The latest batch of Article 13.1 health-claims opinions from the European Food Safety Authority (EFSA) has served up more bad news for the beleaguered functional ingredients sector.
On February 25, EFSA released 31 opinions covering 416 'general function' claims — the second group of the 4,000-plus Article 13.1 claims that will eventually be assessed for inclusion on the Community List of claims that any company can use under the EU Nutrition & Health Claims Regulation.
As with the first batch, which came out last October, the majority of claims were rejected — although this time the failure rate was higher, with just five nutrients receiving positive opinions. The agency said its NDA panel, which is carrying out the assessments, had turned down most of the claims in the second series due to the "poor quality of the information provided to EFSA." It listed three major flaws in the dossiers presented for review, as follows (in EFSA's own words):
- lack of information to identify the substance on which the claim is based, eg; 'probiotics;'
- lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (eg; food with 'antioxidant properties'); and
- lack of human studies with reliable measures of the claimed benefit.
Food and drink companies that put the power of antioxidants at the heart of their marketing strategies were among the biggest losers. EFSA grouped together and rejected 169 claims relating to 'antioxidant activity,' 'antioxidant content' and 'antioxidant properties' on the basis that "no evidence has been provided to establish that having antioxidant activity/content and/or antioxidant properties is a beneficial physiological effect."
"They don't class having general antioxidant properties as beneficial to health," said Nino Binns of Ireland-based NB Consulting, who also noted that EFSA had given short shrift to tests such as ORAC, which measure the antioxidant potency of a product. "It's like a litmus test measuring the pH of something," she said. "It's a measure and in itself it doesn't mean anything. They've written those values off as meaningless."
In reality, EFSA's verdict on the 416 opinions was no great shock. There is a growing acceptance that the way in which Article 13.1 claims were submitted two years or so ago bore little resemblance to the manner in which EFSA wanted them submitted, a factor the industry says was because of a lack of guidance at the time.
"The opinions don't come as a huge surprise as they confirm the general trend that was already visible with the first series of opinions," said Stefanie Geiser, regulatory affairs manager at Brussels-based consultancy EAS. "It is important to remark that applicants did not know, and member states did not seem to question at the time Article 13 claims submissions were made, how EFSA would perform the evaluations for the Article 13 list. The requested data by EFSA ended up being of equal detail and standards to those for Article 14 and 13.5 dossiers. This resulted in submissions that did not reflect the detail and level of clinical data now requested by EFSA."
What this means is that companies intent on gaining approval for a health claim will probably have to go through the Article 13.5 route, which is reserved for claims backed by new or proprietary scientific evidence. But Geiser questioned why three different procedures are provided for in the legislation, "if, in the end, all claims have to go the full way."
There is some hope, however, that this may not be necessary for some. The European Commission looks set to take some "very positive" action, said Geiser. "The European Commission, in its role as decision making body, has indicated it may allow — within a short timeframe which still needs to be agreed with member states and EFSA — the submission of some new data for claims that have been judged insufficiently supported in the Article 13 EFSA opinions and also give a chance for the submission of missing characterising data for probiotics."