BASF-Stepan CLA claim rejection fall-out
EFSA: Only national bodies can withdraw health claim applications
The European Food Safety Authority (EFSA) affirmed that only European Union member state competent authorities like the UK Food Standards Agency (FSA) can request dossier retrieval under the remit of the EU nutrition and health claims regulation (NHCR) on behalf of an applicant.
EFSA noted companies often sought to pull their application if they could not answer questions from its Panel on Dietetic Products, Nutrition and Allergies (NDA) posed during a phase of the review process known as ‘stop the clock’.
An adjunct to the NHCR regulation states applications “may be withdrawn by the applicant up to the moment the Authority adopts its opinion”.
NutraIngredients previously reported that BASF-Stepan had queried the NDA opinion but not tried to have it withdrawn, but documents seen this week show the firms did seek to withdraw its joint application for the weight loss nutrient that had previously been rejected by the NDA.
The firms’ consultant expressed growing frustration with the process as it became apparent the dossier would be rejected and what they considered NDA stonewalling about when the opinion would be published.
In the correspondence with BASF-Stepan’s consultant, EFSA said it was legally bound not to reveal such details and that the opportunity to withdraw the opinion (via a competent authority) during the stop the clock procedure was not acted upon.
By the time the firms sought to withdraw it the opinion had been adopted and it was too late.
On January 7 the agency emailed the consultant stating: “In light of these specifications your email of 7th December to EFSA in which you inquire about the possible outcome of the opinion cannot be considered as a request for withdrawal. Since we are bound by these rules, a withdrawal of the application is no longer possible and the opinion will be published as scheduled.”
An EFSA spokesperson told us likely opinion publication timing could be determined by the publication of NDA Working Group minutes on the EFSA website.
“Also, the health claim opinions are on the agenda of the Panel meeting flagged as scientific outputs for discussion and possible adoption. The agenda is published ahead of a Panel meeting on EFSA’s website.”
The consultant also criticised the agency for what they considered the NDA panel’s failure to assess the full body of data present in the dossier. They said there was a lack of transparency in the assessment process.
On January 7 the consultant wrote to EFSA: “This draft opinion has not reviewed a single study that was submitted…it really should not be published in its current form.”
At the time the opinion was published in January, Bernd Haber, head of regulatory affairs at BASF Human Nutrition, along with Stepan Lipid Nutrition’s head of regulatory and scientific affairs, Jaap Kluifhooft, queried the omission of chapter three of the opinion, normally entitled: “Scientific substantiation of the claimed effect”.
The NDA responded that the rejection was not based on safety concerns but because it found that “a reduction in body fat mass when accompanied by some negative metabolic changes” was not a beneficial physiological effect as required by the NHCR for a health to be substantiated. Because of this the full data set was not scrutinised.
The panel had in earlier opinions noted no safety concerns about CLA consumption for periods up to six months.
The joint submission sought to link well-researched conjugated linoleic acid (CLA) and a reduction in body fat mass using the two firm’s proprietary forms, Clarinol and Tonalin.
The consultant said the negative opinion would “kill the category”.
The firms, and any other parties, have now had 30 days to submit comments on the NDA opinion to the European Commission. No appeal has ever seen EFSA substantially change its initial opinion since the NHCR kicked into life in 2008.
Publication of appeal proceedings is expected soon.
Many applicants have withdrawn from the NHCR process before the NDA published its opinions, including the likes of Danone for probiotics.
CLA is most commonly used in food supplements and baked and dairy products.
The NDA’s CLA opinion is here .