Commission Implementing Regulation (EU) 2021/1378 of 19 August 2021 laying down certain rules concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic and in-conversion products into the Union and establishing the list of recognised control authorities and control bodies in accordance with Regulation (EU) 2018/848 of the European Parliament and of the Council (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2021/1378@2021-08-19/en
Contents
- Preamble
- ANNEX
- ANNEX I MODEL OF THE CERTIFICATE CERTIFICATE FOR OPERATORS, GROUPS OF OPERATORS AND EXPORTERS IN THIRD COUNTRIES FOR PRODUCTS TO BE IMPORTED INTO THE EUROPEAN UNION AS ORGANIC PRODUCTS OR IN-CONVERSION PRODUCTS
- Part I Mandatory elements 1.2.3.4.5.6.7.8.9.10.
- (a) ☐
- (b) ☐
- (c) ☐
- (d) ☐
- (e) ☐
- (f) ☐
- (g) ☐
- ☐
- Part II Specific optional elements 1.2.3.4.5.6.7.8.
- ANNEX II List of control authorities and control bodies recognised in accordance with Article 46 of Regulation (EU) 2018/848
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007, and in particular Articles 45(4) and 46(1) thereof,
Whereas:
(1) In accordance with point (b)(i) of 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 in-conversion product, if operators and groups of operators, including exporters in the third country concerned, have been subject to controls by control authorities or control bodies recognised in accordance with Article 46 of that Regulation, and those authorities or bodies have provided all such operators, groups of operators and exporters with a certificate confirming that they comply with Regulation (EU) 2018/848.
(2) In order to give effect to point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, the content of the certificate referred to in that provision should be specified, as well as the technical means by which it is to be issued.
(3) In addition, for the purposes of point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, it is appropriate to establish in this Regulation the list of recognised control authorities and control bodies that are competent to carry out those controls and to issue that certificate in third countries.
(4) In the interest of clarity and legal certainty, this Regulation should apply from the date of application of Regulation (EU) 2018/848.
(5) The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee,
HAS ADOPTED THIS REGULATION:
Article 1 Certificate for operators, groups of operators and exporters in third countries
Control authorities and control bodies that have been recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 shall provide operators, groups of operators and exporters in third countries that have been subject to the controls referred to in point (b)(i) of Article 45(1) of that Regulation with a certificate confirming that such operators, groups of operators and exporters comply with Regulation (EU) 2018/848 (the certificate). The certificate shall:
(a) be issued in electronic form, in accordance with the model set out in Annex I to this Regulation, and by using the electronic Trade Control and Expert System (TRACES) referred to in point (36) of Article 2 of Commission Implementing Regulation (EU) 2019/1715;
(b) allow the identification of:
(i) the operator, group of operators or exporter covered by the certificate, including the list of members of a group of operators;
(ii) the category of products covered by the certificate, classified in the same way as provided for in Article 35(7) of Regulation (EU) 2018/848; and
(iii) its period of validity;
(c) certify that the activity of the operator, group of operators or exporter complies with Regulation (EU) 2018/848; and
(d) be updated whenever changes occur concerning the data included in it.
Article 2 List of recognised control authorities and control bodies
1. The list of control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 is set out in Annex II to this Regulation. The list shall contain the following information on each recognised control authority or control body:
(a) the name and code number of the control authority or control body;
(b) the product categories, as set out in Article 35(7) of Regulation (EU) 2018/848, for each third country;
(c) the third countries in which the product categories have their origin, provided that those third countries are not already covered for the product category or product concerned by an agreement on trade in organic products in accordance with Article 47 of Regulation (EU) 2018/848 or through an equivalence recognition in accordance with Article 48 of that Regulation;
(d) the duration of the recognition; and
(e) the exceptions to the recognition, where appropriate.
2. Detailed information relating to the mailing address, website address and email contact point of the control authority or control body, as well as the name of the accreditation body granting the accreditation in accordance with point (d) of Article 46(2) of Regulation (EU) 2018/848, shall be publicly available via the Commission organic farming website.
Article 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, 19 August 2021. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX I MODEL OF THE CERTIFICATE CERTIFICATE FOR OPERATORS, GROUPS OF OPERATORS AND EXPORTERS IN THIRD COUNTRIES FOR PRODUCTS TO BE IMPORTED INTO THE EUROPEAN UNION AS ORGANIC PRODUCTS OR IN-CONVERSION PRODUCTS
Part I Mandatory elements 1.2.3.4.5.6.7.8.9.10.
Document number (choose as appropriate) Name and address of the operator, group of operators or exporter: Name, address and code number of the control authority or control body of the operator, group of operators or exporter: Activity or activities of the operator, group of operators or exporter (choose as appropriate): Category or categories of products as referred to in Article 35(7) of Regulation (EU) 2018/848 of the European Parliament and of the Council and production methods (choose as appropriate): Directory of products: Name of the product and/or Combined Nomenclature (CN) code as referred to in Council Regulation (EEC) No 2658/87 for products within the scope of Regulation (EU) 2018/848 This document has been issued in accordance with Commission Implementing Regulation (EU) 2021/1378 to certify that the operator, group of operators or exporter (choose as appropriate) complies with Regulation (EU) 2018/848. Date, place Name and signature on behalf of the issuing control authority or control body: Certificate valid from………. [insert date] to..………[insert date] List of members of the group of operators as defined in Article 36 of Regulation (EU) 2018/848 Name of member Address or other form of member identification
Operator
Group of operators – see point 10
Exporter
Production
Preparation
Distribution
Storing
Import
Export
Mandatory elements 1.2.3.4.5.6.
(a) unprocessed plants and plant products, including seeds and other plant reproductive material Production method:
(a) ☐
organic production excluding during the conversion period
production during the conversion period
organic production with non-organic production
(b) livestock and unprocessed livestock products Production method:
(b) ☐
organic production excluding during the conversion period
production during the conversion period
organic production with non-organic production
(c) algae and unprocessed aquaculture products Production method:
(c) ☐
organic production excluding during the conversion period
production during the conversion period
organic production with non-organic production
(d) processed agricultural products, including aquaculture products, for use as food Production method:
(d) ☐
production of organic products
production of in-conversion products
organic production with non-organic production
(e) feed Production method:
(e) ☐
production of organic products
production of in-conversion products
organic production with non-organic production
(f) wine Production method:
(f) ☐
production of organic products
production of in-conversion products
organic production with non-organic production
(g) other products listed in Annex I to Regulation (EU) 2018/848 or not covered by the previous categories Production method:
(g) ☐
production of organic products
production of in-conversion products
organic production with non-organic production
Mandatory elements 1.2.3.4.5.6.7.
☐
Organic
In-conversion
Part II Specific optional elements 1.2.3.4.5.6.7.8.
One or more elements to be completed if so decided by the control authority or control body that issues the certificate to the operator, group of operators or exporter in accordance with Implementing Regulation (EU) 2021/1378 Quantity of products Name of the product and/or CN code as referred to in Regulation (EEC) No 2658/87 for products within the scope of Regulation (EU) 2018/848. ☐ Organic ☐ In-conversion Quantity estimated in kilograms, litres or, where relevant, in number of units. Information on the land Name of the product ☐ Organic ☐ In-conversion ☐ Non-organic Surface in hectares List of premises or units where the activity is performed by the operator or group of operators Address or geolocation Description of the activity or activities as referred to in point 5 of part I Information on the activity or activities carried out by the operator or group of operators and whether the activity is, or the activities are performed for their own purpose or as a subcontractor carrying out the activity or activities for another operator, while the subcontractor remains responsible for the activity or activities performed Description of the activity or activities as referred to in point 5 of part I ☐ Carrying out activity/activities for own purpose ☐ Carrying out activity/activities as a subcontractor for another operator, while the subcontractor remains responsible for the activity or activities performed Information on the activity or activities carried out by the subcontracted third party Description of the activity or activities as referred to in point 5 of part I ☐ Operator or group of operators remains responsible ☐ Subcontracted third party is responsible List of subcontractors carrying out an activity or activities for the operator or group of operators for which the operator or group of operators remains responsible as regards organic production and for which it has not transferred that responsibility to the subcontractor Name and address Description of the activity or activities as referred to in point 5 of part I Information on the accreditation of the control body in accordance with point (d) of Article 46(2) of Regulation (EU) 2018/848 Other information
Specific optional elements 1.2.3.4.5.6.7.
(a) name of the accreditation body;
(b) hyperlink to the accreditation certificate.
ANNEX II List of control authorities and control bodies recognised in accordance with Article 46 of Regulation (EU) 2018/848
For the purposes of this Annex, the product categories are designated by the following codes: A unprocessed plants and plant products, including seeds and other plant reproductive material; B livestock and unprocessed livestock products; C algae and unprocessed aquaculture products; D processed agricultural products, including aquaculture products, for use as food; E feed; F wine; G other products listed in Annex I to Regulation (EU) 2018/848 or not covered by the previous categories. Information relating to the mailing address, website address and email contact point of the control authority or control body, as well as the name of the accreditation body granting its accreditation, can be found on the Commission organic farming website. Name of the control authority or control body:
1. Code numbers, third countries and product categories concerned Code number Third country Category of products XX-BIO-XXX A B C D E F G
2. Duration of the recognition:
3. Exceptions:
Versions
Cited by
- Commission Implementing Regulation (eu) 2025/2138 of 21 October 2025 amending Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Annex II to Commission Implementing Regulation (EU) 2021/1378 contains the list of control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union in accordance with Article 45(1), point (b)(i), of that Regulation.
- Commission Implementing Regulation (eu) 2025/2138 of 21 October 2025 amending Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Implementing Regulation (EU) 2021/1378 should therefore be amended accordingly.
- Commission Implementing Regulation (eu) 2025/2138 of 21 October 2025 amending Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Annex II to Implementing Regulation (EU) 2021/1378 is amended in accordance with the Annex to this Regulation.
- Commission Implementing Regulation (eu) 2025/2138 of 21 October 2025 amending Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
The third paragraph of Annex II to Implementing Regulation (EU) 2021/1378 is amended as follows:
- Commission Implementing Regulation (EU) 2025/882 of 14 May 2025 amending Commission Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Annex II to Commission Implementing Regulation (EU) 2021/1378 contains the list of control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union in accordance with Article 45(1), point (b)(i), of that Regulation.
- Commission Implementing Regulation (EU) 2025/882 of 14 May 2025 amending Commission Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
The Commission acknowledges receipt of notification from Balkan Biocert Macedonia DOOEL Skopje of its intention to voluntarily relinquish its recognition. Based on this notification, the Commission has concluded that it is appropriate to remove this control body from the list of recognised control bodies set out in Annex II to Implementing Regulation (EU) 2021/1378.
- Commission Implementing Regulation (EU) 2025/882 of 14 May 2025 amending Commission Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Commission Implementing Regulation (EU) 2025/883 extended the scope of the recognition of Japan for the purposes of equivalence to live animals and unprocessed animal products as well as to all processed agricultural products for use as food, including wine and alcoholic beverages, with organically grown ingredients that have been grown in Japan, or imported into Japan from the European Union, from third countries whose production methods and control measures have been recognised by Japan as equivalent to those laid down in the Japanese legislation, or from third countries through the system o
- Commission Implementing Regulation (EU) 2025/882 of 14 May 2025 amending Commission Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Implementing Regulation (EU) 2021/1378 should therefore be amended accordingly.
- Commission Implementing Regulation (EU) 2025/882 of 14 May 2025 amending Commission Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Annex II to Implementing Regulation (EU) 2021/1378 is amended in accordance with the Annex to this Regulation.
- Commission Implementing Regulation (EU) 2025/882 of 14 May 2025 amending Commission Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
The third paragraph of Annex II to Implementing Regulation (EU) 2021/1378 is amended as follows:
- Commission Implementing Regulation (EU) 2021/1378 of 19 August 2021 laying down certain rules concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic and in-conversion products into the Union and establishing the list of recognised control authorities and control bodies in accordance with Regulation (EU) 2018/848 of the European Parliament and of the Council (Text with EEA relevance) Regulation · Grade B
Document number (choose as appropriate) Name and address of the operator, group of operators or exporter: Name, address and code number of the control authority or control body of the operator, group of operators or exporter: Activity or activities of the operator, group of operators or exporter (choose as appropriate): Category or categories of products as referred to in Article 35(7) of Regulation (EU) 2018/848 of the European Parliament and of the Council and production methods (choose as appropriate): Directory of products: Name of the product and/or Combined Nomenclature (CN) code as refe
- Commission Implementing Regulation (EU) 2021/1378 of 19 August 2021 laying down certain rules concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic and in-conversion products into the Union and establishing the list of recognised control authorities and control bodies in accordance with Regulation (EU) 2018/848 of the European Parliament and of the Council (Text with EEA relevance) Regulation · Grade B
One or more elements to be completed if so decided by the control authority or control body that issues the certificate to the operator, group of operators or exporter in accordance with Implementing Regulation (EU) 2021/1378 Quantity of products Name of the product and/or CN code as referred to in Regulation (EEC) No 2658/87 for products within the scope of Regulation (EU) 2018/848. ☐ Organic ☐ In-conversion Quantity estimated in kilograms, litres or, where relevant, in number of units. Information on the land Name of the product ☐ Organic ☐ In-conversion ☐ Non-organic Surface in hectares Lis
- Commission Implementing Regulation (EU) 2021/2307 of 21 October 2021 laying down rules on documents and notifications required for organic and in-conversion products intended for import into the Union (Text with EEA relevance) Regulation · Grade B
the category of the product in accordance with Annex II to Commission Implementing Regulation (EU) 2021/1378;
- Corrigendum to Commission Implementing Regulation (EU) 2025/882 of 14 May 2025 amending Commission Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Official Journal of the European Union L, 2025/882, 15 May 2025) Corrigendum · Grade B
On page 4, in point (4) of the Annex, in the third paragraph of Annex II to Implementing Regulation (EU) 2021/1378, in the entry for Bio Latina Certificadora: for: Code numbers, third countries and product categories concerned: Code number Third country Category of products A B C D E F G BO-BIO-108 Bolivia x x — x — — — CO-BIO-108 Colombia x — — x — — — SV-BIO-108 El Salvador x — — x — — — GT-BIO-108 Guatemala x — — x — — — HN-BIO-108 Honduras x — — x — — — NI-BIO-108 Nicaragua x x — x — — — PA-BIO-108 Panama x — — x — — — PE-BIO-108 Peru x — — x — — — VE-BIO-108 Venezuela x — — x — — — read:
- 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) Regulation · Grade B
the category of the product in accordance with Annex II to Commission Implementing Regulation (EU) 2021/1378;
- Commission Implementing Regulation (EU) 2024/2140 of 6 August 2024 amending and correcting Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Annex II to Commission Implementing Regulation (EU) 2021/1378 was adopted to contain the list of control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union in accordance with Article 45(1), point (b)(i), of that Regulation.
- Commission Implementing Regulation (EU) 2024/2140 of 6 August 2024 amending and correcting Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Since the adoption of Implementing Regulation (EU) 2021/1378, the Commission has received requests for recognition, submitted in accordance with Article 46(4) of Regulation (EU) 2018/848, from a number of control bodies.
- Commission Implementing Regulation (EU) 2024/2140 of 6 August 2024 amending and correcting Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Commission Implementing Regulation (EU) 2024/1748 amended Implementing Regulation (EU) 2021/1378 and provided for the recognition of, among others, the control bodies CCPB Srl and ECOGLOBE LLC for certain third countries and product categories. However, the recognition of CCPB Srl erroneously did not include Armenia for product category G and the recognition of ECOGLOBE LLC erroneously did not include Armenia for product category G and Uzbekistan for product category B. Those errors should therefore be corrected.
- Commission Implementing Regulation (EU) 2024/2140 of 6 August 2024 amending and correcting Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Implementing Regulation (EU) 2021/1378 should therefore be amended and corrected accordingly.
- Commission Implementing Regulation (EU) 2024/2140 of 6 August 2024 amending and correcting Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union (Text with EEA relevance) Regulation · Grade B
Annex II to Implementing Regulation (EU) 2021/1378 is amended in accordance with Annex I to this Regulation.