S.L. 433.33 ст. 6Establishment of demarcated areas.

(1) Where the presence of the specified organism is identified, the Directorate shall without delay demarcate an area in accordance with sub-regulation (2) hereinafter referred to as a "demarcated area".

By way of derogation from the first sub-paragraph, where the presence of one particular subspecies of the specified organism is confirmed, the Directorate may demarcate an area with regard to that subspecies only.

Where the presence of more than one subspecies of the specified organism is identified, the Directorate shall demarcate that area with regard to the specified organism and all of its possible subspecies.

Where the identification of the presence of a subspecies is pending, the Directorate shall demarcate that area with regard to the specified organism and all of its possible subspecies.

The identification of the presence of the subspecies shall be based on the results of tests referred to in regulation 4(3).

(2) The demarcated area shall consist of an infected zone and a buffer zone.

(a) The infected zone shall include all plants known to be infected by the specified organism, all plants showing symptoms indicating possible infection by that organism, and all other plants liable to be infected by that organism due to their close proximity to infected plants, or common source of production, if known, with infected plants, or plants grown from them.

(b) The buffer zone shall be of a width of at least 5km surrounding the infected zone. The buffer zone may be reduced to a width of no less than 1km if there is a high degree of confidence that the initial presence of the specified organism did not result in any spread, and if all of the following conditions have been fulfilled:

(i) all host plants, irrespective of their health status, have been immediately removed within a radius of 100m around the plant found infected;

(ii) no other plants have been found infected by the specified organism 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 technical guidelines for the survey of Xylella fastidiosa provided on the Commission website. Those tests shall be based on a sampling scheme able to identify with 99% reliability a level of presence of infected plants of 1% or above, and targeting symptomatic plants, as well as asymptomatic plants in the proximity of the symptomatic ones;

(iii) a delimiting survey has been carried out in a zone with a width of at least 5km surrounding the infected zone, concluding that the specified organism has not been found present in that zone. That survey shall be based on a grid split into 100m × 100m squares within a zone of a width of at least 1 km surrounding the infected zone, and a grid split into 1km × 1km squares within the rest of the buffer zone. In each of those squares, visual inspections shall be carried out of the specified plants and symptomatic plants shall be sampled and tested, as well as asymptomatic plants in the proximity of the symptomatic ones;

(iv) no vectors carrying the specified organism have been detected in the infected zone 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. Those tests shall lead to the conclusion that natural spread of the specified organism is excluded.

When reducing the width of the buffer zone, the Directorate shall immediately notify the Commission and the other Member States of the justification for that reduction.

In the case of an infected zone for the purpose of containment measures as referred to in regulation 9(1), the buffer zone shall be of a width of at least 10km.

The exact delimitation of the zones shall be based on sound scientific principles, the biology of the specified organism and its vectors, the level of infection, the presence of the vectors, and the distribution of specified plants in the area concerned.

(3) If the presence of the specified organism is confirmed in the buffer zone, the delimitation of the infected zone and buffer zone shall immediately be reviewed and changed accordingly.

(4) The Directorate shall keep and update a list of the demarcated areas established in Malta and shall publish that list and any updates. The Directorate shall notify the Commission of this list and any updates in accordance with Commission Implementing Decision 2014/917/EU.

(5) Where, based on the surveys referred to in regulation 4 and on the monitoring referred to in regulation 8(8), the specified organism is not detected in a demarcated area for a period of five (5) years, this demarcation may be lifted. In such cases, the Directorate shall notify the Commission and other Member States.

By way of derogation from the first sub-paragraph, where the Directorate has reduced the buffer zone to a width of no less than 1km pursuant to sub-regulation (2), the Directorate may lift that demarcated area after 12 months since its initial establishment, if both of the following conditions are fulfilled:

(a) as result of the measures taken pursuant to sub-regulation (2), it is concluded with a high degree of confidence that the initial presence of the specified organism was an isolated case and no further spread occurred in the respective demarcated area;

(b) as practically close to the time of lifting, official tests have been carried out within the demarcated area, taking into account the technical guidelines for the survey of Xylella fastidiosa provided on the Commission website, using a sampling scheme able to identify with 99% reliability a level of presence of infected plants of 1% in accordance with international standards, and targeting symptomatic plants, as well as asymptomatic plants in the proximity of the symptomatic ones.

Where a demarcated area is lifted pursuant to the second sub-paragraph, the specified plants located in the previously established demarcated area shall be subject to intensive surveys during the following two years. That survey shall be carried out using a sampling scheme able to identify with 99% reliability a level of presence of infected plants of 1% or above in accordance with international standards and based on scientific and technical principles related to the potential spreading of the specified organism in the immediate surroundings, and targeting symptomatic plants, as well as asymptomatic plants in the proximity of the symptomatic ones. When lifting the demarcated area after 12 months since its initial establishment, the Directorate shall immediately notify the Commission and the other Member States of the justification for that lifting.

(6) By way of derogation from sub-regulation (1), the Directorate may decide not to establish a demarcated area immediately where all of the following conditions are fulfilled:

(a) there is evidence that the specified organism was recently introduced into the area with the plants on which it was found, or that the specified organism has been found in a site with physical protection from the vectors of that organism;

(b) there is an indication that those plants were infected before their introduction into the area concerned;

(c) no vectors carrying the specified organism have been detected, on the basis of tests carried out in accordance with internationally validated testing methods, in the vicinity of those plants.

(7) In the case referred to in sub-regulation (6), the Directorate shall:

(a) carry out an annual survey for at least two years to determine whether any plants, other than those on which the specified organism was first found to be present, have been infected;

(b) on the basis of that survey, determine whether there is a need to establish a demarcated area;

(c) 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 paragraph (a) as soon as they become available.