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Monday, June 7, 2021Regulation

European consultation on the definition of a nanomaterial

Consultation européenne sur la définition d'un nanomatériau

As long awaited, the European Commission is working on a harmonised definition of nanomaterials. After revising its 2011 Recommendation, it is now launching a stakeholder consultation. The aim is 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”. This consultation is open until 30 June 2021… but does not incorporate the definition as it is worded in the Cosmetics Regulation!

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In 2011, the European Commission adopted the Recommendation 2011/696/EU on the definition of nanomaterial. A common definition of the term “nanomaterial” across EU regulation supports a harmonised approach, facilitates implementation and enforcement, and can serve as the technical and scientific basis for EU legislation and policies that set provisions specific to nanomaterials. Member States are also invited to consider the definition in the Recommendation in their national legislation.

The Recommendation foresees a review of the definition by the Commission. The aim of the review is to reassess the definition in light of experience and scientific and technological developments since the adoption of the Recommendation. The review should address the objective, scope, clarity, usefulness, relevance, effectiveness, completeness and implementation.

To prepare the review, the Commission performed a number of consultations (targeted stakeholder survey, a comprehensive assessment and a workshop), and the Commission’s Joint Research Centre (JRC) published three technical reports. The first JRC report compiles the collected experiences (EUR 26567 EN), the second report evaluates these experiences (EUR 26744 EN) and the third report presents a scientific-technical evaluation of options to clarify the definition and to facilitate its implementation (EUR 27240 EN). The consultations and the JRC reports highlighted the following …

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