EFSA Timeline Indicates Final Article 13 List Delay

EFSA published the Commission’s list of over 4000 'generic claims' in January and set its first deadline for the assessment of 1,024 claims for the end of July 2009. The second deadline has been set for the end of November, for the assessment of an additional 468 claims.

02/03/09 The European Food Safety Authority’s (EFSA) timeline for assessing the article 13 list of health claims indicates the adoption of the final article 13 list will be delayed, a food and nutrition policy consultant has said.

Stefanie Geiser, Regulatory Affairs Manager at international consultancy EAS’ Italy branch, said that with only two timings set and one still to be negotiated for the largest remaining set of 2,693 claims entries, the chances of the European Commission adopting its final ‘Community’ list of article 13 claims (claimes based on generally accepted scientific evidence) by the end-January 2010 deadline set out in the Nutrition and Health Claims Regulation seemed unlikely.

EFSA published the Commission’s list of over 4000 'generic claims' in January and set its first deadline for the assessment of 1,024 claims for the end of July 2009. The second deadline has been set for the end of November, for the assessment of an additional 468 claims.

“The final deadline,” Ms Geiser explained, “has yet to be determined because EFSA is currently in the process of seeking specific clarifications for these claims from the European Commission and Member States, and cannot proceed with its work before these have been received.”

“Although the Commission has not yet officially announced a delay,” she continued, “the volume of claims and currently proposed evaluation time-lines illustrate that it will prove difficult for it to adopt the 'Community list' of generic health claims by the official January 2010 deadline.”

Should a delay in the adoption of the Community list occur, it would also mean an extension of the transition period granted for companies to get their products in line with the regulation. Ms Geiser said that if the current EU approach towards assessing claims would be maintained, stringent rules for health claims innovations would be inevitable, regardless of the potential delay.

She said: “Once the 'Community list' has been adopted and transition periods have passed, the climate for claims will change significantly. The new applicable rules will require companies to either heavily invest in scientific studies to approve further claims, adapt to the 'Article 13' list, or get creative in developing alternative marketing messages that fall outside the scope of the EU Regulation.”