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Review of the Recommendation 2011/696/EU - Stakeholder consultation

The European Commission has been performing a review of its Recommendation on the definition of nanomaterial. The Commission services have recently concluded an online targeted stakeholder consultation to update, test and verify the preliminary findings of this comprehensive review, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the EU. The online consultation closed on 30 June 2021. After that date, several requests for minor revisions of individual contributions have been received and accepted.

Requests for minor revisions to individual contributions have been received and accepted.

The 136 non-duplicated replies to the survey are compiled in the XLS spreadsheet. Additional contribution by the French authorities is available here, together with the supplemental information provided by the Industrial Minerals Association IMA and the Germany Federal Institute for Risk Assessment BfR.

The Commission services is thanking all the participants for their contributions. These are currently being analysed in detail to help conclude the review.

The outcome of the review, providing also a summary of the feedback including statistical analysis of the responses, will be published as a Commission Staff Working document still within 2021. At the time, the Commission will also indicate the plans for potential revision or replacement of the Recommendation 20122/696/EU.


Background info

The Recommendation 2011/696/EU was developed to provide consistent definition of nanomaterial for any legislation with specific provisions for nanomaterials, such as to ensure adequate safety assessment or inform consumers. Its definition of nanomaterial was applied by several EU regulations and also Member State national legislations; for some, the legislator is presently awaiting the outcome of the ongoing review.

The Commission has already consulted on and assessed the implementation experience as well as scientific and technological developments. The Joint Research Centre published three reports: on collected experiences (EUR 26567 EN), evaluation (EUR 26744 EN) and the scientific-technical options to clarify the definition and to facilitate its implementation (EUR 27240 EN).