EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
ANNEXES 1 to 4  
 
ANNEXES  
to the  
COMMISSION DELEGATED REGULATION (EU)  
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 certified organic 
and on o rganic 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   EN 1  EN ANNEX I 
Content of the assessment report referred to in Article 1(2)(i)  
PART A 
An assessment report referred to in point (h) of Article 1(2) shall consist of a document and 
record review report, an on -site assessment report and a witness audit report, and may contain 
any other information deemed necessary by the accreditation body or  competent authority .   
1. Document and record review report  
The document and record review report shall contain the following elements:  
1.1. Assessment of the following:  
(a) the structure and size;  
(b) IT management system;  
(c) branch offices;  
(d) type of activities, includin g subcontracting activities other than inspection and 
sampling;  
(e) organisational chart;  
(f) quality management;  
1.2. Assessment of the procedures for the exchanges of information between headquarter 
and branch offices, and subcontracted laboratories, as well as with  the Commission, 
Member States , other control authorities and other control  bodies;  
1.3. Assessment of the knowledge and qualification of the staff as regards Union 
legislation on organic production rules and controls;  
1.4. Verification that the language regime cho sen and the documents issued by the 
control authority or control body are understandable for the  contracted  operators or 
group s of operators, in particular internal procedures for the staff involved in the 
certification process or in the controls;  
1.5. Assessment of the continuous training programmes, and effective monitoring by the 
control authority or control body of the compete ncies acquired during the trainings;  
1.6. Assessment of the experience and the competenc y of the staff on the category(ies) of 
products as set out in Article 35(7) of Regulation  (EU) 2018/848 subject to the 
controls and in each third country covered by the recognition, including the 
employment status of inspectors concerned and their contractual relationship with the 
control body;  
1.7. Assessment of the internal procedures related to the control activities in respect of 
operators and group s of operators , if any, and the specific skills and training required 
for the inspectors of the control authority or control body controlling the system f or 
internal control s of group s of operators;  
1.8. A description and an evaluation of the performance of the control system to be put in 
place for each third country, including where relevant, control specificities for gro ups 
of operators;  
1.9. Any other information  deemed necessary by the accreditation body.  EN 2  EN 2. On-site assessment report  
An on -site assessment report by the accreditation body or, as appropriate, by the 
competent authority, shall contain the following elements:  
2.1. An assessment report of the office(s) w here certification decisions are taken , 
containing the following information : 
(a) result of the checking of files of all categories of product s as set out in Article 
35(7) of Regulation (EU) 2018/ 848 for which recognition is requested, and 
confirmation that  operators and  group s of operators fulfil the control 
requirements as set out in  Chapter III  of this Regulation and in particular  
Article s 9 and  10; 
(b) evaluation of the catalogue of measures to be taken in case of established non -
compliance;  
(c) evaluation of the risk analysis procedures for the purpose of the inspections, 
including inspections without prior notice;  
(d) evaluation of the sampling  strategy , procedure and methodology ;  
(e) evaluation of the communication with the Commission and other control 
authorities and other control  bodies;  
(f) conclusions from interviews with control and certification staff regarding their 
performance and competenc y on certification  and control tasks;  
(g) confirmation that the control authority or control body has the means to 
implement t he control system in line with this Regulation in each third country 
for which it requests recognition , in particular sufficient inspectors to carry out 
any physical checks at any stage of production, preparation and distribution, as 
appropriate, based on their risk assessment, additional inspections or samplings 
and documents in languages that are understandable by the contracted 
operators, when these documents are intended for operators  or group s of 
operators;  
(h) confirmation of the capacity and competenc ies of the control authority or 
control body to perform its tasks for each third country for which it requests 
recognition, taking into account, in particular, the expected number of 
operators or members of the group of operators, volume of exported products , 
nature and origin of products, including evaluation of operators and inspectors 
files. 
 2.2. A witness audit report, resulting from a witness audit carried out in accordance with 
Part B, containing  the following elements:  
(a) the name  of the operator, the audited inspector and the accreditation body’s 
assessor ;  
(b) general information about the witness audit such as venue, time, audit plan  or 
parties, and the operator ’s or group of o perators’ experience with regard to 
organic production rules;  
(c) scope of inspection;  
(d) inspector preparation and knowledge , such as  planning of work, working 
instructions, documents and material made available to the inspector, 
knowledge of the inspector on the relevant category of product s, evaluation of EN 3  EN the robustness  of the organic system plan of the operator  or the system of 
internal control of  the group of operators , checking of conflicts of interest, 
knowledge on Regulation (EU) 2018/848, knowledge of the internal 
procedures of its control body as regard the functioning or the implementation  
of the control system and certification process;  
(e) inspector performance , such as  relevance of the duration of the inspection, 
evaluation of the interview, verification  of previous non -compliances , 
collection of relevant information, authority and analytical skills, conversation 
and questioning technique, effective language skills, knowledge of the local 
agricultural conditions and agricultural practices, processing practices in that 
country  or social skills ;  
(f) quality of the physical inspection of the facility/holding/unit such as 
methodology and quality of the inspection check list used, information 
provided by the operator in the organic system plan, robustness of the mass 
balance and traceability  checks, the methodology used for the sampling and the  
inspection of critical areas ; 
(g) findings, status of the non -compliances detected and corrective measures 
applied;  
(h) evaluation of the non -compliances identified by the accreditation body ’s 
assessor  but no t detected by the inspe ctor;  
(i) quality and completeness of the exit interview conducted;  
(j) overall assessment of the effectiveness of the inspection;  
(k) list of non -compliances detected, description and time line for the corrective 
measures to be carried out b y the control authority or control body to solve 
them;  
(l) in the case of a group of operators, a specific section providing a description 
and evaluation of the  effectiveness  of the system for internal control s; and  
(m) an overall assessment of the capacity and r eliability of the control authority or 
control body for performing the certification activities. Any other information 
deemed necessary by the accreditation body or competent authority, including 
for instance, reports and conclusions of additional witness audits.  
PART B 
1. The witness audit referred to in point 2.2 of Part A  shall  be:  
(a) carried out by the accreditation body or, as appropriate, the competent 
authority ;  
(b) based on a risk analysis  and shall  document the whole activity under witness ;  
(c) carried out physically and may only be carried out remotely if so decided by 
the Commission.  
2. In addition  to Section  1, the witness audit  shall be carried out:  
(a) for each category of products as set out in Article 35(7) of Regulation (EU) 
2018/848 for which the recognition is requested . All non -compliances detected 
by the accreditation body or competent authority shall be  fully addressed by the EN 4  EN control authority or control body respectively  and confirmed by the 
accreditation body or competent authority ;  
(b) for each category of products in a different third country , if the control 
authority or control body requests or is already recognised for more than one 
third country ; and  
(c) as a matter of priority in group s of operators, in case the control authority or 
control  body certifies group s of operators.  
3. For a control authority or control body recognised under Article 33(3) of Council 
Regulation (EC) No 834/20071 and included in the list established in accordance 
with Article 57(2) of Regulation (EU) No 2018/848, the in formation referred to in 
point  2.2 of Part A of this Annex shall result from witness audits carried out:  
(a) during the last 2 years by their accreditation body or competent authority for 
the purpose of their recognition under Regulation (EC) No 832/2007 for e ach 
category of products for which the control authority or control body requests 
recognition in accordance with Article 46 of Regulation (EU) 2018/848; and  
(b) in a third country for which the control authority or control body is recognised 
under Article 33(3) of Regulation (EC) No 834/2007.  
However, for each of these witness audits, the accreditation body or competent 
authority shall confirm that all non-compliances have been fully addressed by the 
control authority or control body.  
                                                 
1 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).  EN 5  EN ANNEX  II  
General and specific requirements for the annual report referred to in Article 4  
 
1. The annual report  shall update all the elements contained in the technical dossier as 
set out in Article 1(2 ).   
2. The annual report shall contain t he information of the control authority or control 
body to be updated for the purpose of the annual report and shall include  the name 
and code number of the control authority or control body, mailing  address, telephone 
number, email contact point and website address, which shall include a direct link, 
with an easy access from the home webpage, to the up -to-date list of operators  or 
groups of operators . 
3. For the purpose s of the annual report , the technical dosser shall be completed with 
the following:  
(a) the control activities of the control authority or control body in the third 
country or third countries in the previous year, per categ ory of product s, as set 
out in Article 35(7) of Regulation (EU) 2018/848, including the information 
about the number of operators and group s of operators  as well as the number of 
their members (including subcontractors , if the operators  or groups of operat ors 
do not remain responsible for the subcontractors) which were subject to their 
controls on 31 December of the previous year, broken down by third country 
and category of product s;  
(b) an undertaking that the control authority or control body has performed the 
required updates of the translation of the production rules according to Article 
1(2)(d) of this Regulation or any other relevant documents required for the 
purposes of Article 46(2) of Regulation (EU)  2018/848 or this Regulation;  
(c) any update of the int ernal procedures, including the certification and control 
system set up by the control authority or control body in compliance with this 
Regulation;  
(d) a link to the website of the control authority or control body, with the 
information required in accordance  with Article 17 ; 
(e) an annual assessment report of the office(s) where certification decisions are 
taken , as referred to  in point 2.1 of Part A of  Annex I:  
(i) ensuring that the control authority or control body has been satisfactorily 
assessed  by the accred itation body or competent authority  in the previous 
year on its ability  to ensure that products imported from third countries 
comply with Regulation (EU) 2018/848;  
(ii) confirming that the control authority or control body still has the capacity 
and the co mpetencies 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, in each third country for which it is 
recognised;   
(iii) including any updated information of the  annual assessment report as 
regards the results and an evaluation of:  
– the checks of the files of the  operator s or group s of operators;  EN 6  EN – the list of non -compliances, as well as the number of non -
compliances in relation to the number of certified operators o r 
group s of operators ; 
– the handling of non -compliances and complaints, if any , with a n 
explanation on the corrective measures implemented by the 
operator s or group s of operators  for the lasting closure of its non -
compliances;  
– the catalogue of measures and its implementation;  
– the risk analysis procedure;  
– the annual risk plan;  
– the sampling strategy , procedure and methodology ; 
– the changes to any of the procedures;  
– the exchange of information with other control authorities, control 
bodies and the Commission;  
– the competence of the staff involved in the inspection and 
certification process;  
– the training programmes;  
– the knowledge and competence of new staff;  
– the effectiveness and reliability of the activity witnessed and an 
overall assessment of the performance of the control authority or 
control body;  
– other elements that the accreditation body or competent authority 
considers relevant for the purposes of Regulation (EU) 2018/848;  
(iv) confirming as regards the extensions of the scope of recognition to 
additiona l third countries or categories of products in the previous year, 
the capacity and competencies of the control authority or control body to 
perform controls in accordance with this Regulation in each new third 
country or for each new category of products c oncerned, if there are 
active operators  or group s of operators .  
4. The annual report shall include the following information with regard to cases of 
non-compliance and the measures taken:  
(a) the number of physical on -the-spot inspections with and without prior notice;  
(b) the number of the samples collected in inspections  with and without prior 
notice and where applicable, the actions taken;  
(c) the number of samples collected due to suspicion, complaints or during an 
investigation as referred to point (a) of Article 2 2(1) notified through OFIS as 
referred to in Article 2 1(2) (OFIS  case);  
(d) the number of OFIS cases of suspected or established non -compliance;  
(e) the number of non -compliances found, broken down into minor, major and 
critical according to the classifications of  non-compliances of organic or in -
conversion products laid down in Annex IV;  EN 7  EN (f) measures referred to Annex IV taken in respect of  operator s or group s of 
operators in cases of non -compliances.  
5. When the control authority or control body has certified operator s or group s of 
operators from another control authority or control body , the annual report of the 
receiving control authority or control body shall indicate for each transferred 
