Regulation - EUON
Information And Communications Technology
ICT - Overview - Regulation - Text
Regulatory frameworks applying to the ICT sector tend to focus on electronic communications and networks where nanotechnologies are not directly involved at the current stage of development.
Materials used in ICT are the highly regulated as environmental protection is paramount. Nanoscale materials used in ICT are also covered under nano-specific regulations such as the registers that have appeared in several countries.
European regulations for nanotechnology
Some key regulatory documents within the European Union as a whole and within Member States include:
- Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - 1907/2006(EC)
- European Commission Recommendation on the Definition of a Nanomaterial
|Status||Name of the document||Country/Region||Scope||Nano-specific|
|Implemented||Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - 1907/2006(EC)||EU||Chemicals & Raw Materials||No, but 'substance' covers nanomaterials|
|Implemented||Decree on the annual declaration on substances at nanoscale - 2012-232||France||Substance at the nanoscale||Yes|
|Implemented||European Commission Recommendation on the Definition of a Nanomaterial||EU||Substance at the nanoscale||Yes|
|Implemented||Royal Decree regarding the Placement on the Market of Substances manufactured at the Nano-scale||Belgium||Substances manufactured at the nanoscale||Yes|
|Implemented||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||Denmark||Nanomaterials||Yes|
In the European Union, ICT is regulated under the European framework directive for Electronic communications and is mostly oriented towards the provision of network services and international trade. This regulatory framework does not address the uses of nanotechnology in ICT.
Nanomaterials used to make or improve ICT must comply with the overarching regulatory framework in place for chemical substances. ICT innovations using nanotechnologies also 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.
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.’ This directive also states that the European Commission should 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 directly addressed in this annex.
The RoHS2 directive restricts the use of hazardous materials for electronic and electronical materials and mentions nanomaterials. In the absence of scientific evidence concerning nanomaterials 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, under this methodology nanomaterials are not prioritised but assessors are still invited to be cautious when dealing with such substances. An exemption from restriction is ongoing for the use of cadmium quantum dots (CdQD) in illumination and display lighting applications, this exemption is however subject to debate in the European Parliament.
Some ICT applications may have both military and civil purposes; such goods are subjected to the EU Regulation setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items (428/2009). This text is set in the context of the international regime known as the Wassenaar Arrangement. Trade of dual use goods is restricted and requires an authorisation from national authorities, dual use goods are identified in a ‘dual use list’ where ICT is addressed in Categories 3 (Electronics), 4 (computers) and 5 (Telecommunications and information security). Some nanotechnology applications appear in the dual use list; under Electronics, ‘nano-imprint lithography tools capable of producing features of 95nm or less (3.B)‘ are per example submitted to dual use rules.
Nano-specific regulations may also apply. The European Union is well-advanced but not alone in seeing the need for greater scrutiny on the use of nanotechnologies. With the first Regulatory Review on Nanomaterials SEC (2008) 2036 and the Second Regulatory Review on Nanomaterials SWD (2012) 288 final, the EC has given Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) a central role in regulating nanomaterials. “There are no provisions in REACH referring explicitly to nanomaterials. However, nanomaterials are covered by the ‘substance’ definition in REACH”, states the 2008 Communication. A third Regulatory Review is planned in 2016.
Since the summer of 2013, there has been ongoing work to adapt the Annexes of REACH to specifically address nanomaterials; an impact assessment and a large consultation on this issue have been run by the European Commission but discussions are still ongoing.
To facilitate regulation, inter alia, a definition of nanomaterials has been defined by the European Commission in its Recommendation on the Definition of a Nanomaterial - 2011/696/EU. This non-binding document has also been used by other pieces of regulation to define the term ‘nanomaterial’.
The definition is the following:
“2. ‘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 table below lists some key regulatory documents within the European Union as a whole and within Member States. Nano-specific regulations may come into force at different stages of the production process (e.g. at the manufacturing stage of a batch of nanomaterials with uses in various sectors including ICT).
There are also efforts underway within the research community to develop a testing strategy for engineered nanomaterials. These include the ITS-NANO project under FP7-NMP which seeks to establish a roadmap for the development of advanced tools and databases that help to assess the risks through knowledge-based decision making.(1)
While the European Union has been developing a regulatory framework for nanomaterials under REACH, some European Member States (as in the table above) have sought to find additional ways to regulate nanotechnologies e.g. through databases and reporting schemes for nanomaterials.
Under the Belgian Presidency of the European Union, in 2010, the European Union 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, signed by 10 then European Member States, plus Croatia.
The French Grenelle Acts (Lois Grenelle I & II) led to the creation of a mandatory reporting scheme for nanomaterials. In 2012, the Decree(2) 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 Belgian FPS (Public Health, Food Chain Safety and Environment) has also 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(3). The registration of substances will begin from 1 January 2016, while mixtures will have to be registered from 1 January 2017.
In June 2014, 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. With this Order, the Ministry of the Environment created a national mandatory database of nanomaterial-containing products that will register the first products (for 2014) in 2015.
Norway is considering such a nanomaterials register under its Pollution Control Authority (SFT). From 2013, the Norwegian Product Register requires information for chemicals containing ‘a substance in nano form’ with a ‘tickbox’ system. Sweden has given the mandate to its chemical agency (KEMI) to develop a reporting scheme and Italy is also considering setting up a similar system.
Nanotechnology regulation in the rest of the world
The European RoHS2 and WEEE directives enacting restrictions for the use of certain hazardous materials are applied in ICT have been adapted in numerous countries outside of Europe (i.e. Argentina, China, Vietnam, the State of California, India, etc.). The Japanese authorities have taken a slightly different approach and did not introduce restrictions but labelling requirements. These do not specifically target nanomaterials.
In the United States of America, the Toxic Substances Control Act (TSCA) is the main chemical regulation. The US Environmental Protection Agency (EPA) is in charge of adapting 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’.
In Canada, Health Canada and Environment Canada have been looking at similar approaches and requires manufacturers and importers to register information on a selection of 206 substances at the nanoscale under the Canadian Environmental Protection Act (CEPA 1999).
European products are also subject to regulatory frameworks in other countries if they are to be marketed abroad. Marketing authorisations have to be applied for in each region or country and there are considerable differences between, for example, the US (implemented by the FDA(4)), Canada, Australia, China and Japan.
- 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
- 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
- US Food and Drug Administration http://www.fda.gov/