EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down detailed rules for the implementation of Regulation (EU) 2018/848 of the 
European Parliament and of the Council on controls and other measures ensuring 
traceability and compliance in organic production and the labelling of organic products  
(Tex t with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down detailed rules for the implementation of Regulation (EU) 2018/848 of the 
European  Parliament and of the Council on controls and other measures ensuring 
traceability and compliance in organic production and the labelling of organic products  
(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 Art icles 28(3) (a), 29(8) (a), 30(8), 32(5), 
36(4), 38(9), 41(5) and 43(7) thereof,  
Whereas:  
(1)  Chapter III of Regulation (EU) 2018/848 lays down general production rules for 
operators, including necessary measures to avoid the presence of non -authorised 
products and substances and measures to be taken in the event of the presence of non -
authorised p roducts or substances. In order to ensure harmonised conditions for the 
implementation of that Regulation, some additional rules should be laid down.  
(2) Considering the importance of the precautionary measures that operators have to  take 
to avoid the presence of non -authorised products and substances referred to in Article 
28 of Regulation (EU) 2018/848 , it is appropriate to  establish  procedural steps to be 
followed and the relevant documents to be provided in case operators suspect,  due to 
presence of non -authorised products or substances , that the product that is intended to 
be used or marketed  as organic or in -conversion product does not comply with 
Regulation (EU) 2018/848 . 
(3) In order to ensure a harmonised approach across the Union  as regards the official 
investigation referred to in Article 29(1)(a) of Regulation (EU) 2018/848 in the event 
of suspected non -compliance due to the presence of non -authorised products or 
substances in organic or in -conversion products, further rules cov ering the elements to 
be determined when carrying out the investigation, the expected results of the 
investigation as well as minimum reporting obligations should be established.  
(4) Chapter IV of Regulation (EU) 2018/848 lays down labelling rules for organic 
products. In order to ensure uniform conditions for the implementation of that 
Regulation, some additional rules should be laid down as regards the place and the 
appearance of certain indications on the label.   
(5) Chapter V of Regulation (EU) 2018/848 lays do wn rules for certification of operators 
and group s of operators. In order to ensure harmonised conditions for the 
                                                 
1 OJ L 150, 14.6.2018, p. 1.   
EN 2  EN implementation of that Regulation, some additional rules for the certification of a 
group of operators should be laid down.  
(6) In the interest of  the efficiency and affordable operational cost of the system for 
internal controls (ICS), it is appropriate to provide for a maximum size of a group of 
operators. By setting thi s limit , it is expected that the ICS can ensure the compliance 
of all members of the group with Regulation  (EU) 2018/848  by means of internal 
controls , necessary training and support . Further more,  the competent authority or , 
where appropriate , the control authority or control body that certifies the group can re -
inspect a reasonable number of members. The limitation of the size will provide 
additional guarantee s for an updated list of member s, rapid and regular exchange of 
information with control authorities  or control bodies , and ensure the implementation 
of adequate measures. However, the maximum size should take into consideration that 
a group of operators should be able to generate sufficient resources to establish an 
efficient ICS relying on qualified staff.    
(7) In order to provide evi dence of compliance and to allow the exchange of information 
and sharing of knowledge, the list of documents and records that a group of operators 
has to keep for the purposes of the ICS should be laid down.  
(8) The ICS should constitute the basis for the cer tification of a group of operators. 
Therefore, ICS managers should be required to inform the competent authority or, 
where appropriate, the control authority o r control body that provides the certificate of 
the most important issues, such as suspicions of non-compliances, suspensions or 
withdrawals of members and  any prohibition of the placing on the market of products 
as organic or in -conversion  products . 
(9) Chapter VI of Regulation (EU) 2018/848 lays down rules for official controls and 
other official activi ties. In order to ensure harmonised conditions for the 
implementation of that Regulation, some additional rules should be laid down.  
(10) In order to ensure the continuity of the current national control systems in the Member 
States, rules on minimum percentag es for official controls and sampling should be 
established.  
(11) With a view to eliminating the substantial divergence in the current application of 
national catalogues of measures in the Member States, a common template for a 
catalogue of measures should be established and further guidelines on the 
classification of non -compliances and the appropriate measures should be provided 
for. 
(12) Information on suspicion of non -compl iance should be shared between the Member 
States and the Commission directly and as effect ively as possible, primarily in order to 
allow all competent authorities concerned to carry out investigations and apply 
necessary measures as required in Article 29 (1) and (2) , Article 41 (1), (2) and (3)  and 
Article 42 of Regulation (E U) 2018/848 . Further more , it is appropriate  to specif y the 
details and procedures for sharing that information, including functionalities of the 
Organic Farming Information System. In that context, t his Regulation should also 
clarify  that in case of any suspicion or establish ed non -compliance that affects the 
integrity of organic or in -conversion products discovered by the control authority or 
control b ody, such information should be transferred without delay to their competent 
authorities. Finally, this Regulation should specify which information should  at least 
be shared by control authorities and control bodies with other control authorities and 
control bodies and their competent authorities and set an obligation for the competent  
EN 3  EN authorities to take the appropriate measures  and establish documented procedures to 
enable such exchange of information on their territory.  
(13) Groups of operators in third countries operating in compliance with Council 
Regulation (EC) No 834/20072 and Commission Regulations (EC) No 889/20083 and 
(EC) N o 1235/20084 may have a number of members significantly higher than the 
maximum size set by  this Regulation. Establishing new groups of operators complying 
with this new requirement may imply tangible adaptations for establishing the 
corresponding legal en tity, an efficient ICS and the necessary elements for the 
certification by a control authority  or control body . Hence, a transitional period of 
maximum 3 years from 1 January 2021 should be provided for in respect of th ose 
group s of operators to permit the m to carry out the necessary adaptations to comply 
with the new maximum size.  
(14) The requirement related to the national catalogue of measures may imply the changing 
of already existing national catalogues of measures  that have been developed in 
Member States  until now in compliance with Regulations (EC) No 834/2007 and (EC) 
No 889/2008. Hence, a transitional period of maximum 1  year from 1 January 2021 
should be provided for all Member States in respect of th ose existing national 
catalogues of measures  in ord er to permit them to carry out the necessary 
improvements  or the replacement of their national catalogues of measures  to comply 
with the new requirements.  
(15) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of applica tion of Regulation (EU) 2018/848 . 
(16) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee on Organic Production,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Procedural steps in case of  a suspicion of non -compliance due to the presence of non -
authorised products or substances  
1. In order to check whether the suspicion of non -compliance can be eliminated or to 
establish that the suspicion is substantiated in accordance with Article 28(2) (b) of 
Regulation (EU) 2018/848, the op erator shall take into account the following 
elements:  
(a) where the suspicion of non -compliance concerns an incoming organic or in -
conversion product, the operator shall check whether : 
(i) the information on the label of the organic or in -conversion organic or in-
conversion product and the information on the accompanying documents 
match;  
                                                 
2 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic 
products and repealing Regulation (EEC) No 2092/91  (OJ L 189, 20.7.2007, p. 1 ). 
3 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the 
implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of 
organic products with  regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).  
4 Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for 
implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of 
organic products from third countries (OJ L 334, 12.12.2008, p. 25).   
EN 4  EN (ii) the certificate provided by the supplier refers to the product actually 
purchased;  
(b) where there is a suspicion that the cause of the presence of the non -authorised 
products or substances lies under the control of the operator, the operator shall 
examine any possible cause for the presence of non -authorised products or 
substances.  
2. When the  operator informs the competent authority or, where appropriate, the control 
authority or control body in accordance with Article 28(2) (d) of Regulation  (EU) 
2018/848  about a substantiated suspicion or when the suspicion cannot be 
immediately eliminated, t he operator shall provide  at least  the following elements:  
(a) information and documents about the supplier (delivery note, invoice, 
certificate of the supplier, Certificate of Inspection for organic products (COI) 
where relevant);  
(b) the internal traceability of  the product with the batch number, stock quantity, 
quantity of product sold;  
(c) accredited laboratory results;  
(d) the sampling sheet detailing the  time, place and method used to submit the 
sample ; 
(e) any information about any previous suspicion with regard to  the specific 
product or substance ; 
(f) every other relevant document to clarify the case.  
