EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11531/2013 Rev. 3 CIS (POOL/G4/2013/11531R3-EN CIS.doc)[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annexe s II, VII, VIII, IX and X to Regu lation (EC) No 999/2001 of the 
European Parliament and of the Council layi ng down rules for the prevention, control 
and eradication of certain transmis sible spongiform encephalopathies 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annexes II, VII, VIII, IX and X to Regulation (EC) No 999/2001 of the 
European Parliament and of the Council layi ng down rules for the prevention, control 
and eradication of certain transmi ssible spongiform encephalopathies 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard 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 sp ongiform encephalopathies
1, and in particular the first paragraph of 
Article 23 thereof, 
Whereas: (1) Regulation (EC) No 999/2001 lays down ru les for the preven tion, control and 
eradication of transmissible spongiform en cephalopathies (TSEs) in bovine, ovine and 
caprine animals. It applies to the producti on and placing on the market of live animals 
and products of animal origin and in cer tain specific cases to exports thereof. 
(2) Annex II to Regulation (EC) No 999/ 2001 lays down rules governing the 
determination of the bovine  spongiform encephalopathy (BSE) status of Member 
States or third countries or regions thereo f. These rules are base d on the international 
standard established by the World Organi sation for Animal Health (OIE) in the 
Terrestrial Animal Health Code (the Code).  In the BSE chapter of the 2013 version of 
the Code, the expression 'release assessment' has been replaced by 'entry assessment', and the table providing the points targets for a country or region has been significantly 
amended to better meet the needs of count ries with a small or very small cattle 
population. These amendments should be reflected in Annex II. 
(3) Point 2.2.1 of Chapter B of A nnex VII to Regulation (EC) No 999/2001 refers to the 
methods and protocols set out  in Annex X. The wording of this point should be 
amended to reflect amendments to Annex X brought by this act. 
(4) Chapter A of Annex VIII to Regulation (EC) No 999/2001 lays down rules governing 
intra-Union trade in live animals, seme n and embryos, including the exemption of 
homozygote ovine ARR embryos from any othe r classical scrapie related requirement 
                                                
 
1 OJ L 147, 31.5.2001, p. 1. EN 3   EN in intra-Union trade. On 24 January 2013, the European Food Safety Authority 
(EFSA) adopted a scientific opi nion on the risk of transmissi on of classical scrapie via 
in vivo derived embryo transfer in ovine animals2, where it concluded that the risk of 
transmitting classical scrapie by the implantation of homozygous or heterozygous ovine ARR embryos could be considered  negligible providing that the OIE 
recommendations and procedures relating to embryo transfer are adhered to. The 
relevant provisions of Annex VIII should th erefore be amended to also exempt intra-
Union trade of heterozygous ovine ARR em bryos from any other classical scrapie 
related requirement. 
(5) Points 1.2. and 1.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 
999/2001 mention the term 'oocytes', whereas th is commodity is designated in the rest 
of Regulation (EC) No 999/2001 by the term 'ova'. For the sake clarity, the term 
'oocytes' should be systematically replaced by 'ova'. 
(6) Point 2 of Section A of  Chapter A of  Annex VIII to Regulation (EC) No 999/2001 
lays down the rules governing the approval of the negligible risk status for classical 
scrapie of a Member State or zone of a Member State. On 4 July 2013, Austria 
submitted to the Commission the appropriate supporting documentation. Given the favourable outcome of the assessment of th is application by the Commission, Austria 
should be listed as a Member State with a negligible risk of classical scrapie. 
(7) Point 3.2 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 
lists Member States with an approved na tional control programme for classical 
scrapie. Considering that Austria should be listed as a Member State with a negligible 
risk of classical scrapie, it should simultane ously be deleted from the list of Member 
States with an approved nati onal control programme for classi cal scrapie, as this status 
offers guarantees over and above thos e offered in the control programme. 
(8) Chapter H of Annex IX to Regulation (EC) No 999/2001 lays down rules for the 
import in the Union of ovine and caprine semen and embryos. These import rules 
should be updated to reflect amendments  to Annex VII broug ht by this act. 
(9) Annex X to Regulation (EC) No 999/2001 lays down the methods of analysis 
applicable to TSE testing in bovine, ovine and caprine animals. This Annex should be 
reviewed to update the information on the desi gnated laboratories, adjust the reference 
to various guidelines, harmonize some techni cal terms, and clarify the discriminatory 
testing process in case of positive TSE cases in ovine and caprine animals, in accordance with the latest sc ientific knowledge and current  practices in the Union. 
(10) Point 4 of Chapter C of Annex X to Regula tion (EC) No 999/2001 sets out the lists of 
rapid tests approved for the monitoring of TS Es in bovine, ovine and caprine animals. 
On 18 September 2013, IDEXX made an applicati on in order that the name of the test 
IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA be changed to HerdChek BSE-
Scrapie Antigen (IDEXX Laboratories). The new package insert for this test has been 
approved by the European Union Reference laboratory for TSEs  on 2 May 2013. 
Furthermore, on 6 December 2013, the Enfer Group informed that it has ceased the 
manufacture of the Enfer Version 3 TSE di agnostic kit and request ed the deletion of 
                                                
 
2 EFSA Journal 2013; 11(2):3080. EN 4   EN this kit from the list of approved BSE rapid te sts in bovine animals. The lists in point 4 
of Chapter C of Annex X should th erefore be adapted accordingly. 
(11) In order to offer sufficient time to Memb er States to align their scrapie-related 
certification procedures for ovine embryos, certain amendments introduced by this 
Regulation should apply from 1 January 2015. 
(12) Regulation (EC) No 999/2001 should therefore be amended accordingly. 
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes II, VII, VIII, IX and X to Regula tion (EC) No 999/2001 are amended in accordance 
with the Annex to this Regulation. 
Article 2 
This Regulation shall enter into  force on the twentieth day follo wing that of its publication in 
the Official Journal of  the European Union . 
Paragraphs (a), (b) and (e) of point 3 and poi nt 4 of the Annex sha ll apply from 1 January 
2015. 
 This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO