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
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 20/10/2010.