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 official controls in respect of consignments of organic products 
and in -conversion products intended for import into the Union and on the certificate of 
inspection  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the adoption of Regulation (EU) 2018/848, which will enter int o application on 1 
January 2022 , it is necessary to adopt this Delegated Regulation supplementing that 
Regulation as regards the rules for the certificate of inspection, a document that accompan ies 
each consignment of organic product imported into the EU, and the official co ntrols carried 
out by Member States before the release for free circulation into the Union of the organic 
products originated in third countries.  
 2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The draft delegated act was discussed thoroughly with the Member States at the Group of 
Experts on Organic Production . DG AGRI cooperated closely with other DGs in the field of 
their specific expertise when drafting these rules , in particular DG SANTE and DG TAXUD . 
WTO partners were notified and general public con sultations were carried out.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
Regulation (EU) 2018/848 establishes , in Article 45 , that an organic  or in -conversion  product 
may be imported from a third country for the purpose of placing that product on the market 
within the Union, if the product complies with Union rules on organic production or come s 
from a third country or a control body or control authority whose organic production and 
control systems have been recogni sed as equivalent .  
In order to allow the competent authorities to check  whether  imported products are in 
accordance with Regulation (EU) 2018/848, the consignments of products intended for import 
should be covered by a certificate of inspection issued by the recognised control authority or 
control body in the third country after having carried out the relevant verifications of the 
consignments.  In order to ensure it , supplementing rules are necessary.  
The controls of products intended for import into the Union are part of the official controls 
carried out on importers established in the Union and responsible for products intended for 
import. It is therefore necessary to clarify the criteria and conditi ons for the performance of 
those official controls before the release for free circulation into the Union . Finally, specific 
provisions are  laid down  regarding  the information to be provided by a competent authority, 
control authority or control body in a third country on cases of  non-compliances on 
consignments  intended for import into the Union.  
  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 official controls in respect of consignments of organic products 
and in -conversion products intended for import into the Union and on the certificate of 
inspection  
(Text with EEA relevance)  
THE EUROPEA N COMMISSION,  
Having regard to the Treaty on the Functi oning 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 particula r Article 38(8), point (a)(ii), Article 46(7), 
point (b), and Articles 48(4) and 57(3)  thereof,  
Whereas:  
(1) In accordance with Article 45( 1) of Regulation (EU) 2018/848, a product may be 
imported from a third country for the purpose of placing that product on  the market 
within the Union  as an organic product or as an in -conversion product , if that product 
complies with Union rules on organic production or with the equivalent production 
and control rules of a third country as referred to in Article 48 of that R egulation that 
has been recognised under Article 33(2) of Council Regulation (EC) No 834/20072, or 
has been subject to controls by a control authority  or control body as referred to in 
Article 57 of Regulation (EU) 2018 /848 that has been recognised under Article 33(3 ) 
of Regulation (EC) No 834/2007 .  
(2) In order to allow the competent authorities in the Member States to check the 
compliance of the imported products with Regulation (EU) 2018/848,  each 
consignment should be covered by a certificate of inspectio n issued by the control 
authority or control body in the third country after having carried out the relevant 
verifications of the consignments. Th ose verifications should always include a 
documentary check and , according to the risk , a physical check of th e consignment.  
(3) It is necessary to lay down rules with regard to the content of the certificate of 
inspection, the way it is issued  and the technical means used for it s issuance . Those 
rules should also cover  the obligations of the competent authorit ies in  the Member 
States  as regards the extract of the certificate of inspection.  
(4) The official controls performed on products  intended to be placed on the Union  market 
as organic products or in -conversion products for the verification of their compliance 
with Re gulation (EU) 2018/848 are part of the official controls carried out in 
                                                 
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).  EN 3  EN accordance with Regulation (EU) 2017/625  of the European Parliament and of the 
Council3. 
(5) It is necessary to lay down additional rules in order to clarify the criteria and 
conditions fo r the performance of official controls before the release for free 
circulation in the Union  of organic products and in -conversion products subject to 
official controls at border control posts in accordance with Article 45(5) of  Regulation 
(EU) 2018 /848. Those rules should also cover  products exempted from official 
controls at border control posts  pursuant to  Commission Delegated Regulation (EU) 
2021/xxx4 [DA SANTE ]. 
(6) Certain  specific rules on official controls as regards consignments placed under special 
custom s procedures should be laid down . 
(7) In addition, the obligations  of control authorities and control bodies issuing the 
certificate of inspection  in cases of unavailability of the Trade Control and Expert 
System (TRACES ) referred to in Article 2 , point (36), of Commission Implementing 
Regulation (EU) 2019/17155 should be laid down .  
(8) Furthermore , it is  necessary  to lay down rules on situations where  competent 
authorities,  control authorities or control bodies in third countries  are required  to carry 
out an  investigation after the notification of cases of suspected or established  non-
compliance  with Regulation (EU) 2018/848 found during the verification of the 
consignment by the competent authority  of the Member States . 
(9) The use of the qualified electronic se al in TRACES for the issuance of the certificate 
of inspection in third countries and for the endorsement of t hat certificate , and of 
extracts thereof , by the competent authorities of the Member States might not  be 
feasible before  1 July 2022. It is therefore necessary to lay down transitional 
provisions  for the use of hand -signed paper certificates of inspection , and extracts 
thereof , to apply  until 30 June 2022  as an alternative to the use of electronic 
certificates of inspection , and extracts there of, bearing  a qualified electronic seal . 
(10) Currently, rules on the certificate of inspection and extracts of the certificate of 
inspection for the purposes of Regulation (EC) No 834/2007 are laid down  in 
                                                 
3 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on offi cial 
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 
999/2001, (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, 96/93/EC and 97/78/EC and Council Decision 
92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).  
4 Commission Delegated Regulation (EU) 2021/XXX of [date] supplementing Regulation (EU) 2017/625 
of the European Parliament and of the Council with rules on the cases whe re and conditions under 
which organic products and in -conversion products are exempted from official controls at border 
control posts of first arrival into the Union, the place of official controls for such products and 
amending Commission Delegated Regulati ons (EU) 2019/2123 and (EU) 2019/2124  (OJ L xxx, xxx, p. 
xxx).   
5 Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the 
functioning of the information management system for official controls and its system compone nts (the 
IMSOC Regulation)  (OJ L 261, 14.10.2019, p. 37).  EN 4  EN Commission Regulation (EC) No 1235/20086. As this Regu lation and Commission 
Implementing Regulation (EU) 2021/xxxx7[IA COI]  lay down rules for the purposes 
of Regulation (EU) 2018/848, Regulation (EC) No 1235/2008 should be repealed.  
(11) In the interest of clarity and legal certainty, this Regulation should appl y from the date 
of application of Regulation (EU) 2018/848 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Subject matter  
This Regulation lays down rules on:  
(a) the verification in third countries of consignments of products intended to be 
placed on the market within the Union as organic products or in -conversion 
products  and the issuance of the certificate of inspection;  
(b) official  controls on products entering the Union  from  third countries  intended 
to be placed on  the Union  market  as organic products or in -conversion 
products;  and 
(c) action in cases of non -compliance with Regulation (EU) 2018/848 to be taken 
by competent authorities , control authorities and control bodies in third 
countries.   
Article 2  
Definitions  
For the purposes of this Regulation, the following  definitions apply:  
(1) ‘consignment’ means a consignment, as defined in Article 3, point (37), of 
Regulation (EU) 2017/625 , of products intended to be placed on the market within 
the Union as organic products or in -conversion products;  however, in case of org anic 
products and in -conversion products exempted from official controls at border 
control posts in accordance with Delegated Regulation (EU) 2021/xxx (DA SANTE) , 
it means a quantity of products under one or more Combined Nomenclature codes, 
covered by a s ingle certificate of inspection, conveyed by the same means of 
transport and importer from the same third country;  
(2) ‘border control post’ means a border control  post as defined in Article 3, point (38), 
of Regulation (EU) 2017/625;  
(3) ‘designated point of release for free circulation’ means a point of release for free 
circulation designated by a Member State for the performance of official controls on 
organic and in -conversion products exempted from official controls at border control 
posts in accordance with Delegated Regulation (EU) 2021/xxx[ DA SANTE] ;  
                                                 
6 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. 25 ). 
7 Commission Implementing Regulation (EU) 2021/xxx [full title to be copied once the parallel IA is 
finalised ] (OJ L xxx, xxx, p. xxx).  EN 5  EN (4) ‘documentary check’ means a documentary check as defined in Article 3, point (41), 
of Regulation (EU) 2017/625 ;  
(5) ‘identity check’ means an identity check as defined in Article 3, point (42), of 
Regulation (EU) 2017/625;  
(6) ‘physical check’ means a physical check as defined in Article 3, point (43) of 
Regulation (EU) 2017/625 ; 
(7)  ‘qualified electronic seal’ means a qualified electronic seal as defined in  Article 3, 
point ( 27), of Regulation  (EU) No 910/2014 of the European Parliament and of the 
Council8. 
Article 3  
Verification in the third country  
1. The relevant  control authority or control body recognised in accordance with Article 
46 of Regulation (EU) 2018/848 shall verify the consignment in accordance with 
Article 16 of Commission Delegated Regulation (EU) 2021/xxx9. 
2. For the purposes of Article s 48 and 57 of Regulation (EU) 2018/848, t he relevant 
control authority or control body shall verify the consignment with regard to 
compliance with the  requirements laid down in Regulation (EC) No 834/2007 and 
production  standards and control measures accepted as equivalent . That 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.   
3. For the purposes of paragraphs 2 to 5, the relevant control authority or control body 
shall be:  
(a) a control authority or control body as referred to in Article 57 of Regulation 
(EU) 201 8/848 that has been recognised for the products concerned and for the 
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; or  
(b) a control authority or co ntrol body that has been designated by a competent 
authority of a recognised third country as referred to in Article 48 of 
Regulation  (EU) 2018/848  in which the products have their origin, or, where 
applicable, in which the last operation for the purpose o f preparation has been 
carried out . 
4. The verification referred to in paragraph 2 shall be carried out by:  
(a) the control authority or control body of the producer or the processor of the 
product concerned; or  
                                                 
8 Regulation (EU) No 910/2014 of the European Parliament an d of the Council of 23 July 2014 on 
electronic identification and trust services for electronic transactions in the internal market and 
repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73 ). 
9 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 certified organic a nd 
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. xxx).  EN 6  EN (b) where the operator or the group of operators carrying out the last operation for 
the purpose of preparation as defined in Article 3, point (44), of Regulation 
(EU) 2018/848  is different from the producer or processor of the product, the 
control authority or control body of the operator  or the group o f operators  
carrying out the last operation for the purpose of preparation.  
5. The documentary checks referred to in paragraph 2 shall  verify : 
(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 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 by groups of operators  certified in a third 
country by a control authority or control body recognised in  accordance with 
Article 46 or  referred to in Article  57 of Regulation (EU) 2018/848 or by a 
third country recognised in accordance with Article 47 or 48 of Regulation 
(EU) 2018/848, or have  been produced and certified in the Union in 
accordance with that Regulation.  
Those documentary checks shall be based on all relevant documents, including the 
certificate of operators  referred to in  Article 45(1 ), point (b)(i) , of Regulation (EU) 
2018/848 , records of the inspections, the production plan for the product concerned 
and records kept by the operators  or the gr oups of operators , available transport 
documents, commercial and financial documents and any other documents deemed 
relevant by the control authority or control body.  
Article 4  
Issuance of the certificate of inspection  
1. The control authority or control bod y that has verified the consignment in accordance 
with Article 3  shall issue a certificate of inspection in accordance with Article 5 for 
every consignment  before the consignment leaves the third country of export or of 
origin .  
2. Where the control authority  or control body has been recognised in accordance with 
Article 46 of Regulation (EU) 2018/848, it shall issue the certificate of inspection f or 
consignments containing high risk products as referred to  in Article 8 of Delegated 
Regulation (EU) 2021/xxx [DA on controls ] only once it is in possession of the 
complete documentation of the traceability and  it has received and assessed the 
results of the analyses of the samples taken on the consignment  in accordance with 
Article 16(6) of that Delegated Regulation .  EN 7  EN Article 5  
Format of the certificate of inspection and use of TRACES   
1. The control authority or control body shall issue  in the Trade Control and Expert 
System (TRACES ) the certificate of inspection in accordance with the model and the 
notes set out in the Annex and shall complete boxes 1 to 18 of that certificate.  
2. When issuing the certificate of inspection , the control body or control authority shall 
upload into TRACES  all the supporting documents , including the following:  
(a) the results of analyses or tests carried out on the samples taken;   
(b) the commercial and transport documents such as the bill of lading, invoices and 
packaging list and , where the control authority or c ontrol body has been 
recognised in accordance with Article 46 of Regulation (EU) 2018/848,  the 
travel plan as drawn up  in accordance with Article 16(5) of Delegated 
Regulation (EU) 2021/xxx [DA on controls] .  
3. The certificate of inspection shall be issued in  TRACES and shall bear a qualified 
electronic seal . 
If unavailable at  the moment of the issuance, the information relat ing to the number 
of packages referred to in box 13 of the certificate  of inspection  and the information 
referred to in boxes 16 and 17  thereof,  as well as  the documents referred to in 
paragraph 2 , shall  be included or updated in th e certificate of inspection within 10 
days from its issuance and, in any case, before its verification and endorsement by 
the competent  authorit y in accordance  with Article 6 .  
4. The certificate of inspection  shall  be drawn up:  
(a) in the official language or in one of the official languages of the Member State 
of the border control post of entry into the Union, in the case of products 
subject to official controls at border control posts;  
(b) in the official language or in one of the official languages of the Member State 
where the consignment is to be released for free circulation, in the case of 
products exempted from official controls at border control posts in accordan ce 
with Delegated Regulation (EU) 2021/xxxx  [DA SANTE ]. 
5. By way of derogation from paragraph 4 , a Member State may consent to certificates 
being drawn up in another official language of the Union and accompanied, if 
necessary, by an authenticated translatio n. 
Article 6  
Official controls on consignments  
1. The competent authority  at a border control post or at a designated point of release 
for free circulation, as appropriate, shall perform official controls on consignments 
for the verification of compliance with Regulation (EU) 2018/848 as follows:  
(a) documentary check s on all consignments ;  
(b) identity checks carried out randomly; and   
(c) physical checks at a frequency depending on the likelihood of non -compliance 
with Regulation (EU) 2018/848.  EN 8  EN Documentary checks shall  include an examination of the certificate of inspection, of 
all other supporting documents as provided in A rticle 5, and, where applicable , of the 
results of analyses or tests carried out on the samples taken . 
In case a certificate of inspection requires corrections of a purely clerical or editorial 
nature, the competent authority may accept that the control authority or control body 
that has issued the certificate of inspection updates the information in TRACES  by 
replacing the document in accordance with the procedure available in TRACES  
without modifying the information in the initial certificate concerning the 
identification of the consignment, its traceability and the guarantees.  
2. For consignments of high -risk products referred to in Article 8 of Delegated 
Regulation (EU) 2021/xxx [DA on controls] , the competent authority referred to in 
paragraph 1 of this Article shall carry out systematic identity and physical checks, 
take at least one representative sample o f the consignments and check the 
documentation referred to  in Article 16(6) of that Regulation. The competent 
authority shall establish a representative sampling procedure appropriate to the 
category, quantity and packaging of the product.  
3. After the verifi cation as referred to in paragraph 1, and, where applicable, in 
paragraph 2, the competent authority shall take a decision on each consignment. Th e 
decision on the consignment shall be recorded in box 22 of the certificate of 
inspection in accordance with  the model and the notes set out in the Annex and 
indicat e one of the following:  
(a) the consignment can be released for free circulation as  organic;  
(b) the consignment can be released for free circulation  as in-conversion;  
(c) the consignment can be released for fre e circulation as non -organic;  
(d) the consignment cannot be relea sed for free circulation;  
(e) part of the consignment can be released for free circulation  with an extract of 
the certificate of inspection . 
The competent authority shall endorse the certificate of inspection in TRACES with 
a qualified electronic  seal.  
4. For products subject to official controls at border control posts, paragraph 3 shall 
apply in addition to the rules regarding the use of the Common Health Entry 
Document (CHED) by the competent author ities at border control posts in 
accordance with Article 56(3) , point (b)(i) , of Regulation (EU) 2017/625  and at 
control points other than border control posts  in accordance with Commission 
Delegated Regulation (EU) 20 19/212310 and with the rules on decisio ns on 
consignments laid down in Article 55 of Regulation  (EU) 2017/625 . 
5. The decision on consignments taken in accordance with Article 55 of Regulation 
(EU) 2017/625 shall refer to one of the indications referred to in paragraph 3, first 
subparagraph, point s (a) to (d) , of this Article . Where the importer has requested the 
placing under a special custom s procedure referred to in Article 7  of this Regulation , 
by completing box 20 of the certificate of inspection, the decision on consignments 
                                                 
10 Commission Delegated Regulation (EU) 2019/2123 of 10  October 2019 supplementing Regulation 
(EU) 2017/625 of the European Parliament and of the Council as regards rules for the cases where and 
the conditions under which identity checks and physical checks on certain goods may be performed at 
control points a nd documentary checks may be performed at distance from border control posts  (J L 
321, 12.12.2019, p. 64 ). EN 9  EN in accordance with Article 55 of Regulation (EU) 2017/625 shall indicate the 
applicable custom s procedure.  
The decision recorded in the certificate of inspection indicating that the consignment 
or part thereof cannot be released for free circulation shall be notified wi thout delay 
in TRACES to the relevant competent authority  performing official controls in order 
to verify compliance  with the rules referred to in Article 1(2), points (a) to (h) and 
(j), of Regulation (EU) 2017/625 .  
In case the decision taken in  the CHED  in accordance with Article 55 of Regulation 
(EU) 2017/625 indicates that the consignment does not comply with the rules 
referred to in Article 1(2) of that Regulation, the competent authority at the border 
control post shall inform in TRACES the competent  authority that has taken the 
decision in accordance with paragraph 3 of this Article, in order to update the 
certificate of inspection.  In addition, any  competent authority performing official 
controls  in order to verify compliance  with the rules referred  to in Article 1(2), points 
(a) to (h) and (j), of Regulation (EU) 2017/625 shall provide in TRACES any 
relevant information , such as laboratory analysis results,  to the competent authority 
that has taken the decision in accordance with paragraph 3 of this  Article  in order to 
update, if relevant, the certificate of inspection.  
6. In case only part of a consignment is released for free circulation , the consignment 
shall be split into different batches before its release for free circulation. For each of 
the bat ches, the importer shall complete  and submit  in TRACES  an extract of the 
certificate of inspection in accordance with Implementing Regulation (EU ) 
2021/xxxx  [IA COI ]. The competent authority of the Member State where the batch 
is intended to  be released for free circulation shall perform t he verification of the 
batch and shall endorse  the extract of the certificate of inspection  in TRACES  with a 
qualified electronic seal .  
7. For consignments subject to official controls at border control posts  referred to in 
paragraph 4, the custom s authorities shall allow the release for free circulation of the 
consignment  only upon presentation of a duly finalised CHED in accordance with  in 
Article 57(2) , point (b), of Regulation (EU) 2017/625, and of a certif icate of 
inspection endorsed in accordance with Article 6  of this Regulation . 
Article 7  
Special customs procedures  
1. Where  a consignment is placed under a custom s warehous ing or inward processing  
procedure as referred to in Article 2 40(1) and Article 256(3) , point (b), of Regulation 
(EU) No 952/2013  of the European Parliament and of the Council11, and  undergoes 
one or more preparations  as referred to in the second subparagraph  of this paragraph , 
the competent authority  shall verify the consignment in accordan ce with Article 6 of 
this Regulation  before the first preparation is carried out . The reference number of 
the customs declaration by which the goods have been declared for the customs 
warehousing or inward processing procedure shall be indicated by the imp orter in 
box 20 of the certificate of inspection.  
