Date: 2025-12-23Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2025/2651 of 16 October 2025 amending Delegated Regulation (EU) 2021/1698 as regards certain criteria for the establishment of the list of high-risk third countries and high-risk products
Issued by European Commission
· Directorate-General for Agriculture and Rural Development
**Executive Summary**
This document is Commission Delegated Regulation (EU) 2025/2651, dated October 16, 2025, amending Delegated Regulation (EU) 2021/1698 regarding criteria for establishing a list of high-risk third countries and high-risk products related to organic production. The amendment focuses on including suspected non-compliance cases in the criteria for listing high-risk products. This regulation enters into force three days after its publication in the Official Journal of the European Union.
**Key Points / Main Content**
* **Purpose of the Regulation:**
* Amends Delegated Regulation (EU) 2021/1698 regarding the listing of high-risk third countries and high-risk products.
* **Amendment to Article 8 of Delegated Regulation (EU) 2021/1698:**
* The list of high-risk products and originating third countries will be established considering major, critical, or repetitive non-compliances *and suspicions* of such non-compliances that affect the integrity of organic or in-conversion products or production.
* The shares of consignments of high-risk products to be subject to identity and physical checks and sampling can be lower than 100%.
* These shares may differ for controls by control authorities and control bodies in third countries for the same product.
* **Entry into Force:**
* The regulation enters into force on the third day following its publication in the Official Journal of the European Union.
**Impact Analysis**
**Stakeholder: Control Authorities and Control Bodies**
* **Impact:** They will need to consider both established and suspected cases of non-compliance when identifying high-risk products and third countries. They will need to adapt their sampling strategies to account for potentially variable inspection rates.
* **Action Required:** Update procedures to include evaluation of suspected non-compliance and implement variable inspection rates for high-risk products based on the new criteria.
**Stakeholder: Operators in Third Countries**
* **Impact:** Operators in third countries may face increased scrutiny and potential listing of their products and countries as high-risk based on suspected non-compliance, leading to increased checks and potential trade restrictions.
* **Action Required:** Ensure robust compliance with organic production standards to avoid suspicion of non-compliance and potential listing.
**Stakeholder: European Commission**
* **Impact:** The Commission is responsible for adopting implementing acts to list high-risk countries and products, and this regulation modifies the criteria on which they are to make that decision.
* **Action Required:** Update the criteria for the implementing acts on high-risk countries and products based on the amended regulation.
**Stakeholder: EU Member States**
* **Impact:** Implementation and enforcement of the new regulation.
* **Action Required:** Adapt monitoring and reporting activities to align with the new procedures.
Key Entities Referenced
Regulation (EU) 2018/848: Regulation on organic production and labeling of organic products.
Delegated Regulation (EU) 2021/1698: Regulation supplementing Regulation (EU) 2018/848 with procedural requirements for the recognition of control authorities and control bodies.
Commission Delegated Regulation (EU) 2025/2651: Regulation amending Delegated Regulation (EU) 2021/1698 regarding criteria for establishing the list of high-risk third countries and products.
Organic Farming Information System (OFIS): System used for notification and investigation of non-compliance in organic farming.
Third Countries: Countries outside the European Union that are relevant due to the origin of high-risk products.
Official Journal EN
of the European Union L series
2025/2651 23.12.2025
COMMISSION DELEGATED REGULATION(EU) 2025/2651
of 16 October 2025
amending Delegated Regulation (EU) 2021/1698 as regards certain criteria for the establishment of
the list of high-risk third countries and high-risk products
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(1), and in particular
Article 46(7), point (b)(ii), thereof,
Whereas:
(1) Commission Delegated Regulation (EU) 2021/1698(2) lays down provisions dealing with controls on operators in
third countries carried out by control authorities and control bodies recognised pursuant to Article 46(1) of
Regulation (EU) 2018/848 and establishes the rules on the verification of the consignments intended for import into
the Union to be carried out by those control authorities and control bodies.
(2) Pursuant to Article 8 of Delegated Regulation (EU) 2021/1698, high-risk products originating from third countries
are to be listed in an implementing act adopted in accordance with Article 46(8) of Regulation (EU) 2018/848 on
the basis of a selection made after major, critical or repetitive cases of non-compliance affecting the integrity of
organic or in-conversion products or their production.
(3) The list of high-risk products may therefore currently be established only on the basis of established cases of non-
compliance affecting the integrity of organic or in-conversion products at any stage of production, preparation and
distribution.
(4) Article 46(8) of Regulation (EU) 2018/848 provides that the Commission may adopt implementing acts to ensure the
application of the measures to be taken in relation to cases of both established and suspected non-compliance.
(5) A specific organic or in-conversion product and its third country of origin should be inserted in the list of high-risk
products where this product has been involved in major, critical or repetitive cases of non-compliance with
Regulation (EU) 2018/848 and that those cases have been established by the control authority or the control body
as non-compliances affecting the integrity of the product. Article 22(3) of Delegated Regulation (EU) 2021/1698
lays down criteria for the classification of a non-compliance as major, critical or repetitive non-compliance.
(6) Many suspected cases of non-compliance affecting the integrity of organic or in-conversion products never become
established. The reason is that the control authority or control body carrying out an investigation in the third
country concerned upon notification by a Member State in the Organic Farming Information System (OFIS) cannot
substantiate the cases due to a lack of sufficient information on the source or the cause of the contamination, but
where suspicion nevertheless persists.
(7) It is therefore appropriate that the high-risk products and the third countries in which they originate should be listed
on the basis of a selection made after both established and suspected major, critical or repetitive cases of non-
compliance that affect the integrity of organic or in-conversion products or production.
(1) OJ L 150, 14.6.2018, p. 1, ELI: http://data.europa.eu/eli/reg/2018/848/oj.
(2) Commission Delegated Regulation (EU) 2021/1698 of 13 July 2021 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 and groups of operators certified organic and 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 336, 23.9.2021, p. 7, ELI: http://data.europa.eu/eli/reg_del/2021/1698/oj).
ELI: http://data.europa.eu/eli/reg_del/2025/2651/oj 1/2EN
OJ L, 23.12.2025
(8) Delegated Regulation (EU) 2021/1698 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
Amendment to Delegated Regulation (EU) 2021/1698
Article 8 of Delegated Regulation (EU) 2021/1698 is replaced by the following:
‘Article 8
List of high-risk third countries and high-risk products
High-risk products and the third countries in which they originate shall be listed together with the shares of consignments
of those products to be subject to identity and physical checks and sampling by control authorities and control bodies in
third countries, in an implementing act adopted in accordance with Article 46(8) of Regulation (EU) 2018/848 on the
basis of a selection made after major, critical or repetitive non-compliances affecting the integrity of organic or
in-conversion products or production, or the suspicion thereof.
The shares referred to in the first paragraph can be lower than 100 % and may, for the same product, be different for
controls by control authorities and control bodies in third countries.’.
Article 2
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 October 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/reg_del/2025/2651/oj