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U.S. export of collagen and gelatin products to the European Union (EU) and the United Kingdom (UK) are subject to establishment listing requirements as a precondition for market access.
Industry may apply for inclusion on these lists via the Export Listing Module (ELM). Please visit Online Applications for Export Lists for a link to this electronic system and step-by-step instructions. Please note that FDA does not have a separate application process for the UK lists; establishments that wish to export to the UK should apply for the relevant EU list in the ELM.
The EU’s listing requirements apply to establishments involved in the preparation and dispatch of consignments containing products of animal origin, unless one of the exemptions in Article 6 of Regulation (EU) 2019/625 applies. Generally, the EU’s listing requirements will apply to establishments that produce collagen or gelatin, establishments that use collagen or gelatin as an ingredient in products for export to the EU, and establishments that package and ship products containing collagen or gelatin to the EU. U.S. establishments are only eligible to be included on the EU lists for collagen and gelatin if they manufacture collagen and gelatin in the United States or if they use collagen or gelatin sourced from U.S. establishments that appear on the EU lists.
Collagen vs. Gelatin
The EU and the UK define gelatin as “natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals” (Regulation (EC) 853/2004). The EU and the UK define collagen as “the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of [Regulation (EU) 853.2004]” (Regulation (EC) 853/2004). Please note that the EU and UK listing requirements do not apply to exports of empty gelatin capsules.
For more information, visit Regulation (EC) No 853/2004.
To be eligible for the EU and UK collagen and gelatin export lists, establishments must provide documentation identifying the source of the collagen and gelatin in the products intended for export and a laboratory report from an accredited, private laboratory demonstrating that the finished products do not exceed the following criteria:
- Total aerobic bacteria - 10^3/g
- Coliforms (30°C) - 0/g
- Coliforms (44.5°C) - 0/10g
- Anaerobic sulphite-reducing bacteria (no gas production) -10/g
- Clostridium perfringens - 0/g
- Staphylococcus aureus - 0/g
- Salmonella - 0/25g
- As - 1 ppm
- Pb - 5 ppm
- Cd - 0.5 ppm
- Hg - 0.15 ppm
- Cr - 10 ppm
- Cu - 30 ppm
- Zn - 50 ppm
- SO2 - 50 ppm
- H2O2 - 10 ppm (may be reported as Peroxide Value)
Additional Information on Collagen and Gelatin Exports to the EU:
Additional Information on Collagen and Gelatin Exports to the UK:
To view U.S. establishments eligible to export collagen products to the UK, filter by Country Name (United States), Sector (Food), and then Section (Section XV Collagen). To view U.S. establishments eligible to export gelatin products, filter by the same country and sector and then Section (Section XIV Gelatine).