EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2018/848 of the European Parliament and of the Council as 
regards the requirements for groups of operators and the model of certificate attesting 
compliance with the rules on organic production  
 
(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 amending Regulation (EU) 
2018/848 in order to add further provisions on groups of operators and amend the model of 
the certificate provided to operators or group of operators. Organic sector nee ds 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 tho roughly 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 their specific ex pertise 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 additional rules on groups of operators and amends the model of 
the certif icate provided to operators or group of operators.  EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2018/848 of the European Parliament and of the Council as 
regards the requirements for groups of operators and the model of certificate attesting 
compliance with the rules on organic production  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having reg ard 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 Articles 35(9) and 36(3) thereof,  
Whereas:  
(1) Article 36(1) of Regulation (EU) 2018/848 sets out certain requirements for groups of 
operators. In the interest of a  harmonised interpretation of the geographical proximity 
of the members of a group of operators, it should be stated explicitly  that the activit ies 
of the members are to take place in the same country.  
(2) For the purpose of establishing minimum requirements regarding the set -up and 
functioning of the system for internal controls (ICS), the following aspects should be  
defined : registrat ion of members, internal inspections, approval of new members or 
new production units or activities of existing members, training of ICS inspectors, 
measures in cases of non -compliances and internal traceability.  
(3) In that context , the requirement to appoin t an ICS manager and one or more  ICS 
inspector s should be added in order to ensure the proper implementation of the ICS by 
the competent personnel.  
(4) In addition, in order  to provide for a harmonised assessment framework for the ICS, it 
is appropriate to inc lude a list of situations that are to be considered as deficien t. 
(5) Annex VI to Regulation (EU) 2018/848 sets out the model of certificate to be issued to 
any operator or group of operators that has notified its activity and complies with that 
Regulation.  It is necessary  to provide for clear rules on the classification of activities 
and the validity of the certificate . To ensure a harmonised implementation, the model 
of the certificate contains common elements, which are mandatory in all Member 
States, such a s the name and address, activities of operators and categories of products . 
However, competent authorities or, where appropriate,  control authorities or control 
bodies that issue the certificate may decide to require  specific additional information 
such as  a detailed list of products, information on land and premises, a list of 
subcontractors and information on the accreditation of the control body.  Therefore it 
is appropriate to add a dedicated part to the certificate.  
                                                 
1 OJ L 150, 14.6.2018, p. 1.  EN 3  EN (6) Regulation (EU) 2018/848 should therefore be amended accordingly.  
(7) 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  
Amendments to Regulation (EU) 2018/848  
Regulatio n (EU) 2018/848 is amended as follows:  
(1) Article 36 is amended as follows:  
(a) paragraph 1 is amended as follows:  
 (i) point (e) is replaced by the following:  
“(e) only be composed of members whose production activities or possible 
additional activities referred to in point (a)  take place in geographical 
proximity to each other in the same Member State or in the same third 
country;” ; 
(ii) in point (g) , the following paragraph is added:  
“The  system  for internal controls (ICS ) shall comprise documented procedures 
on:  
(i) the registration  of the members of the group;  
(ii) the annual internal physical on -the-spot inspections  of each 
member of the group , and any additional  risk-based internal 
inspection s, in any case scheduled by the ICS manager and 
conducted by ICS inspectors , whose roles are defined in point (h) ;  
(iii) the approval of new members in an existing group or, where 
appropriate , the approval of  new production units or new activities 
of existing members  upon the approval by the ICS manager on the 
basis of the internal inspection report ;  
(iv) the training of the ICS inspectors, which is to take place  at least 
annually and to be accompanied by an assessment of the 
knowledge acquired by the participants;  
(v) the measures in case s of non -compliance detected during the 
internal inspections ; 
(vi) the internal traceabilit y, which shows the origin of the products 
delivered in the joint marketing system of the group of operators 
and allows the tracing of all product s of all members throughout all 
stages , such as production, processing, preparation or placing on 
the market, including estimating and cross -checking the yields of 
each member of the group of operators; ”; 
(iii) the following point (h) is added:  
“(h) appoint an ICS manager and  one or more  ICS inspector s who may be a 
member of the group. Their positions shall not be combined. The number  of EN 4  EN ICS inspectors shall be  adequate and  proportional  in particular to the size , 
products, activities and output of org anic production of the group of operators.  
The ICS manager shall:  
(i) verify  the eligibility of each member of the group regarding the 
criteria set out in points (a), (b) and (e) ; 
(ii) ensure that there is a written and signed membership agreement , 
betwe en each of the members and the legal entity which represents 
the group , by which the members commit themselves to:  
– comply with this Regulation;  
– participate in the ICS and comply with the ICS procedures, 
including the tasks and responsibilities assigned t o them by 
the ICS manager and the obligation for records keeping;  
– permit access to production units and premises and be present 
during the internal inspections carried out by the ICS 
inspectors and official controls carried out by the competent 
authority or, where appropriate, the control authority or 
control body , and make available to them all documents and 
records;  
– accept and implement the measures in cases of non -
compliances in accordance with the decision of the ICS 
manager or the competent authority or, where appropriate, 
the control authority or control body , within the given time -
frame;  
– immediately inform the ICS mana ger on suspected  non-
compliance;  
(iii) develop the ICS procedures and the relevant documents and 
records ,  keep  them up  to date and m ake them readily available to 
the ICS inspectors, and where relevant, to the members of the 
group;  
(iv) draw up the list of the members of the group and keep it up to date;  
(v) assign tasks and responsibilities to the ICS inspectors;  
(vi) be the liaison b etween the members of the group of operators and 
the competent authority or, where appropriate, the control authority 
or control body, including requests for derogations;  
(vii) verify the conflict of interest statements of the ICS inspectors;  
(viii)  sched ule internal inspections and ensure the ir adequate 
implementation;  
(ix) ensure adequate trainings for the ICS inspectors and carry out an 
annual assessment of ICS inspectors’ competences and 
qualifications;  
(x) approve new members and/or new production uni ts or activities of 
existing members;  EN 5  EN (xi) decide on measures in case of non -compliance in line with the 
national catalogue of measures in  the Union and the catalogue of 
measures applied by control authorities and control bodies 
recognised to certify organic products in third countries and ensure 
the follow -up of those measures ;  
(xii) decide to subcontract activities and sign relevant  agreements.  
The ICS inspector shall:  
(i) carry out internal inspections of the members of the group 
according to the schedule and the procedures provided by the ICS 
manager;  
(ii) draft internal inspection reports on the basis of a template and 
submit it within a reasonable time to the ICS manager;  
(iii) submit at appointment a written and signed statement on conflict of 
interest and update it annually;  
(iv) participate in trainings .”; 
(b) in paragraph 2, the following subparagraph is added:  
“At least t he following  situations shall be considered as deficiencies in the ICS: 
(a) placing on the market of products from suspended/withdrawn members 
or production units;  
(b) changing the list of members without following the internal approval 
procedure;  
(c) not carrying out the annual physical on -the-spot inspection of a member 
of the group in a given year;   
(d) the incorrect indication of the status of the members in the list of 
members;  
(e) serious deviations in findings betw een internal inspections carried out by 
the ICS inspectors and offic ial controls carried out by the competent 
authority or, where appropriate, the control authority o r control body;  
(f) serious deficiencies in imposing appropriate measures and/or carrying 
out the necessary follow -up in response to non -compliance identified by 
the ICS inspectors or by the competent authority or, where appropriate, 
the control authority of control body;  
(g) inadequate number of ICS inspectors or inadequate competences of ICS 
inspectors for the type, size and/or structure of the group of operators .”; 
(2) Annex VI is replaced by the text in the Annex to this Regulation.  
Article  2 
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 . EN 6  EN It shall apply from 1 January 2021.  
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