Regulation and Standards
Nanomaterials are being regulated in Canada under existing legislation including the Canadian Environmental Protection Act, 1999, the Pest Control Products Act, the Fertilizers Act, the Feeds Act and the Food and Drugs Act. It is recognized that, due to the unique properties associated with nanomaterials, the science surrounding the risk assessment of these substances needs to be developed further. To that end, the Federal Government is funding nanomaterial health and safety research within Canada, and actively participating in international efforts to study, quantify and understand the behaviour and toxicity of nanomaterials.
In the 2008 report, Small is Different: A Science Perspective on the Regulatory Challenges of the Nanoscale, the Council of Canadian Academies found that "existing regulatory approaches and risk management strategies are appropriate for the challenges presented by nanomaterials," however, it recommended that more investment be made in strategic risk assessment research.
Environment Canada and Health Canada use the Canadian Environmental Protection Act, 1999 to regulate nanomaterials that are imported or manufactured in Canada. To be more precise, Part 5 of the act establishes a legal regime for the assessment and management of new and existing substances (including nanomaterials), and requires importers or manufacturers of new substances to provide specific information to government officials so that it can be evaluated for potential effects on human health and the environment.
- Proposed Regulatory Framework For Nanomaterials Under The Canadian Environmental Protection Act, 1999
Health Canada regulates a wide range of products and substances that are or could be affected by nanotechnology. Health Canada has authorities within the existing legislative and regulatory frameworks, which include, but not limited to:
- Food and Drugs Act
- Cosmetic Regulations
- Food Additive Regulations
- Food and Drug Regulations
- Medical Devices Regulations
- Natural Health Products Regulations
Health Canada and Environment Canada share responsibility under the Canadian Environmental Protection Act, 1999 to assess threats posed by chemical and other substances and to undertake risk reduction measures where necessary. Environment Canada focuses on risks to the environment, while Health Canada focuses on risks to human health.
Under the Canadian Environmental Protection Act, 1999, Health Canada also assesses the human health risks associated with the use of new substances as well as the environmental risks for substances in products regulated under the Food and Drugs Act. To assess risks, HC scientists look at a number of factors, including type of hazard and level of exposure. Health Canada also plays a role in managing the risks identified, particularly if an Act, administered by Health Canada, would be the place to manage this risk. The Canadian Environmental Protection Act, 1999 serves as a safety net by requiring environmental and health assessments for substances and products that are not subject to premarket notification and assessment under other federal Acts.
Health Canada is announcing the adoption of the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials and its posting on the Health Canada website. The Interim Policy is effective immediately and comments on this policy statement are being collected so that it may be updated as necessary.
Currently, the Acts and Regulations administered by Health Canada have no explicit reference to nanomaterial. Among four key objectives, this policy statement establishes a transparent working means of identifying nanomaterials. It will also provide Health Canada with a consistent set of approaches across the department and a trigger to request information. Given the range of nanomaterial-related regulatory responsibilities at Health Canada, the working definition is intentionally broad and will be applied more specifically in each regulatory program area.
In preparing the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials, Health Canada sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments.
Canada's regulatory systems for food, health and consumer products have served Canadians well over the years. However, recent trends such as advances in science and technology, globalization and changing consumer demands are driving the need for regulatory modernization in Canada and around the world.
OECD Working Party on Nanotechnology (WPN)
The OECD Working Party on Nanotechnology (WPN) was established in March 2007 to advise upon emerging policy issues of science, technology and innovation related to the responsible development of nanotechnology. It is a subsidiary group of, and receives its mandate from, the Committee for Scientific and Technological Policy (CSTP).
The WPN works co-operatively with other OECD groups, including the Working Party on Manufactured Nanomaterials (WPMN, subsidiary to the Chemicals Committee); the Working Party on Biotechnology (WPB); the group of National Experts for Scientific and Technological Indicators (NESTI) and their parent committees.
The WPN meets twice a year. Its most recent meeting took place in Paris on 30 September and 1 October 2010.
OECD Working Party on Manufactured Nanomaterials (WPMN)
The Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) was established in September 2006. The WPMN concentrates on human health and environmental safety implications of manufactured nanomaterials and aims to ensure that the approach to hazard, exposure and risk assessment is of a high, science-based and internationally harmonized standard. Its programme seeks to promote international co-operation on the human health and environmental safety of manufactured nanomaterials and involves the safety testing and risk assessment of manufactured nanomaterials. The WPMN is comprised of delegates from ministries and agencies throughout the world which are responsible for the safety of human health and the environment.
Terminology and Nomenclature
International standardization will play a critical role in ensuring that the full potential of nanotechnology is realised and that nanotechnology is safely integrated into society. Standards will help create a smooth transition from the laboratory to the marketplace, promote progress along the nanotechnology value chain - from nanoscale materials that form the building blocks for components and devices to the integration of these devices into functional systems - and facilitate global trade.
The International Organization for Standardization (ISO) has a nanotechnologies technical committee (ISO TC 229) working towards standardization in the field of nanotechnologies that includes either or both of the following:
- Understanding and control of matter and processes at the nanoscale, typically, but not exclusively, below 100 nonametres in one or more dimensions where the onset of size-dependent phenomena usually enables novel applications,
- Utilizing the properties of nanoscale materials that differ from the properties of individual atoms, molecules, and bulk matter, to create improved materials, devices, and systems that exploit these new properties.
Many of the documents produced by ISO/TC229 will be anticipatory (developed ahead of the technology that act as "change agents" and guide the market) and horizontal (provide underlying support to a technology or range of technologies but are not themselves application specific) as nanotechnology is still in the early stages of development and evolution.
Four categories of standards are being developed; terminology and nomenclature standards provide a common language for scientific, technical, commercial and regulatory processes; measurement and characterisation standards provide an internationally accepted basis for quantitative scientific, commercial and regulatory activities; health, safety and environmental standards will improve occupational safety, and consumer and environmental protection, and promote good practice in the production, use and disposal of nano-materials, nanotechnology products and nanotechnology-enabled systems and products; and materials specification standards will specify the relevant characteristics of manufactured nanoscale materials for use in specific applications.
International Cooperation on Cosmetic Regulation
The International Cooperation on Cosmetic Regulation (ICCR) initiative is a group of cosmetic regulatory authorities from the United States, Japan, the European Union and Canada. The purpose of the multilateral framework of the ICCR is to maintain the highest level of global consumer protection, while minimizing barriers to international trade.
- Date Modified: