The European Commission published their 2nd Regulatory Review on Nanomaterials. This comprises a Commission Communication and a Staff Working Paper (SWP) and follows up from the previous 2008 Communication. The Communication explains that 'the benefits of nanomaterials range from saving lives, breakthroughs enabling new applications or reducing the environmental impacts to improving the function of everyday commodity products'. The Communication summarises the actions implemented over the last four years, which include the 2011 adoption of the Commission Recommendation for a definition of nanomaterials that is being implemented in various EU legislation.
On the topic of the definition recommendation, a European Commission official noted during a regulatory meeting on day of the launch (3 October 2012) that the European Commission would apply a 'flexible' approach to the current 50% threshold, implying that the threshold could be raised or lowered according to the exposure and hazard profile of the nanomaterial in question. The official furthermore indicated that the Commission was working on an impact assessment of the definition recommendation, which was anticipated to be finalised in 2013.
In addition, REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) and its activities are also described; stating that 'the REACH approach to hazard assessment and risk characterisation, with its built in flexibility, makes it overall suitable for nanomaterials'. The key remaining question, according to the Commission is 'to what extent data from one form of a substance can be used to demonstrate the safety of another form'. The Commission will assess relevant regulatory options in the upcoming REACH review (scheduled for publication later in the autumn of 2012) to ensure clarity on how nanomaterials are addressed and safety demonstrated in REACH registrations. Its view remains that potential risks of nanomaterials are best addressed 'upstream' by REACH and product legislation, including CLP (Classification and Labelling and Packaging).
In the health, safety and environmental protection legislation there is work underway to adapt relevant legislations in order to transpose the definition and to introduce specific provisions on nanomaterials. Nano-ingredient labeling has been introduced in products relevant for consumers, notable food and cosmetics, and similar provisions can be envisaged for other legislations where ingredient labelling already exists. The Communication states that 'experience so far shows that if risks where to be identified, they could be handled with existing tools such as the General Product Safety Regulation and the RAPEX system'.
The Communication concludes that 'nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not' and the 'Commission remains convinced that REACH sets the best possible framework for the specific risk management of nanomaterials... but more specific requirements for nanomaterials within the framework have proven necessary'.