E.F.S.A. ? N.O.P.E.!

Courtesy of the SupplySide Community

By James J. Gormley

Let me start off by saying that EFSA (the European Food Safety Authority) and I go way back, as it were.

As a natural products industry regulatory officer, while I found having to not only go through individual European Union (EU) member states (countries) but also specifically through each country’s version of the U.S. Food and Drug Administration (FDA) to be maddening and frustrating, I happened to ultimately achieve success with the EFSD (European Food Supplements Directive) derogation requests that I submitted in over 20 EU countries. The ingredient form for which I submitted dossiers was, in fact, eventually added to Annex II of the EFSD and ultimately received a Positive Opinion from EFSA, meaning that that particular ingredient form is good to go in the 27 countries of the European Union.

However, as a health freedom advocate and industry association member, I---along with the U.K.’s Health Food Manufacturers Association (HFMA), Citizens for Health (CFH) and others---agreed with the European Court of Justice (ECJ) which, in an April 2005 ruling, said that EFSA’s procedures "had the transparency of a black box" and recommended that the EFSD be invalidated.

On top of that, recent research by the watchdog, Corporate Europe Observatory (CEO), found that 11 of the 20 experts on EFSA’s food additives panel (ANS), for example, have a conflict of interest as defined by the Organization for Economic Co-operation and Development (OECD).

CEO is calling for stricter rules on the way conflicts of interest are handled at EFSA, and in the report compares EFSA's approach to conflicts of interest with the new rules at EFSA’s sister agency, the European Medicines Agency. “If these new rules, although far from perfect, were applied at EFSA,” said CEO, “four of the experts on the ANS panel would be disqualified from sitting on the [EFSA] panel.”

Into this maelstrom comes the regulation on nutrition and health claims made on foods, which went live on January 19, 2007. The regulation, EC No. 1924/2006, has 37 clauses, 29 articles and an annex for nutrition claims and related conditions. The three main types of health claims are referenced in Articles 13 and 14.

The focus of industry angst over this regulatory Cirque du Soleil is that 80 to 95 percent of health claims submitted have received a negative opinion from EFSA, a fact which has angered a number of Members of European Parliament (MEPs), who voiced their criticisms of EFSA’s approach to health claims at an April 20^th workshop in Brussels, noting that EFSA’s evaluation of health claims endangers consumer choice and hurts small- and medium-sized supplement and ingredient businesses.

According to Dr. Joerg Gruenwald, head of the German consultancy, analyze & realize (http://www.analyze-realize.com/en/contact/): “The evaluations by EFSA are not yet legally binding. The positive list of generic claims has to be enforced by the EU Commission, which is expected to occur by the end of 2011; the transitional period for negatively evaluated claims will therefore end by mid-2012.”

In the spirit of “You gotta be in it to win it,” there is now (until August 31^st) an open period for industry comments to EFSA on three separate “draft guidances”:

• health claims related to antioxidants, oxidative damage and cardiovascular health (http://www.efsa.europa.eu/en/consultations/call/nda110426a.htm);
• health claims related to bone, joints and oral health (http://www.efsa.europa.eu/en/consultations/call/nda110426b.htm); and
• health claims related to appetite ratings, weight management and blood glucose concentrations (http://www.efsa.europa.eu/en/consultations/call/nda110426.htm).

Upshot? For companies selling in Europe, make sure to submit comments on the three open EFSA draft guidances above. That being said, EFSA’s approach to nutritional supplements, botanicals and health claims is deeply compromised and broken, not a system we in the U.S. would ever want to emulate, especially considering the U.S. FDA’s own historical and deep-seated animus towards dietary supplements and its apparent inability to regulate fairly and rationally.