On May 17 the European Parliament (EP) voted in favour of two pieces of legislation that will affect in great detail the life of functional foods and food supplements manufacturers in Europe and exporting to Europe: The Nutrition and Health Claims Regulation and the Regulation on the Addition of Vitamins and Minerals and Other Substances to Foods.
The adoption by the Parliament did not come as a surprise since in the course of the week before a compromise package had been agreed between the Parliament and the EU’s MemberStates. While in first reading the Parliament had rejected the concept of nutrient profiles and pre-marketing authorisation procedure, these were now accepted with only slight modifications. With the Council now to approve the text within the next three months, we can already make a good analysis of the challenges that await functional ingredient manufacturers on the European market.
The main observations that one could make, are that the rules are tight and the text is far from complete. Many aspects still have to be clarified or filled in. It is not 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. The only concrete part of the Regulation concerns the annex with nutrition claims. The setting of nutrient profiles may still take two years and three years are foreseen for the finalisation of the list with so-called ‘generic’ claims.
So now the single big issue at stake for companies is to become aware of the consequences for their product portfolio and start working on the dossiers to get their claims and products introduced and accepted under the new rules.
The Regulation’s annex contains the criteria for 23 nutrition claims. These relate to energy, fat, sodium/salt, sugar, fibre, 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 they will have to disappear from the product label and advertising, unless a dossier supporting their use 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 behavioural functions, or to slimming or weight-control. All the claims should be based on generally accepted scientific evidence and be well understood by the average consumer. This is the bulk of health claims currently used on foodstuffs and they will all need to be included in a list or will disappear from the market. Work to compile the list is being shared by industry. EHPM, ERNA and CIAA 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.
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.
Once set, nutrient profiles will identify what foods can or cannot carry nutrition and health claims, based on their composition. Although the Parliament provided one exemption, concerning products exceeding the nutrient profile for one nutrient (on condition that in close proximity to, on the same side and with the same prominence as the claim it is also stated that the product is ‘high in’ that nutrient), it is feared that many foods that are carrying claims today will be targeted.
Furthermore, the concept of nutrient profiles will also affect the Addition of Nutrients Regulation so that also the addition of vitamins and minerals to such foods may no longer be possible in the future.
With this legislation now close to final, companies should start analysing 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 functional ingredients.
European Advisory Services (EAS) is Brussels based consultancy specialising in regulatory advice on nutritional issues. EAS has been advising private and public organisations on regulatory strategies for over 14 years. For further details on EAS services visit the web-site: http://www.eas.be. Or you can contact: EAS – Strategic Advice on Nutritional Products, Rue de l’Association 50, 1000 Brussels, Belgium Tel: +322 218 1470, Fax: +322 219 7342, E-mail: email@example.com
 EHPM: European Federation of Associations of Health Product Manufacturers, www.ehpm.org
 ERNA: European Responsible Nutrition Alliance, www.erna.org
 CIAA: Confederation of the Food and Drink Industries of the EU, www.ciaa.be