You are here > Knowledge Base > Regulation > Substances and Products

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.)
  • U.S. Environmental Protection Agency (EPA)
  • U.S. Food and Drug Administration (FDA)
  • U.S. Consumer Product Safety Commission (CPSC)
  • Health Canada
  • Food Standards Australia and New Zealand (FSANZ)
  • Australian Government Department of Health and Ageing (NICNAS)
  • New Zealand Environmental Protection Authority (EPA)
The current stance of these bodies with regards to nanotechnology regulation is summarised below, with further details available on their associated websites.

Collapse All Expand All

In 2011, the European Commission adopted a 'Recommendation on the Definition of a  Nanomaterial', which defines 'nanomaterial' as:

"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%.

By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.”

The definition will be used primarily to identify materials for which special provisions might apply e.g. risk assessment or ingredient labelling. It is noted that those special provisions are not part of the definition but of specific legislation in which the definition will be used.

Further information on the Recommendation, and access to it in full is available on the European Commission website.

The European Commission (EC), in close co-operation with the member states and stakeholder experts of the CARACAL sub-group on nanomaterials (CASG Nano), prepares advice on how to manage nanomaterials under the REACH and CLP Regulation.

REACH is the E.U. Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which entered into operation on 1st June 2008.   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. It 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.

Although there are no provisions in REACH referring specifically to nanomaterials, REACH deals with substances, in whatever size, shape or physical state. As stated in the 2008 EC document "Nanomaterials in REACH" [pdf], 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.  The European Chemicals Agency (ECHA) receives the REACH registrations and the Agency plays a central role in the collection, evaluation and dissemination of information on substances and preparations, including nanomaterials.

The legislation on classification and labelling (67/548/EEC and 1999/45/EC), as well as the new Classification, Labelling and Packaging(CLP) Regulation (1272/2008/EC), which came into force in 2009 and implements the Globally Harmonised Systems (GHS), also provides the general framework for the classification and labelling of nanomaterials. In 2009, the EC published a document on the "Classification, labelling and packaging of nanomaterials in CLP and REACH" [pdf].   It is stated that nanomaterials  that fulfil the criteria for classification as hazardous under the CLP Regulation must be classified and labelled. This applies to nanomaterials as substances in their own right, or nanomaterials as special forms of the substance. Many of the related provisions, including safety data sheets and classification and labelling apply already today, independently of the tonnage in which the substances are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous should have been notified to ECHA by 3rd January 2011. Any further update to the classification must also be notified without undue delay. ECHA has established a classification and labelling inventory, containing the information provided in accordance with the regulation.

Technical Guidance for Nanomaterials

Until recently, ECHA’s REACH Technical Guidance Documents  gave no specific guidance concerning nanomaterials. However, over the last couple of years, ECHA has initiated activity to ensure the availability and applicability of guidance for those registering nanomaterials under REACH.

A technical manual providing guidance on how to include information on nanomaterials in registration dossiers prepared in the International Uniform Chemical Information Database (IUCLID) was released in 2010, and subsequently updated in 2013. This manual includes instructions on how registrants can explicitly report when a nanoform has been used in experimental studies and aims to help registrants to prepare or update registration dossiers for substances that are nanomaterials or include nanoforms. A video tutorial is also available. 

In 2009, the European Commission launched the REACH Implementation Projects on Nanomaterials (RIP-oNs) to provide advice on key aspects of the implementation of REACH with regard to nanomaterials.  Final reports from these projects are available concerning:
  • Substance Identification of Nanomaterials (RIP-oN 1
  • Specific Advice on Fulfilling Information Requirements for Nanomaterials under REACH (RIP-oN 2
  • Specific Advice on Exposure Assessment and Hazard/Risk Characterisation for Nanomaterials under REACH (RIP-oN 3
It should be noted that, whilst the final report of the RIP-oN 1 project is available, it was not possible to reach consensus amongst the experts on the recommendations of this project and further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA. 

However, based on the scientific and technical state of the art recommendations made in the RIP-oN 2 & 3 final reports, on the 30th April 2012 ECHA published three new appendices, updating Chapters R.7a, R.7b and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) with recommendations for registering nanomaterials.

Nano Support Project

In 2010, DG Environment initiated a project on "Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information". The project was divided in two separate Tasks:
  • Task I (completed in March 2012) entailed identification of REACH registration dossiers that cover nanomaterials, scientific assessment of the information on nanomaterials contained in these dossiers and proposing how potential cross-cutting shortcomings can be addressed. Click here to access the final report
  • Task II (completed in January 2013) focused on assessing potential economic and environmental consequences of the technical proposals made in Task I. Click here to access the final report

REACH Legal Text

In February 2013, the European Commission (EC) completed its five-year review of the REACH Regulation.  In relation to nanomaterials, the pre-publication version of the EC’s report [pdf]  states that the EC "will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers.  If appropriate the Commission will come forward with a draft implementing act by December 2013." The pre-publication version of the staff working paper [pdf] specifically recommends that, if REACH needs amending "for other reasons," then "consideration should be given to the introduction of the definition of a nanomaterial in line with Recommendation 2011/696/EU."  Further details of the REACH review are available on the EC website

Following publication of this report, the European Commission launched a public consultation on the modification of the REACH Annexes on nanomaterials, which was open for input from 21 June 2013 until 13 September 2013.  Further information is available here.

Further information on REACH & CLP in general can be found on the European Chemicals Agency (ECHA) 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".

Further information on nanotechnology and food can be found on the Food Standards Agency (FSA) website,  where it is stated that applicants looking to develop nanotechnology-enabled foods or food contact materials can contact the FSA to gain regulatory advice, either in general or specific terms. Initial enquiries should be emailed to

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.  Adaptation of this definition, to bring it in line with the EU definition of the term 'nanomaterial', is understood to be underway.
In July 2012, the European Commission published Guidance on the Safety Assessment of Nanomaterials in Cosmetics [pdf].  The document was drafted by the Scientific Committee on Consumer Safety (SCCS) to help the cosmetics industry comply with article 16 of the Regulation on cosmetic products , which will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials on the responsible persons and the SCCS respectively, starting on January 2013. 

From the 11th January 2013, the cosmetics industry have been obligated to notify to the Commission, through the Cosmetic Products Notification Portal, all cosmetic products containing nanomaterials, six months prior to placing them on the market. They will also have to provide specific data relevant for risk assessment purposes, which the Commission will submit to the SCCS, in case it has concerns. A checklist of required data has been included in the new Guidance to help them do so.

In light of the rapid advances in the field of nanotechnology and the ever increasing scientific knowledge about the safety of nanomaterials, the present Guidance is likely to be updated regularly.

In addition to the notification requirement described above, the Cosmetics Regulation requires labelling of nanomaterials (name of the ingredient, followed by 'nano' in brackets) in the ingredients list. When there are concerns over the safety of a nanomaterial, the Commission will refer it to the Scientific Committee on Consumer Safety (SCCS) for risk assessment.

Further information on the EU Cosmetics Regulation is available here

The new European Regulation on Biocidal Products (EU) No 528/2012 entered into operation on the 1st September 2013.  The Biocidal Product Regulation (BPR) is the first piece of EU legislation to implement the European Commission definition on nanomaterials. 

The nanomaterial provisions apply both for active and non-active substances with the following characteristics:
  • 50% or more of the particles have a size of 1-100 nanometres in at least one dimension;
  • Particles are in an unbound state, as an aggregate or as an agglomerate.
According to the BPR, the approval of the active substance does not cover the nanomaterial form of it except where explicitly mentioned. A separate dossier with all data requirements must usually be prepared for nanoforms of active substances.

A dedicated risk assessment is needed when a nanomaterial form of an active or non-active substance is used in a biocidal product. Such biocidal products must also be labelled and indicate the name the nanomaterial followed by the word "nano" in brackets. However, the simplified procedure for authorisation introduced in the BPR is not applicable for nanomaterials.

European Member States must report on the implementation of the BPR every five years. This reporting must include information on the use of nanomaterials in biocidal products.  All biocidal products must get authorisation before they can be made available on the market. Industry has to apply through the European Chemicals Agency (ECHA) for the approval of an active biocidal substance as well as authorisation for a biocidal product containing an approved one. The BPR requires that the active substances used in a biocidal product are technically equivalent to approved ones.

Under the new regulation, articles can only be treated with biocidal products containing approved active substances. Treated articles must be appropriately labelled according to the BPR and the regulation on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation). The new BPR repeals and replaces the former Directive (98/8/EC).

Further information on the Biocidal Products Regulation can be found on the ECHA website

The mission of the U.S. 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 U.S. congress via development and enforcement of Regulations.

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.  The Agency released an Interim Report [pdf] on the NMSP in January 2009 and was expected to issue a final report in 2010. Although the NMSP provided U.S. EPA with useful information regarding a limited number of nanoscale materials in commerce, a significant number of the environmental health and safety data gaps remain. To address these gaps and prevent potential risks that may be posed by nanoscale materials, EPA is taking a number of regulatory actions under the Toxic Substances Control Act (TSCA).  

