EFSA has published its first set of guidelines on the submission of health claims dossiers under the new EU regulation, covering applications for risk reduction, children's health and development, and newly-developed scientific evidence or proprietary data (articles 14 and 18).
The health and nutrition claims regulation entered into force when it was published in the EU official journal in January and will be applicable from July. Industry has started to prepare for the full implementation, but the absence of guidance from EFSA on how what it expected from dossiers was a cause of concern.
The guidance, published last week, will be instrumental for companies wanting to take an early initiative towards having their claims approved. It covers a series of questions that companies may have, including eligibility of health claims for evaluation, organisation and format of submissions, making multiple submissions, timings and timescales, and how to communication with EFSA (the European Food Standards Agency) or its scientific panel on dietetic products, nutrition and allergies.
The guidance is available online . Two aspects will provide some measure of reassurance to industry.
The first relates to proprietary and confidential information, which may be marked as such, but which should not appear in the summary, which will be made public on EFSA's website.
The second relates to the cost of English translations, that it was feared small and medium enterprises unfamiliar with English would incur, the guidance provides a measure of reassurance.
It says that, in the absence of an English summary, EFSA will initiate the translation and request validation from the applicant before it begins scientific evaluation.
Lorene Courrege, director of regulatory affairs of the European Health Product Manufacturers' Association (EHPM) said: "We are happy to see that SME specificities have been taken into account, as required by article 15.5 of the regulation, by EFSA's proposal to take charge of the translation of the summary."
"We will remain vigilant that this indeed remains part of the guidance for applicants."
EHPM is an umbrella association, which represents some 2000 health product manufacturers in Europe. With around 85 per cent of the European food supplements industry made up of SMEs, it has been particularly sensitive to ensuring that the regulation does not ride roughshod over their interests and place them at a major financial disadvantage to the big players.
Another key concern has been the idea of charging fees for EFSA 's scientific panel to assess dossiers - a procedure that is presently under discussion as a potential way to ward off EFSA's budgetary that is not in line with
EHPM chairman Peter van Doorn said recently that fees would be "added financial burden to the already challenging cost of compliance some SMEs face with the various legislative changes and the newly adopted regulations for food supplements".
As for further guidance on health claims submissions, EFSA has said that more will be available in the coming months, with a comprehensive document expected by the summer.
It is advising companies to hold off from submitting any claims until this document is available.