Policy Statement on Health Canada's Working Definition for Nanomaterial
Health Canada is 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 addition, the National Office of the Workplace Hazardous Materials Information System operates through Health Canada. Nanomaterials are increasingly being used in the marketplace in a wide range of these products and substances. 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. However, it is recognized that new approaches may be necessary in the future to keep pace with advances in this area as there is inadequate information on risks associated with nanomaterials at this time.
This Policy Statement describes Health Canada's Working Definition of Nanomaterials and elaborates on its objectives, scope and application. It is intended to be used as a tool to help the Department gather safety information about nanomaterials.
The objectives of this Policy Statement are to:
- Establish a working means of identifying nanomaterials;
- 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;
- Support communications about nanomaterials with the broader community of interested stakeholders; and,
- 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.
Nanomaterials that are manufactured and intended to be sold or represented for use as, or as part of a regulated product or substance, or that otherwise fall within Health Canada's mandate, are within the scope of this Policy Statement.
4. Policy Statement
4.1 Health Canada's Working Definition of Nanomaterial
Health Canada considers any manufactured substance or product and any component material, ingredient, device, or structure to be nanomaterial if:
- It is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale, or;
- It is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.
For the purposes of this definition:
- The term "nanoscale" means 1 to 100 nanometres, inclusive;
- The term "nanoscale properties/phenomena" means properties which are attributable to size and their effects; these properties are distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and,
- The term "manufactured" includes engineering processes and the control of matter.
The Working Definition is not an additional source of authority, but works within the existing regulatory frameworks that allow for obtaining information.
Information is submitted to Health Canada regulatory programs as required by legislation and their associated regulations. Within these legislative and regulatory frameworks, Health Canada may request specific information (see Section 6) for a regulated substance or product that is, or contains, a nanomaterial as described in the Working Definition.
The term "manufactured" includes engineering processes and control of matter that lead to the synthesis, generation, fabrication or isolation of nanomaterials. Health Canada may request information regarding a deliberately or incidentally manufactured nanomaterial for risk assessment purposes. This term also includes natural components that have been deliberately used or engineered to have nanoscale properties/phenomenaFootnote 1Footnote 2 used in nanoscale encapsulation of bioactive compoundsFootnote 3, or used in tissue engineeringFootnote 4.
"Part a" of the Working Definition relates to current evidence suggesting that nanoscale properties/phenomena are more likely observable at the scale of 1-100 nanometres (more often at the lower end)Footnote 5 and "Part b" reflects that it is possible for nanoscale properties/ phenomena to be exhibited outside this size range, such as select quantum devicesFootnote 6.
A variety of lexicons and interpretations of "nano-terminology" currently exist, underlining the importance of understanding the context in which these terms are used. In the risk assessment context supporting hazard and exposure assessment for risk characterization and management, the term "nanoscale properties/phenomena" refers to size-related properties which have qualities or characteristics that do not readily extrapolate from those observed in individual atoms, molecules or bulk materials. For example, "bulk" gold is not very reactive, but nanoscale gold can act as a chemical catalystFootnote 7. For risk assessment purposes, this term includes observable biological or environmental effects resulting from size-related properties as described above. Examples of such biological or environmental effects could be increased permeability through cell membranesFootnote 8 or increased reactivity of iron/iron oxides for the purposes of groundwater remediationFootnote 9, respectively.
Internal or surface structures at the nanoscale include nanomaterials that are aggregated or agglomerated to form a larger group. While the break-up of aggregates is less likelyFootnote 10, a larger group could be broken down into component nanomaterials in the human body or the environment. Some regulatory programs may request information above the 100 nm size range to an upper limit of 1000 nm in order maintain flexibility to assess potential nanomaterials, including suspected nanoscale properties/phenomena. The 1000 nm cut-off attempts to separate characteristics attributable to macro-scaled materials from those of nanomaterials. However, a product or substance that contains nanomaterial could measure beyond 1 micron in size (for example (e.g.) bundles of carbon nanotubes that are very long). In these cases, regardless of the size, information may be requested for risk assessment purposes.
In addition to requesting information about nanomaterials, information regarding particles above the 100 nm size range may also be requested by some regulatory programs to assess possible biological effects that could be attributable to their dimension or sizeFootnote 11. These approaches may be applied on a case-by-case basis or to a whole product class.
