Europe To Implement New Sunscreen Labeling, Efficacy Guides This Summer

This summer the European Commission is phasing in new expectations for full-spectrum UV protection and new labeling requirements to make sunscreen claims more easily understood by consumers.

Meanwhile, an educational campaign has been launched to inform consumers of the new regime and the dangers of UV radiation.

"Sunscreen products protect from UV radiation and can be effective in preventing sunburn and skin cancer. Consumers should therefore use sunscreens and clearer labeling should help consumers to make informed choices," the EC states in a July 9 release.

Sunscreen claims giving the impression of total protection - such as "sunblock" - should begin to disappear, as should claims suggesting that the product need not be reapplied, such as "all-day prevention," the Commission says.

Labels are to bear clear usage instructions - including specific dosage amounts so consumers apply enough sunscreen to realize the promised protection level - and warnings about the effects of the sun, which might include an emphasis on frequent sunscreen re-application.

Furthermore, sunscreen products should not suggest that they provide sufficient protection for babies and young children, as exposure to the sun in childhood contributes to the development of skin cancer at a later age, the EC notes.

Additional warnings such as "Overexposure to the sun is a serious health threat" and "Do not stay too long in the sun, even while using a sunscreen product" are recommended.

The labeling guidelines can be located in a September 2006 recommendation from the Commission also aimed at setting a standard for "the minimum efficacy of sunscreen products in terms of ensuring a high level of protection against UVB and UVA radiation."

The initiative was announced in May 2006 (¹ 'The Rose Sheet' May 8, 2006, In Brief).

The EC notes that the SPF (sun protection factor) on a sunscreen label communicates mainly the strength of the product's protection against UVB radiation, which is responsible for sunburn and skin cancer.

However, UVA protection also is an important component of sunscreen products because exposure is linked to skin aging, increased risk of skin cancer and effects on the immune system, according to the EC.

Currently marketed sunscreens claim variously to "keep short UVA radiation away" or offer "broad spectrum" protection or "protection according to the Australian standard" - all statements the Commission maintains are insufficiently informative.

Beginning now, a standardized logo for sun protection will be introduced to show that products meet "a quantified minimum UVA protection," defined by the Commission as one-third the SPF as obtained through application of the persistent-pigment darkening method.

The degree of UVB protection provided by a sunscreen product should be, at minimum, SPF 6 as obtained through application of the International Sun Protection Factor Test Method.

Sunscreen products should also have a critical wavelength of 370 nm, as determined by way of the critical wavelength testing method.

Due to the looming animal testing ban for cosmetic products in Europe, the EC notes that the three test methods cited are to be used as "reference methods," but preference should be given to in vitro tests. The Commission urges industry to develop new in vitro tests for assessing UVA and UVB protection.

The EC also seeks to prevent consumer confusion around the significance of a product's SPF value. It points out that while an increase in SPF from 15 to 30 means twice the protection against sunburn, the jump does not have the same favorable implications when it comes to the amount of UVB radiation absorbed.

In addition, the EC highlights the fact that sunscreens with SPF 50 or higher "do not substantially increase the protection from UV radiation."

The Commission holds that labeling sunscreen protection as low (SPF 6 to 14), medium (SPF 15 to 29), high (SPF 30 to 59) and very high (SPF 50 and above) is a "simpler and more meaningful" means of describing efficacy. The language should appear "at least as prominently" alongside the SPF number on the label, it says.

- Molly Laas ([email protected])