Potential BSE risk posed by the use of ruminant collagen and gelatine in feed for non‐ruminant farmed animals

BSE, collagen, feed, gelatine, risk, ruminants
First published in the EFSA Journal
28 ottobre 2020
22 settembre 2020
Scientific Opinion

Waiver: In accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management a waiver was granted to John Griffin, Working Group member. Pursuant to Article 21(6) of the aforementioned Decision, the concerned expert was allowed to take part in the discussions and in the drafting of the scientific output but was not allowed to be or act as chair, vice‐chair or rapporteur of the Working Group. Any competing interests are recorded in the respective minutes of the meetings of the Working Group, available online: https://www.efsa.europa.eu/sites/default/files/wgs/biological-hazards/wg-ruminant-collagen-gelatine.pdf


EFSA was requested to estimate the cattle bovine spongiform encephalopathy (BSE) risk (C‐, L‐ and H‐BSE) posed by ruminant collagen and gelatine produced from raw material fit for human consumption, or from material classified as Category 3 animal by‐products (ABP), to be used in feed intended for non‐ruminant animals, including aquaculture animals. Three risk pathways (RP) were identified by which cattle could be exposed to ruminant feed cross‐contaminated with ruminant collagen or gelatine: 1) recycled former foodstuffs produced in accordance with Regulation (EC) No 853/2004 (RP1), 2) technological or nutritional additives or 3) compound feed, produced either in accordance with Regulation (EC) No 853/2004 (RP2a) or Regulation (EU) No 142/2011 (RP2b). A probabilistic model was developed to estimate the BSE infectivity load measured in cattle oral ID50 (CoID50)/kg, in the gelatine produced from the bones and hide of one infected animal older than 30 months with clinical BSE (worst‐case scenario). The amount of BSE infectivity (50th percentile estimate) in a member state (MS) with negligible risk status was 7.6 × 10–2 CoID50/kg, and 3.1 × 10–4 CoID50/kg in a MS with controlled risk status. The assessment considered the potential contamination pathways and the model results (including uncertainties) regarding the current epidemiological situation in the EU and current statutory controls. Given the estimated amount of BSE infectivity to which cattle would be exposed in a single year, and even if all the estimated undetected BSE cases in the EU were used for the production of collagen or gelatine (either using raw materials fit for human consumption or Category 3 ABP raw materials), it was concluded that the probability that no new case of BSE in the cattle population would be generated through any of the three RP is 99–100% (almost certain).

Panel members at the time of adoption

Ana Allende, Avelino Alvarez‐Ordóñez, Declan Bolton, Sara Bover‐Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Kostas Koutsoumanis, Roland Lindqvist, Maarten Nauta, Luisa Peixe, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis and Elisabetta Suffredini.
Panel on Biological Hazards
biohaz [at] efsa.europa.eu
EFSA Journal 2020;18(10):6267
Question Number
On request from
European Commission