In part 1, we looked at the current regulations on sunscreens and SPF ratings in the USA presented by Anne-Gael Glaverec. Part 2 will examine the European Union (EU) which was also covered in Anne’s very informative presentation. Sunscreens in the EU are considered cosmetics and currently regulated by the European Cosmetic Directive (76/768/ECC)*. After July 11, 2013, they will fall under the new European Cosmetic Regulation (EC 1223/2009)* which I have learned a great deal about here at In-Cosmetics and will be covering in a upcoming post.
The EU has 26 registered UV filters that are allowed in specific concentrations in sunscreens. Currently, zinc oxide and titanium dioxide are not considered approved filters in the EU. Any individual ingredient claiming sunscreen protection also has to be registered and approved in the EU before being incorporated in to a sunscreen formulation. On top of this, specific UV filters need to be in compliance with a separate Chemical Legislation called REACH (EC 1907/2006). Due to this, the process of bringing a new sunscreen to market is very expensive and time consuming. It can take anywhere from ~4-7 years to complete the safety doser and SCCS safety evaluation process before bringing the UV protectant ingredient to market to be used in sunscreens. The good news is these specific ingredients are generic, not brand specific, so once the filter is approved it may be used in other formulations without the ~4-7 year process. The sunscreen must meet the EU industry guidelines for Evaluation of Water Resistance which was released in 2005. ISO tests must be conducted to evaluate the SPF rating and UV protection through in-vivo and in-vitro testing.
The EU has a minimum SPF rating of 6, with UVA protection being at least 1/3 of the SPF. The EU has developed testing categories that determine the SPF value. For example:
~if the sunscreen performs in tests with an SPF of 6-14.9, it must be labeled with an SPF value of SPF 6-10, considered “Low Protection“.
~”Medium Protection” tests at levels of SPF 15-29.9 and will be given the SPF ratings of 15, 20, or 25 according to the test results.
~”High Protection” tests must show ratings of 30-59.9 and may claim a SPF of 30-50 on the product.
~”Very High Protection” must test in at > or = to 60, but are only allowed to carry the maximum SPF rating of 50+ (like the US) on the label.
The EU has also instituted banned labeling claims such as “total protection”, “100% protection”, “sunblock” and “all day prevention” on any marketing info associated with the sunscreen. The EU has taken this one step further by instituting pictograms* for labeling to help the consumer understand the SPF rating and safety.
The biggest change to come in the EU will happen when the implementation of the EU Cosmetic Regulation 1223/2009 goes into effect in July 2013. Nano labeling will be required at that point for sunscreens in the EU, and approval of both zinc oxide and titanium dioxide are expected to be passed by 2013 in the EU.
*please see references for more info
Anne-Gael Glaevic – presentation on EU and US regulatory status for sunscreen at In-Cosmetics 2012 Barcelona
EU Cosmetic Directive 76/768/EEC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20100301:en:PDF
EU Cosmetic Regulation No 1223/2009 (goes into effect July 11, 2013): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009R1223:EN:NOT
Pictogram’s to inform consumers on dangers linked to sun exposure created by the EU Commission: http://ec.europa.eu/health-eu/news/sun_uv_en.htm
EU Commission Consumer information: http://ec.europa.eu/consumers/citizen/my_holidays/sunscreens_en.print.htm