Substantiation of cosmetic product claims (efficacy)
Laboratory testing of cosmetic product claims (efficacy) provided by the laboratory
CoLab is a modern testing laboratory in Kyiv specializing in testing cosmetic products and raw materials, medical devices, as well as cosmetic products for animals.
The CoLab laboratory conducts testing for the substantiation of claims (efficacy) of cosmetic products, as well as all mandatory tests (stability, challenge test and packaging compatibility).
Our test protocols serve as the basis for regulatory documentation, safety assessment and substantiation of a product's claimed properties. We carry out laboratory testing, the results of which are used to demonstrate that products comply with the requirements of the technical regulations of Ukraine, the European Union, the United Kingdom and other international markets.
What is a claim?
A claim is a promise of any result of a cosmetic product made on the labelling, accompanying documents, website or in advertising.
Examples of claims
Skin effects
Safety and testing
Sensory properties
Requirements for claims
Every claim must be truthful and accurate, supported by appropriate evidence and must not mislead as to the properties or intended use of the product.
The results of claim testing are documented as protocols and reports and are included in the relevant section of the PIF — "proof of the effect claimed for the cosmetic product, where justified by the nature of the effect of the cosmetic product".
Regulatory requirements
In accordance with paragraph 53 of the Technical Regulation on Cosmetic Products and Article 20 of EU Regulation 1223/2009, in the labelling and advertising of cosmetic products made available on the market, the text, names, trademarks, pictures and other signs must not give the impression that the product has characteristics or functions which it does not possess.
In the European Union, the common criteria that claims must meet are established by Regulation (EU) No 655/2013. Its main purpose is to ensure a high level of consumer protection, transparency of information and fair competition in the cosmetic products market.
The six criteria of Regulation 655/2013
Regulation 655/2013 establishes six mandatory criteria that all claims must meet:
Legal compliance
Claims must comply with applicable legislation
Truthfulness
Claims must be truthful
Evidential support
Claims must be supported by evidence
Honesty
Claims must be honest
Fairness
Claims must be fair
Informed decision-making
Claims must enable informed decision-making
In practice
All claims must be supported by appropriate and verifiable evidence, in particular the results of laboratory testing.
Regulatory documents
- Technical Regulation Paragraph 53 — labelling requirements
- EU Regulation 1223/2009 Article 20 — product claims
- EU Regulation 655/2013 Criteria for cosmetic claims
Claims about an ingredient vs the finished product
Example: Glycerin
Glycerin is a well-known humectant with a proven ability to attract and retain water in the stratum corneum of the skin. Its moisturizing properties are widely described in the scientific literature and are not in doubt at the ingredient level.
Despite the presence of glycerin in the formulation, the finished cosmetic product cannot legitimately claim a moisturizing effect for the following reasons:
Conclusion
This is exactly why testing the claims of the finished product is essential before placing the cosmetic product on the market.
Claim substantiation
Claim testing is carried out according to a predefined protocol that clearly describes the aim of the study, its design, the inclusion and exclusion criteria, and the methods of evaluation and statistical processing of the results.
All stages, from planning and sampling to the collection, analysis and interpretation of data, are documented in detail to ensure traceability, reproducibility and the possibility of regulatory review.
Declaration of Helsinki
When studies involving volunteers are conducted, the testing is carried out in compliance with the principles of the Declaration of Helsinki regarding informed consent and the protection of the rights, safety and well-being of participants.
Confidentiality
Studies are conducted on a voluntary basis, ensuring the confidentiality of personal data and the participant's right to withdraw at any time without adverse consequences.
Independence and impartiality
The evaluation of claims is carried out independently and impartially, with a clear separation of roles between the client, the party conducting the studies and the persons analyzing the results.
Scientific integrity
The final reports reflect the actual results without selective interpretation or exaggeration of effects, which ensures trust in the data obtained on the part of regulatory authorities, partners and consumers.
Participant exclusion criteria
When conducting claim testing, the involvement of interested or dependent persons is not permitted:
- Employees of the manufacturing company
- Employees of the study client or the laboratory
- Students, interns or other persons in a subordinate relationship
Claim testing must be conducted exclusively on independent volunteers who have no personal, professional or financial interest in the results of the study.
Other services
Order claim testing
The CoLab laboratory conducts comprehensive, scientifically grounded studies to substantiate the claims and efficacy of cosmetic products, taking into account legal requirements and the principles of good laboratory practice.