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Document 02020R1201-20211223
Commission Implementing Regulation (EU) 2020/1201 of 14 August 2020 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.)
Consolidated text: Commission Implementing Regulation (EU) 2020/1201 of 14 August 2020 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.)
Commission Implementing Regulation (EU) 2020/1201 of 14 August 2020 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.)
ELI: http://data.europa.eu/eli/reg_impl/2020/1201/2021-12-23
02020R1201 — EN — 23.12.2021 — 002.001
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
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1201 of 14 August 2020 (OJ L 269 17.8.2020, p. 2) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1688 of 20 September 2021 |
L 332 |
6 |
21.9.2021 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/2130 of 2 December 2021 |
L 432 |
19 |
3.12.2021 |
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Corrected by:
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1201
of 14 August 2020
as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.)
CHAPTER I
DEFINITIONS
Article 1
Definitions
For the purposes of this Regulation, the following definitions shall apply:
‘specified pest’ means Xylella fastidiosa (Wells et al.) and any of its subspecies;
‘host plants’ means all plants for planting, other than seeds, belonging to the genera or species listed in Annex I;
‘specified plants’ means host plants for planting, other than seeds, belonging to the genera or species listed in Annex II and known to be susceptible to the specific subspecies of the specified pest.
CHAPTER II
ANNUAL SURVEYS FOR THE PRESENCE OF THE SPECIFIED PEST AND CONTINGENCY PLANS
Article 2
Surveys of the specified pest in the territories of the Member States
Article 3
Contingency plans
Each Member State shall establish a contingency plan. That contingency plan shall set out the actions to be taken in its territory concerning:
the eradication of the specified pest, as set out in Articles 7 to 11;
the movements of specified plants within the Union, as set out in Articles 19 to 26;
the official checks to be carried out on movements of specified plants within the Union and of host plants into the Union, as set out in Articles 32 and 33.
Each Member State shall update its contingency plan, as appropriate, by 31 December of each year. Contingency plans established under Implementing Decision (EU) 2015/789 shall be updated by 31 December 2020.
In addition to the elements referred to in Article 25(2) of Regulation (EU) 2016/2031, the contingency plan shall include all of the following elements:
the minimum resources to be made available and the procedures for making those additional resources available in case of a confirmed or suspected presence of the specified pest;
rules detailing the procedures for identifying the owners of the plants to be removed, for notifying the order of removal and for accessing private properties.
CHAPTER III
DEMARCATED AREAS
Article 4
Establishment of demarcated areas
Where only the presence of one or more particular subspecies of the specified pest is confirmed, the Member State concerned may demarcate an area with regard to those subspecies only.
Where the confirmation of the presence of a subspecies is pending, the Member State concerned shall demarcate that area with regard to the specified pest and all of its possible subspecies.
The infected zone shall have a radius of at least 50 m around the plant found infected by the specified pest.
The buffer zone shall be of the following width:
at least 2,5 km in the case of an infected zone established for the purpose of taking the eradication measures referred to in Articles 7 to 11;
at least 5 km in the case of an infected zone established for the purpose of taking the containment measures referred to in Articles 12 to 17.
Article 5
Derogations for the establishment of demarcated areas
By way of derogation from Article 4, the buffer zone surrounding the infected zone established for the purpose of eradication may be reduced to a width of no less than 1 km, where there is a high degree of confidence that the initial presence of the specified pest did not result in its spread and where all of the following conditions have been fulfilled:
all specified plants located in the infected zone, irrespective of their health status, have been immediately sampled and removed;
no other plants have been found infected by the specified pest in the infected zone since the eradication measures have been taken, on the basis of official tests carried out at least once during the course of the year, taking into account the Authority’s Pest Survey Card on Xylella fastidiosa;
a survey has been carried out at least once during the first year following the identification of the specified pest in a zone with a width of at least 2,5 km surrounding the infected zone, which shows that the specified pest has not been found present in that zone. The Member State concerned shall sample and test the host plants located in that zone. For that purpose, and taking into account the Authority’s Guidelines for statistically sound and risk-based surveys of Xylella fastidiosa, the survey design and sampling scheme shall be able to identify with at least 90 % confidence a level of presence of infected plants of 1 %, taking into account that the first 400 m surrounding the infected plants has a higher risk compared to the other part of that area;
no vectors carrying the specified pest have been detected in the infected zone and its immediate vicinity since the eradication measures have been taken, on the basis of tests carried out twice during the flight season of the vector, and in accordance with International Standards for Phytosanitary Measures. Those tests shall lead to the conclusion that the natural spread of the specified pest is excluded.
By way of derogation from Article 4, the Member State concerned may decide not to establish a demarcated area immediately, where all of the following conditions are fulfilled:
there is evidence that the specified pest was recently introduced into the area with the plants on which it was found, or that the specified pest has been found in a site with physical protection from the vectors of that pest;
the results of inspection activities indicate that those plants were infected before their introduction into the area concerned;
no vectors carrying the specified pest have been detected, on the basis of tests carried out in the vicinity of those plants.
In the case referred to in paragraph 3, the Member State concerned shall:
carry out, in the area where the presence of the specified pest was first confirmed, an annual survey for at least two years to determine whether any other plants have been infected and whether any further measures should be taken;
notify to the Commission and the other Member States the justification for not establishing a demarcated area, and the outcome of the survey referred to in point (a) as soon as it becomes available.
Article 6
Lifting of the demarcated areas
By way of derogation from paragraph 1, in the case where the Member State concerned has reduced the buffer zone to a width of no less than 1 km in accordance with Article 5(1), the Member State may lift the demarcated area after 12 months since its initial establishment, where both of the following conditions are fulfilled:
as a result of the measures taken pursuant to Article 5(1), it is concluded with a high degree of confidence that the initial presence of the specified pest was an isolated case and no further spread occurred in the respective demarcated area;
as practically close to the time of lifting, official tests have been carried out within the demarcated area, taking into account the Authority’s Pest Survey Card on Xylella fastidiosa. For that purpose, and taking into account the Authority’s Guidelines for statistically sound and risk-based surveys of Xylella fastidiosa, the survey design and sampling scheme shall be able to identify with at least 95 % confidence a level of presence of infected plants of 1 %.
