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EWG 2014 Sunscreens Database
 
 

Does Europe Have Better Sunscreens?

Americans have fewer choices and notably poorer protection from ultraviolet A rays than Europeans – mainly because of the federal Food and Drug Administration’s repeated delays.

FDA sunscreen rules that went into effect in December 2012 allow nearly every product to be marketed as “broad spectrum,” a term that implies good UVA protection.

EWG estimates that about half of the 462 beach and sport sunscreens we assessed this year are too weak for the European market, where manufacturers voluntarily comply with a European Union recommendation that all sunscreens provide meaningful UVA protection.

In Europe, sunscreens must offer UVA protection that is at least a third as potent as the SPF (sunburn protection factor), 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.

Until the FDA approves new ingredients that are safe and provide strong UVA protection, American manufacturers are faced with a formidable challenge: how to make products as effective as those that can be bought in Europe. It is illegal to sell European products in the U.S.

European companies can meet high European Union standards for effectiveness because they can pick and choose among 27 chemicals, including seven expressly designed to filter UVA radiation. Some of these appear to offer significant performance advantages over U.S. sunscreen chemicals.

Companies that make sunscreens for the U.S. market can use only 17 chemicals approved by the FDA, including just three chemicals that screen UVA rays. The most common is avobenzone, approved by the FDA in 1972.Neither avobenzone nor other sunscreen chemicals on the market in 1978, when FDA initiated its rulemaking process for sunscreen, have been subjected to thorough tests with modern scientific techniques. They are classified as ”Generally Regarded as Safe and Effective” because they have had decades of widespread use.

Both U.S. sunscreen chemicals and European chemicals now under consideration for the U.S. market should be subjected to the same 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. This situation should be rectified with more independent research on the subtle effects of sunscreen chemicals over years of exposure. Ingredients that offer ineffective skin protection or cause irritation, skin allergy or other health risks should be barred or tightly restricted.

In 2002, the FDA adopted a rule that committed it to evaluating the safety of proposed sunscreen chemicals within 180 days. Essentially, this process created a supposedly faster track for sunscreen chemicals than the time-consuming and cumbersome process for approving new medicines. But in practice, the fast-track process has not achieved its what it set out to do.

Beginning in 2003, U.S. 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 UVA blocker permitted for use in the U.S. The FDA has not acted on the applications for these four promising sunscreen chemicals. Nor has it moved on two other chemicals –enzacamene and octyl triazone – which are primarily UVB filters and less critical to the quality of U.S. sunscreens. The FDA rejected applications for two more chemicals on the grounds that manufacturers hadn’t submitted enough information.

Tinosorb S and Tinosorb M, developed by the German chemical company BASF, appear to be much stronger and more photostable UVA-blockers 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 (Regulations.gov 2008a,b). This documentation should be sufficient for FDA to make a safety determination. (CIBA 2005a,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.

Mexoryl SX, also called Ecamsule, developed by La Roche-Posay, the active cosmetics division of the French cosmetics giant L’Oreal, claims to offer strong, photo-stable protection. It has been on the market in Europe since 1993. La Roche-Posay applied through the FDA’s more complicated process for new pharmaceuticals for permission to market a sunscreen containing Mexoryl SX. As evidence of the chemical’s safety, the company submitted the results of 28 studies totaling 2,500 patients. Evidently, these data convinced the FDA that the chemical was not hazardous to human health. The agency approved the application in 2006.

Two years later, the company applied to the FDA under the nominally fast-track process to use Mexoryl SX more broadly in sunscreens. This application is still in bureaucratic limbo. Meanwhile, Canada has admitted Mexoryl SX to its market and recently approved a successor chemical, Mexoryl XL, at concentrations up to 10 percent (Canada 2013).

The Sunscreen Innovation Act introduced this year by Sens. Jack Reed D-R.I. and Johnny Isakson R-Ga., along with Reps. Ed Whitfield, R-Ky. and John Dingell, D-Mich., seeks to speed up the FDA review process for ingredients used in other countries. EWG has testified in support of the goals of the proposed legislation and has proposed improvement to ensure that American consumers have access to the most effective and safest available sunscreen ingredients.

Not all European chemicals should be admitted to the U.S. market. For instance, one European sunscreen ingredient under consideration by FDA is 4-methylbenzylidene camphor (4-MBC or Enzacamene), made by Merck. European regulators recently disallowed as unsafe a related chemical, 3-benzylidine camphor, due to toxicity data. Researchers have detected both ingredients in European women’s breast milk, a finding that is especially consequential because laboratory tests suggest that it 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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