Nanotechnology

Regulatory Content Overview

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.

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 European Union (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 nanomaterial or products containing nanomaterials to their national products register or nano register.

In the United States (US), under TSCA, manufacturers of new nanomaterials are required to submit a pre-manufacture notice to the Environmental Protection Agency (EPA) prior to manufacturing or importing them. In Canada, manufacturers and importers of nanomaterials must ensure that they are in compliance with the Canadian Environmental Protection Act, 1999 (CEPA) 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
• EU: Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices, SCENIHR Opinion, January 2015
• USA: Application of Nanotechnology in FDA-Regulated Products, Guidance, June 2014
• Australia: Changes to Medical Device Essential Principles for Nanomaterials, Guidance Document, March 2023
• China: Evaluation of Safety and Effectiveness of Medical Devices Using Nanomaterials Part III: Biocompatibility/Toxicology Evaluation, Guidelines, August 2024 

We cover standards for our core products that are available from our partner Accuris. These are available through our Product Compliance Solution.