EU Commissioner urged to make claims regulation 'a win-win' for all

By Jane Byrne

- Last updated on GMT

Related tags Health claims regulation Nutrition

Using article 13.5, the proprietary and emerging science route, for article 13.1 claims revision would seem to fly in the face of the goal of EU health claims regulation, which was to have claim substantiation by generally accepted scientific evidence, and proves a review of legislation implementation is critical, argues consultants PA Europe.

The Brussels based firm has written to the newly appointed EU Commissioner for Health and Consumer Policy, John Dalli, urging him to reflect on the current implementation of the EU claims regulation, particularly, it said, in relation to the lack of transparency around the process and market distortions stemming from EFSA’s batch opinion system.

The representatives of small and medium-sized enterprises (SMEs) across the bloc, the UEAPME, as well as food and supplement ingredient companies and food manufacturers are also signatories of the letter.

David Webber, senior advisor at PA Europe, said that the communication again reiterates that the community list for 13.1 articles should only include authorised claims and not the negative or borderline (grey zone) opinions, and he said the signatories are seeking a sufficient transition period of considerably longer than the envisaged six months before the list is published, to allow stakeholders time to comment on those claims that received ‘inconclusive evaluation.’

“We believe the new Commissioner should now take the time to consider again the intent of the regulation, and whether the current process accurately reflects the legisilation's original intentions,”​ Webber told this publication.

The UEAPME said that it believed that it was not the purpose of the EU health claims regulation to stifle innovation, to distort the level playing field or to be an insurmountable burden for SMEs, and they are calling for more open dialogue with the Commission and member states to correct a “misguided implementation of a principally good piece of legislation.”

The representatives of SMEs claim that this regulation has left many of its members in a state of limbo, in that they are unable to develop new products until they know which criteria will be used in the assessment of applications for authorisation and which health claims will be permitted.

Last week, EFSA 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 came 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.”

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