02020R1191 — EN — 03.11.2021 — 002.001

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Amended by:









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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1191

of 11 August 2020

establishing measures to prevent the introduction into and the spread within the Union of Tomato brown rugose fruit virus (ToBRFV) and repealing Implementing Decision (EU) 2019/1615







Article 1

Definitions

For the purpose of this Regulation, the following definitions shall apply:

(a) ‘specified pest’ means Tomato brown rugose fruit virus (ToBRFV);

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(b) ‘specified plants’ means plants, other than specified seeds and specified fruits, of Solanum lycopersicum L. and its hybrids and of Capsicum spp.;

(c) ‘specified seeds’ means seeds of Solanum lycopersicum L. and its hybrids and of Capsicum spp.;

(d) ‘specified fruits’ means fruits of Solanum lycopersicum L. and its hybrids and of Capsicum spp.

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Article 2

Prohibitions concerning the specified pest

The specified pest shall not be introduced into, moved within, or held, multiplied or released within the Union territory.

Article 3

Detection or suspected presence of the specified pest

1. Any person within the Union territory who suspects or becomes aware of the presence of the specified pest shall immediately inform the competent authority and provide it with all relevant information concerning the presence, or suspected presence, of the specified pest.

2. On receiving such information, the competent authority shall: (a) immediately record the information provided; (b) take all necessary measures to confirm the presence or suspected presence of the specified pest; (c) ensure that any person having plants which may be infected with the specified pest under their control is immediately informed of: (i) the presence or the suspected presence of the specified pest, and (ii) of the possible risks associated with the specified pest and of the measures to be taken.

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Article 4

Measures concerning the confirmed presence of the specified pest

1. Where the presence or the suspected presence of the specified pest is officially confirmed in the territory of a Member State, the competent authority of the Member State concerned shall ensure that appropriate measures are taken to eradicate the specified pest in accordance with Article 17 of Regulation (EU) 2016/2031.

In addition, that competent authority shall take the measures laid down in paragraphs 2 and 3 of this Article, unless the conditions of Article 18(4) of Regulation (EU) 2016/2031 are fulfilled with regards to the specified pest.

2. The competent authority shall without delay establish a demarcated area as follows: (a) in the case of the presence of the specified pest in production sites with physical protection, the demarcated area shall consist of at least the production site where the specified pest has been found; (b) in the case of the presence of the specified pest in production sites other than those referred to in point (a), the demarcated area shall consist of: (i) an infested zone including at least the production site where the presence of the specified pest has been found; (ii) a buffer zone of at least 30 m surrounding the infested zone.

3. In the demarcated area, the competent authority, or the professional operator under the official supervision of the competent authority, shall: (a) for production sites intended for the production of specified plants for planting or for the production of specified seeds: (i) immediately remove and destroy all infected lots of the specified plants for planting and, where applicable, the specified seeds originating from those lots. The removal and destruction shall be carried out in such a way that there is no risk of spreading the specified pest; (ii) apply specific hygiene measures on personnel, production site structures, tools and machinery, materials and means of transport, to prevent the spread of the specified pest to the other lots present in the production site and to the successive crops of the specified plants or to other production sites; (iii) destroy or treat the growing medium at least at the end of the cropping season such that there is no identifiable risk of spreading the specified pest; (b) for production sites intended for the production of specified fruits: (i) remove and destroy all specified plants from the production site, at least at the end of the cropping season. The removal shall be carried out in such a way that there is no identifiable risk of spreading the specified pest; (ii) apply specific hygiene measures on personnel, production site structures, tools and machinery, materials and means of packing and transport of the fruits, to prevent the spread of the specified pest to successive crops of the specified plants or to other production sites; (iii) destroy or treat the growing medium at least at the end of the cropping season such that there is no identifiable risk of spreading the specified pest.

4. The competent authorities may abolish a demarcated area and terminate the respective eradication measures, where following sampling and testing of the specified plants of a successive crop, the site has been found free from the specified pest for a period of at least 6 months after the planting of those plants.

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Article 5

Surveys on the presence of the specified pest in the Member States

1. Member States shall conduct annual surveys for the presence of the specified pest on specified plants for planting, specified seeds and specified fruits in their territory, including in places of production of specified seeds and specified plants for planting.

2. Those surveys shall: (a) include sampling and testing as laid down in the Annex; and (b) be based on: (i) the assessed risk of introduction and spread of the specified pest into and within the Member State concerned, and (ii) sound scientific and technical principles, with regard to the possibility to detect the specified pest.

3. Member States shall notify the Commission and the other Member States by 30 April of each year of the results of the surveys that were carried out during the preceding calendar year.

Article 6

Movement of the specified plants for planting within the Union

1. The specified plants for planting may only be moved within the Union if they are accompanied by a plant passport and if both of the following conditions are fulfilled: (a) the specified plants have been grown in a production site where the specified pest is known not to occur, on the basis of official inspections carried out at the appropriate time to detect the specified pest, and, where specified plants are displaying symptoms of the specified pest, these plants have been subjected to sampling and testing by the competent authority, and these tests have shown them to be free of the specified pest; (b) the lots of the specified plants for planting have been kept separate from other lots of specified plants by applying appropriate hygiene measures and physical separation.

Sampling for testing, as referred to in this paragraph, shall be carried out as set out in the Annex.

2. Paragraph 1 shall not apply to: (a) specified plants of Capsicum spp. varieties which are known to be resistant to the specified pest; (b) specified plants for planting produced in accordance with Implementing Decision (EU) 2019/1615.

Article 7

Movement of the specified seeds within the Union

1. Specified seeds may only be moved within the Union if they are accompanied by a plant passport and if they fulfil all of the following conditions: (a) their mother plants have been produced in a production site where the specified pest is known not to occur, on the basis of official inspections carried out at the appropriate time to detect the specified pest; ▼M2 (b) they or their mother plants have undergone sampling and testing for the specified pest by the competent authority, or have been subjected to sampling and testing by professional operators under official supervision of the competent authority, and have been found, according to those tests, to be free from the specified pest. When mother plants are tested, the sampling shall take place within the shortest possible time prior to the first harvest of the fruits. In case of suspicion of the presence of the specified pest, that sampling and testing shall only be carried out by the competent authorities in accordance with Article 87(3), point (c), of Regulation (EU) 2016/2031; ▼B (c) the origin of all lots of specified seeds are recorded and documented.

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Specified seeds that have been harvested before 15 August 2020 shall be exempted from the condition under point (a).

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2. By way of derogation from point (a) and from the first subparagraph of point (b) of paragraph 1, specified seeds that have been harvested prior to 15 August 2020 shall have been sampled and tested for the specified pest by the competent authority or by professional operators under official supervision of the competent authority and found free from that pest, before their first movement within the Union.

The specified seeds moved for the first time within the Union from 1 April 2021 on, and which have been tested before 30 September 2020 with Elisa method, shall be tested again with a testing method, other than ELISA, as referred to in point 3 of the Annex.

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3. Seed sampling and testing shall be carried out as set out in the Annex.

4. Paragraphs 1 and 2 shall not apply to specified seeds of Capsicum spp. varieties which are known to be resistant to the specified pest.

Article 8

Ιntroduction into the Union of the specified plants for planting

1. Specified plants for planting, other than the ones of Capsicum spp. varieties which are known to be resistant to the specified pest, originating from third countries may only be introduced into the Union if they are accompanied by a phytosanitary certificate which, under the heading ‘Additional declaration’, includes the following elements: (a) an official statement that the specified plants for planting derive from specified seeds which have undergone sampling and testing for the specified pest as set out in the Annex, and these tests have shown them to be free from the specified pest; (b) an official statement that the specified plants for planting have been produced in a production site which is registered and supervised by the national plant protection organisation in the country of origin and known to be free from the specified pest on the basis of official inspections carried out at the appropriate time to detect that pest, and, in case of symptoms, have undergone official sampling and testing for the specified pest and have been found, according to those tests, to be free from the specified pest; (c) the name of the registered production site.

2. Specified plants of Capsicum spp. varieties which are known to be resistant to the specified pest, originating from third countries, may only be introduced into the Union if they are accompanied by a phytosanitary certificate, which, under the heading ‘Additional Declaration’, confirms that resistance.

Article 9

Introduction of the specified seeds into the Union

1. Specified seeds originating from third countries, other than the ones of Capsicum spp. varieties which are known to be resistant to the specified pest, may only be introduced into the Union if they are accompanied by a phytosanitary certificate, which, under the heading ‘Additional Declaration’, contains the following: (a) an official statement that all of the following conditions have been fulfilled: (i) the mother plants of the specified seeds concerned have been produced in a production site where the specified pest is known not to occur, on the basis of official inspections carried out at the appropriate time to detect the specified pest; ▼M2 (ii) the specified seeds concerned or the mother plants of the specified seeds concerned have undergone official sampling and testing for the specified pest as set out in the Annex and have been found, according to those tests, to be free from the specified pest. When mother plants are tested, the sampling shall take place within the shortest possible time prior to the first harvest of the fruits; ▼B (b) ►M1 information ensuring the traceability of the production site of the mother plants. ◄

2. Specified seeds of Capsicum spp. varieties which are known to be resistant to the specified pest, originating from third countries may only be introduced into the Union if they are accompanied by a phytosanitary certificate, which, under the heading ‘Additional Declaration’ confirms that resistance.

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3. By way of derogation from point (a)(i) of paragraph 1, for the specified seeds, which have been harvested prior to 15 August 2020, the Additional Declaration shall only state the fulfilment of the condition under point (a)(ii) of paragraph 1 and shall include the statement: ‘The seeds have been harvested before 15 August 2020.’

4. In phytosanitary certificates issued after 31 March 2021, the Additional Declaration shall confirm that specified seeds originating from third countries have been tested under one of the testing methods, other than ELISA, as referred to in point 3 of the Annex to Implementing Regulation (EU) 2020/1191.

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Article 10

Official checks on introduction into the Union

No less than 20 % of the consignments of specified seeds and specified plants for planting shall be sampled and tested by the competent authority at the border control posts of first arrival into the Union, or at a control point as referred to in Commission Delegated Regulation (EU) 2019/2123 ( 1 ), as set out in the Annex to this Regulation.

For consignments of specified seeds and specified plants for planting originating in Israel that sampling and testing rate shall be 50 % and for consignments of specified seeds originating in China it shall be 100 %.

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Article 11

Repeal of Implementing Decision (EU) 2019/1615

Implementing Decision (EU) 2019/1615 is repealed from 15 August 2020.

Article 12

Application period

This Regulation shall apply until ►M2 31 May 2023 ◄ .

Article 13

Entry into force

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

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









ANNEX

1. Sampling schemes of seeds, other than seeds of Capsicum spp. varieties which are known to be resistant to the specified pest

Sampling of seeds for testing shall be carried out under the following sampling schemes depending on the seed lots as referred to in the relevant table of the International Standards for Phytosanitary Measures No 31 Methodologies for sampling of consignments (ISPM31):

— for seed lots less than or equal to 3 000 seeds: application of a hypergeometric sampling scheme able to identify with 95 % reliability a level of presence of infected plants of 10 % or above;

— for seed lots of more than 3 000 but less than 30 000 seeds: application of a sampling scheme able to identify with 95 % reliability a level of presence of infected plants of 1 % or above;

— for seed lots of more than 30 000 seeds: application of a sampling scheme able to identify with 95 % reliability a level of presence of infected plants of 0,1 % or above.

Sub samples shall consist of 1 000 seeds maximum for Polymerase Chain Reaction (PCR) methods.

Sub samples shall consist of 250 seeds maximum for the Enzyme Linked Immuno Sorbent Assay (ELISA) method.

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2. Sampling schemes of specified plants, other than those of Capsicum spp. varieties which are known to be resistant to the specified pest

In the case of specified plants, other than those of Capsicum spp. varieties which are known to be resistant to the specified pest, 200 leaves shall be collected per site of production and cultivar, preferably young leaves on the top of the plants.

In case of symptomatic plants, sampling for testing shall be performed on at least 3 symptomatic leaves.

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3. Testing methods for detecting and identifying the specified pest on seeds, other than seeds of Capsicum spp. varieties which are known to be resistant to the specified pest

One of the following testing methods shall be used for the detection of the specified pest on the specified seeds:

— ELISA, until 1 October 2020, only for confirmation of pest freedom for the issuance of plant passports or phytosanitary certificates;

— real-time RT-PCR using the primers and probes described in the ISF protocol (2020) ( 2

— real-time RT-PCR using primers and probe of Menzel and Winter ( Acta Horticulturae , in press).

In case of a positive result of the detection test, a second testing method, different from the one used for detection, shall be carried out with one of the real-time RT-PCR methods listed above, using the same sample to confirm the identification. In the case of inconsistency between detection and identification results obtained for coated seeds, the coating of the seeds shall be removed and the seeds shall be retested.

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4. Testing methods for detecting and identifying the specified pest on the specified plants, other than those of Capsicum spp. varieties which are known to be resistant to the specified pest, and on the specified fruits

One of the following testing methods shall be carried out for the detection of the specified pest on the specified plants, other than those of Capsicum spp. varieties which are known to be resistant to the specified pest, and on the specified fruits:

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— ELISA, only for symptomatic material;

— conventional RT-PCR using the primers of Alkowni et al . (2019);

— conventional RT-PCR using the primers of Rodriguez-Mendoza et a l. (2019);

— real-time RT-PCR using the primers and probes described in the ISF protocol (2020) ( 3 );

— real-time RT-PCR using primers and probe of Menzel and Winter ( Acta Horticulturae , in press).

In case of a positive result of the detection test, a second testing method, different from the one used for detection, shall be carried out with one of the RT-PCR methods listed above, using the same sample to confirm the identification.