Regulation - EUON
Construction - Overview - Regulation - Text
The use of nanotechnology in construction has implications for three main areas of regulation: construction products; occupational health and safety aspects of construction work; and compliance with environmental performance legislation for new construction.
Regulation in the European Union
In Europe, construction products are covered by the Construction Products Regulation (CPR) 305/2011. This legislation establishes the European rules for marketing construction product. It contains provisions on the CE marking of construction products, and sets up a system of notified bodies as well as a system of harmonised technical specifications for construction products.
CPR defines a construction product as follows:
Article 2(1): A ‘construction product’ means any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works.
This regulation evaluates the environmental impact of construction products but does not specifically cover nanomaterials. Nanomaterials used in construction must also 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), and CPR specifically refers to REACH. However, recital 25 of the CPR states that ‘the specific need for information on the content of hazardous substances in construction products should be further investigated with a view to completing the range of substances covered so as to ensure a high level of protection of the health and safety of workers using construction products’.
With the first Regulatory Review on Nanomaterials SEC (2008) 2036 and the Second Regulatory Review on Nanomaterials SWD (2012) 288 final, the European Commission has given 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 EC 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 cover nanomaterials. An impact assessment and a large consultation on this issue have been run by the European Commission but discussions are still ongoing. However, the rules of ECHA (the European Chemicals Agency) prevent the modification of the regulation two years prior to the next round of registration, which is set for 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
One of the milestones of the European regulatory framework 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 with a planned conclusion date of December 2014. An outcome of this review could be a revision of the definition. The process of review of this definition is still ongoing.
Construction workers are also covered by occupational health and safety legislation. Under the European Framework Directive on Safety and Health at Work (Directive 89/391 EEC), employers are required to assess and manage the risks of nanomaterials for their workers. While nanomaterials are not expressly covered by the directive, the European Agency for Safety and Health at Work (EU-OSHA), dedicates a part of its work to nanomaterials.
In 2013, the Agency published E-Fact 74 Nanomaterials in Maintenance Work: Occupational Risks and Prevention. A fact sheet on the use of nanomaterials in maintenance work which according to which it ‘could be the main activity for construction workers’. The fact sheet notes the lack of information on nanomaterials accessible to workers on Safety Data Sheets, depending directly on REACH and CLP.
Finally, the building industry must comply with the Energy Performance of Buildings Directive –EPBD (2010/31/EU) and the Energy Efficiency Directive (2012/27/EU). With this directive, the European Union set a target for all new buildings to be nearly zero-energy by the end of 2020. EU Member States are required to set minimum energy performance requirements as well as independent control systems. In order to attain these objectives, the European Regional Development Fund (ERDF) and the European Investment Bank (EIB) support the investment in energy-efficient materials, which may include nanotechnology innovations.
An overview of regulations for nanotechnology use in Europe is given below, followed by information about nanoregistries.
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|
While the European Union has been developing a regulatory framework 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 has 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 and signed by ten European Member States, plus Croatia. The European institutions are still weighing up the pros and cons of such a reporting scheme. Nevertheless, some European Member States have been proceeding.
In addition, as part of the electoral promises of the 2007 French Presidential Elections, the ‘Grenelle de l’Environnement’, a large environmental debate was organised in France and resulted in two major environmental acts, the Grenelle Acts (Lois Grenelle I & II), that 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: 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 2015 report of r-nano identified 122 declarations referring to the use code su19, Building and Construction work. This represents 0.81% of the total registrations that year.
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. 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.
Other EU Member States and associated countries have been considering options for a registration scheme for nanomaterials. Norway is considering such a register under its Pollution Control Authority (SFT). Since 2013, the Norwegian Product Register has required 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 leading the way and encouraging 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 RPA and BiPro. Three reports were published to help the EC to 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 in the rest of the world
No country has currently developed specific legislation to cover the use of nanomaterials in construction.
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 record-keeping 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 Autumn 2016.
The 2013 American Occupational Safety and Health Administration fact sheet on Working Safely with Nanomaterials states that nanomaterials fall under OSHA Construction Standards.
In Canada, Health Canada and Environment Canada have been looking at similar approaches. 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).
 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
 Ministère de l’Environnment de l’Energie et de la Mer. 2015, Bilan 2015 des déclarations des substances importées, fabriquées ou distribuées en France en 2014. Available at ; http://www.developpement-durable.gouv.fr/IMG/pdf/Rapport_public_R-nano_2015.pdf