January was a particularly busy period for both the food industry and the Member States of the European Union (EU) in terms of the future use of generic health claims on food products. The introduction of the EU Nutrition and Health Claims Regulation in 2006 initiated a Member State process of developing an EU list of generic health claims (the infamous Article 13 list), and the deadline for their submissions to the European Commission passed on 31 January, 2008.

Months before that date, industry too had begun compiling Article 13 'claims dossiers' based on generally accepted scientific data, in the hope that these claims would be accepted by individual Member States and passed on to the Commission as part of their national list. Jointly compiled by European trade organisations CIAA, EHPM, ERNA and the European Botanical Forum, the industry Article 13 list was completed last year totalling more than 700 generic claims dossiers.

With the deadline now passed, Member State submissions are being examined by the European Commission in conjunction with a working group of Member State officials, with the aim of sending a single consolidated list of generic health claims to the European Food Safety Authority (EFSA) by May this year for scientific scrutiny. The final establishment of an Article 13 EU claims list is foreseen for 31 January 2010 at the latest.

What many companies do not realise is that their role in determining whether future health claims make it onto the EU market is by no means redundant. There is still the opportunity to submit health claims dossiers directly to EFSA via the EU Member States, and while it is a route that will require significant company resources, success also offers significant rewards — for companies wanting to submit claims based on proprietary data. An approved substantiation on the basis of proprietary data can be protected for a five-year period. In other words, no other company would be permitted to use the same proprietary data to substantiate a claim.

New health claims applications can be submitted to an EU Member State which will forward it to EFSA for a scientific assessment, and to the Commission and other Member States for their information. EFSA is expected to be able to deliver its opinion within five months if no further information is requested from the applicant.

The European Union's long-term goal is to regulate the use of all claims (generic health claims, nutrition claims, reduction of disease risk claims and claims based on children's development and health) on its market. A health claim is defined as 'any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents'. In some cases, there is a need for interpretation to determine whether a statement should be regarded as a nutrition or generic health claim. 'Contains lycopene' for example, is a nutrition claim, while 'contains antioxidants' and 'contains probiotics' are regarded as health claims. The reasoning is that 'contains lycopene' refers only to factual information and the other statements imply a health effect.

Once the Article 13 list of generic health claims is established, most companies will be making use of identical or similar claims. Companies using claims based on proprietary data will have a distinct advantage in the marketplace, and as per the requirements of the Regulation, consumers will be presented with product claims they can trust.

Article by Pieter Lagae, Regulatory Adviser, EAS, 50 Rue de l'Association, 1000 Brussels, Belgium. Tel: (+32 2) 218 14 70, Fax: (+32 2) 219 73 42, email [email protected], visit www.eas.eu.