                                                 
11 Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying 
down the Union Customs Code  (OJ L 269 10.10.2013 , p. 1) . EN 10  EN The preparation s referred  to in the first subparagraph shall be limited to the following 
types of operations:  
(a) pack aging or change of pack aging; or  
(b) affixing, removal and altering of labels concerning the presentation of the 
organic production method.  
2. After the preparations referred  to in paragraph  1, the competent authority shall verify 
the consignment and endorse  the certificate of inspection in accordance with Article 
6 prior to the release  of the consig nment for free circulation . 
3. Before the release for free circulation, a consignment may be split into different 
batches  under custom supervision  after the verification and the endorsement of the 
certificate of inspection in accordance with Article 6. The im porter shall complete 
and submit in TRACES an extract of the certificate of inspection in accordance with 
Implementing Regulation (EU) 2021/xxx [IA COI ] for each batch resulting from the 
split.  
4. The competent authority of the Member State where the batch is to be released for 
free circulation shall  perform the verification  of the batch in accordance with Article 
6(1), and shall  endorse the extract of the certificate of inspection  in TRACES with a 
qualified electronic seal .  
5. The preparation and splitting operations referred to in paragraphs 1 and 3 shall be 
carried out in accordance with the relevant provisions set out in Chapters III and IV 
of Regulation (EU) 2018/848.  
Article 8  
Contingency arrang ements for TRACES in case of unavailability and in case of force majeure  
1. Control authorities and control bodies issuing  the certificate of inspection in 
accordance with Article 4  shall maintain available a fillable template of that 
certificate in accordance  with the model set out in the Annex  and of all documents 
required by Regulation (EU) 2018/848 that may be uploaded  in TRAC ES. 
2. Where TRACES or one of its functionalities is continuously unavailable for more 
than 24 hours, its users may use a fill able printed or electronic template, as referred 
to in paragraph 1 , to record and exchange information . 
The control authority or control body  referred to in paragraph 1 shall give a reference 
to each issued certificate and keep a register of the issued cer tificates in 
chronological order to ensure the correspondence with the alphanumeric reference 
given by TRACES once it becomes functional.  
In case paper certificate s of inspection are used, uncertified alterations or erasures 
shall invalidate it.  
3. Once TRACE S or its functionalities become available again, its users shall use the 
information recorded in accordance with paragraph 2 to produce electronically the 
certificate of inspection and  upload  the documents referred in paragraph  1. 
4. Certificates and d ocument s produced in accordance with paragraph 2  shall bear the 
text ‘produced during contingency’.  EN 11  EN 5. In case of an event of force majeure , paragraphs 1 to 4 shall apply. In addition, the 
competent authorities, control  authorities  or control bodies shall inform the 
Commission without delay about such an event and control authorities or control 
bodies shall insert all the necessary details in  TRACES within ten calendar days 
following the end of this event .  
6. Article 5(4) and (5) shall apply mutatis mutandis  to certificates  and d ocuments  
produced in accordance with paragraph 2 of this Article.  
Article 9 
Use of the certificate of inspection and extract of the certificate of inspection by customs 
authorities  
For products subject to official controls at a designated point of release for free circulation in 
accordance with Article 4 of Delegated Regulation  (EU) 2021/xxx  (DA SANTE), the custom s 
authorities shall allow the release for free circulation of a consignment  only upon presentation 
of a certificate of inspection indicating  in box 22 that the consignment can be released for free 
circulation.  
Where the  consignment is split into different batches, the customs authorities shall  require the 
presentation of an extract of the certificate of inspection in accordance with  Implementing 
Regulation (EU) 2021/xxx [IA COI ] indicating in box 1 2 that the batch can be released for 
free circulation.  
Article 10 
Information  to be provided by  a competent authority, control aut hority or control body in a 
third country on suspected  or established non -compliances  on consignments  
1. Where a competent authority , control  authority or control body  in a third country is 
notified by the Commission, after the Commission has received a notification from a 
Member State in accordance with Article 9  of Implementing Regulation (EU) 
2021/xxx  [IA COI ] as regards suspected or established non -compliance affecting the 
integrity of the organic products or in -conversion products in  a consignment, i t shall 
carry out an investigation. The competent authority, control authority or control body 
shall reply to the Commission and the Member State that sent the initial notification  
(notifying Member State) 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 available information and/or 
required by the notifying Member State , using the template set out in Section X  of 
Annex  II to Commission Implementing Regulation (EU) 2021/27912.  
2. The competent authority, control authority or control body shall provide any further 
information requested by a Member State as regards additional actions or measures 
taken.  
                                                 
12 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, 23.7.2021, p. 6).  EN 12  EN The Commission or a Mem ber State may request the competent authority, control 
authority or control body to make a vailable, without delay, the list of all operators  or 
groups of operators  in the organic production chain of which the consignment is part, 
and of their control authorities or control bodies.  
3. Where the control authority or control body  has been recognised in accordance with 
Article 46 of Regulation (EU) 2018/848, Article 21(2)  and (3) of Delegated 
Regulation (EU) 2021/xxx [DA on controls ] shall apply.  
Article 1 1  
Transitional provisions  for paper certificate s of inspection  and extract s thereof  
 
1. By way of derogation from Article 5(3), first subparagraph, until 30 June 2022, the 
certificate of inspection may be issued on paper  after being completed in  TRACES  
and printed. Th at paper ce rtificate  shall meet the following requirements:  
(a) in box 18, it shall bear  the hand signature of the auth orised person of the 
control  authority or control body issuing the certificate and the official stamp ; 
(b) it shall be issued before the consignment to which it relates leaves the third 
country of export or of origin . 
2. By way of derogation from Article 6 (3), until 30 June 2022, the following shall 
apply : 
(a) in case the certificate of inspection is issued on paper in accordance with 
paragraph 1  of this Article , that certificate shall be endorsed on paper with the 
hand signature of the authorised person of the competent authority at the border 
control post or at the designated point of release for free circulation, in boxes 
20 and 22,  as appropriate, after being complet ed in  TRACES  and printed ; 
(b) in case the certificate of inspection is issued in TRACES and bears a qualified 
electronic seal, in accordance with Article 5 (3), first subparagraph,  that 
certificate may be endorsed on paper with the hand signature of the authorised 
person of the competent  authority at the border control post or at the designated 
point of release for free circulation, in boxes 20 and 22, as appropriate, after 
being complet ed in  TRACES  and printed.  
3. Control author ities, control bodies and competent authorities shall verify at ea ch 
stage of issuing,  and endorsement of the certificate of inspection , as appropriate,  that 
the information on the paper certificate of inspection corresponds to the information 
on the certificate  that is  completed  in TRACES.  
In case the information relating to  the number of packages  referred to in box 13 of 
the certificate of inspection or the information in boxes 16 and 17  of that certificate  is 
not completed on the paper certificate  of inspection , or in case such information is 
different from the i nformation completed in the certificate in TRACES, the 
competent authorities shall consider for the purpose of the verification of the 
consignment and of the endorsement of the certificate , only the information 
completed in TRACES.  
4. The paper certificate of inspection referred to in paragraph 1 shall be present ed to the 
competent authority at  the border control post of entry into the Union where the EN 13  EN consignment is subjected to official controls or to the competent authority at the 
designated point of relea se for free circulation , as appropriate.  That competent 
authority shall  return that paper certificate to the  importer .  
5. By way of derogation from Article s 6(6) and 7(4), until 30 June 2022, t he extract of 
the certificate of inspection may be endorsed  on paper, after being completed in  
TRACES  and printed . That paper extract of certificate  shall meet the following 
requirements:  
(a) in box 12, it shall be endorsed on paper with the hand signature of the 
authorised person of the competent authority ; 
(b) it shall bear the hand signature of the consignee of the batch, in box 1 3. 
The competent authority  referred to in point (a) of th e first sub paragraph  shall return 
that paper extract of the certificate to the person that presented it .  
 
Article 1 2 
Repeal  
Regulation (EC) No 1235/2008 is repealed.  
Article 1 3 
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.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN