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Sunscreen Products - European Regulatory Framework

Updated: Nov 23, 2023

Sunscreen products play a crucial role in protecting the skin from harmful ultraviolet (UV) radiation, preventing sunburn, premature aging, and reducing the risk of skin cancer.

But what is their regulatory framework.

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 protecting it from UV radiation by absorbing, scattering, or reflecting radiation.

Sunscreen regulatory framework in EU

According to Regulation (EC) No 1223/2009, a cosmetic product is defined as “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”. Therefore, in the European Union, sunscreens are within the scope of cosmetic products and must comply with the requirements set out in the European Cosmetic Regulation.

Due to sunscreen products’ specific protective purpose, in 2006, the European Commission published a recommendation on the efficacy of sunscreen products and the claims made relating thereto. The Recommendation aims to standardize and simplify the way sunscreen products are labelled throughout Europe and sets out examples of claims which should not be made in relation to sunscreen products, precautions that should be observed, usage instructions that should be recommended for some of the characteristics claimed and the minimum efficacy of a sunscreen product in order to ensure a high level of protection of public health.

How to determine sunscreens efficacy?

To protect from UV radiations, sunscreen products contain UV filters. The list of the UV filters allowed in cosmetic products is in the Annex VI of the EU Cosmetics Regulation - any additional UV filters that are not listed in Annex VI are not permitted in the formulation of cosmetic products that are marketed on the EU market.

Even though no sunscreen product can filter all UV rays, they need to protect against both UVB and UVA radiation and tests must be performed to evaluate the degree of protection of the product, which should be measured using standardized, reproducible testing methods and taking photo-degradation into account.

The following methods can be used:

  • EN ISO 24442:2022 – Sun protection test methods – In vivo determination of sunscreen UVA protection;

  • EN ISO 24443:2021 – Determination of sunscreen UVA photoprotection in vitro;

  • EN ISO 24444:2019/Amd 1:2022– Sun protection test methods – In vivo determination of the sun protection factor (SPF) - Amendment 1.

The minimum degree of protection to consider a sunscreen effective are:

  • A sun protection factor (SPF) 6 against UVB;

  • A UVA protection factor of 1/3 of the SPF;

  • A critical wavelength of 370 nm.

Sunscreen products compliance with EU regulation

Labelling and Claims

In addition to the labelling requirements of Regulation (EC) nº 1223/2009, sunscreen products must also contain specific information according to the European recommendation.

The efficacy of sunscreen products should be indicated on the label by reference to categories such as ‘low protection’, ‘medium protection’, ‘high protection’ and ‘very high protection’ and the label should also indicate the SPF.

Sunscreen products’ labels should also include precautions for use such as information on the quantity needed to be effective, and instructions to ensure that the claim made for the effectiveness of the product is achieved.

Finally, as with all cosmetics placed on the European Union market, the marketing claims of sunscreen products must be substantiated and claims concerning their efficacy should be simple, meaningful and based on identical criteria in order to help the consumer to compare products and to choose the right product for a given exposure and skin type.

Do you want to place a sunscreen product on the European market and have questions about the process?

Contact us!

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