EU Commission to Amend Article 13 Health Claim Progressive Adoption Process

The solution adopted now will increase legal certainty for operators and national enforcement authorities and reduce implementation burden.

Sep 28 2010 --- The EU Commission has announced its intention to restructure the process of progressive adoption of the list of permitted health claims on food products (also known as "Article 13 claims"). Without moving away from the principle of the progressive adoption of the list, the Commission is to amend the process in a pragmatic way to address issues highlighted during discussions with the Member States and interested parties. The list of permitted claims will therefore be established in two steps. First, the list of permitted health claims for all substances other than so-called "botanicals" will be adopted in a single step. EFSA opinions on all claims other than "botanicals" are expected to be finalised by the end of June 2011. Subsequently, the claims regarding the botanicals will be considered.

Due to the large number of health claims (more than 44,000, then consolidated into a list of more than 4,600) and to the delay in submissions by stakeholders through Member States to the Commission, the deadline of 31 January 2010, for the adoption of the list of permitted health claims, could not be met. EFSA has published so far two series of opinions and will publish a third one in the coming weeks. It expected to finalise its assessment by end 2011 in another or more series of opinions.

With a view to protect consumers from unsubstantiated health claims displayed on the food they buy, remaining on the market until the completion of the evaluation, the Commission had announced that it would favour a process facilitating a progressive adoption of the Union list of permitted health claims. In the past months, many concerns have been raised by a number of Member States and by stakeholders. These referred to potential distortion on the market between operators whose claims are rejected, and operators using claims for which assessment is still pending.

In addition, a difference in the treatment of botanical ingredients under the legislation on health claims and that on Traditional Herbal Medicinal Products (THMP) was underlined as a potential problem.

EFSA is being asked to finalize its evaluation of all remaining claims, other than botanicals, by the end of June 2011 in order to allow the Commission to immediately follow-up with the necessary legislative measures.

This approach will be beneficial for the consumer, who, once the list is adopted and fully operational, will be assured that all health claims on the market have been substantiated by science. Moreover, the solution adopted now will increase legal certainty for operators and national enforcement authorities and reduce implementation burden, according to the EU Commission. Furthermore, it will allow the Commission to reflect on a consistent treatment of claims on botanicals (which include, for example, Linum usitatissimum, Aloe barbadensis, Hypericum perforatum, Echinacea pallida).