Standards for cosmetic products and sunscreens

Standards for cosmetic products and sunscreens

ISO standards

ISO (the International Organization for Standardization) is a worldwide known federation of national standard bodies. The ISO technical committees are responsible for preparing International Standards.

The ISO member bodies assess the ability of a product to maintain the desired physical, chemical, and microbiological properties together with the functionality and sensory properties when stored and used under appropriate conditions by the consumer. Therefore, the stability studies are a prerequisite for ensuring product quality.


Stability tests on cosmetic products are mandatory for:

- Obtaining guidance on the formulation of the product and the appropriate packaging material;

- Optimizing the formulation and manufacturing process;

- Determining conditions of transportation, storage, display, and manner of use;

- Estimating and confirming shelf life, and Preservative efficacy testing (Challenge Test) can be done according to the ISO 11930 standard-Evaluation of the antimicrobial protection of a cosmetic product. The microorganisms used for challenge testing are often the following ones: Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. If required, other microorganisms can be added.


Looking at the case of sunscreen cosmetic products, ISO standards have been also developed to cover products’ specific protective aim, for ex.:

® ISO/CD 23675 — Sun protection test Methods — In Vitro determination of Sun Protection Factor

® ISO/CD 23698 — Sun protection test methods - Measurement of the Sunscreen Efficacy by Diffuse Reflectance Spectroscopy

® ISO/DIS 24442 — Sun protection test methods — In vivo determination of sunscreen UVA protection

® ISO 24443:2012 —Determination of sunscreen UVA photoprotection in vitro

As seen, various standards apply to sunscreen products.


EU

In the European Union, sunscreen products are defined as “any preparation (creams, oils, gels, sprays) intended to be placed in contact with the human skin with a view of exclusively or mainly to protecting it from UV radiation by absorbing, scattering or reflecting radiation” (EC, 2006) and they fall within the scope of the EU Cosmetics Regulation.  You can read more about sunscreens here.


Moreover, in July 2006, the European Committee for Standardization (CEN) established a European standard for testing methods for the efficacy of sunscreen products. The following standards were published:

- EN ISO 24442:2011 – Sun protection test methods – In vivo determination of sunscreen UVA protection;

- EN ISO 2443:2021 – Determination of sunscreen UVA photoprotection in vitro;

- EN ISO 24444:2020 – Sun protection test methods – In vivo determination of the sun protection factor (SPF).

It is advisable to use the most recent version of the standard when testing your sunscreen products.


In April 2005, Cosmetics Europe published Guidelines for Evaluating Sun Product Water Resistance indicating the required tests to establish the water resistance of a sunscreen product. If the assessment is positive, the cosmetic is labeled with the claim ‘water-resistant’ or ‘very water resistant’. On the other hand, it is necessary to include some warnings and instructions for use such as:

- Over-exposure to the sun is a serious health threat;

- Babies and young children must be kept out of direct sunlight;

- Users must reapply the protection frequently.

Consumers must be protected against UV radiation, as this concern is a serious public health issue. As a consequence, ensuring that sunscreen products comply with the EU regulatory framework is highly important.


Federica Russo

Regulatory Affairs Department

15/11/2021


References

COSlaw. (2021). Sunscreen products and claims: a guidance to the EU regulatory framework. Retrieved on 15/11/2021 from https://www.coslaw.eu/sunscreen-products-and-claims-a-guidance-to-the-eu-regulatory-framework/

ISO. (2018). ISO/TR 18811:2018(en) Cosmetics — Guidelines on the stability testing of cosmetic products. Retrieved on 15/11/2021 from https://www.iso.org/obp/ui/#iso:std:iso:tr:18811:ed-1:v1:en

Intertek. Cosmetic Preservative Efficacy Challenge Testing. Retrieved on 15/11/2021 from https://www.intertek.com/cosmetics/preservative-efficacy-challenge-testing/

Cosmetics Europe (2005). Guidelines for evaluating sun product water resistance. Retrieved on 15/11/2021 from https://www.cosmeticseurope.eu/files/7914/6407/7400/Guidelines_for_Evaluating_Sun_Product_Water_Resistance_-_2005.pdf