Sport nutrition is tightly regulated in the European Union and, depending on composition, products can fall either under (1) food law or (2) medicines law. The latter scenario concerns only products presented as having properties for treating or preventing disease in human beings or products containing substances having the effect of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.
ESSNA engages with all this legislation and seeks to influences those pieces that have a significant impact on sport nutrition innovation, manufacturing and marketing.
The production, processing, distribution, retail, packaging and labelling of food stuffs is governed by a considerable body of laws, regulations, codes of practice and guidance. Much of the detailed legislation on food standards originates today in the European Union.
In short all products placed on the EU market – including sport nutrition products – must comply with general food legislation which includes general safety requirements (risk analysis, traceability, withdrawal, recall and notification, precautionary principle), general labelling requirements (name of food, list of ingredients, quantity, use-by date etc.), nutrition and health claims rules (authorisation procedures), food additives, flavourings and enzymes regulations, as well as specific requirements on the addition of vitamins, minerals and other substances to foods.
In addition to general food legislation, certain sports nutrition products may be subject to other particular pieces of legislation. Depending on the marketing of a sports nutrition product, it could come within the scope of the Food Supplements Directive or the Fortified Foods Regulation – each containing specific compositional and labelling requirements. A sports nutrition product could even fall under the Novel Foods Regulation if a new food/ingredient is put on the EU market that has not been used before 5th May 1997.
EU legislation is being transposed, enforced and, where needed or deemed opportune, complemented at national level. In the UK for example, Trading Standards visit manufacturing and retail facilities to ensure that all of these requirements have been adhered to.
Please find below a non-exhaustive list of EU food legislation that sport nutrition products have to comply with:
General Food Law
- General principles of food law
- Additives Regulation
- Flavouring Regulation
- Enzymes Regulation
- Contaminants Regulation
- Food Information to Consumers Regulation
- Nutrition and Health Claims Regulation
- Fortified Foods Regulation
- Foods for Specific Groups (weight reduction food)
- Food Supplements Directive
- Novel Foods
Medicines are regulated in the EU by Directive 2001/83/EC on the Community code relating to
medicinal products for human use. As mentioned above, this Directive defines a ‘medicinal product’ as:
Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;
Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
The general principle established by that regulation is that no medicinal product may be placed on the market of a Member State unless an authorisation has been issued by the competent authorities of that Member State or by the European Medicines Agency. The authorisation is valid for five years and is renewable.
In case of doubt – when it is uncertain whether a product falls under food or medicines law – borderline situations are solved by relevant competent authorities.
It is also worth noting here that certain products may fall under a simplified registration procedure established by the Traditional Herbal Medicinal Products Directive. This procedure is intended for herbal medicinal products with a long tradition, provided that there is sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the Community.
Member State competent authorities
- Austria: Federal Ministry of Health
- Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
- Bulgaria: National Centre of Public Health Protection and Ministry of Health
- Croatia: Ministry of Health
- Cyprus: Ministry of Health
- Czech Republic: Ministry of Agriculture and Czech Agriculture and Food Inspection Authority
- Denmark: Danish Veterinary and Food Administration
- Estonia: Veterinary and Food Board
- Finland: Finnish Food Safety Authority Evira
- France: Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail
- Germany: Federal Ministry of Food and Agriculture
- Greece: Hellenic Food Authority
- Hungary: National Institute of Food Science and Nutrition and Ministry of Agriculture
- Ireland: Food Safety Authority Ireland
- Italy: Health Ministry
- Latvia: Food and Veterinary Service
- Lithuania: Ministry of Health and Food and Veterinary Service
- Luxembourg: Ministère de la Santé
- Malta: Competition and Consumer Affairs Authority
- Netherlands: Netherlands Food and Consumer Product Safety Authority
- Poland: Chief Sanitary Inspectorate
- Portugal: Autoridade de Segurança Alimentar e Económica and Ministerio da Agricultura, do Desenvolvimento Rural e das Pescas
- Romania: National Institute of Public Health and Ministry of Agriculture and Rural Development
- Slovakia: Public Health Authority and State Veterinary and Food Administration
- Slovenia: Ministry of Agriculture, Forestry and Food
- Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad and Agencia Española de Consumo, Seguridad Alimentaria y Nutrición
- Sweden: National Food Agency
- United Kingdom: Food Standards Agency and Department of Health