ACT : Commission Regulation 1041/2006/EC amending Annex III to Regulation 999/2001/EC of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in ovine animals.

CONTENT : Regulation 999/2001/EC lays down rules for the monitoring of transmissible spongiform encephalopathies (TSE) in ovine animals.

On 8 March 2006, a panel of experts on TSEs in small ruminants, chaired by the Community Reference Laboratory for TSEs (CRL), confirmed that bovine spongiform encephalopathy (BSE) in those animals cannot be excluded following the results of the second stage of discriminatory testing of brain samples of two sheep from France and one sheep from Cyprus. Further testing is required in order to exclude the presence of BSE in such animals.

In April 2002, the former Scientific Steering Committee of the European Commission (SSC) adopted an opinion on safe sourcing of small ruminant materials should BSE become likely in small ruminants. In its opinion of November 2003, the Scientific Panel on Biological Hazards of the European Food Safety Authority (EFSA) endorsed the recommendations of the SSC opinion with regard to the TSE-related safety of certain small ruminant products.

The significance of those TSE cases in France and Cyprus, where the presence of BSE cannot be excluded should be assessed. In order to do so, the results of an increased monitoring of TSEs in sheep is essential. Therefore, and in line with the SSC and EFSA opinions, the monitoring of sheep should be extended in order to improve the Community eradication programmes. Those programmes also increase the level of consumer protection, in addition to the safe sourcing of sheep products assured by the current measures, in particular the provisions on the removal of specified risk materials, in Regulation 999/2001/EC.

The extended monitoring should be based on a statistically valid survey in order to determine the likely prevalence of BSE in sheep as soon as possible and to improve knowledge of the geographical distribution of the disease.

In view of the high level of TSEs in the ovine and caprine population in Cyprus the extended monitoring of ovine animals can be limited to non-infected flocks.

The monitoring programme in ovine animals should be reviewed after at least six months of effective monitoring.

Regulation 999/2001/EC should therefore be amended accordingly. This is the aim of this Regulation.

Lastly, in order to ensure the highest possible level of consumer protection by assessing the possible prevalence of BSE in ovine animals, the amendments made by this Regulation should enter into force without delay.

ENTRY INTO FORCE : 09/07/2006.

ACT: Commission Regulation 657/2006/EC amending Regulation 999/2001/EC of the European Parliament and of the Council as regards the United Kingdom and repealing Council Decision 98/256/EC and Decisions 98/351/EC and 1999/514/EC.

CONTENT: this Decision repeals Decision 98/256/EC, prohibiting the export, from the United Kingdom, of live cattle and products derived from cattle slaughtered in the United Kingdom, which are liable to enter the food or feed chain or which are destined for use in cosmetics or medical/pharmaceutical products.

The ban on the export of UK beef was issued in March 1996, due to the high incidence of BSE cases in the UK at the time. The provisions of this Decision state that the UK will be able to export live cattle born after 1 August 1996, and bovine meat and products produced after 15 June 2005, under the same terms as other Member States.

The export ban on UK cattle, their meat and products, has been in place since March 1996. In 1999, the ban was amended to allow de-boned beef and beef products from the UK produced under the Date-based Export Scheme (DBES) to be exported. Under the DBES, the UK could export beef and products from cattle born after 1 August 1996, subject to a series of strict and limited conditions. These included requirements that the animal was between 6 and 30 months old, had been clearly traced and identified throughout its lifetime, its mother did not develop BSE, and that beef from cattle older than 9 months was de-boned.

In proposing to end the ban, the Commission laid out very clear conditions which had to be met before the restrictions on UK beef exports could be lifted. Firstly, the UK would have to have a BSE incidence below 200 cases per million animals, and secondly, the EU Food and Veterinary Office (FVO) would have to deliver a favourable report on the enforcement of BSE controls in the UK and its compliance with EU legislation in this field.

The European Food Safety Authority (EFSA) issued an Opinion in May 2004, confirming that BSE incidence in the UK was below 200 cases per million, and therefore not anymore considered a high BSE risk country. In June 2005, an inspection carried out by the EU Food and Veterinary Office confirmed that BSE controls were being properly enforced in the UK, and that its compliance with EU legislation, particularly in relation to identification and registration of bovine animals and testing, was satisfactory.

In the interest of clarity and coherence the following Decisions have also been repealed: Commission Decision 98/351/EC setting the date on which dispatch from Northern Ireland of bovine products under the Export Certified Herds Scheme may commence; Council Decision 98/256/EC and Commission Decision 1999/514/EC setting the date on which dispatch from the United Kingdom of bovine products under the date-based export scheme may commence.

ENTRY INTO FORCE: 2 May 2006.

ACT: Commission Regulation 546/2006/EC implementing Regulation 999/2001/EC of the European Parliament and of the Council as regards national scrapie control programmes and additional guarantees and derogating from certain requirements of Decision 2003/100/EC and repealing Regulation 1874/2003.

CONTENT: Regulation 999/2001 provides for the approval of “national scrapie control programmes” in cases where a Member State is likely to have a low prevalence, or indeed absence of scrapies on its territory. In addition, those Member States whose national scrapie programmes have been approved may derogate from Commission Decision 2003/100/EC. This Decision lays down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep.

In 2003, the Commission approved the national scrapie control programmes for Denmark, Sweden and Finland on the basis that they can all prove a low prevalence of, or indeed absence of, scrapies on their territories. On the basis of this approval the Commission also granted Denmark, Sweden and Finland permission to derogate from the breeding programme established in Decision 2003/100/EC. Further, provisions on additional guarantees relating to holdings, official movement restrictions and derogations from the requirement to establish a breeding programme, have also been spelt out in implementing Regulation 1874/2003.

