EUROPEAN REGULATIONS FOR SUNSCREEN PRODUCTS

Unlike other regions, sunscreen products are classified as cosmetic products in the European Union, therefore they must comply with EU Cosmetics Regulation 1223/2009.

The European Commission takes the efficacy and safety of sunscreen products very seriously, which is why it has published a document with a series of recommendations on the efficacy of sunscreen products that every manufacturer must take into account during the development of a sunscreen product.

According to this Recommendation, a ‘sunscreen product’ means any preparation (such as creams, oils, gels, sprays) intended to be placed in contact with the human skin with a view exclusively or mainly to protect it from UV radiation by absorbing, scattering or reflecting radiation.

For a sunscreen product to be considered effective in the European Union, it must protect against UVB and UVA radiation.

Claims and warnings required for sunscreen products

The European Commission requests that claims don’t imply the following:

• 100 % protection from UV radiation (such as ‘sunblock’, ‘sunblocker’ or ‘total protection’)
• No need to re-apply the product under any circumstances (such as ‘all-day prevention’).

No sunscreen can provide 100% protection from the sun, which is why sunscreen products are required to have warnings such as the following:

• ‘Do not stay too long in the sun, even while using a sunscreen product’.
• ‘Keep babies and young children out of direct sunlight’.
• ‘Over-exposure to the sun is a serious health threat’.

It is also recommended to include instructions for use on the product labelling to ensure consumers use it correctly and the claims on the label can be verified. Providing information on the correct amount of product to apply is crucial for effectiveness. Additionally, it is important to include warnings about the consequences of reducing the recommended amount of product used.

• ‘Apply the sunscreen product before exposure’.
• ‘Re-apply frequently to maintain protection, especially after perspiring, swimming or towelling’
• ‘Warning: reducing this quantity will lower the level of protection significantly’.

Sunscreen efficacy

The European Commission, through the Recommendation, has established a minimum efficacy that sunscreen products marketed in the European Union must have. For this, it has given details on three key aspects directly related to efficacy:

• UVB protection: A sunscreen product must have a sun protection factor (SPF) of at least 6.
• UVA protection: The UVA protection factor must be 1/3 of the sun protection factor.
• Critical Wavelength: The minimum critical wavelength of a sunscreen product must be 370 nm.?

Efficacy testing of sunscreen products

To accurately measure the protection level of a sunscreen, it is essential to conduct various tests on the product using specific, valid methods. The Recommendation specifies that these methods should be standardised and reproducible, and must also consider photo-degradation. Preference is often given to in-vitro methods. Only certain validated methods are recognized for conducting these tests:

• Sun Protection Factor (SPF) test: It must be carried out according to the International Sun Protection Factor Test Method (ISO-EN-UNE 24444, in vivo) or any in vitro method.
• UVA Protection test: This information must be obtained using the Persistent Pigment Darkening Method as modified by the French health agency Agence fran?aise de sécurité sanitaire des produits de santé – Afssaps (ISO-EN-UNE 24443) or any in vitro method.
• Critical Wavelength test: It must be carried out using the Critical Wavelength Testing Method (ISO-EN-UNE 24443).

The results from these tests will allow for various claims to be made about the product. It’s important that these claims are clear, unambiguous, and meaningful, and they must be based on standardised, reproducible criteria. Depending on these results, the product should then be classified into one of the following protection categories:

And remember, as with any other cosmetic product, any additional claims made on a sunscreen product must be supported by evidence. If a sunscreen meets the minimum efficacy standards, it can feature claims such as “Broad Spectrum” or “UVA protection.”

Therefore, when formulating and developing sunscreen products, it’s crucial to carefully select a UV filter or a combination of UV filters. This ensures that the resulting product not only meets the minimum required efficacy but also becomes a top-choice product for individuals seeking effective sun protection.

You can read the whole article by Senior Safety Assessor Maria Jose Coronado at Taobé Consulting's blog:

EUROPEAN REGULATIONS FOR SUNSCREEN PRODUCTS

If you have any doubts about the sunscreen requirements in Europe or the United Kingdom, please feel free to reach out to us via our contact page. We’re here to assist you every step of the way!