Danone for the second time in a year withdrew its article 13.5 immune and gut health claims from the European Union health claims process in April, citing a lack of clarity about dossier requirements which it hoped would at least in part be resolved at the European Food Safety Authority (EFSA) stakeholder’s meeting held Tuesday in Parma, Italy.
“We will wait to receive additional guidance at the workshop and then decide how to resubmit our claims,” Danone head of press relations, Marie-Liesse Calmejane told NutraIngredients this morning.
“The EFSA meeting in Parma was similar to the one of a year ago [in Brussels] in that a lot of the information was quite general and there were a lot of people there. It was a positive meeting but it is still too early to say whether we will resubmit.”
EFSA says it will host the workshop this year but no date has as yet been set in stone.
Danone announced the withdrawal of its article 13.5 claims for spoonable yoghurt, Activia, and drinkable yoghurt, Actimel during its Q1 results presentation in April. Both dossiers contain more than 10 probiotic, strain-specific clinical trials.
Zero claims
While Danone’s dossiers remain outside of the EU health claims system the company is technically able to continue making the digestive and immune claims it has employed on-product and in marketing campaigns for around 20 years, depending on the staus of such claims within each member state.
But responding to the regulatory uncertainty, the company has been implementing a “zero claims” policy in select European Union markets since January.
All gut health and immunity claims have been removed from the French market since January, with Spain and the UK following suit as well as other EU markets.
Calmejane said Activia and Actimel sales had not fallen since it stripped the products of the claims that included, “aids digestive transit”.
“Without clarity on claims criteria, processes and deadlines we thought it was more reasonable to see what happens if we take the claims from the products,” she said. “The decision was taken as a reasonable measure to anticipate a situation where we may not be able to use claims and we thought it was the best solution for us. There has been no impact on sales so far.”
Claim game
She said the fact sales hadn’t fallen post-claims showed consumers had not lost faith in Danone’s products and emphasised the fact many bought the products for taste, not health, in addition to those that bought the products for the benefits they felt, regardless of the claims being made.
“It shows that not everybody is listening to what is said in advertising,” she said. “Responses to these kinds of advertising is as emotional as it is rational.”
She said if and when Danone resubmits the claims, and if and when they achieve positive opinions from EFSA and are written into the EU-wide approved claims register, the company would immediately reinstate the claims.
“We can’t say whenor what claims, but we believe claims are useful and would prefer to be in a position to continue making claims but we are talking about a very complicated regulatory process here.”