Nanomaterials and Regulatory framework

EU Regulatory Bulletin contents

• Nano & regulatory framework
• Animal testing & Cosmetics
• Honey bees

In the EU

At a recent meeting of the Competent Authorities for REACH and CLP (CARACAL), ten EU Member States called for stricter regulation of nanomaterials.

The same ten EU Member States had sent a letter to the European Commission in July 2012, urging it to take measures to safeguard EU citizens and the environment against possible risks from the production and use of nanomaterials.  They reiterated their view, calling for the Commission to go beyond the proposals set out in the Second Regulatory Review on Nanomaterials (see our previous article).  Their concerns relate mainly to the REACH tonnage thresholds, market surveillance and registries, and the time needed to access information on nanomaterials on the market.

Similarly, 3 NGOs, namely ClientEarth, the Centre for Environmental Law and Friends of the Earth Germany, have highlighted the shortcomings of REACH as the main regulatory framework for nanomaterials.  Their "nano-patch" proposals include the integration of the definition of nanomaterials recommended by the Commission in 2011 into all existing regulations, following which nanomaterials would be considered independently of their corresponding bulk substances, and lower thresholds would apply for registration purposes, for example 10 kg per year. 

So far the Commission has not indicated any intention to change its position, which is that REACH provides the best framework for gathering information on nanomaterials and the risk management of nanomaterials.  It believes that a few amendments to REACH Annexes and guidance documents, and the integration of the definition of nanomaterials in EU legislation where appropriate, should perfect the regulatory framework for nanomaterials. 

Outside the EU

In November 2012, the Parliamentary Assembly of the Council of Europe published draft recommendations on guidelines on nanotechnology.  It believes that the guidelines should be based on scientific knowledge and the precautionary principle, and achieve balance between the need to protect European citizens from risk of harm from nanomaterials, and the need to encourage innovation.  Its recommendations also highlight the need for guidelines that can be applied consistently across borders, to all types of nanomaterials, and enable the harmonisation of regulatory frameworks relating to: risk assessment and management, notification, registration and labelling requirements, and the protection of workers, consumers and patients.  It also promotes the development of ethical and advertising rules to manage consumer expectations, and aspires to create an international interdisciplinary centre to undertake cutting-edge research on nanosafety.  The recommendations may be adopted in the form of binding instruments should Member States agree. 

Experts on the UN Globally Harmonized System (GHS) of classification and labelling of chemicals Sub-Committee met in mid-December 2012 to discuss amendments to the GHS.  Proposals include France's suggestion to improve the guidance on classification and hazard communication of nanomaterials in GHS, in particular as regards characterisation and risk assessment.  To date there is no specific guidance available on how to communicate information on nanomaterials for classification and labelling purposes, notably hazard communication through Safety Data Sheets. 

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