The wording of the claim is that a ready-to-eat breakfast cereal ‘can help to reduce body weight, can help to reduce body fat, can help to reduce waist circumference.’ The same weight health relationship claim is currently pending approval under Article 13.1, as the EU legislation allows for parallel article claim applications.
Marta Baffigo, public affairs director Europe for Kellogg’s, told NutraIngredients that seeking a claim through article 13.5 allows the applicant a real platform to put forward its case for substantiation in comparison to article 13.1, which she argues is just too rigid a procedure and inhibits the full disclosure of all the evidence.
“We are very confident about our scientific evidence having conducted clinical trials around the world, and having peer reviewed studies in our portfolio.
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 continued.
Baffigo said that as far as Kellogg’s knew, the science still remains proprietary and does not require disclosure through this process. “As we understand article 13.5, five years after approval of the health claim, the wording can then can be used by other cereal manufacturers but our scientific data does not have to be made public.”
She said that as the health claims legislation is proving to have a high learning curve, Kellogg’s sought external consultants to assist with the dossier submission for article 13.5 approval: “Many companies are still going through the learning phase in relation to the regulation and dossier compilation is time consuming - the rules of the game definitely need to be made clearer.”
Kellogg’s has, in the interim period, reviewed all communication on its cereals sold in Europe, particularly on its Special K brand, said Baffigo, to ensure it is compliant with the EU health claims regulation during the transition phase, as article 12 of the legislation does not permit the use of weight loss amounts.
The cereal manufacturer thus dropped the message that following the Special K two week diet could help consumers to drop a jean size and could help them to lose between 3 and 6 lbs over that timeframe.
Last week saw the first weight management claims to gain approval from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) with the panel finding causality between meal replacements and the claim of reduction of body weight and maintenance of body weight after weight loss.
Meanwhile food law specialist, Nicole Coutrelis, of the French and Belgian-based legal firm, Coutrelis & Associates, said that many article 13.1 health claims are being rejigged and resubmitted under article 13.5, after EFSA rejected all but a few submissions in its second batch of 416 claim opinions last week.
Most observers were not surprised by the EFSA’s negative opinions, given similar rejection rates when the first batch of 500+ opinions was published in October, and noted dossiers were already being reworked for presentation via article 13.5.
We are already in the process of resubmitting claims under article 13.5 from the first batch of opinions,” said Coutrelis “Even before the latest batch of opinions it was clear how high EFSA’s criteria is so while it is disappointing, it is not surprising to see so many negative opinions. Even though they are negative, we are learning a lot from them.”
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.
The biotech firm said the approval has helped it win substantial capital investment and a seat at the R&D tables of some of the biggest food and beverage companies in the business.