- an importer of fish and fish products?
- a processor of fish and fish products?
- involved in developing genetically modified fish or genetically engineered fish?
- involved in developing fish biotechnology applications?
You may be importing, manufacturing or producing novel fish and fish products.
What is considered a novel food product in Canada?
The following are definitions applicable to Division 28 of the Food and Drug Regulations.
"Novel food" means:
- a substance, including a microorganism, that does not have a history of safe use as a food;
- a food that has been manufactured, prepared, preserved or packaged by a process that:
- has not been previously applied to that food, and
- causes the food to undergo a "major change"; and
- a food that is derived from a plant, animal or microorganism that has been "genetically
modified" such that:
- the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,
- the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or
- one or more characteristics no longer fall within the anticipated range for that plant, animal or microorganism.
"Genetically modify" means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation.
"Major change", in respect of a food, means a change in the food that, based on the manufacturer's experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to:
- the composition, structure or nutritional quality of the food or its generally recognized physiological effects;
- the manner in which the food is metabolized in the body; or
- the microbiological safety, the chemical safety or the safe use of the food.
Why is regulatory oversight required for novel foods?
The globalization of the food supply has resulted in the introduction of many new foods to the Canadian marketplace and recent biotechnology applications and food science developments have also resulted in the production of many new, novel food products.
Globally, new manufacturing and production applications continue to be developed in order to increase production, expand shelf life, diversify product types and develop value added products.
Fish is no exception and many new product applications are currently under development.
The regulations for novel foods were developed by Health Canada to ensure that the introduction of these novel foods does not adversely affect the safety of the Canadian food supply.
How are novel foods regulated?
The regulatory responsibility for novel food safety is shared between Health Canada (HC) and the Canadian Food Inspection Agency (CFIA).
HC is responsible for establishing the standards and policies governing the safety and nutritional quality of all food, including novel foods, sold in Canada. The CFIA is responsible for the enforcement of these standards and policies.
Since 1999, HC has regulated the sale of novel foods in Canada by a mandatory pre-market notification process. This process requires the submission of information by the manufacturer or importer of a "novel" food so that a determination can be made with respect to the acceptability of the food prior to sale.
What are the responsibilities of manufacturers and importers regarding novel foods?
It is the responsibility of manufacturers and importers to ensure that products offered for sale in Canada are in compliance with all applicable regulatory requirements.
Developers are responsible to asses whether or not the product they are manufacturing is captured under the definition of novel foods.
Domestic food manufacturers are responsible to assess whether or not food substances, ingredients and processes are captured under the definition of a novel food.
Importers are responsible to asses whether or not imported food products contain novel substances, genetically modified food ingredients or were prepared by a novel process.
Since international regulatory regimes differ, care should be taken to determine the novelty status of all food ingredients and products that are being imported.
Imported food products may not necessarily be identified as a novel food; or, food products approved in other countries may not have been notified and evaluated under the Food and Drug Regulations.
Import control systems can contribute to making informed import decisions and are of particular importance for fish and fish products as these are widely traded food commodities.
How do I know if my food product is novel?
With such a wide range of foods, it is sometimes difficult to determine whether or not the food being manufactured or imported is captured under the definition of novel. For reference purposes, novel food decisions are available on the HC website at: www.hc-sc.gc.ca.
Often, it is the developer of the novel food product, domestic or foreign, who is the best suited to address novel food regulatory requirements.
Consultation with HC is encouraged during the development phase of a product to determine food safety data requirements. Requirements can be product specific and safety assessments are made on a case by case basis.
If my fish or fish product is captured under the definition of "novel", what do I need to do to gain approval?
The manufacturer or importer must notify HC of the intention to sell or to advertise for sale a novel food in Canada and address the basic information requirements outlined in the Food and Drug Regulations. Preferably, written notification should be provided well in advance of the period when the manufacturer or importer intends to market the product in Canada.
HC will review the notification and provide in writing either:
- a letter stating that they have no objection to the sale of the novel food, or
- in the case that preliminary information is insufficient to determine the safety of the novel food, request that additional scientific data be submitted in order to further assess the safety of the novel food. Once all the required data has been submitted, HC will decide if the novel food is suitable for consumption in Canada.
In order to assist industry with information and data requirements, HC is currently developing guidelines for the safety assessment of novel foods derived from animals. Notifications can be mailed to:
Novel Food Notification, Food Program
Food Directorate, Health Canada
4th Floor West, Sir Frederick G. Banting Research Centre
Tunney's Pasture, Postal Locator 2204A1
Ottawa, ON, K1A 0L2
What happens after Health Canada's review?
Once HC has determined that a novel food is suitable for consumption, the food is subject to traditional regulations and standards applicable to foods sold in Canada. In the case of novel fish and fish products, these products also need to meet the requirements of the Fish Inspection Regulations.
The Fish Inspection Regulations require that importers be licensed by the CFIA prior to importing fish or fish products destined for human consumption in Canada.
In order to effectively manage the introduction of approved novel food fish products to the Canadian marketplace; new inspection tools, policies and compliance strategies are currently under development by the CFIA. Inspection ensures fish and seafood products meet food safety and quality standards.
The CFIA is committed to cooperation and collaboration with its stakeholders, partners and other government departments, domestically and internationally.
For more information on the regulation of novel fish and fish products of biotechnology please visit our website at www.inspection.gc.ca or contact your local CFIA office.
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