1. Why is Health Canada interested in nanomaterials?
A nanomaterial may exhibit different or unfamiliar properties and effects attributable to its nanoscale size that are not observable in the bulk or non-nanoscale counterpart. For example, "bulk" gold is not very reactive, but nanoscale gold can act as a chemical catalyst.1 While these size-related properties promise benefits, they may raise concerns for their potential to cause harm to humans and the environment, and may bring new challenges to assessing their quality, safety, and efficacy. Health Canada's interest is in obtaining information that will improve the understanding of nanomaterials for their risk assessment and risk management. Health Canada's approach will adapt as more information becomes available.
2. Why did Health Canada adopt the Policy Statement on Health Canada's Working Definition for Nanomaterial?
Nanomaterials are increasingly being used in the marketplace in a wide range of regulated substances and products. Health Canada is taking a flexible approach given that the state of science around nanomaterials is evolving as are international norms and consensus on terminology. Health Canada has developed a working definition as a matter of Departmental policy.
A broad working definition provides Health Canada with a consistent approach across several diverse regulatory program areas to identify regulated products and substances that may be or may contain nanomaterials. Importantly, it allows for the Department to ask for information, to establish internal inventories and to integrate that new knowledge into regulatory decision making processes. The first step to assuring adequate risk assessment and risk management is to identify potential nanomaterials using the Working Definition as a tool.
3. Does Health Canada currently regulate nanomaterials?
Yes. While Health Canada Acts and Regulations have no explicit reference to nanomaterial at this time, Health Canada helps protect and promote health by using existing legislative and regulatory frameworks to mitigate the potential health risks of nanomaterials and to help realize their health benefits. Some examples of nanomaterial that fall within the Health Canada's regulatory mandate are described in the table below.
|Name of Nanomaterial||Example of a Regulated Product/Substance|
|Quantum dots||Medical diagnostic agent|
|Nanoscale colloid/emulsion/liposome||Drugs- formulation and delivery|
|Nano silver||Antibacterial coatings (for example (e.g.) bandages, clothing, & surgical instruments)|
|Nano gold||Facial cream|
|Nano titanium dioxide||Sunscreen|
|Nanocrystalline cellulose||Industrial coatings and paints (mechanical reinforcement and optical properties)|
|Single and multi-wall carbon nanotubes||Polymer products (electrical conductivity and mechanical reinforcement)|
|Surface coated nano-silicas||Polymer products and coatings
(increased resistance to wear)
4. What about nanomedicine, is that regulated too?
The Canadian Institutes of Health Research broadly defines nanomedicine as the specialized measurement or intervention - at a molecular scale - needed to treat disease or restore function. This definition is meant to be inclusive of techniques and methodologies relevant to health research that do not necessarily fit within the more narrow definitions of nanotechnology or nanomaterials. Outside of assessing possible contaminants or by-products of manufacturing products, Health Canada does not regulate technologies, or whole areas of medicine, but focuses on its regulatory responsibilities regarding substances, products, and applications of technology.
At Health Canada, nanomedicines are regulated within the existing legislative and regulatory frameworks. For example, Health Canada applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act so that the pharmaceutical drugs and medical devices offered for sale in Canada are safe, effective and of high quality. The current Acts and Regulations administered by Health Canada have no explicit reference to nanomaterial.
5. Is Health Canada's Working Definition of Nanomaterial a regulatory definition?
The Working Definition is not technically a regulatory definition as it is not written in regulations, however, it is applied within the existing legislative and regulatory frameworks. A key objective is to identify nanomaterials for information gathering. Specific regulatory programs across the Department may request information from manufacturers/sponsors for risk (and benefit) assessment, and to provide assistance to manufacturers/sponsors and other stakeholders to meet their current statutory obligations. The Working Definition is not an additional source of authority.
6. How is Health Canada addressing worker safety in regards to nanomaterials?
The objective of the Workplace Hazardous Materials Information System (WHIMS) is to ensure the protection of Canadian workers from the adverse effects of hazardous materials through the provision of health and safety information. Under WHIMS, the Controlled Products Regulations (CPR) set out criteria for chemical and biological hazards, and acute and chronic toxicity. While there are currently no specific hazard criteria based on particle size, a product containing a nanomaterial would be covered under WHIMS if it falls within any of existing hazard criteria in the CPR; a WHMIS "controlled product" is then subject to supplier labelling and Material Safety Data Sheet (MSDS) requirements. In addition to specified categories of chemical and toxicity information, the MSDS must also disclose all hazardous ingredients, their hazards (including those specifically attributable to particle size) and the health and safety measures (including engineering controls and personal protective equipment such as the specific type of respirators), that workers need to protect themselves.
