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Health Claims Regulation - How To Proceed Further?

This article was originally published in the schoenherr roadmap'10 - if you would like to receive a complimentary copy of this publication, please visit: http://www.schoenherr.eu/roadmap.

Permission requirements:

The Regulation stipulates in Article 13 that the EU member states shall provide the European Commission (the Commission) by 31 January 2008 at the latest with a list of claims to be included in the "Community List of Permitted Claims", accompanied by the conditions applying to them and by references to the relevant scientific justification.

According to Article 13(3), the Commission shall by 31 January 2010 at the latest, and after consulting the European Food Safety Authority (EFSA), adopt according to the Committee procedure (Article 25(3)) a Community list of permitted claims.

According to Article 14, health claims referring to a "reduction of disease risk claims" or to "children's development and health" are excluded from this rule. These must be specifically examined and can only be included in a Community list after having passed the procedures under Article 15 et seq.

EFSA opinions regarding Article 14 claims

The EFSA has already finished several opinions on Article 14 claims. They concern health claims that can rely on a broad basis of scientific evidence, especially due to the fact that, regarding these claims, individual applications for permission had been filed.

The first EFSA opinions caused general consternation. The highest scientific standards had been applied in the examination of the claims. But for EFSA, proof of the effect of certain food ingredients did not suffice. Only proof concerning the final product, often by way of randomised human double-blind studies, sufficed. Such kind of evidence follows the standard of the pharmaceutical sector but is not common in the food sector where such studies are conducted only rarely and therefore appropriate evidence is lacking.

Comprehensive study material did exist primarily for those claims for which permission had been applied for under Article 14 and Article 13(5). Despite this, more than 80% of the applications did not succeed. The EFSA considered most of the studies as being not sufficiently significant. The food industry became intimately familiar with EFSA's standard rejection that "a cause and effect relationship has not been established".

The high number of negative EFSA opinions led to hectic lobbying. The Commission had been pressed to push EFSA towards applying less strict criteria, or at least cease preliminary publication of opinions (i.e. before adoption of the final Community list). The Commission refused these initiatives. This augurs badly for those claims that had been notified by member states by way of lists (which are, from experience, less supported by scientific evidence).

EFSA opinions regarding Article 13 claims

On 1 October 2009 EFSA opinions regarding a large number of claims were published. This was after EFSA had announced that the publication of opinions would not be delayed until the final Community list was issued, but would be published in "batches". The opinions of the scientific authority lead to commentaries that the food industry had to refrain from the use of hundreds of health claims that had been commonly used, often already over years. Again a huge part of the claims had been assessed negatively. Especially health claims regarding vitamins (such as vitamin A, B-complex, biotin and vitamin D) and mineral nutrients (such as calcium, iron and magnesium), which traditionally can rely on a broad scientific basis, had been permitted.

At the same time, especially agents of botanic origin ("botanicals") had been refused. But the bulk of the material submitted for botanicals had not yet been examined but had been returned to the Commission for "reworking".

When will the prohibitions have to be applied?

The negative EFSA opinions do not lead to any prohibitions at the moment. However, such opinions should be considered, especially by consumer protection organisations. The transitional provision of Article 28(5) of the Regulation stipulates that health claims under Article 13(1) can be used under the responsibility of the food business operators "until the adoption of the list referred to in Article 13(3)" (i.e. the Community List) if the claims comply with the further provisions of the Regulation and applicable provisions laid down in national law. Even if "the list referred to in Article 13(3)" did not consist of one single, final list and preliminary partial lists were published, the adoption of the list in the sense of Article 13(3) requires the consent of the Commission according to the proceedings mentioned in Article 25(3) and, in addition, the consent of the European Parliament. Further, the lists would have to be included in the Community Register according to Article 20, which not only contains permitted health claims and the prerequisites of their use, but also the refused health claims and the reasons for refusal.

Although the regulation, especially in Article 28(5), does not contain an express provision for this, already now there is consent that for refused health claims, a further deadline of six months will be granted to give food business operators the chance to remove them from the labelling and advertising of the food.

Health claims that (as with most of the "botanicals") have not yet been examined by the EFSA can not be affected by the prohibition. The effective prohibition of claims under Article 13(1) is therefore unlikely before 2011.

The opinions of the European Food Safety Authority related to the Health Claims Regulation will lead to the result that food business operators must refrain from using hundreds of health claims that have been used in the past without objection. However, prohibitions of claims under Article 13(1) are unlikely to enter into force before 2011.

This article was originally published in the schoenherr roadmap'10 - if you would like to receive a complimentary copy of this publication, please visit: http://www.schoenherr.eu/roadmap.

The content of this article - outside the responsability of Tropifood-  is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mr Christian Hauer

Schonherr Rechtsanwalte

Tuchlauben 17

Vienna

A-1010

AUSTRIA

Fax: 1534376100

E-mail: ta.gruber@schoenherr.at

URL: www.schoenherr.eu