Regulatory requirements and licence conditions for imported fresh enoki mushrooms from the Republic of Korea and the People's Republic of China (March 2023)
On this page
- Regulatory requirements
- SFC licence conditions
- Guidance on the SFC licence conditions
- Legislative authority
Imported fresh enoki mushrooms (Flammulina velutipes) from the following countries have been implicated in several food recalls in Canada due to contamination with Listeria monocytogenes (L. monocytogenes):
- Republic of Korea
- People's Republic of China
Similar product recalls and outbreaks of illnesses linked to the consumption of fresh enoki mushrooms have occurred in other countries.
To manage the risk associated with L. monocytogenes in imported fresh enoki mushrooms, the Canadian Food Inspection Agency (CFIA) is adding conditions to Safe Food for Canadians (SFC) licences for the import of fresh enoki mushrooms from the Republic of Korea and the People's Republic of China. These conditions include the requirement to hold and test fresh enoki mushrooms imported from these countries at the first destination in Canada, as provided by the importer under paragraph 13(1)(d) of the Safe Food for Canadians Regulations (SFCR).
In the SFC licence conditions, the expression "hold" or "held" means that the fresh enoki mushrooms are to be tested and kept at the address provided under paragraph 13(1)(d) of the SFCR until the test results reveal that L. monocytogenes has not been detected.
Pursuant to section 13 of the SFCR, importers are required to describe the food that they import, which includes using the appropriate code for each import declaration.
In August 2022, the CFIA introduced the following specific HS-OGD (harmonized commodity description and coding system – other government departments) extensions for fresh enoki mushrooms:
- 07.09.59.3025.03 – Cultivated Enoki mushroom (Flammulina velutipes)
- 07.09.59.3025.04 – Wild Enoki mushroom (Flammulina velutipes)
- 07.09.59.3027.03 – Cultivated Enoki mushroom (Flammulina velutipes) – Organic
- 07.09.59.3027.04 – Wild Enoki mushroom (Flammulina velutipes) – Organic
Failure to provide import information (as per section 13 of the SFCR) may result in the incoming food(s) being seized and detained, destroyed and/or ordered removed from Canada. In addition, importers who do not provide the required import information may be subject to other enforcement measures including having their SFC licence suspended or cancelled. For additional information on importing foods into Canada, refer to Overview: importing fresh fruit or vegetables.
In addition, a person who imports food that is contaminated with L. monocytogenes is in contravention of subsection 10(3) of the Safe Food for Canadians Act (SFCA) and paragraph 8(1)(a) of the Safe Food for Canadians Regulations (SFCR).
In response to this hazard (L. monocytogenes in fresh enoki mushrooms from the Republic of Korea and the People's Republic of China) and pursuant to section 47 of the SFCR, licence holders are responsible for analyzing the risk to human health associated with these foods and for having control measures to prevent, eliminate or reduce that hazard. In accordance with sections 86, 88 and 89(1)(c) of the SFCR, licence holders must include, but are not limited to including, the detailed procedures to prevent or eliminate or reduce that hazard in their preventive control plan (PCP).
SFC licence conditions
As of March 15, 2023 and until further notice, SFC licences to import fresh enoki mushrooms from the Republic of Korea and the People's Republic of China will be subject to specific conditions. Once the fresh enoki mushrooms have reached their first destination in Canada, as provided under paragraph 13(1)(d) of the SFCR, SFC licence holders will have to hold, sample and test each sampling lot for L. monocytogenes, in accordance with the procedures detailed in the conditions below. Each sampling lot is to be kept at this location until the results of analysis reveal that L. monocytogenes has not been detected.
According to subsection 20(4) of the SFCA, a licence holder must comply with all the conditions to which their licence is subject.
