reportRegulation & Standards
1 Executive Abstract
The umbrella terms of nanoscience and nanotechnologiesare still not precisely defined, however, one thing which is clear, and which all definitions share, is the ambition to understand and control the fundamental structure and behaviour of matter at the atomic and molecular level. The realm of nanotechnologies is generally agreed to lie within the range of 1 and 100 nanometres. A further restriction of the definition of nanoscience and nanotechnologies is that new functionalities are made available by manipulation of matter at this scale or through specificities of the nano dimensions, where the physical, chemical and biological properties of materials differ from those of the bulk matter. Nanotechnologies promises advances in controlling and manipulating matter and with this promise a vision of novel ways of creating and developing a new generation of products with original features, performances and functionalities.
In the main, nanoscience and nanotechnologies will form part of microsystems and macro devices or materials and thus is termed an enabler of innovations.This enabling character promises to augment innovations in a wide variety of industrial sectors, but creates difficulties in the development of regulations because it is generally part of a system of elements. Thus nanoregulation is an entanglement of nano-specific and sector specific regulation and standards.
Over the past 10 years, anticipation has been rife around the potential benefits nanotechnologies may bring, leading to large resources being poured into the emerging area. Equally anticipation on potential risks of nanotechnologies have become increasingly high on the agenda. With expected risks becoming ever more specific (observe the shift from broad societal changes to concerns about toxicity, privacy, transparency etc.) and the nano-enabled products on the market increasing at a rapid pace, the need to embrace the complexities of regulation of nanotechnologies as they emerge has become apparent.
With little alignment in regulatory stances from the many potential stakeholders, there is a general feeling that a regulatory framework needs to be in place both to enable and check developments in nanotechnologies to create socially beneficial technologies.
This report gives a brief overview of the present situation on nanotechnologies regulation. As part of the ObservatoryNANO project, it is an evolving document, to keep pace with the changes in the regulation landscape (and governance more broadly).
Several factors, briefly indicated below, are making the implementation of effective regulatory schemes complex:
- The wide variety of materials and applications under the umbrella term of nanotechnologies
- The limited knowledge on the toxic effects of nanomaterials in living systems and their transport in living and environmental systems.
- The proprietary nature of information on novel nanomaterials making access to relevant information a difficult issue
- The lack of harmonised standards or guidance
- The potential inadequacy of statutory authorities
Much of the concern is focused on "free" engineered nanoparticles and their effects on environment, and health and safety (EHS) during their entire life cycle. Combined with the ethical, legal and social aspects (ELSA) of nanotechnologies R&D, the question of what could be an integrated nanotechnologies governance approach is rapidly becoming one of the most discussed topic in the nanotechnologies area.
In spite of this attention, specific regulatory actions for nanotechnology-related products are still rare. In some cases, studies on nanotechnologies in specific sectors show that existing regulatory schemes should be adequate (such as for medical technologies) although there is still a request for improved EHS data. In other cases there is less agreement (for example in the area of cosmetics). The European Commission also shows this, highlighting that, with the necessary adaptations for nanotechnologies, existing regulatory schemes can go some way to regulating this emerging field without constraining growth too much. With this in mind, the focus is more on the improvement of instruments to ensure compliance with existing legislation.
Addressing these issues properly is essential and many countries with active nanotechnologies RTD are promoting initiatives which highlight the needs for tailored standards and regulation, and the development of expertise and technical capabilities to cope with the proliferation of nanotechnologies. There have been a number of reviews of regulatory regimes, identifying actions and priorities, (in the main) advising an increase in funding for research aiming to better characterise nanomaterials and understand their EHS effects.
In the last year, results of these reviews have prompted an in depth debate within regulatory authorities and stakeholders, including civil society, that in some cases have led to the adoption of specific regulatory actions improving the applicability of existing provisions to nanomaterials and nano-related products.
In Europe, within the European Commission, different Technical Committees and Agencies have published scientific opinions and reviews of regulation with respect to nanotechnologies and a number of them have created dedicated working groups to this end. Most of these activities have been summarised in the report "Regulatory Aspects of Nanomaterials" published in June 2008. This concluded that the current EU legislative framework "covers in principle the potential health, safety and environmental risks in relation to nanomaterials", but recognises that current regulations may need to be modified as the scientific knowledge on nanomaterials increases.
This position has been challenged by a non-binding resolution adopted in April 2009 by the European Parliament, following a detailed report on nanomaterials presented by the European Parliament's Environment Committee. The resolution asks for tighter controls on nanotechnologies, in particular with respect to legislation on chemicals, food, waste, air and water, workers protection.
In response, the Commission will review all relevant legislation within 2011 with a view to propose regulatory change whenever necessary and to develop nano-specific instruments for the implementation of regulation. The recent recast of the EU cosmetic regulation and the on-going discussion on the novel food regulation are also taking into consideration the position of the EU Parliament.
Though on regulatory matters, the European member states tend to follow the inputs from the EC, several countries have activities at the national level of their own. France, Germany, Switzerland, the Netherlands, UK, Austria, Norway have been the most active in this area, with commitment at institutional level to deepen knowledge on EHS and regulatory issues. Most of the other European Countries have also started activities on nanoregulation, mainly with respect to REACH and occupational and health safety aspects of nanomaterials.
Looking beyond Europe, the USA, Canada and Australia have also been active for several years. EHS and regulatory issues are receiving increasing resources within their national strategies for nanotechnologies, and regulatory agencies and other interested bodies are becoming more proactive in coping with the complexity of nanoregulation. Canada and Australia, in particular, explicitly identify the need to adopt a precautionary approach, and they have growing involvement from regulatory authorities in different sectors to provide guidance and adapt regulation in view of nanotechnologies.
With regards to Asia, the present document reports the situation in China, Japan, India, Taiwan. None of these countries is planning specific regulatory actions for nanotechnologies, but they are generally quite active in the field of standardization and have all established specific working groups at institutional level on nanomaterials, in particular regarding occupational and health safety aspects. Taiwan has had the NanoMark certification scheme since 2004.
Generally, Asian Countries are looking at legislation developed in Europe (and USA) as a benchmark for the development of their own. Particular attention is given to the debate on REACH and nanomaterials.
At the moment, related regulatory regimes under investigation refer to:
- chemicals and materials
- cosmetics
- foods
- occupational health and worker safety
- environmental safety,
- medical devices and pharmaceuticals.
Existing regulatory provisions regarding chemicals and materials have begun to include nanomaterials in their listings and the requirements to monitor/control the introduction of them into the market.
Various regulatory agencies in Europe (EC/ECHA), USA (EPA), Canada (Environment Canada) and Australia (NICNAS), are considering such specific notification requirements.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), in particular, which regulates in Europe the production, use and commercialisation of chemicals, is at present, the most compelling legislation for nanomaterials, although questions still remain in some quarters concerning its effectiveness, in particular in relation to threshold levels and exemption of particular materials.
In March 2008, ECHA (European Chemicals Agency) established for this purpose the Competent Authorities Sub Group on Nanomaterials (CASG Nano). The Sub Group published two technical guidelines and has launched in 2010 three projects devoted to the application of REACH to nanomaterials (to be ended in 2012). These activities, together with the end of the first registration phase, will provide the base for further specific regulatory action for nanomaterials within REACH.
The way nanomaterials will be considered in REACH will influence also regulatory actions at national level, in particular in countries such as France, Austria and Norway that are considering to introduce notification and registration mechanisms for nanomaterials (though they would generally prefer to avoid any kind of duplication with REACH procedures).
In the US, nanomaterials fall under TSCA (Toxic Substances Control Act) of the EPA which is the US equivalent of REACH and regulates chemicals. However, there is a big difference between the two regulatory schemes. REACH requires the producer (or importer) to demonstrate that a chemical is safe before it enters the market, whilst TSCA places responsibility on the regulators to prove that a chemical is harmful before it can be restricted or removed from the market. An agreement for a common international approach is fundamental to avoid barriers and mismatches.
In effect, since mid 2009, EPA has been evaluating a series of actions to ensure an appropriate regulation of nanomaterials within TSCA, including specific notification and registration procedures for nanomaterials. Particular attention is devoted to carbon nanotubes.
The recent (April 2010) debate of the U.S. senate on the Safe Chemical Act of 2010, includes a proposal for a reform of the TSCA that would introduces relevant changes to this statute and could lead to an approach similar to the one used by REACH (burden of the proof on the producer).
