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Nutraceuticals Regulatory Compliance.

The term "nutraceuticals" is often interchanged with "functional foods" even though there are subtle differences between the two.

Nutraceuticals are "naturally derived bioactive compounds that are found in foods, dietary supplements and herbal products, and have health promoting, disease preventing, or medicinal products"¹
Functional foods are foods which contain an ingredient that gives that food health-promoting properties over and above its usual nutritional value, for example, probiotic yoghurts.

"Nutraceuticals" appears to be the favoured term used by industry which includes functional foods and supplements. As yet the term has no legal status in EU or UK Law but they are subject to existing EU food laws which are implemented on a national basis. This can make it particularly challenging for a company to determine the best route to market.

Companies also have to consider whether the food or ingredient could be classed as "novel" and therefore require authorisation under the EU procedures for novel foods (regulation (EC) No 258/97).

To avoid any confusion, it is important that companies consult professionals, such as Global Regulatory Services, who are familiar with the regulations of governmental bodies such as the MHRA (UK Health Authority) or the Food Standards Agency (FSA).

Please refer to our nutraceuticals services for further information or contact us to discuss your specific regulatory compliance requirements.

¹Source: Nutraceuticals Institute

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