EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2018/848 of the European Parliament and of the Council as 
regards the criteria for the recognition of control authorities and control bodies that are 
competent to carry out controls on organic products in third countries, and for t he 
withdrawal of their recognition  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the adoption of the 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.  
Building on the Commission’s experience with the s upervision of control authorities and 
control bodies operating in third countries , and with a view to ensuring the robustness of 
controls performed by control authorities and control bodies and to guaranteeing the integrity 
of organic products imported fro m third countries, it is necessary to reinforce the capacity of 
control authorities and control bodies to carry out effective controls on operators producing 
organic products in third countries.  
In order to ach ieve these  objective s, and in the interest of transparency, additional criteria for 
the recognition or the withdrawal of control authorities and control bodies should be laid 
down.  
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 these rules. WTO partners were notified and general public consultations were 
carried out.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
This delegated act lays down further criteria to those laid down in Article 46(2) of Regulation 
(EU) 2018/848 for the recognition of the control authorities and control bodies and criteria for 
the withdrawal of such recognition.  EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2018/848 of the European Parliament and of the Council as 
regards the criteria for the recognition of control authorities and control bodies that are 
competent to carry out controls on organic products in third countries, and for the 
withdrawal of their recognition  
(Text with EEA relevance)  
THE EUROPEAN COMMISSIO N, 
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 point (a) 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) Building on the Commission’s experience with the supervision of control authorities 
and control bodies operating in third countries , and with a view to ensuring the 
robustness of controls performed by control authorities and control bodies and to 
guaranteeing the integrity of organic products imported from third countries, it is 
necessary to reinforce the capacity of control authorities and control bodies to carry 
out effective controls on operators producing organic products in third countries. In 
order to achieve this objective, additional criteria for the recognition of control 
authorities and control bodies should be introduced.  
(3) In particular, point (b) of Article 46(2) of R egulation (EU) 2018/848 requires control 
authorities and control bodies to have the capacity to carry out controls to ensure that 
the conditions set out in points (a), (b)(i) and (c) of Article 45(1) of that Regulation are 
met in relation to organic produc ts and in -conversion products. As those controls  are 
essential to ensure compliance with Regulation (EU) 2018/848, a  control authority or 
control body should  not be allowed to delegate control tasks . However, in order to 
give the necessary flexibility to control authorities  or control bodies , sampling should 
not be included in the prohibition to delegate control tasks.  
(4) In case of serious or repetitive infringements as regards the certification of operators or 
the controls and actions performed by the contr ol authority or control body, or when 
the control authority or control body has failed to take appropriate and timely remedial 
action, the Commission should be able to withdraw the recognition of the control 
authority or control body. Therefore, in the int erest of transparency, criteria for the 
withdrawal of the recognition of control authorities and control bodies should be laid 
down.  
                                                 
1 OJ L 150, 14.6.2018, p. 1.  EN 3  EN (5) Regulation (EU) 2018/848 should therefore be amended accordingly.  
(6) In the interest of clarity and legal certainty, this Regu lation should apply from the date 
of application of Regulation (EU) 2018/848,  
HAS ADOPTED THIS REGULATION:  
Article 1  
In Article 46 of Regulation (EU) 2018/848 , paragraph 2  is replaced by the following:  
‘2. Control authorities and control bodies shall be re cognised in accordance with 
paragraph 1 for the control of the import of the categories of products listed in Article 35(7) if 
they fulfil the following criteria:  
(a) they are legally established in one Member State or third country;  
(b) they have the capacity to  carry out controls  to ensure that the conditions set out in 
points (a), (b)(i) and (c) of Article 45(1) and in this Article are met in relation to 
organic products and in -conversion products intended for import into the Union , 
without delegating control t asks; for the purposes of this point, control  tasks carried 
out by  persons working under an individual contract or a formal agreement that place 
them under the management control and the procedures of the contracted control 
authorities or control bodies  shall not be considered as delegation , and the 
prohibition to delegate control tasks shall not apply to sampling ; 
(c) they offer adequate guarantees of objectivity and impartiality and are free from any 
conflict of interest as regards the exercise of their control tasks; in particular, they 
have procedures in place ensuring that the staff performing controls and other act ions 
is free from any conflict of interest, and that the operators are not inspected by the 
same inspectors for more than 3 years consecutively;  
(d) in the case of control bodies, they are accredited for the purpose of their recognition 
in accordance with thi s Regulati on by only one accreditation body under the relevant 
harmonised standard for ‘Conformity assessment – Requirements for bodies 
certifying products, processes and services’, the reference of which has been 
published in the Official Journal of the E uropean Union ;  
(e) they have the expertise, equipment and infrastructure required to carry out control 
tasks, and have a sufficient number of suitable qualified and experienced staff;  
(f) they have the capacity and the competency to carry out their certification  and control 
activities in accordance with the requirements of this Regulation and in particular 
Commission Del egated Regulation (EU) 2021/XXX * for each type of operator 
(single operator or group of operators) in each third country and for each category of 
product s they want to be recognised for;  
(g) they have procedures and arrangements in place to ensure the impartiality, the 
quality, the consisten cy, the effectiveness and the appropriateness of controls and 
other actions performed by them;  
(h) they have sufficient qualified and experienced staff so that controls and other actions 
can be performed effectively and in due time;  
(i) they have appropriate and p roperly maintained facilities and equipment to ensure that 
staff can perform controls and other actions effectively and in due time;  EN 4  EN (j) they have procedures in place in order to ensure that their staff have access to the 
premises of, and documents kept by ope rators so as to be able to accomplish their 
tasks;  
(k) they have internal skills, training and procedures suitable to supervise and inspect 
operators as well as the internal control system of a group of operators, if any;  
(l) their previous recognition for a speci fic third country and/or for a category of 
products has not been withdrawn in accordance with paragraph 2a or their 
accreditation has not been withdrawn or suspended by any accreditation body in 
accordance with its procedures for the suspension or withdraw al established in 
accordance with the relevant international standard, in particular the International 
Organisation for Standardisation (ISO) standard 17011 – Conformity assessment – 
general requirements for accreditation bodies accrediting conformity asse ssment 
bodies , during the 24 months preceding:  
(i) their request for recognition for the same third country and/or for the same 
category of products, except where the previous recognition was withdrawn in 
accordance with point (k) of paragraph 2a;  
(ii) their request for an extension of the scope of recognition to an additional third 
country in accordance with Article 2 of  Delegated Regulation (EU) 2021/XXX , 
except where the previous recognition was withdrawn in accordance with point 
(k) of paragraph 2a  of this Article ;  
(iii) their request for an extension of the scope of recognition to an additional 
category of products in accordance with Article 2 of  Delegated Regulation 
(EU) 2021/XXX;  
(m) in the case of control authorities, they are public administrative orga nisations in the 
third country for which they request recognition;  
(n) they meet the procedural requirements laid down in Chapter I of Delegated 
Regulation (EU) 2021/XXX ; and  
(o) they meet any additional criteria that may be laid down in a delegated act adopted 
pursuant to paragraph 7.  
2a. The Commission may withdraw the recognition of a control authority or control body for 
a specific third country and/or a category of products if:   
(a) one of the recognition criteria set out in paragraph 2 is no longer met;  
(b) the Commi ssion has not received the annual report referred to in Article 4 of 
Delegated Regulation (EU) 2021/XXX  by the deadline specified in that Article or the 
information included in the annual report is incomplete, inaccurate or does not 
comply with the require ments set out in that Regulation;  
(c) the control authority or control body does not make available or does not 
communicate all the information related to the technical dossier referred to in 
paragraph 4, to the control system applied by it, or to the up -to-date list of operators 
or groups of operators or to the organic products covered by the scope of its 
recognition;  
(d) the control authority or control body does not notify the Commission within 30 
calendar days of changes to its technical dossier referred to in paragraph 4;  EN 5  EN (e) the control authority or control body does not provide information requested by the 
Commission or by a Member State within the deadlines set, or the information is 
incomplete, inaccurate or does not comply with the requirements set out in this  
Regulation , in Delegated Regulation (EU 2021/XXX and in an implementing  act to 
be adopted pursuant to paragraph 8, or does  not cooperate with the Commission, in 
particular during the investigations of a non -compliance;  
(f) the control authority or control bod y does not agree to an on -the-spot examination or 
audit initiated by the Commission;  
(g) the result of the on -the-spot examination or audit indicates a systematic 
malfunctioning of control measures or the control authority or control body is unable 
to implemen t all the recommendations made by the Commission after the on -the-spot 
examination or audit, in their proposed action plan submitted to the Commission;  
(h) the control authority or control body fails to take adequate corrective measures in 
response to the non -compliances and infringements observed within a deadline set by 
the Commission according to the severity of the situation, which shall not be shorter 
than 30 calendar days;  
(i) in case an  operator changes  its control authority or control body , the control authority 
or control body does not communicate to the new control authority or control body 
the relevant elements of the control file, including written records, of the operator 
within a maximum of 30 calendar days after having received the req uest for transfer 
from the operator or the new control authority or control body;  
(j) there is a risk for the consumer to be misled about the true nature of the products 
covered by the scope of the recognition; or  
(k) the control authority or control body has not  certified any operator for 48 consecutive 
months in the third country for which it is recognised.  
----- 
* Commission Delegated Regulation (EU) 2021 /... of [date] 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 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  (OJ L xxx, xxx, p. x). ’. 
Article  2 
This Regulation shall enter into force on the twen tieth 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 6  EN Done at Brussels,  
 For the Commis sion 
 The President  
 Ursula VON DER LEYEN