EFSA's Article 13.1 Opinions Set a New Bar for Claims

Last week, the European Food Safety Authority (EFSA) panel on dietetic products, nutrition and allergies (NDA) released the first of their opinions in regards to Article 13.1 claims in Europe.

Article 13.1 claims deal with “function” health food claims, such as “calcium is good for your bones.” The opinions from the panel will go on to be reviewed now by the European Union committee which is currently working on a list of permissible health claims.

Overall EFSA gave positive opinions to roughly one-third of the claims submitted. These were noticeably high in regards to vitamin and mineral claims, and a fair amount of omega-3 claims. One noticeable area that missed out on positive opinions was the probiotics category, which has had approximately 180 individual rejections.

Albert Flynn, chair of the EFSA NDA Panel, spoke to the BBC and explained “It's been an issue for some time that general health claims are made about these products using the family name for the active ingredient and not saying which member of the family is in the pot… We expect the claims that will come now from the companies will be much more specific."

Cantox Senior Scientific & Regulatory Consultant Nigel Baldwin spoke with NPIcenter and shared his thoughts on the ramifications of EFSA’s work: “Some of the claims had clearly not cited references in populations acceptable to EFSA as representative of the healthy population and herein lies proof (of what at least I have been saying all along,) which is that the Article 13 submission process was flawed in that it gave no opportunity, unless you provided your reasoning when you submitted, to provide your own interpretation of the data.”

“Thus all you have is EFSA's take on a list of references. For Article 13.5 and 14 you at least get a proper chance to put your case. So in many cases these opinions can be considered GAP analyses and now applicants know what they have to do for full applications.”

Currently the standing health claims and products will not change until the EU develops and votes in legislation requiring any changes.

Baldwin sums the release of the opinions up pretty fairly, explaining that “basically the gloves are off now, so its best to roll our sleeves up as an industry and let the science lead the industry and get working on dossiers to put things right.”

For an ongoing list of all the EFSA NDA Panel Opinions on NPIcenter, click here.

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