EU Health Claims Regulation: Italian Association Files Complaint

In September, FederSalus, an Italian association of health products and manufacturers, filed a complaint in the European Court of Justice against EU Regulation No. 432/2012, the so-called “Permitted List” of allowed Article 13.1 health claims. Issued by the European Commission, this list came into force on June 14, 2012, with a do-or-die implementation deadline for manufacturers of December 14, 2012. After this date, all non-authorized claims (except any listed as “pending”) are prohibited from use in the EU market.

FederSalus summed up the nature of its complaint in an interview with Nutritional Outlook: “Our main arguments [concern] the lack of transparency and the absence of clear rules or guidelines issued by the European Food Safety Authority (EFSA).”

Additionally, FederSalus believes, some of the complex wording EFSA requires for approved health claims are incomprehensible to the average consumer. FederSalus offers the following examples: “Betain […] contributes to normal homocysteine metabolism” and “Molybdenum […] contributes to normal sulphur amino acid metabolism.” The average consumer would probably need a course in nutritional biochemistry to make heads or tails out of health claims such as those, FederSalus says.

FederSalus certainly isn’t the first to file suit regarding the EU’s health claims process. On July 2, two of Europe’s largest trade associations-the UK Health Food Manufacturers Association (HFMA) and the Dutch Natuur-en Gezondheidsproducten Nederland (NDN) organization-filed a legal action in the General Court of the European Union to “halt the restrictive list of permitted health claims which effectively outlaw hundreds of other well-established health claims.”

And therein lies the biggest reason behind  these organizations’ complaints: the high number of health claims EFSA has rejected or that are in regulatory limbo. When asked about the current status of the 44,000 health claims submitted by member states, of which approximately 4,600 were forwarded to EFSA for review, Graham Keen, executive director of the HFMA, provides these updated statistics: 222 claims approved; 2,300 “on hold” (including more than 2,000 botanical claims); and all other claims rejected.

In a July 2012 joint statement released by NDN and HFMA, HFMA chair Martin Last wrote: “From the start, we’ve cooperated in good faith to help execute the Health Claims Regulation, but are now very unhappy with the flawed and inappropriate way that both the Commission and EFSA have decided to implement this legislation. […] It was never intended to prohibit many hundreds of claims that have been well understood and accepted by the average consumer for decades.”

In the same joint statement, NDN chair Mischa Strijder complained that the European Commission “failed to provide clear and timely guidance” with the first regulatory guidance, only issued 18 months after the health claims submission deadline. Strijder also criticized EFSA’s adoption of drug-style standards in its “approach to the assessment of Article 13.1 [health] claims, which is not appropriate for evaluating the long-term, health-maintenance benefits of good nutrition.”

FederSalus, HFMA, and NDN say EFSA’s extremely restrictive approach to Article 13.1 health claims will reduce research and innovation in food supplements and ingredients, provides no clarity on various implementation issues, and makes it challenging for companies to comply with the new regulations and make changes to packaging, labeling, and advertising given the looming deadline and unclear guidance.

HFMA and NPN stated in a stakeholder Q&A to the media, “We are seeking the annulment of the [Article 13.1] permitted list regulation, thereby requiring the Commission to go back and correct the illegalities in its approach and produce another permitted list.”

With the EU being assailed by challenges in both the European Court of Justice and General Court, observers are hopeful that the courts will accomplish what stakeholder/regulator collaboration has not: a way forward for health claims in the EU.