Current status of substances and products regulations for nanotechnologies
Nanomaterials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges may be magnified both because nanotechnology can be used in, or to make, any product, and because, at this scale, properties of a material relevant to the safety and effectiveness of the products might change repeatedly as size enters into or varies within the nanoscale range. In addition, the emerging and uncertain nature of the science and potential for rapid development of applications for products highlights the need for timely development of a transparent, consistent, and predictable regulatory pathway (
FDA, 2007). However, due to the ongoing uncertainty regarding the environmental, health and safety implications of nanomaterials, there is significant debate concerning whether nanotechnology or nanotechnology-based products merit specific government regulation.
Several regulatory bodies have initiated activity to assess, and in some cases ensure, the coverage of nanomaterials under existing substances and products regulations, including:
- European Union (E.U.), regarding substances, novel foods and cosmetic products
- U.S. Environmental Protection Agency (EPA)
- U.S. Food and Drug Administration (FDA)
- Food Standards Australia and New Zealand (FSANZ)
- U.S. Consumer Product Safety Commission (CPSC)
- Australian Government Department of Health and Ageing (NICNAS)
The current stance of these bodies with regards to nanotechnology regulation is summarised in the Substances and Products section below, with further details available on their associated websites.
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REACH is the E.U. Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which entered into operation on 1st June 2008. The purpose of REACH is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on internal market while enhancing competitiveness and innovation. REACH lays down provisions on substances, which apply to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. REACH is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.
Although there are no provisions in REACH referring specifically to nanomaterials, REACH deals with substances, in whatever size, shape or physical state. Substances at the nanoscale are therefore covered by REACH and its provisions apply. It thus follows that under REACH manufacturers, importers and downstream users have to ensure that their nanomaterials do not adversely affect human health or the environment.
Although, at present, there is no specific guidance for registering substances in the nanoscale under REACH, the EC document '
Nanomaterials in REACH' presents the initial conclusions of the REACH Competent Authorities subgroup on nanomaterials and can be used by companies as a starting point to prepare registration documents for nanomaterials.
Important issues raised by this subgroup, and broadly amongst researchers, in terms of regulating nanomaterials under REACH include concerns that many substances may be produced/imported below the 1 tonne per year registration threshold and that information on low-volume phase-in nanomaterials will only become available following the 2018 registration deadline. It has been suggested by some experts that all substances at the nanoscale should be registered, even if produced at < 1 tonnes per year, with a reduced information set.
The European Commission plans to respond to these concerns through a
review of the REACH Regulation and its associated Guidance Documents in 2012, to which SAFENANO is contributing through the RIP-oN 2&3 projects [link to projects page].
Further information on the REACH Regulation can be found on the
European Chemicals Agency (ECHA) website.
The mission of the
US EPA is to protect human health and the environment. It accomplishes this via research activities (including internal research and a grant award system), sponsorship of partnerships, and provision of education. In relation to regulation, the EPA is charged with implementation of environmental laws passed by US congress via development and enforcement of Regulations.
The current status of NMs within the regulatory framework
In October 2008, the EPA announced that carbon nanotubes were distinct from graphite and other forms of carbon listed on the Toxic Substances Control Act (TSCA) inventory (
EPA, 2008). This announcement sparked much debate amongst stakeholders as to its potential impact on other nanomaterials, in particular whether:
- all NM may be listed as new substances (and hence subject to 90-day pre-manufacturing notices (PMN) prior to manufacture or importation in the US), or
- the EPA may implement tools such as the Significant New Use Rules (SNURs) to restrict the uses of particular nanomaterials shown to pose risks to consumers or the environment.
At the current time, it remains the case that for NMs other than CNT the original TSCA policy (which considers that a chemical's size doesn't affect its molecular identity) still stands. Thus, TSCA does not require registration and testing for nanoscale versions of materials already in its inventory, but considers nanoparticles with novel molecular structures as new materials (i.e. carbon nanotubes).
The NanoMaterials Stewardship Programme (NMSP)
In 2008, the EPA created the Nanoscale Materials Stewardship Program (NMSP) to collect information about the EHS risks of nanomaterials on a voluntary basis from participating manufacturers. An interim report of this programme was published in january 2009. This stated that the EPA was approximately halfway through its data collection and development of well-characterized tests for risk assessment, and concluded that 'based on the current interim results, the NMSP can be considered successful'. However, the report also acknowledged that gaps in data do exist and that some unresolved risk concerns remained.
It is expected that EPA officials will complete the data collection phase of the NMSP in 2010. Following this, they expect to be in a position to propose new rules and to open these for public comment (a legal requirement for any Significant New Use Rules (SNUR)). Based on evidence to date, it is possible that the EPA may implement new regulations for nanomaterials within 2011.
Nanomaterials and TSCA
Many nanoscale materials are regarded as "chemical substances" under the US Toxic Substances Control Act (TSCA). In order to ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, the US EPA is pursuing implementation of a comprehensive regulatory approach under TSCA, which encompasses:
- Premanufacture notifications;
- Significant New Use Rules;
- Information gathering rules; and
- Test rules.
1. Premanufacture Notifications
TSCA requires manufacturers of new chemical substances to provide specific information to the EPA for review prior to manufacturing chemicals or introducing them into commerce. Through this, EPA may take action to ensure that those chemicals that pose an unreasonable risk to human health or the environment are effectively controlled.
The EPA states that since 2005, it has received and reviewed over 100 new chemical notices under TSCA for nanoscale materials, including carbon nanotubes (EPA, 2011). The Agency has taken a number of actions to control and limit exposures to these chemicals, including:
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limiting the uses of the nanoscale materials,
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requiring the use of personal protective equipment, such as impervious gloves and NIOSH approved respirators,
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limiting environmental releases, and
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requiring testing to generate health and environmental effects data.
In addition, EPA has permitted limited manufacture of new chemical nanoscale materials through the use of administrative orders - Significant New Use Rules (SNUR) - under TSCA. The Agency has also allowed the manufacture of new chemical nanoscale materials under the terms of certain regulatory exemptions, but only in circumstances where exposures were tightly controlled to protect against unreasonable risks (using, for example, the protective equipment and environmental release limitations as outlined above).
2. Significant New Use Rules (SNUR)
Significant New Use Rules require that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use." In the case of nanomaterials, EPA is developing a SNUR under section 5(a)(2) of TSCA to ensure that nanoscale materials receive appropriate regulatory review. The SNUR would require persons who intend to manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before commencing that activity. The SNUR will identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary Nanoscale Materials Stewardship Program (NMSP) and other information.
Such SNUNs will provide the Agency with a basic set of information on nanoscale materials, such as chemical identification, material characterization, physical/chemical properties, commercial uses, production volume, exposure and fate data, and toxicity data. This information should enable the Agency evaluate the intended uses of these nanoscale materials and to take action to prohibit or limit activities that may present an unreasonable risk to human health or the environment.
3. Information Gathering Rule
To assist in developing a more comprehensive understanding of nanoscale materials that are already in commerce, EPA is developing a proposed rule under TSCA section 8(a) to require the submission of additional information. This rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data.
4.Test Rule
Under TSCA section 4, the EPA is to propose a rule to require testing for certain nanoscale materials that are already in commerce. This will have a particular focus on classes of nanoscale materials not already being tested by other Federal and international organizations. The results of the required tests should assist the EPA in understanding potential health and environmental effects of the nanoscale materials. They could also help to establish a correlation between the chemical/physical properties and the effects of the nanoscale materials.
Further information on the EPA's nanotechnology activities can be found on the
EPA website.
Regulation
EC 258/97 of 27 January 1997 of the European Parliament and the Council lays out detailed rules for the authorisation of novel foods and novel food ingredients (those that have not been used for human consumption to a significant degree within the European Community before 15th May 1997). A draft update of this regulation, passed by the European Parliament in July 2010, included a stipulation to ban nanoscale ingredients from food until the risks posed are better understood, and would have required that any nanoscale ingredients eventually authorised be clearly labelled as such. However, the European Parliament and European Union Council have thus far failed to reach agreement on an update to the novel foods regulation to address several issues, including nanoscale ingredients in food. The EP issued a
statement on the 29th March 2011, statement, which notes that the failure to reach an agreement on the legislation means "[t]here will continue to be no special measures regarding nanomaterials in food".
The U.S. FDA regulates a wide range of products, including foods, cosmetics, drugs, devices, veterinary products, and tobacco products some of which may utilise nanotechnology or contain nanomaterials.
The FDA Nanotechnology Task Force, formed in August 2006, is charged with determining regulatory approaches that encourage the continued development of innovative, safe, and effective FDA-regulated products that use nanotechnology materials.
At present the FDA considers its existing regulatory approaches are sufficient to handle nanomaterials, but the agency will issue guidance on data to be included in submissions, including size. The FDA intends to modify its policy on a case-by-case basis, as and when scientific information emerges regarding the EHS risks of nanomaterials (
FDA, 2007).
The FDA Nanotechnology Regulatory Science Research Programme, intended to increase scientific understanding to facilitate assessment of data needs for regulated products, has the following research categories for 2011:
- Physico-chemical characterisation in FDA-regulated products;
- Non-clinical modelling of nanomaterials in FDA-regulated products;
- Risk characterisation information;
- Risk assessment.
Further information regarding FDA’s nanotechnology related activities and policy developments can be found on the
FDA website.
