Commission Implementing Regulation (EU) 2025/1078 of 2 June 2025 establishing a derogation from Implementing Regulation (EU) 2019/2072 concerning the introduction into the Union territory of unrooted cuttings for planting of Calibrachoa spp., Petunia spp. and their hybrids from Guatemala

Official Journal EN of the European Union L series 2025/1078 3.6.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1078 of 2 June 2025 establishing a derogation from Implementing Regulation (EU) 2019/2072 concerning the introduction into the Union territory of unrooted cuttings for planting of Calibrachoaspp., Petuniaspp. and their hybrids from Guatemala 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 42a(1) thereof,

Whereas:

(1) Article 7 in conjunction with point 18 of Annex VI to Commission Implementing Regulation (EU) 2019/2072(2) prohibits the introduction of plants for planting from the family Solanaceae into the Union from certain third countries.

(2) Several Member States have expressed their interest in importing unrooted cuttings for planting of Calibrachoaspp. and Petuniaspp. and their hybrids (‘the specified plants’) from Guatemala, from where trade is currently prohibited.

Those Member States and Guatemala have submitted a technical dossier including the procedures for the production of the specified plants in Guatemala.

(3) In December 2023, the European Food Safety Authority (‘the Authority’) adopted a scientific opinion regarding the risk assessment of unrooted Petuniaand Calibrachoaplants from Guatemala(3).

(4) The Authority identified Bactericera cockerelli(Šulc.), Bemisia tabaciGenn. (non-European population), Chloridea virescens Fabricius, Eotetranychus lewisi (McGregor), Epitrix cucumeris (Harris), Epitrix subcrinita (Lec.), Helicoverpa zea (Boddie), Liriomyza huidobrensis(Blanchard), Liriomyza sativaeBlanchard, Liriomyza trifolii(Burgess),Pepper golden mosaic virus, Pepper huasteco yellow vein virus, Phenacoccus solenopsis Tinsley, Ralstonia pseudosolanacearum Safni et al., Ralstonia solanacearum(Smith) Yabuuchi et al.Emend. Safni et al., Spodoptera ornithogalliGuenée, Squash leaf curl virus, Tomato severe leaf curl virus, Tomato spotted wilt virus, Tomato yellow leaf curl virus and Xanthomonas vescicatoria (ex Doidge) Vauterin et al. as pests relevant for the specified plants.

(5) The Authority evaluated the risk mitigation measures described in the dossier for the identified pests and estimated the likelihood of freedom of the specified plants from those pests.

(6) On the basis of that opinion, the measures necessary to address the risk of those pests should be adopted as phytosanitary import requirements, in order to ensure that the phytosanitary risk from the introduction of the specified plants into the Union is reduced to an acceptable level.

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

(2) 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).

(3) EFSA PLH Panel (EFSA Panel on Plant Health), 2024, Commodity risk assessment of Petunia spp. and Calibrachoa spp. unrooted cuttings from Guatemala (EFSA Journal 2024;22:e8544, https://doi.org/10.2903/j.efsa.2024.8544).

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(7) Bactericera cockerelli (Šulc.), Bemisia tabaci Genn. (non-European population), Eotetranychus lewisi (McGregor), Helicoverpa zea(Boddie), Liriomyza sativaeBlanchard,Pepper golden mosaic virus, Pepper huasteco yellow vein virus, Ralstonia pseudosolanacearumSafni et al., Ralstonia solanacearum(Smith) Yabuuchi et al.Emend. Safni et al.,Squash leaf curl virus and Tomato severe leaf curl virus are listed as Union quarantine pests in Annex II to Implementing Regulation (EU) 2019/2072. Liriomyza huidobrensis(Blanchard) and Liriomyza trifolii(Burgess) are listed as protected zone quarantine pests in Annex III to Implementing Regulation (EU) 2019/2072. Epitrix cucumeris (Harris), Epitrix subcrinita (Lec.) are subject to the measures of Commission Implementing Decision 2012/270/EU(4) and Chloridea virescens Fabricius and Spodoptera ornithogalli Guenée are subject to the measures of Commission Implementing Regulation (EU) 2022/1941(5). Since the specified plants are currently prohibited from entering the Union territory, they are not subject to the special requirements of Annex VII to Implementing Regulation (EU) 2019/2072.

