Hope among EFSA’s harsh health claim rulings

Such was the range of positions expressed by about 80 speakers and delegates at the 3rd Nutrition and Health Claims interactive workshop in Brussels yesterday.

While many are surprised by the severity of EFSA’s article 13.5 and article 14 rulings which have seen the regulator turn in negative opinions on eight of the first nine claims assessed, others saw light in the apparent gloom.

Companies that have failed to receive positive opinions from EFSA despite, in some cases, spending hundreds of thousands of euros compiling scientific dossiers, include Martek Biosciences, Bio Serae and Unilever. (Unilever also received a positive opinion for its plant sterol/cholesterol lowering claim.)

Chair of the morning session, Nigel Baldwin worked with suppliers on many dossiers in his role as senior scientific and regulatory consultant at UK-based Cantox Health Sciences International.

Grounds for optimism​

Despite the fact EFSA had despatched a negative opinion to one of those dossiers, Baldwin remains optimistic about the process.

“EFSA has set up a scientifically sound, transparent system that will deliver opportunities for innovation in claims and product formulation,”​ Baldwin told NutraIngredients.com.

He added EFSA had highlighted positive aspects of submissions in its opinions that offered hope for claims when they were passed to the European Commission and Member States for final approval or rejection.

“There is leeway between EFSA’s opinions and the EC and Member States,” ​he said. “EFSA has applied a very literal approach to the way it has assessed the science that has come before it, but it is not written in the law that the EC and the Member States have to literally apply EFSA’s opinion into the legislature. There is room for interpretation there.”​

It is expected the Commission will deliver decisions on EFSA’s opinions by year’s end.

Targeted science​

In her presentation, Dr Alwine Kardinaal from the Netherlands-based TNO Quality of Life consultancy, highlighted how marginally more targeted science could have drawn positive EFSA opinions.

Dr Kardinaal said companies needed to match claims to the available science and not the other way around.

In the case of an article 13.5 weight loss claim for the product Elancyl, she noted a better designed study that demonstrated sustained weight loss might have met EFSA’s tight definition of causality between nutrient or food and health benefit.

A similar situation applied to Martek’s article 14, infant nutrition, DHA/ARA brain and visual health claim. It failed, principally, because its submitted science did not extend past one-year-olds while the claim applied to infants aged six months to three years.

Martek has indicated it may resubmit a claim that better fits with the science it has its disposal.

Transparency​

However, others criticised the claims submissions process for its lack of transparency.

Peter Loosen, the managing director of the Brussels office of the German Federation for Food Law and Food Science, pointed to unresolved nutrition profiling principles and labelling guidelines in what he called “the biggest construction site in food law”.​

He said a lack of transparency in what constituted “totality of evidence” ​was likely to lead to claim withdrawals, a position supported by the secretary general of the European Responsible Nutrition Alliance (ERNA), Patrick Coppens.

“EFSA claims that the dossiers have been evaluated according to uniform criteria, but these are not disclosed or open to scrutiny,”​ he said. “There is no definition of ‘generally accepted scientific evidence’.”​

He said EFSA’s apparent preference for intervention over epidemiological studies, if applied to the 2500 article 13 claims, would mean most of them would draw negative opinions.

In his presentation, Dr Robert Child of Nutrisciences, spoke of borderline claims that may be treated as medicinal by Member State medical agencies, even if approved by the EC as food health claims.

“Medical agencies can deem many claims medicinal,”​ he said.

Borderline product concerns aside, he questioned the scientific hierarchy EFSA appeared to be following, as “some foods simply don’t have intervention studies and even some intervention studies are being discounted purely on the grounds of sample size which is not strictly rational.” ​

But he noted the system had produced a positive opinion. “EFSA have reviewed big impact dossiers so far,”​ he told NutraIngredients.com. “They have been quite strategic and political in accepting the sterol claim to show the system works.”​

Further concerns​

Companies such as Arla Foods, Finnish dairy and ingredients supplier, Valio, and National Starch expressed concern with the system if not with their own pending submissions.

Arla Foods legal consultant, Susanne Hyttel, said the Danish company was confident its probiotic claims would be accepted but remain concerned about how data protection for proprietary (five year protection) article 13.5 claims would pan out.

“We are not sure about documentation required and fear EFSA is too strict because they are using a medical methodology,”​ she said.

Valio’s nutrition manager Tuula Tuure also questioned the article 13.5 procedures. She said the fact companies only had 15 days to respond to any EFSA dossier query was impractical and should be amended.

EFSA has about 220 article 14 claims and 2500 article 13 claims to be assessed by January 31, 2010.

A seminar on the implications of health claims regulations for food supplements will be held in December. For information click here​.