Ban of Rejected Article 13.1 Health Claims in EU Not Likely Before Next Spring

The European Commission (EC) is not expected to start banning Article 13.1 health claims rejected by the European Food Safety Authority (EFSA; Parma, Italy) before spring of next year-or even summer of next year, says international food policy consultancy EAS.

Those health claims that received a negative opinion from EFSA will no longer be able to be used in the market once the EC initiates the ban. Before this happens, the EC must settle on a list of allowed claims (those that received positive EFSA opinions). This list must be sent to a standing committee for discussion, and EAS regulatory affairs manager Stefanie Geiser said that EFSA has indicated it will present this list for discussion no sooner than the end of this year. The EC must also await the final batch of Article 13.1 claim opinions from EFSA, expected for release in June and September of this year, before it can finalize any list.

EAS says that EFSA has so far completed 80% of its Article 13.1 claims assessments for all substances (excluding botanicals). Approximately 600 claims are still awaiting assessment.

“If the Commission’s proposal is adopted at the end of the year, there must still be a final adoption process, which includes a three-month European Parliament scrutiny procedure,” Geiser stated. “In addition, the Commission will most likely also provide a post-Article 13 list transition period of some months. Therefore, it’s unlikely that we will see a ban on any Article 13.1 claims before summer 2012.”

Still, companies with rejected claims should be preparing now, as “the ban is imminent, and companies should be carefully monitoring the EFSA opinions and planning future strategies for marketing products that currently bear Article 13.1 claims,” said Geiser.

EFSA has rejected the majority of Article 13.1 claims submitted so far. In its latest batch of opinions, EFSA delivered positive opinions for only 22%.

Claims that have been deemed successful include those for unsaturated fatty acids and lowering of blood cholesterol, and dental health claims for sugar-free chewing gum and sugar replacers.

“One surprise in the April batch, in light of EFSA’s trend so far, has been a first positive opinion for an antioxidant claim-on polyphenols from olive oil and the protection of lipids from oxidative damage,” Geiser added. “Until now, EFSA had only issued positive antioxidant claims opinions for vitamins and minerals.”

Claims that haven’t fared well include those related to immune function, digestive health, and antiaging. Notably, only one amino acid claim has received a positive opinion.