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Always use enough sun protection!

32/2005, 06.10.2005

Most UV filters are safe for consumers

The end of the German summer marks the beginning of the long-distance travel season for sun lovers. But watch out: the sun’s rays are frequently stronger in far-off countries than on hot summer days at home. That’s why sufficient sun protection is particularly important. Discussions about the possible hormonal effects of UV filter substances and the reliability of the UV protection of sun creams have caused concerns amongst some consumers. This prompted the Federal Institute for Risk Assessment (BfR) to assess these products from that specific angle. The result: when used correctly scarcely any UV filters constitute a risk for consumers according to the current level of scientific knowledge. "Only in the case of the filter substance 4-methylbenzylidene camphor (4-MBC) were we unable to refute the suspicion of a hormonal effect", says BfR President Professor Dr. Dr. Andreas Hensel. "We recommend that these products be taken off the market on precautionary grounds if their safety cannot be definitely proven."

Sunshine promotes a feeling of wellbeing but it can also be dangerous. Light-sensitive individuals and children should, therefore, avoid direct exposure to the sun’s rays for longer periods. For all others the following applies: besides protective clothing, sun cream is the best way of protecting the skin from damaging UV rays. But it’s not enough to apply sun cream just once to protect the skin from the sun for a whole day. Perspiration and friction reduce the cream film. That’s why sun cream has to be applied frequently in order to maintain protection. It’s also important to apply a thick layer of sun cream. This is the only way of reaching the indicated level of sun protection. Studies show that most consumers do not apply enough sun cream and do not, therefore, achieve the desired effect.

UV filter substances, so-called “sun protection factors” are added to cosmetic sun creams.  There is a very wide range of these substances. Before they are approved on the European level as UV filters, their safety must be proven in scientific studies. What’s important here is, for instance, that there is a sufficiently large safety margin between the amount of the substance that migrates through the skin to the body when the sun cream is used correctly and the amount that produces an adverse reaction in animal experiments.

Nevertheless, there have been repeated discussions in the past about the effects and side-effects of UV filters. In order to counter any concerns amongst consumers, BfR has undertaken a specific assessment of individual safety and efficacy aspects of UV filter substances. The Institute comes to the conclusion that, with the exception of the substance 4-methylbenzylidene camphor, in short 4-MBC, all UV filter substances available on the market do not constitute a risk to consumers according to the current level of scientific knowledge. The Institute had already voiced its concerns in 2003 about the use of the UV filter 4-MBC in sun creams and had called for further safety studies. In animal experiments 4-MBC had shown signs of a hormonal effect. According to BfR the suspicion of an effect on the thyroid gland hormone has not been refuted by the latest study findings. A “no observed adverse effect level (NOAEL)“, a dose without any effect, could not be established. The competent body of the European Commission had called for the setting of the NOAEL in a suitable test design as proof of safety. BfR, therefore, recommends withdrawing 4-MBC from the market on precautionary grounds.

As scientific knowledge continuously develops, BfR also calls for an examination of all UV filter substances approved on the EU level in order to take into account the latest findings on the substances and new requirements for safety assessment.

Finally, BfR points out that the sun protection factor indicated on the packaging of sun creams is not achieved given the way the products are normally used. The Institute, therefore, believes it is essential for the test methods in the laboratory to be brought into line with consumer behaviour.

Further information on this subject can be accessed on our website (www.bfr.bund.de) under “Cosmetics”.

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