 Article 2   
Methodology of an official investigation  
1. Without prejudice to Article 38(2) of Regulation (EU) 2018/848, when carrying out 
an official investigation referred to i n Article 29(1)(a) of that Regulation, the 
competent authorities or, where appropriate, control bodies or control authorities 
shall determine at least the following:  
(a) the name, batch number, ownership and physical location of the organic or in -
conversion pr oducts concerned;  
(b) whether the products concerned are still placed on the market as organic or in -
conversion product s or used in organic production;  
(c) the type, name, quantity and other relevant information of the present non -
authorised products or substances;  
(d) at which stage of production, preparation or distribution and where exactly the 
presence of non -authorised products or substances has been detected, in 
particular for plant production, whether the sample was taken pre -harvest or 
post-harvest;  
(e) whether other operators in the supply chain are affected;  
(f) the results of previous official investigations on the products and operators 
concerned.   
EN 5  EN 2. The official investigation shall be pursued by using appropriate methods and 
techniques, including those refer red to in Article 14 and Article 137(3) of Regulation 
(EU) 2017/625 of the European  Parliament and of the Council5. 
3. The official investigation shall at least conclude on:  
(a) the integrity of organic and in -conversion products;  
(b) the source and the cause of the presence of non -authorised products or 
substances;  
(c) the elements provided in Article 29(2) (a), (b) and (c)  of Regulation (EU) 
2018/848.  
4. The competent authorities or, where appropriate, control bodies or control authorities 
shall draw up a final report for e ach official investigation. That final report shall 
contain:  
(a) the records of the specific elements required pursuant to this Article;  
(b) the records of the information exchanged with the competent authority, other 
control authorities and control bodies and the  Commission related to th is 
investigation.  
Article 3   
Conditions for the uses of certain indications  
1. The indication provided for the in -conversion products of plant origin as referred to 
in Article 30(3) of Regulation (EU) 2018/848 shall  appear in : 
(a) a colou r, size and style of lettering that is not more prominent than the sales 
description of the product , while  the entire indication shall have the same size 
of letters;  
(b) the same visual field as the code number of the control authority  or control 
body  as refer red to in Article 32(1)(a) of Regulation (EU) 2018/848.  
2. The indication of the code number of the control authority or control body referred to 
in Article 32(1)(a) of Regulation (EU) 2018/848 shall appear i n the same visual field 
as the o rganic  production  logo of the E uropean Union, where it is used in the 
labelling.  
3. The indication of the place where the agricultural raw materials of which the 
products  are composed have been farmed, as referred to in Article 32(2) of 
Regulation (EU) 2018/848 , shall be placed  immediately below the code number 
referred to in paragraph 2  of this Article . 
                                                 
5 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 applica tion 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).  
  
EN 6  EN Article 4   
Composition and m aximum size of a group of operators  
A member of a group of operators shall register to only one group of operators for the same 
activity for a given product.  
The maximum size of a group of operators shall be 2000 members.  
Article 5   
Documents and records of a group of operators  
The group of operators shall keep the following documents and records for the purposes of the 
system for internal controls (ICS):  
(a) the list of members of the group of operators based on their registration of each 
member and consisting of the following elements for each member of the group of 
operators:  
(i) name and identification (code number);  
(ii) contact details;  
(iii) date of registration;  
(iv) total land surface under the management of the member and whether organic, 
in-conversion or non -organic;  
(v) a map with each production unit and/or activity: size, location, product, date of 
the beginning of the conversion period and  yield estimates;  
(vi) date of the last internal inspection with the name of the ICS inspector;  
(vii) date of the last official c ontrol performed by the competent authority or, where 
appropriate, control authority or control body with the name of the inspector;  
(b) the signed membership agreements between the member and the group as legal 
person, which shall include the rights and respo nsibilities of the member;  
(c) the internal inspection reports signed by the ICS inspector and the inspected member 
of the group and including at least the following elements:  
(i) the name of the member and the location of the production unit or premises 
where  the activity subject to the inspection takes place;  
(ii) the date and duration of the internal inspection;  
(d) the training records of the ICS inspectors consisting of:  
(i) the dates of the training;  
(ii) the subject  matter of the training;  
(iii) the name of the trainer;  
(iv) the signature of the trainee;  
(v) where appropriate, an assessment of the knowledge acquired;  
(e) the records of the measures taken in case of non -compliance by the ICS manager, 
which shall include:   
EN 7  EN (i) the list of members subject to measures  in case of non -compliance, including 
those suspended, withdrawn or required to comply with a new conversion 
period;  
(ii) documentation of identified non -compliance;  
(f) traceability records, including information on the quantities, on the following 
activities , where relevant:  
(i) purchase and distribution of farm inputs including seeds by the group;  
(ii) production including harvest;  
(iii) storing;  
(iv) preparation;  
(v) delivery of products from each member to the joint marketing system;  
(vi) placing on the m arket of products by the group;  
(g) the written agreements and contracts between the group of operator s and 
subcontractors including information on the nature of the subcontracted activities.  
The list of members referred to in point (a) of the first paragraph shall be updated by the ICS 
manager after any modification of the elements listed in point (a) (i) to (vii) and of the status 
of a member due to mea sures in case of non -compliance  resulting from internal  inspection s or 
official controls.  
Article 6   
Notifica tions from the ICS manager  
The ICS manager shall immediately notify the competent authority or, where appropriate, the 
control authority or control body of the following information:  
(a) any suspicion of major and critical non -compliance;  
(b) any suspension or withdrawal of a member or a production unit or premise s from the 
group;  
(c) any prohibition of the placing on the market of a product as organic or in -conversion  
product , including the name of the operator or operators concerned, the relevant 
quantities and lo t/batch information.  
Article 7   
Minimum percentages of controls and sampling  
The following rules on minimum percentages shall apply to the official controls referred to in 
Article 38(4) of Regulation (EU) 2018/848 to be carried out by each competent author ity or, 
where appropriate, control authority or control body according to the risk of non -compliance:  
(a) minimum 10% of all official controls of operators or groups of operators shall be 
carried out without prior notice every year;  
(b) minimum 10% of additional c ontrols to those referred to in Article 38 (3) of 
Regulation (EU) 2018/848 shall be carried out every year;   
EN 8  EN (c) minimum 5% of the number of operators shall be subject to sampling in accordance 
with Article 14 (h) of Regulation (EU) 2017/625 every year;  
(d) minimum 2% of the members of each group of operators shall be subject to sampling 
in accordance with Article 14 (h) of Regulation (EU) 2017/625 every year;  
(e) minimum 5% of the operators that are members of a group of operators, but not less 
than 10 members, shall be controlled in connection with the verification of 
compliance referred to in  Article 38 (3) of Regulation (EU) 2018/848 every year. 
Where the group has 10 members or less, all members shall be controlled in 
connection with the verification of compliance referred to in  Article 38 (3) of that 
Regulation.  
Article 8   
Measures in case of established non -compliance  
The competent authorities may use the uniform arrangements set out in the Annex I to this 
Regulation to develop a national catalogue of measures as r eferred to in Article 41(4) of 
Regulation (EU) 2018/848.  
That national catalogue of measures shall  cover at least:  
(a) a list of non -compliances with a reference to the specific rules of Regulation (EU) 
2018/848 or of the delegated or implementing act adopted in accordance with that 
Regulation;  
(b) the classification of the non -compliances into three categories: minor, major and 
critical, taking into account at least the following criteria:  
(i) the precautionary measures referred to in Article 28(1) of Regulation ( EU) 
2018/848 a nd the own controls referred to in A rticle 9(1)(d) of Regulation 
(EU) 2017/625;  
(ii) the integrity of the organic or in -conversion status of products;  
(iii) the ability of the  traceability system to locate the affected product(s) in the 
supp ly chain and prohibition of placing products on the market with reference 
to organic production;  
(iv) the response to previous requests by the competent authority or, where 
appropriate, the control authority or control body;  
(c) the measures corresponding to d ifferent categories of non -compliances.  
