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EU Regulatory Update: Cosmetic Ingredients Under EU Scrutiny
By: Annelie Struessmann, PhD, CONUSBAT
Posted: August 23, 2011
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Meanwhile Denmark has banned propylparabens and butylparabens in cosmetic products for children under three, which implies a marketing ban for the EU member state territory according to Article 12 of the Cosmetics Directive. This ban went into effect on March 15, 2011, and the EU Commission requested the SCCS to clarify if the safety concerns raised in the justification for the Danish ban are scientifically valued. However, when a draft legislation proposition to the French National Assembly in May 2011 requested to generally prohibit parabens, phthalates and alkylphenols, concerns on infringement with European Union law were raised and persecuted by European industry associations.
In addition to the opinions, four open mandates for preservatives have been published in 2011, including: benzoisothiazolinone, climbazole, methenamine 3-chloroallylochloride and zinc pyrithione.
The SCCS has published one opinion so far in 2011 on UV filters, which found that based on data available, the safety of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane could not be assessed.
Also, the SCCS has published four new mandates for the UV filters zinc oxide, ETH50, titanium dioxide and FAT 75’808 (HAA299, C-1332). The reviews for titanium dioxide and zinc oxide are both related to nanomaterial issues and are addressing the safety in use of the ingredients as UV filters in a maximum concentration of 25% based on new information obtained. Also targeted will be the option to differentiate in the regulatory provisions between materials in their nano form and their non-nano form while questioning how this differentiation could potentially be made.
In cosmetic products, zinc oxide is used for various ingredient functions such as bulking, skin protection, UV absorption and as an authorized colorant (CI 77947). Its use a as UV filter in sunscreen products at a maximum level of 25% had already been targeted in earlier activities. Resulting main concerns were related to the risk assessment of micronized zinc oxide, which had demonstrated photo-DNA damaging potential in cultured mammalian cells. Therefore, the SCCS had requested a repeated safety dossier on micronized and nano-sized zinc oxide. A clarification was adopted in 2009 that considered the use of zinc oxide in its non-nano form to be safe. As a consequence, micronized zinc oxide was approved for use as UV filter, e.g. in Germany, with the prerequisite of a yearly renewal of the approval. Meanwhile, new information became available providing for an overall safety assessment, including the micronized and the nano form.
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