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 procedural requirements for the recognition of control authorities and 
control bodies that are competent to carry out controls on operators and groups of 
operators ce rtified organic and on organic products in third countries and with rules on 
their supervision and the controls and other actions to be performed by those control 
authorities and control bodies  
(Text 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 EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the adoption of Regulation  (EU) 2018/848 , which will enter into application on 1 
January 2022, the Commission may recognise control authorities and control bodies that are 
competent to carry out controls of imported organic products and to issue organic certificates 
in third countries.  
This Reg ulation lay down:  
 The procedural requirements to be fulfilled when requesting an initial recognition, or 
when requesting an extension of the scope of their recognition to an additional third 
country or category of products. In particular, this Regulation s hould specify the 
information to be included in the technical dossier that is part of the request for 
recognition.  
 The tools for supervision control authorities and control bodies by the Commission 
which are the annual reports, the on -the spot examinations , the traceability checks of 
products from operators certified by them and the list of high -risk products. For each 
of those tools of supervision, this Regulation set s out different  requirements.   
 Rules on the controls on operators in third countries carr ied out by control authorities 
and control bodies recognised that are similar to the relevant provisions of 
Regulation (EU) 2018/848 and Regulation (EU) 2017/625 , in order to ensure a 
consistent approach . 
 Specific requirements for control authorities and c ontrol bodies  as regards additional 
information requests, detailed production rules on algae and aquaculture , details of 
certain derogations granted during the previous year.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The draft delegated 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. 
DG AGRI cooperated closely with other DGs in the field of their specific expertise when 
drafting t hese rules. WTO partners were notified and general public consultations were 
carried out.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
This delegated act lays down supplementing provisions to Regulation  (EU) 2018/848 as 
regards the exercise of the supervision of  the control authorities and control bodies recognised 
by the Commission in accordance by article 46(1) of that regulation and the controls and other 
actions to be performed by those control authorities and control bodies   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2018/848 of the European Parliament and of the 
Council with procedural requirements for the recognition of control authorities and 
control bodies that  are competent to carry out controls on operators and groups of 
operators certified organic and on organic products in third countries and with rules on 
their supervision and the controls and other actions to be performed by those control 
authorities and c ontrol bodies  
(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 22(1) in conjunction with Article 
45(3), and point (b) of Article  46(7) thereof,  
Whereas:  
(1) Pursuant to Article 46 of Regulation (EU) 2018/848, the Commission may recognise 
control authorities and control bodies that are competent to carry out controls of 
imported organic products and to issue organic certificates in third countries.  
(2) In order to ensure equal treatment amongst the contro l authorities and control bodies 
that submit a request for recognition to the Commission, this Regulation should lay 
down the procedural requirements to be fulfilled when requesting an initial 
recognition, or when requesting an extension of the scope of th eir recognition to an 
additional third country or category of products. In particular, this Regulation should 
specify the information to be included in the technical dossier that is part of the 
request for recognition.  
(3) Chapter VI of Regulation (EU) 2018/84 8, which establishes the provisions on controls 
on certified operators and other obligations of those operators in the Union, does not 
apply to operators in third countries. In addition, organic production in the Union is 
subject to official controls and t o other official activities carried out in accordance with 
Regulation (EU) 2017/625 of the European Parliament and of the Council2 to verify 
                                                 
1 OJ L 150, 14.6.2018, p. 1.  
2 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 application of food and feed law, rules on 
animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 
999/20 01, (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, 96/9 3/EC and 97/78/EC and Council Decision 
92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).   
EN 3  EN compliance with the rules on organic production and the labelling of organic products. 
Therefore, in order to ensur e a consistent approach, this Regulation should lay down 
rules on the controls on operators in third countries carried out by control authorities 
and control bodies recognised pursuant to Article 46(1) of Regulation (EU) 2018/848 
that are similar to the re levant provisions of Chapter VI of that Regulation and 
Regulation (EU) 2017/625. It is also necessary to lay down provisions dealing with 
certain aspects of the controls that are specific to the certification of operators in third 
countries, for instance, as regards the verification of the consignments intended for 
import into the Union.  
(4) In relation to group s of operators, it follows from point (b)(i) of Article 45(1) of 
Regulation (EU) 2018/848 that the provisions of that Regulation concerning group s of 
operators also apply to group s of operators in third countries. Therefore, it is 
appropriate to clarify that the provisions set out in the delegated and implementing 
acts adopted pursuant to Regulation (EU) 2018/848 apply to group s of operators in 
third cou ntries.   
(5) In order to enable the Commission to exercise its supervision on the  control authorities 
and control bodies recognised as competent to carry out controls and issue certificates 
in third countries, they should submit an annual report to the Commiss ion with 
information on their control activities and the implementation of the organic rules. 
This Regulation should specify the information to be included in that annual report.   
(6) For the purpose of applying the detailed production rules on algae and aqua culture 
animal production set out in Regulation (EU) 2018/848 and in particular in Annex II to 
that Regulation, it is appropriate to set up certain procedures to carry out such 
obligations by control authorities and control bodies in third countries.  
(7) The c ontrol authorities and control bodies should set up procedures to ensure exchange 
of information between them and the Commission and with other control authorities 
and control bodies, the accreditation body and Member States. Such communication 
should be d one via a computer system made available by the Commission, which  
enables electronic exchange of documents and information.  
(8) In addition to the rules on non -compliances set out in Regulation (EU) 2018/848, it is 
necessary to provide for investigations to b e carried out on suspected and established 
cases of non -compliance, and to set the requirements in that respect, including the 
need to develop a catalogue of measures.  
(9) It follows from point (b)(i) of Article 45(1) of Regulation (EU) 2018/848 that the 
provisions on the precautionary measures and measures to be taken in case of 
suspected or established non -compliance set out in that Regulation, and the delegated 
and implementing acts adopted pursuant to it, apply to third countries. Therefore, it is 
appropriate to lay down the necessary rules with regard to third countries and their 
specific situation.  
(10) Chapter III of Regulation (EU) 2018/848, and the delegated and implementing acts 
adopted pursuant to it,  set out rules  on the conversion period and retroactive 
recognition of previous periods. The conversion to the organic production method 
requires certain periods of adaptation of all means in use. The required conversion 
period starts at the earliest after  the operator concerned has  notified the activity to the 
control authority or control body. As an exception , and under certain conditions, a 
previous period may be recognised retroactively as being part of the conversion 
period. The documents to be submitted by operators in third  countries to the control  
EN 4  EN authority or control body for the purpose of the retroactive recognition of a previous 
period should be specified.  
(11) Furthermore, it is necessary to lay down certain reporting requirements with respect  to 
general production rules as well as certain specific  derogations or authorisations in 
accordance with Regulation (EU) 2018/848.  
(12) By analogy with the rules laid down in Commission Delegated Regulation (EU) 
2020/21463 in respect of Member States, this Reg ulation should specify the conditions 
under which the derogation for catastrophic circumstances occurring in third countries 
can be granted and the role and obligations of the control authority or control body in 
that respect .  
(13) Detailed production rules se t out in Annex II to Regulation (EU) 2018/848 refer to 
certain tasks and obligations of the competent authorities in the Member States. As 
those rules apply by analogy to control authorities and control bodies recognised as 
competent to carry out controls of imported organic products and issue organic 
certificates in third countries, it is appropriate to clarify that certain references to 
competent authorities or to Member States should be read as references to control 
authorities and control bodies recogni sed in accordance with Article 46(1) of 
Regulation (EU) 2018/848.  
(14) 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:  
CHAPTER I  
PROCEDURAL REQUI REMENTS FOR THE RECOGNITION 
OF CONTROL AUTHORITIES AND CONTROL BODIES  
Article 1  
Requirements referred to in point (n) of Article 46(2) of Regulation (EU) 2018/848  
1. A control authority or control body shall submit the request for recognition referred 
in Art icle 46(4) of Regulation (EU) 2018/848 using the model made available by the 
Commission. Only complete requests shall be taken into account.  
 
2. The technical dossier referred to in Article 46(4) of Regulation (EU) 2018/848 shall 
contain the following informa tion in one of the official languages of the Union:  
(a) the following information about  the control  authority or control body:   
(i) name ;  
(ii) mailing address;  
(iii) telephone number;  
                                                 
3 Commission Delegated Regulation (EU) 2020/2146 of 24 September 2020 supplementing Regulation 
(EU) 2018/848 of the European Parliament and of the C ouncil as regards exceptional production rules 
in organic production (OJ L 428, 18.12.2020, p. 5).   
EN 5  EN (iv) email contact point ; 
(v) for control bodies, the name of their accreditation body;  
(b) an overview of the intended activities of the control authority or control body in the 
third country or third countries concerned, including an indication of the organic 
products, together with their Combined Nomenclature  (CN) codes according to 
Coun cil Regulation (EEC) No 2658/874, distributed per category of product s as set 
out in Article 35(7) of Regulation (EU) 2018/848, that are intended to be imported 
into the Union in accordance with point (b)(i) of Article 45(1) of  Regulation (EU) 
2018/848 during the first year of activity following the recognition by the 
Commission;  
(c) a description of the control authority or control body as regards:  
(i) its structure and size;  
(ii) its IT management system;  
(iii) its branch offices,  if any;  
(iv) its type of activities, including delegated  activities , if any ;  
(v) its organi sational chart;   
(vi) its quality management;  
(d) the certification procedures, in particular for granting or rejecting, suspension or 
withdrawal of the certificate  referred to in point (b)(i) of Article 45(1) of Regulation 
(EU) 2018/848 ; 
(e) the translation of the production rules set out in Regulation (EU) 2018/848 in 
languages that are understandable for the contracted operators in the third countries 
for which the contr ol authority or control body requests recognition;  
(f) the documents proving that the criteria  set out in Article 46(2) of Regulation (EU) 
2018/848 are fulfilled, in particular a copy of the accreditation certificate granted by 
the accreditation body covering all categories of product s for which recognition is 
requested;  
(g) the procedures describing in detail the functioning and the implementation of the 
control system to be set up in accordance with this Regulation, including, where 
relevant, control specificitie s for the group of operators;  
(h) a catalogue of measures to be taken in cases of established non -compliance as laid 
down in Article 22 of this Regulation;  
(i) a copy of the most recent assessment report referred to in the second subparagraph of 
Article 46(4) of Regulation (EU) 2018/848, drawn up by the accreditation body or, as 
appropriate, by the competent authority, containing the information referred to in 
Part A of  Annex I to this Regulatio n, including a witness audit report on a witness 
audit carried out within two years preceding  the submission of the request for 
recognition,  and giving the following guarantees:  
(i) that the control authority or control body has been satisfactorily assessed  on its 
ability to ensure that products imported from third countries meet the 
                                                 
4 Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on 
the Common Customs Tariff (OJ L 256 7.9.1987, p. 1).   
EN 6  EN conditions set out in points (a), (b)(i) and (c) of Article 45(1) and in Article 
46(2) of Regulation (EU) 2018/848;  
(ii) that the control authority or control body has the capac ity and the competencies 
to implement effectively the control requirements and fulfil the criteria set out 
in Article 46(2) of Regulation (EU) 2018/848 and in this Regulation in each 
third country for which it requests recognition;  
(j) proof that the control a uthority or control body has notified its activities to the 
relevant authorities of the third country concerned and its undertaking  to respect the 
legal requirements imposed on it by the authorities of the third country concerned;  
(k) a website address, with a content available in at least one of the official languages of 
the Union and also understandable for the contracted operators, where the list 
referred to in point (a) of  Article 17 of this Regulation  can be found;  
(l) an undertaking by the control authority or control body to give access to all its 
offices and facilities to  independent  experts designated by the Commission and keep 
available and communicate all information related to its control activities in the third 
country concerned;  
(m) a statement by the con trol authority or control body that it has  not been subject to 
withdrawal by the Commission, or withdrawn or suspended by any accreditation 
body, in the 24 months preceding their request for recognition for the third country 
and/or category of product s they request a recognition for. This requirement does not 
apply in case of withdrawal pursuant to point (k) of Article 46(2a ) of Regulation 
(EU) 2018/848;  
(n) any other information deemed relevant by the control authority or control body, or by 
the accreditation body.  
3. The control authority or control body shall provide any further information requested 
by the Commission for the purpose of its recognition.  
4. If the Commission finds that the information provided pursuant to paragraph 2 or 3 is 
incomplete, outdated or unsatisfactory, it shall reject the request for recognition.  
Article  2 
Extension of the scope of the recognition  
A control authority or control body recognised in accordance with Article 46 of Regulation 
(EU) 2018/848 may submit a request for extension of the scope of its recognition to an 
additional third country or to an additional category of product s using the model made 
available by the Commission.  
The request for extension of the scope of recognition shall consist of an update of the relevant 
parts of the technical dossier referred to in Article 1(2) with the appropriate information on 
the additional third country or the additional category of produ cts subject to the scope 
extension.   
EN 7  EN Chapter II  
 SUPERVISION OF THE CONTROL AUTHORITIES AND 
CONTROL BODIES BY THE COMMISSION  
Article 3  
General requirements for the supervision of control authorities and control bodies  
1. The supervisory activities of the Commission in respect of control authorities and 
control bodies recognised in accordance with Article 46(1) of Regulation (EU) 
2018/848 shall focus on the evaluation of the operational performance of the control 
authoritie s and control bodies, taking into account the results of the work of the 
accreditation bodies referred in point (d) of Article 46(2) of that Regulation.  
2. The intensity and frequency of the supervisory activities carried out by the 
Commission shall be adapte d according to the risk of non -compliances in accordance 
with Article 46(6) of Regulation (EU) 2018/848.  
3. Control authorities and control bodies recognised in accordance with Article 46 (1) of 
Regulation (EU) 2018/848 shall maintain the ability to meet the conditions and 
criteria set out in points (a), (b)(i) and (c) of Article 45(1)  and Article 46(2) of that 
Regulation  as set out  in the technical dossier at the moment of their recognition. 
They shall also maintain the capacity and competenc ies to implement the control 
requirements, conditions and measures set out in Article 46(2) and (6) of Regulation 
(EU) 2018/848 and in this Regulation . 
For that purpose, they shall demonstrate:  
(a) that they have effectively implemented their activities according to the 
condit ions and criteria referred to in the first subparagraph; and  
(b) compliance with their operating procedures and the effectiveness of their 
control measures . 
4. For the purpose of the annual report , the control bodies shall ensure that witness 
audits are carried o ut in accordance with Sections  1 and 2  of Part B of Annex I to this 
Regulation and the following rules:   
(a) the duration period between two witness audits shall not exceed 4 years ; 
(b) the number of witness audits carried out for the initial request for recognit ion 
shall not be considered for the calculation of the total number of witness audits 
to be carried out during the 4 years referred to in point (a);   
(c) one additional witness audit shall be carried out:  
(i) every 2 years in those third countries where the high-risk product as 
referred to in Article 8 is produced or processed;  
(ii) for every 10 third countries recognised. This additional witness audit 
shall be carried out within 4 years;  
(d)  more witness audits shall be performed at the request of the Commission or  of 
the accreditation body based on a risk analysis of, in particular, the following 
factors:    
EN 8  EN (i) the number of inspectors;  
(ii) the number of operators;  
(iii) the type of activities carried out by the operators;  
(iv) the number of witness audits carried out by the accreditation body;  
(v) the irregularities concerning the control bodies;  
(vi) the number of certified groups of operators and the size of them;  
(vii) the critical findings for the control bodies or the specific inspecto r or 
inspectors;  
(viii)  the nature of the products and the risk of fraud;  
(ix) Commission feedback based on the previous annual report of the control 
body;  
(x) suspicions of fraud by operators.  
5. Control authorities and control bodies shall submit documentat ion on their risk - 
analysis procedure at the Commission’s request.   
6. For the purpose of supervision of the control authorities and control bodies 
recognised by the Commission, the latter may be assisted by two Member States to 
act as co -reporters for the e xamination of technical dossiers submitted by control 
authorities and control bodies for initial recognition or the extension  of their scope of 
recognition, the management and review of the list of recognised control authorities 
and control bodies and the evaluation of the operational performance , including 
annual reports, of the control authorities and control bodies.  
7. The Commission may divide the requests between the Member States proportionally 
with the number of votes of each Member State in the Commit tee on organic 
production . 
Article 4  
Annual report  
By 28 February every year, the control authority or control body shall submit an annual report 
to the Commission.  
That annual report shall set out the activities of the control authority or control body i n the 
previous year in accordance with Annex II  
It shall be submitted in one of the official languages of the Union and in English if the official 
language chosen is not English.  
Article 5  
On–the-spot examinations and audits  
1. The Commission shall regularly organise risk -based on -the-spot examinations and/or 
audits of the control authorities and control bodies to evaluate the quality and 
effectiveness of the controls carried out by each control authority or control body. 
Those examinations and audits may be c oordinated with the relevant accreditation  
EN 9  EN body. The Commission may be accompanied by independent experts during these 
on-the-spot examinations and audits.   
2. The Commission may request any further information, including the presentation of 
one or more ad -hoc on-the-spot examination reports established by independent 
experts that it designates.  
3. On-the-spot examinations and  audits may include:  
(a) a visit to the offices or premises of the control authorities and control 
bodies, their outsourced services and opera tors or groups of operators  
under their control, in the Union and in third countries;  
(b) a document review of the relevant documents describing the structure, 
functioning and quality management of the control authorities or control 
bodies;  
(c) a document review  of staff files, including evidence of their 
competenc ies, training records, conflict of interest statements and records 
of evaluation and supervision of staff;  
(d) a check of operator s’ or groups of operators ’ files in order to verify the 
treatment of non -compliances and complaints, the minimum control 
frequency, the use of a risk -based approach in the conduct of inspections, 
the implementation of follow -up visits and visits without prior notice, the 
sampling policy and the exchange of information with other control 
bodies and control authorities;  
(e) a review audit, which is the inspection of operator s or groups of operators  
to verify compliance with the standard control and risk assessment 
procedures of the control authority or control body and to verify its 
effectiveness, taking into account the evolution of the operators ’ situation  
from the last inspection of the control authority or control body;   
(f) a witness audit, which is the evaluation of the performance of the 
physical on -the-spot inspection carried out by an inspector of the control 
authority or control body.  
Article 6  
Traceability checks  
The Commission may perform traceability checks on produc ts or consignments  covered by 
the scope of the recognition of  a control authority or control body recognised in accordance 
with Article 46(1) of Regulation (EU) 2018/848.  
For the purpose of  tracing the ingredients or production phases of an organic product, the 
Commission may ask information from  the competent authorities or from control authorities 
or control bodies involved in the control of those products falling under their supervision .  
The Com mission may perform t raceability checks based on the annual risk assessment 
performed by it, complaints received by the Commission or Member States, or randomly.  
The Commission shall perform t raceability checks in a timeframe defined by it, which shall 
be communicated in time to the relevant competent authorities, control authorities  and control 
bodies involved.   
EN 10  EN Article 7  
Ad hoc request by the Commission  
The Commission may, at any time, based on a substantial analysis proving the necessity, 
make ad -hoc requ ests for information to a control authority or control body.  
Article 8  
List of high -risk products  
Control authorities and control bodies operating in respect of third countries shall apply the 
measures referred to in Articles 9(6), 12(5) and 1 6(6) of this Regulation in respect of the high -
risk products originating from third countries as listed in an implementing act adopted 
pursuant to Article 46(8) of Regulation (EU) 2018/848 on the basis of a selection made after 
major or repetitive non -compliances affec ting the integrity of organic or in -conversion 
products or production.  
CHAPTER III  
Controls in respect of operators and group s of operators by the 
control authorities and control bodies  
Article 9  
General provisions  
1. Controls performed by control authorities  and control bodies  for the verification of 
compliance with Regulation (EU) 2018/848 by operators and group s of operators in 
third countries shall include:  
(a) the verification of the application of preventive and precautionary measures, as 
referred to in Arti cle 9(6) and in Article 28 of Regulation (EU) 2018/848, at 
every stage of production, preparation and distribution;  
(b) where the holding includes non -organic or in -conversion production units, the 
verification of the records and of the measures or procedures  or arrangements 
in place to ensure the clear and effective separation between organic, in - 
conversion and non -organic production units as well as between the respective 
products produced by those units, and of the substances and products used for 
organic,  in-conversion and non -organic production units. Such verification 
shall include checks on parcels for which a previous period was recognised 
retroactively as part of the conversion period, and checks on the non -organic 
production units;  
(c) where organic, in -conversion and non -organic products are collected 
simultaneously by operators, are prepared or stored in the same preparation 
unit, area or premises, or are transported to other operators or units, the 
verification of the records and of t he measures, procedures or arrangements in 
place to ensure that operations are carried out separated by place or time, that 
suitable cleaning measures and  measures to prevent substitution of products are 
implemented, that organic products and in -conversion  products are identified at  
EN 11  EN all times , that organic, in -conversion and non -organic products are stored, 
before and after the preparation operations, separated by place or time from 
each other , and that traceability of each lot from the individual  land parc els to 
the collection centre  has been ensured .  
2. Controls by control authorities and control bodies  for the verification of compliance 
with Regulation (EU) 2018/848 shall be performed on  all operators and groups of 
operators in third countries regularly, on  a risk basis  and with appropriate frequency, 
throughout the entire process at all stages of production, preparation and distribution 
on the basis of the likelihood of non -compliance as defined in point (57) of Article 3 
of Regulation (EU) 2018/848, which shall be determined taking into account the 
following elements:  
(a) the type, size , including newly added  land parcels,  and structure of the 
operators and group s of operators , as well as the number of new members 
joining the group of operators ;  
(b) location and complexity of the activities or operations of operators and groups 
of operators;  
(c) the length of time during which operators and group s of operators have been 
involved in organic production, preparation and distribution;  
(d) the results of the controls performe d in accordance with this Article, in 
particular as regards compliance with Regulation (EU) 2018/848;  
(e) in the case of a group of operators, the results of the internal inspections carried 
out in accordance with the documented procedures of the system for internal 
control s of the group of operators;  
(f) whether  the holding includes  non-organic or in -conversion production units;  
(g) the type, quantity and value of products;  
(h) the risk of commingling of products or contamination with non -authorised 
products or substan ces;  
(i) the application of derogations or exceptions to the rules by operators and 
group s of operators;  
(j) the critical points for non -compliance at every stage of production, preparation 
and distribution;  
(k) subcontracting activities;  
(l) whether  operator s or grou ps of operators ha ve changed their certifying control 
authority or control body;  
(m) any information indicating the likelihood that consumers might be misled;   
(n) any information that might indicate non -compliance with Regulation (EU) 
2018/848.  
3. Article 2 of Com mission Del egated Regulation (EU) 202 1/XXX5 and Articles 4 , 5 
and 6 of Commission Implem enting Regulation (EU) 2021/2796 shall apply mutatis 
mutandis  to controls in respect of group s of operators in third countries.   
                                                 
5 Commission Delegated Regulation (EU) 2021/XXX of 21 January 2021  supplementing Regulation 
(EU) 2018/848 of the European Parliament and of the Council by laying down specific criteria and  
EN 12  EN 4. The control authority or control body s hall carry out a verification of compliance 
with Regulation (EU) 2018/848 for all operators and group s of operators  at least once 
a year. The verification of compliance shall include a physical on -the-spot 
inspection . 
5. The control authority or control body shall ensure that it carries out every year a 
minimum of 10% of additional controls to those referred to in paragraph 4. Of all 
physical on -the-spot inspection s carried out by the control authority or control body, 
10% shall be without prior notice .  
6. Controls carried out as a follow -up on a suspected or established non -compliance 
shall not count towards the additional controls  referred to in paragraph 5 . 
7. Every year , the control authority or control body shall re -inspect minimum 5% of the 
members of a group of operator s, but not less than 10 members . Where the group of 
operators has 10 members or less, all members shall be re-inspected . 
8. The physical on -the-spot inspection and the sampling shall be carried out by the 
contro l authority or control body  at the most appropriate times  in order to verify 
compliance on critical control points.  
For the high -risk products referred to in Article 8, the control authority or control 
body shall carry out, at least, two physical on -the-spot inspections per year of  
operator s or group s of operators . One of these physical on-the-spot inspections shall 
be without prior notice.    
9. Where operator s or group s of operators run several production units or premises, 
including purchase and collection  centres , all production units or premises, including 
purchase and collection centres, used for non -organic products shall also be subject 
to the control requirements set out in paragraph 4.  
10. The delivery or renewal of the certificate referred to in point (b)(i) of Article 45(1) of 
Regulation (EU) 2018/848 shall be based on the results of the verification of 
compliance referred to in this Article.  
Article 10   
Checks for the certification of op erators or group s of operators  
1. Before accepting to certify operators or group s of operators, a control authority or 
control body shall ensure that the operators or group s of operators have  provided the 
following:  
(a) a document in the form of a signed declaration, setting out:  
(i) a description  of the organic and/or in -conversion production unit and, 
where relevant, of the non -organic production units and of the activities 
to be performed in accordance with Regulation  (EU) 2018/848;  
                                                                                                                                                         
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 xxx, xxx, p. xxx).  
6 Commission Implementing Regulation (EU 2021/279 of 22 February 2021 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 (OJ L 62, 23.2.2021, p. 6).   
EN 13  EN (ii) the relevant measures to be taken at the level of the organic and/or in -
conversion unit and/or premises and/or activities to ensure compliance 
with Regulation (EU) 2018/848;  
(iii) the precautionary measures to be taken in order to red uce the risk of 
contamination by non -authorised products or substances and the cleaning 
measures to be taken throughout the stages of production, preparation 
and distribution;  
(b) a confirmation that the operators or group s of operators have  not been certified  
by another control body in relation to activities carried out in the same third 
country regarding the same category of products, including in cases in which 
operators or group s of operators operate at different stages of production, 
preparation or distrib ution ; 
(c) a confirmation by the members of a group of operators that they have not been 
certified on an individual basis for the same activity for a given product 
covered by the certification of the group of operators to which they belong;  
(d) a signed undert aking by which the operators or group s of operators commit 
themselves : 
(i) to give the control authority or control body access to all parts of all 
production units and all premises for control purposes, as well as to the 
accounts and relevant supporting d ocuments;  
(ii) to provide the control authority or control body with any information 
necessary for the purposes of the controls;  
(iii) to submit, when requested by the control authority or control body, the 
results of its own quality assurance programmes ;  
(iv) to inform buyers of the products in writing and without undue delay, and 
to exchange relevant information with the control authority or control 
body, in the event that a suspicion of non -compliance has been 
substantiated, that a suspicion of non -compliance cannot be eliminated, 
or that non -compliance that affects the integrity of the products in 
question has been established;  
(v) to accept the transfer of the control file in case of a change of control 
authority or control body or, in the case of w ithdrawal from organic 
production, the keeping of the control file for 5 years by the last control 
authority or control body;  
(vi) to inform immediately the control  authority or control body in the event 
of withdrawal from organic production;   
(vii) in the event that the subcontractors of the operators or of group s of 
operators are subject to controls by different control authorities or control 
bodies, to accept the exchange  of information among those control 
authorities or control bodies;  
(viii)  to perform the activities in accordance with the organic production rules;  
(ix) to accept the enforcement of the corrective measures established by  the 
control authority or control body in the event of non -compliances.   
EN 14  EN 2. Before certifying operators or group s of operators, the control authority or control 
body shall verify:  
(a) that the operators or group s of operators compl y with Chapters II, III and 
IV of Regulation (EU ) 2018/848  and Article 36 of that Regulation . The 
verification shall include at least one phy sical on-the-spot inspection;  
(b) that, where the operators or group s of operators subcontract any of its 
activities to third parties, both the operators or group s of operators and 
the third parties to whom those activities have been  subcontracted, have 
been c ertified by recognised control authorities or control bodies 
confirming that they comply with Chapters II, III and IV of Regulation 
(EU) 2018/848  and Article 36 of that Regulation , unless the operator s or 
group s of operators inform the relevant control aut hority or control body 
that they remain responsible as regards organic production and that they 
have not transferred that responsibility to the subcontractor. In such 
cases, the control authority or control body shall verify that the 
subcontracted activiti es comply with Chapters II, III and IV of 
Regulation (EU) 2018/848 and Article 36 of that Regulation in the 
context of the control activities it carries out in respect of the operators or 
group s of operators that have subcontracted their activ ities.  
3. Beside s any other element that may be considered relevant by the control authority or 
control body , before certifying operators or group s of operators that were previously 
certified by another  control authority or control body, the new control authority or 
contr ol body shall assess the following information to be transmitted by the previous 
control authority or control body :  
(a) the status and validity of certification, including cases of scope reduction, 
suspension and withdrawal as referred to in International Organisation 
for Standardisation (ISO) standard 17065;  
(b) reports of inspection carried out in the preceding 3 years;  
(c) the list of non -compliances and the measures put in place to address 
them, and the fact that all non -compliances were addressed ; 
(d) derogations granted or requests for derogation being processed by the 
previous control authority or control body;  
(e) information relat ing to any ongoing dispute relevant for the certification 
of the operators or group s of operators.  
If the previous control authority or control body does not transmit the information as 
required in Article 21(5) of this Regulation to the new control author ity or control 
body or in case of doubts concerning the information transmitted, the new control 
authority or control body shall not issue the certificate referred to in point (b)(i) of 
Article 45(1) of Regulation (EU) 20 18/848 to operators or group s of op erators until 
this new control authority or control body has eliminated  their doubts by other means 
of control.  
4. The control authority or control body shall not certify operators or group s of 
operators that have been suspended or withdrawn by their previous  control authority 
or control body in the last 2 years, unless the recognition of the previous control 
authority or control body has been withdrawn by the Commission in accordance with  
EN 15  EN Article 46(2a) of Regulation (EU) 2018/848 for the specific third count ry and 
category of produc ts.  
Article 11  
Methods and techniques for controls  
1. Control methods and techniques applied by a control authorit y or control bod y shall 
include the following:  
(a) a check whether the maps or sketches with cardinal directions and geo-location 
of the production units and premises to be physically inspected,  as provided by 
the operator s or group s of operators , is up-to-date;  
(b) an inspection of, as appropriate:  
(i) the production units, equipment, means of transport, premises and other  
places under the control of the operator  or group of operators ;  
(ii) animals, plants and goods, including semi -finished goods, raw materials, 
ingredients, processing aids and other products used for the preparation 
and production of goods or for feeding or treating animals, and 
substances authorised for use in organic production;  
(iii) traceability, labelling, presentation, advertising and relevant packaging 
materials;  
(c) an examination of documents, traceability records and other records and 
practices and procedures that are relevant for the assessment of compliance 
with Regulation (EU) 2018/848. This include s documents accompanying food, 
feed and any substance or material entering or leaving an establishment;  
(d) interviews with operators  and their staff;  
(e) sampling and laboratory analysis;  
(f) the examination of the control system that operators  and groups of operators  
have put in place , including an evaluation of its effectiveness ; 
(g) the examination of non -compliances found during previous inspections and the 
measures taken by the operator s or by the groups of operators  to address them;  
(h) any other action required to identify cases of non-compliance.  
2. The annual physical on -the-spot inspection referred to in Article 9(4) shall include  a 
traceability check and a mass balance check of the operator s or group s of operators , 
carried out by means of checks of documentary accounts  and of any other relevant 
element deemed necessary by the control authority or control body .  
3. For the purpose of the traceability check and the mass balance check, the selection of 
products, groups of products and period under verification shall be based on a risk 
assessment  by the control authority or control body .  
4. Besides any other relevant elem ent deemed necessary by the control authority or 
control body, t he traceability check shall cover the following elements justified by 
appropriate documents includi ng 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 products;   
EN 16  EN (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 an implementing act adopted 
pursuant Article  45(4) of Regulation (EU) 2018/848;  
(d) the information referred to in the first paragraph of point 2.1 of Annex III to 
Regulation (EU) 2018/848;  
(e) the appropriate l ot identification ; 
(f) in the case of processors, the necessary information  to allow internal 
tracea bility and guarantee the organic status of ingredients . 
5. Where relevant, the mass balance check shall cover 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 
including at the time of the physical on -the-spot inspection;   
(c) the nature and quantities of the products that have left the unit of the operator s 
or group s of operators to the consignee's premises or storage facilities;  
(d) in case of operators or groups of operators who buy or sell the product (s) 
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 over the previous 
year;  
(f) the estimated or  actual yield of the produc ts obtained, collected or harvested 
over the current year;  
(g) the number and/or weight of livestock managed over the current and previous 
year;  
(h) any losses, increase or decrease in quantity of products at any stage of 
production, preparation and distribution;  
(i) the total output  of the holding in terms of or ganic and non -organic products.  
Article 12  
Sampling , methods used for sampling and selection of laboratories for sample analysis   
1. The control authority or control body shall take and analyse samples for detecting the 
use of non -authorised products and substances for organic production, for checking 
production techniques not in compliance with the organic production rules or for 
detecting possible contamination by non -authorised products and substances for  
organic production.  
2. The control authority or control body shall carry out sampling on minimum  5% of 
the number of  individual  operators  under its control . For a  group of operators , the 
control authority or control body carry out sampling on minimum 2% of t he 
members of each group .   
EN 17  EN 3. The selection of the operators where samples have to be taken shall be based on risk 
assessment including the likelihood of non -compliance with the organic production 
rules, taking into account all stages of production , preparati on and distribution.  
4. In addition to the minimum sampling rate set in paragraph 2, the control authority or 
control body shall take and analyse samples in each case where the use of non -
authorised products and substances or techniques for organic production  is suspected, 
unless the control authority or control body considers that sufficient evidence is 
available without sampling.  
5. For the high -risk products referred to in Article 8, the control authority or control 
body shall take, in addition to the samplin g rate set in paragraph 2  and 3  of this 
Article, at least one field sample of the crop each year. That sample shall be taken 
from crops in the field, at the most appropriate moment to detect potential use of 
non-authorised substances according to the asses sment of the control authority or 
control body. For operators not growing crops, a relevant sample of incoming raw 
material or intermediate product or proc essed product shall be taken .   
6. The control authority and control body shall ensure that the laboratories used comply 
with the following:  
(a) they are accredited laboratories that meet the applicable requirements of ISO 
standard EN ISO/IEC 17025 on ‘General requirements for the competence of 
testing and calibration laboratories’;  
(b) their accreditation bodies are signatory of the International Lab oratory 
Accreditation Cooperation (ILAC) Mutual Recognition Arrangement;  
(c) they have sufficient capacity for analysis and testing and they can ensure that 
samples are always tested with relevant methods included in the scope of their 
accreditation;  
(d) as regar ds residue pesticide testing, they are accredited for gas and liquid 
spectrometry in order to be able to cover the list of pesticide residues 
monitored under the coordinated multi -annual control programme of the Union 
set out in Commission Implemen ting Reg ulation (EU) 2019/5337. 
7. The control authority or control body may delegate sampling tasks to other control 
authorities or control bodies recognised by the Commission or accredited in 
accordance with ISO standard 17020 for ‘Conformity assessment – Requireme nts for 
the operation of various types of bodies performing inspection’ .  
Article 13  
Documented control procedures  
1. Control authorities and control bodies shall perform controls on operators and group s 
of operators in accordance with documented procedures.  
Those documented procedures shall cover:  
(a) a statement on the objectives to be achieved;  
                                                 
7 Commission Implementing Regulation (EU) 201 9/533 of 28 March 2019 concerning a coordinated 
multiannual control programme of the Union for 2020, 2021 and 2022 to ensure compliance with 
maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and 
on food of pl ant and animal origin (OJ L 88, 29.3.2019, p. 28).   
EN 18  EN (b) tasks, responsibilities and duties of staff;  
(c) sampling strategy, procedures  and methodology , control methods and 
techniques, including laboratory analysis, testing and i nterpretation and 
evaluation of results and consequent decisions;  
(d) cooperation and communication with other control authorities , other control  
bodies and the Commission;  
(e) a procedure for assessing the risk linked to operators or groups of operators  and 
for carrying out physical  on-the-spot inspections and sampling ; 
(f) verification of the appropriateness of methods of sampling and of laboratory 
analysis, testing and diagnosis;   
(g) any other activity or information required for the effective functioning of t he 
controls, including in relation to training of inspectors and evaluation of their 
competenc ies; 
(h) for groups of operators , the effectiveness of the system for internal controls.  
2. Control authorities and control bodies shall:  
(a) take corrective measures in al l cases where the procedures provided for in 
paragraph 1 identify shortcomings;  and 
(b) update the documented procedures provided for in paragraph 1 as appropriate.  
Article 14  
Written records of controls  
1. Control authorities and control bodies shall draw up written records of each control 
they perform to verify compliance with Regulation (EU) 2018/848. Those records 
may be on paper or in electronic form. The control authorities and control bodies 
shall keep  these records for 5 years from the day of the decision on certification  by 
the control authority or control body.  
Those records shall contain in particular:  
(a) a description of the purpose of the controls;  
(b) the control methods and techni ques applied;  
(c) the outc ome of the controls, in particular the results of verifying the elements 
listed in Article s 11 and 12 of this Regulation; and  
(d) actions that the operator or group of operators concerned is required to take as 
a result of the controls carried out by the contr ol authority or control body, with 
an indication of the deadline  to take action.  
2. The written copy of the records shall be countersigned by the operator or the 
responsible person of the group of operators as  confirmation of their receipt of that 
written record.   
EN 19  EN Article 15  
Specific control requirements for algae and aquaculture animal production  
1. For the purpose of determining the start of the conversion period provided in Article 
10(2) of Regulation (EU) 201 8/848, the control authority or control body shall ensure 
that operator s or groups of operators  produc ing algae or aquaculture animals notif y 
the control authority or control body of the relevant  activity.  
2. The control authority or control body shall ensure  that organic production of algae or 
aquaculture animals takes place  in a location with no risk of contamination in 
accordance with point 1.1. of Part III of Annex II to Regulation (EU) 2018/848. In 
particular, the control authority or control body shall e nsure that adequate separation 
measures have been taken in accordance with point 1.2. of that Part III.  
3. For the purposes of point 3.1.3.1(c) of Part III of Annex II to Regulation (EU) 
2018/848, the control authority or control body shall ensure that the p lant fraction of 
feed is organic and the feed fraction derived from aquatic animals originates from 
organic aquaculture or from fisheries that have been certified as sustainable in line 
with the 2009 FAO's Guidelines for the ecolabelling of fish and fisher ies products 
from marine capture fisheries.  
4. For the purposes of point 3.1.4.2(e) of Part III of Annex II to Regulation (EU) 
2018/848, the control authority or control body shall ensure that they have 
information on all treatments, and they shall check tha t these treatments are carried 
out in accordance with the requirements of that Regulation.  
5. For the purpose of authorising the use of wild seed within the meaning of point 3.2.1 
of Part III of Annex II to Regulation (EU) 2018/848, the control authority or control 
body shall ensure that points (a), (b) and (c) of that point are respected.  
Article 16  
Verification of consignments intended for import into the Union  
1. The relevant control authority or control body shall verify consignments intended for 
import into  the Union with regard to the compliance with Regulation (EU) 2018/848 
and this Regulation. This verification shall include systematic documentary checks 
and, as appropriate according to a risk assessment, physical checks, before the 
consignment leaves the  third country of export or of origin.  
2. For the purposes of this Article, the relevant control authority or control body shall 
be: 
(a) the control authority or control body of the producer or the processor of the 
product concerned; or  
(b) where the operator  or gro up of operators  carrying out the last operation for the 
purpose of preparation is different from the producer or processor of the 
product, the control authority or control body of the operator or group of 
operators carrying out the last operation for the p urpose of preparation as 
defined in point (44) of Article 3 of Regulation (EU) 2018/848.  
The relevant control authority or control body shall be recognised in accordance with 
Article 46(1) of Regulation (EU) 2018/848 for the products concerned and for the  
EN 20  EN third country in which the products have their origin, or, where applicable, in which 
the last operation for the purpose of preparation has been carried out.  
3. The documentary checks referred to in paragraph 1 shall aim at verifying:  
(a) the traceability of the products and ingredients;  
(b) that the volume of the products included in the consignment is in line with the 
mass balance checks of the respective operators  or groups of operators  
according to the assessment carried out by the control authority or control 
body; 
(c) the relevant transport documents and commercial documents (including 
invoices) of the products;  
(d) in case of processed products, that all organic ingredients of such products 
have been produced by operators  or groups of operators  certified in a third 
country by a control authority or control body recognised in accordance with 
Article 46(1) or referred to in Article 57 of Regulation (EU) 2018/848 or by a 
third country recognised in accordance with Articles 47 and 48 of Regulation 
(EU) 2018/848, or have bee n produced and certified in the Union in 
accordance with that Regulation.  
Those documentary checks shall be based on all relevant documents, including the 
certificate referred to in point (b)(i) of Article 45(1) of Regulation (EU) 2018/848 , 
records of the  inspections, the production plan for the product concerned and records 
kept by the operators  or groups of operators , available transport documents, 
commercial and financial documents and any other documents deemed relevant by 
the control authority or cont rol body.  
4. In relation to the risk assessment preceding physical checks as referred to in 
paragraph 1, the relevant control authority or control body shall take into account the 
following criteria:  
(a) the relevant criteria listed in Article 9(2);  
(b) whether there  are several operators involved in the distribution chain of the 
products who do not store or physically handle organic products;  
(c) high-risk products referred to in Article 8;  
(d) any criteria deemed relevant by the control authority or control body.  
5. For cons ignments made out of bulk organic products, the relevant control authority 
or control body shall draw up a travel plan in the Trade Control and Expert System 
(TRACES), including all the premises to be used during the travel from the third 
country of origin  or export to the Union.  
6. For consignments of high-risk products referred to in Article 8, the relevant control 
authority or control body shall carry out systematic physical checks and take at least 
one representative sample of the consignments. Moreover, the control authority or 
control body shall have complete documentation of the traceability of the operators 
or groups of operators and the product, including transport and commercial 
documents , including invoices . At the request of the Commission or the competent 
authority of a Member State, the control authority or control body sh all send this 
traceability documentation as well as the results of the sampling analysis to the 
control authority or control body of the importer  and to the competent authorit y of 
the Member State where the consignment is verified .   
EN 21  EN 7. In case of suspicion of non -compliance, the Commission or the competent authority 
of a Member State  may request  the relevant control authority or control body to 
make available without delay the list of all operators  and all groups of operators  in 
the organic production chain of which the consignment is part, and of their control 
authorities or control bodies.   
Chapter IV  
Other actions to be carried out by the cont rol authorities and 
control bodies  
Article 17  
List of operators and other relevant information to be publically available  
The control authority or control body shall make the following information available on its 
website, in at least one official language  of the Union:   
(a) a list of certified operators  and certified groups of operators, contain ing: 
 (i) for operators, their name and address;  
(ii) for groups of operators, the name and address of the group and the number of 
its members;   
(iii) information relating to the certificates, in particular, the certificate number, 
category of products covered by the certification, status and validity of 
certification, including cases of scope reduction, suspension and withdrawal as 
referred to in ISO standard 17065 ;  
(b) in the case of control bodies, updated information on their accreditation, including a 
link to the latest accreditation certificate issued by its accreditation body.  
The list referred to in point (a) shall be immediately updated after any change of the status of 
the certif ication . In case of withdrawal, th e information referred to in point (a)(iii) shall be 
kept in the list for 5 years  after the withdrawal ; 
 
Article 18  
Database of operators and group s of operators  
The control authority or control body s hall keep an updated electronic database of operators 
and group s of operators . That database  shall  include the following information:  
(a) name and address of the operator s or group s of operators. In case of a group of 
operators, the size of the group, name and  address of each member of the group;  
(b) information concerning the scope of the certification, certificate number, status and 
validity of the certificate;  
(c) status of the operator s or group s of operators , whether in conversion (including 
period of conversion ) or organic;  
(d) risk level of the operator s or group s of operators in accordance with Article 9;   
EN 22  EN (e) in case of subcontracting activities that are under the control of the certified operator s 
or groups of operators , name and address of the subcontracted third party or third 
parties;  
(f) the geographical coordinates and surface area of all the production units and 
premises;  
(g) inspection reports and the results of sampling analysis, as well as the results of any 
other controls performed, including the controls carried  out on consignments;  
(h) non-compliances and measures applied ;  
(i) notifications via the system referred to in Article 20(1);  
(j) derogations granted and relevant supporting documents in accordance with the 
requirements of this Regulation; and  
(k) any other information  deemed relevant by the control body or the control authority.  
The information shall be kept by the control authority or control body for 5 years. The control 
authority or control body shall make that information available to the Commission upon 
request.  
Article 19  
Information requirements  
1. After its recognition, the control authority or control body shall notify the 
Commission in due time, and not later than within 30 calendar days, of the 
occurrence of changes to the content of its technical dossier.  
2. The control authority or control body shall keep available and communicate at the 
request of the Commission or the competent authorities of the Member States all 
information related to its control activities in the third country.  
3. The supporting documents rela ting to the request for recognition under Article 46 of 
Regulation (EU) 2018/848 and those required under this Regulation shall be kept by 
the control authorities or control bodies at the disposal of the Commission and the 
Member States for 5 years followi ng the year in which the controls took place or the 
certificate referred to in point (b)(i) of Article 45( 1) of Regulation (EU) 2018/848 
and documentary evidence were delivered.  
Article 20  
Systems and procedures for the exchange of information  
1. The control authority or control body shall use the Organic Farming Information 
System (OFIS) for the exchange of information with the Commission, with other 
control authorities and other control bodies, and with the competent authorit ies of the 
Member Sta tes and  of the  third countries concerned.  
2. The control authority or control body shall take the appropriate measures and 
establish documented procedures to ensure timely exchanges of information with the 
Commission and with other control authoritie s and con trol bodies.  
3. Where a document or procedure provided for in Article 46 of Regulation (EU) 
2018/848 or in the delegated and implementing acts adopted pursuant to that Article  
EN 23  EN requires the signature of an authorised person or the approval by a person at one o r 
more of the stages of that procedure, the computer systems set up for the 
communication of those documents shall make it possible to identify each person and 
guarantee that the integrity of the content of the documents, including as regards the 
stages of  the procedure , cannot be altered, in accordance with Union law, and in 
particular with Commissio n Decision 2004/563/EC, Euratom8. 
Article 21  
Exchange of information between the Commission, control authorities, control bodies and 
competent authorities  
1. The control authority or control body shall immediately share information with the 
Commission, with other control authorities and control bodies, and with the 
competent authorit ies of the Member States and  of the  third  countries concerned on 
any suspicion of n on-compliance that affects the integrity of organic or in -conversion 
products.  
2. Where a control authority or control body is notified by the Commission, after the 
Commission has received a notification from a Member State in accordance with 
Article 9 of Imp lementing Regulation (EU) 2021/279  as regards suspected or 
established non -compliance affecting the integrity of imported organic or in -
conversion products, it shall carry out an investigation in accordance with Article 22 
of this Regulation. The control a uthority or control body shall inform the 
Commission and the Member State that sent the initial notification (notifying 
Member State), using the template set out in Annex III to this Regulation.  The 
control authority or control body shall reply within 30 calendar days from the date of 
receiving that notification  and shall inform about the actions and measures taken, 
including the results of the investigation and provide any other information when 
available and/or required by the notifying Member State.  
3. The notified  control authority or control body shall provide further necessary 
information if requested by the notifying Member State.   
4. Where operators or group s of operators and/or the ir subcontractors are subject to 
controls by different control authorit ies or control bodies, those control authorities or 
control bodies shall exchange the relevant information on the operations covered by 
their control activities.  
5. Where operators or group s of operators and/or their subcontractors change their 
control autho rity or control body, the new  control authority or control body shall 
request the control file of the operator or group of operators concerned from the 
previous control authority or control body. The previous control authority or control 
body shall , within  30 days , provide  to the new control authority or control body the 
control file of the operator or group of operators concerned and the written records 
referred to in Article 14, the status of the certification, the list of non -compliances 
and the correspo nding  measures taken by the previous control authority or control 
body.  
