Does Europe Have Better Sunscreens?

Americans have fewer choices and notably poorer protection from ultraviolet A rays than Europeans. While most sunscreens prevent sunburn effectively when used correctly, they are not as good at preventing the more subtle skin damages produced by lower- energy UVA radiation. UVA rays have less energy and don’t burn the skin, but they can cause the skin to age, can suppress the immune system, and contribute to the development of melanoma.

Sunscreen manufacturers who make products for the market in Europe meet high standards for UVA protection, because they can pick and choose among 27 chemicals, including seven that offer strong protection against UVA radiation. Some of these chemicals appear to offer significant performance advantages over the 17 sunscreen chemicals the federal Food and Drug Administration permits in products sold on the American market. Only three of the FDA-approved chemicals screen UVA rays.

Between 2003 and 2010, sunscreen makers applied for FDA permission to use eight sun-filtering chemicals developed by European companies. Four of these – Tinosorb S, Tinosorb M, Mexoryl SX and Mexoryl XL – appear to be more effective than avobenzone, the most common UVA filter permitted by the FDA. The FDA’s failure to respond to these applications prompted Congress to pass the Sunscreen Innovation Act, signed by President Obama last November. This act requires the FDA to review new applications for sunscreen active ingredients within 300 days. The FDA informed the companies involved that they had not submitted enough information to prove that their chemicals were, in fact, safe and effective for use in sunscreens (FDA 2015a).

The agency asked for more data, including complete study results, measurements of ingredient levels in people’s blood and long-term studies on systemic toxicity and potential endocrine system disruption. FDA officials have said that many chemicals now used in sunscreens that were on the market in 1978, when FDA began to develop sunscreen rules, would not pass muster under the regulations now in force.

Some of the information FDA wanted, such as complete copies of studies, might be easy for sunscreen makers to produce. But in other cases, the companies might need years to satisfy FDA requests.

In the meantime, American consumers are being shortchanged. When its most recent round of sunscreen regulations went into effect in December 2012, the FDA set lax standards for UVA protection – in part because good UVA filtering ingredients had not been approved. Those regulations allowed nearly every sunscreen product to be marketed as “broad spectrum,” a term that implied good UVA protection. Many don’t.

British researcher Brian Diffey evaluated the UV protection of four U.S. sunscreens and four sold in Europe, each of which had an SPF value of 50 or 50+. He found that the U.S. sunscreens allowed, on average, three times more UVA rays to pass through to skin than European products, which included the modern UVA filters (Diffey 2015).

EWG estimates that about half of the 750-plus beach and sport sunscreens we assessed this year are too weak for the European market. In the nations regulated by the European Commission, manufacturers voluntarily comply with a recommendation that all sunscreens must offer UVA protection that is at least a third as potent as the SPF, the measure of the product’s ability to shield against UVB rays that burn the skin (European Commission 2006, Colipa 2009). In other words, if a product advertises SPF 30, its UVA protection must be at least 10.

American consumers do not have an easy way to gauge whether a product protects well from UVA radiation. In general, products must contain zinc oxide or avobenzone to provide good UVA filtering. Sunscreens with SPF values greater than 50 offer poorer balance between UVA and UVB protection.

The newest UVA filters

Four European sunscreen ingredients merit close consideration for inclusion in U.S. products. Tinosorb S and Tinosorb M UVA -filters, developed by the German chemical company BASF, appear to be much stronger and more photostable than avobenzone. In an effort to gain access to the U.S. market, BASF gave the FDA the results of toxicity and safety testing, including skin and eye irritation, phototoxicity, dermal toxicity and oral feeding studies ( 2008a,b). The European Commission examined Tinosorb S in 1999 (SCCNFP 1999) and Tinosorb M last year (SCCS 2013) and determined that both sunscreens could safely be used in sunscreens in concentrations of up to 10 percent. Last fall, the FDA asked BASF for more details about tests of both chemicals.

La Roche-Posay, the active cosmetics division of the French cosmetics giant L’Oreal, developed Mexoryl SX, also called Ecamsule, which claims that it offers strong, photo-stable protection. The company has sold sunscreens containing this chemical in Europe since 1993. In 2006, the FDA allowed La Roche-Posay to produce one specific sunscreen formulation with Mexoryl SX for the U.S. market. Canada admitted Mexoryl SX to its market and recently approved a successor chemical, Mexoryl XL, at concentrations of up to 10 percent (Canada 2013). Last February, the FDA asked La Roche-Posay for more information about its chemicals’ safety tests before approving the company’s application to use them in a range of sunscreen products.

EWG agrees that all sunscreen chemicals now under consideration for the U.S. market should be subjected to careful review and high standards for safety, to protect Americans from chemicals that may endanger human health and provide UV protection. At present, scientists know considerably more about the effectiveness of these chemicals in shielding the skin than about their toxicity. Ingredients that offer ineffective skin protection or cause irritation, skin allergy or other health risks should be barred or tightly restricted. However, many of the active ingredients currently allowed in U.S. products have a poor safety profile.

It’s already clear that some European chemicals should not be admitted to the U.S. market. For instance, Merck has applied to FDA for permission to market a sunscreen ingredient called 4-MBC or Enzacamene, a UVB filter. Researchers have detected 4-MBC in European women’s breast milk and in wildlife (Krause 2012). These findings are troubling because laboratory tests suggest that 4-MBC disrupts the hormone system (Krause 2012). Hormone disruptors pose particular dangers to the fetus because small perturbations to hormone systems could cause lasting changes in the developing brain, thyroid and reproductive system.


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About the ratings

EWG provides information on sunscreen products from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings indicate both efficacy and the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other sunscreens. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Methodology | Privacy Policy | Terms & Conditions

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