EN   EN 
 
 
 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)   EN 1  EN 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 co untry 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 f or 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 a nd 
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 Co ntrols 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 require ments 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 th e 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 
                                                 
1 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 Decemb er 2018 on 
veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).  
2 Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on 
transmissible animal diseases and amending and repealing cert ain acts in the area of animal health 
(‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).  
3 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 app lication 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 Article 149 of Regulation (EU) 2019/6.  EN 2  EN the preceding paragraph, i t would not be possible to imp lement 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 exclu sion, 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 V MPs 
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 wi de 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, t he 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 antimicro bials 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 Un ion 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 o f 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 e mpowerment in Article 118(2) of Regulation (EU) 
2019/6 would not allow the Commission to adopt the necessary rules on official controls for EN 3  EN 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  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATION S AND  IMPACT  ASSESSMENTS  
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 i nto 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. BUDGETAR Y 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 ensur e 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 impo rts 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 im ports 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.  EN 4  EN 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 transmis sion 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 pr ocedure,  
Whereas:  
(1) 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.  
(2) 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.  
(3) Under Article 118(1) of Regulation (EU) 2019/6, third country operators exporting 
animals and products of animal origin t o 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 th e efficacy of those antimicrobials.  
                                                 
5 OJ C…,p…  
6 OJ C…, p…  
7 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 E uropean 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).  
8 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).  EN 5  EN (4) 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.  
(5) 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 ver ification 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.  
(6) In accordance with Article 47(1)(e) of Regulation (EU) 201 7/625, 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 wit h 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 m ade to 
Article 261 of Regulation (EU) 2016/429.  
(7) Regulation (EU) 2017/625 should therefore be amended accordingly.  
(8) Since Regulation (EU) 2019/6 applies from 28 January 2022, this Regulation should 
apply from the same date,  
HAVE ADOPTED THIS REGULATI ON: 
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*; 
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:  
                                                 
9 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.  
10 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 .  
11 Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on 
transmissible animal diseas es and amending and repealing certain acts in the area of animal health 
(‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).  EN 6  EN ‘(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 t o 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  For the Council  
The President  The President