Our food supplement regulatory service is here to help you market products successfully without spending time interpreting complex legislation. Food supplements (also known as nutritional supplements, nutraceuticals or dietary supplements) are covered by import guidelines and European and national law and regulations on food safety; food supplements; enzymes, food additives and flavourings; nutrition and health claims, and novel foods.
From in-depth evaluations of single products and summarising regulatory guidelines, to analysis of entire product lines, we define each project according to your needs:
We can advise whether your product is classed as a food supplement (and the adjustments you may need to comply with the Food Supplement Directive 2004/EC/42) or as a medicine, traditional herbal product or a medical device. We also inform companies of the precise status of ‘grey area’ ingredients such as amino acids, botanicals (particularly non-EU), essential nutrients and enzymes.
We analyse nutrition and health claims and the Scientific Opinions of the European Food Standards Agency (EFSA) to advise how to legally market products and build your strategy.
Labelling and copy reviews
Avena Consultants assess food supplement product labels and packaging copy and create easy to read instructions documents for compliance with UK and EU labelling legislation.
Advertising and marketing reviews
We assess natural product websites and advertising literature to make sure they comply with Advertising Standards Authority (ASA) and CAP codes. We can also supply well-written alternative copy.
Novel food applications
A ‘novel food’ is one with no significant history of consumption within the EU before May 1997. These foods require a pre-market safety assessment in the form of a Novel Food Application or the simplified procedure for ‘substantial equivalence’ foods. Avena consultants compile novel food application dossiers covering history of use, intended purpose, nutritional value, composition, and toxicological and nutritional data.