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By Patrick Coppens
On May 17 the European Parliament (EP) voted in favor of 2 pieces of legislation tightening the rules for functional foods and food supplements manufacturers in Europe and exporting to Europe: (1) the “Nutrition and Health Claims Regulation” and (2) the “Regulation on the Addition of Vitamins and Minerals and of Certain Other Substances to Foods”.
The adoption of these 2 measures by the Parliament did not come as a surprise. In the course of the week before compromise packages had been agreed between the Parliament and the EU’s Member States (Council). While in first reading on the claims proposal, the Parliament had rejected the concept of nutrient profiles and pre-marketing authorization procedure, the proposals by the Council were now accepted with only slight modifications. With the Council set to approve the texts within the next 3 months, one can already make a good analysis of the challenges that await food supplements (aka dietary supplements in the United States), especially those containing botanicals, on the European market.
Nutrition and Health Claims Regulation
The main observations that one could make on the Claims proposal are that the rules are tight but that the text is far from complete. Many aspects still have to be clarified or filled in. The only concrete part of the Regulation concerns the annex with nutrition claims. The setting of nutrient profiles may still take 2 years. Three years are foreseen for the finalization of the list with so-called ‘generic’ claims (see below). And more fundamentally, it is not even clear what level of evidence will be acceptable for the substantiation of a claim and what will be the criteria to approve or disapprove a claim.
Companies therefore need to become aware of the consequences for their product portfolio and start working to get their claims and products introduced and accepted under the new rules.
Nutrition claims:
The Regulation’s annex contains the criteria for 23 nutrition claims. These relate to energy, fat, sodium/salt, sugar, fiber, protein, minerals and vitamins and other substances. Some nutrition claims that are widely used today, including those relating to omega-3 fatty acids and glycemic index are not included. This means that after the transition period these claims will no longer be allowed on the product label and advertising, unless a dossier supporting the claim is introduced and accepted for inclusion in the annex.
‘Generic’ Health Claims:
This concerns health claims describing or referring to the role of a nutrient or other substance in growth, development and the functions of the body, or to psychological and behavioral functions, or to slimming or weight-control. The Regulation specifies that all the claims should be based on generally accepted scientific evidence and be well understood by the average consumer. This includes the bulk of the health claims currently used and they will all need to be included in a list or they will disappear from the market. Work to compile the list is being shared by industry. EHPM (European Federation of Associations of Health Product Manufacturers, www.ehpm.org), ERNA (European Responsible Nutrition Alliance, www.erna.org) and CIAA (Confederation of the Food and Drink Industries of the EU, www.ciaa.be) have joined forces to compile a list with such claims based upon submissions from their members. They have developed a joint methodology on how to make submissions for inclusion in the list and established a deadline of the end of 2006 for this to be complete. This work will include claims for botanicals.
Other Health Claims:
Health claims based on newly-developed scientific evidence and/or which include a request for the protection of proprietary data shall be adopted following an accelerated or fast-track procedure. This procedure is the result of a compromise to have a more speedy procedure for approving new claims. If applied, a new claim could be approved within 7 months. It remains to be seen if and how this will work in practice.
Reduction of disease risk claims and claims relating to children’s development and health will need to follow the full procedure, which is estimated to take at least 9-12 months.
Regulation on the Addition of Vitamins and Minerals and of Certain Other Substances to Foods
This Regulation deals with the addition of nutrients to foodstuffs. In parallel with
the Food Supplements Directive1 in place since 2002, the Regulation specifies the conditions and requirements for the addition of vitamins and minerals to conventional foods. An important element is that maximum levels will be established, as will be the case for food (dietary) supplements. In order to facilitate this exercise, the European Commission recently published a discussion paper for public comment by September 30. 2
A second part of the addition of nutrients Regulation deals with other substances. It contains the so-called “scrutiny list”, a mechanism to control the use of certain other substances, including botanicals, which are added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of these substances at levels greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers. The use of such substances could be prohibited, restricted or made subject to certain conditions of use.
The European Botanical Forum
The European Botanical Forum, a joint forum created by ERNA and EHPM, has proposed a model for the substantiation of claims for botanicals. Associations and companies have been invited to introduce claims for botanicals, using this agreed methodology. A key element is the acceptance of traditional use and grading of levels of evidence for efficacy. Under the recently adopted Traditional Herbal Medicinal Product (THMP) legislation 3, proof of efficacy would not need to be submitted for THMPs if manufacturers can document tradition of use. However, this principle is not foreseen under the claims Regulation for food supplements. This means that it is likely that botanical food supplements would need more proof than THMPs before they can be put on the market, i.e. if the product carries a claim. (This legislation is a claims approval procedure, not a product approval one, but of course, without a claim, many products would appear meaningless to those consumers who lack the necessary background knowledge of the activity or benefits of the ingredient.)
The European Botanical Forum will be instrumental for the development of the claims list for botanicals, the application of the scrutiny list, and the novel food revision that is scheduled to start by the end of this year.
With the claims legislation now close to final, companies should start analyzing the consequences of this new legislation for their product portfolio and start the necessary work to safeguard their claims and/or products for the European Market. This is especially relevant for manufacturers of botanical food/dietary supplements.
Patrick Coppen is a consultant with the European Advisory Services (EAS), a Brussels-based consultancy specializing in regulatory advice on nutritional issues. EAS has been advising private and public organizations on regulatory strategies for over 14 years. More on EAS at http://www.eas.be; e-mail: info@eas.be.
References
1. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L183/51 12/07/2002); http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:183:0051:0057:EN:PDF.
2. Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs, June 2006; http://ec.europa.eu/food/food/labellingnutrition/supplements/discus_paper_amount_vitamins.pdf.
3. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use; (OJ L136/85 30/04/2004); http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:EN:PDF.
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