Regulation (EC) No 999/2001, EU rules for the prevention, control and eradication of TSEs

Key facts

• Dated 22 May 2001, published in OJ L 147 of 31 May 2001 (pages 1 to 40), in force from 1 June 2001 and applicable from 1 July 2001 under article 26; adopted by co-decision (procedure 1998/0323/COD) with Article 152(4)(b) EC as legal basis.
• Recital 1 records that BSE was first identified in cattle in 1986, that a new variant of CJD was described in 1996, and that evidence of similarity between the BSE and vCJD agents was growing; recital 2 cites the risk to human and animal health.
• Article 1 limits the regulation to TSEs in animals and to the production and placing on the market of live animals and animal products; cosmetics, medicinal products, medical devices and their starting materials are excluded.
• As adopted, article 5 classified countries and regions into five BSE risk categories under Annex II, and countries that did not apply within six months of 1 July 2001 were treated as the highest category until they did.
• Article 6 requires each Member State to run an annual BSE and scrapie monitoring programme under Annex III, including screening with approved rapid tests, and to report each year by 31 March. The adopted Annex X listed three approved rapid tests: the Prionics Check western blot, the Enfer chemiluminescent ELISA and the Bio-Rad sandwich immunoassay.
• Article 7 bans feeding protein derived from mammals to ruminants, with wider bans in the highest risk category, and lists exempt products such as milk and certain gelatine and blood products. EFSA refers to the EU feed ban as enforced in 2001 and in 2017 judged contaminated feed the most likely source of 60 classical BSE cases in cattle born after it.
• Article 8 requires SRM to be removed and destroyed under Annex V; SRM may not be imported and may be exported only for destruction. In the adopted Annex V the cattle SRM list included skull, brain, eyes, tonsils and spinal cord of older animals and the intestines, with more tissues for the highest risk category.
• Article 19 as adopted had each Member State designate a national reference laboratory and set a Community reference laboratory, named in Annex X as the Veterinary Laboratories Agency at Addlestone, United Kingdom. Commission Regulation 2018/221 replaced that entry from 1 January 2019 with a consortium led by the Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d Aosta in Turin with the Istituto Superiore di Sanita in Rome. EUR-Lex now lists articles 19 and 21 and Annex X chapters A and B as repealed by Regulation 2017/625.
• Regulation 1923/2006 (effect 19 January 2007) replaced or added many articles, including article 6a, which lets Member States run sheep breeding programmes for TSE resistance with an optional framework for recognising flock resistance status.
• EUR-Lex lists 78 amending entries, from Regulation 1248/2001 to Regulation 2025/328; the current consolidated version is dated 12 March 2025. Feed rules in Annex IV were reworked by Regulations 2017/893 and 2021/1372, among others; their content was not read here.
• The UK keeps a retained version on legislation.gov.uk, last revised there on 19 November 2020 and updated only for UK amendments after 31 December 2020; it is not the current EU text.
• EFSA states that all EU measures on animal TSEs are consolidated in this regulation, and since December 2016 it has written the annual EU summary of TSE surveillance data reported under it.
• Under article 6 and Annex III, the 2024 EU summary (published 13 November 2025) reports 980,624 cattle tested in the EU27 and Northern Ireland with 3 atypical BSE cases and no classical case, 277,064 sheep with 458 scrapie cases and 93,960 goats with 71 scrapie cases; the last classical BSE case in the EU27 and Northern Ireland was reported by France in 2016.
• Spanish law cites the regulation: Real Decreto 21/2013 bases its sheep breeding programme on article 6a, and the current text of Real Decreto 3454/2000 refers to it in article 3.2 on reference laboratory functions and in Annex X on measures after a TSE case in sheep or goats (Annex VII of the regulation).

Timeline

1. 1986BSE first identified in cattle, as recorded in recital 1.
2. 1996New variant CJD described, as recorded in recital 1.
3. 2001Regulation adopted by the European Parliament and the Council.
4. 2001Published in OJ L 147.
5. 2001Enters into force.
6. 2001Applies; first amendment (Regulation 1248/2001) takes effect the same day.
7. 2006Regulation 1923/2006 inserts article 6a on breeding programmes.
8. 2007Body text changes of Regulation 1923/2006 take effect.
9. 2013Spanish Real Decreto 21/2013, based on article 6a, comes into force.
10. 2016EFSA publishes its first annual EU TSE surveillance summary.
11. 2017EFSA reports on 60 classical BSE cases born after the 2001 feed ban.
12. 2018Commission Regulation 2018/221 names the Turin and Rome consortium as EU reference laboratory for TSEs.
13. 2019New EU reference laboratory designation applies.
14. 2019Date shown on EUR-Lex for the repeal of articles 19 and 21 and Annex X chapters A and B by Regulation 2017/625.
15. 2020Last revised version in the UK retained text.
16. 2025Latest EU consolidated version, after Regulation 2025/328.
17. 2025EFSA publishes the 2024 EU TSE surveillance summary.