Despite the Innéov rejection, Unilever spokesperson Flip Dotsch said the company was confident of its article 13.5 emerging and proprietary science dossier due to the quality of science it possessed.
“Our ingredients are significantly different from Innéov in a number of areas,” he said, noting the applied for claim (wrinkle reduction versus dry skin improvement) was a significant point of differentiation.
“The proprietary data we submitted relates specifically to our formulation,” he said.
Ingredient specific rather than formulation specific science was one of the major justifications for EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) issuing a negative opinion to Innéov.
Dotsch would not expand on the number of studies the submission contains or dosage levels for the formulation comprised of fish oil, isoflavones, lycopene, vitamin C and vitamin E.
The submitted wording for the undisclosed product states: "[X] reduces wrinkles and lines in skin”.
Comprehensive clinical research programme
Dotsch said Unilever’s, “long history in skin products” had helped it develop the dossier and the science behind it.
“An increasing amount of evidence revealed in recent years has highlighted the potential effects of diet on skin particularly aging appearance,” it said. “Based on these insights, Unilever carried out a comprehensive clinical research programme to investigate the impact of various food ingredients on skin in close collaboration with external experts in both nutrition and skin.”
“With such a claim Unilever would make the next step in exploiting this unique field of research by combining our strong foods and personal care expertise.”
Innéov and improved skin condition
Innéov – a joint venture between L’Oreal and Nestlé – submitted the claim ‘Helps to improve dry skin condition.’
It also submitted alternative wordings:
- Helps to improve skin dryness.
- Helps to improve dry skin aspect.
- Helps to improve skin comfort.
- Helps to improve skin soothing.
- Helps to improve skin ageing signs.
- Helps to act against skin dryness.
The NDA rejected the dossier that contained 29 scientific publications because it deemed many were of no scientific import because they were conducted on individual components of the Innéov blend, and not the blend itself.
Of the three trials deemed relevant, the NDA detailed two proprietary, unpublished human, clinical trials which it concluded, “did not result in a significant improvement in skin dryness”, including a pilot study that included a targeted sub-group of 40 elderly nuns.
Innéov’s softgel blend contained blackcurrant seed oil (920mg), fish oil (920mg), lycopene (2mg), vitamin C (60mg), and vitamin E (10mg).