"Extra Light!", "Contains antioxidants", "Cholesterol free", "Meets your daily omega 3 needs", "With probiotics to strengthen your immune system". Claims about nutrition and health benefits are becoming increasingly popular in the food industry. In fact, even trademarks can be construed as health or nutrition claims.
Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (hereinafter, the "Regulation") is intended to ensure a high degree of consumer protection and fair competition. The Regulation entered into force on 1 July 2007 and was immediately applicable as from that date but required significant implementation and provided for several transitional measures for nutrition and health claims.
Needless to say, the situation has changed since the entry into force of the Regulation. Indeed all transitional measures for nutrition claims expired on 19 January of this year. The Belgian Food Safety Agency (Agence Fédérale pour la Sécurité de la Chaine Alimentaire/Federaal Agentschap voor de Veiligheid van de Voedselketen) now has unrestricted powers to check whether the nutrition information provided on a product label or in an advertisement complies with the Regulation.
Therefore, if they have not already done so, all players in the food industry should take a close look at the Regulation's - unfortunately often unclear – provisions and review their nutrition and health claims in order to ensure regulatory compliance.
Nutrition and health claims
The Regulation distinguishes between nutrition claims (i.e., any claim that states, suggests or implies that a food has particular beneficial nutritional properties due to the absence of, or increased or reduced percentages of, calories, nutrients or other substances) and health claims (i.e., any claim that states, suggests or implies that a relationship exists between a food category, a particular food or one of its constituents, on the one hand, and health). The difference between these two types of claims may not always be so clear in practice. The term "antioxidant", for example, is often associated with substances in food or with specific foods ("rich in antioxidants"); however, this term actually refers to any substance that prevents or slows down oxidative damage to the human body. Hence, the claim "contains antioxidants" is in fact a health claim.
One of the key objectives of the Regulation is to ensure that all nutrition and health claims made in the EU are clear and substantiated by sufficient scientific evidence. The idea is to work with exhaustive lists of permissible claims. Any claim not covered by these lists will in principle be prohibited. Claims are first submitted to the European Food Safety Agency ("EFSA"), which is responsible for verifying the scientific basis of submitted claims. EFSA's opinions are in turn used by the European Commission and the Member States in order to determine whether to authorise a particular claim and include it on the lists.
As indicated above, all transitional measures for nutrition claims have now expired. The only authorised nutrition claims are those contained in the Annex to the Regulation, as amended by Regulation (EC) No 116/2010. Click here to view an updated list of authorised nutrition.
The situation is less clear-cut as far as health claims are concerned. There are several categories of health claims:
- claims referring to a reduction in a risk factor for the development of a disease;
- claims referring to children's development and health;
- claims based on newly developed scientific evidence and/or which include a request to protect proprietary data; and
- general-function health claims (e.g., calcium strengthens bones).
The first three categories of claims are subject to a specific authorisation procedure. For the last category, which is by far the largest, the Member States had to submit lists of claims by 31 January 2008 to EFSA. Approximately 44,000 claims were submitted in total. EFSA reduced this number to just 4,637, of which slightly over 500 have been assessed thus far. EFSA rejected many of the claims (e.g., all general-function health claims relating to probiotics or antioxidants) on the ground that they were insufficiently substantiated. Some of these claims may be reassessed following the submission of additional scientific evidence by the Member States.
The initial plan was to adopt a regulation listing all authorised general-function claims no later than 31 January 2010. Needless to say, the Commission is running behind schedule. It is now unclear whether it will pass regulations containing exhaustive lists of health claims in "batches", on the basis of EFSA's opinions. The Commission has indicated that it intends to do so, but there is an active lobby against the piecemeal adoption of general-function health claims lists. A list of rejected – and hence unauthorised – health claims will also be published.
It goes without saying that the transitional measures for health claims are automatically extended. In brief, health claims which are allowed under national law may continue to be used, provided they also comply with the Regulation's general provisions. Of course, there is substantial legal uncertainty in this regard. In this context and during the transition period, the Belgian Royal Decree of 17 April 1980 on the advertising of foodstuffs remains in force. This royal decree, which is currently under review, contains very restrictive provisions.
The system put in place by the Regulation is due to be assessed no later than 19 January 2013. However, given the very slow implementation of the Regulation, no significant revision is expected in the coming years. National food safety agencies will continue to verify compliance with the Regulation.