Regulatory-wise, the EU Commission, supported by European Food Safety Agency (EFSA), establishes maximum limits for vitamins and minerals in food supplements for different population groups to ensure a correct daily intake that will not pose a risk of adverse health effects.

Annex I to the Directive 2002/46/EC frames the regulatory threshold, however, each EU Member State has the power to impose a stricter approach of any element, reducing the maximum levels

Additional Additional substances can be allowed in FS after a favourable safety assessment; those are, however, often subject to national regulations.

Annex II to the above Directive contains a list of permitted sources for these vitamins and elements, which cannot be changed by the Member States.

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Ingredients not included in any of the above-mentioned groups are classified as “other substances”.

OTHER SUBSTANCES:

Their use can be restricted or banned by the European Union following Regulation 1925/2006, in case scientific research finds an adverse effect on human health. If this is the case, they would be part of the Annex III of the mentioned Regulation, listing them for public reference.

The lack of a specific EU-level restriction does not preclude substances from being regulated by national legislation within EU Member States..

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Food additives specifically are regulated by Regulation EC 1333/2008, as they are recognized as not essential yet important ingredients in the food industry. They are also subject to national regulations, if applicable.

Check if your formula is compliant with the EU standards and Regulations!

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