Supplements in the EU & UK
CERT provides specialist regulatory and technical support across all product sectors, including supplements. We help businesses navigate complex EU and UK requirements with clarity and confidence.
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The EU framework for food supplements is built on the General Food Law (Regulation (EC) No 178/2002) and Regulation (EU) No 1169/2011 on food information to consumers, with specific provisions under Directive 2002/46/EC on food supplements and related implementing and national measures. In Great Britain, the Food Supplements (England) Regulations 2003 and equivalent regulations in Scotland, Wales and Northern Ireland implement Directive 2002/46/EC as retained EU law, alongside wider food safety and nutrition/health claims legislation.
What counts as Supplements
Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form such as capsules, tablets, pills, powders in sachets, liquids in ampoules, or drop dispensing bottles, intended to supplement the normal diet.
They are regulated as food, which means they must meet all applicable food law in addition to the specific supplement rules, and borderline assessments may determine whether a product instead falls under medicinal products, novel foods, or other specialised regimes.
Certain ingredients (e.g. vitamins, minerals and their sources) are restricted to permitted lists under Directive 2002/46/EC and retained UK schedules, while botanicals and other substances may be subject to national conditions, guidance lists or novel food determinations.
Some products positioned as high‑dose supplements, functional foods or performance products may require additional review under the Nutrition and Health Claims Regulation, novel foods regulation or other horizontal legislation.
Core obligations include:
Confirming whether the product qualifies as a food supplement, a conventional food with a claim, a food for specific groups, or a medicinal or novel product, and ensuring any required prior authorisation (e.g. novel food approval) is obtained before placing on the market.
Ensuring formulation compliance by checking that all vitamins, minerals and permitted sources are on the applicable EU/GB positive lists, that other substances are allowed and within national or EU limits, and that additives, flavourings and sweeteners comply with relevant primary legislation such as Regulation (EC) No 1333/2008 on food additives.
Operating and documenting robust food safety management systems based on HACCP principles, supported by supplier approval, specifications, Certificates of Analysis, Declarations/Certificates of Conformity and stability data appropriate to the dosage form and shelf‑life.
Implementing quality control, traceability and recall procedures, and preparing for official controls and market surveillance, including the ability to provide a technical file or regulatory dossier (formulation rationale, safety data, label proofs, claims substantiation) to authorities on request.
Ensuring that any nutrition and health claims comply with Regulation (EC) No 1924/2006 (and GB retained law), are limited to authorised or on‑hold claims, respect the specific conditions of use, and do not attribute to the supplement the property of preventing, treating or curing human disease.