In November 2009, the Council of the European Union requested the update of the European Regulation on Cosmetic Products to include a specific definition of (insoluble) manufactured nanomaterials and requirements for notification, labelling and reporting of all products containing these kind of nanomaterials. A similar initiative concerning food regulation is under discussion, in particular the labelling of foodstuffs containing nanomaterials.
Regarding occupational health and workers safety, most efforts are devoted to evaluating and adapting the existing risk management methods, and to develop appropriate guidance for the handling and disposal of engineered nanoparticles/nanomaterials. Almost all countries surveyed have research activities and have established specific working groups at institutional level on these topics.
Reference documents have been produced by the National Institute for Occupational Safety and Health (NIOSH) in USA, the German Chemical Industry Association (VCI), the Federal Office of Public Health (FOPH) in Switzerland, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) in Canada among others.
The lack of appropriate measurement and monitoring tools, of detailed information on hazards and exposure levels and use of nanomaterials are evident challenges to provide comprehensive indications on these matters.
With respect to medical devices and pharmaceuticals products, the existing provisions are generally considered adequate for nano-related products, due to the detailed authorisation procedures required, but a case by case approach in the evaluation and authorisation procedures is envisaged to take into account their peculiar properties. One issue is the blurring of regulatory boundaries for advanced nanotechnologies. Both sectors are active at a European level in following the state the art, discussing the consequences of developments in nanomedicine for risk assessment and are developing guidance.
Alongside the "hard" regulation, other soft regulatory approaches are being implemented or developed, primarily addressing the safe use of nanomaterials. In particular: reporting schemes (stewardship programmes) and voluntary measures (code of conduct, risk management systems).
Examples of the first instrument are the initiatives of USA-EPA and UK-DEFRA, or others carried out at EC level (EFSA), in Germany (UBA-VCI), Australia (NICNAS), Taiwan (Nanomark). Most of the attention is currently focused on regulatory triggers (e.g. threshold levels) and classification issues, thus on the ability to regulate and control the introduction and use of nanomaterials and nano-related products into the market. These initiatives are extremely important to build a firm knowledge base to support policy and regulatory decisions, and for this reason also under consideration are mandatory reporting schemes, for example in countries such as Canada and France.
A unique source of reference on this matter is provided by a report from the OECD Working Party on Manufactured Nanomaterials (OECD WPMN, Steering Group 5), which recently was made publicly available. The document provides a detailed review and comparison of information gathering schemes and of the applicability to nanomaterials of registration and notification procedures in several different regulatory regimes.
Codes of conduct and risk management systems are measures that can have an important role to cope with current uncertainties about the impact of nanotechnologies during the redefinition of existing hard regulation and to raise trust on their use, through creating a culture of responsibility.
The most relevant example of code of conduct aiming to contribute to this culture of responsibility is the EC "Code of Conduct for responsible nanoscience and nanotechnologies research" (February 2008) which provides principles and indications that should guide the research activity in this field. Its objectives are far reaching and among the principles that must be respected of particular relevance are: (a) Sustainability, (b) Precaution (c) Inclusiveness and (d) Accountability.
The EC is actively promoting the Code and strongly recommends all Member States to adopt it. A public consultation on the Code was held at the end of 2009 and the publication of the first revision of the Code is expected in mid 2010.
In addition, based on the current uncertainty in the regulatory situation, some stakeholders, mainly at industrial level, have developed (or are developing) their own risk management systems, defining best practises and procedure for safety control and handling of nanomaterials in occupational settings. The DuPont/Envrionmental Defence NanoRiskFramework and the CENARIOS risk management and monitoring system, are two examples of this approach.
The availability of appropriate standards to name, describe, specify, measure and characterise nanomaterials is pivotal to implement an appropriate regulation for nanotechnology-related products.
Currently, it is the International Standards Organization (ISO) Technical Committee (TC) 229, in conjunction with the International Electrotechnical Commission (IEC) TC 113, that directs activities on nanotechnologies standards at the international level. However, other standard bodies have started to work on nanotechnologies since 2004. Various ISO Technical Committees, national standards bodies, such as BSI/NT1 in UK, SAC/TC279 in China, ANSI-NSP in USA, and Standard Developing Organisations such as ASTM and IEEE have all produced standards relevant for nanotechnologies. Most of these activities are in liaison with ISO TC229 and IEC TC 113, analogous to the work of CEN, CENELEC and ETSI, which received a new mandate from the EC on the development of standards in nanotechnologies at the beginning of 2010.