SFC licence conditions
Pursuant to subsection 20(3) of the SFCA and effective March 15, 2023 and until further notice, SFC licences for the import of fresh enoki mushrooms from the Republic of Korea and the People's Republic of China are subject to the following conditions:
- upon arriving at the address provided under SFCR 13(1)(d), each lot of imported fresh enoki mushrooms (sampling lot) is held, sampled and tested for the presence/absence of L. monocytogenes according to the sampling and testing conditions outlined in points b, c, d, e, f and g
- a "sampling lot" is one type of homogeneous enoki mushroom product that has been exposed to same growing, harvesting and packaging conditions and bears the same lot code from the foreign producer or exporter
- for each sampling lot, the minimum sampling and testing requirement is a total sample weight of 125 g consisting of 5 individual random sample units of 25 g each
- testing for screening or for confirmation is to be performed in a laboratory accredited by the Standards Council of Canada (SCC), or the Canadian Association for Laboratory Accreditation (CALA)
- the chosen method of analysis is to be on the laboratory's scope of accreditation; in addition the "application" section of the method chosen is appropriate for the intended purpose, including that it is intended for testing fresh enoki mushrooms. Enumeration methods for which the scope of application is limited to the enumeration of L. monocytogenes (and not the detection of L. monocytogenes) are not acceptable to use for presence/absence testing
- a presumptive positive result from a screening method is considered as a positive result for L. monocytogenes unless a recognized cultural confirmation test compatible with the screening method is performed as per the requirements of the screening method, and produces a negative result (that is, not detected)
- each sampling lot is kept at the address provided under SFCR 13(1)(d) pending results of analysis for L. monocytogenes. The lot is not to be released for distribution in Canada unless the result of analysis is "not detected" (negative) for L. monocytogenes
- if L. monocytogenes is not detected in a sampling lot and the condition outlined in point (g) has been complied with, fresh enoki mushrooms do not need to be kept at the address provided under SFCR 13(1)(d)
- the licence holder is to document the written procedure describing how the sampling and testing requirements outlined above are being implemented including evidence to confirm the identity and accreditation status of the laboratory
- the licence holder is to keep records of analysis (ROA) for the products tested to demonstrate that each lot complies with the SFC licence conditions
If the results of analysis detect the presence of L. monocytogenes in a sampling lot, the licence holder has a legal responsibility to notify the CFIA as per section 82 of the SFCR.
Guidance on the SFC licence conditions
The SFC licence conditions apply to all fresh enoki mushrooms from the Republic of Korea and the People's Republic of China that are imported in pre-packaged consumer packaging or in bulk.
Lot and sampling considerations
A "sampling lot" is one type of homogeneous fresh enoki mushroom product that has been exposed to same growing, harvesting and packaging conditions and bears the same lot code from the foreign producer or exporter, between 2 complete sanitation cycles but not exceeding one day's production.
A sampling lot may only have 1 lot code. There may be more than 1 sampling lot in 1 shipment of fresh enoki mushrooms.
Although the term "lot code" is not specifically defined in the SFCA nor in the SFCR, in general terms, "lot code" when used in Part 5 – Traceability of the SFCR refers to a code that can be used to identify a lot that was manufactured, prepared, produced, stored, graded, packaged or labelled, under the same conditions.
Records of analysis
Records of analysis (ROA) for the products tested are to be kept on file to demonstrate that each lot complies with the SFC licence conditions. The following key information should be included in the ROA:
- the name and address of the laboratory
- the date the results were reported
The information provided is to be sufficient to confirm the identity and accreditation status of the laboratory.
The ROA is to also provide a description of:
- the client
- the product sampled
- sampling information
- date of sampling
- location of sampling
- sample size
- number of samples
- lot number(s) sampled
- lab sample identification
- method used
- results of analysis
The sample units are to be collected aseptically and be representative of the lot being tested.
Recognized methods can be found in the Compendium of Analytical Methods (Health Canada, 2021).
Examples of appropriate sampling
When to sample:
- upon receipt of the imported fresh enoki mushrooms at the first destination in Canada
- example 1: a 2,000 kilogram shipment containing 4,000 cartons of pre-packaged fresh enoki mushrooms in 250 g packages and 2,000 cartons of pre-packaged fresh enoki mushrooms in 500 g packages
- this shipment should be considered 2 sampling lots. 1 sampling lot is 4,000 cartons of 250 g pre-packages, and the other sampling lot is 2,000 cartons of 500 g pre-packages of fresh enoki mushrooms
- when fresh enoki mushrooms in a shipment have different bar codes or Price Look-Up (PLU) codes, they should be treated as separate sampling lots
- example 2 : a shipment of fresh enoki mushrooms in bulk with a weight of 5,000 kilograms. This shipment will be re-packaged by the importer in Canada.
