EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11096/2021 feedback 
(POOL/G1/2021/11096/11096 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
establishing measures to prevent the introduction into, establishment and spread within 
the Union territory of Anoplophora chinensis  (Forster) and repealing Decision 
2012/138/EU  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
establishing measures to prevent the introduction into, establishment and spread within 
the Union territory of Anoplophora chinensis  (Forster) and repealing Decision 
2012/138/EU  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the  European Union , 
Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council 
of 26 October 2016 on protective measures against pests of plants, amending Regulations 
(EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of th e European Parliament 
and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 
98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC1, and in particular Article 28(1) and (2) 
and Article 41(2) thereof,  
Whereas:  
(1) Commission Implementi ng Decision 2012/138/EU2 provides for measures to prevent 
the introduction into, and the spread within, the Union territory of Anoplophora 
chinensis  (Forster) (‘the specified pest’).  
(2) The recent outbreaks of the specified pest in some Member States and the experience 
gained during the application of Implementing Decision 2012/138/EU show the need 
to update those measures to have a more targeted approach for the surveillance and 
control of the specified pest in the Union territory.  
(3) Article 1, point (a), of I mplementing Decision 2012/138/EU includes a list of specified 
plants, hosts of the specified pest on which that pest has been reported in the Union 
territory. Those specified plants are subject to requirements for introduction into, 
movement within the Uni on territory,  and eradication or containment of that pest .  
(4) These specified plants are still of phytosanitary concern. Therefore, this Regulation 
should also provide for such a list of specified plants, subject to the respective 
measures. Following findings of the specified pest on Vaccinium corymbosum , Melia  
spp.,  Ostrya spp. and Photinia spp. plants and since those plants are host plants of the 
specified pest, they should be added to that list.  
(5) The host plants present in the Union territory, namely plants of Acer  spp., Aesculus 
hippocastanum , Alnus  spp., Betula spp., Carpinus spp., Chaenomeles spp., Citrus spp., 
Cornus spp., Corylus spp., Cotoneaster spp., Crataegus spp., Cryptomeria spp., 
Hibiscus spp., Fagus  spp., Ficus  spp., Lagerstroemia spp., Malus spp., Melia spp., 
Morus spp., Ostrya  spp., Parrotia spp., Photinia spp., Platanus spp., Populus spp., 
Prunus laurocerasus , Pyrus spp., Rosa  spp., Salix  spp. and Ulmus  spp. and Vaccinium 
                                                 
1 OJ L 317, 23.11.2016, p. 4.  
2 Commission Implementing Decision 2012/138/EU of 1 March 2012 as regards emergency measures to 
prevent the introduction into and the spread within the Union of Anoplophora chinensis  (Forster)  (OJ L 
64, 3.3.2012, p. 38).   
EN 2  EN corymbosum , should be subject to annual surveillance in order to ensure that their list 
is up -to-date and based on the technical a nd scientific developments.  
(6) In order to ensure a better overview of the presence of the specified pest, Member 
States should intensify the annual surveys for that presence and employ methods in 
line with the latest scientific and technical information.  
(7) In order to eradicate the specified pest and prevent its spread in the Union territory, 
Member States should establish demarcated areas consisting of an infested zone and a 
buffer zone and apply eradication measures. The width of a buffer zone should be 2 
km, as this is appropriate taking into account the spreading capacity of the specified 
pest.  
(8) However, in cases of isolated occurrences of the specified pest, the establishment of a 
demarcated area should not be required if the specified pest can be eliminat ed from 
those plants, and if there is evidence that those plants were infested before their 
introduction into the area, or that it is an isolated finding, not expected to lead to 
establishment. This is the most proportionate approach, as long as the survey s carried 
out in the area concerned confirm the absence of the specified pest.   
(9) In certain areas of the Union territory, the eradication of the specified pest is no longer 
possible. The Member States concerned should therefore be allowed to apply measures  
for the containment of that pest within those areas, instead of eradication. Those 
measures should be less stringent than the measures for eradication, but they should 
ensure a diligent survey approach and more precautionary actions, mainly in the 
respect ive buffer zones, in order to prevent the spread of the specified pest to the rest 
of the Union territory.  
(10) Member States should notify to the Commission and to the other Member States every 
demarcated area for containment that they intend to designate or m odify, in order for 
the Commission to obtain an overview of the spread of the specified pest in the Union 
territory, and to be able to review this Regulation and include that area in a list of 
demarcated areas for containment.  
(11) In order to ensure the immedi ate removal of the infested plants and prevent further 
spread of the specified pest to the rest of the Union territory, the surveys of the buffer 
zones should be carried out annually at the most appropriate time of the year and with 
sufficient intensity, t aking into account t he possibility for the competent authorities to 
further monitor the host plants in the infested zones for containment.  
(12) Plant species, which are known to be susceptible to the specified pest detected in the 
demarcated area and which have  been grown for at least part of their life in that 
demarcated area or have been moved through such an area, are more likely to become 
infested with the specified pest. Therefore, it is justified to establish special 
requirements for the movement within th e Union territory of the specified plants.  
(13) With the aim of facilitating trade while protecting plant health , host plants originating 
in a third country where that pest is not present should, when introduced into the 
Union territory, be accompanied by a ph ytosanitary certificate including an additional 
declaration stating that that country is free from the specified pest.  
(14) In order to ensure that host plants introduced into the Union territory from areas of 
third countries where the specified pest is known t o be present, are free from the 
specified pest, the requirements for their introduction into the Union territory should 
be similar to those set out for movement of specified plants originating in demarcated 
areas.   
EN 3  EN (15) In light of the latest scientific and tech nical evidence, survey activities carried out by 
third countries to confirm the absence of the specified pest in areas of their territory or 
in production sites authorised to export to the Union territory should be intensified.  
(16) It is appropriate to establi sh rules concerning official checks on movements of the 
specified plants out of the demarcated areas to the rest of the Union territory, and the 
introduction into the Union territory of host plants from third countries.  
(17) Implementing Decision 2012/138/EU s hould be repealed.  
(18) As regards survey activities carried out in areas of the Union territory where the 
specified pest is known not to occur or in areas or production sites of third countries, it 
is appropriate to allow sufficient time to Member States and t hird countries to design 
those activities so that they provide sufficient level of statistical confidence required. 
Therefore, the requirements relating to those survey activities should apply from 1 
January 2025.  
(19) The provisions concerning the conduct of s urveys in demarcated areas on the basis of 
the European Food Safety Authority’s (‘the Authority’) General guidelines for 
statistically sound and risk -based surveys for plant pests3 should apply from 1 January 
2025 in order to allow sufficient time for the competent authorities to plan, prepare the 
design and allocate sufficient resources for such surveys.  
(20) The provisions concerning the contingency plans should apply from 1 August 2023 in 
order to allow sufficient time for Member States to prepare those plans . 
(21) The requirements concerning the introduction of specified plants into the Union 
territory from third countries should apply from 1 July 2024 in order to allow 
sufficient time for the Member States, the third countries and the professional 
operators conce rned to prepare for the implementation of those requirements.  
(22) The phytosanitary risk of the specified pest for the Union territory needs to be further 
assessed, as the full range of host plants is still to be determined on the basis of its 
spread within t he Union territory and any technical and scientific evidence collected 
from the rest of the world. This Regulation should therefore apply until 31 December 
2029 to allow for that further assessment and its review.   
(23) The measures provided for in this Regula tion are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
CHAPTER I  
SUBJECT MATTER AND DEFINITIONS  
Article 1  
Subject matter  
This Regulation sets out measures to prevent the introduction into,  the establishment and 
spread within the Union territory of Anoplophora chinensis  (Forster), and its eradication or 
containment if found present in that territory.  
                                                 
3 EFSA, General guidelines for statistically sound and risk‐based surv eys of plant pests, 8 September 
2020, DOI: 10.2903/sp.efsa.2020.EN -1919.   
EN 4  EN Article 2  
Definitions  
For the purposes of this Regulation, the following definitions apply:  
(1) ‘specified pest’ means Anoplophora chinensis  (Forster);  
(2) ‘specified plants’ means plants for planting, that have a stem or root collar diameter 
of 1 cm or more at their thickest point, of Acer  spp., Aesculus hippocastanum, Alnus  
spp., Betula  spp., Carpinus  spp., Citrus  spp., Cornus  spp., Corylus  spp., Cotoneaste r 
spp., Crataegus  spp., Fagus  spp., Lagerstroemia  spp., Malus  spp., Melia  spp., Ostrya 
spp., Photinia spp.,  Platanus  spp., Populus  spp., Prunus laurocerasus , Pyrus  spp., 
Rosa spp., Salix  spp., Ulmus  spp. and  Vaccinium corymbosum ; 
(3) ‘place of production’ means a place of production as defined in the FAO 
International Standard for Phytosanitary Measures (‘ISPM’) No 5  (4);  
(4) ‘host plants’ means plants for planting, that have a stem or root collar diameter of 1 
cm or more at their thick est point, of Acer  spp., Aesculus hippocastanum , Alnus  spp., 
Betula  spp., Carpinus  spp., Chaenomeles spp., Citrus  spp., Cornus  spp., Corylus  
spp., Cotoneaster  spp., Crataegus  spp., Cryptomeria  spp., Hibiscus  spp., Fagus  spp., 
Ficus  spp., Lagerstroemia  spp., Malus  spp., Melia  spp., Morus  spp.,  Ostrya spp., 
Parrotia spp., Photinia spp.,  Platanus  spp., Populus  spp., Prunus laurocerasus , 
Pyrus  spp., Rosa  spp., Salix  spp., Ulmus  spp. and Vaccinium corymbosum ; 
(5) ‘sentinel plants’ means specified plants specific ally planted to support the early 
detection of the specified pest and used for surveillance.  
CHAPTER II  
ANNUAL SURVEYS FOR THE PRESENCE OF THE 
SPECIFIED PEST AND CONTINGENCY PLANS  
Article 3  
Surveys of the host plants in Member States  
1. Competent authorities shall carry out annual risk -based surveys of the host plants in 
the areas of their territories where the specified pest is not known to occur for the 
presence of the specified pest.  
The design and sampling scheme of those surveys sha ll allow to detect, within the 
Member State concerned, with a sufficient level of confidence, a low level of 
presence of infested plants. The surveys shall be based on the Authority’s General 
guidelines for statistically sound and risk -based surveys for pl ant pests.  
2. The surveys shall be carried out:  
(a) on the basis of the level of the respective phytosanitary risk;  
(b) in open air, as well as in nurseries, garden centres, trading centres, natural and 
urban areas and other relevant sites as appropriate;  
                                                 
4 Glossary of Phytosanitary Terms — Reference Standard ISPM No 5 by the Secretariat of the 
International Plant Protection Convention, Rome.  
  
EN 5  EN (c) at appro priate times of the year with regard to the possibility to detect the 
specified pest, taking into account the biology of that pest, the presence and 
biology of host plants, and the scientific and technical information referred to 
in the Authority’s Pest Su rvey Card on Anoplophora chinensis5. 
3. The surveys shall consist of:  
(a) visual examination of host plants; and  
(b) where appropriate, collection of samples and testing of plants for planting.  
In order to complement visual examinations specifica lly trained sniff er dogs may be 
used, where appropriate . 
Article 4  
Contingency plans  
1. Each Member State shall, in addition to the obligations provided for in Article 25 of 
Regulation (EU) 2016/2031, establish a contingency plan setting out the actions to be 
taken in its territory concerning:  
(a) the eradication of the specified pest, as set out in Article 8;  
(b) the movements of specified plants within the Union territory, as set out in 
Article 10;  
(c) the official inspections to be carried out on movements of specified plants 
within the Union territory and of host plants into the Union territory, as set out 
in Articles 10 and 11;  
(d) the minimum resources to be made available and the procedures for making 
those additional resources available in case of a suspected or confirmed 
presence of the specified pest;  
(e) rules detailing the procedures for identifying the owners of the plants to be 
removed, notifying the order of removal and accessing private properties.  
2. Member States shall update their contingency plans, as appropriate, by 31  December 
of each year.  
CHAPTER III  
DEMARCATED AREAS  
Article 5  
Establishment of demarcated areas  
1. Where the presence of the specified pest is officially confirmed, the Member State 
concerned shall without delay establish a demarcated area consisting of:   
(a) a zone including the infested plants and all specified plants which are liable to 
become infested within a 100 m radius around infested plants (“infested 
zone”);  
                                                 
5 EFSA (European Food Safety Authority), 2020. Story map for survey of Anoplophora chinensis . EFSA 
supporting publication 2020:EN -1825. Available online: https://arcg.is/19HTyn. Last updated: 24 March 2020.   
EN 6  EN (b) a buffer zone with a width of at least 2 km beyond the boundary of the infested 
zone.  
2. The delimitation of the demarcated area shall be based on the scientific principles, 
the biology of the specified pest, the level of infestation, the particular distribution of 
the host plants in the area concerned and the evidence on the establishm ent of the 
specified pest.  
3. For the purposes of taking eradication measures referred to in Article 8 and where 
the competent authority concludes that eradication of the specified pest is possible, 
taking into account the circumstances of the outbreak, s uch as its size and location , 
the level of infestation  or the number and distribution of host plants, the width of the 
buffer zone may be reduced to no t less than 1 km.  
4. For the purposes of taking containment measures referred to in Article 9, the buffer  
zone shall be of a width of at least 4 km.  
The width of the buffer zone may be reduced to not less than 2 km, taking into 
account the circumstances of the outbreak, such as its size and location, the level of 
infestation or the number and distribution of host plants.  
5. Where the presence of the specified pest has been officially confirmed in the buffer 
zone of a demarcated area for containment, Articles 17 and 18 of Regulation (EU) 
2016/2031 shall apply.   
Article 6  
Derogations from the establishment of demarcated  areas  
1. By way of derogation from Article 5, the competent authorities may choose not to 
establish a demarcated area if the following conditions are fulfilled:  
(a) there is evidence that the specified pest has been introduced into the area wit h 
the plants on which it was found and those plants were infested before their 
introduction into the area concerned, or it is an isolated finding, not expected to 
lead to establishment; and  
(b) it is ascertained that there is no establishment of the specif ied pest and the 
spread and successful breeding of the specified pest is not possible due to its 
biology, based on the results of a specific investigation and eradication 
measures taken.  
2. Where the competent authority uses the derogation provided for in  paragraph 1, it 
shall:  
(a) immediately take measures to ensure the prompt eradication of the specified 
pest and to exclude the possibility of its spread;  
(b) during at least one life cycle of the specified pest plus one additional year,  and 
at least fou r consecutive years, monitor a width of at least 1 km around the 
infested plants or the place where the specified pest was found, regularly and 
intensively at least during the first year;   
(c) destruct any infested plant material;  
(d) trace back the origin of the infestation and the plants associated with the 
infestation as far as possible and examine those plants for any sign of 
infestation, including by targeted destructive sampling;   
EN 7  EN (e) raise public awareness of the threat of the sp ecified pest; and  
(f) take any other measure, which may help eradicate the specified pest, taking 
account of ISPM No 96 and applying an integrated approach in accordance 
with the principles set out in ISPM No 147.  
Article 7  
Lifting of demarcation  
1. The dem arcation may be lifted when, based on the surveys referred to in Article 8(1), 
point (h), the specified  pest is not detected in a demarcated area for at least one life 
cycle of the specified pest plus one additional year, in total no less than four 
consecu tive years.  
For the purposes of the first subparagraph, the exact length of the life cycle of the 
specified pest shall depend on evidence that is available for the area concerned or a 
similar climate zone.  
2. The demarcation may also be lifted in cases wher e the conditions set out in Article 
6(1) are fulfilled.  
CHAPTER IV  
ERADICATION AND CONTAINMENT MEASURES  
Article 8  
Eradication measures  
1. In the demarcated areas for eradication, the competent authorities shall take all of the 
following measures:  
(a) immediate felling of infested plants and plants suspected to be infested, and 
complete removal of their roots;  
(b) immediate felling of all specified plants and removal of their roots within a 
radius of 100 m around infested plants, and examination of those s pecified 
plants for any sign of infestation, except in cases where the infested plants were 
found outside the flying period of the specified pest, when the felling and 
removal shall be carried out in time before the start of the next flying period ;  
(c) remova l, examination and safe disposal of plants felled in accordance with 
points (a) and (b) and of their roots, taking all necessary precautions to avoid 
spreading of the specified pest during and after felling;  
(d) prohibition of any movement of potentially infes ted material out of the 
demarcated area;  
(e) investigation of the origin of the infestation by the tracing of plants, as far as 
possible, and the examination of those plants for any sign of infestation, 
including targeted destructive sampling;  
                                                 
6 Guidelines for pest eradication programmes — Refe rence Standard ISPM No 9 by the 
Secretariat of the International Plant Protection Convention, Rome.  
7 The use of integrated measures in a systems approach for pest risk management — Reference 
Standard IS PM No 14 by the Secretariat of the International Pla nt Protection Convention, Rome.  
  
EN 8  EN (f) replacement of  specified plants by other non -susceptible plant species, where 
appropriate;  
(g) prohibition of planting of new specified plants in the open air in the area 
referred to in point (b), except for the places of production referred to in Article 
10(1);  
(h) surveys c arried out in accordance with Article 3(2) and (3), of the host plants in 
the demarcated area, with specific focus on the buffer zone, for the presence of 
the specified pest and including, where appropriate, targeted destructive 
sampling carried out by the  competent authority and with an indication of the 
number of samples in the report referred to in Article 13(1);  
(i) in the cases of sentinel plants, those plants shall be subject of inspections at 
least once a month and shall be destroyed and examined after t wo years at the 
latest;  
(j) raising public awareness of the threat of the specified pest and the measures 
adopted to prevent its introduction into and spread within the Union territory, 
including the conditions regarding movement of specified plants from the 
demarcated area;  
(k) where necessary, specific measures to address any particularity or complication 
that could reasonably be expected to prevent, hinder or delay eradication, in 
particular those related to the accessibility and adequate eradication of all 
plants that are infested or suspected of infestation, irrespective of their location, 
public or private ownership or the person or entity responsible for them;  
(l) any other measure which may contribute to the eradication of the specified 
pest, in accordance wi th International Standard for Phytosanitary Measure 
(‘ISPM’) No 98 and to applying a systems approach in accordance with the 
principles set out in ISPM No 149. 
In the case of the first subparagraph, point (a), where it is not possible to remove 
deeply seated stumps and surface roots, they shall be ground to not less than 40 cm, 
below the surface level, or covered by insect -proof material.  
The surveys referred to in paragraph (1), point (h), shall be intensified compared to 
the surveys referred t o in Article 3.  
The surveys in the buffer zone shall be based on the Authority’s General guidelines 
for statistically sound and risk -based surveys for plant pests and the survey design 
and sampling scheme used in the buffer zone shall be able to identify w ith at least 
95% of confidence, a level of presence of infested plants of 1%.   
2. By way of derogation from paragraph 1, first subparagraph, point (b), where a 
competent authority concludes that felling is inappropriate for a limited number of 
individual p lants, due to their particular social, cultural or environmental value, those 
individual plants shall be subject to a monthly individual examination for any sign of 
infestation and measures alternative to felling ensuring high level of protection shall 
be taken to prevent any possible spread of the specified pest from those plants.  
                                                 
8 Guidelines for pest eradication programmes — Reference Standard ISPM No 9 by the Secretariat of the 
International Plant Protection Convention, Rome. Published 15 December 2011.  
9 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.   
EN 9  EN (m) The reasons for such conclusion and the measures taken as a result of it shall 
be communicated to the Commission in the report under Article 13.  
Article 9  
Containment measures  
1. When the results of the surveys referred to in Article 8(1), point (h), have confirmed 
the presence of the specified pest in an area during more than four consecutive years 
and there is evidence that the specified pest can no longer be eradicated, the 
competent authorities may limit the measures to the containment of the specified 
pest.  
In the demarcated areas for containment, the competent authorities  shall take the 
following measures:  
(a) immediate  start of  the felling of infested plants and plants with symptoms 
caused by the specified pest, and the complete removal of their roots, and 
completion of all activities in time before the start of the next flying period;  
(b) removal, examination and disposal of plant s felled and of their roots, while 
taking the necessary precautions to avoid spreading of the specified pest after 
felling;  
(c) prohibition of any movement of potentially infested material out of the 
demarcated area;  
(d) where appropriate, replacement of specifi ed plants by other non -susceptible 
plants;  
(e) prohibition of planting in the infested zone of new specified plants in the open 
air, except for places of production referred to in Article 10(1);  
(f) surveys  carried out in accordance with Article 3(2) and (3), of the host plants in 
the buffer zone for the presence of the specified pest, at appropriate times  and 
including , where appropriate , targeted destructive sampling;    
(g) in the cases where sentinel plants are used, those plants shall be subject of 
inspections at  least once a month and shall be destroyed and examined after 
two years at the latest;  
(h) raising public awareness of the threat of the specified pest and the measures 
adopted to prevent its introduction into and spread within the Union territory, 
including the conditions regarding movement of specified plants out of the 
demarcated area established pursuant to Article 5;  
(i) where necessary, specific measures to address any particularity or complication 
that could reasonably be expected to prevent, hinder or del ay containment, in 
particular those related to the accessibility and adequate felling and destruction 
of all plants that are infested or suspected of infestation, irrespective of their 
location, ownership or the person responsible for them ;  
(j) any other meas ure, which may help contain the specified pest.  
In the case of the second subparagraph, point (a), where it is not possible to remove 
deeply seated stumps and surface roots, they shall be ground to at least 40 cm below 
surface level, or covered by insect -proof material.   
EN 10  EN The surveys referred to in the second  subparagraph, point (f), shall be intensified 
compared to the surveys referred to in Article 3.  
Those surveys shall be based on the Authority’s General guidelines for statistically 
sound and risk -based s urveys for plant pests and the survey design and sampling 
scheme used shall be able to identify with at least 95%  of confidence, a level of 
presence of infested plants of 1%.  
2. Member States shall notify to the Commission and to the other Member States every 
demarcated area for containment that they intend to designate or modify.  
CHAPTER V  
MOVEMENTS WITHIN THE UNION TERRITORY  
Article 10  
Movements within the Union territory  
1. Specified plants originating in demarcated areas established in accordance with  
Article 5 may be moved out of the demarcated areas and from the infested zones into 
the buffer zones only if accompanied by a plant passport prepared and issued in 
accordance with Articles 78 to 95 of Regulation (EU) 2016/2031, and if they have 
been grown  during at least two years prior to movement, or in the case of plants 
which are younger than two years, throughout their life, in a place of production 
which fulfils all of the following requirements:  
(a) it is registered in accordance with Article 65 of  Regulation (EU) 2016/2031;  
(b) it has been subjected annually to at least two official inspections for any sign of 
the specified pest carried out at appropriate times, and no such sign has been 
found;  
(c) it is located in a demarcated area where  official surveys for the presence or 
signs of the specified pest were carried out annually  within a width of at least 1 
km around the site at appropriate times and no specified pest or signs of it were 
found and  where the plants have been grown in a site:  
(i) with physical protection against the introduction of the specified pest; 
or 
(ii) where appropriate preventive treatments have been applied; or  
(iii) where targeted destructive sampling is carried out on each lot of 
specified plants prior to movement .  
The inspections referred to in the first subparagraph, point (b), shall include targeted 
destructive sampling of the roots and stems of plants. The size of the sample for 
inspection shall be such as to enable at least the detection of 1 % level of infestation 
with a level of confidence of 99 %.  
The targeted destructive sampling referred to in the first subparagraph,  point (c), 
shall be carried out at the level set out in the table in Annex II.  
The surveys referred to in the first subparagraph, point (c), shall  be based on the 
Authority’s General guidelines for statistically sound and risk -based surveys of plant 
pests, and the survey design and sampling scheme used shall be able to identify with 
at least 95% confidence level, a level of presence of infested plan ts of 1%.   
EN 11  EN Rootstocks grown in a place of production which fulfils all of the requirements of the 
first subparagraph may be grafted with scions which have not been grown under the 
conditions referred to in the first subparagraph, but which are no larger th an 1 cm in 
diameter at their thickest point.  
2. Specified plants not originating in demarcated areas, but introduced into a place of 
production in such areas, may be moved within the Union territory only if that place 
of production complies with the requi rements set out in paragraph 1, first 
subparagraph, point (c), and only if the plants are accompanied by a plant passport as 
referred to in paragraph 1.  
3. Specified plants imported from third countries, where the specified pest is known to 
be present, in  accordance with Chapter VI, may be moved within the Union territory 
only if accompanied by the plant passport as referred to in paragraph 1.  
CHAPTER VI  
INTRODUCTION INTO THE UNION TERRITORY OF 
SPECIFIED PLANTS ORIGINATING IN A THIRD COUNTRY  
Article 11  
Plants originating in a third country where the specified pest is known not to be present  
Specified plants originating in a third country, where the specified pest is known not to be 
present, may only be introduced into the Union territory if the following conditions are 
fulfilled:  
(a) the national plant protection organisation of the third countr y concerned has 
communicated in writing to the Commission that the specified pest is known not to 
be present in that country; and  
(b) the host plants are accompanied by a phytosanitary certificate stating under the rubric 
‘Additional Declaration’ that the spec ified pest is not present in the respective third 
country.  
Article 12  
Specified plants originating in third countries where the specified pest is known to be 
present  
1. Specified plants originating in third countries where the specified pest is known to b e 
present shall be accompanied by a phytosanitary certificate indicating under the 
rubric ‘Additional Declaration’ one of the following:  
(a) that the plants have been grown throughout their life in a place of production 
which is registered and supervised by t he national plant protection organisation 
in the country of origin and situated in a pest -free area established by that 
organisation in accordance with relevant International Standards for 
Phytosanitary Measures and on the basis of official surveys;  
(b) that the plants have been grown during a period of at least two years prior to 
export or in the case of plants which are younger than two years have been 
grown throughout their life in a place of production:  
(i) established as free from the specified pests in a ccordance with 
International Standards for Phytosanitary Measures;   
EN 12  EN (ii) registered and supervised by the national plant protection organisation 
in the country of origin;  
(iii) subjected annually to at least two official inspections for any sign of the 
specified pest carried out at appropriate times and no signs of the pest 
have been found; and  
(iv) where the plants have been grown in a site:  
- with physical protection against the introduction of the specified pest, 
or  
- with the application of appropri ate preventive treatments and 
surrounded by a buffer zone with a width of at least 1 km where official 
surveys for the presence or signs of the specified pest  are carried out 
annually at appropriate times; and  
(v) where immediately prior to export consig nments of the plants have 
been subjected to an official inspection for the presence of the specified 
pest, in particular in roots and stems, including targeted destructive 
sampling; or  
(c) that the plants have been grown from rootstocks which meet the require ments 
of point (b), grafted with scions which meet the following requirements:  
(i) at the time of export, the grafted scions have been no larger than 1 cm 
in diameter at their thickest point; and  
(ii) the grafted plants have been inspected in accordance w ith point (b)( iii).  
(d) The name of the pest -free area referred to in the first subparagraph, point (a), 
shall be mentioned under the rubric ‘place of origin’.   
(e) The surveys referred to in the first subparagraph, point (a), have been based on 
Authority’s Gener al guidelines for statistically sound and risk -based surveys of 
plant pests, while the survey design and sampling scheme used has been able to 
identify with a sufficient level of confidence, a low level of presence of 
infested plants.  
The surveys referred  to in the first subparagraph, point (b)(iv), second indent, have 
been based on  the Authority’s General guidelines for statistically sound and risk -
based surveys of plant pests, the survey design and sampling scheme used have been 
able to identify with at least 95% confidence level of presence of infested plants of 
1%. In case signs of the specified pest have been found, eradication measures have 
been immediately taken to restore the pest freedom in the buffer zone.   
The size of the sample for the inspection referred to in the first subparagraph, point 
(b)(v),  shall be such as to enable at least the detection of 1 % level of infestation with 
a level of confidence of 99 %.  
2. Specified plants introduced into the Union t erritory in accordance with paragraph 1, 
shall be inspected at the point of entry or at the approved place of their destination.  
The inspection methods applied shall aim at the detection of any sign of the specified 
pest, in particular in roots and stems, and include targeted destructive sampling. The 
size of the sample for inspection shall be such as to enable at least the detection of 1  
EN 13  EN % level of infestation with a level of confidence of 99 %, taking account of ISPM No 
3110.  
3. The targeted destructive s ampling referred to in this Article shall be carried out at the 
level set out in the table in Annex II.   
CHAPTER VII  
FINAL PROVISIONS  
Article 13  
Reporting on measures  
Member States shall, by 30 April of each year, submit to the Commission and to the other  
Member States a report on the measures taken during the preceding year pursuant to this 
Regulation and on the results of the measures provided for in Articles 3 to 9.  
The results of the surveys carried out pursuant to Articles 8 and 9 shall be submitted t o the 
Commission using one of the templates set out in Annex I.  
Article 14  
Compliance  
Member States shall, as necessary in order to comply with this Regulation, repeal or amend 
the measures, which they have adopted to protect their territory against the in troduction and 
spread of the specified pest. They shall immediately inform the Commission of the repeal or 
amendment of those measures.    
Article 15  
Repeal  
Implementing Decision 2012/138/EU is repealed, with the exception of its Article 2 , Article 3  
and Annex I,  which are repealed with effect from 1 January 2023.  
Article 16  
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union .  
Articles 11 and 12, with the exception of Article 12(1), third and fourth subparagraph, shall 
apply from 1 July 2024. 
Article 4 shall apply from 1 August 2023.  
Τhe following provisions shall apply from 1 January 2025:  
(a)  Article 3(1), second subparagraph;  
(b)  Article 8(1), fifth subparagraph;  
(c)  Article 9(1), sixth  subparagraph;  
                                                 
10 Methodologies for sampling of consignments — Reference Standard ISPM No 31 by the Secretariat of 
the International Plant Protection Convention, Rome.   
EN 14  EN (d)  Article 10(1), fourth  subparagraph;  
(e)  Article 12(1), third and fourth subparagraph s.  
This Regulation shall apply until 31 December 2029.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN