EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (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 
control s of groups of operators  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the adoption of the new organic regulation, which will enter into application on 1 
January 2021, it is necessary to adopt a delegated regulation supplementing Regulation (EU) 
2018/848 on the official controls by laying down further rules on traceability and mass 
balance checks as well as on specific controls on groups of operators. Organ ic sector needs to 
have legal certainty on the rules that will apply for these two issues and EU Member States 
need to have enough time to integrate these rules into their national legislation.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The act was discussed thoroughly with Member States at the Group of Experts on Organic 
Production as well as with the main organisations representing the organic sector, namely 
IFOAM, COPA -COGECA and EOCC. DG AGRI cooperated closely with other DGs in the 
field of thei r specific expertise when drafting these rules. WTO partners were notified and 
general public consultations were carried out.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
This delegated act lays down specific rules for official controls to ensure the traceabili ty at all 
stages of production, preparation and distribution and to ensure proper controls performed on 
groups of operators.  EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 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 38(8)(a)(i)  and (ii) thereof,  
Whereas:  
(1) In order t o ensure the integrity of organic production , it is necessary to lay down 
specific criteria an d conditions for the performance of official controls conducted to 
ensure the traceability at all stages of production, preparation and distribution, and 
compliance with Regulation (EU) 2018/848, in particular with regard to the physical 
on-the-spot inspec tion referred to in Article 38(3) of that Regulation at the premises of 
the organic operators or group s of operators.  In order to be effective, that physical on -
the-spot inspection should at least include  a traceability check and a mass balance 
check  by me ans of checks of documentary accounts . The traceability check is intended 
to confirm whether products received or sent by the operator or group of operators are 
organic or in -conversion . The purpose of the m ass balance check is to determine the 
balance bet ween the input and output of the operator or group of operators and, in 
particular, the plausibility of the traded volumes of organic or in -conversion products . 
The elements to be covered by the traceability check and the mass balance check 
should be laid down.   
(2)  For the purpose of official controls, the concept of group of operators as laid down  in 
Article  36(1) of  Regulation (EU) 2018/848 consist s of a specific category of operators  
who are farmers or operators that produce algae or aquaculture animals  and who in 
addition may be engaged in processing, preparation or placing on the market of food 
or feed . Each group of operators is to  establish a system for internal controls (ICS) 
comprising a documented set of control activities . The competent authority or , where 
appropriate , the control authority or control body , should be appropriately qualified to 
assess the ICS and carry out re -inspections on a risk based sample of the members of 
the group in order to make a conclusion on the overall compliance of the g roup. 
Therefore, it is necessary to lay down requirements for the competence of the 
competent authority or , where app ropriate , the control authority or  control body , to 
assess that specific composition of operators within a group as well as the ICS, for a 
                                                 
1 OJ L 150, 14.6.2018, p. 1.  EN 3  EN harmonised framework for the assessment of the ICS and for the selection of the 
sample of the members for the re -inspections.  
(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  
Checks of documentary accounts  
1. The physical on -the-spot inspection pursuant  to Article 38(3) of Regulation (EU) 
2018/848 shall include at least a traceability check  and a mass balance check of the 
operator or group of operators carried out by means of checks of documentary 
accounts .  
2. For the purpose of the traceability check and mass balance check, the selection of 
products, groups of products and period under verification shall be based on a risk 
assessment .  
3. The traceability check shall cover at least the following elements justified by 
appropriate documents  including stock and financial records : 
(a) the name and address of the supplier and, where different, of the owner or the 
seller, or the exporter of the produ cts; 
(b) the name and address of the consignee and, where different, of the buyer or 
importer of the products;  
(c) the certificate of the supplier in accordance with Article 35(6) of Regulation 
(EU) 2018/848;  
(d) the inform ation referred to in  the first paragraph of  point 2.1.  of Annex III to 
Regulation (EU) 2018/848;   
(e) the appro priate lot identification . 
4. Where relevant, the mass balance check shall cover at least the following elements 
justified by appropriate documents including stock and financial records:  
(a) the nature and the quantities of products delivered to the unit and, where 
relevant, of materials bought and the use of such materials, and, where 
relevant, the composition of products ; 
(b) the nature and the quantities of products held in storage at the premises  at the 
time of the physical on -the-spot inspection ;  
(c) the nature and the quantities of the products that have left the unit of operator 
or group of operators to the consignee's premises or storage facilities;  
(d) in case of operators who buy or sell t he product without storing  or physically 
handling  the product s, the nature and the quantities of products that have been 
bought and sold ; 
(e) the yield of the products obtained, collected or harvested , or managed in case 
of livestock , over the previous year;  
(f) the estimated or actual yield of the products obtained, collected  or harvested , or 
managed in case of livestock , over the current year;  EN 4  EN (g) any losses , increase or decrease  in quantity  of products at any stage of 
production, preparation and distribution;  
(h) organi c products that are sold on the market as non -organic or under different 
schemes.  
Article 2  
Official controls of group s of operators  
1. In order to certify and verify the compliance of a group of operators , the competent 
authorit y or, where appropriate, the control authorit y or control bod y, shall assign 
inspectors competent to assess systems for internal c ontrols  (ICS) .  
2. For the purpose of evaluating the set -up, functioning and maintaining of the ICS of a 
group of operators,  the compe tent authority or, where appropriate, the control 
authority or control body , shall  determine at least that:  
(a) the documented procedures of the ICS that have been put in place comply with 
the requirements established in th is Regulation ;   
(b) the list of members of the group with the required information for each 
member  is continuously updated and aligned with the scope of the certificate ; 
(c) all members  of the group  comply with the criteria  set out in Article 36 (1)(a), 
(b) and (e) of Regulation (EU) 2018/848  throughout their participation in the 
group ; 
(d) the number , training and competence  of ICS inspectors  are proportiona te and 
adequate and ICS inspectors are without conflicts of interest ; 
(e) the internal inspections  of all group members/production units and activ ities as 
well as collective purchase and collective centres have been carried out at least 
annually and are documented ; 
(f) new members  or new  production units and new activities  of existing members , 
including new purchase and collective centres , have been accepted only  after 
they have been approved  by the ICS manager  on the basis of the internal 
inspection report ;  
(g) the ICS manager takes appropriate measures in case  of non -compliance, 
including their follow up, according to the ICS documented procedures  that 
have been put in place ; 
(h) the ICS manager’s notifications to the competent authority or, where 
appropriate, the control authority or control body , are appropriate and 
sufficient ; 
(i) the internal traceability for all products and members of the group is ensured  
by estimating quantities and by cross -checking the yields of each member of 
the group .  
3. The competent authority or, where appropriate, the control authority or control body , 
shall apply risk assessment to select the sample of the members of the group for the 
re-inspections in accordance with  Article 38 (4)(d) of Regulation (EU) 2018/848. In 
doing so , it shall take  into account at least the volume and the value of the production 
and the assessment of the likelihood of non -compliance with the provisions of EN 5  EN Regulation (EU) 2018/848 . Re-inspections shall be carried out on the spot wi th the 
presence of the members selected .  
4. The competent authority or, where appropriate, the control authority or control body , 
shall allocate  reasonable time for the control of a group of operators , proportional to 
the size, the products, the activities and the structure of the group .   
5. The competent authority or, where appropriate, the control authority or control body , 
shall assess whether there is a failure of the ICS based on the number of non -
compliances undetected by the ICS inspect ors and the result of the investigation of 
the cause and the nature of the non -compliances.  
Article  3 
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 2021.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brus sels, 
 For the Commission  
 The President  
 Ursula VON DER LEYEN