ISSN 1977-0677 |
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Official Journal of the European Union |
L 131 |
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English edition |
Legislation |
Volume 64 |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/1 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/614
of 7 April 2021
entering a name in the register of protected designations of origin and protected geographical indications (‘Bayramiç Beyazı’ (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
Whereas:
(1) |
Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Turkey’s application to register the name ‘Bayramiç Beyazı’ was published in the Official Journal of the European Union (2). |
(2) |
As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Bayramiç Beyazı’ should therefore be entered in the register, |
HAS ADOPTED THIS REGULATION:
Article 1
The name ‘Bayramiç Beyazı’ (PDO) is hereby entered in the register.
The name specified in the first paragraph denotes a product in Class 1.6 – Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 April 2021.
For the Commission,
On behalf of the President,
Janusz WOJCIECHOWSKI
Member of the Commission
(1) OJ L 343, 14.12.2012, p. 1.
(2) OJ C 435, 16.12.2020, p. 14.
(3) Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/3 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/615
of 7 April 2021
entering a name in the register of protected designations of origin and protected geographical indications (‘Taşköprü Sarımsağı’ (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
Whereas:
(1) |
Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Turkey’s application to register the name ‘Taşköprü Sarımsağı’ was published in the Official Journal of the European Union (2). |
(2) |
As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Taşköprü Sarımsağı’ should therefore be entered in the register, |
HAS ADOPTED THIS REGULATION:
Article 1
The name ‘Taşköprü Sarımsağı’ (PDO) is hereby entered in the register.
The name specified in the first paragraph denotes a product in Class 1.6 – Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 April 2021.
For the Commission,
On behalf of the President,
Janusz WOJCIECHOWSKI
Member of the Commission
(1) OJ L 343, 14.12.2012, p. 1.
(2) OJ C 436, 17.12.2020, p. 25.
(3) Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/4 |
COMMISSION REGULATION (EU) 2021/616
of 13 April 2021
amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benalaxyl, benalaxyl-M, dichlobenil, fluopicolide, proquinazid and pyridalyl in or on certain products
(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,
Whereas:
(1) |
For benalaxyl and benalaxyl-M maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For fluopicolide, proquinazid and pyridalyl MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For dichlobenil MRLs were set in Annex V to Regulation (EC) No 396/2005. |
(2) |
For benalaxyl and benalaxyl-M the European Food Safety Authority (‘the Authority’), submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). It took into account a previous review for benalaxyl (3). For some products the Authority recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority concluded that concerning the MRLs for table grapes, potatoes, garlic, onions, shallots, lettuces and leeks some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
(3) |
For dichlobenil the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005. (4) As Dichlobenil is no longer approved in the EU and all authorisations for this substance have been revoked, the MRLs should remain in Annex V at the limit of determination (LOD). |
(4) |
For fluopicolide the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (5). It recommended lowering the MRL for lettuces. For certain other products, it recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority concluded that concerning the MRLs for escaroles/broad-leaved endives, hops, swine (muscle, fat, liver, kidney), bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney), poultry (muscle, fat, liver, kidney), other farmed terrestrial animals (muscle, fat, liver, kidney), milk (cattle, sheep, goat, horse) and birds’ eggs some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
(5) |
For proquinazid the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (6). It proposed to change the residue definition for commodities of animal origin and recommended raising or keeping the existing MRLs for certain products. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. It concluded that concerning the MRLs for barley, oats, bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney) and milk (cattle, sheep, goat, horse) some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
(6) |
For pyridalyl the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (7). It recommended lowering the MRL for sweet peppers/bell peppers. For other products, the Authority recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. |
(7) |
As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or Codex maximum residue limits (CXLs) exist, MRLs should be set at the specific LOD or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005. |
(8) |
The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination. |
(9) |
Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. |
(10) |
Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
(11) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
(12) |
In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. |
(13) |
A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. |
(14) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II, III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 6 November 2021.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 6 November 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(2) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for benalaxyl-M according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2019;17(9):5818.
(3) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for benalaxyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(10):3405.
(4) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for dichlobenil according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(5):3218.
(5) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for fluopicolide according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2019;17(7):5748.
(6) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for proquinazid according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(1):5987.
(7) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for pyridalyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2019;17(9):5814.
ANNEX
Annexes II, III and V to Regulation (EC) No 396/2005 are amended as follows:
(1) |
Annex II is amended as follows:
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(2) |
Annex III is amended as follows:
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(3) |
in Annex V, the column for dichlobenil is replaced by: “Pesticide residues and maximum residue levels (mg/kg)
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(*1) Limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(*2) Limit of analytical determination
(2) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(*3) Limit of analytical determination
(3) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.”
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/41 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/617
of 14 April 2021
amending Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 as regards model animal health certificates and animal health/official certificates for the entry into the Union of certain aquatic animals and products of animal origin
(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 853/2004 of the European Parliament and of the Council of 29 April 2004 on laying specific hygiene rules for food of animal origin (1), and in particular Article 7(2)(a) thereof,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (2), and in particular Articles 213(2) and 224(4) thereof,
Whereas:
(1) |
Commission Implementing Regulations (EU) 2020/2235 (3) and (EU) 2020/2236 (4) lay down rules for the application of Regulation (EU) 2016/429 and Regulation (EU) 2017/625 of the European Parliament and of the Council (5) as regards models of animal health certificates and animal health/official certificates for the entry into the Union of certain aquatic animals and products of animal origin. |
(2) |
Consignments of live aquatic animals intended for human consumption may enter the Union only if they comply with the rules laid down in Regulation (EC) No 853/2004. The wording of certain notes set out in the model animal health/official certificates for live fish, live crustaceans, live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from those animals in Chapters 28 and 31 of Annex III to Implementing Regulation (EU) 2020/2235 has presented the potential for ambiguity with regard to public health requirements. Therefore, in order to prevent misunderstandings and to ensure coherence between public and animal health requirements for the entry into the Union of consignments of certain live aquatic animals intended for human consumption, the notes set out in the model animal health/official certificates for live fish, live crustaceans, live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from those animals in Chapters 28 and 31 of Annex III, should be amended accordingly. |
(3) |
To ensure complete clarity in the notes of the model animal health/official certificates for live fish, live crustaceans, live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from those animals, set out in Annex III to Implementing Regulation (EU) 2020/2235, should be explicitly clear that consignments of live aquatic animals intended for human consumption may enter the Union only if they comply with Regulation (EC) No 853/2004. |
(4) |
In addition, in order to ensure coherence between public and animal health requirements for the entry into the Union of certain live aquatic animals intended for human consumption, certain amendments are required to the title and in the notes of the model animal health certificate for aquatic animals intended for certain aquaculture establishments, for release into the wild, or for other purposes, as set out in Annex II to Implementing Regulation (EU) 2020/2236. These amendments are required to ensure that it is explicitly clear that this certificate may not be used for consignments of aquatic animals intended for human consumption. Whilst purification centres and dispatch centres are aquaculture establishments in accordance with Regulation (EU) 2016/429, the public health rules prevent aquatic animals from entering the Union if they are destined for purification centres, or under certain circumstances, if they are destined for dispatch centres. |
(5) |
To provide clarity in that respect, and in order to prevent misunderstandings, the model animal health certificate for the entry into the Union of aquatic animals intended for certain aquaculture establishments, for release into the wild, or for other purposes, excluding human consumption which is set out in Annex II to Implementing Regulation (EU) 2020/2236, should be amended to ensure it is clear that consignments of live aquatic animals intended for human consumption can enter the Union only if they comply with Regulation (EC) No 853/2004. |
(6) |
As Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 apply with effect from 21 April 2021, this Regulation should also apply from that date. |
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex III to Implementing Regulation (EU) 2020/2235 is amended as follows:
(1) |
in Chapter 28, the model animal health/official certificate for the entry into the Union of live fish, live crustaceans and products of animal origin from those animals intended for human consumption (MODEL FISH- CRUST-HC) is amended as follows:
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(2) |
in Chapter 31, in the model animal health/official certificate for the entry into the Union of live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from those animals intended for human consumption (MODEL MOL-HC), the Notes are replaced by the following: ‘Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this certificate include the United Kingdom in respect of Northern Ireland. “Aquatic animals” are animals as defined in point (3) of Article 4 of Regulation (EU) 2016/429 of the European Parliament and of the Council. “Aquaculture animals” are aquatic animals which are subject to aquaculture as defined in point (7) of Article 4 of Regulation (EU) 2016/429. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this certificate applies, must originate from a country/territory/zone/compartment which appears in a list of third countries and territories adopted by the Commission in accordance with Article 230(1) of Regulation (EU) 2016/429. Part II.2.4. of the certificate does not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in by the Commission in accordance with Article 127(2) of Regulation (EU) 2017/625:
This animal health/official certificate shall be completed according to the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I:
Part II:
(*2) Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).’." |
Article 2
Implementing Regulation (EU) 2020/2236 is amended as follows:
(1) |
Article 7 is replaced by the following: ‘Article 7 Model animal health certificate for the entry into the Union of aquatic animals intended for aquaculture establishments, for release into the wild, or for other purposes, excluding human consumption The animal health certificate referred to in Article 1(2)(b) to be used for the entry into the Union of consignments of aquatic animals intended for aquaculture establishments, for release into the wild, or for other purposes, excluding human consumption shall correspond to the model AQUA-ENTRY-ESTAB/RELEASE/OTHER drawn up in accordance with the model set out in Annex II.’; |
(2) |
Annex II is replaced by the text set out in the Annex to this Regulation. |
Article 3
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 139, 30.4.2004, p. 55.
(3) Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).
(4) Commission Implementing Regulation (EU) 2020/2236 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates for the entry into the Union and movements within the Union of consignments of aquatic animals and of certain products of animal origin from aquatic animals, official certification regarding such certificates and repealing Regulation (EC) No 1251/2008 (OJ L 442, 30.12.2020, p. 410).
(5) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
ANNEX
‘ANNEX II
Annex II contains the following model animal health certificate:
Model
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MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF AQUATIC ANIMALS INTENDED FOR CERTAIN AQUACULTURE ESTABLISHMENTS, FOR RELEASE INTO THE WILD OR FOR OTHER PURPOSES, EXCLUDING HUMAN CONSUMPTION (MODEL ‘AQUA-ENTRY-ESTAB/RELEASE/OTHER’)
COUNTRY |
Certificate model AQUA-ENTRY-ESTAB/RELEASE/OTHER |
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Part II: Certification |
II. Health information |
II.a |
Certificate reference |
II.b |
IMSOC reference |
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I, the undersigned official veterinarian, hereby certify:
The aquatic animals referred to in Box I.27 of Part I meet the following animal health requirements:
This animal health certificate is valid for a period of 10 days from the date of issuing. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this certificate include the United Kingdom in respect of Northern Ireland. ‘Aquatic animals’ are animals as defined in point (3) of Article 4 of Regulation (EU) 2016/429. ‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in point (7) of Article 4 of Regulation (EU) 2016/429. This model certificate is intended for entry into the Union of aquatic animals for the purposes indicated in its title, including when the Union is not the final destination of those animals. This model certificate shall not be used for the entry into the Union of aquatic animals intended for human consumption in accordance with Regulation (EC) No 853/2004 and Commission Regulation (EC) No 2073/2005, including those animals which are intended for the following aquaculture establishments:
for which the model certificate FISH-CRUST-HC, as set out in Chapter 28 of Annex III to Commission Implementing Regulation (EU) 2020/2235, or MOL-HC as set out in Chapter 31 of Annex III to the same Regulation, must be used, as relevant. This animal health certificate shall be completed according to notes for the completion of certificates provided for in Chapter 4 of Annex I to Commission Implementing Regulation (EU) 2020/2235. Part II:
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16.4.2021 |
EN |
Official Journal of the European Union |
L 131/55 |
COMMISSION REGULATION (EU) 2021/618
of 15 April 2021
amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diclofop, fluopyram, ipconazole and terbuthylazine in or on certain products
(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a) and Article 49(2) thereof,
Whereas:
(1) |
For diclofop, fluopyram, ipconazole and terbuthylazine maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. |
(2) |
For diclofop the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). It proposed to change the residue definition. The Authority concluded that concerning the MRLs for barley and wheat, some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
(3) |
For fluopyram the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (3). It recommended lowering the MRLs for mulberries (black and white), elderberries, cassava roots/manioc, arrowroots, beetroots, garlic, onions, shallots, chervil, chives, celery leaves, parsley, sage, rosemary, thyme, laurel/bay leaves, tarragon, lentils, buckwheat and other pseudocereals and herbal infusions from roots. For other products, the Authority recommended raising or keeping the existing MRLs. Based on rotational crops studies and taking into account that the uptake of residues in succeeding crops cannot be fully avoided, specific MRLs reflecting uptake of residues from soil were derived for cassava roots/manioc, sweet potatoes, yams, arrowroots, other root and tuber vegetables except sugar beets, chicory roots, broccoli, cauliflowers, Brussels sprouts, head cabbages, kales, kohlrabies, watercresses, herbal infusions from roots, root and rhizome spices, sugar beet roots, sweet corn, maize/corn, buckwheat and other pseudocereals and common millet/proso millet. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. The Authority further concluded that concerning the MRLs for lemons, mandarins, bananas, spring onions/green onions and Welsh onions, tomatoes, melons, watermelons, Chinese cabbage/pe-tsai, escaroles/broad-leaved endives, land cresses, red mustards, spinaches, chards/beet leaves, globe artichokes and leeks some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
(4) |
For ipconazole the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (4). It recommended keeping the existing MRLs. The MRLs for the products concerned should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. |
(5) |
For terbuthylazine the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (5). The Authority proposed to change the residue definition for milk. It recommended lowering the MRLs for maize/corn and sorghum. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority further concluded that concerning the MRLs for sweet corn, lupins/lupini beans, sunflower seeds, cotton seeds, bovine (muscle, fat, liver, kidney, milk) and equine (muscle, fat, liver, kidney, milk) some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
(6) |
Existing Codex maximum residue limits (CXLs) were taken into account in the reasoned opinions of the Authority. CXLs, which are safe for consumers in the Union, were considered for MRL setting. |
(7) |
As regards products on which the use of the plant protection product concerned is not authorised in the EU, and for which no import tolerances or CXLs exist, MRLs should be set at the specific Limit of Determination (‘LOD’) or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005. |
(8) |
The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LOD. As regards all substances concerned by this Regulation, those laboratories concluded that for certain commodities technical development requires the setting of specific LOD. |
(9) |
Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. |
(10) |
Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
(11) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
(12) |
In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. |
(13) |
A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. |
(14) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 6 November 2021.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 6 November 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(2) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for diclofop according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 18(1): 5981.
(3) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for fluopyram according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 18(4): 6059.
(4) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for ipconazole according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 18(1): 5961.
(5) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for terbuthylazine according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020; 18(1): 5980.
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
(1) |
in Annex II, the following columns for diclofop, fluopyram, ipconazole and terbuthylazine are added: Pesticide residues and maximum residue levels (mg/kg)
|
(2) |
in Part A of Annex III, the columns for diclofop, fluopyram, ipconazole and terbuthylazine are deleted. |
(*1) Limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/72 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/619
of 15 April 2021
amending Implementing Regulations (EU) 2020/2235, (EU) 2020/2236 and (EU) 2021/403 as regards transitional provisions for the use of animal health certificates, animal health/official certificates and official certificates
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 146(2), Article 156(2), first subparagraph, point (a), and Articles162(5), 168(4), 213(2) 224(4), 238(3) and 239(3) thereof,
Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (2), and in particular Article 90, Article 126(3) and Article 134, first subparagraph, point (f) thereof,
Whereas:
(1) |
Commission Implementing Regulations (EU) 2020/2235 (3), (EU) 2020/2236 (4) and (EU) 2021/403 (5) lay down models of animal health certificates, animal health/official certificates and official certificates required to accompany movements within the Union and for entry into the Union of consignments of animals and goods. |
(2) |
To facilitate the transition to the use of the new animal health certificates and animal health/official certificates for movements of consignments within the Union and between Member States and to allow for appropriate training of operators and of staff of competent authorities in all Member States, it is necessary to establish a transitional period during which the competent authorities in the Member States should be able to use certificates issued in accordance with legislation applicable before the date of application of Implementing Regulations (EU) 2020/2235, (EU) 2020/2236 and (EU) 2021/403. |
(3) |
Implementing Regulation (EU) 2020/2235 provides for a transitional period for the entry into the Union of consignments of products of animal origin, composite products, sprouts intended for human consumption and seeds intended for the production of sprouts for human consumption which are accompanied by the appropriate certificate issued in accordance with the models laid down in Commission Regulation (EU) No 28/2012 (6) and Commission Implementing Regulation (EU) 2019/628 (7). Therefore, in the interest of legal certainty, the duration of the transitional period for use of such certificates should be clarified. |
(4) |
Implementing Regulation (EU) 2020/2235 repeals Commission Regulation (EC) No 599/2004 (8) with effect from 21 April 2021. That Regulation lays down the harmonised model template of certificates for intra-Union movements of consignments of animals and goods. In addition, that Regulation provides for the compatibility of harmonised model template of certificates with the Trade Control and Expert System (TRACES) and facilitates the system of certification and notification of intra-Union movements of such consignments. To enable the further use in TRACES of certificates issued in accordance with legislation applicable before 21 April 2021, the date of the repeal of that Regulation should be amended in view of the end of the transitional periods in Implementing Regulations (EU) 2020/2236 and (EU) 2021/403, as amended by this Regulation. |
(5) |
Implementing Regulation (EU) 2020/2236 provides for a transitional period for the entry into the Union of consignments of aquatic animals and products of animal origin from aquatic animals which are accompanied by the appropriate animal health certificate issued in accordance with Commission Regulation (EC) No 1251/2008 (9). Therefore, in the interest of legal certainty, the duration of the transitional period for use of such certificates should be clarified. |
(6) |
In order to facilitate the necessary arrangements by the competent authorities to ensure compliance with Implementing Regulation (EU) 2020/2236 for movements within the Union of consignments of aquatic animals and products of animal origin from aquatic animals, a transitional period should be introduced during which consignments may be accompanied by the appropriate animal health certificate issued in accordance with Regulation (EC) No 1251/2008. |
(7) |
Implementing Regulation (EU) 2021/403 provides for a transitional period for the entry into the Union of consignments of terrestrial animals and germinal products thereof which are accompanied by the appropriate certificate issued in accordance with the models laid down in Commission Regulations (EC) No 798/2008 (10) and (EU) No 206/2010 (11), Commission Implementing Regulations (EU) No 139/2013 (12) and (EU) 2018/659 (13), Commission Decisions 2006/168/EC (14) and 2010/472/EU (15), as well as in accordance with Commission Implementing Decisions 2011/630/EU (16), 2012/137/EU (17) and (EU) 2019/294 (18). Therefore, in the interest of legal certainty, the duration of the transitional period for use of such certificates should be clarified. |
(8) |
In order to facilitate the necessary arrangements by the competent authorities to ensure compliance with Implementing Regulation (EU) 2021/403 for movements between Member States of consignments of terrestrial animals and germinal products thereof, a transitional period should be introduced during which consignments may be accompanied by the appropriate certificate issued in accordance with Council Directives 64/432/EEC (19), 88/407/EEC (20), 89/556/EEC (21), 90/429/EEC (22), 91/68/EEC (23), 92/65/EEC (24), 2009/156/EC (25) and 2009/158/EC (26), as well as in accordance with Commission Decision 2010/470/EU (27). |
(9) |
As Implementing Regulations (EU) 2020/2235, (EU) 2020/2236 and (EU) 2021/403 apply with effect from 21 April 2021, this Regulation should also apply from that date. |
(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Amendment to Implementing Regulation (EU) 2020/2235
Article 35 of Implementing Regulation (EU) 2020/2235 is replaced by the following:
‘Article 35
Transitional provisions
1. Consignments of products of animal origin, composite products, sprouts intended for human consumption and seeds intended for the production of sprouts for human consumption accompanied by the appropriate certificate issued in accordance with the models laid down in Regulation (EU) No 28/2012 and Implementing Regulation (EU) 2019/628 shall be accepted for entry into the Union until 20 October 2021 provided that the certificate was signed by the person authorised to sign the certificate in accordance with that Regulation and Implementing Regulation before 21 August 2021.
2. The harmonised model template of certificates for intra-Union movements laid down in Regulation (EC) No 599/2004 shall be accepted for movements within the Union until 17 October 2021.
3. References to provisions of repealed acts within the certificates and in the Annex to Regulation (EC) No 599/2004 shall be construed as references to corresponding replacement provisions and shall be read in accordance with the correlation tables, where applicable.’.
Article 2
Amendment to Implementing Regulation (EU) 2020/2236
Article 10 of Implementing Regulation (EU) 2020/2236 is replaced by the following:
‘Article 10
Transitional provisions
1. Consignments of aquatic animals and products of animal origin from aquatic animals accompanied by the appropriate animal health certificate issued in accordance with the model laid down in Regulation (EC) No 1251/2008 shall be accepted for entry into the Union until 20 October 2021 provided that the animal health certificate was signed by an official inspector before 21 August 2021.
2. Consignments of aquatic animals and products of animal origin from aquatic animals accompanied by the appropriate animal health certificate issued in accordance with the model laid down in Regulation (EC) No 1251/2008 shall be accepted for movements within the Union until 17 October 2021.
3. References to provisions of repealed acts within the certificates shall be construed as references to corresponding replacement provisions and shall be read in accordance with the correlation tables, where applicable.’.
Article 3
Amendment to Implementing Regulation (EU) 2021/403
Article 27 of Implementing Regulation (EU) 2021/403 is replaced by the following:
‘Article 27
Transitional provisions
1. Consignments of terrestrial animals and germinal products thereof accompanied by the appropriate certificate issued in accordance with the models laid down in Regulations (EC) No 798/2008 and (EU) No 206/2010, Implementing Regulations (EU) No 139/2013 and (EU) 2018/659, Decisions 2006/168/EC and 2010/472/EU, as well as in accordance with Implementing Decisions 2011/630/EU, 2012/137/EU and (EU) 2019/294, shall be accepted for entry into the Union until 20 October 2021 provided that the certificate was signed by the person authorised to sign the certificate in accordance with those Regulations, Implementing Regulations, Decisions and Implementing Decisions before 21 August 2021.
2. Consignments of certain categories of ungulates accompanied by the appropriate certificate issued in accordance with the models laid down in Council Directives 64/432/EEC (*1), 91/68/EEC (*2), Directive 92/65/EEC and Council Directive 2009/156/EC (*3) shall be accepted for movements between Member States until 17 October 2021.
3. Consignments of certain categories of birds and germinal products thereof accompanied by the appropriate certificate issued in accordance with the model laid down in Council Directive 2009/158/EC (*4) shall be accepted for movements between Member States until 17 October 2021.
4. Consignments of certain types of germinal products of bovine animals accompanied by the appropriate certificate issued in accordance with the models laid down in Directives 88/407/EEC and 89/556/EEC shall be accepted for movements between Member States until 17 October 2021.
