32001R0999

WHAT IS THE AIM OF THE REGULATION?

• It sets out rules to prevent, control and eradicate transmissible spongiform encephalopathies (TSEs)¹ in the European Union (EU).
• It covers the production, the placing on the market and, in some cases, the export of animals and animal products.

KEY POINTS

The European Commission ranks EU Member States or regions by their level of risk of bovine spongiform encephalopathies (BSE):

• Level 1: negligible risk
• Level 2: controlled risk
• Level 3: undetermined risk.

Member States must put in place a monitoring programme, with screening for animals suspected of BSE or scrapie. Rapid post-mortem screening must also be carried out.

Suspected animals and others on a holding cannot be moved until the test results are known. If the animals may have been exposed elsewhere, other holdings may be monitored.

When a case of classical BSE is officially confirmed, the following measures are applied.

• An inquiry into the origin of the disease and all potentially affected animals or products.
• The affected holding is placed under official control. Any movement of susceptible animals (or animal products) must be authorised.
• The killing and complete destruction of at-risk cattle. Different rules apply to sheep and goats.

Compensation is paid without delay for the loss of animals or animal products.

Risk reduction measures

• Feeding animal protein to ruminants is prohibited, with the exception of hydrolysed proteins from non-ruminants or from ruminant hides and skins, gelatin and collagen from non-ruminants, and eggs, egg products, milk, milk products and colostrum.
• Feeding processed animal protein (PAP) from ruminants, gelatin, or blood products from ruminants to any farm animal (with the exception of fur-producing carnivores such as mink) is prohibited.
• Based on the favourable European Food Safety Authority (EFSA) opinions from 2015 (insect PAP), 2018 (pig and poultry PAP) and 2020 (collagen and gelatin derived from ruminants), certain prohibitions that were no longer justified were repealed by Regulation (EU) 2021/1372 of 17 August 2021. Since then, it is authorised:
  • to feed non-ruminant farmed animals (e.g. pigs and poultry) with collagen and gelatin of ruminant origin;
  • to feed pigs with poultry PAP and poultry with pig PAP;
  • to feed pigs and poultry with insect PAP.
• Specific risk material must be removed from carcasses, even in areas where there is negligible BSE risk. In areas of controlled or undetermined risk, bones from cattle, sheep or goats cannot be used for mechanically separated meat. There are specific methods for certain body parts such as head meat and tongue.
• Animals for export or import must have health certificates. Similar rules apply to imports from non-EU countries, except for those with negligible BSE risk.

Production and inspection workers must have basic training in TSEs.

To ensure uniform scientific analysis and reliable results, national and European reference laboratories must be designated.

Member States must ensure that animals suspected of a TSE are notified to the authorities, and regularly inform each other and the Commission of such cases. They must also carry out frequent official inspections to check that the rules are being observed.

Derogations from these rules may be granted to reflect new scientific knowledge.

Amendments to Regulation (EC) No 999/2001

• The regulation has been amended many times, mostly to make adjustments to the annexes. These changes have been incorporated into the consolidated version of the regulation.
• Amending Regulation (EU) 2017/625 introduced a more harmonised and coherent system of official controls and enforcement measures along the agri-food chain, and strengthened the principle of risk-based controls (see summary). The amending regulation deleted Articles 19 (relating to reference laboratories) and 21 (on spot checks) of Regulation (EC) No 999/2001 and Chapters A and B of its Annex X (which concerned reference laboratories) and laid down the rules on the designation and tasks of the EU reference laboratories and reference centres.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 1 July 2001.

BACKGROUND

• Control of TSEs (including BSE and scrapie) (European Commission)
• Biological safety (European Commission).

KEY TERMS

1. Transmissible spongiform encephalopathies (TSEs). TSEs are fatal diseases in which brain tissue degenerates, giving a sponge-like appearance. They include:

MAIN DOCUMENT

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 spongiform encephalopathies (OJ L 147, 31.5.2001, pp. 1–40).

Successive amendments to Regulation (EC) No 999/2001 have been incorporated in the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Communication from the Commission to the European Parliament and the Council — The TSE road map 2 — A strategy paper on transmissible spongiform encephalopathies for 2010–2015 (COM(2010) 384 final, 16 July 2010).

Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, pp. 84–86).

See consolidated version.

Communication from the Commission: TSE road map (COM(2005) 322 final, 15 July 2005).

Commission Decision 2002/1003/EC of 18 December 2002 laying down minimum requirements for a survey of prion protein genotypes of sheep breeds (OJ L 349, 24.12.2002, pp. 105–107).