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Presentations from EU event 'Towards a regulatory framework for nanomaterials' available for download
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(Nanowerk News) The Belgian Presidency of the Council of the European Union organized a high level
event on September 14, 2010, bringing together representatives of various associations (consumers,
environmental protection, workers, industrial federations), scientists, regulatory experts as well as national and
European regulatory bodies, in order to review the legislative initiatives in progress with regard to nanomaterials and to establish an operational framework for the management of incidents in the short term and to achieve improved risk management in the long term.
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PRESIDENCY CONCLUSIONS
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TAKING INTO ACCOUNT:
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the European strategy for nanotechnology and the nanotechnology Action Plan ("Towards a European Strategy for Nanotechnology" COM(2004) 338)
that the 10/042008 European Parliament resolution concerning the 6th Environment and Health Action Plan (EHAP) mid-term evaluation highlights the information to citizens as a priority and supports a labelling system for helping consumers to "make the right choice";
that EU cosmetics legislation makes compulsory to indicate nanomaterials in the list of ingredients;
that the 6th EHAP mid-term review highlights nanotechnology as an emerging issue and the Commission 6th EHAP progress report calls for more research into adverse effects of nanoparticles;
that the Parma Declaration (WHO/Europe fifth Ministerial Conference on Environment and Health, Parma, Italy, 2010) calls for an increase of research regarding nanomaterials, in order to evaluate possible harmful exposures, expresses the will to develop and use improved health risk and benefit assessment methods, and qualifies nanoparticles as one of the key environment and health challenges of our time;
the European Parliament resolution of 24 April 2009 on regulatory aspects of nanomaterials stating that, due to the lack of appropriate data and methods, the current legislation is actually unable to address the nanomaterials risks;
the work that is being done by the Commission, ISO and SCENIHR in order to arrive to a definition of nanomaterials;
that the EU SCENIHR scientific committee reported on nanomaterials and nanotechnologies issues (about risk assessment, in 2006, 2007 and 2009; about the scientific aspects of definitions in 2007 and 2010);
the efforts made at the OECD WPMN (Working Party on Manufactured Nanomaterials) towards the generation of data on high-volume nanomaterials and towards the establishment of guidelines for nanomaterials characterization and testing will contribute in the long term to nanosafety improvement;
the ongoing reflexions of the European Commission (COM) regarding the REACH and CLP implementation for nanomaterials, and the preparation of a response to the European Parliament resolution of 24 April 2009;
the efforts made at the EU level by industry, Member States (MS), and the COM regarding expertness, data and materials supply in the framework of the REACH Competent authorities subgroup on nanomaterials, the REACH implementation projects on nanomaterials, the reference Nanomaterials Repository and the NAPIRAhub Database at the JRC;
the variety of proposals being put forward by MS and various stakeholders to close the gaps for nanomaterials in REACH and CLP regulations, either trough reviewing, adaptation, new guidances or additional complementary or interim regulationsii.
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AND HIGHLIGHTING:
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the lack of specific measures for nanomaterials in the majority of the current EU legislation framework;
that the ongoing reflexions of the COM regarding nanomaterials leave many unaddressed issuesiii and that REACH and the existing databases give no specific information on the presence of nanomaterials in products;
that the views about the way to go forward towards a high level of protection of the health and environment differ: some advocate for immediate specific measures while others prefer the option of a review and adaptation of the existing legislation;
that nanomaterials voluntary reporting schemes have been experimented in various MS and around the world, with limited results, and that national compulsory declaration measures are being taken in France and are examined in Italy, Belgium and the Netherlands;
that national measures may lead to a fragmented internal market;
the interest shown by a part of the nanotechnology sector for a database of raw nanomaterials and products containing them;
that there is a strong demand from many stakeholdersiv for transparency and information regarding nanomaterials as well as for registration and labelling of nanomaterials, in order to protect the health of the workers, consumers and citizens as well as the environment;
that compulsory information to the public about the presence of nanomaterials in products is a way to regulate false claims and avoid unfair commercial practices;
the imbalance between the low level of investments in environment and health safety research as compared to the high investments in the technological development;
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THE PRESIDENCY CONCLUDES THAT, IN ORDER TO
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protect the workers, consumers health and the environment, and at the same time guarantee the development of
a secure and sound economy based notably on innovation and societally acceptable industrial applications that
create quality jobs,
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THE FOLLOWING OBJECTIVES MUST BE REACHED, IN RELATION TO NANOMATERIALS, PRODUCTS CONTAINING NANOMATERIALS AND NANOTECHNOLOGIES:
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1) REGARDING THE REGULATORY FRAMEWORK:
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to effectively address their potential risks and uncertainties, at the earliest, and thus ensure a high level of environment and health protection;
to consider their challenges transversally, across sectors, disciplines and regulations;
in parallel, to implement specific regulatory measures to deal with their particularities;
to appropriately inform and consult consumers, workers and citizens;
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2) REGARDING SCIENCE, RESEARCH, INNOVATION AND KNOWLEDGE:
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to develop the necessary scientific knowledge in a global, coordinated and open manner;
to be proactive and to anticipate when dealing with the risks and uncertainties of new technological developments.