operator or group of operator s:  
(a) the name of the operator or group of operators , its geographical location and its 
previous certificate number;  
(b) the name of its previous control authority or control body;  
(c) the date of transfer of the control file;  
(d) the list and nature of open non -compliances and measures required by the 
previous control  authority or control body, if any;  
(e) the measures put in place by the operator or group of operators to ensure that 
the non -compliances will not occur again, and the date(s) of the inspection(s) 
carried out by the new control authority or control body to ve rify that 
corrective measures have been correctly implemented;  
(f) the indication whether the operator or group of operator s was involved in any 
OFIS case.  
6. Concerning high -risk products referred to in Article 8, the following information 
shall be provided:   
(a) the list of the operators or groups of operators responsible for the high -risk 
products;  
(b) for each operator or group of operators:  
(i) the inspections carried out, indicating the date of each inspection;  
(ii) the sampling and analyses carried out;  
(iii) non-compliances found;  
(iv) the measures applied;  
(v) for each operator or group of operators that changed its control authority 
or control body, the corrective measures and/or sanctions applied if non -
compliances were noted in the report of the previous control authority or 
control body;  
(c) for each consignment showing a non -compliance:  
(i) reference to the certificate of inspection for imported consignments;   
(ii) overview of sampling analysis results that indicate the presence of 
residues of non -authorised  substances;  
(iii) investigations and follow -up measures taken by the control authority or 
control body in case of commingling  or residues of non -authorised 
substances found in the consignment, including the decision concerning 
the consignment as well as c onfirmation that operator s have taken 
corrective measures.  EN 8  EN 7. For authorisations for  the use of non -organic plant reproductive material in 
accordance with point 1.8.5.2. of Part I of Annex II to Regulation (EU) 2018/848, the 
following information shall be pro vided:  
(a) scientific and common name (common and Latin name);  
(b) variety;  
(c) number of derogations and total weight of seeds or number of plants derogated;  
(d) number of operators and group s of operators which have been granted an 
authorisation.  
8. For 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 for each non -organic livestock species 
(bovine, equine, ovine, caprine, porcine and cervine animals, rabbits, poultry) , the 
following information shall be pro vided:  
(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) number of derogations and total number of animals derogated;  
(e) number of operators and groups of operators, which have been granted a 
derogation.  
9. For authorisations granted for 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 following information shall be pro vided :  
(a) species and genus (common and Latin name);  
(b) breeds and strains when applicable;  
(c) total number of derogations and number of juveniles for each species;  
(d) number of operators and group s of operators, which have been granted an 
authorisation.  
10. The annual report shall contain any other information deemed relevant to satisfy a 
specific requirement of Regulation (EU) 2018/848 by the control authority , the 
control body or the accreditation body . EN 9  EN ANNEX  III 
OFIS template as referred to in Article 2 1(2) 
Template for a standard reply to a standard international notification on suspected or 
established non -compliance  
A. Investigation  
1) Which  control authority( -ies) and/or control body( -ies) are/were in charge of the 
investigation?:  
2) Describe cooperation between the different operators and competent authority( -ies) or, 
where appropriate, control authority( -ies) and/or control body( -ies) involved, in the different 
countries involved (if any)?:  
3) Which investig ation methods/procedures have been used?:  
For instance, have the operators concerned been submitted to a specific control?:  
Have samples been taken and analysed ?: 
4) What is the outcome of the investigation?:  
What are the results of the inspections/analyses (if any)?:  
Has the origin of the n on-compliance/s uspicion of non-compliance/ other problem raised been 
cleared up?:  
What is your assessment of the seriousness of the n on-compliance/ suspicion of non-
compliance/other problem raised ?: 
5) Has the origin of the contamination/n on-compliance/ suspicion of non-compliance/ other 
problem raised and the responsibility of the actors been clearly identified and established?:  
Comment on the origin of the conta mination/non -compliance/other problem raised and the 
responsibility of the actors:  
6) Have the operators identified been involved in other n on-compliance/ suspicion of non-
compliance/other problem raised  cases in the last 3 years?  
Comment on the operators identified in other non -compliance/suspicion of non -
compliance/other problems in the last 3 years:  
B. Measures and penalties:  
*1) What preventive and corrective measures have been taken (e.g. as regards the 
distribution/circulation  of the product on the Union market and third -country markets)?:  
*2) What actions in case of non -compliance/suspicion of non -compliance/other problem 
raised were taken on the operators and/or the products concerned? 2: 
                                                 
2 Measure pursuant to Article 29(1) and (2) of Regulation (EU) 2018/848 and Article 22(1), (2) 
and (3) and Article 23(1) and (4) of this Regulation.    EN 10  EN *Mode of actions (written form, war ning, etc.)?:  
Was the certification of the producer/processor limited, suspended or withdrawn?:  
Date of entry into force of the actions (if any) (DD/MM/YYYY):  
Duration of the actions (if any) (in months):  
Control authority and/or control body which adopted and applied the actions (if any):  
3) Are additional inspections planned at the operators concerned?:  
4) What other measures are the  control authority or control body planning to prevent the 
occurrence of similar cases?:  
C. Other information:  
D. Annexes:  
Reply comments:  
Contact point  
-----------  
(*) Mandatory fields.  EN 11  EN ANNEX IV 
Catalogue of measures referred to in Article 22(3)  
PART  A 
ELEMENTS FOR THE DEVE LOPMENT AND APPLICAT ION OF THE CATALOGUE  OF 
MEASURES  
1. Subject to Part B, the control authority or control body may classify cases of non -
compliance as minor, major or critical , on the basis of the classification criteria in 
point (b) of A rticle 22(3)  when one or more of the following  situations  apply:  
(a) the cas e of non -compliance is minor when:  
(i) the precautionary measures put in place by the operator are proportionate 
and appropriate, and the controls that the operator has put in place are 
efficient according to the assessment by the control authority or cont rol 
body;  
(ii) the non -compliance does not affect the integrity of the organic or in -
conversion product;  
(iii) the traceability system can locate the affected product(s)  in the supply 
chain and the product can be prevented from being imported from a third 
country for the purpose of placing that product on the market within the 
Union with reference to organic production;  
(b) the case of non -compliance is major when:  
(i) the precautionary measures are not proportionate and appropriate and the 
controls that the operator has put in place are inefficient according to the 
assessment by the control authority or control body ;  
(ii) the non -compliance affects the integrity of the organic or in -conversion 
product;  
(iii) the operator did not correct in a timely manner a minor non -compliance;  
(iv) the traceability can locate the affected product(s) in the  supply chain and 
the product can be prevented from being imported from a third country 
for the purpose of placing that product on the market within the Union 
with referen ce to organic production;  
(c) the case of non -compliance is critical when:  
(i) the precautionary measures are not proportionate and appropriate and the 
controls that the operator has put in place are inefficient  according to the 
assessment by the control auth ority or control body ; 
(ii) the non -compliance affects the integrity of the organic or in -conversion 
product;  
(iii) the operator fails to correct previous major non -compliances or 
repeatedly fails to correct other categories of non -compliances; and  
(iv) there is no information from the traceability system to locate the affected 
produ ct(s) in the supply and the products  cannot be prevented from being EN 12  EN imported from a third country for the purpose of placing that product on 
the market within the Union with ref erence to organic production.  
2. Measures  
Control authorities or control bodies may apply  one or more of  the following measures in a 
proportionate manner to the listed categories of cases of non -compliance:  
Category of non -compliance  Measure  
Minor  Submission  by the operator of an action plan 
within a time limit setting on the correction of 
the non -compliance(s)  
Major  No reference to organic production in the 
labelling and advertising of the entire lot or 
production run concerned (crop(s) or 
animal(s) affecte d) according to Article 42(1) 
of Regulation (EU) 2018/848  
 
