Interim operational procedure: Verification of maximum level of cyanide in imported apricot kernels

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1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on verifying regulated parties controls related to the import of apricot kernels and composite products containing apricot kernels.

This document is intended to be used in conjunction with other guidance documents as referenced in Section 4.0.

The guidance outlined below should be used when conducting targeted Preventive Control Inspections (tPCIs) of regulated parties importing apricot kernels or composite products containing apricot kernels. Currently, there are no known domestic producers, therefore the scope of this operational procedure is limited to importers.

2.0 Background

On July 25, 2019, Health Canada (HC) published a Notice of modification to the List of contaminants and other adulterating substances in foods to add a maximum level for cyanide in apricot kernels of ≤ 20 parts per million (ppm) total extractable cyanide in apricot kernels sold for human consumption or used as an ingredient in other foods. This maximum level went into effect on January 25, 2020.

As of January 25, 2020, importers of apricot kernels and composite products containing apricot kernels for human consumption are responsible for ensuring that the concentration of total extractable cyanide in their products are in compliance with HC's maximum levels.

3.0 Authorities

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline – food regulatory response guidelines.

4.0 Reference documents

5.0 Definitions

Unless specified below, definitions are located in either the:

Apricot kernels: are the seeds found inside the pits (stones) of fresh apricots. Apricot kernels resemble small almonds and have an almond-like taste. Apricot kernels may also be ground, packaged, and sold as powder and meals.

Composite products: any food that contains apricot kernels in any form (whole, ground, etc.) as an ingredient.

6.0 Acronyms

Acronyms are spelled out the first time they are used and are consolidated in the Food business line acronyms list.

7.0 Operational procedure

Importers must be able to demonstrate that the concentration of total extractable cyanide in imported apricot kernels and composite products containing apricot kernels does not exceed 20 ppm. Known importers are subject to targeted Preventive Control Inspections (tPCIs) that are prioritized at a rating and frequency outside the Importer Risk Assessment (IRA) risk rating.

7.1 Identify importer

Refer to SIP, section 3.0, step 1 - Prepare for the inspection. In addition to the general guidance provided in SIP, the following applies.

7.1.1 Identify importer

Import data is used to identify current importers of apricot kernels, and the PCI cases of these importers are tagged with Special Instructions "imports apricot kernels". Using the Special Instruction tags, identify the importers for the purpose of tPCI inspection.

Table 1: Recording inspection data in Digital Service Delivery Platform (DSDP)
DSDP field DSDP data field selection
Inspection Trigger Preventive Control Plan Inspection
Task type Preventive control inspection
Inspection task level 1 System Verification
Inspection task level 2 Sub-Element 1.3 Import Controls
Sub-Element 7.1 Traceability and Control
Sub-Element 7.2 Complaints

Document the name of the apricot kernel product assessed in SE 1.3, within one of the free text fields in the inspection case i.e., Document & Record Review, Interviews or Observations.

7.2 Conduct inspections

Refer to SIP, section 4.0, step 2 – Conduct the inspection. In addition to the general guidance provided in the SIP, the following applies.

  • request and review records the importer keeps to demonstrate compliance to the HC's maximum limit (ML) for apricot kernels (for example: records of analysis, product specification indicating level of cyanide)
  • verify that records effectively demonstrate compliance (for example a letter of guarantee from supplier does not demonstrate compliance)
  • if the results of analysis are from a foreign lab, verify that analysis has been performed by an accredited laboratory
  • verify that records correspond to the lots in question and demonstrate compliance
  • confirm product description against the HS code to ensure the imported food is apricot kernel or a composite product containing apricot kernel ( not kernel of other stone fruits)

If no records of analysis are available, or existing records do not demonstrate compliance, conduct a sampling task as per section 7.2.1 for all importers.

The foreign analysis results submitted must come from a laboratory accredited to ISO/IEC 17025 by an accrediting body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). The method of analysis must be on the laboratory's scope of accreditation as published by the accrediting body. The laboratory's accreditation status and whether or not the method is on their scope of accreditation can be confirmed by checking the accrediting body's website. Some lab results may contain the logo of the accrediting body on the lab report. You may request the name of accrediting body from importer to verify their accreditation.

If you have difficulty determining the acceptability of the results of analysis from a foreign lab, contact CFIA Lab Coordination at cfia.labcoordinationcoordinationdeslaboratoires.acia@inspection.gc.ca for advice.

7.2.1 Sample and test

If the importer cannot demonstrate compliance (for example: by providing test results), sample and test as per the procedures in section 4.4.2 of the SIP. The method of analysis currently used by CFIA is specific to apricot kernels, not composite products containing apricot kernels. If products containing apricot kernels as an ingredient are found and the importer is not able to demonstrate that the apricot kernel ingredient meets the requirements of the Maximum Residue Limits (ML), contact CFIA Lab Coordination (prior to sampling) to discuss the feasibility of analysis of the composite product and next steps.

For apricot kernels, use sampling plan FS401D (Imported: Chemistry and chemical contaminants – complaints and investigations), and obtain five sample units of 100 grams per sample unit for imported products. If the importer has multiple lots, sample from each lot. Contact CFIA's Lab Coordination (LCD) at: cfia.labcoordination-coordinationdeslaboratoires.acia@canada.ca to obtain the correct lab assignment and the correct method of analysis required.

When submitting the samples, enter "testing is related to verification of cyanide in apricot kernels" in the submitter comments field.

Request the importer to hold the lots or detain the lots (if necessary) until results are available. Refer to the Operational procedure – Procedure for seizure and detention, authorizing movement and disposition if required.

7.2.2 Verify labels

Refer to the Operational procedure – Basic food label verification to verify compliance to SFCR and FDR. Regulations. A full label verification is not required unless inspector stumbles upon labelling issues other than non-permitted claims.

Any claims, stated or implied, that food can treat or prevent diseases and health conditions, such as cancer or diabetes are subject to mandatory pre-market assessment under the Food and Drugs Act [FDA 3(2)]. Health Canada has not reviewed any such claims for apricot kernels sold as a food.

In addition, Vitamin B17 is not a recognized vitamin under the FDR. Therefore, any food, including apricot kernels or products containing apricot kernels, making a statement or claim relating to its "Vitamin B17" content would be considered to be in violation of the FDR.

Presence of Health Canada's consumer advice (no more than three kernels/day (adults), should not consume (children)), is not applicable or required on the labels for safety purposes. However, labels containing Health Canada's consumption advice would be considered inaccurate and out-of-date. Inspectors can advise the importer accordingly.

7.2.3 Determine compliance

Apricot kernels and products containing apricot kernels that do not meet the maximum level of ≤ 20 ppm for total extractable cyanide cannot be sold for human consumption or used as an ingredient in other foods.

Follow the Food regulatory response guidelines to respond to non-compliance and take immediate product controls if required. If the non-compliant product is in distribution, follow the Food incident response (accessible on the Government of Canada web page only) to determine the next step.

Note: currently CFIA is not aware of a further processing that would reduce or eliminate the chemical contaminants such as Cyanide in food.

7.3 Communicate the results

Refer to SIP, section 5.0, step 3 – Communicate the inspection results.

7.4 Conduct follow up inspection

Refer to SIP, section 6.0, step 4 – Conduct the follow-up inspection.

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).