Regulation - EUON
Environment - Overview - Regulation - Text
The European Union regulatory framework for environmental protection covers the use of nanotechnologies in a number of acts. These have been designed by the Environment Directorate-General of the European Commission which has also dedicated specific efforts to the assessment of the regulatory framework on nanomaterials. Two regulatory reviews in 2008 and 2012, which may be followed by a third regulatory review in 2016, have assessed the role of different pieces of regulation and set targets for further steps.
The regulatory reviews have confirmed the overarching regulatory framework in place for chemical substances as the main act to regulate nanomaterials: Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). “There are no provisions in REACH referring explicitly to nanomaterials. However, nanomaterials are covered by the ‘substance’ definition in REACH”, states the 2008 Communication. In 2012, the Commission reiterated the statement and committed to modify the REACH annexes while inviting the European Chemicals Agency (ECHA) to develop further guidance regarding nanomaterials.
Since the summer of 2013, there has been ongoing work to adapt the Annexes of REACH to specifically cover nanomaterials; an impact assessment and a large consultation on this issue have been run by the European Commission but discussions are still ongoing. The rules of ECHA however prevent the modification of the regulation two years prior to the next round of registration which is set in June 2018. A modification of the REACH annexes is therefore very unlikely before that date. This rule also applies to guidance documents that the Agency provides to support registrants; in 2016, ECHA nevertheless announced that four guidance documents related to nanomaterials would be released in May 2017, one year prior to the next registration deadline. These are:
- Guidance on Nanoforms
- Guidance on information requirements for nanomaterials for human health
- Guidance on information requirements for nanomaterials for the environment
- Guidance on read-across for nanoforms.
Recommendation on the definition of a nanomaterial
One of the milestones of the European regulatory framework for nanotechnologies is the European Commission Recommendation on the Definition of a Nanomaterial (2011/696/EU). This non-binding document has been used by other pieces of regulation that needed to define the term ‘nanomaterial’.
The definition is the following:
“ ‘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 %.”
Developed in 2011, this definition is undergoing a review process that should have been concluded in December 2014; an outcome of this review could be a revision of the definition. The process of review of this definition is still ongoing.
Biocidal product regulation
Nanomaterials are also covered in the Biocidal Product Regulation (BPR) (EU/528/2012). Applicable since 1 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 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.
Other environmental regulations
While considering that ‘all environmental regulation reviewed could be considered to address nanomaterials in principle’, the second regulatory review states that classifications under the Regulation for the Classification and Labelling and Packaging of Substances and Mixtures (CLP) EU/1272/2008 are the main trigger of pollutant identification.
The Second Regulatory Review was supported by a Review of Environmental Legislation for the Regulatory Control of Nanomaterials. Conducted in 2011 by the environmental consultancy Milieu, the study had a specific look at nanomaterials in environmental regulation; a thorough analysis of the following pieces of legislation was undertaken:
- Waste Framework Directive 2008/98/EC
- Decision 2000/532/EC on the List of Waste
- Directive 2000/53/EC on end-of-life vehicles
- Landfill Directive 1999/31/EC
- WEEE Directive 2002/96/EC
- Directive 2002/95/EC on RoHS
- Packaging and Packaging Waste Directive 1994/62/EC
- Directive 86/278/EEC on the protection of the environment, and in particular of the soil, when the sewage sludge is used in agriculture (Sewage sludge Directive)
- Water Framework Directive 2000/60/EC
- Directive 2008/105/EC on EQS in the Field of Water Pollution
- Directive 2006/118/EC on the protection of groundwater against pollution and deterioration
- Urban Waste Water Directive 91/271/EEC
- Drinking Water Directive 98/83/EC
- Directive 96/82/EC on the control of major-accident hazards involving dangerous substances (Seveso II Directive)
- Air Quality Directive 2008/50/EC
- Regulation (EC) No 66/2010 on the EU Ecolabel
In principle, the consultants found that nanomaterials fall under these regulations. However, the report notes that only a few of the aforementioned acts list or precisely refer to these substances; these are:
- The WEEE Directive 2002/96/EC, this directive requires the European Commission to consider nanomaterials when reviewing Annex VII - Selective treatment for materials and components of waste electrical and electronic equipment referred to in Article 8(2) of the Directive. At the moment, nanomaterials have not been addressed in this annex.
