The German ingredients giant told us it and US-based co-submitter Stepan Lipid Nutrition had raised questions about the January 2015 opinion as it was entitled to do in a 30-day review period, but had never tried to halt the opinion’s publication.
The joint submission sought to link well-researched conjugated linoleic acid (CLA) and a reduction in body fat mass but EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) refused the claim as it had done on previous occasions, raising safety and efficacy concerns.
It is believed the firms were distressed when they received the NDA opinion under 36 hour embargo back in January as they considered that it did not address the efficacy and scientific data in the dossier. They contacted EFSA to see if there had been some kind of mistake but gained no reply and the opinion was published on EFSA’s website 36 hours later on January 8.
BASF-Stepan: Questions were of “completeness, consistency and procedural conformity”
Bernd Haber, head of regulatory affairs at BASF Human Nutrition, told us there had been no attempt to block the opinion’s publication.
“When BASF got the EFSA opinion we reviewed it and raised the question of its completeness, consistency and procedural conformity to EFSA,” said Haber.
These comments have been filed with the European Commission as is standard appeal procedure and EFSA’s assessment of them is awaited.
The firms would not commit to any further submissions in the EU nutrition and health claims regulation (NHCR) system for CLA until the appeal procedure concluded.
“We are currently waiting for the answers to our comments from EFSA,” Haber said.
At the time the opinion was published, Haber and Stepan Lipid Nutrition’s head of regulatory and scientific affairs, Jaap Kluifhooft, said EFSA had failed to evaluate the claimed effect of their CLA products Tonalin and Clarinol on body fat reduction. They said this was shown by the omission of chapter three of the opinion, normally entitled: “Scientific substantiation of the claimed effect”.
No appeal has ever seen EFSA substantially change its initial opinion since it began issuing health claim opinions under the NHCR in 2008.
CLA is most commonly used in food supplements and baked and dairy products.
The NDA’s CLA opinion is here.