Testing plays a crucial role in the cosmetic product manufacturing process. Compliance with specific testing requirements is essential to ensure that cosmetic products are safe for use under reasonably foreseeable conditions.
European Union
Based on Article 20 of Regulation (EC) No 1223/2009 on cosmetic products (CPR), Commission Regulation (EU) No 655/2013 established EU harmonised common criteria in order to assess whether or not the use of a claim is justified. Article 20 of the CPR applies to products that fall within the definition of a cosmetic product under Article 2 of the CPR2 . The common criteria only come into play when it has been assessed that the product in question is indeed a cosmetic product. It is for the national competent authorities and national courts to decide on a case-by-case basis which regulatory framework applies.
In order to ensure harmonisation across the single market as regards qualification of products, various guidance documents have been produced by the European Commission on the delimitation between cosmetic products and other product categories e.g.:
- between cosmetics and medicines (Guidance document on the demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83/EC as agreed between the Commission services and the competent authorities of the Member States),
- between cosmetics and biocidal products (Guidance document of the Commission services and the competent authorities of the Member States on the borderline between Directive 98/8/EC concerning the placing on the market of biocidal products and Directive 76/768/EEC concerning cosmetic products),
- between cosmetics and other products (Manual on the scope of application of the Cosmetic Products Directive 76/768/EEC (Art. 1(1) of the Directive) in order to determine whether the product falls within the cosmetic definition given in Article 2.
The Commission adopted recommendations on the efficacy of sunscreen products and related claims which were inspired by the same principles as those illustrated in Commission Regulation (EU) No 655/2013 (Commission Recommendation 2006/647/EC of 22 September 2006).
Another important and very helpful document describing the borderline product in the contests of the definition of “cosmetic product” as set out in Article 2(1)(a) of the Cosmetics Regulation is MANUAL OF THE WORKING GROUP ON COSMETIC PRODUCTS (SUB-GROUP ON BORDERLINE PRODUCTS) ON THE SCOPE OF APPLICATION OF THE COSMETICS REGULATION (EC) NO 1223/2009 (ART. 2(1)(A)), the latest version 5.3 (November 2023).
Cosmetic product claims must comply with the legally binding Common Criteria Regulation, which lays down six criteria that must be met for the justification of claims used in relation to cosmetic products:
- legal compliance,
- truthfulness,
- evidential support,
- honesty,
- fairness,
- informed decision-making.
There are two main types of testing conducted for cosmetic products in the EU to proof the claims:
- Cosmetic Safety Testing,
- Cosmetic Efficacy Testing.
Cosmetic Safety Testing
The EU Cosmetics Regulation mandates cosmetic safety as a fundamental requirement, which states that every cosmetic product sold in the market must be safe for human use and should not pose any health risk. To fulfill this requirement, the manufacturer must conduct safety evaluation and safety testing, through which they would get evidential support justifying the product’s safety. These test results are further evaluated by a safety assessor during the preparation of the Cosmetic Product Safety Report (CPSR).
The most common safety testing procedures include the following:
- stability and compatybility testing,
- microbiological testing (including Challenge tests),
- dermatological testing,
- testing with doctors,
- SPF/UVA testing.
Cosmetic Efficacy Testing
Cosmetic efficacy testing plays a key role in supporting product functionality and substantiating cosmetic claims. Proof of the effects claimed forms an obligatory part of the Product Information File (PIF), which is a cosmetic product dossier that authorities must have access to. It is customary for authorities to review all the data supporting the marketing description and claimed effects of a product.
The most common efficacy testing method includes:
- applicational studies (use tests, consumer tests),
- apparatus testing.
This is in European Union, but how it is working in other parts of the world?
Great Britain
On the website: GOV.UK (Making cosmetic products available to consumers in Great Britain – GOV.UK (www.gov.uk) you can find the general guidance, which covers all cosmetic products that are available to a member of the public in Great Britain (GB). This includes products that are sold or given away (for example, free samples) and products used on the public by professionals. This guidance is to support understanding of Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.
This guide does not cover making cosmetic products available in Northern Ireland (NI), for which the Responsible Person must be established in NI or the EU. There is separate technical guidance available for both NI and GB. The Government is seeking to find a new balance in the Northern Ireland Protocol to place it on a more sustainable footing that would impact on how products are regulated in NI.
Cosmetic products available to consumers in GB must be safe for human health. The Product Information File (PIF) contains information on how safe a cosmetic product is for human health. This is why it must be kept up to date. The PIF supports cosmetic product safety by providing:
- a safety assessment, which confirms a cosmetic product is safe and gives the scientific evidence to support this,
- details on good manufacturing practice, which includes what has been done when manufacturing a cosmetic product to make sure it is safe.
Making cosmetic products safe for users also covers how a cosmetic product is presented. It must:
- not be mistaken for food,
- have clear labelling,
- have instructions on use and disposal.
Making claims about what a cosmetic product does: the labelling and advertising of cosmetic products must not imply they have characteristics or functions which they do not have.
As we can see, cosmetic testing is a multi-faceted process that prioritizes consumer safety, claims support, and Regulatory compliance. With its firm commitment to safeguarding public health we are slowly gaining confidence that the cosmetic products available to consumers are safe and effective.
References:
https://www.gov.uk/guidance/making-cosmetic-products-available-to-consumers-in-great-britain
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