Commission Recommendation of 10 June 2022 on the definition of nanomaterial (Text with EEA relevance) 2022/C 229/01

• Celex Number: 32022H0614(01)
• Published date: 14 June 2022
• Date: 10 June 2022
• Date of Signature: 10 June 2022
• Official Gazette Publication: Official Journal of the European Union, C 229, 14 June 2022

14.6.2022 EN Official Journal of the European Union C 229/1

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COMMISSION RECOMMENDATION

of 10 June 2022

on the definition of nanomaterial

(Text with EEA relevance)

(2022/C 229/01)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,

Whereas:

(1) Commission Recommendation 2011/696/EU (1) has been applied as a reference for determining whether a material should be considered a ’nanomaterial’ for legislative and policy purposes in the Union, supporting efficient and consistent implementation across sectors. Recommendation 2011/696/EU refers to a later review of the definition of nanomaterial in the light of experience and of scientific progress.

(2) Between 2013 and 2021, the Commission carried out such a review of Recommendation 2011/696/EU, addressing the objective, scope, clarity and use of its definition of nanomaterial. The review in particular focused on whether the particle number-based size distribution threshold of 50 % should be increased or decreased and whether to include materials with internal structure or surface structure in the nanoscale such as complex nanocomponent materials including nanoporous and nanocomposite materials that may be used in specific sectors.

(3) Technical and scientific elements underpinning the review of the definition of nanomaterial in Recommendation 2011/696/EU were summarised and published in the Commission’s Joint Research Centre’s (JRC) Science for Policy reports ‘Towards a review of the EC Recommendation for a definition of the term ‘nanomaterial’ Part 1 (2), 2 (3) and 3 (4) on the experience of stakeholders with the implementation of the definition and with the identification of possible points of revision. In addition, JRC published two reports providing guidance on the implementation of the definition (5), (6) including relevant developments in standardisation by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN), results of the NanoDefine project of the Commission’s 7th Framework Programme for Research (7), and further information available in the public domain.

(4) Elements for possible modifications of the definition were the subject of a targeted stakeholder consultation between 6 May and 30 June 2021. Information received during that consultation was considered in the Commission’s review of the definition of nanomaterial.

(5) The results of the review and the stakeholder consultation, the description of the modifications made and their rationale are explained in the Commission staff working document (SWD(2022)150) accompanying this Recommendation.

(6) A definition of nanomaterial that is appropriate in the general context of Union policy and legislation (‘the definition’) should be recommended, covering natural, incidental or manufactured materials.

(7) The definition should be based on the relative fraction of particles in a defined range within the particle number-based distribution of the external dimension of the constituent particles of a material, irrespective to its potential inherent hazardous properties or risks to human health and the environment.

(8) The definition and its core terms should, where applicable, be based on existing scientifically defined and standardised terms adopted by the international communities (ISO, CEN). The core terms used in the definition should remain sufficiently specific and should enable practical implementation of the definition within the Union regulatory context. Implementation should be supported by guidance that should be developed by the JRC and kept updated with evolving science and technical progress, listing recommended measurement methods and best practice tools7.

(9) The term nanomaterial should address materials consisting of particles in solid state, present on their own or bound as constituent parts of aggregates or agglomerates. The term ’consist of’ rather than ’contain’ should be used to acknowledge that the particles are the principal component of the material. Other non-particulate components potentially present (e.g. additives necessary to preserve its stability or solvents that may be separated without affecting the particle size distribution) are part of the (nano-) material but should not be taken into account when assessing whether a material is a nanomaterial.

(10) The definition should exclude non-solid (i.e. liquid and gaseous) particles. This should ensure that the highly dynamic nature of the external dimensions of non-solid particles, such as micelles or nanoscale droplets in emulsions or sprays, does not prevent the use of the external dimension as the defining qualifier in the definition.

(11) The definition should not cover large solid products or components, even when they have an internal structure or a surface structure at the nanoscale, such as coatings, certain ceramic materials and complex nanocomponents, including nanoporous and nanocomposite materials. Some of these products or components may have been manufactured by using nanomaterials and may even still contain them.

(12) The definition should continue to follow the 2010 opinion of the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) (8) by defining ‘nanoscale’ as the size range from 1 nm to 100 nm.

(13)

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