Article 9   
Exchange of information  
1. For the purpose s of Article 43 (1) of Regulation (EU) 2018/848, the competent 
authorities shall use the Organic Farming Information System (OFIS) and the 
templates set out in Annex II to this Regulation to exchange information with other  
Member States  and the Commission  in accordance with the following rules:  
(a) a Member State (notifying Member State) shall notify the relevant Member 
State or Member St ates (notified Member State or Member States)  at least in 
the following situations :  
EN 9  EN (i) when the suspected or established non -compliance affects the integrity of 
organic or in -conversion products coming from another Member State;   
(ii) when the suspected or established non -compliance affects the integrity of 
organic or in -conversion products imported from a third country pursuant 
to Article 45(1) or Article 57 of Regulation  (EU) 2018/848 ;  
(iii) when the suspected or established non -comp liance affects the integrity of 
organic or in -conversion products coming from the notifying Member 
State, since it could have implications for one or more notified Member 
States (alert notification);   
(b) in the situations referred to in point (a)(i) and (ii) the notified Member State  or 
Member States  shall reply within 30 calendar days from the date of receipt of 
the notification  and shall  inform about the actions and measures taken, 
including the results of the investigation and provide any other information 
available and/or required by the notifying Member State;  
(c) the notifying Member State  may ask the notified  Member State or Member 
States  for any necessary additional information;  
(d) the notifying Member State  shall, as soon as possible, make the necessary 
entries and updates in OFIS , including the updates relating to the results of its 
own investigations.  
2. In addition to information obligation referred to in Article 32(b) of Regulation (EU) 
2017/625,  the control authority or control body shall , without delay , inform the 
competent authority that has conferred to it or  has delegated to it certain official 
control tasks or certain tasks related to other official activities  in accordance with 
Article 4(3) and Article 28(1) or Article 31 of that Regulation , about any s uspicion or 
established non -compliance that affects the integrity of organic or in -conversion 
products. It shall also provide any other information required by that competent 
authority.  
3. For the purpose s of Article 43 (3) of Regulation  (EU) 2018/848, where operators or 
groups of operators and/or their subcontractors are checked by different control 
authorities or control bodies, th ose control authorities and control bodies shall 
exchange the relevant information on the operations under their control.  
4. For the purpose s of Article 43 (3) of Regulation  (EU) 2018/848 , where operators or 
groups of operators and/or their subcontractors change their control authority or 
control body, the control authority or control body concerned shall notify t he 
competent authority without delay of that change .  
The previous control authority or control body shall hand over to the new control 
authority or control body the control file of the operator or group of operators 
concerned, including the written record s referred to in Article 38(6) of Regulation  
(EU) 2018/848 , the status of the certification, the list of non -compliances and the 
corresponding measures taken by the previous control authority or control body.  
The new control authority or control body shall  ensure that non -compliances noted in 
the records of the previous control authority or control body have been or will be 
addressed by the operator.  
5. For the purpose s of Article 43 (3) of Regulation (EU) 2018/848, where operators or 
groups of operators are s ubject to a traceability check and a mass balance check,  
EN 10  EN control authorities and control bodies shall exchange the relevant information 
allowing finalisation of these checks.  
6. The competent authorities shall take the appropriate measures and establish 
docum ented procedures to enable the exchange of information between them and the 
control authorities and/or control bodies to which they have conferred  or delegated 
certain official control tasks or certain tasks related to other official activities as well 
as between those control authorities and/or control bodies.  
Article 10  
Transitional provisions  
1. Groups of operators in third countries complying with Regulations (EC) No 
834/2007, (EC) No 889/2008 and (EC) No 1235/2008  before the date of entry into 
application  of this Regulation  and for which important administrative, legal and 
structural changes are necessary with  regard to  the maximum size of the group of 
operators laid down  in the second paragraph of Article 4 of this Regulation , shall 
comply with  that provi sion from 1 January 2024 at the latest.  
2. The national catalogue of measures developed in accordance with Article 8 shall 
apply from 1 January 2022  at the latest.  
Article 11  
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 Brussels,  
 For the  Commission  
 The President  
 Ursula VON DER  LEYEN