EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 17.10.2023  
COM(2023) 661 final  
2023/0378 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
amending Regulation (EU) 2016/2031 of the European Parliament and of the Council as 
regards multiannual survey programmes, notifications concerning the presence of 
regulated non -quarantine pests, temporary derogations from import prohibitions and 
special i mport requirements and establishment of procedures for granting them, 
temporary import requirements for high risk plants, plant products and other objects, 
the establishment of procedures for the listing of high risk plants, the content of 
phytosanitary ce rtificates, the use of plant passports and as regards certain reporting 
requirements for demarcated areas and surveys of pest   EN 1  EN Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
amending Regulation (EU) 2016/2031 of the European Parliament and of the Council as 
regards multiannual survey programmes, notifications concerning the presence of 
regulated non -quarantine pests, temporary derogations from import prohibitions and 
special import requirements and establishment of procedures for granting them, 
temporary import requirements for high ri sk plants, plant products and other objects, 
the establishment of procedures for the listing of high risk plants, the content of 
phytosanitary certificates, the use of plant passports and as regards certain reporting 
requirements for demarcated areas and s urveys of pest  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 43(2) thereof,  
Having regard to the proposal from the European Commission,  
After t ransmission of the draft legislative act to the national parliaments,  
Having regard to the opinion of the European Economic and Social Committee1, 
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) Reporting requirements play a key role in ensuring proper monitoring and correct 
enforcement of legislation. However, it is important to streamline those requirements 
in order to ensure that they fulfil the purpose for which they were intended and to limit  
the administrative burden.  
(2) Regulation (EU) 2016/2031  of the European Parliament of the Council2 sets out rules 
on protective measures against pests of plants. Those rules include  the classification 
and listing of regulated pests, requirements concer ning the introduction into, and 
movement within, the Union territory of certain plants, plant products and other 
objects, surveys, notifications of outbreaks, measures to eradicate pests if found 
present in the Union territory  and certification.  
(3) Moreov er Regulation (EU) 2016/2031 contains a number of reporting requirements in 
the fields of establishment of demarcated areas  and surveys of Union quarantine pests,  
priority pests  and protected zones quarantine pests , which should be simplified  in line 
with the Commission’s Communication on ‘Long -term competitiveness of the EU: 
looking beyond 2030’3. 
 
1 …. 
2 Regulation (EU) 2016/2031 of the European Parliament 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 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 20 07/33/EC  
(OJ L 317, 23.11.2016, p. 4 ). 
3 COM(2023)168.  EN 2  EN (4) In accordance with Article 18(6) of Regulation  (EU) 2016/2031 , Member States are to  
notify the Commission and the o ther Member States, by 30 April of each year, of the 
number and locations of the demarcated areas established, the pests concerned and the 
respective measures taken in this regards during the preceding calendar year.  
(5) As experience has shown during the application of Regulation  (EU) 2016/2031 , it is 
more effective, for the purpose of co -ordination of phytosanitary policy at Union level, 
to notify the demarcated areas immediately after their establishment. Immediate 
notification of demarcated areas by a Member State to the other Member States, t he 
Commission and the professional operators helps to become aware about the presence 
and spread of the pest concerned  and to decide on next measures to be taken. 
Therefore , Article 18(6) of Regulation (EU) 2016/2031 should establish an obligation 
for Memb er States to notify the Commission and the other Member States of the 
demarcated areas immediately after their establishment, together with the pests 
concerned and the respective measures taken . Such obligation does  not add any new 
administrative burden, b ecause  the immediate notification of demarcated areas is an 
existing obligation  set out in Annex I, point 7.1, to Commission Implementing 
Regulation (EU) 2019/17154 and is currently practised by all Member States . Setting 
out that obligation in Article  18(6) of Regulation (EU) 2016/2031  will further enhance 
clarity about the applicable rules concerning demarcated areas , while the respective 
obligation in Implementing Regulation (EU) 2019/1715 should be removed to avoid 
overlaps of the respective provisions . 
(6) Moreover,  and as experience from the application of Article 18(6) of Regulation (EU) 
2016/2031 has shown, the obligation for Member States to notify the Commission and 
the other Member States, by 30 April of each year, of the number and loc ations of the 
demarcated areas established, the pests concerned, and the respective measures taken 
during the preceding calendar year,  only adds administrative burden, and no practical 
value, to the obligation of immediate notification of demarcated areas . It should 
therefore be removed from that Article.  
(7) In accordance with Article 22(3 ), Article 24(2) and Article 34(2) of Regulation  (EU) 
2016/2031 , Member States are to  report to the Commission and the other Member 
States, by 30 April of each year, the results of the surveys , which were carried out in 
the preceding calendar year, concerning the presence of certain  pests  within the Union 
territory . Those are Union quarantine  pests, pests subject to the measures adopted 
pursuant to Articles 29 and 30 o f Regulation  (EU) 2016/2031 , priority pests and 
protected zone quarantine pests respectively. Moreover, and in accordance with 
Article 23(2) of Regulation  (EU) 2016/2031 , Member States are, on request, to notify 
their multiannual survey programmes upon the ir establishment to the Commission and 
the other Member States.   
(8) In accordance with Article 23(1), third subparagraph, the multiannual survey 
programmes are to be established  for a period of five to seven years. As experience 
has shown since the date o f application of Regulation  (EU) 2016/2031 , Member States 
need more time to properly design and develop those programmes. Therefore, and also 
in order  to reduce administrative burden for the competent authorities, that period 
should be extended to 10 years . For reasons of legal clarity, it should be specified that 
 
4 Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the 
functioning of the information management system for official controls and its system components (the 
IMSOC Regulation) (OJ L 261, 14.10.2019, p. 37 ). EN 3  EN those programmes are to be established again for consecutive periods of 10 years 
thereafter,  and the first period is to expire on 14 Dec ember 2029, namely 10 years after 
the date of application of Regulation  (EU) 2016/2031 . 
(9) Article 30(1), second subparagraph , of Regulation  (EU) 2016/2031  sets out that, where 
the Commission concludes that the criteria as regards pests not listed as Union 
quarantine pests,  set out in Subsection 2 of  Section 3 of Annex I to that Regulation, are 
fulfilled, it is to immediately, by means of implementing acts, adopt measures for a 
limited time as regards the risks posed by that pest.  
(10) During the implementation of that provision, certain Member State s expressed their 
doubts  concerning the precise scope of the term ‘measures’, and in particular whether 
it concerns actions taken in the context of imports or internal movement of goods , in 
order to prevent the entry and spread of the respective pest in th e Union territory . 
Therefore, and for reasons of legal clarity and completeness, Article 30(1) should be 
amended to specifically indicate  that those measures may include the prohibition of 
the presence  of the respective pest in the Union territory, and requirements concerning 
the introduction into, and movement within, the Union of plants, plant products and 
other objects.   
(11) Article 41 (4) of Regulation  (EU) 2016/2031 sets out that, in the event that plants, plant 
products or other objects have been introduced into, or moved within, the Union 
territory in violation of paragraph 1 of that Article, Member States are to adopt the 
necessary measures, as referred to in Union legislation on official controls, and to 
notify the Com mission and other Member States through the electronic notification 
system  under Article 103 of that Regulation.  That Article sets out the requirement to 
prevent the presence of Union quarantine pests on those plants, plant products or other 
objects.  
(12) However , no requirement to notify violation of the respective rules exists in Article 37 
of Regulation  (EU) 2016/2031 , which concerns measures to prevent the presence of 
regulated non -quarantine pests (‘RNQPs’) on plants for planting.   
Therefore, Article 37 of Regulation (EU) 2016/2031 should be amended, by 
providing that  in case of non -compliance with the requirements on RNQPs, Member 
States  adopt the necessary measures, as referred to in  Regulation (EU) 2017/625 , and 
notify the Commission and other Membe r States through the electronic notification 
system referred to in Article 103  of Regulation  (EU) 2016/2031 . 
