The EU’s Article 13.1 for general health claim regulations started on June 14 this year and from December 14, 2012, any claims that are not authorized and not on hold/under consideration will be prohibited. This closes the door on many long-used health claims and more than 1600 proposed health associations were not authorized. However, products with a vitamin nutrient profile were among the winners under the allowed health claims.

In Leatherhead Food Research’s FoodCom newsletter published in November/December , Luke Murphy, principal regulatory advisor, says with the publication of the article 13.1 health claims list and its application from the 14 December 2012, the legislation will finally have teeth, and most nutrition and health claims which are not approved will have to be removed from product labels.

Mr Murphy says: “The elephant in the room, however, remains botanical health claims. A number of these claims are currently ‘on hold’ while the European Commission has the difficult decision of what exactly to do with them. This means that many of these claims currently sit in a transitional period with no defined endpoint. This period is likely to be extended by the recent and controversial resignation of the EU health commissioner John Dalli.

“The EU regulation was intended to include botanical health claims, though it became apparent that there was overlap with an existing framework for traditional herbal medicines. This presents both regulators and food marketers with a problem. Under Directive 2004/24/EC on traditional herbal medicinal products, it is not required for companies to prove efficacy. Any pharmacological effect is considered plausible based on traditional use only (traditional use is defined here as at least 30 years of medical use, at least 15 of which must be within the EU).

“Any medicine must of course undergo a strict pre-market authorization procedure which includes a stringent safety assessment. However, once registered, these herbal medicines must detail information on their intended therapeutic use. An example would be celery seed – registered in the UK with the traditional use ‘relieves rheumatic aches and pains’. Under food law, to sell the same celery seed as a food supplement and to make a health claim such as ‘celery seed helps maintain healthy joints’ the food business operator would need to submit a comprehensive dossier to EFSA for assessment. There is no such barrier medicines law although the work involved in authorizing any medicinal product should not be underestimated.

“It became clear when the first health claim opinions for botanicals were published that the burden of proof required to substantiate these claims was very high, to the point that all of the botanical claims subject to this initial assessment were rejected. This is when the European Commission began its reflection process.” Mr Murphy says a recent discussion paper suggests two options are being considered by the EC.

The first is to proceed with the existing food law framework, and continue to assess the botanical claims under the existing food framework. The most likely outcome of this will be that all (or nearly all) of the submitted claims will be rejected, and added to the EU register as ‘non authorized health claims’. There will then be a six month transition period for removal of these claims.

The second option is to reassess the scope of the legislation; perhaps allowing traditional use to be considered in the substantiation of botanical health claims. This may allow claims to be made for these botanical products, with a lower burden of proof than that required currently. This could however create a two tier regulatory system; the gold standard being applied to most health claims, and a simplified procedure based on traditional use for botanicals. These are challenging times for food marketers. Much has been decided since the original legislation was published and no doubt the regulatory landscape will change again when enforcement really starts (at least for non-botanical claims) in December 2012.

Leatherhead says now that the 222 harmonized and scientifically-substantiated Article 13.1 health claims have been published, it is even more important for the food industry to focus on establishing new scientific evidence for future health claim applications under Article 13.5 or Article 14. UK-based Leatherhead Food Research provides a regulatory advisory service spanning over 100 countries. Please contact legislation@leatherheadfood.com for further information.