Seit 2005

17.02.2009

Zinkoxid in Kosmetika und Sonnenschutzprodukten - Das Verwirrspiel geht weiter

Die Schwedische Adzneimittelzulassungsbehörde hat 10 Firmen die Vermarktung Sonnencremes mit Zinkoxid-Partikeln als UV-Filter verboten. Das Verbot steht in Einklang mit dem geltenden EU-weiten Verbot für die Verwendung von Zinkoxid in derartigen Anwendungen, während sich ein EU-Kommittee mit der Evaluierung der Daten beschäftigt. In Deutschland hingegen ist Zinkoxid als UV-Filter per Übergangsregelung bis 2010 weiterhin zugelassen und in der Schweiz sind Produktion und Import zwar verboten, bereits auf dem Markt gehandelte Produkte können aber weiter verkauft werden. Artikel auf Englisch.

According to SafeNano News, in 2008, the Swedish Medical Products Agency investigated the presence of zinc oxide (ZnO) as UV filters in sunscreen products on the Swedish market, publishing an interim report on May 28, 2008. The Agency contacted a total of 105 companies known to be involved in the manufacture or importation of sunscreen products according to the Agency’s cosmetics register. 80 companies responded that their products were free of zinc oxide; among the remaining 25 companies 15 confirmed sale of products containing zinc oxide.

Of these 15, the Medical Products Agency investigated why zinc oxide was included in sun protection products in a selection of 10 companies which have products currently the Swedish market.  After review of documentation submitted, it was concluded that the zinc oxide contained in the products was the primary form of protection against UV radiation. As the use of zinc oxide is currently not permitted under current Swedish and EU legislation, the Drug Agency  ruled that the 10 companies are no longer permitted to sell the examined sunscreen products containing zinc oxide.

While in the USA and in Australia, ZnO is approved for use as UV filter, in the EU and in Switzerland it is not allowed [1,2]. In Germany, an exemption clause is in force permitting the use of ZnO as a UV filter until 2010. While production and import of new zinc oxide containing sun protection products is prohibited in Switzerland, selling products that have previously been on the market is allowed.Substances to be used in sunscreen creams to protect skin from the sun's harmful UV rays are examined in advance and subject to approval, so that they do not pose any health risk to consumers. Previously, the scientific committees of the EC has been charged with the evaluation of ZnO in cosmetic products [4] and ZnO suitable for use as UV filters [5]. The committee concluded that for a proper safety evaluation of microfine ZnO for use as a UV filter, more information was required. The SCCP has clarified their position in January 2009 stating that "the use of the non-nanoscale form of ZnO is considered safe. The concern expressed in the previous SCCNFP opinion [4] with regard to phototoxicity is not relevant for this form of ZnO due to the absence of dermal penetration" [6].

Besides the discussion about the safety of using ZnO as UV filter in sunscreen products, some companies have started to use nanoscale particles of ZnO or titanium dioxide in order to be able to produce transparent sunscreens with high UV absorption. Once the discussion about the use of zinc oxide in general has led to consistent regulation, the next debate will probably be about the use of these particles at the nanoscale and reviewing the existing database on this issue [3].

Sources:
[1] Kantonslabor (Basel Stadt, Switzerland)
[2] Verordnung des EDI über kosmetische Mittel (VKos) (Switzerland)
[3] Statement of the Swiss Cosmetic and Detergent Association, 1.7.2008
[4] SCCNFP Opinion on Zinc Oxide (SCCNFP/0932/05)
[5] SCCP Statement on the Zinc oxide used in sunscreens
[6] SCCP Clarification on opinion SCCNFP/0932/05 on zinc oxide