Nanomaterials & Regulation

Annelie Struessmann, CONUSBAT, 29 November 2012 15:33

Nanomaterials & Regulation

Nanomaterials – Return to Member State Regulatory Specifics?

Actually, challenging and time-consuming tasks apply to the international cosmetics industry marketing their products in the European Union. The implementation deadline for the new Cosmetics Regulation [EU Regulation No. 1223/2009 on Cosmetic Products (CPR)] is impending. July 11th, 2013 marks the day when all provisions of the CPR will fully apply and the old Cosmetics Directive 76/768/EEC will be repealed. Before this date, all new and existing products need to be notified electronically at the new cosmetics product notification portal (CPNP).

However, earlier than that, i.e. on January 11th, 2013, another important deadline will be reached. In addition to the general notification requirements, products containing nanomaterials need to be notified six months prior to placing them on the market, with the following information provided:

• identification of the nanomaterial by chemical name,
• nano specification by size of particles, physical and chemical properties,
• an estimate of the quantity intended to be placed on the market per year,
• the toxicological profile of the nanomaterial,
• the safety data of the nanomaterial in relation to the product category,
• reasonably foreseeable exposure conditions.

According to existing knowledge and opinions of scientists and risk assessors, nanomaterials act in a similar way to other, normal chemical substances. As such, some may be toxic and some may not, and a risk assessment is required on a case-by-case basis for the respective use. For nanomaterials in cosmetics, the Scientific Committee on Consumer Safety (SCCS) recently published specific guidance for performing such safety assessments (SCCS/1484/12) (1).

Nanomaterials are also covered under Regulation (EC) No 1907/2006 (REACH), where the general obligations for registration and providing information on the supply chain apply as for any other substance. With that, the material class and its properties seem to be addressed comprehensively at European Union level. Further substantiation for this view is provided by some of the EU Commission's recent publications on this topic, such as a newly launched website with scientific opinions on nanomaterials (2) or a new technical report on 'Requirements on measurements for nanomaterials (3)'.

Therefore, it appears disconcerting that in 2012 the French government released three new decrees (3-6) on nanomaterials, which require companies to declare their quantity of substances at nanoparticle scale manufactured, imported or made available in France. The provisions include nanomaterials intentionally embedded into a mixture from which they can be extracted or released under normal or reasonably foreseeable conditions of use. Before May 1st of each year, an electronic declaration has to be made to the Ministry of Environment with an applicable threshold of 100g per year. The competent authority is ANSES (French Agency for Food, Environmental and Occupational Health & Safety). The law will enter into force on January 1st, 2013, therefore the declaration has to be delivered for the first time before May 1st, 2013. Considerable fines apply in case of non-compliance.

The reasons given for the implementation of the French declaration provisions are to improve the knowledge about these substances and their uses, to trace the channels of use, to gain better knowledge of the market and the volumes sold, and, finally, to collect information on their toxicological and ecotoxicological properties.

All issues targeted with the new French decrees have been addressed at EU level and the respective legal provisions and specific requirements were published on easily accessible EU websites in English, a language easily understood in cosmetics companies worldwide. The question needs to be allowed, why France additionally is going this individual pass? Why is the country not putting its resources into the co-operation with the various EU institutions and committees in order to combine all forces for the exploration of nanomaterials. At the same time, this approach would give all stakeholders involved a fair chance to be precisely informed, to provide their information easily and to profit in return from new insights. As such, a contribution to consumer safety worldwide seems likelier.

CONUSBAT will be running a one-day regulatory workshop on Worldwide Regulatory Affairs at in-cosmetics 2013 on 16 April, where Dr Annelie Struessmann will be speaking.

1) SCCS Guidance Cosmetics Safety Assessment
2)Nanomaterials – EU Commission website
3) JRC Report
4) Décret n°2012-232 du 17 février 2012
5) Décret n°2012-233 du 17 février 2012
6) Arrêté du 6 août 2012

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