5. Consignments of certain types of germinal products of ovine and caprine animals accompanied by the appropriate certificate issued in accordance with the model laid down in Decision 2010/470/EU shall be accepted for movements between Member States until 17 October 2021.
6. Consignments of certain types of germinal products of porcine animals accompanied by the appropriate certificate issued in accordance with the models laid down in Directive 90/429/EEC and Decision 2010/470/EU shall be accepted for movements between Member States until 17 October 2021.
7. Consignments of certain types of germinal products of equine animals accompanied by the appropriate certificate issued in accordance with the model laid down in Decision 2010/470/EU shall be accepted for movements between Member States until 17 October 2021.
8. Consignments of certain categories of bees accompanied by the appropriate certificate issued in accordance with the model laid down in Directive 92/65/EEC shall be accepted for movements between Member States until 17 October 2021.
9. Consignments of certain categories of terrestrial animals and certain germinal products thereof accompanied by the appropriate certificate issued in accordance with the model laid down in Directive 92/65/EEC shall be accepted for movements between Member States until 17 October 2021.
10. References to provisions of repealed acts within the certificates shall be construed as references to corresponding replacement provisions and shall be read in accordance with the correlation tables, where applicable.
Article 4
Entry into force and application
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(3) Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).
(4) Commission Implementing Regulation (EU) 2020/2236 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates for the entry into the Union and movements within the Union of consignments of aquatic animals and of certain products of animal origin from aquatic animals, official certification regarding such certificates and repealing Regulation (EC) No 1251/2008 (OJ L 442, 30.12.2020, p. 410).
(5) Commission Implementing Regulation (EU) 2021/403 of 24 March 2021 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates and model animal health/official certificates, for the entry into the Union and movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU (OJ L 113, 31.3.2021, p. 1).
(6) Commission Regulation (EU) No 28/2012 of 11 January 2012 laying down requirements for the certification for imports into and transit through the Union of certain composite products and amending Decision 2007/275/EC and Regulation (EC) No 1162/2009 (OJ L 12, 14.1.2012, p. 1).
(7) Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates (OJ L 131, 17.5.2019, p. 101).
(8) Commission Regulation (EC) No 599/2004 of 30 March 2004 concerning the adoption of a harmonised model certificate and inspection report linked to intra-Community trade in animals and products of animal origin (OJ L 94, 31.3.2004, p. 44).
(9) Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species (OJ L 337, 16.12.2008, p. 41).
(10) Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).
(11) Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1).
(12) Commission Implementing Regulation (EU) No 139/2013 of 7 January 2013 laying down animal health conditions for imports of certain birds into the Union and the quarantine conditions thereof (OJ L 47, 20.2.2013, p. 1).
(13) Commission Implementing Regulation (EU) 2018/659 of 12 April 2018 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 110, 30.4.2018, p. 1).
(14) Commission Decision 2006/168/EC of 4 January 2006 establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC (OJ L 57, 28.2.2006, p. 19).
(15) Commission Decision 2010/472/EU of 26 August 2010 on imports of semen, ova and embryos of animals of the ovine and caprine species into the Union (OJ L 228, 31.8.2010, p. 74).
(16) Commission Implementing Decision 2011/630/EU of 20 September 2011 on imports into the Union of semen of domestic animals of the bovine species (OJ L 247, 24.9.2011, p. 32).
(17) Commission Implementing Decision 2012/137/EU of 1 March 2012 on imports into the Union of semen of domestic animals of the porcine species (OJ L 64, 3.3.2012, p. 29).
(18) Commission Implementing Decision (EU) 2019/294 of 18 February 2019 laying down the list of territories and third countries authorised for imports into the Union of dogs, cats and ferrets and the model animal health certificate for such imports (OJ L 48, 20.2.2019, p. 41).
(19) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977).
(20) Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species (OJ L 194, 22.7.1988, p. 10).
(21) Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1).
(22) Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra- Community trade in and imports of semen of domestic animals of the porcine species (OJ L 224, 18.8.1990, p. 62).
(23) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19).
(24) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).
(25) Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (OJ L 192, 23.7.2010, p. 1).
(26) Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (OJ L 343, 22.12.2009, p. 74).
(27) Commission Decision 2010/470/EU of 26 August 2010 laying down model health certificates for trade within the Union in semen, ova and embryos of animals of the equine, ovine and caprine species and in ova and embryos of animals of the porcine species (OJ L 228, 31.8.2010, p. 15).
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/78 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/620
of 15 April 2021
laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Articles 31(3) and 36(4) and Article 37(4)(a) thereof,
Whereas:
(1) |
Regulation (EU) 2016/429 establishes a new legislation framework for the prevention and control of diseases, which are transmissible to animals or humans. In particular, Regulation (EU) 2016/429 lays down disease-specific rules for the diseases listed in accordance with Article 5(1) thereof (listed diseases), and Article 9 thereof provides how those rules are to be applied to different categories of listed diseases. Regulation (EU) 2016/429 also provides for the Member States to establish compulsory eradication programmes for the listed diseases referred to in Article 9(1)(b) thereof, and for optional eradication programmes for listed diseases referred to in Article 9(1)(c) thereof, and for the approval of such programmes by the Commission. In addition, it provides for the approval by the Commission of the disease-free status or non-vaccination status of Member States or zones or compartments thereof with regard to certain listed diseases referred to in Article 9(1)(a), (b) and (c) of Regulation (EU) 2016/429. |
(2) |
Commission Implementing Regulation (EU) 2018/1882 (2) defines listed diseases into Categories A to E diseases, and provides that the disease prevention and control rules for listed diseases referred to in Article 9(1) of Regulation (EU) 2016/429 are to apply to the categories of listed diseases for the listed species and groups of listed species referred to in the table set out in the Annex to that Regulation. This Regulation should lay down rules that concern Category A, Category B or Category C diseases. |
(3) |
Regulation (EU) 2016/429 regards the following as listed diseases: infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (MTBC), infection with rabies virus (RABV), enzootic bovine leucosis (EBL), infection with bluetongue virus (serotypes 1-24) (infection with BTV), bovine viral diarrhoea (BVD), infectious bovine rinotracheitis/infectious pustular vulvovaginitis (IBR/IPV), infection with Aujeszky’s disease virus (ADV), infestation with Varroa spp., infection with Newcastle disease virus, infection with highly pathogenic avian influenza (HPAI), viral haemorrhagic septicaemia (VHS), infectious haematopoietic necrosis (IHN), infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV), infection with Marteilia refringens, infection with Bonamia exitiosa, infection with Bonamia ostreae, and infection with white spot syndrome virus (WSSV). All those listed diseases fall within the definitions of Category A, Category B or Category C diseases laid down in Implementing Regulation (EU) 2018/1882, and are duly listed in the table in the Annex to that Implementing Regulation. |
(4) |
Commission Delegated Regulation (EU) 2020/689 (3) supplements the rules on eradication programmes and disease-free status for certain listed diseases of terrestrial, aquatic and other animals, as provided for in Regulation (EU) 2016/429. In particular, Delegated Regulation (EU) 2020/689 establishes criteria for the granting of disease-free status for Member States or zones or compartments thereof, and the requirements for the approval of eradication programmes for Member States or zones or compartments thereof. |
(5) |
Article 85 of Regulation (EU) 2020/689 provides that the Member States or zones thereof with an approved eradication programme or an approved surveillance programme for category C diseases before the date of application of that Regulation are to be deemed to have an approved eradication programme in accordance with that Regulation for a period of six years from the date of application of that Regulation. Accordingly, this limitation should be indicated in the relevant Annexes to this Regulation. |
(6) |
Article 280 of Regulation (EU) 2016/429 provides the rules for the maintenance of the existing disease-free status or approved eradication and surveillance programmes of Member States or zones or compartments thereof for certain listed diseases that were approved by Commission acts adopted in accordance with Council Directives 64/432/EEC (4), 91/68/EEC (5), 92/65/EEC (6), 2005/94/EC (7), 2006/88/EC (8) or 2009/158/EC (9). In addition, Articles 84 and 85 of Delegated Regulation (EU) 2020/689 supplement the rules laid down in Regulation (EU) 2016/429 in that respect by laying down transitional measures concerning existing disease-free statuses, and existing approved eradication and surveillance programmes, with regard to those listed diseases. |
(7) |
For the sake of simplification and transparency, this Regulation should replace the lists of existing disease-free Member States, zones and compartments and the existing approved eradication and surveillance programmes set out in the Commission acts adopted pursuant to the Directives referred to in Article 280 of Regulation (EU) 2016/429 and in certain Directives referred to in Articles 84 and 85 of Delegated Regulation (EU) 2020/689 with lists set out in the Annexes to this Regulation. |
(8) |
For certain listed diseases, Delegated Regulation (EU) 2020/689 lays down rules for the first time for the approval of the disease-free status for Member States or zones or compartments thereof and therefore the provisions of Article 280 of Regulation (EU) 2016/429 do not apply to such situations. This is the case for infection with rabies virus (RABV), infection with bluetongue virus (serotypes 1-24) (infection with BTV), bovine viral diarrhoea (BVD) or infection with Bonamia exitiosa. Several Member States have submitted to the Commission applications to have disease-free status granted for those listed diseases. Following the assessment by the Commission, those applications have been shown to comply with the criteria of Sections 1 and 2 of Chapter 4 of Part II of Delegated Regulation (EU) 2020/689 that lay down rules for the granting of disease-free status for Member States or zones and compartments thereof. Therefore, the disease-free status of those Member States or the relevant zones or compartments thereof, should be granted and they should be duly listed in the Annexes to this Regulation. |
(9) |
For certain listed diseases, Delegated Regulation (EU) 2020/689 lays down rules for the approval of eradication programmes for Member States or zones or compartments thereof that are not subject to the provisions of Article 280 of Regulation (EU) 2016/429. This is the case for infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (MTBC), infection with rabies virus (RABV), enzootic bovine leucosis (EBL), infection with bluetongue virus (serotypes 1-24) (infection with BTV), bovine viral diarrhoea (BVD) or infection with Bonamia exitiosa. Several Member States have submitted to the Commission applications to have the eradication programmes approved for those listed diseases. Following the assessment by the Commission, those applications have been shown to comply with the criteria of Chapters 2 and 3 of Part II of Delegated Regulation (EU) 2020/689 that lay down criteria to be complied with for the approval of eradication programmes for Category B and Category C diseases of terrestrial and aquatic animals, respectively. Therefore, those eradication programmes should be approved and the Member States or zones and compartments thereof should be duly listed in the Annexes to this Regulation. |
(10) |
For certain listed diseases, applications from Member States to have disease-free status granted or to have eradication programmes approved have not yet been received by the Commission or their assessment has not yet been finalised. Once received or once the assessment is finalised the relevant Member States, zones or compartments may be listed in the Annexes to this Regulation. |
(11) |
In addition, for infection with Brucella abortus, B. melitensis and B. suis a Member States has recently submitted to the Commission an application to have disease-free status from infection with Brucella abortus, B. melitensis and B. suis granted for a zone. Following the assessment by the Commission, the application has been shown to comply with the criteria of Article 71 of Delegated Regulation (EU) 2020/689 that lay down rules for the recognition of disease-free status based on eradication programmes. Therefore, the disease-free status of the zone should be granted and it should be duly listed in the Annexes to this Regulation. |
(12) |
With respect to avian influenza, Commission Regulation (EC) No 616/2009 (10), which was adopted pursuant to Directive 2005/94/EC, provides for the approval by the Member States of poultry compartments and other captive birds’ compartments. The list of approved compartments is publicly available and the Commission’s website includes links to the internet-based information pages of the Member States. Poultry compartments and other captive birds’ compartments approved with respect to avian influenza under Regulation (EC) No 616/2009 should have their disease-free status maintained in accordance with Regulation (EU) 2016/429 and should be duly listed in the Annexes to this Regulation. |
(13) |
Commission Decision 2003/467/EC (11) lists the Member States and regions thereof with tuberculosis-free status, brucellosis-free status and EBL-free status in accordance with Directive 64/432/EEC. Those Member States and regions thereof should be duly listed in the Annexes to this Regulation. |
(14) |
Commission Decision 93/52/EEC (12) sets out the list of Member States and regions thereof with official brucellosis-free (B. melitensis) status in accordance Directive 91/68/EEC. Those Member States and regions thereof should be duly listed in the Annexes to this Regulation. |
(15) |
Commission Implementing Decision 2013/503/EU (13) sets out the list of Member States or territories thereof which are recognised as free from varroosis in accordance with Directive 92/65/EEC. Those Members States or territories thereof should be duly listed in the Annexes to this Regulation. |
(16) |
Commission Decisions 94/963/EC (14) and 95/98/EC (15) establish the status of Finland and Sweden as ‘non-vaccinating’ as regards Newcastle disease in accordance with Directive 2009/158/EC. Those Member States should be duly listed in the Annexes to this Regulation. |
(17) |
Commission Decision 2004/558/EC (16) sets out the lists of regions of Member States that have the IBR-free status and the regions of Member States that have an approved IBR eradication programme in accordance with Directive 64/432/EEC. The regions with IBR-free status should be duly listed in the Annexes to this Regulation, whereas the regions with approved IBR eradication programmes should maintain their programme for a limited period of time in accordance with Regulation (EU) 2020/689, and should be listed in the Annexes to this Regulation. |
(18) |
Commission Decision 2008/185/EC (17) sets out the lists of Member States or regions thereof that have the Aujeszky’s disease-free status and the regions that have an approved Aujeszky’s disease eradication programme in accordance with Directive 64/432/EEC. Those Member States or regions thereof with Aujeszky’s disease-free status should be duly listed in the Annexes to this Regulation, whereas the regions with approved Aujeszky’s disease eradication programmes should maintain them for a limited period of time in accordance with Regulation (EU) 2020/689, and should be duly listed in the Annexes to this Regulation. |
(19) |
Commission Decision 2009/177/EC (18) establishes lists of Member States and certain zones and compartments with disease-free status, or subject to approved surveillance programmes or eradication programmes with regard to listed diseases of aquatic animals in accordance with Directive 2006/88/EC. The disease-free status of those Member States, zones and compartments should be duly listed in the Annexes to this Regulation, whereas the approved programmes should be maintained for a limited period of time in accordance with Article 85 of Regulation (EU) 2020/689, and should be duly listed in the Annexes to this Regulation. |
(20) |
With regard to listed diseases of aquatic animals, there are certain disease-free zones and compartments, and approved surveillance programmes, not listed in Decision 2009/177/EC but lists of which are publicly available on the internet-based information pages of the Member States in accordance with Directive 2006/88/EC. Those zones and compartments should have their disease-free status maintained, whereas the programmes should be maintained for a limited period in accordance with Article 85 of Regulation (EU) 2020/689. Up-to-date information concerning the establishments that are located in those disease-free zones and compartments, or which are subject to those programmes, are set out in the publicly available internet page that has been established and maintained in accordance with Article 185(3) of Regulation (EU) 2016/429 and with Article 21(2) of Commission Delegated Regulation (EU) 2020/691 (19). |
(21) |
As the lists set out in Decisions 93/52/EEC, 94/963/EC, 95/98/EC, 2003/467/EC, 2004/558/EC, 2008/185/EC and 2009/177/EC, Regulation (EC) No 616/2009 and Implementing Decision 2013/503/EU are being replaced by the lists set out in the Annexes to this Regulation, those acts should be repealed and replaced by this Regulation. |
(22) |
In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Withdrawal Agreement), and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, Regulation (EU) 2016/429, as well as the Commission acts based on it, apply to and in the United Kingdom in respect of Northern Ireland after the end of the transition period provided for in the Withdrawal Agreement. For that reason, the United Kingdom (Northern Ireland) should be listed in the Annexes to this Regulation where relevant for Northern Ireland. |
(23) |
As Regulation (EU) 2016/429 applies from 21 April 2021, this Regulation should also apply from that date. |
(24) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
1. This Regulation lays down implementing rules for the listed diseases referred to in Article 9(1)(a), (b) and (c) of Regulation (EU) 2016/429 of animals, as regards the disease-free and non-vaccination status of certain Member States (20) or zones or compartments thereof, and the approval of eradication programmes for those listed diseases.
2. The Annexes to this Regulation list both the Member States or zones or compartments thereof whose disease-free status or eradication programmes shall be deemed to be approved as provided for in Article 280 of Regulation (EU) 2016/429, and those whose disease-free status and eradication programmes shall be duly approved by this Regulation and also duly listed in the Annexes thereto.
3. This Regulation lists in the Annexes thereto:
(a) |
the Member States or zones or compartments thereof with approved compulsory eradication programmes for Category B diseases and optional eradication programmes for Category C diseases. |
(b) |
the Member States or zones thereof with approved disease-free status and non-vaccination status; |
(c) |
the compartments of Member States with recognised disease-free status. |
Article 2
Infection with Brucella abortus, B. melitensis and B. suis
1. The Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in bovine animal populations shall be listed in Chapter 1 of Part I of Annex I.
2. The Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in ovine and caprine animal populations shall be listed in Chapter 2 of Part I of Annex I.
3. The Member States or zones thereof with an approved compulsory eradication programme for infection with Brucella abortus, B. melitensis and B. suis shall be listed in Part II of Annex I.
Article 3
Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) (MTBC)
1. The Member States or zones thereof with disease-free status from infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis) (MTBC) shall be listed in Part I of Annex II.
2. The Member States or zones thereof with an approved compulsory eradication programme for infection with MTBC shall be listed in Part II of Annex II.
Article 4
Infection with rabies virus (RABV)
1. The Member States or zones thereof with disease-free status from infection with rabies virus (RABV) shall be listed in Part I of Annex III.
2. The Member States or zones thereof with an approved compulsory eradication programme for infection with RABV shall be listed in Part II of Annex III.
Article 5
Enzootic bovine leukosis (EBL)
1. The Member States or zones thereof with disease-free status from enzootic bovine leukosis (EBL) shall be listed in Part I of Annex IV.
2. The Member States or zones thereof with an approved optional eradication programme for EBL shall be listed in Part II of Annex IV.
Article 6
Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV)
1. The Member States or zones thereof with disease-free status from infectious bovine rinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) shall be listed in Part I of Annex V.
2. The Member States or zones thereof with an approved optional eradication programme for IBR/IPV shall be listed in Part II of Annex V.
Article 7
Infection with Aujeszky’s disease virus(ADV)
1. The Member States or zones thereof with disease-free status from infection with Aujeszky’s disease virus (ADV) shall be listed in Part I of Annex VI.
2. The Member States or zones thereof with an approved optional eradication programme for infection with ADV shall be listed in Part II of Annex VI.
Article 8
Bovine viral diarrhoea (BVD)
1. The Member States or zones thereof with disease-free status from Bovine viral diarroea (BVD) shall be listed in Part I of Annex VII.
2. The Member States or zones thereof with an approved optional eradication programme for infection with BVD shall be listed in Part II of Annex VII.
Article 9
Infection with bluetongue virus (serotypes 1-24) (infection with BTV)
1. The Member States or zones thereof with disease-free status from infection with bluetongue virus (serotypes 1-24) (infection with BTV) shall be listed in Part I of Annex VIII.
2. The Member States or zones thereof with an approved optional eradication programme for infection with BTV shall be listed in Part II of Annex VIII.
Article 10
Infestation with Varroa spp.
The Member States or zones thereof with disease-free status from infestation with Varroa spp. shall be listed in Annex IX.
Article 11
Infection with Newcastle disease virus
The Member States or zones thereof with disease-free status from infection with Newcastle disease virus without vaccination shall be listed in Annex X.
Article 12
Infection with highly pathogenic avian influenza (HPAI)
Compartments of the Member States free from HPAI shall be listed in Annex XI.
Article 13
Viral haemorrhagic septicaemia (VHS)
1. The following shall be listed in Part I of Annex XII:
(a) |
Member States where their whole territory has disease-free status from viral haemorrhagic septicaemia (VHS); |
(b) |
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from VHS; and |
(c) |
zones or compartments of Member States with disease-free status from VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
2. The following shall be listed in Part II of Annex XII:
(a) |
Member States where their whole territory has an approved eradication programme for VHS; |
(b) |
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for VHS; and |
(c) |
zones and compartments of Member States with an approved eradication programme for VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
Article 14
Infectious haematopoietic necrosis (IHN)
1. The following shall be listed in Part I of Annex XIII:
(a) |
Member States where their whole territory has disease-free status from infectious haematopoietic necrosis (IHN); |
(b) |
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from IHN; and |
(c) |
zones or compartments of Member States with disease-free status from IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
2. The following shall be listed in Part II of Annex XIII:
(a) |
Member States where their whole territory has an approved eradication programme for IHN; |
(b) |
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for IHN; and |
(c) |
zones and compartments of Member States with an approved eradication programme for IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
Article 15
Infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV)
1. The following shall be listed in Part I of Annex XIV:
(a) |
Member States where their whole territory has disease-free status from infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV); |
(b) |
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with HPR-deleted ISAV; and |
(c) |
zones or compartments of Member States with disease-free status from infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
2. The following shall be listed in Part II of Annex XIV:
(a) |
Member States where their whole territory has an approved eradication programme for infection with HPR-deleted ISAV; |
(b) |
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with HPR-deleted ISAV; and |
(c) |
zones and compartments of Member States with an approved eradication programme for infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
Article 16
Infection with Marteilia refringens
1. The following shall be listed in Part I of Annex XV:
(a) |
Member States where their whole territory has disease-free status from infection with Marteilia refringens; |
(b) |
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Marteilia refringens; and |
(c) |
zones or compartments of Member States with disease-free status from infection with Marteilia refringens, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
2. The following shall be listed in Part II of Annex XV:
(a) |
Member States where their whole territory has an approved eradication programme for infection with Marteilia refringens; |
(b) |
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Marteilia refringens; and |
(c) |
zones and compartments of Member States with an approved eradication programme for infection with Marteilia refringens, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
Article 17
Infection with Bonamia exitiosa
1. The following shall be listed in Part I of Annex XVI:
(a) |
Member States where their whole territory has disease-free status from infection with Bonamia exitiosa; |
(b) |
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia exitiosa; and |
(c) |
zones or compartments of Member States with disease-free status from infection with Bonamia exitiosa, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
2. The following shall be listed in Part II of Annex XVI:
(a) |
Member States where their whole territory has an approved eradication programme for infection with Bonamia exitiosa; |
(b) |
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia exitiosa; and |
(c) |
zones and compartments of Member States with an approved eradication programme for infection with Bonamia exitiosa, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
Article 18
Infection with Bonamia ostreae
1. The following shall be listed in Part I of Annex XVII:
(a) |
Member States where their whole territory has disease-free status from infection with Bonamia ostreae; |
(b) |
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia ostreae; and |
(c) |
zones or compartments of Member States with disease-free status from infection with Bonamia ostreae, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
2. The following shall be listed in Part II of Annex XVII:
(a) |
Member States where their whole territory has an approved eradication programme for infection with Bonamia ostreae; |
(b) |
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia ostreae; and |
(c) |
zones and compartments of Member States with an approved eradication programme for infection with Bonamia ostreae, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
Article 19
Infection with white spot syndrome virus (WSSV)
1. The following shall be listed in Part I of Annex XVIII:
(a) |
Member States where their whole territory has disease-free status from infection with white spot syndrome virus (WSSV); |
(b) |
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with WSSV; and |
(c) |
zones or compartments of Member States with disease-free status from infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
2. The following shall be listed in Part II of Annex XVIII:
(a) |
Member States where their whole territory has an approved eradication programme for infection with WSSV; |
(b) |
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with WSSV; and |
(c) |
zones and compartments of Member States with an approved eradication programme for infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. |
Article 20
Repeal
The following acts are repealed:
— |
Decision 93/52/EEC, |
— |
Decision 94/963/EC, |
— |
Decision 95/98/EC, |
— |
Decision 2003/467/EC, |
— |
Decision 2004/558/EC, |
— |
Decision 2008/185/EC, |
— |
Decision 2009/177/EC, |
— |
Regulation (EC) No 616/2009, |
— |
Implementing Decision 2013/503/EU. |
Article 21
Entry into force and application
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(2) Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and group of species posing a considerable risk for the spread of those diseases (OJ L 308, 4.12.2018, p. 21).
(3) Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211).
(4) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64).
(5) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19).
(6) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).
(7) Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (OJ L 10, 14.1.2006, p. 16).
(8) Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases of aquatic animals (OJ L 328, 24.11.2006, p. 14).
(9) Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (OJ L 343, 22.12.2009, p. 74).
(10) Commission Regulation (EC) No 616/2009 of 13 July 2009 implementing Council Directive 2005/94/EC as regards the approval of poultry compartments and other captive birds compartments with respect to avian influenza and additional preventive biosecurity measures in such compartments (OJ L 181, 14.7.2009, p. 16).
(11) Commission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis, and enzootic-bovine-leukosis-free status of certain Member States and regions of Member States as regards bovine herds (OJ L 156, 25.6.2003, p. 74).
(12) Commission Decision 93/52/EEC of 21 December 1992 recording the compliance by certain Member States or regions with the requirements relating to brucellosis (B. melitensis) and according them the status of a Member State or region officially free of the disease (OJ L 13, 21.1.1993, p. 14).
(13) Commission Implementing Decision 2013/503/EU of 11 October 2013 recognising parts of the Union as free from varroosis in bees and establishing additional guarantees required in intra-Union trade and imports for the protection of their varroosis-free status (OJ L 273, 15.10.2013, p. 38).
(14) Commission Decision 94/963/EC of 28 December 1994 establishing the status of Finland as non vaccinating as regards Newcastle disease (OJ L 371, 31.12.1994, p. 29).
(15) Commission Decision 95/98/EC of 13 March 1995 establishing the status of Sweden as non-vaccinating as regards Newcastle disease (OJ L 75, 4.4.1995, p. 28).
(16) Commission Decision 2004/558/EC of 15 July 2004 implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradication programmes presented by certain Member States (OJ L 249, 23.7.2004, p. 20).
(17) Commission Decision 2008/185/EC of 21 February 2008 on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease and criteria to provide information on this disease (OJ L 59, 4.3.2008, p. 19).
(18) Commission Decision 2009/177/EC of 31 October 2008 implementing Council Directive 2006/88/EC as regards surveillance and eradication programmes and disease-free status of Member States, zones and compartments (OJ L 63, 7.3.2009, p. 15).
(19) Commission Delegated Regulation (EU) 2020/691 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for aquaculture establishments and transporters of aquatic animals (OJ L 174, 3.6.2020, p. 345).
(20) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Regulation references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX I
INFECTION WITH BRUCELLA ABORTUS, B. MELITENSIS AND B. SUIS
PART I
Disease-free status from infection with Brucella abortus, B. melitensis and B. suis
CHAPTER 1
Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in bovine animal populations
Member State (*1) |
Territory |
Belgium |
Whole territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Estonia |
Whole territory |
Ireland |
Whole territory |
Spain |
Comunidad Autónoma de Andalucía Comunidad Autónoma de Aragón Comunidad Autónoma de Asturias Comunidad Autónoma de Islas Baleares Comunidad Autónoma de Canarias Comunidad Autónoma de Cantabria Comunidad Autónoma de Castilla-La Mancha Comunidad Autónoma de Castilla y León Comunidad Autónoma de Cataluña Comunidad Autónoma de Extremadura: provincia de Badajoz Comunidad Autónoma de Galicia Comunidad Autónoma de La Rioja Comunidad Autónoma de Madrid Comunidad Autónoma de Murcia Comunidad Autónoma de Navarra Comunidad Autónoma de País Vasco Comunidad Autónoma de Valencia |
France |
Whole territory |
Italy |
Regione Abruzzo: Provincia di Pescara Regione Campania: Province di Avellino, Benevento, Napoli Regione Emilia-Romagna Regione Friuli Venezia Giulia Regione Lazio Regione Liguria Regione Lombardia Regione Marche Regione Molise: Provincia di Campobasso Regione Piemonte Regione Puglia: Province di Bari, Barletta-Andria-Trani, Brindisi, Lecce Regione Sardegna Regione Toscana Regione Trentino – Alto Adige Regione Umbria Regione Valle d’Aosta Regione Veneto |
Cyprus |
Whole territory |
Latvia |
Whole territory |
Lithuania |
Whole territory |
Luxembourg |
Whole territory |
Malta |
Whole territory |
Netherlands |
Whole territory |
Austria |
Whole territory |
Poland |
Whole territory |
Portugal |
Região Algarve: all distritos Região Autónoma dos Açores: Ilhas de Corvo, Faial, Flores, Graciosa, Pico, Santa Maria Região Centro: distritos Aveiro, Viseu, Guarda, Coimbra, Leiria, Castelo Branco |
Romania |
Whole territory |
Slovenia |
Whole territory |
Slovakia |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
CHAPTER 2
Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in ovine and caprine animal populations
Member State (*2) |
Territory |
Belgium |
Whole territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Estonia |
Whole territory |
Ireland |
Whole territory |
Spain |
Whole territory |
France |
Région Auvergne et Rhône-Alpes Région Bourgogne-Franche-Comté Région Bretagne Région Centre-Val de Loire Région Corse Région Grande Est Région Hauts-de-France Région Ile-de-France Région Normandie Région Nouvelle-Aquitaine Région Occitanie Région Pays de la Loire Région Provence-Alpes-Côte d’Azur |
Italy |
Regione Abruzzo Regione Calabria: Province di Catanzaro, Cosenza Regione Campania: Provincia di Benevento Regione Emilia-Romagna Regione Friuli Venezia Giulia Regione Lazio Regione Liguria Regione Lombardia Regione Marche Regione Molise Regione Piemonte Regione Puglia: Province di Bari, Barletta-Andria-Trani, Brindisi and Taranto Regione Sardegna Regione Toscana Regione Trentino – Alto Adige Regione Umbria Regione Valle d’Aosta Regione Veneto |
Cyprus |
Whole territory |
Latvia |
Whole territory |
Lithuania |
Whole territory |
Luxembourg |
Whole territory |
Hungary |
Whole territory |
Netherlands |
Whole territory |
Austria |
Whole territory |
Poland |
Whole territory |
Portugal |
Região Autónoma dos Açores |
Romania |
Whole territory |
Slovenia |
Whole territory |
Slovakia |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States or zones thereof with an approved eradication programme for Brucella abortus, B. melitensis and B. suis
None at present.
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
(*2) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX II
INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX (M. BOVIS, M. CAPRAE AND M. TUBERCULOSIS) (MTBC)
PART I
Member States or zones thereof with disease-free status from MTBC
Member State |
Territory |
Belgium |
Whole territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Estonia |
Whole territory |
Spain |
Comunidad Autónoma de Canarias Comunidad Autónoma de Galicia: provincia de Pontevedra |
France |
Whole territory |
Italy |
Regione Abruzzo: Provincia di Pescara Regione Basilicata: Provincia di Matera Regione Emilia-Romagna Regione Friuli Venezia Giulia Regione Lazio: Province di Frosinone, Rieti, Viterbo Regione Liguria Regione Lombardia Regione Marche: Province di Ancona, Ascoli Piceno, Fermo, Pesaro-Urbino Regione Molise Regione Piemonte Regione Sardegna: Citta metropolitana di Cagliari, Provincia di Oristano, Provincia del Sud Sardegna Regione Toscana Regione Trentino – Alto Adige Regione Umbria Regione Valle d’Aosta Regione Veneto |
Latvia |
Whole territory |
Lithuania |
Whole territory |
Luxembourg |
Whole territory |
Hungary |
Whole territory |
Netherlands |
Whole territory |
Austria |
Whole territory |
Poland |
Whole territory |
Portugal |
Região Algarve: all distritos Região Autónoma dos Açores except Ilha de São Miguel |
Slovenia |
Whole territory |
Slovakia |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
PART II
Member States or zones thereof with an approved eradication programme for infection with MTBC
None at present.
ANNEX III
INFECTION WITH THE RABIES VIRUS (RABV)
PART I
Member States or zones thereof with disease-free status from infection with RABV
Member State (*1) |
Territory |
Belgium |
Whole territory |
Bulgaria |
Whole territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Estonia |
Whole territory |
Ireland |
Whole territory |
Greece |
Whole territory |
Spain |
Whole peninsular territory Comunidad Autónoma de Islas Baleares Comunidad Autónoma de Canarias |
France |
Région Auvergne et Rhône-Alpes Région Bourgogne-Franche-Comté Région Bretagne Région Centre-Val de Loire Région Corse Région Grande Est Région Hauts-de-France Région Ile-de-France Région Normandie Région Nouvelle-Aquitaine Région Occitanie Région Pays de la Loire Région Provence-Alpes-Côte d’Azur Région Guadeloupe Région La Réunion Région Martinique Région Mayotte |
Croatia |
Whole territory |
Italy |
Whole territory |
Cyprus |
Whole territory |
Latvia |
Whole territory |
Lithuania |
Whole territory |
Luxembourg |
Whole territory |
Hungary |
Whole territory |
Malta |
Whole territory |
Netherlands |
Whole territory |
Austria |
Whole territory |
Poland |
Voivodship Dolnośląskie: all powiaty Voivodship Kujawsko-pomorskie: all powiaty Voivodship Lubelskie the following powiaty: Lubartowski, Lubelski, m. Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki Voivodship Lubuskie: all powiaty Voivodship Łódzkie: all powiaty Voivodship Małopolskie: all powiaty Voivodship Mazowieckie the following powiaty: Ciechanowski, Gostyniński, Lipski, Makowski, Mławski, Ostrołęcki, m. Ostrołęka, Płocki, m. Płock, Płoński, Przasnyski, Przysuski, Radomski, m.Radom, Sierpecki, Sochaczewski, Szydłowiecki, Zwoleński, Żuromiński, Żyrardowski Voivodship Opolskie: all powiaty Voivodship Podlaskie: all powiaty Voivodship Pomorskie: all powiaty Voivodship Śląskie: all powiaty; Voivodship Świętokrzyskie: all powiaty; Voivodship Warmińsko-mazurskie: all powiaty; Voivodship Wielkopolskie: all powiaty; Voivodship Zachodniopomorskie: all powiaty. |
Portugal |
Whole territory |
Slovenia |
Whole territory |
Slovakia |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States or zones thereof with an approved eradication programme for infection with RABV
None at present.
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX IV
ENZOOTIC BOVINE LEUKOSIS (EBL)
PART I
Member States or zones thereof with disease-free status from EBL
Member State (*1) |
Territory |
Belgium |
Whole territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Estonia |
Whole territory |
Ireland |
Whole territory |
Spain |
Whole territory |
France |
Région Auvergne et Rhône-Alpes Région Bourgogne-Franche-Comté Région Bretagne Région Centre-Val de Loire Région Corse Région Grande Est Région Hauts-de-France Région Ile-de-France Région Normandie Région Nouvelle-Aquitaine Région Occitanie Région Pays de la Loire Région Provence-Alpes-Côte d’Azur Région Guadeloupe Région Guyane Région Martinique Région Mayotte |
Italy |
Whole territory |
Cyprus |
Whole territory |
Latvia |
Whole territory |
Lithuania |
Whole territory |
Luxembourg |
Whole territory |
Netherlands |
Whole territory |
Austria |
Whole territory |
Poland |
Whole territory |
Portugal |
Região Algarve: all distritos Região Alentejo: all distritos Região Centro: all distritos Região Lisboa e Vale do Tejo: all distritos Região Norte: distritos: Braga, Bragança, Viana do Castelo, Vila Real Região Autónoma dos Açores |
Slovenia |
Whole territory |
Slovakia |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States or zones thereof with an approved eradication programme for EBL
None at present.
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX V
INFECTIOUS BOVINE RHINOTRACHEITIS/INFECTIOUS PUSTULAR VULVOVAGINITIS (IBR/IPV)
PART I
Member States or zones thereof with disease-free status from IBR/IPV
Member State |
Territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Italy |
Regione Valle d’Aosta Regione Trentino – Alto Adige: Provincia Autonoma di Bolzano – Alto Adige |
Austria |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
PART II
Member States or zones thereof with an approved eradication programme for IBR/IPV
Member State |
Territory |
Date of initial approval as referred to in point 2 of Article 15 of Delegated Regulation (EU) 2020/689 |
Belgium |
Whole territory |
21 April 2021 |
France |
Région Auvergne et Rhône-Alpes Région Bourgogne-Franche-Comté Région Bretagne Région Centre-Val de Loire Région Grande Est Région Hauts-de-France Région Ile-de-France Région Normandie Région Nouvelle-Aquitaine Région Occitanie Région Pays de la Loire Région Provence-Alpes-Côte d’Azur |
21 April 2021 |
Italy |
Region Friuli Venezia Giulia Regione Trentino – Alto Adige: Provincia Autonoma di Trento |
21 April 2021 |
Luxembourg |
Whole territory |
21 April 2021 |
ANNEX VI
AUJESZKY’S DISEASE VIRUS (ADV)
PART I
Member States or zones thereof with disease-free status from infection with ADV
Member State (*1) |
Territory |
Belgium |
Whole territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Estonia |
Whole territory |
Ireland |
Whole territory |
France |
The departments of Ain, Aisne, Allier, Alpes-de-Haute-Provence, Alpes-Maritimes, Ardèche, Ardennes, Ariège, Aube, Aude, Aveyron, Bas-Rhin, Bouches-du-Rhône, Calvados, Cantal, Charente, Charente-Maritime, Cher, Corrèze, Côte-d’Or, Côtes-d’Armor, Creuse, Deux-Sèvres, Dordogne, Doubs, Drôme, Essonne, Eure, Eure-et-Loir, Finistère, Gard, Gers, Gironde, Hautes-Alpes, Hauts-de-Seine, Haute Garonne, Haute-Loire, Haute-Marne, Hautes-Pyrénées, Haut-Rhin, Haute-Saône, Haute-Savoie, Haute-Vienne, Hérault, Indre, Ille-et-Vilaine, Indre-et-Loire, Isère, Jura, Landes, Loire, Loire-Atlantique, Loir-et-Cher, Loiret, Lot, Lot-et-Garonne, Lozère, Maine-et-Loire, Manche, Marne, Mayenne, Meurthe-et-Moselle, Meuse, Morbihan, Moselle, Nièvre, Nord, Oise, Orne, Paris, Pas-de-Calais, Pyrénées-Atlantiques, Pyrénées-Orientales, Puy-de-Dôme, Réunion, Rhône, Sarthe, Saône-et-Loire, Savoie, Seine-et-Marne, Seine-Maritime, Seine-Saint-Denis, Somme, Tarn, Tarn-et-Garonne, Territoire de Belfort, Val-de-Marne, Val-d’Oise, Var, Vaucluse, Vendée, Vienne, Vosges, Yonne, Yvelines |
Italy |
Regione Friuli Venezia Giulia Regione Trentino – Alto Adige: Provincia Autonoma di Bolzano – Alto Adige |
Cyprus |
Whole territory |
Luxembourg |
Whole territory |
Hungary |
Whole territory |
Netherlands |
Whole territory |
Austria |
Whole territory |
Poland |
Voivodship Podlaskie the following powiaty: Augustowski, Białostocki, Białystok, Bielski, Hajnowski, Moniecki, Sejneński, Siemiatycki, Sokólski, Suwalski, Suwałki |
Slovenia |
Whole territory |
Slovakia |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States or zones thereof with an approved eradication programme for infection with ADV
Member State |
Territory |
Date of initial approval as referred to in point 2 of Article 15 of Delegated Regulation (EU) 2020/689 |
Spain |
Whole territory |
21 April 2021 |
Italy |
Regione Abruzzo Regione Apulia Regione Basilicata Regione Calabria Regione Campania Regione Emilia-Romagna Regione Lazio Regione Liguria Regione Lombardia Regione Marche Regione Molise Regione Piemonte Regione Sicilia Regione Trentino – Alto Adige: Provincia Autonoma di Trento Regione Toscana Regione Valle d’Aosta Regione Umbria Regione Veneto |
21 April 2021 |
Lithuania |
Whole territory |
21 April 2021 |
Poland |
Voivodship Dolnośląskie: all powiaty Voivodship Kujawsko-Pomorskie: all powiaty Voivodship Lubelskie: all powiaty Voidodship Lubuskie: all powiaty Voivodship Lódzkie: all powiaty Voivodship Małopolskie: all powiaty Voivodship Mazowieckie: all powiaty Voivodship Opolskie: all powiaty Voivodship Podkarpackie: all powiaty Voivodship Podlaskie the following powiaty: Grajewski, Kolneński, Łomżyński, Łomża, Wysokomazowiecki, Zambrowski Voivodship Pomorskie: all powiaty Voivodship Sląskie: all powiaty Voivodship Swiętokrzyskie: all powiaty Voivodship Warmińsko-mazurskie: all powiaty Voivodship Wielkopolskie: all powiaty Voivodship Zachodniopomorskie: all powiaty |
21 April 2021 |
Portugal |
Whole peninsular territory |
21 April 2021 |
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX VII
BOVINE VIRAL DIARRHOEA (BVD)
PART I
Member States or zones thereof with disease-free status from with BVD
None at present.
PART II
Member States or zones thereof with an approved eradication programme for BVD
None at present.
ANNEX VIII
INFECTION WITH BLUETONGUE VIRUS (BTV)
PART I
Member States or zones thereof with disease-free status from infection with BTV
Member State (*1) |
Territory |
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Czechia |
Whole territory |
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Denmark |
Whole territory |
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Germany |
Bundesland Bayern:
Bundesland Berlin Bundesland Brandenburg Bundesland Bremen Bundesland Hamburg Bundesland Hessen:
Bundesland Mecklenburg-Vorpommern Bundesland Niedersachsen Bundesland Nordrhein-Westfalen:
Bundesland Sachsen Bundesland Sachsen-Anhalt Bundesland Schleswig-Holstein Bundesland Thüringen |
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Estonia |
Whole territory |
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Ireland |
Whole territory |
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Spain |
Comunidad Autónoma de Andalucía: Province of Almería Province of Córdoba, the following regions: Baena, Guadajoz y Campiña Este, Hinojosa del Duque (Pedroches II), Lucena (Subbética), Montilla (Campiña Sur), Montoro (Alto del Guadalquivir), Peñarroya-Pueblonuevo (Valle del Guadiato), Pozoblanco (Pedroches I), Villanueva de Córdoba (Pedroches III) Province of Granada, the following regions: Alhama de Granada (Alhama/Temple), Baza (Altiplanicie Sur), Guadix (Hoya-Altiplanicie de Guadix), Huescar (Altiplanicie Norte), Iznalloz (Montes Orientales), Loja (Vega/Montes Occ.), Orgiva (Alpujarra/Valle de Lecrin), Santa Fe (Vega de Granada) Province of Huelva, the following regions: Aracena (Sierra Oriental) and Cortegana (Sierra Occidental) Province of Jaén Province of Sevilla, the following region: Cazalla de la Sierra (Sierra Norte) Comunidad Autonoma de Aragón Province of Huesca, the following regions: Binéfar, Fraga, Grañén, Monzón, Sariñena, Tamarite de Litera and Bujaraloz regions; the following municipalities in Ayerbe: Agüero, Ayerbe, Biscarrués, Loarre, Loscorrales, Lupiñén-Ortilla and La Sotonera; the following municipalities in Barbastro: Azara, Azlor, Barbastro, Barbuñales, Berbegal, Castejón del Puente, Castillazuelo, Estada, Estadilla, El Grado, Hoz y Costean, Ilche, Laluenga, Laperdiguera, Lascellas-Ponzano, Olvena, Peralta de Alcofea, Peraltilla, Pozán de Vero, Salas Altas, Salas Bajas, Santa María de Dulcis and Torres de Alcanadre; the following municipalities in Castejón de Sos: Benasque, Bisauri, Bonansa, Laspaúles and Montanuy; the following municipalities in Graus: Arén, Benabarre, Beranuy, Capella, Castigaleu, Estopiñán del Castillo, Graus, Isábena, Lascuarre, Monesma y Cajigar, Perarrúa, La Puebla de Castro, Puente de Montañana, Santaliestra y San Quílez, Secastilla, Sopeira, Tolva, Torre La Ribera, Valle de Lierp and Viacamp y Litera; the following municipalities in Huesca: Albero Alto, Alcalá de Gurrea, Alcalá del Obispo, Alerre, Almudévar, Angüés, Antillón, Argavieso, Banastás, Blecua y Torres, Chimillas, Gurrea de Gállego, Huesca, Monflorite-Lascasas, Novales, Pertusa, Piracés, Quicena, Salillas, Sesa, Tierz, Tramaced and Vicién Province of Teruel Province of Zaragoza, the following regions: Alagón, La Almunia de Doña Godina, Ariza, Belchite, Borja, Bujaraloz, Calatayud, Cariñena, Caspe, Daroca, Ejea de los caballeros, Épila, Fraga, Illueca, Quinto, Sos del Rey Católico, Tarazona, Tauste, Zaragoza and Zuera regions; the following municipalities in Ayerbe region: Murillo de Gállego and Santa Eulalia de Gállego Comunidad Autónoma de Asturias Comunidad Autónoma de Islas Baleares Comunidad Autónoma de Canarias Comunidad Autónoma de Cantabria; Comunidad Autónoma de Castilla-La Mancha Comunidad Autónoma de Castilla y León Comunidad Autónoma de Cataluña Comunidad Autónoma de Extremadura Comunidad Autónoma de Galicia Comunidad Autónoma de La Rioja Comunidad Autónoma de Madrid Comunidad Autónoma de Murcia Comunidad Autónoma de Navarra, the following regions: Tafalla and Tudela regions; the following municipalities in Estella región: Abáigar, Aberin, Aguilar de Codés, Allo, Ancín/Antzin, Aras, Los Arcos, Arellano, Armañanzas, Arróniz, Ayegui/Aiegi, Azuelo, Barbarin, Bargota, El Busto, Cabredo, Desojo, Dicastillo, Espronceda, Estella-Lizarra, Etayo, Genevilla, Igúzquiza, Lana, Lapoblación, Lazagurría, Legaria, Lerín, Luquin, Marañón, Mendavia, Mendaza, Metauten, Mirafuentes, Morentín, Mues, Murieta, Nazar, Oco, Olejua, Oteiza, Piedramillera, Sansol, Sesma, Sorlada, Torralba del Río, Torres del Río, Viana, Villamayor de Monjardín, Villatuerta and Zuñiga; the following municipalities in Sangüesa región: Aibar/Oibar, Cáseda, Eslava, Ezprogui, Gallipienzo/Galipentzu, Javier, Leache/Leatxe, Lerga, Liédena, Petilla de Aragón, Sada, Sangüesa/Zangoza and Yesa. Comunidad Autónoma de País Vasco Province of Álava, the following municipalities: Agurain/Salvatierra, Alegría-Dulantzi, Amurrio, Añana, Armiñón, Arraia-Maeztu, Arratzua-Ubarrundia, Artziniega, Asparrena, Ayala/Aiara, Baños de Ebro/Mañueta, Barrundia, Berantevilla, Bernedo, Campezo/Kanpezu, Elburgo/Burgelu, Elciego, Elvillar/Bilar, Erriberabeitia, Erriberagoitia/Ribera Alta, Harana/Valle de Arana, Iruña Oka/Iruña de Oca, Iruraiz-Gauna, Kripan, Kuartango, Labastida/Bastida, Lagrán, Laguardia, Lanciego/Lantziego, Lantarón, Lapuebla de Labarca, Laudio/Llodio, Legutio, Leza, Moreda de Álava/Moreda Araba, Navaridas, Okondo, Oyón-Oion, Peñacerrada-Urizaharra, Samaniego, San Millán/Donemiliaga, Urkabustaiz, Valdegovia/Gaubea, Villabuena de Álava/Eskuernaga, Vitoria-Gasteiz, Yécora/Iekora, Zalduondo, Zambrana, Zigoitia and Zuia. Comunidad Autónoma de Valencia |
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Italy |
Provincia Autonoma di Bolzano – Alto Adige Regione Valle d’Aosta |
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Latvia |
Whole territory |
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Hungary |
Whole territory |
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Netherlands |
Whole territory |
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Austria |
Whole territory |
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Poland |
Whole territory |
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Slovenia |
Whole territory |
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Slovakia |
Whole territory |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Finland |
Whole territory |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sweden |
Whole territory |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States or zones thereof with an approved eradication programme for infection with BTV
None at present.
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX IX
INFESTATION WITH VARROA SPP.
Member States or zones thereof with disease-free status from infestation with Varroa spp.
Member State |
Territory |
Portugal |
Island of Corvo Island of Graciosa Island of São Jorge Island of Santa Maria Island of São Miguel Island of Terceira |
Finland |
Åland islands |
ANNEX X
INFECTION WITH NEWCASTLE DISEASE VIRUS
Member States or zones thereof with disease-free status from infection with Newcastle disease virus without vaccination
Member State |
Territory |
Finland |
Whole territory |
Sweden |
Whole territory |
ANNEX XI
HIGHLY PATHOGENIC AVIAN INFLUENZA (HPAI)
Compartments free from HPAI
Member State |
Name |
France |
Compartiment ISA Bretagne comprising the establishments with codes EDE 22080055, 22277180, 22203429, 22059174 and 22295000. Compartiment SASSO Sabres comprising the establishment with Code EDE 40246082. Compartiment SASSO Soulitré comprising the establishment with Code EDE 72341105. |
Netherlands |
Verbeek’s poultry international B.V with approval number 1122. Institut de selection animale B.V with approval number 2338. Cobb Europe B.V. with approval number 2951. |
ANNEX XII
VIRAL HAEMORRHAGIC SEPTICAEMIA (VHS)
PART I
Member States whose whole territory has disease-free status from VHS;
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from VHS; and
zones or compartments of Member States with disease-free status from VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State (*1) |
Territory |
Denmark |
Whole continental territory |
Ireland |
Whole territory |
Cyprus |
Whole continental territory |
Finland |
Whole territory, except the Province of Åland |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States where their whole territory has an approved eradication programme for VHS;
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for VHS;
and zones and compartments of Member States with an approved eradication programme for VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State |
Territory |
Date of initial approval as referred to in point 2 of Article 49 of Delegated Regulation (EU) 2020/689 |
Estonia |
Whole territory |
21 April 2021 |
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX XIII
INFECTIOUS HAEMATOPOIETIC NECROSIS (IHN)
PART I
Member States where their whole territory has disease-free status from IHN;
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from IHN;
and zones or compartments of Member States with disease-free status from IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State (*1) |
Territory |
Denmark |
Whole territory |
Ireland |
Whole territory |
Cyprus |
Whole continental territory |
Finland |
Whole territory, except the coastal compartment in Ii, Kuivaniemi, and the following water catchment areas: 14.72 Virmasvesi, 14.73 Nilakka, 4.74 Saarijärvi area and 4.41 Pielinen area |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States where their whole territory has an approved eradication programme for IHN;
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for IHN; and
zones and compartments of Member States with an approved eradication programme for IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State |
Territory |
Date of initial approval as referred to in point 2 of Article 49 of Delegated Regulation (EU) 2020/689 |
Estonia |
Whole territory |
21 April 2021 |
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX XIV
INFECTION WITH HIGHLY POLYMORPHIC REGION DELETED INFECTIOUS SALMON ANAEMIA VIRUS (HPR-DELETED ISAV)
PART I
Member States where their whole territory has disease-free status from infection with HPR-deleted ISAV;
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with HPR-deleted ISAV; and
zones or compartments of Member States with disease-free status from infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State (*1) |
Territory |
Belgium |
Whole territory |
Bulgaria |
Whole territory |
Czechia |
Whole territory |
Denmark |
Whole territory |
Germany |
Whole territory |
Estonia |
Whole territory |
Ireland |
Whole territory |
Greece |
Whole territory |
Spain |
Whole territory |
France |
Whole territory |
Croatia |
Whole territory |
Italy |
Whole territory |
Cyprus |
Whole territory |
Latvia |
Whole territory |
Lithuania |
Whole territory |
Luxembourg |
Whole territory |
Hungary |
Whole territory |
Malta |
Whole territory |
Netherlands |
Whole territory |
Austria |
Whole territory |
Poland |
Whole territory |
Portugal |
Whole territory |
Romania |
Whole territory |
Slovenia |
Whole territory |
Slovakia |
Whole territory |
Finland |
Whole territory |
Sweden |
Whole territory |
United Kingdom (Northern Ireland) |
Northern Ireland |
PART II
Member States where their whole territory has an approved eradication programme for infection with HPR-deleted ISAV;
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with HPR-deleted ISAV; and
zones and compartments of Member States with an approved eradication programme for infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
None at present.
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX XV
INFECTION WITH MARTEILIA REFRINGENS
PART I
Member States where their whole territory has disease-free status from infection with Marteilia refringens;
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Marteilia refringens; and
zones or compartments of Member States with disease-free status from infection with Marteilia refringens, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State (*1) |
Territory |
Ireland |
Whole territory |
United Kingdom (Northern Ireland) |
The whole coastline of Northern Ireland, except for Belfast Lough and Dundrum Bay. |
PART II
Member States where their whole territory has an approved eradication programme for infection with Marteilia refringens;
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Marteilia refringens; and
zones and compartments of Member States with an approved eradication programme for infection with Marteilia refringens, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
None at present.
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX XVI
INFECTION WITH BONAMIA EXITIOSA
PART I
Member States where their whole territory has disease-free status from infection with Bonamia exitiosa;
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia exitiosa; and
zones or compartments of Member States with disease-free status from infection with Bonamia exitiosa, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State |
Territory |
Estonia |
Whole territory |
PART II
Member States where their whole territory has an approved eradication programme for infection with Bonamia exitiosa;
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia exitiosa; and
zones and compartments of Member States with an approved eradication programme for infection with Bonamia exitiosa, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
None at present.
ANNEX XVII
INFECTION WITH BONAMIA OSTREAE
PART I
Member States where their whole territory has disease-free status from infection with Bonamia ostreae;
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia ostreae; and
zones or compartments of Member States with disease-free status from infection with Bonamia ostreae, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
Member State (*1) |
Territory |
Estonia |
Whole territory |
Ireland |
The whole coastline of Ireland, except: Cork Harbour; Galway Bay; Ballinakill Harbour; Clew Bay; Achill Sound; Loughmore, Blacksod Bay; Lough Foyle; Lough Swilly; and Kilkieran Bay. |
United Kingdom (Northern Ireland) |
The whole coastline of Northern Ireland, except: Lough Foyle and Strangford Lough. |
PART II
Member States where their whole territory has an approved eradication programme for infection with Bonamia ostreae;
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia ostreae; and
zones and compartments of Member States with an approved eradication programme for infection with Bonamia ostreae, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
None at present.
(*1) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to Member States include the United Kingdom in respect of Northern Ireland.
ANNEX XVIII
INFECTION WITH WHITE SPOT SYNDROME VIRUS (WSSV)
PART I
Member States where their whole territory has disease-free status from infection with WSSV;
zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with WSSV; and
zones or compartments of Member States with disease-free status from infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
None at present.
PART II
Member States where their whole territory has an approved eradication programme for infection with WSSV;
zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with WSSV; and
zones and compartments of Member States with an approved eradication programme for infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country
None at present.
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/120 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/621
of 15 April 2021
amending Regulation (EU) No 37/2010 to classify the substance imidacloprid as regards its maximum residue limit in foodstuffs of animal origin
(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 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council (1), and in particular Article 14, in conjunction with Article 17 thereof,
Having regard to the opinion of the European Medicines Agency formulated on 9 September 2020 by the Committee for Medicinal Products for Veterinary Use,
Whereas:
(1) |
Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit ('MRL') for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation. |
(2) |
Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin. |
(3) |
The substance imidacloprid is not included in that table. |
(4) |
An application for the establishment of an MRL for imidacloprid in Salmonidae has been submitted to the European Medicines Agency (the 'Agency'). |
(5) |
The Agency, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for imidacloprid in Salmonidae, applicable to muscle and skin in natural proportions. |
(6) |
According to Article 5 of Regulation (EC) No 470/2009, the Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. |
(7) |
The Agency has considered that the extrapolation of the MRL for imidacloprid from Salmonidae to all fin fish is appropriate. |
(8) |
In view of the opinion of the Agency, it is appropriate to establish the recommended MRL for fin fish. |
(9) |
Regulation (EU) No 37/2010 should therefore be amended accordingly. |
(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 152, 16.6.2009, p. 11.
(2) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the following entry is inserted in alphabetical order:
Pharmacologically active Substance |
Marker residue |
Animal Species |
MRL |
Target Tissues |
Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009) |
Therapeutic Classification |
‘Imidacloprid |
Imidacloprid |
Fin Fish |
600 μg/kg |
Muscle and skin in natural proportions |
NO ENTRY |
Antiparasitic agents/Agents against ectoparasites’ |
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/123 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/622
of 15 April 2021
laying down implementing technical standards for the application of Directive 2014/59/EU of the European Parliament and of the Council with regard to uniform reporting templates, instructions and methodology for reporting on the minimum requirement for own funds and eligible liabilities
(Text with EEA relevance)
THE EUROPEAN COMMISSION
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (1), and in particular Article 45j(2), third subparagraph, thereof,
Whereas:
(1) |
Resolution authorities have been given the task of setting minimum requirements for own funds and eligible liabilities (MREL) in accordance with the requirements and procedures laid down in Articles 45 to 45i of Directive 2014/59/EU. To assist the European Banking Authority (EBA) in promoting convergence across the Union for the setting of MREL, resolution authorities are required under Article 45j of that Directive to inform the EBA, in coordination with competent authorities, of the MREL they have set. |
(2) |
Commission Implementing Regulation (EU) 2018/308 (2) specifies formats and templates for the transmission by resolution authorities to the EBA of the information regarding their decisions setting the MREL. Since the adoption of that Implementing Regulation, the requirements related to the loss-absorbing and recapitalisation capacity and, in particular, the features of and methodologies for setting the MREL of credit institutions and investment firms laid down in Directive 2014/59/EU have been amended and further specified by Directive (EU) 2019/879 of the European Parliament and of the Council (3). |
(3) |
In order to facilitate the EBA’s monitoring of MREL decisions and to ensure a meaningful assessment of convergence across the Union for the setting of MREL, the formats and templates specified for the identification and transmission of information on MREL by resolution authorities to the EBA should be adapted to reflect the amendments to Directive 2014/59/EU, relating in particular to MREL subordination levels and the MREL applied to entities that are not themselves resolution entities. |
(4) |
With respect to groups that are subject to MREL on a consolidated basis, it is necessary to clarify which resolution authority should transmit the information on MREL to the EBA. Therefore, resolution authorities responsible for groups’ subsidiaries, in coordination with competent authorities, should inform the EBA of the MREL that has been set for each institution under their jurisdiction. That information should include the MREL set on the basis of a joint decision reached between the resolution authority of the resolution entity, the group-level resolution authority, where different from the former, and the resolution authority responsible for the subsidiary on an individual basis. In the absence of a joint decision, that information should also include decisions setting the MREL taken by the resolution authority of the subsidiary in accordance, where applicable, with the decision that may be taken by the EBA in accordance with Article 19 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (4). |
(5) |
In order to promote convergence of practices regarding MREL decisions and strengthen the monitoring role of the EBA, the reporting periods and submission dates for the transmission of information under full and simplified reporting by the resolution authorities to the EBA should be aligned. |
(6) |
To enhance data quality and ensure comparability, the data items set out in the reporting templates should comply with the single data point model, as is the practice in supervisory reporting. The single data point model should consist of a structural representation of the data items, identify all relevant business concepts for uniform reporting on MREL decisions and contain all the relevant specifications necessary for further development of uniform IT reporting solutions. For the same reason, the data exchange format should be set out in the EBA’s reporting system (EUCLID). |
(7) |
To ensure the quality, consistency and accuracy of data items reported, the data items should be subject to common validation rules. |
(8) |
Given the extent of the necessary amendments to Implementing Regulation (EU) 2018/308, it is appropriate, for reasons of clarity, transparency and legal certainty, to repeal that Implementing Regulation and to replace it by a new Implementing Regulation. |
(9) |
This Regulation is based on the draft implementing technical standards submitted to the Commission by the EBA. |
(10) |
The EBA has conducted open public consultations on the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits, and requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010, |
HAS ADOPTED THIS REGULATION:
Article 1
Information to be transmitted to the EBA
Resolution authorities, in coordination with competent authorities, shall transmit to the EBA the information specified in the templates set out in Annexes I and II to this Regulation relating to the setting of MREL in accordance with Articles 45 to 45h and Article 45m of Directive 2014/59/EU.
Article 2
Simplified reporting requirement for institutions subject to waivers and for institutions for which the recapitalisation amount is zero
1. For institutions for which the application of the MREL has been waived pursuant to Article 45f(3), Article 45f(4) or Article 45g of Directive 2014/59/EU, resolution authorities shall only transmit to the EBA the information specified in columns 0010 to 0100 and 0270 of Annex I to this Regulation.
2. For institutions for which the recapitalisation amount set in accordance with Article 45c(2) of Directive 2014/59/EU is zero, and where no adjustments to the loss absorption amount in accordance with that paragraph are made, resolution authorities shall only transmit to the EBA the information specified in columns 0010 to 0080 and 0270 of Annex I to this Regulation.
Article 3
Reporting authority and information to be reported for groups
For groups that are subject to MREL on a consolidated basis in accordance with Article 45e, Article 45f(1), third subparagraph, and Article 45f(4), point (b), of Directive 2014/59/EU, the information referred to in Articles 1 and 2 shall be submitted by the following authorities and in the following manner:
(a) |
the group-level resolution authority, in coordination with the group level supervisory authority, shall inform the EBA of the MREL of the Union parent undertaking set on a consolidated basis; |
(b) |
the resolution authorities taking the decisions setting the MREL, in coordination with the competent authority, shall inform the EBA of the MREL to be applied to the group subsidiaries under their jurisdiction at the resolution group consolidated level and on an individual basis as applicable. |
Article 4
Reporting periods and submission dates
Resolution authorities shall, by 31 May of each year, transmit the information referred to in Articles 1 and 2 for the MREL applicable as of 1 May of that year.
Article 5
Data exchange formats and information accompanying submissions
1. Resolution authorities shall submit the information referred to in Articles 1 and 2 in the data exchange format and in accordance with the technical specifications and representations of the EBA’s reporting system (EUCLID).
2. When submitting the information referred to in Articles 1 and 2, resolution authorities shall respect the data point definitions of the data point model and the validation rules laid down in Annex III as well as the following specifications:
(a) |
information that is not required or not applicable shall not be included in a data submission; |
(b) |
numerical values shall be submitted as follows:
|
(c) |
institutions, insurance undertakings and legal entities shall be identified by their Legal Entity Identifier (LEI), where available. |
Article 6
Repeal
Implementing Regulation (EU) 2018/308 is hereby repealed.
Article 7
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 173, 12.6.2014, p. 190.
(2) Commission Implementing Regulation (EU) 2018/308 of 1 March 2018 laying down implementing technical standards for Directive 2014/59/EU of the European Parliament and of the Council with regard to formats, templates and definitions for the identification and transmission of information by resolution authorities for the purposes of informing the European Banking Authority of the minimum requirement for own funds and eligible liabilities (OJ L 60, 2.3.2018, p. 7).
(3) Directive (EU) 2019/879 of the European Parliament and of the Council of 20 May 2019 amending Directive 2014/59/EU as regards the loss-absorbing and recapitalisation capacity of credit institutions and investment firms and Directive 98/26/EC (OJ L 150, 7.6.2019, p. 296).
(4) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).
ANNEX I
M 20.00 - Reporting of MREL decisions |
INSTITUTION |
||||||||||||||
ENTITY CODE |
TYPE OF CODE |
RESOLUTION ENTITY CODE |
TYPE OF CODE |
CONSOLIDATION PERIMETER |
TYPE OF INSTITUTION |
INTERNAL OR EXTERNAL MREL |
SIMPLIFIED REPORTING |
WAIVER |
REASON FOR WAIVER |
RESOLUTION STRATEGY AND TOOLS |
||||
RESOLUTION STRATEGY |
MAIN RESOLUTION TOOL (PREFERRED STRATEGY ) |
SECOND RESOLUTION TOOL (PREFERRED STRATEGY ) |
MAIN RESOLUTION TOOL (VARIANT STRATEGY) |
SECOND RESOLUTION TOOL (VARIANT STRATEGY) |
||||||||||
0010 |
0020 |
0030 |
0040 |
0050 |
0060 |
0070 |
0080 |
0090 |
0100 |
0110 |
0120 |
0130 |
0140 |
0150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INSTITUTION |
BALANCE SHEET DATA USED TO CALIBRATE MREL |
|||||||||
ADDITIONAL OWN FUNDS REQUIREMENT AND COMBINED BUFFER REQUIREMENT |
REFERENCE DATE |
BEFORE RESOLUTON |
AFTER RESOLUTON |
|||||||
REFERENCE DATE |
ADDITIONAL OWN FUNDS REQUIREMENT AS % OF TREA |
COMBINED BUFFER REQUIREMENT |
OF WHICH: COUNTERCYCLICAL CAPITAL BUFFER |
TREA |
TLOF |
TEM |
TREA |
TLOF |
TEM |
|
0160 |
0170 |
0180 |
0190 |
0200 |
0210 |
0220 |
0230 |
0240 |
0250 |
0260 |
|
|
|
|
|
|
|
|
|
|
|
MREL DECISION |
|||||||||||
DECISION DATE |
COMPLIANCE DATE |
REQUIREMENT AS % OF TREA |
OF WHICH: MAY BE MET WITH GUARANTEES |
REQUIREMENT AS % OF TEM |
OF WHICH: MAY BE MET WITH GUARANTEES |
TOTAL SUBORDINATION AS % OF TREA |
TOTAL SUBORDINATION AS % OF TEM |
SENIOR DEBT ALLOWANCE |
DE MINIMIS ALLOWANCE |
||
MANDATORY SUBORDINATION REQUIREMENT |
DISCRETIONARY SUBORDINATION REQUIREMENT |
MANDATORY SUBORDINATION REQUIREMENT |
DISCRETIONARY SUBORDINATION REQUIREMENT |
||||||||
0270 |
0280 |
0290 |
0300 |
0310 |
0320 |
0330 |
0340 |
0350 |
0360 |
0370 |
0380 |
|
|
|
|
|
|
|
|
|
|
|
|
ADJUSTMENTS |
TRANSITION PERIOD |
||||||||||||||
ADJUSTMENTS FOR CALIBRATING THE LOSS ABSORBING AMOUNT |
ADJUSTMENTS FOR CALIBRATING THE RECAPITALISATION AMOUNT AS % OF TREA |
ADJUSTMENTS FOR CALIBRATING THE RECAPITALISATION AMOUNT AS % OF TEM |
INTERMEDIATE TARGET |
||||||||||||
ADJUSTMENTS TO ADDITIONAL OWN FUNDS REQUIREMENT |
ADJUSTMENTS TO MARKET CONFIDENCE BUFFER |
ADJUSTMENTS RESULTING FROM CHANGE IN THE BALANCE SHEET POST RESOLUTION |
ADJUSTMENTS RESULTING FROM CHANGE IN THE BALANCE SHEET POST RESOLUTION |
AS A % OF TREA |
AS A % OF TEM |
||||||||||
AS % OF TREA |
AS % OF TEM |
UPWARD |
DOWNWARD |
UPWARD |
DOWNWARD |
UPWARD |
DOWNWARD |
UPWARD |
DOWNWARD |
MREL LEVEL |
SUBORDINATION |
DATE OF APPLICATION |
MREL LEVEL |
SUBORDINATION |
DATE OF APPLICATION |
0390 |
0400 |
0410 |
0420 |
0430 |
0440 |
0450 |
0460 |
0470 |
0480 |
0490 |
0500 |
0510 |
0520 |
0530 |
0540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANNEX II
INSTRUCTIONS FOR COMPLETING REPORTING ON MREL DECISIONS
PART I
GENERAL INSTRUCTIONS
1. |
This Annex covers the instructions for reporting in accordance with Article 45j of Directive 2014/59/EU on the minimum requirement for own funds and eligible liabilities (MREL) set by the resolution authorities. |
2. |
Each resolution authority, in coordination with competent authorities, shall inform the EBA of the MREL set for each institution under its jurisdiction. With regard to resolution groups, the group-level resolution authority shall transmit the relevant information for the Union parent undertaking on a consolidated basis. Each resolution authority shall transmit the information regarding the MREL set in relation to resolution groups and subsidiaries. |
3. |
For groups established or having subsidiaries within the banking union, the Single Resolution Board will report on decisions taken in relation to all entities falling under its jurisdiction as defined in Article 7(2) of Regulation (EU) No 806/2014 of the European Parliament and of the Council (1). |
4. |
Where the underlying data are in a currency other than euro, the authorities shall use European Central Bank euro foreign exchange reference rates (https://www.ecb.europa.eu/stats/policy_and_exchange_rates/euro_reference_exchange_rates/html/index.en.html) as at the date of the MREL decision and report all amounts in euro. |
5. |
Where an institution has been exempted from MREL, this shall be indicated in column 0090, and the resolution authority can opt for simplified reporting with only reporting the information in columns 0010 to 0100. Where an institution is subject to a zero recapitalisation amount and no adjustment is made to the loss-absorption amount, the resolution authority can opt for simplified reporting and report only the information in columns 0010 to 0080. |
1. Scope of the notification
6. |
Institutions (including investment firms, as defined in Article 2(1), point (23), of Directive 2014/59/EU) and entities referred to in Article 1(1), points (b), (c) and (d), of Directive 2014/59/EU that are subject to Article 45(1) of that Directive, except mortgage credit institutions financed by covered bonds that are exempted from the MREL in accordance with Article 45a of Directive 2014/59/EU. |
2. Scope of consolidation
7. |
The underlying data shall be reported on an individual basis for each entity within each Member State, or at the level of any of the following:
|
3. Deadline for submission
8. |
Resolution authorities shall transmit the information for the MREL applicable at 1 May of each year by 31 May of that year. |
PART II
TEMPLATE-RELATED INSTRUCTIONS
4. M 20.00 – Reporting on MREL decisions
4.1. Instructions concerning specific columns
Column |
Legal references and instructions |
||||||||||||
0010 |
ENTITY CODE Code of the entity for which the MREL decision has been made. For institutions, the code shall be the 20-digit, alphanumerical legal entity identifier (LEI) code. For other entities, the code shall be the 20-digit, alphanumerical LEI code, or where not available a code under a uniform codification applicable in the Union, or where not available a national code. The code shall be consistent with the code reported for the same institution under Commission Implementing Regulation (EU) 2018/1624 (2). The code shall always have a value. That code shall be the unique identifier for each column for the relevant entity. |
||||||||||||
0020 |
TYPE OF CODE The reporting authority shall identify the type of code reported in column 0010 as an ‘LEI code’ or ‘Non-LEI code’. The type of code shall always be reported. |
||||||||||||
0030 |
RESOLUTION ENTITY CODE Code of the resolution entity to which the entity belongs. This code shall be the same as in the column 0010 if the decision reported is a group decision. For institutions, the code shall be the 20-digit, alphanumerical LEI code. For other entities, the code shall be the 20-digit, alphanumerical LEI code, or where not available a code under a uniform codification applicable in the Union, or where not available a national code. The code shall be consistent with the code reported for the same institution under Implementing Regulation (EU) 2018/1624. |
||||||||||||
0040 |
TYPE OF CODE The reporting authority shall identify the type of code reported in column 0030 as an ‘LEI code’ or ‘Non-LEI code’. The type of code shall always be reported. |
||||||||||||
0050 |
CONSOLIDATION PERIMETER Reporting authorities shall report on the MREL at one of the following perimeters of consolidation:
|
||||||||||||
0060 |
TYPE OF INSTITUTION Reporting authorities shall report one of the following:
|
||||||||||||
0070 |
INTERNAL OR EXTERNAL Reporting authorities shall report one of the following:
|
||||||||||||
0080 |
SIMPLIFIED REPORTING Reporting authorities shall indicate whether simplified reporting for institutions for which the recapitalisation amount is zero and where no adjustment to the loss-absorbing amount has been made is applied:
|
||||||||||||
0090 |
WAIVER Reporting authorities shall indicate whether the waiver was granted on the basis of the following provisions of Directive 2014/59/EU or whether no waiver was granted:
|
||||||||||||
0100 |
REASON FOR WAIVER Where an option other than ‘No’ has been reported in column 0090, reporting authorities shall describe the reason for applying the waiver. |
||||||||||||
0110–0150 |
RESOLUTION STRATEGY AND TOOLS |
||||||||||||
0110 |
RESOLUTION STRATEGY Reporting authorities shall report one of the following:
|
||||||||||||
0120 |
MAIN RESOLUTION TOOL (PREFERRED STRATEGY) Reporting authorities shall report one of the following:
Where column 0110 was reported as ‘liquidation’, column 0120 shall be reported as N/A. |
||||||||||||
00130 |
SECOND RESOLUTION TOOL (PREFERRED STRATEGY) Reporting authorities shall report one of the following:
Where column 0110 was reported as ‘liquidation’ or where no alternative strategy has been set, this column shall be reported as N/A. |
||||||||||||
0140 |
MAIN RESOLUTION TOOL (VARIANT STRATEGY) Reporting authorities shall report one of the following (where applicable):
Where column 0110 was reported as ‘liquidation’, this column shall be reported as N/A. |
||||||||||||
0150 |
SECOND RESOLUTION TOOL (VARIANT STRATEGY) Reporting authorities shall report one of the following:
Where column 0110 was reported as ‘liquidation’, or where no alternative strategy has been set, this column shall be reported as N/A. |
||||||||||||
0160–0190 |
ADDITIONAL OWN FUNDS REQUIREMENT AND COMBINED BUFFER REQUIREMENT The information on the additional own funds requirement pursuant to Article 104a of Directive 2013/36/EU of the European Parliament and of the Council (4) used as an input for calibrating MREL shall be based on the latest available own funds requirements communicated by the competent authority at the time of the calibration of MREL. |
||||||||||||
0160 |
REFERENCE DATE The date when the competent authority communicated the additional own funds requirements and combined buffer requirement to the institution. |
||||||||||||
0170 |
REQUIREMENT AS A PERCENTAGE OF TOTAL RISK EXPOSURE AMOUNT (TREA) Additional own funds requirement pursuant to Article 104a of Directive 2013/36/EU used to calibrate MREL or as estimated in accordance with regulatory technical standards adopted under Article 45c(4) of Directive 2014/59/EU. |
||||||||||||
0180 |
COMBINED BUFFER REQUIREMENT Combined buffer requirement referred to in Article 128(1), point (6), of Directive 2013/36/EU. The amount reported shall represent the amount of own funds needed to fulfil the respective capital buffer requirements or as estimated in accordance with the regulatory technical standards adopted under Article 45c(4) of Directive 2014/59/EU. |
||||||||||||
0190 |
OF WHICH: COUNTERCYCLICAL CAPITAL BUFFER Article 128, point (2), Article 130 and Articles 135 to 140 of Directive 2013/36/EU. The amount reported shall represent the amount of own funds needed to fulfil the respective capital buffer requirements used to calibrate MREL. |
||||||||||||
0200–0260 |
BALANCE SHEET DATA USED TO CALIBRATE MREL |
||||||||||||
0200 |
REFERENCE DATE Reference date of the data reported in columns 0210 to 0260. |
||||||||||||
0210–0230 |
BEFORE RESOLUTION Balance sheet data used to calibrate MREL before resolution. |
||||||||||||
0240–0260 |
AFTER RESOLUTION Balance sheet data used to calibrate MREL after resolution. |
||||||||||||
0210 , 0240 |
TREA Total risk exposure amount in accordance with Article 45(2), point (a), of Directive 2014/59/EU and Article 92(3) of Regulation (EU) No 575/2013. |
||||||||||||
0220, 0250 |
TOTAL LIABILITIES AND OWN FUNDS (TLOF) Sum of all liabilities and own funds of the reporting entity. With respect to derivatives, the value to be used shall be the sum of net liability positions, taking into account prudential netting rules. This item corresponds to the information reported in row 0600 of template Z 02.00 of Annex I to Implementing Regulation (EU) 2018/1624. |
||||||||||||
0230, 0260 |
TOTAL EXPOSURE MEASURE (TEM) Total exposure measure in accordance with Article 45(2), point (b) of Directive 2014/59/EU, Article 429(4) and Article 429a of Regulation (EU) No 575/2013. |
||||||||||||
0270–0380 |
MREL DECISION |
||||||||||||
0270 |
DECISION DATE Date when the resolution authority decided on the MREL or adopted a waiver decision. |
||||||||||||
0280 |
COMPLIANCE DATE Date from when the institution shall comply with the MREL or waiver decision. |
||||||||||||
0290 |
REQUIREMENT AS A PERECENTAGE OF TREA Reporting authorities shall report MREL expressed as a percentage of TREA calculated in accordance with Article 92(3) of Regulation (EU) No 575/2013. |
||||||||||||
0300 |
OF WHICH: MAY BE MET WITH GUARANTEES The part of the requirement reported in column 0290 that upon permission of the relevant resolution authority may be met with a guarantee provided by the resolution entity in accordance with Article 45f(5) of Directive 2014/59/EU, expressed as a percentage of TREA calculated in accordance with Article 92(3) of Regulation (EU) No 575/2013. |
||||||||||||
0310 |
REQUIREMENT AS A PERCENTAGE OF TEM The entity’s MREL expressed as a percentage of TEM calculated in accordance with Article 429(4) and Article 429a of Regulation (EU) No 575/2013. |
||||||||||||
0320 |
OF WHICH: MAY BE MET WITH GUARANTEES The part of the requirement reported in column 0310 that upon permission of the relevant resolution authority may be met with a guarantee provided by the resolution entity in accordance with Article 45f(5) of Directive 2014/59/EU, expressed as a percentage of TEM calculated in accordance with Article 429(4) and Article 429a of Regulation (EU) No 575/2013. |
||||||||||||
0330–0340 |
TOTAL SUBORDINATION AS A PERCENTAGE OF TREA Reporting authorities shall report the subordination requirement levels expressed as a percentage of TREA (100 % for internal MREL). |
||||||||||||
0350–0360 |
TOTAL SUBORDINATION AS A PERCENTAGE OF TEM Reporting authorities shall report the subordination requirement levels expressed as a percentage of TEM (100 % for internal MREL). |
||||||||||||
0330, 0350 |
MANDATORY SUBORDINATION REQUIREMENT Reporting authorities shall report the subordination requirement levels in accordance with Article 45c, paragraphs (5) and (6), and Article 45d(2), point (a), of Directive 2014/59/EU, including any impact from the application of Article 45b(4) of Directive 2014/59/EU. |
||||||||||||
0340, 0360 |
DISCRETIONARY SUBORDINATION REQUIREMENT Reporting authorities shall report the subordination requirement levels in accordance with Articles 45b, paragraphs (5) or (7) of Directive 2014/59/EU. |
||||||||||||
0370 |
SENIOR DEBT ALLOWANCE For G-SIIs, reporting authorities shall report the share of liabilities allowed to qualify as eligible liabilities instruments up to an aggregate amount that does not exceed 3,5 % of the TREA calculated in accordance with Article 92, paragraphs (3) and (4) of Regulation (EU) No 575/2013. |
||||||||||||
0380 |
DE MINIMIS ALLOWANCE For GSIIs, reporting authorities shall report the share of excluded liabilities referred to in Article 72a(2) of Regulation (EU) No 575/2013 which are allowed to rank in insolvency pari passu or below eligible liabilities of the institution in accordance with Article 72b(4) of Regulation (EU) No 575/2013. |
||||||||||||
0390–0480 |
ADJUSTMENTS |
||||||||||||
0390–0400 |
ADJUSTMENTS FOR CALIBRATING THE LOSS-ABSORPTION AMOUNT AS PERCENTAGES OF TREA AND TEM Adjustments to the loss absorbing amount pursuant to the second subparagraph of Article 45c(2) of Directive 2014/59/EU expressed as a percentage of TREA and TEM. |
||||||||||||
0410–0460 |
ADJUSTMENTS FOR CALIBRATING THE RECAPITALISATION AMOUNT AS A PERCENTAGE OF TREA Adjustments to the recapitalisation amount pursuant to Article 45c(3), first subparagraph, point (a)(ii) or Article 45c(7), first subparagraph, point (a)(ii), of Directive 2014/59/EU expressed as a percentage of TREA. |
||||||||||||
0410–0420 |
ADJUSTEMENTS TO ADDITIONAL OWN FUNDS REQUIREMENT Input any adjustment to additional own funds requirement referred to in Article 104a of Directive 2013/36/EU pursuant to, Article 45c(3), fifth subparagraph, point (b), or Article 45c(7), fifth subparagraph, point (b), of Directive 2014/59/EU. |
||||||||||||
0430–0440 |
ADJUSTMENTS RELATED TO MARKET CONFIDENCE BUFFER Adjustments pursuant to Article 45c(3), sixth subparagraph, or Article 45c(7), sixth subparagraph, of Directive 2014/59/EU. |
||||||||||||
0450–0460 |
ADJUSTMENTS RESULTING FROM CHANGE IN THE BALANCE SHEET POST RESOLUTION Adjustments pursuant to Article 45c(3), fifth subparagraph, point (а), or 45c(7), fifth subparagraph, point (a), of Directive 2014/59/EU. |
||||||||||||
0470–0480 |
ADJUSTMENTS FOR CALIBRATING THE RECAPITALISATION AMOUNT AS A PERCENTAGE OF TEM Adjustments to the recapitalisation amount resulting from changes in the balance sheet post resolution pursuant to of Article 45c(3), first subparagraph, point (b)(ii), or of Article 45c(7), first subparagraph, point (b)(ii), of Directive 2014/59/EU expressed as a percentage of the total exposure amount. |
||||||||||||
0410 , 0430, 0450, 0470 |
UPWARDS |
||||||||||||
0420, 0440, 0460, 0480 |
DOWNWARDS |
||||||||||||
0490–0540 |
TRANSITION PERIOD Reporting authorities shall indicate any intermediary target they may have set for the years after the reporting date. The target shall be expressed both as a percentage of TREA and as a percentage of TEM. |
||||||||||||
0490, 0520 |
MREL LEVEL Reporting authorities shall indicate the total MREL level institutions shall meet at the intermediary date. |
||||||||||||
0500, 0530 |
SUBORDINATION Reporting authorities shall indicate the total subordinated level institutions shall meet at the intermediary date. |
||||||||||||
0510 , 0540 |
DATE OF APPLICATION Reporting authorities shall indicate the transition dates of the path to MREL compliance. |
(1) Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, p. 1).
(2) Commission Implementing Regulation (EU) 2018/1624 of 23 October 2018 laying down implementing technical standards with regard to procedures and standard forms and templates for the provision of information for the purposes of resolution plans for credit institutions and investment firms pursuant to Directive 2014/59/EU of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) 2016/1066 (OJ L 277, 7.11.2018, p. 1).
(3) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).
(4) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
ANNEX III
Single Data Point Model and Validation Rules
PART ONE
Single Data Point Model
All data items set out in the Annexes I and II shall be transformed into a single data point model which is the basis for uniform IT systems of resolution authorities.
The single data point model shall meet the following criteria:
(a) |
provide a structured representation of all data items set out in Annexes I and II; |
(b) |
identify all the business concepts set out in Annexes I and II; |
(c) |
provide a data dictionary identifying table labels, ordinate labels, axis labels, domain labels, dimension labels and member labels; |
(d) |
provide metrics which define the property or amount of data points; |
(e) |
provide data point definitions that are expressed as a composition of characteristics that univocally identify the financial concept; |
(f) |
contain all the relevant technical specifications necessary for developing IT reporting solutions producing uniform resolution reporting. |
PART TWO
Validation Rules
The data items set out in Annexes I and II shall be subject to validation rules ensuring data quality and consistency.
The validation rules shall meet the following criteria:
(a) |
determine the logical relationships between relevant data points; |
(b) |
contain filters and preconditions that determine a set of data to which a validation rule applies; |
(c) |
check the consistency of the reported data; |
(d) |
check the accuracy of the reported data; |
(e) |
set default values that shall be applied where the relevant information has not been reported. |
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/137 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/623
of 15 April 2021
amending Annex I to Implementing Regulation (EU) 2021/605 laying down special control measures for African swine fever
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 71(3) thereof,
Whereas:
(1) |
African swine fever is an infectious viral disease affecting kept and wild porcine animals and can have a severe impact on the concerned animal population and the profitability of farming causing disturbance to movements of consignments of those animals and products thereof within the Union and exports to third countries. |
(2) |
Regulation (EU) 2016/429 establishes a new legislative framework for the prevention and control of diseases, which are transmissible to animals or humans. African swine fever falls within the definition of a listed disease in that Regulation, and it is subject to the disease prevention and control rules laid down therein. |
(3) |
Commission Implementing Regulation (EU) 2021/605 (2) was adopted within the framework of Regulation (EU) 2016/429, and it lays down special disease control measures regarding African swine fever to be applied for a limited period of time by the Member States listed in that Annex I thereto, in the restricted zones listed in that Annex. However, the areas listed as restricted zones I, II and III in Annex I to Implementing Regulation (EU) 2021/605 are based on the epidemiological situation of African swine fever in the Union at the time leading up to the process of adoption of that act. Both Regulation (EU) 2016/429 and Implementing Regulation (EU) 2021/605 apply from 21 April 2021. |
(4) |
The epidemiological situation in the Union as regards African swine fever is dynamic and constantly evolving. As a result, the epidemiological situation in the Union as regards that disease has changed since the time leading up to the process of adoption of Implementing Regulation (EU) 2021/605. Accordingly, Annex I to that Implementing Regulation should be amended so that the areas listed as restricted zones I, II and III therein reflect the current epidemiological situation of that disease in the Union. |
(5) |
In addition, Commission Implementing Decision 2014/709/EU (3) lays down animal health control measures in relation to African swine fever in the Member States or areas thereof listed in the Annex thereto, and it applies until 21 April 2021. The Annex to that Implementing Decision was last amended by Commission Implementing Decision (EU) 2021/544 (4), following recent changes in the epidemiological situation as regards that disease in the Union. Accordingly, the current epidemiological situation of African swine fever in the Union is reflected in the Annex to Implementing Decision 2014/709/EU, as recently amended by Implementing Decision (EU) 2021/544. |
(6) |
Therefore, restricted zones I, II and III listed in the Annex I to Implementing Regulation (EU) 2021/605 should be updated to take account of the areas currently listed in the Annex to Implementing Decision 2014/709/EU, as recently amended by Implementing Decision (EU) 2021/544. This is also necessary for continuity and consistency following the expiry of Implementing Decision 2014/709/EU, and the commencement of application of Implementing Regulation (EU) 2021/605. |
(7) |
Annex I to Implementing Regulation (EU) 2021/605 should therefore be amended in order to take account of the current epidemiological situation of African swine fever in the Union and in order to combat the risks associated with the spread of that disease in a proactive manner by ensuring a smooth transition to the new legislative framework applicable from 21 April 2021. |
(8) |
Given the urgency of the epidemiological situation in the Union as regards the spread of African swine fever and taking into account the fact that Implementing Regulation (EU) 2021/605 applies from 21 April 2021, the amendments to be made to Annex I to Implementing Regulation (EU) 2021/605 by this Regulation should also apply from that date. |
(9) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Implementing Regulation (EU) 2021/605 is replaced by the text set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(2) Commission Implementing Regulation (EU) 2021/605 of 7 April 2021 laying down special control measures for African swine fever (OJ L 129, …, p. 1).
(3) Commission Implementing Decision 2014/709/EU of 9 October 2014 concerning animal health control measures relating to African swine fever in certain Member States and repealing Implementing Decision 2014/178/EU (OJ L 295, 11.10.2014, p. 63).
(4) Commission Implementing Decision (EU) 2021/544 of 25 March 2021 amending the Annex to Implementing Decision 2014/709/EU concerning animal health control measures relating to African swine fever in certain Member States (OJ L 110, 30.3.2021, p. 1).