(8) Tomato spotted wilt virus, Tomato yellow leaf curl virus and Xanthomonas vesicatoria (ex Doidge) Vauterin et al. are listed in Annex IV to Implementing Regulation (EU) 2019/2072 as Union regulated non-quarantine pests for commodities other than plants of Petuniaspp. and Calibrachoaspp. As these pests have not been identified as pests causing an economic impact on the production of Petunia spp. and Calibrachoa spp. in the Union territory, they should not be considered as specified pests for the purposes of this Regulation.

(9) Phenacoccus solenopsis Tinsley is not listed as a Union quarantine pest in Annex II to Implementing Regulation

(EU) 2019/2072, and no significant impact has been observed on host plants infected by that pest in the Union territory. Therefore, no import requirements are necessary with respect to that pest.

(10) In order to ensure that the introduction of the specified plants will not present a risk of introduction of specified pests in the Union territory, the plants should be grown from plants originating in the Union territory to prevent the presence of pests in the starting material.

(11) The production of the specified plants should take place in production sites that are approved by the National Plant Protection Organisation (‘the NPPO’) of Guatemala for the production of the specified plants for export to the Union and are identified with a unique traceability code to allow the competent authorities to identify, in case of a finding of a specified pest in a specified plant in the Union territory, the production site from which that specified plant originates.

(12) Moreover, to ensure that the specified plants are free from the specified pests, they should be grown under physical protection and be inspected prior to export.

(13) As symptoms of the presence of the specified pests may not yet be visible on the unrooted cuttings imported into the Union, after import in the Union territory the specified plants should be planted and rooted at the premises of professional operators specifically authorised to issue plant passports for these plants originating in Guatemala or professional operators for whom the competent authorities issue the plant passports, as they are subject to regular official inspections. Professional operators that are to grow or root the specified plants should inform the competent authorities prior of receiving the specified plants in order for the latter to timely plan the official inspections.

(4) Commission Implementing Decision 2012/270/EU of 16 May 2012 as regards emergency measures to prevent the introduction into and the spread within the Union of Epitrix cucumeris (Harris), Epitrix similaris (Gentner), Epitrix subcrinita (Lec.) and Epitrix tuberis

(Gentner) (OJ L 132, 23.5.2012, p. 18, ELI: http://data.europa.eu/eli/dec_impl/2012/270/oj).

(5) Commission Implementing Regulation (EU) 2022/1941 of 13 October 2022 on the prohibition of introduction, movement, holding, multiplication or release of certain pests pursuant to Article 30(1) of Regulation (EU) 2016/2031 of the European Parliament and of the Council (OJ L 268, 14.10.2022, p. 13, ELI: http://data.europa.eu/eli/reg_impl/2022/1941/oj).

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(14) To prevent that the specified plants are moved for the first time to the premises of professional operators who are not authorised to issue plant passports for the specified plants, the importer should present a document issued by the competent authority confirming that the plants are to be moved to the premises of professional operators that, pursuant to Article 89(1) of Regulation (EU) 2016/2031, are specifically authorised to issue plant passports for plants rooted or grown from the specified plants, or to the premises of professional operators for whom the competent authorities issue the plant passports for the specified plants.

(15) As no introduction of the specified plants into the Union territory has taken place up to date and there is no experience with this trade yet, the specified plants present a phytosanitary risk which is not yet fully assessed.

Therefore, the requirements this regulation provides should be of a temporary nature pursuant to Article 42a(1) of Regulation (EU) 2016/2031.

(16) The measures provided for in this Regulation are in accordance with the opinion of the of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 Definitions For the purposes of this Regulation, the following definitions apply:

(1) ‘specified pests’ means Bactericera cockerelli(Šulc.), Bemisia tabaciGenn., Chloridea virescensFabricius, Eotetranychus lewisi

(McGregor), Epitrix cucumeris (Harris), Epitrix subcrinita (Lec.), Helicoverpa zea (Boddie), Liriomyza huidobrensis

(Blanchard), Liriomyza sativae Blanchard, Liriomyza trifolii (Burgess), Pepper golden mosaic virus, Pepper huasteco yellow vein virus, Ralstonia pseudosolanacearumSafni et al., Ralstonia solanacearum(Smith) Yabuuchi et al.Emend. Safni et al., Spodoptera ornithogalliGuenée,Squash leaf curl virus and Tomato severe leaf curl virus;

(2) ‘specified plants’ means unrooted cuttings intended for planting of Calibrachoaspp. and Petuniaspp. and their hybrids, grown in Guatemala and derived in direct line from mother plants imported from the Union.

Article 2 Derogation from the prohibition to introduce the specified plants into the Union territory By way of derogation from point 18 of Annex VI to Implementing Regulation (EU) 2019/2072, the introduction into the Union territory of the specified plants shall be allowed subject to compliance with the requirements set out in Article 3 of this Regulation.

Article 3 Requirements for the introduction of the specified plants into, and their movement within, the Union territory

1. The specified plants may be introduced into the Union only if all of the following requirements are fulfilled:

(a) prior to the start of trade, the National Plant Protection Organisation (NPPO) of Guatemala has communicated in writing to the Commission the list of measures intended to ensure the fulfilment of the requirements set out in point 1 of Annex I;

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(b) the NPPO of Guatemala submits to the Commission by 31 December of each year, the list of production sites, with their traceability codes, that are approved to export the specified plants to the Union the following calendar year, and immediately communicates any amendment to that list;

(c) the NPPO of Guatemala submits to the Commission, by 31 March of each year, an annual report on the activities carried out during the previous calendar year, containing all the elements set out in point 2 of Annex I.

2. In order for the specified plants to be introduced into the Union territory, the importing professional operator shall present a document issued by the competent authority confirming that the professional operator receiving the specified plants fulfils the requirements set out in paragraph 3.

3. Once introduced into the Union, the specified plants may only be moved to:

(a) the premises of professional operators that, pursuant to Article 89(1) of Regulation (EU) 2016/2031, are specifically authorised to issue plant passports for plants rooted or grown from the specified plants; or

(b) the premises of professional operators for whom the competent authorities issue the plant passports for the specified plants.

Prior to receiving the specified plants, the professional operators referred to in the first subparagraph shall inform the competent authorities of the expected date of arrival of those plants and shall keep the traceability code referred to in point 1(c)(iii) of Annex I.

4. Plants that are directly rooted or grown from the specified plants shall be kept separated from any other plant susceptible to the specified pests. They shall be subjected to official inspections at least once before they are moved for the first time out of the premises of the professional operator concerned and as close as possible to the time of their movement.

Those inspections shall include, in case of suspicion of infection, sampling and molecular testing for Pepper golden mosaic virus, Pepper huasteco yellow vein virus, Squash leaf curl virus and Tomato severe leaf curl virus.

In case of findings of specified pests on plants rooted or grown from the specified plants, at least all the plants rooted or grown from the same lot of specified plants shall be immediately destroyed, and if appropriate, the respective premises shall be cleaned and disinfected.

5. Member States shall immediately notify the Commission and the other Member States of any finding of the presence of a specified pest on the specified plants or on plants rooted or grown from the specified plants. The Commission shall immediately inform the NPPO of Guatemala thereof.

Where the NPPO of Guatemala is informed of the presence of a specified pest on specified plants or on plants rooted or grown from the specified plants, the production site from where the specified plants originate shall no longer be approved to export to the Union and the NPPO of Guatemala shall remove immediately that production site from the list of approved production sites referred to in paragraph 1, point (b), until it has been demonstrated that pest freedom has been restored.

Article 4 Amendment to Annex VI to Implementing Regulation (EU) 2019/2072 Annex VI to Implementing Regulation (EU) 2019/2072 is amended in accordance with the text set out in Annex II.

4/8 ELI: http://data.europa.eu/eli/reg_impl/2025/1078/ojEN OJ L, 3.6.2025 Article 5 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 until 30 April 2028.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 2 June 2025.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2025/1078/oj 5/8EN OJ L, 3.6.2025 ANNEX I Requirements referred to in Article 3 for the introduction of the specified plants into the Union territory

1. The specified plants may only be introduced into the Union territory if they fulfil all of the following requirements:

(a) they have been produced in production sites which:

(i) are included by the NPPO of Guatemala in a list of approved production sites recognised as free from the specified pests and allowed to export the specified plants to the Union;

(ii) are identified by a unique traceability code that appears on the list referred to in point (i);

(iii) are physically isolated against insects, with double doors, where the second door only opens after the first door has been completely closed, and have a system in place to ensure hygiene and disinfection procedures for the staff, equipment and all production processes;

(iv) have a system to supply pest-free irrigation water, which is subject to at least two annual official inspections, including molecular testing, to ensure absence of Ralstonia pseudosolanacearum Safni et al., and Ralstonia solanacearum(Smith) Yabuuchi et al.Emend. Safni et al.,;

(v) are entirely dedicated to the production of the specified plants, or other plants fulfilling the requirements of Union legislation on plant health and are subject to a complete cleaning and disinfection before the introduction of new specified plants;

(vi) have shelves to keep the pots at least 50 cm above the ground;

(vii) have a system in place to keep record of all processes, including the lots produced and the procedures to control the specified pests during each production cycle;

(viii) in case of findings of a specified pest, are removed from the list of production sites referred to in point (i) until the pest free situation has been restored and are only then re-approved for the production and export of this material;

(b) they have been:

(i) grown in Guatemala and derived in direct line from mother plants imported from the Union;

(ii) produced using growing media and pots that are either new or subject to treatments to ensure freedom from soil-borne organisms and any specified pests before being used in the production process;

(iii) monitored with traps for the presence of insects by trained staff;

(iv) subject to visual examinations to ensure the absence of the specified pests or their symptoms by trained staff on a weekly basis;

(v) subject, when appropriate, to treatments against pests;

(vi) subject to molecular testing for the detection of Pepper golden mosaic virus, Pepper huasteco yellow vein virus, Squash leaf curl virus, Tomato severe leaf curl virus at least once before the first batch of unrooted cuttings is exported to the Union during that production cycle or after any finding of Bemisia tabaciGenn. in the production site;

(c) prior to export, each lot of specified plants from each production site has been:

(i) subject to an official inspection for the presence of the specified pests, by means of a sampling method allowing to detect at least a level of infestation of 1 %, with a level of confidence of 99 % in accordance with the International Standard for Phytosanitary Measures ISPM 31, including molecular testing for Pepper golden mosaic virus, Pepper huasteco yellow vein virus, Squash leaf curl virus, Tomato severe leaf curl virus in case of suspicion of infection;

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(ii) transported from the production site to the storage, cooling or packaging facilities in the places of production, in such a way as to prevent contamination with the specified pests;

(iii) packed in boxes, where each box includes a label with the traceability code of the production site;

(d) they are accompanied by a phytosanitary certificate, issued by the NPPO of Guatemala, which certifies compliance with the requirements of this Regulation and includes, under the rubric Additional Declaration:

(i) the name(s) of the approved production site(s) from which the plants originate;

(ii) the traceability code(s) of the production site(s) from which the plants originate;

(iii) the statement ‘This consignment meets the requirements laid down in Commission Implementing Regulation (EU) 2025/1078’.

2. The annual report on the activities of the previous calendar year shall include for each production site:

(a) the number of specified plants exported to the Union;

(b) the overview of the official inspections carried out prior to export;

(c) the findings of the presence of the specified pests;

(d) the number of plants destroyed because of a suspicion of infestation or infestation with the specified pests; and

(e) the actions taken to restore pest freedom of the production site and prevent recurrence of the specified pests.

ELI: http://data.europa.eu/eli/reg_impl/2025/1078/oj 7/8EN OJ L, 3.6.2025 ANNEX II In point 18 of Annex VI to Implementing Regulation (EU) 2019/2072, the text of the column ‘Description’ is replaced by

the following: ‘Plants for planting of Solanaceaeother than seeds and the plants covered by entries 15, 16 or 17(*) _____________ (*) Except the following plants: — unrooted cuttings intended for planting of Calibrachoaand Petuniaand their hybrids from Kenya, which may be introduced into the Union subject to the requirements set out in Commission Implementing Regulation (EU) 2025/1082 of 2 June 2025 establishing a derogation from Implementing Regulation (EU) 2019/2072 concerning the introduction into the Union territory of unrooted cuttings for planting of Calibrachoaspp., Petuniaspp. and their hybrids from Kenya (OJ L, 2025/1082,

3.6.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/1082/oj), — unrooted cuttings intended for planting of Calibrachoaand Petuniaand their hybrids from Guatemala, which may be introduced into the Union subject to the requirements set out in Commission Implementing Regulation (EU) 2025/1078 of 2 June 2025 establishing a derogation from Implementing Regulation (EU) 2019/2072 concerning the introduction into the Union territory of unrooted cuttings for planting of Calibrachoa spp., Petunia spp. and their hybrids from Guatemala (OJ L, 2025/1078, 3.6.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/1078/oj).’.

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