May 2001     © Regulatory Affairs Journals Ltd 2001   BSE/TSE Risks BSE/TSE Risks Associated with Active
Pharmaceutical Ingredients and Starting Materials Brian Matthews The following Tables provide reference information for the feature article published in this issue (see page XXX). Further
information on this topic (covering the chronology of selected activities relating to BSE) will be published in a future issue
of the Journal. Date November 1986 5 June 1987 15 December 1987 14 June 1988 (effective 18 July 1988) 21 June 1988
1 April 1990 8 August 1988
(28 November 1988 in
Northern Ireland)
29 June 1988 October 1988 22 December 1988 28 July 1989 13 November 1989 (UK;
30 January 1990 in Scotland and
Northern Ireland) 31 January 1990 3 February 1990 1 March 1990 30 March 1990 10 May 1990 Commentary Table 1. Selected events in the BSE story BSE identified at the UK Central Veterinary Laboratory, Ministry of Agriculture
Fisheries and Food UK government ministers advised Initial epidemiology study results in a suggestion that ruminant-derived meat and bone
meal caused BSE (substantiated by examination of feeding histories of affected animals in
April–May 1998) Prohibition of use of certain feeds (containing ruminant derived protein) for ruminants
Extended 30 December 1988 (with additional restriction on the use of milk from
suspected/affected animals to their own calves)
Extended to Northern Ireland on 11 January 1989
Further extended 31 December 1989
Export of feeding stuffs containing SBO to third countries banned 10 July 1991 BSE made notifiable in the UK
BSE made notifiable throughout the EU Slaughter policy announced Compulsory slaughter of affected animals introduced Intracerebral transmission of BSE in mice reported in Veterinary Record BSE designated a zoonosis EU bans export of cattle born before 18 July 1988 from the UK Specified bovine offal (SBO) banned for human consumption (with extension of the list of
SBO on 2 November 1994) Report of kudu, Arabian oryx, eland, nyala and gemsbok affected by TSE Intra-cerebral and intravenous transmission of BSE from cattle to cattle; and oral
transmission to mice reported in the Veterinary Record EU allows export from the UK of cattle less than 6 months in age provided that they are
slaughtered before that age Administrative ban on the export of specified bovine offal and certain glands and organs
from the UK to other EU Member States
(EC ban on SBO and other tissue exports 9 April 1990)
Ban on SBO extended to all animal feed, including exports 25 September 1990 TSE in domestic cat

© Regulatory Affairs Journals Ltd 2001     May 2001 BSE/TSE Risks Date 24 September 1990 27 March 1991 6 November 1991
27 June 1994
19 April 1996
29 March 1996 10 June 1996
30 April 1998 4 March 1992 1 January 1993
August 1997–98
29 July 1998 27 June 1994 6 March 1995 1 April 1995 15 August 1995 15 December 1995 20 March 1996 3 April 1996 11 June 1996 1 August 1996
18 April 1987 15 September 1996 December 1996 14 May 1997
22 July 1997 29 June 2000
December 2000 Commentary Table 1. Selected events in the BSE story (contd.) Laboratory transmission to pig First case of BSE in offspring born after the ruminant feed ban introduced Meat and bone meal from SBO banned as a fertiliser
EU ban on feeding mammalian protein
Meat and bone meal banned as a fertiliser on agricultural land
Mammalian meat and bone meal and feeding stuffs containing it banned from use in farm
animals including horses and farmed fish
Feed recall scheme – 10 000 tons recovered by October 1996
Mammalian meat and bone meal banned from use as a fertiliser on agricultural land, and
for use in fertiliser unless a specified production process was applied BSE transmitted to marmoset (inoculation to brain and body cavity) Scrapie made notifiable
Abattoir survey
Compulsory slaughter policy for affected animals EC ban on feeding mammalian protein Lifting of ban of feeding milk, gelatin, amino acids, dicalcium phosphate, dried plasma
and other blood products to ruminants Removal of spinal cord and obvious nervous and lymphatic tissue from bovines more
than six months old at slaughter (and the removed materials banned from human
consumption) Whole skull to be treated as SBO
Brain and eyes not to be removed
Spinal cord to be removed from vertebral column only in slaughterhouses and licensed
alternatives Prohibition of use of bovine vertebral column for the manufacture of mechanically
recovered meat and some other products for human consumption New variant CJD in humans announced Over 30 month slaughter scheme announced Partial lifting of export ban on gelatin, tallow and semen from the UK Very low maternal transmission rate of BSE notified
Confirmed at conclusion of study
Genetic susceptibility of offspring to BSE possible
No evidence to suggest BSE risk from milk Prohibition of use of head (except tongue) from sheep or goats for human
consumption/food use Proposal for control on specified risk materials rejected by Standing Veterinary
Committee (EU)
Commission insists on SRM controls
Agriculture ministers council accepts SRM controls
Commission Decision 97/534 adopted, effective date 1 January 1998
Standing Veterinary Committee deferred implementation until 1 April 1998
Agriculture Council deferred implementation until 1 January 1999
Agriculture Council deferred implementation until 30 June 2000
Replacement Commission Decision adopted
Intestine added to SRM