Prohibition of import from a third country for 
the purpose of placing that product on the 
market within the Union  as organic 
production for a given period according to 
Article 42(2) of Regulation ( EU) 2018/848  
 
New conversion period required  
 
Limitation of  the certificate’s scope  
 
Improvement of the implementation of the 
precautionary measures and the controls that 
the operator has put in place to ensure 
compliance  
 
Critical  No reference to organic production in the 
labelling and advertising of the entire lot or 
production concerned (crop(s) or animal(s) 
affected) according to Article 42(1) of 
Regulation (EU) 2018/848  
 
Prohibition of import from a third country for 
the purpose of placing that  product on the 
market  within the Union as organic 
production for a given period according to 
Article 42(2) of Regulation (EU) 2018/848  EN 13  EN  
New conversion period required  
Limitation of the certificate’s scope  
Suspension of the certificate  
Withdrawal of the c ertificate  
PART  B 
LIST OF CASES OF NON -COMPLIANCE AND THE C ORRESPONDING 
CLASSIFICATION MANDA TORY TO BE INCLUDED IN THE CATALOGUE OF 
MEASURES  
Non-compliance  Category  
Significant deviation between input and 
output calculation (mass balance)  Major  
Absence of records and financial records 
showing the compliance with Regulation 
(EU) 2018/848  Critical  
Intentional omission of information leading to 
incomplete records  Critical  
Falsification of documents connected with the 
certification of organic prod ucts Critical  
Intentional re -labelling of downgraded 
products as organic  Critical  
Intentional mixing organic with  in-conversion 
or non-organic products  Critical  
Intentional use of non -authorised substances 
or products within the scope of the 
Regulation (EU) 2018/848  Critical  
Intentional use of GMOs  Critical  
The operator refuses the control authority or 
the control body access to premises subject to 
controls, or to its book keepings, including 
financial records, or refuses to allow the 
contro l authority or control body to take 
samples  Critical