Note: Although Health Canada, through its National WHMIS Office, has a governing role for WHMIS, under Canada's constitution, labour legislation falls primarily under the jurisdiction of Canada's provinces and territories. Health Canada itself is not an occupational health and safety (OHS) regulator. As such, each Federal, Provincial and Territorial (FPT) agency responsible for OHS in Canada has established the interlocking employer WHMIS requirements. These requirements place an obligation on employers to ensure that controlled products used, stored and/or handled in the workplace are properly labelled, that MSDSs are readily available to workers, and that workers receive education and training to ensure the safe storage, handling and use of these products. It is also each OHS regulator that establishes occupational exposure limits within its jurisdiction.
7. Who did Health Canada consult with to develop the Policy Statement on Health Canada's Working Definition for Nanomaterial?
In late 2009, Health Canada adopted the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials (Interim Policy Statement) and posted it on the Health Canada website on March 1, 2010 for a six month public comment period. The revisions to the current Policy Statement on Health Canada's Working Definition for Nanomaterial were based on the comments received through the open consultative process, as well as developments in international norms, evolving scientific evidence, and regulatory program needs. For more information, please refer to the "Summary of Comments Received on the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials - March 1 to August 31, 2010", which is posted along with these frequently asked questions.
8. Does Health Canada take a precautionary approach to nanomaterials?
Taking a precautionary approach is key to fostering the development and inclusion of new knowledge into decision making. The precautionary approach is part of the Canadian Environmental Protection Act, 1999, the Pest Control Products Act, and is referenced in the Canada Consumer Product Safety Act which will further support existing authorities to collect information regarding nanomaterial for the assessment of potential health risks and benefits.
Over the next few years, Health Canada will take an incremental approach to address regulatory, science and policy needs while allowing for the integration of new scientific evidence as it becomes available. Health Canada's principle interest is in obtaining information that will improve the understanding of nanomaterials for risk assessment and risk management purposes.
9. Did Health Canada consider other definitions of nanomaterials when developing the Policy Statement on Health Canada's Working Definition for Nanomaterial?
Yes. A multitude of nanotechnology-related definitions exists for scientific, public, and decision making objectives2 . There are many definitions for nanomaterials. Health Canada considered recent international developments such as those of the International Organization for Standardization, the Organisation for Economic Cooperation and Development, and the European Commission. The Department also considered the approaches of other regulators, such as in the United States of America, Australia, and the European Union. Domestically, Health Canada liaised with federal organizations, including Environment Canada, the National Research Council, the Canadian Institutes for Health Research, the Public Health Agency of Canada, and the Canadian Food Inspection Agency. The Policy Statement will continue to be updated as the body of scientific evidence evolves and as international norms progress; at this time it remains a Departmental Policy on a working definition in order to maintain flexibility.
10. Will the Policy Statement on Health Canada's Working Definition for Nanomaterial be used by other Canadian federal departments or agencies?
The Policy Statement addresses Health Canada's broad regulatory responsibilities and integrates key elements of international definitions. The Pest Management Regulatory Agency is a branch of Health Canada and as such, has adopted the Policy Statement. Health Canada and Environment Canada regulatory programs that share responsibility under the Canadian Environmental Protection Act (CEPA), 1999 work together and share a similar focus in its application. Health Canada and the Canadian Food Inspection Agency will also take a similar approach to the application of the Policy Statement for shared responsibilities under the Food and Drugs Act. In the future, it is possible that other federal organisations may choose to adopt the Policy Statement and/or its Working Definition. Health Canada will continue to work with Canadian federal organizations in support of a consistent federal approach.
11. Why doesn't Health Canada simply adopt the definition for nanomaterial described by the International Organization for Standardization (ISO)?
Terms defined by ISO represent current international consensus. In its Working Definition, Health Canada modified the ISO term "material" to describe both substances and products of interest to Health Canada. The Department wishes to collect information about potential "size-related" risks and benefits (where applicable) for informed risk assessments. By having information regarding material size available, it may be possible to classify materials, indications, applications or other general categories that may require additional analyses, and distinguish them from those that do not pose additional size-related risk. Through the development of accurate internal databases, risk assessors at regulatory agencies would be well-positioned to increase the knowledge related to the safety of nanomaterials. Question 12 below describes similarities between the two definitions.
12. Are there similarities between the ISO definition for nanomaterial and Health Canada's Working Definition?
There are a number of similarities between the two definitions. ISO defines nanomaterial as a material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale. Health Canada's Working Definition of Nanomaterial - Section 4.1; Part a) states that a "manufactured substance or product and any component material, ingredient, device, or structure is a nanomaterial if it is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale". This concept correlates with that communicated in the ISO definition: Both describe a nanomaterial as having at least one dimension in the 1 - 100 nm range (e.g. nanoparticle, nanofibre, and nanofilm) or a material that has structure in the 1 - 100 nm range (e.g. porous and fibrous materials). Furthermore, ISO defines the nanoscale as the size range from approximately 1 nm to 100 nm. Application of the term "approximately" or "typically" in a regulatory context is challenging, thus Health Canada elected to define the nanoscale as an absolute range of 1 - 100 nm, inclusive. However, based on the current state of knowledge, it is possible that a nanomaterial with potential "nanoscale properties/phenomena" may fall outside this size range and would be excluded from Part a). Therefore, Section 4.1, Part b) is meant to capture these nanomaterials.
