Sunscreen products are considered as cosmetic product under the EU directive 76/768/EEC and the newly updated regulation in EU regulation 1223/2009.
Sunscreens are defined as any cosmetic product, which is “exclusively or mainly”, intended to protect from UV radiations by absorbing, scattering or reflecting irradiation.
Based on Article 6 (3) of directive 76/768/EEC, products placed on the market should have the characteristics which they claim. Hence, it is important to address appropriate methods relating to sunscreen products’ efficacy.
Sun radiation consists of UVB radiation (290-320 nm) and UVA radiation (320-400 nm). UVB radiation contributes to the skin erythema, while UVA radiation can cause premature skin aging. However, excessive exposure to both UVB and UVA can impact skin health and the body’s immune system. Hence, it is critical that sunscreen products should be sufficiently effective against UVB and UVA radiation.
What is SPF?
The sun protection factor (SPF) is a score used to describe the strength of the product to protect against sunburn, mainly from UVB radiation exposure. SPF is defined as the ratio of minimum erythemal dose on sunscreen-protected skin to the minimum erythemal dose on the same unprotected skin.
Sun Protection Factor Tests
In order to ensure the reproducibility and comparability of the recommended minimum protection against UVB radiation, Europe, Japan, South Africa, and the U.S. recommended the International Sun Protection Factor Test in 2006.
The recommendation for the minimum protection against UVA radiation was the persistent-pigment darkening method as applied by the Japanese industry and modified by the French health agency Agence française de sécurité sanitaire des produits de santé (Afssaps) as well as the critical wavelength test.
These testing methods have been submitted to the European Committee for Standardisation (CEN) in order to establish European standards in this field and the process to address the repeatability and reproducibility of methods is still ongoing.
In 2010, the Standard EN ISO 24444:2010 (Cosmetics - Sun protection test methods - In vivo determination of sun protection factor) replaced the previously recommended International Sun Protection Factor Test Method of 2006. Although the EN ISO test method is now considered as the reference method within the EU, the products tested with the International Test Method do not have to be re-tested.
There is currently no in vitro method that can provide reliable and meaningful test results for SPF, therefore no in vitro method should be used for consumer information purposes.
Within the EU, the Standard EN ISO 24443:2012 (Determinination of a sunscreen UVA photoprotection in vitro) is considered as a reference method for UVA protection.
This standard was published by CEN in June 2012 and replaces the earlier reference method (COLIPA Guidelines - Method for in vitro Determination of UVA protection, 2011.) However, earlier test results obtained by using the above-cited COLIPA Test Method remain valid and can be considered as equivalent to the EN ISO test results.
The Standard EN ISO 24442:2011 (Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection) replaced the persistent-pigment darkening method the Japanese industry published in 1995. In vivo determination of UVA protection can be also used to test products, as specified in the 2006 EU Recommendation.
Due to ethical reasons, preference is given to the standardised in vitro test method for UVA protection measurement.
In the next part of this series, I will review the regulation for sunscreen products’ labelling and claims.
- Formulating an Emulsifier-Free Sunscreen
- Sunshine Not Required: Sunless Tanning Trends and Formulation Tips
- SPF Boosting Technologies
- Developing Superior Sun Care Formulations
- 2006, COMMISSION RECOMMENDATION on the efficacy of sunscreen products and the claims made relating thereto (notified under document number C (2006) 4089)(2006/647/EC)
- 2013, Cosmetics Europe Recommendation No 25, Use of appropriate validated methods for evaluating sun product protection
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5 Responses to “EU SPF Regulations: A Historical Review of Sunscreen Product Testing”
Safest UVR filters are those that do not penetrate the living dermis. These are mainly the physical filters Titanium dioxide and Zinc Oxide and composites materials.
All chemical organic filters diffuse bery fast into the live dermis and are active on blood vessel corculation most within minutes of application.
Today very high concentrated dispersions exist of UVR filters as Creasperse series TR and Zn, where powder percentages are over 70%.
No dusting during manufacturing process. Easy to use , and dispersed only in photostable emollients
of synthetic or ISO 16128 naturality.
Hi Alain, thank you for the comment. The next part of this article (in Sep) will be focused on sunscreen ingredients & labeling. So, welcome to send me any comments on that.
Great article !.
What I miss is the part on UV-A protection and how this is defined within the EU.
Hi Martin, there is the definition of UVA in the article and relevant testing method. However, regarding claims for UVA on the labels, all will be in the next part: labelings and claims. In the next part all the regulation regarding UVA labelings will be explained.T he articles had to be into two sections. Otherwise, it would be too long to publish in a blog format.
What about UVA/UVB additives: SunCat-MTA
This is an additive that is intended to provide UVA / UVB protection when added to an existing formulation, claiming that it will not react with it, as the product has been designed with ‘double sphere enwrapping’ and a negatively charged outer sphere to prevent flocculation in order to deliver even protection.
Their blending chart suggests that at a level of 17% SunCat-MTA, the resulting cream will of a broad-spectrum and an SPF of 50+.
As it was intended to take the guess-work out of formulating a sunscreen, will the resulting product require any further testing.