Commission Implementing Regulation (EU) 2025/1289

Contents

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^note, and in particular Article 42a(1) thereof,Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)^note, and in particular Article 52 thereof,Whereas:

(1)Commission Implementing Decision 2011/787/EU^note authorises Member States to temporarily take emergency measures against the dissemination of Ralstonia solanacearum (Smith) Yabuuchi et al. emend. Safni et al. (‘the specified pest’) as regards the import of tubers of Solanum tuberosum L., other than those intended for planting, originating in Egypt (‘the specified plants’). That Implementing Decision was adopted on the basis of Article 16(3) of Council Directive 2000/29/EC^note.

(2)Regulation (EU) 2016/2031 has replaced Directive 2000/29/EC, while Commission Implementing Regulation (EU) 2019/2072^note has replaced Annexes I to V to that Directive.

(3)The specified pest is listed in Part B of Annex II to Implementing Regulation (EU) 2019/2072 as a pest known to occur in the Union. The introduction into the Union territory of the specified plants is subject to the special requirement of point 21 of Annex VII to that Regulation with regard to the specified pest and other species of Ralstonia.

(4)There is evidence justifying the adoption of requirements more stringent than the ones referred to in point 21 of Annex VII to Implementing Regulation (EU) 2019/2072 and the requirements of Implementing Decision 2011/787/EU, with respect to the specified pest. That evidence is based on the experience gained from the application of that Decision, the increased number of interceptions of the specified pest during the two last import seasons of the specified plants and an audit carried out by the Commission in Egypt in January 2024.

(5)Further assessment by the Commission has shown that the specified plants pose a risk that can be reduced to an acceptable level by applying measures which are necessary to address the phytosanitary risk concerned. That assessment took into account, inter alia, the technical developments in the fields in Egypt, the testing schemes based on the new diagnostic protocols developed for the specified pest by the European and Mediterranean Plant Protection Organisation (EPPO) and the experience of Member States with the import controls of the specified plants.

(6)In order to ensure the reduction to an acceptable level of the phytosanitary risk from the introduction into the Union territory of the specified plants, it is necessary to establish specific requirements for the production, packaging and inspections of the specified plants in Egypt.

(7)Due to the nature of the specified pest, it is necessary, for the phytosanitary protection of the Union territory, to provide that the specified plants introduced into the Union territory have to be grown in production sites officially declared by the National Plant Protection Organisation (NPPO) of Egypt to be free from the specified pest, in accordance with the relevant International Standard for Phytosanitary Measures. For the same reason, it should be ensured that in those sites, during the year of production and the three previous years, no specified plants or other vegetative parts of potato plants, and no other cultivated or wild solanaceous host plants capable to host the specified pest have been found infected by the specified pest, and no related water sources have been found contaminated by the specified pest. Moreover, it is necessary to provide that no specified plants originating from those production sites have been found positive after testing for the presence of the specified pest by the NPPO of Egypt or Member States, after leaving those production sites.

(8)Those requirements should ensure the production of the specified plants in areas free from the specified pest, and in areas where actions have been taken to prevent the presence of that pest. They should further ensure that the specified plants are grown from plants that fulfil certain requirements concerning their freedom from the specified pest.

(9)The phytosanitary certificate for introduction into the Union of the specified plants should include, under the heading ‘Additional declaration’, certain elements to ensure transparent information and clarity about the origin of the specified plants and fulfilment of the respective requirements. Those elements should include the statement ‘In accordance with European Union requirements laid down in Commission Implementing Regulation (EU) 2025/1289’, the lot number corresponding to each exported lot of the specified plants, the code of the production site of origin of each lot of the specified plants, and the name and the identification number of the officially approved packing station(s) and exporter(s).

(10)Rules should be established for the inspections, sampling and testing to be carried out by Member States concerning the import of the specified plants, in order to ensure the protection of the Union territory from the specified pest. Testing should be carried out, in the Union, in accordance with the test scheme of Annex I to Commission Implementing Regulation (EU) 2022/1193^note, as that scheme is based on the applicable international standards and has proven to be effective for the detection of the specified pest.

(11)A system should be established whereby the NPPO of Egypt effectively controls the production sites, exporters and packing stations of the specified plants, by approving and listing them for that purpose. In the case of presence, or suspected presence, of the specified pest in the specified plants, and in order to prevent the entry into the Union territory of specified plants infected by the specified pest, those lists should be updated and the respective production sites’ codes, exporters and packing stations’ names should be removed from them, if needed.

(12)Rules should be set out concerning the disposal of waste from the specified plants in the Union, in order to prevent any spread of the specified pest resulting from a possible latent infection.

(13)As the phytosanitary risk from the introduction of the specified plants into the Union territory, subject to the new requirements of this Regulation, is not yet fully assessed, it needs to be further assessed through the application of those requirements in practice. It is in particular necessary to assess the phytosanitary risk following the application of the new requirements for the production of the specified plants in Egypt, the application of the testing scheme on those plants, and the rules on inspection, sampling and testing of the specified plants in the Union, as well as the rules concerning their labelling and waste management in the Union.

(14)Implementing Decision 2011/787/EU should be repealed and replaced by this Regulation, in order to align its provisions with the relevant terms and requirements set out in Regulation (EU) 2016/2031 concerning the introduction into the Union territory of plants, plant products and other objects from third countries.

(15)The requirement for the specified plants to have been grown in production sites, where during the year of production and the three years preceding it, certain additional requirements had to be met, should apply from 1 December 2028, in order to grant time for the specified plants to comply with those requirements.

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

HAS ADOPTED THIS REGULATION:

Article 1Subject matter and scope#

This Regulation sets out requirements and rules concerning the introduction into the Union territory of tubers of Solanum tuberosum L., other than those intended for planting, originating in Egypt, in order to prevent the introduction and spread of Ralstonia solanacearum (Smith) Yabuuchi et al. emend. Safni et al. in the Union territory.It applies by way of derogation from point 21 of Annex VII to Implementing Regulation (EU) 2019/2072, with respect to the specified pest.

Article 2Definitions#

For the purposes of this Regulation, the following definitions apply:

(1)‘specified pest’ means Ralstonia solanacearum (Smith) Yabuuchi et al. emend. Safni et al.;

(2)‘specified plants’ means tubers of Solanum tuberosum L., other than those intended for planting, originating in Egypt and destined for export to the Union;

(3)‘pest free area’ means an area established by the national plant protection organisation (‘NPPO’) of Egypt as being free from the specified pest, in accordance with the relevant International Standard for Phytosanitary Measures^note^,^note;

(4)‘production site’ means a site of production that is managed as a separate unit for phytosanitary purposes, identified by its individual official code number and located in a pest free area.

Article 3Requirements for the introduction into the Union of the specified plants#

The specified plants shall be introduced into the Union territory only where:

(a)the specific requirements set out in Part A of Annex I have been fulfilled;

(b)in the case of suspicion of the presence or confirmed presence of the specified pest in production sites and water sources in Egypt, the requirements set out in Part B of Annex I have been fulfilled;

(c)the requirements of Article 6(1) have been fulfilled;

(d)where applicable, the measures as set out in Article 7 have been taken.

Article 4Phytosanitary certificate#

The phytosanitary certificate for introduction into the Union of the specified plants shall include, under the heading ‘Additional declaration’, all of the following elements:

(a)the statement ‘In accordance with European Union requirements laid down in Commission Implementing Regulation (EU) 2025/1289’;

(b)the lot number corresponding to each exported lot of the specified plants;

(c)the code of the production site of origin of each lot of the specified plants as listed in accordance with Article 6(1), point (a);

(d)the name and the identification number of the officially approved packing station(s) and exporter(s) as listed in accordance with Article 6(1), points (b) and (c).

Article 5Inspections, sampling and testing to be carried out by Member States#

1.Without prejudice to Commission Implementing Regulations (EU) 2019/2130^note and (EU) 2022/2389^note, at the border control posts or at the control points referred to in Commission Delegated Regulation (EU) 2019/2123^note, the specified plants shall be subject to physical checks, as set out in paragraphs 2 to 6.

2.Sampling for testing of lots, originating from a production site, at least when introduced into a Member State for the first time during the year of concern shall be carried out as follows:

(a)at least one sample shall be taken from at least one lot from each production site;

(b)a sample shall consist of at least 200 specified plants per lot;

(c)if, in a consignment, the total weight of the lots originating from the same production site as the lot referred to in point (a) exceeds the weight of 200 tons, an additional sample shall be taken from another lot than the lot referred to in point (a).

3.Visual inspections of cut tubers shall be carried out for each consignment as follows:

(a)at least one sample shall be taken from at least one lot of each production site represented in the consignment;

(b)a sample shall consist of at least 200 specified plants per lot;

(d)where cut tubers presenting symptoms are observed during the visual inspections, those cut tubers shall be taken for laboratory testing.

4.Testing of the specified plants shall be carried out in accordance with the test scheme of Annex I to Implementing Regulation (EU) 2022/1193.

5.While visual inspections, sampling and testing are carried out, and pending the results of those checks, all lots of specified plants originating in the same production site, including lots placed in consignments other than the consignment of the tested lot, that arrive at the same border control post or at the same control point, shall remain under official supervision of the competent authorities of the Member State concerned.

6.Where the presence of the specified pest is confirmed, all lots of specified plants originating in the same production site, including lots placed in consignments other than the consignment of the tested lot, shall not be introduced into the Union territory.

