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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 AX-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 transport sector in the EU
Regulation of transport is based a framework that covers all aspects of transportation, from the manufacture of vehicles and the construction of infrastructure to the end of life of vehicles. Transport is one of the key policies of the European Union and is featured in the Treaty on the Functioning of the European Union (Title VI: Transport).6 The Directorate General for Mobility and Transport has the main responsibility for European transport policy, consisting of a package of directives and regulation. The use of nanotechnology in the transport sector is not incorporated in this legislation.
The reuse and recycling of vehicles is mainly regulated by the End-of-Life Vehicles Directive 2000/53/EC.7 It sets clear targets for reuse, recycling and recovery of end-of-life vehicles (ELV) and their components and prohibits the use of hazardous substances when manufacturing new vehicles, except for defined exemptions when adequate alternatives do not exist.8 There are no provision for nanomaterials in this directive. The ELV directive is supported by the Directive on batteries and accumulators and waste batteries and accumulators 2006/66/EU9, amended in 2013.
The aim is to contribute to protect and improve the environment by minimising the negative impact of batteries and accumulators and waste batteries and accumulators. The Directive also prohibits the marketing of batteries that contain some hazardous substances. Nanomaterials are also not covered by this directive. In 2020, the European Commission proposed to update EU legislation on batteries, delivering its first initiative among the actions announced in the new Circular Economy Action Plan.10
Nanomaterials used in transportation must comply with the overarching regulatory framework for chemical substances, such as REACH. Electronic items used in vehicles and incorporating nanomaterials may fall under the scope of electronics regulations, such as the Waste Electrical and Electronic Equipment Directive (WEEE) 2012/19/EU and the Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2) 2011/65/EU. For articles containing nanomaterials that are used in road vehicles, only electrical or electronic articles that can be bought separately and that are not specifically designed to be used in vehicles would be covered by the RoHS2 Directive.
The WEEE directive lays out criteria for the collection, treatment and recovery of waste electrical and electronic equipment. Its objective is to promote re-use, recycling and other types of recovery of WEEE to reduce the amount of such waste and improve environmental performance of the treatment of such waste.11 The aim of RoHS2 Directive is to prevent risks posed to human health and the environment related to the management of electronic and electrical waste by restricting the use of certain hazardous substances in EEE that can be substituted by safer alternatives.
The WEEE directive refers to a 2009 Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) entitled ‘Risk assessment of Products of Nanotechnologies’ stating that ‘when nanomaterials are firmly embedded in large structures, for example in electronic circuits, they are less likely to escape this structure and no human or environmental exposure is likely to occur.’12 Under Article 8 of WEEE, the European Commission is invited to evaluate the need for amending Annex VII to address nanomaterials contained in waste electrical and electronic equipment.13 With RoHS2, European institutions, based on scientific evidence and taking into account the precautionary principle, keep on the possibility to add substances to Annex II (the list of restricted substances), including nanomaterials. To date, nanomaterials have not been directly addressed in this annex. The list of main European legislation for the transport sector is presented in the table below.
|Table AX-6: Overview of legislation for the transport sector in the EU|
|Status||Document title||Country/ Region||Scope||Nano-specific|
|Implemented||Directive 2000/53/EC on end-of life vehicles||EU||End-of-life vehicles||No|
|Implemented||Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators||EU||Batteries and accumulators||No|
|Implemented||Directive 2012/19/EU on waste electrical and electronic equipment (WEEE)||EU||Waste electrical and electronic equipment||Yes|
|Implemented||Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2)||EU||Hazardous substances||Yes|
Nanotechnology regulation in the transport sector in the rest of the world
Countries around the world have not developed nano-specific regulations in their transport policy.
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’.14 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.15 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.16 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.17 Northern Ireland, on the other hand, has to comply with EU legislation on chemicals.18
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.19
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 Nanomaterial20 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.21
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 Plan22 where findings and lessons learnt from the RCC Nanotechnology Initiative are discussed.23
In Australia, 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 201124 and the Work Health and Safety Regulation 2017, 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.25
Safe Work Australia released recommendations regarding nanomaterial emission and exposure management to be adopted within workplaces.26 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.27
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. 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 Commission. (2008). Consolidated version of the Treaty on the functioning of the European Union – Part three: Union policies and internal actions – Title VI: Transport – Article 91. Official Journal of the European Union, 115, 85. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12008E091
7 European Commission. (2020). Directive 2000/53/ED of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02000L0053-20200306
8 European Commission. (n.d.). End-of-life vehicles. Available at: https://environment.ec.europa.eu/topics/waste-and-recycling/end-life-vehicles_en
9 European Commission. (2006). Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing directive 91/157/EEC. Official Journal of the European Union, 266, 1-14. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32006L0066
10 European Commission. (2020). Green Deal: Sustainable batteries for a circular and climate neutral economy. Available at: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2312
11 European Commission. (2012). Directive 2012/19/EU of The European Parliament and of The Council of 4 July 2012 on waste electrical and electronic equipment (WEEE). Official Journal of the European Union, 197, 38-71. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:197:0038:0071:EN:PDF
12 Scientific Committee on Emerging and Newly Identified Health Risks. (2009). Risk assessment of products of nanotechnologies. Available at: https://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf
13 European Commission. (2012). Directive 2012/19/EU of The European Parliament and of The Council of 4 July 2012 on waste electrical and electronic equipment (WEEE). Official Journal of the European Union, 197, 38-71. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:197:0038:0071:EN:PDF
14 Legislation.gov.uk. (2020). EU legislation and UK law. Available at: https://www.legislation.gov.uk/eu-legislation-and-uk-law
15 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
16 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
17 Health and Safety Executive. (n.d.a). Brexit: Implications for businesses. Available at: https://www.hse.gov.uk/biocides/brexit.htm
18 Health and Safety Executive for Northern Ireland (HSENI). (n.d.) Chemicals. Available at: https://www.hseni.gov.uk/topic/chemicals
19 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
20 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
21 Government of Canada. (2016). Nanomaterials. Available at: https://www.canada.ca/en/health-canada/services/chemical-substances/chemicals-management-plan/initiatives/nanomaterials.html
22 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
23 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.
24 Queensland Government. (2020). Work Health and Safety Act 2011. Available at: https://www.legislation.qld.gov.au/view/pdf/inforce/current/act-2011-018
25 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
26 Queensland Government. (2017). What laws apply. Available at: https://www.worksafe.qld.gov.au/safety-and-prevention/hazards/hazardous-exposures/nanotechnology/what-laws-apply
27 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
28 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.