EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Commission Delegated Regulation (EU) 2021/1342 as regards the information 
to be sent by third countries and by control authorities and control bodies for the 
purpose of supervision of their recognition under Article  33(2) and  (3) of Council 
Regula tion (EC) No  834/2007 and the measures to be taken in the exercise of that 
supervision  
  EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Commission Delegated Regulation (EU) 2021/13421 supplements Regulation (EU) 2018/848 
with rules on the information to be sent by third countries and by control authorities and 
control bodies for the purpose of supervision of their recognition under Article 33(2) and (3) 
of Council Regulation (EC) No 83 4/20072 for imported organic products and the measures to 
be taken in the exercise of that supervision.  
In order to ensure the appropriate supervision of the third countries recognised under Article 
33(2) of Regulation (EC) No 834/2007, it is necessary to clarify and further specify provisions 
concerning actions taken by the competent authorities following a notification by the 
Commission of a substantiated suspicion of an irregularity or infringement .  
In addition, it is necessary to elaborate further the grounds for measures to be taken by the 
Commission in the exercise of its supervision of recognised third countries.  
In order to ensure the appropriate supervision of the control authorities and control bodies 
recognised under Article 33(3) of Regulation ( EC) No 834/2007, it is necessary to lay down 
additional rules on the procedures for the regular review of their recognition.  
Furthermore, it is necessary to elaborate further the grounds for measures to be taken by the 
Commission in the exercise of its sup ervision of recognised control authorities and control 
bodies.  
Finally, considering that Member State authorities have acquired substantial experience and 
expertise in the field of granting access to imported organic goods into the Union , this act 
provide s specific provisions for the roles of Member State authorities in assisting the 
Commission with the review of the recognitions of third Countries and control authorities and 
control bodies.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The act was discussed thoroughly with the Group of Experts on Organic Production as well as 
with the main organisations representing accreditation and control bodies active in the import 
of organic products from third countries. [A public consultation was carried out]  and DG 
AGRI cooperated closely with other DGs in the field of their specific expertise when drafting 
these rules.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
This delegated act modifies the provisions laid out in Article 1(6) and in point (d) of Article 3 
of Delegated Regulation (EU) 2021/1342 as regards the actions taken by the competent 
authorities of third countries following a notification by the Commission  of a substantiated 
suspicion of an irregularity or infringement and the way that th ose competent authorities 
should inform the Commission and the Member State concerned of the result of the 
                                                 
1 Commission Delegated Regulation (EU) 2021/1342 of 27  May 2021 supplementing Regulation (EU) 
2018/848 of the European Parliament and of the Council with rules on the information to be sent by 
third co untries and by control authorities and control bodies for the purpose of supervision of their 
recognition under Article  33(2) and  (3) of Council Regulation (EC) No  834/2007 for imported organic 
products and the measures to be taken in the exercise of that supervision ( OJ L 292, 16.8.2021, p. 20 ). 
2 Council Regulation (EC) No 834/2007 of 28  June 2007 on organic production and labelling of organic 
products and repealing Regulation (EEC) No  2092/91  (OJ L 189, 20.7.2007, p. 1 ); EN 2  EN investigation. Furthermore, it elaborates further the grounds for measures to be taken by the 
Commission in the exercise of its supervision of recognise d third countries.  
The act amends provisions in Article 2 and in Article 4(1) of the Delegated Regulation (EU) 
2021/1342 to specify additional information to be provided by control authorities and control 
bodies to the Commission and to elaborate further t he grounds for measures to be taken by the 
Commission in the exercise of its supervision of the control authorities and control bodies .  
The act lays down an additional provision in Article 4a of the Regulation concerning  the role 
of Member State authoriti es in assisting the Commission with the review of the recognitions 
of third countries and control authorities and control bodies. This Articles regulates the way 
the tasks of assisting the Commission with the review of the recognitions should be divided 
between the Member States.  EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Commission Delegated Regulation (EU) 2021/1342 as regards the information 
to be sent by third countries and by control authorities and control bodies for the 
purpose of supervision of their recognition under Article  33(2) and  (3) of Council 
Regula tion (EC) No  834/2007 and the measures to be taken in the exercise of that 
supervision  
 
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 s 48(4) and 57(3)  thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) 2021/13422 suppleme nts Regulation (EU) 
2018/848 with rules on the information to be sent by third countries and by control 
authorities and control bodies for the purpose of supervision of the ir recognition under 
Article 33 (2) and  (3) of Council Regulation (EC) No 834/2007 fo r imported organic 
products and the measures to be taken in the exercise of that supervisio n. 
(2) In order to ensure the appropriate supervision of the third countries recognised under 
Article 33(2) of Regulation (EC) No 834/2007 , it is necessary to clarify  that the 
actions taken by the competent authorities  in third countries  following a notification 
by the Commission of a substantiated suspicion of an irregularity or infringement as 
regards compliance of imported organic products with the requirements laid do wn in 
Regulation (EC) No 834/2007, production standards and control measures accepted as 
equivalent may include on -the-spot examinations of operators. It is also necessary to 
specify that the competent authorities should inform the Commission and the Membe r 
State concerned of the result of the investigation and the action taken using the 
template in A nnex III to Commission Delegated Regulation (EU) 2021/16983.  
                                                 
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).  
2 Commission Delegated Regulation (EU) 2021/1342 of 27  May 2021 supplementing Regulation (EU) 
2018/848 of the European Parliament and of the Council with rules on the information to be sent by 
third countries and by control authorities and con trol bodies for the purpose of supervision of their 
recognition under Article  33(2) and  (3) of Council Regulation (EC) No  834/2007 for imported organic 
products and the measures to be taken in the exercise of that supervision ( OJ L 292, 16.8.2021, p. 20 ). 
3 Commission Delegated Regulation (EU) 2021/1698 of 13  July 2021 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 control bodies ( OJ L 336, 23.9.2021, p. 7 ). EN 4  EN (3) Furthermore, it is necessary to elaborate further the grounds for measures to be taken 
by the Com mission in the exercise of its supervision of recognised third countries.  
(4) In order to ensure the appropriate supervision of the control authorities and control 
bodies  recognised under Article 33(3) of Regulation (EC) No 834/2007 , it is necessary 
to lay dow n additional rules on the procedures for the regular review of their 
recognition . 
(5) For that purpose, this Regulation should specify additional information to be provided 
by those control authorities and control bodies to the Commission for the exercise of 
that supervision. This Regulation should also provide for the possibility for the 
Commission to o rganise risk -based on -the-spot examinations of the control authorities 
and control bodies  as well as for the modalities of carrying out those examinations. 
For the exercise of the supervision of the control authorities and control bodies by the 
Commission, it is also necessary to provide for the checks to be carried out for 
certifications of new operators or groups of operators.  
(6) Furthermore, it is necessary to e laborate further the grounds for measures to be taken 
by the Commission in the exercise of its supervision of recognised control authorities 
and control bodies.  
(7) Member State authorities have acquired substantial experience and expertise in the 
field of gr anting access  to imported organic goods into the Union . The Commission 
should be able to draw on the experience  of Member States in checks performed 
during import controls for the purpose of supervision of recognised third countries and 
control authorities and control bodies, including the evaluation of their operational 
performance . The tasks of assisting the Comm ission with the review of the 
recognitions should be divided in a just and proportionate way  between the Member 
States taking into account the number of votes of each Member State in the Committee 
of Organic Production.   
(8) Delegated Regulation (EU) 2021/1342  should therefore be amended accordingly,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Delegated Regulation (EU) 2021/1342 is amended as follows:   
(1) in Article 1, paragraph 6 is replaced by the following:  
‘6. Where the Commission has received a notification from a  Member State 
informing it of a substantiated suspicion of an irregularity or infringement as regards 
compliance of imported organic products with the requirements laid down in 
Regulation (EC) No 834/2007 and production standards and control measures 
accep ted as equivalent on the basis of the assessment made, it shall notify the 
competent authority of the third country thereof. That competent authority shall 
investigate the origin of the suspected irregularity or infringement and shall, within 
30 calendar d ays from the Commission’s notification, inform the Commission and 
the Member State concerned of the result of the investigation and of the actions 
taken, including , as appropriate,  on the spot examinations  of operators , using the 
template set out in Annex III to Commission Delegated Regulation (EU) 
2021/1698. ’; 
(2) Article 2  is amended as follows:  EN 5  EN (a) the following paragraph 1a is inserted:  
‘1a. The control authority or control body shall notify to the Commission in due 
time, and no later than within 30 calendar da ys, of the occurrence of changes to the 
content of its technical dossier.’;  
(b) paragraph 3 is replaced by the following:  
‘The Commission may at any time request any further information from the control 
authorities and control bodies, including concerning the annual report. That 
additional information shall be provided in electronic form. ’; 
(c) the following paragraphs 4 to 7 are added:  
‘4. The Commission may o rganise risk -based on -the-spot examinations  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 may be coordinated with the relevant accreditation body.  The 
Commission may be accompanied by independent experts during th ose on -the-
spot e xaminations.  
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.  
On-the-spot examinations may include:  
(a) a visit to the of fices or premises of the control authorities and control 
bodies, their outsourced services and operators 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 
competencies, training records, conflict of interest statements and records 
of evaluation and supervision of staf f; 
(d) a check of operators’ 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 operators or groups of operators 
to verify compliance with the standard cont rol 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, w hich 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.  
5. For the purpose of preparing on -the-spot examinations of the control 
authorities and control bodies , the Commission may request information from EN 6  EN the control bodies and control authorities. That information must be provided 
within a  period to be determined by the Commission . 
6. Where the Commission has received a notification from a Member State 
informing  it of a substantiated suspicion of an irregularity or infringement as 
regards compliance of imported organic products with the requirements laid 
down in Regulation (EC) No 834/2007 and production standards and control 
measures accepted as equivalent on th e basis of the assessment made, it shall 
notify the control authority and control body thereof. The control authority or 
the control body shall investigate the origin of the suspected irregularity or 
infringement and shall, within 30 calendar days from the  Commission’s 
notification, inform the Commission and the Member State concerned of the 
result of the investigation and of the actions taken  by the control authority or 
the control body , including , as appropriate , on the spot examinations  of 
operators , usi ng the template set out in Annex III to Regulation (EU) 
2021/1698 ; 
7. Before certifying a new operator or group of operator s, the control authority 
or control body shall ensure that , if the operator or group of operators have 
been suspended or withdrawn within the last 2 years by their previous control 
authority or control body , the non -conformities identified by th ose control 
authorities or control bodies  have been or are being addre ssed by the operator 
or group of operators. If the control authority or control body cannot ensure 
that the non -conformities have been or are being addressed , the control 
authority or control body shall not certify the operator or group of operators. ’; 
(3) in Article 3, point (d) is amended as follows:  
(a) the introductory wording is replaced by the following:  
‘the Commission may withdraw the entry of a third country from the list 
where:’;  
(b) point (iv) is replaced with the following:  
‘(iv) after a request from the Commission, the third country does not agree to an 
on-the-spot examination , or if an on -the-spot examination comes up with a 
negative result due to a systematic malfunctioning of the control measures ;’; 
(c) the following point (v) is added:  
‘(v) in any other situation where there is a risk for the consumer to be misled 
about the true nature of the products certified by the third country.’;  
(4) in Article 4, paragraph (1) is amended as follows:  
(a) point (b) is replaced with the following:  
‘(b) the Commission may susp end the entry of a control authority or control 
body from the list either on the basis of the information received, or where the 
control authority or control body has not supplied sufficient information as 
required within a period to be determined by the C ommission according to the 
severity of the problem, which shall not be less than 30 days, or where it has 
not agreed to an on -the-spot examination ;’ 
(b) point (d) is amended as follows:  
(i) point (iii) is replaced by the following:  EN 7  EN ‘(iii) the control authority  or control body does not keep available or does 
not communicate all information related to its technical dossier or control 
system  after a request from the Commission within a period to be 
determined by the Commission, according to the severity of the pro blem 
and which shall not be less than 30 days or in accordance with Article 
2(1a);’ 
(ii) point (iv) is replaced by the following:  
‘the control authority or control body does not keep available or does not 
communicate  information on the investigations of a non-compliance ’; 
(iii) point (vi) is replaced by the following:  
‘(vi) the control authority or control body does not agree to an on -the-spot 
examination required by the Commission , or does not send all the 
information requested under Article 2(5) , or if an  on-the-spot examination 
comes up with a negative result due to a systematic malfunctioning of the 
control measures;  or’  
(5) the following Article 4a is inserted:  
‘Article 4 a 
Assistance to supervision by Member States  
1. For the purpose of the review of the recognition of third countries  in accordance with 
Article 3 , the Commission, when requesting the assistance of Member States, shall 
be assisted by two Member States to act as co -rapporteurs  for the examination of the 
annual report and any  other information received, and for the evaluation of the 
operational performance of the third countries.  
2. For the purpose of the review of the recognition of control authorities and control 
bodies in accordance with Article 2, the Commission, when reques ting the assistance 
of Member States, shall be assisted by two Member States to act as co -rapporteurs  
for the examination of the annual report and any other information received, and for 
the evaluation of the operational performance of the control authorit ies and control 
bodies.  
3. The Commission may divide the requests for assistance in accordance with 
paragraphs 1 and 2 between the Member States proportionally with the number of 
votes of each Member State in the Committee on organic production.’;  
(6) in Article 5, the third and fourth paragraph are replaced by the following:  
‘Articles 1 , 3 and Article 4a(1) shall apply until 31  December 2026.  
Articles 2 , 4 and Article 4a(2) shall apply until 31  December 2024. ’ 
 
Article  2 
This Regulation shall enter into force on the third day following  that of its publication in the 
Official Journal of the European Union . EN 8  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For t he Commission  
 The President  
 Ursula VON DER LEYEN