All food supplied in Australia and New Zealand must comply with the
Australia New Zealand Food Standards Code (the Code) and be safe for human consumption. Any new food substances that are manufactured using nanotechnologies that may present safety concerns will, as with any other substance, have to undergo a comprehensive scientific safety assessment under the appropriate Standard before they can be legally supplied in Australia and New Zealand.
An application must be submitted to FSANZ that meets the requirements set out in the
FSANZ Application Handbook. Amendments have been made to the Application Handbook requiring additional information about substances used in certain areas of food production and their properties to be supplied to the regulator. Applications for food additives, processing aids, novel foods and nutritive substances must include particle size, size distribution and morphology, where the substance(s) is particulate in nature and will remain so in the final food. Applications to approve a food substance must also include the raw data and studies necessary to conduct a comprehensive risk assessment and establish the safety of the exact same food substance.
FSANZ has stated that if it receives an application for a new type of engineered nanometre scale particle in food, it would be assessed depending on the standard that applies. For example, the premarket requirements of the novel food standard apply to non traditional foods where an assessment of the public health and safety considerations is required having regard to:
- the potential for adverse effects in humans
- the composition or structure of the food
- the process by which the food has been prepared
- the source from which it is derived; or patterns and levels of consumption of the food
- any other relevant matters.
FSANZ aims to monitor research developments related to nanotechnology and food safety occurring around the world on an ongoing basis, and will continue to ensure the safety of food is rigorously assessed through the application of the current provisions of the Code and make adjustments to the regulatory framework should it become necessary.
Further information on FSANZ stance with regard to nanotechnology in food products is available on its
website.
In November 2009, the European Union Council agreed to recast some 55 directives relating to cosmetics into a single regulation on cosmetic products,
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products. As the first piece of national or supranational legislation to incorporate rules relating specifically to the use of nanomaterials in any products, this regulation is considered to be very significant (
Bowman et al., 2010).
For the purposes of this Regulation, the following definition applies to the term “nanomaterial”: an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
The approved text requires the manufacturers of new cosmetic products containing nanomaterials to notify the European Commission (EC) and provide certain information six months before the product is placed on the European market, including:
- the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors;
- the specification of the nanomaterial including size of particles, physical and chemical properties;
- an estimate of the quantity intended to be placed on the market per year;
- the toxicological profile of the nanomaterial;
- its safety data related to the category of cosmetic product as used in it;
- the reasonably foreseeable exposure conditions.
In addition, the Regulation requires labelling cosmetics products containing nanomaterials in the EU and stipulates that, by 11th January 2014, the EC shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market.
Further information on the EU Cosmetics Regulation is available
here.
The U.S. CPSC is tasked with protecting the public from unreasonable risks of injury or death from thousands of types of consumer products under the agency's jurisdiction.
At present, the CPSC considers its current policies sufficient to cover nanomaterials until further information is known, and will consider modifications on a case-by-case basis as evidence emerges.
In its 2012 Strategic Plan, CPSC aims to complete several activities in relation to nanotechnology in consumer products in order to increase the current knowledge base, including:
- Airborne nanoparticles from consumer paints;
- Carbon nanotubes in consumer products;
- Enhancement of the National Library of Medicine (NLM) Household Products Database;
- Exposure and risk assessment of nanomaterials in consumer products.
Established in 1990, NICNAS:
- Provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effect of industrial chemicals; and
- Assesses all chemicals new to Australia and assesses those chemicals already used (existing chemicals) on a priority basis, in response to concerns about their safety on health and environmental grounds.
Nanomaterials, when used as industrial chemicals, fall within the remit of NICNAS. NICNAS is engaging with the National Nanotechnology Strategy via a cross-portfolio working group on health, safety and environment issues, and is examining nanotechnology to determine if and how NICNAS needs to adapt its legislation and processes to ensure the safe and sustainable use of industrial chemicals that contain nanomaterials. NICNAS has established a Nanotechnology Advisory Group to advise on strategic directions NICNAS might take in addressing the potential impacts of nanomaterials as industrial chemicals
NICNAS has engaged in activity to determine the volumes, types and data holdings of nanomaterials that are being used within Australia as industrial chemicals via a voluntary call for information directed to industry and researchers. Summary results of the 2008 call for information on the use of manufactured nanomaterials are available here.
In November 2010, NICNAS announced the introduction of new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be New Chemicals under Part 3 (Notification and Assessment of Industrial Chemicals) of the Industrial Chemicals Notification and Assessment Act 1989, effective from the 1st January 2011.
These new administrative arrangements apply to any new chemical that falls under the following working definition of 'industrial nanomaterial':
"… industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale)"
While all NICNAS regulatory requirements applicable to conventional chemicals also apply to their nano-forms, specific amendments to current processes and practices vary between new chemicals exemptions and new chemical certificates and permits. Further additional information may be required on the nano-specific characteristics of chemical on a case-by-case basis.
Further details of NICNAS’ regulatory activity in regards to nanotechnology are available on its website.