Monday, December 28, 2009

Overview of European Activities for the Regulation of Industrial Nanomaterials




At this point in time little is known about the potential effects of nanomaterials and there are still many uncertainties about the health and safety aspects of nanotechnologies,” Stavros Dimas, European Commissioner for the Environment, October 2009 speech “Nanotechnologies… challenges for the future.” 

The table shows a European Union schedule for registration of nanomaterials under the REACH program.


 Image Credit: Maila Puolamaa,“Current information on the market presence of nanomaterials”

The table "Pre-registration/registration of OCED-NMs to ECHA" presents the European Union (EU) schedule to register nanomaterials with the European Chemicals Agency (ECHA), a major EU organization gathering information on the production of nanomaterials as well as the potential implications of  manufactured nanomaterials for human health and environmental safety for the European Union REACH program. 

The EU will begin registering nanomaterials in 2010 and will continue to register materials through 2018.  ECHA has recorded 2.7 million pre-registrations of substances as well as early registrations of some nanomaterials. OECD is the 30 nation member Organization for Economic Co-operation and Development. WPMN is the OECD Working Party on Manufactured Nanomaterials.  There is a global effort to develop standard nomenclature and regulations for nanomaterials

The EU registration effort is part of a longer on-going effort to determine the safety of nanomaterials and the possible need for further regulation. By 2015, nanotechnology will have created 2 million jobs & will generate $1 trillion annual economic activity, according to estimates by the U.S. National Nanotechnology Initiative (NNI)) 

EU government (REACH) approach to regulation of industrial nanomaterials:

REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances. The new law entered into force on 1 June 2007.

The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances.

Stavros Dimas, European Commissioner for the Environment, said in his October 2009 speech, that during the decision process for REACH, the feasibility and cost of its implementation were discussed at length. A fair balance was struck between the administrative cost for the companies and the level of environmental protection.  One of the key elements in this balance was setting the volume threshold for registrations at 1 metric ton – significantly higher than the old legislation which made notification of new substances mandatory from 10 kg.

Today the EU has by far the most advanced chemicals legislation in the world – REACH. REACH is there to ensure a safe use of all chemicals, including nanomaterials. Nanomaterials are, as a matter of principle, covered by REACH under the definition of a chemical substance. The general obligations in REACH therefore apply as for any other substance, even if there are no provisions referring explicitly to nanomaterials.

Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki. The Agency will act as the central point in the REACH system: it will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.

The first registration deadline under REACH (November 30, 2010) applies to substances manufactured or imported at 1000 tons or more per year. The registrations of nanomaterials in this tonnage band will help to generate more information useful for the assessment of risks. The European Chemicals Agency (ECHA) receives the registrations and the Agency plays a central role in the collection, evaluation and dissemination of information on substances and preparations, including nanomaterials.

Moreover, nanomaterials that fulfill the criteria for classification as hazardous under Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures must be classified and labeled. Many of the related provisions, including safety data sheets and classification and labeling apply already today, independently of the tonnage in which the nanomaterials are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous must be notified to ECHA by  January 1, 2011.

In close co-operation with the CARACAL subgroup on nanomaterials ("CASG Nano", composed of Member States and stakeholder experts) the Commission is elaborating advice on how nanomaterials should be managed in accordance with REACH.

The first paper Nanomaterials in REACH pdf - 236 KB[236 KB] provides an overview of how the provisions of REACH apply to nanomaterials. Additional papers are planned on registration and classification and labelling. These papers will be handed over to ECHA for integration into the relevant guidance documents.

Nanomaterials are chemical substances or materials that are manufactured and used at a very small scale (down to 10,000 times smaller than the diameter of a human hair). Nanomaterials are developed to exhibit novel characteristics (such as increased strength, chemical reactivity or conductivity) compared to the same material without nanoscale features.

Hundreds of products containing nanomaterials are already in use. Examples are batteries, coatings, anti-bacterial clothing etc. Analysts expect markets to grow to hundreds of billions of Euros by 2015.

 Nano innovation will be seen in many sectors including public health, information society, industry, innovation, environment, energy, transport, security and space. Nanomaterials have the potential to improve the quality of life and to contribute to industrial competitiveness in Europe.

However, the new materials may also pose risks to the environment and raise health and safety concerns. These risks, and to what extent they can be tackled by the existing risk assessment measures in the EU, have been subject to several opinions from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) http://ec.europa.eu/wel/images/doc_icons/f_pdf_16.gif.

The overall conclusion so far is that, even though nanomaterials are not per se dangerous, there still is scientific uncertainty about the safety of nanomaterials in many aspects and therefore the safety assessment of the substances must be done on a case-by-case basis.

REACH provides an over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a "substance" in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH, such as registration of substances manufactured at 1metric ton or more and providing information in the supply chain apply as for any other substance.

The first registration deadline under REACH (30 November 2010) applies to substances manufactured or imported at 1000 tons or more per year. The registrations of nanomaterials in this tonnage band will help to generate more information useful for the assessment of risks. The European Chemicals Agency (ECHA) receives the registrations and the Agency plays a central role in the collection, evaluation and dissemination of information on substances and preparations, including nanomaterials.

Moreover, nanomaterials that fulfill the criteria for classification as hazardous under Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures must be classified and labeled. Many of the related provisions, including safety data sheets and classification and labelling apply already today, independently of the tonnage in which the nanomaterials are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous must be notified to ECHA by 1 January 2011.

The European Commission has published a communication entitled ‘Preparing for our future: Developing a common strategy for key enabling technologies in the EU’ (Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, COM(2009) 512 final), which outlines the importance of Key Enabling Technologies (KETs) for society and economy: [...] (23rd October 2009) as does Nanotechnologies top the European Commission’s List of Key-Enabling Technologies for Society and Economy.

The European Chemical Industry Council (Cefic) joins ECHA in urging companies to form SIEFs.  Indeed as announced by ECHA on its second stakeholder day, there is no time to waste. One of the first actions to carry out in the SIEF is the appointment of a Lead Registrant (LR). Cefic recommends that the LR is one of the leading companies aiming to register for the first deadline. In order to help companies, Cefic is providing documents and tools to support the SIEF activities.


Other regulatory information may be found in the following links:   

Communication From The Commission To The European Parliament, The Council And The European Economic And Social Committee, Regulatory Aspects Of Nanomaterials

NM in REACH-CLP: http://ec.europa.eu/enterprise/sectors/chemicals/reach/nanomateri
als/index_en.htm

The 2nd Implementation Report for the Action Plan 2004-2009
http://ec.europa.eu/nanotechnology/pdf/comm_2009_0607_en.pdf
http://ec.europa.eu/nanotechnology/pdf/2nd_nano_impl_rep_sec_2
009_1468.pdf

Second Implementation Report 2007-2009
DE | EN | FR http://ec.europa.eu/nanotechnology/images/pdficon_small.gif(54Kb)
Accompanying Staff Working Document (containing detailed information)
EN http://ec.europa.eu/nanotechnology/images/pdficon_small.gif( 534Kb)
The Communication on Regulatory Aspects of Nanomaterials
EN - FR - DE http://ec.europa.eu/nanotechnology/images/pdficon_small.gif( 70Kb)
Accompanying Staff Working Document (summary of legislation)
EN http://ec.europa.eu/nanotechnology/images/pdficon_small.gif( 207Kb)

Information on how EU regulation in general applies to nanomaterials can be found in the Commission Communication on Regulatory Aspects of Nanomaterials
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