European Union (EU) - Export requirements for composite products

The information presented below is under review.

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According to Commission Delegated Regulation (EU) 2019/625 'composite product' means food containing both products of plant origin and processed products of animal origin. Please note that a composite product (CP) cannot contain an unprocessed animal product.

It is important to note that the addition of a product of plant origin during the processing defined in Article 2(1) (m) of Regulation (EC) No 852/2004 of an animal product does not automatically mean that the resulting food falls within the definition of composite products. If the addition of the plant product to the processed product of animal origin during the manufacturing procedures does not modify the main characteristics of the processed product of animal origin, the final food product is not a composite product. Pizza with salami and cheese and chicken Caesar salad containing chicken and parmesan cheese are examples of composite products.

1. Eligible/ineligible product

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.
  • Composite products made exclusively from processed products of animal origin eligible for export to the EU, that is an EU approved country, region or zone of origin and EU approved establishment.

Ineligible

  • Information not available.

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

Country

Canada is authorized to export composite products.

Establishments

The EU has not yet established a specific list of establishments of third countries authorized to export CPs to the Union.

The CPs that fall under the HS codes listed on the model certificate for export of CP and which contain processed product of animal origin (POAO) can be exported to the EU if each processed POAO contained in the CPs has been produced in an establishment on the list administered by the Directorate-General of Health and Food Safety (DG-SANTE) in TRACES under the chapter: Food Establishment Lists – TRACES NT (europa.eu).

Products

No information known regarding products registration.

3. Production controls and inspection requirements

The CPs requiring an export certificate must originate from an establishment licensed under the Safe Food for Canadians Regulations (SFCR) with a CFIA establishment identification number and must be operated in accordance with the requirements applicable to the commodity of POAO used in the production of the CPs, for example, meat products, dairy products, fishery products.

The CP must come from an establishment licensed under the Safe Food for Canadian Regulations (SFCR) with a preventive control plan in place which is deemed to meet the EU requirements under Article 5 of Regulation (EU) No 852/2004.

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 manufacture and export procedure in place. This procedure should clearly refer to the relevant EU regulations (see section 6 below), particularly regarding the controls for the eligibility of the processed POAO used in the manufacture of the CP and the traceability controls regarding the eligibility of the processed POAO to ensure only compliant CP are exported to the EU.

Processed products of animal origin – eligibility

The eligibility of processed meat products other than gelatine, collagen and highly refined products (HRP) should be determined as per Export requirements for meat intended for export to the EU. For example in the case of products received from another Canadian producer, the load of processed meat product should be accompanied by Annex J.

The eligibility of the dairy products or colostrum-based products contained in the CPs should be determined according to the export requirements of dairy products to the EU.

The eligibility of the fishery products contained in CPs must come from an establishment authorized to export to the EU as well as the country of origin. In case of fishery products derived from bivalve molluscs the country of origin must be authorized for entry into the Union of live bivalve molluscs. Please refer to the export requirements of fish and seefood to the EU.

The eligibility of the egg products in the CPs should be determined according to the export requirements of egg products to the EU.

The eligibility of gelatin and collagen products in the CPs should be determined according to the export requirements of gelatin and collagen products to the EU. Please note that the CP certificate refers to gelatin and collagen derived from ruminant bones only.

Manufacturer's declaration

  • All final export requests for CPs must be accompanied by a Manufacturer's declaration for Composite Products for the EU (accessible only on the Government of Canada network - RDIMS 15597846) issued and signed by an authorized person of the licensed establishment where the product was manufactured or prepared.
  • it is important that the manufacturer is familiar with the EU certificate for CPs as well as the relevant regulations. Additional supporting documents may be required depending on the POAO used.
  • If necessary, please take into account the notes at the end of the composite products certificate to complete the manufacturer's declaration.
  • The product(s) must be clearly identified on the Manufacturer's certificate and match exactly the product(s) that are part of the export shipment.

Imported ingredients of animal origin

The use of imported ingredients from certain countries may limit the ability to export to the EU. Commission Implementing Regulation (EU) 2021/404Commission Implementing Regulation (EU) 2021/405  and the lists of EU approved establishments can be consulted to verify the eligibility of imported products.

  • In the case of imported products, in addition to originate from an EU approved establishment, the Canadian Official Meat Import Certificate (OMIC) and the additional compliance with EU requirements issued by the competent authorities (CA) of the exporting country for the shipment to Canada should be used to demonstrate eligibility of the processed meat product. Section 1.4.2.4 of the Export requirements for meat intended to the EU should be consulted for details.
  • If imported ingredients of animal origin are used in the CP manufactured in Canada, the competent authority of the exporting foreign country must provide a certificate attesting to the statements as written on the CP certificate except for imported fish and seafood ingredients where no certification from the source country is required.
  • The manufacturer of the imported ingredients of animal origin requires to be included on the EU eligibility list.
  • If foreign POAO ingredients are used in the CP, this must be indicated in the manufacturer's declaration.

Note: if the CP contains both processed meat products and other POAO, than the eligibility requirements for both must be met.

4. 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.

5. Documentation requirements

Canada does not have a bilateral certificate negotiated with the EU. The certificate issued for composite 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 or an official inspector, depending on the case. 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 certificates.

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

Certificate

  • (2020/2235) – Model animal health/official certificate for the entry into the Union of non-shelf-stable composite products intended for human consumption and shelf-stable composite products intended for human consumption and containing any quantity of meat products except gelatine not derived from ruminant bones, collagen not derived from ruminant bones and highly refined products, and any quantity of colostrum-based products – Model COMP.
  • (2020/2235) – Model animal health certificate for the transit through the Union to a third country either by immediate transit or after storage in the Union of non-shelf-stable composite products intended for human consumption and shelf-stable composite products intended for human consumption and containing any quantity of meat products except gelatine, collagen and highly refined products, and any quantity of colostrum-based products – Model TRANSIT-COMP

Notes:

For animal health reasons, guarantees shall accompany shipments of composite products exported to a third country that will transit in the Union or that will be temporarily stored in the Union. The above TRANSIT-COMP certificate should be issued at the request of exporters.

Other composite products, for example, those for which the above certification is not required, must be accompanied by a private attestation drawn up in accordance with the model private attestation in Annex V of Commission Regulation (EU) 2020/2235. The private attestation is to be completed and signed by a representative of the importer. The CFIA does not need to be involved in the issuance of this document.

6. Other information

Exported products transiting through a third 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 composite products may be subject to the same requirements as 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.

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.

  • Link to the list of the Member countries of the European Union (EU). Please note that the EU has international agreements with some countries (example Switzerland, Norway, Iceland and Liechtenstein), which means that they implement EU veterinary legislation with regard to movement of animal products.
  • EU guidance on composite products. Exporters should consult the EU guidance documents and familiarize themselves with requirements applicable to the products they intend to export.
  • Regulation (EU) No 2017/625 of the European Parliament and the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products.
  • Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption.
  • 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) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases.
  • 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) 2021/404 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.
  • 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.
  • Commission Delegated Regulation (EU) 2021/630 of 16 February 2021 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards certain categories of goods exempted from official controls at border control posts.
  • Commission Implementing Regulation (EU) 2021/632 of 13 April 2021 laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the lists of animals, products of animal origin, germinal products, animal by-products and derived products, composite products, and hay and straw subject to official controls at border control posts.
  • Commission Delegated Regulation (EU) 2019/2122 of 10 October 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards certain categories of animals and goods exempted from official controls at border control posts, specific controls on passengers' personal luggage and on small consignments of goods sent to natural persons which are not intended to be placed on the market.
  • Commission Decision of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC.