02020R1191-20210130

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Document 02020R1191-20210130

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Consolidated text: 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

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02020R1191 — EN — 30.01.2021 — 001.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B	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 (OJ L 262 12.8.2020, p. 6)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION IMPLEMENTING REGULATION (EU) 2021/74 of 26 January 2021	L 27	15	27.1.2021

▼B

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);

(b)

‘specified plants for planting’ means plants for planting of Solanum lycopersicum L. and Capsicum spp. other than seeds;

(c)

‘specified seeds’ means seeds of Solanum lycopersicum L. and Capsicum spp;

(d)

‘specified fruits’ means fruits of Solanum lycopersicum L. and Capsicum spp.

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

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.

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.

Article 4

Measures concerning the confirmed presence of the specified pest

Where the presence or the suspected presence of the specified pest is 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.

Article 5

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

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.

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.

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

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.

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

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;

(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;

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 point (c) of Article 87(3) of Regulation (EU) 2016/2031.

(c)

the origin of all lots of specified seeds are recorded and documented.

▼M1

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

▼M1

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.

▼B

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

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

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.

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

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;

(ii)

►M1 the specified seeds concerned or their mother plants 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; ◄

(b)

►M1 information ensuring the traceability of the production site of the mother plants. ◄

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.

▼M1

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.’

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.

▼B

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 post of first arrival into the Union, as set out in the Annex.

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 31 May 2022.

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.

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

In the case of plants for planting, 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.

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) ( 1 )

—

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.

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

—

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 al. (2019);

—

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 RT-PCR methods listed above, using the same sample to confirm the identification.

( 1 ) Protocol developed by the International Seed Federation (International Seed Health Initiative for Vegetable Crops (ISHI-Veg).

( 2 ) Protocol developed by the International Seed Federation (International Seed Health Initiative for Vegetable Crops (ISHI-Veg).

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