First article 13.1 claims to be released in the autumn

The first set of opinions on article 13.1 health claims - expected this month - will not now be released until September or October.

The European Food Safety Authority (EFSA) had originally committed to evaluating 1,024 of the 4,185 article 13.1 claims in its in-tray by July 31 and a further 468 by November, leaving 2,693 more requiring assessment by the end of the year to give the Commission time to put together the final list by January 2010.
This, EFSA has now acknowledged, is a logistical impossibility. “Given the large number of opinions that will require final editorial work after adoption, publication [of the first set of article 13.1 opinions] is expected in September-October 2009.”
There is no plan, however, to re-evaluate the way claims are actually assessed - something that trade associations have been lobbying for. And there are no plans for a meeting to discuss article 13.1 claims along the lines of last month’s meeting in Brussels on article 13.5 and article 14 claims - something stakeholders have also been demanding.
Haravgi-Nina Papadoulaki, spokeswoman for health at the Commission, said: ”The Commission is aware of concerns raised by a number of stakeholders regarding timing aspects and is considering the implications of their requests. But for the moment a similar meeting is not planned. The Commission is discussing different options of stakeholder involvement.”
Meanwhile, the European Health Products Manufacturers (EHPM) association has published a model it feels is more appropriate for the assessment of article 13.1 claims. The model “addresses the different missions assigned to EFSA for the assessment of article 13.1 and article 14 claims” and was also “in line with the international guidance that Codex Alimentarius has just adopted on the scientific substantiation of health claims”, said EHPM chairman Peter van Doorn.

“The nutrition and health claims regulation makes it clear that there should be a different type of assessment for claims submitted for inclusion in the article 13.1 list and applications for authorisation under article 14.”

Crucially, the new approach would “help to achieve the balance between the two main purposes of the law - that permitted claims are truthful and not misleading to the consumer, and that a stimulating environment for innovation is created that enables equal opportunities for all businesses, both large and small”, he claimed.

However, it is not clear whether EFSA or the Commission will change course now given that they have repeatedly argued that there is no distinction possible as to the criteria and level of scientific evidence for applications under different articles of the Regulation.
Article 13.1 claims are based on “generally accepted science” and cover the role of nutrients in the body (eg ‘calcium is necessary for the normal structure of bone’) and have been collated by the Commission for assessment by EFSA based on lists of references to supporting science. Those that make it on to an approved ‘Community list’ will become available for any firm to use.