European Food Safety Authority: we'll assess health claims by our deadline ... hopefully

The expert panel tasked with assessing health claims under the EU Nutrition and Health Claims Regulation may have to outsource large chunks of the work in order to meet its challenging deadlines, its chairman has admitted.

Albert Flynn, associate professor in nutrition at University College Cork and chair of the European Food Safety Authority's (EFSA's) panel on dietetic products, nutrition and allergies said resourcing issues were still being thrashed out. "Have we got a huge challenge ahead? Yes. We are in completely new territory. I can't give guarantees about whether we can cope because we don't know what will be thrown at us.

"We have recruited new people to our nutrition and health working group, but we may well have to outsource work to independent experts under contract. But they can only do preparation and support work. We make the final decisions."

Hundreds, if not thousands, of claims were likely to be submitted for EFSA's scrutiny under article 13 of the Regulation for claims backed by "generally accepted science", he acknowledged.

Several article 14 claims covering disease risk reduction and children's health have already been submitted, while claims based on new science under article 18 can now be submitted from February 2008 instead of 2010, as originally planned. "This could considerably add to our workload next year," said Flynn.

There was also confusion about whether certain claims fell under article 13 or 14 of the Regulation, he said.

Although EFSA would make scientific assessments, the final decision over what would appear on Europe's list of permitted health claims rested with the European Commission (EC) and Member States, he added. "The Parliament also has powers of scrutiny, but we don't know to what extent it will use them."

If article 13 claims were rejected, companies could make a new application under article 18 if new science emerged, suggested Flynn. "But there is no formal appeals process."

His comments came as manufacturers continued to voice concerns over EFSA's ability to fulfil its legal obligations under the Regulation and the lack of guidance given to companies submitting article 13 applications.

Julie Scott, European regulatory compliance manager at National Starch Food Innovation, said the lack of clear guidance had left many applicants feeling like they were operating in a 'black hole'.

Most companies were assuming that using the PASSCLAIM approach [developed by the International Life Sciences Institute, Europe, to develop standard principles to assess health claims on foods] was their best bet in the absence of any official criteria, she said.

EFSA has until late 2009 to give its recommendations to the EC about which article 13 claims to approve. The final list will be published in January 2010.