“Dialogue is key” says EFSA, but industry not satisfied

In a lively meeting that swelled to around 400 people, industry representatives posed upward of 30 questions to EFSA’s assembled representatives, but many complained afterward that the responses were too generic.

“It was very positive that EFSA organised this event but it revealed that EFSA remains ‘straight in its boots’,” ​said Herve Gasnier, research and development manager at French ingredients supplier, Ingredia.

"This meeting was about EFSA clarifying its position and not about any revolution of its methods. There is a lot of talk about transparency and it is clear EFSA are making an effort to be more transparent but that doesn’t mean industry is going to like what it sees.”​

An EFSA spokesperson wondered exactly what "new information" ​industry sought, and said the meeting was about clarifying the way its health claims panel works.

Concerns​

Industry concerns raised at the meeting included:

• the way proprietary data is being treated
• dosage required to make health claims
• scientific criteria not applied consistently
• greater involvement in final claim wording
• whether the regulation is meeting a remit to protect consumers
• removing most remaining dossiers from the system

In her presentation,​EFSA executive director Catherine Geslain-Lanéelle said “dialogue is key”​.

“EFSA does not work in a vacuum; while our ​raison d’être​ is the protection of the European consumer, we are aware of the wider implications of our work and our responsibilities in supporting the innovation that is required to keep our industries competitive.​

By ensuring that there is a shared understanding of the scientific evidence required, the work we have delivered thus far will, we trust, support the work of industry by helping to establish future directions for research and innovation.”​

EFSA has committed to hosting a series of workshops on topics such as antioxidants, satiety and mental health. The first will explore immune and gut health claims and take place this year.

Responding to an industry suggestion that the remaining 3000+ article 13.1 claim submissions should be scrapped and resubmitted in the light of renewed understanding of the process, Professor Albert Flynn, the chair of the Panel on Dietetic Products Nutrition and Allergies (NDA), said such a scenario, “was impossible”.​

It was added that the suggestion made sense because the December 2011 deadline for all claims to be processed was unlikely to be met, and that it was a waste of resources for all parties involved to go through the process when it was now known that a majority of dossiers contained insufficient data to win positive opinions from the NDA.

Characterisation, pathogens, people​

Alwine Kardinaal, consultant in nutrition and health and head of clinical trials at Dutch firm TNO, welcomed discussion about a potential list of pathogenic bacteria that may be published soon and may assist in probiotic dossiers, along with suggestions that rejected probiotic claims can be resubmitted with updated characterisation data.

“We were hoping to hear more about article 13.1 procedures and to know more about the detailed criteria the NDA is working with in certain areas but which has not yet been published. But there was some good information about study design and the submission of claims.”​

A spokesperson for the European Federation of Associations of Health Product Manufacturers (ERNA), the European Health Products Manufacturers (EHPM) and the European Botanical Forum (EBF) said there were, “too many people to meet requests to discuss details”.​

She said the three groups that have been vocal critics of EFSA’s interpretation of the nutrition and health claims regulation would continue to lobby for changes it outlined in a recent letter to another of yesterday’s speakers, Basil Mathioudakis, the Head of Unit, Food Law, Nutrition and Labelling at DG Health and Consumers (DG Sanco) in the European Commission.

In the letter, the groups stated, "the way in which EFSA assesses health claims is not appropriate for food research."​

It can be found here.​

Proprietary data ​

Cedric Bourges, the general manager of French claims consultancy, Nutraveris, said the indication that all proprietary data be treated as public once published in a peer-reviewed journal would act as a massive disincentive for companies to engage in research.

He said EFSA had been very selective in answering questions from the floor. “There were many questions that came in one after the other and in the end it was difficult to know which questions EFSA was answering in the end. There are many aspects that remain incomprehensible,” ​he said.

All presentations from the day can be found here.​