EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2018/848 of the European Parliament and of the 
Council with rules on the issuance of complementary certificates certifying the non -use 
of antibiotics in organic production of animal products for the purpose of export  
(Text wit h EEA relevance)    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the adoption of Regulation (EU) 2018/848 , which will apply from  1 January 2022, 
it is necessary to adopt a delegated regulation supplementing that Regulation by laying down 
the model of a complementary certificate, which certifies that organic animal products are 
produced without the use of antibiotics . This is necess ary to facilitate  the access  of EU 
organic operators  to markets in certain third  countrie s, which  require that organic animal 
products are produced without the use of antibiotics . EU o rganic operators need to have legal 
certainty on the rules that will app ly for this issue . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The act was discussed thoroughly with Member States at the Group o f Experts on Organic 
Production, as well with the main organisations representing the organic sector. WTO 
partners were n otified and general public consultations were carried out.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
This delegated act lays down the model of a complementary certificate, which certifies that 
organic animal products are produced without the use of antibiotics  for the purpose of export .  
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2018/848 of the European Parliament and of the 
Council with rules on the issuance of complementary certificates certifying the non -use 
of antibiotics in organic production of animal products for the purpose of export  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the Europea n Union , 
Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 
30 May 2018 on organic production and labelling of organic products and repealing Council 
Regulation (EC) No 834/20071, and in particular Article  44(2) thereof, 
Whereas:  
(1) Certain third countries require that organic  animal products are produced without the 
use of antibiotics. In order to facilitate access to markets in those  countrie s, operators 
or groups of operators in the Union wanting to export such products should be able to 
prove the non-use of antibiotics by means of an official document . 
(2) Pursuant to Article 35 of Regulation (EU) 2018/848, c ompetent authorities or, where 
appropria te, control authorities or control bodies, are to  provide a certificate to any 
operator or group of operators that has notified its activity and complies with that  
Regulation . In order to certify  that the organic animal products  are produced  without 
the us e of antibiotics, the operator or group of operators should have the possibility to 
request those competent authorities or, where appropriate, control authorities or 
control bodies , to issue a complementary certificate.  The model for that 
complementary cer tificate should be established.  
(3) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of application of Regulation (EU) 2018/848 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Complementary certificate  certifying the non -use of antibiotics in organic production of 
animal products  for the purpose of export   
At the request of a n operator or group of operators that is already in possession of a certificate 
as referred to in Article 35 of Regulation (EU) 20 18/848 , the relevant competent authority  or, 
where appropriate, the relevant control authority or control body , shall  issue a complementary 
certificate certifying that the operator or group of operators produced organic  animal products 
without the use of a ntibiotics if such certificate  is needed for the purpose of export  of those 
products from the Union. The model for that complementary certificate is set out in the Annex 
to this Regulation.  
                                                 
1 OJ L 150, 14.6.2018, p. 1.   
EN 3  EN Article  2 
Entry into force an application  
This Regulation shall en ter into force on the twentieth day  following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 1 January 2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at  Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN