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Nanomaterials are increasingly used in beauty products, but regardless of the consumer benefits, questions persist about the real and perceived risks to human health and safety. This uncertainty arises, in particular, because the chemical and physical properties of particles at the nanoscale may be significantly different from those of the same substance at a larger scale. According to the Scientific Committee of Emerging and Newly Identified Health Risks (SCENIR): “there is insufficient knowledge and data concerning nanoparticle characterisation, their detection and measurement, the fate (and especially the persistence) of nanoparticles in humans and in the environment, and all aspects of toxicology and environmental toxicology related to nanoparticles.”
Thus, an important balancing act has to be made between safety concerns and the desire to avoid constraining one of the EU’s fastest developing industries.
In the EU, the new Cosmetic Products Regulation 1223/2009 (which will fully replace Directive 76/768/EEC by July 11, 2013) attempts to go some way in addressing concerns over nanomaterials. The regulation sets out four key provisions concerning nanomaterials:
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Definition: under Article 2(1)(k), “‘nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.” However, following the more general definition published by the European Commission on October 18, 2011 in recommendation 2011/696/EU, a working group is currently analyzing whether the definition of nanomaterial in the Cosmetic Products Regulation should be modified.
Labelling: under Article 19(1)(g), all ingredients present as nanomaterials must be indicated on the package, beginning July 11, 2013, with the word “nano” in brackets.
Notification: under Article 16(3), cosmetic products containing nanomaterials must be notified by electronic means to the Commission, providing data on identification, specification, quantity, toxicological profile, safety data and foreseeable exposure conditions. Such notification must occur six months before a cosmetic product containing nanomaterials is placed on the market, unless:
- the cosmetic products are included in Annex III (list of substances which cosmetic products must not contain except subject to the restrictions laid down)
- the cosmetic products were on the market before January 11, 2013, in which case they must be notified between January 11, 2013 and July 11, 2013. Furthermore, based on the notifications, by January 11, 2014, the Commission is required to make available a catalog of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions.
Safety assessments (Cosmetic Product Safety Report): Part A of Annex I reconfirms that:“Particular consideration shall be given to any possible impacts on the toxicological profile due to particle sizes, including nanomaterials”.
The brand owners should also be aware that in October 2011, the Commission asked the SCCS to prepare a guidance document on the safety of nanomaterials in cosmetics. The guidance is currently being drafted and is expected to be made available later in 2012.
Further, product developers and brand owners should keep in mind that ongoing research and new scientific evidence may compel companies to find new ingredients within a short time-frame, as some previously allowed nanomaterials may become restricted. Thus, companies should review and, if necessary, adapt their supply chain as well as their contracts in order to take account of the obligations (current and possible future) on nanomaterials.
To hear more about how National, EU and International frameworks (including the EU Cosmetics Regulation, REACH and the General Product Safety Directive) can affect your products and strategies come and attend InnoCos Europe (Geneva, May 30&31 2012) Giles is also a member of the Global Cosmetics Community advisory board so be sure to join the online community to discuss cosmetics and personal care regulations, strategies and initiatives with your peers as well as stay up to date on the latest news and gain access to presentations.
Giles Chappell, attorney, legal consultant, will present "National, EU and International Institutional Frameworks for Cosmetics and Personal Care Products" at InnoCos Europe (Geneva, May 30-31, 2012).