Nanomaterials and TSCA

In October 2008, the U.S. 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 U.S.), 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).

Many nanoscale materials are regarded as "chemical substances" under 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: 
  • limiting the uses of the nanoscale materials,
  • requiring the use of personal protective equipment, such as impervious gloves and NIOSH approved respirators,
  • limiting environmental releases, and
  • 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 (SNUR) 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." 

On the 26th June 2013, the EPA promulgated final SNURs for 17 chemical substances, including carbon nanotubes.  The SNURs require persons who intend to manufacture or process any of these 17 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  

The proposed SNURs would allow the submission of data in support of a new chemical exposure limit (NCEL) under 40 C.F.R. Section 721.30  which relates to EPA approval of alternative control measures. EPA notes that, because of the uncertainty surrounding the National Institute for Occupational Safety and Health (NIOSH) recommended exposure limit (REL) of 1 microgram per cubic meter (µg/m
3) for carbon nanotubes and carbon nanofibres, it "will not adopt the NIOSH REL as a NCEL at this time because EPA cannot determine that at the REL the potential exposures may not present an unreasonable risk."  EPA commented that it will consider the final NIOSH REL, or other alternative exposure controls for carbon nanotubes, if a submission requesting such is made under 40 C.F.R. Section 721.30. 

The final rule was effective from the 26th August 2013.  
Further information can be found in the corresponding Federal Register docket

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

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.

FDA Nanotechnology Task Force

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. In 2007, the Task Force issued a report which included: 
  • A synopsis of the state of the science for biological interactions of nanoscale materials;
  • Analysis and recommendations for science issues; and
  • Analysis and recommendations for regulatory policy issues.
A general finding of the report was that: "[N]anoscale materials 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 FDA-regulated product, and because, at this scale, properties of a material relevant to the safety and (as applicable) effectiveness of FDA-regulated 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 FDA-regulated products highlights the need for timely development of a transparent, consistent, and predictable regulatory pathway."

FDA’s Approach to Regulation of Nanotechnology Products

In April 2012, the FDA released a Nanotechnology Fact Sheet which states:

"In general, FDA considers the current framework for safety assessments sufficiently robust and flexible to be appropriate for a variety of materials, including nanomaterials."

"FDA will continue to regulate nanotechnology products under its existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. FDA intends to ensure transparent and predictable regulatory pathways grounded in the best available science. 
  • Onesize does not fit all. We intend our regulatory approach to be adaptive and flexible. It is necessary for technical assessments to be product-specific, taking into account the effects of nanomaterials in the particular biological and mechanical context of each product and its intended use.  
  • Particular approaches for each product area will vary according to the statutory authorities. The scope and issues covered in the two draft guidance documents released today – one for foods and one for cosmetics – reflect this approach.
  • FDA’s regulatory policy approach is consistent with relevant overarching U.S. government policy principles, and supports innovation under appropriate oversight."
In addition, the FDA states that industry remains responsible for ensuring that its products meet all applicable legal requirements, including standards for safety -- regardless of the emerging nature of a technology involved in the manufacturing a product.

Product-specific Guidance

In June 2011, FDA issued a draft guidance a Draft Guidance for Industry entitled, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" to present its thinking on considerations related to nanotechnology.  In that draft guidance, it was indicated that the FDA would issue product-specific guidance in the future, as appropriate.

Accordingly, in April 2012, FDA issued for public comment two product-specific draft guidance documents to address the use of nanotechnology by the foods and cosmetics industries:
Both guidance documents are being issued as part of FDA’s ongoing implementation of recommendations from FDA’s 2007 Nanotechnology Task Force Report.   

Further information regarding FDA’s nanotechnology related activities and policy developments can be found on the FDA website

The U.S. Consumer Product Safety Commission (CPSC) is an independent regulatory agency created in 1973. CPSC’s jurisdiction includes over 15,000 types of consumer products used in or around the home, except certain items excluded by statute, for example, motor vehicles, tobacco, food, drugs, cosmetics, most medical devices, and pesticides. Examples of products that are regulated by CPSC include clothing, hazardous household cleaners and substances, electronic devices, appliances, furnishings, building materials, toys and other juvenile products.

According to the CPSC nanotechnology statement [pdf]:  

"The potential safety and health risks of nanomaterials, as with other compounds that are incorporated into consumer products, can be assessed under existing CPSC statutes, regulations and guidelines. Neither the Consumer Product Safety Act (CPSA) nor the Federal Hazardous Substances Act (FHSA) requires the pre-market registration or approval of products. Thus, it is usually not until a product has been distributed in commerce that the CPSC would evaluate a product’s potential risk to the public."

"In the absence of an express regulation, as it does with other consumer products, the staff will look to see whether a defective product composed of or containing nanomaterials creates a substantial risk of injury to the public because of, among other factors, the pattern of the defect, the number of defective products distributed in commerce, and the severity of the risk."

In its 2013 Strategic Plan [pdf], CPSC aims to complete several activities in relation to nanotechnology in consumer products in order to identify the potential release of nanoparticles from selected consumer products and to determine potential health effects from such exposure, including
  • Airborne nanoparticles from consumer products;
  • Enhancement of the National Library of Medicine (NLM) Household Products Database;
  • Exposure and risk assessment of nanomaterials in consumer products;
  • Nanomaterials in spray and aerosol products.
In its recently released 2014 Operating Plan [pdf], CPSC have outlined a nanotechnology project with focus on the "use and safety of nanotechnology applications in consumer products". They aim to collaborate with federal agencies to "identify new product applications for existing nanomaterials in addition to new nanomaterials entering the market, and to develop methods to test for the release of nanomaterials from these products".  In addition, CPSC aim to develop voluntary standards that incorporate assessment approaches for nanomaterials.

Click here to visit the CSPC website.

Health Canada is the Federal department responsible for regulating products and substances, including drugs, biologics, medical devices, natural health products, foods and food packaging, pesticides, new and existing substances, consumer products and cosmetics in Canada.

As international consensus on a definition for the products of nanotechnology has not been reached yet, Health Canada has adopted a working definition for nanomaterials to provide a consistent approach across several diverse regulatory program areas to identify regulated products and substances that may contain nanomaterials. The working definition, effective as of October 2011, is described in the Policy Statement on Health Canada's Working Definition for Nanomaterial. The objectives of this Policy Statement are to:
  1. Establish a working means of identifying nanomaterials;
  2. Assist Health Canada to collect information and establish internal inventories regarding regulated substances, products, and any component material, ingredient, device, or structure that are nanomaterials;
  3. Support communications about nanomaterials with the broader community of interested stakeholders; and,
  4. Support the administration of the legislative and regulatory frameworks under the authority of Health Canada and to help further the development of policy, guidance and programs applicable to nanomaterials.
Currently, there are no regulations specific to nanotechnology-based health and food products. Health Canada relies on authorities within existing legislative and regulatory frameworks, which require the assessment of potential risks and benefits of products to the health and safety of Canadians before they can be authorised for sale.

Further information about Health Canada’s nanotechnology activity is available on its 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 [pdf].

Using the best available scientific evidence, FSANZ states it has adopted a range of strategies to continually review and manage potential risks associated with nanotechnologies in foods to ensure the public are not exposed to any health or safety issues.  These strategies include:
  • amending the FSANZ Application Handbook to support new food regulations and ensure applicants provide all the necessary information to help FSANZ conduct a risk assessment;
  • advising the food industry about the amendments to the Application Handbook involving nanotechnology and asking industry for information about proposed nanotechnology applications;
  • engaging with other national regulatory agencies, industry and the public to outline FSANZ’s regulatory responses.
FSANZ states that it has not yet received any applications to approve new or novel nanoscale particles for food use.

Further information on FSANZ stance with regard to nanotechnology in food products is available on its website.

Established in 1990, NICNAS:

i) 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;

ii) 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.

NICNAS regulates industrial nanomaterials within the framework operating for conventional industrial chemicals. Consistent with the objects of the Industrial Chemicals Notification and Assessment Act 1989, NICNAS' strategy for regulating industrial nanomaterials aims to: 
  • identify substances that are considered to be nano-forms of industrial chemicals for regulatory purposes, through a NICNAS working definition;
  • review and revise regulatory requirements and assessment methodology for new and existing conventional chemicals to determine their appropriateness for nanomaterials; 
  • benchmark our regulatory and assessment approach against those of comparable national and international regulatory authorities;
  • harmonise data requirements and assessment methodology, where appropriate;
  • enhance organisational risk assessment capability;
  • educate stakeholders on health, safety and environmental impacts of industrial nanomaterials;
  • monitor industry compliance with NICNAS legislative and administrative requirements.
The regulation of industrial chemicals in Australia distinguishes between those listed on the Australian Inventory of Chemical Substances (AICS) (i.e. chemicals with a prior history of approval and use in Australia) known as 'existing' industrial chemicals, and those not listed on the AICS, known as 'new' industrial chemicals.

In January 2011, and following extensive consultations with stakeholders (both in industry and the public more generally) from 2006 to 2010, NICNAS changed the administrative arrangements for the regulation of 'new' industrial chemicals to provide that nanoforms of these chemicals must be notified and assessed for their safety before they can be marketed. Exemption is subject to very strict criteria.

On the 3rd September 2013, NICNAS posted an electronic copy of its "Handbook for Notifiers", which provides guidance for importers and manufacturers of industrial chemicals in Australia. Appendix H includes guidance and requirements for notification of new chemicals that are industrial nanomaterials, and addresses the following topics:
  • NICNAS working definition of industrial nanomaterial;
  • Exemption categories;
  • Permit categories;
  • Certificate categories;
  • Specified conditions for requesting additional data requirements;
  • Guidance on providing additional data requirements;
  • Guidance on testing health effects of nanomaterials; and
  • Guidance on testing the environmental fate and effects of nanomaterials.
NICNAS continues to build its technical capacity in the identification of potential hazards and in risk assessment methodology, processes and practices to ensure that it takes a precautionary approach in making recommendations about risk mitigation.  NICNAS's specific areas of technical interest include:
  • international best practice in the risk assessment of industrial nanomaterials;
  • toxicity of selected nanomaterials that have been commercialised or are nearing commercialisation. 
  • hazard assessment of titanium dioxide, zinc oxide, cerium oxide and silver nanoforms (a series of publications on these nanoforms is in development).
NICNAS engages with its regulatory and scientific counterparts through multi-lateral forums and bi-lateral arrangements with comparable regulatory authorities. Representatives, of industry, community and academic stakeholder groups are engaged through the NICNAS Nanotechnology Advisory Group (NAG).

Further details of NICNAS's regulatory activity in regards to nanotechnology are available on its website.

The Environmental Protection Authority (EPA) is the government agency responsible for regulatory functions concerning New Zealand's environmental management.  This includes regulating the introduction and use of hazardous substances and new organisms under the Hazardous Substances and New Organisms (
HSNO) Act 1996. 

In June 2012, EPA approved amendments to the Cosmetic Products Group Standard.  Group standards are approvals for a group of hazardous substances of a similar nature, type or use and this group standard is closely based on European Union (EU) legislation.  The amendments include aligning the definitions of some cosmetic products with EU legislation and requiring manufacturers to provide batch and source code information on cosmetic labels, helpful for identifying products subject to a recall.  The amended standard requires that, as of 1st July 2015, the presence of nanomaterials in cosmetic products available in New Zealand must be identified on labelling.  In addition, any person intending to import or manufacture a cosmetic product containing nanoparticles other than zinc oxide or titanium dioxide must, at the time they first import or manufacture the substance, notify the EPA using the form provided on the EPA website.   A list of nanomaterials which have been notified to the EPA is available here.   

Visit the EPA website for further information. 

Recent News Articles
Danish Nano Product Register Order comes into effect

The Danish Order on a register of mixtures and products containing nanomaterials has come into effect.

European Parliament reject proposed amendments to Food Labelling Regulation

The European Parliament has rejected a proposed regulation concerning the provision of food information to consumers as regards the definition of engineered nanomaterials.

German FAQs regarding the safety of cosmetics address nanomaterials

The German Federal Institute for Risk Assessment has posted frequently asked questions regarding the risk assessment of cosmetic products, several of which address nanomaterials.

New ISO vocabulary for nanomanufacturing processes

The International Organization for Standardization has published a new standard which gives terms and definitions related to nanomanufacturing processes.

First edition of the NanoSafety Cluster Newsletter now available

The NanoSafety Cluster, an E.C. initiative to maximise the synergies between FP7 nanosafety projects, has published its first newsletter.

Researchers to develop more realistic models of drug and nanoparticle uptake

Researchers in Nottingham are to develop a more realistic model of drug uptake which could offer a reliable alternative to animal testing methods.

European Parliament calls for adequate consumer protection for goods produced using nanotechnology

European Parliament resolution calls for adequate consumer protection and product safety in the markets for consumer goods produced using nanotechnology.

Concern-driven integrated approaches to nanomaterial testing and assessment

A new publication from the NanoSafety Cluster aims at identifying key areas for further research on risk assessment methodologies for nanomaterials.

Study identifies benefits and potential environmental and health impacts of Lithium-ion batteries for electric vehicles

Life Cycle Assessment highlights ways to reduce global warming emissions and addresses nanotechnology innovations to improve battery performance

Nanosilver quickly breaks down in wastewater, Swiss study indicates

A study conducted under the Swiss National Research Programme has shown that nanosilver is quickly transformed into less problematic substances on its way to the wastewater treatment plant.

Upcoming Events