COMMISSION IMPLEMENTING REGULATION (EU) 2025/311

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2025/311 | 17.2.2025 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2025/311 of 14 February 2025 on measures to eradicate and to prevent the establishment and spread within the Union territory of fruit flies of the species Bactrocera dorsalis (Hendel), Bactrocera latifrons (Hendel) and Bactrocera zonata (Saunders) 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 28(1), points (d), (e), (f), (g) and (i), thereof, Whereas: (1) | Fruit flies of the species Bactrocera dorsalis (Hendel), Bactrocera latifrons (Hendel) and Bactrocera zonata (Saunders) (‘the specified pests’) are listed in Part A of Annex II to Commission Implementing Regulation (EU) 2019/2072 (2) as Union quarantine pests. ---|--- (2) | Bactrocera dorsalis (Hendel) and Bactrocera zonata (Saunders) are also listed as priority pests in Commission Delegated Regulation (EU) 2019/1702 (3). ---|--- (3) | The specified pests are frequently found present in consignments sent to the Union from third countries. Since 2019, the specified pests have been found present in Belgium, Greece, France, Italy, Cyprus and Austria. The Member States concerned have taken measures (such as intensive trapping, removal of infested fruits and of windfall, prohibition to move infested fruits) and the specified pests have either been eradicated or are under eradication in those Member States for the time being. ---|--- (4) | In order to ensure a uniform and efficient approach preventing the establishment and spread of the specified pests within the Union territory, it is appropriate to adopt harmonised measures concerning the surveys for the specified pests, the contingency plans, the demarcation of areas, the eradication and the prevention of the establishment and spread of the specified pests outside the demarcated areas. ---|--- (5) | It is necessary to establish a list of host plants for the specified pests which are cultivated in the Union territory (‘host plants’), in order to survey and eradicate the specified pests and prevent their establishment and spread. For the same reason, appropriate measures should be taken concerning the fruits of those plants (‘the specified fruits’). ---|--- (6) | The specified pests may enter the Union territory through commercial consignments or passengers’ luggage and are able to spread actively. Therefore, rules on surveys concern also techniques of detecting infestation of specified fruits while on host plants, surveys in the areas where the specified fruits are imported and traded, trapping of the specified pests and sampling of possibly infested fruits, in order to enable competent authorities to adapt those surveys to the biology of those pests. ---|--- (7) | Competent authorities should be allowed not to establish a demarcated area in certain cases, when, due to the particular biology of the specified pest or due to characteristics of the site, it is concluded that the pest can be eliminated immediately. This is the case where there is evidence that the specified pests have been introduced into the area with the fruits on which they were found, those fruits were infested before their introduction into the area concerned and the specified pest cannot establish itself within that area, where the specified pest is officially confirmed in a site of production with physical isolation or in a site with protected cultivation and where it cannot establish outside that site. Competent authorities should in particular be able to take into account situations where the specified pest is not expected to survive because of unfavourable winter conditions. ---|--- (8) | The trapping protocols used in surveys in demarcated areas should be specifically adapted to the biology of the specified pests. This is necessary to ensure a proper monitoring of the presence of the specified pest and the process of eradication. ---|--- (9) | The eradication measures should take into account the biology of the specified pests as fruit flies and, therefore, include methods such as male annihilation treatments, bait application techniques, collection and safe disposal of windfall and of (early) harvested specified fruits, soil treatment (such as mechanical, chemical or microbiological) in and around areas of production of specified plants for destroying soil-bound stages of the specified pest, or the use of sterile insect technique. ---|--- (10) | Measures should be adopted to prevent the spread of the specified pests outside the demarcated areas. Those measures should concern the movements of host plants for planting, specified fruits, and soil from the infested zone to the rest of the Union territory. Bearing in mind that such host plants and soil are the likeliest pathways for the spread of the specified pests, measures should be taken to ensure that they are free from the specified pests, in any of their stages. ---|--- (11) | Sufficient time should be given for the competent authorities and the professional operators to adapt to this Regulation. Therefore, this Regulation should apply from 1 March 2025. ---|--- (12) | Moreover, additional time should be given to the competent authorities to prepare the design of each survey and allocate sufficient resources for conducting it in conformity with the methodology of statistical sampling. Therefore, the respective provision should apply from 1 January 2026. ---|--- (13) | 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 1 Subject matter This Regulation sets out measures to eradicate, to prevent the establishment in, and the spread within the Union territory of Bactrocera dorsalis (Hendel), Bactrocera latifrons (Hendel) and Bactrocera zonata (Saunders). Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) | ‘specified pests’ means fruit flies belonging to the species Bactrocera dorsalis (Hendel), Bactrocera latifrons (Hendel) or Bactrocera zonata (Saunders); ---|--- (2) | ‘host plants’ means plants belonging to the species listed in Annex I; ---|--- (3) | ‘specified fruits’ means fruits of the host plants. ---|--- Article 3 Surveys of the Union territory of the specified pests 1\. The sampling design and scheme of the risk-based surveys for the specified pests shall allow to detect with a sufficient level of confidence a low level of presence of the specified pest on specified fruits. The surveys shall be based on the European Food Safety Authority’s (‘the Authority’s) General guidelines for statistically sound and risk-based surveys for plant pests and on the scientific and technical information referred to in the Authority’s Pest Survey Cards on the specified pest (4) (‘pest survey card’). 2\. The surveys shall be conducted in particular: (a) | in the fruiting parts of the host plants, by using techniques capable of detecting the presence of the specified pest; ---|--- (b) | in and around airports and harbours, in and around facilities of auctions and retailers where specified fruits are traded, in areas where specified fruits are packed, processed or discharged, in areas where specified fruits are produced, and other relevant sites, as appropriate; ---|--- (c) | by trapping with appropriate traps, as specified in the International Standard for Phytosanitary measures (ISPM) 26 (5); and ---|--- (d) | in the case of any suspicion of presence of the specified pest on specified fruits, by collecting samples of specified fruits and identification of the pest. ---|--- Article 4 Contingency plans for priority pests Member States, when drawing up their contingency plans for Bactrocera dorsalis and Bactrocera zonata, shall include in those plans procedures to: (a) | identify the owners of private properties, in the areas of which the measures provided for in this Regulation are to be applied; and ---|--- (b) | ensure access of the competent authorities to properties referred to in point (a). ---|--- Member States shall annually review and, as appropriate, update their contingency plans. Article 5 Establishment of demarcated areas 1\. Where the presence of the specified pest is officially confirmed, the competent authorities shall, without delay, establish a demarcated area. 2\. The demarcated area shall consist of the following zones: (a) | an infested zone, which is the zone where the presence of a specified pest has been confirmed, and has a radius of at least 500 m around the place(s) of the findings of the specified pest; and ---|--- (b) | a buffer zone with a radius of at least 7 km beyond the boundary of the infested zone. ---|--- 3\. The exact delimitation of the demarcated area shall take into account the biology of the specified pests, the level of infestation, the characteristics of the attractant, and the particular distribution of the host plants in the area concerned. 4\. In case of a finding of the specified pest outside the infested zone, the demarcated area established in accordance with this Article shall be adjusted accordingly. 5\. Within the demarcated areas, the competent authorities shall ensure that the general public and professional operators are aware of the delimitation of the demarcated areas and any possible restrictions concerning the movement of the specified fruits. Article 6 Derogations from the establishment of demarcated areas 1\. By way of derogation from Article 5, the competent authorities may choose not to establish a demarcated area, if at least one of the following criteria is fulfilled: (a) | it is concluded by the competent authorities that the specified pest cannot establish within the area where it was observed; ---|--- (b) | there is evidence that the specified pest has been introduced into the area with the consignment where it was found, the specified fruits in that consignment were infested before their introduction into the area concerned, and no multiplication of the specified pest has taken place following that introduction; ---|--- (c) | the presence of the specified pest is officially confirmed in a production site with physical isolation from its surroundings, which prevents the specified pest from spreading out of that site; ---|--- (d) | the presence of the specified pest is officially confirmed in a production site which is protected in such way that allows to avoid further presence of the specified pests on host plants and specified fruits, and it has been concluded by the competent authorities that the specified pests cannot become established outside that production site because of unfavourable winter conditions. ---|--- 2\. Where the competent authority applies a derogation provided for in paragraph 1, it shall: (a) | take measures to ensure the prompt eradication of the specified pest and exclude any possibility of its spread; ---|--- (b) | carry out an intensive survey in a zone of a radius of at least 500 m around the place(s) of the finding of the specified pest; and ---|--- (c) | where appropriate, and in particular in case of paragraph 1, points (c) and (d), apply efficient measures preventing the spread of the specified pest through specified fruits or host plants out of the production site. ---|--- In case of paragraph 1, point (b), if the competent authorities conclude that the specified pest is not capable to survive the winter conditions, the period for the survey may be limited to the period before the start of the winter conditions. Article 7 Surveys in demarcated areas 1\. In the demarcated areas, the competent authorities shall carry out annual surveys, as referred to in Article 19(1) of Regulation (EU) 2016/2031, taking into account the information referred to in the pest survey card. 2\. The number of traps deployed per km2 in such survey shall gradually increase from the edge to the centre of the surveyed area. When determining the number of traps, the type of traps, the trapping design and possible attractants to be used with the traps, Member States shall take into account the details set out in international guidance, and in particular ISPM 26, as well as the pest survey card. 3\. Sampling of the specified fruits growing in the surveyed area shall be considered. In determining sampling protocols, the competent authorities shall apply the pest survey card as well as the principles set out in internationally recognised protocols for official control of the specified pest. Survey design and sampling schemes shall be used, which enable identifying with at least 95 % of confidence a level of presence of the specified pest of 1 %. 4\. The results of the surveys carried out in demarcated areas shall be submitted to the Commission using one of the templates referred to in Annex II. Article 8 Abolition of the demarcated areas The demarcated area referred to in Article 5 may be abolished, if one of the following conditions is fulfilled: (a) | the specified pest is, on the basis of the surveys referred to in Article 7, not detected in the demarcated area for a period of at least 120 days; or ---|--- (b) | it has been concluded by the competent authorities that the specified pest has undergone a period of sufficiently cold temperatures. ---|--- Article 9 Eradication measures The competent authorities shall apply, as appropriate, one or more of the following measures for the purpose of eradicating the specified pests in the infested zone: (a) | use of male annihilation treatments and/or bait application techniques, using appropriate attractants; ---|--- (b) | collection and safe disposal of windfall and of harvested specified fruits at an early stage of ripening and soil treatment, including mechanical, chemical or microbiological one, in and around areas of production of specified plants so as to destroy soil-bound stages of the specified pest; ---|--- (c) | use of sterile insect technique; ---|--- (d) | use of plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (6); ---|--- (e) | where available, mass trapping of the specified pests with a sufficient number of traps, including the traps deployed in accordance with Article 7(2). ---|--- Article 10 Measures preventing the spread of the specified pest 1\. Specified fruits grown or stored in the infested zone may only be moved from that zone into the buffer zone, or out of the demarcated area, if they are treated effectively against the specified pest. The treatments referred to in the first subparagraph shall include the use of appropriate and sufficiently efficient plant protection products as authorised pursuant to Regulation (EC) No 1107/2009, or the use of alternative methods in accordance with internationally recognised phytosanitary standards, and in particular ISPM 28 (7), such as heat treatment, cold treatment or irradiation. Specified fruits may also be moved from the infested zone into the buffer zone or out of the demarcated area: (a) | for the purpose of an appropriate treatment, if effective measures are taken to prevent the spread of the specified pest during transport and through the treatment facility; ---|--- (b) | if they originate from outside the demarcated area, are only moving through the infested zone, and effective measures are taken to prevent their infestation by the specified pest; or ---|--- (c) | if the specified fruits were harvested in a season of the year, as defined by the competent authorities, where no live stages of the specified pest are expected to occur in those fruits, due to the reproductive biology of the specified pest. ---|--- 2\. Host plants intended for planting and moved from the infested zone into the buffer zone, or out of the demarcated area, shall be free from fruits and, where soil or another growing medium is attached, that soil shall be free from the specified pests. However, host plants bearing fruits may be moved out of, or through, the infested zone, if those plants originate from outside the demarcated area, and effective measures are taken to prevent infestation of the plants by the specified pests. 3\. Soil of the upper 10 cm of the topsoil layer, from production sites, where specified fruits were grown, may only be moved from the infested zone into the buffer zone, or out of the demarcated area, if: (a) | it has been subject to appropriate measures to eliminate the specified pest; or ---|--- (b) | it is buried under landfill, with a minimum of 50 cm cover material, under the supervision of the competent authorities. ---|--- Any transport of that soil towards the place of treatment or burying shall take place under conditions effectively preventing the spread of the specified pest. 4\. Waste from specified fruits shall be disposed safely, in a way that prevents the development and spread of the specified pest. Article 11 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 from 1 March 2025. However, Article 3(1), second subparagraph, shall apply from 1 January 2026. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 14 February 2025. For the Commission The President Ursula VON DER LEYEN * * * (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) Commission Delegated Regulation (EU) 2019/1702 of 1 August 2019 supplementing Regulation (EU) 2016/2031 of the European Parliament and of the Council by establishing the list of priority pests (OJ L 260, 11.10.2019, p. 8, ELI: http://data.europa.eu/eli/reg_del/2019/1702/oj). (4) EFSA (European Food Safety Authority). Story map for surveillance of non- EU Tephritidae in the EU. https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/tephritidae- pestsurveycards. (5) International Standard for Phytosanitary Measures (ISPM) 26: Establishment of pest-free areas for fruit flies (Tephritidae). https://www.ippc.int/core- activities/standards-setting/ispms. (6) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj). (7) International Standard for Phytosanitary measures (ISPM) 28: Phytosanitary treatments for regulated pests. https://www.ippc.int/core- activities/standards-setting/ispms. * * * ANNEX I LIST OF HOSTS FOR EACH SPECIES OF THE SPECIFIED PEST Bactrocera dorsalis: | Abelmoschus spp. ---|--- | Annona cherimola ---|--- | Annona montana ---|--- | Annona muricata ---|--- | Annona reticulata ---|--- | Annona senegalensis ---|--- | Annona squamosa ---|--- | Averrhoa carambola ---|--- | Capparis spp. ---|--- | Capsicum annuum ---|--- | Capsicum frutescens ---|--- | Carica papaya ---|--- | Citrofortunella floridana ---|--- | Citrofortunella macrocarpa ---|--- | Citrullus colocynthis ---|--- | Citrullus lanatus ---|--- | Citrus amblycarpa ---|--- | Citrus aurantifolia ---|--- | Citrus aurantium ---|--- | Citrus depressa ---|--- | Citrus jambhiri ---|--- | Citrus latifolia ---|--- | Citrus limon ---|--- | Citrus maxima ---|--- | Citrus meyerii ---|--- | Citrus natsudaidai ---|--- | Citrus nobilis ---|--- | Citrus paradisi ---|--- | Citrus reticulata ---|--- | Citrus sinensis ---|--- | Citrus swinglei ---|--- | Citrus unshiu ---|--- | Coccinia grandis ---|--- | Cucumis ficifolius ---|--- | Cucumis melo ---|--- | Cucumis prophetarum ---|--- | Cucumis sativus ---|--- | Cucurbita spp. ---|--- | Cydonia oblonga ---|--- | Diospyros dasyphylla ---|--- | Diospyros decandra ---|--- | Diospyros ebenaster ---|--- | Diospyros lotus ---|--- | Diospyros mespiliformis ---|--- | Diospyros montana ---|--- | Eriobotrya spp. ---|--- | Ficus spp. ---|--- | Fortunella spp. ---|--- | Fragaria chiloensis ---|--- | Fragaria vesca ---|--- | Juglans nigra ---|--- | Juglans regia ---|--- | Lagenaria siceraria ---|--- | Malus domestica ---|--- | Malus sylvestris ---|--- | Mangifera indica ---|--- | Momordica balsamina ---|--- | Momordica charantia ---|--- | Momordica cochinchinensis ---|--- | Morus alba ---|--- | Morus nigra ---|--- | Passiflora edulis ---|--- | Persea americana ---|--- | Physalis minima ---|--- | Physalis peruviana ---|--- | Prunus armeniaca ---|--- | Prunus avium ---|--- | Prunus bokhariensis ---|--- | Prunus cerasoides ---|--- | Prunus domestica ---|--- | Prunus persica ---|--- | Psidium cattleianum ---|--- | Psidium guajava ---|--- | Punica granatum ---|--- | Pyrus communis ---|--- | Pyrus pashia ---|--- | Pyrus pyrifoli ---|--- | Sambucus spp. ---|--- | Solanum aculeatissimum ---|--- | Solanum aethiopicum ---|--- | Solanum americanum ---|--- | Solanum anguivi ---|--- | Solanum betaceum ---|--- | Solanum capsicoides ---|--- | Solanum donianum ---|--- | Solanum erianthum ---|--- | Solanum granuloso-leprosum ---|--- | Solanum incanum ---|--- | Solanum lasiocarpum ---|--- | Solanum linnaeanum ---|--- | Solanum lycopersicum ---|--- | Solanum mauritianum ---|--- | Solanum melongena ---|--- | Solanum nigrum ---|--- | Solanum pimpinellifolium ---|--- | Solanum pseudocapsicum ---|--- | Solanum seaforthianum ---|--- | Solanum sessiliflorum ---|--- | Solanum sodomeum ---|--- | Solanum stramoniifolium ---|--- | Solanum torvum ---|--- | Solanum trilobatum ---|--- | Vaccinium reticulatum ---|--- | Vitis vinifera (including hybrids) ---|--- | Ziziphus mauritiana ---|--- | Ziziphus mucronata ---|--- Bactrocera latifrons: | Capsicum annuum ---|--- | Capsicum baccatum ---|--- | Capsicum chinense ---|--- | Capsicum frutescens ---|--- | Citrullus lanatus ---|--- | Citrus aurantifolia ---|--- | Cucumis dipsaceus ---|--- | Cucumis melo ---|--- | Cucumis sativus ---|--- | Cucurbita spp. ---|--- | Lagenaria siceraria ---|--- | Momordica charantia ---|--- | Momordica trifoliolata ---|--- | Passiflora foetida ---|--- | Persea americana ---|--- | Physalis alkekengi ---|--- | Physalis angulate ---|--- | Physalis peruviana ---|--- | Psidium guajava ---|--- | Punica granatum ---|--- | Solanum aculeatissimum ---|--- | Solanum aethiopicum ---|--- | Solanum americanum ---|--- | Solanum anguivi ---|--- | Solanum capsicoides ---|--- | Solanum donianum ---|--- | Solanum erianthum ---|--- | Solanum granuloso-leprosum ---|--- | Solanum incanum ---|--- | Solanum indicum ---|--- | Solanum lanceifolium ---|--- | Solanum lasiocarpum ---|--- | Solanum linnaeanum ---|--- | Solanum lycopersicum ---|--- | Solanum macrocarpon ---|--- | Solanum mammosum ---|--- | Solanum melongena ---|--- | Solanum muricatum ---|--- | Solanum nigrescens ---|--- | Solanum nigrum ---|--- | Solanum pimpinellifolium ---|--- | Solanum pseudocapsicum ---|--- | Solanum scabrum ---|--- | Solanum seaforthianum ---|--- | Solanum sisymbriifolium ---|--- | Solanum stramoniifolium ---|--- | Solanum torvum ---|--- | Solanum trilobatum ---|--- | Solanum viarum ---|--- | Solanum violaceum ---|--- | Solanum virginianum ---|--- | Ziziphus jujuba ---|--- | Ziziphus mauritiana ---|--- | Ziziphus nummularia ---|--- Bactrocera zonata: | Annona reticulata ---|--- | Annona squamosa ---|--- | Citrullus lanatus ---|--- | Citrus aurantium ---|--- | Citrus limon ---|--- | Citrus paradisi ---|--- | Citrus reticulata ---|--- | Citrus sinensis ---|--- | Cucumis sativus ---|--- | Cucurbita spp. ---|--- | Cydonia oblonga ---|--- | Diospyros kaki ---|--- | Eriobotrya japonica ---|--- | Ficus spp. ---|--- | Lagenaria siceraria ---|--- | Malus domestica ---|--- | Malus sylvestris ---|--- | Mangifera indica ---|--- | Momordica charantia ---|--- | Persea americana ---|--- | Prunus armeniaca ---|--- | Prunus domestica ---|--- | Prunus persica ---|--- | Psidium cattleianum ---|--- | Psidium guajava ---|--- | Punica granatum ---|--- | Pyrus communis ---|--- | Pyrus pyrifolia ---|--- | Pyrus ussuriensis ---|--- | Ziziphus mauritiana ---|--- * * * ANNEX II TEMPLATES FOR REPORTING THE RESULTS OF THE SURVEYS CARRIED OUT PURSUANT TO ARTICLE 7 PART A TEMPLATE FOR REPORTING THE RESULTS OF THE ANNUAL SURVEYS | 1. | Description of the Demarcated Area (DA) ---|--- | 2. | Initial size of DA (ha) ---|--- | 3. | Updated size of DA (ha) ---|--- | 4. | Approach (eradication) ---|--- | 5. | Zone ---|--- | 6. | Survey sites ---|--- | 7. | Risk areas identified ---|--- | 8. | Risk areas inspected ---|--- | 9. | Plant material / Commodity ---|--- | 10. | List of host plant species ---|--- | 11. | Timing ---|--- | 12. | Survey details ---|--- | 13. | No of symptomatic samples analysed: | i: | Total ---|--- ii: | Positive ---|--- iii: | Negative ---|--- iv: | Undetermined ---|--- | 14. | No of asymptomatic samples analysed: | i: | Total ---|--- ii: | Positive ---|--- iii: | Negative ---|--- iv: | Undetermined ---|--- | 15. | Notification number of the outbreaks notified, as applicable, in accordance with Commission Implementing Regulation (EU) 2019/1715 (1) ---|--- | 16. | Comments ---|--- | A) | Number of visual examinations ---|--- | B) | Total number of samples taken ---|--- | C) | Type of traps (or other alternative method (e.g. sweep nets)) ---|--- | D) | Number of traps (or other capturing method) ---|--- | E) | Number of trapping sites, when different from data reported in (D) ---|--- | F) | Type of tests (e.g. microscopic identification, PCR, ELISA, etc.) ---|--- | G) | Total number of tests ---|--- | H) | Other measures (e.g. sniffer dogs, drones, helicopters, awareness raising campaigns, etc.) ---|--- Name | Date of establishment | Description | Number | | I) | Number of other measures ---|--- Number | Date A | B | C | D | E | F | G | H | I | i | ii | iii | iv | i | ii | iii | iv | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Instructions how to fill in the template If this template is filled, the template in Part B of this Annex is not to be filled. For column 1: Indicate the name of the geographical area, outbreak number or any information that allows identification of this demarcated area (DA) and the date when it was established. For column 2: Indicate the size of the DA before the start of the survey. For column 3: Indicate the size of the DA after the survey. For column 4: Indicate the approach: Eradication. Please, include as many rows as necessary, depending on the number of DA per pest. For column 5: Indicate the zone of the DA where the survey was carried out, including as many rows as necessary: Infested (IZ) or buffer zone (BZ), using separate rows. When applicable, indicate the area of the IZ where the survey was carried out (e.g adjacent to the BZ, around nurseries, etc.) in different rows. For column 6: Indicate the number and the description of the survey sites, by choosing one of the following entries for the description: 1. | Open air (production area): 1.1. field (arable, pasture); 1.2. orchard/vineyard; 1.3. nursery; 1.4. forest; ---|--- 2. | Open air (other): 2.1. private garden; 2.2. public sites; 2.3. conservation area; 2.4. wild plants in areas other than conservation areas; 2.5. other, with specification of the particular case (e.g. garden centre, commercial sites that use wood packaging material, wood industry, wetlands, irrigation and drainage network); ---|--- 3. | Physically closed conditions: 3.1. greenhouse; 3.2. private site, other than greenhouse; 3.3. public site, other than greenhouse; 3.4. other, with specification of the particular case (e.g. garden centre, commercial sites that use wood packaging material, wood industry). ---|--- For column 7: Indicate, which are the risk areas identified based on the biology of the pest(s), presence of host plants, eco-climatic conditions and risk locations. For column 8: Indicate the risk areas included in the survey, from those identified in column 7. For column 9: Indicate plants, fruits, seeds, soil, packaging material, wood, machinery, vehicles, water, other, specifying the specific case. For column 10: Indicate the list of plant species/genera surveyed using one row per plant species/genera. For column 11: Indicate the months of the year when the survey was carried out. For column 12: Indicate the details of the survey, depending on the specific legal requirements of each pest. Indicate with N/A when the information of certain column is not applicable. For columns 13 and 14: Indicate the results, if applicable, providing the information available in the corresponding columns. ‘Undetermined’ are those analysed samples for which no result was obtained due to different factors (e.g. below detection level, unprocessed sample-not identified, old). For column 15: Indicate the outbreak notifications of the year when the survey took place for findings in the BZ. The outbreak notification number does not need to be included when the competent authority has decided that the finding is one of the cases referred to in Article 14(2), Article 15(2) or Article 16 of Regulation (EU) 2016/2031. In this case, indicate the reason for not providing this information in column 16 (‘Comments’). PART B Template for reporting the results of the annual surveys, using statistically- based approach | 1. | Description of the Demarcated Area (DA) ---|--- | 2. | Initial size of DA (ha) ---|--- | 3. | Updated size of DA (ha) ---|--- | 4. | Approach ---|--- | 5. | Zone ---|--- | 6. | Survey sites ---|--- | 7. | Timing ---|--- | A. | Survey definition (input parameters for RiBESS+) ---|--- | B. | Sampling effort ---|--- | C. | Survey results ---|--- | 25. | Comments ---|--- | 8. | Target population ---|--- | 9. | Epidemiological units ---|--- | 10. | Detection methods ---|--- | 11. | Sampling effectiveness ---|--- | 12. | Method sensitivity ---|--- | 13. | Risk factors (activities, locations and areas) ---|--- | 14. | N° of epidemiological units inspected ---|--- | 15. | N° of visual examinations ---|--- | 16. | N° samples ---|--- | 17. | N° of traps ---|--- | 18. | N° of trapping sites ---|--- | 19. | N° of tests ---|--- | 20. | N° of other measures ---|--- | 21. | Results ---|--- | 22. | Notification number of the outbreaks notified, as applicable, in accordance with Implementing Regulation (EU) 2019/1715 ---|--- | 23. | Achieved Confidence level ---|--- | 24. | Design prevalence ---|--- Name | Date of establishment | Description | Number | Host species | Area (ha or other more relevant unit) | Inspection units | Description | Units | Visual examinations | Trapping | Testing | Other methods | Risk factor | Risk levels | N° of locations | Relative risks | Proportion of the host population | Positive | Negative | Undetermined | Number | Date | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Instructions on how to fill in the template Explain the underlying assumptions for the survey design per pest. Summarise and justify: — | the target population, epidemiological unit and inspection units; ---|--- — | the detection method and method sensitivity; ---|--- — | the risk factor(s), indicating the risk levels and corresponding relative risks and proportions of host plant population. ---|--- For column 1: Indicate the name of the geographical area, outbreak number or any information that allows identification of this demarcated area (DA) and the date when it was established. For column 2: Indicate the size of the DA before the start of the survey. For column 3: Indicate the size of the DA after the survey. For column 4: Indicate the approach: Eradication or Containment. Please, include as many rows as necessary, depending on the number of DA per pest and the approaches these areas are subject to. For column 5: Indicate the zone of the DA where the survey was carried out, including as many rows as necessary: Infested zone (IZ) or buffer zone (BZ), using separate rows. Where applicable, indicate the area of the IZ where the survey was carried out (e.g. last 20 km adjacent to the BZ, around nurseries) in different rows. For column 6: Indicate the number and the description of the survey sites, by choosing one of the following entries for the description: 1. | Open air (production area): 1.1 field (arable, pasture); 1.2. orchard/vineyard; 1.3. nursery; 1.4. forest; ---|--- 2. | Open air (other): 2.1. private gardens; 2.2. public sites; 2.3. conservation area; 2.4. wild plants in areas other than conservation areas; 2.5. other, with specification of the particular case (e.g. garden centre, commercial sites that use wood packaging material, wood industry, wetlands, irrigation and drainage network); ---|--- 3. | Physically closed conditions: 3.1. greenhouse; 3.2. private site, other than greenhouse; 3.3. public site, other than greenhouse; 3.4. other, with specification of the particular case (e.g. garden centre, commercial sites that use wood packaging material, wood industry). ---|--- For column 7: Indicate the months of the year when the surveys were carried out. For column 8: Indicate the chosen target population providing accordingly the list of host species/genera and area covered. The target population is defined as the ensemble of inspection units. Its size is defined typically for agricultural areas as hectares, but could be lots, fields, greenhouses e,tc. Please justify the choice made in the underlying assumptions. Indicate the inspection units surveyed. ‘Inspection unit’ means plants, plant parts, commodities, materials, pest vectors that had been scrutinised for identifying and detecting the pests. For column 9: Indicate the epidemiological units surveyed, indicating its description and unit of measurement. ‘Epidemiological unit’ means a homogeneous area where the interactions between the pest, the host plants and the abiotic and biotic factors and conditions would result into the same epidemiology, should the pest be present. The epidemiological units are a subdivision of the target population that are homogenous in terms of epidemiology with at least one host plant. In some cases the whole host population in a region/area/country may be defined as epidemiological unit. They could be Nomenclature of territorial units for statistics (NUTS) regions, urban areas, forests, rose gardens or farms, or hectares. The choice of the epidemiological units has to be justified in the underlying assumptions. For column 10: Indicate the methods used during the survey including the number of activities in each case, depending on the specific legal requirements of each pest. Indicate with N/A when the information of certain column is not available. For column 11: Indicate an estimation of the sampling effectiveness. Sampling effectiveness means the probability of selecting infected plant parts from an infected plant. For vectors, it is the effectiveness of the method to capture a positive vector when it is present in the survey area. For soil, it is the effectiveness of selecting a soil sample containing the pest when the pest is present in the survey area. For column 12: ‘Method sensitivity’ means the probability of a method to correctly detect pest presence. The method sensitivity is defined as the probability that a truly positive host tests positive. It is the multiplication of the sampling effectiveness (i.e. probability of selecting infected plant parts from an infected plant) by the diagnostic sensitivity (characterised by the visual inspection and/or laboratory test used in the identification process). For column 13: Provide the risk factors in different rows, using as many rows as necessary. For each risk factor indicate the risk level and corresponding relative risk and proportion of host population. For column B: Indicate the details of the survey, depending on the specific legal requirements for each pest. Indicate with N/A when the information of certain column is not applicable. The information to be provided in these columns is related to the information included in the column 10 ‘Detection methods’. For column 18: Indicate the number of trapping sites in case this number differs from the number of traps (column 17) (e.g. the same trap is used in different places). For column 21: Indicate the number of samples found positive, negative or undetermined. ‘Undetermined’ are those analysed samples for which no result was obtained due to different factors (e.g. below detection level, unprocessed sample-not identified, old). For column 22: Indicate the outbreak notifications of the year when the survey took place. The outbreak notification number does not need to be included when the competent authority has decided that the finding is one of the cases referred to in Article 14(2), Article 15(2) or Article 16 of Regulation (EU) 2016/2031. In this case, indicate the reason for not providing this information in column 25 (‘Comments’). For column 23: Indicate the sensitivity of the survey, as defined in International Standard for Phytosanitary Measures (ISPM) 31. This value of the achieved confidence level of pest freedom is calculated based on the examinations (and/or samples) performed given the method sensitivity and the design prevalence. For column 24: Indicate the design prevalence based on a pre-survey estimate of the likely actual prevalence of the pest in the field. The design prevalence is set as a goal of the survey and corresponds to the compromise the risk managers are making between the risk of having the pest and the resources available for the survey. Typically, for a detection survey a value of 1 % is set. * * * (1) Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation) (OJ L 261, 14.10.2019, p. 37, ELI: http://data.europa.eu/eli/reg_impl/2019/1715/oj). * * * ELI: http://data.europa.eu/eli/reg_impl/2025/311/oj ISSN 1977-0677 (electronic edition) * * *