Annex X: Canadian Program for Monitoring of Residues in Casings for Export to the European Union (EU)

Introduction

As per Animal Health Law (Commission Implementing Regulation (EU) 2020/2235), to mitigate the risk posed by the presence of antimicrobial residues in casings, which have been found in consignments tested at entry to the European Union (EU), guarantees on the residues status of casings will be required as a condition for their entry into the EU. In addition, third countries as well as establishments that export casings to the EU, will have to be approved and listed as such.

To meet these requirements, the Canadian program for monitoring of residues in casings for export to the EU will be implemented in EU approved casings establishments.

Instructions

1. Before the end of each fiscal year, the operator will submit, to the local Canadian Food Inspection Agency (CFIA), total annual production of casings (in tonnes) produced during that fiscal year regardless of the proportion of that production which was exported to the EU.
2. At the beginning of each fiscal year, the CFIA Food Import and Export Division (FIED) will inform the operator of each EU-approved casings establishment of the number of targeted samples for the upcoming fiscal year through the local CFIA:
   • At least one sample from casings will be taken per 300 tonnes of total production of casings in Canada in the previous fiscal year, in all EU approved casings establishments, regardless of the proportion of that production which was exported to the EU.

     Note: if total annual production of casings in Canada, in EU approved casings establishments, is less than 1,500 tonnes (5 samples per year), sampling may be carried out once per two years. If within a two-year period, total annual production in Canada, in EU approved casings establishments, is less than 300 tonnes, a minimum of one sample once per two years shall be analysed provided that there is production of casings in EU approved casings establishments.

   • The CFIA-FIED will allocate the number of samples to each establishment proportionate to the production volume in the previous fiscal year regardless of the proportion of that production which was exported to the EU. Dates of sampling will be distributed randomly throughout the fiscal year for each EU approved casings establishment.
   • The local CFIA may modify the date of sampling in order to ensure that processed casings eligible for export to the EU are sampled and to ensure that different suppliers are sampled at each establishment. The CFIA may also modify the date of sampling in case of operational constraints.
   • If a new establishment becomes eligible to export casings to the EU after the beginning of a fiscal year, the CFIA-FIED will reallocate samples to include the new establishment in the sampling program. The total number of samples to be taken in Canada will not change.
3. The operator will inform the CFIA of the days when casings will be produced and if they will be for export to the EU at least 7 days in advance. The CFIA will collect the sample without providing prior notification to the operator.
4. Sampling for Canadian residue monitoring plan for casings will take place as follows:
   • A random sample will be taken from casings (if treated with dry salt) or casing or brine (if treated with brine).
   • If available, samples will be taken from processed casings eligible for export to the EU.
   • Samples will be only taken from the final product (and in any case, not before the salting/curing step) after treatment and before export.
   • There will be traceability from the samples taken to the casings sampled, including when brine is the matrix sampled.
   • All samples will be stored and shipped in tamper evident containers and strict control must be maintained over their identity and security. The details of the security measures should be clearly described in operator's control program and accepted by the CFIA.
   • The CFIA will select, collect, pack, secure, freeze and ship casings sample.
5. All samples will be submitted for monitoring for the presence of chemical residues of chloramphenicol, nitrofurans and nitro-imidazoles to the following laboratory:

   Eurofins Central Analytical Laboratories, Food Chemistry
   2219 Lakeshore Dr., Suite 500
   New Orleans, LA 70122 USA
   +1-504-293-7835

   Note: laboratories which are interested in being listed should contact CFIA.

   Analytical methods used for the purpose of this sampling plan must be validated in accordance with the provisions of Commission Implementing Regulation (EU) 2021/808 or equivalent for the chosen matrix (casings, brine).

6. The operator will be responsible for providing containers and packaging material for samples and for covering all costs associated with the collection, packing, securing, shipping and testing of the samples.
7. The test results will be sent by the laboratory directly and simultaneously to the operator and the local CFIA.
8. An appropriate Standard Inspection Procedures (SIP) task will be conducted by the CFIA when each casings sample is taken and when each sample result is received.
9. CFIA-FIED will submit the results of residue testing to the European Commission on an annual basis, following the conclusion of each fiscal year.
10. In the event of a positive test result for the presence of chloramphenicol, nitrofurans or nitro-imidazoles in casings or a port of entry (POE) violation reported by the EU, the operator must implement corrective and preventive actions without delay to:
    • confirm that all potentially non-complaint product is controlled
    • ensure that none of the potentially non-compliant product is exported to the EU; and if any product has been shipped to the EU, then immediately inform the CFIA, who will in turn inform the EU authorities
    • conduct a thorough investigation to identify and manage the root cause of the deviation
    • present the findings of the investigation, including corrective and preventative action plans, to the CFIA Inspector in Charge (IIC) or the Veterinary in Charge (VIC); the corrective and preventative action plans will be reviewed and their implementation will be verified by the IIC/VIC
    • after implementation of the corrective and preventive actions, the operator must test at least the first shipment sourced from the supplier/farm from where the casings showed a positive result

    As the use of these drugs is banned in Canada, the root cause of any positive test result is to be identified by the operator and enforcement actions could be taken by the CFIA.

    Any questions related to sample collection under this program for sampling of casings destined to be exported to the European Union (EU) should be directed to the designated CFIA Area Specialist responsible of meat exports.