DELEGATED REGULATION EU 2021-2306

02021R2306 — EN — 02.12.2024 — 003.001 

 

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B , COMMISSION DELEGATED REGULATION (EU) 2021/2306of 21 October 2021supplementing 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)(OJ L 461 27.12.2021, p. 13) 

Amended by: 

 Official Journal 

  No, page, date 

M1 , COMMISSION DELEGATED REGULATION (EU) 2022/760 of 8 April 2022,   L 139, 13, 18.5.2022 

M2 , COMMISSION DELEGATED REGULATION (EU) 2022/2238 of 22 August 2022,   L 294, 3, 15.11.2022 

M3 , COMMISSION DELEGATED REGULATION (EU) 2024/2975 of 25 September 2024,   L 2975, 1, 29.11.2024 

 

Corrected by: 

C1 , Corrigendum, OJ L 013, 20.1.2022, p.  76 (2021/2306) 

C2 , Corrigendum, OJ L 068, 3.3.2022, p.  21 (2021/2306) 

C3 , Corrigendum, OJ L 140, 19.5.2022, p.  61 (2021/2306) 

 

B  

COMMISSION DELEGATED REGULATION (EU) 2021/2306 

of 21 October 2021 

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) 

 

 

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 suspected or established 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 organic products and in-conversion products exempted from official controls at border control posts in accordance with Delegated Regulation (EU) 2021/2305, 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 imported 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)  

‘point of release for free circulation’ means a point of release for free circulation where official controls on organic and in-conversion products exempted from official controls at border control posts are carried out in accordance with Delegated Regulation (EU) 2021/2305; 

(4)  

‘control point’ means a control point other than a border control post as referred to in Article 53(1), point (a), of Regulation (EU) 2017/625; 

(5)  

‘documentary check’ means a documentary check as defined in Article 3, point (41), of Regulation (EU) 2017/625; 

(6)  

‘identity check’ means an identity check as defined in Article 3, point (42), of Regulation (EU) 2017/625; 

(7)  

‘physical check’ means a physical check as defined in Article 3, point (43) of Regulation (EU) 2017/625; 

(8)  

‘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 Council ( 1 ). 

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) 2021/1698 ( 2 ).
  2. For the purposes of Articles 48 and 57 of Regulation (EU) 2018/848, the 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) 2018/848 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 control 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 of preparation has been carried out. 

  1. 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 

(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 of operators carrying out the last operation for the purpose of preparation. 

  1. 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 groups 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 body 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 for consignments containing high risk products as referred to in Article 8 of Delegated Regulation (EU) 2021/1698 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.

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, where applicable; 

(b)  

the commercial and transport documents such as the bill of lading, invoices and packaging list and, where the control authority or control 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) 2021/1698. 

  1. 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 relating 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 the certificate of inspection within 10 days from its issuance and, in any case, before its verification and endorsement by the competent authority in accordance with Article 6. 

  1. 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 accordance with Delegated Regulation (EU) 2021/2305. 

  1. 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 translation.

Article 6 

Official controls on consignments 

  1. The competent authority at a border control post or at a 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 checks 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. 

Documentary checks shall include an examination of the certificate of inspection, of all other supporting documents as provided in Article 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. 

  1. M3   For consignments of high-risk products referred to in Article 8 of Delegated Regulation (EU) 2021/1698, the competent authority referred to in paragraph 1 of this Article shall check the documentation referred to in Article 16(6) of that Regulation and carry out identity and physical checks and take at least one representative sample of consignments in accordance with the applicable percentage laid down in the implementing act referred to in Article 8 of Delegated Regulation (EU) 2021/1698. The competent authority shall establish a representative sampling procedure appropriate to the category, quantity and packaging of the product.
  2. After the verification as referred to in paragraph 1, and, where applicable, in paragraph 2, the competent authority shall take a decision on each consignment. The decision on the consignment shall be recorded in box 30 of the certificate of inspection in accordance with the model and the notes set out in the Annex and indicate 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 free circulation as non-organic; 

(d)  

the consignment cannot be released 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. 

  1. For products subject to official controls at border control posts, the following shall apply:

(a)  

paragraph 3 shall apply in addition to the rules regarding the use of the Common Health Entry Document (CHED) by the competent authorities at border control posts in accordance with Article 56(3), point (b)(i), of Regulation (EU) 2017/625 and at control points in accordance with Commission Delegated Regulation (EU) 2019/2123 ( 3 ) and with the rules on decisions on consignments laid down in Article 55 of Regulation (EU) 2017/625; 

(b)  

documentary checks referred to in paragraph 1, point (a), may be performed at distance from border control posts in relation to certain organic products and in-conversion products in accordance with Articles 7 and 8 of Delegated Regulation (EU) 2019/2123; 

(c)  

identity and physical checks referred to in paragraph 1, points (b) and (c), may be performed at control points in relation to certain organic products and in-conversion products in accordance with Articles 2 to 6 of Delegated Regulation (EU) 2019/2123. 

  1. 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, of this Article. Where the importer has requested the placing under a special customs procedure in accordance with Article 7(1) of this Regulation, by completing box 23 of the certificate of inspection, the decision on consignments in accordance with Article 55 of Regulation (EU) 2017/625 shall indicate the applicable customs 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 without 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. 

  1. 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 batches, the importer shall complete and submit in TRACES an extract of the certificate of inspection in accordance with Implementing Regulation (EU) 2021/2307. The competent authority of the Member State where the batch is intended to be released for free circulation shall perform the verification of the batch and shall endorse the extract of the certificate of inspection in TRACES with a qualified electronic seal.
  2. For consignments subject to official controls at border control posts referred to in paragraph 4, the customs 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 certificate of inspection endorsed in accordance with paragraph 6 of this Article indicating 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 a duly finalised CHED in accordance with Article 57(2), point (b), of Regulation (EU) 2017/625, and of an extract of the certificate of inspection in accordance with Implementing Regulation (EU) 2021/2307 indicating in box 12 that the batch can be released for free circulation. 

Article 7 

Special customs procedures 

  1. Where a consignment is placed under a customs warehousing or inward processing procedure as referred to in Article 240(1) and Article 256(3), point (b), of Regulation (EU) No 952/2013 of the European Parliament and of the Council ( 4 ), and undergoes one or more preparations as referred to in the second subparagraph of this paragraph, the competent authority shall verify the consignment in accordance 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 importer in box 23 of the certificate of inspection.

The preparations referred to in the first subparagraph shall be limited to the following types of operations: 

(a)  

packaging or change of packaging; or 

(b)  

affixing, removal and altering of labels concerning the presentation of the organic production method. 

  1. 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 consignment for free circulation.
  2. 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 importer shall complete and submit in TRACES an extract of the certificate of inspection in accordance with Implementing Regulation (EU) 2021/2307 for each batch resulting from the split.
  3. 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 (2), and shall endorse the extract of the certificate of inspection in TRACES with a qualified electronic seal.
  4. 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 arrangements 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 TRACES.
  2. Where TRACES or one of its functionalities is continuously unavailable for more than 24 hours, its users may use a fillable 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 certificates in chronological order to ensure the correspondence with the alphanumeric reference given by TRACES once it becomes functional. 

In case paper certificates of inspection are used, uncertified alterations or erasures shall invalidate it. 

  1. Once TRACES 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.
  2. Certificates and documents produced in accordance with paragraph 2 shall bear the text ‘produced during contingency’.
  3. 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.
  4. Article 5(4) and (5) shall apply mutatis mutandis to certificates and documents 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 point of release for free circulation in accordance with Article 4 of Delegated Regulation (EU) 2021/2305, the customs authorities shall allow the release for free circulation of a consignment only upon presentation of a certificate of inspection indicating in box 30 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) 2021/2307 indicating in box 12 that the batch can be released for free circulation. 

Article 10 

Information to be provided by a competent authority, control authority or control body in a third country on suspected or established non-compliances on consignments 

  1. C2   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 7 of Implementing Regulation (EU) 2021/2307 as regards suspected or established non-compliance affecting the integrity of the organic products or in-conversion products in a consignment, it 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, C3   using the template set out in Annex III to Delegated Regulation (EU) 2021/1698. 
  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.

The Commission or a Member State may request the competent authority, control authority or control body to make available, 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. 

  1. 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) 2021/1698 shall apply.

Article 11 

Transitional provisions for paper certificates of inspection and extracts thereof 

  1. M2   By way of derogation from Article 5(3), first subparagraph, until 30 November 2022, the certificate of inspection may be issued on paper after being completed in TRACES and printed. That paper certificate shall meet the following requirements: 

(a)  

in box 18, it shall bear the hand signature of the authorised 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. 

M2 

1a.   By way of derogation from Article 5(3), first subparagraph, until 30 November 2022, an authorised person located in Ukraine of a control authority or a control body which is not equipped with a qualified electronic seal may produce and submit in TRACES the certificate of inspection in electronic format without the application of a qualified electronic seal in box 18 thereof. Such certificate shall be issued before the consignment to which it relates leaves Ukraine. 

B 

  1. M2   By way of derogation from Article 6(3), until 30 November 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 point of release for free circulation, in boxes 23, 25 and 30, as appropriate, after being completed 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 point of release for free circulation, in boxes 23, 25 and 30, as appropriate, after being completed in TRACES and printed; 

M1 

(c)  

in case the certificate of inspection is produced and submitted in TRACES in electronic format in accordance with paragraph 1a, that certificate shall be endorsed in TRACES with a qualified electronic seal or on paper with the hand signature of the authorised person of the competent authority at the border control post or at the point of release for free circulation, in boxes 23, 25 and 30, as appropriate, after being completed in TRACES and printed. 

B 

  1. Control authorities, control bodies and competent authorities shall verify at each 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 information 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. 

  1. The paper certificate of inspection referred to in paragraph 1 shall be presented to the competent authority at the border control post of entry into the Union where the consignment is subjected to official controls or to the competent authority at the point of release for free circulation, as appropriate. That competent authority shall return that paper certificate to the importer.
  2. M2   By way of derogation from Articles 6(6) and 7(4), until 30 November 2022, the 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 13. 

The competent authority referred to in point (a) of the first subparagraph shall return that paper extract of the certificate to the person that presented it. 

Article 12 

Repeal 

Regulation (EC) No 1235/2008 is repealed. 

However, that Regulation shall continue to apply for the purpose of completing and endorsing pending certificates of inspection issued before 1 January 2022 and pending extracts of certificates of inspection submitted by the importer before 1 January 2022, as well as for the purpose of the declaration of the first consignee or the consignee in the certificate of inspection or the extract of the certificate of inspection. 

Article 13 

Entry into force and application 

This Regulation shall enter into force on the third 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. 

 

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