EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down detailed rules on certain records and declarations required from operators 
and groups of operators and on the technical means for the issuance of certificates in 
accordance with Regulation (EU) 2018/848 of the European Parliament and of the 
Council  EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down detailed rules on certain records and declarations required from operators 
and groups  of operators and on the technical means for the issuance of certificates in 
accordance with Regulation (EU) 2018/848 of the European Parliament and of the 
Council  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Unio n, 
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  35(10) and  Artic le 39(2) , points (a) 
and (b) , thereof,  
Whereas:  
(1) In accordance with Article 35(1) , point  (a), of Regulation (EU) 2018/848 , the 
certificate provided by the c ompetent authorities or, where appropriate, control 
authorities or control bodies to operator s or group s of operators  is to  be issued in 
electronic form wherever possible. With the development and full deployment of the 
electronic Trade Control and Expert System (TRACES ) referred to in Article 2, point 
(36), of Commission Implementing Regulation (E U) 2019/17152, the issuance of 
certificates in electronic form will be come  possible for all competent authorities, 
control authorities and control bodies in the Union. For this reason , it is necessary to 
provide  that the certificate referred to in Article 35 of Regulation (EU) 2018/848 has 
to be issued in electronic form, using TRACES .  
(2) Regulation (EU) 2018/848 requires  operators and groups of operators  to keep records 
to demonstrate their compliance  with that Regulation . Certain m inimum record -
keeping requirements and details are laid down in Article 9(10) , point (c), and Article 
34(5) of Regulation (EU) 2018/848 and in Annexes II and III to that Regulation .  
(3) In accordance with the general production rules of Regulation (EU) 2018/848 , 
preventive and pre cautionary measures must be put in place , where appropriate,  at 
every stage of production, preparation and distribution . For that reason, the relevant 
official controls include, in particular , the verification of  the application of such 
measures  by operato rs and groups of operators . Although the application of some of 
those measures can be verified by physical on -the-spot inspection s, for other measures 
records are necessary to demonstrate the ir application . Therefore, operator s and groups 
of operators should keep those records to allow them to provide evidence  when 
needed . For example, evidence of measures taken to avoid  contamination with non -
authorised products and substances and the commingling with non -organic products  
                                                 
1 OJ L 150, 14.6.2018, p. 1 . 
2 Commission Implementing Regulation (EU) 2019/1715 of 30  September 2019 laying down rules for the 
functioning of the information management system for official controls and its system components ( ‘the 
IMSOC Regulation ’) (OJ L 261 14.10.2019, p. 37)  EN 2  EN can be provid ed by keeping  proof of cleaning of facilities, equipment and transport 
vehicles, and proof of training . 
(4) Documentary accounts are also relevant for traceability purposes and mass balance , 
and consequently for  the assessment of compliance with Regulation (EU) 2018/848.  
The t raceability and mass balance checks u nder Commission Delegated Regulation 
(EU) 2021/7713 cover specific information that is to be  justified by appropriate 
documents.  Operators and groups of operators should keep  those documents i n order 
to provide evidence  of compliance of their activities .  
(5) In accordance with Article 38(2) of Regulation (EU) 2018/848, official controls are to 
be performed  in particular based on the likelihood of non -compliance.  For that 
purpose, competent authorit ies or, where appropriate, control authorit ies or control 
bodies need relevant information. Therefore,  Article 39(1) , point (b), of Regulation 
(EU) 2018/848 requires  operators and groups of operators to make all declarations and 
other communications that are necessary for official controls . In addition, Article 
39(1) , point (d)(i) , of that Regulation  requires , inter alia , a full description of the ir 
organic or in -conversion production units  and of the ir activities .  
(6) In order t o ensure that official control s can be appropriately planned, it is necessary to 
specify the information that is to be included in those declarations and other 
communications, in particular, information relating to the activities that are 
subcontracted  and certain details of the producti on units and other premises , facilities 
and units used for the activities  of the operators and groups of operators , and the 
schedule of production.  
(7) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of application of  Regulation (EU) 2018/848.  
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Organic Production  Committee , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Issuance of the certificate referred to in Article 35 (1) of Regulation (EU) 2018/848  in 
electronic form  
 
The certificate  referred to in Article 35 (1) of Regulation (EU) 2018/848 shall be issued in 
accordance with the model set out in Annex VI to that Regulation and in electronic form, 
using the electronic Trade  Control and Expert System (TRACES) referred to in Article 2 , 
point (36), of Implementing Regulation (EU) 2019/1715.   
                                                 
3 Commission Delegated Regulation (EU) 2021/771  supplementing R egulation (EU) 2018/848 of the 
European Parliament and of the Council by laying down specific criteria and conditions for the checks 
of documentary accounts in the framework of official controls in organic production and the official 
controls of groups of operators (OJ L 165, 11.5.2021, p. 25.)  EN 3  EN Article 2  
Records to be kept by  operators  and groups of operators  
1. Operators and groups of operators shall keep all the necessary  documents, including 
stock and financial records , that will enable competent authorities or, where 
appropriate, control authorities or control bodies to carry out , in particular , the 
following checks : 
(a) checks on the preventive and precautionary measures tak en in accordance with 
Article 9(6) and Article 28 of Regulation (EU) 2018/848 ; 
(b) the traceability check in accordance with  Article 1(4) of Delegated Regulation 
(EU) 2021/771 ;  
(c) the mass balance check in accordance with  Article 1(5) of Delegated 
Regul ation (EU ) 2021/771 . 
2. The documents to be kept for the purposes of the checks referred to in paragraph  1, 
point (a) , shall include , in particular , documents confirming  that the operator or 
group of operators has taken  the proportionate and appropriate  measures  in order to : 
(a) prevent pests and diseases ; 
(b) avoid contamination with products and substances that are not authorised for 
use in organic production in accordance with Regulation (EU) 2018/848 and 
the commingling with non -organic products.  
Article 3 
Declarations and other communications necessary for official controls  
 
Operators and groups of operators shall include the following information in their declaration s 
or communications  pursuant to Article 39(1), point (b), of Regulation (EU) 2018/848 to the 
competent authority , control authority or control body  that performs  official controls : 
(a) which activities covered by  the certificate  referred to in Article 3 5(1) of Regulation 
(EU) 2018/848  are subcontracted ; 
(b) the address or the geolocation of the organi c, in -conversion and non -organic 
production units , the area of collection of wild plants or algae  and of other premises  
and units used for  their activities ; 
(c) in case of holdings split into different production units in accordance with Article 
9(7) of Regula tion (EU) 2018/848, the description and the address or geolocation of 
the non -organic production units ;  
(d) their schedule of production  for agricultural and aquaculture units , including , where 
applicable , a breakdown by land parcel . 
Those declarations and communications shall be updated  where appropriate . 
The schedule of production referred to in point ( d) shall be transmitted  before the date 
indicated by the competent authority, control authority or control body  that performs official 
controls . EN 4  EN Article  4 
Entry into force and application  
 
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 1 January 2022.  
This Regulation shall be binding in its en tirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN