Don’t take it lightly: Fines for serious breaches of Regulation (EC) No 1223/2009 on cosmetic products could be astronomical!

Similar to the pharmaceutical industry, the cosmetic industry is regulated, one aspect being cosmetic claims. Where in the pharmaceutical industry an indication describes a medical condition that a medicinal product is used for, in a similar way a cosmetic claim is an excellent mechanism to promote and communicate the intended purpose and advantage of a cosmetic product. These claims are highly regulated for the main reason of avoiding misleading advertising, which might lead to large fines.

What is a cosmetic claim?

A cosmetic claim should help the end user make an informed decision on which product to select and for what purpose, describing the effect of the product in some detail. Claims are used to make a product more appealing than any other comparable product on the market. Claims could appear in magazines, on packaging, but also on websites and social media.

What about compliance?

According to the European Commission Regulation (EU) No 655/2013, claims on cosmetic products should conform to the following common criteria:

  1. Legal compliance – Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements should not be allowed.
  2. Truthfulness – A claim cannot state “WHO approved” if it is not.
  3. Evidential support – All claims need to be adequately supported.
  4. Honesty – Claims have to be based on substantial supporting evidence.
  5. Fairness – Claims should be objective and fair, not denigrating competitors.
  6. Allow informed decisions – Claims should be clear and understandable, providing enough information allowing informed decisions.

Claims vary widely though throughout the world and some claims might be acceptable in some countries, but not in others.

Taking the above criteria, here are some claims you might want to think about:

  1. Legal compliance
    a) The claim ‘this product complies with provisions of the EU cosmetics legislation’ is not allowed since all products placed on the EU market must comply.
    b) The claim ‘skin care product does not contain hydroquinone’ is not allowed, as hydroquinone is banned by EU cosmetics legislation for this use.
  2. Truthfulness
    a) The claim ‘silicone-free’ should not be made if the product contains silicone.
    b) The claim ‘contains moisturising aloe vera’ or prominently picturing aloe vera should not be made if the product itself has no moisturising effect.
  3. Evidential support
    a) The presentation of results from in vitro or in silico studies should not suggest a result in vivo.
    b) A claim ‘this perfume gives you wings’ is metaphorical, as no one would take it literally and expect to grow wings.
  4. Honesty
    a) Claims about improved properties of a new formulation should reflect the actual improvement and should not be overstated.
    b) If the claimed performance of a shampoo is based on the combined use of that shampoo with a hair conditioner, this should be specified.
  5. Fairness
    a) A claim ‘contrary to product X, this product does not contain ingredient Y which is known to be irritating’ should not be made.
    b) ‘Well tolerated as it does not contain mineral oils’ is an unfair statement towards other products containing oils which are equally well tolerated.
  6. Allow informed decisions
    a) If the product is targeting professionals, it might be appropriate to use technical language.

In summary

Cosmetic claims on their own are already highly regulated – never mind the claim substantiations – and different countries have different requirements and regulations. All of this can end up a nightmare to manage, trying to answer the following:

  1. Which claim has been used for which cosmetic product?
  2. Which cosmetic product is using which cosmetic claim?
  3. Which cosmetic product is marketed in which country?
  4. Which cosmetic claim is used in which country?
  5. Which claim uses which substantiation information?
  6. Which claim has been used how often for which cosmetic product and which country?
  7. Which claim expires for which cosmetic product?
  8. Which claim has been used by which comparable product?

Wouldn’t it be an advantage to have all this information at your fingertips in real time with a Cosmetic Claims Management System?

Don’t hesitate to get in touch if this has sparked your interest.

Published by Olaf Schoepke

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

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