EN 1  EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10944/2018 
(POOL/G1/2018/10944/10944 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2016/2031 of the European Parliament and of the 
Council on protective measures against pests of plants, authorising Member States to 
provide for temporary derogations in view of official testing, scientific or educational 
purp oses, trials, varietal selections, or breeding  
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 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2016/2031 of the European Parliament and of  the 
Council on protective measures against pests of plants, authorising Member States to 
provide for temporary derogations in view of official testing, scientific or educational 
purposes, trials, varietal selections, or breeding  
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 the Council of 
26 October 2016 on protective measures against pests of plants , amending Regulations (EU) 
No 228/2 013, (EU) No 652/2014 and (EU) No 1143/2014 of the 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 s 8(5) and 
48(5)  thereo f, 
Whereas:  
(1) In accordance with Regulation (EU) 2016/2031, Member States may, on application, 
temporarily authorise the introduction into, the movement within, and the holding and 
multiplication in their territory of Union quarantine pests or pests subject to the 
measures adopted pursuant to Article 30(1) of that Regulation  for official testing, 
scientific or educational purposes, trials, varietal selections, or breeding. Moreover, 
Member States may, on application, authorise temporarily the introduction into, and 
the movement within, their territory of plants, plant products and other objects used 
for official testing, scientific or educational purposes, trials, varietal selection or 
breeding.  
(2) It is necessary to supplement  Regulation (EU) 2016/2031 by ado pting rules  on the 
exchange of information between Member States and the Commission concerning the 
introduction into, and movement within, the Union territory of the pests, plants, plant 
products and other objects concerned, the procedures and conditions f or granting the 
respective authorisations, as well as the requirements for the monitoring of compliance 
and the actions to be taken in the event of non -compliance.  
(3) In order to ensure that the phytosanitary risk linked to the specified activities is 
elimina ted or reduced to an acceptable level , the authorisation of the introduction into , 
and the movement within, the Union of any specified material  should be subject to 
certain conditions ensuring the submission of a complete and appropriate application, 
the e xamination of the nature and objectives of the specified activities , the 
confirmation that the specified activities are performed in quarantine stations or 
confinement facilities  and the destruction  and safe removal of contaminated material .  
(4) In order to ensure monitoring and traceability of the specified material  concerned, and 
to immediately address any associated phytosanitary risk , it is appropriate that, 
following th e granting of that authorisation, the competent authority of the Member 
                                                 
1 OJ L 317, 23.11.2016 , p. 4. EN 3  EN State in which  the approved specified activity is to be carried out should issue a letter 
of authority , which  should  always accompany the specified material  concerned.   
(5) Since it has proven to be implemented in an effective and consistent manner, the 
format of the letter of authority should be similar  to the format set out in Annex II to 
Commission Directive 2008/61/EC2 .  
(6) A single letter of authority should be used for the multiple introductions into, and 
movement s within  the Union of specified material  subject to t he specified activities , 
and in accordance with special conditions , so as  to ensure a proportionate and effective 
framework for such introductions and movements.  
(7) Official testing  presents a lower level of phytosanitary risk and is carried out more 
frequent ly than the other specified activities. It is therefore proportionate to allow  less 
string ent conditions for official testing than for the other specified activities . 
(8) Rules should be established concerning the actions to be taken by the competent 
authorities, in the cases of non -compliance with the provisions of this Regulation, to 
ensure  corrective actions as soon as possible. Those actions should include obligations  
for the person responsible for the specified activities.  
(9) For purposes of legal certainty and clarity Directive 2008/61/EC should be repealed.  
(10) In order to allow for the  smooth termination  of the activities authorised , it is 
appropriate to extend  the validity  of the approvals of those activities  for a specified 
period of time .  
(11) For reasons of legal certainty , this Regulation should  apply from the same date as 
Regulation (EU) 2016/2031 ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Scope  
This Regulation lays down the  conditions for derogation from Articles 5(1), 30(1), 32(1), 
40(1), 41(1), 42(2), 49(1), 53(1) and 54(1) of Regulation  (EU)  2016/2031, under which 
specified pests and plants, plant products and other objects, as defined in Article 2  of this 
Regulation , may  be introduced into, or moved, held, multiplied  or used within, the Union, or 
protected zones therein, for official testing, scientific or educational purposes, trials, varietal 
selection or breeding.  
In particular, this Regulation establishes:  
(a) the rul es concerning the exchange of information between Member States and the 
Commission concerning the introduction into, and movement within, or holding, 
multiplying  or use within the Union, or protected zones therein, of specified pests or 
plants, plant produ cts and other objects;  
(b) the procedure and the conditions under which a temporary authorisation shall be 
granted by Member States for the performance of the specified activities;  
                                                 
2 Commission Directive 2008/61/EC of 17 June 2008 establishing the conditions under which certain 
harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council 
Directive 2000/29/EC may be introduced into or moved within the Community or certain protected 
zones thereof, for trial or scientific purposes and for work on varietal selections (OJ L158, 18.6.2008, 
p. 41). EN 4  EN (c) the rules concerning the monitoring of compliance, and the actions to b e taken in 
case of non -compliance . 
Article 2  
Definitions  
For the purpose s of this Regulation, the following definitions shall apply : 
(a) ‘specified pests’ means one of the following:  
(i) Union quarantine pests, listed pursuant to Article 5 of Regulation (E U) 
2016/2031 , 
(ii) pests subject to the measures adopted pursuant to Article 30(1) of that 
Regulation , 
(iii) protected zone quarantine pests, listed pursuant to Article 32(3) of that 
Regulation.  
(b) 'plants, plant products or other objects' means the plan ts, plant products or other 
objects listed pursuant to Article s 40(2), 41(2), 42(2), 49(1), 53(2) and 54(2) of 
Regulation (EU) 2016/2031;  
(c) ‘specified material’ means any specified pests, plants, plant products or other objects  
requiring an authorisation  within the meaning of this Regulation ; 
(d) 'official testing' means testing carried out by competent authorities, or under the 
official supervision of the competent authorities;  
(e) ‘specified activities’ means any activity carried out by any person, incl uding 
competent authorities, academic institutions, research institutions or professional 
operators, related to official testing, scientific or educational purposes, trials, varietal 
selection or breeding, that involves the introduction into, the movement within, 
holding , multiplication  or use in the Union and protected zone thereof, of any  
specified  material.  
Article 3  
Exchange of information between Member States and the Commission  
1. Member States shall cooperate administratively with regard to the excha nge of 
information between Member States and the Commission concerning the 
introduction into, movement within, and holding, multiplication and use in, the 
Union territory or protected zones thereof of any specified material . 
2. For the purpos es of paragraph 1, Member  States shall send, before 31 M arch each 
year, to the Commission and to the other Member States all of the following 
information:  
(a) a list with types and quantities of specified material  authorized under this  
Regulation , and introduce d into or moved within the Union, during the 
preceding calendar year;  
(b) a report on the presence of the specified pests authorized under this Regulation , 
and, where  applicable,  on the infestation  of the specified material  by any other 
specified pests or  any other pests considered as a risk to the Union by the 
competent authority, and detected during the specified activities.  In the case 
where the  specified  material is a specified pest itself, the report shall concern , EN 5  EN where  applicable, the presence of an y other specified pests, or any other pests 
considered a risk to the Union by the competent authority, and detected during 
the specified activities;  
(c) measures taken in case of non -compliance;  
(d) the list of quarantine stations and confinement facilitie s used for the purpos es 
of this Regulation.  
3. The introduction into the Union of the specified material  for the purpose of specified 
activities authorised pursuant to Article 5 shall be recorded , together with the 
respective authorisation,  in a computeri sed information management system for 
official controls ( IMSOC ) as referred to in Article 131 of Regulation (EU) 2017/625  
of the European Parliament and of the Council3. 
Article 4  
Application  
Prior to any  introduction into, and movement within, holding , multiplication , and use,  in the 
Union of the specified material, in accordance, as applicable, with Articles 8(1) and 48(1) of 
Regulation (EU) 2016/2031 , an application shall be submitted to the competent authorities.  
Its content shall comply with the requ irements laid down in  Annex I  to this Regulation . 
Article 5  
Conditions to grant the authorisation  
The authorisation of the  introduction into, and movement within, holding , multiplication and 
use, in the Union of the specified material , in accordance, as ap plicable, with Articles 8(1) and 
48(1) of Regulation (EU) 2016/2031  shall be granted  by the Member States for a limited 
period of time and only where the following conditions are satisfied:  
(a) the application has been found to be in compliance with Article  4 of this Regulation ;  
(b) the nature and objectives of the specified activities proposed in the application have 
been examined by the competent authority and found to comply with the definition 
of specified activities provided in Article 2 of this  Regulation;  
(c) the specified activities have been confirmed to be performed in quarantine stations or 
confinement facilities indicated in the application and designated by the competent 
authority in compliance with Articles 60 and 61 of Regulation (EU) 2 016/2031 ; 
(d) it has been ensu red that, following the completion of the specified activity concerned 
by that authorisation, where the material is a specified pest or a plant, plant product 
or other object infested by a specified pest , it has been  destroyed  and safely removed,  
or stored under appropriate conditions for further use .  
                                                 
3 Regulation (EU) 2017/625 of the European Parli ament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal health and welfare, plant health and plant protection products, amending Regulations (EC)  
No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) 
No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, 
Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 
1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) 
No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 
89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/2 3/EC, 96/93/EC and 97/78/EC and Council 
Decision 92/438/EEC (Official Controls Regulation)  (OJ L 95, 7.4.2017, p. 1 ). EN 6  EN Article 6  
Letter of authority following the authorisation  
1. Following the granting of the authorisation referred to in Article 5, a letter of 
authority shall be issued by the co mpetent authority of the Member State in which 
the approved specified activity is to be carried out. This letter of authority shall 
always accompany the specified material  concerned.  
2. In the case of specified material  originating in the Union, the letter of authority shall 
conform to the format set out in Part A of Annex II. It shall be officially endorsed by 
the Member State of origin, for movement of the respective specified material  under 
quarantine or confinement conditions.  
3. In the case of specified material  originating in third countries, the letter of authority 
shall conform to the format set out in Part B of Annex II. It shall be officially 
endorsed by the third country of origin, for introduction of the respective specified 
material  under q uarantine or confinement conditions.  
4. In the case of multiple introductions into, or movements within, the Union, of a 
specific type of specified material , one single letter of authority may be issued by the 
competent authority at the moment of the first  sending and covering all those 
introductions or movements, subject to all of the following conditions:  
(a) the introductions or movements take place several times per year;   
(b) the specified material  is unde r the same packaging conditions ; 
(c) the specified material  is from the same provider and to the same person 
responsibl e for the approved activities .  
The competent authority shall explicitly indicate in box 10 of the format set out in  Parts A and 
B of Annex II, that that endorsement covers multi ple introductions into, or movements within, 
the Union of that specified material . That endorsement shall last from the date of issuance of 
the letter of authority up to the 31 December of the year of that issuance.  
Article 7  
Special provisions for official testing  
By way of derogation from Articles 4 , 5 and  6, Member States shall grant an authorisation for 
the performance of official testing, only if all of the following conditions are fulfilled:  
(a) the person responsible for the approved activitie s has notified that official testing to 
the competent authority;  
(b) that notification contains the nature and objectives of that testing;  
(c) the notification contains a confirmation that the official testing is performed in 
quarantine stations or confine ment facilities as referred to in point (c) of Article 4(2).  
Article 8  
General provisions concerning monitoring of compliance  
The competent authority shall monitor the specified activities to ensure that all of the 
following requirements are fulfilled : 
(a) any infestations of the specified material by any specified pests  which are not 
authorized under this Regulation, or by any other pest s considered a risk to the 
Union, and detected during the specified activities , are notified immediately by the EN 7  EN person re sponsible for the activities to the competent authority. Where the material is 
a specified pest itself, the monitoring shall concern its potential infestation by other 
specified pests  not authorized under this Regulation , or any other pest s considered a 
risk to the Union by the competent authority, and detected during the specified 
activities;   
(b) any event resulting in the escape, or likelihood of escape, of pests referred to in point 
(a) into the environment, is notified immediately to the competent auth ority  by the 
person responsible for the activities.  
Article 9  
Actions to be taken in the event of non -compliance  
1. The competent authority may require the person responsible for the activities to 
implement corrective actions to ensure compliance with the provisions set out in this 
Regulation, either immediately or within a specified period of time.  
2. Where the competent authority concludes that the person responsible for the 
activities fails to comply with the provisions set out in this Regulation, that a uthority 
shall without delay take the measures necessary to ensure that non -compliance with 
those provisions does not continue. Those measures may include the revocation or 
the temporary suspension of the authorisation referred to in Article 5.  
3. Where th e competent authority has taken measures in accordance with paragraph 2, 
other than the revocation of the authorisation, and non -compliance with this 
Regulation continues, that authority shall without delay revoke that authorisation.  
Article 10  
Repeal of Directive 2008/61/EC and transitional period for its approved activities  
Directive 2008/61/EC is repealed.  
References to the repealed Directive shall be construed as references to this Regulation and 
shall be read in accordance with the correlation table in  Annex III.  
The approvals of the activities granted pursuant to Article 2 of that Directive shall expire on 
31 December 2020.  
Article 11  
Date of e ntry into force and date of application  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 14 December 2019.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER