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.

(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

(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).