Efficacy and Safety Claims: testing cosmetic products

Cosmetic claims are among the main elements defining a cosmetic product, directing consumers’ choices and differentiating products on the market.

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

  • Legal compliance: Presumed for all products circulating in the EU.
  • Truthfulness: Concerning the presence of certain ingredients or properties in the finished product.
  • Evidential support: All manufacturers should provide a proof of effect claimed for their products, taking into account the state of the art at the moment when the product is marketed.
  • Honesty: The effect claimed should not go further than the evidence available.
  • Fairness: Different products shall not be compared to prove the benefits of one of them.
  • Informed decision making: Claims and advertising shall be clear and understandable for the target audience.

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These criteria should be taken into account when it comes to best-practice verification for personal care and cosmetic products. Ensuring adequate testing for products should then be a key concern for the industry, regardless of the mere regulatory requirements.

This issue acquires particular relevance considering the case-by-case evaluation approach outlined in the «Technical document on cosmetic claims», as agreed by the Sub-Working Group on Claims. Although non-legally binding, the document is meant as a “tool” for national competent authorities and national courts to assess on a case-by-case basis which claims made in relation to cosmetic products are allowed.

As general guidelines, the kinds of tests performed on a cosmetic product shall depend on:

  • product;
  • user;
  • type of claim.

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It is also useful to take into consideration existing relevant guidelines, e.g. guidelines relating to instrumental clinical techniques and other European or international guidelines or standards (e.g. CEN, ISO, etc.).

Whatever the type of study, it is important that the person conducting the test has:

  • the appropriate qualifications;
  • training and experience in the field of the proposed study;
  • high ethical qualities standards and professional integrity.

Similarly, test facilities should maintain a quality assurance system, including standardised operating procedures.

If you wish to learn more about the compliance of your products and how to access the EU market, please do not hesitate to contact us. Obelis Expert Consultants, with nearly 30 years of experience with EU regulatory affairs, will gladly answer your questions.

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