The article 13.5 proprietary and emerging science claim was approved by the European Food Safety Authority (EFSA) in May, but with heavily modified wording to that submitted by Provexis. EFSA said it did this to better "reflect the scientific evidence”.
The modification meant that Provexis’s claim that its extract, “Helps to maintain a healthy blood flow and benefits circulation” was altered to read, “Helps maintain normal platelet aggregation”.
Provexis is the only company to earn a positive article 13.5 opinion so far. Twelve others have failed to impress EFSA scientists for varying reasons including poor trial design and inappropriate claim wording.
Blinded with science
Provexis chief operating officer, Steve Morrison, said his company was not concerned it would be forced to communicate with consumers in ‘science-speak’ few will understand as the Commission was being proactive in fulfilling its mandate to make claims user-friendly.
“Although we would like to be more involved in the consultation, we are encouraged by reports of discussions from the last EC meeting, where it was clear EFSA’s wording was being viewed as a scientific interpretation of the evidence,” he told NutraIngredients.com.
“It is up to the EC to produce a comprehensible claim and it seems it is well on the way doing that.”
Minutes of that mid-July meeting of the EC Standing Committee on the Food Chain and Animal Health (SCFCAH), reveal the Commission observing that while claims should reflect the available science, they must at the same time ensure, “the consumer can understand the beneficial effect.”
It was suggested the more technical, blood aggregation part of the claim could be employed as a footnote on product marketing. The difference between normal and healthy blood flow was also discussed, along with whether the 35-70-year old target group of healthy adults should be referenced in labelling.
“Some concerns were also raised about the fact that the validity of the effect may be influenced by pasteurization,” the EC said.
Now what?
The 2006 nutrition and health claims regulation states that the EC should deliver final claim wording within 60 days of EFSA issuing an opinion, which means it should have completed this task by the end of July, but the summer recess has delayed the process.
Morrison said Provexis was lobbying the EC to ensure the claim verdict is issued as soon as possible.
“We are waiting for the EC to come back to us so we can proceed with this,” he said, noting the regulation does not specify what companies can do if they object to the final claim wording.
“But we are happy with how the process is going.”
He said carefully designed clinically trials had been the difference between his company succeeding in winning a positive EFSA opinion and others failing, along with a claim that matched the science.
The manner in which proprietary data is being treated was also discussed with the EC noting “ongoing evaluation” was occurring in regard to Provexis's dossier that included 10 proprietary studies.
The extract is available in a UK juice drink called Sirco.