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Revision of Health Canada's Guidelines for the Safety Assessment of Novel Foods
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(PDF Version - 40 KB)July 2003,
Health Canada Public Consultation
Introduction | Guidelines | Part 1 | Part 2 | Part 3 | Appendix 1 | Appendix 2 | Appendix 3
Part I
REGULATING AND ASSESSING NOVEL FOODS
Table of Contents
1.3 What are the procedures for determining whether or not a food is novel?
1.4 How are assessments conducted and final decisions made?
1.5 What are the criteria for assessing the safety of a novel food?
Federal responsibility for the regulations dealing with foods, including novel foods, sold in Canada is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds.
The mechanism by which the sale of novel foods is controlled in Canada is through a mandatory pre-market notification requirement stipulated in the Food and Drug Regulations. The part of the regulations that deals explicitly with novel foods is Division B.28, " Novel Foods". These regulations were promulgated in 1999.
Prior to the promulgation of the regulations on novel foods in October 1999, guidelines were published that describe the voluntary notification procedure and safety assessment criteria for novel foods derived from microorganisms and plants. As committed in the Government of Canada's Action Plan, Health Canada is updating its guidelines for novel foods derived from plants and microorganisms and developing guidelines for the safety assessment of novel foods derived from animals.
The current consultation focuses on the document entitled "Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms (June 2003 revised version)". While the document builds upon the original guidelines published in 1994, significant revisions are proposed to reflect:
- the promulgation of the regulations on Novel Foods which introduced changes to the definition of novel foods and made the pre-market notification process mandatory;
- the experience gained over the past eight years of conducting safety assessments of novel foods derived from microorganisms and plants in Canada; and
- relevant national and international developments in the area of safety assessment of novel foods.
The proposed revised guidelines include information on the pre-market notification requirement, more explicit guidance on the safety assessment data requirements for the different categories of novel foods derived from microorganisms and plants, and the latest international guidance in the area of the safety assessment of foods derived from biotechnology.
In addition, Part II of the consultation is designed to provide information and seek opinions and recommendations on broad issues related to the context under which novel foods are regulated in Canada. Furthermore, as a preamble to future consultations on the assessment criteria for novel foods derived from animals, we would also like your opinion on the topic of foods derived from cloned animals. This topic is covered in Part III of the consultation.
We are particularly interested in learning what changes in how novel foods are regulated in Canada interested Canadians - whether producers, importers, industry associations, provincial and territorial governments, special interest groups, health professionals, academics and consumers - would like to see.
Comments received will be used to finalize Health Canada's Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms and to further refine relevant policies and regulations that need to be updated, improved or clarified. This is your chance to provide input on the framework for the control of novel foods in Canada. Please let us know your views.
A range of factors, including advances in food science and technology, globalization of the food supply as well as socio-cultural considerations, have resulted in the diversification of the Canadian food supply. In view of these changes, Health Canada has put in place a process for the regulation of novel foods to ensure consumer safety while permitting continued development and importation of new and safe food products into Canada.
With the promulgation of the Novel Foods regulations in October 1999, foods that are considered novel are subject to mandatory pre-market notification (see Appendix I) . Notifying Health Canada prior to the sale or advertisement for sale of a novel food may be a one or a two step process depending on the complexity of the product. In the first step, the manufacturer or importer (hereafter referred to as the proponent) must notify Health Canada of the intention to sell or advertise for sale a novel food in Canada and address the basic information requirements outlined in the regulation. Depending on the nature of the novel food, the process may involve a second step which is the submission of a detailed safety assessment package.
This part of the consultation document provides background information on selected aspects of Health Canada's Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms (June 2003 revised version) to facilitate the submission of comments on these revised guidelines.
1.1 What is a novel food?
The regulations require proponents of foods with a significant level of novelty to notify Health Canada prior to the sale or advertising for sale of these foods in Canada. Foods considered as novel foods under these regulations fall under the following three categories:
A. Substances with no history of safe use as a food - A substance may be considered to have no history of safe use as a food if it has not been part of the diet for several generations in a representative population and used in ways as well as at levels that are similar to those expected or intended after its introduction into the Canadian food supply. If a history of safe use cannot be established, data would be required to assess the nutrition and safety concerns.
Examples: The use of a fungal protein source or parts of a marine species not previously exploited for food use may be examples of products with no history of safe use.
B. Foods produced by novel processes - A novel process refers to a method of manufacturing, preparing preserving or packaging that has not been previously used on a food with a history of safe use. The application of such a process to a food which results in a major change to the food would require notification. A food would be considered to have undergone a "major change" if its compositional, nutritional, physiological, chemical or microbiological characteristics were altered so as to place the food outside the generally accepted limits of natural variation for these parameters.
Example: Example of such novel foods would be eggs processed by in-shell pasteurization or apple cider processed by UV-light to reduce the bacterial load.
C. Foods derived from genetically modified organisms - A novel food could also be a food derived from a microorganism, a plant or an animal that has been genetically modified such that the organism exhibits characteristic(s) that were previously not observed in that organism, that are no longer observed in that organism, or that no longer fall in the anticipated range for that specific organism.
It is important to note that the trigger for notification is the change to the food product as opposed to the technique used to introduce the change. Genetic changes can be achieved through the use of a variety of genetic manipulation techniques. Consequently, this category of novel foods captures foods not only derived through modern techniques, such as recombinant nucleic acid methods (also often referred to as genetic engineering) but also through more traditional breeding or selection techniques.
Examples: Examples of novel foods falling into this category include such products as a corn line expressing an insect tolerance trait obtained by a recombinant nucleic acid technique, oils derived from herbicide tolerant canola lines obtained by either a recombinant nucleic acid technique or mutagenesis*, and oil derived from a soybean line with a reduced linolenic acid content obtained from selective breeding*. (Note: the asterisk (*) indicates plant lines obtained by traditional breeding techniques.)
1.2 What is not a novel food?
New food formulation using familiar ingredients
Many food products are simply new formulations of otherwise familiar ingredients which do not fall within any of the novel food categories (for example, a chocolate bar with a new flavour made using an ingredient that is already commonly used in Canada). For this reason, the majority of new food products commercialized every year in Canada are not considered to be novel foods.
Products subject to pre-market safety evaluation requirements under other Divisions of the Food and Drug Regulations
To avoid duplication, submissions for products subject to other divisions of the Food and Drug Regulations that require pre-market safety evaluations (i.e., food additives, infant formulas and irradiated foods) are not also required to meet the pre-market requirement for novel foods. However, the use of a novel ingredient in a product subject to pre-clearance requirements (e.g., infant formula) may require an assessment of the major change in the novel ingredient first and then the assessment of the overall food product can be finalized.
1.3 What are the procedures for determining whether or not a food is novel?
Pre-notification consultation
Proponents have the responsibility for providing notification that their product is a novel food. If a proponent is unsure of the status of a product, a pre-notification consultation with the Novel Foods Section (formerly Office of Food Biotechnology) is encouraged to determine whether or not they need to submit a pre-market notification to Health Canada. As the coordinating office, the Novel Foods Section is responsible for communicating with proponents, receiving notifications and submissions, and initiating the review process for a novel food (See section 1.4 of this document for more information on the Novel Foods Section).
In cases where notifications may be required by Health Canada and other regulatory department(s), for example, where a novel food is derived from a genetically modified crop intended to be grown and used as animal feed in Canada, a joint pre-notification consultation with all relevant regulatory departments is advised. This is to ensure all regulatory requirements are met. This is particularly important considering Health Canada's and the Canadian Food Inspection Agency's new policy regarding the coordination of regulatory decisions (See section 2.1 of this document for more information regarding this policy).
Food Rulings Committee Consideration
If, after consultation with other relevant bureaus of the Food Directorate, the Novel Foods Section cannot determine whether a food product should be regulated as a novel food, guidance will be sought from the Food Rulings Committee (See Appendix II for the terms of reference for the committee).
Point(s) of Consultation:
The purpose of the Novel Foods regulations is to ensure that the safety of all novel foods entering the Canadian marketplace is assessed by Health Canada prior to marketing. The purpose of the revised guidelines is to clarify which foods require pre-market notification, to detail the information that must be submitted to Health Canada and to define the relevant timelines.
Point # 1:
a. How could the clarity of the information about the mandate and legislative authority of Health Canada provided in section 1 of the revised guidelines be improved?
b. How could the clarity of the information regarding the mandatory pre-market notification for novel foods and associated time frames outlined in section 2 of the revised guidelines be improved?
Point # 2:
a. Do the revised guidelines provide enough guidance concerning what is and is not considered a novel food? (See sections 1.3, 4.1.1 - 4.1.3 and 4.2.1 - 4.2.3 of the revised guidelines.) Please indicate which section(s) need improvement and how the clarity and comprehensiveness of the specific section(s) could be improved.
b. How could the guidance provided in the revised guidelines on the concept of novelty as a trigger for pre-market notification be improved? Please consider the following three categories:
- substances with no history of safe use as food (N.B. The definition of the concept of "history of safe use " is new and comments on the latter are particularly requested)
- foods derived from application of novel processes
- foods derived from genetically modified organisms (either through the use of conventional or more modern techniques)
1.4 How are assessments conducted and final decisions made?
The Novel Foods Section is responsible for communicating with proponents, receiving notifications and submission material, and initiating the assessment process for a novel food. Upon receipt, documentation is distributed to scientific evaluators in the relevant Food Directorate bureaus for assessment. In some cases, the Environmental Assessment Unit, Healthy Environments and Consumer Safety Branch will be asked to conduct environmental assessments of novel foods pursuant to the New Substances Notification Regulations under the Canadian Environmental Protection Act (CEPA). All requests for obtaining additional information from proponents are also communicated through the Novel Foods Section, ensuring a single window approach to submission reviews.
When the assessment teams agree on a conclusion regarding a submission, a proposal that includes a summary of the multi-disciplinary scientific review is drafted for consideration by the Food Rulings Committee. This committee is the decision-making forum for all risk management decisions related to foods, including the consideration of new regulatory initiatives, food additives and novel foods (See Appendix II of this document for the terms of reference of the committee).
If the proposal is found acceptable by the committee, the proponent is notified in writing by the Director General of the Food Directorate that the Department has no objection to the sale of the novel food in Canada. This decision is then made public through the posting of this decision, along with a decision document which summarizes key considerations of the safety assessment, on the website of Health Canada (http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/index-eng.php).
A diagram illustrating how novel food are assessed and final decisions are made by Health Canada is provided in Appendix III of this consultation document.
Point(s) of Consultation:
Section 2.5 of the revised guidelines outlines Health Canada's standard operating procedures for conducting safety assessments and making final determinations regarding novel foods.
Point # 3:
a. How could the clarity of section 2.5 of the revised guidelines be improved?
b. What additional information on the safety assessment and decision-making processes would you like to see in this section of the guidelines? Please explain your answer.
1.5 What are the criteria for assessing the safety of a novel food?
The safety assessments conducted by Health Canada's scientific evaluators follow a stepwise process of addressing factors that include:
- History of use
- Dietary exposure
- Detail of novel process
- History of an organism(s)
- Characterization of modified line/strain
- Genetic modification considerations
- Nutritional considerations
- Toxicology considerations Allergenicity considerations
- Chemical considerations
- Microbiological considerations
For novel foods derived from a new process or novel foods derived from genetically modified organisms, safety assessments are conducted through a comparative approach. In these situations, there is a conventional food with a history of safe use (i.e., a counterpart for comparison) which provides a template for examining the effects of the process or modification on the novel food. The goal of the assessment is to identify any new or altered safety and nutritional characteristics in the food and determine their relevance to human health.
For novel foods with no history of safe use, no conventional food would be available to guide the safety assessments. In these circumstances, the assessment would take into consideration factors such as taxonomy, habitat, history of the source, and how it is intended to be used in the diet. Experimental studies would also be required to assess the safety and nutritional quality of the proposed food.
Experiments intended to generate data to demonstrate the safety of a novel food should be designed and conducted in accordance with sound scientific principles. In all cases, experimental protocols and raw data have to be submitted by the proponent to Health Canada for examination.
With the wide range of products included in the different categories of novel foods, it is important to note that the information necessary for determining the safety and nutritional quality of a novel food will vary from one case to another.
Point(s) of Consultation:
The revised guidelines describe the requirements for all three categories of novel foods: substances with no history of safe use as food, application of novel processes to existing foods and foods derived from genetically modified organisms. For the latter category, care was taken for the revised guidelines to reflect the risk analysis principles and safety assessment guidelines developed by the Codex Ad Hoc Intergovernmental Task Force of Foods derived from Biotechnology .
Point # 4:
- substances with no history of safe use
- foods derived from application of novel processes
- foods derived from genetically modified organisms (either through the use of conventional or more modern techniques)
Point # 5:
Given the approach described in this section (section 1.5) and relevant sections of the revised guidelines, when would it be appropriate to consider a previously approved novel food as a suitable counterpart for comparison in the safety assessment of a proposed novel food?
Point # 6:
How could the clarity of the revised guidelines on the use and specific assessment considerations for antibiotic resistance marker genes be improved?
Point # 7:
How could these sections of the revised guidelines be improved with respect to format, content, readability and consistency with international guidance?
1 Those products are regulated under the Seeds Act, the Plant Protection Act, the Health of Animals Act, the Fertilizers Act and the Feeds Act.
2 Guidelines for the Safety Assessment of Novel Foods, Volume I: Preamble and Guidance Scheme for Notification. Guidelines for the Safety Assessment of Novel Foods, Volume II: Genetically Modified Microorganisms and Plants (Health Protection Branch, 1994)
http://www.hc-sc.gc.ca/fn-an/gmf-agm/index-eng.php
3 Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (http://www.hc-sc.gc.ca/sr-sr/pubs/index-eng.php#1).
4 The Food Rulings Committee is a management committee of senior officials representing all bureaus in the Food Directorate. Representatives from several organizations within Health Canada and the CFIA are invited to participate in discussions of the committee. The committee oversees and directs the development of regulatory and policy proposals related to food safety and nutritional quality by the Food Directorate bureaus or science and policy teams. The committee considers these proposals and plays a key role in the policy development process by making policy, regulatory and other risk management recommendations to ensure the safety and nutritional quality of foods offered in the Canadian marketplace.
5 Novel Foods Section, Food Directorate, Health Products and Food Branch, Health Canada, 4th Floor West, Sir Frederick G. Banting Research Centre, Tunney's Pasture, Postal Locator 2204A1, Ottawa, ON K1A 0L2
6 Recent documents developed by the Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology are the Draft Principles the Risk Analysis of Foods derived from Modern Biotechnology, the Draft Guidelines for the Conduct of Safety Assessment of Foods derived from Recombinant-DNA Plants and the Draft Guidelines for the Conduct of Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (see reports of the Third and Fourth Sessions of the Task Force at: http://www.codexalimentarius.net/reports.asp).
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