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
Date: 2021-03-09
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, animal product, antimicrobial resistance, food inspection, import (EU), live animal, originating product, third country, veterinary inspection, veterinary medicinal product

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   EUROPEAN COMMISSION  Brussels, 9.3.2021  COM(2021) 108 final 2021/0055 (COD)  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 (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

• 
Regulation (EU) 2019/61, which enters into application on 28 January 2022, replaces the legal 
framework for veterinary medicinal products (“VMPs”) established by Directive 2001/82/EC 
and  Regulation  (EC)  No  726/2004.  Article  118(1)  of  Regulation  (EU)  2019/6  provides  that 
third country operators exporting animals and products of animal origin to the EU will have to 
respect the prohibition against using antimicrobials for growth promotion and yield increase 
(Article  107(2)),  as  well  as  the  ban  against  using  antimicrobials  reserved  for  treatment  of 
certain infections in humans (Article 37(5)).  

Article 118(2) of Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts 
providing  detailed  rules  on  the  application  of  the  prohibitions  referred  to  in  Article  118. 
Regulation  (EU)  2019/6  sets  out  the  legal  framework  for  the  authorisation  of  veterinary 
medicinal products, whereas Article 118 of that Regulation by contrast applies to animals and 
products  of  animal  origin.  Unlike  other  legislation  that  lays  down  rules  for  animals  and 
products of animal origin, Regulation (EU) 2019/6 does not contain any basic provisions on 
import  conditions/requirements  or  on  official  controls  of  compliance  of  imports  with  these 
requirements.  Import  requirements  and  conditions  (such  as  third  country  and  establishment 
listing and certificates) for animals and for products of animal origin are laid down in relevant 
sectorial legislation, such as the Animal Health Law2, but may also be laid down on the basis 
of Regulation (EU) 2017/625 (‘the Official Controls Regulation’)3. For a third country to  be 
included in a list of third countries authorised to export to the Union, it needs, for example, to 
provide  guarantees  that  the  animals  and  goods  concerned  comply  with  the  Union’s 
requirements or with requirements equivalent thereto laid down in the relevant legislation. 

However, Article 1(4)(c) of the Official Controls Regulation states that that Regulation does 
not apply to official controls for the verification of compliance with Directive 2001/82/EC on 
veterinary  medicinal  products.  When  Regulation  (EU)  2019/6  enters  into  application  on  28 
January  2022,  the  reference  to  Directive  2001/82/EC  will  in  effect  become  a  reference  to 
that Regulation.4  Article  1(4)(c)  of  the  Official  Controls  Regulation  excludes  the  entirety  of 
Regulation  (EU)  2019/6  from  its  scope.  In  the  absence  of  relevant  provisions  in  Regulation 
(EU) 2019/6 on official controls of compliance of imports with the requirements referred to in 

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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). 
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). 
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). 
Article 149 of Regulation (EU) 2019/6. 

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the  preceding  paragraph,  it  would  not  be  possible  to  implement  and  enforce  Article  118  of 
Regulation (EU) 2019/6 properly without amending the Official Controls Regulation. 

The  objective  of  this  amendment  is  to  modify  Article  1(4)(c)  of  the  Official  Controls 
Regulation  to  include  an  exception  to  the  above  exclusion,  integrating  controls  to  verify 
compliance  with  Article  118  of  Regulation  (EU)  2019/6  into  the  scope  of  the  Official 
Controls  Regulation.  This  would  mean  that  the  Union’s  official  control  system  for  animals 
and  products  of  animal  origin  could  be  used  to  ensure  compliance  with  the  prohibitions  in 
Article 118 of Regulation (EU) 2019/6. This would in turn make it possible to implement and 
enforce Article 118 properly. 

Article  123  of  Regulation  (EU)  2019/6,  which  was  part  of  the  Commission’s  proposal, 
provides  for  controls  of  compliance  with  the  Regulation  by  Member  State  competent 
authorities. However, these controls only apply to manufacturers and importers of VMPs and 
active substances (and other persons involved in the placing on the market and use of VMPs 
and active substances). To ensure that animals and products of animal origin imported into the 
Union  comply  with  Article  118  of  Regulation  (EU)  2019/6,  it  is  necessary  to  provide  that 
controls of compliance with Article 118 are included into the scope  of the Official Controls 
Regulation. 

Under its Farm to Fork Strategy, the EU has set the ambitious target of reducing by 50% its 
overall  EU  sales  of  antimicrobials  used  for  farmed  animals  and  in  aquaculture  by  2030. 
Building on the One Health approach, Regulation (EU) 2019/6 provides for a wide range of 
concrete  measures  that  will  apply  to  EU  operators  in  order  to  enhance  the  fight  against 
antimicrobial  resistance  (‘AMR’)  and  promote  a  more  prudent  and  responsible  use  of 
antimicrobials in animals. As a leader in the global fight against AMR, the Union also has the 
responsibility  to  encourage  the  reduction  of  use  and  consumption  of  antimicrobials  in  third 
countries, in particular linked to imports from third countries, and has the duty to promote its 
vision  of  a  more  sustainable  use  of  antimicrobials  to  help  preserve  their  efficiency  on  the 
international  stage.  Article  118  of  Regulation  (EU)  2019/6  is  a  key  element  in  the  fight 
against AMR. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  legal  bases  of  this  proposal  are  Article  43(2),  Article  114  and  Article  168(4)(b)  of  the 
Treaty on the Functioning of the European Union. 

• 

Subsidiarity (for non-exclusive competence)  

Imports  of  animals  and  products  of  animal  origin  from  third  countries  have  been 
comprehensively regulated at Union level. Therefore, it would not be possible to address the 
issue at national level. 

• 

Proportionality 

Amending the Official Controls  Regulation  to  cover verification of compliance with  Article 
118(1) of Regulation (EU) 2019/6 is the only effective way of ensuring that Article 118(1) of 
that  Regulation  is  complied  with  in  relation  to  imports  of  animals  and  products  of  animal 
origin from third countries. Regulation (EU) 2019/6 itself does not have the necessary basic 
provisions  to  make  this  possible.  The  empowerment  in  Article  118(2)  of  Regulation  (EU) 
2019/6 would not allow the Commission to adopt the necessary rules on official controls for 

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animals  and  products  of  animal  origin  similar  to  those  set  out  in  the  Official  Controls 
Regulation.  The  amendment  is  indispensable  in  order  to  allow  the  Union’s  official  control 
system for animals and products of animal origin to apply to verification of compliance with 
Article 118(1) of Regulation (EU) 2019/6. 

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

From  a  Better  Regulation  perspective,  a  roadmap,  stakeholder  consultation  or  impact 
assessment  are  not  necessary,  as  the  proposal  is  a  technical  measure,  necessary  to  ensure 
implementation of Article 118 of Regulation (EU) 2019/6. The proposal, when adopted, will 
allow  for  official  controls  in  accordance  with  the  Official  Controls  Regulation  and  thus  not 
introduce any significant burden on economic operators and on Member States. The proposal 
needs to be adopted ahead of the entry into application of Regulation (EU) 2019/6 in January 
2022  and  in  good  time  to  allow  for  the  preparation  of  implementing  acts  specifying  the 
modalities  for  official  controls  in  relation  to  Article  118  of  Regulation  (EU)  2019/6  before 
that date.  

4. 

BUDGETARY IMPLICATIONS 

The proposal has no implications on the Union budget.  

5. 

• 

OTHER ELEMENTS 

Detailed explanation of the specific provisions of the proposal 

Article 1(4)(c) 

The  modification  of  Article  1(4)(c)  of  the  Official  Controls  Regulation  is  a  technical 
amendment  to  allow  verification  of  compliance  with  Article  118(1)  of  Regulation  (EU) 
2019/6 to be covered by the Official Controls Regulation. It would allow the Union’s official 
control system for animals and products of animal origin to be used to ensure compliance with 
the prohibitions in Article 118(1) of Regulation (EU) 2019/6.  

The Commission has to adopt a delegated act in accordance with Article 118(2) of Regulation 
(EU)  2019/6  which  should  set  out  the  substantive  rules  that  need  to  be  met  for  imports  of 
animals  and  products  of  animal  origin  entering  the  Union  from  third  countries  in  order  for 
them  to  comply  with  Article  118(1).  The  amendment  of  Article  1(4)(c)  of  the  Official 
Controls  Regulation  would  include  Article  118(1),  which  applies  to  the  imports  of  animals 
and products of animal origin, in the scope of the Official Controls Regulation and allow the 
Commission to subsequently adopt the necessary implementing act(s).  

Article 47(1)(e) 

The  aim  of  this  provision  is  to  correct  a  manifest  error  in  the  Official  Controls  Regulation 
with respect to a reference to Regulation (EU) 2016/429. 

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2021/0055 (COD) 

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 

(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 Article 168(4)(b) 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 Committee5, 
Having regard to the opinion of the Committee of the Regions6, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

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Regulation (EU) 2017/625 of the European Parliament and of the Council7 lays down 
the rules for the performance of official controls to verify compliance with, inter alia, 
rules on food and feed safety.  
Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council8  lays  down 
rules for, inter alia, the control and use of veterinary medicinal products. 

Under  Article  118(1)  of  Regulation  (EU)  2019/6,  third  country  operators  exporting 
animals  and  products  of  animal  origin  to  the  Union  are  required  to  respect  the 
prohibition  of  the  use  of  antimicrobials  for  growth  promotion  and  yield  increase,  as 
well  as  the  prohibition  of  the  use  of  antimicrobials  reserved  for  treatment  of  certain 
infections in humans in order to preserve the efficacy of those antimicrobials. 

OJ C…,p… 
OJ C…, p… 
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). 
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). 

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(4) 

(5) 

(6) 

(7) 

(8) 

Article 118 of Regulation (EU) 2019/6 builds on the One Health Action Plan against 
antimicrobial resistance (‘AMR’)9, by enhancing the prevention and control of AMR 
and promoting a more prudent and responsible use of antimicrobials in animals. This 
is  also  reflected  in  the  Commission’s  Farm  to  Fork  Strategy10,  in  which  the 
Commission  has  set  the  ambitious  target  of  reducing  by  50%  overall  EU  sales  of 
antimicrobials used for farmed animals and in aquaculture by 2030.  

In  order  to  ensure  an  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. 

In  accordance  with  Article  47(1)(e)  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 Council11. However, 
Article  249  of  Regulation  (EU)  2016/429  does  not  concern  Commission  emergency 
measures. Accordingly, this error should be corrected and reference should be made to 
Article 261 of Regulation (EU) 2016/429. 

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

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

HAVE ADOPTED THIS REGULATION: 

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

Article 1 

(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*; 
however, this Regulation shall apply to official controls for the verification of 
compliance with Article 118(1) of that Regulation.’ 

------------------ 

* 

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) 

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

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European Commission, A European One Health Action Plan against Antimicrobial Resistance (AMR), 
June 2017, https://ec.europa.eu/health/sites/health/files/antimicrobial_resistance/docs/amr_2017_action-
plan.pdf. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of  the Regions of 20 May 2020, A Farm to Fork 
Strategy for a fair, healthy and environmentally-friendly food system, COM (2020) 381 final . 
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). 

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‘(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 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 28 January 2022. 

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

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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