Commission Delegated Regulation (EU) 2026/1195 of 5 June 2026 supplementing Regulation (EU) 2016/2031 of the European Parliament and of the Council as regards the procedure to conduct the listing of high-risk plants, plant products or other objects

Official Journal EN of the European Union L series 2026/1195 14.8.2026 COMMISSION DELEGATED REGULATION(EU) 2026/1195 of 5 June 2026 supplementing Regulation (EU) 2016/2031 of the European Parliament and of the Council as regards the procedure to conduct the listing of high-risk plants, plant products or other objects THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and

(EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC(1), and in particular Article 42(1a) thereof,

Whereas:

(1) In accordance with Article 42(3) of Regulation (EU) 2016/2031 high-risk plants, plants products and other objects are provisionally listed in the Annex to Commission Implementing Regulation (EU) 2018/2019(2). Their introduction into the Union is prohibited pending a risk assessment.

(2) In accordance with Article 42(1a) of Regulation (EU) 2016/2031, it is appropriate to establish rules setting out the procedure to conduct the listing of high-risk plants, plant products or other objects. Those rules should ensure that the listing is conducted on the basis of a timely, effective and transparent process.

(3) In order for the Commission to decide whether to list plants, plant products or other objects as high-risk plants, plant products or other objects, Member States should submit to the Commission a request indicating the plants, plant products or other objects that they wish to be listed as high-risk plants, plant products or other objects (‘the plants, plant products and other objects concerned’), accompanied by a technical dossier containing the relevant technical and scientific supporting evidence.

(4) It is also appropriate to establish rules concerning the procedure for the listing of high-risk plants, plant products or other objects on the basis of a Commission initiative, where the Commission considers that initiative necessary for addressing a phytosanitary risk. In those cases, the Commission should prepare a technical dossier containing the relevant technical and scientific supporting evidence.

(5) Experience has shown that the following scientific and technical evidence is essential: data on the import, or interest for the import, of the plants, plant products or other object concerned into the Union from third countries; data on the interceptions of plants, plant products or other objects due to the presence of pests associated with those plants, plant products or other objects; data on the production in the Union of the plants, plant products or other objects concerned and other host plants that may be affected by pests; information on the pests hosted by the plants, plant products or other objects concerned; and data demonstrating that the plants, plant products or other objects concerned may present a pest risk of an unacceptable level for the Union territory, when introduced from a third country.

(6) In order to ensure that the technical dossier submitted by a Member State contains the required elements for the preliminary assessment, it is appropriate that the Commission checks its completeness and asks, where necessary, for additional information or clarifications.

(1) OJ L 317, 23.11.2016, p. 4, ELI: http://data.europa.eu/eli/reg/2016/2031/oj.

(2) Commission Implementing Regulation (EU) 2018/2019 of 18 December 2018 establishing a provisional list of high risk plants, plant products or other objects, within the meaning of Article 42 of Regulation (EU) 2016/2031 and a list of plants for which phytosanitary certificates are not required for introduction into the Union, within the meaning of Article 73 of that Regulation (OJ L 323,

19.12.2018, p. 10, ELI: http://data.europa.eu/eli/reg_impl/2018/2019/oj).

ELI: http://data.europa.eu/eli/reg_del/2026/1195/oj 1/4EN OJ L, 14.8.2026

(7) A preliminary assessment group should be established in order to carry out the preliminary assessment of the plants, plant products or other objects concerned. The preliminary assessment group should consist of experts designated by the Member States, experts from the European Food Safety Authority, and from the Commission.

(8) Rules should be established concerning the procedure to conduct the preliminary assessment by the preliminary assessment group, its communication with the requesting Member State, if appropriate, and the publication of the assessment.

(9) Rules should be established concerning the confidential treatment of certain pieces of information, in particular, where that is requested by any person with a legitimate interest, in order to protect the interests of that person from the disclosure of that information. Those pieces of information should comprise the manufacturing or production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of safety; commercial links between a producer or importer and the requesting person, where applicable; and commercial information revealing sourcing, market shares or business strategy of the requesting person,

HAS ADOPTED THIS REGULATION:

Article 1 Subject matter and scope This Regulation lays down the procedure to conduct the listing of high-risk plants, plant products or other objects pursuant to Article 42(1a) of Regulation (EU) 2016/2031. This procedure shall consist of the following elements:

(a) the preparation of the evidence for the assessment of the high-risk plants, plant products or other objects;

(b) the actions to be taken following the receipt of that evidence;

(c) the procedures for that assessment, and

(d) the handling of dossiers concerning confidentiality and data protection.

Article 2 Preparation of the required scientific and technical evidence for the preliminary assessment of high-risk plants, plant products or other objects following a request by Member States

1. In order for plants, plant products or other objects to be listed as high-risk plants, plant products or other objects, a Member State shall submit to the Commission a request indicating the plants, plant products or other objects which are to be listed as high-risk plants, plant products or other objects.

2. Each request under paragraph 1 shall be accompanied by a technical dossier.

3. The technical dossier shall contain at least the following information:

(a) data on the import, or interest for the import, of the plant, plant product or other object concerned into the Union from third countries;

(b) data on interceptions of the plants, plant products and other objects concerned due to the presence of pests associated with those plants, plant products or other objects;

(c) data on the production in the Union of the plants, plant products or other objects concerned, and of other host plants that may be affected by pests hosted by the plant, plant product or other object concerned;

(d) information on the pests hosted by the plants, plant products or other objects concerned;

2/4 ELI: http://data.europa.eu/eli/reg_del/2026/1195/ojEN OJ L, 14.8.2026

(e) data demonstrating that the plant, plant product or other objects concerned may present a pest risk of an unacceptable level for the Union territory due to the likelihood that they host a pest for which the risk is not sufficiently addressed by the requirements set out in Annex VII to Commission Implementing Regulation

(EU) 2019/2072(3);

(f) the contact details of the competent authority and the natural person in the Member State responsible for liaising with the Commission; and

(g) any request to treat certain evidence as confidential.

Article 3 Preparation of the required scientific and technical evidence for the preliminary assessment of high-risk plants, plant products or other objects, on the basis of a Commission initiative Where the Commission considers that it is necessary to address a phytosanitary risk, it shall prepare a technical dossier in support of the listing of certain plants, plant products or other objects as high-risk plants, plant products or other objects.

The technical dossier shall contain at least the evidence listed in points (a) to (e) of Article 2(3).

The Commission shall submit the technical dossier to the preliminary assessment group referred to in Article 5(1).

Article 4 Actions to be taken by the Commission following receipt of the technical dossier submitted by the Member State

1. The Commission shall acknowledge receipt of the technical dossier submitted by the Member State pursuant to Article 2.

2. The Commission shall examine whether the technical dossier includes the evidence listed in Article 2(3) and may ask the Member State for additional information or clarifications, as required by the contents and the subject of that technical dossier.

3. The Commission shall further verify whether confidentiality has been requested in respect of certain pieces of evidence.

4. Where the requirements set out in paragraphs 1, 2 and 3 are fulfilled, the Commission shall submit the technical dossier of the Member State to the preliminary assessment group referred to in Article 5(1).

Article 5 Procedure for the preliminary assessment referred to in Article 42(1) of Regulation (EU) 2016/2031

1. The Commission shall establish without delay a group of experts responsible for conducting the preliminary assessment referred to in Article 42(1) of Regulation (EU) 2016/2031 (‘the preliminary assessment group’).

The preliminary assessment group shall consist of experts designated by the Member States, experts from the European Food Safety Authority, and from the Commission.

(3) Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation

(EU) 2018/2019 (OJ L 319, 10.12.2019, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2019/2072/oj).

ELI: http://data.europa.eu/eli/reg_del/2026/1195/oj 3/4EN OJ L, 14.8.2026 The preliminary assessment group may ask the Member State concerned or the Commission for additional information or clarifications, as required by the contents and the subject of their technical dossier.

The preliminary assessment group shall assess the phytosanitary risk of the plants, plant products or other objects concerned. The preliminary assessment group shall complete the preliminary assessment within a reasonable period of time. The Commission shall make that assessment available to the Member States.

2. On the basis of that preliminary assessment, the Commission shall add, or shall decide not to add, the respective plants, plant products or other objects to the list of high-risk plants, plant products or other objects set out in the Annex to Implementing Regulation (EU) 2018/2019.

Article 6 Confidentiality The members of the preliminary assessment group shall not make public any confidential information. In assessing whether the information is confidential, account shall be taken of whether a person with a legitimate interest (‘requesting person’) requested confidential treatment. That assessment shall take place without prejudice to the national rules on protection of confidential information.

The obligation not to make public confidential information shall concern the following pieces of information, where the disclosure of such information may potentially harm the competitive position or any other interest of the requesting

person:

(a) the manufacturing or production process, including the method thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of safety;

(b) commercial links between a producer or importer and the requesting person, where applicable;

(c) commercial information revealing sourcing, market shares or business strategy of the requesting person.

Article 7 Entry into force This Regulation shall enter into force on the twentieth 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, 5 June 2026.

For the Commission The President Ursula VON DER LEYEN 4/4 ELI: http://data.europa.eu/eli/reg_del/2026/1195/oj