# C_2022081EN.01018401.xml

| 18.2.2022 | EN | Official Journal of the European Union | C 81/184 |
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18.2.2022

EN

Official Journal of the European Union

C 81/184

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P9_TA(2021)0312

Official controls on animals and products of animal origin in order to ensure compliance with the prohibition of certain uses of antimicrobials ***I

Amendments adopted by the European Parliament on 24 June 2021 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/625 as regards official controls on animals and products of animal origin exported from third countries to the Union to ensure compliance with the prohibition of certain uses of antimicrobials (COM(2021)0108 — C9-0094/2021 — 2021/0055(COD)) (1)

(Ordinary legislative procedure: first reading)

[Amendments 1 — 7, unless otherwise indicated]

(2022/C 81/20)

AMENDMENTS BY THE EUROPEAN PARLIAMENT (*1)

to the Commission proposal

REGULATION (EU) 2021/... OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulation (EU) 2017/625 as regards official controls on animals and products of animal origin exported from third countries to the Union in order to ensure compliance with the prohibition of certain uses of antimicrobials and Regulation (EC) No 853/2004 as regards the direct supply of meat from poultry and lagomorphs [AMs 8, 10 and 11]

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114 and point (b) of Article 168(4) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (2),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

| (1) | Regulation (EU) 2017/625 of the European Parliament and of the Council (4) lays down the rules for the performance of official controls to verify compliance with, inter alia, rules on food and feed safety. |
| --- | --- |

(1)

Regulation (EU) 2017/625 of the European Parliament and of the Council (4) lays down the rules for the performance of official controls to verify compliance with, inter alia, rules on food and feed safety.

| (2) | Regulation (EU) 2019/6 of the European Parliament and of the Council (5) lays down rules for, inter alia, the control and use of veterinary medicinal products
  , with a particular focus on antimicrobial resistance
  . |
| --- | --- |

(2)

Regulation (EU) 2019/6 of the European Parliament and of the Council (5) lays down rules for, inter alia, the control and use of veterinary medicinal products
  , with a particular focus on antimicrobial resistance
  .

| (3) | In accordance with Regulation (EU) 2019/6, a more prudent and responsible use of antimicrobials in animals is ensured, inter alia, by way of the prohibitions on the use of antimicrobials for growth promotion and yield increase and on the use of antimicrobials reserved for treatment of certain infections in humans.
  Under Article 118(1) of Regulation (EU) 2019/6, operators in third countries are required to respect
  those prohibitions
  when exporting animals and products of animal origin to the Union
  . As highlighted in Recital (49) of that Regulation, it is important to consider the international dimension
  of the
  development of antimicrobial resistance by taking non-discriminatory and proportionate measures, while respecting Union obligations under international agreements
  . |
| --- | --- |

(3)

In accordance with Regulation (EU) 2019/6, a more prudent and responsible use of antimicrobials in animals is ensured, inter alia, by way of the prohibitions on the use of antimicrobials for growth promotion and yield increase and on the use of antimicrobials reserved for treatment of certain infections in humans.
  Under Article 118(1) of Regulation (EU) 2019/6, operators in third countries are required to respect
  those prohibitions
  when exporting animals and products of animal origin to the Union
  . As highlighted in Recital (49) of that Regulation, it is important to consider the international dimension
  of the
  development of antimicrobial resistance by taking non-discriminatory and proportionate measures, while respecting Union obligations under international agreements
  .

| (4) | Article 118 of Regulation (EU) 2019/6 builds on the Commission communication of 29 June 2017 entitled ‘A European One Health Action Plan against antimicrobial resistance (“AMR”)’, by enhancing the prevention and control of antimicrobial resistance and promoting a more prudent and responsible use of antimicrobials in animals. ▌ |
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(4)

Article 118 of Regulation (EU) 2019/6 builds on the Commission communication of 29 June 2017 entitled ‘A European One Health Action Plan against antimicrobial resistance (“AMR”)’, by enhancing the prevention and control of antimicrobial resistance and promoting a more prudent and responsible use of antimicrobials in animals. ▌

| (5) | In order to ensure the effective implementation of the prohibition of the use of antimicrobials for growth promotion and yield increase and of the use of antimicrobials reserved for treatment of certain infections in humans, official controls for the verification of compliance of animals and products of animal origin exported to the Union with Article 118(1) of Regulation (EU) 2019/6 should be included in the scope of Regulation (EU) 2017/625
  , again while respecting Union obligations under international agreements
  . |
| --- | --- |

(5)

In order to ensure the effective implementation of the prohibition of the use of antimicrobials for growth promotion and yield increase and of the use of antimicrobials reserved for treatment of certain infections in humans, official controls for the verification of compliance of animals and products of animal origin exported to the Union with Article 118(1) of Regulation (EU) 2019/6 should be included in the scope of Regulation (EU) 2017/625
  , again while respecting Union obligations under international agreements
  .

| (6) | In accordance with point (g) of Article 18(7) of Regulation (EU) 2017/625, the Commission is to adopt specific rules for the performance of official controls on criteria and conditions to determine, in relation to Pectinidae, marine gastropods and Holothuroidea, when production and relaying areas are not to be classified. Holothuroidea are a class of the phylum Echinodermata. Echinoderms are generally not filter-feeding animals. Consequently, the risk of such animals accumulating micro-organisms related to faecal contamination is remote. In addition, no epidemiological information has been reported which could link public health risks to echinoderms that are not filter feeders. For that reason, the possibility laid down in point (g) of Article 18(7) of Regulation (EU) 2017/625 to derogate from the requirement to classify the production and relaying areas should be extended to all echinoderms which are not filter feeders, for example to those belonging to the class Echinoidea, and not be limited to Holothuroidea. For the same reason, it should be clarified that the conditions for the classification and monitoring of classified production and relaying areas to be laid down by the Commission apply to live bivalve molluscs, echinoderms, tunicates and marine gastropods, except those marine gastropods and echinoderms that are not filter feeders. The terminology used in Article 18(6), (7) and (8) of Regulation (EU) 2017/625 should be aligned accordingly. |
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(6)

In accordance with point (g) of Article 18(7) of Regulation (EU) 2017/625, the Commission is to adopt specific rules for the performance of official controls on criteria and conditions to determine, in relation to Pectinidae, marine gastropods and Holothuroidea, when production and relaying areas are not to be classified. Holothuroidea are a class of the phylum Echinodermata. Echinoderms are generally not filter-feeding animals. Consequently, the risk of such animals accumulating micro-organisms related to faecal contamination is remote. In addition, no epidemiological information has been reported which could link public health risks to echinoderms that are not filter feeders. For that reason, the possibility laid down in point (g) of Article 18(7) of Regulation (EU) 2017/625 to derogate from the requirement to classify the production and relaying areas should be extended to all echinoderms which are not filter feeders, for example to those belonging to the class Echinoidea, and not be limited to Holothuroidea. For the same reason, it should be clarified that the conditions for the classification and monitoring of classified production and relaying areas to be laid down by the Commission apply to live bivalve molluscs, echinoderms, tunicates and marine gastropods, except those marine gastropods and echinoderms that are not filter feeders. The terminology used in Article 18(6), (7) and (8) of Regulation (EU) 2017/625 should be aligned accordingly.

| (7) | In accordance with point (e) of Article 47(1) of Regulation (EU) 2017/625, competent authorities are to perform official controls at the border control post of first arrival into the Union on each consignment of animals and goods subject to, inter alia, the emergency measures provided for in acts adopted in accordance with Article 249 of Regulation (EU) 2016/429 of the European Parliament and of the Council (6). However, Article 249 of Regulation (EU) 2016/429 does not concern Commission emergency measures. That error should be corrected and reference should be made to Article 261 of Regulation (EU) 2016/429. |
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(7)

In accordance with point (e) of Article 47(1) of Regulation (EU) 2017/625, competent authorities are to perform official controls at the border control post of first arrival into the Union on each consignment of animals and goods subject to, inter alia, the emergency measures provided for in acts adopted in accordance with Article 249 of Regulation (EU) 2016/429 of the European Parliament and of the Council (6). However, Article 249 of Regulation (EU) 2016/429 does not concern Commission emergency measures. That error should be corrected and reference should be made to Article 261 of Regulation (EU) 2016/429.

| (8) | Since the objective of this Regulation, namely to allow for official controls on the use of antimicrobials in animals and products of animal origin entering into the Union, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. |
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(8)

Since the objective of this Regulation, namely to allow for official controls on the use of antimicrobials in animals and products of animal origin entering into the Union, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

| (9) | Regulation (EU) 2017/625 should therefore be amended accordingly. |
| --- | --- |

(9)

Regulation (EU) 2017/625 should therefore be amended accordingly.

| (10) | Since Regulation (EU) 2019/6 applies from 28 January 2022, the corresponding provisions of this Regulation should apply from the same date, |
| --- | --- |

(10)

Since Regulation (EU) 2019/6 applies from 28 January 2022, the corresponding provisions of this Regulation should apply from the same date,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EU) 2017/625 is amended as follows:

| (1) | in Article 1(4), point (c) is replaced by the following:






  ‘(c) | Regulation (EU) 2019/6 of the European Parliament and of the Council (*2); however, this Regulation shall apply to official controls for the verification of compliance with Article 118(1) of that Regulation. |
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(1)

in Article 1(4), point (c) is replaced by the following:

‘(c)

Regulation (EU) 2019/6 of the European Parliament and of the Council (*2); however, this Regulation shall apply to official controls for the verification of compliance with Article 118(1) of that Regulation.

(*2)  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).’;"

| (2) | Article 18 is amended as follows:










  (a) | paragraph 6 is replaced by the following:





  ‘6.
     
  For the purposes of official controls referred to in paragraph 1 performed in relation to live bivalve molluscs, echinoderms, tunicates and marine gastropods, the competent authorities shall classify production and relaying areas.’; |
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(2)

Article 18 is amended as follows:

(a)

paragraph 6 is replaced by the following:

‘6.
     
  For the purposes of official controls referred to in paragraph 1 performed in relation to live bivalve molluscs, echinoderms, tunicates and marine gastropods, the competent authorities shall classify production and relaying areas.’;

| (b) | in paragraph 7, point (g) is replaced by the following:










  ‘(g) | criteria and conditions to determine, by way of derogation from paragraph 6, when production and relaying areas are not to be classified in relation to:










  (i) | Pectinidae, and |
| --- | --- | --- | --- |

(b)

(b)

in paragraph 7, point (g) is replaced by the following:

in paragraph 7, point (g) is replaced by the following:

‘(g)

‘(g)

criteria and conditions to determine, by way of derogation from paragraph 6, when production and relaying areas are not to be classified in relation to:

criteria and conditions to determine, by way of derogation from paragraph 6, when production and relaying areas are not to be classified in relation to:

(i)

(i)

Pectinidae, and

Pectinidae, and

| (ii) | where they are not filter feeders: echinoderms and marine gastropods;’; |
| --- | --- |

(ii)

(ii)

where they are not filter feeders: echinoderms and marine gastropods;’;

where they are not filter feeders: echinoderms and marine gastropods;’;

| (c) | in paragraph 8, point (b) is replaced by the following:










  ‘(b) | the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs, echinoderms, tunicates and marine gastropods;’; |
| --- | --- | --- |

(c)

(c)

in paragraph 8, point (b) is replaced by the following:

in paragraph 8, point (b) is replaced by the following:

‘(b)

‘(b)

the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs, echinoderms, tunicates and marine gastropods;’;

the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs, echinoderms, tunicates and marine gastropods;’;

| (3) | in Article 47(1), point (e) is replaced by the following:






  ‘(e) | animals and goods which are subject to an emergency measure provided for in acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002, Article 261 of Regulation (EU) 2016/429, or Articles 28(1), 30(1), 40(3), 41(3), 49(1), 53(3) and 54(3) of Regulation (EU) 2016/2031 requiring consignments of those animals or goods, identified by means of their codes from the Combined Nomenclature, to be subject to official controls at their entry into the Union;’. |
| --- | --- | --- |

(3)

in Article 47(1), point (e) is replaced by the following:

‘(e)

animals and goods which are subject to an emergency measure provided for in acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002, Article 261 of Regulation (EU) 2016/429, or Articles 28(1), 30(1), 40(3), 41(3), 49(1), 53(3) and 54(3) of Regulation (EU) 2016/2031 requiring consignments of those animals or goods, identified by means of their codes from the Combined Nomenclature, to be subject to official controls at their entry into the Union;’.

Article 1a

Regulation (EC) No 853/2004 is amended as follows:

In Article 1(3), point (d) is replaced by the following:

| ‘(d) | the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer;’. [AMs 8, 10 and 11] |
| --- | --- |

‘(d)

the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer;’. [AMs 8, 10 and 11]

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.

It
  shall apply from ... [the date of the entry into force of this Regulation].

However, point (1) of Article 1
  shall apply from 28 January 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ..., ...

For the European Parliament

The President

For the Council

The President

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(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A9-0195/2021).

1

(*1)  Amendments: new or amended text is highlighted in bold italics; deletions are indicated by the symbol ▌.

*1

(2)  Opinion of 9 June 2021 (not yet published in the Official Journal).

2

(3)  Position of the European Parliament of ... [(OJ ...)/(not yet published in the Official Journal)] and decision of the Council of ....

3

(4)  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).

4

(5)  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).

5

(6)  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’) (OJ L 84, 31.3.2016, p. 1).

6

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