- The Directive 2002/95/EC on RoHS, this directive revised in 2011 as the Directive on the restriction of the use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS2) - 2011/65/EU. RoHS2 restricts the use of hazardous materials for electronic and electronical materials and mentions nanomaterials. In the absence of scientific evidence that nanomaterials have hazardous properties, the European institutions are invited to consider such substances during the process of reviewing Annex II – List of Restricted Substances. Between late 2012 and June 2014, Environment Agency Austria (Umweltbundesamt) had been tasked with writing up a methodology for the review of the List of Restricted Substances under RoHS2. This methodology does not prioritise nanomaterials, but assessors are still invited to be cautious when dealing with such substances.
- The Regulation (EC) No 66/2010 on the EU Ecolabel sets the rules for the award of the European environmental quality ‘ecolabel’. It excludes products containing hazardous substances but has no rules regarding nanomaterials. However, in 2014, a decision by the European Commission excluded nanosilver from eligibility for the EU Ecolabel for rinse-off cosmetic products. Other decisions have added requirements for information regarding the state and physical form of substances used in the final product.
In addition, a specific study was commissioned by the EU to tackle the coherence of waste legislation. Compiled in 2011 by Bio Intelligence Service, the study lists nano-waste as one of the waste streams with potentially inadequate coverage. The report also features a section dedicated to nanomaterials and considers that “adaptation of EU waste policy might be required in the future to take into account possible new risks identified”.
While regulations covering cosmetic products, food contact materials and novel foods also target nanomaterials, these do not address environmental issues.
While the EU has been developing a regulatory framework for nanomaterials under REACH, some European Member States have sought to find additional ways to define and regulate nanotechnologies. In recent years, databases and reporting schemes for nanomaterials have been developed in Europe. Whilst these are not specific to the market sector covered by this report, they are still relevant to the regulation of nanotechnologies.
Under the Belgian Presidency of the European Union, in 2010, the EU has opened the discussion on a “harmonised database of nanomaterials”; it was followed by a 2012 letter to the European Commission calling for a European Reporting Scheme and signed by 10 EU Member States, plus Croatia. The European institutions are still weighing the pros and cons of such a reporting scheme; nevertheless, some EU Member States have been going forward.
The Belgian FPS (Public Health, Food Chain Safety and Environment) has been working on a similar scheme: in February 2014, the Belgian Council of Ministers validated the Royal Decree regarding the Placement on the Market of Substances manufactured at the Nano-scale (Koninklijk besluit betreffende het op de markt brengen van als nanodeeltjes geproduceerde stiffen or Arrêté royal relatif à la mise sur le marché des substances manufacturées à l’état nanoparticulaire). The registration of substances began on 1 January 2016, while mixtures will have to be registered from 1 January 2017.
The definition of nanomaterials used is that of the EC Recommendation 2011/696/EU, but excluding naturally occurring and incidental nanomaterials, as well as pigments. Also excluded are nanomaterials which fall under other EU legislation (e.g. biocides, food products).
Following a public consultation, the Danish Order on a Register of Mixtures and Articles that contain Nanomaterials as well as the Requirement for Manufacturers and Importers to report to the Register - BEK nr 644 came into force in June 2014. With this Order, the Ministry of the Environment creates a national mandatory database of nanomaterial-containing products that will register the first products for the year 2014 in the year 2015. The definition of nanomaterials included in the executive order follows the European Commission definition.
Certain activities or products are excluded from the registration requirement: nano-products sold between businesses and products that fall under specific regulations (e.g. food, feed, pharmaceuticals, medical devices, cosmetics, pesticides and waste). The following specific products in which nanomaterials are used are also excluded:
- Nano-sized products of substances in REACH Annex V
- Products where the material is not consciously produced in nano-size
- Products where the nanomaterial is in a fixed matrix
- Products where the nanomaterial is used as printing ink directly on the product or on labels on the product
- Textiles where the nanomaterial is used as printing ink or to colouring of the textile
- Paints and wood protection products containing titanium dioxide where the sole purpose for the titanium dioxide is to colour the product
- Products of rubber or rubber parts that contain the nanomaterials carbon black or silicon dioxide.
- Products imported for private use
- Products used for research and development
As part of the electoral promises of the 2007 Presidential Elections, the ‘Grenelle de l’Environnement’, a large environmental debate was organised in France and resulted in major environmental acts: Grenelle Acts (Lois Grenelle I & II) which enacted the future creation of a mandatory reporting scheme for nanomaterials. France hence took steps towards setting up the first registration scheme for substances at the nano-scale in Europe; in 2012, the Decree9 on the annual declaration on substances at nano-scale - 2012-232 was published; it came into force on 1 January 2013. It grants to the French Agency for Food Safety, the Environment and Labour (ANSES) the authority to collect “information from a production, distribution, import of nano-scale substances of 100 grams”. The French legislation refers to, and is applicable to, substances as defined in article 3 of EC Regulation no. 1907/2006 (REACH), that are intentionally produced at nanometre scale, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for a minimum proportion of particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm. Furthermore: "in specific cases and where warranted by concerns for the environment, health, safety or competitiveness, this minimum proportion may be reduced".
A Joint Order (Ministerial Order of 6 August 2012) issued by the Ministers of environment, agriculture, health labour and industry states that “The minimum proportion of the number size distribution is specified to be 50%”.
Other EU Member States
Other EU Member States have been considering options for a registration scheme for nanomaterials. Sweden has given the mandate to its chemical agency (KEMI) to develop a reporting scheme; in the spring of 2016, KEMI declared that it aimed at establishing a Swedish registry in 2019 which would register manufactured and imported quantities during 2018. Italy is also considering setting up a similar system.
With these initiatives, EU Member States have been pushing the European Commission to act; the Second Regulatory Review on Nanomaterials of 2012 included an impact assessment of potential transparency measures which include approaches similar to the reporting schemes set in action in several Member States. The Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market was led by consultancies Risk & Policy Analysis (RPA) and BiPRO; three reports were published to help the EC decide on an eventual EU-wide registry of nanomaterials. Early in 2016, the European Commission has stated that it will not go forward with an EU-wide nanomaterial registry but would rather support the establishment of a knowledge base entitled the ‘nanomaterials observatory’ which would contain publically available information on nanomaterials and their use in Europe.
Regulation and standards in the rest of the world
Environmental protection is the main driver for the development of regulation directed to nanomaterials.
Other European countries
Norway developed a register under its Pollution Control Authority (SFT). From 2013, chemical products must be registered in the Norwegian Product Register of Chemicals at the Norwegian Environment Agency, which includes chemicals that are classified as dangerous, and whose quantity produced in/imported to Norway and/or placed on the market each year is 100 kg or more. Registrants are required to provide information on chemicals containing “a substance in nano form” with a ‘tickbox’ system
If the chemical contains nanomaterials this must be declared in the registration, and information on any substance in nano form must be given for all mandatory declared chemicals, including the identity of the constituent that is in nano form. Only intentionally added nanomaterials need to be registered in the Norwegian Product Register of Chemicals, and the definition of nanomaterials follows the EC Recommendation 2011/696/EU.
The Swiss Secretariat for Economic Affairs (SECO) published a guideline document for the compilation of safety data sheet for synthetic nanomaterials, with as definition:
“A material whose particle size distribution includes over 1% nanoparticles (1-100 nm) in an unbound state, either as an aggregate or as an agglomerate. Fullerenes, graphene flakes and single-wall carbon nanotubes are classed as nanomaterials even if they have dimensions of less than 1 nm. Should the particle size distribution not be known, then any material with an average grain size less than 500 nm will be classed as a nanomaterial”
The definition adopted, as explained in the guideline, is mainly based on the definitions of nanomaterial of the 2011/696/EU Recommendation1 and on the ISO definition CEN ISO/TS 27687.8 The differentiation between nano-particles, nano-fibres and nano-plates and the definition of agglomerates and aggregates (not cited here) are adopted from the ISO definition.
