COMMISSION IMPLEMENTING DECISION
of 17 June 2011
amending Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes
(notified under document C(2011) 4194)
(Text with EEA relevance)
(2011/358/EU)
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 spongiform encephalopathies (1), and in particular the second subparagraph of Article 6(1b) thereof,
Whereas:
(1)
Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It requires each Member State to carry out an annual monitoring programme for TSEs in accordance with Annex III to that Regulation.
(2)
Regulation (EC) No 999/2001 provides that the annual monitoring programmes are to cover as a minimum certain subpopulations of bovine animals referred to in Article 6 thereof. Those subpopulations are to include all bovine animals above 24 or 30 months of age, the age limit depending on the categories listed in points 2.1, 2.2 and 3.1 of Part I of Chapter A of Annex III to that Regulation.
(3)
The Annex to Commission Decision 2009/719/EC of 28 September 2009 authorising certain Member States to revise their annual BSE monitoring programmes (2) lists 17 Member States authorised to revise their annual monitoring programme in accordance with Regulation (EC) No 999/2001. That list includes all the Member States that were Members of the Union before 1 May 2004, as well as Slovenia and Cyprus.
(4)
On 9 December 2010, the Panel on Biological Hazards (Biohaz) of the European Food Safety Authority (EFSA) adopted a scientific opinion on a second update on the risk for human and animal health related to the revision of the BSE monitoring regime in some Member States (3) (the EFSA opinion of 9 December 2010). For the EFSA opinion of 9 December 2010, the Biohaz was asked to analyse the data available for the 17 Member States listed in Decision 2009/719/EC and eight other Member States. The Biohaz assumed that all 25 Member States had implemented for at least six years a BSE surveillance system and control measures, as provided for in Regulation (EC) No 999/2001. The EFSA opinion of 9 December 2010 confirms that the BSE epidemic has been declining in the 17 Member States listed in Decision 2009/719/EC.
(5)
The EFSA opinion of 9 December 2010 also concludes that if the age limit for BSE testing would be raised to 72 months in healthy slaughtered cattle, less than one classical BSE case could be expected to be missed in 2011. In addition, it concludes that if BSE testing for healthy slaughtered cattle would stop as from 1 January 2013, less than one classical BSE case would be missed each calendar year from 2013 onwards. It can be inferred from that findings that the risk for human and animal health would be negligible if the current BSE testing is adapted accordingly.
(6)
Taking into account the conclusions of the EFSA opinion of 9 December 2010, the ages of the categories of bovine animals should be increased for animals covered by the revised annual monitoring programmes of the Member States listed in the Annex to Decision 2009/719/EC. Therefore, Member States that have been authorised to revise their annual monitoring programmes should be given the option to apply alternative but equally effective sampling plans while adapting to the epidemiological situation from 1 January 2013 onwards.
(7)
Regarding the eight Member States not listed in Decision 2009/719/EC, the EFSA opinion of 9 December 2010 concludes that the classical BSE epidemiological situation is different for a group of five Member States comprised of Estonia, Latvia, Lithuania, Hungary and Malta and another group comprised of three Member States, namely the Czech Republic, Poland and Slovakia.
(8)
In the group of five Member States, no BSE cases have been detected since full implementation of the Union surveillance system on 1 May 2004, and the classical BSE epidemiological situation should be considered to be ‘at least equivalent’ to that of the 17 Member States listed in Decision 2009/719/EC. Therefore, a similar testing regime should be applied to that group of 22 Member States as the epidemiological situation is comparable in all of them.
(9)
In addition, the EFSA opinion of 9 December 2010 concludes that the trend of the classical BSE epidemic in the Czech Republic, Poland and Slovakia shows two waves in the classical BSE incidence per birth cohort and in the average age of the classical BSE cases detected. This second wave pattern compromises the establishment of clear similarities between the trend of the classical BSE epidemic in the 17 Member States already listed in Decision 2009/719/EC and this group of three Member States. For these three Member States, it concludes that at present, it would not be informative to estimate the number of undetected classical BSE cases, should the testing age be changed in this group.
