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Towards a smoother assessment of nanomaterials under REACH?

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Towards a smoother assessment of nanomaterials under REACH?

EU Regulatory Bulletin contents

 

In a recent workshop organised at the end of May, ECHA shared experiences in evaluating registration dossiers containing nanomaterials and proposed the initiation of an ECHA working group on nanomaterials.

Nano & REACH

Nanomaterials are covered by the definition of a “substance” in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH apply as for any other substance. ECHA receives the registrations and the Agency plays a central role in the collection, evaluation and dissemination of information on substances and preparations, including nanomaterials.

Ambiguities about the scope of the registration and the level of nano-specific information provided, has shown that there is space for improvement. ECHA agreed on a common approach for addressing the current information requirements in nanomaterial dossiers taking into account the scientific uncertainties and legislative framework provided by REACH.

The Agency will use the EU recommendation on the nano-definition (See our previous alert on the Recommendation) as a benchmark in assessing substances and it invites registrants to proactively characterise their substances in light of this definition.   

New working group

The plan to set up a working group on nanomaterials (containing representatives of member states, the Commission and stakeholder groups) that would provide advice on scientific and technical principles related to nanomaterials under REACH, was supported during the workshop. This group, which should be operational by next autumn, would act independently but report to the relevant ECHA committees.

The Commission indicated that the overlap between this new working group and the existing Competent Authorities' subgroup on nanomaterials - or CASG Nano for short (composing of the Commission, ECHA, Member States and stakeholders) - would not be an issue; while the working group will concentrate on the implementation of REACH, CASG Nano will advise the Commission on regulatory issues related to REACH and CLP. It would also be of a more permanent nature compared to that of the Group Assessing Already Registered Nanomaterials (GAARN), which is an informal and temporary group led by ECHA and also including the Commission, Member States and lead registrants,  and which assesses selected registration dossiers.    

Best practices, collected from the relevant stakeholders who registered nanomaterials, will be disseminated normally throughout the summer; the practices, together with the support of the recently updated guidance concerning nanomaterials, should facilitate the work of those registrants that intend to register their nanomaterials by the next registration deadline of 31 May 2013.

For further information, please contact us.

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