Two important aspects of this definition: the percentage used for the particle size distribution (1% versus 50% of the EC recommendation) and the 500 nm upper size limit to be used when the PSD is unknown. The adoption of 500 nm as upper size limit is justified by the following considerations: a) in size distributions of manufactured nanomaterials (MNM) with a maximum at 500 nm, a large fraction of the MNM can still be in the low nm range; b) potential nano-specific interaction with cells can occur for sizes < 300 nm.
United States of America
In the United States of America, the Toxic Substances Control Act (TSCA) is the main chemical regulation. The US Environmental Protection Agency (EPA) is leading the adaptation of this regulation to nanoscale materials (the US authorities have decided not to write a binding definition of a nanomaterial). The latest regulatory initiative was taken by US EPA in April 2015 with the publication of a proposed rule for section 8 (a) of TSCA. This proposal would introduce reporting and recordkeeping requirements for nanoscale materials as well as a 135-days pre-notification requirement for the manufacturers of “chemical substances as discrete nanoscale materials”. The inclusion of a new rule addressing nanomaterials under TSCA is intended to be promulgated in the fall of 2016.
In Canada, Health Canada and Environment Canada require manufacturers and importers to register information on a selection of 206 substances at the nanoscale under the Canadian Environmental Protection Act (CEPA 1999). Health Canada published a "Policy Statement on Health Canada's Working Definition for Nanomaterials" (2011).
The Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS) covers nanomaterials: nanoforms of substances in the Australian Inventory of Chemical Substances may be used and introduced in Australia while nanomaterials that are “new substances” are submitted to notification and assessment procedures. It is worth noting that the Australian regulations rely on a NICNAS working definition of “industrial nanomaterial” which reads as follows:
“…industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale)”.
In 2016, NICNAS published a consultation on its reform initiative. The publication includes criteria for classifying materials as hazardous if it is a nanomaterial. This reform initiative also suggests that safety data sheets are provided to workers handling nanomaterials (even if they are not classified as hazardous substances) and that nanomaterials are labelled as “caution: hazards unknown” or “caution: hazards not fully characterised”.
The Republic of South Korea has established the "National Nano-safety Strategic Plan (2012/2016)". The Ministry of Knowledge and Economy and the Korean Agency for Technology and Standards, published in 2011 a "Guidance on safety Management of Nano-based products", (Korean Agency for Technology and Science Public Notice No.2011-0108 of 12 May 2011).
Taiwan (Chinese Taipei)
Under the Council of Labour Affairs, Taiwan addresses nanomaterials within the context of Chemical Substance Nomination & Notification (2012).
Efforts to regulate nanomaterials are harmonised globally at the Organisation for Economic Co-operation and Development (OECD). Under the Working Party on Manufactured Nanomaterials, the OECD has a testing programme on manufactured nanomaterials. The organisation promotes its system of Mutual Acceptance of Data and develops Guidelines for the Testing of Chemicals that specifically address endpoints adapted to nanomaterials.
SEE ALSO UNDER STANDARDS
 European Commission. 2008, Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Regulatory aspects of nanomaterials [SEC(2008) 2036]. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0366:FIN:en:PDF
 European Commission. 2012, Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Second Regulatory Review on Nanomaterials. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0572:FIN:en:PDF
 European Commission. 2014, Commission Decision of 9 December 2014 establishing the ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products (notified under document C(2014) 9302). Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2014.354.01.0047.01.ENG
 European Commission. 2012. Commission Decision of 14 November 2012 establishing the ecological criteria for the award of the EU Ecolabel for Industrial and Institutional Automatic Dishwasher Detergents. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012D0720-20121201 and European Commission. 2012. Commission Decision of 14 November 2012 establishing the ecological criteria for the award of the EU Ecolabel for Industrial and Institutional Laundry Detergents (notified under document C(2012) 8055). Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012D0721-20121201
 Bio Intelligence Service, 2011, Study on coherence of waste legislation – Final Report, DG ENV. Available at: http://ec.europa.eu/environment/waste/studies/pdf/Coherence_waste_legislation.pdf
 Décret n° 2012-232 du 17 février 2012 relatif à la déclaration annuelle des substances à l'état nanoparticulaire pris en application de l'article L. 523-4 du code de l'environnement
 This legislation was reformed in 2013 with the Toxic Chemical Substance Control Act (TCSCA) but, at the moment, it is not clear how nanomaterials will be affected