In conjunction with co-applicant, US-Dutch firm Stepan Lipid Nutrition, the two conjugated linoleic acid (CLA) players have strongly criticised the claims assessment processes within EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), stating the panel is engaging in risk management work it is not set up for.
“We regret that within this application, EFSA has avoided taking into account the full scientific proof for the health benefit,” said BASF Human Nutrition head of global regulatory & external affairs, Bernd Haber, and Jaap Kluifhooft, head of regulatory and scientific affairs at Stepan Lipid Nutrition in a joint statement to NutraIngredients.
“Unfortunately, EFSA has chosen to give more weight to some indicative factors for which there seems to be less scientific proof or data available.”
“In our opinion, EFSA failed in their evaluation to provide the answer to the question that was addressed to them with our application.”
The business of risk
Haber and Kluifhooft criticised the agency for what they said were activities that fell outside its stated EU role as a scientific risk assessor. (In theory its risk assessment work informs risk management work carried out by other organs of the EU like the European Commission and the European Parliament.)
“We hope, also for future applicants, that EFSA will focus more on their concrete mandate in answering a scientific question instead of taking over the role of risk management.”
In the initial article 13.5 proprietary science opinion delivered in January under the EU nutrition and health claims regulation (NHCR), the NDA found body fat reduction was not beneficial when accompanied by an increase in lipid peroxidation and in markers of inflammation.
Because of this finding it did not evaluate the full data set, which annoyed BASF-Stepan, and which led to it unsuccessfully attempting to withdraw its application from the nutrition and health claims regulation (NHCR) system in January this year.
On this matter the two regulatory specialists said: “In our opinion, EFSA mingled solid data from human intervention trials with potential health concerns from indicative, so far non-conclusive studies.”
Holding out EC hope
The two firms have not indicated if they may in time resubmit another dossier under the NHCR, but said they were by no means giving up on CLA, and the strength of the science behind it to deliver weight management results to large numbers of people.
“In the case of Tonalin [BASF] and Clarinol [Stepan], we remain convinced that there is enough scientific proof to back up a health claim,” the two men said.
“We trust that the European Commission will take all facts and opinions into account when taking their final decision. We will continue to participate in the ongoing process and share our opinion with the relevant stakeholders.”
They noted, while health claims were important, they were not the only way to communicate around CLA which has been available in foods and supplements in North America, Europe, Asia and other markets for about 20 years.