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 risk 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 surveys of pest
Date: 2023-10-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: disclosure of information, exchange of information, health certificate, import (EU), import restriction, marketing standard, pest, plant health control, plant health treatment, surveillance concerning imports

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   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 import 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 certificates, the use of plant passports and as regards certain reporting requirements for demarcated areas and surveys of pest  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Legislation on protective measures against pests of plants or plant products has been 
established  at  Union  level  since  the  1970s.  That  legislation  has  been  of  major 
importance for the protection of the agriculture, the landscape and the environment in 
the Union. The first evaluation and revision of the Union phytosanitary policy took 
place  between  2008  and  2016  and  resulted  in  the  adoption  of  Regulation  (EU) 
2016/2031  of  the  European  Parliament  of  the  Council1  (‘the  Regulation’),  which 
repealed  and  replaced  Council  Directive  2000/29/EC2.  The  Regulation  is  currently 
the basic legal framework for the Union plant health policy. 

Article  50  and  Article  79(6)  of  the  Regulation  prescribed  that  the  Commission 
submits, by the end of 2021, to the European Parliament and the Council reports on 
the enforcement and effectiveness of the import measures, and the experience gained 
by operators from the extension of the plant passport to all plants  for planting (‘the 
reports submitted in accordance with Article 50 and Article 79(6)’). 

The Commission submitted those reports on 10 December 2021.  

The  report  on  import  measures  concluded  that  it  could  be  considered  that  those 
import measures, as well the inclusion of the plant health controls within the scope of 
Regulation  (EU)  2017/625  of  the  European  Parliament  and  of  the  Council3  have 
contributed towards achieving the objectives to enhance the phytosanitary protection 
of  the  Union  and  to  increase  proactive  action  against  pests  in  compliance  with  the 
rules of the International Plant Protection Convention (IPPC) through risk-based and 
transparent approaches.  

The  report  on  the  extension  of  the  plant  passport  system  to  all  plants  for  planting 
concluded that that extension has contributed towards achieving the objectives of the 
Regulation.  More  specifically  it  contributed  to  increased  effectiveness  of  the 
protection  against  quarantine  pests,  improved  preparedness  for  the  identification  of 
new plant pests of Union concern, improved understanding and awareness on the part 

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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 2007/33/EC 
(OJ L 317, 23.11.2016, p. 4). 
Council Directive of 8 May 2000 on protective measures against the introduction into the Community 
of organisms harmful to plants or plant products and against their spread within the Community  (OJ L 
169, 10.07.2000, p. 1). 
Regulation (EU) 2017/625 of the European Parliament 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,  96/23/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). 

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of  relevant  stakeholders  concerning  the  plant  health  importance,  and  increased 
possibility to identify pests.  

The  reports  identified  areas  for  further  discussion  to  enhance  the  effectiveness  and 
practical  implementation  of  the  rules  for  plant  health  but  also  for  official  controls. 
Those  discussions  took  place  in  2022  with  the  Member  States’  Chief  Plant  Health 
Officers, as well as with Union associations relevant to plant health. They led to the 
conclusion  that  certain  improvements  of  the  system  were  needed,  which  were  only 
possible by amending the Regulation. Those improvements refer to the need for  (i) 
declarations  on  the  phytosanitary  certificate  for  regulated  non-quarantine  pests 
(RNQPs), (ii) reporting the non-compliances with  the RNQP rules in  the electronic 
notification  notification  system  (Information  Management  System  for  Official 
Controls  –  IMSOC),  (iii)  procedural  rules  for  the  submission  and  examination  of 
non-EU countries’ requests for temporary derogations from import prohibitions, (iv) 
procedures  for  identifying  and  listing  of  high-risk  plants  and  (v)  rationalising  the 
obligation to attach a plant passport to certain plants.  

Further improvements were identified through elements deriving from the experience 
gained  by  the  Commission  during  the  first  5  years  of  the  application  of  the 
Regulation, with  regard  to  (i) measures  against pests qualifying as  quarantine pests 
but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary 
derogations from import prohibitions, and special import requirements, (iii) the need 
for  setting  temporary  import  requirements  for  the  introduction  into  the  Union  of 
palnts, plant products or other objects which have been removed from the list of high 
risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting 
out  requirements  for  third  countries’  equivalence,  and  (v)  the  alternative  official 
attestations.  

Finally,  certain  reporting elements  were identified as falling  under the scope of the 
Commission’s commitment to rationalise the reporting obligations of Member States 
and  professional  operators  on  the  basis  of  its  Communication  on  ‘Long-term 
competitiveness of the EU: looking beyond 2030’4. 

Rationalisation of the reporting obligations  

As regards the rationalisiation of reporting obligations, the Commission has taken a 
horizontal  initiative.  In  its  Communication  on  ‘Long-term  competitiveness  of  the 
EU:  looking  beyond  2030’,  it  stressed  the  importance  of  a  regulatory  system  that 
ensures that objectives are reached at minimum costs. It has committed therefore to a 
fresh push to rationalise and simplify reporting requirements, with the ultimate aim 
to reduce such burdens by 25%, without undermining the related policy objectives.  

