European Union (EU) - Animal Products - TREATED Animal Byproducts for the production in the EU of gelatin and/or collagen FOR human consumption

Last Modified: March 15, 2024

CHAPTER 44 MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION (MODEL TCG) [Incorporating changes from Regulation 2022/36].

The “Annex III: MODEL CERTIFICATE FOR THE TRANSIT THROUGH THE UNION, IMMEDIATE TRANSIT OR AFTER STORAGE, FOR RAW MATERIALS OR TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN FOR HUMAN CONSUMPTION” previously available (before 2022) for consignments transiting the European Union (EU) is no longer accepted by the EU.  The “CHAPTER 44 MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION (MODEL TCG)” (as amended) is now required whether the consignment is:

  • Being imported into the EU (i.e., a “for internal use” shipment); or
  • Transiting (without storage) the EU; and
  • Transiting (with storage) the EU. 

Facilities must be listed by APHIS for this certificate prior to endorsement of the certificate.   Please contact your Field Operations Veterinary Export Trade Services for details on how to request any required listings and certificates.

Please note facilities exporting on this certificate must not only be listed as eligible on the internal APHIS database but also be listed on the EU’s TRACES-NT website in the “ TCG Treated raw material for the production of gelatine and collagen (TCG)” section, which is available on the EU’s website.

General Guidance for the Completion of Part I of the TCG - April 2022 (pdf 891kb)
 

Select the appropriate version of the certificate based upon the source materials and the processing method utilized.  Bullets I through V are for shipments for import into the EU.  [Bullet V contains the certificates that should be utilized for shipments transiting the EU and in other cases where the certificates in bullets I through V are not appropriate.]

  1. Bones of bovine, ovine, or caprine animals
    1. Crushed to pieces of approximately 15 mm and degreased with hot water at a temperature of minimum 70°C for at least 30 minutes, minimum 80°C for at least 15 minutes, or minimum 90°C for at least 10 minutes, and then separated and subsequently washed and dried for at least 20 minutes in a stream of hot air with an initial temperature of minimum 350˚C, or for 15 minutes in a stream of hot air with an initial temperature of more than 700°C: 
      Pdf - April 2022
       
    2. Sun-dried for a minimum of 42 days at an average temperature of at least 20˚C:
      Pdf - April 2022 (pdf 336kb)
       
    3. Acid treatment such that the pH is maintained at less than 6 to the core for at least one hour before drying:
      Pdf - April 2022 (pdf 340kb)
  2. Bones of porcine or avian animals
    1. Crushed to pieces of approximately 15 mm and degreased with hot water at a temperature of minimum 70°C for at least 30 minutes, minimum 80°C for at least 15 minutes, or minimum 90°C for at least 10 minutes, and then separated and subsequently washed and dried for at least 20 minutes in a stream of hot air with an initial temperature of minimum 350˚C, or for 15 minutes in a stream of hot air with an initial temperature of more than 700°C:
      Pdf - April 2022
       
    2. Sun-dried for a minimum of 42 days at an average temperature of at least 20˚C:
      Pdf - April 2022
       
    3. C. Acid treatment such that the pH is maintained at less than 6 to the core for at least one hour before drying:
      Pdf - April 2022
       
  3. Hides and skins of ruminant, porcine, or avian animals
    1. Alkali treatment which ensures a PH>12 to the core followed by salting for at least seven days: 
      Pdf - April 2022
       
    2. Dried for at least 42 days at a temperature of at least 20°C
      Pdf - April 2022
       
    3. Acid treatment that provides at least a pH of less than 5 to the core for a minimum of one hour:
      Pdf - August 2023
       
    4. Alkali treatment which ensures a pH > 12 to the core for at least 8 hours:
      Pdf - April 2022
  4. Alternative treatment method
    1. Bones from bovine, ovine, or caprine animals:
      Pdf - April 2022
       
    2. Bones from porcine, avian, or ruminant (other than bovine, ovine, and caprine) animals:
      Pdf - August 2023
       
    3. Hides from porcine, avian, or ruminant animals:
      Pdf - April 2022
       
    4. Fish skins and/or bones:
      Pdf - April 2022
  5. Other (These versions should be utilized when the line-outs in the above versions are not appropriate.
    To utilize these versions, in addition to completing the fillable areas, the inappropriate text must be lined out prior to endorsement.)
    1. Dispatch (other)
      Pdf - April 2022
       
    2. Transit without storage (other than fish-origin)
      Pdf - April 2022
       
    3. Transit with storage (other than fish-origin)
      Pdf -April 2022
       
    4. Transit without storage (fish-origin)
      Pdf - April 2022
       
    5. Transit with storage (fish-origin)
      Pdf - April 2022