The wording of the claim, which was only submitted in February this year, is that a ready-to-eat breakfast cereal 'consumed at breakfast and as part of a second meal (either lunch or dinner) in a two week dietary programme can help to reduce body weight.'
The same weight health relationship claim is currently pending approval under Article 13.1, as the EU legislation allows for parallel article claim applications.
Speaking this morning to BakeryandSnacks.com, Marta Baffigo, public affairs director Europe for Kellogg’s, would not disclose the specific reason for the withdrawal but said that it was, in fact, the more open exchange between the petitioner and the agency, afforded by the Article 13.5 process, which provided data that prompted the decision to withdraw.
She added that Kellogg’s, who had engaged external consultants to assist with the dossier submission for the article 13.5 approval, was not ruling out the possibility of resubmission of the claim at a later stage.
The move from Kellogg’s comes as a surprise, with Baffigo telling this publication in March that the cereal maker believed that Article 13.5 would allow the applicant a real platform to put forward its case for substantiation in comparison to article 13.1, which she argued was too rigid a procedure and inhibited full disclosure of all the evidence.
“As our understanding of the implementation of the regulation has evolved we decided that article 13.5 would ensure that EFSA would have access to all the supporting data in order to approve our claim and not just a list of references as per article 13.1,” she said at the time.
But today Baffigo reiterated her previous statement that the health claims legislation is proving to have a high learning curve:
“Like many other companies we are still going through the learning phase in relation to the regulation. We are not the first to withdraw claims under Article 13.5 and we certainly won’t be the last.
However, we are still very confident about our scientific evidence having conducted clinical trials around the world, and having peer reviewed studies in our portfolio.”
Re-formatting and re-submitting rejected, article 13.1 health claim dossiers under article 13.5 will not miraculously turn red lights green as many are hoping, according to a leading European health claims expert.
Patrick Coppens, the secretary general of the Brussels-based trade group, European Responsible Nutrition Alliance (ERNA), said recently that article 13.5 may provide better opportunities for dialogue between applicants and EFSA’s health claims panel, but results may be similar given the scientific criteria is similar.
“New submissions under article 13.5 may change the way the data is presented but not the data itself and so the end-result is likely to be the same,” Coppens told our sister site NutraIngredients earlier this month.
So far, Provexis is the only company to get a positive health claim opinion under article 13.5 linking its tomato extract Fruitflow to blood circulation benefits.
Many queries raised at EFSA’s stakeholder’s meeting also remained unanswered, said Coppens, although EFSA has committed to producing a briefing document that will address some of the 50-odd questions that came in at the meeting and other industry input it received in the lead-up to the event.