Regulation - EUON
Transport - Overview - Regulation - Text
Legislation and regulation of transport is mainly based on a broad and well-established framework that covers all aspects of transportation from the manufacture of vehicles and the construction of infrastructure to the end of life of these vehicles. In this mature sector, the use of nanomaterials is not incorporated in the transport regulations of the relevant authorities. They rely rather on the adaptation of regulations for chemicals to the use of nanomaterials.
Regulation in the European Union
Transport is one of the key policies of the European Union and is featured in Title VI – Transport of the Treaty on the Functioning of the European Union. The Directorate General for Mobility and Transport has the main responsibility for European transport policy, a dense package of directives and regulations. These never directly address the use of nanotechnologies in the final products.
The reuse and recycling of vehicles, for example, is mainly regulated by the End of Life Vehicles Directive (Directive 2000/53/EC - the "ELV Directive", amended in 2008) of the European Commission. It restricts the use of some substances and includes targets for the recycling and reuse of vehicles, but no provision in this directive targets nanomaterials. The ELV directive is supported by Directive 2006/66/EU on Batteries and Accumulators and Waste Batteries and Accumulators, amended in 2013, which also does not cover nanomaterials.
Nanomaterials used in transportation must comply with the overarching regulatory framework in place for chemical substances: Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Electronic items used in vehicles and incorporating nanomaterials may 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. Currently, nanomaterials are not addressed in that annex.
The RoHS2 directive restricts the use of hazardous materials for electronic and electrical materials and mentions nanomaterials. In the absence of scientific evidence concerning any hazardous properties of nanomaterials, use can also be made of an associated annex: Annex II – List of Restricted Substances. Between late 2012 and June 2014, the Environment Agency of Austria (Umweltbundesamt) was tasked with formulating a methodology for the review of the List of Restricted Substances under RoHS2, under which methodology nanomaterials are not prioritised but assessors are still invited to be cautious when dealing with such substances.
For articles containing nanomaterials that are used in road vehicles, only electrical or electronic articles that can be bought separately and that are not specifically designed to be used in vehicles1 would be covered by the RoHS Directive.
Regulations specific to nanotechnology
Nano-specific regulations may also apply. The EU is actively developing a set of regulations around nanotechnology. 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 also been ongoing work to adapt the Annexes of REACH to specifically cover nanomaterials. An impact assessment and a wide consultation process on this issue has taken place and discussions are still ongoing. However, the rules of ECHA (the European Chemicals Agency) prevent the modification of the regulation during the two years prior to the next round of deadlines for registration (June 2018). 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
One of the milestones of the European Regulatory Framework for nanotechnologies is the European Commission Recommendation on the Definition of a Nanomaterial. This non-binding document has been used by other pieces of regulation that needed 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 (which was scheduled to reach its conclusion in December 2014). One outcome of this review could be a revision of the definition. The process of review of this definition is still ongoing.
While a regulatory framework has been under development for nanomaterials under REACH, some European Member States have sought to find additional ways to 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 European Union opened the discussion on a 'harmonised database of nanomaterials’. This was followed by a 2012 letter to the European Commission calling for a European Reporting Scheme, signed by ten European Member States, plus Croatia. The European institutions are still weighing the pros and cons of such a reporting scheme. Nevertheless, some European Member States have been moving forward on this.
In addition, 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: the 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 Decree on the annual declaration on substances at nano-scale - 2012-232 was published and 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 grammes”.
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 (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.
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. Under this Order, the Ministry of the Environment is creating a national mandatory database of nanomaterial-containing products, registering the first products for the year 2014 in the year 2015.
Other EU Member States have been considering options for a registration scheme for nanomaterials e.g. Norway, 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. In the spring of 2016, KEMI declared that it aimed to establish 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 a 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.
The table below lists some key regulatory documents within the European Union as a whole and within Member States.
Table: Overview of regulations for nanotechnology use in Europe
|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||European Commission Recommendation on the Definition of a Nanomaterial||EU||Substances at the nanoscale||Yes|
|Implemented||Decree on the annual declaration on substances at nano-scale - 2012-232||France||Substances at the nano-scale||Yes|
|Implemented||Royal Decree regarding the Placement on the Market of Substances manufactured at the Nano-scale||Belgium||Substances manufactured at the nano-scale||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 no. 644||Denmark||Nanomaterials||Yes|
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.
Regulation in the rest of the world
Similarly to Europe, countries across the planet have not developed nano-specific regulations in their transport policy.
The European legislation that may be applied to vehicles in Europe: the RoHS2 and WEEE directives enacting restrictions for the use of certain hazardous materials have been adapted in numerous countries outside of Europe (i.e. Argentina, China, Vietnam, the State of California, India etc.), but 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’. 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 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 Commission, Frequently Asked Questions on Directive 2002/95/EC on the Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) and Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE), available at http://ec.europa.eu/environment/waste/pdf/faq_weee.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