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IN CONSEQUENCE, THE FOLLOWING ACTIONS HAVE TO BE TAKEN:
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to take up responsibilities at the Member States level and, during a transitory period, draw up coordinated and integrated national strategies and concrete measures in favour of risk management, information and monitoring;
to develop urgently a regulatory definition for nanomaterials that must include nanomaterials all along their lifecycle, including into substances, products, articles, wearing residues and waste;
to consider nanotechnology as a priority into a future 2nd Environment and Health Action Plan, including inter alia basic and applied research related to them, their specific potential risks, their traceability and the link between innovation, environment and health safety;
to clarify the various issues that remain presently unaddressed in the Commission proposals to adapt REACH to the nanomaterials and, in addition to the adaptations to the guidances to include significant modifications into the REACH 2012 review, including the lowering of the tonnage triggers for nanomaterials, modifications to data requirements in REACH annexes, consideration of nanomaterials as new substances, annexes V (exemptions) and XIII review (PBT, vPvB) and the inclusion in REACH of a definition of nanomaterials and articles containing nanomaterials;
to increase public and private resources, especially the financial inputs to the OECD WPMN, with the goal of obtaining results to be used for regulatory purposes as soon as possible;
to develop harmonized compulsory databases of nanomaterials and products containing nanomaterials;
such databases must be the base for traceability, market surveillance, gaining knowledge for better risk prevention and for the improvement of the legislative framework;
to take into account, in the design of such databases, the need for providing information to the citizens, workers and consumers regarding nanomaterials and products containing nanomaterials as well as the industry's need for data protection;
claims made on labels of products containing nanomaterials must be regulated and the requirements to inform the consumer of the presence of nanomaterials in consumer products must be defined;
to consider sustainability, societal benefits, demands for public participation, and ethical considerations in the public investments in innovative technologies;
to establish a systematic, balanced and appropriate link between on the one hand the assessment of risk, early warnings and uncertainties and on the other hand the public investments in innovative technologies in general and nanotechnologies in particular, including financing mechanisms that take such a link into account;
to consider research in toxicology and ecotoxicology of nanomaterials, as well as their fate along the whole lifecycle as a high priority.
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NOTES
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i) The program and conference presentations are available at:
http://www.health.belgium.be/eportal/Aboutus/eutrio/environment/Nanomaterials/index.htm?fodnlang=en
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ii) Amongst others, the following options are considered: - allow CLP rules to classify substances as nanomaterials, and implement an inventory based on this information; - a mandatory reporting scheme for nanomaterials to close the gaps in REACH and CLP regulations; - consider all nanomaterials as new substances under REACH; - the Commission evaluates the need for review REACH concerning : simplified registration for nanomaterials below 1 ton/y, consideration of all nanomaterials as new substances, a chemical safety report with exposure assessment for all registered nanomaterials, notification requirements for all nanomaterials placed on the market on their own, in preparations or in articles.
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iii) Various issues remains unaddressed in the present REACH review process by the COM: - which is the usefulness of a notification if at the same time a registering is made compulsory? - what is the exact meaning of a simplified registration and its consequences on need to develop a chemical safety report? - which is the applicability of annex XIII to nanomaterials? - some nanomaterials are exempted from various REACH titles through the annex V provisions: when a nanoform of substance in annex V appears in the market, the exemption should be deleted from annex V; - prioritization of completeness and content evaluation for substances which are (also) produced and used in a nanoform); - ECHA advocates that the use of REACH-IT data is limited to the framework of the EU legislation, while those data are potentially useful at the national level for environment and health protection
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iv) As indicated by many speakers at the high level event as well as by the results of a public consultation organised by the Commission in May 2010
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