List of Permitted Health Claims Enters Into Force in EU
The controversial Regulation, which was adopted on 16 May 2012, foresaw a transitional period allowing food companies to adapt their commercial practices to the new requirements. This transitional period has now expired.
14 Dec 2012 --- From today (14 December 2012) the Health Claims Regulation (EC) No 432/2012 which authorises 222 health claims on food products enters into force.
The controversial Regulation, which was adopted on 16 May 2012, foresaw a transitional period allowing food companies to adapt their commercial practices to the new requirements. This transitional period has now expired.
Only permitted health claims featuring on the list and those which are still under consideration by the European Food Safety Authority (EFSA) can be used on food packaging across the EU. The list of permitted claims is aimed at protecting EU consumers against misleading claims and will ensure a level playing field for food business operators.
The European Commission says that the priority now is to finalise the review of all health claims submitted for evaluation to EFSA (botanicals) which were put “on hold” when establishing the list of permitted health claims.
EU-countries provided national lists of approximately 44,000 health claims to the Commission. These were consolidated into a list of some 4600 claims and sent to EFSA for evaluation. The opinions of EFSA are published in series.
The Commission announced the adoption of the Article 13 list in 2 steps:
1. health claims other than those for botanical substances;
2. health claims for botanical substances.
Since EFSA began returning batches of negative claim assessments in 2009, Innova Market Insights has reported a steady decline in the number of products featuring an “active health” positioning (e.g. “functional and fortified”), with manufacturers instead opting for less dramatic “passive health” claims (e.g. “low and light”). The mass omission of generic Article 13 claims on the European Commission’s “Union List” of health claims resulted in just over 220 approved and more than 2,000 rejected. The global picture also illustrates a lack of innovation growth in functional foods, with the percentage of product launches tracked with a specific active health claim stagnating at around 22% in recent years.
The big winners from EFSA’s Article 13 generic claim batches were the large catalogue of vitamins and minerals, which have a strong history of use and therefore easily passed the EFSA hurdle. The big regulatory losers were the whole host of probiotics, which were all grouped together and dismissed, now forcing suppliers to resubmit dossiers. This has not really held back the probiotic market financially, however, and it remains the largest sector of the functional dairy market, well ahead of the market for cholesterol-reducing dairy products using plant sterols and stanols. But it has certainly forced the major players such as Danone and Yakult to shift their marketing strategy.
The Activia probiotic yogurt brand from Danone, for example, has continued to grow, using its mainstream market positioning and its ongoing program of product and promotional activity. It has taken steps to soften its digestive health claims positioning by dropping its “reduced digestive transit” on-pack and advertising claims and using visual imagery of a stomach instead. In the meantime, an ongoing welter of new product activity has seen lactose-free variants in Scandinavia and Germany, breakfast variants with fruit juice in Spain, Pur variants with just three ingredients (Activia natural yogurt, fruit and raw sugar) in Germany and Greek-Style variants and dessert-style flavors in the UK.
Interestingly, Danone used a very smart strategy to deliberately maintain an immunity claim for Actimel by using vitamin C, rather than probiotics. A line of superfruit (e.g. acerola) containing Actimel products utilizes a list of fruits with high enough vitamin C to meet the RDA for an immunity claim. The original drinks had no fruit juice in them.
Many suppliers are now in the process of resubmitting health claims under company specific Article 13.5 of the Regulation and the industry is still confident that there is a future for functional foods in the EU. A recent poll on FoodIngredientsFirst asked, “is there still a future for functional foods in the EU after the health claims removal deadline of December 14, 2012.” An overwhelming majority (70%) said “yes,” while 30% responded “no.”
Lu Ann Williams of Innova Market Insights is also keen to stress that opportunities still exist for product development. “We now know what the rules are. It is time to stop complaining and about the process, not that it has been perfect and it still isn’t perfect. At least we know that the regulations are strict and we know what we have to work with and look for opportunities there. We know for example that konjac is approved for weight management, but is hardly used in products. I could only find 30 products with a weight management positioning that contained konjac. It is about being creative and focusing on the benefit.”
In 2006, the European Responsible Nutrition Alliance (ERNA) contributed to the establishment of this list and welcomes it as a tool that will help companies provide correct and accurate communication about the many health benefits of vitamins and minerals, omega 3 fatty acids and some other ingredients.
Despite the delayed establishment of this list, the application of the Nutrition and Health Claims Regulation remains complex and interpretations on a number of its provisions are seen to differ between Member States. ERNA has therefore developed a guidance document on how to apply the Nutrition and Health Claims Regulation in a number of situations.
“One of the aims of this legislation is to create a uniform set of rules for the whole of the EU,” said ERNA Chair Catherine Mignot. “Companies, however, are confronted with aspects that have not been clarified or that remain subject to differences of opinion among the Member States. The ERNA guidance intends to provide clarity on a number of aspects to help companies apply the requirements in a correct and responsible way.”
The guidance covers elements such as which claims fall within the scope of the legislation, flexibility of wording, communication to professionals and how to apply the general conditions of use for approved claims.
“This guidance contains information that will help companies, in particular small and medium-sized companies, to apply those elements of the legislation that are particularly difficult,” explained ERNA Secretary-general Patrick Coppens. “The information is compiled from existing EU and national guidance, legal opinions and outcomes of discussions with and between Member States. We hope that it will help to create a uniform basis for enforcement and avoid the need for companies to adapt communication on a country-to-country basis.”
The guidance document wilis downloadable at www.erna.org
“Health Traffic Jam” is one of the key trends identified by Innova Market Insights for 2013. For more information contact@innovami.com
