Environment - 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 AV-6: 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 environmental sector in the EU

The European Union regulatory framework for environmental protection covers the use of nanomaterials. These have been prepared by the Environment Directorate-General of the European Commission (DG ENV), which has also dedicated efforts to the assessment of the regulatory framework on nanomaterials. Two regulatory reviews in 20086 and 20127 have assessed the role of different pieces of regulation and set targets for further steps. The following regulatory review was meant to take place in 2016 and DG ENV commissioned a study to support this review. However, due to delays in some of the actions of the 2nd regulatory review, the Commission had decided not to formally launch a 3rd regulatory review on nanomaterials.8  

The study, which was published in November 2016,9 still provided a useful update. The objective was to compile and develop information on nanomaterials and advanced materials in the environment and explore further the regulatory implementation challenges. The study had a review of progress on the application of environmental and other key legislation to nanomaterials. 

The regulatory reviews have confirmed the overarching regulatory framework for chemical substances as the main act to regulate nanomaterials. Nanomaterials are also covered in the Biocidal Product Regulation (BPR) 528/2012/EU. The provisions apply to products and substances that meet the criteria of the definition of nanomaterial in the BPR. The approval of the active substance does not cover the nanoform of the active substance unless this is explicitly mentioned in the BPR. For nanoforms of active substances, a separate dossier with all data requirements must usually be prepared. Applicable since 1st of September 2013, it requires a dedicated risk assessment when a nanomaterial form of an active or non-active substance is used in a biocidal product. Such biocidal products must also be labelled and indicate the name of the nanomaterial followed by the word ‘nano’ in brackets. In addition, the simplified procedure for authorisation introduced in the BPR is not applicable for nanomaterials.10  

The regulatory reviews and the study in 2016 summarised the coverage of environmental legislation in relation to nanomaterials. While regulations covering cosmetic products, food contact materials and novel foods target nanomaterials, these do not specifically address environmental issues. However, this legislation could be potentially relevant due to environmental exposure pathways of nanomaterials. The list of EU environmental legislation and other relevant legislation is presented in the table below.

Table AV-7: Overview of legislation for the environment sector in the EU
Status Document title Country/ Region Scope Nano-specific
Implemented Directive 2008/98/EC on waste (Waste Framework Directive) EU Waste No
Implemented Decision 2000/532/EC (European Waste Catalogue)  EU Waste No
Implemented Directive 2000/53/EC on end-of life vehicles (ELV Directive)  EU End-of-life vehicles No
Implemented Directive 1999/31/EC on the landfill of waste (Landfill Directive)  EU Landfills No
Implemented Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2)  EU Electrical and electronic equipment Yes
Implemented Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) EU Waste electrical and electronic equipment Yes
Implemented Directive 94/62/EC on packaging and packaging waste (Packaging Directive)  EU Packaging No
Implemented Directive 86/278/EEC on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (Sewage Sludge Directive)  EU Sewage sludge No
Implemented Directive 2000/60/ establishing a framework for Community action in the field of water policy (the Water Framework Directive) EU Surface waters, transitional waters, coastal waters and groundwater No
Implemented Directive 2008/105/EC on environmental quality standards in the field of water policy (the Environmental Quality Standards Directive)  EU Environmental quality  Yes
Implemented Directive 2006/118/EC on the protection of groundwater against pollution and deterioration (the Groundwater Directive)  EU Groundwater No
Implemented Directive (EU) 2020/2184 on the quality of water intended for human consumption (recast) (the Drinking Water Directive) EU Drinking water No
Implemented Directive 91/271/EEC concerning urban waste-water treatment (the Urban Wastewater Treatment Directive)  EU Wastewater No
Implemented Directive 2008/56/EC establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive – MSFD)  EU Marine environment No
Implemented Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances (Seveso Directive)  EU Dangerous substances No
Implemented Directive 2008/50/EC on ambient air quality and cleaner air for Europe EU Air quality No
Implemented Regulation (EC) No 66/2010 on the EU Ecolabel  EU Ecolabel award scheme No
Implemented Directive 2010/75/EU on industrial emission (IED)  EU Industrial emissions No
Implemented Regulation (EC) No 166/2006 concerning the establishment of a European Pollutant Release and Transfer Register  EU Pollutants register No
Implemented Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products (BPR)  EU Biocidal products Yes
Implemented Regulation (EC) No 1223/2009 on cosmetic products (Cosmetic Products Regulation)  EU Cosmetic products Yes
Implemented Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market (PPP)  EU Plant protection products No
Implemented Regulation (EU) 2015/2283 on novel foods (Novel Food Regulation)  EU


Implemented Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food  EU Materials in contact with food Yes
Implemented Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food  EU Materials in contact with food Yes
Implemented Regulation (EU) No 1169/2011 on the provision of food information to consumers  EU Food Yes
Implemented Regulation No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control  EU Food Yes


The study carried out in 2016 stated that the majority of EU legislation did not adequately address the nanoscale properties of nanomaterials and any potential hazards associated with these nanoscale properties. One of the main reasons is that REACH and CLP Regulations do not effectively identify and generate information on nanomaterials, whereas a great deal of downstream environmental legislation, such as for air emissions, waste or water, relies on these two instruments to trigger their risk management measures for hazardous chemical substances. Although some pieces of EU legislation have been amended to address potential risks from nanomaterials, there is still no apparent consistent approach across all EU acquis on the regulation of nanomaterials.


Nanotechnology regulation in the environmental sector in the rest of the world

In the UK, the environmental risks are regulated by the Environment Agency. EU legislation which applied directly or indirectly to the UK before the 31st of December 2020 has been retained in UK law as a form of domestic legislation known as ‘retained EU legislation’. The REACH etc (Amendment) Regulations 2021 (SI 2021/904) were implemented on the 26th of July 2021 to ensure that the UK REACH chemicals regime legislation continues to function in the country after Brexit. From the 1st of 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. 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. Hence, most aspects of EU BPR continue in the same way under the new stand-alone regime.11 Overall, EU legislation which applied directly or indirectly to the UK before the 31st of December 2020 has been retained in UK law as a form of domestic legislation known as ‘retained EU legislation’.12 Northern Ireland, on the other hand, has to comply with EU legislation on chemicals.13 

In the United States, the US Environmental Protection Agency (EPA) can regulate engineered nanomaterials in the air and water, in solid and hazardous waste disposal sites, and in pesticides or other chemical products used in agriculture or industry.14 The 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 the 12th of May 2017.15  

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, the 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.16  

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 Nanomaterial17 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.18 

The 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 Plan19 where findings and lessons learnt from the RCC Nanotechnology Initiative are discussed.20 

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 201921 is the legal framework for the regulation of the import and manufacture of industrial chemicals in Australia. The Industrial Chemicals (General) Rules 201922 form part of the legislative framework and contain technical and operational details of AICIS.23 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. This legislative framework also covers risks to the environment arising from chemical substances. Nanotechnology applications that impact the environment are governed by the Australian Government Department of Climate Change, Energy, the Environment and Water.



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 

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

European Commission. (2022a). 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

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

ECHA. (n.d.) Nanomaterials. Available at: https://echa.europa.eu/regulations/nanomaterials

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://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0366:FIN:EN:PDF

European Commission. (2012a). Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee second regulatory review on nanomaterials. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52012DC0572

European Commission. (n.d.g) Selected commission studies related to regulatory management of nanomaterials. Available at: https://ec.europa.eu/environment/chemicals/nanotech/studies/index_en.htm

Broomfield, M., Foss Hansen, S., & Pelsy, F. (2016). Support for 3rd regulatory review on nanomaterials. Commissioned by the European Commission. Available at: https://op.europa.eu/en/publication-detail/-/publication/cf73479b-b601-11e6-9e3c-01aa75ed71a1

10 European Union Observatory for Nanomaterials (EUON). (n.d.a). Biocidal Products Regulation (BPR) and nanomaterials. Available at: https://euon.echa.europa.eu/the-biocidal-products-regulation-bpr-and-nanomaterials

11 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

12 Legislation.gov.uk. (2020). EU legislation and UK law. Available at: https://www.legislation.gov.uk/eu-legislation-and-uk-law

13 Health and Safety Executive for Northern Ireland (HSENI). (n.d.) Chemicals. Available at: https://www.hseni.gov.uk/topic/chemicals

14 Resnik, D. B. (2019). How should engineered nanomaterials be regulated for public and environmental health? AMA Journal of Ethics, 21(4), 363-369.

15Mohajerani, 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.

16 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

17 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

18 Government of Canada. (2016). Nanomaterials. Available at: https://www.canada.ca/en/health-canada/services/chemical-substances/chemicals-management-plan/initiatives/nanomaterials.html

19 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

20 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.

21 Australian Government. (2019). Industrial Chemicals Act 2019. Available at: https://www.legislation.gov.au/Series/C2019A00012

22 Australian Government. (2022). Industrial chemicals (general) rules 2019. Available at: https://www.legislation.gov.au/Details/F2022C00255

23 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