CHAPTER IV
ERADICATION MEASURES
Article 7
Removal of plants
The Member State concerned shall immediately remove from the infected zone:
plants known to be infected by the specified pest;
plants showing symptoms indicating possible infection by that pest or suspected to be infected by that pest;
plants which belong to the same species as that of the infected plant, regardless of their health status;
plants of other species than that of the infected plant, which have been found infected in other parts of the demarcated area;
specified plants, other than the ones referred to in points (c) and (d), which have not been immediately subjected to sampling and molecular testing and have not been found free from the specified pest.
By way of derogation from points (b), (c) and (d) of paragraph 1, Member States may decide that individual specified plants officially designated as plants with historic value do not need to be removed, provided that all of the following conditions have been fulfilled:
the specified plants concerned are subject to annual inspection, sampling and testing by one of the molecular tests listed in Annex IV and it is confirmed that they are not infected by the specified pest;
the individual specified plants or the area concerned are subject to appropriate phytosanitary treatments against the vector population of the specified pest, in all its stages. Those treatments may include chemical, biological or mechanical methods, taking into account the local conditions.
Article 8
Measures against the vectors of the specified pest
Article 9
Destruction of plants
Article 10
Annual surveillance of the demarcated area
In the entire demarcated area, the Member State concerned shall monitor, at the most appropriate times, the presence of the specified pest by annual surveys, in accordance with Article 2(5) and (6), and taking into account the information referred to in the Authority’s Pest Survey Card on Xylella fastidiosa.
In the infected zones, the Member State concerned shall sample and test the host plants, including the specified plants which have not been removed pursuant to Article 7(1). For that purpose, and taking into account the Authority’s Guidelines for statistically sound and risk-based surveys of Xylella fastidiosa, the survey design and sampling scheme shall be able to identify with at least 90 % confidence a level of presence of infected plants of 0,5 %.
In buffer zones, the Member State concerned shall sample and test the host plants, as well as other plants showing symptoms indicating possible infection or suspected to be infected by that pest. For that purpose, and taking into account the Authority’s Guidelines for statistically sound and risk-based surveys of Xylella fastidiosa, the survey design and sampling scheme shall be able to identify with at least 90 % confidence a level of presence of infected plants of 1 %, taking into account that the first 400 m surrounding the infected zones has a higher risk.
The Member State concerned shall also monitor the presence of the specified pest in the vectors located in the demarcated area in order to determine the risk of further spreading posed by vectors and to evaluate the effectiveness of the phytosanitary control measures applied in accordance with Article 8.
Article 11
Other relevant measures for the eradication of the specified pest
CHAPTER V
CONTAINMENT MEASURES
Article 12
General provisions
The competent authority of the Member State concerned may decide to apply the containment measures set out in Articles 13 to 17, instead of eradication measures, in an infected zone listed in Annex III.
Article 13
Removal of plants in an infected zone listed in Annex III
That removal shall take place immediately after the official identification of the presence of the specified pest or, if the specified pest is detected outside the flight season of the vector, that removal shall take place before the next flight season of the vector. All necessary precautions shall be taken to avoid spreading of the specified pest and its vectors during and after removal.
Article 14
Measures against the vectors of the specified pest in the infected zones listed in Annex III
Article 15
Annual surveillance of the infected zones listed in Annex III
The Member State concerned shall, at least in the parts of the infected zone referred to in paragraph 2, immediately sample and test, within a radius of 50 m around the plants which have been found to be infected by the specified pest, the following plants:
all specified plants which belong to the species of the specified plants which have been found infected in the same demarcated area; and
all other plants showing symptoms indicating possible infection by that pest or suspected to be infected by that pest.
The Member State concerned shall monitor, at the most appropriate times, the presence of the specified pest by annual surveys, taking into account the information referred to in the Authority’s Pest Survey Card on Xylella fastidiosa. That monitoring shall take place at least in the following parts of the infected zone listed in Annex III:
within an area measuring at least 5 km from the border of the infected zone with the buffer zone;
in the proximity of the sites of plants with particular cultural and social value located outside the area referred to in point (a) and designated accordingly by the Member State.
In those parts of the infected zone, the Member State concerned shall carry out sampling and testing of the species of host plants found infected in the demarcated area, in accordance with Article 2(6). For that purpose, taking into account the Authority’s Guidelines for statistically sound and risk-based surveys of Xylella fastidiosa, the survey design and sampling scheme shall be able to identify with at least 90 % confidence a level of presence of infected plants of 0,7 %. It shall also sample and test the vector population for the presence of the specified pest.
Article 16
Destruction of plants
Article 17
Other relevant measures for the containment of the specified pest
The Member State concerned shall take measures addressing any particularity or complication that could reasonably be expected to prevent, hinder or delay containment, in particular those related to the adequate destruction of all plants that are infected or suspected of infection, or to the accessibility of their location, public or private ownership or the person or entity responsible for them.
CHAPTER VI
PLANTING OF SPECIFIED PLANTS IN INFECTED ZONES
Article 18
Authorisation concerning the planting of specified plants in infected zones
The planting of specified plants in infected zones may only be authorised by the Member State concerned in one of the following cases:
those specified plants are grown in insect-proof sites of production free from the specified pest and its vectors;
those specified plants preferably belong to varieties assessed as being resistant or tolerant to the specified pest and are planted in the infected zones listed in Annex III, but outside the area referred to in Article 15(2)(a);
those specified plants belong to the same species of plants which have been tested and found free from the specified pest on the basis of the survey activities carried out for at least the past two years in accordance with Article 10 and are planted in the infected zones established for the purpose of eradication.
CHAPTER VII
MOVEMENT WITHIN THE UNION OF SPECIFIED PLANTS
Article 19
Movement out of a demarcated area, and from the respective infected zones into the buffer zones, of specified plants which have been grown in authorised production sites located in that demarcated area
The movement out of a demarcated area, and from the respective infected zones into the buffer zones, of specified plants which have been grown in a production site located in that demarcated area, may only be allowed where all of the following conditions are fulfilled:
the specified plants have been grown during their entire production cycle in a site that has been authorised in accordance with Article 24 or have been present in such a site for at least the last three years;
throughout the time of growth of the specified plants, neither the presence of the specified pest nor that of its vectors were found in the site;
the specified plants are subject to phytosanitary treatments against the vector population, in all its stages, at appropriate times of the year to maintain freedom from vectors of the specified pest. Those treatments shall include, as appropriate, efficient chemical, biological or mechanical methods, taking into account the local conditions;
the specified plants are transported through or within the demarcated area in closed containers or packaging, ensuring that infection with the specified pest or any of its vectors cannot occur;
as close as possible to the time of movement, the specified plants have been subjected to molecular testing for the presence of the specified pest on the basis of a test listed in Annex IV, using a sampling scheme able to identify with at least 80 % confidence a level of presence of infected plants of 1 %.
Article 20
Movement out of a demarcated area, and from the respective infected zones into the buffer zones, of specified plants which have never been found infected in that demarcated area
The movement out of a demarcated area, and from the respective infected zone into the buffer zones, of specified plants which have never been found infected in that demarcated area, may only be allowed where all of the following conditions are fulfilled:
the specified plants have been grown in a site that belongs to a professional operator registered in accordance with Article 65 of Regulation (EU) 2016/2031;
the specified plants belong to species of plants which have been grown for at least part of their life in a demarcated area and have been subjected, during three years from the establishment of the demarcated area, to survey activities as referred to in Articles 10 and 15 and never found to be infected with the specified pest;
the species of the specified plants referred to in point (b) are published in the Commission database of host plants which are not known to be infected in that specific demarcated area;
the specified plants are subject to phytosanitary treatments against the vector population, in all its stages, at appropriate times of the year to maintain freedom from vectors of the specified pest. Those treatments shall include, as appropriate, efficient chemical, biological or mechanical methods based on local conditions;
as practically close to the time of movement as possible, the lots of the specified plants were subjected to inspection and molecular testing by the competent authority, using a sampling scheme able to identify with at least 95 % confidence a level of presence of infected plants of 1 %;
as practically close to the time of movement as possible, the lots of the specified plants were subjected to phytosanitary treatments against all vectors of the specified pest.
Article 21
Movement out of a demarcated area, and from the respective infected zones into the buffer zones, of specified plants which have been grown for the entire production cycle in vitro in that demarcated area
The movement out of a demarcated area, and from the respective infected zones into the buffer zones, of specified plants which have been grown for the entire production cycle in vitro in that demarcated area, may only be allowed where all of the following conditions are fulfilled:
the specified plants have been grown for their entire production cycle in a site that has been authorised in accordance with Article 24;
the specified plants have been grown in a transparent container under sterile conditions and fulfil one of the following conditions:
they have been grown from seeds;
they have been propagated, under sterile conditions, from mother plants which have spent their entire lives in an area of the Union territory free from the specified pest and which have been tested and found free from the specified pest;
they have been propagated, under sterile conditions, from mother plants which have been grown in a site fulfilling the conditions laid down in Article 19 and which have been tested and found free from the specified pest using a sampling scheme able to identify with at least 95 % confidence a level of presence of infected plants of 1 %;
the specified plants are transported through or within demarcated areas in a container under sterile conditions that precludes the possibility of infection by the specified pest through its vectors.
Article 22
Movement out of a demarcated area, and from the respective infected zones into the buffer zones, of dormant plants of Vitis which have been grown for part of their life in that demarcated area
Movement out of a demarcated area, and from the respective infected zones into the buffer zones, of dormant plants of Vitis intended for planting, other than seeds, which have been grown for part of their life in that demarcated area and are listed as specified plants for that demarcated area, may only be allowed where all of the following conditions are fulfilled:
the plants have been grown in a site that belongs to an operator registered in accordance with Article 65 of Regulation (EU) 2016/2031;
as practically close to the time of movement as possible, the plants have undergone an appropriate thermotherapy treatment in a treatment facility authorised and supervised by the competent authority for that purpose, whereby the dormant plants are submerged for 45 minutes in water heated to 50 °C.
Article 23
Movement within the infected zones, within the buffer zones, and from the buffer zones into their respective infected zones, of specified plants which have been grown for part of their life in a demarcated area
The movement within the infected zones, within the buffer zones, and from the buffer zones into their respective infected zones, of specified plants which have been grown for at least part of their life in a demarcated area may only be allowed where all of the following conditions are fulfilled:
the specified plants have been grown in a site that belongs to an operator registered in accordance with Article 65 of Regulation (EU) 2016/2031;
that site is subject to annual sampling and testing by the competent authority for the presence of the specified pest, taking into account the information set out in the Authority’s Pest Survey Card on Xylella fastidiosa;
the results of the annual inspection and of the testing of a representative sample confirm the absence of the specified pest;
the specified plants are subject to phytosanitary treatments against the vector population, in all its stages, at appropriate times of the year to maintain freedom from vectors of the specified pest. Those treatments shall include, as appropriate, efficient chemical, biological or mechanical methods, taking into account the local conditions;
the professional operators shall ask the person receiving those plants to sign a declaration that those plants are not going to be moved out of those zones.
Article 24
Authorisation of production sites
The competent authority may only authorise a production site for the purposes of Articles 19 and 21 where it fulfils all of the following conditions:
it is registered in accordance with Article 65 of Regulation (EU) 2016/2031;
it has been authorised by the competent authority as a site physically protected against the specified pest and its vectors;
it has been subjected annually to at least two inspections by the competent authority, at the most appropriate time.
It shall transmit that list to the Commission and the other Member States immediately after establishing or updating that list.
Article 25
Movement within the Union of specified plants which have never been grown inside a demarcated area
Specified plants which have never been grown inside a demarcated area may only be moved within the Union where they have been grown in a site that fulfils the following conditions:
it belongs to a professional operator registered in accordance with Article 65 of Regulation (EU) 2016/2031 and is subject to annual inspection by the competent authority;
it is subject, as appropriate for the level of risk, to sampling and testing for the presence of the specified pest, using a test listed in Annex IV and taking into account the information set out in the Authority’s Pest Survey Card on Xylella fastidiosa.
By way of derogation from paragraph 1, plants for planting, other than seeds, of Coffea, Lavandula dentata L., Nerium oleander L., Olea europaea L., Polygala myrtifolia L. and Prunus dulcis (Mill.) D.A. Webb, may only be moved for the first time within the Union where the following conditions are fulfilled:
they have been grown in a site that is subject to annual inspection by the competent authority;
that site is subject to sampling and testing for the presence of the specified pest, taking into account the information set out in the Authority Pest Survey Card on Xylella fastidiosa and using a sampling scheme able to identify with at least 80 % confidence a level of presence of infected plants of 1 %.
Article 26
Movement within the Union of pre-basic mother plants or pre-basic material, which have been grown outside a demarcated area
Pre-basic mother plants as defined in Article 1(3) of Commission Implementing Directive 2014/98/EU ( 3 ) or pre-basic material as defined in Article 2(5) of Council Directive 2008/90/EC ( 4 ) which belong to the species Juglans regia L., Olea europaea L., Prunus amygdalus Batsch, P. amygdalus x P. persica, P. armeniaca L., P. avium (L.) L., P. cerasus L., P. domestica L., P. domestica x P. salicina, P. dulcis (Mill.) D.A. Webb, P. persica (L.) Batsch, and P. salicina Lindley and which have been grown outside a demarcated area and spent at least part of their life outside insect-proof facilities, may only be moved within the Union where they are accompanied by a plant passport and the following conditions have been fulfilled:
they have been certified in accordance with Article 1 of Commission Implementing Decision (EU) 2017/925 ( 5 );
within the shortest possible time prior to their movement, they have been subjected to visual inspection, sampling and molecular testing for the presence of the specified pest carried out in accordance with International Standards for Phytosanitary Measures.
Article 27
Plant passports
The plants referred to in Articles 19 to 26 shall only be moved within the Union if accompanied by a plant passport, subject to the requirements of Articles 78 to 95 of Regulation (EU) 2016/2031.
In the case of the specified plants referred to in Article 23, the following additional conditions shall apply:
in the case where they move within the infected zones only, the indication ‘Infected Zone – XYLEFA’ shall be included next to the traceability code referred to in paragraph 1(e) of Part A of Annex VII to Regulation (EU) 2016/2031;
in the case where they move within the buffer zone, or from the buffer zone into the infected zone, the indication ‘Buffer Zone and Infected Zone – XYLEFA’ shall be included next to the traceability code referred to in paragraph 1 (e) of Part A of Annex VII to Regulation (EU) 2016/2031.
CHAPTER VIII
INTRODUCTION INTO THE UNION OF HOST PLANTS
Article 28
Introduction into the Union of host plants originating in a third country where the specified pest is known not to be present
Host plants originating in a third country where the specified pest is known not to be present, may only be introduced into the Union where the following conditions are fulfilled:
the national plant protection organisation of the third country concerned has communicated in writing to the Commission that the specified pest is known not to be present in the country on the basis of inspection, sampling and molecular testing by the competent authority, using a test listed in Annex IV, and in accordance with relevant International Standards for Phytosanitary Measures. Taking into account the Authority’s Guidelines for statistically sound and risk-based surveys of Xylella fastidiosa, the survey design and sampling scheme used are able to identify with at least 80 % confidence a level of presence of infected plants at national level of 1 %;
the host plants are accompanied by a phytosanitary certificate stating under the rubric ‘Additional Declaration’ that the specified pest is not present in the country;
host plants have been grown in a site that is subject to annual inspection by the competent authority and, as appropriate for the level of risk, with sampling and testing, listed in Annex IV, carried out at the appropriate times on those plants for the presence of the specified pest;
plants for planting, other than seeds, of Coffea, Lavandula dentata L., Nerium oleander L., Olea europaea L., Polygala myrtifolia L. and Prunus dulcis (Mill.) D.A. Webb, have been grown in a site that is subject to annual inspection by the competent authority, with sampling and testing, listed in Annex IV, carried out at the appropriate times on those plants for the presence of the specified pest, using a sampling scheme able to identify with at least 80 % confidence a level of presence of infected plants of 1 %;
on entry into the Union, the host plants have been checked by the competent authority in accordance with Article 33 and the presence of the specified pest has not been found.
Article 29
Introduction into the Union of host plants originating in a pest free area of an infected country
Host plants originating in a third country where the specified pest is known to be present may only be introduced into the Union where all of the following conditions are fulfilled:
the host plants originate in an area which has been declared to be free from the specified pest, by the national plant protection organisation concerned in accordance with the relevant International Standards for Phytosanitary Measures and on the basis of official surveys based on sampling and testing, using a test listed in Annex IV. Taking into account the Authority’s Guidelines for statistically sound and risk-based surveys of Xylella fastidiosa, the survey design and sampling scheme used are able to identify with at least 80 % confidence a level of presence of infected plants of 1 %;
the national plant protection organisation of the third country concerned has communicated in writing to the Commission the name of that area;
the host plants are accompanied by a phytosanitary certificate stating under the rubric ‘place of origin’ that the host plants concerned have spent their entire life in the area referred to in point (a), with specific reference to the name of that area;
host plants have been grown in a site that is subject to annual inspection by the competent authority and, as appropriate for the level of risk, with sampling and testing, listed in Annex IV, carried out at the appropriate times on those plants for the presence of the specified pest;
plants for planting, other than seeds, of Coffea, Lavandula dentata L., Nerium oleander L., Olea europaea L., Polygala myrtifolia L. and Prunus dulcis (Mill.) D.A. Webb, have been grown in a site that is subject to annual inspection by the competent authority, with sampling and testing, listed in Annex IV, carried out at the appropriate times on those plants for the presence of the specified pest, using a sampling scheme able to identify with at least 80 % confidence a level of presence of infected plants of 1 %;
on entry into the Union, the host plants have been checked by the competent authority in accordance with Article 33 and the presence of the specified pest has not been found.
Article 30
Introduction into the Union of host plants originating in a pest free production site of an infected country
Host plants originating in a third country where the specified pest is known to be present may only be introduced into the Union where the following conditions are fulfilled:
the host plants originate in a production site that has been authorised as pest free by the national plant protection organisation in accordance with Article 31;
the national plant protection organisation of the third country concerned has communicated in writing to the Commission the list of pest free production sites, including their location within the country;
the host plants are accompanied by a phytosanitary certificate stating the following:
under the rubric ‘additional declaration’, that the host plants have been produced for their entire production cycle in one or more sites authorised as pest free by the national plant protection organisation in accordance with Article 31 and that the host plants have been transported in closed containers or packaging, ensuring that infection with the specified pest through its vectors cannot occur;
under the rubric ‘place of origin’, the name or code of the pest free production site(s);
on entry into the Union, the host plants have been checked by the competent authority in accordance with Article 33 and the presence of the specified pest has not been found.
Host plants which originate in a third country where the specified pest is known to be present and have been grown for the entire production cycle in vitro, may only be introduced into the Union where the following conditions are fulfilled:
the host plants meet one of the following conditions:
they have been grown from seeds;
they have been propagated, under sterile conditions, from mother plants which have spent their entire lives in an area free from the specified pest and which have been tested and found free from the specified pest;
they have been propagated, under sterile conditions, from mother plants which have been grown in a site fulfilling the conditions of Article 31 and which have been tested and found free from the specified pest;
the host plants have been grown in a production site that has been authorised as pest free by the national plant protection organisation in accordance with Article 31;
the national plant protection organisation of the third country concerned has communicated in writing to the Commission the list of pest free production sites, including their location within the country.;
the host plants are accompanied by a phytosanitary certificate stating the following:
under the rubric ‘additional declaration’, that the host plants have been produced in vitro for their entire production cycle in one or more sites authorised as pest free by the national plant protection organisation in accordance with Article 31 and that the host plants have been transported in closed containers or packaging, ensuring that infection with the specified pest or any of its known vectors cannot occur;
under the rubric ‘place of origin’, the name or code of the pest free production site.
Article 31
Authorisation of production sites as pest free
A production site may only be authorised as pest free where all of the following conditions are fulfilled:
the production site has been declared by the national plant protection organisation as an insect-proof site free from the specified pest and its vectors, in accordance with the relevant International Standards for Phytosanitary Measures;
the production site has undergone phytosanitary treatments against the vector population, in all its stages, at appropriate times of the year to maintain freedom from vectors of the specified pest. Those treatments shall include efficient chemical, biological or mechanical methods based on local conditions;
the production site is subjected annually to at least two inspections by the competent authority, at the most appropriate time;
as close as possible to the time of movement, the host plants originating in the production site have been subjected to molecular testing for the presence of the specified pest using a test listed in Annex IV and using a sampling scheme able to identify with at least 90 % confidence a level of presence of infected plants of 1 %.
Where during the annual inspections, the competent authorities detect the presence of the specified pest, or damages compromising the insect-proof conditions of the pest free production site, they shall immediately revoke the authorisation of the site and temporarily suspend the movement of the host plants. They shall immediately inform the Commission thereof.
CHAPTER IX
OFFICIAL CHECKS ON MOVEMENT OF SPECIFIED PLANTS WITHIN, AND OF HOST PLANTS INTO, THE UNION
Article 32
Official checks on movements of specified plants within the Union
Article 33
Official checks at introduction into the Union
CHAPTER X
COMMUNICATION ACTIVITIES
Article 34
Awareness campaigns
CHAPTER XI
FINAL PROVISIONS
Article 35
Reporting on measures by Member States
The results of the surveys carried out pursuant to Articles 10 and 15 in demarcated areas shall be transmitted to the Commission using the templates referred to in Annex V.
Article 36
Compliance
Member States shall, as necessary in order to comply with this Regulation, repeal or amend the measures, which they have adopted to protect themselves against the introduction and spread of the specified pest. They shall immediately inform the Commission of the repeal or amendment of those measures.
Article 37
Repeal
Implementing Decision (EU) 2015/789 is repealed.
Article 38
Entry into force and application
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
However, the second sentence of Article 2(4), the third sentence of Article 5(1)(c), the second sentence of Article 28(a) and the second sentence of Article 29(a) shall apply from 1 January 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
‘ANNEX I
List of plants known to be susceptible to one or more subspecies of the specified pest (“host plants”)
Acacia
Acer
Adenocarpus lainzii
Albizia julibrissin Durazz.
Alnus rhombifolia Nutt.
Amaranthus retroflexus L.
Ambrosia
Ampelopsis arborea (L.) Koehne
Ampelopsis brevipedunculata (Maxim.) Trautv.
Ampelopsis cordata Michx.
Anthyllis hermanniae L.
Artemisia
Asparagus acutifolius L.
Athyrium filix-femina
Baccharis
Brassica
Calicotome spinosa (L.) Link
Calicotome villosa (Poiret) Link
Callicarpa americana L.
Callistemon citrinus (Curtis) Skeels
Calluna vulgaris (L.) Hull
Carya
Catharanthus roseus
Celtis occidentalis L.
Cercis canadensis L.
Cercis occidentalis Torr.
Cercis siliquastrum L.
Chamaecrista fasciculata (Michx.) Greene
Chenopodium album L.
Chionanthus
Chitalpa tashkentensis T. S. Elias & Wisura
Cistus
Citrus
Clematis cirrhosa L.
Coelorachis cylindrica (Michx.) Nash Coffea
Conium maculatum L.
Convolvulus cneorum L.
Coprosma repens A.Rich.
Coronilla
Cyperus eragrostis Lam.
Cytisus
Digitaria
Diospyros kaki L.f.
Diplocyclos palmatus (L.) C.Jeffrey
Dodonaea viscosa (L.) Jacq.
Echium plantagineum
Elaeagnus angustifolia L.
Encelia farinosa A. Gray ex Torr.
Eremophila maculata (Ker Gawler) F. von Müller.
Erigeron
Erodium moschatum (L.) L’Hérit.
Erysimum hybrids
Euphorbia chamaesyce L.
Euphorbia terracina L.
Euryops chrysanthemoides (DC.) B.Nord
Euryops pectinatus (L.) Cass.
Fagus crenata Blume
Fallopia japonica (Houtt.) Ronse Decr.
Fatsia japonica (Thunb.) Decne. & Planch.
Ficus carica L.
Fortunella
Frangula alnus Mill.
Fraxinus
Genista
Ginkgo biloba L.
Gleditsia triacanthos L.
Grevillea juniperina Br.
Hebe
Helianthus
Helichrysum
Heliotropium europaeum L.
Hemerocallis
Hevea brasiliensis (Willd. ex A.Juss.) Müll.Arg.
Hibiscus
Humulus scandens (Lour.) Merr.
Ilex aquifolium L.
Ilex vomitoria Sol. ex Aiton
Iva annua L.
Jacaranda mimosifolia D. Don
Juglans
Juniperus ashei J. Buchholz
Koelreuteria bipinnata Franch.
Lagerstroemia
Laurus nobilis L.
Lavandula
Lavatera cretica
Ligustrum lucidum L.
Liquidambar styraciflua L.
Lonicera implexa
Lonicera japonica Thunb.
Lupinus aridorum
Lupinus villlosus
Magnolia grandiflora L.
Mallotus paniculatus (Lam.) Müll.Arg.
Medicago arborea L.
Medicago sativa L.
Metrosideros
Mimosa
Modiola caroliniana (L.) G. Don
Morus
Myoporum insulare R. Br.
Myrtus communis L.
Nandina domestica Murray
Neptunia lutea (Leavenw.) Benth.
Nerium oleander L.
Olea
Osteospermum ecklonis DC.
Osteospermum fruticosum (L.) Norl.
Parthenocissus quinquefolia (L.) Planch.
Paspalum dilatatum Poir.
Pelargonium
Perovskia abrotanoides
Persea americana Mill.
Phagnalon saxatile (L.) Cass.
Phillyrea angustifolia L.
Phillyrea latifolia L.
Phlomis fruticosa L.
Phoenix
Pinus taeda L.
Pistacia vera L.
Plantago lanceolata L.
Platanus
Pluchea odorata (L.) Cass.
Polygala grandiflora
Polygala myrtifolia L.
Prunus
Psidium
Pteridium aquilinum
Pyrus
Quercus
Ratibida columnifera (Nutt.) Wooton & Standl.
Rhamnus
Rhus
Robinia pseudoacacia L.
Rosa
Rubus
Ruta chalepensis
Salvia mellifera Greene
Salvia officinalis
Salvia rosmarinus
Sambucus
Santolina chamaecyparissus L.
Santolina magonica
Sapindus saponaria L.
Sassafras
Setaria magna Griseb.
Solidago fistulosa Mill.
Solidago virgaurea L.
Sorghum halepense (L.) Pers.
Spartium
Stewartia pseudocamellia
Strelitzia reginae Aiton
Streptocarpus
Symphyotrichum divaricatum (Nutt.) G.L.Nesom
Teucrium capitatum L.
Trifolium repens L.
Ulex
Ulmus
Vaccinium
Vinca
Vitis
Westringia fruticosa (Willd.) Druce
Westringia glabra R.Br.
Xanthium strumarium L.
ANNEX II
List of plants known to be susceptible to specific subspecies of the specified pest (“specified plants”)
Specified plants susceptible to Xylella fastidiosa subspecies fastidiosa
Acer
Ambrosia artemisiifolia L.
Calicotome spinosa (L.) Link
Cercis occidentalis Torr.
Cistus monspeliensis L.
Citrus sinensis (L.) Osbeck
Coffea
Erysimum
Genista lucida L.
Juglans regia L.
Lupinus aridorum
Magnolia grandiflora L.
Medicago sativa L.
Metrosideros
Morus
Nerium oleander L.
Pluchea odorata (L.) Cass.
Polygala myrtifolia L.
Prunus
Psidium
Rhamnus alaternus L.
Rubus rigidus Sm.
Rubus ursinus Cham. & Schldl.
Ruta chalepensis
Salvia rosmarinus
Sambucus
Spartium junceum L.
Streptocarpus
Teucrium capitatum L.
Ulmus americana L.
Vaccinium corymbosum
Vinca
Vitis
Specified plants susceptible to Xylella fastidiosa subspecies multiplex
Acacia
Acer griseum (Franch.) Pax
Acer pseudoplatanus L.
Acer rubrum L.
Adenocarpus lainzii
Alnus rhombifolia Nutt.
Ambrosia
Ampelopsis cordata Michx.
Anthyllis hermanniae L.
Artemisia
Asparagus acutifolius L.
Athyrium filix-femina
Baccharis halimifolia L.
Calicotome spinosa (L.) Link
Calicotome villosa (Poir.) Link
Callistemon citrinus (Curtis) Skeels
Calluna vulgaris (L.) Hull
Carya
Celtis occidentalis L.
Cercis canadensis L.
Cercis occidentalis Torr.
Cercis siliquastrum L.
Chionanthus
Cistus
Clematis cirrhosa L.
Convolvulus cneorum L.
Coprosma repens A. Rich.
Coronilla
Cytisus
Dodonaea viscosa (L.) Jacq.
Echium plantagineum
Elaeagnus angustifolia L.
Encelia farinosa Gray ex Torr.
Erigeron
Erodium moschatum
Euryops chrysanthemoides (DC.) B.Nord.
Euryops pectinatus (L.) Cass.
Fallopia japonica (Houtt.) Ronse Decr.
Ficus carica L.
Frangula alnus Mill.
Fraxinus
Genista
Ginkgo biloba L.
Gleditsia triacanthos L.
Grevillea juniperina Br.
Hebe
Helianthus
Helichrysum
Hibiscus syriacus
Ilex aquifolium L.
Iva annua L.
Koelreuteria bipinnata Franch.
Lagerstroemia
Laurus nobilis L.
Lavandula
Lavatera cretica
Liquidambar styraciflua L.
Lonicera
Lupinus aridorum
Lupinus villosus Willd.
Magnolia grandiflora L.
Medicago arborea L.
Medicago sativa L.
Metrosideros
Myrtus communis L.
Nerium oleander
Olea
Osteospermum ecklonis (DC.) Norl.
Pelargonium
Perovskia abrotanoides
Phagnalon saxatile (L.) Cass.
Phillyrea angustifolia L.
Phillyrea latifolia
Phlomis fruticosa L.
Pistacia vera L.
Plantago lanceolata L.
Platanus
Polygala grandiflora
Polygala myrtifolia L.
Prunus
Pteridium aquilinum
Quercus
Ratibida columnifera (Nutt.) Wooton & Standl.
Rhamnus
Robinia pseudoacacia L.
Rosa
Rubus
Salvia mellifera Greene
Salvia officinalis
Salvia rosmarinus
Sambucus
Santolina chamaecyparissus L.
Santolina magonica
Sapindus saponaria L.
Solidago virgaurea L.
Spartium
Strelitzia reginae Aiton
Ulex
Ulmus
Vaccinium
Vinca
Westringia fruticosa Guerin.
Xanthium strumarium L.
Specified plants susceptible to Xylella fastidiosa subspecies pauca
Acacia
Amaranthus retroflexus L.
Asparagus acutifolius L.
Catharanthus roseus (L.) G. Don
Chenopodium album L.
Cistus albidus L.
Cistus creticus L.
Citrus
Coffea
Dodonaea viscosa (L.) Jacq.
Eremophila maculata (Ker Gawler) F. von Müller.
Erigeron
Euphorbia chamaesyce L.
Euphorbia terracina L.
Grevillea juniperina Br.
Hebe
Heliotropium europaeum L.
Hibiscus
Laurus nobilis L.
Lavandula
Myoporum insulare Br.
Myrtus communis L.
Nerium oleander L.
Olea europaea L.
Osteospermum fruticosum (L.) Norl.
Pelargonium
Phillyrea latifolia L.
Pistacia vera
Polygala myrtifolia L.
Prunus
Rhamnus alaternus L.
Salvia rosmarinus
Spartium junceum L.
Ulex parviflorus
Vinca minor L.
Westringia fruticosa (Willd.) Druce
Westringia glabra Br.
ANNEX III
Infected zones referred to in Article 4(2) where containment measures set out in Articles 13 to 17 are applied
PART A
Infected zone in Italy
The infected zone of Italy includes the following areas:
The province of Lecce
The province of Brindisi
Municipalities located in the province of Taranto:
Municipality located in the province of Bari:
PART B
Infected zone in France
The infected zone in France includes the following area:
The region of Corsica
PART C
Infected zone in Spain
The infected zone in Spain includes the following area:
The Autonomous Community of Balearic Islands
ANNEX IV
Tests for the identification of Xylella fastidiosa and its subspecies
A. Tests for the screening and identification of the presence of Xylella fastidiosa
Real time PCR based on Harper et al., 2010 (and erratum 2013) ( 6 );
Loop-mediated isothermal amplification (LAMP) based on primers developed by Harper et al. 2010 (and erratum 2013) ( 7 );
Real time PCR based on Ouyang et al., 2013 ( 8 )
Conventional PCR based on Minsavage et al. 1994 ( 9 )
B. Molecular tests for the identification of the subspecies of Xylella fastidiosa
Multi Locus Sequence Typing (MLST) based on Yuan et al., 2010 determining all subspecies ( 10 );
PCR based on Hernandez-Martinez et al., 2006 determining the subspecies fastidiosa, multiplex and sandyi ( 11 );
PCR based on Pooler & Hartung 1995 determining the subspecies pauca ( 12 ).
ANNEX V
Templates for the reporting of the results of the surveys carried out pursuant to Articles 10 and 15 in demarcated areas
PART A
Template for the report of results of statistically based annual surveys
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1. Geographical location of the DA |
2. Initial size of DA (ha) |
3. Updated size of DA (ha) |
4. Approach (E/C) |
5. Zone (e.g. BZ/IZ) |
6. Survey sites |
7. Timing |
A. Survey definition (input parameters for RiBESS+) |
B. Sampling effort |
C. Survey results |
23. Comments |
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8. Target population |
9. Epidemiological units |
10. Detection method |
11. Sampling effectiveness |
12. Method sensitivity |
13. Risk factors (activities, locations and areas) |
14. N° epidemiological units inspected |
15. N° examinations |
16. N° samples |
17. N° tests |
18. N° other measures |
19. Results |
20. Notification number of the outbreaks notified, as applicable, in accordance with Implementing Regulation (EU) 2019/1715 |
21. Achieved Confidence level |
22. Design prevalence |
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Host species |
Area (ha or other more relevant unit)) |
Inspection units |
Description |
Units |
Visual examinations |
Testing |
Other methods |
Risk factor |
Risk levels |
N° of locations |
Relative risks |
Proportion of the host population |
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Positive |
Negative |
Undetermined |
Number |
Date |
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Instructions on how to fill in the template
Explain the assumptions for the survey design. Summarise and justify:
Indicate the name of the geographical area, outbreak number or any information that allows the identification of the Demarcated Area (DA) concerned and the date when it was established.
Indicate the size of the DA before the start of the survey and any relevant update.
Indicate the approach: Eradication (E), Containment (C). Please, include as many rows as necessary, depending on the number of DA and the approaches these areas are subject to.
Indicate the zone of the DA where the survey was carried out, including as many rows as necessary: Infected/infested zone (IZ) or buffer zone (BZ), using separate rows. When applicable, indicate the area of the IZ where the survey was carried out (e.g. last 5 km adjacent to the BZ, around nurseries, etc.) in different rows.
Indicate the survey sites, using more than one row if needed. Please, always report the surveys carried out in nurseries in a different row. When using the option “other”, please specify what it is:
Open air (production area): 1.1 field (arable, pasture); 1.2. orchard/vineyard; 1.3. nursery; 1.4. forest;
Open air (others): 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, etc.);
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).
Indicate the months of the year when the surveys were carried out.
Indicate the chosen target population providing accordingly the list of host species and area covered. The target population is defined as the ensemble of inspection units. Its size is typically defined for agricultural areas as hectares, but it could be lots, fields, greenhouses, etc. Please justify the choice made in the underlying assumptions in column 23 (“Comments”). 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.
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 which are homogenous in terms of epidemiology and which include 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 NUTS regions, urban areas, forests, rose gardens or farms, or hectares. The choice shall be justified in the underlying assumptions.
Indicate the methods used during the survey including the number of activities in each case. Indicate with N/A when the information of certain column is not available.
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.
“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).
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.
Indicate the details of the survey. 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”.
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, etc.).
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 Articles 14(2), 15(2) or 16 of Regulation (EU) 2016/2031. In this case, please indicate the reason for not providing this information in column 21 (“Comments”).
Indicate the sensitivity of the survey, as defined in ISPM 31. This value of the achieved confidence level of pest freedom is calculated based on the inspections (and/or samples) performed given the method sensitivity and the design prevalence.
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.
PART B
Template for the report of results of surveys carried out for insect vectors of Xylella fastidiosa
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1. Description of the DA |
2. Approach |
3. Zone |
4 Vector species |
5. Visual examinations |
6. Type of traps (or other vector capture method (e.g.,sweep net, etc.) |
7. No of traps (or other capture method) |
8. Frequency of traps checking (or other method, if applicable) |
9. Timing of traps checking (or other method, if applicable) |
10. No of vector samples collected |
11. No of vectors trapped |
12. No of vectors analysed |
13. No of vector samples analysed |
14. No of positive vector samples |
15. No of negative vector samples |
16. No of undetermined vector samples |
17. Comments |
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Name |
Date of establishment |
Timing |
Number |
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Instructions on how to fill in the template
Indicate the name of the area, outbreak number or any information that allows identifying the Demarcated Area (DA) and the date it was established.
Indicate: Eradication (E), Containment (C). Please include as many rows as necessary, depending on the number of DA and the approaches these areas are subject to.
Indicate the zone of the DA where the survey was carried out: Infected/infested zone (IZ) or buffer zone (BZ), using separate rows. When applicable, indicate the area of the IZ where the survey was carried out (e.g. last 5 km, around nurseries, etc.).
Indicate the list of vector species of the pest indicated in the first column, using different rows per vector.
Indicate only if applicable.
Indicate the type of vector capture method. When more than one method is used for the same vector, provide the data in separate rows.
Indicate the number of traps or other capture method, using a separate row per method.
Indicate when the traps or capture method were checked (e.g. once per week, once per month, four times per year, etc.).
Indicate the months of the year when the traps are checked.
Indicate the number of samples collected (a sample may contain several vectors).
Indicate the total number of vector trapped. Please include only the number of the vector of interest, no bycatch.
Indicate the number of vector samples analysed for the pest, applicable when a sample is composed by more than one vector.
The number of undetermined samples, namely samples analysed but where due to different factors no result was obtained (e.g. below detection level, etc.).’
( 1 ) Guidelines for pest eradication programmes – Reference Standard ISPM No 9 by the Secretariat of the International Plant Protection Convention, Rome. Published 15 December 2011.
( 2 ) The use of integrated measures in a systems approach for pest risk management – Reference Standard ISPM No 14 by the Secretariat of the International Plant Protection Convention, Rome. Published 8 January 2014.
( 3 ) Commission Implementing Directive 2014/98/EU of 15 October 2014 implementing Council Directive 2008/90/EC as regards specific requirements for the genus and species of fruit plants referred to in Annex I thereto, specific requirements to be met by suppliers and detailed rules concerning official inspections, OJ L 298, 16.10.2014, p. 22.
( 4 ) Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production, OJ L 267, 8.10.2008, p. 8.
( 5 ) Commission Implementing Decision (EU) 2017/925 of 29 May 2017 temporarily authorising certain Member States to certify pre-basic material of certain species of fruit plants, produced in the field under non-insect proof conditions, and repealing Implementing Decision (EU) 2017/167, OJ L 140, 31.5.2017, p. 7.
( 6 ) DOI: 10.1094/PHYTO-06-10-0168.
( 7 ) DOI: 10.1094/PHYTO-06-10-0168.
( 8 ) DOI: 10.1371/journal.pone.0081647.
( 9 ) DOI:10.1094/Phyto-84-456.
( 10 ) DOI: 10.1094/PHYTO-100-6-0601.
( 11 ) DOI: 10.1094/PD-90-1382.
( 12 ) DOI: 10.1007/BF00294703.