(13) Consequently , Article 104 of Regulation (EU) 2016/2031 , which concerns 
notification s in the case of presence of pests , should also include a reference to Article 
37(1) . 
(14) In certain cases, it is appropriate to allow the introduction into the Union territory of 
certain plants, plant products or other objects,  from certain third countrie s, by way of 
derogation from the respective prohibition established pursuant to Article 40(1) of 
Regulation (EU) 2016/2031 or the special and equivalent requirements established by 
the implementing act adopted in accordance with Article 41(2). The respecti ve plants, 
plant products and other objects are currently  listed respectively in Annexes VI and 
VII to Implementing Regulation (EU) 2019/20725. Such cases are those in which a 
 
5 Commis sion Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform 
conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the 
Council, as regards protective measures against pests of plants, and repe aling Commission Regulation 
 EN 4  EN third country has made a request for such a temporary derogation and has provided 
written guarantees that the measures it is applying on its territory are effective in 
reducing the respective risk from these  plants, plant products or other objects and a 
provisional risk assessment has shown that the risk for the Union territory  can be 
reduce d to an acceptable level by application of certain temporary measures set out in 
points 2 and 3 of Section 1 of Annex II to Regulation (EU) 2016/2031.  
(15) For purposes of clarity and transparency, the Commission should be empowered to 
adopt  implementing acts providing for such derogations. For reasons of completeness, 
those acts should also set out the temporary measures[which are necessary to reduce 
the respective phytosanitary risk to an acceptable level and which allow the 
appropriate tim e for the full assessment of all pest risks, which are not yet fully 
assessed in relation to the particular plants, plant products or other objects. This will 
allow, once the respective assessment is completed, in accordance with the principles 
of Section 2 of Annex II to Regulation (EU) 2016/2031, those plants, plant products or 
other objects to be kept in or removed from the list of commodities in accordance with 
Article 40(3) or Article 41(3) of Regulation (EU) 2016/2031.  
(16) In accordance with Article 42(4) of Regulation (EU) 2016/2031, a plant, plant product 
or other object is to be removed from the list of high -risk plants, plant products and 
other objects, if it is concluded, on the basis of a risk assessment, that their 
introduction into the Union t erritory is to be subject to prohibition, special 
requirements or no requirements at all. However, as the experience of the application 
of that Article has shown, in certain cases the introduction of those commodities into 
the Union territory could be subj ect to special measures that reduce the respective 
phytosanitary risk to an acceptable level, while for some of the pests they host a full 
assessment is still pending. For this reason, the Commission should be empowered to 
adopt an implementing act to remo ve plants, plant products or other objects from the 
list of high -risk plants, plant products or other objects adopted pursuant to Article 
42(3), if they present a phytosanitary risk which is not yet fully assessed and no 
implementing act has yet been adopt ed for them pursuant to Article 42(4). In order to 
reduce any phytosanitary risk to an acceptable level, those acts should set out 
temporary measures  concerning the introduction of those plants, plant products and 
other objects into the Union territory.  
(17) In order to ensure a proportionate approach and the swiftest possible conclusion of the 
respective risk assessments, the application period of all those implementing acts 
should be such as to reasonably allow to fully assess all phytosanitary risks and  the 
measures applied by the third countries concerned, and should not be longer than 5 
years.  
(18) Moreover, the Commission should be empowered to adopt a delegated act, 
supplementing Regulation (EU) 2016/2031 with elements concerning the procedure to 
be followed in order to grant temporary derogations from Article 40(2) and Article 
41(2). This is necessary because, the experience since the adoption of Regulation (EU) 
2016/2031 has shown that a standardised procedure in respect of granting such 
temporary d erogations is necessary to guarantee transparency and consistency to 
Member States, third countries and the professional operators concerned.  
 
(EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 (OJ L 319, 
10.12.2019, p. 1 –279). EN 5  EN (19) The Commission should be empowered to adopt a delegated act, supplementing this 
Regulation by setting out procedures to be complied with for the listing of high risk 
plants, plant products and other objects. That procedure should include all of the 
following elements: the preparation, content and submission of the respective dossiers 
by the third countries concer ned; the actions to be taken following the reception of 
those dossiers; the procedures on the performance of the respective risk assessment; 
the handling of dossiers concerning confidentiality and data protection. This is 
necessary because, experience has shown that a specified procedure  in respect of 
listing high risk plants could guarantee transparency and consistency to Member 
States, third countries and the professional operators concerned.  
(20) In accordance wi th Article 44(1), point (a), of Regulation  (EU) 2016/2031 , the 
Commission is to set out equivalent requirements, by means of implementing acts, on 
request of a particular third country, if the third country concerned ensures, through 
the application under its official control of one or more specified measures, a level of 
phytosanitary protection which is equivalent to the special requirements in respect of 
the movement within the Union territory of the plants, plant products and other objects 
concerned.  
(21) Experience with the implementat ion of th at provision has shown  that setting out 
requirements equivalent only to the special requirements in respect of the movement 
of plants, plant products and other objects within the Union territory , is neither  
adequat e nor possible  in the case where such requirements for movement do not exist.  
This is a frequent case in practice, whe re the Union rules concern pests which are only 
present in third countries and not in the Union territory  and where  only requirements 
for the introduction of commodities into the Union territory have been adopted .  
(22) For this reason, the requested level of phytosanitary protection o n the part of the 
respective third country  should be also equivalent to the applicable special 
requirements in respect of the introduction into the Union territory of the plants, plant 
products and other objects concerned , from all or certain third countries .  
(23) In accordance with Article 71(2)  of Regulation  (EU) 2016/2031 , the phytosanitary 
certificate is to specify under the heading ‘Additional Declaration’ which specific 
requirement is fulfilled, whenever the respective implementing act, adopted 
respectively pursuant to Article 28(1) and (2),  Article 30(1) and (3), Article 37(2), 
Article 41(2) and (3) and Article 54(2) and (3), provides for several options for such 
requirements. That specification is to  include the full wording of the relevant 
requirement.  
(24) The practical implementation  of Regulation  (EU) 2016/2031  has shown that the 
phytosanitary certificates should also indicate reference to the require ments adopted 
pursuant to Article 37(4) of the Regulation, namely measures to prevent the presence 
of RNQPs on the plants for planting conc erned, as referred to in point (f) of Article 36 
of that Regulation , in the case where  the respective provision provides for several 
different options for such requirements . This is consistent with the approach 
concerning the Union quarantine pests, as Art icle 71(2) of that Regulation refers to the 
implementing act adopted pursuant to Article 41(2) and (3). It will also offer more 
clarity  and certainty to the competent authorities , the professional operators and the 
third countries , with regards to the  application of the rules concerning RNQPS and  the 
respective plants for planting.  
(25) For this reason, Article 71(2)  of Regulation  (EU) 2016/2031 should include a 
reference to the implementing acts adopted pursuant to Article 37(4). Moreover, the EN 6  EN reference to Article 37(2) should be removed, as it is not relevant to the content of the 
Additional Declaration of a phytosanitary certificate.  
(26) In ac cordance with Article 88 of Regulation  (EU) 2016/2031 , plant passports are to  be 
attached by the professional operators concerned to the trade unit of the plants, plant 
products and other objects concerned before they are moved within the Union territory 
pursuant to Article 79 or into or within a protected zon e pursuant to Article 80 of 
Regulation  (EU) 2016/2031 . Where such plants, plant products or other objects are 
moved in a package, bundle or container, the plant passport is to be attached to that 
packa ge, bundle or container.  
(27) Trade practises based on  Regulation  (EU) 2016/2031  have  shown that, in certain 
cases, it is not practically feasible to attach plant passports to  trade units of  particular 
plants, plant products or other objects  due to  their size, shape or other specific 
characteristics , or due to the  speed of its transfer from one professional operator to 
another . Instead, the trade units  of those plants, plant products or other objects  should 
be allowed to be moved within the Union territory  with a plant passport associated 
with them in way other than b y physical attachment . The requirements of Regulation 
(EU) 2016/2031 for the issuance of plant passports for the respective plants, plant 
products and other obje cts are to remai n as applicable.  
(28) Therefore, the Commission  should be empowered to adopt a delegated act  allowing 
certain plants, plant products and other objects to be moved without a plant passport 
attached to their trade units , due to  their size, sh ape, speed of their trade or other  
specific  characteristics that make that attachment impractical . In this regard, it is 
necessary to  determine the modalities ensuring that the plant passport remains in use, 
although not attached, and still refers to the respective plants, plant products and other 
objects, in order to make sure that a plant passport always remains connected to its 
respective commodity  by means of a special mark, chip, database or other appropriate 
elements .  
(29) In accordance with Article 99(1) of Regulation  (EU) 2016/2031 , the Commission is 
empowered to adopt delegated acts supplementing that Regulation by setting out the 
elements to be contained in official attestations specific for plants, plant products or 
other objects, other than wood packaging material, which are required by the 
applicable international standards . Since the adoption of Regulation  (EU) 2016/2031 , 
no such international standards have been adopted, and no preparatory work is 
currently being car ried out by any international organisation to produce such 
standards. As a result, and in the absence of such international standards, it is not 
possible , based on  Article 99 of Regulation (EU) 2016/2031,  to adopt a delegated act  
setting out the necessary elements for the respective official attestations . Due to the 
lack of such a delegated act , the introduction into the Union territory  of the relevant 
plants, plant products or other objects  cannot take place with those official attestations 
as alternatives to phytosanitary certificates .  
(30) Moreover, and i n accordance with certain implementing acts  adopted pursuant to 
Council Directive s 77/93/EEC6 and 2000/29/EC7, plant s, plant products and other 
 
6 Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into 
the Member States of harmful organisms of plants or plant products  (OJ L 26, 31.1.1977, p. 20 ). 
7 Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the 
Community of organisms harmful to plants or plant products and agains t their spread within the 
Community (OJ L 169, 10.7.2000, p. 1) . EN 7  EN objects are still being introduced into the U nion territory accompanied by  official 
attestations , other than phytosanitary certificates,  issued in several third countries . 
Those acts are, in particular , Commission Decision s 93/365/EC8, 93/422/EEC9, 
93/423/EEC10, and Implementing Decision 2013/780 /EU11. Those Decisions  have 
been adopted in the absence of any respective international standards.  
(31) The experience gained from the  application  of Regulation (EU) 2016/2031 and those 
Decisions , which are still in force, indicates that those offi cial attestations  offer 
adequate guarantees for the phytosanitary protection of the Union territory,  despite the 
fact that no respective international standards  have ever exist ed. For this reason, and in 
order to ensure the continu ed use of official attestations u nder Regulation  (EU) 
2016/2031 , the condition that the elements of that delegated act are required by the 
applicable international standards should be removed from Articl e 99(1). 
(32) In accordance with Article 103 of Regulation (EU) 2016/2031, the Commission is to 
establish an electronic system for the submission of notifications by the Member 
States. In order to ensure that such electronic system could be applicable also  for the 
submissions of reports , such as the reports  for the surveys of Union quarantine pests, 
priority pests and protected zones quarantine pests, the first sentence of th at Article 
should be amended in order to also include  the submission of reports by the Member 
States.  This is necessary to rationalise the reporting system and strengthen the process 
of digitalisation of phytosanitary measures.  
(33) Regulation (EU) 2016/2031  should therefore be amended accordingly.  
