# L_2016141EN.01013101.xml

| 28.5.2016 | EN | Official Journal of the European Union | L 141/131 |
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28.5.2016

EN

Official Journal of the European Union

L 141/131

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COMMISSION IMPLEMENTING DECISION (EU) 2016/851

of 26 May 2016

amending the Annex to Decision 2009/719/EC as regards the authorisation for Croatia to revise its BSE annual monitoring programme

(notified under document C(2016) 3097)

(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 spongiform encephalopathies (1), and in particular Article 6 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 based on active and passive surveillance, in accordance with Annex III thereto. In addition, Article 6(1b) of Regulation (EC) No 999/2001 provides that the Member States which can demonstrate an improvement in the epidemiological situation of their country, according to certain criteria set out in point 7 of Part I of Chapter A of Annex III to that Regulation, may have their annual monitoring programme revised. |
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(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 based on active and passive surveillance, in accordance with Annex III thereto. In addition, Article 6(1b) of Regulation (EC) No 999/2001 provides that the Member States which can demonstrate an improvement in the epidemiological situation of their country, according to certain criteria set out in point 7 of Part I of Chapter A of Annex III to that Regulation, may have their annual monitoring programme revised.

| (2) | Commission Decision 2009/719/EC (2) authorises the Member States listed in the Annex thereto to revise their Bovine Spongiform Encephalopathy (BSE) annual monitoring programme in accordance with Article 6(1b) of Regulation (EC) No 999/2001. There are currently 25 Member States listed in that Annex, namely all the Member States except Bulgaria, Croatia and Romania. |
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(2)

Commission Decision 2009/719/EC (2) authorises the Member States listed in the Annex thereto to revise their Bovine Spongiform Encephalopathy (BSE) annual monitoring programme in accordance with Article 6(1b) of Regulation (EC) No 999/2001. There are currently 25 Member States listed in that Annex, namely all the Member States except Bulgaria, Croatia and Romania.

| (3) | On 22 January 2015, Croatia submitted an application to the Commission to revise its BSE annual monitoring programme. |
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(3)

On 22 January 2015, Croatia submitted an application to the Commission to revise its BSE annual monitoring programme.

| (4) | On 8 February 2016, the European Food Safety Authority (EFSA) published a scientific report on the evaluation of the revision of the BSE monitoring regime in Croatia (3) (‘the EFSA report’). The EFSA report indicates that the addition of Croatia to the epidemiological unit comprising the 25 Member States currently listed in the Annex to Decision 2009/719/EC, assuming the implementation of the current surveillance regime as authorised by Decision 2009/719/EC for those 25 Member States, would result in it being possible, in an epidemiological unit made up of those 25 Member States plus Croatia, to detect BSE with a design prevalence of at least 1 per 3 789 838 of the adult cattle population at a confidence level of 95 %. That design prevalence is more sensitive than the minimum design prevalence requirement for Type A surveillance, which is defined in point 1(a) of Chapter D of Annex II to Regulation (EC) No 999/2001 as 1 case per 100 000 in the adult bovine animals' population of the country or region, at a confidence level of 95 %. |
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(4)

On 8 February 2016, the European Food Safety Authority (EFSA) published a scientific report on the evaluation of the revision of the BSE monitoring regime in Croatia (3) (‘the EFSA report’). The EFSA report indicates that the addition of Croatia to the epidemiological unit comprising the 25 Member States currently listed in the Annex to Decision 2009/719/EC, assuming the implementation of the current surveillance regime as authorised by Decision 2009/719/EC for those 25 Member States, would result in it being possible, in an epidemiological unit made up of those 25 Member States plus Croatia, to detect BSE with a design prevalence of at least 1 per 3 789 838 of the adult cattle population at a confidence level of 95 %. That design prevalence is more sensitive than the minimum design prevalence requirement for Type A surveillance, which is defined in point 1(a) of Chapter D of Annex II to Regulation (EC) No 999/2001 as 1 case per 100 000 in the adult bovine animals' population of the country or region, at a confidence level of 95 %.

| (5) | From 14 to 23 June 2010 and from 26 November to 6 December 2012, the Commission carried out audits in Croatia in order to evaluate measures concerning BSE (‘the Commission audits’). The Commission audits covered the identification and traceability system of bovine animals and the implementation of the feed ban in Croatia. The outcome of the Commission audits was therefore used as an element to evaluate compliance of the application submitted by Croatia with the criteria set out in points 7.1(b) and (c) of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001. |
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(5)

From 14 to 23 June 2010 and from 26 November to 6 December 2012, the Commission carried out audits in Croatia in order to evaluate measures concerning BSE (‘the Commission audits’). The Commission audits covered the identification and traceability system of bovine animals and the implementation of the feed ban in Croatia. The outcome of the Commission audits was therefore used as an element to evaluate compliance of the application submitted by Croatia with the criteria set out in points 7.1(b) and (c) of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001.

| (6) | Based on the information included in the application submitted by Croatia to revise its BSE annual monitoring programme, on the information provided by the EFSA report, and on the information resulting from the Commission audits, the application submitted by Croatia has been favourably evaluated. It is therefore appropriate to authorise Croatia to revise its BSE annual monitoring programme under the same conditions as granted to the 25 Member States currently listed in the Annex to Decision 2009/719/EC. |
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(6)

Based on the information included in the application submitted by Croatia to revise its BSE annual monitoring programme, on the information provided by the EFSA report, and on the information resulting from the Commission audits, the application submitted by Croatia has been favourably evaluated. It is therefore appropriate to authorise Croatia to revise its BSE annual monitoring programme under the same conditions as granted to the 25 Member States currently listed in the Annex to Decision 2009/719/EC.

| (7) | The Annex to Decision 2009/719/EC should therefore be amended accordingly. |
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(7)

The Annex to Decision 2009/719/EC should therefore be amended accordingly.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(8)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1

In the Annex to Decision 2009/719/EC, the entry ‘— Croatia’ is inserted after the entry ‘— France’ and before the entry ‘— Italy’.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 26 May 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  
  OJ L 147, 31.5.2001, p. 1.

1

(2)  Commission Decision 2009/719/EC of 28 September 2009 authorising certain Member States to revise their annual BSE monitoring programmes (OJ L 256, 29.9.2009, p. 35).

2

(3)  EFSA Journal 2016;14(2):4399.

3

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