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Things are hurrying slowly,….

Nearly 6 years after the implementation of the EU regulation 1924/2006, the list of the authorized health claims, based on “generally accepted scientific evidence”, are to be adopted by the European Parliament. This correspond to what are known as “article 13-1” claims.

This is the result of a long process, which started in 2006 with a large (probably too large) collection of probably all the health claims which were, have been or were expected to be used in the EU 27. A list of more than 4,000 health claims was sent by the Commission to the EFSA experts for a scientific evaluation. Unfortunately “generally accepted scientific evidence” does not have the same meaning for EFSA experts, regulatory bound to perform this evaluation with the “highest scientific standards”, and for business operators, and even some academic scientists….

Many dossiers were rejected because of inadequate characterization of the food (it was the case for numerous probiotic bacteria), because the claimed benefit was either not measurable by reliable means or not thought to be relevant to human health. But experts also estimated that a cause-effect relationship was often not established between the consumption of the food and the benefit. All this resulted in only 222 health claims being finally retained by the European Commission, which should soon be published in the so-called “register of claims”, available at http://ec.europa.eu/nuhclaims/. These 222 pending health claims can already be consulted at: http://register.consilium.europa.eu/pdf/en/12/st05/st05984-ad01.en12.pdf.

What about the 3,778 remaining ones? Well, a significant part of them, approximately 1,500, corresponds to “botanical products” and their fate is unclear… for now, their use is still authorized (or rather tolerated), as their evaluation is still pending and apparently not precisely planned. Around a hundred of other claims is currently being re-evaluated by EFSA, which felt it was not provided with all the needed information. But the majority of the remaining ones will be included in the register of claim, in the section “rejected health claims”. From their publication in the register, the rejected health claims will be allowed for a further 6 months and will become forbidden thereafter, with significant fines for trespassers.

The claim routes remaining opened will thus be the use of one or several of the 222 authorized claims (have a look at them: they offer a large range of possibilities, even though one should be smart to keep specificity…). Or the difficult but rewarding route of an article 13-5 or 14 claims….

Whatever your choice, or if the choice is difficult, do not hesitate to contact us!

April 2012
Editor: V. Braesco

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) has launched an open consultation on a draft guidance on the scientific requirements for health claims related to neurological and psychological functions.

This document has been drawn from scientific opinions of the NDA Panel on health claims related to the neurological and psychological functions. Thus, it represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. The document should be read in conjunction with the briefing document for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims[1]. The document does not include an exhaustive list of beneficial effects and studies/outcome measures which are acceptable. Rather it presents examples drawn from evaluations already carried out to illustrate the approach of the Panel.

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