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EU Update—Changes with Implementation of 1223/2009
By: Chris Flower, PhD; and Emma Meredith, PhD, CTPA
Posted: March 5, 2013, from the March 2013 issue of Cosmetics & Toiletries.
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There appears to be a misconception regarding the extent to which nanomaterials are used in cosmetic products, and contrary to popular belief, the use and safety of nanomaterials in cosmetic products is already covered by the Cosmetics Directive.
The regulation provides a definition of a nanomaterial, which is open to some interpretation. A cosmetics industry interpretation is available but an interpretation by the EC has not been provided. In October 2011, the EC issued its Recommendation on the Definition of a Nanomaterial. This recommendation provides a broad regulatory definition within the EU; however, the possibility for narrowing the scope under sector specific legislation can be foreseen. Therefore, it is the industry view that both the recommendation and the regulation’s definition can coexist.
The impact of the recommendation’s particle size distribution cut-off in the existing regulation definition is currently a point of discussion, as is the interpretation of the various criteria of the regulation’s definition. This does have an impact on compliance with the regulation’s requirements for notifying and labeling nanomaterials by the 2013 deadline.
From July 2013, notification of products containing certain nanomaterials is required six months prior to placing them on the market. Products already on the market as of Jan. 11, 2013, will also need to submit notification during the six month period from Jan. 11 to July 11. The regulation does clarify what nanomaterials will require notification by naming those that are exempt: those used as colorants, UV filters or preservatives, or substances listed specifically as nanomaterials in Annex III. In relation, the electronic nano-notification facility was launched in January 2013.
In the future, any ingredient present in the nano-form will have to be labeled with the word “nano” in brackets after its name in the ingredient listing. It is worth stressing that the addition of the “nano” indication is for consumer information only, and is of no relevance to safety. It is not a warning statement. This labeling requirement applies to all products on the market as of July 11, 2013.