Sunscreen products and claims: a guidance to the EU regulatory framework

Sunscreen products are “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” (EC, 2006) and they fall within the scope of the EU Cosmetics Regulation. Due to sunscreen products’ specific protective aim, some additional requirements have been set out – in particular concerning their efficacy, claims and testing methods.

Efficacy and testing methods

There are two types of ultraviolet (UV) radiations: UVA and UVB. UVA radiations (spectrum of 320-400 nm) can pass into deep layers of skin and, therefore, may lead to premature skin aging and skin cancer (melanoma). Conversely, UVB radiations (spectrum of 290-320 nm) reach the skin’s surface level only and are the causes of sunburns and erythemas.

To protect from UV radiations, sunscreen products contain UV filters. The ones allowed in the European Union are listed in Annex VI to the EU Cosmetics Regulation – this means that any other filter not mentioned there cannot be included in the formula of cosmetic sold on the EU market. In order to be added to Annex VI, a new UV filter has to be positively assessed by the Scientific Committee for Consumer Safety and approved by the EU Commission.

Sunscreen products cannot filter all UV radiations, but they have to protect against both UVA and UVB. According to the EU Commission Recommendation of September 22, 2006 on the efficacy of sunscreen products and the claims made relating thereto, minimum degrees of protection to consider a sunscreen effective are:

  • Sun protection factor (SPF) 6 against UVB;
  • UVA protection factor of 1/3 of the sun protection factor;
  • A critical wavelength of 370 nm.

Products that do not meet the above criteria cannot be marketed as sunscreen products.

On July 12, 2006, the EU Commission mandated the European Committee for Standardization (CEN) to establish a European standard for testing methods for the efficacy of sunscreen products. As a result, the following standards have been 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).

Four additional standards are currently under drafting and approval process.

Claims and labels

The above-mentioned EU Commission Recommendation set out requirements concerning claims and labels as well. Claims “should be simple, unambiguous and meaningful and based on standardised, reproducible criteria” (EC, 2006) In light of this, the following and similar claims are banned: ‘sun blocker’, ‘total protection’, ‘all day prevention’, as they imply that the product can protect against all UV radiations and that there is no need for re-application, which is not true.

In April 2005, Cosmetics Europe has published a guidance indicating which tests a manufacturer has to perform in order to determine the water resistance of a sunscreen product. In case of a positive assessment, the cosmetic can be labelled with the claim ‘water resistant’ or ‘very water resistant’.

Conversely, some warnings and instructions for use are necessary. In particular, it has to be highlighted that:

  • Over-exposure to the sun is a serious health threat;
  • Babies and young children must be kept out of direct sunlight;
  • The protection must be reapplied frequently.

There are no standard warnings, therefore manufacturers can rephrase them at their discretion, as long as the meaning remains the same. Moreover, it must be clearly stated how much product needs to be applied to ensure sufficient UV protection (the EU Commission suggests using approximately 36 grams of product for an average adult).

When it comes to additional labelling requirements, the efficacy of a certain sunscreen product must be classified as ‘low’, ‘medium’, ‘high’ or ‘very high’, depending on the level of sun protection factor; and the category has to be stated on the artwork, in the same font as the SPF. To better inform consumers, it is advisable not to indicate the SPF only, but also the level of protection against UVA. This can be done by using the UVA logo proposed by Colipa (the letters UVA inside a circle).

 

Protecting consumers against UV radiations is a serious public health issue; therefore, ensuring that sunscreen products comply with the EU regulatory framework is of the highest importance. Follow COSlaw to be always updated on any cosmetics-related news!

 

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