(10)
On 26 March 2010, Latvia submitted to the Commission an application to revise its annual BSE monitoring programme.
(11)
On 16 June 2010, Estonia submitted to the Commission an application to revise its annual BSE monitoring programme.
(12)
On 7 October 2010, Lithuania submitted to the Commission an application to revise its annual BSE monitoring programme.
(13)
On 21 October 2010, Luxembourg submitted to the Commission an application to revise its annual BSE monitoring programme.
(14)
On 27 October 2010, Germany submitted to the Commission an application to revise its annual BSE monitoring programme.
(15)
On 24 November 2010, Greece submitted to the Commission an application to revise its annual BSE monitoring programme.
(16)
On 26 November 2010, Slovenia submitted to the Commission an application to revise its annual BSE monitoring programme.
(17)
On 30 November 2010, Sweden submitted to the Commission an application to revise its annual BSE monitoring programme.
(18)
On 13 December 2010, Spain submitted to the Commission an application to revise its annual BSE monitoring programme.
(19)
On 13 December 2010, Belgium submitted to the Commission an application to revise its annual BSE monitoring programme.
(20)
On 13 December 2010, Finland submitted to the Commission an application to revise its annual BSE monitoring programme.
(21)
On 14 December 2010, Denmark submitted to the Commission an application to revise its annual BSE monitoring programme.
(22)
On 15 December 2010, United Kingdom submitted to the Commission an application to revise its annual BSE monitoring programme.
(23)
On 15 December 2010, Austria submitted to the Commission an application to revise its annual BSE monitoring programme.
(24)
On 20 December 2010, Ireland submitted to the Commission an application to revise its annual BSE monitoring programme.
(25)
On 23 December 2010, Portugal submitted to the Commission an application to revise its annual BSE monitoring programme.
(26)
On 5 January 2011, Cyprus submitted to the Commission an application to revise its annual BSE monitoring programme.
(27)
On 13 January 2011, Italy submitted to the Commission an application to revise its annual BSE monitoring programme.
(28)
On 18 January 2011, the Netherlands submitted to the Commission an application to revise its annual BSE monitoring programme.
(29)
On 19 January 2011, France submitted to the Commission an application to revise its annual BSE monitoring programme.
(30)
On 11 February 2011, Hungary submitted to the Commission an application to revise its annual BSE monitoring programme.
(31)
On 14 February 2011, Malta submitted to the Commission an application to revise its annual BSE monitoring programme.
(32)
The applications submitted by those 22 Member States were found to meet all the requirements for the revision of the annual monitoring programmes laid down in Article 6(1b) of Regulation (EC) No 999/2001 and set out in point 7 of Part I of Chapter A of Annex III thereto. Therefore, they should be authorised to revise their BSE annual monitoring programmes.
(33)
Article 3 of Regulation (EEC) No 706/73 of the Council of 12 March 1973 concerning the Community arrangements applicable to the Channel Islands and the Isle of Man for trade in agricultural products (4) provides that Union veterinary and food legislation are to apply, under the same conditions in the Channel Islands and the Isle of Man as in the United Kingdom, to the agricultural products imported into those islands or exported from them to the Union. However, Decision 2009/719/EC does not currently apply to the islands as the United Kingdom did not provide the relevant data at the time of its adoption.
(34)
The United Kingdom has now provided the relevant data concerning the epidemiological situation and the implementation of the Union legislation regarding BSE in the Channel Islands and the Isle of Man. That data shows that the BSE epidemiological situation in those islands is comparable to that of the United Kingdom and that all the relevant requirements laid down in the Article 6(1b) and set out in point 7 of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001 are met. Decision 2009/719/EC should therefore apply to those islands.
