out regulatory limits for contaminants in food and food supplements, such as nitrate, mycotoxins, metals, 3-MCPD, dioxins, and PAHs.

8.3 Pesticides

The category of "Food Supplements" should comply with the regulatory requirements related to Pesticides outlined in Section 8.3 of the "General Foods" guidebook for the UK.

8.4 Veterinary Standards

The category of "Food Supplements" should comply with the Veterinary Standards outlined in Section 8.4 of the "General Foods" guidebook for the UK.

8.5 Chemical Testing

The following types of food supplements must be chemically tested:

• Vitamins and Minerals: assay of individual vitamins or minerals by an appropriate validated and stability-indicating method.
• Herbal/Botanicals: qualitative assessment such as Thin Layer Chromatography (TLC) or Infra Red Spectroscopy (IR) and/or quantitative assay for claimed active constituents. When possible, the assay should be performed by an appropriate validated stability-indicating methods.
• Oil-Based Products (e.g. tests for peroxide value and free fatty acids): assay for claimed active ingredients (EPA, DHA, GLA, and oil soluble vitamins) should be carried out by an appropriate validated and stability-indicating method.
• Syrups: preservatives should be assayed by an appropriate validated stability-indicating method where their presence is required for antimicrobial effect in the product.
• Emulsions: applicable chemical testing, as for oil-based products and syrups. 

8.6 Food Contact Materials

The category of "Food Supplements" should comply with the regulatory requirements related to Food Contact Materials explained in Section 8.5 of the "General Foods" guidebook for the UK.

8.7 References

1. Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R2073

2. Contaminants in Food (England) Regulation 2013

https://www.legislation.gov.uk/uksi/2013/2196/contents/made