Regulations - EUON
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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 AII-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 (exclude medicinal products and substances used in medical devices from some requirements)||No|
European Commission Recommendation on the Definition of a Nanomaterial (2011/696/EU)
Substances at the nanoscale
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
Registration duties and obligations for nanomaterials
Nanotechnology regulation in the agricultural sector in the EU
The overarching regulatory framework for chemical substances is the main act to regulate nanomaterials in the agricultural sector (REACH, CLP). Nanomaterials are also covered in the Biocidal Product Regulation (BPR) 528/2012/EU. Biocidal products may be used in current agricultural practises related to the use of insecticides and disinfectants in animal farming. The provisions of BPR 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 it is explicitly mentioned in the BPR. For nanoforms of active substances, a separate dossier with all data requirements must usually be prepared. Applicable since the 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.6
Nanotechnology is also used in plant protection products, such as pesticides, which are regulated by the Plant Protection Products (PPP) Regulation 1107/2009/EC. It requires authorisation for active substances in plant protection products at the EU and a Member State level. Active substances and products are assessed on a case-by-case basis, which provides the possibility to assess the risk of nanomaterials as active substances, even if they are not explicitly mentioned in the legislation. Authorisation of plant protection products is only granted under the conditions that not only the active substance, but also safeners and synergists included in the product have been approved. Pesticides containing nanoforms or nano-encapsulations of approved active substances could be considered as a different product and, as such, would require a separate risk assessment and authorisation (Amenta et al., 2015).7
Other relevant legislation for agriculture includes regulations for animal feed. The Regulation on placing on the market and use of feed 767/2009/EU8 aims to harmonise conditions for placing on the market and the use of feed to ensure high-level of feed safety and protection of public health and to provide adequate information for users and consumers. The main objective of the Regulation on additives for use in animal nutrition 1831/2003/EC is to establish a procedure for authorising the the use of feed additives, their placement on the market and setting the rules for the supervision and labelling of feed additives and premixtures in order to assure a high-level of protection for human health, animal health and welfare, the environment and the interests of users and consumers in relation to feed additives. Although nanomaterials are not specifically mentioned in these regulations, nanomaterials and nano-enabled products are covered by this legislation.
The list of main European regulations for agricultural sector is presented in the table below.
|Table AI-6: Overview of legislation for agricultural sector in the EU|
|Status||Document title||Country/ Region||Scope||Nano-specific|
|Implemented||Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market (PPP)||EU||Plant protection products||No|
|Implemented||Regulation (EC) No 767/2009 on the placing on the market and use of feed||EU||Animal feed||No|
|Implemented||Regulation (EC) No 429/2008 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives||EU||Animal feed||No|
|Implemented||Regulation (EC) No 1831/2003 on additives for use in animal nutrition||EU||Animal feed||No|
|Implemented||Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products||EU||Biocidal products||Yes|
Nanotechnology regulation in the agricultural sector in the rest of the world
No country has currently developed specific legislation to cover the use of nanomaterials in the agriculture sector.
In the UK, 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’.9 The REACH (Amendment) Regulations 2021 (SI 2021/904) were implemented on 26th of July 2021 to ensure that the UK REACH chemicals regime legislation continues to function in the country after Brexit.10 From the 1st of January 2021, the classification, labelling and packaging of chemicals placed on the Great Britain 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.11 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 Great Britain.12 Northern Ireland, on the other hand, has to comply with EU legislation on chemicals.13
In the United States, the Food and Drug Administration (FDA) is responsible to ensure safety of food additives, food contact materials and feed additives that are placed on the market under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA).14 The FFDCA does not specify nanotechnology-based products. The US Environmental Protection Agency (EPA) is responsible for regulating pesticides under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)15, although no specific provisions for nanomaterials are available under this regulation (Amenta et al., 2015). The EPA can regulate engineered nanomaterials in other chemical products used in agriculture 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 2017.16
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.17
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 Nanomaterial18 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 the 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.19
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 Plan20 where findings and lessons learnt from the RCC Nanotechnology Initiative are discussed (Amenta et al., 2015).
In Australia, the regulation of the use of nanotechnology within the agriculture sector is governed by the Australian Pesticides and Veterinary Medicines Authority (APVMA) up to the point of retail sale. Protecting human health and the environment from any harmful effects of these substances is a legislated responsibility of the APVMA. For the foreseeable future, the existing regulatory framework (the National Registration Scheme for Agricultural and Veterinary Chemicals) developed for non-nanoscale agricultural and veterinary chemicals, in conjunction with a case-by-case approach, will be used to regulate nanomaterials in Australia.21
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. (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
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.a). Biocidal Products Regulation (BPR) and nanomaterials. Available at: https://euon.echa.europa.eu/the-biocidal-products-regulation-bpr-and-nanomaterials
7 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.
8 European Commission (2009b). Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R0767-20180101
9 Legislation.gov.uk. (2020). EU legislation and UK law. Available at: https://www.legislation.gov.uk/eu-legislation-and-uk-law
10 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
11 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
12 Health and Safety Executive. (n.d.a). Brexit: Implications for businesses. Available at: https://www.hse.gov.uk/biocides/brexit.htm
13 Health and Safety Executive for Northern Ireland (HSENI). (n.d.) Chemicals. Available at: https://www.hseni.gov.uk/topic/chemicals
14 United States Food & Drug Administration. (2018). Federal Food, Drug, and Cosmetic Act (FD&C Act). Available at: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
15 United States Government. (2012). Federal Insecticide, Fungicide, and Rodenticide Act. Available at: https://www.agriculture.senate.gov/imo/media/doc/FIFRA.pdf
16 Mohajerani, A., Burnett, L., Smith, J. V., Kurmus, H., Milas, J., Arulrajah, A., Horpibulsuk, S., & Kadir, A. A. (2019). Nanoparticles in construction materials and other applications, and implications of nanoparticle use. Materials, 12(19), 3052.
17 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
18 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
19 Government of Canada. (2016). Nanomaterials. Available at: https://www.canada.ca/en/health-canada/services/chemical-substances/chemicals-management-plan/initiatives/nanomaterials.html
20 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
21 Australian Pesticides and Veterinary Medicines Authority. (2015). Nanotechnologies for pesticides and veterinary medicines: Regulatory considerations. Available at: https://apvma.gov.au/sites/default/files/publication/15626-nanotechnologies-pesticides-veterinary-medicines_regulatory-considerations_july2015.pdf