The European Commission has set itself to evaluate 1024 generic article 13 claims by the end of July, a further 468 claims by the end of November, leaving 2693 claims that EFSA has sent back to the EC and member states for further clarification.
“The volume of claims and currently proposed evaluation time-lines illustrate that it will prove difficult for the European Commission to adopt its 'Community list' of generic health claims by the end of January 2010, the official deadline set by the EU claims Regulation,” said EAS regulatory affairs manager, Stefanie Geiser.
“Although the Commission has not yet officially announced a delay, this will be inevitable, meaning also a longer transition period for the permitted continued use of health claims that are in line with formerly existing national rules.”
She added that if the deadline is breached it would bring few changes to the EU’s 27-member bloc, as member state rulings would continue to apply until the matter is resolved at EU level. Only in 2011, when transition periods are factored in, would the “climate for claims” be altered drastically. “Although it is in principle good news for the industry that the process could be slightly delayed, more stringent rules for health claims innovations are inevitable in the near future,” Geiser added.
“The new applicable rules will require companies to either heavily invest in scientific studies to approve further claims, adapt to the 'Community list' (Article 13 list) and/or get creative in developing alternative marketing messages that fall outside the scope of the EU Regulation.”
Claims backlog
EFSA only published its finalised article 13 list this year that include generic nutrient claims such as calcium is good for your bones. Click here to see that list.
So far EFSA has issued five article 13.5 opinions which relate to new product claims. These have all been negative including one linking black tea and focus of attention and another linking probiotic consumption and gastrointestinal discomfort.
EFSA has also delivered 42 article 14 disease reduction and children’s claim verdicts, most of which have also failed to impress the Parma-based risk assessment agency.
The EC’s General Food Law section of the Standing Committee on the Food Chain and Animal Health (SCFCAH) recently processed its first batch of 21 EFSA health claim opinions, including 14 negative and seven positive opinions.
The SCFCAH is comprised of representatives of the EU’s 27 member states, and it has the capacity to challenge EFSA’s opinions from a risk management point of view.
The fact the SCFCAH found no issue with EFSA’s opinions may be of concern to industry given the large number of negative opinions issued by EFSA to date, particularly in regard to article 14 claims, of which the Parma-based assessor has principally concerned itself so far.
After claims are voted on by the European Parliament they can then be written into the EU register and be authorised for use across the bloc.