Substantiating cosmetic claims is a necessary step for any cosmetic manufacturer wishing to sell products in the EU. From experimental studies to consumer perception studies, and published information, find out about the options at your disposal to ensure compliance with EU regulations.

How to Substantiate Cosmetic Claims?

Cosmetic manufacturers wishing to sell their products in the EU need to comply with EU cosmetics labelling requirements. These obligations state that any claims made to convince consumers to purchase the product in question should be fully substantiated. In other words, if you're making promises as to the efficacy of a cosmetic product, you need to be able to prove that everything you are saying is true and not misleading in any way. What is a substantiated claim? How to substantiate cosmetic claims? Here is all you need to know.

Why Substantiate a Cosmetic Claim?

If you have a cosmetic claim to substantiate, the definition you apply needs to match that of the EU Commission Regulation No 655/2013. The latter states that any explicit or implicit claim for a cosmetic product needs to be supported by relevant, verifiable evidence to substantiate (meaning prove) it. The regulation in question outlines a number of common criteria that cosmetic claims should comply with. The RP – or EU Responsible Person – ensures that everything is in order and uses the PIF (Product Information File) to verify the accuracy of the information.


Claim substantiation in the cosmetic industry endeavours to protect consumers from being misled. The goal is to provide objective information that the end user can rely on to decide whether the product is right for them. It also gives brands the opportunity to illustrate how innovative and effective their product is.

How to Substantiate a Claim?

When it comes to providing substantiated evidence about a cosmetic product, following best practices is paramount. The main way to support claims is to carry out experimental studies, to perform consumer perception tests, or to publish unbiased information (marketing data or scientific data, for instance) on the topic. Naturally, brands may choose to make even more information public if they wish to do so. 

Experimental Studies

Experimental studies that can be carried out to substantiate claims for cosmetics include:
  • Ex-vivo tests performed on a biological substrate derived from a living organism, such as cut hair, for instance.
  • In vitro tests performed in test tubes or other labware, or on biological substrates such as artificial skin models or cell cultures. Just like ex-vivo tests, in vitro studies must be performed in a controlled, standardised environment and follow validated protocols.
  • In silico tests
  • Biochemical approaches
  • Instrumental approaches
  • Sensory evaluation
  • Clinical studies on volunteers, etc.
These various types of studies should all be performed under very specific guidelines and produce reliable, reproducible results. The tests should follow a scientifically valid, standardised protocol and provide statistically relevant information. For example, the tests should involve a suitable range of subjects, be conducted by qualified personnel, etc.

The aim of the tests is to predict an in vivo effect and to serve as evidence that the product performs as advertised.

Cosmetic brands wishing to substantiate their products' claims must strive to interpret their results appropriately and fairly. They also need to follow ethical principles when carrying out tests on volunteers, who should never be exposed to a product deemed unsafe.

Experimental studies may be used to substantiate the following claims:
  • "Dermatologically tested", which means that the product was tested on human beings under the supervision of a dermatologist who verified either its tolerance or its efficacy. It is worth noting that such a claim may not be substantiated by consumer self-perception studies as consumers lack the medical background to support such observations.
  • "Tested under medical supervision" is another claim which implies that the tests were conducted under the supervision of a medically qualified health care professional, such as a dentist or a medical doctor. As such, it could refer to the efficacy of a particular effect, or to how well it is tolerated by the skin.
  • "Clinically tested" signifies that the product was tested on human beings under very specific conditions. The phrase may also refer to a process or expertise applied when testing the product in a clinical setting or following a clinical protocol.
  • "Tolerance tested" implies that the product was scientifically tested to ensure it was well tolerated by a target group.

Consumer Perception Studies

These studies may be performed to substantiate claims on how consumers perceive the product in terms of a specific aspect. To carry out these tests, brands prepare an easy-to-understand questionnaire for volunteers to report on how they feel and what they can observe. To ensure accuracy and statistical relevance, the tests should be standardised and follow a strict protocol, as should the interpretation of the results.

Published Information

So long as the information in question is relevant to the claim you wish to substantiate, any official publication may be used. Good examples include scientific publications (such as studies) or market data. The documents should also be representative. For instance, market data needs to be based on the brand's target market for the product.

Cosmetic claim testing is crucial for any brand wishing to substantiate – meaning to provide evidence for – the promises they make about their products. With the right tools, you can perform studies and compile all the necessary information to prove the efficacy of your cosmetic products.