Current EU law

In the European Union (EU), nanomaterials fall within the scope of various regulations and directives. Below, the definitions of nanomaterials given in the legislation are briefly summarised, and the nano-specific provisions contained in the various EU Regulations are briefly described.

European Commission definition (2022/C 229/01)

On 10 June 2022, the European Commission published a revised recommendation for the definition of the term «nanomaterial» (summary):

«Nanomaterial» means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions:

one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.

In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 μm need not be considered.

However, a material with a specific surface area by volume of < 6 m²/cm³ shall not be considered a nanomaterial.

Chemicals: Information requirements and chemical safety assessment for nanomaterials under REACH

For substances that are manufactured in or imported into the EU in a nanoform in quantities of one or more tonnes per year, specific requirements for registration in line with the REACH Regulation have been applicable since 1 January 2020. Registration dossiers previously submitted for substances with nanoforms must be updated by the registrants. This is designed to ensure that the specific risks involved in the handling of the nanoforms of substances can be evaluated and appropriate risk management measures developed and recommended.

IT programs and reporting formats for nanomaterials have been modified. The updated IUCLID* tool (version 6.4) enables nanoforms or sets of nanoforms to be linked to the relevant data on their properties and hazards in other parts of the dossier

*IUCLID is a software application used in OECD member states for regulatory purposes, in which data on intrinsic and hazard properties of chemical substances can be recorded, stored, maintained and exchanged.

The European Chemicals Agency (ECHA) has published a number of nano-specific appendices to the Guidance on information requirements and chemical safety assessment under REACH.

Food

EU Regulation on the provision of food information to consumers

In this Regulation, the term «engineered nanomaterial» is defined as follows:

«engineered nanomaterial» means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Properties that are characteristic of the nanoscale include:

those related to the large specific surface area of the materials considered; and/or
specific physico-chemical properties that are different from those of the non-nanoform of the same material.

Guidance on nanotechnology risk assessment

The European Food Safety Authority (EFSA) has issued guidance on nanotechnology risk assessment in relation to the food and feed chain.

Cosmetic products

EU Regulation on cosmetic products

In this Regulation, the term «nanomaterial» is defined as follows:

«nanomaterial» means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

Guidance on the safety assessment of nanomaterials in cosmetics

In 2019, the Scientific Committee on Consumer Safety (SCCS) published guidance on the safety assessment of nanomaterials in cosmetics. This guidance provides the methodological basis for the safety report that is to be submitted as part of the registration procedure in accordance with Regulation (EC) No 1223/2009 on cosmetic products. The guidance can be found under “Documents” below.

Medical devices: Guidance on risk assessment for the use of nanomaterials

In 2015, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published a guideline for assessing the risks of nanomaterials in medical products. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials. It can also be used for particles larger than 100 nm.

Worker protection

There are no specific regulations for nanomaterials in the EU as yet. However, in the area of worker protection the employer is basically responsible for protecting the worker’s health. (European: Framework directive on Safety and Health 89/391/EEC, Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work). In view of the workplace risk, the special «nano-properties» must be taken into account. If there is insufficient information about these properties, appropriate measures to control the risk must be established as a precaution.

Further information on the topic of nanomaterials and worker protection can be found on the website of the German Federal Institute for Occupational Safety and Health (BAuA) and of the French Agency of food and nutrition, animal health and welfare, occupational health and environmental health (ANSES).

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