(35)
Subsequently, on 15 February 2011, the Standing Committee on the Food Chain and Animal Health delivered a positive opinion on a draft Decision amending Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes. That draft Decision which, however, has not yet been adopted by the Commission, authorises the 22 Member States to apply a revised and harmonised BSE testing regime as from 1 July 2011.
(36)
On 13 April 2011, EFSA adopted a scientific opinion on the review on the risk for human and animal health related to the revision of the BSE monitoring regime in three EU Member States (5). That opinion concludes that with the additional data of a further year of monitoring results, namely the data for 2010, the model employed shows that the confidence in the predictions of the number of cases in the cohorts since 2000 for the Czech Republic, Poland and Slovakia has increased substantially. Due to this and based on the results of the analysis performed, EFSA concludes that the decline of the BSE epidemic is now significant in these three Member States.
(37)
The EFSA opinion of 13 April 2011 also concludes that if the age limit for BSE testing would be raised to 72 months in healthy slaughtered cattle, less than one classical BSE case could be expected to be missed in 2012. It can be inferred from that findings that the risk for human an animal health would be negligible if the current BSE testing is adapted accordingly.
(38)
On 10 February 2011, the Czech Republic submitted to the Commission an application to revise its annual BSE monitoring programme.
(39)
On 15 February 2011, Slovakia submitted to the Commission an application to revise its annual BSE monitoring programme.
(40)
On 26 April 2011, Poland submitted to the Commission an application to revise its annual BSE monitoring programme
(41)
The applications submitted by those three Member States were found to meet all the requirements for the revision of the annual monitoring programmes laid down in Article 6(1b) of Regulation (EC) No 999/2001 and set out in point 7 of Part I of Chapter A of Annex III thereto. Therefore, they should be authorised to revise their BSE annual monitoring programmes and the BSE testing regime in these three Member States should be aligned to that which received a positive opinion from the Standing Committee on the Food Chain and Animal Health on 15 February 2011.
(42)
Taking into consideration the new circumstances that have arisen after the vote, the draft Decision which received on 15 February 2011 a positive opinion of the Standing Committee on the Food Chain and Animal Health should not be adopted and a new draft Decision extending the provisions already voted to the Czech Republic, Poland and Slovakia should be presented for a opinion of the Standing Committee on the Food Chain and Animal Health.
(43)
Decision 2009/719/EC should therefore be amended accordingly.
(44)
This Decision should apply from 1 July 2011 in order to give sufficient time to Member States to align their BSE monitoring procedures with the amendments made to Decision 2009/719/EC by this Decision.
(45)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Decision 2009/719/EC is amended as follows:
(1)
Article 2 is replaced by the following:
‘Article 2
1. The revised annual monitoring programmes shall apply only to bovine animals born in the Member States listed in the Annex and shall cover at least the following categories:
(a)
all bovine animals above 72 months of age subject to normal slaughter for human consumption, or slaughtered in the context of a disease eradication campaign but showing no clinical signs of disease, as referred to in point 2.2 of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001;
(b)
all bovine animals above 48 months of age subject to emergency slaughter or with observations at ante mortem inspection as referred to in point 2.1 of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001;
(c)
all bovine animals above 48 months of age, as referred to in point 3.1 of Part I of Chapter A of Annex III to that Regulation, which have died or been killed but which were not:
(i)
killed for destruction pursuant to Commission Regulation (EC) No 716/96 (6);
(ii)
killed in the framework of an epidemic, such as foot-and-mouth disease;
(iii)
slaughtered for human consumption.
2. When bovine animals belonging to the animal categories referred to in paragraph 1 and born in one of the Member States listed in the Annex are tested for BSE in another Member State, the age limits for testing in force in the Member State where the tests are performed shall apply.
3. By way of derogation from point (a) of paragraph 1, from 1 January 2013 Member States listed in the Annex may decide to test only a minimum annual sample of the subpopulations referred to in that point.
(2)
the Annex is replaced by the text in the Annex to this Decision.
Article 2
This Decision shall apply from 1 July 2011.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 17 June 2011.