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The EU Food Supplement Regime
December 12, 2011
8 Min Read
by Paul Ranson and Melanie Eggers
Medicinal products in the EU face large regulatory hurdles, so it's critical for dietary supplement manufacturers to ensure their products are not classed as medicinal products, either through how they are presented or through their constituents.
In the EU, medicinal product" is defined in Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use (2001/83) as a substance:
presented for treating or preventing disease;" or
which may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions."1
The "presentation" test will therefore take into account any claims (implicit or explicit) that are made for the product, and the characteristics of its presentation as a whole, based on the impression of the averagely informed consumer.
Claims to relieve symptoms or prevent, cure, remedy or heal a specific disease or adverse condition of body or mind are regarded as medicinal claims and can only be made by medicinal products. On the other hand, claims that a product maintains" or helps to maintain" or supports" health or a healthy lifestyle, or claims made in relation to healthy bodily functions or organs are not likely to be considered as medicinal in themselves.
The "function" test is applied on a case-by-case basis, taking into account all the characteristics of the product, particularly its composition, pharmacological properties, use, the extent of its distribution, consumer perceptions and any inherent risks in its use. A recent case involving the status of red rice established a product that cannot be scientifically established to restore, correct or modify physiological functions by means of pharmacological, immunological or metabolic action cannot be considered a medicinal product.2
Competent authorities decide whether a product is medicinal based on legislation and decisions of the European Court.
Specific Laws Relating to Supplements
Directive 2002/46/EC should be the next consideration, assuming the manufacturer has successfully negotiated the issue of avoiding medicinal product status.
Food Supplement" is defined in 2002/46 to mean, foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients [vitamins or minerals] or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and other similar forms of liquids and powders designed to be taken in measured small unit quantities."3
A key principle is the product must contain only the permitted vitamins and minerals and their sources as listed in the "positive list" comprising the Annexes to 2002/46. Currently, the legislation contains positive lists only for vitamins and minerals. At this stage, other substances do not have such requirements. The vitamins, minerals and their sources permitted for use in food supplements are consolidated under Commission Regulation (EC) No.1170/2009.4
Vitamins or minerals on the list that are subsequently proven to endanger human health can be suspended from the market by member states and removed from the list by the European Commission..5 2002/46 also makes provision for the setting of maximum and minimum levels for vitamins and minerals in food supplements.6
In addition, food supplements must conform to the prescribed purity criteria.7 Dosage must also fall within safe levels established by scientific risk assessment based on generally accepted scientific data.8 A procedure is defined for the submission of requests for substances to be considered for inclusion in the permitted list.9
Herbal Products
Special provisions apply to products that qualify as traditional herbal medicinal products. These are subject to a simplified registration procedure rather than the full rigor applicable to medicinal products generally.10 Manufacturers must submit an application to the competent authority in a member state. The manufacturer does not need to undertake biological testing or clinical trials, or provide evidence of pharmacological properties for a traditional herbal medicine. However, the manufacturer must compile a bibliographic review of relevant safety data, have such safety data available on request by the health authority and commission an expert report,11 unless it is a listed herbal substance already, in which case it is exempt. The data or report must evidence that the herbal medicine has been in medicinal use for at least 30 years, including at least 15 years use within the EU.
The presence in the herbal medicinal product of vitamins or minerals will not prevent the product from being eligible for registration, provided that safety is well documented and the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).
Traditional herbal medicines are, however, still subject to the general principles of quality applicable to medical products, and the same labeling requirements and approvals.
General Food Law and Food Supplements
As a form of food, food supplements will need to comply with not only the requirements in the Food Supplements Directive, but also to certain requirements applying to foodstuffs generally. This is an extensive body of law, but some key measures include the following:
European Regulation No. 1924/2006 regulates nutrition and health claims made on food. This regulation requires nutrition and health claims to be authorized at the EU level. 1924/2006 applies to claims made in any commercial communication, including on labels, leaflets and websites and in advertising.
The Annex to 1924/2006 contains the list of permitted nutrition claims, and the criteria for using them.12 Claims that are not on the list, but would be understood to have the same meaning to consumers as a listed claim may be used. Claims not on the list cannot be used.
A large number of health claims (any claim that states, suggests or implies that health benefits can result from consuming a given food, such as helps build strong bones" or maintains healthy cholesterol levels" or general references to overall health and well-being) are currently being assessed by the European Food Safety Authority (EFSA), which is responsible for evaluating the scientific evidence behind claims. The regulation required the list of authorized health claims to be completed by January 2010, but this deadline has not been met. The EU Commission indicated it will adopt partial lists of authorized claims as EFSAs opinions are published with transition periods, which allow most claims to continue to be used while they are undergoing assessment. These are detailed in EFSA guidance to Regulation 1924/2006.13 Authorized health claims are listed in the Community Register of nutrition and health claims, which will be added to over time.14
Health claims are subject to specific requirements, such as the information that must be provided and certain content that is prohibited. By way of derogation from Directive 2000/13/EC on labeling (which prohibits any reference to properties for the prevention, treatment or cure of a human disease), the regulation authorizes claims concerning the reduction of the risk of a disease, provided that an application for authorization has been approved.15
Guidance in relation to an application for a health claim is provided in EFSA guidance.
The EU Food Labeling Directive 2000/13/EC requires the labeling, presentation and advertising of foodstuffs do not mislead the consumer about its characteristics or effects.16 Nor may the foodstuff be attributed with properties for the prevention, treatment or cure of a human illness. Labels must bear certain information including the product name, the list of ingredients comprising more than 25 percent of the whole and expressed as percentages, the net quantity and the shelf life.
The Novel Food Regulation (EC) 258/97 applies to any product a company may wish to market that contains any ingredients that are new to the EU.17 Novel foods are defined as foods that do not have a significant history of consumption within the EU prior to May 15, 1997, and these are subject to a rigorous pre-market safety assessment.
Those seeking to promote food supplements in the EU will first need to ensure the product does not unintentionally become considered a medicinal product by the relevant competent authorityand each member state is entitled to reach its own decision on this, provided applicable EU laws are applied. Even if successful, manufacturers will still be subject to an onerous regime prescribing the permitted vitamins and minerals and their quantities and the claims that can be made.
References listed on the next page.
Melanie Eggers, associate in Fasken Martineau LLP, London, and member of the technology, intellectual property and life sciences practice groups, is a qualified solicitor and barrister in Australia. Paul Ranson, partner at Fasken Martineau DuMoulin LLP, Toranto, and Fasken Martineau LLP and member of the technology and intellectual property practice group, leads the Life Sciences practice group in London.
References for " The EU Food Supplement Regime"
1. Art.1(2) of Directive 2001/83/EC of 6 November 2001on the Community Code relating to Medicinal Products for Human Use (as amended) (EC).
2. Case C-140/07, Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg of 15 January 2009
3. Article 2a of Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of Member States relating to food supplements (EC).
4. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:314:0036:0042:EN:PDF
5. Art.12 of Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of Member States relating to food supplements (EC).
6. Article 5 of Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of Member States relating to food supplements (EC).
7. Art.4(2) & (4) of Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of Member States relating to food supplements (EC).
8. Art.5 of Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of Member States relating to food supplements (EC).
9. http://ec.europa.eu/food/food/labellingnutrition/nutritional/adm_guidance_safety_substances_en.pdf
10. Art.16 of Directive 2001/83/EC of 6 November 2001on the Community Code relating to Medicinal Products for Human Use (as amended) (EC).
11. Art.16c(1)(d) of Directive 2001/83/EC of 6 November 2001on the Community Code relating to Medicinal Products for Human Use (as amended) (EC).
12. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:012:0003:0018:EN:PDF
13. http://ec.europa.eu/food/food/labellingnutrition/claims/guidance_claim_14-12-07.pdf
14. http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm
15. http://www.efsa.europa.eu/en/efsajournal/doc/530.pdf
16. http://eur-lex.europa.eu/LexUriServ/site/en/consleg/2000/L/02000L0013-20070112-en.pdf
17. http://eurlex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31997R0258&model=guichett
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