ANNEX
Annex I to Implementing Regulation (EU) 2021/605 is replaced by the following:
‘ANNEX I
RESTRICTED ZONES
PART I
1. Germany
The following restricted zones I in Germany:
Bundesland Brandenburg:
|
Bundesland Sachsen:
|
2. Estonia
The following restricted zones I in Estonia:
— |
Hiiu maakond. |
3. Greece
The following restricted zones I in Greece:
— |
in the regional unit of Drama:
|
— |
in the regional unit of Xanthi:
|
— |
in the regional unit of Rodopi:
|
— |
in the regional unit of Evros:
|
— |
in the regional unit of Serres:
|
4. Latvia
The following restricted zones I in Latvia:
— |
Pāvilostas novada Vērgales pagasts, |
— |
Stopiņu novada daļa, kas atrodas uz rietumiem no autoceļa V36, P4 un P5, Acones ielas, Dauguļupes ielas un Dauguļupītes, |
— |
Grobiņas novada Medzes, Grobiņas un Gaviezes pagasts. Grobiņas pilsēta, |
— |
Rucavas novada Rucavas pagasts, |
— |
Nīcas novads. |
5. Lithuania
The following restricted zones I in Lithuania:
— |
Klaipėdos rajono savivaldybė: Agluonėnų, Dovilų, Gargždų, Priekulės, Vėžaičių, Kretingalės ir Dauparų-Kvietinių seniūnijos, |
— |
Palangos miesto savivaldybė. |
6. Hungary
The following restricted zones I in Hungary:
— |
Békés megye 950950, 950960, 950970, 951950, 952050, 952750, 952850, 952950, 953050, 953150, 953650, 953660, 953750, 953850, 953960, 954250, 954260, 954350, 954450, 954550, 954650, 954750, 954850, 954860, 954950, 955050, 955150, 955250, 955260, 955270, 955350, 955450, 955510, 955650, 955750, 955760, 955850, 955950, 956050, 956060, 956150 és 956160 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Bács-Kiskun megye 600150, 600850, 601550, 601650, 601660, 601750, 601850, 601950, 602050, 603250, 603750 és 603850 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Budapest 1 kódszámú, vadgazdálkodási tevékenységre nem alkalmas területe, |
— |
Csongrád-Csanád megye 800150, 800160, 800250, 802220, 802260, 802310 és 802450 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Fejér megye 400150, 400250, 400351, 400352, 400450, 400550, 401150, 401250, 401350, 402050, 402350, 402360, 402850, 402950, 403050, 403250, 403350, 403450, 403550, 403650, 403750, 403950, 403960, 403970, 404570, 404650, 404750, 404850, 404950, 404960, 405050, 405750, 405850, 405950, 406050, 406150, 406550, 406650 és 406750 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Jász-Nagykun-Szolnok megye 750150, 750160, 750260, 750350, 750450, 750460, 754450, 754550, 754560, 754570, 754650, 754750, 754950, 755050, 755150, 755250, 755350 és 755450 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Komárom-Esztergom megye 250150, 250250, 250350, 250450, 250460, 250550, 250650, 250750, 250850, 250950, 251050, 251150, 251250, 251350, 251360, 251450, 251550, 251650, 251750, 251850, 252150 és 252250, kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Pest megye 571550, 572150, 572250, 572350, 572550, 572650, 572750, 572850, 572950, 573150, 573250, 573260, 573350, 573360, 573450, 573850, 573950, 573960, 574050, 574150, 574350, 574360, 574550, 574650, 574750, 574850, 574860, 574950, 575050, 575150, 575250, 575350, 575550, 575650, 575750, 575850, 575950, 576050, 576150, 576250, 576350, 576450, 576650, 576750, 576850, 576950, 577050, 577150, 577350, 577450, 577650, 577850, 577950, 578050, 578150, 578250, 578350, 578360, 578450, 578550, 578560, 578650, 578850, 578950, 579050, 579150, 579250, 579350, 579450, 579460, 579550, 579650, 579750, 580250 és 580450 kódszámú vadgazdálkodási egységeinek teljes területe. |
7. Poland
The following restricted zones I in Poland:
w województwie warmińsko-mazurskim:
|
w województwie podlaskim:
|
w województwie mazowieckim:
|
w województwie podkarpackim:
|
w województwie świętokrzyskim:
|
w województwie łódzkim:
|
w województwie pomorskim:
|
w województwie lubuskim:
|
w województwie dolnośląskim:
|
w województwie wielkopolskim:
|
w województwie zachodniopomorskim:
|
8. Slovakia
The following restricted zones I in Slovakia:
— |
the whole district of Vranov nad Topľou, except municipalities included in part II, |
— |
the whole district of Humenné, except municipalities included in part II, |
— |
the whole district of Snina, |
— |
the whole district of Medzilaborce |
— |
the whole district of Stropkov |
— |
the whole district of Svidník, except municipalities included in part II, |
— |
the whole district of Stará Ľubovňa, except municipalities included in part II, |
— |
the whole district of whole Kežmarok, |
— |
the whole district of Poprad, |
— |
in the district of Rimavská Sobota the whole municipalities of Jesenské, Ožďany, Sútor, Rimavské Janovce, Belín, Pavlovce, Gortva, Bizovo, Čenice, Hodejovec, Blhovce, Hodejov, Čierny Potok, Gemerček, Konrádovce, Dolné Zahorany, Husiná, Rimavská Sobota, Hajnáčka, Stará Bašta, Nová Bašta, Večelkov, Studená, Tachty, |
— |
the whole district of Lučenec, except municipalities included in part II, |
— |
the whole district of Veľký Krtíš, except municipalities included in part II, |
— |
in the district of Zvolen, the whole municipality of Lešť, |
— |
the whole district of Detva, |
— |
the whole district of Brezno. |
PART II
1. Bulgaria
The following restricted zones II in Bulgaria:
— |
the whole region of Haskovo, |
— |
the whole region of Yambol, |
— |
the whole region of Stara Zagora, |
— |
the whole region of Pernik, |
— |
the whole region of Kyustendil, |
— |
the whole region of Plovdiv, |
— |
the whole region of Pazardzhik, |
— |
the whole region of Smolyan, |
— |
the whole region of Dobrich, |
— |
the whole region of Sofia city, |
— |
the whole region of Sofia Province, |
— |
the whole region of Blagoevgrad, |
— |
the whole region of Razgrad, |
— |
the whole region of Kardzhali, |
— |
the whole region of Burgas excluding the areas in Part III, |
— |
the whole region of Varna excluding the areas in Part III. |
2. Germany
The following restricted zones II in Germany:
Bundesland Brandenburg:
|
Bundesland Sachsen:
|
3. Estonia
The following restricted zones II in Estonia:
— |
Eesti Vabariik (välja arvatud Hiiu maakond). |
4. Latvia
The following restricted zones II in Latvia:
— |
Ādažu novads, |
— |
Aizputes novada Aizputes, Cīravas un Lažas pagasts, Kalvenes pagasta daļa uz rietumiem no ceļa pie Vārtājas upes līdz autoceļam A9, uz dienvidiem no autoceļa A9, uz rietumiem no autoceļa V1200, Kazdangas pagasta daļa uz rietumiem no ceļa V1200, P115, P117, V1296, Aizputes pilsēta, |
— |
Aglonas novads, |
— |
Aizkraukles novads, |
— |
Aknīstes novads, |
— |
Alojas novads, |
— |
Alsungas novads, |
— |
Alūksnes novads, |
— |
Amatas novads, |
— |
Apes novads, |
— |
Auces novads, |
— |
Babītes novads, |
— |
Baldones novads, |
— |
Baltinavas novads, |
— |
Balvu novads, |
— |
Bauskas novads, |
— |
Beverīnas novads, |
— |
Brocēnu novads, |
— |
Burtnieku novads, |
— |
Carnikavas novads, |
— |
Cēsu novads |
— |
Cesvaines novads, |
— |
Ciblas novads, |
— |
Dagdas novads, |
— |
Daugavpils novads, |
— |
Dobeles novads, |
— |
Dundagas novads, |
— |
Durbes novads, |
— |
Engures novads, |
— |
Ērgļu novads, |
— |
Garkalnes novads, |
— |
Grobiņas novada Bārtas pagasts, |
— |
Gulbenes novads, |
— |
Iecavas novads, |
— |
Ikšķiles novads, |
— |
Ilūkstes novads, |
— |
Inčukalna novads, |
— |
Jaunjelgavas novads, |
— |
Jaunpiebalgas novads, |
— |
Jaunpils novads, |
— |
Jēkabpils novads, |
— |
Jelgavas novads, |
— |
Kandavas novads, |
— |
Kārsavas novads, |
— |
Ķeguma novads, |
— |
Ķekavas novads, |
— |
Kocēnu novads, |
— |
Kokneses novads, |
— |
Krāslavas novads, |
— |
Krimuldas novads, |
— |
Krustpils novads, |
— |
Kuldīgas novada, Laidu pagasta daļa uz ziemeļiem no autoceļa V1296, Padures, Rumbas, Rendas, Kabiles, Vārmes, Pelču, Ēdoles, Īvandes, Kurmāles, Turlavas, Gudenieku un Snēpeles pagasts, Kuldīgas pilsēta, |
— |
Lielvārdes novads, |
— |
Līgatnes novads, |
— |
Limbažu novads, |
— |
Līvānu novads, |
— |
Lubānas novads, |
— |
Ludzas novads, |
— |
Madonas novads, |
— |
Mālpils novads, |
— |
Mārupes novads, |
— |
Mazsalacas novads, |
— |
Mērsraga novads, |
— |
Naukšēnu novads, |
— |
Neretas novads, |
— |
Ogres novads, |
— |
Olaines novads, |
— |
Ozolnieku novads, |
— |
Pārgaujas novads, |
— |
Pāvilostas novada Sakas pagasts, Pāvilostas pilsēta, |
— |
Pļaviņu novads, |
— |
Preiļu novads, |
— |
Priekules novads, |
— |
Priekuļu novads, |
— |
Raunas novads, |
— |
republikas pilsēta Daugavpils, |
— |
republikas pilsēta Jelgava, |
— |
republikas pilsēta Jēkabpils, |
— |
republikas pilsēta Jūrmala, |
— |
republikas pilsēta Rēzekne, |
— |
republikas pilsēta Valmiera, |
— |
Rēzeknes novads, |
— |
Riebiņu novads, |
— |
Rojas novads, |
— |
Ropažu novads, |
— |
Rucavas novada Dunikas pagasts, |
— |
Rugāju novads, |
— |
Rundāles novads, |
— |
Rūjienas novads, |
— |
Salacgrīvas novads, |
— |
Salas novads, |
— |
Salaspils novads, |
— |
Saldus novads, |
— |
Saulkrastu novads, |
— |
Sējas novads, |
— |
Siguldas novads, |
— |
Skrīveru novads, |
— |
Skrundas novada Raņķu pagasta daļa uz ziemeļiem no autoceļa V1272 līdz robežai ar Ventas upi, Skrundas pagasta daļa no Skrundas uz ziemeļiem no autoceļa A9 un austrumiem no Ventas upes, |
— |
Smiltenes novads, |
— |
Stopiņu novada daļa, kas atrodas uz austrumiem no autoceļa V36, P4 un P5, Acones ielas, Dauguļupes ielas un Dauguļupītes, |
— |
Strenču novads, |
— |
Talsu novads, |
— |
Tērvetes novads, |
— |
Tukuma novads, |
— |
Vaiņodes novada Vaiņodes pagasts un Embūtes pagasta daļa uz dienvidiem autoceļa P116, P106, |
— |
Valkas novads, |
— |
Varakļānu novads, |
— |
Vārkavas novads, |
— |
Vecpiebalgas novads, |
— |
Vecumnieku novads, |
— |
Ventspils novads, |
— |
Viesītes novads, |
— |
Viļakas novads, |
— |
Viļānu novads, |
— |
Zilupes novads. |
5. Lithuania
The following restricted zones II in Lithuania:
— |
Alytaus miesto savivaldybė, |
— |
Alytaus rajono savivaldybė, |
— |
Anykščių rajono savivaldybė, |
— |
Akmenės rajono savivaldybė, |
— |
Birštono savivaldybė, |
— |
Biržų miesto savivaldybė, |
— |
Biržų rajono savivaldybė, |
— |
Druskininkų savivaldybė, |
— |
Elektrėnų savivaldybė, |
— |
Ignalinos rajono savivaldybė, |
— |
Jonavos rajono savivaldybė, |
— |
Joniškio rajono savivaldybė, |
— |
Jurbarko rajono savivaldybė: Eržvilko, Girdžių, Jurbarko miesto, Jurbarkų, Raudonės, Šimkaičių, Skirsnemunės, Smalininkų, Veliuonos ir Viešvilės seniūnijos, |
— |
Kaišiadorių rajono savivaldybė, |
— |
Kalvarijos savivaldybė, |
— |
Kauno miesto savivaldybė, |
— |
Kauno rajono savivaldybė: Akademijos, Alšėnų, Batniavos, Ežerėlio, Domeikavos, Garliavos, Garliavos apylinkių, Karmėlavos, Kulautuvos, Lapių, Linksmakalnio, Neveronių, Raudondvario, Ringaudų, Rokų, Samylų, Taurakiemio, Vandžiogalos, Užliedžių, Vilkijos, ir Zapyškio seniūnijos, Babtų seniūnijos dalis į rytus nuo kelio A1, ir Vilkijos apylinkių seniūnijos dalis į vakarus nuo kelio Nr. 1907, |
— |
Kazlų rūdos savivaldybė, |
— |
Kelmės rajono savivaldybė, |
— |
Kėdainių rajono savivaldybė: Dotnuvos, Gudžiūnų, Kėdainių miesto, Krakių, Pelėdnagių, Surviliškio, Šėtos, Truskavos, Vilainių ir Josvainių seniūnijos dalis į šiaurę ir rytus nuo kelio Nr. 229 ir Nr. 2032, |
— |
Klaipėdos rajono savivaldybė: Judrėnų, Endriejavo ir Veiviržėnų seniūnijos, |
— |
Kupiškio rajono savivaldybė, |
— |
Kretingos rajono savivaldybė, |
— |
Lazdijų rajono savivaldybė, |
— |
Marijampolės savivaldybė, |
— |
Mažeikių rajono savivaldybė, |
— |
Molėtų rajono savivaldybė, |
— |
Pagėgių savivaldybė, |
— |
Pakruojo rajono savivaldybė, |
— |
Panevėžio rajono savivaldybė, |
— |
Panevėžio miesto savivaldybė, |
— |
Pasvalio rajono savivaldybė, |
— |
Radviliškio rajono savivaldybė, |
— |
Rietavo savivaldybė, |
— |
Prienų rajono savivaldybė, |
— |
Plungės rajono savivaldybė: Žlibinų, Stalgėnų, Nausodžio, Plungės miesto, Šateikių ir Kulių seniūnijos, |
— |
Raseinių rajono savivaldybė: Betygalos, Girkalnio, Kalnujų, Nemakščių, Pagojukų, Paliepių, Raseinių miesto, Raseinių, Šiluvos, Viduklės seniūnijos, |
— |
Rokiškio rajono savivaldybė, |
— |
Skuodo rajono savivaldybės: Aleksandrijos, Ylakių, Lenkimų, Mosėdžio, Skuodo ir Skuodo miesto seniūnijos, |
— |
Šakių rajono savivaldybė, |
— |
Šalčininkų rajono savivaldybė, |
— |
Šiaulių miesto savivaldybė, |
— |
Šiaulių rajono savivaldybė, |
— |
Šilutės rajono savivaldybė, |
— |
Širvintų rajono savivaldybė, |
— |
Šilalės rajono savivaldybė, |
— |
Švenčionių rajono savivaldybė, |
— |
Tauragės rajono savivaldybė, |
— |
Telšių rajono savivaldybė, |
— |
Trakų rajono savivaldybė, |
— |
Ukmergės rajono savivaldybė, |
— |
Utenos rajono savivaldybė, |
— |
Varėnos rajono savivaldybė, |
— |
Vilniaus miesto savivaldybė, |
— |
Vilniaus rajono savivaldybė, |
— |
Vilkaviškio rajono savivaldybė, |
— |
Visagino savivaldybė, |
— |
Zarasų rajono savivaldybė. |
6. Hungary
The following restricted zones II in Hungary:
— |
Békés megye 950150, 950250, 950350, 950450, 950550, 950650, 950660, 950750, 950850, 950860, 951050, 951150, 951250, 951260, 951350, 951450, 951460, 951550, 951650, 951750, 952150, 952250, 952350, 952450, 952550, 952650, 953250, 953260, 953270, 953350, 953450, 953550, 953560, 953950, 954050, 954060, 954150, 956250, 956350, 956450, 956550, 956650 és 956750 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Borsod-Abaúj-Zemplén megye valamennyi vadgazdálkodási egységének teljes területe, |
— |
Fejér megye 403150, 403160, 403260, 404250, 404550, 404560, 405450, 405550, 405650, 406450 és 407050 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Hajdú-Bihar megye valamennyi vadgazdálkodási egységének teljes területe, |
— |
Heves megye valamennyi vadgazdálkodási egységének teljes területe, |
— |
Jász-Nagykun-Szolnok megye 750250, 750550, 750650, 750750, 750850, 750970, 750980, 751050, 751150, 751160, 751250, 751260, 751350, 751360, 751450, 751460, 751470, 751550, 751650, 751750, 751850, 751950, 752150, 752250, 752350, 752450, 752460, 752550, 752560, 752650, 752750, 752850, 752950, 753060, 753070, 753150, 753250, 753310, 753450, 753550, 753650, 753660, 753750, 753850, 753950, 753960, 754050, 754150, 754250, 754360, 754370, 754850, 755550, 755650 és 755750 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Komárom-Esztergom megye: 251950, 252050, 252350, 252450, 252460, 252550, 252650, 252750, 252850, 252860, 252950, 252960, 253050, 253150, 253250, 253350, 253450 és 253550 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Nógrád megye valamennyi vadgazdálkodási egységeinek teljes területe, |
— |
Pest megye 570150, 570250, 570350, 570450, 570550, 570650, 570750, 570850, 570950, 571050, 571150, 571250, 571350, 571650, 571750, 571760, 571850, 571950, 572050, 573550, 573650, 574250, 577250, 580050 és 580150 kódszámú vadgazdálkodási egységeinek teljes területe, |
— |
Szabolcs-Szatmár-Bereg megye valamennyi vadgazdálkodási egységének teljes területe. |
7. |
Poland |
The following restricted zones II in Poland:
w województwie warmińsko-mazurskim:
|
w województwie podlaskim:
|
w województwie mazowieckim:
|
w województwie lubelskim:
|
w województwie podkarpackim:
|
w województwie pomorskim:
|
w województwie świętokrzyskim:
|
w województwie lubuskim:
|
w województwie dolnośląskim:
|
w województwie wielkopolskim:
|
w województwie łódzkim:
|
w województwie zachodniopomorskim:
|
8. Slovakia
The following restricted zones II in Slovakia:
— |
the whole district of Gelnica, |
— |
the whole district of Spišská Nová Ves, |
— |
the whole district of Levoča, |
— |
in the whole district of Michalovce, |
— |
the whole district of Košice-okolie, |
— |
the whole district of Rožnava, |
— |
the whole city of Košice, |
— |
the whole district of Sobrance, |
— |
in the district of Vranov nad Topľou, the whole municipalities of Zámutov, Rudlov, Jusková Voľa, Banské, Cabov, Davidov, Kamenná Poruba, Vechec, Čaklov, Soľ, Komárany, Čičava, Nižný Kručov, Vranov nad Topľou, Sačurov, Sečovská Polianka, Dlhé Klčovo, Nižný Hrušov, Poša, Nižný Hrabovec, Hencovce, Kučín, Majerovce, Sedliská, Kladzany and Tovarnianska Polianka, Herrmanovce nad Topľou, Petrovce, Pavlovce, Hanušovce nad Topľou, Medzianky, Radvanovce, Babie, Vlača, Ďurďoš, Prosačov, Remeniny, Skrabské, Bystré, Petkovce, Michalok, Vyšný Žipov, Čierne nad Topľou, Zlatník, Hlinné, Jastrabie nad Topľou, Merník, Ondavské Maťašovce, Tovarné, |
— |
in the district of Humenné the whole municipalities of Hudcovce, Brekov, Jasenov, Ptičie, Chlmec, Porúbka, |
— |
the whole district of Prešov, |
— |
in the whole district of Sabinov, |
— |
in the district of Svidník, the whole municipalities of Dukovce, Želmanovce, Kuková, Kalnište, Lužany pri Ondave, Lúčka, Giraltovce, Kračúnovce, Železník, Kobylince, Mičakovce, |
— |
the whole district of Bardejov, |
— |
in the district of Stará Ľubovňa, the whole municipalities of Kyjov, Pusté Pole, Šarišské Jastrabie, Čirč, Ruská Voľa nad Popradom, Obručné, Vislanka, Ďurková, Plaveč, Ľubotín, Orlov, |
— |
the whole district of Revúca, |
— |
the whole district of Rimavská Sobota except municipalities included in part I, |
— |
in the district of Veľký Krtíš, the whole municipalities of Ľuboriečka, Muľa, Dolná Strehová, Závada, Pravica, Chrťany, Senné, Brusník, Horná Strehová, Slovenské Kľačany, Vieska, Veľký Lom, Suché Brezovo, Horné Strháre, Dolné Strháre, Modrý Kameň,Veľký Krtíš, Veľké Zlievce, Malé Zlievce, Veľké Stračiny, Malé Stračiny, Bušince, Čeláre, Gabušovce, Zombor, Olováry, Malý Krtíš, Nová Ves, |
— |
in the district of Lučenec the whole municipalities of Kalonda, Panické Dravce, Halič, Mašková, Lehôtka, Ľuboreč, Jelšovec, Veľká nad Ipľom, Trenč, Rapovce, Mučín, Lipovany, |
— |
the whole district of Poltár. |
PART III
1. Bulgaria
The following restricted zones III in Bulgaria:
— |
the whole region of Gabrovo, |
— |
the whole region of Lovech, |
— |
the whole region of Montana, |
— |
the whole region of Pleven, |
— |
the whole region of Ruse, |
— |
the whole region of Shumen, |
— |
the whole region of Silistra, |
— |
the whole region of Sliven, |
— |
the whole region of Targovishte, |
— |
the whole region of Vidin, |
— |
the whole region of Veliko Tarnovo, |
— |
the whole region of Vratza, |
— |
in Varna region:
|
— |
in Burgas region:
|
2. Italy
The following restricted zones III in Italy:
— |
tutto il territorio della Sardegna. |
3. Latvia
The following restricted zones III in Latvia:
— |
Aizputes novada Kalvenes pagasta daļa uz austrumiem no ceļa pie Vārtājas upes līdz autoceļam A9, uz ziemeļiem no autoceļa A9, uz austrumiem no autoceļa V1200, Kazdangas pagasta daļa uz austrumiem no ceļa V1200, P115, P117, V1296, |
— |
Kuldīgas novada, Laidu pagasta daļa uz dienvidiem no autoceļa V1296, |
— |
Skrundas novada Rudbāržu, Nīkrāces pagasts, Raņķu pagasta daļa uz dienvidiem no autoceļa V1272 līdz robežai ar Ventas upi, Skrundas pagasts (izņemot pagasta daļa no Skrundas uz ziemeļiem no autoceļa A9 un austrumiem no Ventas upes), Skrundas pilsēta, |
— |
Vaiņodes novada Embūtes pagasta daļa uz ziemeļiem autoceļa P116, P106. |
4. Lithuania
The following restricted zones III in Lithuania:
— |
Jurbarko rajono savivaldybė: Seredžiaus ir Juodaičių seniūnijos, |
— |
Kauno rajono savivaldybė: Čekiškės seniūnija, Babtų seniūnijos dalis į vakarus nuo kelio A1ir Vilkijos apylinkių seniūnijos dalis į rytus nuo kelio Nr. 1907, |
— |
Kėdainių rajono savivaldybė: Pernaravos seniūnija ir Josvainių seniūnijos pietvakarinė dalis tarp kelio Nr. 229 ir Nr. 2032, |
— |
Plungės rajono savivaldybė: Alsėdžių, Babrungo, Paukštakių, Platelių ir Žemaičių Kalvarijos seniūnijos, |
— |
Raseinių rajono savivaldybė: Ariogalos ir Ariogalos miesto seniūnijos, |
— |
Skuodo rajono savivaldybės: Barstyčių, Notėnų ir Šačių seniūnijos. |
5. Poland
The following restricted zones III in Poland:
w województwie warmińsko-mazurskim:
|
w województwie podlaskim:
|
w województwie mazowieckim:
|
w województwie lubelskim:
|
w województwie podkarpackim:
|
w województwie lubuskim:
|
w województwie wielkopolskim:
|
w województwie dolnośląskim:
|
w województwie świętokrzyskim:
|
6. Romania
The following restricted zones III in Romania:
— |
Zona orașului București, |
— |
Județul Constanța, |
— |
Județul Satu Mare, |
— |
Județul Tulcea, |
— |
Județul Bacău, |
— |
Județul Bihor, |
— |
Județul Bistrița Năsăud, |
— |
Județul Brăila, |
— |
Județul Buzău, |
— |
Județul Călărași, |
— |
Județul Dâmbovița, |
— |
Județul Galați, |
— |
Județul Giurgiu, |
— |
Județul Ialomița, |
— |
Județul Ilfov, |
— |
Județul Prahova, |
— |
Județul Sălaj, |
— |
Județul Suceava |
— |
Județul Vaslui, |
— |
Județul Vrancea, |
— |
Județul Teleorman, |
— |
Judeţul Mehedinţi, |
— |
Județul Gorj, |
— |
Județul Argeș, |
— |
Judeţul Olt, |
— |
Judeţul Dolj, |
— |
Județul Arad, |
— |
Județul Timiș, |
— |
Județul Covasna, |
— |
Județul Brașov, |
— |
Județul Botoșani, |
— |
Județul Vâlcea, |
— |
Județul Iași, |
— |
Județul Hunedoara, |
— |
Județul Alba, |
— |
Județul Sibiu, |
— |
Județul Caraș-Severin, |
— |
Județul Neamț, |
— |
Județul Harghita, |
— |
Județul Mureș, |
— |
Județul Cluj, |
— |
Județul Maramureş. |
7. Slovakia
The following restricted zones III in Slovakia:
— |
the whole district of Trebišov. |
DECISIONS
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/168 |
COUNCIL DECISION (EU) 2021/624
of 12 April 2021
on the position to be taken on behalf of the European Union within the Joint Committee established by the Convention between the European Economic Community, the Republic of Austria, the Republic of Finland, the Republic of Iceland, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation, on a common transit procedure as regards amendments of Appendices I and III to that Convention
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4) in conjunction with Article 218(9) thereof,
Having regard to the proposal from the European Commission,
Whereas:
(1) |
The Convention between the European Economic Community, the Republic of Austria, the Republic of Finland, the Republic of Iceland, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation, on a common transit procedure (1) (‘the Convention’) was concluded on 20 May 1987 and entered into force on 1 January 1988. |
(2) |
Pursuant to Article 15(3), point (a), of the Convention, the Joint Committee established by the Convention is to adopt, by decision, amendments to the Appendices to the Convention. |
(3) |
In early 2021, the Joint Committee is to adopt a decision on the amendments of Appendices I and III to the Convention. |
(4) |
Article 311 of Commission Implementing Regulation (EU) 2015/2447 (2) (the ‘Implementing Regulation’), on the request to transfer the recovery of the customs debt, has been amended by Commission Implementing Regulation (EU) 2019/1394 (3). Therefore, Article 50 of Appendix I to the Convention, which mirrors Article 311 of the Implementing Regulation, should be amended accordingly. |
(5) |
Annex 72-04 to the Implementing Regulation, on the business continuity procedure for Union transit, has been amended by Commission Implementing Regulation (EU) 2020/893 (4). The validity of the paper-based comprehensive guarantee certificates and guarantee waiver certificates was prolonged in order to allow for more flexibility in the business continuity procedure in transit and reduce the formalities and costs incurred by customs authorities. Therefore, Article 79 of Appendix I to the Convention and point 19.3, Chapter III, Annex II to Appendix I to the Convention, which mirror point 19.3, Chapter III, Part I, Annex 72-04 to the Implementing Regulation, should be amended accordingly. |
(6) |
When the Union Customs Code ceases to apply to and in the United Kingdom, with the exception of Northern Ireland, the United Kingdom will accede to the Convention as a separate Contracting Party (5) and the Protocol on Ireland/Northern Ireland, which forms an integral part of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (6), will apply. The Convention contains references to the names of Member States of the European Union, common transit countries and the respective country codes. It is therefore necessary to amend Appendix III to the Convention in order to indicate that the United Kingdom is a common transit country and that the Union Customs Code, in particular as regards the provisions concerning guarantees, applies in Northern Ireland. |
(7) |
It is appropriate to establish the position to be taken on the Union’s behalf in the Joint Committee, with regard to the amendments of Appendices I and III to the Convention, as those amendments will be binding on the Union. |
(8) |
The position of the Union within the Joint Committee should therefore be based on the draft Decision of the Joint Committee, |
HAS ADOPTED THIS DECISION:
Article 1
The position to be taken on the Union’s behalf within the Joint Committee either during its 33rd meeting or a subsequent meeting or by means of a written procedure, as regards the amendments to Appendices I and III to the Convention, shall be based on the draft Decision of the Joint Committee (7).
Minor technical changes to the draft decision of the Joint Committee may be agreed to by the representatives of the Union in the Joint Committee, without further decision of the Council.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 12 April 2021.
For the Council
The President
A. P. ZACARIAS
(1) OJ L 226, 13.8.1987, p. 2.
(2) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558).
(3) Commission Implementing Regulation (EU) 2019/1394 of 10 September 2019 amending and correcting Implementing Regulation (EU) 2015/2447 as regards certain rules on surveillance for release for free circulation and exit from the customs territory of the Union (OJ L 234, 11.9.2019, p. 1).
(4) Commission Implementing Regulation (EU) 2020/893 of 29 June 2020 amending Implementing Regulation (EU) 2015/2447 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 206, 30.6.2020, p. 8).
(5) Decision No 1/2018 of the EU-CTC Joint Committee of 4 December 2018 as regards an invitation to the United Kingdom to accede to the Convention on a common transit procedure (2018/1987) (OJ L 317, 14.12.2018, p. 47).
(7) See document ST 6126/21 onhttp://register.consilium.europa.eu
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/170 |
COMMISSION DECISION (EU, Euratom) 2021/625
of 14 April 2021
on the establishment of the primary dealer network and the definition of eligibility criteria for lead and co-lead mandates for syndicated transactions for the purposes of the borrowing activities by the Commission on behalf of the Union and of the European Atomic Energy Community
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to the Treaty establishing the European Atomic Energy Community,
Having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union (1),
Whereas:
(1) |
To help address the economic and social consequences of the COVID-19 crisis, the Commission is empowered by Decision (EU, Euratom) 2020/2053 (2) to borrow up to EUR 750 000 million in 2018 prices on the capital markets on behalf of the Union. In accordance with Council Regulation (EU) 2020/2094 (3), those borrowings are to finance the recovery in the aftermath of the COVID-19 crisis. The Union will provide repayable and non-repayable support under different programmes, and in particular support public investments and reforms under the Recovery and Resiliency Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (4). |
(2) |
The Commission is already empowered to act as a borrower on the capital markets on behalf of the Union to finance loans for financial assistance granted in accordance with Council Regulation (EU) No 407/2010 (5), Council Regulation (EC) No 332/2002 (6), and the Decisions of the European Parliament and of the Council providing macro-financial assistance to various countries on the basis of a provisioning in accordance with, in particular, Council Regulation (EC, Euratom) No 480/2009 (7), Decision (EU) 2020/701 of the European Parliament and of the Council (8), and Council Regulation (EU) 2020/672 (9). |
(3) |
The Commission is also authorised by Council Decision 77/270/Euratom (10), to borrow funds on the capital markets on behalf of the European Atomic Energy Community (Euratom) to finance certain investment projects in the nuclear energy industry in the Member States and in some third countries of Central and Eastern Europe. |
(4) |
In accordance with Article 282(3) of the Financial Regulation, the provisions of Title X of the Financial Regulation regarding financial assistance started to apply on 1 January 2021. |
(5) |
Recourse to the capital markets will take place on a large scale, and issuance will have a high frequency. The absorption capacity of capital markets is finite. As a consequence, the organisation of funding operations has to be flexible. In the light of this, it is necessary for the Commission to reinforce its capacity to call on a capable and qualified network of credit institutions for the primary placement of debt securities, for the promotion of such placements and, as the case may be, for the provision of relevant financial services, such as the provision of fair market advice and intelligence. |
(6) |
Primary dealers admitted to the network are entitled to participate in auctions conducted by the Commission for borrowing on capital markets. The definition of the eligibility criteria builds on the experience in the selection of credit institutions under existing financial assistance programmes. It also draws on best practices of sovereign and supranational issuers. |
(7) |
To achieve the smooth and efficient conduct of borrowing and debt management activities, the arrangements regarding the network of primary dealers should apply to any borrowing activity of the Commission. |
(8) |
Credit institutions should be entitled to membership of the primary dealer network if they fulfil the eligibility criteria. Those aim to guarantee the efficient performance of the primary dealers’ function, in particular the proficient conduct of market operations and the compliance with underwriting commitments. In this regard, it is crucial that eligible primary dealers demonstrate a solid organisational structure, professional and management capacity, significant market activity in underwriting sovereign and supranational bond issuance, and compliance with the relevant regulatory framework, especially with regard to Union prudential requirements (11) and supervision thereof (12). In compliance with the principle of transparency, those criteria and the decisions admitting a credit institution as primary dealer should be published in the Official Journal of the European Union. |
(9) |
Membership of primary dealer networks operated by a Member State or a supranational issuer entitles the credit institution to participate in public debt auctions of that issuer. Regular and active involvement in sovereign or supranational auction procedures is a reliable demonstration of experience in public debt management operations. Eligibility for membership of the Union primary dealer network should therefore be conditional upon membership of at least one Member State or European supranational issuer’s primary dealer network or primary dealership mechanism. |
(10) |
Once admitted to the primary dealer network, primary dealers should be permitted to carry the title of ‘Member of the European Union Primary Dealer Network’ and to participate in all auctions of debt securities of the Union and the Euratom. Those dealers should buy a minimum weighted average of auctioned volumes and should comply with certain reporting obligations. |
(11) |
The primary dealers should also adhere to the general terms and conditions governing participation in the primary dealer network, in particular the rights, commitments and obligations of the members of the primary dealer network, annual review, reporting obligations, as well as rules on controls, on suspension of membership, on the exclusion from and on the possibility to withdraw from the primary dealer network. |
(12) |
The issuance of debt securities under the borrowing programmes referred to under recitals (3) and (4) is carried out, in addition to auctions, also through syndication or private placements. To this end, credit institutions fulfilling established eligibility requirements for syndicated transactions and private placements are appointed by the Commission for the purpose of each borrowing transaction. |
(13) |
Members of the primary dealer network, which buy a higher weighted average percentage of auctioned volumes than required to be a member of the primary dealer network and with a sufficient secondary market share in debt securities of the Union and the Euratom should be eligible to serve as lead and co-lead managers in syndicated transactions. This group of dealers should also undertake to promote liquidity of debt securities of the Union and the Euratom through a market-making activity, to provide fair advice and market intelligence to the Commission and to promote the Union and the Euratom issuances with investors. |
(14) |
The tasks connected with the roles of lead manager and co-lead manager should be considered financial services as referred to in Chapter 1, Section 2, point 11.1, point (j), of Annex I to Regulation (EU, Euratom) 2018/1046. The appointment of eligible primary dealers as members of the syndicate for a specific issuance transaction should therefore be based on a negotiated procedure without prior publication of a contract notice. This procedure should include the sending of a request for proposals to eligible dealers and the evaluation of proposals received by the Commission. |
(15) |
Taking into account the expected high frequency of the Commission’s recourse to the capital markets, it is necessary to establish a smooth, swift and efficient mechanism to appoint banks as lead and co-lead managers for syndicated transactions. It is therefore necessary to provide a fair and transparent basis for limiting the request for proposals to a subset of the primary dealers eligible to participate in syndicates. This additional selection is necessary to balance the need for competition in the procurement procedure for the services of supporting the syndicate with the need for efficient preparation of time-sensitive transactions, and to avoid duplication of effort by primary dealers in bidding for syndicate mandates. This selection of banks should be based on qualitative and quantitative criteria, relating to the proven capacity of eligible primary dealers in supporting sovereign and supranational issuance in primary and secondary markets, and their ability to distribute debt securities to investors. This process should also provide a rotation mechanism ensuring an equal chance for participation across all eligible primary dealers. |
(16) |
Taking into account the need to protect the financial interests of the Union, monitoring rules should be established in order to ensure compliance by the members of the primary dealers network with the obligations set forth under this Decision and other relevant applicable provisions, in particular the general terms and conditions. The European Anti-Fraud Office (OLAF) should be involved, where appropriate, in that supervision. |
(17) |
Borrowing and debt management activities taking place through public institutions and through electronic platforms do not involve selection of financial counterparties. For that reason, this Decision should not apply to them, |
HAS ADOPTED THIS DECISION:
CHAPTER 1
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Decision establishes the primary dealer network and lays down the eligibility criteria and procedural provisions for the selection of its members as well as the rights and obligations of those members.
2. This Decision applies to any borrowing and debt management activity carried out by the Commission on behalf of the Union and the Euratom, where the Commission selects private financial counterparties.
Article 2
Definitions
For the purposes of this Decision, the following definitions apply:
(1) |
‘auction’ means the issuance process of the Union and Euratom debt securities based on competitive bids through an auction platform on primary market; |
(2) |
‘borrowing programmes’ means the Union and the Euratom programmes involving borrowing activities on the financial markets, in particular, financial assistance decided in accordance with Regulation (EU) No 407/2010, Regulation (EC) No 332/2002, the Decisions of the European Parliament and of the Council providing macro-financial assistance to various countries on the basis of a provisioning in accordance with Regulation (EC, Euratom) No 480/2009 or Decision (EU) 2020/701, as well as Regulation (EU) 2020/672, the Euratom programme under Decision 77/270/Euratom, and borrowing on the basis of Article 5 of Decision (EU, Euratom) 2020/2053; |
(3) |
‘credit institution’ means credit institution as defined in Article 4, paragraph 1 (1), of Regulation (EU) No 575/2013 of the European Parliament and of the Council (13); |
(4) |
‘debt securities’ means notes and/or short term financial instruments, such as treasury bills, as well as any other financial instrument, issued by the Union and/or the Euratom; |
(5) |
‘members of the primary dealer network’ means any credit institutions fulfilling the eligibility criteria set out in Article 4 and included in the list referred to in Article 11; |
(6) |
‘European supranational issuer’ means the Council of Europe Development Bank, the European Financial Stability Facility, European Stability Mechanism, the European Investment Bank and the Nordic Investment Bank; |
(7) |
‘affiliate’ means any entity belonging to the same group as defined by Article 2(12) of Directive 2002/87/EC (14). |
Article 3
Establishment of the primary dealer network
The Union primary dealer network (‘primary dealer network’) shall be a group of credit institutions eligible to participate in the following borrowing and debt management activities of the Commission:
(a) |
the placement of debt securities on the primary capital markets, in particular through auctions and syndicated transactions; |
(b) |
the promotion of liquidity of the Union and the Euratom debt securities on the financial markets; |
(c) |
the provision of fair advice and market intelligence to the Commission; |
(d) |
the promotion and development of the placement of the Union and the Euratom debt securities. |
CHAPTER 2
MEMBERSHIP OF THE PRIMARY DEALER NETWORK
Article 4
Eligibility criteria for the primary dealer network
Credit institutions fulfilling the following criteria shall be eligible for membership of the primary dealer network:
(a) |
being a legal entity established and having its head office in the Union or in a European Economic Area country; |
(b) |
being authorised to carry out the business of credit institution in the Union in accordance with Directive 2013/36/EU of the European Parliament and of the Council (15) and being supervised by a Union competent authority; and |
(c) |
being a member of a European sovereign or supranational primary dealer network established for the purpose of serving as counterparty of a Member State or of a European supranational issuer. For the purpose of this Decision a European sovereign or supranational primary dealer network shall be intended as either of the following entities:
|
Article 5
Commitments
Members of the primary dealer network shall undertake the following commitments:
(a) |
to buy a minimum weighted average of 0,05% of volumes auctioned by the Union and/or the Euratom on a semi-annual basis in accordance with part A of the Annex; |
(b) |
to comply with the obligation to accurately, timely and integrally report on a monthly basis to the Commission the traded volumes on Union and Euratom debt securities, according to the harmonised reporting format for trading on the secondary European sovereign debt market established by the Sub-Committee on EU Sovereign Debt Markets of the European Union Economic and Financial Committee. The quality of the reporting shall be regularly assessed and the results notified the interested primary dealer. The primary dealer shall be notified if the data provided are not accurate; |
(c) |
to submit a signed copy of the ‘General terms and conditions for European Union primary dealers (‘GTC’); |
(d) |
to ensure that the trading authorisations provided to its trading personnel are quarterly reviewed and validly in force; |
(e) |
to comply with market practices and ethics, in particular
|
(f) |
to treat all information received from the Commission confidentially. |
Article 6
General terms and conditions
1. The GTC shall apply to any borrowing and debt management activity carried out by the Commission under the borrowing programmes under this Decision.
2. The GTC shall, in accordance with this Decision:
(a) |
establish the details of the obligations for the duration of the participation in the primary dealer network; |
(b) |
establish the content of and procedure for the annual review; |
(c) |
establish the details of reporting obligations; |
(d) |
establish rules on controls; |
(e) |
establish the details of the rules and procedure for the suspension of membership, lifting of that suspension, and exclusion from the primary dealer network; and |
(f) |
regulate the possibility to withdraw from the primary dealer network. |
3. Any time limit shall be calculated as follows:
(a) |
where a time limit is expressed in days or months from a certain date or event, the day or month on which that date falls or that event occurs shall not be counted as falling within the time limit; |
(b) |
time limits expressed in days shall include business days only. Business days shall be determined in accordance with Luxembourgish calendar of public and bank holidays (https://www.abbl.lu/fr/topic/bank-holidays/); |
(c) |
a time limit expressed in months shall end with the expiry of the day in the last month corresponding to the same day on which the date or the event, from which the time-limit is calculated, fell or occurred. |
(d) |
if, in a time limit expressed in months, the day on which it should expire does not occur in the last month, the time limit shall end with the expiry of the last day of that month; |
(e) |
if a time expressed in months expires on a public or bank holiday day, it shall be extended until the end of the first subsequent business day. |
Article 7
Rights of members of the primary dealer network
Members of the primary dealer network are entitled to the following rights:
(a) |
to advertise themselves as ‘Member of the European Union Primary Dealer Network’; |
(b) |
to participate and bid in any auction of debt securities of the Union or the Euratom; |
(c) |
to receive on a regular basis, at least yearly, feedback on its performance, especially in relation to its ranking in the auctions and in the secondary markets; this feedback shall be based on the internal evaluation process referred to under Article 11 with objective criteria to be communicated to the primary dealers; |
(d) |
without prejudice to Chapter 3, to be eligible for debt management operations, including the following operations:
|
(e) |
Right to resign at any moment its membership of the primary dealer network by notifying it to the Commission. The withdrawal shall take effect the first business day of the second month following the date of the notification. |
CHAPTER 3
LEAD AND CO-LEAD MANDATES FOR SYNDICATED TRANSACTIONS
Article 8
Eligibility criteria for lead and co-lead mandates for syndicated transactions
Members of the primary dealer network are eligible to serve as lead managers and as co-lead managers for syndicated transactions, subject to the fulfilment of the following criteria:
(a) |
having bought a minimum of 2,00% of auctioned volumes by the Union and the Euratom, on weighted average based on the last three auctions on a rolling basis; |
(b) |
having provided evidence, based on the transaction data reported in accordance with this Decision, of having a market share in Union and Euratom debt securities on the secondary markets of at least 2,00%; |
(c) |
having agreed with the general terms and conditions for lead and co-lead mandates for syndicated transactions, which may be part of GTC; and |
(d) |
having agreed with the fee schedule. |
Article 9
Fee schedule
The fee schedule referred to in point (d) of Article 8 shall apply to borrowing and debt management operations. The fee schedule shall establish a remuneration commensurate with the costs and risks born by the eligible primary dealers in carrying out Union and Euratom borrowing and debt management operations, while ensuring cost-efficiency for the Union and taking into account specificities of the Union’s debt issuances, in particular volumes and maturities. The fee schedule shall be referred to in an annex to the general terms and conditions for lead and co-lead mandates for syndicated transactions.
Article 10
Additional commitments
Members of the primary dealer network fulfilling the eligibility criteria laid down in Article 8 may be selected to lead and co-lead mandates for syndicated transactions on the basis of the assessment of their commitment to carry out any of the following activities:
(a) |
on a best effort basis, to promote the liquidity of Union and Euratom debt securities with a market-making activity, thereby contributing to price discovery, to the efficiency of the secondary market and to an orderly execution of trading; |
(b) |
to provide fair advice and market intelligence to the Commission in order to design and implement the borrowing programmes, and, in particular, to provide advice prior to the publication of the funding programme and in the context of the preparation of the debt management transactions under the borrowing programmes; |
(c) |
to provide the Commission with regular information on market trends, analysis and research on functioning of fixed-income markets and, in particular, the sovereigns, supranationals and agencies; |
(d) |
to promote and develop the placement of Union and Euratom debt securities within a diversified and broad investor community as part of their business strategy. |
Article 11
Selection of the syndicate
1. Syndicates shall be selected pursuant to Chapter 1, Section 2, point 11.1, point (j), of Annex I to Regulation (EU, Euratom) 2018/1046 in a negotiated procedure without prior publication of a contract notice.
2. The Commission shall send the requests for proposals to a subgroup of eligible members of the primary dealer network fulfilling the criteria laid down in Articles 8 and 10, soliciting an offer for participation as lead or co-lead managers.
3. The selection of the subgroup of eligible primary dealers to whom the request for proposals shall be sent, shall be based on objective qualitative and quantitative criteria, relating to the proven capacity of eligible primary dealers in supporting sovereign and supranational issuance in primary and secondary markets, and their ability to distribute debt securities to investors. Those criteria shall also include an assessment of the performance of the activities listed in Article 10. The Commission shall implement a rotation criterion to ensure that all eligible members of the primary dealer network are regularly invited to respond to requests for proposals.
4. The proposals received from eligible members referred to in paragraph 2 shall be evaluated on the basis of an additional set of objective qualitative and quantitative criteria and in view of the establishment of a syndicate, whose composition is the best possible combination of managers for the optimal performance of a given transaction.
5. The criteria for the transmission of requests for proposals and for the evaluation of the received proposals shall be communicated to the subgroup of members of the primary dealer network together with the request for proposals.
CHAPTER 4
APPLICATION FOR MEMBERSHIP AND ESTABLISHMENT OF THE LIST OF THE MEMBERS OF THE PRIMARY DEALER NETWORK AND MONITORING
Article 12
Application for membership and list of primary dealers
1. Interested credit institutions shall submit to the Commission an application for membership to the primary dealer network by filling in and submitting the application form and the annexed checklist in respect of admission criteria available on Commission website.
2. Applications for admission to the primary dealer network shall include proof of compliance with Articles 4 and 5. To such end, evidence and supporting documents to be enclosed are detailed in the application form and its annexes.
3. In case of an incomplete application form, incomplete information or insufficient data, the applicant may be requested to submit necessary additional information. Failure to provide the necessary additional information within a specified deadline shall result in rejection of the application form.
4. Provision of false, misleading or incorrect information or documents during the application process shall result in non-admission to the primary dealer network or, as the case may be, may lead to an exclusion from the primary dealer network in accordance with Article 15 of this Decision.
5. In the application form each primary dealer shall declare to accept the GTC, thereby acknowledging their binding nature and committing to them.
6. The application form and the GTC shall be signed and the GTC shall also be paraphed on each page by a duly authorised representative of the primary dealer who, based on applicable laws of the relevant jurisdiction and on the relevant corporate documents is empowered to validly commit such primary dealer for the purpose of the performance of the obligations and activities under the GTC. To such end, an extract from the relevant company register shall be provided when submitting the application form.
7. Any communication, notice or information relating to this Decision and the GTC shall be made at the address for notice elected by primary dealers in their application form and shall be addressed to the person therein designated as ‘coordinator’.
Article 13
Admission to primary dealer network
1. The decision on whether to include an applicant in the list of the primary dealer network shall be adopted, at the latest, within two months of the submission of the relevant application. If an applicant is requested to submit additional information in accordance with paragraph 3 of Article 12, the time limit for a decision relating to that applicant shall be suspended until the date of submission of that additional information. If the applicant informs the Commission that it considers the application to be complete, the decision shall be adopted within two months. The decision shall be notified to the applicant.
The non-admission decision shall state reasons on which it is based.
2. The up-dated list of members of the primary dealer network shall be published once a year in the Official Journal of the European Union.
3. In view of performing the annual review the primary dealers shall be invited to represent and declare to the Commission that they still fulfil all the eligibility criteria for the membership laid down in Article 4.
Article 14
Monitoring
The Commission may conduct, or may appoint a third party to conduct, verifications to check the compliance of members of the primary dealer network with this Decision. Members of the primary dealer network shall cooperate with and facilitate the conduct of those verifications, especially by providing necessary information and data as well as access thereto.
Each member of the primary dealer network shall:
(a) |
provide the Commission with the risk limit set for the trading activity of the debt securities of the Union and the Euratom in accordance with the General terms and conditions for Union primary dealers referred to in Article 5, point (c); |
(b) |
notify the Commission of any downgrade by the European Securities and Markets Authority recognised rating agencies in the Union; |
(c) |
promptly notify the Commission of any supervening non-compliance with any eligibility criterion laid down in Article 4. |
By accepting the GTC, the primary dealer gives its consent to possible audits and verification related to the data transmitted to the Commission in the framework of its reporting obligations, in particular with regard to the data to be used to assess its performance on the secondary market.
Article 15
Suspension and exclusion from the primary dealer network
1. The membership of the primary dealer in the primary dealer network may be suspended in the following cases:
(a) |
initiation of proceedings against a primary dealer as referred to in point (iii) of paragraph (e) of Article 5; |
(b) |
initiation of procedure, which may result in the cessation of membership in the network or the mechanism referred to in point (c) of Article 4; |
Primary dealer shall be invited by a pre-suspension notice to submit its observations within a time limit of no less than 7 days from the receipt of the notice. The suspension decision shall take effect the first business day following the date of the notification to the non-compliant primary dealer.
The suspension may be lifted upon request from the suspended primary dealer. The primary dealer shall submit sufficient evidence that, as applicable, either the proceedings referred to under point (a) of the first subparagraph are no longer pending and have not resulted in a sanction of whichever nature against the suspended dealer, or the procedure referred to under point (b) of the first subparagraph is no longer pending and has not resulted in the cessation of membership in the network or the mechanism referred to in point (c) of Article 4. The presented evidence shall be assessed and decision taken within 15 working days as of the request.
2. Primary dealer shall be excluded from the primary dealer network in the following cases:
(a) |
primary dealer ceases to fulfil any of the conditions referred to in Article 4; |
(b) |
exclusion of the primary dealer pursuant to Articles 135 to 142 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (18). |
3. The following procedure shall apply to the exclusion from the primary dealer network in cases laid down under paragraph 2:
(a) |
the primary dealer shall be invited with a pre-exclusion notice to submit its observations within a time-limit of no less than 7 days from the receipt of the notice; |
(b) |
the exclusion decision shall be notified to the primary dealer. The exclusion decision takes effect the first business day following the date of its notification to the excluded primary dealer. |
4. Primary dealer may be excluded from the primary dealer network in the case of:
(a) |
non-compliance with obligations laid down under Article 5; |
(b) |
commitment of an infringement referred to in Article 30 of Regulation (EU) 596/2014 of the European Parliament and of the Council (19), as decided in a final decision adopted by relevant competent authority; |
(c) |
a final decision by the competent authority taken as a result of any proceeding referred to under subparagraph (v) of point (e) of Article 5, or relating to AML and CTF laws and regulations; |
(d) |
non-compliance with subparagraph (vi) of point (e) of Article 5; or |
(e) |
disclosure of information, which is subject to confidentiality obligation under point (f) of Article 5. |
5. The following procedure shall apply in cases laid down under paragraph 4:
(a) |
The primary dealer concerned shall receive a notice specifying the grounds for non-compliance and setting a time-limit to submit observations of no less than 7 days from the receipt by the primary dealer of the notice. |
(b) |
Taking into account the submitted observations, if any, the primary dealer shall receive a warning notice, inviting it to take relevant corrective measures to restore and/or ensure compliance with the relevant criteria and/or obligations. |
(c) |
The primary dealer shall communicate the corrective measures that it intends to adopt, within a set deadline, which is no shorter than one week from the date receipt of the warning notice. |
(d) |
If no information has been communicated within the time limit referred to under paragraph (c), the primary dealer shall receive a second warning notice, inviting it to take the corrective measures referred to in paragraph (b). Paragraph (c) shall apply mutatis mutandis. |
(e) |
The primary dealer shall provide sufficient evidence of the implementation of the corrective measures within a set deadline set which is not shorter than one month from the date of the communication of the warning notice referred to in point (b). Where no or insufficient evidence is provided, the pre-exclusion notice shall be addressed to the primary dealer with an invitation to submit observations within a time-limit of no less than 7 days from the receipt of the notice. Taking into account the submitted observations, if any, the decision to exclude the non-compliant primary dealer from the primary dealer network may be taken. |
(f) |
The exclusion decision shall state reasons on which the exclusion is based. |
(g) |
The exclusion decision shall take effect the first business day following the date of its notification to the excluded primary dealer. |
6. Suspension of membership pursuant to paragraph 1, exclusion from a membership pursuant to paragraphs 2 to 6 and resignation on membership in primary dealer network pursuant to point (e) of Article 7 shall have no effect on the rights and obligations of the primary dealer in question in respect of contracts concluded prior to the effective date of exclusion, suspension or resignation respectively.
7. Suspension shall not entail the suspension of obligations under point (f) of Article 5 and under Article 14.
CHAPTER 5
TRANSITIONAL PROVISIONS
Article 16
Transitional provision
After the date of publication of the list in accordance with Article 13 and until the Commission has sufficient data available to assess the fulfilment of the eligibility criteria under Article 8, each member of the primary dealer network fulfilling the eligibility criteria under Article 4 shall be eligible for the lead and co-lead mandate.
This Decision shall apply to borrowing and debt management activities of the Commission launched after the date of the first publication of the list in accordance with Article 13. Until that date, the appointment of dealers for the purpose of borrowing and debt management activities shall be carried out on the basis of the internal operational framework in place under the existing borrowing programmes.
Article 17
Final provision
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 14 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 193, 30.7.2018, p. 1.
(2) Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1).
(3) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433 I, 22.12.2020, p. 23).
(4) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.02.2021, p. 17).
(5) Council Regulation (EU) No 407/2010 of 11 May 2010 establishing a European financial stabilisation mechanism (OJ L 118, 12.5.2010, p. 1).
(6) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States’ balances of payments (OJ L 53, 23.2.2002, p. 1).
(7) Council Regulation (EC, Euratom) No 480/2009 of 25 May 2009 establishing a Guarantee Fund for external actions (OJ L 145, 10.6.2009, p. 10).
(8) Decision (EU) 2020/701 of the European Parliament and of the Council of 25 May 2020 on providing macro-financial assistance to enlargement and neighbourhood partners in the context of the COVID-19 pandemic (OJ L 165, 27.5.2020, p. 31).
(9) Council Regulation (EU) 2020/672 of 19 May 2020 on the establishment of a European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) following the COVID-19 outbreak (OJ L 159, 20.5.2020, p. 1).
(10) Council Decision 77/270/Euratom of 29 March 1977 empowering the Commission to issue Euratom loans for the purpose of contributing to the financing of nuclear power stations (OJ L 88, 6.4.1977, p. 9).
(11) See, in particular, Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).
(12) See, in particular, Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation) (OJ L 141, 14.5.2014, p. 1) and Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63).
(13) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1)
(14) Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73/239/EEC, 79/267/EEC, 92/49/EEC, 92/96/EEC, 93/6/EEC and 93/22/EEC, and Directives 98/78/EC and 2000/12/EC of the European Parliament and of the Council (OJ L 35, 11.2.2003).
(15) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
(16) Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, p. 1).
(17) Commission Delegated Regulation (EU) 2017/583 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of bonds, structured finance products, emission allowances and derivatives (OJ L 87, 31.3.2017, p. 229).
(18) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(19) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1).
ANNEX
1. Fulfilment of the obligation to purchase a minimum weighted average of 0,05 % of volumes auctioned by the Union and/or the Euratom on a semi-annual basis
(a) |
Auctions shall be carried out through an auction system operated by an auction provider selected by the Commission (‘auction provider’). |
(b) |
Participation in the auctions and purchase of auctioned debt securities shall take place in accordance with auction rules arranged by the auction provider and endorsed by the Commission. The primary dealers shall subscribe to the auction rules and comply with them. |
(c) |
It should be understood by all primary dealers, that they act and participate in the auctions at their own risk and that the Commission shall not be responsible in any manner for the decisions of any participant in the auctions and in particular for any losses, direct or indirect, arising in relation to any transaction entered into by such participants. |
(d) |
The primary dealers shall take all measures to ensure that they are able to participate in the auction, in particular conclude the contracts with the auction provider, complete any step and formality necessary to participate in the auctions, and have in place the technical infrastructure to participate. |
(e) |
The Commission shall not bear any costs or responsibility towards the primary dealer in relation to the contracts between the auction provider and the primary dealer or in relation to the technical infrastructure for the auction. |
(f) |
Primary dealers may only be dispensed from the fulfilment of their obligation under Article 5(a) in cases of force majeure, which shall in particular not comprise cases of malfunctioning or technical issues relating to the infrastructure. |
(g) |
The calculations of the volume purchased by primary dealers over the relevant 6-month period shall be weighted according to the following table: |
(h) |
This calculation shall be applied for 6-month periods, running from January to June and from July to December, except for the first period, which shall run as of the date of the first auction until the end of the subsequent 6-month period. |
2. Reporting obligations
(a) |
The primary dealers shall, on request, submit information on the risk limit that this primary dealer has set, for the purpose of its own position management, for the trading activity of the debt securities of the Union and the Euratom as well as on the extent to which the risk limit is used. The information to be submitted shall be specified in the request. |
(b) |
The primary dealers shall immediately notify the Commission in case it is subject to rating upgrades or downgrades by one of the external rating agencies recognised by ESMA in accordance with Article 18 (3) of Regulation (EC) 1060/2009 (1). |
(c) |
The primary dealers shall promptly notify the Commission of non-compliance with any eligibility criterion laid down in Article 4. |
(d) |
The primary dealers shall submit to the Commission any change in contact details communicated through the application form by using the template attached to the application form within two weeks of the date when the change took effect. |
(e) |
The primary dealers shall submit to the Commission, on its request, any information relevant for the execution of its activities of primary dealer, in particular on its primary or secondary market activities related to the debt securities of the Union and the Euratom. |
(1) Regulation (EC) No 1060/2009 of the European Parliament and of the Council of 16 September 2009 on credit rating agencies (OJ L 302, 17.11.2009, p. 1); the list is available at:https://www.esma.europa.eu/supervision/credit-rating-agencies/risk
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/183 |
COMMISSION IMPLEMENTING DECISION (EU) 2021/626
of 14 April 2021
establishing the InvestEU Portal and setting out its technical specifications
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (1), in particular Article 26 thereof,
Whereas:
(1) |
The InvestEU Portal should contribute to catalysing and accelerating the development and the fruition of investment projects in the Union. |
(2) |
Pursuant to Article 26(2) of Regulation (EU) 2021/523, only projects that are compatible with Union law and policies shall be listed on the InvestEU Portal. Admission criteria should be laid down to ensure that this requirement is met. |
(3) |
In order to ensure a transparent management of the InvestEU Portal, the technical specifications thereof should be set out, |
HAS ADOPTED THIS DECISION:
Article 1
The InvestEU Portal is established. It shall comply with the technical specifications set out in the Annex.
Article 2
The inclusion of projects in the InvestEU Portal shall comply with the following admission criteria:
(a) |
the project (or the programme consisting of smaller projects) shall have a minimum size of EUR 500 000 in terms of required investments; |
(b) |
the project shall fall in the areas eligible for financing and investment operations as set out in Annex II to Regulation (EU) 2021/523; |
(c) |
the promoter shall not be excluded from contracts financed by the Union budget or sanctioned for grave professional misconduct, criminal activities, or significant deficiencies in complying with its obligations under Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (2); |
(d) |
the project shall not constitute excluded activities as set out under point B of Annex V to Regulation (EU) 2021/523; |
(e) |
the project shall be situated in the Union, or in an overseas country or territory linked to a Member State as set out in Annex II to the TFEU; |
(f) |
the project shall not entail reputational risks for the Commission; |
(g) |
the project implementation shall have commenced or shall be expected to commence within three years of the date of submission to the InvestEU Portal; |
(h) |
the project shall be clearly described in the project application as an investment project and the information provided therein shall be accurate and shall specify the amount of financing necessary for undertaking the project; and |
(i) |
the project shall be compatible with Union law and policies. |
Article 3
No application processing fee shall be charged for the inclusion of a project in the InvestEU Portal.
Article 4
This Decision shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 14 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 107, 26.3.2021, p. 30.
(2) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 OJ L 193, 30.7.2018, p. 1.
ANNEX
TECHNICAL SPECIFICATIONS OF THE INVESTEU PORTAL
1. General description
The InvestEU Portal shall be an easily accessible and user-friendly project database that provides relevant information for each project, thus providing a channel for project promoters to bring projects for which they are seeking finance visible to investors, including donors and philathropists. Detailed project information shall be made available to registered users only.
The publication of a project on the InvestEU Portal shall not amount to its endorsement by the Commission. The inclusion of projects in the InvestEU Portal shall be without prejudice to decisions on the final projects selected for support under Regulation (EU) 2021/523, under any other instrument of the Union, or to decisions for public funding.
The main components of InvestEU Portal shall be:
(1) |
a public portal: part of the InvestEU programme website containing publicly available information, including:
|
(2) |
an online platform for registered users (‘front office’): part of the InvestEU Management Information System allowing the registration of users (including project promoters and investors) and providing detailed information, such as:
|
(3) |
an internal platform (‘back office’): part of the InvestEU Management Information System used by the Commission services for screening and management purposes. |
2. Management of the InvestEU Portal
The InvestEU Portal shall be managed by the Commission. The Portal’s content shall be generated by project promoters, i.e. by private and public legal entities. The Portal may be supported by targeted events.
Participation of project promoters and other registered website users to the InvestEU Portal shall be subject to their acceptance of the Terms and Conditions which shall aim at ensuring the quality of published information received from project promoters while making clear that the Commission does not guarantee the accuracy of the information published and cannot be held liable for any claims based on the publication of the project.
A disclaimer shall alert the website users that the Commission cannot guarantee the accuracy of the information published and that potential investors have to carry out their own usual due diligence, including on financial aspects and any other aspect relevant for their decision on whether to invest in a project.
An overview of public advisory services at national level shall be set out. The Commission shall transmit projects that meet the conditions set out in Article 2 to the relevant InvestEU implementing partners. Where appropriate, and where an advisory initiative exists, the Commission shall also transmit such projects to the InvestEU Advisory Hub.
3. Project screening
A project screening shall be performed by the services of the Commission on the basis of the admission criteria set out in Article 2. Some technical aspects of the validation process, such as the verification of project promoters’ identity, may be outsourced to third parties. The Member States shall be invited to appoint one or more contact points for the purposes of the screening of projects with actual and direct security implications, in particular in the sectors of space, defence and cybersecurity. The Early Detection and Exclusion System (EDES) shall be consulted as appropriate.
The publication of information submitted by promoters shall be denied if the information is inaccurate or if the project does not fulfil the requirements set out in Article 2.
The information on a project shall be removed from the InvestEU Portal if it is has not been updated by the project promoter for three years.
16.4.2021 |
EN |
Official Journal of the European Union |
L 131/187 |
COMMISSION IMPLEMENTING DECISION (EU) 2021/627
of 15 April 2021
laying down rules on keeping and accessing of the logs in the European Travel Information and Authorisation System (ETIAS) pursuant to Regulation (EU) 2018/1240 of the European Parliament and of the Council
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (1), and in particular point (b)(iii) of the third subparagraph of Article 73(3) thereof,
Whereas:
(1) |
Regulation (EU) 2018/1240 establishes the European Travel Information and Authorisation System (‘ETIAS’) for third-country nationals exempt from the requirement to be in the possession of a visa for the purposes of entering and staying in the territory of the Member States. |
(2) |
The operation of the European Travel Information and Authorisation System requires the development and technical implementation of the ETIAS Information System. The system is to comprise logs recording all data processing operations performed. |
(3) |
It is necessary to lay down rules on the keeping and accessing of logs. Logs should be used solely for verifying compliance with data processing obligations and for ensuring the integrity and security of the operational personal data. |
(4) |
As regards the keeping of logs, it is necessary to specify the location at which they are to be stored, the manner in which they are to be technically recorded, including when they derive from different components of the European Travel Information and Authorisation System, as well as the rules applicable to the deletion of the logs after their retention period ends. |
(5) |
As regards accessing logs, it is necessary to specify the competent authorities including, where appropriate, the persons within such authorities, to which access to the logs should be granted and for the purposes for which they may be accessed. In order to ensure that the competent authorities are able to perform their duties carried out for the purpose of monitoring the admissibility of data processing and of ensuring data security and integrity, the identification of logs should be facilitated through an effective search function. |
(6) |
Logs recording access by duly authorised staff of the national authorities of each Member State and by the duly authorised staff of the Union agencies for the purposes referred to in Article 13(4a) of Regulation (EU) 2018/1240 should be kept in accordance with the requirements laid down in Article 24(2) and (3) of Regulation (EU) 2019/817. |
(7) |
The European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (‘eu-LISA’) is responsible for the design and development phase of the ETIAS Information System. The measures laid down by this Decision should enable the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice to define the design of the physical architecture of the European Travel Information and Authorisation System including its Communication Infrastructure, as well as the technical specifications of the system and to develop the European Travel Information and Authorisation System. The European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice should complete those measures by the Technical Specifications and the Interface Control Document of the European Travel Information and Authorisation System. |
(8) |
In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark did not take part in the adoption of Regulation (EU) 2018/1240 and is not bound by it or subject to its application. However, given that Regulation (EU) 2018/1240 builds upon the Schengen acquis, Denmark notified on 21 December 2018, in accordance with Article 4 of that Protocol, its decision to implement Regulation (EU) 2018/1240 in its national law. |
(9) |
This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (2); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application. |
(10) |
As regards Iceland and Norway, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (3), which fall within the area referred to in Article 1, point A of Council Decision 1999/437/EC (4). |
(11) |
As regards Switzerland, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (5), which fall within the area referred to in Article 1, point A of Council Decision 1999/437/EC, read in conjunction with Article 3 of Council Decision 2008/146/EC (6). |
(12) |
As regards Liechtenstein, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (7) which fall within the area referred to in Article 1, point A of Council Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (8). |
(13) |
As regards Cyprus, Bulgaria and Romania and Croatia, this Decision constitutes an act building upon, or otherwise relating to, the Schengen acquis within, respectively, the meaning of Article 3(1) of the 2003 Act of Accession, Article 4(1) of the 2005 Act of Accession and Article 4(1) of the 2011 Act of Accession. |
(14) |
The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (9) and delivered an opinion on 4 September 2020. |
(15) |
The measures provided for in this Decision are in accordance with the opinion of the Smart Borders Committee (ETIAS), |
HAS ADOPTED THIS DECISION:
Article 1
Keeping of logs of data processing operations
1. The logs of all data processing operations within the ETIAS Information System to be kept in accordance with Article 69(1) of Regulation (EU) 2018/1240, which include logs involving access by carriers as provided for in Article 45(7), by border authorities and immigration authorities as provided for in Article 69(3) of Regulation (EU) 2018/1240 and by the central access points as provided for in Article 70(1) of Regulation (EU) 2018/1240, shall be recorded and stored by the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice in the ETIAS Central System.
2. Each data processing operation within the ETIAS information system shall be recorded as a separate log entry.
The log entry shall have a specific field allowing for the identification of the details relating to the operation performed.
3. The log entry shall be recorded with the time and date of each data processing operation (‘timestamp’).
4. Each log entry shall store the unique ID of the authority as well as of the official or staff member accessing, amending or erasing data stored in the ETIAS Central System.
5. Log entries shall be deleted daily by the ETIAS Central System in accordance with the retention periods provided for in Article 45(7), Article 69(4) and Article 70(4) of Regulation (EU) 2018/1240.
A timestamp shall be used to identify the log entries to be deleted at the end of the relevant retention period for each type of log.
Article 2
Access to logs of data processing operations
1. Access to the logs kept by the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice pursuant to Regulation (EU) 2018/1240 shall be limited to:
(a) |
duly authorised administrators of ETIAS of the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice and Data Protection Officer for the purposes referred to in Article 58(2) of Regulation (EU) 2018/1240 and in particular for ensuring compliance with Article 69(4) of that Regulation; |
(b) |
duly authorised staff and Data Protection Officer of the European Border and Coast Guard Agency, for the purposes laid down in Articles 7(2)(e) and 61 of Regulation (EU) 2018/1240 and ensuring the lawfulness of data processing, data integrity and security; |
(c) |
duly authorised staff and Data Protection Officers of the ETIAS National Units, for the purposes referred to in Article 57(2). |
2. The European Data Protection Supervisor and the competent national supervisory authorities carrying out the supervisory functions referred to in Articles 66 and 67 of Regulation (EU) 2018/1240 shall have access to the logs on request to eu-LISA or to the ETIAS National Unit(s).
3. The log entries and the specific fields recorded in the ETIAS Central System, in accordance with Article 1, shall be searchable at least by reference to author, date of access or type of processing operation.
4. For the purposes of Article 45(5) and (7) of Regulation (EU) 2018/1240, the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice may transmit logs to ETIAS National Units necessary for the resolution of a dispute arising from the application of that Article provided that the following conditions are met:
(a) |
the ETIAS National concerned has submitted an explicit reasoned request for such logs to the European Border and Coast Guard Agency as data controller within the meaning of the first sentence of Article 57(1) of that Regulation; |
(b) |
the European Border and Coast Guard Agency has verified and approved the request. |
5. Logs recording access to the logs carried out pursuant to paragraph 1 shall be traceable at least according to the author or date of access.
6. Logs recording access to the logs carried out pursuant to paragraph 1 shall be searchable at least by reference to author, date of access or type of processing operation.
Article 3
Entry into force
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 15 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 236, 19.9.2018, p. 1.
(2) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20).
(3) OJ L 176, 10.7.1999, p. 36.
(4) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31).
(5) OJ L 53, 27.2.2008, p. 52.
(6) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1).
(7) OJ L 160, 18.6.2011, p. 21.
(8) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19).
(9) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).