# Official Journal L 387/2020

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 387 |
| | |
| English edition | Legislation | Volume 6319 November 2020 |

ISSN 1977-0677

Official Journal

of the European Union

L 387

English edition

Legislation

Volume 6319 November 2020

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2020/1727 of 18 November 2020 amending Implementing Regulation (EU) 2015/2447 as regards certain rules on Authorised Economic Operators | 1 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2020/1728 of 17 November 2020 on authorising methods for grading pig carcasses in Croatia
  (notified under document C(2020) 7880) | 3 |
| | * | Commission Implementing Decision (EU) 2020/1729 of 17 November 2020 on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria and repealing Implementing Decision 2013/652/EU
  (notified under document C(2020) 7894)

   (
  1
  ) | 8 |
| | * | Commission Decision (EU) 2020/1730 of 18 November 2020 confirming the participation of Ireland in Regulation (EU) 2017/1954 of the European Parliament and of the Council amending Council Regulation (EC) No 1030/2002 laying down a uniform format for residence permits for third-country nationals | 22 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2020/1727 of 18 November 2020 amending Implementing Regulation (EU) 2015/2447 as regards certain rules on Authorised Economic Operators

1

DECISIONS

*

Commission Implementing Decision (EU) 2020/1728 of 17 November 2020 on authorising methods for grading pig carcasses in Croatia
  (notified under document C(2020) 7880)

(notified under document C(2020) 7880)

3

*

Commission Implementing Decision (EU) 2020/1729 of 17 November 2020 on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria and repealing Implementing Decision 2013/652/EU
  (notified under document C(2020) 7894)

   (
  1
  )

(notified under document C(2020) 7894)

1

8

*

Commission Decision (EU) 2020/1730 of 18 November 2020 confirming the participation of Ireland in Regulation (EU) 2017/1954 of the European Parliament and of the Council amending Council Regulation (EC) No 1030/2002 laying down a uniform format for residence permits for third-country nationals

22

| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| 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. |
| --- | --- |

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.

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II Non-legislative acts

REGULATIONS

| 19.11.2020 | EN | Official Journal of the European Union | L 387/1 |
| --- | --- | --- | --- |

19.11.2020

EN

Official Journal of the European Union

L 387/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1727

of 18 November 2020

amending Implementing Regulation (EU) 2015/2447 as regards certain rules on Authorised Economic Operators

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 41 thereof,

Whereas:

| (1) | In order to ensure, for the purpose of granting the status of authorised economic operator, a uniform implementation of the criterion laid down in Article 39(a) of Regulation (EU) No 952/2013 (‘the Code’) on the absence of any serious or repeated infringements of customs legislation and taxation rules including no record of serious criminal offences, relating to the economic activity of the applicant, certain provisions of Article 24 of Commission Implementing Regulation (EU) 2015/2447 (2) need to be clarified. First, it is necessary to clarify that, as regards infringements, the criterion is fulfilled where no administrative or judicial authority has taken a decision concluding that one of the persons described in point (b) of Article 24(1) has committed such infringements over the previous three years. The facts giving rise to the infringements must have occurred in the previous three years, even though the administrative or judicial authority might in some cases conclude on those facts after those three years have elapsed. Second, it is necessary to clarify that the relevant serious or repeated infringements of customs legislation and taxation rules are those related to the economic activity of the persons described in point (b) in that Article. Third, it is necessary to clarify which persons other than the applicant must, depending on the organisational structure of the applicant, be assessed with respect to the criterion. |
| --- | --- |

(1)

In order to ensure, for the purpose of granting the status of authorised economic operator, a uniform implementation of the criterion laid down in Article 39(a) of Regulation (EU) No 952/2013 (‘the Code’) on the absence of any serious or repeated infringements of customs legislation and taxation rules including no record of serious criminal offences, relating to the economic activity of the applicant, certain provisions of Article 24 of Commission Implementing Regulation (EU) 2015/2447 (2) need to be clarified. First, it is necessary to clarify that, as regards infringements, the criterion is fulfilled where no administrative or judicial authority has taken a decision concluding that one of the persons described in point (b) of Article 24(1) has committed such infringements over the previous three years. The facts giving rise to the infringements must have occurred in the previous three years, even though the administrative or judicial authority might in some cases conclude on those facts after those three years have elapsed. Second, it is necessary to clarify that the relevant serious or repeated infringements of customs legislation and taxation rules are those related to the economic activity of the persons described in point (b) in that Article. Third, it is necessary to clarify which persons other than the applicant must, depending on the organisational structure of the applicant, be assessed with respect to the criterion.

| (2) | Implementing Regulation (EU) 2015/2447 should therefore be amended accordingly. |
| --- | --- |

(2)

Implementing Regulation (EU) 2015/2447 should therefore be amended accordingly.

| (3) | The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee, |
| --- | --- |

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Implementing Regulation (EU) 2015/2447

Article 24 of Implementing Regulation (EU) 2015/2447 is amended as follows:

| (1) | paragraph 1 is replaced by the following:

  ‘1.   The criterion laid down in Article 39(a) of the Code shall be considered to be fulfilled if,






  (a) | there is no decision taken by an administrative or judicial authority concluding that one of the persons described in point (b) has committed, over the last three years, a serious or repeated infringements of customs legislation or taxation rules in relation to his-her economic activity; and |
| --- | --- | --- |

(1)

paragraph 1 is replaced by the following:

‘1.   The criterion laid down in Article 39(a) of the Code shall be considered to be fulfilled if,

(a)

there is no decision taken by an administrative or judicial authority concluding that one of the persons described in point (b) has committed, over the last three years, a serious or repeated infringements of customs legislation or taxation rules in relation to his-her economic activity; and

| (b) | none of the following persons has a record of serious criminal offence in relation to his/her economic activity including the applicant’s economic activity, where applicable:






  (i) | the applicant, |
| --- | --- | --- |

(b)

none of the following persons has a record of serious criminal offence in relation to his/her economic activity including the applicant’s economic activity, where applicable:

(i)

the applicant,

| (ii) | the employee(s) in charge of the applicant’s customs matters, and |
| --- | --- |

(ii)

the employee(s) in charge of the applicant’s customs matters, and

| (iii) | the person(s) in charge of the applicant or exercising control over its management.’; |
| --- | --- |

(iii)

the person(s) in charge of the applicant or exercising control over its management.’;

| (2) | paragraph 3 is replaced by the following:

  ‘3.   Where the person referred to in paragraph 1(b) (iii), other than the applicant is established or has his/her residence in a third country, the customs authority competent to take the decision shall assess the fulfilment of the criterion referred to in Article 39(a) of the Code on the basis of the records and information that are available to it.’ |
| --- | --- |

(2)

paragraph 3 is replaced by the following:

‘3.   Where the person referred to in paragraph 1(b) (iii), other than the applicant is established or has his/her residence in a third country, the customs authority competent to take the decision shall assess the fulfilment of the criterion referred to in Article 39(a) of the Code on the basis of the records and information that are available to it.’

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, 18 November 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 269, 10.10.2013, p. 1.

1

(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).

2

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DECISIONS

| 19.11.2020 | EN | Official Journal of the European Union | L 387/3 |
| --- | --- | --- | --- |

19.11.2020

EN

Official Journal of the European Union

L 387/3

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COMMISSION IMPLEMENTING DECISION (EU) 2020/1728

of 17 November 2020

on authorising methods for grading pig carcasses in Croatia

(notified under document C(2020) 7880)

(Only the Croatian text is authentic)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 20(p) thereof,

Whereas:

| (1) | Point 1 of Section B.IV of Annex IV to Regulation (EU) No 1308/2013 provides that, for the classification of pig carcasses, the lean-meat content has to be assessed by means of grading methods authorised by the Commission and only statistically proven assessment methods based on the physical measurement of one or more anatomical parts of the pig carcass may be authorised. The authorisation of grading methods should be subject to compliance with a maximum tolerance for statistical error in assessment. That tolerance is defined in Part A of Annex V to Commission Delegated Regulation (EU) 2017/1182 (2). |
| --- | --- |

(1)

Point 1 of Section B.IV of Annex IV to Regulation (EU) No 1308/2013 provides that, for the classification of pig carcasses, the lean-meat content has to be assessed by means of grading methods authorised by the Commission and only statistically proven assessment methods based on the physical measurement of one or more anatomical parts of the pig carcass may be authorised. The authorisation of grading methods should be subject to compliance with a maximum tolerance for statistical error in assessment. That tolerance is defined in Part A of Annex V to Commission Delegated Regulation (EU) 2017/1182 (2).

| (2) | Croatia has requested the Commission to authorise five methods (‘Hennessy Grading Probe 2 (HGP2)’, ‘Hennessy Grading Probe 7 (HGP7)’, ‘OptiGrade-MCP’, ‘OptiScan-TP’ and ‘Manual method-ZP’). For that purpose, Croatia has presented a detailed description of the dissection trial, indicating the principles on which the methods are based, the results of its dissection trial and the equations used for assessing the percentage of lean meat in the protocol provided for in Article 11(3) of Delegated Regulation (EU) 2017/1182. |
| --- | --- |

(2)

Croatia has requested the Commission to authorise five methods (‘Hennessy Grading Probe 2 (HGP2)’, ‘Hennessy Grading Probe 7 (HGP7)’, ‘OptiGrade-MCP’, ‘OptiScan-TP’ and ‘Manual method-ZP’). For that purpose, Croatia has presented a detailed description of the dissection trial, indicating the principles on which the methods are based, the results of its dissection trial and the equations used for assessing the percentage of lean meat in the protocol provided for in Article 11(3) of Delegated Regulation (EU) 2017/1182.

| (3) | Examination of that request has revealed that the conditions for authorising the grading methods are fulfilled. These grading methods and formulas should therefore be authorised in Croatia. |
| --- | --- |

(3)

Examination of that request has revealed that the conditions for authorising the grading methods are fulfilled. These grading methods and formulas should therefore be authorised in Croatia.

| (4) | The measures provided for in this Decision are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets, |
| --- | --- |

(4)

The measures provided for in this Decision are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

HAS ADOPTED THIS DECISION:

Article 1

1.   The use of the following methods is authorised for grading pig carcasses pursuant to Point 1 of Section B.IV of Annex IV to Regulation (EU) No 1308/2013 in Croatia:

| (a) | the ‘Hennessy Grading Probe 2 (HGP2)’ apparatus and the assessment methods related thereto, details of which are set out in Part I of the Annex; |
| --- | --- |

(a)

the ‘Hennessy Grading Probe 2 (HGP2)’ apparatus and the assessment methods related thereto, details of which are set out in Part I of the Annex;

| (b) | the ‘Hennessy Grading Probe 7 (HGP7)’ apparatus and the assessment methods related thereto, details of which are set out in Part II of the Annex; |
| --- | --- |

(b)

the ‘Hennessy Grading Probe 7 (HGP7)’ apparatus and the assessment methods related thereto, details of which are set out in Part II of the Annex;

| (c) | the ‘OptiGrade-MCP’ apparatus and the assessment methods related thereto, details of which are set out in Part III of the Annex. |
| --- | --- |

(c)

the ‘OptiGrade-MCP’ apparatus and the assessment methods related thereto, details of which are set out in Part III of the Annex.

| (d) | the ‘OptiScan-TP’ and the assessment methods related thereto, details of which are set out in Part IV of the Annex. |
| --- | --- |

(d)

the ‘OptiScan-TP’ and the assessment methods related thereto, details of which are set out in Part IV of the Annex.

| (e) | the ‘manual method (ZP)’ with a ruler and the assessment methods related thereto, details of which are set out in Part V of the Annex. |
| --- | --- |

(e)

the ‘manual method (ZP)’ with a ruler and the assessment methods related thereto, details of which are set out in Part V of the Annex.

2.   The manual method ZP with a ruler and the assessment methods related thereto, referred to in point (e) of paragraph 1, shall only be authorised for slaughterhouses where the number of pigs slaughtered per week does not exceed 500, calculated as an annual average.

Article 2

Modifications of the authorised apparatuses or grading methods shall not be allowed unless explicitly authorised by Commission Implementing Decision.

Article 3

This Decision is addressed to the Republic of Croatia.

Done at Brussels, 17 November 2020.

For the Commission

Janusz WOJCIECHOWSKI

Member of the Commission

---

(1)  OJ L 347, 20.12.2013, p. 671.

1

(2)  Commission Delegated Regulation (EU) 2017/1182 of 20 April 2017 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the Union scales for the classification of beef, pig and sheep carcasses and as regards the reporting of market prices of certain categories of carcasses and live animals (OJ L 171, 4.7.2017, p. 74).

2

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ANNEX

Methods for grading pig carcasses in Croatia

PART I

Hennessy Grading Probe 2 (HGP 2)

| 1. | The rules provided for in this part shall apply when the grading of pig carcasses is carried out by means of the apparatus known as ‘Hennessy Grading Probe 2 (HGP 2)’. |
| --- | --- |

1.

| 2. | The apparatus shall be equipped with a probe of 5,95 millimetres diameter (and of 6,3 millimetres at the blade on top of the probe) containing a photodiode (Siemens LED of the type LYU 260-EO and photodetector of the type 58 MR) and having an operating distance of between 0 and 120 millimetres. |
| --- | --- |

2.

| 3. | The lean meat content of a carcass shall be calculated according to the following formula: | LMPHGP 2 = 68,54165 – (0,7727577 × F) + (0,008924575 × M) |
| --- | --- | --- |

3.

LMPHGP 2 = 68,54165 – (0,7727577 × F) + (0,008924575 × M)

where:

| LMPHGP 2 | = | the estimated percentage of lean meat in a carcass; |
| --- | --- | --- |
| F | = | the thickness of backfat (including rind) in millimetres, measured 7 centimetres off the split line on the outside and 4 cm off the split line on the inside between the second and third last rib; |
| M | = | the thickness of muscle in millimetres, measured at the same time and in the same place as F. |

LMPHGP 2

=

the estimated percentage of lean meat in a carcass;

F

=

the thickness of backfat (including rind) in millimetres, measured 7 centimetres off the split line on the outside and 4 cm off the split line on the inside between the second and third last rib;

M

=

the thickness of muscle in millimetres, measured at the same time and in the same place as F.

| 4. | This formula shall be valid for carcasses weighing between 60 and 120 kilograms (warm weight). |
| --- | --- |

4.

PART II

Hennessy Grading Probe 7 (HGP 7)

| 1. | The rules provided for in this part shall apply when the grading of pig carcasses is carried out by means of the apparatus known as ‘Hennessy Grading Probe 7 (HGP 7)’. |
| --- | --- |

1.

| 2. | The apparatus shall be equipped with a probe of 5,95 millimetres diameter (and of 6,3 millimetres at the blade on top of the probe) containing a photodiode (Siemens LED of the type LYU 260-EO and photodetector of the type 58 MR) and having an operating distance of between 0 and 120 millimetres. |
| --- | --- |

2.

| 3. | The lean meat content of a carcass shall be calculated according to the following formula: | LMPHGP 7 = 66,92177 – (0,7505144 × F) + (0,03170816 × M) |
| --- | --- | --- |

3.

LMPHGP 7 = 66,92177 – (0,7505144 × F) + (0,03170816 × M)

where:

| LMPHGP 7 | = | the estimated percentage of lean meat in a carcass; |
| --- | --- | --- |
| F | = | the thickness of backfat (including rind) in millimetres, measured 7 centimetres off the split line on the outside and 4 cm off the split line on the inside between the second and third last rib; |
| M | = | the thickness of muscle in millimetres, measured at the same time and in the same place as F. |

LMPHGP 7

=

the estimated percentage of lean meat in a carcass;

F

=

the thickness of backfat (including rind) in millimetres, measured 7 centimetres off the split line on the outside and 4 cm off the split line on the inside between the second and third last rib;

M

=

the thickness of muscle in millimetres, measured at the same time and in the same place as F.

| 4. | This formula shall be valid for carcasses weighing between 60 and 120 kilograms (warm weight). |
| --- | --- |

4.

PART III

OptiGrade-MCP

| 1. | The rules provided for in this part shall apply when the grading of pig carcasses is carried out by means of the apparatus known as ‘OptiGrade-MCP’. |
| --- | --- |

1.

| 2. | The apparatus shall be equipped with an optical probe of 6 mm in diameter, one infrared photodiode (Siemens) and a photo transistor (Siemens). The operating distance shall be between 0 and 110 mm. |
| --- | --- |

2.

| 3. | The lean meat content of a carcass shall be calculated according to the following formula: | LMPMCP = 66,863 – (0,6809437 × F) + (0,02633554 × M) |
| --- | --- | --- |

3.

LMPMCP = 66,863 – (0,6809437 × F) + (0,02633554 × M)

where:

| LMPMCP | = | the estimated percentage of lean meat in a carcass; |
| --- | --- | --- |
| F | = | the thickness of backfat (including rind) in millimetres, measured 7 centimetres off the split line on the outside and 4 cm off the split line on the inside between the second and third last rib; |
| M | = | the thickness of muscle in millimetres, measured at the same time and in the same place as F. |

LMPMCP

=

the estimated percentage of lean meat in a carcass;

F

=

the thickness of backfat (including rind) in millimetres, measured 7 centimetres off the split line on the outside and 4 cm off the split line on the inside between the second and third last rib;

M

=

the thickness of muscle in millimetres, measured at the same time and in the same place as F.

| 4. | This formula shall be valid for carcasses weighing between 60 and 120 kilograms (warm weight). |
| --- | --- |

4.

PART IV

OptiScan-TP

| 1. | The rules provided for in this part shall apply when the grading of pig carcasses is carried out by means of the apparatus known as ‘OptiScan TP’. |
| --- | --- |

1.

| 2. | The OptiScan-TP apparatus shall be equipped with a digital imager taking an illuminated photo of the two measurement points on the carcasses. The images shall be the base for the calculation of fat and muscle thickness. The results of the measurements shall be converted into estimated lean meat content by means of the Optiscan-TP apparatus itself. The photos are saved and can later be controlled. The integrated Bluetooth® interface permits easy data transfer. |
| --- | --- |

2.

| 3. | The lean meat content of a carcass shall be calculated according to the following formula: | LMPTP = 66,52167 – (0,5215984 × F) + (0, 01604653 × M) |
| --- | --- | --- |

3.

LMPTP = 66,52167 – (0,5215984 × F) + (0, 01604653 × M)

where:

| LMPTP | = | the estimated percentage of lean meat in a carcass; |
| --- | --- | --- |
| F | = | the minimal thickness of visible fat (including rind) in millimetres, on the midline of the split carcass, covering the muscle gluteus medius; |
| M | = | the minimal muscle depth between the anterior extremity of the muscle gluteus medius and the dorsal part of the medullar canal |

LMPTP

=

the estimated percentage of lean meat in a carcass;

F

=

the minimal thickness of visible fat (including rind) in millimetres, on the midline of the split carcass, covering the muscle gluteus medius;

M

=

the minimal muscle depth between the anterior extremity of the muscle gluteus medius and the dorsal part of the medullar canal

| 4. | This formula shall be valid for carcasses weighing between 60 and 120 kilograms (warm weight). |
| --- | --- |

4.

PART V

Manual method (ZP)

| 1. | The rules provided for in this part shall apply when the grading of pig carcasses is carried out by means of the ‘manual method (ZP)’ measuring by ruler. |
| --- | --- |

1.

| 2. | This method may be implemented using a ruler, with the grading determined on the basis of the prediction equation. It is based on the manual measurement on the midline of the split carcass of the thickness of the fat and of the thickness of the muscle. |
| --- | --- |

2.

| 3. | The lean meat content of a carcass shall be calculated according to the following formula: | LMPZP = 66,18242 – (0, 5312573 × F) + (0,02048905 × M) |
| --- | --- | --- |

3.

LMPZP = 66,18242 – (0, 5312573 × F) + (0,02048905 × M)

where:

| LMPZP | = | the estimated percentage of lean meat in a carcass; |
| --- | --- | --- |
| F | = | the minimal thickness of visible fat (including rind) in millimetres, on the midline of the split carcass, covering the muscle gluteus medius; |
| M | = | the minimal muscle depth between the anterior extremity of the muscle gluteus medius and the dorsal part of the medullar canal |

LMPZP

=

the estimated percentage of lean meat in a carcass;

F

=

the minimal thickness of visible fat (including rind) in millimetres, on the midline of the split carcass, covering the muscle gluteus medius;

M

=

the minimal muscle depth between the anterior extremity of the muscle gluteus medius and the dorsal part of the medullar canal

| 4. | This formula shall be valid for carcasses weighing between 60 and 120 kilograms (warm weight). |
| --- | --- |

4.

---

| 19.11.2020 | EN | Official Journal of the European Union | L 387/8 |
| --- | --- | --- | --- |

19.11.2020

EN

Official Journal of the European Union

L 387/8

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COMMISSION IMPLEMENTING DECISION (EU) 2020/1729

of 17 November 2020

on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria and repealing Implementing Decision 2013/652/EU

(notified under document C(2020) 7894)

(Only the English version is authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (1), and in particular Articles 4(5), 7(3), 8(3) and the fourth subparagraph of Article 9(1) thereof,

Whereas:

| (1) | Directive 2003/99/EC requires Member States to ensure that monitoring provides comparable data on the occurrence of antimicrobial resistance (‘AMR’) in zoonotic agents and, in so far they present a threat to public health, other agents. |
| --- | --- |

(1)

Directive 2003/99/EC requires Member States to ensure that monitoring provides comparable data on the occurrence of antimicrobial resistance (‘AMR’) in zoonotic agents and, in so far they present a threat to public health, other agents.

| (2) | Directive 2003/99/EC also requires Member States to assess the trends and sources of AMR in their territory and to transmit a report every year covering data collected in accordance with that Directive to the Commission. |
| --- | --- |

(2)

Directive 2003/99/EC also requires Member States to assess the trends and sources of AMR in their territory and to transmit a report every year covering data collected in accordance with that Directive to the Commission.

| (3) | Commission Implementing Decision 2013/652/EU (2) lays down detailed rules for the harmonised monitoring and reporting of AMR in zoonotic and commensal bacteria. These rules are applicable until 31 December 2020. |
| --- | --- |

(3)

Commission Implementing Decision 2013/652/EU (2) lays down detailed rules for the harmonised monitoring and reporting of AMR in zoonotic and commensal bacteria. These rules are applicable until 31 December 2020.

| (4) | In its Communication of 29 June 2017 to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance’ (3), the Commission committed to review Union implementing legislation, namely Implementing Decision 2013/652/EU, concerned with the monitoring of AMR in zoonotic and commensal bacteria in farm animals and food to take into account new scientific developments and data collection needs. |
| --- | --- |

(4)

In its Communication of 29 June 2017 to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance’ (3), the Commission committed to review Union implementing legislation, namely Implementing Decision 2013/652/EU, concerned with the monitoring of AMR in zoonotic and commensal bacteria in farm animals and food to take into account new scientific developments and data collection needs.

| (5) | From 2015 to 2018, the Commission carried out a series of audits in Member States for the purposes of evaluating the implementation of Implementing Decision 2013/652/EU by competent authorities. A final overview report (4) summarising this series of audits highlighted certain implementation challenges faced by Member States that should be taken into account by the Commission when revising Implementing Decision 2013/652/EU. |
| --- | --- |

(5)

From 2015 to 2018, the Commission carried out a series of audits in Member States for the purposes of evaluating the implementation of Implementing Decision 2013/652/EU by competent authorities. A final overview report (4) summarising this series of audits highlighted certain implementation challenges faced by Member States that should be taken into account by the Commission when revising Implementing Decision 2013/652/EU.

| (6) | On 5 June 2019, the European Food Safety Authority (‘EFSA’) published a scientific report entitled ‘Technical specifications on harmonised monitoring of antimicrobial resistance in zoonotic and indicator bacteria from food‐producing animals and food’ (5). This report recommends specific adaptations to the current AMR monitoring and reporting system as laid down in Implementing Decision 2013/652/EU in order to respond effectively to the constantly evolving threat of AMR and to ensure continuity in assessing future trends in AMR from 2021. These recommended adaptations primarily concern adaptations as to the food-producing animal populations or food categories to be sampled, the sampling design to be followed, the bacterial species to be tested for AMR and the analytical methods to be used by laboratories in charge of testing for AMR. |
| --- | --- |

(6)

On 5 June 2019, the European Food Safety Authority (‘EFSA’) published a scientific report entitled ‘Technical specifications on harmonised monitoring of antimicrobial resistance in zoonotic and indicator bacteria from food‐producing animals and food’ (5). This report recommends specific adaptations to the current AMR monitoring and reporting system as laid down in Implementing Decision 2013/652/EU in order to respond effectively to the constantly evolving threat of AMR and to ensure continuity in assessing future trends in AMR from 2021. These recommended adaptations primarily concern adaptations as to the food-producing animal populations or food categories to be sampled, the sampling design to be followed, the bacterial species to be tested for AMR and the analytical methods to be used by laboratories in charge of testing for AMR.

| (7) | In order to continue to obtain comparable and reliable data on AMR, it is important to take recommendations of the EFSA scientific report of 5 June 2019 into account when defining the most relevant combinations of bacterial species, food producing animal species and food products to be included in the harmonised monitoring and reporting of AMR from 2021. It is also appropriate to minimise the burden on competent authorities of Member States to the extent possible, notably by addressing known implementation challenges and by focussing AMR monitoring on biological samples or bacterial isolates collected within the framework of existing national control programmes. |
| --- | --- |

(7)

In order to continue to obtain comparable and reliable data on AMR, it is important to take recommendations of the EFSA scientific report of 5 June 2019 into account when defining the most relevant combinations of bacterial species, food producing animal species and food products to be included in the harmonised monitoring and reporting of AMR from 2021. It is also appropriate to minimise the burden on competent authorities of Member States to the extent possible, notably by addressing known implementation challenges and by focussing AMR monitoring on biological samples or bacterial isolates collected within the framework of existing national control programmes.

| (8) | Whole genome sequencing (‘WGS’) is a promising technique to replace conventional phenotypical testing in microbiology and is increasingly used worldwide. However, only a limited number of Member States are currently able to use WGS for AMR monitoring on a routine basis. It is therefore appropriate to authorise the use of WGS as an alternative to the conventional phenotypical techniques on a voluntary basis only, but to impose technical conditions on the WGS technique to ensure data comparability. |
| --- | --- |

(8)

Whole genome sequencing (‘WGS’) is a promising technique to replace conventional phenotypical testing in microbiology and is increasingly used worldwide. However, only a limited number of Member States are currently able to use WGS for AMR monitoring on a routine basis. It is therefore appropriate to authorise the use of WGS as an alternative to the conventional phenotypical techniques on a voluntary basis only, but to impose technical conditions on the WGS technique to ensure data comparability.

| (9) | AMR is a global threat that can easily spread across borders. Therefore, in order to improve coordination and gain a deeper understanding of how to help reduce the impact of AMR impact globally, it is essential that food products imported into the Union are also subjected to AMR monitoring requirements. |
| --- | --- |

(9)

AMR is a global threat that can easily spread across borders. Therefore, in order to improve coordination and gain a deeper understanding of how to help reduce the impact of AMR impact globally, it is essential that food products imported into the Union are also subjected to AMR monitoring requirements.

| (10) | In order to ensure continuity of the harmonised AMR monitoring and reporting by Member States after the period covered by Implementing Decision 2013/652/EU, this Decision should apply from 1 January 2021. |
| --- | --- |

(10)

In order to ensure continuity of the harmonised AMR monitoring and reporting by Member States after the period covered by Implementing Decision 2013/652/EU, this Decision should apply from 1 January 2021.

| (11) | For the sake of legal clarity, Implementing Decision 2013/652/EU should be repealed. |
| --- | --- |

(11)

For the sake of legal clarity, Implementing Decision 2013/652/EU should be repealed.

| (12) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(12)

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

HAS ADOPTED THIS DECISION:

Article 1

Subject matter and scope

1.   This Decision lays down harmonised rules for the period 2021-2027 for the monitoring and reporting of antimicrobial resistance (‘AMR’) to be carried out by Member States in accordance with Article 7(3) and 9(1) of Directive 2003/99/EC and Annex II (B) and Annex IV thereto.

2.   The monitoring and reporting of AMR shall cover the following bacteria:

| (a) | Salmonella spp.; |
| --- | --- |

(a)

Salmonella spp.;

| (b) | Campylobacter coli (C. coli); |
| --- | --- |

(b)

Campylobacter coli (C. coli);

| (c) | Campylobacter jejuni (C. jejuni); |
| --- | --- |

(c)

Campylobacter jejuni (C. jejuni);

| (d) | Indicator commensal Escherichia coli (E. coli); |
| --- | --- |

(d)

Indicator commensal Escherichia coli (E. coli);

| (e) | Salmonella spp. and E. coli producing the following enzymes:






  (i) | Extended Spectrum β-Lactamases (ESBL); |
| --- | --- | --- |

(e)

Salmonella spp. and E. coli producing the following enzymes:

(i)

Extended Spectrum β-Lactamases (ESBL);

| (ii) | AmpC β-Lactamases (AmpC); |
| --- | --- |

(ii)

AmpC β-Lactamases (AmpC);

| (iii) | Carbapenemases (CP). |
| --- | --- |

(iii)

Carbapenemases (CP).

3.   The monitoring and reporting of AMR may cover indicator commensal Enterococcus faecalis (E. faecalis) and Enterococcus faecium (E. faecium).

4.   The monitoring and reporting of AMR shall cover the following food-producing animal populations and food:

| (a) | broilers; |
| --- | --- |

(a)

broilers;

| (b) | laying hens; |
| --- | --- |

(b)

laying hens;

| (c) | fattening turkeys; |
| --- | --- |

(c)

fattening turkeys;

| (d) | bovine animals under one year of age; |
| --- | --- |

(d)

bovine animals under one year of age;

| (e) | fattening pigs; |
| --- | --- |

(e)

fattening pigs;

| (f) | fresh meat from broilers; |
| --- | --- |

(f)

fresh meat from broilers;

| (g) | fresh meat from turkeys; |
| --- | --- |

(g)

fresh meat from turkeys;

| (h) | fresh meat from pigs; |
| --- | --- |

(h)

fresh meat from pigs;

| (i) | fresh meat from bovine animals. |
| --- | --- |

(i)

fresh meat from bovine animals.

5.   Member States shall monitor and report AMR in specific combinations of bacteria/antimicrobial substances/food-producing animal populations and fresh meat derived thereof in accordance with Articles 3 and 4.

Article 2

Definitions

For the purposes of this Decision, the following definitions shall apply:

| (a) | the definitions laid down in Regulation (EU) 2017/625 of the European Parliament and of the Council (6); |
| --- | --- |

(a)

the definitions laid down in Regulation (EU) 2017/625 of the European Parliament and of the Council (6);

| (b) | the definitions laid down in Commission Regulation (EC) No 2073/2005 (7); |
| --- | --- |

(b)

the definitions laid down in Commission Regulation (EC) No 2073/2005 (7);

| (c) | the definitions laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council (8); |
| --- | --- |

(c)

the definitions laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council (8);

| (d) | the definitions laid down in Regulation (EC) No 2160/2003 of the European Parliament and of the Council (9); |
| --- | --- |

(d)

the definitions laid down in Regulation (EC) No 2160/2003 of the European Parliament and of the Council (9);

| (e) | the definitions laid down in Directive 2003/99/EC; |
| --- | --- |

(e)

the definitions laid down in Directive 2003/99/EC;

| (f) | the definitions laid down in Regulation (EU) 2019/6 of the European Parliament and of the Council (10); |
| --- | --- |

(f)

the definitions laid down in Regulation (EU) 2019/6 of the European Parliament and of the Council (10);

| (g) | ‘slaughter batch’ means a group of animals originating from the same herd, raised together under the same conditions and sent to the slaughterhouse on the same day. |
| --- | --- |

(g)

‘slaughter batch’ means a group of animals originating from the same herd, raised together under the same conditions and sent to the slaughterhouse on the same day.

Article 3

Sampling framework and analysis

1.   Member States shall sample the different food-producing animal populations and fresh meat derived thereof, as referred to in Article 1(4), and test the bacterial isolates obtained therefrom for antimicrobial susceptibility in accordance with the technical requirements set out in Part A of the Annex.

However, for the monitoring of Salmonella spp. in populations of broilers, laying hens and fattening turkeys, Member States may use bacterial isolates already obtained within the sampling framework of the national control programmes provided for in Article 5 of Regulation (EC) No 2160/2003.

2.   National reference laboratories for AMR, or other laboratories designated by the competent authority in accordance with Article 37 of Regulation (EU) 2017/625, shall be responsible for carrying-out:

| (a) | the antimicrobial susceptibility testing of bacterial isolates, referred to in paragraph 1, in accordance with the technical requirements set out in point 4 of Part A of the Annex; |
| --- | --- |

(a)

the antimicrobial susceptibility testing of bacterial isolates, referred to in paragraph 1, in accordance with the technical requirements set out in point 4 of Part A of the Annex;

| (b) | the specific monitoring of ESBL-, AmpC- or CP-producing E. coli in accordance with the technical requirements set out in point 5 of Part A of the Annex; |
| --- | --- |

(b)

the specific monitoring of ESBL-, AmpC- or CP-producing E. coli in accordance with the technical requirements set out in point 5 of Part A of the Annex;

| (c) | the alternative method referred to in point 6 of Part A of the Annex. |
| --- | --- |

(c)

the alternative method referred to in point 6 of Part A of the Annex.

Article 4

Annual AMR reporting and assessment

Member States shall report the results of their AMR monitoring to the Commission annually, in accordance with the requirements of Part B of the Annex.

Member States shall also assess the results of their annual AMR monitoring and include that assessment in the report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance provided for in Article 9(1) of Directive 2003/99/EC.

Article 5

Publication of the data

The European Food Safety Authority shall publish the national isolate-based quantitative antimicrobial resistance data and results of the analyses reported in accordance with Article 4.

Article 6

Repeal

Implementing Decision 2013/652/EU is hereby repealed.

Article 7

Application

This Decision shall apply from 1 January 2021.

Article 8

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 17 November 2020.

For the Commission

Stella KYRIAKIDES

Member of the Commission

---

(1)  OJ L 325, 12.12.2003, p. 31.

1

(2)  Commission Implementing Decision 2013/652/EU of 12 November 2013 on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria (OJ L 303, 14.11.2013, p. 26).

2

(3)  COM/2017/0339 final.

3

(4)  DG(SANTE) 2019-6789.

4

(5)  EFSA Journal 2019;17(6):5709.

5

EFSA Journal

(6)  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).

6

(7)  Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1)

7

(8)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).

8

(9)  Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1).

9

(10)  Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).

10

---

ANNEX

PART A

Sampling framework and analysis

1.   Origin of bacterial isolates subject to antimicrobial susceptibility testing

Member States shall obtain bacterial isolates for AMR monitoring from at least each of the following combinations of isolates/food-producing animal populations/food:

| (a) | Salmonella spp. isolates obtained from:






  (i) | samples of each population of laying hens, broilers and fattening turkeys taken in the framework of the national control programmes provided for in Article 5 of Regulation (EC) No 2160/2003; |
| --- | --- | --- |

(a)

Salmonella spp. isolates obtained from:

(i)

samples of each population of laying hens, broilers and fattening turkeys taken in the framework of the national control programmes provided for in Article 5 of Regulation (EC) No 2160/2003;

| (ii) | samples of caecal content taken at slaughter from fattening pigs, except for Member States implementing a national programme for the control of salmonella which has been approved at EU level; |
| --- | --- |

(ii)

samples of caecal content taken at slaughter from fattening pigs, except for Member States implementing a national programme for the control of salmonella which has been approved at EU level;

| (iii) | samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year; |
| --- | --- |

(iii)

samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year;

| (iv) | samples of fresh meat of broilers and turkeys taken at the border control posts. |
| --- | --- |

(iv)

samples of fresh meat of broilers and turkeys taken at the border control posts.

| (b) | C. coli and C. jejuni isolates obtained from






  (i) | samples of caecal content taken at slaughter from broilers; |
| --- | --- | --- |

(b)

C. coli and C. jejuni isolates obtained from

(i)

samples of caecal content taken at slaughter from broilers;

| (ii) | samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year; |
| --- | --- |

(ii)

samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year;

| (iii) | samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year; |
| --- | --- |

(iii)

samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year;

| (iv) | samples of caecal content taken at slaughter from fattening pigs. |
| --- | --- |

(iv)

samples of caecal content taken at slaughter from fattening pigs.

| (c) | Indicator commensal E. coli isolates obtained from:






  (i) | samples of caecal content taken at slaughter from broilers; |
| --- | --- | --- |

(c)

Indicator commensal E. coli isolates obtained from:

(i)

samples of caecal content taken at slaughter from broilers;

| (ii) | samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year; |
| --- | --- |

(ii)

samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year;

| (iii) | samples of caecal content taken at slaughter from fattening pigs; |
| --- | --- |

(iii)

samples of caecal content taken at slaughter from fattening pigs;

| (iv) | samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year; |
| --- | --- |

(iv)

samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year;

| (v) | samples of fresh meat of broilers, turkeys, pigs and bovine animals taken at the border control posts. |
| --- | --- |

(v)

samples of fresh meat of broilers, turkeys, pigs and bovine animals taken at the border control posts.

| (d) | ESBL- or AmpC- or CP-producing E. coli isolates obtained from:






  (i) | samples of caecal content taken at slaughter from broilers; |
| --- | --- | --- |

(d)

ESBL- or AmpC- or CP-producing E. coli isolates obtained from:

(i)

samples of caecal content taken at slaughter from broilers;

| (ii) | samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year; |
| --- | --- |

(ii)

samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year;

| (iii) | samples of caecal content taken at slaughter from fattening pigs; |
| --- | --- |

(iii)

samples of caecal content taken at slaughter from fattening pigs;

| (iv) | samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year; |
| --- | --- |

(iv)

samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year;

| (v) | samples of fresh meat of broilers, turkeys, pigs and bovine animals taken at retail; |
| --- | --- |

(v)

samples of fresh meat of broilers, turkeys, pigs and bovine animals taken at retail;

| (vi) | samples of fresh meat of broilers, turkeys, pigs and bovine animals taken at the border control posts. |
| --- | --- |

(vi)

samples of fresh meat of broilers, turkeys, pigs and bovine animals taken at the border control posts.

| (e) | Where a Member State decides to monitor indicator commensal E. faecalis and E. faecium in accordance with Article 1(3), isolates of these bacteria obtained from:






  (i) | samples of caecal content taken at slaughter from broilers; |
| --- | --- | --- |

(e)

Where a Member State decides to monitor indicator commensal E. faecalis and E. faecium in accordance with Article 1(3), isolates of these bacteria obtained from:

(i)

samples of caecal content taken at slaughter from broilers;

| (ii) | samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year; |
| --- | --- |

(ii)

samples of caecal content taken at slaughter from fattening turkeys where the national production of turkey meat is more than 10 000 tonnes per year;

| (iii) | samples of caecal content taken at slaughter from fattening pigs; |
| --- | --- |

(iii)

samples of caecal content taken at slaughter from fattening pigs;

| (iv) | samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year. |
| --- | --- |

(iv)

samples of caecal content taken at slaughter from bovine animals under one year of age where the national production of meat of those bovine animals is more than 10 000 tonnes per year.

2.   Sampling frequency

Member States shall carry out the AMR monitoring of each combination of bacterial isolates/food-producing animal populations/food, as listed in point 1, in accordance with the following rotational system:

| (a) | In the years 2021, 2023, 2025 and 2027: AMR monitoring shall be carried out in fattening pigs, bovine animals under one year of age, pig meat and bovine meat. |
| --- | --- |

(a)

In the years 2021, 2023, 2025 and 2027: AMR monitoring shall be carried out in fattening pigs, bovine animals under one year of age, pig meat and bovine meat.

| (b) | In the years 2022, 2024 and 2026: AMR monitoring shall be carried out in laying hens, broilers, fattening turkeys and fresh meat derived from broilers and turkeys. |
| --- | --- |

(b)

In the years 2022, 2024 and 2026: AMR monitoring shall be carried out in laying hens, broilers, fattening turkeys and fresh meat derived from broilers and turkeys.

3.   Sampling design and sample size

3.1.   At slaughterhouse level

(a)   Sampling design:

When designing their sampling plan at slaughterhouse level, Member States shall take into account EFSA technical specifications on randomised sampling for harmonised monitoring of antimicrobial resistance in zoonotic and commensal bacteria (1).

Member States shall ensure a proportionate stratified sampling of samples of caecal content in slaughterhouses processing at least 60 % of the specific domestic animal population in the Member States with an even distribution over the monitoring period of the samples taken, and, to the extent possible, a randomisation of the sampling days of each month. The samples shall be taken from healthy animals sampled from randomly selected epidemiological units. The epidemiological unit for broilers and fattening turkeys is the flock. The epidemiological unit for fattening pigs and bovine animals under one year of age is the slaughter batch. Only one sample from the same epidemiological unit shall be taken per year. Each sample shall be taken from one carcass randomly selected from the epidemiological unit. However, for broilers, each sample shall be taken from ten carcasses randomly selected from the epidemiological unit.

The number of samples collected per slaughterhouse shall be proportional to the annual throughput of each slaughterhouse covered by the sampling plan.

(b)   Sample size:

In order to test for antimicrobial susceptibility the required minimum number of bacterial isolates referred to in point 4.1, Member States shall take annually a sufficient number of samples referred to in points 1(a)(ii) and (iii), 1(b) and 1(c)(i) to (iv) by accounting for the estimated prevalence of the bacterial species monitored in the animal population considered.

By way of derogation, when the prevalence of the bacterial species monitored is known to be inferior or equal to 30 % in the animal population considered or when this prevalence is unknown in the first year of the monitoring or when the number of epidemiological units available for sampling is insufficient to prevent the repeated sampling of the same units, Member States may decide to limit to 300 the annual number of samples to be taken. This annual number can be further reduced to 150 for each specific combination of bacterial isolates/animal populations where Member States have an annual national production of less than 100 000 tonnes of broiler meat, less than 100 000 tonnes of turkey meat, less than 100 000 tonnes of pig meat or less than 50 000 tonnes of bovine meat. Member States making use of the possibility of limitation of the annual number of samples shall base their decision on documented evidence, such as results of surveys, and shall submit this evidence to the Commission before implementing the reduced sampling for the first time.

Member States shall take annually at least 300 samples from each animal population referred to in points 1(d)(i) to (iv). By way of derogation, where Member States have an annual national production of less than 100 000 tonnes of broiler meat, less than 100 000 tonnes of turkey meat, less than 100 000 tonnes of pig meat or less than 50 000 tonnes of bovine meat, they may decide to take a minimum of 150 samples instead of 300 samples for each specific animal population considered.

3.2.   At retail level

(a)   Sampling design:

When designing their sampling plan at retail level, Member States shall take into account EFSA technical specifications on randomised sampling for harmonised monitoring of antimicrobial resistance in zoonotic and commensal bacteria (2).

Member States shall ensure a proportionate stratified sampling of samples of the fresh meat taken at retail without pre-selecting samples based on the origin of the food, with a proportional allocation of the number of samples to the population of the geographical region. They shall also ensure an even distribution over the monitoring year of the samples of fresh meat and, to the extent possible, a randomisation of the sampling days of each month. The batches to be sampled on a given day shall be randomly selected.

(b)   Sample size:

Member States shall take 300 samples from each fresh meat category referred to in point 1(d)(v). By way of derogation, where Member States have an annual production of less than 100 000 tonnes of broiler meat, less than 100 000 tonnes of turkey meat, less than 100 000 tonnes of pig meat or less than 50 000 tonnes of bovine meat, they may decide to take 150 samples instead of 300 samples for each specific category of fresh meat considered.

3.3.   At border control posts

(a)   Sampling design:

When designing their sampling plan at border control posts, Member States shall take into account EFSA technical specifications on randomised sampling for harmonised monitoring of antimicrobial resistance in zoonotic and commensal bacteria (3).

Member States shall ensure a proportionate stratified sampling of consignments and meat samples per border control post and country of origin with an even distribution over the monitoring year of the consignments of imported fresh meat sampled at border control posts level. All border control posts designated for fresh meat shall be included in the sampling plan. The consignments to be sampled on a given day shall be randomly selected and when sampling a consignment, samples shall be randomly taken. If a consignment is composed of different batches, the samples shall be taken from different batches. Samples shall not be pooled.

(b)   Sample size:

Member States shall determine the appropriate number of samples they shall take per year from each fresh meat category referred to in points 1(a)(iv), 1(c)(v) and 1(d)(vi) based on the indicative sampling frequency rates set out in Table 1.

Table 1

Fresh meat subject to AMR testing at import: indicative sampling frequency rates

| Type of fresh meat | Recommended annual sampling frequency rates of consignments arrived at the border control posts |
| --- | --- |
| Broiler meat | 3 % |
| Turkey meat | 15 % |
| Pig meat | 10 % |
| Bovine meat | 2 % |

Type of fresh meat

Recommended annual sampling frequency rates of consignments arrived at the border control posts

Broiler meat

3 %

Turkey meat

15 %

Pig meat

10 %

Bovine meat

2 %

4.   Antimicrobial susceptibility testing

4.1.   Number of isolates to be tested

Member States shall test for antimicrobial susceptibility the following number of isolates annually and ensure that no more than one isolate per bacterial species/Salmonella serovar from the same epidemiological unit is tested per year:

For Salmonella spp:

| — | up to 170 isolates obtained from samples referred to in point 1(a)(i). Where Member States have a national annual production of less than 100 000 tonnes of broiler meat, they may decide to set an upper limit of 85 isolates instead of 170 isolates. The isolates shall be obtained from healthy animals. Where the number of isolates yearly available per animal population in a Member State is higher than the upper limit, a random selection of those isolates shall be performed in a way that ensures a geographical representativeness and, where possible, an even distribution of the date of sampling over the year. When the number of isolates yearly available is lower than the upper limit, all of them shall be tested, |
| --- | --- |

—

up to 170 isolates obtained from samples referred to in point 1(a)(i). Where Member States have a national annual production of less than 100 000 tonnes of broiler meat, they may decide to set an upper limit of 85 isolates instead of 170 isolates. The isolates shall be obtained from healthy animals. Where the number of isolates yearly available per animal population in a Member State is higher than the upper limit, a random selection of those isolates shall be performed in a way that ensures a geographical representativeness and, where possible, an even distribution of the date of sampling over the year. When the number of isolates yearly available is lower than the upper limit, all of them shall be tested,

| — | at least 170 isolates obtained from samples referred to in point 1(a)(ii) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples. By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of pig meat, they may decide to test a minimum of 85 isolates instead of 170 isolates, |
| --- | --- |

—

at least 170 isolates obtained from samples referred to in point 1(a)(ii) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples. By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of pig meat, they may decide to test a minimum of 85 isolates instead of 170 isolates,

| — | at least 170 isolates obtained from samples referred to in point 1(a)(iii) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples, |
| --- | --- |

—

at least 170 isolates obtained from samples referred to in point 1(a)(iii) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples,

| — | all isolates obtained from samples referred to in point 1(a)(iv). |
| --- | --- |

—

all isolates obtained from samples referred to in point 1(a)(iv).

For C. coli and C. jejuni:

| — | at least 170 isolates of the nationally most prevalent species of Campylobacter (among C.
  coli and C.
  jejuni) obtained from samples referred to in point 1(b)(i) to (iii) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples. By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of broiler meat, they may decide to test a minimum of 85 isolates instead of 170 isolates, |
| --- | --- |

—

at least 170 isolates of the nationally most prevalent species of Campylobacter (among C.
  coli and C.
  jejuni) obtained from samples referred to in point 1(b)(i) to (iii) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples. By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of broiler meat, they may decide to test a minimum of 85 isolates instead of 170 isolates,

| — | up to 170 isolates of the nationally less prevalent species of Campylobacter (among C. coli and C. jejuni) identified while recovering the isolates of the most prevalent Campylobacter species obtained from samples referred to in point 1(b)(i) to (iii), |
| --- | --- |

—

up to 170 isolates of the nationally less prevalent species of Campylobacter (among C. coli and C. jejuni) identified while recovering the isolates of the most prevalent Campylobacter species obtained from samples referred to in point 1(b)(i) to (iii),

| — | at least 170 isolates of C. coli obtained from samples referred to in point 1(b)(iv) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples. By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of pig meat, they may decide to test a minimum of 85 isolates instead of 170 isolates. |
| --- | --- |

—

at least 170 isolates of C. coli obtained from samples referred to in point 1(b)(iv) or, for Member States making use of the derogation referred to in the second paragraph of point 3(1)(b), all isolates obtained from these samples. By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of pig meat, they may decide to test a minimum of 85 isolates instead of 170 isolates.

For indicator commensal E. coli:

| — | at least 170 isolates obtained from samples referred to in points 1(c)(i) to (iv). By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of broiler meat, less than 100 000 tonnes of turkey meat or less than 100 000 tonnes of pig meat, they may decide to test a minimum of 85 isolates instead of 170 isolates for each specific animal population considered, |
| --- | --- |

—

at least 170 isolates obtained from samples referred to in points 1(c)(i) to (iv). By way of derogation, where Member States have a national annual production of less than 100 000 tonnes of broiler meat, less than 100 000 tonnes of turkey meat or less than 100 000 tonnes of pig meat, they may decide to test a minimum of 85 isolates instead of 170 isolates for each specific animal population considered,

| — | all isolates obtained from samples referred to in point 1(c)(v). |
| --- | --- |

—

all isolates obtained from samples referred to in point 1(c)(v).

For ESBL-, AmpC- and CP- producing E. coli:

| — | all isolates obtained from samples referred to in point 1(d). |
| --- | --- |

—

all isolates obtained from samples referred to in point 1(d).

4.2.   Analytical methods for detection and antimicrobial susceptibility testing

Member States shall use the epidemiological cut-off values and the concentration ranges set out in Tables 2, 3 and 4 below to determine the antimicrobial susceptibility of Salmonella spp., C. coli, C. jejuni, indicator commensal E. coli, E. faecalis and E. faecium.

Any E. coli and Salmonella isolate tested in accordance with Table 2 showing resistance to cefotaxime or ceftazidime or meropenem shall be further tested with a second panel of antimicrobial substances in accordance with Table 5.

For the specific monitoring of ESBL-, AmpC- and/or CP-producing E. coli, Member States shall use the methods referred to in point 5.

The antimicrobial susceptibility testing shall be performed by the laboratories referred to in Article 3(2). The testing shall be performed by using the broth micro dilution method according to the reference method ISO 20776-1:2019.

Table 2

Panel of antimicrobial substances to be included in AMR monitoring, EUCAST thresholds for resistance and concentration ranges to be tested in Salmonella spp. and indicator commensal E. coli (First panel)

| Antimicrobial | Class of antimicrobial | Species | Interpretative thresholds of AMR (mg/L) | Range of concentrations (mg/L)
  (No of wells in brackets) |
| --- | --- | --- | --- | --- |
| ECOFF | Clinical breakpoint |
| Amikacin | Aminoglycoside | Salmonella | > 4 (*) | > 16 | 4-128 (6) |
| E. coli | > 8 | > 16 |
| Ampicillin | Penicillin | Salmonella | > 8 | > 8 | 1-32 (6) |
| E. coli | > 8 | > 8 |
| Azithromycin | Macrolide | Salmonella | NA | NA | 2-64 (6) |
| E. coli | NA | NA |
| Cefotaxime | Cephalosporin | Salmonella | > 0,5 | > 2 | 0,25-4 (5) |
| E, coli | > 0,25 | > 2 |
| Ceftazidime | Cephalosporin | Salmonella | > 2 | > 4 | 0,25-8 (6) |
| E, coli | > 0,5 | > 4 |
| Chloramphenicol | Phenicol | Salmonella | > 16 | > 8 | 8-64 (4) |
| E, coli | > 16 | > 8 |
| Ciprofloxacin | Fluoroquinolone | Salmonella | > 0,06 | > 0,06 | 0,015-8 (10) |
| E, coli | > 0,06 | > 0,5 |
| Colistin | Polymyxin | Salmonella | NA | > 2 | 1-16 (5) |
| E, coli | > 2 | > 2 |
| Gentamicin | Aminoglycoside | Salmonella | > 2 | > 4 | 0,5-16 (6) |
| E, coli | > 2 | > 4 |
| Meropenem | Carbapenem | Salmonella | > 0,125 | > 8 | 0,03-16 (10) |
| E, coli | > 0,125 | > 8 |
| Nalidixic acid | Quinolone | Salmonella | > 8 | NA | 4-64 (5) |
| E, coli | > 8 | NA |
| Sulfamethoxazole | Folate pathway antagonist | Salmonella | NA | NA | 8-512 (7) |
| E, coli | > 64 | NA |
| Tetracycline | Tetracycline | Salmonella | > 8 | NA | 2-32 (5) |
| E, coli | > 8 | NA |
| Tigecycline | Glycylcycline | Salmonella | NA | NA | 0,25-8 (6) |
| E, coli | > 0,5 | > 0,5 |
| Trimethoprim | Folate pathway antagonist | Salmonella | > 2 | > 4 | 0,25-16 (7) |
| E, coli | > 2 | > 4 |
| NA: not available. |

Antimicrobial

Class of antimicrobial

Species

Interpretative thresholds of AMR (mg/L)

Range of concentrations (mg/L)

(No of wells in brackets)

ECOFF

Clinical breakpoint

Amikacin

Aminoglycoside

Salmonella

> 4 (*)

> 16

4-128 (6)

E. coli

> 8

> 16

Ampicillin

Penicillin

Salmonella

> 8

> 8

1-32 (6)

E. coli

> 8

> 8

Azithromycin

Macrolide

Salmonella

NA

NA

2-64 (6)

E. coli

NA

NA

Cefotaxime

Cephalosporin

Salmonella

> 0,5

> 2

0,25-4 (5)

E, coli

> 0,25

> 2

Ceftazidime

Cephalosporin

Salmonella

> 2

> 4

0,25-8 (6)

E, coli

> 0,5

> 4

Chloramphenicol

Phenicol

Salmonella

> 16

> 8

8-64 (4)

E, coli

> 16

> 8

Ciprofloxacin

Fluoroquinolone

Salmonella

> 0,06

> 0,06

0,015-8 (10)

E, coli

> 0,06

> 0,5

Colistin

Polymyxin

Salmonella

NA

> 2

1-16 (5)

E, coli

> 2

> 2

Gentamicin

Aminoglycoside

Salmonella

> 2

> 4

0,5-16 (6)

E, coli

> 2

> 4

Meropenem

Carbapenem

Salmonella

> 0,125

> 8

0,03-16 (10)

E, coli

> 0,125

> 8

Nalidixic acid

Quinolone

Salmonella

> 8

NA

4-64 (5)

E, coli

> 8

NA

Sulfamethoxazole

Folate pathway antagonist

Salmonella

NA

NA

8-512 (7)

E, coli

> 64

NA

Tetracycline

Tetracycline

Salmonella

> 8

NA

2-32 (5)

E, coli

> 8

NA

Tigecycline

Glycylcycline

Salmonella

NA

NA

0,25-8 (6)

E, coli

> 0,5

> 0,5

Trimethoprim

Folate pathway antagonist

Salmonella

> 2

> 4

0,25-16 (7)

E, coli

> 2

> 4

NA: not available.

Table 3

Panel of antimicrobial substances to be included in AMR monitoring, EUCAST interpretative thresholds for resistance and concentration ranges to be tested in C. jejuni and C. coli

| Antimicrobial | Class of antimicrobial | Species | Interpretative thresholds of AMR (mg/L) | Range of concentrations (mg/L)
  (No of wells in brackets) |
| --- | --- | --- | --- | --- |
| ECOFF | Clinical breakpoint |
| Chloramphenicol | Phenicol | C. jejuni | > 16 | NA | 2-64 (6) |
| C. coli | > 16 | NA |
| Ciprofloxacin | Fluoroquinolone | C. jejuni | > 0,5 | > 0,5 | 0,12-32 (9) |
| C. coli | > 0,5 | > 0,5 |
| Ertapenem | Carbapenem | C. jejuni | NA | NA | 0,125-4 (6) |
| C. coli | NA | NA |
| Erythromycin | Macrolide | C. jejuni | > 4 | > 4 | 1-512 (10) |
| C. coli | > 8 | > 8 |
| Gentamicin | Aminoglycoside | C. jejuni | > 2 | NA | 0,25-16 (7) |
| C. coli | > 2 | NA |
| Tetracycline | Tetracycline | C. jejuni | > 1 | > 2 | 0,5-64 (8) |
| C. coli | > 2 | > 2 |
| NA: not available |

Antimicrobial

Class of antimicrobial

Species

Interpretative thresholds of AMR (mg/L)

Range of concentrations (mg/L)

(No of wells in brackets)

ECOFF

Clinical breakpoint

Chloramphenicol

Phenicol

C. jejuni

> 16

NA

2-64 (6)

C. coli

> 16

NA

Ciprofloxacin

Fluoroquinolone

C. jejuni

> 0,5

> 0,5

0,12-32 (9)

C. coli

> 0,5

> 0,5

Ertapenem

Carbapenem

C. jejuni

NA

NA

0,125-4 (6)

C. coli

NA

NA

Erythromycin

Macrolide

C. jejuni

> 4

> 4

1-512 (10)

C. coli

> 8

> 8

Gentamicin

Aminoglycoside

C. jejuni

> 2

NA

0,25-16 (7)

C. coli

> 2

NA

Tetracycline

Tetracycline

C. jejuni

> 1

> 2

0,5-64 (8)

C. coli

> 2

> 2

NA: not available

Table 4

Panel of antimicrobial substances to be included in AMR monitoring, EUCAST thresholds for resistance and concentration ranges to be tested in E. faecalis and E. faecium

| Antimicrobial | Class of antimicrobial | Species | Interpretative thresholds of AMR (mg/L) | Range of concentrations (mg/L)
  (No of wells in brackets) |
| --- | --- | --- | --- | --- |
| ECOFF | Clinical breakpoint |
| Ampicillin | Penicillin | E. faecalis | > 4 | > 8 | 0,5-64 (8) |
| E. faecium | > 4 | > 8 |
| Chloramphenicol | Phenicol | E. faecalis | > 32 | NA | 4-128 (6) |
| E. faecium | > 32 | NA |
| Ciprofloxacin | Fluoroquinolone | E. faecalis | > 4 | > 4 | 0,12-16 (8) |
| E. faecium | > 4 | > 4 |
| Daptomycin | Lipopeptide | E. faecalis | > 4 | NA | 0,25-32 (8) |
| E. faecium | > 8 | NA |
| Erythromycin | Macrolide | E. faecalis | > 4 | NA | 1-128 (8) |
| E. faecium | > 4 | NA |
| Gentamicin | Aminoglycoside | E. faecalis | > 64 | NA | 8-1 024 (8) |
| E. faecium | > 32 | NA |
| Linezolid | Oxazolidinone | E. faecalis | > 4 | > 4 | 0,5-64 (8) |
| E. faecium | > 4 | > 4 |
| Quinupristin/Dalfopristin | Streptogramin | E. faecalis | NA | NA | 0,5-64 (8) |
| E. faecium | NA | > 4 |
| Teicoplanin | Glycopeptide | E. faecalis | > 2 | > 2 | 0,5-64 (8) |
| E. faecium | > 2 | > 2 |
| Tetracycline | Tetracycline | E. faecalis | > 4 | NA | 1-128 (8) |
| E. faecium | > 4 | NA |
| Tigecycline | Glycylcycline | E. faecalis | > 0,25 | > 0,25 | 0,03-4 (8) |
| E. faecium | > 0,25 | > 0,25 |
| Vancomycin | Glycopeptide | E. faecalis | > 4 | > 4 | 1-128 (8) |
| E. faecium | > 4 | > 4 |
| NA: not available |

Antimicrobial

Class of antimicrobial

Species

Interpretative thresholds of AMR (mg/L)

Range of concentrations (mg/L)

(No of wells in brackets)

ECOFF

Clinical breakpoint

Ampicillin

Penicillin

E. faecalis

> 4

> 8

0,5-64 (8)

E. faecium

> 4

> 8

Chloramphenicol

Phenicol

E. faecalis

> 32

NA

4-128 (6)

E. faecium

> 32

NA

Ciprofloxacin

Fluoroquinolone

E. faecalis

> 4

> 4

0,12-16 (8)

E. faecium

> 4

> 4

Daptomycin

Lipopeptide

E. faecalis

> 4

NA

0,25-32 (8)

E. faecium

> 8

NA

Erythromycin

Macrolide

E. faecalis

> 4

NA

1-128 (8)

E. faecium

> 4

NA

Gentamicin

Aminoglycoside

E. faecalis

> 64

NA

8-1 024 (8)

E. faecium

> 32

NA

Linezolid

Oxazolidinone

E. faecalis

> 4

> 4

0,5-64 (8)

E. faecium

> 4

> 4

Quinupristin/Dalfopristin

Streptogramin

E. faecalis

NA

NA

0,5-64 (8)

E. faecium

NA

> 4

Teicoplanin

Glycopeptide

E. faecalis

> 2

> 2

0,5-64 (8)

E. faecium

> 2

> 2

Tetracycline

Tetracycline

E. faecalis

> 4

NA

1-128 (8)

E. faecium

> 4

NA

Tigecycline

Glycylcycline

E. faecalis

> 0,25

> 0,25

0,03-4 (8)

E. faecium

> 0,25

> 0,25

Vancomycin

Glycopeptide

E. faecalis

> 4

> 4

1-128 (8)

E. faecium

> 4

> 4

NA: not available

5.   Specific monitoring of ESBL- or AmpC- or CP-producing E. coli

5.1.   Methods for detection of presumptive ESBL- or AmpC- or CP-producing E. coli

For the purpose of estimating the proportion of samples containing presumptive ESBL- or AmpC- or CP-producing E. coli among the caecal and fresh meat samples collected in accordance with point 1(d), the laboratories referred to in Article 3(2) shall use detection methods detailed in the protocols of the EURL for AMR (4).

All presumptive ESBL- or AmpC- or CP-producing E. coli isolates identified through the methods referred to in above shall be tested with the first panel and the second panel of antimicrobial substances in accordance with Table 2 and Table 5 respectively.

Table 5

Panel of antimicrobial substances, EUCAST epidemiological cut-off values (ECOFFs) and clinical resistance breakpoints and concentrations ranges to be used for testing only Salmonella spp. and E. coli isolates resistant to cefotaxime or ceftazidime or meropenem – (Second panel)

| Antimicrobial | Class of antimicrobial | Species | Interpretative thresholds of AMR (mg/L) | Range of concentrations (mg/L)
  (No of wells in brackets) |
| --- | --- | --- | --- | --- |
| ECOFF | Clinical breakpoint |
| Cefepime | Cephalosporin | Salmonella | NA | > 4 | 0,06-32 (10) |
| E. coli | > 0,125 | > 4 |
| Cefotaxime | Cephalosporin | Salmonella | > 0,5 | > 2 | 0,25-64 (9) |
| E. coli | > 0,25 | > 2 |
| Cefotaxime + clavulanic acid | Cephalosporin/beta-lactamase inhibitor combination | Salmonella | NA | NA | 0,06-64 (11) |
| E. coli | > 0,25 | NA |
| Cefoxitin | Cephamycin | Salmonella | > 8 | NA | 0,5-64 (8) |
| E. coli | > 8 | NA |
| Ceftazidime | Cephalosporin | Salmonella | > 2 | > 4 | 0,25-128 (10) |
| E. coli | > 0,5 | > 4 |
| Ceftazidime + clavulanic acid | Cephalosporin//beta-lactamase inhibitor combination | Salmonella | NA | NA | 0,125-128 (11) |
| E. coli | > 0,5 | NA |
| Ertapenem | Carbapenem | Salmonella | NA | > 0,5 | 0,015-2 (8) |
| E. coli | NA | > 0,5 |
| Imipenem | Carbapenem | Salmonella | > 1 | > 4 | 0,12-16 (8) |
| E. coli | > 0,5 | > 4 |
| Meropenem | Carbapenem | Salmonella | > 0,125 | > 8 | 0,03-16 (10) |
| E. coli | > 0,125 | > 8 |
| Temocillin | Penicillin | Salmonella | > NA | NA | 0,5-128 (9) |
| E. coli | > 16 | NA |
| NA: not available |

Antimicrobial

Class of antimicrobial

Species

Interpretative thresholds of AMR (mg/L)

Range of concentrations (mg/L)

(No of wells in brackets)

ECOFF

Clinical breakpoint

Cefepime

Cephalosporin

Salmonella

NA

> 4

0,06-32 (10)

E. coli

> 0,125

> 4

Cefotaxime

Cephalosporin

Salmonella

> 0,5

> 2

0,25-64 (9)

E. coli

> 0,25

> 2

Cefotaxime + clavulanic acid

Cephalosporin/beta-lactamase inhibitor combination

Salmonella

NA

NA

0,06-64 (11)

E. coli

> 0,25

NA

Cefoxitin

Cephamycin

Salmonella

> 8

NA

0,5-64 (8)

E. coli

> 8

NA

Ceftazidime

Cephalosporin

Salmonella

> 2

> 4

0,25-128 (10)

E. coli

> 0,5

> 4

Ceftazidime + clavulanic acid

Cephalosporin//beta-lactamase inhibitor combination

Salmonella

NA

NA

0,125-128 (11)

E. coli

> 0,5

NA

Ertapenem

Carbapenem

Salmonella

NA

> 0,5

0,015-2 (8)

E. coli

NA

> 0,5

Imipenem

Carbapenem

Salmonella

> 1

> 4

0,12-16 (8)

E. coli

> 0,5

> 4

Meropenem

Carbapenem

Salmonella

> 0,125

> 8

0,03-16 (10)

E. coli

> 0,125

> 8

Temocillin

Penicillin

Salmonella

> NA

NA

0,5-128 (9)

E. coli

> 16

NA

NA: not available

5.2.   Quantitative method to assess the proportion of ESBL- or AmpC-producing E. coli

Member States may decide to assess the proportion of ESBL- or AmpC-producing E. coli compared to the total E. coli isolates present in a sample. In this case they shall enumerate ESBL- or AmpC-producing E. coli and the total E. coli by using dilution methods and subsequent by plating onto selective media and non-selective media, according to the protocols of the EURL for AMR (5).

