Batch two fall-out: Goodbye article 13.1, hello article 13.5

By Shane Starling

- Last updated on GMT

Related tags Member states Efsa Nutrition Scientific method

Article 13.1 health claims are being rejigged and resubmitted under the proprietary and emerging science, article 13.5, after EFSA rejected all but a few submissions in its second batch of 416 claim opinions yesterday.

Most observers were not surprised by the European Food Safety Authority 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.

Others highlighted ongoing flaws in EFSA’s methodology such as dual scientific standards for vitamins/minerals and botanicals; the implausibility of demonstrating causality outside of the pharma paradigm and a lack of process transparency.

No surprises

But it seems for most there is acceptance that EFSA’s methodologies are not going to change very much, so the 920-odd article 13.1 opinions issued to date, are being used as source materials to fill ‘data gaps’ for resubmissions in other articles of the regulation.

“We are already in the process of resubmitting claims under article 13.5 from the first batch of opinions,” ​said food law specialist, Nicole Coutrelis, of the French and Belgian-based legal firm, Coutrelis & Associates.

“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.”

She said article 13.4 also offered hope for claim revision, via member states rather than individual companies.


Lutein supplier, Cognis, said it was “disappointed” ​by EFSA’s rejection of a lutein-eye health submission, and was considering courses of action.

Holger Becker, PhD, Cognis Nutrition & Health’s global product manager for Xangold Natural Lutein Esters, said the submission was based on a, “significant body of scientific evidence supporting the eye health benefits of lutein and lutein esters.”

“We have worked with other lutein suppliers to secure health claim approval for lutein products in Europe and will now address our future options,"​ he said.

Stefanie Geiser at the Brussels-based consultancy EAS said the mass rejections could partially be blamed on the fact the scientific criteria was not clear when many of the dossiers were submitted.

That meant many dossiers including many botanicals dossiers referencing predominantly traditional use data, observational studies and authoritative statements/textbook knowledge were always going to struggle to demonstrate causality, even if they had previously been approved in individual member states.

“This obviously resulted in the submission of a list of references for many entries that did not reflect the detail and level of clinical data now equally requested by EFSA for Art 14/13.5 dossiers and Art 13.1,”​ she said.

“This cannot have been the original purpose of the Article 13.1 list process when applicants were asked by member states to provide a summarised set of data in a chart, accompanied by a list of scientific references.”


The CIAA (Confederation of Food and Drink Industries of the EU) diplomatically stated that the publication of the second batch of opinions was an important step to establishing a central list of approved health claims in the EU but asked for, “greater transparency in the scientific process” ​to assist the​agri-food industry in meeting scientific requirements.

Lorène Courrège, the director of regulatory affairs at the European Federation of Associations of Health Product Manufacturers (EHPM), said it was, “very concerning that so few claims got through”.

Jean Sevigny, veteran food lawyer and senior partner at Brussels-based Keller and Heckman, highlighted the fact the opinions still had to be assessed by the European Commission and member states, and could be amended.

But as most expect little amendment to occur, he said the momentum for a legal challenge to the regulation – or several legal challenges – was growing, although he would not reveal by which parties, or when such challenges might occur.

However Michael Le Brocq, the managing director of UK-based probiotics company, Symprove, said EFSA’s scientific criteria was appropriate, even if no probiotic claim is yet to win approval.

“As an industry we’re asking to make medical claims for foods so we should expect to have to support this with robust data,” ​he said.

“I think some of the arguments about EFSA moving the goalposts or not providing clarity are simply frustration at the bar being set so high.”

Yesterday’s batch saw negative opinions handed to probiotics, green tea, black tea, lutein, beta glucans, meso-zeaxanthin, alpha-lipoic acid and melatonin, xanthan gum, sugar-free gum, guar gum, gamma-linolenic acid (GLA), fermented whey and linoleic acid (LA) among others.

Only potassium’s ability to benefit blood pressure and normal muscular and neurological function; melatonin's capacity to reduce jet leg; vitamin D’s potential to boost immunity and maintain normal muscle function; guar gum's ability to maintain normal blood cholesterol concentrations and meal replacements potential to reduce body weight and maintain body weight after weight loss were affirmed by the NDA.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) grouped the 416 submissions into 31 opinions that can be found here​ .

The full text of the 2006 nutrition and health claims regulation can be found here​.

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