Article 6Submission of lists to the Commission and Member States#

1.The specified plants shall be introduced into the Union territory only if the NPPO of Egypt has submitted to the Commission the following lists related to the year of their production in Egypt, before the start of the season of export to the Union and not later than 30 November of that year:

(a)list of codes of all approved production sites and their associated pest free areas;

(b)list of names and identification numbers of all officially approved exporters of the specified plants; and

(c)list of names and identification numbers of all officially approved packing stations.

2.The Commission shall submit to Member States the lists referred to in paragraph 1 of this Article, Article 7(1), point (b), and point 3(c) of Part B of Annex I.

Article 7Measures in case of confirmed presence of the specified pest on the specified plants during import controls#

1.Where the presence of the specified pest in the specified plants has been confirmed during the import controls carried out by a Member State, other consignments of specified plants originating from the same production site shall not be introduced into the Union territory and the following measures shall be immediately taken by the NPPO of Egypt:

(a)delisting of the code of the respective production site from the list referred to in Article 6(1), point (a);

(b)submission to the Commission of an updated list keeping track of the changes made;

(c)prohibition of the export of the specified plants from the delisted production site to the Union territory.

2.Following investigations by the NPPO of Egypt, and in cases where evidence exists that the presence of the specified pest is not linked to a specific production site, the respective production site may be re-introduced to the list referred to in Article 6(1), point (a).

3.No specified plants originating from a delisted production site as referred to in paragraph 1, point (a), of this Article and in points 3(a) and (b) of Part B of Annex I, shall be introduced into the Union territory during the ongoing year of concern and during the three following years. Introduction of specified plants originating from a delisted production site shall be allowed from the fourth year after the year of concern, and only if the absence of the specified pest has been confirmed by the NPPO of Egypt during the three years preceding the year of concern.

Article 8Labelling#

In the case of re-packaging of the specified plants within the Union territory, professional operators shall ensure that appropriate labels accompany the packages, indicating the origin of the specified plants from Egypt and the prohibition to plant them within the Union territory.

Article 9Waste management#

Professional operators shall take appropriate hygiene measures for the disposal of waste after packaging, re-packaging or processing of the specified plants, in a way which is appropriate to prevent any spread of the specified pest resulting from a possible latent infection. Such measures shall include:

(a)appropriate treatment of all water resulting from the washing and processing of the specified plants, before it is being discharged into surface or irrigation water; and

(b)preventive actions for the spread on agricultural land of untreated adherent soil, potato waste and rejected potatoes.

Article 10Amendment of Implementing Regulation (EU) 2019/2072#

Implementing Regulation (EU) 2019/2072 is amended in accordance with Annex III to this Regulation.

Article 11Repeal of Implementing Decision 2011/787/EU#

Implementing Decision 2011/787/EU is repealed.

Article 12Entry 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.Point (b) of Part A of Annex I shall apply from 1 December 2028.This Regulation shall apply until 30 November 2029.

Annex II · Specific requirements to be fulfilled for the surveys of the production sites as referred to in Article 3

(a)inspections of the growing crop, sampling of specified plants for testing, and examination of cut tubers for symptoms of the specified pest and for testing;

(b)in case of growing of other cultivated solanaceous crops on a production site within three years before production of specified plants for import into the Union territory, inspections of and sampling from the growing crops for laboratory testing;

(c)in case of the presence of wild solanaceous host plants, inspections and sampling of those plants for laboratory testing;

(d)sampling for laboratory testing of water sources in Egypt, and in case one water source has been used for different production sites, at least one water sample from this source has been taken and tested;

(e)sampling for laboratory testing in accordance with Annex I to Implementing Regulation (EU) 2022/1193.

Production sites have been subject to intensive surveys during the production of the specified plants for the detection of the specified pest, which have been carried out by the NPPO of Egypt, or by a body delegated by that NPPO.

For each production site, those surveys have included:

Every year, the results of the surveys of the calendar year have been submitted by the NPPO of Egypt to the Commission, in any case not later than when the lists referred to in Article 6(1) have been provided.

III · Amendment of Implementing Regulation (EU) 2019/2072

In Annex VII, point 21, the text in the second column is replaced by the following:

‘Tubers of Solanum tuberosum L., other than those for planting^note^note

Requirements for the introduction into the Union of the specified plants as referred to in Article 3

PART A — Specific requirements to be fulfilled for the specified plants in Egypt

(a)The specified plants have been grown in production sites, which have been subject to surveys carried out by the NPPO of Egypt, or by a body delegated by that NPPO, in accordance with Annex II;

(b)the specified plants have been grown in production sites, where during the year of production and the three previous years, the survey results showed that:

(i)no specified plants or other vegetative parts of potato plants and no other cultivated or wild solanaceous plants capable to host the specified pest have been found infected by the specified pest, and no related water sources have been found contaminated by the specified pest, after testing for the presence of the specified pest by the NPPO of Egypt, or by a body delegated by that NPPO; and

(ii)no specified plants originating from those production sites have been found positive after testing for the presence of the specified pest by the NPPO of Egypt, or by a body delegated by the NPPO of Egypt or by Member States, after leaving those production sites;

(c)the specified plants have been grown in a production site, identified by its individual official code number assigned by the NPPO of Egypt, or by a body delegated by that NPPO;

(d)the specified plants have been grown from plants for planting certified in, and imported from, the Union into Egypt, or have been grown from plants for planting officially certified by the NPPO of Egypt as being free from Union quarantine pests;

(e)in the case of plants for planting, as referred to in point (d), certified by the NPPO of Egypt, those have been grown in a production site, and each lot has been subject to official sampling by the NPPO of Egypt and testing by the NPPO of Egypt, or by a body delegated by the NPPO of Egypt for the specified pest;

(f)during sorting, the specified plants have been inspected by the NPPO of Egypt in the packing station, and the tubers with symptoms, or suspicion, of the presence of the specified pest have been officially tested by the NPPO of Egypt, or by a body delegated by that NPPO and found free from it;

(g)the specified plants have been packed in lots, each lot being made up of specified plants originating in a single production site;

(h)the specified plants have been packed in material that is new, or cleaned and disinfected in accordance with appropriate methods officially approved by the NPPO of Egypt;

(i)their packaging bears a clearly visible label affixed with an official seal and issued by the NPPO of Egypt, or a professional operator under the official supervision of the NPPO of Egypt, in one of the official languages of the Union and containing all of the following elements:

(i)the indication: ‘Origin: Egypt’;

(ii)the code of the production site;

(iii)the number of the lot;

(iv)the name and identification number of the packing station;

(v)the name and identification number of the exporter;

(vi)the indication ‘not for planting’;

(j)as close as possible to the time of export to the Union territory, a representative sample of 200 specified plants per lot of maximum 27,5 tons of specified plants have been sampled and subjected to inspection of cut tubers by the NPPO of Egypt, and the sample has been subjected to laboratory tests carried out by a professional operator, or by the NPPO of Egypt, or by a body delegated by that NPPO aiming to detect and identify the presence of the specified pest;

(k)immediately after the sampling referred to in point (j), packages of the specified plants have been closed and sealed by the NPPO of Egypt;

(l)the specified plants have been stored in storage facilities, which are only used for storing specified plants or, where the storage facilities have been used for other purposes, they have been subjected to appropriate hygiene measures, including cleaning and disinfection before being used for storing them;

(m)the specified plants have been handled using machinery which is only used for handling specified plants or, where it has been used for other purposes, which has been cleaned and disinfected through appropriated methods before handling those plants;

(n)testing of the specified plants, for the purpose of points (a), (b), (e), (f) and (j) and of Annex II, has been carried out in accordance with the test scheme of Annex I to Implementing Regulation (EU) 2022/1193.

PART B — Requirements in the case of suspicion of the presence or confirmed presence of the specified pest in production sites and water sources in Egypt

1.In the case of any suspicion of the presence of the specified pest in a production site, or in any specified plant originating from that production site, all lots of specified plants originating from that production site have not been moved and have remained under the supervision of the NPPO of Egypt unless it has been concluded, following investigations by that NPPO, that the presence of the specified pest is not linked to the respective production site.

2.In the case of any suspicion of the presence of the specified pest in a water source in Egypt, all lots of specified plants originating from the production site(s), where that water source had been used for irrigation, have not been moved and have remained under the supervision of the NPPO of Egypt, unless it has been concluded, following investigations by that NPPO, that the presence of the specified pest is not linked to the respective water source.

3.Where the presence of the specified pest has been confirmed on specified plants in a production site prior to their export to the Union territory or in a water source in Egypt, the NPPO of Egypt has immediately:

(a)delisted the code of the production site, found as source of infection of the specified plants with the specified pest, from the list referred to in Article 6(1), point (a);

(b)delisted the code(s) of all production site(s), which have made use of infected water during the last year, from the list referred to in Article 6(1), point (a);

(c)submitted to the Commission an updated list keeping track of the changes made; and

(d)prohibited exports to the Union territory of specified plants from the delisted production site(s).

4.Where the NPPO of Egypt has delisted an exporter or a packing station from the lists referred to in Article 6(1), point (b) or (c), it has immediately submitted to the Commission updated lists keeping track of the changes made and prohibited exports to the Union territory of specified plants by the delisted exporters and specified plants packaged at delisted packing stations.