Following recent controversy in respect of the piecemeal time-scale for appraisal of health claim applications under Regulation 1924/2006, and the length of time taken to review the over 4500 submitted claim applications, DG SANCO has now announced that the European Food Safety Authority ("EFSA") is to issue opinions on all non-botanical, EFSA-generic, article 13(1) health claim applications by late 2011 or early 2012. This approach will replace the current focus on publication of opinions in batches, which has slowed the appraisal process down considerably.

Claim applications relating to botanical / herbal products, which constitute up to 40% of the applications that are currently outstanding, are to be carved out from the process and appraised at a later date.

The shake up will take place after the next batch of approximately 500 EFSA article 13(1) opinions is issued and this is expected by the end of October 2010.   EFSA has set an ambitious internal deadline for completion of the non-botanical opinions, which should be published by June 2011. If this is the case, an implementation period of a further year (up to mid-2012) will be imposed upon the industry.

Article 13.1 health claims include those referring, for instance, to growth, development and the functions of the body and to psychological and behavioural functions, but not to the reduction of the risk of disease, nor to child development or health. The European Commission is required to draw up a "positive list" of the many well-established "general function" health claims in the EU, such as "calcium is good for your bones", on the basis of claims submitted by the EU Member States.

The publication of 'batches' of approvals had been criticised by industry for distorting competition in the market; creating unnecessary and disproportionate costs for manufacturers due to successive label changes; and creating confusion in the market as non-harmonised claims co-exist with harmonised claims with unequal conditions of access to markets across the EU.

It is as yet unclear what the practical impact of these changes will be and, in any event, there is much still to consider in the context of health and nutrition claims. However, this appears to be a step in the right direction. Although it may not yet lead to clarity in respect of the specific claims that can and cannot be used in respect of food products, it may give more of an idea as to time-line for achievement of such clarity, create more legal certainty and reduce the implementation burdens of repeated label changes.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

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The original publication date for this article was 20/10/2010.