The cosmetic industry needs to substantiate their claims as serious breaches of Regulation (EC) No 1223/2009 could be costly.

In our last blog on Cosmetic Claims Management we discussed cosmetic claims and the impact of not being compliant to Regulation (EC) No 1223/2009. A Cosmetic Claims Management System might answer in real time many of the questions faced with regards to cosmetic claims. The advantages of a Cosmetic Claims Management System are clear and include being able to

  1. Identify each claim for each cosmetic product;
  2. Identify which cosmetic product is using which claim;
  3. Identify which cosmetic product is marketed in which country;
  4. Identify each cosmetic claim on a country per country basis;
  5. Get statistics on claims usage;
  6. Get notification on claim expiry;
  7. Get knowledge on which claim has been used by which comparable product.

But how can each claim be supported?

That is where ‘cosmetic claim substantiation’ comes in, in the form of studies, published data, consumer or in vitro testing.

For the cosmetic industry, Regulation (EU) No 655/2013 already states that claims for a cosmetic product “…shall be supported by adequate and verifiable evidence…”. Annex II section 3. Evidential Support (4) states:

The level of evidence or substantiation shall be consistent with the type of claim being made, in particular for claims where lack of efficacy may cause a safety problem.

This also highlights that any substantiation should be available at the time of the claim being made, not after. The responsibility remains with the ‘Responsible Person’ and depends on the type of product and claim.

What level of evidence might be required?

According to the ‘Cosmetic Toiletry and Perfumery Association’ (ref. Cosmetic Claims 2018), there are different levels that should be considered for cosmetic claim substantiation:

The first level is when a claim is considered widely accepted, such as the use of a common ingredient proven to provide a particular effect.

The second level of evidence is when there is a widely accepted claim, but additional substantiation might be required, for example for

• high dependency on formulation factor(s);
• a product type not normally associated with an established claim;
• a significant enhancement of an established claim.

The highest level of evidence is based upon the advances in science and technology, examples being

• the action of an entirely new type of ingredient;
• an entirely new consumer benefit;
• an entirely new sensory property.

In summary

Under Regulation (EU) No 655/2013 cosmetic claim substantiation is required and should be available at the time of the claim, not after the claim has been made. The ‘Responsible Person’ is required to keep the claims and their substantiation up to date, with the Product Information File being one place to manage both. Fines for failing to comply are substantial. A Cosmetic Claims Management System can eliminate many of the challenges faced.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

%d bloggers like this: