No appeal has ever seen EFSA substantially change its initial opinion since the NHCR kicked into life in 2008.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) affirmed its earlier opinion that 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 has 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.
At the time, BASF’s consultant wrote to EFSA: “This draft opinion has not reviewed a single study that was submitted…it really should not be published in its current form.”
The demand was to no avail as EFSA said the opinion had already been adopted, if not published on its website.
In the current appeal, the firms charged that the NDA failed to review “the scientific substantiation of the health claim applied for” instead ending the evaluation at the point of deciding whether the claimed effect is beneficial or not.
The NDA said the effect being beneficial was one of three elements that could default an opinion, the others being lack of nutrient or foodstuff characterisation or finally, a failure to demonstrate cause and effect when the full data set has been analysed.
“Thus, a cause and effect relationship is considered not to be established if the outcome of any one of these assessments is unfavourable, and the evaluation would therefore stop after the assessment which is considered to be unfavourable,” the NDA wrote.
“The comments received do not require any change to the considerations of the NDA Panel.”
Safety; body fat mass; body weight
BASF (markets its CLA as Tonalin TG 80) and Stepan (Clarinol) argued the NDA had carried out an unnecessary safety assessment that was “beyond its legal mission”, as the ingredient had already been deemed safe in earlier NDA opinions in 2010 and 2012 linked to a novel foods approval that permitted conjugated linoleic acid (CLA) forms in food supplements across the EU.
Those opinions found CLA to be safe in foods at doses of 3-3.5g per day but noted that was only for consumption periods of six months or less.
Here, the NDA responded to BASF-Stepan by saying it did not “carry out a safety assessment but rather assessed whether the proposed claimed effect, i.e. a reduction in body fat mass (and not body weight), is a beneficial physiological effect, and under what circumstances would the proposed claimed effect constitute a beneficial physiological effect.”
The Panel acknowledged that reducing fat, in particular abdominal fat, could improve health outcomes like glucose tolerance, dyslipidaemia and high blood pressure. “In this context, the Panel considered that a reduction of body fat, with or without a reduction of body weight, is a beneficial physiological effect for overweight subjects in the general population.”
Seemingly good news for BASF-Stepan but it went on: “However, the proposed claimed effect was on the reduction of body fat in the absence of body weight loss. In this context, the beneficial changes in the metabolic profile generally found after loss of body fat were not observed, but rather an increase in markers of lipid peroxidation and subclinical inflammation were reported…”
It said on this point it requested further information from BASF-Stepan during a ‘stop-the-clock’ procedure when the claim dossier was being assessed late last year.
“No evidence, however, was provided by the applicant to explain how a reduction in body fat mass could be considered to be a beneficial physiological effect under such circumstances.”
The companies argued that previous positive opinions had identified risks with eating the food or ingredient in question, but the NDA made the distinction that these were in fact side-effects such as polyol-provoked diarrhoea.
In 2011 analyst Euromonitor International predicted CLA would be a key nutrient in the global weight management market.
Look here for industry reaction to this appeal in coming days.