While not expressly stated in the Working Definition, information regarding nanomaterial size distribution, especially number size distribution, is also relevant for risk assessment purposes.
Currently, there is insufficient evidence to establish common threshold values for size distributions of relevance across all substances and product lines that Health Canada regulates.
5.1 Application of the Policy Statement
This Policy Statement is to be applied in specific regulatory contexts across the Department to support the assessment of nanomaterials and to provide assistance to manufacturers and other stakeholders in meeting their respective statutory obligations for the health and safety of Canadians, pursuant to applicable Acts and Regulations including, but not limited to, those stated in Appendix A. Other sources of definition provide context for the application of this statement, including the sources listed in Appendix B.
The state of science around nanomaterials is evolving. Nanomaterials typically have increased surface-to-volume ratio and may exhibit changes in other properties (such as electrical, mechanical, or optical) due to nanoscale size as compared to their non-nanoscale counterparts. These nanoscale properties and their effects could raise concerns for their potential to cause harm to humans and the environment. In general, current risk assessment methodologies are applicable for nanomaterials as they allow for sufficient flexibility.Footnote 12 However, the first step to assuring adequate risk assessment is to identify nanomaterials using the Working Definition as a tool. Health Canada guidance documents for nanomaterials specific to products, substances or commodity groups will be developed over time.
Maintaining a flexible approach is important to integrate new knowledge about risks and benefits related to nanomaterials into regulatory decision-making processes. The Working Definition intentionally casts a wide net so that diverse program areas and legislative and regulatory authorities across Health Canada can request and collect necessary information for nanomaterials characterization and nanoscale measurement, as described in the general guidance section.
The Policy Statement will continue to be updated as the body of scientific evidence increases and international norms progress. Comments specific to this Policy Statement can be sent to email@example.com.
The Department will apply the appropriate precautionary approachesFootnote 13 as may be warranted, according to the best available information.
Furthermore, Health Canada encourages manufacturers and other stakeholders to communicate with the Department early in the development process, especially for combination products that are, contain or make use of nanomaterials. For additional guidance regarding any elements of the working definition and to address specific questions, consultation with the individual program areas is recommended.
5.2 Explanatory Note
This Policy Statement, and more specifically the Working Definition, is applied under existing regulatory authority to gather information, as required, in a transparent and consistent manner across different Health Canada regulatory programs. Health Canada's interest is in obtaining information that will improve the understanding of nanomaterials for risk assessment and risk management purposes.
The Department's current interest mainly lies with determining what potentially unfamiliar or different properties and their effects may be evident in nanomaterials that are not observable in the "bulk" form, and are different from the properties of individual atoms and molecules. Many biological substances, structures and processes are at the nanoscale.Footnote 14 Materials that either naturally exist within the nanoscale size range, or exhibit nanoscale properties/phenomena in nature will not automatically be re-classified as nanomaterials (e.g. naturally occurring chemical or biological molecules like nucleic acids/DNA/proteins, micro-organisms or cell structures like flagella or ribosomes, etc). Health Canada currently regulates some biotechnology-based health productsFootnote 15, and at this time, Health Canada has no reason to reconsider those products as nanomaterials if they simply fall within the nanoscale. However, an example where a natural macromolecule would be considered to be a nanomaterial is the class of Ribonucleic acid (RNA) nanostructures designed specifically to achieve higher order structures, and ultimately, increased functionality.Footnote 16
This approach does not necessarily imply that all nanomaterials represent an increased risk to human health or the environment given that human and environmental risk and benefit depend on the precise biological effects of the specific nanomaterial in concert with how it is used or consumed, who it is used by, and its transportation, transformation and persistence in humans and the environment. Impacts of some nanomaterials may be similar to their non-nanoscale counterparts. In addition, risks may be mitigated through formulation and packaging, the way the substances and products are used in the workplace and in the marketplace, and the manner in which they are disposed.
Health Canada will continue to work closely with domestic and international partners toward consistency with relevant international norms.
Health Canada has authorities within existing legislative and regulatory frameworks, including those listed in Appendix A, to require the submission of information that is essential to the assessment of potential risks to the health and safety of Canadians.