6.   Alternative method

Member States may decide to authorise the use of Whole Genome Sequencing (‘WGS’) as an alternative method to broth micro dilution using the testing panels of antimicrobial substances of Tables 2 and 5 when carrying out the specific monitoring of ESBL- or AmpC- or CP-producing E. coli as referred to in point 5. They may also authorise WGS as an alternative method to broth micro dilution using the testing panel of antimicrobial substances of Table 5 when further testing, in accordance with point 4.2, E. coli and Salmonella isolates showing resistance to cefotaxime or ceftazidime or meropenem.

Laboratories implementing WGS as an alternative method shall use the protocols of the EURL for AMR (6).

7.   Quality control, storage of the isolates and confirmatory testing

The Member States shall ensure participation of the laboratories referred to in Article 3(2) to a quality assurance system including proficiency testing set up at either national or Union level, to target species identification, sub-typing and antimicrobial susceptibility testing of the bacteria collected for the harmonised monitoring of AMR.

Resistant isolates shall be stored by the laboratories at a temperature of – 80 °C for a minimum period of five years. Other temperatures of storage may be used provided that they ensure viability and absence of changes in strain properties.

When deemed scientifically relevant by EFSA and the EURL for AMR, the laboratories referred to in Article 3(2) shall send for a confirmatory testing to the EURL for AMR any isolate tested in accordance with points 4, 5 and 6.

PART B

Reporting

1.   General provisions for reporting of the data

Member States shall draft reports and include the information referred to in point 2 for each individual isolate, considering separately each bacterial species and animal population combination and bacterial species and food combination referred to in point 1 of Part A. Member States shall submit the results of the harmonised AMR monitoring provided for in this Decision in the form of isolate-based data using the data dictionary and the electronic collection forms provided by EFSA. Member States shall describe sampling designs, stratification and randomisation procedures per animal populations and food categories.

Where AMR monitoring is performed by using antimicrobial susceptibility testing, Member States shall report the information referred to in point 2.1.

Where AMR monitoring is performed by using WGS, Member States shall report the information referred to in point 2.2.

Where Member States decide to report to EFSA data collected on a voluntary basis, these data shall be reported separately from data whose collection is compulsory.

2.   Reporting dataset

2.1.   Reporting antimicrobial susceptibility testing results

The following information shall be included for each individual isolate:

| — | Unique identifier or code of the isolate |
| --- | --- |

—

Unique identifier or code of the isolate

| — | Bacterial species |
| --- | --- |

—

Bacterial species

| — | Serovar (for Salmonella spp.) |
| --- | --- |

—

Serovar (for Salmonella spp.)

| — | Food-producing animal population or food category |
| --- | --- |

—

Food-producing animal population or food category

| — | Stage of sampling |
| --- | --- |

—

Stage of sampling

| — | Type of sample |
| --- | --- |

—

Type of sample

| — | Trade Control and Expert System (TRACES) code of the border control post (for testing of imported meat only) |
| --- | --- |

—

Trade Control and Expert System (TRACES) code of the border control post (for testing of imported meat only)

| — | Common Health Entry Document (CHED) reference of the consignment (for testing of imported meat only) |
| --- | --- |

—

Common Health Entry Document (CHED) reference of the consignment (for testing of imported meat only)

| — | Country of origin of the consignment (for testing of imported meat only) |
| --- | --- |

—

Country of origin of the consignment (for testing of imported meat only)

| — | Sampler |
| --- | --- |

—

Sampler

| — | The sampling strategy |
| --- | --- |

—

The sampling strategy

| — | Date of sampling |
| --- | --- |

—

Date of sampling

| — | Date of start of analysis (isolation) |
| --- | --- |

—

Date of start of analysis (isolation)

| — | Identifier or code of the isolate given by the laboratory performing the antimicrobial susceptibility testing of the isolate |
| --- | --- |

—

Identifier or code of the isolate given by the laboratory performing the antimicrobial susceptibility testing of the isolate

| — | Date of susceptibility testing |
| --- | --- |

—

Date of susceptibility testing

| — | Antimicrobial substance |
| --- | --- |

—

Antimicrobial substance

| — | Minimum Inhibitory Concentration (MIC) value (in mg/L) |
| --- | --- |

—

Minimum Inhibitory Concentration (MIC) value (in mg/L)

| — | Synergy testing with clavulanic acid for ceftazidime |
| --- | --- |

—

Synergy testing with clavulanic acid for ceftazidime

| — | Synergy testing with clavulanic acid for cefotaxime |
| --- | --- |

—

Synergy testing with clavulanic acid for cefotaxime

2.2.   Reporting WGS testing results

The following information shall be included for each individual isolate:

| — | Unique identifier or code of the isolate |
| --- | --- |

—

Unique identifier or code of the isolate

| — | Bacterial species |
| --- | --- |

—

Bacterial species

| — | Food-producing animal population or food category |
| --- | --- |

—

Food-producing animal population or food category

| — | Stage of sampling |
| --- | --- |

—

Stage of sampling

| — | Type of sample |
| --- | --- |

—

Type of sample

| — | TRACES code of the border control post (for testing of imported meat only) |
| --- | --- |

—

TRACES code of the border control post (for testing of imported meat only)

| — | CHED reference of the consignment (for testing of imported meat only) |
| --- | --- |

—

CHED reference of the consignment (for testing of imported meat only)

| — | Country of origin of the consignment (for testing of imported meat only) |
| --- | --- |

—

Country of origin of the consignment (for testing of imported meat only)

| — | Sampler |
| --- | --- |

—

Sampler

| — | The sampling strategy |
| --- | --- |

—

The sampling strategy

| — | Date of sampling |
| --- | --- |

—

Date of sampling

| — | Date of start of analysis (isolation) |
| --- | --- |

—

Date of start of analysis (isolation)

| — | Identifier or code of the isolate given by the laboratory |
| --- | --- |

—

Identifier or code of the isolate given by the laboratory

| — | Date of sequencing |
| --- | --- |

—

Date of sequencing

| — | Version of the predictive tool |
| --- | --- |

—

Version of the predictive tool

| — | AMR-conferring genes data |
| --- | --- |

—

AMR-conferring genes data

| — | Sequencing technology used |
| --- | --- |

—

Sequencing technology used

| — | Library preparation used |
| --- | --- |

—

Library preparation used

---

(1)  https://www.efsa.europa.eu/it/efsajournal/pub/3686

(2)  See footnote 1.

(3)  See footnote 1.

(*)  tentative EUCAST threshold

(4)  https://www.eurl-ar.eu/protocols.aspx

(5)  https://www.eurl-ar.eu/protocols.aspx

(6)  https://www.eurl-ar.eu/protocols.aspx

---

| 19.11.2020 | EN | Official Journal of the European Union | L 387/22 |
| --- | --- | --- | --- |

19.11.2020

EN

Official Journal of the European Union

L 387/22

---

COMMISSION DECISION (EU) 2020/1730

of 18 November 2020

confirming the participation of Ireland in Regulation (EU) 2017/1954 of the European Parliament and of the Council amending Council Regulation (EC) No 1030/2002 laying down a uniform format for residence permits for third-country nationals

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Protocol No 21, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, and in particular Article 4 thereof,

Whereas:

| (1) | By letter to the European Commission of 29 July 2020, Ireland notified its wish to accept and be bound by Regulation (EU) 2017/1954 of the European Parliament and of the Council (1). |
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(1)

By letter to the European Commission of 29 July 2020, Ireland notified its wish to accept and be bound by Regulation (EU) 2017/1954 of the European Parliament and of the Council (1).

| (2) | There are no specific conditions attached to the participation of Ireland in that Regulation and there is no need for transitional measures. |
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(2)

There are no specific conditions attached to the participation of Ireland in that Regulation and there is no need for transitional measures.

| (3) | Harmonised formats and common security standards for residence permits throughout the European Union facilitate border crossing and contribute thus to a good functioning of an area of freedom and security and justice. |
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(3)

Harmonised formats and common security standards for residence permits throughout the European Union facilitate border crossing and contribute thus to a good functioning of an area of freedom and security and justice.

| (4) | The participation of Ireland in Regulation (EU) 2017/1954 should therefore be confirmed. |
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(4)

The participation of Ireland in Regulation (EU) 2017/1954 should therefore be confirmed.

| (5) | In order to allow Ireland to apply Regulation (EU) 2017/1954 as soon as possible, this Decision should enter into force on the day following that of its publication, |
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(5)

In order to allow Ireland to apply Regulation (EU) 2017/1954 as soon as possible, this Decision should enter into force on the day following that of its publication,

HAS ADOPTED THIS DECISION:

Article 1

The participation of Ireland in Regulation (EU) 2017/1954 is confirmed.

Article 2

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, 18 November 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  Regulation (EU) 2017/1954 of the European Parliament and of the Council of 25 October 2017 amending Council Regulation (EC) No 1030/2002 laying down a uniform format for residence permits for third-country nationals (OJ L 286, 1.11.2017, p. 9).

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