ISO TC 229 is organised into 4 working groups that focus on issues that are crucial for the development of an effective regulation for nanotechnology-related products. In particular:
- Terminology and Nomenclature
- Measurements and Characterisation
- Health, Safety, and Environment
- Materials Specification
At present more than 35 standards documents related to the above themes are under development, but due to the lengthy process, it will be some time before the matter is thoroughly addressed. So far ISO TC 229 has published three documents:
- ISO/TS27687 (Technical Specification): Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplates;
- ISO/TR 12885 (Technical Report): Health and safety practices in occupational settings relevant to nanotechnologies.
- ISO/PRF TS 80004-3 (Technical Specification):Nanotechnologies -- Vocabulary -- Part 3: Carbon nano-objects
The work on standards developed quite rapidly in the last year, with different documents that reached the approval or publication stage, and some new work proposals. Most of work underway is related to terminology, nomenclature, measurement and characterization of nanomaterials.
A contribution to the standardisation activities, will also be made by the eight Steering Groups of OECD WPMN who are gathering reference data and information on characterisation and safety of nanomaterials, and liaise with ISO TC 229 and other relevant authorities.
In particular, in the OECD sponsorship programme, launched in 2007 (Steering Group 3), several countries are sharing the testing of a representative set of manufactured nanomaterials. More than 30 countries worldwide are currently participating to OECD-WPMN and most of them are also actively engaged in the sponsorship program.
As an outcome of the first part of the sponsorship program (now concluded) the Working Party agreed a priority list of 14 nanomaterials for testing (based on materials which are in or close to commerce) as well as a list of 61 endpoints for which they should be tested. During the implementation stage (from 2009 to 2012), the main output of the project will be to develop characterisation dossier for the substances identified.
In conclusion, the activity linked to nanoregulation is increasing in intensity across the globe, nevertheless, given the gaps in the scientific knowledge and the different positions and stances of regulatory agencies around the world, it seems unlikely that new laws specific for nanotechnologies will be introduced in the short term.
The demand to clarify the existing uncertainties and, at least in some cases, of specific provisions, is mounting. While in the period considered by the 1st year Report (2008/mid 2009) the focus was mainly on the analysis and review of existing legislation, in the last year the debate was geared around the first attempts to introduce adjustments for nanomaterials in regulatory provisions in EU and some other countries.
The most relevant example of this action is the recast of the Cosmetic regulation in EU.
The adjustment/amendment to the existing legislation discussed, relates to the inclusion of a definition of nanomaterials, improved notification and registration procedures, specific guidelines for safety assessment, labelling and inventories of the use of nano-related products.
While some authorities are more oriented toward amendments of legislation, also in the form of mandatory reporting schemes, others prefer to consider the option of voluntary measures or a combination of both.
However, the number of countries (and regulatory provisions) in which authorities are planning to introduce such changes in the near future is still limited.
There is also a strong position, shared by some authorities and industries, that exiting legislation, though not specific for nano- related products, is capable of dealing with any potential risks.
Nanoregulation requires a dynamic approach: it must adapt to the evolution of the scientific knowledge, to the increase of applications, to the concern and attitude of current and potential stakeholders. Continuous research, cooperation and productive and constructive dialogue are key to supporting nanotech development and to build justified trust among stakeholders, including civil society.
The productive mixing of hard and self regulation approaches seem an appropriate option in the short-term.
Finally, another important point is highlighted by the analysis of the existing situation. Excepting international standards and the work within OECD, there is no concerted effort aimed at elaborating common rules for nanoregulation that could be shared at an international level. The various countries active in nanoregulation have initiatives independent from each other, although in Europe the situation is less disparate and the EC is actively fostering collaboration.
The Code of Conduct, if largely adopted among the Member States, could be the first step in determining a common ground for research whilst REACH provides a certain degree of coherence for product development, at least on nanomaterials. However, the development of a regulatory framework accepted at global level is a necessary goal to have common to facilitate trade and avoid regional divide. Thus the promotion of international cooperation in nanoregulation is fundamental.
To cite the conclusion of the Nanotechnologies for sustainable development Conference, Brussels (12 November 2009): "Future developments in regulation and standardisation should ensure safety and transparency and thus public trust on one hand, and give to industry sufficient certainty on the other hand, without stifling innovation".
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