In November 2005, the Commission approved a similar “national scrapie control programme” for Austria based on the fact that it too can prove a low prevalence or absence of scrapies on its territory. Similarly, on the basis of that national scrapie control programme Austria has been granted a derogation from the breeding programme provided for in Commission Decision 2003/100/EC. Accordingly, trade guarantees required by Annex VIII, Chapter A and Annex IX, Chapter E of Regulation 999/2001/EC have been amended.

However, for practical reasons and in the interest of clarity, the Commission has decided to repeal Commission Regulation 1874/2004 and replace it by the present Regulation. Effectively, the new Regulation states that the national scrapie control programmes of Denmark, Sweden, Finland and Austria have been approved. Additional provisions relating to:

- the actual approval of national scrapie control programmes,

- additional guarantees relating to holdings,

- official movement restrictions and

- derogations from the requirement to establish a breeding programme,

have been included in this Regulation.

ENTRY INTO FORCE: 21 April 2006.

ACT: Commission Regulation 1053/2003/EC amending Regulation 999/2001/EC of the European Parliament and of the Council as regards rapid tests.

CONTENT: the purpose of this implementing legislative act is three-fold fold. Firstly, to change the reference to the Greek “national reference laboratory” for the monitoring and carrying out of tests on transmissible spongiform encephalopathy (TSE’s). Secondly, one of the companies authorised to test for TSE’s under the terms of Regulation 999/2001, has informed the Commission of its intention to market its test under a new trade name. Thirdly, the Scientific Steering Committee has recommended the inclusion of two new tests for monitoring bovine spongiform encephalopathy (BSE). The producers of both tests have provided enough data to conclude that their tests may also be used for the monitoring of TSE in sheep. In order to ensure a high level of performance after approval of a test, a new procedure has been laid down for possible modifications to the test or the test protocol.

Bearing the above in mind, the Commission has amended Annex X of Regulation 999/2001. The amended Annex now includes new reference details for the authorised Greek national laboratory. Further, Chapter C on “Rapid Tests” has been modified so as to include the new testing methods. As far as the new procedure is concerned the following shall apply.

The producer of the rapid tests must have a quality assurance system in place agreed by the Community reference laboratory which ensures that the test performance does not change. The producer must provide the test protocol to the Community reference laboratory. Modifications to the rapid test or to the test protocol may only be made following advance notification to the Community reference laboratory and provided that the Community reference laboratory finds that the modification does not reduce the sensitivity, specificity or reliability of the rapid test. The findings shall be communicated to the Commission and to the national reference laboratories.

ENTRY INTO FORCE: 10 July 2003.

ACT: Commission Regulation 650/2003/EC amending Regulation 999/2001/EC of the European Parliament and of the Council as regards the import of live ovine and caprine animals.

CONTENT: this implementing act has been introduced following the introduction of new Community rules for the eradication of scrapies following confirmed cases in a small ruminant holding. To recall, the Commission changed the rules for intra-Community trade in breeding sheep in order to remove scrapie-related restrictions from trade in sheep of the ARR/ARR prion protein genotype. Similarly, rules for the import of live ovine and caprine animals were amended in Annexes VII, VIII and XI.

The specific purpose of this act is to amend Annex IX of Regulation 999/2001 to allow this Annex to become compatible with the new rules. More specifically speaking, Regulation 999/2001 and Chapter E of Annex IX on the “Import of ovine and caprine animals” now states that: as from 1 October 2003 the import of ovine and caprine animals into the Community will be subject to the presentation of an animal health certificate. This certificate must certify that animals were born in and continuously reared on holdings in which a case of scrapie has never been diagnosed. In the case of ovine and caprine animals for breeding they must now satisfy certain specific requirements stated elsewhere in the Annexes. Alternatively, the certificate must certify that the sheep being imported are of the ARR/ARR prion protein genotype and come from a holding where no case of scrapie has been reported in the last six months.

ENTRY INTO FORCE: 1 May 2003. It applies as from 1 October 2003.

ACT: Commission Regulation 260/2003/EC amending Regulation 999/2001/EC of the European Parliament and of the Council as regards the eradication of transmissible spongiform encephalopathies in ovine and caprine animals and rules for the trade in live ovine and caprine animals and bovine embryos.

CONTENT: in April 2002, the Scientific Steering Committee (SSC) recommended the culling of entire flocks in cases where scrapies has been diagnosed on a small ruminant holding. At the same time, however, the SSC noted that culling sheep of the ARR/ARR prion protein genotype would be of little “risk-reduced” benefit. In a bid to safeguard breeds which may have a low level of resistance it has been agreed to introduce a gradual approach to culling. Such a measure has the additional advantage of helping to prevent farmers from hiding suspected cases. In adopting this act the rules for intra-Community trade in breeding sheep have been amended in order to remove scrapie-related restrictions from trade in sheep of the ARR/ARR genotype.

In a further amendment, based on advice from the SSC and OIE, it has been agreed to delete all trade conditions related to bovine embryos and ova. BSE related trade conditions for bovine embryos and ova in Regulation 999/2001 have therefore been deleted. Commission Decision 92/290/EEC, concerning certain protection measures relating to bovine spongiform encephalopathy (BSE) in the United Kingdom, as amended by the Act of Accession of Austria, Finland and Sweden has been repealed.

In order to enact the above provisions, Annexes VII, VIII and XI of Regulation 999/2001/EC have been amended.

ENTRY INTO FORCE: 5 March 2003.