EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down rules on documents and notifications required for organic and in -
conversion products intended for import into the Union  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down rules on documents and notifications required for organic and in -
conversion products intended for import into the Union  
(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 20 18 on organic production and labelling of organic products and repealing Council 
Regulation ( EC) No 834/20071, and in particular Article  39(2), points (b) and (c), and Article 
43(7) 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.  Therefore , it is 
necessary to lay down detailed rules for certain operators in the U nion in respect of  
consignments  at the entry into the Union and after the release for free  circulation in the 
Union of a consignment or of a part of a consignment. Th ose operators are the 
importers who present the consignment for release for free circulation in the Union 
and the first consignees  and consignees  who will receive the consignment or a part of 
the consignment.   
(2) With a view to  organising a system of official controls on consignments  ensuring 
traceability , the importe r should give prior notification  of the arrival of a consignment 
to the competent authority  and its own control authority or control body by submitting 
the relevant information on the certificate of inspection provided for in Commission 
Delegated Regulatio n (EU) 2021/xxx2 [delegated act on the certificate of inspection to 
be adopted pursuant to 38(8)(a)(ii), 46(7)(b), 48(4) and 57(3) of Regulation (EU) 
2018/848  (DA COI) ].  
(3) In addition, it is necessary to lay down detailed rules with regard to the content of  the 
extract of the certificate of inspection as well as with regard to the technical means by 
which it is to be issued . 
(4) The importer, the first consignee and the consignee should provide the certificate of 
inspection or the extract of the certificate of inspection upon request of the control 
authorities or control bodies. It is necessary to lay down additional obligations as 
regards the information to be included by the importer, the first consignee and the 
                                                 
1 OJ L 150, 14.6.2018, p. 1.  
2 Commission Delegated Regulation (EU) 2021/x xxx of [ date] 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  (OJ L xxx, xxx, p. xxx’ ). EN 2  EN consignee , respectively,  in the description of the organic or in -conversion production 
unit referred to in Article 39(1) , point (d)(i) , of Regulation (EU) 2018/848.  
(5) To ensure that case s of non -compliance are followed up  properly , information on any 
suspected or established non -compliance found during the verification carried out by 
the competent authority of a Member State on a consignment should be shared 
between the Member States and the Commission using the Organic Farming 
Information System.  
(6) In relation to the paper certificate of inspection and to the paper extract of certificate s 
of inspection, endorsed on paper with a hand signature in accordance with Delegated 
Regulation (EU) 2021/ xxx [DA COI ], it is necessary to lay down transitional 
requirements for the use of such a certificate and extracts thereof by the first consignee 
and the consignee , as well as t he requirement for such a certificate and extracts thereof 
to accompany the goods to the premises of the first consignee and of the  consignee.  
(7) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of application of Regu lation (EU) 2018/848.  
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Organic Production Committee,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Subject matter  
This Regulation lays down  rules  on: 
(a) the declarations and commun ications  by importers , first consignees and 
consignees  for the import of  products from third countries  for the purpose of 
placing those products on the market within the Union as organic  products  or 
in-conversion products; and 
(b) the notification by the competent authorities of the Member States of suspected 
or established non-compliance of consignments . 
Article 2 
Definitions  
For the purpose s of this Regulation , the following definitions apply : 
(1) ‘importer’ means a natural or legal person established  in the Union and subject to the 
control system referred to in Regulation (EU) 2018/848 , who presents the 
consignment for release for free circulation in the Union either  on its own , or through 
a representative;  
(2) ‘first consignee’ means a natural or legal p erson established in the Union and subject 
to the control system referred to in Regulation (EU) 2018/848  to whom the 
consignment is delivered by the importer after the release for free circulation and 
who receive s it for further preparation and/or marketin g;  
(3) ‘consignee’ means a natural or legal person established in the Union and subject to 
the control system referred to in Regulation (EU) 2018/848  to whom the batch EN 3  EN obtained from the splitting of a consignment is delivered by the importer after the 
release  for free circulation and who receive s it for further preparation and/or 
marketing;  
(4) ‘consignment’ means a consignment, as defined in Article 3, point (37), of 
Regulation (EU) 2017/625  of the European Parliament and of the Council3, of 
products intended to be placed on the market within the Union as organic products or 
in-conversion products ; however, in case of organic products  and in -conversion 
products exempted from official controls at border control posts in accordance with 
Comm ission Delegated Regulation (EU) 2021/xxx4 (DA SANTE) , it means a 
quantity of products under one or more Combined Nomenclature codes, covered by a 
single certificate of inspection, conveyed by the same means of transport and 
importer from the same third co untry . 
Article 3  
Prior notification of arrival  
1. For each consignment, the importer shall give prior notification of the arrival of the 
consignment  at the  border control post or the point of release for free circulation  by 
completing and submitting in the Tr ade Control and Expert System ( TRACES ) 
referred to in Article 2 , point (36), of Commission Implementing Regulation (EU) 
2019/17155 the relevant part of the certificate of inspection in accordance with the 
model and the notes set out in the Anne x to Delegated Regulation (EU)  2021/xxx 
[DA COI ] to the following entities:  
(a) the competent authority  referred to in Article 6 of  Delegated Regulation (EU) 
2021/xxx [DA COI] ; 
(b) the control authority or control body of the importer.  
2. For each consignment subject to official controls at border control posts, paragraph 1 
shall apply in addition to the requirements on prior notification to the competent 
authorities at the border control posts of arrival of consignments pursuant to  Article 
56(3) , point (a), of Regulation (EU) 2017/625 . 
                                                 
3 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
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 produ cts, 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 a rrival into the Union, the place of official controls for such products and 
amending Commission Delegated Regulations (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 components (the 
IMSOC Regulation)  (OJ L 261, 14.10.2019, p. 37).  EN 4  EN 3. Prior notifications pursuant to  paragraph 1 shall be given  in accordance with the 
minimum time requirements laid down in Commission  Implementing Regulation 
(EU) 2019/10136.  
Article 4  
Certificate of i nspection and extract of the certificate of inspection  
1. The importer and the first consignee shall complete the certificate of inspection in 
TRACES as follows:  
(a) in box 20 on special custom s procedures, the importer shall complete in 
TRACES  all the informatio n, except the inform ation on the verification carried 
out by the relevant competent authority;   
(b) in box 2 1 on the first consignee , the importer shall complete in TRACES the 
information if the information has not been filled in by the control authority or 
control body  in the third country before the verification of the consignment and 
the endorsement of the certificate of inspection  by the competent a uthority ; and  
(c) box 2 3 on the declaration of the first consignee shall be completed  in TRACES  
by the first consignee at the reception of the consi gnment after its release for 
free circulation.  
2. If the decision taken on the consignment in accordance with Article 6(3) of 
Delegated Regulation (EU) 2021/xxx [DA COI]  indicates that the consignment  is to 
be release d for free circulation , the importer shall report the number of the certificate 
of inspection in the customs declaration for release for free circulation as referred to 
in Article 158(1) of Regulation (EU) No 952/2013 of the European Parliament and of 
the Coun cil7. 
3. Where a consignment is split into different batches under customs supervision and 
before the release for free circulation in accordance with Article 6( 6) of Delegated 
Regulation (EU) 2021/xxx [ DA COI ], the importer shall complete and submit an 
extract of the certificate of inspection through TRACES  for each of the batches  in 
accordance with the model and the notes set out in the Annex to this Regulation.  
The same applies if a consignment  is split into different batches  in accordance with 
Articl e 7(3) of Delegated Regulation (EU) 2021/xxx [ DA COI ] after the verification 
and the endorsement of the certificate of inspection  
If the decision in relation to a batch recorded in the extract of the certificate of 
inspection in accordance with Article s 6(6) and 7(4)  of Delegated Regulation (EU) 
2021/xxx [DA COI]  indicates that the batch is to be released for free circula tion, the 
number of the extract of the certificate of inspection shall be  reported in the customs 
declaration for release for free circulation as referred to in Article 158(1) of 
Regulation EU) No 952/ 2013 . 
The consignee shall, at the reception  of a batch , complete  in TRACES box 1 3 of the 
extract of the certificate of inspectio n, confirming whether , at the reception of the 
                                                 
6 Commission Implementing Regulation (EU) 2019/1013  of 16 April 2019 on prior notification on 
consignments of certain categories of animals and goods entering the Union (OJ L 165, 21.6.2019 , p. 
8). 
7 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 2 69 10.10.2013, p. 1) . EN 5  EN batch , the packaging or container and, where relevant, the certificate of inspection 
are in accordance with point 6 of Annex III to Regulation (EU) 2018/848.  
4. The extract of the certificate of inspection shall be drawn up in the official language 
or in one of the official languages of the Member State where the batch is to be 
released for free circulation. A Member State may consent to an extract of the 
certific ates being drawn up in another official language of  the Union and 
accompanied, if necessary, by an authenticated translation.  
Article 5 
Documentary accounts  
Upon request by  the relevant competent authorit y, control authorit y or control bod y, the 
importer , the first consignee  or the consignee  shall  provid e the certificate of inspection or, 
where relevant, the extract of the certificate of inspection in which they are mentioned.  
Article 6 
Description of the production units  and activities  
In the case of an importer declaring the consignment for the release for free circulation , the 
full description of the organic or in-conversion production unit and of the activities  as referred  
to in Article 39(1) , point (d)(i) , of Regulation (EU) 2018/848 shall include:  
(a) the premises;  
(b) the activities, indicating the points of release for free circulation in the Union;  
(c) any other facilities  that the importer intends to use for the storage of the imported 
products pending their delivery to the first consignee; and  
(d) an undertaking to ensure that any facilities that will be used f or the storage of 
imported products are submitted to control, to be carried out either by the control 
authority  or control body  or, whe re these storage facilities are situated in another 
Member State or region, by a control authority  or control body  recogn ised for 
controls in that Member State or region.  
In the case of the first consignee and the consignee , the description  shall include the facilities 
used for the reception of consignments and their storage.  
 Article  7 
Notification  of suspected or established non -compliance   
If during the verification of compliance  of a consignment in accordance with Article 6 of 
Delegated Regulation (EU) 2021/xxx  [DA COI ] cases of suspected or established non -
compliance are identified, the Member  State concerned  shall immediately notify  the 
Commission and the other Member States using  the Organic Farming Information System 
(OFIS) and t he template  set out in Section  4 of Annex II to Commission Implement ing EN 6  EN Regulation (EU) 2021/2798. The Commission shall inform the competent  authority, or where 
relevant, the control authority or control body of the third country  concerned .  
Article  8 
Transitional provisions  for paper certificates of inspection and extracts thereof  
 
1. The paper certificate of inspection  endorsed with a hand signature in accordance with 
Article 11 (2) of Delegated Regulation (EU) 2021/ xxx [DA COI ] and the paper 
extract of the certificate of inspection  endorsed with a hand signature in accordance 
with Article 11 (5) of that Regulation shall accompany the goods to the premises of 
the first consignee  or of the consignee . 
2. Upon reception of the paper  certificate of inspection  referred to in paragraph 1 , the 
first consignee shall verify whether the information reported in th at certificate 
correspo nds to the information completed in that certificate in TRACES .  
In case the information relating to  the number of packages referred to in box 13  of 
the certificate of inspection and the information in boxes 16 and 17  of that certificate  
is not completed i n the paper certificate  of inspection , or in case that information is 
different from  the information  completed in the certificate in TRACES, the first 
consignee shall consider the information completed  in the certificate in TRACES .  
3. After the verific ation referred to in paragraph 2 , the first consignee shall  hand sign 
the paper certificate of inspection  in box 23 and shall send th at certificate  to the 
importer mentioned in box 12  thereof .  
4. The importer  shall keep the paper certificate of in spection referred  in paragraph 3  at 
the disposal of the control authority or the control body for at least two years.  
5. In case of a paper extract of the certificate of inspection  as referred to in paragraph 1 , 
the consignee shall, at the reception of the batch, hand sign that paper extract in box 
13.  
6. The consignee of the batch shall keep the paper extract of the certificate of inspection 
referred to in paragraph 5 at the disposal of the control authorities and/or control 
bodies for at least  two years.  
7. The first consignee or, where relevant, the importer may make a copy of the paper 
certificate of inspection referred to in paragraph 3 for the purpose of info rming the 
control authorities and control bodies in accordance with Article 5. Any such copy 
shall  carry the indication ‘COPY’ printed or stamped thereon.  
8. The consignee  or, where relevant, the importer may make a copy of the paper extract 
of the certificate of inspection  referred to in paragraph 5  for the purpose of informing 
the control authorities and control bodies in accordance with  Article 5. Any such 
copy shall carry the indication ‘COPY’ printed or stamped thereon.  
 
                                                 
8 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 7  EN Article 9 
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 Brusse ls, 
 For the Commission  
 The President  
 Ursula VON DER LEYEN