United Kingdom of Great Britain and Northern Ireland - Export requirements for highly refined products

The information presented below is subject to change.

The United Kingdom is now considered by the European Union (EU) as a third country. However, a special status has been granted to Northern Ireland which remains aligned with the EU on sanitary and phytosanitary (SPS) measures.

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This directive applies to food business operators manufacturing highly refined products (HRPs) of animal origin such as chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass, amino acids that are authorized as food additives in accordance to EC No 1333/2008, food flavourings that are authorized in accordance to EC No 1333/2008 and fat derivatives. These HRPs are derived from bovine, sheep, goats pigs, poultry, equine and fishery products.

1. Eligible/ineligible product

UK certificate for HRPs refers to a list of harmonized system (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 HS codes which can be found on the model of health certificate of the UK.

Ineligible

  • Information not available.

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

Country

Canada is authorized to export PHR to the UK.

Establishments

The highly refined products must come from an establishment licensed under the Safe Food for Canadian Regulations (SFCR).

The UK requires that HRPs originate from an establishment operating under the Hazard Analysis Critical Control Point (HACCP) principles (see Preventive control plan (PCP)) as stipulated in Commission Regulation (EC) No 852/2004 of the European Parliament and of the Council. In addition, these establishments must be regularly audited by the competent authorities (CA).

If applicable, the raw animal material used in the HRP must come from an establishment (such as: meat or fish, etc.) which is approved to export to the UK and on the list administered by the Department for Environment, Food and Rural Affairs (DEFRA)

Products

This information is not available.

3. Production controls and inspection requirements

The HRPs must meet the requirements as described on the UK model certificate. The inspector must verify during a preventive control inspection that the manufacturer is aware of the standards and requirements of the UK and has a specific export procedure in place. This procedure must contains the following elements in particular:

  • reference to relevant UK regulations
  • how the manufacturer follows changes in the UK legislation
  • comparison of UK regulations/standards/parameters with those of Canada
  • the procedure to be followed in the event of a difference between the regulations/standards/parameters of the UK and those of Canada in order to ensure that the product meets the requirements of the UK
  • the corrective and preventive actions to be considered in the event of non-compliance

Manufacturer's Declaration

All export requests must be accompanied by a Manufacturer's declaration that has been completed on a company letterhead and signed by an authorized person of the food manufacturing establishment/facility. The following information must be included:

  • product name on label
  • establishment ID number/establishment registration number
  • lot number
  • names and origin (Canadian and/or imported) of ingredients of animal origin
  • animal species (bovine, porcine, apiculture)
  • if applicable, description of the heat and/or chemical treatments used
  • any other relevant information

Note: Inspectors will verify that the manufacturer's declaration is completed appropriately and reserve the right to request any other information that they think is necessary for the final certification of the product.

Certification requirements

The export certificate contains public health requirements.

  • the raw material used to manufacture the HRP must be food grade
  • the raw material of animal origin must be from animals, including feathers thereof, which have been slaughtered in a slaughterhouse and whose carcasses have been found fit for human consumption following ante-mortem and post-mortem inspection or from approved fishery products establishments
  • the raw material of animal origin must come from a meat or fish establishment approved for export to the UK
  • human hair must not be used as a source for the manufacture of amino acids

Part II of the certificate is completed by a certifying officer, however some information will have to be provided by the applicant. The applicant should provide a manufacturer's declaration on company letterhead, which confirms:

  • the manufacturer has an SFC licence with preventive controls and a traceability system in place

    Reference: Article 5 of Regulation (EC) No 852/2004

  • the product is manufactured as per Regulation (EC) No 852/2004

    Reference: Annex II of Regulation (EC) No 852/2004

  • the product complies with Section XVI of Annex III to Regulation (EC) No 853/2004. Indicate:
    • animals, including feathers thereof, which have been slaughtered in a slaughterhouse and whose carcasses have been found fit for human consumption following ante-mortem and post-mortem inspection as per Section XVI of Annex III to Regulation (EC) No 853/2004
    • if raw materials of animal origin are used, they must come from an UK listed establishment. Indicate which establishment (establishment identification number)
  • if statement is applicable, confirm that human hair was not used as a source for production of amino acids and that the amino acids comply with Regulation (EC) No 1333/2008
  • if statement is applicable, fat derivatives comply with Regulation (EC) No 1333/2008 and are subjected to appropriate heat and/or chemical treatment
  • if the statement is applicable, food flavourings comply with Regulation (EC) No 1333/2008

Traceability

The manufacturer must develop and implement control programs to demonstrate that products produced for the UK market meet applicable requirements and to assure complete segregation when both eligible and ineligible products are present on the premises.

Imported ingredients of animal origin

If imported ingredients of animal origin are used in the HRP, the competent authority of the exporting foreign country must provide support documentation attesting that the imported ingredients comply with the UK requirements.

4. Labelling, packaging and marking requirements

Exported products depending on their final destination (Great Britain and/or Northern Ireland) mainly must meet certain packaging and labelling requirements. The exporter must work closely with the importer to ensure the compliance of their products.

5. Required documents

Canada does not have negotiated certificates with Great Britain.

The export health certificate below covers products exported to Great Britain, the Channel Islands and the Isle of Man. References to EU legislation within this certificate are references to direct EU legislation which has been retained in Great Britain (retained EU law as defined in the European Union (Withdrawal) Act 2018).

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 UK model certificates including the notes in part III. All health certificates of GB are published on the website gov.uk.

It's the responsibility of the applicant to choose model health certificate that corresponds to the product intended for export and to provide the inspector with the information entered in Part I. Details of dispatched consignment of the certificate.

Part II. Certification, must be completed by an official veterinarian in collaboration with the official inspector. 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.

Official health certificates shall be completed according to the guidance provided at How to complete a health certificate for export to Great Britain, as well as the notes on the export certificates.

If a container is used to ship the products, it is mandatory that the exporter provides the container and seal number in Part I: Details of dispatched consignment.

Certificate

  • Health certificate for highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids intended for human consumption (HRP) GBHC452. (CFIA/ACIA FA1042)

Note:

  • The health certificate is signed by the official veterinarian after having read and understood the notes in Part III.
  • Please ensure that the certificate issued by the CFIA does not contain Part III. Notes for completion the certificates.
  • Export certificates cannot be issued after the products have left Canada.

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 products may be subject to the same requirements as a regular shipment. A special import permit could be required. It is strongly recommended that the exporter verify these requirements with their importer and/or with the border control post where the products will be shipped.

Relevant links