Date: 2016-05-28Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Executive Summary:
This Commission Implementing Decision (EU) 2016/851 amends the Annex to Decision 2009/719/EC, authorizing Croatia to revise its Bovine Spongiform Encephalopathy (BSE) annual monitoring program. The decision follows a favorable evaluation based on Croatia's application, an EFSA report, and Commission audits. It aims to align Croatia's BSE monitoring program with the standards applied to 25 other Member States. The decision was made in Brussels on 26 May 2016.
Key Points / Main Content:
* **Purpose:**
* To authorize Croatia to revise its BSE annual monitoring program.
* **Basis for the Decision:**
* Regulation (EC) No 999/2001 provides rules for the prevention, control, and eradication of TSEs.
* Article 6(1b) of Regulation (EC) No 999/2001 allows Member States with improved epidemiological situations to revise their monitoring programs.
* Croatia submitted an application to revise its BSE annual monitoring program on 22 January 2015.
* **Evaluation:**
* The European Food Safety Authority (EFSA) published a favorable scientific report on Croatia's BSE monitoring regime revision on 8 February 2016.
* Commission audits in Croatia evaluated measures concerning BSE, including the identification and traceability of bovine animals and the implementation of the feed ban.
* **Decision:**
* Croatia is authorized to revise its BSE annual monitoring program under the same conditions as the 25 Member States listed in the Annex to Decision 2009/719/EC.
* The Annex to Decision 2009/719/EC is amended to include Croatia.
* **Implementation:**
* The decision is addressed to the Member States.
* The decision was adopted on 26 May 2016.
Impact Analysis:
European Union Member States:
Impact: All Member States are subject to the decision. Croatia's BSE monitoring program is now aligned with that of 25 other Member States.
Action Required: Review and implement the changes to Decision 2009/719/EC.
Croatia:
Impact: Croatia is authorized to revise its BSE annual monitoring program.
Action Required: Implement the revised BSE annual monitoring program in accordance with the conditions granted to the other 25 Member States listed in the Annex to Decision 2009/719/EC.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's budget.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining the scope of the EU's authority and the procedures for its decision-making.
Regulation EC No 999/2001: A European Parliament and Council regulation laying down rules for the prevention, control, and eradication of certain transmissible spongiform encephalopathies (TSEs).
Croatia: A Member State of the European Union seeking authorization to revise its Bovine Spongiform Encephalopathy (BSE) annual monitoring programme.
Commission Decision 2009/719/EC: A Commission Decision authorizing certain Member States to revise their annual BSE monitoring programmes.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Bovine Spongiform Encephalopathy (BSE): A transmissible spongiform encephalopathy (TSE) affecting cattle, commonly known as mad cow disease.
28.5.2016 EN Official Journal of the European Union L 141/131
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.
(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.
(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.
(1) OJ L 147, 31.5.2001, p. 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).
(3) EFSA Journal 2016;14(2):4399.L 141/132 EN Official Journal of the European Union 28.5.2016
(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.
(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