Nanotechnology

Nanotechnology regulations aim to ensure that products containing nanoscale materials – including nanoparticles, nanoscale particles, nanomaterials, nanosized particles, nanosized materials, nano-objects, and nanostructured materials – are manufactured and used in a manner that protects against unreasonable risks to human health and the environment.

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Nanotechnology

195

Countries Covered

483

Sources in C2P

Regulatory Content Overview

Nanotechnology is a broad term used to describe the science of manipulating materials operating at a scale of 1 to 100 nm (1 billionth of a meter), i.e., nanomaterials. Nanomaterials may be used to exhibit characteristics such as increased strength, chemical reactivity or conductivity compared to the same material without nanoscale features.

Regarded as chemical substances under major global regulatory frameworks for chemicals, nanoscale materials are subject to the regulatory regime for the assessment and management of chemical substances. These include:

Reporting
Registration
Authorization
Restriction
Testing
Records keeping
Safety data sheets
Classification and labeling obligations

In the EU, nanomaterials are regulated by the REACH and CLP Regulations and a string of other regulatory instruments depending on the specific product, such as the Plastic Food Contact Material Regulation. Additionally, certain EU Member States, including France, Norway, Denmark, and Belgium have adopted mandatory reporting of nanomaterials or products containing nanomaterials to their national products register or nano register.

In the United States, under TSCA, manufacturers of new nanomaterials are required to submit a pre-manufacture notice to the Environmental Protection Agency prior to manufacturing or importing of them. In Canada, manufacturers and importers of nanomaterials must ensure that they are in compliance with the Canadian Environmental Protection Act, 1999, and requirements related to Significant New Activities (SNAcs).

Coverage Included

Compliance & Risks’ coverage of nanomaterials requirements is historically comprehensive and includes, but is not limited to:

EU: Definition of Nanomaterial, Commission Recommendation 2022/C 229/01
EU Regulation (EU) 2018/1881 addressing nanoforms of substances
EU: Cosmetic Products Regulation (EC) 1223/2009
France: Annual Reporting of Substances Placed on the Market in Nanoparticle Form, Decree 2012-232
France: Content and Conditions of Annual Declaration of Nanoparticle Substances, Ministerial Order, August 2012
France: Conditions for Application for Exemption for Annual Declaration of Nanoparticle Substances, Ministerial Order, January 2013
Belgium: Placing on the Market of Substances Manufactured at the Nanoscale, Royal Decree, 27 May 2014
Denmark: Register of Mixtures and Products Containing Nanomaterials, Statutory Order No. 644/2014
USA: Toxic Substances Control Act (TSCA), Reporting and Recordkeeping Requirements – Amendment – (on nanoscale materials reporting and recordkeeping), Final Rule, 40 CFR 704.20, January 2017
Australia: Adjustments to NICNAS New Chemical Processes for Industrial Nanomaterials, Notice, October 2010
Canada: Requirement to Provide Information on Certain Nanomaterials, Notice, July 2015