                                                 
8 Commission Decision 2004/563/EC, Euratom of 7 July 2004 amending its Rules of Procedure (OJ L 
251, 27.7.2004, p. 9).   
EN 24  EN The new control authority or control body shall ensure that non -compliances noted in 
the report of the previous control authority or control body have been addressed by 
the operator s or groups of operators .  
6. Where operators or groups of operators are subject to a traceability check and a mass  
balance check, control authorities and control bodies shall exchange the relevant 
information allowin g finalisation of these checks.  
Article 22  
Additional rules on actions to be taken in case of non -compliance  
1. In addition to the measures referred to in Article 29(1), (2) and (3) of Regulation 
(EU) 2018/848 and Article 2 of Implem enting Regulation (EU) 2021/ 279, where a 
control authority or control body suspects or receives substantiated information, 
including information from other control authorities or control bodies, that a product, 
which may not be in compliance with Regulation (EU) 2018/848, is intended to be 
imported from a third country for t he purpose of placing that product on the market 
within the Union, but which bears terms referring to the organic production, or where 
such a control authority or control body has been informed by an operator  of a 
suspicion of non -compliance in accordance with Article 27 of that Regulation:  
(a) it shall immediately carry out an investigation with a view to verifying 
compliance with Regulation (EU) 2018/848 or with the delegated or 
implementing acts adopted pursua nt to that Regulation; such investigation shall 
be completed as soon as possible, within a reasonable period, and shall take 
into account the durability of the product and the complexity of the case;  
(b) it shall prohibit the import from that third country for  the purpose of placing 
the product concerned  on the market within the Union as organic or in -
conversion product pending the results of the investigation referred to in point 
(a). Before taking such a provisional decision, the control authority or control 
body, shall give the operator  or group of operators  an opportunity to comment.  
2. In the event that the results of the investigation referred to in point (a) of paragraph 1 
do not show any non -compliance affecting the integrity of organic or in -conversion 
products, those products shall be allowed to be used and labelled as organic or in -
conversion products.   
3. The control authority or control body shall develop a catalogue of measures to be 
taken in case of established non -compliance. That catalogue of measures shall be 
based on the elements specified in Annex IV to this Regulation and shall cover at 
least:  
(a) a list of non -compliances with reference to the specific rules of Regulation 
(EU) 2018/848 or of the delegated or implementing acts adopted pursuant to 
that R egulation. That list shall include, at least  the non -compliances listed in 
Part B of Annex IV to this Regulation;  
(b) the classification of the non -compliances into three categories: minor, major 
and critical as set out in Part A of Annex IV to this Regulation , taking into 
account at least the following criteria:  
(i) the application of precautionary measures referred to in Article 28(1) of 
Regulation (EU) 2018/848, the practical measures referred in point (a)(ii)  
EN 25  EN of Article 10(1) of this Regulation and the reliability of own controls 
carried out by the operator  or group of operators in line with point (f) of 
Article 11(1) of this Regulation;  
(ii) the impact on the integrity of the organic or in -conversion of products;  
(iii) the ability of the traceability sy stem to locate the affected product(s) in 
the supply chain and prohibition of importing from a third country for the 
purpose of placing the product (s) on the market within the Union with 
reference to organic production;  
(iv) the response of the operator  of group of operators  to previous requests 
from the control authority or control body;  
(c) the measures to be applied for each non -compliance.  
4. The control authority or control body shall document the results of the investigations 
referred to in  point (a) of  Article 29(1) of Regulation (EU) 2018/848 .  
Article 23  
Additional rules on measures in the event of non -compliance  
 
1. In the event of non -compliance affecting the integrity of organic or in -conversion 
products throughout any of the stages of production, prepara tion and distribution, for 
example as a result of the use of non -authorised products, substances or techniques, 
or commingling with non -organic products, the control authority or control body 
shall ensure, in addition to the measures to be taken in accorda nce with paragraphs 2 
and 3 of this Article, that no reference is made to organic production as set out in 
Chapter IV of Regulation (EU) 2018/848, in the labelling and advertising of the 
entire lot or production run of the product intended to be imported f rom a third 
country for the purpose of placing that product on the market within the Union.  
2. Where the non -compliance is established, the control authority or control body shall:  
(a) take any action necessary to determine the origin and extent of the non -
comp liance and to establish the  responsibilities  of the operator or group of 
operators ; and  
(b) take appropriate measures to ensure that the operator  or group of operators  
remed ies the non -compliance and prevents fu rther occurrences of such non -
compliance.  
When deciding which measures to take, the control authority or control body shall 
take account of the nature of that non -compliance and the  past record of the  operator  
or of the group of operators  with regard to compliance . 
3. When acting in accordance with p aragraph 2 of this Article, the control authority or 
control body shall take any measure it deems appropriate to ensure compliance with 
Regulation (EU) 2018/848 and the delegated and implementing acts adopted 
pursuant that Regulation, including:  
(a) applying  the catalogue of measures referred to in Article 22(3) of this 
Regulation;   
EN 26  EN (b) ensur ing that the operator  or group of operators  increase s the frequency of own 
controls;  
(c) ensur ing that certain activities of the operator  or of the group of operators  are 
subject to increased  or systematic controls by the control authority or control 
body.   
4. In the event of serious, or repetitive or continued non -compliance, the control 
authority or control body shall ensure that the operator  or group of operators, in 
addition to t he measures laid down in paragraphs 2 and 3, is prohibited from placing 
on the market within the Union for a given period products which refer to organic 
production, and that its certificate referred to in point (b)(i) of Article 45 of 
Regulation (EU) 2018 /848 be suspended or withdrawn, as appropriate.  
5. The control authority or control body shall provide the operator  or group of operators 
with a written notification of its decision concerning the action or measure to be 
taken in accordance with this Article , together with the reasons for that decision.  
Article 24   
Checks to be carried out for the purpose of the retroactive recognition of a previous period  
1. Before granting retroactive recognition of a previous period as part of the conversion 
period for the purposes of point (b) of Article 10(3) of Regulation (EU) 2018/848, 
the control authority or control body shall ensure that the operator  submits the 
follo wing documents proving that the land parcels were natural or agricultural areas 
that, for a period of at least 3 years, have not been treated or have not been 
contaminated with products or substances that are not authorised for use in organic 
production in  accordance with Regulation (EU) 2018/848:  
(a) maps identifying clearly each land parcel covered by the request for retroactive 
recognition and information on the total surface of those land parcels and, if 
relevant, on the nature and the volume of the on -going production and their 
geolocation coordinates;  
(b) any other relevant documents deemed necessary by the control authority or 
control body to assess the request for retroactive recognition.  
2. In addition, the control authority or control body shall take the fol lowing steps:  
(a) it shall carry out a detailed risk analysis based on documentary evidence to 
assess whether any land parcel covered by the request for retroactive 
recognition has been treated with products or substances that are not authorised 
for use in org anic production for a period of at least 3 years,  taking into 
account in particular the size of the total surface to which the request relates 
and the agronomic practices carried out during that period on each land parcel 
subject to the request. The contro l authority or control body shall keep 
documents on the risk analysis;  
(b) it shall take samples on soil and/or plant from each land parcel  in line with the 
results of the risk analysis referred to in point (a),  including those land parcels 
identified as pres enting the risk of being contaminated ; 
(c) it shall draw up an inspection report in one of the official languages of the 
Union, including photographs of the parcels, following a physical inspection of 
the operator , including the land parcels covered by the request for retroactive  
EN 27  EN recognition for the purpose of verifying the consistency of the information 
collected, but before any cultivation measures have been taken by the operator .  
3. Based on the information provided  by the operator in accordance with paragraph 1 
and after having completed the steps set out in paragraph 2, the control authority or 
control body shall draw up a final written report. The final written report shall 
include a justification why the previous  period can be recognised retroactively as part 
of the conversion period. This final written report shall also indicate the starting 
period considered as organic for each land parcel concerned as well as the total 
surface of the land parcels benefiting fro m this retroactive recognition of a period.  
4. The control authority or control body shall immediately notify the Commission, the 
Member States  and in case of a control body its accreditation body of any retroactive 
recognition granted. For each retroactive recognition granted, the control authority or 
control body shall provide the final written report referred to in paragraph 3.  
5. The control authority or control  body shall ensure that the operator to whom the 
granted retroactive recognition applies keeps do cumentary evidence relating to that 
recognition, as well as documentary evidence on the use of the land parcels covered 
by that recognition, for 3 years.  
Article 25  
Authorisations for the use of non -organic plant reproductive material  
1. Before granting auth orisations for the use of non -organic plant reproductive material 
as set out in point 1.8.5.2 of Part I of Annex II to Regulation (EU) 2018/848, the 
control authority or control body shall assess the following information and draw up 
a justification for ea ch derogation granted:  
(a) scientific and common name (common and Latin name);  
(b) variety;  
(c) number and total weight of seeds or number of plants concerned;  
(d) the availability of organic or in -conversion plant reproductive material;  
(e) documentation or a statement from  the operator proving  that the requirements 
set out in point 1.8.5.2 of Part I of Annex II to Regulation (EU) 2018/848 have 
been fulfilled.   
2. For each authorisation for the use of non -organic plant reproductive material as set 
out in point 1.8.5.2 of Part I of Annex II to Regulation (EU) 2018/848, the control 
authority or control body shall include the relevant information in the annual report 
referred to in Article 4 of this Regulation.  
Article 26  
 Derogations as regards the use of non -organic animals and  aquaculture juveniles  
1. Before granting derogations as regards the use of non -organic livestock species 
(bovine, equine, ovine, caprine, porcine and cervine animals , rabbits, and poultry) in 
accordance with points 1.3.4.3 and 1.3.4.4 of Part II of Annex II to Regulation (EU) 
2018/848, the control authority or control body shall assess the following 
information and draw up a justification for each derogation:   
EN 28  EN (a) scientific and common name (common and Latin name , i.e. species and genus);  
(b) breeds and strains;  
(c) production purposes: meat, milk, eggs, dual purpose or breeding;  
(d) total number of animals;  
(e) availability of the relevant organic livestock species;  
(f) documentation or a statement from the operator proving  that the requirements 
set out in point 1.3.4.3 and 1.3.4.4 of Part II of Annex II to Regulation (EU) 
2018/848 have been fulfilled.  
2. For each non -organic livestock species (bovine, equine, ovine, caprine, porcine and 
cervine animals, rab bits, and poultry ), the control authority or control body shall 
include the relevant information on the derogations granted in accordance with points 
1.3.4.3 and 1.3.4.4 of Part II of Annex II to Regulation (EU) 2018/848 in the annual 
report referred to in  Article 4 of this Regulation.  
3. Before granting derogations as regards the use of non -organic aquaculture juveniles 
in accordance with point 3.1.2.1 of Part III of Annex II to Regulation (EU) 2018/848, 
the control authority or control body shall assess the  following information and draw 
up a justification for each derogation:  
(a) species and genus (common and Latin name);  
(b) breeds and strains when applicable;  
(c) life stage (such as eggs, fry, juveniles) as available for sale as organic;  
(d) quantity available as estima ted by the operator ; 
(e) total number of juveniles;  
(f) availability of the relevant organic aquaculture species;  
(g) documentation or a statement from the operator  proving that the requirements 
set out in point 3.1.2.1 of Part III of Annex II to Regulation (EU) 2018 /848 
have been fulfilled.  
4. For each derogation granted as regards the use of non -organic aquaculture juveniles 
in accordance with point 3.1.2.1 of Part III of Annex II to Regulation (EU) 2018/848, 
the control authority or control body shall include the rel evant information in the 
annual report referred to in Article 4 of this Regulation.  
Article 27  
Reporting on provisional authorisation for the use of non -organic agricultural ingredients for 
processed organic food  
The control authority or control body shall  immediately notify the Commission, the Member 
States, accreditation bodies and other control authorities and control bodies recognised in 
accordance with Article 46(1) of Regulation (EU) 2018/848 of any provisional authorisation 
granted for the use of non -organic agricultural ingredients for processed organic food in 
accordance with Article 25(4) of that Regulation. That notification shall include the 
justification, presented in the dedicated form made available by the Commission, that such 
authorisation h as been granted in accordance with Article 25(1) of Regulation (EU) 2018/848.   
EN 29  EN Chapter V  
Derogations from Regulation (EU) 2018/848 in catastrophic 
circumstances  
Article 28  
Recognition of catastrophic circumstances  
For the purposes of the exceptional production rules referred to in Article s 22(1)  and 45(3)  of 
Regulation (EU) 2018/848, in order for a situation to qualify as catastrophic circumstances 
deriving from an ‘adverse climatic event’, ‘animal diseases’, an ‘en vironmental incident’, a 
‘natural disaster’ or a ‘catastrophic event’, as well as any comparable situation, the control 
authority or control body may recognise a situation as catastrophic circumstances based on a 
statement issued by the relevant authoritie s of the third country in which the situation occurs, 
where available. If such a statement is not available , any such recognition by the control 
authority or control body shall be based on data provided by official organisations justify ing 
the catastrophic  circumstance s. 
Article 29  
Conditions for derogations  
1. Following the recognition  referred to in Article 28, a control authority or control 
body may, upon identification of the operators affected in the area concerned or upon 
request from the individual oper ator or the member of the group of operators 
concerned, grant the relevant derogations set out in Article 3 of Delegated Regulation 
(EU) 2020/2146 and the conditions related thereto, provided that those derogations 
and conditions apply:  
(a) for a limited perio d and no longer than necessary, and in no case longer than 12 
months, to continue or recommence organic production as carried out before 
the date of application of those derogations;  
(b) in relation to specifically affected types of production or, where relev ant, land 
parcels; and  
(c) to the individual operator or the member of the group of operators concerned.  
2. The application of the derogations referred to in paragraph 1 shall be without 
prejudice to the validity of the certificates referred to in point (b)(i) of  Article 45 of 
Regulation (EU) 2018/848 during the period where the derogations apply, provided 
that the operator or operators concerned fulfil the conditions under which derogations 
were granted.  
3. Control authorities and control bodies shall immediately no tify the Commission, the 
Member States and , in case of a control body their accreditation body , of the 
derogations granted by them pursuant to this Regulation via the system referred to in 
Article 20(1). In particular, the control authority or control body  shall indicate the 
name of the operator  or operators concerned , the time period for the derogation, the 
type of production or, where relevant, land parcels, the justification for the 
derogation and include a statement from the relevant authority  of the th ird country as  
EN 30  EN referred to in Article 28. Where such a statement is not available, the control 
authority or control body shall  justify the non -inclu sion of  such a statement and 
provide the relevant data on which the recognition  is based.  
4. The control autho rity or control body shall ensure that any operator to whom the 
granted derogations apply keep documentary evidence relating to the granted 
derogations as well as documentary evidence on the use of those derogations during 
the period where those derogation s apply. The control authorit y or control bod y shall 
verify the compliance of the operator or  operat ors with the conditions of the granted 
derogations.  
CHAPTER VI  
GENERAL AND FINAL PROVISIONS  
Article 30  
References to competent authorities and Member States  in Annex II to Regulation (EU) 
2018/848  
1. References to competent authorities in the following points of Annex II to 
Regulation (EU) 2018/848 shall be read as referring to control authorities and control 
bodies recognised in accordance with Article 46(1) of  that Regulation:  
(a) point 1.7.2 and the first paragraph of point 1.7.3 of Part I;  
(b) points 1.3.4.3, 1.3.4.4.3, 1.6.7, 1.7.5, 1.7.8, 1.9.3.1, 1.9.4.1 and 1.9.4.2 of Part 
II; 
(c) points 3. 1.2.1  and 3.1.3.1 of Part III . 
The information referred to in point 1.9.4.1 of  Part II shall be sent to the Commission 
only.  
2. The reference to Member States in point 1.9.4.4(c) of Part II of Annex II to 
Regulation (EU) 2018/848 shall be read as referring to control authorities  and control 
bodies recognised in accordance with Article 46(1) of that Regulation . 
Article 31  
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 entirety and directly applicable in all Member States.   
EN 31  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula  VON DER LEYEN