Its overall objectives are summarised as follows: 

(a) 

(b) 

improve 

to 
professional operators, both in the Union and in third countries; 

legal  certainty  and  clarity  for  competent  authorities  and 

to  increase  transparency,  flexibility  and  consistency  of  the  Union  regulatory 
procedures; 

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Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the regions ‘Long-term competitiveness of the 
EU: looking beyond 2030’, COM(2023)168. 

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(c) 

to  contribute  through  digitalisation,  to  the  rationalisation  of  reporting 
obligations and the administrative tasks linked to them. 

Reporting requirements  play a key role in  ensuring correct  enforcement  and proper 
monitoring  of  legislation.  Their  costs  are  overall  largely  offset  by  the  benefit  they 
bring, in particular in monitoring and ensuring compliance with key policy measures. 
Reporting  requirements  can  however  also  impose  disproportionate  burden  on 
stakeholders,  particularly  affecting  SMEs  and  micro-companies.  Their  cumulation 
over  time  can  result  in  redundant,  duplicating  or  obsolete  obligations,  inefficient 
frequency and timing, or inadequate methods of collection.  

The proposal  thus  aims also  at rationalising  reporting obligations by a combination 
of measures: 

– 

– 

– 

removal of reports which are not necessary any longer; 

digitalisation of transmission of information; 

reduction of frequency of reporting requirements 

The  reporting  requirements  concern  public  authorities  and,  in  certain  cases, 
indirectly,  professional  operators.  According  to  the  proposed  amendments,  certain 
reporting obligations are removed, while others are digitalised or are requested with 
reduced frequency. 

• 

Consistency with existing provisions in the policy area 

The proposal introduces amendments that concern the implementation of provisions 
which  constitue  the  Union’s  plant  health  policy.  They  do  not  change  the  Union’s 
plant health policy itself. Therefore, the proposed amendments are highly consistent 
with  the  existing  plant  health  policy  of  the  Union,  and  aim  at  contributing  to  the 
improvement of its application. 

The  proposals  on  reporting  obligations  are  part  of  a  first  package  of  Commission 
initatives to rationalise reporting requirements. This is a step in a continuous process 
looking  comprehensively  at  existing  reporting  requirements,  with  a  view  to  assess 
their continued relevance and to make them more efficient.  

The proposal will only positively affect the achievement of objectives in the policy 
area,  as  it  will  increase  transparency  and  decrease  administrative  burden  for  the 
competent authorities, the professional operators and the Commission. 

• 

Consistency with other Union policies 

The  consistency  of  the  Regulation  with  other  Union  policies  related  to  agriculture, 
and  the  environment,  such  as  biodiversity  and  climate  change,  is  ensured  by  its 
existing  provisions  and 
their  implementation.  Since  the  proposed  technical 
amendments  do  not  change  the  policy  direction  of  the  Regulation,  the  consistency 
with those policies remains unchanged. 

The  Commission  ensures  that  its  legislation  is  fit  for  purpose  and  targeted  to  the 
needs  of  stakeholders.  It  minimizes  administrative  burdens,  while  achieving  its 
objectives under the Regulatory Fitness and Performance Programme (REFIT). The 
proposed  amendments  concerning  the  rationalisation  of  reporting  obligations,  by 
reducing  the  complexity  of  reporting  burdens  arising  from  the  Union  legal 
framework. 

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2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposal amends the technical implementation of rules necessary for the pursuit 
of the objectives of the common agricultural policy, in the sector of production and 
marketing of plants, plant products and other objects in the Union. 

In this respect, Article 43(2) of the Treaty on the Functioning of the European Union 
(TFEU),  which  provides  the  legal  basis  for  adopting  provisions  necessary  for  the 
pursuit of the objectives of the common agricultural policy, has been selected. 

• 

Subsidiarity (for non-exclusive competence)  

According to Article 4(2), point (d), of the TFEU a shared competence between the 
Union and Member States applies in the area of agriculture and fisheries, excluding 
the conservation of marine biological resources.  

Since the adoption of Directive 2000/29/EC and also under the Regulation, all fields 
of plant health have been regulated at Union level to a very large extent. Those rules 
have proven to be a major contributor to the protection of the Union territory from 
pests  and  diseases.  Similarly,  the  objectives  of  the  proposed  amendments  can  be 
better achieved by exclusively regulating the issues concerned at Union level. 

As  regards  the  reporting  obligations,  the  requirements  concerned  are  already 
established by the Union law. Similarly, their rationalisation should be done at Union 
level.  

• 

Proportionality 

The measures proposed are limited to actions that need to be taken at Union level in 
order  to  be  effective  and  efficient.  To  achieve  the  effectiveness  and  efficiency  of 
these  actions,  the  amendment  of  the  Regulation  is  considered  most  appropriate, 
considering that a key element of the proposal is to reinforce the implementation of 
harmonised  measures  for  Member  States.  The  uniform  requirements  through  the 
Regulation are the only way to ensure a high level of quality for those applying the 
Regulation,  the  functioning  of  internal  market  and  a  level  playing  field  for  the 
operators as well as sustainable agricultural and food production. 

The  rationalisation  of  reporting  requirements  simplifies  the  legal  framework  by 
introducing  minimum  changes  to  existing  requirements  that  do  not  affect  the 
substance  of  the  wider  policy  objective.  The  proposal  is  therefore  limited  to  those 
changes that are necessary to ensure efficient reporting without changing any of the 
substantive elements of the legislation concerned.  

• 

Choice of the instrument 

The proposal takes the form of a Regulation of the European Parliament and of the 
Council. Other means  would not  be appropriate because the proposal  amends basic 
provisions of a Regulation of the European Parliament and of the Council for which 
the Commission  does  not  have the  empowerment to  achieve through implementing 
acts. 

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3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS  

EVALUATIONS, 

EX-POST 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

The  reports  submitted  in  accordance  with  Article  50  and  Article  79(6)  of  the 
Regulation  were  supported  by  a  stakeholder  consultation  which  included,  where 
necessary, gathering of the available data concerning imports.  

As  regards  the  reporting  obligations,  an  ex-post  evaluation  or  fitness  check  is  not 
applicable.  

• 

Stakeholder consultations 

For the preparation of the reports submitted in accordance with Article 50 and Article 
79  of  the  Regulation,  an  extensive  consultation  took  place  addressing  all  relevant 
stakeholders.  At  a  first  stage  the  Expert  Group  on  Plant  Health,  consisting  of 
Member  States’  competent  authorities  for  plant  health,  and  for  the  certification  of 
plant  and  forest  propagating  material,  the  European  Parliament,  and  the  relevant 
professional associations at Union level, were invited to participate in the process of 
developing fit-for-purpose questionnaires. A total  of 5 detailed questionnaires were 
developed 
import  prohibitions,  phytosanitary 
certificates  for  imports,  official  controls,  and  plant  passports,  comprising  a  total  of 
234 questions and covering the main changes introduced with the Regulation. 

import  procedures, 

regarding 

The  competent  authorities  of  the  Union  and  the  professional  associations  at  Union 
level, were invited to participate in the consultation process by a dedicated invitation, 
while  the  national  associations  and  individual  Union  operators  were  informed  by 
those  competent  authorities  and  professional  associations  at  Union  level  about  the 
possibility to participate in the consultation through an open-access link. Due to the 
highly  technical  nature  of  the  changes  very  few  questions  were  addressed  to  the 
public which was approached through social media. 

A total of 563 responses were received, a detailed analysis of which was presented in 
the  5  technical  reports5  produced  by  the  Commission’s  DG  SANTE  and  the  Joint 
Research Centre (JRC). 

As  regards  import  related  provisions,  Member  States’  views  were  positive  on 
provisions  and  proposals  that  provided  clarity  in  plant  health  controls  and  further 
enhanced  protection  of  the  Union  against  pests.  Union-  and  Member  State-  level 
associations  considered  certain  provisions,  such  as  the  temporary  prohibitions  of 
high-risk  plants,  to  have  caused  difficulties  in  already  established  trade,  thus 
requested  more  legal  clarity,  transparency.  The  associations  requested  more  legal 
clarity  and  transparency  also  for  other  procedures  that  can  positively  contribute  to 
trade, such as the derogations from permanent prohibitions. This is being addressed 
with  the  current  proposal.  As  regards  plant  passports,  stakeholders  considered  that 
attaching  them  to  each  trade  unit  poses  additional  administrative  burden  and 
associated  costs  that  outweigh  their  perceived  additional  benefits.  This  is  also 
addressed in this proposal. 

5 

Reports-2021 (europa.eu)  

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• 

Collection and use of expertise 

Besides the proposed amendments deriving from the reports submitted in accordance 
with  Article  50  and  Article  79(6)  of  the  Regulation  the  proposal  includes 
amendments deriving from the experience gained by the Commission during the first 
5  years  of  application  of  the  Regulation.  While  no  stakeholder  consultation  was 
carried out for these proposals, the specific proposed amendments refer to procedures 
that were considered problematic in their implementation and they aim at providing 
legal  clarity  and  certainty  for  the  competent  authorities,  the  operators  and  the  third 
countries. 

As regards the reporting obligations, these proposals have been identified following a 
process  of  internal  scrutiny  of  existing  reporting  obligations  and  based  on  the 
experience from the application of the related legislation. Since this is a step in the 
process  of  continuous  assessment  of  reporting  requirements  arising  from  Union 
legislation,  the  scrutiny  of  such  burdens  and  of  their  impact  on  stakeholders  will 
continue. 

• 

Impact assessment 

According to the analysis carried out by the Commission, the proposed amendments 
do not bare significant economic, environmental, or social impacts. The Commission 
hence  decided  not  to  carry  out  an  impact  assessment  for  the  targeted  technical 
amendments included in the proposal.  

The proposal is partly the result of the reports submitted by the Commission to the 
European Parliament and the Council pursuant  to  Articles 50 and 79 of  Regulation 
2016/2031. It is also based on experience gained from the application of Regulation 
(EU)  2016/2031.  For  the  preparation  of  the  report  an  extensive  consultation  took 
place with all relevant stakeholders. Following the submission of those reports to the 
European  Parliament  and  the  Council  on  10  December  2021,  areas  which  merited 
further discussion were identified. Therefore, discussions took place in 2022 with the 
Chief  Plant  Health  Officers  and  EU  associations  relevant  to  plant  health  and  plant 
and  forest  reproductive  material,  which  led  to  the  conclusion  that  certain 
improvements were needed and were only possible by amending the Regulation. As 
regards  the  reporting  obligations,  the  proposed  amendments  concern  limited  and 
the  reporting 
targeted  changes  of 
requirements.  They  are  based  on  experience  from  implementing  the  respective 
legislation.  Those  amendments  do  not  have  significant  impacts  on  the  policy,  but 
only ensure a more efficient and effective implementation. Their targeted nature and 
the lack of relevant policy options make an impact assessment not necessary.  

in  view  of  rationalising 

legislation 

the 

Overall,  any  impacts  of  the  proposed  amendments  are  expected  to  be  minimal  and 
positive both for the competent authorities and the professional operators. They will 
reduce  administrative  burden,  increase  legal  clarity  and  facilitate  the  trade  of  the 
respective commodities.  

• 

Regulatory fitness and simplification 

The  proposal  introduces  targeted  provisions  that  improve  an  already  functioning 
system  through  a  simpler,  clearer  and  less  burdensome  regulatory  regime  for  EU 
operators  and  competent  authorities  and  through  increased  transparency  for  third 
countries. 

As  regards  the  reporting  obligations,  this  proposal  aims  to  simplify  legislation  and 
cut  burdens  for  stakeholders,  in  particular  administrative  authorities.  It  aims  at 

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minimizing compliance costs by reducing the administrative burden and workload of 
national authorities through removal of certain reporting obligations. As regards the 
removal  of  the  obligation  for  annual  reporting  of  the  locations  of  the  demarcated 
areas,  that  information  can  be  retrieved  from  the  Commission  information  system 
(EUROPHYT) on reporting of outbreaks.  

The proposal also aims at rationalising the reporting obligation regarding the multi-
annual  survey  programmes  through  extending  the  current  frequency  of  performing 
those surveys from 5-7 years to 10 years. This will provide national authorities with 
additional  time  to  carry  out  the  respective  surveys.  Finally,  the  proposal  aims  at 
digitalising certain reporting obligations, taking into account the information systems 
developed and currently applicable for the purposes of Regulation (EU) 2017/625 as 
well  as  an  IT  system  for  plant  health  surveys.  Such  digitalisation  would  make  the 
application  of  the  respective  reporting  provisions  more  suitable  to  the  digital 
environment. 

• 

Fundamental rights 

The  proposed  amendments  do  not  have  any  effect  on  the  fundamental  rights 
protected by the Chapter of Fundamental Rights of the European Union. 

4. 

BUDGETARY IMPLICATIONS 

There are no budgetary implications. 

5. 

• 

• 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

Reporting  arrangements  are  rationalised.  No  amendment  is  introduced  concerning 
implementation  plans  and  monitoring  obligations.  A  6-month  transition  period  will 
be granted to the third countries as regards the obligation to indicate on the additional 
declaration of the phytosanitary certificate the measures applied by them, concerning 
the RNQPs rules. 

Explanatory documents (for Directives) 

Not applicable 

Detailed explanation of the specific provisions of the proposal 

(i)  Clarification concerning the measures against pests which are provisionally 

qualifying as quarantine pests but have not been fully assessed yet. 

Article  30  of  the  Regulation  empowers  the  Commission  to  adopt,  through 
implementing acts, temporary measures concerning the risk of pests which are 
not yet fully assessed and not yet regulated as Union quarantine pests. It offers 
the  possibility  to  treat  those  pests  as  listed  Union  quarantine  pests.  That 
provision  does  not  clearly  state  whether  those  measures  also  cover  special 
import requirements for plants and other commodities. 

Therefore,  and  for  reasons  of  enhanced  clarity,  the  proposal  amends  Article 
30(1) of the Regulation  to  specify that the temporary measures to  be adopted 
may cover both the internal movement of plants and other commodities within 
the Union and their imports into the Union.  

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(ii)  Amendment  of 

the  requirements  regarding 

the  declarations  on 

the 

phytosanitary certificate for regulated non-quarantine pests (RNQPs) 

• 

• 

Article 71(1) of the Regulation requires that the third country certifies the 
absence  of  Union  quarantine  pests  and  the  absence  of  (or  compliance 
with  the  relevant  tolerance  levels  for)  regulated  non-quarantine  pests 
(RNQPs)  on  the  respective  plants  and  commodities.  This  is  done  by  a 
standard  statement  on  the  phytosanitary  certificate  regarding  the 
compliance of the consignment with the import rules for quarantine pests 
as well as for RNQPs.  

In  line  with  the  International  Standard  for  Phytosanitary  Measures 
(ISPM)  No  12,  Article  71(2)  of  the  Regulation  requires  that,  where 
several  options  are  possible  under  the  applicable  special  import 
requirements,  the  third  country  declares  on  the  phytosanitary  certificate 
which option it applied, in order to ensure freedom from quarantine pests. 
However, this provision applies only to quarantine pests and not RNQPs. 

The proposal therefore amends Article 71(2) of the Regulation, in order for the 
third countries to declare on the phytosanitary certificate how compliance with 
the  RNQP  rules  has  been  ensured,  if  different  options  are  available  in  the 
Union  legislation.  This  amendment  would  also  be  in  line  with  the  relevant 
International Standard. 

(iii)  The  reporting  of  non-compliances  with  the  RNQP  rules  in  the  electronic 
notification system (Information Management System for Official Controls – 
IMSOC). 

Under  the  Regulation  there  is  an  obligation  to  report  to  IMSOC  non-
compliances with the rules on Union quarantine pests (e.g. presence of Union 
quarantine  pests  on  imported  plants).  That  obligation  does  not  exist  in  the 
Regulation for the rules on RNQPs.  

The  absence  of  this  requirement  for  RNQPs  has  led  to  non-harmonised,  non-
digitalised approaches among Member States regarding the means of reporting 
to  the  Union  and  the  third  country  about  non-compliances  with  the  rules  on 
RNQPs.  

The proposal therefore amends Articles 37 and 104 of the Regulation to ensure 
that  non-compliances  with  the  rules  on  RNQPs  and  the  follow-up  actions  are 
notified  in  a  harmonised  way  within  the  Union.  This  will  also  ensure 
consistency  with  the  respective  rules  on  quarantine  pests  and  will  overall 
increase the level of the EU phytosanitary protection. 

(iv)  The  introduction  of  an  empowerment  for  a  Commission  act  to  adopt  with 
autonomous  acts,  temporary  derogations  from  import  prohibitions  and 
special  import  requirements  and  temporary  special  import  requirements  for 
commodities that have been removed from the list of high-risk plants, plant 
products  and  other  objects  but  for  which  the  pest  risk  has  not  been  fully 
assessed. . 

Article 40 of the Regulation on prohibitions of imports of plants, plant products 
or  other  objects  from  third  countries,  sets  out  the  obligation  for  the 
Commission  to  establish  a  single  list  containing  those  prohibitions.  Those 

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prohibitions  are  related  to  one  or  more  specific  quarantine  pests,  they  do  not 
have an expiration date, and they usually apply to all or many third countries.  

However, according to SPS rules, a third country should be allowed to request 
a derogation from those import prohibitions if it considers that it has a system 
in place that could guarantee the level of phytosanitary protection required by 
the Union. For such cases there is a need to grant temporary derogations from 
the relevant prohibitions.  

Similarly to the case of derogating from the import prohibitions, there are cases 
where  the  need  arises  to  grant  temporary  derogations  from  the  special  and 
equivalent  requirements  described  under  the  list  of  Article  41(2).  As  an 
example,  a  third  country  might  request  that  the  Union  accepts  alternative 
measures that it considers efficient to reduce the risk to an acceptable level the 
risk of introducing into the Union of plants, plant products or other objects with 
pests..  The  proposal  introduces  the  possibility  to  adopt  a  derogation  from  the 
special requirements of Article 41(2) based on a provisional assessment. 

Such temporary derogations, usually concern one third country, or a part of it. 
They should be granted, only if very detailed special import requirements are 
complied  with.  Those  requirements  could  cover  all  steps  from  production  to 
export to the Union, such as production methods, treatments and other methods 
to  mitigate  the  risk  of  the  relevant  pests,  as  well  as  visual  inspections, 
sampling,  testing  and  other  phytosanitary  measures  for  achieving  the  level  of 
protection required by the Union. Those derogations should be provided for in 
autonomous acts for a temporary period of time to allow for a full assessment 
of  the  effectiveness  of  the  measures  and  for  a  flexible  modification  of  the 
conditions or the derogation itself, if so needed. Once the temporarymeasures 
have been estabilised and audited, and a full assessment becomes available, the 
temporary  status  of  the  derogation  can  be  dropped.  As  regards  commodities 
suject to derogations from the import prohibitions, at that point the respective 
commodity from the third country concerned will be as a result included in the 
list  of  special  import  requirements  adopted  under  Article  41(2)  of  the 
Regulation. Equally, if in the period of application of a temporary derogation it 
becomes  evident  that  the  risk  is  not  reduced  to  an  acceptable  level,  that 
derogation  will  be  immediately  dropped  and  the  respective  commodity  from 
the third country concerned will be moved in the list of prohibited commodities 
under Article 40 of the Regulation. 

the  derogations  from 

import  prohibitions  and  special 

Besides 
import 
requirements,  experience  with  the  removal  of  commodities  from  the  high-rik 
plants,  plant  products  and  other  objects  has  shown  that  there  are  cases  where 
while  the  overall  risk  of  the  commodity  has  been  assessed,  certain  identified 
pests  have  not  been  assessed.  Therefore,  a  need  arises  to  adopt  temporary 
special  import requirements  in  order to  allow  for those pests risks to  be  fully 
assessed. Once that risk has been fully addressed, respective commodity from 
the third country concernconcerned will be  included in  the list  adopted under 
rticle 41(2) of the Regulation or be granted equivalence. 

To  bring  more  clarity  and  transparency  to  the  process  of  granting  temporary 
derogations  from  import  prohibitions  and  special  import  requirements,  and  to 
the  process  of  imposing  special  import  requirements  and  temporary  special 
import requirements for commodities that have been removed from the list of 

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high-risk plants,  as well as  for  plant products  and other objects  for which the 
pest risk has not been fully assessed, the proposal introduces a new Article 42a 
in the Regulation, providing for a separate empowerment for the Commission 
temporary 
to  adopt  autonomous 
derogations 
import 
from  of 
requirements.  

implementing  acts,  addressing 
the  established  prohibitions,  or  special 

those 

(v)  The  introduction  of  an  empowerment  for  a  Commission  act  to  adopt 
procedural  rules  for  the  submission  and  examination  of  third  countries’ 
requests for temporary derogations from import prohibitions or from import 
requirements. 

Article  40  of  the  Regulation  introduces  the  rules  concerning  prohibitions  of 
imports  for  certain  plants  of  certain  origins,  while  Article  41  introduces  the 
rules  concerning  import  and  movement  requirements  for  certain  plants  of 
certain origin. As explained regarding the previous proposed amendment, upon 
request from a third country, the Commission grants in certain cases temporary 
derogations  to  third  countries  from  those  prohibitions,  to  allow  the  import  of 
some  of  their  plants  or  other  commodities  or  from  import  and  movement 
requirements,  to  allow  the  import  and  further  movement  into  the  Union  [of 
some of their plants or other commodities.  

However,  no  standardised  procedures  for  assessing  those  third  countries’ 
requests  exist.  Currently,  when  receiving  a  request  for  such  a  temporary 
derogation  from  a  third  country,  the  procedure  for  granting  the  derogation  is 
based on an ad-hoc request for information and an ad-hoc decision to involve 
or  not  the  European  Food  Safety  Authority  (EFSA)  in  that  assessment.  A 
standardised  procedure  would  provide  rules  for  the  decision-making  process 
and consequently the currently lacking transparency. 

The proposal therefore introduces in the new Article 42a of the Regulation an 
empowerment for the Commission to adopt rules on a standardised procedure 
on  how  to  submit  and  examine  a  request  for  granting  temporary  derogations 
from the import prohibitions or import requirements. Those rules could include 
instructions  on the submission  of the respective dossiers and the elements for 
the assessment.  

(vi)  The introduction of an empowerment for a Delegated act to adopt procedures 

for identifying and listing of high-risk plants. 

According to Article 42 of the Regulation, the provisional listing of the plants 
as high-risk plants should be based on a preliminary assessment. However, no 
further details  are set  out  on how to carry out  this  assessment. To date, there 
has  been  only  one  listing  of  several  plant  species  as  high-risk  plants  with 
Commission  Implementing  Regulation  (EU)  2018/20196.  Member  States 
experts  took  part  in  the  process  of  drawing  up  the  list  of  high-risk  plants  by 
submiting proposals which were thoroughly assessed and that assessment took 
into consideration scientific and technical evidence.  

6 

Commission  Implementing  Regulation  (EU)  of  18  December  2018  establishing  a  provisional  list  of 
high risk plants, plant products or other objects, within the meaning of Article 42 of Regulation (EU) 
2016/2031 and a list of plants for which phytosanitary certificates are not required for introduction into 
the Union, within the meaning of Article 73 of that Regulation (OJ L 323, 19.12.2018, p. 10). 

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However,  the  procedure  has  been  characterised  by  several  actors  as  not 
transparent  enough,  especially  in  view  of  the  fact  that  this  process  led  to  a 
provisional prohibition of an already existing trade.  

Therefore,  and  for  reasons  of  transparency,  that  procedure  and  the  elements 
needed  for  the  assessment  should  be  described.  In  this  respect,  the  proposal 
amends Article 42 of the Regulation by introducing an empowerment to allow 
the  Commission  to  adopt  a  delegated  act  describing  the  procedure  for 
identifying and listing those high-risk plants, and the specific elements needed 
to carry out the assessment.  

(vii)  The  clarification  of  the  legal  basis  for  setting  out  requirements  for  third 
countries’  equivalence,  in  order  to  refer  not  only  to  internal  movement 
requirements  but  also  to  existing  import  requirements,  in  line  with  the 
relevant International Standard. 

In  accordance  with  Article  44  of  the  Regulation,  the  Commission  is 
empowered, through implementing acts, to set out equivalent requirements for 
third countries’ systems, when such countries provide a level of phytosanitary 
protection  which  is  equivalent  to  the  special  requirements  applicable  to  the 
movement of plants and other goods within the Union territory. In such cases, 
the  third  country’s  phytosanitary  system  is  assessed  by  the  European  Food 
Safety  Authority  (EFSA),  followed  by  a  Union  decision  to  consider  the 
respective requirements as equivalent or not.  

The possibility to set out equivalent requirements for third countries’ systems 
only  when  requirements  for  internal  movement  of  plants,  plant  products  or 
other  objects  are  in  place  is  restrictive,  because  it  does  not  cover  the  cases 
where  no  such  requirements  for  movement  within  the  Union  exist,  as  the 
respective pest is not known to be present in the Union territory, nevertheless, 
special import requirements are in place. For this reason, and according to the 
proposed amendment, the third country concerned will be required to ensure a 
level  of  phytosanitary  protection  which  is  equivalent  not  only  to  the 
requirements for internal movement of the respective plants and commodities, 
but  also  to  the  special  import  requirements  from  other  third  countries  for  the 
same plants and other commodities, if such special import requirements are in 
place. 

The  proposal  therefore  amends  Article  44(1)  of  the  Regulation  to  expand  the 
scope of such requirements.  

(viii)  The introduction of an empowerment for a Commission act, to rationalise the 

obligation to attach a plant passport to certain plants.  

Article  88  of  the  Regulation  sets  out  an  obligation  of  attaching  the  plant 
passport  to  all  respective  plants,  plant  products  or  other  objects,  without 
allowing  for  any  exception.  However,  in  certain  cases,  such  as  that  of  wood 
logs or grass sods (turf), the nature of certain commodities, or the speed of the 
their  trade  between  professional  operators,  is  such  that  compliance  with  that 
obligation is rendered impractical, if not impossible. 

The proposal therefore amends Article 88 of the Regulation by introducing an 
empowerment for the Commission to list specific commodities to be exempted 
from the obligation to attach the plant passport on them, and to determine the 
modalities for the application of such an exemption. 

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(ix)  The  alignment  of  the  possibility  to  accept  alternative  official  attestations 

issued by third countries with the international state of play. 

According  to  Article  99  of  the  Regulation,  the  Commission  is  empowered  to 
adopt  delegated  acts  setting  out  the  elements  to  be  contained  in  official 
attestations  issued  by  third  countries  for  specific  imported  plants,  plant 
products  and  other  objects,  other  than  wood  packaging  material,  which  are 
required  by  the  applicable  international  standards.  However,  no  international 
standards  so  far  exist  for  such  attestations.  This  is  because  such  official 
attestations usually refer to very specific types of commodities and countries of 
origin, while the international standards usually are of a more general  nature. 
This  restricted  possibility  to  accept  official  attestations,  only  when  they  are 
drawn  up  in  accordance  with  relevant  international  standards,  also  affects 
Commission Implementing Decisions applicable since many years ago. 

The  proposal  therefore  amends  Article  99  of  the  Regulation  to  broaden  the 
requirement  concerning  ‘the  applicable  international  standards’,  by  including 
other criteria as an alternative to the existence of international standards, and to 
empower  the  Commission  to  adopt  delegated  acts  setting  out  the  elements  of 
those attestations without the need for international standards to be adopted. 

(x)  Rationalisation of reporting obligations  

The  proposal  amends  the  relevant  Articles  of  the  Regulation  regarding  the 
following reporting obligations: 

(a) 

(b) 

removal  of  annual  reporting  of  the  number  and  locations  of  the 
demarcated  areas  established,  the  pests  concerned,  and  the  respective 
measures taken during the preceding calendar year (Article 18);  

rationalisation  of  reporting  by  decreasing  its  frequency  and  prolonging 
the  duration  of  the  multiannual  survey  programmes  (i.e.,  period  during 
which Member States have to survey all quarantine pests) from 5-7 years 
to 10 years (Article 23).  

(c) 

digitalisation of the following reporting measures:  

(i) 

ad-hoc reporting of demarcated areas (Article 18);  

(ii) 

annual reporting of results of surveys for quarantine pests (Article 
22); 

(iii)  reporting of the multiannual survey programmes (Article 23);  

(iv)  annual reporting of results of surveys for priority pests (Article 24);  

(v) 

annual reporting of results of surveys for protected-zone quarantine 
pests (Article 34); 

This  initiative  also  includes  the  establishment  of  an  electronic  system  for  the 
submission of reports (Article 103). 

(xi)  Relevant amendments in other Union acts and final provisions 

Not applicable. 

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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 import 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 certificates, the use of plant passports and as regards certain reporting 
requirements for demarcated areas and surveys 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 transmission 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) 

(2) 

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.  
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  concerning  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)  Moreover 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 

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 2007/33/EC 
(OJ L 317, 23.11.2016, p. 4). 

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(4) 

(5) 

with  the  Commission’s  Communication  on  ‘Long-term  competitiveness  of  the  EU: 
looking beyond 2030’3. 

In accordance with Article 18(6) of Regulation (EU) 2016/2031, Member States are to 
notify the Commission and the other 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. 

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,  the 
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  Member  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,  because  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 locations 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) 

(8) 

3 
4 

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  of  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 their establishment to the Commission and 
the other Member States.  

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 of application of Regulation (EU) 2016/2031, Member States 

COM(2023)168. 
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). 

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14 

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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 
those  programmes  are  to  be  established  again  for  consecutive  periods  of  10  years 
thereafter, and the first period is to expire on 14 December 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  States  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  the  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  Commission  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 Member 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 
notifications 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 countries, 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 respective plants, 
plant  products  and  other  objects  are  currently  listed  respectively  in  Annexes  VI  and 

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VII  to  Implementing  Regulation  (EU)  2019/20725.  Such  cases  are  those  in  which  a 
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 
reduced 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  time  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  territory  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  subject  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 remove 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 adopted 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 

5 

Commission  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 repealing Commission Regulation 
(EC)  No  690/2008  and  amending  Commission  Implementing  Regulation (EU)  2018/2019  (OJ  L  319, 
10.12.2019, p. 1–279). 

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temporary  derogations  is  necessary  to  guarantee  transparency  and  consistency  to 
Member States, third countries and the professional operators concerned. 

(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  concerned;  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  with  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  implementation  of  that  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 
adequate nor possible in the case where such requirements for movement do not exist. 
This is a frequent case in practice, where 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  on  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) 

is  fulfilled,  whenever 

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 
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. 

the  respective 

(24)  The  practical  implementation  of  Regulation  (EU)  2016/2031  has  shown  that  the 
phytosanitary  certificates  should  also  indicate  reference  to  the  requirements  adopted 
pursuant to Article 37(4) of the Regulation, namely measures to prevent the presence 
of RNQPs on the plants for planting concerned, 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 Article 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.  

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(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 
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 accordance 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  zone  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 
package, 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 by physical attachment. The requirements of Regulation 
(EU)  2016/2031  for  the  issuance  of  plant  passports  for  the  respective  plants,  plant 
products and other objects are to remain 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,  shape,  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  carried  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  in  accordance  with  certain  implementing  acts  adopted  pursuant  to 
Council  Directives  77/93/EEC6  and  2000/29/EC7,  plants,  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). 

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objects  are  still  being  introduced  into  the  Union  territory  accompanied  by  official 
attestations,  other  than  phytosanitary  certificates,  issued  in  several  third  countries. 
Those  acts  are,  in  particular,  Commission  Decisions  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  official  attestations  offer 
adequate guarantees for the phytosanitary protection of the Union territory, despite the 
fact that no respective international standards have ever existed. For this reason, and in 
order  to  ensure  the  continued  use  of  official  attestations  under  Regulation  (EU) 
2016/2031,  the  condition  that  the  elements  of  that  delegated  act  are  required  by  the 
applicable international standards should be removed from Article 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  that  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 amendment 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 

Amendments to Regulation (EU) 2016/2031 

7 

8 

9 

10 

11 

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  against  their  spread  within  the 
Community (OJ L 169, 10.7.2000, p. 1). 
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). 
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). 
Commission  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 establishing the details of the indicator system to 
be applied to the kiln dried wood (OJ L 195, 4.8.1993, p. 55). 
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 in 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). 

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Regulation (EU) 2016/2031 is amended as follows: 

(1) 

in Article 18(6), the first subparagraph is replaced by the following: 

‘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 
consecutive periods of 10 years. The first period shall expire on 14 December 
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 

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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: 

’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  notify  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 notify 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 subparagraphs 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 products and other objects; 

(b) 

the actions to be taken following the reception of that 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 42: 

‘Article 42a 

Temporary derogations from the prohibitions 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 the 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) 

(b) 

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 

amend the respective parts of the implementing act 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 following conditions have been fulfilled: 

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(a) 

(b) 

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 which 
are necessary for addressing the respective phytosanitary risk; and 

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 referred to in paragraph 1. 
That delegated act shall provide for the following elements of the procedure: 

(a) 

(b) 

(c) 

the  preparation,  content  and  submission  of  the  respective  request  and 
dossiers by the third countries concerned; 

the  actions  to  be  taken  following  the  reception  of  those  requests  and 
dossiers; 

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  derogations  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, 
concerning  the  introduction  of  those  plants,  plant  products  and  other  objects 
into the Union,. 

5. 

6. 

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 
conclusion  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.  

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 

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which  is  equivalent  to  the  special  requirements  in  respect  of  the  introduction 
into, and/or movement within, the Union territory of the plants, plant products 
and other objects concerned from other third countries;’; 

(11) 

in Article 71, paragraph 2 is replaced by the following: 

‘2.  The  phytosanitary  certificate  shall  specify  under  the  heading  ‘Additional 
Declaration’  which  specific  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 requirements. That specification shall include 
the full wording of the relevant requirement.’; 

(12) 

in Article 88, the following paragraphs are added: 

‘The Commission is empowered to adopt a delegated act, in accordance with Article 
105, supplementing this Regulation by:  

(a) 

determining  the  plants,  plant  products  and  other  objects  which,  by  way  of 
derogation  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  ensure  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 
implementation  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. 

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Article  1,  point  (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. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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