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EFSA mass rejects probiotics and antioxidants as article 13.1 batch two published

The European Food Safety Authority (EFSA) has issued negative opinions to ‘most’ of 416 health claim dossiers including submissions linking health benefits to vitamin D, probiotics, green tea, black tea, lutein, beta glucans, meso-zeaxanthin, alpha-lipoic acid and melatonin.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) also found causality for various health benefits had not been demonstrated for peptides, xanthan gum, sugar-free gum, guar gum, gamma-linolenic acid (GLA), fermented whey and linoleic acid (LA).

The NDA’s latest raft of opinions will come as a massive blow to the European and international functional foods and nutraceuticals industries, especially the herbal antioxidant and probiotic sectors, which have yet to see a positive NDA opinion.

“This proves that the article 13.1 list was only ever suitable for vitamins and minerals,” said Nigel Baldwin, the senior scientific and regulatory consultant and EU manager at claims consultancy, Cantox Health Sciences International.

“The Article 13.1-13.3 list regulation principle was flawed in that regard. So many opinions really allude to the fact that they only went on the data provided. So without an opportunity to present data in full and discuss the relevance of studies, it’s not really surprising.”

He suggested many rejected dossiers will now be tweaked and resubmitted under the proprietary and emerging science article 13.5 route.

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 were affirmed by the NDA, which grouped the 416 submissions into 31 opinions which can be found here .

Meal replacements were also backed to help reduce body weight and maintain body weight after weight loss - making them the first weight management claims to gain NDA approval.

In a statement EFSA said the NDA had issued, “unfavourable opinions on most of the claims in the second series due to the poor quality of the information provided…”

This included:

·         lack of information to identify the substance on which the claim is based, e.g. “probiotics”;

·         lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g. food with “antioxidant properties”);

·         lack of human studies with reliable measures of the claimed health benefit..

Range of opinions

The NDA found:

·         Sugar-free chewing gum does not reduce dental plaque

·         Melatonin does not benefit sleep

·         Xanthan gum does not boost satiety

·         Sodium bicarbonate does not reduce gastric acid

·         Green and black tea extracts do not protect DNA, proteins and lipids from oxidative damage; reduce acid production in dental plaque; maintain normal bone; decrease potentially pathogenic intestinal microorganisms; maintain vision; maintain normal blood pressure; maintain normal blood cholesterol concentrations

·         Beta-glucans do not contribute to the maintenance of healthy blood glucose levels

·         Alpha-cyclodextrin does not reduce post-prandial glycaemic responses or help maintain normal body weight

·         GLA does not benefit joints; weight maintenance after weight loss; maintenance of peripheral blood flow; maintenance of normal blood pressure; maintenance of normal blood cholesterol concentrations; benefit bone health

·         C12-peptide does not help maintain normal blood pressure

·         Honey does not produce a range of antioxidant effects (not characterized)

·         Lactobacillus plantarum BFE 1685 does not decrease potentially pathogenic intestinal microorganisms

·         Lactobacillus rhamnosus LB21 NCIMB 40564 does not decrease potentially pathogenic intestinal microorganisms; reduce mutans streptococci in the mouth or boost digestive health (both insufficiently defined)

·         Lactobacillus plantarum 299v (DSM 9843) does not support the immune system (insufficiently defined effect)

·         Stearic acid does not maintain normal blood cholesterol concentrations

·         LA does not maintain normal neurological function

·         Prunes do not help maintain normal bowel function

·         Meso-zeaxanthin does not help maintain normal vision

·         Lutein does not help maintain normal vision

·         A range of foods do not benefit glycaemic control

·         A range of antioxidant foods and constituents (relating to about 170 dossiers) do not deliver “antioxidant properties” or protect body cells and molecules such as DNA, proteins and lipids from oxidative damage

·         A range of foods do not benefit joint, bone or muscle health (relating to 42 dossiers)

·         Alpha-lipoic acid does not protect body lipids from oxidative damage; maintain normal blood cholesterol concentrations; increase beta-oxidation of fatty acids leading to a reduction in body fat mass; maintain normal blood glucose concentrations; regenerate genes or gene transcription

·         50 dossiers related to yeasts and bacteria were not sufficiently characterised

·         Guar gum does not maintain normal blood glucose concentrations; increase satiety

·         Partially hydrolysed guar gum does not increase satiety; maintain normal body weight; maintain normal (fasting) blood concentrations of triglycerides; maintain normal blood cholesterol concentrations; reduce post-prandial glycaemic responses; maintain normal blood glucose concentrations

·         Fermented whey does not support gut health (insufficient characterisation)

·         Vitamin D does not benefit cardiovascular health.

“This is only a selection of the whole list, so it is too early to conclude on the value of many substances for health as other health relationships are still in the process,” said Stefanie Geiser at the Brussels-based consultancy, EAS.

“Submitters now will have to assess the reasons for the rejections.”