European Union (EU) – Export requirements for highly refined products
On this page
- 1. Eligible/ineligible product
- 2. Pre-export approvals by the competent authority of the importing country
- 3. Production Controls and Inspection Requirements
- 4. Labelling, packaging and marking requirements
- 5. Export documents available upon request
- 6. Additional information
This directive applies to food business operators manufacturing highly refined products (HRPs) such as chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids. These HRPs are derived from bovine, sheep, goats pigs, poultry, equine and fishery products.
1. Eligible/ineligible product
EU certificate for highly refined products (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 Harmonized System (HS) codes which can be found on the model of health certificate available in the TRACES system.
Ineligible
- Information not available.
2. Pre-export approvals by competent authority of importing country
Establishments
The highly refined products must come from an establishment licensed under the Safe Food for Canadian Regulations (SFCR).
The EU 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), and be listed as an EU approved establishment in accordance with Regulation (EC) 853/2004 which applies to processed and unprocessed products of animal origin.
The establishments producing HRP must appear on the appropriate establishment list administered by the Directorate-General of Health and Food Safety (DG-SANTE).
- Section: Highly refined products (HRP)
Note: TRACES should be used to consult the lists of authorized establishments. The list of the HRP is under the "Publications" tab, consult the lists of authorized establishments.
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 EU and on the list administered by the Directorate-General of Health and Food Safety (DG-SANTE).
To request inclusion on any of the EU approval lists, please submit the following information to your local CFIA office:
- Safe Food for Canadians licence number
- full legal name as it appears on the Safe Food for Canadians licence
- physical site address associated with the Safe Food for Canadians licence
- indicate the type of activity (processing plant-PP) of the establishment
- any other relevant information
The CFIA is responsible to keep the lists of establishments up to date and to inform the commission of any changes necessary. However, the manufacturer also has the obligation to inform the CFIA changes are made to the information provided above.
3. Production controls and inspection requirements
The HRPs must meet the requirements as described on the EU model certificate. The manufacturer must implement an auditable specific procedure which demonstrates that the final product meets among others the following:
- 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 EU
- 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 (modified 26/07/2019).
- if raw materials of animal origin are used, they must come from an EU listed establishment. Indicate which establishment (establishment identification number).
- if statement is applicable, confirm that human hair was not used as a source for their production; and food additives are to comply with Regulation (EC) No 1333/2008.
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 EU requirements.
4. Labelling, packaging and marking requirements
Products need to satisfy EU labelling requirements.
5. Export documents available upon request
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. 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 a certifying officer (official veterinarian or 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. See 3 above.
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.
For more information about TRACES, refer to the CFIA web page Exporting food and animal products to the European Union
Certificate
- 2021/1471 (2020/2235) Highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids intended for human consumption (HRP)
Export certificates cannot be issued after the products have left Canada.
6. Additional 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. Work closely with your importer.
Samples (personal or commercial) of highly refined 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 :
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.
- Member countries of the European Union (EU)
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 Veterinary border control posts
- Regulation (EC) No 852/2004 of the European parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.
- 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.
- Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives
- 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) 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.
- 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.
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