The company had prepared a dossier for EFSA’s health claims panel containing a range of scientific studies to support the claim that its ingestible blend of blackcurrant seed oil, lycopene, vitamin C and vitamin E, ‘helps to improve dry skin conditions’.
Innéov is one of the leading companies in the beauty from within field which has been tipped as a promising sector by many market analysts. However, the market could suffer from the lack of clarity surrounding the scope of EFSA’s health claims regulation as it remains unclear which cosmetic-related claims are covered by the regulation and which fall outside its scope.
Innéov’s director for regulatory affairs and product security Michel Donat explained that although EFSA did not grant the claim for dry skin improvement, it has recognised dry skin as a health condition.
Much of the data irrelevant to specific claim
According to EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), the majority of the 29 scientific publications referenced by Innéov were not relevant to the proposed claim, many because they were conducted on individual components of the blend and not on the blend itself.
However, the panel did conclude that some endpoints investigated in the trials, for example the ceramide concentration of the stratum corneum, as well as dermatological assessments such as the papery appearance of leg skin, did show some improvement.
According to Donat, the refusal from EFSA is related to the breadth of the claim.
“Narrow parameters appear to be better for EFSA. With the dry skin claim there are many parameters involved, if we had chosen one which is more specific we may have had more luck,” he told CosmeticsDesign-Europe.com.
However, Donat explained that this was not known when Innéov’s clinical trials were being designed in 2006 and 2007, as EFSA’s guidelines were published after the regulation was put into place.
The company now has a month to make comments to the European Commission which is, in theory, not obliged to accept EFSA’s decision.
“We will use this time to make some comments, I appreciate that we will not reverse the opinion of EFSA but we would like some kind of recognition of the product’s efficacy,” he said.
In addition, Donat said the experience would inform future applications from the company.
“We have been investing for many years in the efficacy evaluation of our products. Therefore we are not abandoning the idea of having an EFSA claim, and this has helped us gain experience for other dossiers we might submit.”
The company currently markets a product called Innéov dry skin and Donat said it would be looking into the claims made by this product to make sure none of them are at odds with current regulation.
Scope of EFSA
Although in this case EFSA has ruled that improving the dry skin experienced by healthy adults that results in feelings of tightness and creasing is a beneficial physiological effect, it remaines unclear which other skin-related claims are covered by the regulation.
“I think it’s a case by case basis. If you are talking about smooth skin, or skin with a better glow, then you are probably not falling under the scope of the regulation in my opinion, but cell or skin ageing probably may well be.”
However, he said the European Commission and member states had not been clear on this.
EFSA is holding a meeting on June 1 in Parma to discuss with industry stakeholders recent developments relating to health focusing on claim substantiation and requirements for scientific evidence.