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 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 834/2007 for imported organic 
products and the measures to be taken in the exercise of that supervision  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the entry into force  of Regulation  (EU) 2018/848  of the European Parliament and 
of the Council1, it is necessary to adopt this Delegated Regulation supplementing that  
Regulation as regards  the rules on  the information to be sent by third countries and by control 
authorities and control bodies for the pu rpose of supervision of their recognition under Article 
33(2) and (3) of Council Regulation (EC) No 834/20072 for imports of organic products into 
the Union  and the measures  to be taken in the exercise of that supervision .  
 2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The act was thoroughly discussed with Member States at the Group of Experts on Organic 
Production as well as with the main organisations represen ting the organic sector.  
WTO partners were notified and general public consultations were c arried out. Following the 
general public consultation, all comments received via the feedback mechanism have been 
considered and the act has not been amended.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
Regulation (EU) 2018/848 underlines in its recital 96 that  third countries recognised for the 
purpose of equivalence under Regulation (EC) No 834/2007 should continue to be recognised 
as such under Regulation (EU) 2018/848 , for a limited period necessary to ensure a smooth 
transition to the scheme of recognition through an international agreement, p rovided  that they 
continue to ensure their organic production and control rules are equivalent to the relevant 
Union rules and they fulfil all the requirement s related to the supervision of their recognition 
by the Comm ission. In order to ensure that supervision supplementing rules are necessary.  
Moreover, recital 97 of Regulation (EU) 2018/848 states that sufficient time should be given 
to control authorities and control bodies recognised by the Commission under the equ ivalence 
scheme to issue certificates in third countries for the purpose of importing products in order to 
allow those control authorities and control bodies to prepare themselves to obtain recognition 
for the purposes of import of products that comply wit h Union rules.  
As provided for in Article 48(4) and 57(3)  of Regulation (EU) 2018/848 , this delegated act 
supplement s that Regulation with  provisions concerning  the appropriate supervision of such 
third countries or the control authorities and control bodies  concerned. In particular, it 
provides for  rules on the procedures for the regular review  of their recognition  during  the 
transitional period s. In addition, this Regulation set out the measures to be taken by the 
Commission in the exercise of that supervision, including suspension or withdrawal of 
recognised third countries or control authorities and control bodies from the lists established 
pursuant to Articles 48(3) and 57(2) of Regulation (EU)  2018/848 . 
                                                 
1 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 834/2007  (OJ 
L 150, 14.6.2018, p. 1 ). 
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 COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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 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  
(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 C ouncil 
Regulation (EC) No 834/20071, and in particular Articles 48(4) and 57(3)  thereof,  
Whereas:  
(1) Pursuant to Article 48(1) of Regulation (EU) 2018/848 , the recognition  of third 
countries for the purposes of equivalence under Article 33(2) of Council Regul ation 
(EC) No 834/20072 for imports of organic products into the Union  will expire on  31 
December 202 6. 
(2) Pursuant to Article 57(1) of Regulation (EU) 2018/848 , the recognition  of control 
authorities and control bodies for the purpose s of equivalence under A rticle 33(3) of 
Regulation (EC) No 834/2007 for import s of organic products  into the Union  will 
expire on  31 December 202 4. 
(3) When placed on the Union market until the end of those transitional periods,  o rganic 
products imported into the Union under those  import schemes have to be produced in 
accordance with the production rules and subject to control arrangements equivalent to 
those laid down in Regulation (EC) No 834/2007 as well as with the associated 
implementing rules laid down in Commission Regulatio ns (EC) No 889/20083 and 
(EC) No 1235/20084. 
(4) Therefore, a t all stages of production, preparation and distribution in third countries , 
operators  should continue to submit their activities either to a control system  of a third 
country  recognised for the purp oses of equivalence as referred to in Article 48(1) of 
                                                 
1 OJ L 150, 14.6.2018, p. 1.  
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 L189, 20.7.2007, p. 1 ). 
3 Commission Regulation (EC) No 88 9/2008 of 5 September 2008 laying down detailed rules for the 
implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of 
organic products with regard to organic production, labelling and control ( OJ L 250, 18.9.2008, p. 1 ). 
4 Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for 
implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of 
organic products from third countries  (OJ L 334, 12.12.2008, p. 2 5). EN 3  EN Regulation (EU) 2018/848 , or to a control  authority or control body as referred to in 
Article 57 (1) of that Regulation . 
(5) In order t o ensure the appropriate supervision of such third countries or the control 
authorities and control bodies  concerned , it is necessary to lay down rules on the 
procedures for the regular review  of their recognition  during  the transitional period s. 
For that purpose , this Regulation  should  specify , in particular , the inf ormation to be 
provided by the third countries  or the control authorities and control bodies to the 
Commission for the exercise of that supervision, including through on -the-spot 
examination . In addition, this Regulation should set out the measures  to be t aken by 
the Commission in the exercise of that supervision, including suspension or 
withdrawal of recognised third countries or control authorities and control bodies from 
the lists established pursuant to Articles 48(3) and 57(2) of Regulation (EU) 2018/8 48. 
(6) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of application of Regulation (EU) 2018/848 until the expiry of the recognition of  the 
third countries or control authorities and control bodies , 
HAS ADOPTED THIS  REGULATION:  
Article 1  
Supervision of third countries  
1. The annual report to be sent to the Commission  in accordance with Article 48(2) of 
Regulation (EU) 2018/848 , by 31 March of each year, by a third countr y referred to 
in Article 48(1) of that Regulation and included in the list established by  an 
Implementing Regulation  to be ado pted pursuant to  Article 48(3 ) of Regulation  (EU) 
2018/848  (‘third country’)  shall include:  
(a) information on the development of organic production in the third country , 
including the  products produced, the area in cultivation, the production regions, 
the number of producers, and the food processing activities ; 
(b) information on the nature of organic agricultural products and foodstuffs 
exported to the Union;  
(c) a description of the monitor ing and supervisory activities carried out by the 
competent authority of the third country in the previous year, the results 
obtained and the corrective measures taken;  
(d) any updates on the production standards applied in the third country assessed 
as equivalent to the production rules referred to in Titles III and IV of 
Regulation (EC) No 834/2007;  
(e) any updates on the control measures  applied in the third country, assessed as 
having equ ivalent effectiveness to those referred to in Title V of Regulation 
(EC) No 834/2007 , and confirmation that such control measures have been 
permanently and effectively applied;  
(f) any other updates on the third country’s technical dossier;  
(g) the Internet websi te or other address where the up -to-date list of operators 
subject to the control system can be found, as well as a contact point where 
information is readily available on their certification status and the product 
categories concerned;  
(h) any other informat ion deemed relevant by the third country .  EN 4  EN 2. The third country shall notify the Commission without delay , via the electronic 
platform Organic Farming Information System (OFIS), of any changes made to the 
measures in force in that third country or to their i mplementation , and in particular to 
its control system.  
3. The third country shall notify the Commission without delay, via OFIS, of a ny 
changes made to the administrative data  included in the list established by an 
Implementing Regulation  to be adopted pursu ant to  Article 48(3) of Regulation (EU) 
2018/848 . 
4. The Commission may at any time request any further information  from the third 
country , including the submission  of one or more on -the-spot examination reports 
established by independent experts .  
5. The Commission may, based on a risk -assessment or in case of suspected non -
compliances , organise an on -the-spot examination in the third country by experts it 
designates.  
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 
the basi s 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 days from th e 
Commission’s  notification , inform the Commission and the Member State concerned 
of the result of the investigation and of the action taken.   
Article 2  
Supervision of control authorities and control bodies  
1. On the basis of annual reports and in the light of any other inform ation received, the 
Commission shall ensure appropriate supervision of the control authorities and 
control bodies referred to in Article 57(1) of Regulation (EU) 2018/848 and included 
in the list established by  an Implementing Regulation  to be adopted purs uant to 
Article 57 (2) of Regulation (EU) 2018/848  (‘control authorities and control bodies’) 
by regularly reviewing their recognition. For this purpose, the Commission may 
request the assistance of Member States. The nature of the supervision of the control 
authorities and control bodies shall be determined on the basis of a risk based 
approach  of non -compliance, taking into account in particular the volume of certified 
products and their exports to the Union and the results of the regular on -the-spot 
evaluation, surveillance and multiannual re -assessment of their activities by an 
accreditation body or, as appropriate, by a competent authority.  
2. By 28 February of each year, the control authorities and control bodies shall send the 
Commission an annual  report. The annual report shall update the information of the 
technical dossier included in the initial application for the recognition, as last 
modified. It shall at least include:  
(a) an overview of the activities of the control authority or control body in the third 
country or third countries  for which it has  been recognised , including the 
number of operators and group s of operators involved and the nature of 
agricultural products and foodstuffs, sorted by categories and grouped by tariff 
codes ; EN 5  EN (b)  any updates  on the production standards applied in the third country or third 
countries for which the control authority or control body  has been recognised , 
including an assessment of the equivalence of those standards to the production 
rules referred to in Titles II I and IV of Regulation (EC) No 834/2007;  
(c) any updates on the control measures applied in the third country or third 
countries for which the control authority or control body  has been recognised , 
including an assessment of the equivalence to those referred to in Title V of 
Regulation (EC) No 834/2007 , and confirmation that such control measures 
have been permanently and effectively applied;  
(d) a description of the control activities carried out by the control authority or 
control body in the previous year in the third country or third countries for 
which it has been recognised , the results obtained, the irregularities and 
infringements observed and the corrective measures taken;  
(e) any other updates on the information of the technical dossier that was sent with 
the initial application for the recognition and its further updates;  
(f) a copy of the latest assessment report issued by the accreditation body or, 
where appropriate, by a competent authority, which shall contain the results of 
the regular on -the-spot evaluation , surveillance and multiannual re -assessment 
of the activities  of the control authority or control body in the third country or 
third countries for which it has been recognised . That assessment report shall 
confirm that the control authority  or control body has been satisfactorily 
assessed on its ability to meet the conditions applicable to its recognition by the 
Commission and that it has effectively implemented its activities according to 
those conditions. Furthermore, the assessment report shall demonstr ate and 
confirm the equivalence of the production standards and control measures 
referred to in points  (b) and (c); 
(g) the Internet website where the list of operators subject to the control system 
can be found in an official language  of the Union , as well as  a contact point 
where information is readily available on their certification status, the product 
categories concerned, as well as suspended and decertified operators and 
products;  
(h) any other information deemed relevant by the control authority  or control body   
The annual report and any additional information requested by the Commission 
concerning the annual report shall be provided via OFIS.  
3. The Commission may request a ny additional information concerning the annual 
report . That additional information shall be provided in electronic form .  
Article 3  
Review of the recognition  of third countries  
In the framework of its regular review of the recognition of third countries pursuant to Article 
48(2) of Regulation (EU) 2018/848, the Commission shall apply the following rules and 
amend  the list of third countries  accordingly pursuant to Article 48(3) of that Regulation :   
(a) the Commission may at any time amend the specifications in the list on the basis of 
the information received;  EN 6  EN (b) the Commission may suspe nd the entry of a third country in the list  either on the 
basis of the information received, or where a third country has not supplied sufficient 
information as required or where it has not agreed to an on -the-spot examination ;  
(c) the Commission shall suspend the entry of a third country in the list where , after a 
request from the Commission,  the third country fails to take appropriate and timely 
remedial action within a period  to be determined by the Commission according to the 
severity of the problem , which shall  not be less than 30 days ; 
(d)  the Commission shall withdraw the entry of a third country from the list where:  
(i) the third country does not send on time the annual report referred to Article 
1(1) of this Regulation;  
(ii) the information included in that annual report is incomplete;  
(iii) after a request from the Commission within a period to be determined by the 
Commission according to the severity of the problem, which shall not be less 
than 30 days, the third country does not keep available the information or does 
not communicate all information related to its technical dossier or control 
system;  or 
(iv) after a request from the Commission, the third country does not agree to an on -
the-spot examination.   
Article 4  
Review of the recognition  of control authorities and control bodies  
1. In the framework of its regular review of the recognition of control authorities and 
control bodies pursuant to Article 2(1) of this Regulation, the Commission shall 
apply the following rules  and amend the list of control authorities and control bodies 
accordingly pursuant to Article 57(2) of Regulation (EU) 2018/848:   
(a) the Commission may at any time amend the specifications relating to a control 
authority or control body in the list on the  basis of the information received;  
(b) the Commission may suspend the entry of a control authority or control body  
in the list either on the basis of the information received, or where the control 
authority or control body  has not supplied sufficient info rmation as required or 
where it has not agreed to an on -the-spot examination;  
(c) the Commission shall suspend the entry of a control authority or control body 
in the list where, after a request from the Commission, the control authority or 
control body f ails to take appropriate and timely remedial action within a 
period to be determined by the Commission according to the severity of the 
problem, which shall not be less than 30 days;  
(d) the Commission shall withdraw the entry of a control authority or con trol body 
from the list where:  
(i) the control authority or control  body  does not send on time the annual 
report referred to in Article 2(2) of this Regulation;  
(ii) the information included in th e annual report is incomplete;  
(iii) the control authority o r control body  does not keep available or does not 
communicate all information related to its tech nical dossier or control 
system;  EN 7  EN (iv) the control authority or control body  does not keep available information 
on the investigations of a non -compliance ;   
(v)  the control authority or control body  fails to take adequate corrective 
measures in response to the non -compliance and infringements observed ; 
(vi)  the control authority or control body  does not agree to an on -the-spot 
examination required by the Comm ission, or if an on -the-spot 
examination comes up with a negative result due to a systematic 
malfunctioning of the control measures ; or 
(vii)  in any other situation , there is  a risk for the consumer to be misled about 
the true nature of the products certi fied by the control authority or control 
body.   
2. Prior to a withdrawal in accordance with point (d) of paragraph 1, the Commission 
shall  request the control authority or control body to remedy the situations referred to 
in that point  within a period to be determined by the Commission according to the 
severity of the problem, which shall not be less than 30 days .  
Article 5  
Entry into force  and application  
This Regulation shall enter into force on the twentieth day following that of it s publication in 
the Official Journal of the European Union . 
It shall apply from 1 January 2022.  
Articles 1 and 3 shall apply  until 31 December 2026.  
Articles 2 and 4 shall apply until  31 December 2024.  
This Regulation shall be binding in its entirety and directly applicable in all Member States . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  