The European health claim regulations continue to make headlines. Most of these headlines are negative, ranging from complaints about increased costs for manufacturers who wish to market a new product with a health claim, to stifled innovation. And there is certainly reason to complain: The European Food Safety Authority (EFSA) is rejecting more claims than it is accepting, especially product-specific health claims based on proprietary clinical studies. In fact, the entire segment of probiotic health products is effectively being blocked by EFSA, since none of the probiotic claim applications have been approved.
Another criticism is that EFSA is taking too harsh a stance, expecting drug-level substantiation for food-based effects. Even many well-established generic claims (Article 13.1) were rejected during EFSA’s batch-wise evaluations.
However, it is not all doom and gloom. Of the aforementioned Article 13.1 (generic) claims, several have received positive EFSA opinions, and, as soon as the European Commission compiles its positive list and definitive claim wordings based on these opinions, these claims will be free for anyone to use on products containing the respective ingredients. So far, this mostly concerns vitamins and minerals, since the botanical 13.1 health claims have not been evaluated yet. But if the conditions of use are met, (i.e., if the vitamin or mineral in question is contained in the product in the specified amount), any approved health claim for the ingredient can be used.
Many of the approved Article 13.1 health claims apply to several ingredients, which means a lot of vitamins and minerals can carry the same claim. It is therefore possible to pick a claim, (e.g., “supports normal function of the immune system”) and formulate an immune drink containing those vitamins and minerals from EFSA’s approved 13.1 health claims, which have received positive opinions for that claim.
For this example, the list of possible ingredients is quite long: vitamins A, B6, B9, B12, C and D, as well as zinc, selenium, copper and iron all have approved EFSA evaluations for the support of the normal function of the immune system. Just pick one (or several) of them, add it in the required amount (usually the condition of use is “source of,” (i.e., 15% RDA of the respective ingredient), and make a strong immune claim on your product.
By the same token, since most ingredients have several approved generic health claims, you could also take, say, four ingredients and just use different claims for a whole range of EFSA-approved health claims. Just add vitamins A, C, D and B12, and claim “vision,” “collagen formation,” “maintenance of normal muscle function,” and “normal function of the immune system,” and you could have, for instance, a nice all-around functional drink.
Or you could go by positioning. Want to make a beauty bar? Just browse the claim list, pick anything that has a beauty-specific claim (in the preceding example, vitamin C and “collagen formation”) and mix and match.
Of course, those are not the claim wordings that will appeal to consumers. So far, the EFSA claim wordings reflect the scientific evidence, nothing more. The final wordings, which are expected to be more consumer-friendly, will be approved by the European Commission by the end of 2011, or the beginning of 2012, along with EFSA’s opinions.
The functional food sector in Europe is already making use of this opportunity. Functional juice maker Multi12 GmbH, for example, is marketing a new range of fruit juices fortified with ingredients such as magnesium, iron and various vitamins. By adding these ingredients, the company can market a juice “for muscles and bones,” another “for protection of the cells,” and yet another “for the digestion.”
Those are pretty good claims, considering that all the manufacturer has to do is add some vitamins and minerals. No product-specific studies, no claim application, no long wait for approval. And above all, no risk of rejection, provided the conditions of use are met.
Many more such uses of the Article 13.1 health claims are expected to turn up on the market in the near future, both for the functional food and the dietary supplement categories. All a manufacturer needs for this strategy is knowledge of EFSA’s opinions so far, as well as the guidance of experienced consultancies such as analyze & realize to identify relevant ingredients and appropriate claims.
Eurotrends: The Silver Lining in Europe’s Claim Regulations
There are plenty of ways to get the most out of Article 13.1 claims.
By Joerg Gruenwald