On December 14, 2012, the European Health Claim (HC) Regulation took full effect. The community list of 222 approved health claims applies to all foodstuffs on the market, meaning that new products can only carry these generic health claims listed in EC 432/2012, provided the product in question meets the conditions of use. All other claims will be illegal.
The only remaining exceptions are botanical claims made on products that were on the market before 2007—since the European Food Safety Authority (EFSA) has put evaluation of those claims on hold—and some claims with decisions still pending (e.g., caffeine claims).
However, companies can still apply for individual health claims—the so-called Article 13.5 and 14 claims, which require at least one EFSA-approved, product-specific study substantiating the claimed effect before they can be used.
The new regulation covers all health-related claims made on food products, which, in Europe, includes dietary supplements. Many manufacturers have already responded by preemptively removing most health claims, expecting the watchdog organization to become active immediately following the transition period. At the moment, it is unknown how strictly the new regulation will be enforced.
The HC regulation is not the only new regulation coming into effect in Europe at this time. In 2011, the new food-labeling directive passed EU parliament and will take effect by December 2016. Many manufacturers, faced with the need to change their product labels to comply with the HC regulation, are taking the opportunity to change the labels in accordance with the new labeling directive since they are already changing things, even if it will only be necessary to do so by January 2014 at the earliest.
However, there is some hope the situation won’t be quite so negative for companies following implementation of the new HC regulation. For one thing, in many EU countries, authorities and manufacturers have reached an agreement: products already on the shelves by December 14th can be sold off until they reach their expiry dates, which in the case of dietary supplements can be as long as three years. The consumer will, therefore, experience a gradual phasing out of familiar product claims rather than a hard cutoff.
This is actually quite an ironic development. The HC regulation was devised mainly to do away with the disharmonious regulatory landscape in Europe with regard to claims. Yet, the implementation of the very regulation is being handled quite disharmoniously throughout Europe, as exemplified by the aforementioned agreement in some EU countries. Another example is rooted in the various political systems of many countries. Belgium, for instance, regulates its foods through one national authority for the whole country. In contrast, Germany consists of many federal lands—each with its own authority—all of which may handle the enforcement of the HC regulation differently. Thus, there are international as well as intra-national differences throughout Europe, and this is expected to continue for the next 2-3 years until things even out.
Amid all the agreements and preemptive manufacturer actions, however, there is one segment of the food industry that may be caught somewhat off guard by recent developments: the sports nutrition segment.
Until recently, sports nutrition products in Europe were regulated as a sub-category of foods for particular nutritional purposes (PARNUT), a category that also included products for diabetics, babies and infants and other persons requiring special diets. The PARNUT regulation is currently under revision, and one foreseeable outcome is that sports nutrition will no longer be regulated under this umbrella. Instead, these products will be subject to food regulations in general, and fruit juice regulations and dietary supplement regulations in particular.
This development means the HC regulation now—and quite suddenly—also applies to sports nutrition. This may come as a bit of a surprise to manufacturers, which up until now have been allowed to make quite adventurous health claims on their products (and have used ingredients skirting the edge of being pharmacological, which is not allowed in food products in Europe). As of December 14th, most of these health claims are now illegal. Only some manufacturers have taken an interest in the proceedings and sought consultant help with their product labels, which adds fuel to the impression that many of them may not even be aware of the situation.
All in all, interesting times are ahead of the European food industry, and it is too late for a wait-and-see attitude. Fortunately, experienced consultancies such as analyze & realize are ready to assist manufacturers with label checks, including health claims, as well as mid- and long-term strategies to protect existing market shares of established products, or launching and positioning of new products.
Dr. Joerg Gruenwald is president of analyze & realize ag, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize ag, Waldseeweg 6, 13467 Berlin, Germany, Tel: 49-30-40008100; Fax: 49-30-40008500; E-mail: email@example.com; Website: www.analyze-realize.com.