Cosmetic Products Testing in the European Union
A cosmetic product which is made available on the European Union market needs to prove that it is safe for consumers. Apart from the mandatory testing, depending on the claims to be used or the type of cosmetic product to be placed on the market, additional tests may be required.
Liliana Teles

Liliana Teles

Regulatory Affairs Manager


A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use.

According to the European Cosmetic Regulation no. 1223/2009, in order to demonstrate that a cosmetic product complies with this statement, the Responsible Person (RP) shall, before placing a cosmetic on the market, ensure that the product has undergone a safety assessment and that a Cosmetic Product Safety Report (CPSR) is made in accordance with the Regulation.

A CPSR, which shall be included in the Product Information File (PIF), must contain cosmetic product safety information (part A), which includes:

  • Qualitative and quantitative composition of the cosmetic product;
  • Physical/chemical characteristics and stability of the cosmetic product;
  • Microbiological quality;
  • Impurities, traces, information about the packaging material;
  • Normal and reasonably foreseeable use;
  • Exposure to the cosmetic product;
  • Exposure to the substances;
  • Toxicological profile of the substances;
  • Undesirable effects and serious undesirable effects;
  • Information on the cosmetic product.

So as to fulfil some of these requirements, the product/substances need to go through particular tests, which should be performed by accredited laboratories, following Good Laboratory Practices (GLP). The majority of the tests are performed with the final cosmetic product and need to be repeated if there is a change in the formula, packaging or manufacturing process.

The cosmetic product safety assessment (part B of the CPSR) is developed according to the information provided in part A and has to include the assessment conclusion, labelled warnings and instructions of use, a reasoning, the assessor’s credentials and its approval of part B.


Testing the stability of the finished cosmetic product is mandatory for an estimation of the product lifetime to be made. The stability test allows the estimation of the shelf life and the Period After Opening (PAO). In the European Union (EU) stability tests must follow the international guideline ISO/TR 18811:2018. The stability test evaluates if the product will meet the defined physical, chemical and microbiological quality standards and also evaluate its functionality, safety and aesthetics from the moment it is manufactured until the end of its use life.

The stability tests performed in accordance with ISO 18811:2018 monitor physical, chemical and microbiological specifications, organoleptic properties and packaging compatibility of the cosmetic product.

There is a wide range of different cosmetic products available on the market making it impossible to define a single way to assess product stability. The manufacturer has the responsibility to specify and justify the stability protocol to cover test methods, specifications and conditions at which the products shall be tested.

The interaction between the product and the packaging material chosen must also be evaluated. The aim is to prove an absence of migrations (e.g., ingredients, trace substances, part of the packaging) or interactions between the formula and the packaging, ensuring that no quality problems occur due to the packaging material used.

As mentioned in one of our previous posts, data on microbiological quality must be indicated in the CPSR. Moreover, “particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses”. It is mandatory include in the CPSR the results of a preservation challenge test. This test is performed using the final cosmetic product (and prototype) to evaluate the antimicrobial protection of a cosmetic product and, consequently, ensure the correct preservation during storage and use. The microbiological quality of a cosmetic product should be assessed using the guideline ISO 17516:2014. The challenge test can be performed in accordance with ISO 11930:2012. Microbiological testing does not need to be performed on products that have low microbiologically risk (e.g., very low or very high pH).

Regarding sun care products, SPF means “sun protection factor” and it refers only to protection against the radiation which causes erythema (mainly UVB radiation) (for more information, see our previous post). Different regulations (EU, U.S, Japan, etc.) have set out different methods for testing sunscreen products and the differences between methods make it impossible to compare the SPF effectiveness, as there are no equivalent factors or tables. For this reason, an ISO standard was created (harmonized and global methodology) to ensure that all sun care products can be measured under the same conditions and ensure the safety of consumers. ISO 24444:2019 (which has updated ISO 24444:2010) sets global and harmonized guidelines for the in vivo determination of the sun protection factor (SPF) of sunscreen products. 

Besides the mandatory tests, cosmetic products can be evaluated through clinical tests in order to ensure skin compatibility or tolerance and avoid potential adverse effects in certain target groups. Human Repeated Insult Patch Tests (HRIPT), in use tests and patch/open tests are the most common clinical tests used in cosmetic products. Some companies use this type of tests in order to include claims such as “dermatologically tested” in their products.

It is also possible to perform efficacy evaluation tests of cosmetic products, which are particular important when specific claims are made (e.g., anti-ageing, anti-wrinkle, firming, non-comedogenic, etc.)

In sum, before making available a cosmetic product in the European market, it is mandatory to perform some tests: stability test; microbiological quality test; challenge test; compatibility test; SPF test (if applicable). Moreover, with the purpose of making specific claims or to demonstrate skin compatibility/tolerance, clinical tests with the final cosmetic product can be performed in human volunteers.

Placing a cosmetic product in the market may not be a simple task, but our company can help you through every step of the way. Feel free to contact us at


  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Commission Recommendation of 22 September 206 on the efficacy of sunscreen products and the claims made relating thereto. Available from:
  3. ISO/TR 18811:2018. Cosmetics – Guidelines on the stability testing of cosmetic products.
  4. ISO 11930:2019. Cosmetics – Microbiology – Evaluation of the antimicrobial protection of a cosmetic product.
  5. ISO 29621:2017. Cosmetics – Microbiology – Guidelines for the risk assessment and identification of microbiologically low-risk products.


medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »