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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 AIII-7: 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 consumer products sector in the EU
The overarching regulatory framework for chemical substances is the main act to regulate nanomaterials in the consumer products (REACH, CLP). There is no specific regulation that covers nanomaterials in textiles. However, nanomaterials are explicitly covered under the Regulation on cosmetic products 1223/2009/EC (Cosmetics Regulation).6 Cosmetic Products Regulation specifies that all ingredients containing nanomaterials must be clearly indicated in the list of ingredients with the word ‘nano’ in brackets following the name of an ingredient. Certain groups of substances, such as colourants, preservatives and UV-filters, including those that are nanomaterials, must be authorised by the European Commission prior to their use in cosmetic products. Until now, four UV-filters have been authorised as nanomaterials by the Commission. It has also allowed carbon black in nano form for use as a colourant in cosmetic products. According to Regulation, the Commission must publish a catalogue of all nanomaterials used in cosmetic products placed on the market. Nanomaterials used as UV-filters, colourants and preservatives must be specified in a different section.7 According to Article 16 of the Cosmetics Regulation, the Commission is required to submit to the European Parliament and the Council an annual status report on the use of nanomaterials in cosmetic products and to review the provisions concerning nanomaterials of the Cosmetics Regulation. In 2021, the Commission issued the review of the Cosmetics Regulation, where it addressed four main elements of the provisions governing nanomaterials to assess if the regulation is still fit for purpose in the light of scientific and technical progress. The report focused on the definition, notification of nanomaterials, scientific assessment of nanomaterials and labelling of cosmetic products containing nanomaterials.8 The list of main European regulations for consumer products sector is presented 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) No 1223/2009 on cosmetic products | EU | Cosmetic products | Yes |
Nanotechnology regulation in the consumer products sector in the rest of the world
In the UK, all cosmetic products placed on the market intended for sale or to be given away for free must comply with Schedule 34 of the Product Safety and Metrology Statutory Instrument, also called the UK Cosmetics Regulation, for cosmetics marketed in Great Britain (England, Wales and Scotland) and Regulation EC 1223/2009 on cosmetic products (the EU Cosmetics Regulation) for cosmetics marketed in Northern Ireland. This is in accordance with the terms of the Northern Ireland Protocol to the UK/EU Withdrawal Agreement. Products placed on the market in Great Britain and Northern Ireland, must comply with both the UK Cosmetics Regulation and EU Cosmetic Products Regulation.9 According to Article 13 of the UK Cosmetics Regulation, before placing a cosmetic product on the market, the responsible person must provide the information on the presence of substances in the form of nanomaterials to the Secretary of State. Article 16 of the same regulation lays out the provisions explicitly for nanomaterials.10
Cosmetic products placed on the UK market also have to comply with other horizontal legislation, including legislation on chemicals. 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’.11 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.12 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.13 Northern Ireland, on the other hand, has to comply with EU legislation on chemicals.14
In the US, the Food and Drug Administration (FDA) monitors the use of nanotechnology and the use of nanoscale materials in cosmetics. In 2007, the FDA issued a report prepared by its Nanotechnology Task Force. It presented an assessment of scientific and regulatory considerations relating to the safety and effectiveness of FDA-regulated products containing nanomaterials and made recommendations because of these considerations. Regarding cosmetic products, the Task Force recommended that the FDA issues guidance that describes safety issues manufacturers should consider in order to ensure that cosmetic products made with nanomaterials are safe and not adulterated. The ‘Guidance for Industry, Safety of Nanomaterials in Cosmetic Products’ was issued as part of efforts to implement the Task Force recommendations.15
The FDA has not established regulatory definitions of nanomaterial or other related terms. According to the guidance issued for industry by the FDA in 2014, titled ‘Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology’16, when considering whether an FDA-regulated product involves the application of nanotechnology, the FDA would ask ‘whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm) and whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometre (1,000 nm).’ The FDA applies these considerations broadly to all FDA-regulated products, including cosmetic products. The general framework for assessing the safety of nanomaterials in cosmetic products is the Federal Food, Drug, and Cosmetic Act.
In Canada, Health Canada helps protect the Canadian public from the health risks and safety hazards associated with consumer products that Canadians use every day. As part of this rigorous processes, a high attention is placed on maximising the safety of all consumer products and cosmetics, including those that use nanotechnology. The Canada Consumer Product Safety Act (CCPSA)17 provides Health Canada with the authority to address and prevent any dangers to human health or safety posed by consumer products, including those that contain nanomaterials. The CCPSA also prohibits retailers, manufacturers, or importers from manufacturing, importing, advertising, or selling any consumer product that is a dangerous to human health or safety.
Cosmetics are regulated under the Cosmetic Regulations18 and under the Food and Drugs Act19. Nano-scale substances and substances that are considered new to Canada, whether consumer products or cosmetics, are also subject to New Substances Notification Regulations (Chemicals and Polymers)20. Health Canada and Environment Canada share responsibility under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to assess and manage risks from chemicals and other substances, including nanomaterials, that are imported, used, or manufactured in Canada.21
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 201922 is the legal framework for the regulation of the import and manufacture of industrial chemicals in Australia. The Industrial Chemicals (General) Rules 201923 form part of the legislative framework and contain technical and operational details of AICIS.24 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. In addition, all suppliers of cosmetics, including manufacturers, importers, distributors and retailers, must comply with the Australian Competition and Consumer Commission’s (ACCC) mandatory standard for ingredient labelling of cosmetics.25 Cosmetic products must also comply with any applicable requirements in the Standard for the Uniform Scheduling of Medicines and Poisons.26 However, none of these pieces of legislation explicitly mention nanomaterials.
In China, a new regulation titled ‘Instructions for New Cosmetic Ingredient Registration and Notification Dossiers was first drafted in 2020 by China’s National Medical Products Administration (NMPA) and implemented on 1 January 2021. In this regulation, new cosmetic ingredients are defined as artificial or natural ingredients that are used in cosmetics for the first time in the country and is outside of the Inventory of Existing Cosmetic Ingredients in China. Under Article 21 of the regulation, the information on nano ingredients must indicate particle size and distribution, agglomeration and aggregation characteristics of ingredients, surface chemical information, and morphology information. The regulation lays out provisions for registration and notification of new cosmetic products and categorise them into high risk and low risk.27
No specific provisions for nanotechnology use in textiles have been identified in these countries. The rules and regulations for commercialisation of nano-products are maintained within the existing bodies, which measures or control products in various sectors.28
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. (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 Commission. (2009c). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union, 342, 59-209. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32009R1223
7 European Commission. (n.d.e). Nanomaterials. Available at: https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-products-specific-topics/nanomaterials_en
8 European Commission (2021). Report from the Commission to the European Parliament and the Council on the use of nanomaterials in cosmetics and on the review of Regulation (EC) No 1223/2009 on cosmetic products as regards nanomaterials. Available at: https://data.consilium.europa.eu/doc/document/ST-11068-2021-INIT/en/pdf
9 Cosmetic, Toiletry and Perfumery Association (CTPA). (n.d.). UK cosmetics regulations and amendments. Available at: https://www.ctpa.org.uk/uk-cosmetic-regulations-amendments
10 Legislation.gov.uk. (200(0. Schedule 34: Amendment of regulation (EC) No 1223/2009 and related amendments. Available at: https://www.legislation.gov.uk/uksi/2019/696/schedule/34/made
11 Legislation.gov.uk. (2020). EU legislation and UK law. Available at: https://www.legislation.gov.uk/eu-legislation-and-uk-law
12 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
13 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
14 Health and Safety Executive for Northern Ireland (HSENI). (n.d.) Chemicals. Available at: https://www.hseni.gov.uk/topic/chemicals
15 United States Department of Health and Human Services, Food and Drug Administration & Center for Food Safety and Applied Nutrition. (2014). Guidance for industry: Safety of nanomaterials in cosmetic products. Available at: https://www.fda.gov/media/83957/download
16 United States Department of Health and Human Services, Food and Drug Administration & Office of the Commissioner. (2014). Guidance for industry: Considering whether an FDA-Regulated product involves the application of nanotechnology. Available at: https://www.fda.gov/media/88423/download
17 Government of Canada. (2010). Canada Consumer Product Safety Act. Available at: https://laws-lois.justice.gc.ca/eng/acts/c-1.68/
18 Government of Canada. (2019). Cosmetic regulations (C.R.C., c. 869). Available at: https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/
19 Government of Canada. (1985). Food and Drugs Act (R.S.C., 1985, c. F-27). Available at: https://laws-lois.justice.gc.ca/eng/acts/f-27/
20 Government of Canada. (2005). New substances notification regulations (chemicals and polymers) (SOR/2005-247). Available at: https://laws-lois.justice.gc.ca/eng/Regulations/SOR-2005-247/index.html
21 Government of Canada. (2014). Consumer products. Available at: https://www.canada.ca/en/health-canada/services/science-research/emerging-technology/nanotechnology/consumer-products.html
22 Australian Government. (2019). Industrial Chemicals Act 2019. Available at: https://www.legislation.gov.au/Series/C2019A00012
23 Australian Government. (2022). Industrial chemicals (general) rules 2019. Available at: https://www.legislation.gov.au/Details/F2022C00255
24 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
25 Australian Government. (2020). Consumer goods (cosmestics) information standard 2020. Available at: https://www.legislation.gov.au/Details/F2020L01469
26 Australian Government. (2021). Poisons standard Februrary 2021 : Compilation No. 1. Available at: https://www.parliament.vic.gov.au/file_uploads/2021-02-01_Poisons_Standard_Abridged_PDF__for_Tabling_DXfYnGKs.PDF
27 Lim, G. Y. (2021). Enterprise boost: China ready to allow use of nano and biotech materials in cosmetics for the first time. Available at: https://www.cosmeticsdesign-asia.com/Article/2021/01/12/Enterprise-boost-China-ready-to-allow-use-of-nano-and-biotech-materials-in-cosmetics-for-the-first-time
28 Kumar, N., Sangma, S. N., Ray, D. P., Ghosh, R. K., Ammayappan, L., & Chattopadhyay, S. N. (2020). Nanomaterial regulation and its applications in textile sector: A review. International Journal of Bioresource Science, 7(2), 75-81.