(34) In order to allow for the third countries and their professional operators to adapt to the 
new rules on the issuance of phytosanitary certificates concerning compliance with the 
respective RNQP rules, the amen dment of Article 71(2) of Regulation (EU) 2016/2031 
should apply from … [6 months from the entry into force of this Regulation ], 
HAVE ADOPTED THIS REGULATION:  
Article 1  
Amendment s to Regulation (EU) 2016/2031  
Regulation (EU) 2016/2031 is amended as follows:  
(1) in Article 18(6) , the first subparagraph  is replaced by the following:  
 
8 Commission Decision 93/365/EEC of 2 June 1993 authorizing the Member States to provide for 
derogations from certain provisions of Council Directive 77/93/EEC in respect of heat -treated 
coniferous wood, originating in Canada, and establishing the details of the indicator system to be 
applied to the heat -treated wood , (OJ L 151 , 23.6.1993,  p. 38). 
9 Commission Decision 93/422/EEC of 22 June 1993 authorizing the Member States to provide for 
derogations from certain provisions of Council Directive 77/93/EEC in respect of kiln dried coniferous 
wood, originating in Canada, and establishing the details of the indicator system to be applied to the 
kiln dried wood (OJ L 195, 4.8.1993, p. 51).  
10 Com mission Decision 93/423/EEC of 22 June 1993 authorizing the Member States to provide for 
derogations from certain provisions of Council Directive 77/93/EEC in respect of kiln dried coniferous 
wood, originating in the United States of America, and establish ing the details of the indicator system to 
be applied to the kiln dried wood (OJ L 195, 4.8.1993 , p. 55).  
11 Commission Implementing Decision 2013/780/EU of 18 December  2013 providing for a derogation 
from Article 13(1)(ii) of Council Directive 2000/29/EC i n respect of bark -free sawn wood of Quercus 
L., Platanus  L. and Acer saccharum  Marsh. originating in the United States of America  (OJ L 346, 
20.12.2013, p. 61 ). EN 8  EN ‘Member States shall notify the Commission and the other Member States of the 
demarcated areas immediately after their establishment , together with the pests 
concerned and the respective measures taken. Those notifications shall be made 
through the electronic notification system referred to in Article 103.’ ; 
(2) in Article 22(3) , the first subparagraph  is replaced by the following:  
‘Member States shall report to the Commission and the other Member States, by 30 
April of each year, the results of the surveys referred to in paragraph 1 which were 
carried out in the preceding calendar year. Those reports shall include information on 
where the surveys were conducted, the timing of the surveys, the pests and the plants, 
plant products or other objects concerned, the number of inspections and samples 
taken, and the finding of each pest concerned. Those reports shall be submitted to the  
electronic system for the submission of  notifications and  reports referred to in Article 
103, established by the Commission for that purpose ; 
(3) Article 23  is amended as follows : 
(a) in paragraph 1 , the third subparagraph  is replaced by the following:  
‘The multiannual survey programmes shall be established for a period of 10 
years , and shall be prolonged and as necessary updated  thereafter  for further 
conse cutive periods of 10 years . The first period shall expire on 14 Dec ember 
2029. ’; 
(b) paragraph 2 is replaced by the following:  
‘2. Member States shall, on request  from  the Commission , notify their 
multiannual survey programmes. Those notifications  shall be submitted 
to the  electronic system for the submission of notifications and reports 
referred to in Article 103 ‘’; 
(4) in Article 24 , paragraph 2 is replaced by the following:  
‘2. Member States shall report to the Commission and the other Member States by 
30 April of each year the results of the surveys referred to in paragraph 1 which 
were  carried out in the preceding calendar year. Those reports shall be 
submitted to the electronic system for the submission of  notifications and  
reports referred to in Article 103 ’; 
(5) in Article 30( 1), the third subparagraph is replaced by the following : 
‘Those measures shall, where appropriate, implement, specifically for each of the 
pests concerned, one or more of the provisions referred to in points (a) to (g) of the 
first subparagraph of Article 28( 1). They may include the prohibition of the presence 
of that pest in the Union territory  and/or  requirements concerning the introduction 
into, and the movement within, the Union territory of plants, plant products and other 
objects .’; 
(6) in Article 34 , paragraph 2 is replaced by the following:  
‘2. Member States shall notify the Commission and the other Member States, by 
30 April of each year , of the results of the surveys referred to in paragraph 1 
which were carried out in the preceding calendar year.  Those notifications  shall 
be submitted to the  electronic system  for the submission of notifications and 
reports referred to in Article 103 ; 
(7) in Article 37 , the following paragraph is added : EN 9  EN ’10. In the event that plants for planting have been introduced into, or moved 
within, the Union territory in violation of paragraph 1, Member States shall 
adopt the necessary measures, as referred to in Article 66(3) of Regulation 
(EU) 2017/625 and shall notif y that violation and those measures to the 
Commission and other Member States through the electronic notification and 
reporting system referred to in Article 103.  
Member States shall also notif y those measures  to the third country from which 
the plants for  planting were introduced into the Union territory.’ ; 
(8) in Article 42( 1), the following subparagraph s are added : 
‘The Commission is empowered to adopt a delegated act, in accordance with Article 
105, supplementing this Regulation by setting out the procedure to conduct the 
listing of high risk plants, plant products and other objects.  
That procedure shall provide for all the following elements:  
(a) the preparation of the resepctive  evidence for the assessment of the high risk 
plants, plant plant pro ducts and other objects ; 
(b) the actions to be taken following the reception of th at evidence ; 
(c) the procedures of the respective assessment;  
(d) handling of dossiers concerning confidentiality and data protection .’; 
(9) the following Article 42a is inserted after Article 4 2: 
‘Article 4 2a 
Temporary derogations from the prohibition s provided for in Articles 40 and 42, and 
from the requirements referred to in Article 41  
1. By way of derogation from Article 40(1) and Article 41(1), the Commission 
may, by means of implementing acts, adopt temporary derogations from the 
prohibition provided for in Article 40(1), and from the special and equivalent 
requirements referred to in Article 41(2), concerning th e introduction into the 
Union territory of specific plants, plant products and other objects originating 
from one or more third countries, which present a phytosanitary risk which  is 
not yet fully assessed.  
Those implementing acts shall:  
(a) set out temporary measures concerning the introduction of those plants, 
plant products and other objects into the Union territory, in accordance 
with the principles set out in Section 2 of Annex II; and  
(b) amend the respective parts of the implementing ac t referred to in Article 
40(2) and Article 41(2), by inserting a reference to the derogation 
concerning the respective plant, plant product or other object concerned . 
2. The temporary derogations referred to in paragraph 1 may  be adopted only if 
the follow ing conditions have been fulfilled:  
(a) the third country concerned has submitted to the Commission a request, 
containing official written guarantees for the application in its territory , 
prior to and at the moment of making the request, of the measures wh ich 
are necessary for addressing the respective phytosanitary risk; and  EN 10  EN (b) a provisional assessment has shown that those plants, plant products or 
other objects pose a risk that can be reduced to an acceptable level by 
applying one or more of the measures  in respect  of the phytosanitary risk 
concerned . 
3. The Commission is empowered to adopt a delegated act, in accordance with 
Article 105, supplementing this Regulation as regards the procedure to be 
followed in order to grant the temporary derogations refe rred to in paragraph 1. 
That delegated act shall provide for the following elements of the procedure:  
(a) the preparation, content and submission of the respective request and 
dossiers by the third countries concerned;  
(b) the actions to be taken following  the reception of those requests and 
dossiers;  
(c) handling of the requests and dossiers concerning confidentiality and data 
protection.  
4. By way of derogation from Article 42(2), the Commission may, by means of 
implementing acts, adopt temporary derogati ons from the acts referred to in 
Article 42(3), if both of the following is fulfilled:  
(a) the respective phytosanitary risk of the high -risk plants, plant products or 
other objects is not yet fully assessed;  
(b) no implementing act pursuant to Article 42(4) has yet been adopted as 
regards the plants, plant products or other objects concerned.  
Those implementing acts shall set out temporary measures , which are 
necessary to reduce the respective phytosanitary risk to an acceptable level,  
concernin g the introduction of those plants, plant products and other objects 
into the Union,.  
5. The implementing acts referred to in paragraphs 1, 2 and 4 shall provide for 
yearly  reporting from the third country concerned about the application of the 
respective temporary measures . In case the report concerned leads to the 
conclu sion that the risk concerned is not appropriately addressed by the 
measures  reported on, the act providing for those measures  shall be 
immediately repealed or amended as necessary.  
6. The application period of the implementing acts referred to in paragraphs 1, 2 
and 4 shall be such as to reasonably allow a full assessment of all phytosanitary 
risks and the measures of the third countries concerned, and shall not be longer 
than 5 years.  
7. The implementing acts referred to in paragraphs 1, 2 and 4 shall be adopted in 
accordance with the examination procedure referred to in Article 107(2).  
(10) in Article 44(1), point (a) is replaced by the following:  
‘(a) the third country concerned ensures, through the application under its official 
control of one or more specified measures, a level of phytosanitary protection 
which is equivalent to the special requirements in respect of the introduction 
into, and /or movement within, the Union territ ory of the plants, plant products 
and other objects concerned  from other third countries ;’; 
(11) in Article 71 , paragraph 2 is replaced by the following:  EN 11  EN ‘2. The phytosanitary certificate shall specify under the heading ‘Additional 
Declaration’ which speci fic requirement is fulfilled, whenever the respective 
implementing act, adopted pursuant to Article 28(1) and (2), Article 30(1) and 
(3), Article 37(4), Article 41(2) and (3) and Article 54(2) and (3), allows for 
several different options for such requirem ents. That specification shall include 
the full wording of the relevant requirement .’; 
(12) in Article 88 , the following paragraph s are added : 
‘The Commission is empowered to adopt a delegated act, in accordance with Article 
105, supplementing this Regulation by :  
(a) determining the plants, pla nt products and other objects which, by way of 
derogatio n from the first paragraph, may be moved within the Union with a 
plant passport associated with them in a way  other  than that of a physical 
attachment , due to  their size, shape  or speed of their trade that make that 
attachment impossible or very difficult ; and  
(b) providing for rules to  ensur e that the plant passport concerned , although  not 
attached, still refers to the respective plants, plant products and other objects  by 
means of a special mark, chip and/or  database ;  
(13) in Article 99 , paragraph 1 is replaced by the following:  
‘1. The Commission is empowered to adopt delegated acts in accordance with 
Article 105 supplementing this Regulation by setting out the elements to be 
contained in official attestations specific for plants, plant products or other 
objects, other than wood packaging material, as form of proof of the 
implementati on of measures adopted pursuant to Article 28(1) or (2), Article 
30(1) or (3), Article 41(2) or (3), Article 44, or Article 54(2) or (3). ’; 
(14) In Article 103, the first sentence is replaced by the following:  
‘The Commission shall establish an electronic system for the submission of 
notifications and reports by the Member States.’ ; 
(15) in Article 104 , first paragraph, the first sentence  is replaced by the following:  
‘The Commission may, by means of implementing acts, lay down specific rules 
concerning the submission of notifications referred to in Article 9(1) and (2), Article 
11, Article 17(3), Article 18(6), Article 19(2), Article 28(7), Article 29(3), first 
subparagraph, Article 30(8), Article 33(1), Article 37(10), Article 40(4), Article 
41(4), Article 46(4), Article 49(6), Article 53(4), Article 54(4), Article 62(1), Article 
77(2) and Article 95(5).’  
Article 2 
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 . 
Article 1, p oint (11) shall apply from … [6 months from the entry into force of this 
Regulation ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  EN 12  EN Done at Brussels,  
For the European Parliament  For the Council  
The President  The President