Section 4.1; Part b) focuses on nanomaterial that is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena. Nanoscale properties/phenomena" refer to properties which are attributable to size and their effects. This term relates to nanomaterial that exhibits different properties attributable to size (e.g. a substance that acts as a chemical catalyst at the nanoscale 3 ) or demonstrates biological effects due to the size-related properties (e.g. interaction with select immune cells4 ), when they are distinguishable from those of individual atoms, molecules and their typical form/bulk material. At Health Canada, risk (and benefit) assessments of nanomaterials are conducted within program areas on a case-by-case basis.
13. What are some examples of properties which are attributable to size and their effects?
From Health Canada's perspective, a material that falls within the range of 1 - 100 nm in at least one dimension is not necessarily a nanomaterial. Furthermore, a nanomaterial is not any arbitrary material that falls within the range of 100 - 1000 nm. Some of these materials do not have "unusual" properties/phenomena.
Some examples of properties attributable to size and their effects which could be of interest in a risk/benefit assessment context include the following5 :
|Catalytic:||Better catalytic efficiency through higher surface to volume ratio|
|Electrical:||Increased electrical conductivity in ceramics and increased electrical resistance in metals|
|Magnetic:||Increased magnetic coercivity up to a critical grain size, super magnetic behaviour|
|Mechanical:||Improved hardness and toughness of metals and alloys, ductility and super plasticity of ceramic|
|Optical:||Spectral shift of optical absorption and fluorescence properties, increased quantum efficiency|
|Sterical:||Increased selectivity, hollow spheres for specific drug transportation and controlled release|
|Biological:6||Increased permeability through biological barriers (blood-brain) and improved biocompatibility|
14. Does Health Canada set one threshold value for size distribution of nanomaterial?
No. Based on current knowledge, Health Canada is unable to set a single nanomaterial size distribution threshold, a content threshold by weight, or a threshold for volume specific surface area (VSSA) for all nanomaterials that Health Canada regulates. However, as information becomes available, program-areas may establish such threshold values consistent with their regulatory responsibilities and international norms.
15. Is Health Canada focussing on manufactured nanomaterials?
The term "manufactured" in the Policy Statement on Health Canada's Working Definition for Nanomaterial includes engineering processes and control of matter that lead to the synthesis, generation, fabrication or isolation of nanomaterials. Health Canada may request information for risk assessment and risk management purposes regarding a deliberately or incidentally manufactured nanomaterial. The term also includes natural components that have been deliberately used or engineered to have nanoscale properties/phenomena.
16. What type of information regarding nanomaterials might Health Canada request?
As per Section 7 "General Guidance" of the Policy Statement on Health Canada's Working Definition for Nanomaterial, in order to identify and assess potential risks and benefits (where applicable) of nanomaterials, the Department may require the following types of information, when relevant:
Future guidance documents that are specific to regulatory program areas will be developed in a manner that is both consistent with the Policy Statement and in accordance with the unique parameters of program-specific legislative and regulatory authorities.
Health Canada is working to make public participation part of policy development. If you would like more information, please consider any of the options below.
Address Locator 0900C2,
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Science Policy Directorate, Health Canada,
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1 Zhou, X.; Xu, W.; Liu, G.; Panda, D.; Chen, P. Journal of the American Chemical Society (2009), Vol 132, 138-146. b) Sardar, R.; Funston, A. M.; Mulvaney, P.; Murray, R. W. Langmuir (2009), Vol 25, 13840-13851.
2 L.P. Balogh, Why do we have so many definitions for Nanoscience and Nanotechnology? Nanomedicine: NBM 2010;6:397-398.
3 a) Zhou, X.; Xu, W.; Liu, G.; Panda, D.; Chen, P. Journal of the American Chemical Society (2009), Vol 132, 138-146. b) Sardar, R.; Funston, A. M.; Mulvaney, P.; Murray, R. W. Langmuir (2009), Vol 25, 13840-13851.
4 Anne-Marie Caminade, CÚdric-Olivier Turrin and Jean-Pierre Majoral. New Journal of Chemistry 2010, 34, 1512-1524
6 The term "biological" in this context does not refer to the outcome of toxicological study, rather it refers to a specific interaction between a nanomaterial and biological material.