European Union (EU) – Export requirements for processed egg

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1. Eligible/ineligible products

EU export certificates for processed eggs refer to a list of HS code(s). It is the responsibility of the exporter to ensure that the product being exported will be covered by the certificates issued by the Canadian Food Inspection Agency (CFIA).

Eligible

As per the list of Harmonized System (HS) codes which can be found on the models of health certificates available in the TRACES system.

Ineligible

Information not available.

2. Pre-export approval by competent authority of the importing country

Country

To export to the EU, the exporting country must be on the list of third countries authorized by the EU. Canada is authorized to export processed eggs.

Establishments

Processed egg establishments must meet the following requirements:

  • be licensed under the Safe Food for Canadian Regulations(SFCR) and registered or licensed by the Canadian Food Inspection Agency (CFIA)
  • operate using Hazard Analysis and Critical Control Point (HACCP) principles (see Preventive control plan (PCP) for domestic guidance) as stipulated in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, detailing hygiene of foodstuffs
  • meet all the conditions outlined in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin detailing specific hygiene rules for food of animal origin
  • appear on the appropriate establishment list administered by the Directorate-General for Health and Safety (DG-SANTE). The lists pertinent to processed egg are available on the EU website for Establishments Lists. Select:
    • countries: Canada
    • chapter: Food
    • section: EPP – Eggs and egg products

Establishments seeking addition to the EU list must contact their CFIA regional office and complete the following form:

HACCP plan compliance checklist for processed egg establishments seeking addition to European Union (EU) export approval list PDF (4 kb)

Text version of the form

HACCP plan compliance checklist for processed egg establishments seeking addition to European Union (EU) export approval list

Date of inspection
Establishment licence or registration number
HACCP plan review (plant name)
Generic model used (If applicable)

HACCP plan compliance checklist Yes No

1.1 All pages of the HACCP plan are dated and signed by the HACCP coordinator.

1.2 Any modifications to a HACCP plan are dated and signed by the HACCP coordinator.

1.3 HACCP plan development:

  • Product description (Form 1) is completed
    • (1) list of individual products covered by the HACCP plan
    • (2) product safety characteristics, intended use, packaging, shelf life, where it will be sold, safe handling and usage; and
    • (3) special controls
  • Incoming materials are listed and associated hazards (B, C, P) are listed
  • Process flow diagram is included and reflects plant conditions. Hazards are indicated
  • Plant schematics (raw vs. finished product and employee traffic pattern) are included and reflect current plant conditions. Hazards are indicated

1.4 Hazard identification:

  • A hazard identification has been conducted for all incoming material and all processing steps (Forms 5, 6 and 7 or equivalent are completed)

1.5 Critical control point (CCP) determination (hazard analysis):

  • All hazards identified on Forms 5, 6 and 7 are analyzed on the CCP determination form (Form 8 or equivalent)
  • The form indicates how each hazard is controlled (that is to say, CCP, prerequisite program), or not controlled by the operator

1.6 The HACCP plan (Form 10 or equivalent):

  • lists all CCPs identified on CCP determination form (Form 8 or equivalent); includes critical limits for each CCP;
  • includes monitoring procedures for each CCP
  • includes deviation procedures for each CCP (including corrective and preventive actions, and data)
  • includes verification procedures for each CCP to demonstrate that the HACCP plan is implemented as designed; and
  • indicates records for each CCP for monitoring, deviation and verification procedures

1.7 The establishment has validated its HACCP plans to demonstrate that their plans are functioning as intended.

  • This may be done by relying on CCPs which have been scientifically validated and reported in literature or by using services of laboratories or processing authorities to validate CCPs
  • Processes meeting regulatory requirements will be considered validated

1.8 Records are maintained for monitoring, deviation and verification procedures for each CCP. The review of a sample of these records indicates that they are maintained in a timely manner, dated and signed.

1.9 HACCP plan reassessment:

  • The establishment re-assesses the hazard analysis after any change that could affect food safety (for example process change, formulation change, product flow, etc.); and notes it in the log book
  • The HACCP coordinator reassesses the HACCP plan at least once a year (after one year of operations under HACCP). These activities are noted in the log book

I acknowledge that this establishment is operating under HACCP principles as required by Article 5 and 10 of European Commission Regulation (EC) No 852/2004.

Name of plant representative

Date

CFIA review (to be completed by CFIA inspector prior to approval):

Third (3rd) party HACCP certifier:

Name of company

Date of last audit

Based on this above completed checklist provided by the plant representative and a review of the last 3rd party audit report, the establishment is recommended for addition to the list of establishments approved to export processed egg products to the European Union (EU).

Name of CFIA inspector

Date

Stamp

Note: the form must be signed and dated by the company representative.

Contact your local CFIA office to complete the Request for Addition to the List of Canadian Processed Egg Approved for Export to the European Union (accessible only on the Government of Canada network – RDIMS 23104294). Also, ensure that you have an establishment identification (ID) number for your establishment before you submit your request.

Note: Canada appears on the list of third countries authorized to export to the EU according to Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin.

3. Product specifications

Specifications related to microbiological, chemical contaminant and drug residue limits can be found in the Annexes of various regulations that can be found in the links to the EU regulations (see under section 7).

Microbiological requirements

Egg products requiring certification intended for human consumption must comply with the relevant microbiological criteria laid down in Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

Maximum residue limits for pharmacologically active substances

Maximum residue limits (MRLs) for veterinary drugs are established by Health Canada. In Canada, the MRLs for veterinary drugs in foods can be found at the following link: List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods.

The CFIA inspects, samples and tests a variety of food products under various surveillance programs. The National Chemical Residue Monitoring Program (NCRMP) is one of several surveillance tools used by the CFIA to help ensure the very high level of compliance of egg products.

Egg products intended for the European market must comply with the EU maximum residue limits (MRLs) for residues of pharmacologically active substances in food, as found in the Annex of Commission Regulation (EU) No. 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.

Note: a shipment may be rejected following laboratory testing, for example, in the case of detecting veterinary drug residues exceeding the EU's MRLs. A notification/rejection alert will be published in TRACES and in the Rapid Alert System for Food and Feed (RASFF).

Veterinary medicinal products regulation

The European Union (EU) has implemented Regulation (EU) 2019/6 on veterinary medicinal products (VMPs), aimed at combating antimicrobial resistance and preserving the effectiveness of antimicrobials critical to human health. Article 118 of Regulation (EU) 2019/6 applies to imported animals and animal-derived products and prohibits:

  • the use of antimicrobials reserved exclusively for human medicine; and
  • the use of antimicrobials for growth promotion or yield enhancement

Based on the Canadian regulatory framework and risk‑management measures aimed at reducing antimicrobial resistance in animals and animal products/by-products, Canada is considered to achieve an equivalent level of protection to that of the EU in the Commission Implementing Regulation (EU) 2022/1255, Article 3 of Commission Delegated Regulation (EU) 2023/905 and Regulation (EU) 2019/6. Canada is listed in Regulation (EU) 2024/2598, which establishes the list of third-party countries or regions thereof authorized for the entry into the Union of certain animals and products of animal origin intended for human consumption.

4. Production controls and inspection requirements

The inspector must verify during a preventive control inspection that the manufacturer is aware of the standards and requirements of the EU and has a specific export procedure in place. This procedure should clearly refer to the relevant EU regulations. See 6 below.

The following tests must be completed. These tests can be conducted by a lab accredited by either the Standards Council of Canada (SCC) or the Canadian Association of Laboratory Accreditation (CALA). The results of these analyses must accompany the EU export certificate.

Organic acid (3 OH-butyric acid and lactic acid)

If laboratory results show no detection of organic acids, the results should be recorded as negative. If results are positive, the laboratory should indicate the type and amount of organic acid present.

To be eligible for certification the amount of each organic acid cannot exceed that listed below:

Lactic acid: 1000 mg/kg

3 OH-butyric acid: 10 mg/kg

Example of instruction to the laboratory technician: "Test for organic acids (3 OH-butyric acid and lactic acid) with a method equivalent to AOAC official method 970.31"

Enterobacteriaceae

A lot is not eligible for certification if any result for Enterobacteriaceae is reported as more than 100 colony forming units (CFUs) per gram or mL, or if more than two (2) samples are greater than 10 colony forming units per gram or mL.

Extraneous material (egg shell, egg membrane, and other particles)

Collect and identify a separate sample of finished product for analysis of extraneous material.

Use and authorization of veterinary drugs

Health Canada is the federal authority responsible for the authorization, importation, sale, and labelling of veterinary drugs in Canada. However, the use of veterinary drugs falls under the scope of the practice of veterinary medicine, which is under the jurisdiction of provincial and territorial governments. As such, the use of prescription veterinary medicinal products at the farm level must be conducted by licensed veterinarians within the context of a Veterinary-Client-Patient Relationship (VCPR). Furthermore, the producer must maintain a record of all veterinary drugs used.

For the EU, in accordance with Article 108 of Regulations (EU) 2019/6 keeping these records is a legal requirement. The same applies for the withdrawal period.

Processed egg products: Manufacturer's declaration

When applying for an export certificate, the following information must be submitted to a CFIA inspector. The exporter may use a company letter head to provide the information and must be kept on file by the CFIA certifying inspector or veterinarian:

  • confirmation that the establishment is on the EU list. See 2 above
  • that a specific control plan is in place demonstrating how the product meets the EU requirements.
  • confirm that the microbiological analysis meets the requirements of Regulation (EC) 2073/2005
  • confirmation that the eggs were sourced from farms that are under the control of the competent authority
  • the origin of the eggs (Canadian and/or imported). If imported, indicate among other things, the country, the name and the number of the establishment. Supporting documentation must be attached to the request
  • confirmation that the eggs were evaluated for its acceptability before being accepted for further processing
  • the origin of the processed egg ingredient (Canadian and/or imported). If imported, indicate among other things, the country, the name and the number of the establishment. Supporting documentation must be attached to the request
  • confirmation that the processed egg product was pasteurized according to EU requirements/Model export certificate
  • indicate if this is the first time these products are exported to the EU
  • the animal species
  • the final destination
  • model of certificate for the shipment as per TRACES
  • and any other relevant information

Note: the inspector reserves the right to request any other information that they think is necessary for the final certification of the product.

The products must be clearly identified by the manufacturer and match exactly the products that are part of the export shipment. In the case where a large number of different products are being shipped, a computerized printout containing all the required information may be attached by the manufacturer if it contains all the required information.

Original signed these are to be kept on file at the processing facility. These files may be verified during a preventive control inspection (PCI).

Certification requirements

The model certificate for egg products contains public health and animal health requirements.

Public health attestations

The public health attestations on the model health certificate are met based on Canadian regulations, based on Canada's inspection system. See section 3.

Animal health attestations
  • The certificate refers to the source farm for eggs being free of highly pathogenic avian influenza (or Newcastle disease) for at least 30 days before sourcing the eggs.
  • In addition, for unpasteurized, it also requires that it be from within a 10 km radius where a highly pathogenic avian influenza outbreak has not occurred in at least 30 days before sourcing the egg.
  • For pasteurized egg, the product must have been pasteurized to a minimum temperature and time as in the model certificate.

Note: For details on the model certificate, please see TRACES.

Traceability

The operator must develop and implement control programs to demonstrate that the products it intends to place on the EU market comply with the applicable requirements and, where eligible and non-eligible products are on the premises at the same time, to ensure their complete segregation.

Imported ingredients
  • The use of imported egg product ingredients is acceptable; however, the operator must demonstrate through official documentation (for example, the model health certificate as per Regulation (EU) 2020/2235 issued by the competent authority of the country of origin) that the imported ingredients meet EU requirements. This also applies to imported ingredients from EU member states and countries maintaining international agreements with the EU.
  • The manufacturer of the imported ingredients requires to be included on the EU eligibility list.

Note: egg products imported into Canada for processing must be sourced from EU approved establishments of countries authorized to export to the European Union. Imported egg product must comply with the animal health requirements of Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health; and Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin detailing specific hygiene rules for food of animal origin.

5. Labelling, packaging and marking requirements

Exported products depending on their final destination must meet certain packaging and labelling requirements. The exporter must work closely with the importer to ensure the compliance of their products. Please refer also to regulation (EC) 853/2004. The labelling activity must be conducted in the EU approved establishment.

Effective July 20, 2026, it is exporter's responsibility to work with their EU importer and primary packaging material supplier to ensure that the packaging material used in the packaging of primary material for egg products exported to the EU does not contain any Bisphenol-A and other materials, not only in the manufacture of plastic or epoxy coating but also in any printing inks and adhesives. Please also refer to regulation (EC) 2024/3190 and a "Note for guidance" for further details.

6. Required documents

Canada does not have a bilateral certificate negotiated with the EU. Certificates issued for egg products come from EU regulations.

It is the responsibility of the exporter to ensure that the issued certificate meets the requirements of the entry border control post (BCP)/Member state of destination in terms of official language.

As a manufacturer/exporter and in order to facilitate the certification process, it is important that you are familiar with the content of parts I and II of the EU model certificates.

The export certificate will be issued through TRACES. The applicant must select the EU model certificate that corresponds to the product intended for export and complete Part I. Please note that the applicant is responsible for the details entered in Part I of the certificate. In addition, the applicant will need to include the EU reference IMSOC number (Box I.2.a of Part I of the certificate) with their export request in order for the CFIA to retrieve the certificate in TRACES.

Part II must be completed by an official veterinarian. However, some information will have to be provided by the applicant in order for Part II to be completed, if applicable. This information should be provided in the form of a manufacturer's declaration when applying for an export certificate.

These animal health/official certificates shall be completed according to the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235 as well as the notes on the export certificate.

It is the responsibility of the manufacturer and/or exporter to review the statements in a model EU export certificate for egg/egg products and provide relevant documentation to the certifying official as outlined in the statements. In addition, the CFIA certifying official can request additional information, where required, before signing the export certificate.

If a container is used to ship the products, the exporter must provide the container and seal number in Part I: Information on the lot shipped in TRACES.

For more information about TRACES, please refer to the CFIA web page Exporting food and animal products to the European Union

Certificate

(2020/2235) Egg products intended for human consumption – Model EP

Notes

The EU requires that the certificate above also be presented with exported product intended for a market other than EU, to permit its transit or storage into the Union. In such case, Section II.1. Public health attestation of Part II: Certification is to be deleted (as indicated on the certificate).

As per the World Organisation for Animal Health (WOAH) export certification procedures, the certifying officer should only certify matters that are within their own knowledge at the time of signing the certificate, or that have been separately attested by another CA, and sign only at the appropriate times certificates that have been completed fully and correctly. Where a certificate is signed based on supporting documentation, the certifying officer should have verified or be in possession of that documentation before signing. This is in line with articles 88 and 89 of Regulation (EU) 2017/625 that sets out, among other things, rules to be observed in issuing certificates.

Export certificates cannot be issued after the products have left Canada. The certificate is signed by an official veterinarian.

7. Other information

Exported products transiting through a country may require transit documentation. It is the responsibility of the exporter to ensure that the shipment will be accompanied by all necessary certificates. Please work closely with your importer.

Samples (personal or commercial) of egg products may be subject to the same requirements as a regular shipment. It is strongly recommended that the exporter verify these requirements with his importer and/or at the EU border inspection post where the products will be shipped.

Article 6 of Regulation (EU) 2020/2235 lays down rules on the replacement of certificates required for entry into the Union. The replacement certificate is issued in TRACES.

EU inspectors at the border control post of entry into the EU will check, among other things:

  • whether the product comes from an approved country
  • whether the product comes from an EU-approved establishment
  • the availability of an export certificate and its accuracy
  • whether the consignment matches the health certificate issued by the CFIA
  • whether the labelling meets EU requirements
  • whether there is chemical/microbiological contamination

Relevant links

Links to the EU regulation

Please ensure that you are using the most up to date/consolidated version. See EUR-Lex, the official and most comprehensive online access point to the EU legal documents.

  • Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
  • Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006
  • Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives
    • For more information on permitted additives please consult the DG-SANTE database on Food Additives
  • Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin
  • Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union
  • Regulation (EU) no 852/2004 of the European parliament and of the council of 29 April 2004 on the hygiene of foodstuffs (HACCP principles)
  • Regulation (EU) no 853/2004 of the European Parliament and of the Council of 29 April 2004 lays down specific hygiene rules for food of animal origin including gelatin, collagen, raw material and treated raw material for the production of gelatin and collagen
  • Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625
  • Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council.
  • Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin
  • Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin
  • Commission Implementing Regulation (EU) 2021/1471 of 18 August 2021 amending and correcting Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 as regards references to national measures designed to limit the impact of certain diseases of aquatic animals and to lists of third countries, territories or zones thereof from which entry into the Union of animals and goods is permitted
  • Commission Implementing Regulation (EU) 2022/2293 of 18 November 2022 amending Implementing Regulation (EU) 2021/405 as regards the list of third countries with an approved control plan on the use of pharmacologically active substances, the maximum residue limits of pharmacologically active substances and pesticides and the maximum levels of contaminants
  • Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
  • Commission Regulation (EU) 2024/3190 of 19 December 2024 on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food, amending Regulation (EU) No 10/2011 and repealing Regulation (EU) 2018/213
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