7. General Guidance
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:
- Intended use, function and purpose of the nanomaterial, and information regarding any end product in which it will be used;
- Manufacturing methods;
- Characteristics, and physical chemical properties of the nanomaterial such as:
- structural integrity,
- catalytic or photo-catalytic activity,
- particle size/size distribution,
- electrical/mechanical/optical properties,
- surface-to-volume ratio,
- chemical reactivity,
- surface area/chemistry/charge/structure/shape,
- water solubility/dispersibility,
- agglomeration/aggregation (or other properties), and
- descriptions of the methods used to assign these determinations;
- Toxicological, eco-toxicological, metabolism and environmental fate data that may be both generic and specific to the nanomaterial if applicable; and,
- Risk assessment and risk management strategies, if considered or implemented.
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.
8. Effective date
This is effective October 6, 2011.
Appendix A - Acts and Regulations
The Department of Justice Canada hosts an on-line consolidation of Acts and Regulations of Canada at Justice Laws website.
Information about Health Canada programs is available on the Health Canada website. General inquiries and those regarding a specific regulatory program can be directed to:
Address Locator 0900C2 ,
Ottawa, Ontario K1A 0K9;
Telephone: 613 957 2991;
Toll Free: 1 866 225 0709;
Facsimile: 613 941 5366.
This Policy Statement will be applied pursuant to Acts and Regulations which are relevant to nanomaterials at Health Canada, which include but are not limited to:
- Food and Drugs Act
- Cosmetic Regulations
- Food and Drug Regulations
- Medical Devices Regulations
- Natural Health Products Regulations
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations
- Canada Consumer Product Safety Act
- Canadian Environmental Protection Act 1999
- New Substances Notification Regulations (Chemicals and Polymers)
- New Substances Notification Regulations (Chemicals and Polymers)
- Hazardous Products Act
- Controlled Products Regulations
- Controlled Products Regulations
- Pest Control Products Act
- List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern
- Pest Control Products Regulations
Appendix B - Other Sources of Definitions
- Standards or technical specifications, particularly the standards or technical specifications for nanotechnology established by the International Organization for Standardization Technical Committee 229Footnote 17 (ISO TC 229)
- Intellectual property, as described in the International Patent Classification or in the United States Patent Classification
- Canadian governmental guidance or regulatory definitions, as developed by Federal Departments and Agencies, and international regulatory guidance or regulatory definitions, as developed by peer regulators and/or competent national authorities in other nations and jurisdictions, including the Organization for Economic Cooperation and Development.
- Descriptive lists and examples based on Health Canada's experience and precedent, gathered through operations of applicable Canadian legislative and regulatory frameworks
Appendix C - Other References and Edit History
In addition to the footnoted references, the following documents were considered in the drafting of this document:
- Wolfgang Luther (editor). Technology analysis Industrial application of nanomaterials - chances and risk. Future Technologies No. 54, August 2004 ISSN 1436-5928;
- Guidance manual for the testing of manufactured nanomaterials, Organisation for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (ENV/JM/MOMO92009)20/REV;
- ISO/TS 80004-1:2010, Nanotechnologies - Vocabulary - Part 1: Core terms;
- Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Manual of Policies and Procedures, Reporting Format for Nanotechnology-Related Information in chemistry, manufacturing, and controls (CMC) Review 2010-06-03;
- Draft Scientific Opinion: Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed. European Food Safety Authority, 2011; and
- Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology Guidance for Industry U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner June, 2011 (FDA-2010-D-0530).
Edit History: After internal senior management approval, the first version of the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials was adopted by Health Canada and posted for comment as part of a public web-based consultation from March 1 to August 31, 2010. This version 2 was approved and posted on the Health Canada website on October 6, 2011.
Consultation History: After informal consultations were held during its development, public consultation on the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials was initiated on March 1, 2010 with its posting on the Health Canada website. In addition, over 3000 individuals, organizations and regulatory authorities were contacted via e-mail in order to ensure an opportunity for stakeholders with a diverse range of interests to comment. The comment period ended August 31, 2010. A total of 29 submissions were received by Health Canada, with the majority of comments originating from companies or industry groups. Health Canada also received input from two Canadian government bodies, academics, public interest groups, media, as well as interested individuals. This version of the Policy Statement was developed in response to comments received, international norms, current regulatory program needs and evolving scientific evidence.
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