Regulation - EUON
Manufacturing - Overview - Regulation Text
Nanotechnology regulation in the EU
Nanomaterials are considered substances as defined in the existing regulatory framework for chemical substances. Hence, Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is the main act that regulates nanomaterials as stated in the 2008 Communication1: “There are no provisions in REACH referring explicitly to nanomaterials. However, nanomaterials are covered by the ‘substance’ definition in REACH”. In 2011, the European Commission released a recommendation for a definition of a nanomaterial:
‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.2
It is used in different European regulations to harmonise how nanomaterials are defined across legal frameworks. In June 2022, the European Commission issued another recommendation on the definition of nanomaterials:
'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:
(a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
(b) 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;
(c) 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.3
Since the summer of 2013, there has been an ongoing work to adapt the Annexes of REACH to specifically cover nanomaterials. An impact assessment and a large consultation on this issue have been undertaken by the European Commission. From the 1st of January 2020, explicit legal requirements under REACH apply for companies that manufacture or import nanoforms.4 These reporting obligations are outlined in revised annexes to the REACH regulation:
- characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI);
- chemical safety assessment (Annex I);
- registration information requirements (Annexes III and VII-XI); and
- downstream user obligations (Annex XII).5
Since 2017, ECHA has also prepared a number of guidance documents to support registrants of nanomaterials. The overview of the key legislation concerning nanomaterials in the European Union is listed in the table below.
|Table AVIII-5: Overview of legislation for nanomaterial use in the EU|
|Status||Document title||Country/ Region||Scope||Nano-specific|
|Implemented||Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)||EU||Chemicals and raw materials||No|
|Implemented||European Commission Recommendation on the Definition of a Nanomaterial (2011/696/EU)||EU||Substances at the nanoscale||Yes|
|Implemented||Commission Regulation (EU) 2018/1881 amending Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III, VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances||EU||Registration duties and obligations for nanomaterials||Yes|
|Implemented||Regulation (EC) on classification, labelling and packaging of substances and mixtures (CLP)||EU||Chemicals and raw materials||No|
Nanotechnology regulation in the manufacturing sector in the EU
There is no specific legislation that addresses manufacturing of nanomaterials. Nanomaterials are covered by the same rigorous regulatory framework that ensures the safe use of all chemicals and mixtures. This means that hazardous properties of nanoforms of substances have to be assessed and their safe use needs to be ensured. All manufactured or imported substances within the scope of REACH have to be registered. Manufactures and/or importers, depending on the volume placed on the market, must submit information on both human health and environmental effects, and hazardous nanoforms. The same obligations apply to nanomaterials. When substances have hazardous properties, the CLP Regulation requires them to be notified to ECHA and labelled and packaged so the substances can be used safely.6
Nanotechnology regulation in the manufacturing sector in the rest of the world
No country has currently developed specific legislation to cover the use of nanomaterials in the manufacturing sector.
In the UK, EU legislation which applied directly or indirectly to the UK before 31 December 2020 has been retained in UK law as a form of domestic legislation known as ‘retained EU legislation’.7 The REACH etc (Amendment) Regulations 2021 (SI 2021/904) were implemented on 26 July 2021 to ensure that the UK REACH chemicals regime legislation continues to function in the country after Brexit.8 From 1 January 2021, the classification, labelling and packaging of chemicals placed on the GB market (England, Scotland and Wales) is regulated by the Retained CLP Regulation (EU) No. 1272/2008 as amended for Great Britain, known as GB CLP.9 Also, the existing EU Biocidal Products Regulation has been copied into the Great Britain’s law and amended to enable it to operate effectively in GB.10 Northern Ireland, on the other hand, has to comply with EU legislation on chemicals.11
The occupational use of nanomaterials in the UK is regulated under the Control of Substances Hazardous to Health (COSHH) law. COSHH requires employers to control substances that are hazardous to health and includes nanomaterials. It recommends preventing or reduce workers' exposure to hazardous substances by identifying health hazards, deciding how to prevent harm to health (risk assessment), providing control measures to reduce harm to workers’ health and making sure they are implemented, keeping all control measures in good working order, training employees, providing monitoring and health surveillance in appropriate cases, and planning for emergencies.12
In the United States, the US Environmental Protection Agency (EPA) regulates nanoscale materials under the Toxic Substance Control Act (TSCA) to ensure that the manufacturing and the use of nanomaterials do not pose unreasonable risks to human health and the environment. The EPA introduced a rule requiring persons who manufacture, process or import a reportable substance under the TSCA to declare specific chemical identity, production volume, methods of manufacture, processing, use, exposure and release information, and available health and safety data in order to develop a further understanding of nanoscale materials. The final rule with provisions regarding the reporting of information relating to nanomaterials became effective on 12 May 2017.
Since 2005, under the TSCA ruling, the EPA has received and reviewed over 160 new chemicals within the nanoscale materials bracket. This information has allowed the EPA to make informed decisions on matters surrounding nanoparticles, and, if necessary, control and limit exposure to these chemicals by limiting the use of nanomaterials, requiring the use of personal protective equipment and engineered controls, limiting environmental releases, and requiring the generation of data on health and environmental effects through testing. In addition, EPA has permitted limited manufacture of new nanomaterials through the use of consent orders or Significant New Use Rules under TSCA and allowed the manufacture of new nanomaterials under the terms of certain regulatory exemptions, but only when exposures were tightly controlled to protect against unreasonable risks.13
The US Occupational Safety and Health Administration has the authority to regulate exposure to engineered nanomaterials in the workplace.
Canada requires manufacturers and importers to register information on a selection of 206 substances at the nanoscale under the Canadian Environmental Protection Act (CEPA 1999). A working definition described in the Policy Statement on Health Canada's Working Definition for Nanomaterial14 has been considered in the development of the approach to address certain nanomaterials under the CEPA 1999. Nanoscale forms of substances that are not listed on the Domestic Substances List are subject to the New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999. The Canadian Government wants to ensure that nanomaterials on the market in Canada are addressed, because some may require further action to determine if they pose any potential risks to the environment or to human health.15
US and Canadian regulatory agencies are working towards harmonising the regulatory approaches for nanomaterials under the US-Canada Regulatory Cooperation Council (RCC) Nanotechnology Initiative. Canada and the US recently published a Joint Forward Plan16 where findings and lessons learnt from the RCC Nanotechnology Initiative are discussed.17
In Australia, the Australian Industrial Chemicals Introduction Scheme (AICIS) has been established to regulate the use of nanomaterials in products used in printing, plastics, mining, construction, paints, adhesives, consumer goods, cosmetics and more. Industrial Chemicals Act 201918 is the legal framework for the regulation of the import and manufacture of industrial chemicals in Australia. The Industrial Chemicals (General) Rules 201919 form part of the legislative framework and contain technical and operational details of AICIS.20 The rules introduce the definition of ‘nanoscale’ as the particle size range of 1 to 100 nm and lays out provisions for chemicals consisting of particles in the nanoscale.
The body for workplace safety, Safe Work Australia, has determined that engineered nanoparticles fall under the same legislation governing technologies, chemicals, substances, and materials, and requires that associated risks are addressed via elimination, minimisation, or communication. Engineered nanomaterials are likely to be classified as hazardous chemicals under the Work Health and Safety Act 201121 and the Work Health and Safety Regulation 2017,22 based on the physicochemical properties of the actual nanomaterial and/or that of the parent materials. Although workplace hazardous chemicals legislation does not explicitly refer to nanomaterials, it deals with substances classified as hazardous chemicals in whatever size, shape or physical state.23
Safe Work Australia released recommendations regarding nanomaterial emission and exposure management to be adopted within workplaces.24 Such recommendations are only applicable to the workplace, and any exposure falling outside the bound of a worksite is not governed by Safe Work Australia, but rather the Department of Health National Industrial Chemicals Notification and Assessment Scheme.25
1 Commission of the European Communities. (2008). Communication from The Commission to The European Parliament, The Council and The European Economic and Social Committee regulatory aspects of nanomaterials. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0366:FIN:EN:PDF
2 European Commission. (2011). Commission Recommendation of 18 October 2011 on the definition of nanomaterial Text with EEA relevance. Official Journal of the European Union, 275, 38-40. Available at: https://eur-lex.europa.eu/eli/reco/2011/696/oj
3 European Commission. (2022). Commission Recommendation of 10.6.2022 on the definition of nanomaterial. Official Journal of the European Union, 229, 1-5. Available at: https://ec.europa.eu/environment/chemicals/nanotech/pdf/C_2022_3689_1_EN_ACT_part1_v6.pdf
4 European Commission. (2018). Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance). Official Journal of the European Union, 308, 1-20. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2018.308.01.0001.01.ENG&toc=OJ:L:2018:308:TOC
5 ECHA. (n.d.) Nanomaterials. Available at: https://echa.europa.eu/regulations/nanomaterials
6 European Union Observatory for Nanomaterials (EUON). (n.d.d). Regulation. Available at: https://euon.echa.europa.eu/regulation#:~:text=In%20the%20EU%2C%20nanomaterials%20are,use%20needs%20to%20be%20ensured
7 Legislation.gov.uk. (2020). EU legislation and UK law. Available at: https://www.legislation.gov.uk/eu-legislation-and-uk-law
8 Department for Environment, Food & Rural Affairs. (2021). The REACH etc. (amendment) regulations 2021. Available at: https://www.gov.uk/eu-withdrawal-act-2018-statutory-instruments/the-reach-etc-amendment-regulations-2021
9 Health and Safety Executive. (n.d.b). Classification, labelling and packaging of chemicals (CLP) in GB or NI. Available at: https://www.hse.gov.uk/chemical-classification/brexit.htm#:~:text=From%201%20January%202021%2C%20the,'%2C%20known%20as%20GB%20CLP
10 Health and Safety Executive. (n.d.a). Brexit: Implications for businesses. Available at: https://www.hse.gov.uk/biocides/brexit.htm
11 Health and Safety Executive for Northern Ireland (HSENI). (n.d.) Chemicals. Available at: https://www.hseni.gov.uk/topic/chemicals
12 Health and Safety Executive. (2002). Control of Substances Hazardous to Health 2002 (COSHH). Available at: https://www.hse.gov.uk/nanotechnology/coshh.htm#:~:text=COSHH%20is%20the%20law%20that,to%20health%20(risk%20assessment)%3B
13 United States Environmental Protection Agency. (n.d.). Control of nanoscale materials under the Toxic Substance Control Act. Available at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/control-nanoscale-materials-under
14 Government of Canada. (2011). Policy statement on Health Canada’s working definition for nanomaterial. Available at: https://www.canada.ca/en/health-canada/services/science-research/reports-publications/nanomaterial/policy-statement-health-canada-working-definition.html
15 Government of Canada. (2016). Nanomaterials. Available at: https://www.canada.ca/en/health-canada/services/chemical-substances/chemicals-management-plan/initiatives/nanomaterials.html
16 United States – Canada Regulatory Cooperation Council. (2014). Joint Forward Plan. The White House. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/oira/irc/us-canada-rcc-joint-forward-plan.pdf
17 Amenta, V., Aschberger, K., Arena, M., Bouwmeester, H., Moniz, F. B., Brandhoff, P., ... & Peters, R. J. (2015). Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries. Regulatory Toxicology and Pharmacology, 73(1), 463-476.
18 Australian Government. (2019). Industrial Chemicals Act 2019. Available at: https://www.legislation.gov.au/Series/C2019A00012
19 Australian Government. (2022). Industrial chemicals (general) rules 2019. Available at: https://www.legislation.gov.au/Details/F2022C00255
20 Australian Government Department of Health and Aged Care. (2022). Labelling, SDS and packaging. Available at: https://www.industrialchemicals.gov.au/help-and-guides/labelling-sds-and-packaging
21 Queensland Government. (2020). Work Health and Safety Act 2011. Available at: https://www.legislation.qld.gov.au/view/pdf/inforce/current/act-2011-018
22 New South Wales Government. (2017). Work Health and Safety Regulation 2017. Available at: https://legacy.legislation.nsw.gov.au/~/pdf/view/regulation/2017/404/whole
23 Queensland Government. (2017). What laws apply. Available at: https://www.worksafe.qld.gov.au/safety-and-prevention/hazards/hazardous-exposures/nanotechnology/what-laws-apply
24 Morawska, L., McGarry, P., Morris, H., Knibbs, L., Bostrom, T., & Capasso, A. (2012). Measurements of particle emissions from nanotechnology processes with assessment of measuring techniques and workplace controls. Available at: https://www.safeworkaustralia.gov.au/system/files/documents/1702/measurements_particle_emissions_nanotechnology_processes.pdf
25 Mohajerani, A., Burnett, L., Smith, J. V., Kurmus, H., Milas, J., Arulrajah, A., ... & Abdul Kadir, A. (2019). Nanoparticles in construction materials and other applications, and implications of nanoparticle use. Materials, 12(19), 3052.