- this shipment could be considered 1 sampling lot (if within the description of a "lot" set out in the licence conditions described in Section 3)
- bulk product is to be sampled and tested prior to re-packaging
All packages, cases or containers in the sampling lot are to be equally represented in the sample. For example,
- a shipment of 10,000 cartons is to have no more than 1 package taken from a carton
- the 5 cartons sampled is to be selected from various parts of the shipment
Upon request, importers are to send a copy of the document/records required as per the conditions of the CFIA.
Actions to be taken when L. monocytogenes is detected in imported fresh enoki mushrooms
The following section outlines the importer's responsibilities and the factors to consider when the presence of L. monocytogenes is detected in imported fresh enoki mushrooms.
A sample is considered to be positive in either of the following instances:
- a presumptive positive result is obtained from a screening method that was not followed by a confirmation test; or
- a positive test result from a confirmation method
Notification as per section 82 SFCR and following measures
As required by section 82 of the SFCR, SFC licence holders are required to immediately initiate an investigation if they suspect that the food presents a risk of injury to human health or does not meet the requirements of the SFCA or SFCR. If the investigation determines that there is a risk of injury to human health (for example, if the investigation indicates that contaminated fresh enoki mushrooms left the control of the SFC licence holder and are in distribution), the SFC licence holder must immediately inform the CFIA and take action to mitigate the risk, including conducting a food recall, as appropriate (SFCR 82 to 85).
Upon receipt of a positive test result for L. monocytogenes, a licence holder must immediately segregate the implicated products and ensure it will not be distributed. The licence holder should determine the scope of product implicated by the positive result. Consider:
- the lot(s) of product(s) that tested positive
- how the lot(s) were defined
- whether any other product(s) or lot(s) may represent the same risk based on factors such as:
- source of mushrooms
- time of production
- production or transportation conditions
- product re-packing
- whether the results are indicative of the condition of one lot only or if they may indicate systemic or recurrent contamination (for example, multiple positive results in mushrooms coming from the same supplier or manufacturer)
Options relating to contaminated products
The importer of fresh enoki mushrooms contaminated with L. monocytogenes may voluntarily choose to destroy the contaminated products. Should the importer wish to return the contaminated products to the country of origin, contact your local CFIA office for more details.
If the importer chooses to destroy the products, the importer is to notify the CFIA of their proposed product disposition method and be able to demonstrate that the destruction will not introduce any risk of contamination to the environment, animal and/or animal food sources or cause injury to human, plant or animal health.
If appropriate action is not taken, the CFIA may take enforcement actions such as the seizure of the contaminated products (SFCA s. 25) or order the importer or owner of the product to remove or destroy the products (SFCA s. 32).
The SFC licence conditions are added pursuant to the following legislative authority.
Subsection 20(3) of the Safe Food for Canadians Act states: "The Minister may make a registration or licence subject to any additional conditions that the Minister considers appropriate."
The import requirements are based on the following legislative authority.
Section 8 of the Safe Food for Canadians Regulations and section 4 of the Food and Drugs Act.
Subsection 8(1) of the Safe Food for Canadians Regulations states:
"Any food that is sent or conveyed from one province to another or that is imported or exported
- (a) must not be contaminated
- (b) must be edible
- (c) must not consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; and
- (d) must have been manufactured, prepared, stored, packaged and labelled under sanitary conditions"
Subsection 4(1) of the Food and Drugs Act states: "No person shall sell an article of food that:
- (a) has in or on it any poisonous or harmful substance
- (b) is unfit for human consumption
- (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
- (d) is adulterated; or
- (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions."
Failure to comply with the licence conditions and import requirements may result in enforcement action taken by the CFIA.
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