II 
(Non-legislative acts) 
REGUL ATIONS 
COMMISSION REGUL ATION (EU) 2015/728 
of 6 May 2015 
amending the definition of specif ied risk mater ial set out in Annex V to Regulation (EC) 
No 999/2001 of the European Parliament and of the Council laying down rules for the prev ention, 
control and eradication of certain transmissible spongif orm encephalopathies 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying 
down rules for the prevention, control and eradication of certain transmissible spongif orm encephalopathies (1), and in 
particular the first paragraph of Article 23 thereof, 
Whereas: 
(1)  Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible 
spongif orm encephalopathies (TSEs) in animals. It applies to the production and placing on the mark et of live 
animals and products of animal origin and in certain specific cases to expor ts thereof. 
(2)  Regulation (EC) No 999/2001 provides that specifi ed risk mat erial (SRM) is to be remo ved and disposed of in 
accordance with Annex V to that Regulation. In accordance with that Annex, SRM includes the intestines from 
the duodenum to the rectum and the mesente ry of bovine animals of all ages. 
(3)  The Communication from the Commission to the European Parliament and the Council — The TSE Roadmap 2 
— A Strate gy Paper on Transmissible Spongif orm Encephalopathies for 2010-2015 of 16 July 2010 (2) states that 
any amendment of the current list of SRM referred to in Annex V to Regulation (EC) No 999/2001 (the ‘list of 
SRM’) should be based on new evolving scientifi c kno wledge, while maintaining the existing high level of 
consumer prot ection within the Union. 
(4)  On 13 Febr uary 2014, the European Food Safe ty Author ity (EFSA) issued a Scientific Opinion on BSE risk in 
bovine intestines and mesenter y (3) (‘the EFSA Opinion’) whic h provides a quantifi cation of the amount of 
infectivity in the different parts of the bovine intestines and mesenter y. According to the EFSA Opinion, in BSE 
infected bovine animals: (i) up to 36 months of age, more than 90 % of the BSE infectivity is associated with the 
last 4 metres of small intestine and the caecum; (ii) between 36 and 60 months of age, there is a substantial inter- 
individual variability in the relative contr ibution of intestinal and mesent eric structures to the total infectivity ; 
(iii) from 60 months of age, more than 90 % of the BSE infec tivity is associated with the mesent eric nerves and 
the celiac and mesent eric ganglion complex; (iv) the duodenum, the colon and the mesenter ic lymp h nodes 
contr ibute less than 0,1 % to the total infec tivity in an infect ed animal regardl ess of the age at slaughter . The 
EFSA Opinion also states that the total infectivity associated with those tissues varies with the age of the infec ted 
animal, with a peak in animals younger 18 months before a progressive drop in animals older than 60 months. 7.5.2015 L 116/1 Official Jour nal of the European Union EN     
(1)OJ L 147, 31.5.2001, p. 1. 
(2)Communication from the Commission to the European Parliament and the Council — The TSE Road map 2 — A Strateg y paper on 
Transmissible Spongif orm Encephalopathies for 2010-2015; COM(2010) 384 final. 
(3)EFSA Jour nal 2014; 12(2):3554. (5)  The mesenter ic nerves, the celiac and mesente ric ganglion compl ex are tissues which are associated with the 
mesent ery and the mesente ric fat and theref ore here is no practical way to efficiently separate them from each 
other . 
(6)  In order to ensure that rules for the remo val of SRM are operational and not unnecessar ily compl ex, and to 
facilitate controls, diffe rences in the list of SRM applicable based on the age of the slaughter ed animal should be 
avoided where appropr iate. To preser ve a high level of human health prot ection, the last four meters of the small 
intes tine, the caecum and the mesenter y (which cannot be dissociat ed from the mesent eric nerves, the celiac and 
mesent eric gang lion compl ex and the mesenter ic fat) should theref ore be maintained in the list of SRM for 
animals of all ages. 
(7)  The EFSA Scientific Opinion on the revision of the quantitative risk assessment (QRA) of the BSE risk posed by 
processed animal prot eins (PAPs) published in 2011 (1) states that 90 % of the total infectivity amount in a BSE 
clinical case is associated with central and peripheral nervous system tissues, with about 10 % associated with the 
distal ileum. The residual infectivity in the parts of the intes tines other than the last four meters of the small 
intes tine and the caecum can be considered as negligible. The complet e elimination of risk is not a realistic 
objective for any risk managemen t decision. 
(8)  The excl usion from the list of SRM of the duodenum, the colon and the small intest ine excep t for the last four 
meters would bring the EU list of SRM closer to international standards. Indeed, as regar ds bovine intestines and 
mesent ery, Article 11.4.14 of the OIE Terrestr ial Animal Health Code recommends that the distal ileum (the last 
part of the small intestine) of bovine animals of all ages originating from countr ies with a controlled BSE risk or 
an undetermined BSE risk should not be traded. Theref ore, there is no recommendation of the OIE not to trade 
the remaining parts of the bovine intestines or the mesent ery. 
(9)  On the basis of the EFSA Opinion and of the recommendations of the OIE Terrestr ial Animal Health Code, the 
list of SRM concer ning bovine animals should be amended so as to include the last four meters of the small 
intes tine, the caecum and the mesenter y (which cannot be dissociat ed from the mesent eric nerves, the celiac and 
mesent eric gang lion compl ex and the mesente ric fat), but to excl ude the remaining parts of the bovine intestines, 
namely the duodenum, the colon and the small intestine excep t for the last four meters. 
(10)  Annex V to Regulation (EC) No 999/2001 should theref ore be amended according ly. 
(11)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
In Annex V to Regulation (EC) No 999/2001, point 1(a)(iii) is replaced by the following: 
‘(iii)  the tons ils, the last four meters of the small intestine, the caecum and the mesent ery of animals of all ages’. 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 6 May 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  7.5.2015 L 116/2 Official Jour nal of the European Union EN     
(1)EFSA Jour nal 2011; 9(1):1947.