Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on protective measures against pests of plants
Date: 2013-05-06
Institutions: European Commission
Subjects: biodiversity, destruction of crops, import (EU), marketing standard, plant health control, plant health treatment, plant propagation

EUROPEAN 
COMMISSION 

Brussels, 6.5.2013  
COM(2013) 267 final 

2013/0141 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on protective measures against pests of plants 

{SWD(2013) 168 final} 
{SWD(2013) 169 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Plant health  is  a key factor  for sustainable and competitive agriculture, horticulture 
and forestry. Healthy seeds and propagating material are required for profitable crops 
and  for  ensuring  jobs,  plant  innovation  and  food  security.  In  the  case  of  trees  and 
shrubs, protecting plant health is essential for the preservation of the Union's forests, 
landscape  and  public  and  private  green.  Plant  health  is  also  important  for  the 
protection of biodiversity and ecosystem services. 

Pests  from  other  continents  are  especially  dangerous.  European  plants  and  trees 
usually lack adequate genetic resistance against foreign pests, which moreover often 
do not have natural enemies here. When introduced into Europe, foreign pests cause 
severe  economic  damage.  They  may  jump  to  previously  unaffected  host  species, 
spread  fast  across  countries,  and  cause  lasting  yield  reduction  and  permanently 
increased  costs  for  production  and  control.  The  often  severe  economic  losses 
undermine  the  profitability  and  competitiveness  of  agriculture  and  forestry.  The 
establishment of new pests may elicit trade bans from third countries, damaging EU 
exports.  Not  all  pests  can  be  controlled  with  pesticides  and,  where  available, 
pesticide use may be undesirable.  

Regulatory framework 

The  current  EU  regulatory  framework  for  plant  health  aims  to  protect  European 
agriculture  and  forestry  by  preventing  the  entry  and  spread  of  foreign  pests.  The 
main tool hereby is Council Directive 2000/29/EC1, which also reflects international 
trade agreements in this area. The EU phytosanitary (plant health) regime is unique 
in that it is an open regime: movements of plants and plant products into and within 
the  Union  are  allowed  on  condition  that  specific  restrictions  and  requirements  are 
respected (e.g. provenance from a pest free area or appropriate treatment). The high 
volumes  of  imports  from  other  continents  nevertheless  imply  a  high  probability  of 
future outbreaks of foreign pests.  

The regime is indispensable for protecting the health, economy and competitiveness 
of the EU plant production sector as well as for maintaining the Union's open trade 
policy.  However,  the  existing  regulatory  framework  is  being  criticised  for  being 
unable to stop the increased influx of dangerous new pests caused by globalisation of 
trade. Moreover climate change enables those pests to survive in Europe, while they 
could  not  in  the  past,  and  renders  crops  and  ecosystems  more  vulnerable  to  new 
pests. Major outbreaks in the past decade of dangerous import-related pests affecting 
forestry  have  raised  societal  and  political  awareness  of  the  costs  and  impacts  of 
inadequate protection.  

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OJ L 169, 10.7.2000, p. 1. 

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Problem analysis 

An  evaluation  of  the  regime  (2010)2  has  shown  that  the  basic  legislation  has  to  be 
amended  in  order  to  be  able  to  fully  address  these  increased  risks.  The  main 
problems identified relate to insufficient focus on prevention in relation to increased 
imports of high-risk commodities, the need for prioritising pests at EU level across 
all 27 Member States, the need for better instruments for controlling the presence and 
natural spread of pests in case they eventually reach the Union territory, a need for 
modernising  and  upgrading  the  instruments  concerning  intra-EU  movements  (plant 
passports and protected zones), and a need to foresee additional resources.  

A need for "greening" of the regime has furthermore emerged and objectives relating 
to  the  natural  environment  have  gained  importance.  This  requires  changes  to  the 
intervention logic, also in terms of financing, of the regime, which is moving from a 
private  good  regime  for  agriculture  to  a  mixed  public/private  good  regime  for 
agriculture, forestry, natural environment and landscape. 

The science base of the regime (research, laboratories) needs to be reinforced. There 
has  been  a  steady  erosion  of  the  classical  plant  pathology  and  pest  taxonomy  in 
universities, endangering the support from science to assess risks from new pests and 
to  adequately  diagnose  those  pests  in  the  laboratory.  A  State  of  Emergency 
declaration has been issued in this respect by the European and Mediterranean Plant 
Protection Organisation.  

Finally, a new balance needs to be struck as concerns costs and responsibility sharing 
(partnership  development)  and  there  is  a  need  to  increase  effectiveness  and  reduce 
unnecessary costs and administrative burden. A need for modernisation of the regime 
furthermore exists in terms of incentives for compliance.  

Objective of the proposal 

The  present  revision  aims  to  overcome  these  flaws  and  to  put  in  place  a  robust, 
transparent  and  sustainable  regulatory  framework  that  is  'fit  for  purpose'.  The 
proposed Regulation replaces and repeals Directive 2000/29/EC.  

Relationship to other proposals in the package 

The proposal is part of a package of reviews relating to the health of plants, quality 
of plant reproductive material, health of animals, official controls concerning plants, 
animals, food and feed, and Union expenditures for those policies.  

The  proposal  reinforces  the  synergies  with  the  plant  reproductive  material  regime, 
while  removing  avoidable  duplications  and  unnecessary  burden  from  those 
duplications. This is achieved by repositioning the pests that are currently regulated 
under  the  so-called  marketing  Directives  for  seed  and  plant  propagating  material 
under  the  proposed  plant  health  Regulation.  That  repositioning  will  introduce 
flexibility to change the status of widespread quarantine pests into quality  pests, as 
requested  by  professional  operators  and  Member  States,  so  as  to  use  the  resources 
available to the phytosanitary authorities for true Union priorities. In the meanwhile, 

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http://ec.europa.eu/food/plant/plant_health_biosafety/rules/index_en.htm 

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the  proposal  ensures  that  the  existing  practical  arrangements  in  the  Member  States 
concerning  the  certification  of  plant  reproductive  material  for  quality  pests  can 
remain. Altogether, the rearrangements between the EU plant health regime and plant 
reproductive  material  regime  should  reinforce  the  coherence  between  those  two 
regimes (through shared use of certification schemes, labels and registers) and thus 
result in reduced burden for professional operators. The proposed new arrangements 
will,  however,  require  enhanced  coordination  between  the  competent  authorities  in 
the Member States for plant health and plant reproductive material. 

The  proposal  does  not  contain  provisions  concerning  official  controls  by  the 
competent  authorities  of  compliance  by  professional  operators  with  the  Union 
phytosanitary  legislation,  as  are  currently  present  in  Directive  2000/29/EC.  Those 
controls  are  now  being  positioned  exclusively  in  the  proposal  concerning  official 
controls  (replacing  Regulation  (EC)  882/20043).  This  will  also  allow  improved 
coherence with the new Customs Code and allow simplified procedures at import. 

The  proposal  does  not  contain  provisions  on  expenditures  eligible  for  a  financial 
contribution  from  the  Union,  as  exist  in  Directive  2000/29/EC.  The  provisions 
concerned, drafted in accordance with the preferred option of the impact assessment, 
are included in the accompanying legal proposal for a Regulation on food and feed 
expenditure, which concerns the management of Union expenditures relating to the 
food chain, animal health and animal welfare, and relating to plant health and plant 
reproductive material. 

The  proposal  will  be  complementary  to  the  proposal  concerning  Invasive  Alien 
Species foreseen under the EU Biodiversity Strategy. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

Consultation process 

The  Council  on  21  November  2008  invited  the  Commission  to  proceed  to  an 
evaluation  of  the  EU  plant  health  regime  and  to  consider  possible  modifications  to 
the existing legal framework and the impact of such modifications4. The Commission 
initiated  a  comprehensive  evaluation  of  the  regime  from  the  introduction  of  the 
internal  market  (1993)5  and  contracted  the  necessary  study  out  to  an  external 
consultant6.  Member  State  experts  participated  in  the  Inter-Service  Steering  Group 
for  the  evaluation.  A  conference  took  place  on  23-24  February  2010  to  inform  the 
stakeholders  and  MS  on  the  progress  of  the  evaluation  and  to  consult  them  on  the 
provisional  options  for  the  future  developed  by  the  consultant.  The  input  received 
framed  the  final  options  and  recommendations.  The  report  of  the  evaluation7  was 
presented in a second conference on 28 September 2010 including stakeholders, the 

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OJ L 191, 28.5.2004, p. 1. 
Council of the European Union, 2906th Economic and Financial Affairs / Budget, 21 November 2008. 
Council Conclusions on the Review of the EU Plant Health Regime. Document no. 104228. 
Taking account of a previous evaluation of the financial aspects of the regime, completed in 2008. 
Food  Chain  Evaluation  Consortium  (FCEC),  consisting  of  Civic  Consulting,  Agra  CEAS  Consulting 
(project leader), Van Dijk Management Consultants and Arcadia International.  
http://ec.europa.eu/food/plant/plant_health_biosafety/rules/index_en.htm 

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general  public,  and  representatives  of  MS  and  third  countries.  Linked  to  this 
conference  was  a  public  consultation  on  the  recommendations  from  the  evaluation 
and the scope of the subsequent impact assessment. 

In preparation for the impact assessment, the options recommended by the external 
consultant were discussed with the Member States in Council with the Chief Officers 
for  Plant  Health  (COPHs)  in  many  rounds  of  meetings  and,  as  concerns  the 
coherence with the Plant Reproductive Material (PRM) regime, the Heads of Service 
for that regime and the relevant Working Party. Five task forces with Member State 
experts and Commission were convened to further discuss the main areas of change.  

Stakeholders  (industry  association  representatives  and  NGOs)  were  consulted  from 
the very start  of  the review  process, prior to the initiation of the evaluation, during 
the evaluation study and again during the preparation of the impact assessment. An 
ad-hoc Working Group on Plant Health was set up under the Advisory Group on the 
Food Chain, Animal and Plant Health. The progress was presented and discussed in 
several meetings of the aforementioned Advisory Group, in other Advisory Groups8 
and on invitation in meetings of COPA-COGECA, EUROPATAT, ESA and UNION 
FLEURS.  Stakeholder  consultation  was  a  key  element  of  the  evaluation  study  and 
the  supplementary  economic  study  contracted  out  to  an  external  consultant.  The 
consultation  concerned  changes  of  the  EU  plant  health  regime  itself  as  well  as 
elements  of  the  regime  to  be  transferred  to  or  from  the  plant  reproductive  material 
regime and the EU regime on official controls on food and feed, animal health and 
welfare, plant health and plant reproductive material. 

The conferences organised during the review process ensured stakeholders' input and 
views concerning the recommendations and the scope of the impact assessment, both 
orally at the conferences and through the linked public consultation. A consultation 
on the technical change proposals was linked to the meeting of the Working Group 
on Plant Health on 18 February 2011 and targeted the preferred way forward for the 
changes  with  major  impact.  Consultations  were  additionally  published  on  the 
dedicated  web  page9  of  DG  SANCO.  A  final  consultation  on  the  strategic  options 
was launched on 13 May 2011.  

Data collection 

The collection of data commenced with a comprehensive evaluation of the regime by 
the  external  consultant  from  2009  to  2010.  The  evaluation  included  an  ex  post 
analysis of the regime for the period 1993-2008, the collection of economic data on 
costs and administrative burden for competent authorities and stakeholders stemming 
from the regime, as well as the development ex ante of options and recommendations 
for the future. The evaluation report was delivered in May 2010. 

The  internal  process  to  develop  the  IA  was  further  supported  by  a  second  contract 
with  the  consultant.  This  contract  concerned  a  study  on  the  quantification  of  costs 
and benefits of amendments to the regime, supplementary to the data that had been 
collected  during  the  evaluation.  The  study  consisted  of  modules  addressing  the  ex 

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Advisory  Groups  on  Seeds,  Advisory  Group  on  Cotton,  Advisory  Group  on  Floriculture  and 
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http://ec.europa.eu/food/plant/plant_health_biosafety/rules/index_en.htm  

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ante assessment of the economic impact of specific technical options for the revision 
of  the  legislation.  The  scope  of  the  issues  to  be  addressed  had  been  subject  to 
stakeholder  consultation.  The  modules  were  set  up  in  such  a  way  that  aggregation 
was possible to potential overall policy options. In July 2011, the final report of the 
study  was  delivered  by  the  consultant.  Where  necessary  further  information  was 
gathered from the literature, study reports and queries to assess the key impacts the 
change in policy would have. Furthermore, the social and environmental impacts of 
the policy options were assessed by Commission's services.  

Impact assessment 

Four options were developed to improve the regime: 

Option  1:  Improve  only  the  legal  form  and  clarity  of  the  regime.  The  legislation 
would be converted from a Directive into a Regulation, and simplified and clarified. 
The status quo would be maintained in terms of substance.  

Option  2:  Prioritise,  modernise  and  step  up  prevention.  Additional  to  Option  1, 
prioritisation  would  be  improved  by  transforming  the  current  Annexes  I  and  II, 
which list regulated pests according to technical features irrespective of their priority 
for the Union, into lists based on intervention logic and priority. The plant passport 
and  protected  zone  systems  would  be  modernised  (responsibility  sharing  with 
professional operators) and upgraded (plant passport scope, format, mandatory cost-
recovery  based  plant  passport  fees  as  already  exist  for  import  controls,  rules  for 
surveillance and outbreak eradication in protected zones). The coherence between the 
PHR  and  the  plant  reproductive  material  regime  would  be  improved  to  increase 
effectiveness  and  reduce  costs  for  professional  operators.  Prevention  would  be 
reinforced  by  introducing  a  new  provision  concerning  high-risk  plant  reproductive 
materials (plants for planting) that are not authorised for introduction into the Union 
or subject to specific enhanced physical controls until completion of a risk analysis, 
and by removing exemptions for passenger luggage (to be subject to low frequency 
controls to minimise the cost impacts).  

Option  3:  Prioritise,  modernise,  step  up  prevention  and  reinforce  actions  against 
outbreaks. Additional to Option 2, obligations would be introduced for surveillance 
and  contingency  planning.  In  analogy  with  the  arrangements  in  the  animal  health 
regime,  EU  co-financing  would  be  made  available  for  surveillance  and,  in  certain 
cases, for financial compensation of direct losses of professional operators. The legal 
instruments  for  eradication  and  containment  would  be  further  developed.  The 
exclusion of natural spread related measures would be removed.  

Option  4:  Prioritise,  modernise,  step  up  prevention,  reinforce  actions  against 
outbreaks  and  expand  the  scope  to  invasive  plants.  Additional  to  Option  3,  the 
regime  would  also  cover  invasive  plants,  in  terms  of  legal  provisions  for  measures 
and  EU  co-financing.  Invasive  plants  (other  than  parasitic  plants)  would  not  be 
covered in Options 1, 2 and 3. 

The  assessment  of  the  impacts  of  the  four  options  revealed  that  Option  3  provided 
the best way forward to achieve the objectives with the best cost-benefit level and an 
optimal balance of inputs from Member States, professional operators and the Union. 
Option  3  should  have  a  significant  positive  impact  on  profitability  and  economic 

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growth of the sectors involved; it was also the closest reflection of the outcome of the 
stakeholder and MS consultation.  

The  EU  budget  necessary  to  implement  Option  3  was  secured  in  the  Commission 
proposal  for  the  Multi-Annual  Financial  Framework  (MFF)  for  2014-2020.  The 
corresponding  legal  provisions  are  included  in  the  legal  proposal  for  a  Regulation 
laying down provisions for the management of expenditure relating to the food chain, 
animal health and animal welfare, and relating to plant health and plant reproductive 
material.  

Small and medium-sized enterprises and micro-enterprises 

The  nature  of  the  plant  health  regime  requires  that  small  and  medium-sized 
enterprises  (SME)  are  not  exempted  from  the  obligations  of  this  Regulation.  The 
majority  of  the  enterprises  affected  by  the  regime  are  SME  and  exempting  them  a 
priori  would  fundamentally  jeopardise  the  regime's  objectives.  However,  the 
proposal  exempts  enterprises  selling  plants  and  plant  products  exclusively  to  the 
local market from the obligation to issue plant passports, which will moreover not be 
required  for  sales  to  final  non-professional  consumers  anyhow.  For  micro-
enterprises,  special  arrangements  concerning  potential  refunding  of  fees  for  plant 
health controls, within the framework of State Aid rules, will be made possible under 
the new Regulation concerning official controls.  

Fundamental rights 

This  Regulation  respects  the  fundamental  rights  and  observes  the  principles 
recognised  in  particular  by  the  Charter  on  Fundamental  rights  of  the  European 
Union.  It  should  be  applied  by  the  Member  States  in  accordance  with  those  rights 
and  principles,  implemented  as  appropriate  in  their  national  legislation.  Certain 
provisions  of  this  Regulation  nevertheless  limit  particular  rights  under  the  Charter, 
however only to the extent strictly necessary for protecting the general interest of the 
Union concerned by this Regulation and conserving the essence of the rights at stake.  

Eradication  of  outbreaks  of  foreign  pests  can  only  be  successful  if  all  sources  of 
infestation are removed. Apart from outbreaks of quarantine pests on the premises of 
professional  operators,  outbreaks may also  take  place in  public  or private  green. In 
those  cases,  the  eradication  measures  need  to  include  the  infested  and  potentially 
infested plants  in that public and  private green in order to be successful at all (any 
remaining  infested  plants  will  act  as  a  source  of  new  infestations  elsewhere).  This 
implies  that,  in  certain  cases,  competent  authorities  of  Member  States  need  to  be 
given  access  to  private  premises  for  official  controls,  possibly  followed  by  the 
imposition of treatment or eradication measures or certain restrictions or prohibitions 
on  the  use  of  plants.  This  is  a  limitation  of  Articles  7  and  17  of  the  Charter  on 
Fundamental  Rights  concerning,  respectively,  the  Respect  for  Private  and  Family 
Life and the Right to Property. That limitation is necessary to achieve an objective of 
general interest, being the protection of plant health in the Union. The limitation is 
proportionate  because  the  objective  of  general  interest  cannot  be  achieved  without 
ensuring  that  phytosanitary  measures  are  respected  equally  by  all  (refraining  from 
destruction  of  infested  plants  in  private  gardens  would  annihilate  the  benefits  of 
eradication  measures  imposed  on  professional  operators  and  carried  out  in  public-
owned  green).  It  will  be  the  responsibility  of  the  Member  States  to  provide  fair 

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compensation to affected citizens in good time for the suffered loss. The essence of 
the Right to Property is thus conserved.  

Anybody who is aware of the presence of a quarantine pest will be obliged to notify 
the presence of that quarantine pest to the competent authorities, accompanied with 
the information concerning the origin and the nature of the material concerned. This 
will  also  apply  to  laboratories  and  research  organisation  encountering  pests  in 
samples provided to them. This may in some cases constitute a limitation of Article 8 
of the Charter, concerning the Right to Protection of Personal Data. That limitation is 
necessary  to  achieve  the  public  interest  objective  of  plant  health  in  the  Union,  as 
findings of quarantine pests need to be made known to the competent authorities in 
order  to  ensure  the  immediate  eradication  of  outbreaks.  The  limitation  is 
proportionate  because  personal  data  are  subject  to  the  provision  only  to  the  extent 
that they are indispensable for the competent authorities to locate the outbreaks and 
take the necessary action. The essence of the Right to Protection of Personal Data is 
thus conserved.  

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Chapter I: Subject matter, scope and definitions 

The  territorial  scope  of  the  regime  does  not  include  any  non-European  outermost 
regions of Member States, as those regions belong to other biogeographic regions of 
the world, where exactly those pests occur against which the European territories of 
the  Member  States  require  protection.  The  territorial  scope  of  the  regime  does 
include part of the Macaronesian archipelago (the island of Madeira and the Azores), 
which  forms  a  biogeographic  region  overlapping  with  the  Mediterranean  region,  in 
particular  the  Iberian  peninsula,  in  terms  of  natural  vegetation.  It  is  therefore 
appropriate to include that archipelago in the scope of the regime. Annex I lists the 
territories of the Member States that are covered by the Treaty on the Functioning of 
European  Union  but,  for  the  purpose  of  this  Regulation,  are  considered  as  third 
countries.  

Invasive  plants  other  than  parasitic  plants  (physically  feeding  on  host  plants)  are 
excluded from the scope, in line with the outcome of the impact assessment.  

Definitions are provided as necessary. 

Chapter II: Quarantine pests 

In Directive 2000/29/EC, pests are listed in specific Annexes. The proposal, instead, 
sets  out  the  conceptual  nature  of  quarantine  pests  and  subsequently  lists  them  in 
implementing  acts,  either  as  Union  quarantine  pests  or  Protected  Zone  quarantine 
pests.  Union  quarantine  pests  require  eradication  measures  in  the  entire  Union 
territory,  while  for  Protected  Zone  quarantine  pests  that  is  only  the  case  within 
specified  protected  zones  where  certain  pests  are  absent,  while  they  are  known  to 
occur in other parts of the Union territory. The proposal empowers the Commission 
to list certain quarantine pests as  priority pests for the Union, up to a maximum of 
10% of the listed Union quarantine pests. Those pests will be subject to an enhanced 
level  of  obligations  concerning  preparedness  and  eradication,  supplemented  by 
enhanced financial support from the Union for the required actions. Criteria to decide 

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whether  a  pest  qualifies  as  a  quarantine  pest,  Union  or  Protected  Zone  quarantine 
pest,  or  priority  pest  are  provided  in  Annex  II  of  the  Regulation.  A  transfer  is 
foreseen of the pests currently listed in Annexes I and II of Directive 2000/29/EC to 
the appropriate lists of the future implementing acts. No distinction will be made any 
longer  between  pests  currently  listed  in  Annex  I  and  Annex  II  of  Directive 
2000/29/EC.  

This  chapter  furthermore  sets  out  detailed  rules  on  notification  of  the  presence  of 
quarantine pests, measures to be taken for the eradication of those pests including the 
restriction of areas subject to eradication measures, surveys to be carried out for the 
presence  of  pests  and  the  establishment  of  contingency  plans  and  eradication  plans 
concerning outbreaks of priority pests.  

The provisions in this chapter empower the Commission to adopt implementing acts 
on permanent measures to manage quarantine pests that have become established in 
the  Union  territory.  Those  acts  can  also  be  adopted  on  a  temporary  basis  for  non-
listed  quarantine  pests,  if  necessary  using  the  urgency  procedure  established  under 
the  Lisbon  Treaty.  The  tools  developed  in  this  chapter  exist  today  under  Directive 
2000/29/EC,  however  the  proposal  develops  those  tools  explicitly.  A  provision  is 
included  allowing  Member  States  to  take  stricter  measures  against  pests  than 
foreseen in the Union legislation, on condition that those measures do not restrict in 
any way the free movement of plants, plant products and other regulated objects on 
the internal market. 

The chapter  also  covers the provisions concerning protected  zones,  which maintain 
the existing system, however explicitly reinforced to ensure that protected zones are 
technically  justified  and  that  any  outbreaks  of  the  Protected  Zone  quarantine  pests 
concerned  are  properly  and  timely  eradicated.  If  not,  the  protected  zone  will  be 
revoked. With these changes, the Union's protected zone system aligns with the pest-
free  area  system  under  the  International  Plant  Protection  Convention  (IPPC),  as 
requested by the regime's stakeholders and by third countries. 

Chapter III: Quality pests 

Pests  that  affect  the  intended  use  of  plants  for  planting,  but  do  not  require 
eradication,  are  regulated  today  under  the  marketing  Directives  for  seed  and  plant 
propagating material and, partly, in Annex II to Directive 2000/29/EC. The proposal 
categorises them all as Union quality pests. It sets out the conceptual nature of such 
pests  and  subsequently  lists  them  through  implementing  acts.  Criteria  to  decide 
whether  a  pest  qualifies  as  a  Union  quality  pest  are  provided  in  Annex  II.  Quality 
pests will not be regulated under the legal proposal for Plant Reproductive Material, 
other than their inclusion, where appropriate, in certification schemes. 

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Schematic representation of the various types of pests in the proposal, the decision process 
for their qualification and the measures required against them.

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Chapter IV: Measures concerning plants, plant products and other objects 

Directive  2000/29/EC  has  Annexes  listing  prohibitions  for  certain  plants,  plants 
products and other objects (Annex III), and specific requirements for the introduction 
into  and  movement  within  the  Union  (Annex  IV).  The  proposal  empowers  the 
Commission  to  adopt  such  lists  through  implementing  acts.  The  provisions  in 
Chapter IV furthermore concern rules for recognition of measures of third countries 
as  equivalent  to  the  Union  measures,  and  derogations  to  the  prohibitions.  The 
respective rules concerning the movement of plants, plant products and other objects 
into and within protected zones are also addressed. 

New to the Union plant health regime is an Article empowering the Commission to 
adopt  implementing  acts  to  address  emerging  risks  from  certain  plants  for  planting 
from  certain  third  countries  which  require  precautionary  measures.  Listed  plant 
materials  will  require  intensified  visual  examination  and  testing,  or  subjection  to  a 
quarantine period, or will be subject to a temporary prohibition of introduction into 
the Union. Those measures shall apply for two years, prolongable once. During that 
time, a full risk assessment shall be developed, followed by a decision to regulate the 
material concerned on a permanent basis, or to drop the temporary measures. 

New is also an article setting out the basic rules for quarantine stations, when the use 
of  those  stations  is  required  by  the  Regulation  or  by  secondary  acts  under  the 
Regulation. 

The  introduction  into  the  Union  of  regulated  plants  by  passengers  in  their  luggage 
will no longer be exempted from the respective requirements and prohibitions. This 
is necessary because plants in passenger luggage have been found an increasing risk 
for the phytosanitary status of the Union and jeopardise the success of the regime. 

New  is  finally  an  Article  requiring  that  exports  of  plants,  plant  products  and  other 
objects to third countries shall take place either in accordance to the Union rules, or, 
if the third country's rules so allow or the third country explicitly so agrees through 
bilateral  agreements  or  otherwise,  in  accordance  to  the  requirements  of  that  third 
country. 

Chapter V: Registration of professional operators and traceability 

The  proposal  requires  the  relevant  professional  operators  to  be  registered,  in  a 
register  which  will  also  contain  the  professional  operators  required  to  be  registered 
under  the  proposed  Regulation  concerning  plant  reproductive  material.  This  should 
reduce  burden  for  professional  operators.  Registered  operators  shall  fulfil  certain 
requirements for the traceability of the plant material under their control. 

Chapter VI: Certification of plants, plant products and other objects 

Directive 2000/29/EC has an Annex (V) listing requirements concerning certification 
of  plants,  plant  products  and  other  objects  introduced  into  or  moved  within  the 
Union.  The  proposal  empowers  the  Commission  to  adopt  such  lists  through 
delegated  acts.  The  respective  rules  concerning  the  certification  of  plants,  plant 
products and other objects introduced into and moved within protected zones are also 
addressed. 

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The  proposal  foresees  that  all  plants  for  planting,  other  than  certain  seeds,  shall 
require  a  phytosanitary  certificate  for  introduction  into  the  Union  and  a  plant 
passport  for  movement  within  the  Union.  Plant  passports  shall  be  required  for  all 
movements  between  professional  operators,  but  not  for  sales  to  final  non-
professional users. The plant passport will be simplified and harmonised. Instead of a 
lot  number,  the  plant  passport  may  use  a  chip,  barcode  or  hologram  linking  to  the 
internal traceability systems of professional operators.  

Examinations  on  plants,  plant  products  and  other  objects  requiring  a  plant  passport 
may require the use of certification schemes with regard to certain quarantine pests 
and/or quality pests, where examinations in the field during the growing season are 
indispensable.  This  possibility  could  be  created  thanks  to  the  inclusion  of  quality 
pests in the plant health Regulation. Where certification schemes are required under 
the plant health Regulation, it is provided that the certification schemes created under 
the  proposed  Regulation  concerning plant reproductive material shall be used. This 
should preclude that double schemes are set up, which would result in double costs 
for professional operators. 

Plant passports shall be issued by registered operators that are authorised so by the 
competent authorities, or, on their request, by the competent authorities. Where plant 
material  requires  a  plant  passport  under  the  plant  health  Regulation  and  a 
certification  label  under  the  proposed  Regulation  concerning  plant  reproductive 
material, the plant passport and the certification label shall be combined in a single 
document.  This  should  preclude  double  costs  for  professional  operators,  where  the 
issuance is done by the competent authorities. 

Rules  are  foreseen  concerning  the  authorisation  and  supervision  of  professional 
operators  issuing  plant  passports  and  for  the  examination  of  the  plant  material 
concerned,  in  order  to  ensure  that  that  material  complies  with  all  provisions  of  the 
Regulation.  

Rules  are  also  foreseen  concerning  the  authorisation  and  supervision  of  wood 
packaging material producers who apply a certain mark to that material, following its 
treatment according to the International Standard for Phytosanitary Measures No. 15 
on Regulation of wood packaging material in international trade. 

For export purposes, the proposal foresees the introduction of a pre-export certificate, 
for  cases  where  plant  material  is  exported  from  a  Member  State  which  is  not  the 
Member  State  of  origin.  The  pre-export  certificate  will  replace  the  currently  used 
informal guidance document agreed by the Member States. 

Chapter VII: Measures supporting the implementation of the Regulation 

The  proposal  foresees  the  establishment  of  an  electronic  notification  system  for 
notification and reporting. 

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Chapter VIII: Final provisions 

The  proposal  foresees  that  the  Commission  will  be  assisted  by  a  new  Standing 
Committee, which will include the existing Committees dealing with the food chain, 
animal  and  plant  health  and  plant  reproductive  material  (instead  of  the  existing 
Standing Committee on Plant Health). 

The proposal foresees amendments to the Regulation laying down provisions for the 
management  of  expenditure  relating  to  the  food  chain,  animal  health  and  animal 
welfare,  and  relating  to  plant  health  and  plant  reproductive  material,  which  is 
foreseen to be adopted in advance of the current legal proposal. Those amendments 
include the possibility for the Union to co-finance measures concerning priority pests 
(a  pest  category  created  in  the  current  proposal)  and  compensation  to  operators  for 
the foregone value of plant material that is destroyed as part of eradication measures 
concerning priority pests. 

The proposal repeals six so-called Control Directives concerning the management of 
certain  quarantine  pests  (potato  wart  fungus,  potato  cyst  nematodes,  potato  brown 
rot,  potato  ring  rot,  carnation  leafrollers  and  San  José  scale)  that  are  known  to  be 
present in the Union. Acts of such nature will in future be adopted as secondary acts 
under the proposed Regulation and not as co-decided acts. The Directives on pests of 
potato  will  be  replaced  by  secondary  acts  under  now  proposed  Regulation,  without 
changing their substance. The Directives on carnation leafrollers and San José scale 
will not be replaced. 

4. 

BUDGETARY IMPLICATION 

The  financial  provisions  and  appropriations  for  implementing  the  Regulation  up  to 
31  December  2020  will  be  presented  in  the  forthcoming  legal  proposal  for  a 
Regulation  on  the  management  of  expenditure  relating  to  the  food  chain,  animal 
health  and  animal  welfare,  and  relating  to  plant  health  and  plant  reproductive 
material.  The  current  proposal  does  not  imply  any  expenditures  which  will  not  be 
part  of  the  financial  statement  of  the  legal  proposal  for  that  Regulation  and  it  does 
not require additional human resources.  

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2013/0141 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on protective measures against pests of plants 

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 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 Committee10,  

Having regard to the opinion of the Committee of the Regions11,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

10 
11 
12 
13 

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 Community12 sets out a plant health regime. 

On  21  November  2008,  the  Council  invited  the  Commission  to  proceed  to  an 
evaluation of that plant health regime13. 

In  the  light  of  the  outcome  of  that  evaluation  and  the  experience  gained  from  the 
application  of  Directive  2000/29/EC,  that  Directive  should  be  replaced.  To  ensure 
uniform application of the new rules, the act replacing that Directive should take the 
form of a Regulation. 

Plant  health  is  very  important  for  plant  production,  public  and  private  green,  natural 
ecosystems,  ecosystem  services  and  biodiversity  in  the  Union.  Plant  health  is 
threatened  by  species  injurious  to  plants  and  plant  products,  hereinafter  'pests'.  To 
fight that threat, it is necessary to adopt measures concerning the determination of the 

OJ C , , p. . 
OJ C , , p. . 
OJ L 169, 10.7.2000, p. 1. 
Council of the European Union, 2906th Economic and Financial Affairs / Budget, 21 November 2008. 
Council Conclusions on the Review of the EU Plant Health Regime. Document no. 104228. 

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(5) 

(6) 

(7) 

phytosanitary  risks  posed  by  those  pests  and  the  reduction  of  those  risks  to  an 
acceptable level. 

The need for such measures has long been recognised. They have formed the subject 
of international agreements and international conventions, including the International 
Plant  Protection  Convention  (IPPC)  of  6  December  1951  concluded  at  the  United 
Nations Food and Agricultural Organisation (FAO) and its new revised text approved 
by  the  Food  and  Agriculture  Organisation  Conference  in  November  1997  at  its  29th 
session. The Union is party to the IPPC. 

It  has  appeared  that  for  the  determination  of  the  scope  of  this  Regulation  it  is 
important to take into account bio-geographical factors to avoid that pests not present 
in  the  European  territory  of  the  Union  spread  to  that  territory.  Consequently,  non-
European territories (outermost regions) of Member States referred to in Article 355(1) 
TFEU  should  be  excluded  from  the  territorial  scope  of  this  Regulation.  Those 
territories should be listed. Where the status of such a territory or a territory referred to 
in Article 355(2) TFEU is amended pursuant to Article 355(6) TFEU, that list should 
be amended to ensure that the territorial scope of this Regulation remains confined to 
the European part of the Union territory. References to third countries should be read 
as references also to the territories included in that list. 

Directive  2000/29/EC  sets  out  rules  concerning  official  controls  to  be  carried  out  by 
the competent authorities as regards protective measures against the introduction into 
the  Community  of  organisms  harmful  to  plants  or  plant  products  and  against  their 
spread within the Community. Such rules are presently set out by Regulation (EU) No 
…/….  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 reproductive material, plant protection products and amending Regulations (EC) 
No  999/2001,  1829/2003,  1831/2003,  1/2005,  396/2005,  834/2007,  1099/2009, 
1069/2009,  1107/2009,  Regulations  (EU)  No  1151/2012,  [….]/2013  [Office  of 
Publications,  please  insert  number  of  Regulation  laying  down  provisions  for  the 
management  of  expenditure  relating  to  the  food  chain,  animal  health  and  animal 
welfare, and relating to plant health and plant reproductive material], and Directives 
98/58/EC,  1999/74/EC,  2007/43/EC,  2008/119/EC,  2008/120/EC  and  2009/128/EC 
(Official  controls  Regulation)14  [Office  of  Publications,  please  insert  number  of 
Regulation  on  Official  Controls  and,  in  the  footnote,  the  reference  to  the  Official 
Journal] and therefore should not be part of this Regulation. 

(8) 

Criteria  should  be  set  out  in  order  to  allow  pests  to  be  identified  for  which  it  is 
necessary  to  adopt  measures  of  control  for  the  entire  Union  territory.  Such  pests  are 
referred  to  as  'Union  quarantine  pests'.  Criteria  should  also  be  set  out  for  the 
identification  of  pests  for  which  it  is  necessary  to  adopt  measures  of  control  only  as 
regards one or more parts of that territory. Such pests are referred to as 'protected zone 
quarantine pests'. 

(9) 

In  order  to  allow  efforts  for  the  control  of  Union  quarantine  pests  to  concentrate  on 
pests  whose  economic,  environmental  or  social  impact  is  most  severe  for  the  Union 

14 

OJ L …, ……, p. … 

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territory as a whole, a restricted list of such pests, hereinafter 'priority pests', should be 
established. 

(10) 

(11) 

It  is  appropriate  to  provide  for  exemptions  from  the  prohibition  of  introduction  into 
and  movement  within  the  Union  territory  of  Union  quarantine  pests  for  scientific 
purposes, trials, varietal selections, breeding and exhibitions. 

In  order  to  ensure  effective  and  timely  action  in  case  of  the  presence  of  a  Union 
quarantine  pest,  notification  obligations  should  apply  to  the  public,  professional 
operators and to the Member States. 

(12)  Where  those  notification  obligations  imply  that  personal  data  of  natural  or  legal 
persons  should  be  disclosed  to  the  competent  authorities,  this  may  constitute  a 
limitation  of  Article  8  (Protection  of  Personal  Data)  of  the  Charter  on  Fundamental 
Rights. However that limitation would be necessary and proportionate to achieve the 
public interest objective of this Regulation. 

(13)  A professional operator becoming aware of the presence of a Union quarantine pest in 
a plant, plant product or other object which is or was under its control should be under 
an obligation to take all measures that may be appropriate as regards the elimination of 
the  pest,  the  withdrawal  or  recall  of  the  plants,  plant  products  or  other  objects 
concerned and the information of the competent authority, other persons in the trade 
chain and the public.  

(14)  Member States should take all necessary measures to eradicate Union quarantine pests, 
when found present in their territories. It is appropriate to set out measures which may 
be taken by Member States in such a case and the principles based on which they are 
to decide what measures to take. Those measures should include the establishment of 
restricted areas, consisting of an infested zone and a buffer zone. 

(15) 

In  certain  cases,  Member  States  should  impose  measures  for  the  eradication  of 
quarantine pests on plants in private premises, because eradication of pests can only be 
successful  if  all  sources  of  infestation  are  removed.  For  this  purpose,  the  competent 
authorities  of  Member  States  should  have  legal  access  to  those  premises.  This  may 
constitute a limitation of Article 7 (Respect for Private and Family Life) and Article 17 
(Right to Property) of the Charter on Fundamental Rights. That limitation is necessary 
and  proportionate  to  achieve  the  public  interest  objective  of  the  regime,  in  so  far  as 
Member States ensure fair compensation in good time for the loss of private property.  

(16)  Early detection of the presence of pests is extremely important for timely and effective 
eradication.  Member  States  should  therefore  conduct  surveys  for  the  presence  of 
Union quarantine pests in the areas where those pests were not known to be present. In 
view of the number of Union quarantine pests and the time and resources required to 
carry  out  those  surveys,  Member  States  should  establish  multi-annual  survey 
programmes. 

(17)  The Commission should be empowered to adopt measures in case of the suspected or 
confirmed presence of specific Union quarantine pests, concerning in particular their 
eradication  and  containment,  and  the  establishment  of  restricted  areas,  surveys, 
contingency plans, simulation exercises and eradication plans as regards those pests.  

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(18) 

In  order  to  ensure  swift  and  effective  action  against  pests  which  are  no  Union 
quarantine  pests  but  which  Member  States  consider  may  fulfil  the  conditions  for 
inclusion in the list of Union quarantine pests, provision should be made for measures 
to  be  taken  by  Member  States  in  case  they  become  aware  of  the  presence  of  such  a 
pest. Similar provisions should be set out for the Commission. 

(19)  Under  certain  conditions  Member  States  should  be  allowed  to  adopt  more  stringent 

eradication measures than required by Union legislation.  

(20)  Special  provisions  should  apply  to  priority  pests  as  regards  the  information  of  the 
public, surveys, contingency plans, eradication plans and co-financing of measures by 
the Union, in particular. 

(21)  Quarantine  pests  which  are  present  in  the  Union  territory  but  absent  from  specific 
parts of that territory designated as 'protected zones', and whose presence would have 
unacceptable  economic,  social  or  environmental  impacts  only  for  those  protected 
zones, should be specifically identified and listed as 'protected zone quarantine pests'. 
The  introduction  into,  movement  within,  and  release  into  the  respective  protected 
zones of protected zone quarantine pests should be prohibited. 

(22)  Rules  should  be  set  out  concerning  the  recognition,  modification  or  revocation  of 
recognition of protected zones, survey obligations for protected zones, and actions to 
be  taken  in  case  protected  zone  quarantine  pests  are  found  present  in  the  respective 
protected zones. In case of findings of the presence of the protected zone quarantine 
pest inside the respective protected zone, strict rules should apply for the amendment 
and revocation of those protected zones.  

(23)  A  pest,  which  is  no  Union  quarantine  pest,  should  be  referred  to  as  a  'Union  quality 
pest'  in  case  that  pest  is  mainly  transmitted  through  specific  plants  for  planting,  its 
presence on those plants for planting has an unacceptable economic impact as regards 
the  intended  use  of  those  plants  and  it  is  listed  as  a  Union  quality  pest.  To  limit  the 
presence of such pests their introduction into or movement within the Union territory 
on the plants for planting concerned should be prohibited unless provided otherwise in 
that list. 

(24)  Certain  plants,  plant  products  and  other  objects  pose  an  unacceptable  phytosanitary 
risk by their likelihood to host a Union quarantine pest. For some of those, acceptable 
risk  mitigation  measures  are  available,  while  not  for  others.  Depending  on  the 
availability  of  acceptable  risk  mitigation  measures,  their  introduction  into,  and 
movement within, the Union territory should be either prohibited or subject to special 
requirements. Those plants, plant products and other objects should be listed.  

(25)  Derogations from the prohibitions or special requirements as regards the introduction 
of plants, plant products and other objects into the Union territory should be provided 
for.  The  Commission  should  be  empowered  to  recognise  certain  measures  of  third 
countries  as  equivalent  to  the  requirements  for  the  movement  within  the  Union 
territory of plants, plant products and other objects concerned. 

(26)  Those prohibitions or requirements should neither apply to small quantities of plants, 
plant  products  and  other  objects,  other  than  plants  for  planting,  for  non-commercial 
and  non-professional  purposes  nor  to  the  introduction  into  and  movement  within 
frontier zones of plants, plant products and other objects. Nor should they apply to the 

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introduction  into  and  movement  within  the  Union  territory  of  plants,  plant  products 
and  other  objects  for  scientific  purposes,  trials,  varietal  selection,  breeding  and 
exhibitions.  Proper  safeguards  should  be  set  and  information  should  be  provided  to 
those concerned. 

(27)  A  derogation  from  the  Union  rules  for  introduction  into  and  movement  within  the 
Union  territory  should  be  provided  for  plants,  plant  products  and  other  objects  in 
transit. 

(28)  The international trade of plants for planting with which there is limited phytosanitary 
experience can involve serious risks of the establishment of quarantine pests for which 
no measures have been  adopted pursuant to this Regulation. In order to ensure swift 
and effective action against newly identified risks associated with plants for planting 
which are not subject to permanent requirements or prohibitions, but may qualify for 
such  permanent  measures,  the  Commission  should  have  the  possibility  to  adopt 
temporary measures in accordance with the precautionary principle.  

(29) 

It is necessary to set out prohibitions and special requirements, similar to those set out 
for  the  Union  territory,  in  respect  of  the  introduction  into  and  movement  within 
protected  zones  of  plants,  plant  products  and  other  objects  that  would  pose  a 
phytosanitary  risk  of  an  unacceptable  level  by  their  likelihood  to  host  the  respective 
protected zone quarantine pest. 

(30)  General requirements should be adopted concerning vehicles and packaging material 
of plants, plant products and other objects to ensure that they are free from quarantine 
pests. 

(31)  Member  States  should  designate  quarantine  stations.  Requirements  concerning  the 
designation,  operation  and  supervision  of  those  quarantine  stations  as  well  as  the 
release of plants, plant products or other objects from those stations should be set out. 
Where  those  requirements  include  the  maintenance  of  lists  of  staff  and  visitors 
entering  the  stations,  this  may  constitute  a  limitation  of  Article  8  (Protection  of 
Personal Data) of the Charter on Fundamental Rights. However that limitation would 
be  necessary  and  proportionate  to  achieve  the  public  interest  objective  of  this 
Regulation. 

(32)  Where  so  required  by  a  bilateral  agreement  concluded  by  the  Union  with  a  third 
country,  or  by  the  legislation  of  a  third  country,  plants,  plant  products  and  other 
objects moved out of the Union territory to the third country concerned should comply 
with those rules.  

(33)  Where,  as  regards  certain  plants,  plant  products  or  other  objects  moved  out  of  the 
Union territory to third countries, no bilateral phytosanitary  agreement concluded  by 
the  Union  with  a  third  country  and  no  phytosanitary  legislation  of  a  third  country 
applies, protection should be offered to third countries against Union quarantine pests 
because of their acknowledged harmful nature, except where a Union quarantine pest 
is officially known to be present in the third country concerned and not under official 
control,  or  where  it  can  be  reasonably  assumed  that  that  Union  quarantine  pest  does 
not meet the criteria to qualify as a quarantine pest for the third country concerned.  

(34) 

In order to ensure effective implementation of this Regulation, professional operators 
subject to obligations under this Regulation should be registered in registers set up by 

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the  Member  States.  In  order  to  reduce  administrative  burden,  those  registers  should 
also  include  professional  operators  falling  within  the  ambit  of  Regulation  (EU)  No 
…/…. on ……15 [Office of Publications to insert number, title and, in a footnote, the 
OJ reference for the Regulation on plant reproductive material]. 

(35)  Professional  operators  operating  at  more  than  one  premise  should  be  given  the 

possibility to register separately for each of those premises. 

(36)  To  facilitate  the  detection  of  the  source  of  an  infestation  by  a  quarantine  pest,  it  is 
appropriate to require professional operators to keep records in respect of the plants, 
plant  products  and  other  objects  supplied  to  them  by  professional  operators  and 
supplied  by  them  to  other  professional  operators.  In  view  of  the  latency  periods  of 
some  quarantine  pests,  and  the  time  required  for  the  detection  of  the  source  of 
infestation, records should be kept for three years. 

(37)  Professional  operators  should  also  have  in  place  systems  and  procedures  to  allow 
identification of the movements of their plants, plant products and other objects within 
their own premises.  

(38)  A phytosanitary certificate should be required for the introduction from third countries 
into the Union territory, and into protected zones, of certain plants, plant products and 
other  objects.  Those  plants,  plant  products  and  other  objects  should  be  listed  in  the 
interest of clarity. 

(39)  Those phytosanitary certificates should comply with the requirements of the IPPC and 
attest  compliance  with  the  requirements  and  measures  established  pursuant  to  this 
Regulation.  In  order  to  ensure  the  credibility  of  the  phytosanitary  certificates,  rules 
should be established concerning the conditions of their validity and cancellation. 

(40)  The  movement  within  the  Union  territory,  and  into  and  within  protected  zones,  of 
certain  plants,  plant  products  and  other  objects  should  only  be  permitted  if 
accompanied  by  a  plant  passport,  attesting  compliance  with  the  requirements  and 
measures established pursuant to the provisions of this Regulation. Those plants, plant 
products and other objects should be listed in the interest of clarity. 

(41)  Plant  passports  should  not  be  required  for  plants,  plant  products  and  other  objects 

intended for final users. 

(42) 

In  order  to  ensure  the  credibility  of  the  plant  passports,  rules  should  be  established 
concerning their contents.  

(43)  Plant  passports  should  generally  be  issued  by  the  professional  operator.  Where 
professional  operators  do  not  have  the  resources  to  issue  plant  passports,  the 
possibility  should  exist  that,  upon  their  request,  plant  passports  are  issued  by  the 
competent authorities. 

(44)  Rules should be set out for the issuance of plant passports, the examinations required 
for issuance, the authorisation and supervision of professional operators issuing plant 

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passports,  the  obligations  of  authorised  operators  and  the  withdrawal  of  that 
authorisation. 

(45) 

In order to reduce the burden of authorised operators, examinations for issuing plant 
passports should be combined with the examinations required under Regulation (EU) 
No …/…. [Office of Publications to insert number of Regulation on plant reproductive 
material law], where appropriate. 

(46)  Authorised operators should possess the necessary knowledge concerning pests. 

(47)  Certain  operators  may  desire  to  establish  a  phytosanitary  risk  management  plan, 
ensuring  and  demonstrating  a  high  level  of  competence  and  awareness  as  regards 
phytosanitary  risks  as  regards  critical  points  in  their  professional  activities  and 
justifying  special  control  arrangements  with  the  competent  authorities.  Union  rules 
should be established concerning the contents of those plans. 

(48) 

(49) 

It is appropriate to provide for the replacement of plant passports and of phytosanitary 
certificates. 

In cases of non-compliance with the Union rules, plant passports should be removed, 
invalidated and, for reasons of traceability, kept. 

(50)  FAO  International  Standard  for  Phytosanitary  Measures  No  15  requires  that  wood 
packaging  material  is  marked  with  a  specific  mark,  applied  by  duly  authorised  and 
supervised  professional  operators.  This  Regulation  should  set  out  the  model  and 
contents of that mark and the authorisation and supervision of professional operators 
in the Union territory applying that mark. 

(51)  Where  so  required  by  a  third  country,  the  respective  plants,  plant  products  or  other 
objects should move from the Union territory to that third country with a phytosanitary 
certificate for export or re-export. In respect of the relevant provisions of IPPC, those 
certificates  should  be  issued  by  the  competent  authorities,  respecting  the  contents  of 
the model certificates for export and re-export set out by the IPPC. 

(52)  Where a plant, plant product or other object is moved through more than one Member 
States before it is exported to a third country, it is important that the Member State in 
which the plants, plant product or other objects were produced or processed exchanges 
information  with  the  Member  State  which  issues  the  phytosanitary  certificate  for 
export. This exchange of information is important to enable attestation of compliance 
with  the  requirements  of  the  third  country.  Therefore,  a  harmonised  'pre-export 
certificate' should be established to ensure that the exchange of that information takes 
place in a uniform manner. 

(53)  The Commission should establish an electronic system for the notifications required in 

accordance with this Regulation.  

(54) 

In  order  to  ensure  that  the  exceptions  for  Union  quarantine  pests  used  for  scientific 
purposes,  trials,  varietal  selections,  breeding  or  exhibitions  are  implemented  in  a 
manner that does not pose any phytosanitary risk to the Union territory or parts of it, 
the power to adopt acts in accordance with Article 290 TFEU should be delegated to 
the Commission in respect of rules concerning the exchange of information  between 
Member  States  and  the  Commission  as  regards  the  introduction  into  and  movement 

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within  the  Union  territory  of  the  pests  concerned,  the  respective  assessments  and 
authorisation, and the monitoring of compliance, the action in case of non-compliance 
and the notification thereof. 

In  order  to  ensure  an  effective  system  of  notifications,  the  power  to  adopt  acts  in 
accordance with Article 290 TFEU should be delegated to the Commission in respect 
of  rules  concerning  notification  obligations  concerning  the  suspected  presence  of 
particular Union quarantine pests which has not yet been officially confirmed. 

In  order  to  take  into  account  the  technical  and  scientific  developments  concerning 
surveys on the presence of pests, the power to adopt acts in accordance with Article 
290  TFEU  should  be  delegated  to  the  Commission  in  respect  of  rules  amending  or 
supplementing the elements to be covered by the multi-annual survey programmes. 

In order to ensure the effective functioning of simulation exercises, the power to adopt 
acts in accordance with Article 290 TFEU should be delegated to the Commission in 
respect  of  rules  setting  out  the  frequencies,  contents,  format  and  other  provisions  on 
simulation exercises. 

In  order  to  ensure  that  protected  zones  are  established  and  function  in  a  reliable 
manner,  the  power  to  adopt  acts  in  accordance  with  Article  290  TFEU  should  be 
delegated  to  the  Commission  in  respect  of  rules  on  surveys  to  be  carried  out  for 
purposes of the recognition of protected zones and on whether protected zones comply 
with the respective requirements. 

In  order  to  ensure  a  proportionate  and  restricted  application  of  the  exemptions 
concerning  the  movement  of  plants,  plant  products  or  other  objects  into  or  within 
frontier zones, the power to adopt acts in accordance with Article 290 TFEU should be 
delegated  to  the  Commission  in  respect  of  rules  concerning  the  maximum  width  of 
third country frontier zones and Member State frontier zones, the maximum distance 
of the movement of the plants, plant products and other objects concerned within the 
third  country  frontier  zones  and  Member  State  frontier  zones  and  the  procedures 
concerning  the  authorisation  of  the  introduction  into  and  movement  within  the 
Member State frontier zones of plants, plant products and other objects. 

In  order  to  avoid  phytosanitary  risks  during  transit  of  plants,  plant  products  or  other 
objects,  the  power  to  adopt  acts  in  accordance  with  Article  290  TFEU  should  be 
delegated  to  the  Commission  in  respect  of  rules  setting  out  the  contents  of  a 
declaration  concerning  the  passing  of  plants,  plant  products  or  other  objects  through 
the Union territory for the purpose of moving to a third country. 

In order to ensure that the registration of professional operators is proportionate to the 
objective of controlling phytosanitary risk, the power to adopt acts in accordance with 
Article 290 TFEU should be delegated to  the Commission  in respect of rules  setting 
out categories of, and conditions for, professional operators to be exempted from the 
obligation to register in a register. 

In order to ensure the credibility of phytosanitary certificates of third countries which 
are  not  parties  to  the  IPPC,  the  power  to  adopt  acts  in  accordance  with  Article  290 
TFEU  should  be  delegated  to  the  Commission  in  respect  of  rules  supplementing  the 
conditions for acceptance of phytosanitary certificates from those third countries. 

(55) 

(56) 

(57) 

(58) 

(59) 

(60) 

(61) 

(62) 

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(63) 

(64) 

(65) 

(66) 

(67) 

(68) 

(69) 

(70) 

(71) 

In order to minimise the phytosanitary risks of plants, plant products or other objects 
moved within the Union territory, the power to adopt acts in accordance with Article 
290 TFEU should be delegated to the Commission in respect of rules setting out the 
maximum  figure  for  small  quantities  of  particular  plants,  plant  products  or  other 
objects to be exempted from plant passports. 

In  order  to  ensure  the  reliability  of  examinations  of  plants,  plant  products  and  other 
objects  carried  out  for  the  issuance  of  plant  passports,  the  power  to  adopt  acts  in 
accordance with Article 290 TFEU should be delegated to the Commission in respect 
of  rules  on  visual  examination,  sampling  and  testing  and  the  use  of  certification 
schemes. 

In  order  to  enhance  the  credibility  of  plant  passports,  the  power  to  adopt  acts  in 
accordance with Article 290 TFEU should be delegated to the Commission in respect 
of  rules  setting  out  qualification  requirements  to  be  fulfilled  by  the  professional 
operators in order for them to be authorised to issue plant passports. 

In order to enhance the scope and utility of the phytosanitary risk management plan, 
the power to adopt acts in accordance with Article 290 TFEU should be delegated to 
the Commission in respect of rules supplementing or amending the elements covered 
by such plan. 

In order to take into account the development of international standards, the power to 
adopt  acts  in  accordance  with  Article  290  TFEU  should  be  delegated  to  the 
Commission in respect of rules concerning attestations for commodities of a specific 
nature, other than wood packaging material, which would require the application of a 
specific attestation of compliance with the rules of this Regulation. 

In  order  to  ensure  the  utility  and  reliability  of  official  attestations  and  pre-export 
certificates, the power to adopt acts in accordance with Article 290 TFEU should be 
delegated  to  the  Commission  in  respect  of  rules  setting  out  the  contents  of  official 
attestations,  the  authorisation  and  supervision  of  professional  operators  issuing  those 
attestations, and the contents of the pre-export certificate. 

In  order  to  adapt  to  the  technical  and  scientific  developments,  and  to  adapt  to  a 
decision of the European Council pursuant to Article 355(6) TFEU, the power to adopt 
acts in accordance with Article 290 TFEU should be delegated to the Commission in 
respect of rules amending the Annexes of this Regulation. 

It is of particular importance that the Commission carry out appropriate consultations 
during  its  preparatory  work,  including  at  expert  level.  The  Commission,  when 
preparing  and  drawing  up  delegated  acts,  should  ensure  a  simultaneous,  timely  and 
appropriate transmission of relevant documents to the European Parliament and to the 
Council. 

In order to ensure uniform conditions for the implementation of this Regulation with 
respect  to  establishing  a  list  of  Union  quarantine  pests,  establishing  a  list  of  the 
priority  pests,  setting  out  measures  against specific Union quarantine  pests, adopting 
measures  for  a  limited  time  as  regards  the  phytosanitary  risks  posed  by  pests 
provisionally  qualifying  as  Union  quarantine  pests,  recognising  the  protected  zones 
recognised  in  accordance  with  the  first  subparagraph  of  Article  2(1)(h)  of  Directive 
2000/29/EC  and  establishing  a  list  of  the  respective  protected  zone  quarantine  pests, 

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amending  or  revoking  protected  zones,  amending  the  list  of  those  protected  zones, 
listing of Union quality pests and the plants for planting concerned, listing the plants, 
plant  products  and  other  objects  whose  introduction  into  and  movement  within  the 
Union territory is to be prohibited, and the third countries concerned, listing the plants, 
plant products and other objects, and the requirements for their introduction into and 
movement  within  the  Union  territory,  setting  out  equivalent  requirements  of  third 
countries to the requirements for movement within the Union territory of plants, plant 
products  or  other  objects,  setting  out  specific  conditions  or  measures  concerning  the 
introduction of particular plants, plant products and other objects into frontier zones of 
Member States, adoption of temporary measures as regards the introduction into and 
movement within the Union territory of plants for planting from third countries, listing 
of  plants,  plant  products  and  other  objects,  whose  introduction  into,  and  movement 
within,  particular  protected  zones  is  to  be  prohibited,  listing  requirements  for  the 
introduction  into,  and  movement  within,  particular  protected  zones  of  plants,  plant 
products and other objects, listing of the plants, plant products and other objects, and 
the  respective  third  countries  of  origin  or  dispatch,  for  which  a  phytosanitary 
certificate is to be required for their introduction into the Union territory, listing of the 
plants, plant products and other objects, and the respective third countries of origin or 
dispatch, for which a phytosanitary certificate is to be required for their introduction 
into  certain  protected  zones  from  those  third  countries,  listing  of  the  plants,  plant 
products  and  other  objects,  for  which  a  plant  passport  is  to  be  required  for  their 
movement  within  the  Union  territory,  listing  of  the  plants,  plant  products  and  other 
objects, for which a plant passport is to be required for their introduction into certain 
protected zones, and setting out the format of the plant passport, implementing powers 
should  be  conferred  on  the  Commission.  Those  powers  should  be  exercised  in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council of 16 February 2011 laying down the rules and general principles concerning 
mechanisms  for  control  by  Member  States  of  the  Commission’s  exercise  of 
implementing powers16. 

(72)  The  advisory  procedure  should  be  used  for  the  adoption  of  the  initial  list  of  Union 
quarantine  pests  given  that  that  initial  list  should  merely  contain,  without  any 
modifications,  the  pests  listed  in  Part  A  of  Annex  I  to  Directive  2000/29/EC  and 
Section I of Part A of Annex II to that Directive, for the amendment of the scientific 
name of a pest, where such an amendment is justified on the basis of the development 
of scientific knowledge, for the adoption of the initial list of protected zones and the 
respective  protected  zone  quarantine  pests  given  that  that  initial  list  should  merely 
contain, without any modifications, the protected zones recognised in accordance with 
the  first  subparagraph  of  Article  2(1)(h)  of  Directive  2000/29/EC  and  the  protected 
zone quarantine pests listed in Part B of Annex I and Part B of Annex II to Directive 
2000/29/EC, for the amendment and revocation of protected zones, for the adoption of 
the initial list of Union quality pests given that that initial list should merely contain, 
without any modifications, the pests listed in certain Directives on the production and 
marketing  of  seeds  and  propagating  material,  for  the  adoption  of  the  initial  list  of 
plants, plant products and other objects whose introduction into and movement within 
the Union territory is to be prohibited given that that initial list should merely contain, 
without  any  modifications,  the  plants,  plant  products  and  other  objects,  and  the 
prohibitions  and  the  third  countries  concerned,  as  set  out  in  Part  A  of  Annex  III  to 

16 

OJ L 55, 28.2.2011, p. 13. 

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23 

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Directive  2000/29/EC,  together  with  their  Combined  Nomenclature  (CN)  codes,  for 
the  adoption  of  the  initial  list  of  plants,  plant  products  and  other  objects  whose 
introduction into and movement within the Union territory is to be subject to special 
requirements  given  that  that  initial  list  should  merely  contain,  without  any 
modifications,  the  plants,  plant  products  and  other  objects,  and  the  requirements  and 
the  third  countries  concerned,  as  set  out  in  Part  A  of  Annex  IV  to  Directive 
2000/29/EC, together with their Combined Nomenclature (CN) codes, for the adoption 
of  the  initial  list  of  plants,  plant  products  and  other  objects  whose  introduction  into 
certain  protected  zones  is  to  be  prohibited  given  that  that  initial  list  should  merely 
contain,  without  any  modifications,  the  plants,  plant  products  and  other  objects,  and 
the prohibitions and the third countries concerned, as set out in Part B of Annex III to 
Directive  2000/29/EC,  together  with  their  Combined  Nomenclature  (CN)  codes,  for 
the  adoption  of  the  initial  list  of  plants,  plant  products  and  other  objects  whose 
introduction  into,  and  movement  within,  certain  protected  zones  is  to  be  subject  to 
special  requirements  given  that  that  initial  list  should  merely  contain,  without  any 
modifications, the plants, plant products and other objects, and the requirements, as set 
out  in  Part  B  of  Annex  IV  to  Directive  2000/29/EC,  together  with  their  Combined 
Nomenclature  (CN)  codes,  for  the  adoption  of  the  initial  list  of  the  plants,  plant 
products and other objects, and the respective third countries of origin or dispatch, for 
which  a  phytosanitary  certificate  is  required  for  their  introduction  into  the  Union 
territory, given that that initial list should merely contain, without any modifications, 
the plants, plant products and other objects listed in Point I of Part B of Annex V to 
Directive 2000/29/EC, for the adoption of the initial list of the plants, plant products 
and other objects, and the respective third countries of origin or dispatch, for which a 
phytosanitary certificate is required for their introduction into certain protected zones, 
given that that initial list should merely contain, without any modifications, the plants, 
plant products and other objects listed in Point II of Part B of Annex V to Directive 
2000/29/EC, for the adoption of the initial list of the plants, plant products and other 
objects,  for  which  a  plant  passport  is  required  for  their  movement  within  the  Union 
territory, given that that initial list should merely contain, without any modifications, 
the plants, plant products and other objects listed in Point I of Part A of Annex V to 
Directive  2000/29/EC,  and  for  the  adoption  of  the  initial  list  of  the  plants,  plant 
products and other objects, for which a plant passport is required for their introduction 
into certain protected zones, given that that initial list should merely contain, without 
any modifications, the plants, plant products and other objects listed in Point II of Part 
A of Annex V to Directive 2000/29/EC. 

(73)  Council  Directive  74/647/EEC  of  9  December  1974  on  control  of  carnation  leaf-
rollers17  and  Council  Directive  69/466/EEC  of  8  December  1969  on  control  of  San 
José  Scale18  set  out  measures  on  the  control  of  the  respective  pests.  Following  the 
entry  into force of those Directives, the concerned  pests  have  become  widely  spread 
throughout the Union territory, thus their containment is not feasible any more. Those 
Directives should therefore be repealed. 

(74)  Council  Directive  69/464/EEC  of  8  December  1969  on  control  of  Potato  Wart 
Disease19, Council Directive 93/85/EEC of 4 October 1993 on control of Potato Ring 

17 
18 
19 

OJ L 352, 28.12.1974, p. 41–42. 
OJ L 323, 24.12.1969, p. 5–6. 
OJ L 323, 24.12.1969, p. 1–2. 

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Rot20,  Council  Directive  98/57/EC  of  20  July  1998  on  control  of  Ralstonia 
solanacearum (Smith) Yabuuchi et al.21 and Council Directive 2007/33/EC of 11 June 
2007  on  the  control  of  potato  cyst  nematodes  and  repealing  Directive  69/465/EC22 
should  be  repealed,  as  new  measures  on  the  pests  concerned  should  be  adopted  in 
accordance with the provisions of this Regulation. In view of the time and resources 
required to adopt those new measures, those acts should be repealed by 2021. 

(75)  Regulation (EU) No …/2013 on ……23 [Office of Publications, please insert number 
and  title  of  Regulation  laying  down  provisions  for  the  management  of  expenditure 
relating  to  the  food  chain,  animal  health  and  animal  welfare,  and  relating  to  plant 
health and plant reproductive material and, in the footnote, the reference to the Official 
Journal]  sets  out  that  grants  for  measures  against  pests  are  to  concern  certain  pests 
listed  in  the  Annexes  to  Directive  2000/29/EC,  and  certain  pests  not  listed  in  those 
Annexes but subject to temporary Union measures adopted with regard to them. This 
Regulation  establishes  the  category  of  priority  pests.  It  is  appropriate  that  certain 
measures  taken  by  the  Member  States  as  regards  priority  pests  are  to  be  eligible  for 
Union grants, including compensation paid to professional operators for the value of 
plants,  plant  products  and  other  objects,  subject  to  destruction  pursuant  to  the 
eradication  measures  set  out  in  this  Regulation.  Regulation  (EU)  No  XXX/2013 
should therefore be amended. 

(76)  Since the objective of this Regulation, namely to ensure a harmonised approach with 
regard to protective measures against pests of plants, cannot be sufficiently achieved 
by  the  Member  States  and  can  therefore,  by  reason  of  its  effect,  complexity,  trans-
border and international character, be better achieved at Union level, the Union may 
adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 
of the Treaty on European Union. In accordance with the principle of proportionality, 
as set out in that Article, this Regulation does not exceed what is necessary in order to 
achieve that objective. 

(77)  For  small  and  medium  enterprises,  this  Regulation  does  not  create  disproportionate 
administrative  burden  or  economic  impact.  Under  this  Regulation,  based  on 
consultation with stakeholders, the special situation of small and medium enterprises 
has  been  taken  into  account  where  possible.  A  potential  universal  exemption  for 
micro-enterprises, which make up the majority of companies, has not been considered, 
in view of the public policy objective(s) to protect plant health. 

(78)  This Regulation respects the IPPC, the Agreement on the Application of Sanitary and 
Phytosanitary Measures (SPS Agreement) and the guidelines set out under these.  

(79)  This Regulation respects the fundamental rights and observes the principles recognised 
in particular by the Charter of Fundamental Rights of the European Union and notably 
respect for private and family life, the right to property, the protection of personal data, 
freedom  to  conduct  business  and  the  freedom  of  art  and  science.  This  Regulation 
should  be  applied  by  the  Member  States  in  accordance  with  those  rights  and 
principles, 

20 
21 
22 
23 

OJ L 259, 18.10.1993, p. 1–25. 
OJ L 235, 21.8.1998, p. 1–39. 
OJ L 156, 16.6.2007, p. 12–22. 
OJ L …, ……….., p. …. 

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HAVE ADOPTED THIS REGULATION: 

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26 

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Chapter I 
Subject matter, scope and definitions 

Article 1 
Subject matter and scope 

1. 

2. 

This Regulation lays down rules to determine the phytosanitary risks posed by any 
species, strain or biotype of pathogenic agents, animals or parasitic plants injurious 
to plants or plant products (hereinafter “pests”) and measures to reduce those risks to 
an acceptable level. 

For  the  purposes  of  this  Regulation  references  to  third  countries  shall  be  read  as 
references to third countries and to the territories listed in Annex I. 

For the purposes of this Regulation, references to the Union territory shall be read as 
references to the Union territory without the territories listed in Annex I. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, amending Annex I to ensure that the scope of this Regulation is confined 
to  the  European  part  of  the  Union  territory.  That  amendment  shall  be  either  of  the 
following: 

(a) 

(b) 

an addition to Annex I of one or more territories that are referred to in Article 
355(1) of the Treaty; 

a removal from Annex I of one or more territories that are referred to in Article 
355(2) of the Treaty. 

Article 2 
Definitions 

For the purposes of this Regulation, the following definitions shall apply: 

(1) 

'plants' means living plants and the following living parts of plants:  

(a) 

seeds, in the botanical sense, other than those not intended for planting; 

(b) 

fruits, in the botanical sense; 

(c)  vegetables; 

(d) 

tubers, corms, bulbs, rhizomes, roots, rootstocks, stolons; 

(e) 

shoots, stems, runners; 

(f) 

cut flowers; 

(g)  branches with foliage; 

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(h) 

cut trees retaining foliage; 

(i) 

leaves, foliage; 

(j) 

plant tissue cultures, including cell cultures, germplasm, meristems, chimaeric 
clones, micro-propagated material; 

(k) 

live pollen; 

(l) 

buds, budwood, cuttings, scions, grafts; 

(2) 

'plant  products'  means  products  of  plant  origin,  unprocessed  or  having  undergone 
simple preparation, in so far as these are not plants. 

Except where otherwise provided, wood shall only be considered as a 'plant product' 
if it has not undergone processing eliminating the phytosanitary risks, and complies 
with one or more of the following points:  

(a) 

it retains all or part of its natural round surface, with or without bark; 

(b) 

it has not retained its natural round surface due to sawing, cutting or cleaving; 

(c) 

it is in the form of chips, particles, sawdust, wood waste, shavings or scrap, and 
has not undergone processing involving the use of glue, heat or pressure or a 
combination thereof to produce pellet, briquettes, plywood or particle board; 

(d) 

it  is,  or  is  intended  to  be,  used  as  packaging  material  or  dunnage,  whether  or 
not it is actually in use for transport of goods; 

'plants  for  planting'  means  plants,  which are  capable of and  intended  for  producing 
entire plants, and which are destined to be planted, or replanted, or remain planted;  

'other  object'  means  any  material  or  object,  other  than  plants  or  plant  products, 
capable of harbouring or spreading pests, including soil or growing medium; 

'competent  authority'  means  a  competent  authority  as  defined  in  Article  2(5)  of 
Regulation  (EU)  No  …/….  [Office  of  Publications,  please  insert  number  of 
Regulation on Official Controls]; 

'lot'  means  a  number  of  units  of  a  single  commodity,  identifiable  for  phytosanitary 
purposes  by  its  homogeneity  of  composition  and  origin,  forming  part  of  a 
consignment; 

'professional  operator'  means  any  person,  governed  by  public  or  private  law, 
involved professionally in one or more of the following activities concerning plants, 
plant products and other objects:  

(3) 

(4) 

(5) 

(6) 

(7) 

(a)  planting; 

(b)  growing; 

(c)  production; 

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(d) 

introduction into, and movement within, and out of the Union territory; 

(e)  making available on the market; 

(8) 

(9) 

'final  user'  means  any  person,  acting  for  purposes  which  are  outside  its  trade, 
business or profession, who acquires for its own use plants or plant products; 

'test'  means  an  official  examination,  other  than  visual,  to  determine  if  pests  are 
present or to identify pests; 

(10) 

'treatment' means a procedure for the killing, inactivation or removal of pests, or for 
rendering those pests infertile or for their devitalisation. 

Chapter II 
Quarantine pests 

SECTION 1 
QUARANTINE PESTS 

Article 3 
Definition of quarantine pests 

A pest shall be referred to as a 'quarantine pest', with respect to a defined territory, if it fulfils 
all of the following conditions: 

(a) 

(b) 

(c) 

(d) 

(e) 

its identity is established, within the meaning of point (1) of Section 1 of Annex II; 

it is not present in that territory, within the meaning of point (2)(a) of Section 1 of 
Annex  II,  or,  if  present,  only  distributed  to  a  limited  extent  within  that  territory, 
within the meaning of points (2)(b) and (c) of Section 1 of Annex II;  

it  is  capable  of  entering  into  that  territory,  of  perpetuating  its  presence  in  that 
territory for the foreseeable future after its entry into it (hereinafter: 'to establish') and 
of  spreading  within  that  territory,  or,  if  present,  those  parts  of  it  where  it  is 
distributed to a limited extent, in accordance with point (3) of Section 1 of Annex II; 

its entry, establishment and spread would, within the meaning of point (4) of Section 
1  of  Annex  II,  have  an  unacceptable  economic,  environmental  or  social  impact  for 
that territory, or, if present, those parts of it where it is distributed to a limited extent; 
and 

feasible and effective measures are available to prevent the entry into, establishment 
or  spread  of  that  pest  within  that  territory,  and  mitigate  its  phytosanitary  risks  and 
impacts. 

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SECTION 2 
UNION QUARANTINE PESTS 

Article 4 
Definition of Union quarantine pests 

A  quarantine  pest  shall  be  referred  to  as  a  Union  quarantine  pest  if  the  defined  territory  as 
referred to in the introductory words of Article 3 is the Union territory and it is included in the 
list referred to in Article 5(2). 

1. 

2. 

3. 

Article 5 
Prohibition of introduction and movement of Union quarantine pests 

A  Union  quarantine  pest  shall  not  be  introduced  into  or  moved  within  the  Union 
territory.  

No action shall be taken intentionally which may contribute to the introduction into, 
and establishment and spread within, the Union territory of a Union quarantine pest. 

The  Commission  shall,  by  means  of  an  implementing  act,  establish  a  list  of  pests 
fulfilling the conditions referred to in Article 3(b), (c) and (d) in respect of the Union 
territory, referred to as 'list of Union quarantine pests'. 

That list shall include the pests listed in Part A of Annex I to Directive 2000/29/EC 
and Section I of Part A of Annex II to that Directive.  

Pests  which  are  indigenous  to  any  part  of  the  Union  territory,  whether  naturally  or 
due to their introduction from outside the Union territory, shall be marked in that list 
as pests known to occur in the Union territory. 

Pests which are not indigenous to any part of the Union territory shall be marked in 
that list as pests not known to occur in the Union territory. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2). 

The Commission shall amend the implementing act referred to in paragraph 2, where 
an assessment shows that a pest not listed in that act fulfils the conditions referred to 
in Article 3(b), (c) and (d) in respect of the Union territory, or a pest listed in that act 
no longer fulfils one or more of those conditions. In the first case it shall add the pest 
concerned to the list referred to in paragraph 2, in the second case it shall delete the 
pest concerned from that list. 

The Commission shall make that assessment available to the Member States. 

The  implementing  acts  amending  the  implementing  act  referred  to  in  paragraph  2 
shall be adopted in accordance with the examination procedure referred to in Article 
99(3).  The  same  procedure  shall  apply  to  a  repeal  or  a  replacement  of  the 
implementing act referred to in paragraph 2. 

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4. 

The  Commission  shall  amend  the  implementing  act  referred  to  in  paragraph  2  by 
amending the scientific name of a pest, where such an amendment is justified by the 
development of scientific knowledge.  

Those implementing acts shall be adopted in accordance with the advisory procedure 
referred to in Article 99(2). 

Article 6 
Priority pests 

1. 

A Union quarantine pest is a 'priority pest' if it fulfils all of the following conditions: 

(a) 

(b) 

it fulfils, as regards the Union territory, the condition set out in point (a) or in 
point (b) of point (2) of Section 1 of Annex II; 

its  potential  economic,  environmental  or  social  impact  is  most  severe  for  the 
Union territory as set out in Section 2 of Annex II; 

(c) 

it is listed in accordance with paragraph 2. 

2. 

The Commission shall, by means of an implementing act, establish and amend a list 
of the priority pests, hereinafter: 'list of priority pests'. 

Where  the  results  of  an  assessment  show  that  a  Union  quarantine  pest  fulfils  the 
conditions referred to in paragraph 1, or a pest no longer fulfils one or more of those 
conditions, the Commission shall amend the implementing act referred to in the first 
subparagraph by adding the pest concerned to, or removing it from, that list.  

The Commission shall make that assessment available to the Member States. 

The  number  of  priority  pests  shall  not  exceed  10%  of  the  number  of  the  Union 
quarantine pests listed pursuant to Article 5(2) and (3). Where the number of priority 
pests has exceeded 10% of the number of the Union quarantine pests listed pursuant 
to Article 5(2) and (3), the Commission shall amend the implementing act referred to 
in the first subparagraph by accordingly adjusting the number of pests in that list, on 
the  basis  of  their  potential  economic,  environmental  or  social  impact  as  set  out  in 
Section 2 of Annex II. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 99(3).  

On  duly  justified  imperative  grounds  of  urgency  relating to  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  immediately  applicable  implementing  acts,  in 
accordance with the procedure referred to in Article 99(4), listing Union quarantine 
pests as priority pests.  

Article 7 
Amendment of Section 1 and Section 2 of Annex II 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 98 amending Section 1 of Annex II on criteria to identify pests which qualify 

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as a quarantine pest, as regards the identity of the pest, its presence, its capability of 
entry, establishment and spread, and its potential economic, social and environmental 
impact, taking into account the developments of technical and scientific knowledge.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 98 amending Section 2 of Annex II on criteria to identify Union quarantine 
pests which qualify as a priority pest, as regards their potential economic, social and 
environmental  impact,  taking  into  account  the  developments  of  technical  and 
scientific knowledge. 

Article 8 
Union quarantine pests used for scientific purposes, trials, varietal selections, breeding 
or exhibitions 

1. 

By  way  of  derogation  from  Article  5(1),  Member  States  may,  on  application, 
authorise  the  introduction  into,  and  the  movement  within,  their  territory  of  Union 
quarantine pests for use for scientific purposes, trials, varietal selections, breeding or 
exhibitions if all of the following requirements are fulfilled: 

(a) 

(b) 

(c) 

the introduction, movement and use of the pest concerned do not result in the 
establishment  or  spread  of  that  pest  within  the  Union  territory  if  adequate 
restrictions are imposed; 

the storage facilities in which that pest is to be kept and the quarantine stations, 
as referred to in Article 56, in which that pest is to be used are appropriate; 

the scientific and technical qualifications of the personnel by whom the activity 
involving that pest is to be carried out are appropriate. 

2. 

The competent authority shall assess the risk of establishment and spread of the pest 
concerned, as referred to in paragraph 1(a), taking into account the identity, biology 
and  means  of  dispersal  of  the  pest,  the  activity  envisaged,  the  interaction  with  the 
environment and other relevant factors relating to the risk posed by that pest. 

It shall assess the storage facilities in which that pest is to be kept, as referred to in 
paragraph  1(b),  and  the  scientific  and  technical  qualifications  of  the  personnel  by 
whom the activity involving the pest is to be carried out, as referred to in paragraph 
1(c).  

On  the  basis  of  those  assessments  the  competent  authority  shall  authorise 
introduction  of  the  pest  into,  or  movement  within,  the  Union  territory  if  the 
requirements set out in paragraph 1 are fulfilled.  

3. 

Where an authorisation is granted, it shall include all of the following conditions:  

(a) 

(b) 

the  pest  is  to  be  kept  in  storage  facilities  found  to  be  appropriate  by  the 
competent authorities and referred to in the authorisation; 

the  activity  involving  the  pest  is  to  be  carried  out  in  a  quarantine  station 
designated  in  accordance  with  Article  56  by  the  competent  authority  and 
referred to in the authorisation; 

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(c) 

the activity involving the pest is to be carried out by personnel whose scientific 
and  technical  qualifications  are  found  to  be  appropriate  by  the  competent 
authority and referred to in the authorisation; 

(d) 

the  pest  is  to  be  accompanied  by  the  authorisation  when  introduced  into  or 
moved within the Union territory. 

The  authorisation  shall  be  limited  to  the  amount  that  is  adequate  for  the  activity 
concerned and shall not exceed the capacity of the designated quarantine station.  

It  shall  include  the  restrictions  necessary  to  adequately  mitigate  the  risk  of 
establishment and spread of the Union quarantine pest concerned. 

The competent authority shall monitor compliance with the conditions referred to in 
paragraph 3 and the limitation and the restrictions referred to in paragraph 4 and take 
the necessary action in case those conditions, that limitation or those restrictions are 
not  complied  with.  Where  appropriate,  that  action  shall  be  the  revocation  of  the 
authorisation referred to in paragraph 1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, laying down detailed rules concerning:  

(a) 

the  exchange  of  information  between  Member  States  and  the  Commission 
concerning the introduction into, and movement within, the Union territory of 
the pests concerned; 

(b) 

the assessments and authorisation referred to in paragraph 2; and 

(c) 

the  monitoring  of  compliance,  the  action  in  case  of  non-compliance  and  the 
notification thereof, as referred to in paragraph 5.  

Article 9 
Notification of Union quarantine pests to the competent authorities 

Where  anyone  becomes  aware  of  the  presence  of  a  Union  quarantine  pest  or  has 
reason to suspect such a presence, that person shall notify, in writing, the competent 
authority within ten calendar days. 

If so requested by the competent authority, the person referred to in paragraph 1 shall 
provide that authority with the information concerning that presence which is in its 
possession. 

4. 

5. 

6. 

1. 

2. 

Article 10 
Measures in case of suspicion of the presence of a Union quarantine pest 

Where a competent authority suspect the presence of a Union quarantine pest, in a part of the 
territory  of  the  respective  Member  State  where  that  pest  was  previously  not  known  to  be 
present, it shall immediately take any measures necessary to officially confirm whether that 
pest is present or not.  

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Article 11 
Notification of Union quarantine pests to the Commission and the other Member States 

1. 

A Member State shall notify, through the electronic notification system referred to in 
Article  97,  the  Commission  and  the  other  Member  States,  in  case  one  of  the 
following points is fulfilled: 

(a) 

(b) 

(c) 

its  competent  authority  has  received  a  diagnosis  of  an  official  laboratory,  as 
referred to in Article 36 of Regulation (EU) No …/…. [Office of Publications, 
please  insert  the  number  of  the  Regulation  on  Official  Controls],  confirming 
(hereinafter:  'officially  confirming')  the  presence  in  its  territory  of  a  Union 
quarantine pest not known to be present in that Member State;  

its competent authority has officially confirmed the presence in its territory of a 
Union quarantine pest, if that pest is found to be present in a part of its territory 
where it was previously not present; 

its competent authority has officially confirmed the presence in its territory of a 
Union  quarantine  pest  in  a  consignment  of  plants,  plant  products  or  other 
objects  introduced  into,  intended  to  be  introduced  into  or  moved  within  the 
Union territory.  

The notifications referred to in paragraph 1 shall be submitted within three working 
days following the date of the official confirmation by the competent authority of the 
presence of the respective Union quarantine pest.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  laying  down  that  the  notification  obligations  referred  to  in  paragraph  1 
shall also apply to the suspected presence of particular Union quarantine pests, which 
has not yet been officially confirmed. Those delegated acts may also determine the 
time limit within which those notifications shall be submitted. 

2. 

3. 

Article 12 
Information on Union quarantine pests provided to professional operators by the 
competent authorities 

Where  the  conditions  of  one  of  the  points  of  Article  11(1)  are  fulfilled,  the  competent 
authority concerned shall ensure that professional operators, whose plants, plant products or 
other  objects  may  be  affected,  are  immediately  informed  of  the  presence  of  the  Union 
quarantine pest concerned.  

Article 13 
Information on priority pests provided to the public by the competent authorities 

Where the conditions of one of the points of Article 11(1)(a) or (b) are fulfilled as regards a 
priority pest, the competent authority shall inform the public about the measures taken and to 
be  taken  by  that  competent  authority  and,  where  applicable,  to  be  taken  by  particular 
professional operators or other persons. 

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1. 

2. 

1. 

2. 

3. 

4. 

Article 14 
Notification of imminent dangers  

Where a Member State has evidence that there is an imminent danger of the entry of 
a Union quarantine pest into the Union territory or into a part of that territory where 
it is not yet present, that Member State  shall immediately and in writing notify the 
Commission and the other Member States of that evidence. 

Professional  operators  shall  immediately  notify  the  competent  authorities  of  any 
evidence they may have concerning an imminent danger as referred to in paragraph 1 
concerning Union quarantine pests. 

Article 15 
Measures to be taken immediately by professional operators 

Where a professional operator becomes aware that a Union quarantine pest is present 
in  plants,  plant  products  or  other  objects  which  are  under  its  control,  it  shall, 
immediately,  and  after  informing  and  consulting  with  the  competent  authority 
concerned, take the phytosanitary measures necessary to eliminate that pest from the 
plants,  plant  products  or  other  objects  concerned  and  from  its  premises,  where 
applicable, and prevent the spread of that pest. 

That  professional  operator  shall,  immediately  and  after  informing  and  consulting 
with the competent authority concerned, inform the persons in the trade chain from 
whom those plants, plant products or other objects had been obtained. 

That  competent  authority  shall,  where  appropriate,  ensure  that  the  professional 
operator  concerned  withdraws  from  the  market  the  plants,  plant  products  and  other 
objects in which that pest may be present. 

Where the plants, plant products or other objects referred to in paragraph 1 have left 
the  control  of  the  professional  operator  concerned,  that  professional  operator  shall, 
immediately  and  after  informing  and  consulting  with  the  competent  authority 
concerned,  inform  the  persons  in  the  trade  chain  from  whom  those  plants,  plant 
products or other objects had been obtained and to whom those plants, plant products 
and other objects had been supplied, of the presence of the pest. 

The  competent  authority  shall,  where  appropriate,  ensure  that  the  professional 
operator  concerned  recalls  from  the  market  the  plants,  plant  products  and  other 
objects  in  which  the  pest  may  be  present  and,  where  the  plants,  plant  products  and 
other objects may have reached the final user, to recall them from those final users. 

Where paragraph 1 or 2 applies, the professional operator concerned shall provide all 
information  which  is  relevant  for  the  public  to  the  competent  authority  concerned. 
That authority shall inform the public in case action needs to be taken with regard to 
the  plants,  plant  products  or  other  objects  in  which  the  respective  pest  may  be 
present.  

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1. 

2. 

3. 

4. 

1. 

Article 16 
Eradication of Union quarantine pests 

Where the presence of a Union quarantine pest is officially confirmed, the competent 
authority shall immediately take all necessary measures to eliminate that pest in the 
area concerned and to prevent its spread out of that area (hereinafter: 'to eradicate'). 
Those  measures  shall  be  adopted  in  accordance  with  Annex  IV  on  measures  and 
principles for the management of the risks of pests. 

Where  the  presence  of  the  Union  quarantine  pest  concerned  may  be  related  to 
movements  of  plants,  plant  products  or  other  objects,  the  competent  authority  shall 
investigate the source of that presence and the possibility that the pest concerned has 
been spread to further plants, plant products or other objects by those movements. 

Where  the  measures  referred  to  in  paragraph  1  concern  the  introduction  into,  or 
movement within, the Union territory of plants, plant products and other objects, the 
Member State concerned shall immediately notify those measures to the Commission 
and the other Member States. 

Private premises of citizens shall not be exempted from the measures, referred to in 
paragraph 1, and the investigations, referred to in paragraph 2. 

Article 17 
Establishment of restricted areas  

Following  the  official  confirmation  referred  to  in  Article  11(1)(a),  the  competent 
authority shall immediately establish an area where the measures referred to in that 
Article are to be taken (hereinafter: 'restricted area').  

The restricted area shall consist of an infested zone, as provided for in paragraph 2, 
and a buffer zone, as provided for in paragraph 3. 

2. 

The infested zone shall contain:  

(a) 

all plants known to be infested by the pest concerned; 

(b) 

(c) 

all  plants  showing  signs  or  symptoms  indicating  possible  infestation  by  that 
pest;  

all  other  plants  liable  to  be  infested  by  that  pest  due  to  their  susceptibility  to 
that  pest  and  their  close  proximity  to  infested  plants,  or  common  source  of 
production, if known, with infested plants, or plants grown from them. 

3. 

The buffer zone shall be adjacent to the infested zone and shall surround it.  

Its size shall be appropriate in view of the risk of the pest concerned spreading out of 
the  infested  zone  naturally,  or  by  human  activities  in  the  infested  zone  and  its 
surroundings,  and  shall  be  decided  in  accordance  with  the  principles  set  out  in 
Section 2 of Annex IV on measures and principles for the management of the risks of 
pests. 

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4. 

5. 

6. 

1. 

2. 

3. 

4. 

5. 

However, where any risk of the pest spreading out of the infested zone is sufficiently 
mitigated through natural or artificial barriers, no buffer zone need be established. 

By  way  of  derogation  from  paragraph  1,  where  upon  first  sight  the  competent 
authority concludes, in view of the nature of the pest concerned and the site where it 
was  found,  that  the  pest  concerned  can  be  eliminated  immediately,  the  competent 
authority may decide not to establish a restricted area.  

In  that  case,  it  shall  carry  out  a  survey  to  determine  whether  any  further  plants  or 
plant  products  have  been  infested.  On  the  basis  of  that  survey,  the  competent 
authority  shall  determine  whether  there  is  a  need  to  establish  a  restricted  area.  The 
competent authority concerned shall notify to the Commission and the other Member 
States the conclusions of that survey. 

Where in accordance with paragraphs 2 and 3 a restricted area is to extend into the 
territory of another Member State, the Member State where the pest concerned was 
found to be present shall immediately contact the Member State into whose territory 
the  restricted  area  is  to  extend  in  order  to  allow  that  Member  State  to  take  all 
appropriate actions, as referred to in paragraphs 1 to 4. 

By  31  March  of  each  year,  Member  States  shall  notify  to  the  Commission  and  the 
other Member States the number and locations of the restricted areas established, the 
pests concerned, and the respective measures taken during the preceding year. 

Article 18 
Surveys and modifications of restricted areas, and lifting of restrictions  

Competent  authorities  shall  annually  carry  out  a  survey  of  each  restricted  area  as 
regards the development of the presence of the pest concerned. 

Those surveys shall be carried out in accordance with the provisions on  surveys as 
set out in Article 21(1) and (2). 

Where as a result of an annual survey a competent authority finds a presence of the 
pest  concerned  in  the  buffer  zone,  the  Member  State  concerned  shall  immediately 
notify that presence to the Commission and the other Member States specifying that 
the pest was found present in a buffer zone. 

Competent  authorities  shall  modify  the  boundaries  of  infested  zones,  buffer  zones 
and restricted areas, where appropriate, in view of the results of the surveys referred 
to in paragraph 1. 

Competent  authorities  may  decide  to  abolish  a  restricted  area  and  terminate  the 
respective  eradication  measures,  provided  that  during  the  surveys  referred  to  in 
paragraph 1 no presence of the pest concerned has been found in that restricted area 
for a sufficiently long period.  

When deciding on the modifications referred to in paragraph 3 or the abolition of the 
restricted area referred to in paragraph 4, the competent authority concerned shall at 
least take into account the biology of the pest and the vector concerned, the presence 

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of  host  plants,  the  eco-climatic  conditions  and  the  likelihood  of  the  eradication 
measures having been successful. 

Article 19 
Reports on measures taken in accordance with Articles 16, 17 and 18 

Member States shall prepare a report on the measures taken in accordance with Articles 16, 
17 and 18. 

Where  those  measures  are  taken  by  a  Member  State  in  an  area  adjacent  to  the  border  with 
another Member State, that report shall be submitted to the latter Member State. 

That report shall be submitted, on request, to the Commission and the other Member States. 

Article 20 
Amendment of Annex IV 

The Commission shall be empowered to adopt delegated acts in accordance with Article 98, 
amending  Section  1  of  Annex  IV  on  measures  to  manage  the  risks  of  quarantine  pests,  as 
regards the measures targeting prevention and elimination of infestation of cultivated and wild 
plants, measures targeting consignments of plants, plant products and other objects, measures 
targeting  other  pathways  for  quarantine  pests,  and  amending  Section  2  of  that  Annex  on 
principles for the management of the risks of pests, as regards principles for the management 
of  the  risks  of  pests,  taking  into  account  the  developments  of  technical  and  scientific 
knowledge. 

Article 21 
Surveys on Union quarantine pests and pests provisionally qualifying as Union 
quarantine pest  

1. 

2. 

3. 

Member States shall conduct surveys, over specific periods of time, checking for the 
presence  of  any  Union  quarantine  pest,  and  signs  or  symptoms  of  any  pest 
provisionally qualifying as Union quarantine pest, pursuant to Section 3 of Annex II, 
in all areas where that pest was not known to be present.  

Those  surveys  shall  consist,  at  least,  of  visual  examinations  by  the  competent 
authority,  and,  where  appropriate,  collection  of  samples  and  performance  of  tests. 
They shall be based on sound scientific and technical principles, and shall be carried 
out at appropriate times with regard to the possibility to detect the pest concerned. 

Those surveys shall take account of scientific and technical evidence, and any other 
appropriate information, concerning the presence of the pests concerned.  

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 have 
been carried out in the preceding year. 

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Article 22 
Multi-annual survey programmes and collection of information 

1. 

Member States shall establish multi-annual programmes setting out the content of the 
surveys to be carried out pursuant to Article 21. Those programmes shall provide for 
the  collection  and  recording  of  the  scientific  and  technical  evidence  and  other 
information as referred to in the second subparagraph of Article 21(2).  

Those  programmes  shall  set  out  the  following  elements:  the  specific  objective  of 
each  survey,  its  spatial  and  temporary  scope,  the  pests,  plants  and  commodities 
targeted, the survey methodology and quality management including a description of 
the  procedures  for  visual  examination,  sampling  and  testing  and  their  technical 
justification,  the  timing,  frequency  and  numbers  of  scheduled  visual  examinations, 
samples  and  tests,  the  methods  of  recording  of  the  information  collected  and  their 
reporting.  

The multi-annual programmes shall be for a period of five to seven years. 

Member  States  shall  notify  their  multi-annual  survey  programmes  upon  their 
establishment to the Commission and the other Member States.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  amending  or  supplementing  the  elements  to  be  covered  by  the  multi-
annual survey programmes, as set out in paragraph 1. 

Article 23 
Surveys of priority pests 

For each priority pest, Member States shall annually carry out a separate survey, as 
set  out  in  Article  21(1).  Those  surveys  shall  include  a  sufficiently  high  number  of 
visual  examinations,  sampling  and  testing,  as  appropriate  for  the  relevant  pests,  to 
ensure, at a high level of probability, their timely detection.  

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 year. 

Article 24 
Contingency plans for priority pests 

Each Member State shall draw up and keep up to date, for each priority pest which is 
capable of entering into and establishing in its territory, or a part thereof, a separate 
plan  containing  information  concerning  the  decision  making  processes,  procedures 
and  protocols  to  be  followed,  and  resources  to  be  made  available,  in  case  of  a 
confirmed or suspected presence of the pest concerned, hereinafter ‘the contingency 
plan’. 

2. 

3. 

1. 

2. 

1. 

2. 

The contingency plan shall include the following:  

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(a) 

the  roles  and  responsibilities  of  the  bodies  involved  in  the  execution  of  the 
plan,  in  case  of  a  confirmed  or  suspected  presence  of  the  priority  pest 
concerned,  the  chain  of  command  and  procedures  for  the  co-ordination  of 
actions taken by competent authorities, other public authorities, as referred to 
in  Article  3(2)  of  Regulation  (EU)  No  …/….  [Office  of  Publications,  please 
insert number of Regulation of Official Controls], delegated bodies or natural 
persons involved, as referred to in Article 25(1) of Regulation (EU) No …/…. 
[Office  of  Publication,  please  insert  number  of  Regulation  of  Official 
Controls], laboratories and professional operators, including co-ordination with 
neighbouring  Member  States  and  neighbouring 
third  countries,  where 
appropriate; 

(b) 

access  of  competent  authorities  to  premises  of  professional  operators  and  of 
natural persons, where necessary, laboratories, equipment, personnel, external 
expertise  and  resources  necessary  for  the  rapid  and  effective  eradication  or, 
where appropriate, containment of the priority pest concerned; 

(c)  measures to be taken concerning the information of the Commission, the other 
Member States, the professional operators concerned and the public, as regards 
the presence of the priority pest concerned and the measures taken against it, in 
case a presence of the pest concerned is officially confirmed or suspected;  

(d) 

(e) 

(f) 

arrangements  for  recording  findings  of  the  presence  of  the  priority  pest 
concerned; 

the available assessments as set out in Article 6(2), and any assessment of the 
Member State as regards the risk of the priority pest concerned for its territory;  

the risk management measures to be implemented as regards the priority pest 
concerned, in accordance with Section 1 of Annex IV, and the procedures to be 
followed; 

(g)  principles for the geographical demarcation of restricted areas; 

(h)  protocols  describing  the  methods  of  visual  examinations,  sampling  and 

laboratory testing; and 

(i) 

principles concerning the training of personnel of the competent authorities. 

Where appropriate, points (a) to (i) shall take the form of instruction manuals. 

3. 

Within  one  year  from  the  date  of  the  inclusion  of  the  pest  concerned  in  the  list  of 
priority pests, Member States shall establish a contingency plan for the priority pest 
concerned.  

Member  States  shall  regularly  review  and,  where  appropriate,  update  their 
contingency plans.  

4. 

Member States shall communicate their contingency plans to the Commission and to 
the other Member States on request. 

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1. 

2. 

3. 

4. 

1. 

2. 

Article 25 
Simulation exercises 

Member States shall carry out simulation exercises concerning the implementation of 
the  contingency  plans  at  intervals  set  according  to  the  biology  of  the  priority  pest 
concerned and the phytosanitary risk posed by that pest. 

Those exercises shall take place with regards to all priority pests concerned within a 
reasonable period of time. 

As regards priority pests whose presence in one Member state could have impacts for 
neighbouring  Member  States,  the  simulation  exercises  shall  be  carried  out  together 
by the Member States concerned on the basis of their respective contingency plans. 

Where  appropriate,  Member  States  shall  carry  out  those  simulation  exercises  with 
neighbouring third countries. 

Member  States  shall,  on  request,  make  available  a  report  on  the  results  of  each 
simulation exercise to the Commission and to the other Member States. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, setting out:  

(a) 

the frequencies, contents and format of simulation exercises; 

(b) 

simulation exercises covering more than one priority pest; 

(c) 

co-operation  between  Member  States,  and  of  Member  States  with  third 
countries; 

(d) 

contents of the reports on simulation exercises provided for in paragraph 3. 

Article 26 
Eradication plans for priority pests 

Where  the  presence  of  a  priority  pest  is  officially  confirmed  in  the  territory  of  a 
Member  State  pursuant 
the  competent  authority  shall 
immediately  adopt  a  plan  setting  out  the  measures  for  the  eradication  of  the  pest 
concerned,  as  provided  for  in  Articles  16,  17  and  18,  and  a  time  schedule  for  the 
application of those measures. That plan is referred to as the 'eradication plan.  

to  Article  11(1)(a), 

The eradication plan shall include a description of the design and organisation of the 
surveys to be carried out and set out the number of visual examinations, samples to 
be taken and laboratory tests to be carried out. 

Member  States  shall  notify,  on  request,  to  the  Commission  and  the  other  Member 
States the eradication plans and an annual report on the measures taken in accordance 
with Articles 16, 17 and 18 under the eradication plans concerned. 

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Article 27 
Union measures for specific Union quarantine pests 

1. 

The  Commission  may,  by  means  of  implementing  acts,  set  out  measures  against 
specific  Union  quarantine  pests.  Those  measures  shall  implement,  specifically  for 
each of the pest(s) concerned, one or more of the following provisions: 

(a)  Article 10 concerning measures in case of suspicion of the presence of a Union 

quarantine pest; 

(b)  Article  15  concerning  measures  to  be  taken  immediately  by  professional 

operators; 

(c)  Article 16 concerning eradication of Union quarantine pests;  

(d)  Article 17 concerning establishment of restricted areas; 

(e)  Article  18  concerning  surveys,  modifications  of  restricted  areas  and  lifting  of 

restrictions; 

(f)  Article  21  concerning  surveys  on  Union  quarantine  pests  and  pests 

provisionally qualifying as Union quarantine pest; 

(g)  Article  23  concerning  surveys  for  priority  pests,  as  regards  the  number  of 

visual examinations, samples and tests for particular priority pests; 

(h)  Article 24 concerning contingency plans for priority pests; 

(i)  Article 25 concerning simulation exercises; 

(j)  Article 26 concerning eradication plans for priority pests.  

2. 

3. 

4. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 99(3). 

Where,  as  regards  a  restricted  area,  the  Commission  concludes,  on  the  basis  of  the 
surveys referred to in Article 18 or other evidence, that the eradication of the Union 
quarantine pest concerned is not possible, the Commission may adopt implementing 
acts, as referred to in paragraph 1, which set out measures with the single purpose of 
prevention of the spread of those pests out of the areas concerned. Such prevention is 
referred to as 'containment'. 

In  case  the  Commission  concludes  that  prevention  measures  in  locations  outside 
restricted  areas  are  necessary  to  protect  the  part  of  the  Union  territory  where  the 
Union  quarantine  pest  concerned  is  not  present,  the  Commission  may  adopt 
implementing acts, as referred to in paragraph 1, setting out such measures. 

The measures referred to in paragraphs 1, 2 and 3 shall be taken in accordance with 
Annex  IV  on  measures  and  principles  for  the  management  of  the  risks  of  pests, 
taking into account the specific risks of the Union quarantine pests concerned and the 
need to implement the necessary risk mitigation measures in a harmonised manner at 
Union level. 

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5. 

6. 

7. 

1. 

2. 

3. 

The  implementing  acts  referred  to  in  paragraph  1  may  provide  that  the  measures, 
referred to in points (a) to (j) of paragraph 1, taken by the Member States are to be 
repealed  or  amended.  Until  a  measure  has  been  adopted  by  the  Commission,  the 
Member State may maintain the measures that it has employed. 

On  duly  justified  imperative  grounds  of  urgency  to  address  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  immediately  applicable  implementing  acts,  in 
accordance with the procedure referred to in Article 99(4). 

Member States shall notify, through the electronic notification system referred to in 
Article 97, the Commission and other Member States of any cases of non-compliance 
by professional operators with the measures adopted pursuant to this Article. 

Article 28 
Measures by Member States concerning pests not listed as Union quarantine pests 

Where the presence of a pest that is not included in the list of Union quarantine pests 
in  the  territory  of  a  Member  State  is  officially  confirmed,  and  the  competent 
authority concerned considers that that pest may fulfil the conditions for inclusion in 
the list of Union quarantine pests, it shall immediately assess whether that pest fulfils 
the criteria of Subsection 1 of Section 3 of Annex II. If it concludes that those criteria 
are  fulfilled,  it  shall  immediately  take  eradication  measures  in  accordance  with 
Annex  IV  on  measures  and  principles  for  the  management  of  the  risks  of  pests. 
Articles 16 to 19 shall apply. 

Where a competent authority suspects the presence in its territory of a pest fulfilling 
the criteria referred to in the first subparagraph, Article 10 shall apply accordingly. 

Following  the  actions  referred  to  in  paragraph  1,  the  Member  State  shall  assess 
whether  the  pest  concerned  fulfils,  as  regards  the  Union  territory,  the  criteria  for 
quarantine pests set out in Section 1 of Annex II.  

The  Member  State  concerned  shall  immediately  notify  to  the  Commission  and  the 
other  Member  States  the  presence  of  that  pest,  the  assessment  referred  to  in 
paragraph 1, the measures taken and the evidence justifying those measures. 

It  shall  notify  to  the  Commission  the  results  of  the  assessment  referred  to  in 
paragraph  2  within  24  months  of  the  official  confirmation  of  the  presence  of  that 
pest.  

Notifications  of  the  presence  of  that  pest  shall  be  submitted  through  the  electronic 
notification system referred to in Article 97. 

Article 29 
Measures by the Union concerning pests not listed as Union quarantine pests 

1. 

Where the Commission receives the notification referred to in the first subparagraph 
of  Article  28(3),  or  has  other  evidence  concerning  the  presence  in,  or  imminent 
danger of entry into, the Union territory of a pest which is not included in the list of 
Union  quarantine  pests  and  it  considers  that  that  pest  may  fulfil  the  conditions  for 

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inclusion  in  that  list,  it  shall  immediately  assess  whether,  as  regards  the  Union 
territory, that pest fulfils the criteria of Subsection 2 of Section 3 of Annex II.  

Where it concludes that those criteria are fulfilled, it shall immediately, by means of 
implementing  acts,  adopt  measures  for  a  limited  time  as  regards  the  phytosanitary 
risks  posed  by  that  pest.  Those  implementing  acts  shall  be  adopted  in  accordance 
with the examination procedure referred to in Article 99(3). 

Those measures shall implement, specifically for each of the pests concerned, one or 
more of the provisions referred to in Article 27(1)(a) to (f).  

Where the Commission concludes, on the basis of surveys referred to in Article 18 
and in Article 21, or other evidence, that the eradication of the pest concerned is not 
possible  in  certain  restricted  areas,  the  implementing  acts  referred  to  in  the  second 
subparagraph of paragraph 1 may set out measures with the single purpose to contain 
that pest. 

In  case  the  Commission  concludes  that  prevention  measures  in  locations  outside 
restricted areas are necessary to protect the part of the Union territory where the pest 
concerned  is  not  present,  the  implementing  acts  referred  to  in  paragraph  1  may  set 
out such measures. 

The  measures  referred  to  in  paragraphs  1,  2  and  3  shall  be  adopted  in  accordance 
with Section 1 of Annex IV on measures to manage the risks of quarantine pests and 
Section 2 of that Annex on principles for the management of the risks of pests, taking 
into account the specific risks of the pests concerned and the need to implement the 
necessary risk mitigation measures in a harmonised manner at Union level. 

The  implementing  acts  referred  to  in  paragraph  1  may  provide  that  the  measures 
taken  by  the  Member  States  pursuant  to  Article  28  are  to  be  repealed  or  amended. 
Until  a  measure  has  been  adopted  by  the  Commission,  the  Member  State  may 
maintain the measures that it has employed. 

On  duly  justified  imperative  grounds  of  urgency  to  address  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  immediately  applicable  implementing  acts,  in 
accordance with the procedure referred to in Article 99(4). 

Member States shall notify, through the electronic notification system referred to in 
Article 97, the Commission and other Member States of any cases of non-compliance 
by professional operators with the measures adopted pursuant to this Article. 

2. 

3. 

4. 

5. 

6. 

7. 

Article 30 
Amendment of Section 3 of Annex II 

The Commission shall be empowered to adopt delegated acts in accordance with Article 98 
amending Section 3 of Annex II on criteria to be fulfilled by pests, as provided for in Articles 
28  and  29,  as  regards  the  criteria  concerning  the  identity  of  the  pest,  its  presence,  the 
probability  of  its  entry,  establishment  and  spread,  its  potential  economic,  social  and 
environmental  impact,  taking  into  account  the  developments  of  technical  and  scientific 
knowledge.  

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Article 31 
More stringent requirements adopted by Member States 

1. 

Member  States  may  apply  within  their  territories  more  stringent  measures  than  the 
measures adopted pursuant to Article 27(1), (2) and (3) and Article 29(1), (2) and (3), 
if  justified  by  the  objective  of  phytosanitary  protection  and  in  accordance  with 
Section 2 of Annex IV on measures and principles for the management of the risks of 
pests. 

Those measures shall not impose, or result in, any prohibitions or restrictions on the 
introduction into, or movement within, the Union territory of plants, plant products 
and other objects, other than those imposed by the provisions of Articles 40 to 54 and 
the provisions of Articles 67 to 96. 

2. 

Member  States  shall  immediately  notify  the  Commission  and  the  other  Member 
States of measures adopted by them within the ambit of paragraph 1.  

Member  States  shall,  on  request,  submit  to  the  Commission  and  the  other  Member 
States an annual report on the measures taken in accordance with paragraph 1. 

SECTION 3 
PROTECTED ZONE QUARANTINE PESTS 

Article 32 
Recognition of protected zones  

1. 

Where  a  quarantine  pest  is  present  in  the  Union  territory  but  not  present  in  the 
Member State concerned, and is not a Union quarantine pest, the Commission may, 
upon  application  of  that  Member  State  pursuant  to  paragraph  4,  recognise  the 
territory of that Member State as a protected zone in accordance with paragraph 3.  

Where  a  protected  zone  quarantine  pest  is  absent  from  a  part  of  the  territory  of  a 
Member State the same shall apply with respect to that part. 

Such a quarantine pest is referred to as ‘a protected zone quarantine pest'. 

2. 

A  protected  zone  quarantine  pest  shall  not  be  introduced  into  or  moved  within  the 
respective protected zone.  

Nobody shall intentionally take an action which contributes to the introduction into, 
and  establishment  and  spread  within,  a  protected  zone  of  the  respective  protected 
zone quarantine pest. 

3. 

The Commission shall, by means of an implementing act, establish a list of protected 
zones and the respective protected zone quarantine pests. That list shall include the 
protected  zones  recognised  in  accordance  with  the  first  subparagraph  of  Article 
2(1)(h) of Directive 2000/29/EC and the respective pests, listed in Part B of Annex I 
and  Part  B  of  Annex  II  to  Directive  2000/29/EC.  That  implementing  act  shall  be 
adopted in accordance with the advisory procedure referred to in Article 99(2).  

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45 

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The  Commission  may  recognise  additional  protected  zones,  by  amending  the 
implementing act referred to in the first subparagraph, where the conditions provided 
for in paragraph 1 are fulfilled. Such an amendment shall be adopted in accordance 
with  the  examination  procedure  referred  to  in  Article  99(3).  The  same  procedure 
shall apply to a repeal or replacement of the implementing act referred to in the first 
subparagraph. 

Where Article 35 applies, an implementing act shall be adopted in accordance with 
the advisory procedure referred to in Article 99(2).  

4. 

With  the  application  referred  to  in  paragraph  1,  the  Member  State  concerned  shall 
submit:  

(a) 

(b) 

a  description  of  the  boundaries  of  the  protected  zone  concerned,  including 
maps; and  

the  results  of  surveys  showing  that  during  the  three  years  preceding  the 
application,  the  quarantine  pest  concerned  was  not  present  in  the  territory 
concerned.  

Those  surveys  shall  have  been  carried  out  at  appropriate  times  and  have  been  of 
appropriate  intensity  with  regard  to  the  possibility  to  detect  the  presence  of  the 
quarantine  pest  concerned.  They  shall  have  been  based  on  sound  scientific  and 
technical principles. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, laying down detailed rules for surveys to be carried out for purposes of 
the recognition of protected zones. 

Article 33 
General obligations concerning protected zones 

1. 

With regard to a protected zone, the obligations set out in the following Articles shall 
apply accordingly to the protected zone quarantine pests:  

(a)  Articles  9  to  12  concerning  the  confirmation,  notification  and  information  as 

regards the presence of Union quarantine pests; 

(b)  Article  15  concerning  measures  to  be  taken  immediately  by  professional 

operators; 

(c)  Articles  16,  17  and  18  concerning  the  eradication  of  Union  quarantine  pests, 
the  establishment  and  modification  of  restricted  areas  and  surveys  in  those 
restricted areas. 

2. 

A plant, plant product or other object originating in a restricted area established, in 
accordance with Article 17, in a protected zone for the protected zone quarantine pest 
concerned, may not be moved within or into any protected zone established for that 
protected  zone  quarantine  pest.  When  moved  out  of  the  protected  zone  concerned, 
that plant, plant product or other object shall be packed and moved in such a way that 

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46 

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3. 

1. 

2. 

there is no risk of spreading the respective protected zone quarantine pest within that 
protected zone. 

The restricted areas established within a protected zone and the eradication measures 
taken in those areas pursuant to Articles 16, 17 and 18 shall be immediately notified 
to the Commission and the other Member States. 

Article 34 
Surveys on protected zone quarantine pests 

The competent authority shall carry out an annual survey of each protected zone as 
regards the presence of the protected zone quarantine pest concerned. Those surveys 
shall  be  carried  out  at  appropriate  times  and  be  of  an  appropriate  intensity  with 
regard to the possibility to detect the presence of the protected zone quarantine pest 
concerned. They shall be based on sound scientific and technical principles. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, laying down detailed rules for those surveys to be carried out to confirm 
that the protected zones continue to fulfil the conditions set out in Article 32(1). 

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 
have been carried out in the preceding year. 

Article 35 
Amendment and revocation of the protected zones 

1. 

The  Commission  may  amend  the  size  of  the  protected  zone  on  application  by  the 
Member State whose territory is concerned. 

Where  the  Commission  amends  the  protected  zone,  the  Member  State  concerned 
shall  notify  the  Commission,  the  other  Member  States  and,  via  the  internet,  the 
professional operators of the amendment to that protected zone, including maps. 

Where  that  amendment  concerns  the  extension  of  a  protected  zone,  Articles  32,  33 
and 34 shall apply. 

On application by the Member State referred to in paragraph 1, the Commission shall 
revoke the recognition of a protected zone or shall reduce its size. 

The Commission shall revoke the recognition of a protected zone in case the surveys 
referred to in Article 34 have not been carried out in accordance with that Article. 

The  Commission  shall  revoke  the  recognition  of  a  protected  zone,  in  case  the 
respective protected zone quarantine pest has been found to be present in that zone 
and one of the following conditions is fulfilled: 

(a)  no restricted area has been designated, in accordance with Article 33(1), within 

three months after the presence of that pest was confirmed; 

2. 

3. 

4. 

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47 

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(b) 

(c) 

the  eradication  measures  taken  in  a  restricted  area  pursuant  to  Article  33(1) 
have not been successful within 24 months after the presence of that pest was 
confirmed; 

information at the disposal of the Commission demonstrates, with regard to the 
application of measures pursuant, by virtue of Article 33(1)(c), to Articles 16, 
17  and  18,  negligent  reaction  to  the  presence  of  that  pest  in  the  concerned 
protected zone. 

Chapter III 
Union quality pests  

Article 36 
Definition of Union quality pests 

A pest shall be referred to as a 'Union quality pest' if it fulfils the following conditions and it 
is included in the list referred to in Article 37: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

its identity is established in accordance with point (1) of Section 4 of Annex II; 

it is present in the Union territory; 

it is no Union quarantine pest; 

it is transmitted mainly through specific plants for planting, in accordance with point 
(2) of Section 4 of Annex II; 

its  presence  on  those  plants  for  planting  has  an  unacceptable  economic  impact,  as 
regards the intended use of those plants for planting, in accordance with point (3) of 
Section 4 of Annex II; 

feasible and effective measures are available to prevent its presence on the plants for 
planting concerned. 

Article 37 
Prohibition of the introduction and movement of Union quality pests on plants for 
planting  

1. 

2. 

A Union quality pest shall not be introduced into or moved within the Union territory 
on  the  plants  for  planting  through  which  it  is  transmitted,  as  specified  in  the  list 
referred to in paragraph 2. 

The Commission shall, by means of an implementing act, establish a list setting out 
the Union quality pests and the specific plants for planting, as referred to in Article 
36(d), where appropriate with the categories referred to in paragraph 4 and thresholds 
referred to in paragraph 5. 

That list shall include the pests, and the respective plants for planting, as set out in 
the following acts:  

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48 

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(a)  Section II of Part A of Annex II of Directive 2000/29/EC;  

(b)  points (3) and (6) of Annex I to Council Directive 66/402/EEC of 14 June 1966 

on the marketing of cereal seed24 and point (3) of Annex II thereto; 

(c) 

the Annex of Commission Directive 93/48/EEC of 23 June 1993 setting out the 
schedule indicating the conditions to be met by fruit plant propagating material 
and  fruit  plants  intended  for  fruit  production,  pursuant  to  Council  Directive 
92/34/EEC25; 

(d) 

the Annex of Commission Directive 93/49/EEC of 23 June 1993 setting out the 
schedule indicating the conditions to be  met  by  ornamental  plant  propagating 
material and ornamental plants pursuant to Council Directive 91/682/EEC26;  

(e)  point (b) of Annex II to Council Directive 2002/55/EC of 13 June 2002 on the 

marketing of vegetable seed27; 

(f) 

point (6) of Annex I to Council Directive 2002/56/EC28 of 13 June 2002 on the 
marketing of seed potatoes and point B of Annex II thereto; 

(g)  point (4) of Annex I to Council Directive 2002/57/EC of 13 June 2002 on the 
marketing of seed of oil and fibre plants29 and point (5) of Annex II thereto. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2). 

The Commission shall amend the implementing act referred to in paragraph 2, where 
an assessment shows that a pest not listed in that act fulfils the conditions referred to 
in Article 36, a pest listed in that implementing act no longer fulfils one or more of 
those  conditions  or  where  amendments  to  that  list  are  necessary,  as  regards 
categories referred to in paragraph 4 or thresholds referred to in paragraph 5. 

The Commission shall make that assessment available to the Member States. 

Where Article 36(e) is only fulfilled for one or more of the categories referred to in 
Article  12(1)  of  Regulation  (EU)  No  …/….  [Office  of  Publications,  please  insert 
number  of  Regulation  on  plant  reproductive  material  law],  the  list  referred  to  in 
paragraph 1 shall set out those categories stating that the prohibition of introduction 
and movement provided for in paragraph 1 only applies to those categories. 

Where Article 36(e) is only fulfilled if the pest concerned is present above a certain 
threshold,  the  list  referred  to  in  paragraph  1  shall  set  out  that  threshold  stating  that 
the  prohibition  of  introduction  and  movement  provided  for  in  paragraph  1  only 
applies above that threshold. 

OJ L 125, 11.7.1966, p. 2309. 
OJ L 250, 7.10.1993, p. 1. 
OJ L 250, 7.10.1993, p. 9. 
OJ L 193, 20.7.2002, p. 33. 
OJ L 193, 20.7.2002, p. 60. 
OJ L 193, 20.7.2002, p. 74. 

3. 

4. 

5. 

24 
25 
26 
27 
28 
29 

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A threshold shall only be set if the following points are fulfilled: 

(a) 

it is possible to ensure by measures taken by the professional operator that the 
presence of that Union quality pest on those plants for planting does not exceed 
that threshold; and 

(b) 

it  is  possible  to  verify  whether  that  threshold  is  not  exceeded  in  lots  of  those 
plants for planting. 

The principles for the management of the risk of pests set out in Section 2 of Annex 
IV shall apply. 

6. 

For  amendments  to  the  implementing  act  referred  to  in  paragraph  2  which  are 
necessary to adapt that implementing act in view of changes to the scientific name of 
a pest, the advisory procedure referred to in Article 99(2) shall apply. 

All  other  amendments  to  the  implementing  act  referred  to  in  paragraph  2  shall  be 
adopted  in  accordance  with  the  examination  procedure  referred  to  in  Article  99(3). 
The same procedure shall apply to a repeal or a replacement of the implementing act 
referred to in paragraph 2. 

Article 38 
Amendment of Section 4 of Annex II 

The Commission shall be empowered to adopt delegated acts in accordance with Article 98 
amending Section 4 of Annex II on criteria to identify pests which qualify as a Union quality 
pest, as regards the criteria concerning the identity of the pest, its relevance, the probability of 
its  spread,  its  potential  economic,  social  and  environmental  impact,  taking  account  of  the 
developments of technical and scientific knowledge. 

Article 39 
Union quality pests used for scientific purposes, trials, varietal selections, breeding or 
exhibitions 

The prohibition provided for in Article 37 shall not apply to Union quality pests present on 
the plants for planting concerned, and used for scientific purposes, trials, varietal selections, 
breeding or exhibitions. 

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Chapter IV 
Measures concerning plants, plant products and other objects 

SECTION 1 
MEASURES RELATING TO THE ENTIRE UNION TERRITORY  

Article 40 
Prohibition of introduction of plants, plant products and other objects into the Union 
territory 

1. 

The  Commission  shall  adopt  an  implementing  act,  containing  the  plants,  plant 
products and other objects, and the prohibitions and the third countries concerned, as 
set out in Part A of Annex III to Directive 2000/29/EC. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2) of this Regulation. 

In the list established by that implementing act, the plants, plant products and other 
objects  shall  be  identified  by  their  respective  code  in  accordance  with  the 
classification  in  the  Combined  Nomenclature  as  laid  down  in  Council  Regulation 
(EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on 
the Common Customs Tariff30 (hereinafter: 'CN code'). 

2. 

In case a plant, plant product or other object, originating in or being dispatched from 
a third country, poses a phytosanitary risk of an unacceptable level by its likelihood 
to  host  a  Union  quarantine  pest,  and  that  risk  cannot  be  reduced  to  an  acceptable 
level by applying one or more of the measures set out in points 2 and 3 of Section 1 
of Annex IV on measures and principles for the management of the risks of pests, the 
Commission  shall  amend,  as  appropriate,  the  implementing  act  referred  to  in 
paragraph  1,  to  include  in  it  that  plant,  plant  product  or  other  object  and  the  third 
countries, concerned.  

In case a plant, plant product or other object included in that implementing act does 
not pose a phytosanitary risk of an unacceptable level, or it poses such a risk but that 
risk can be reduced to an acceptable level by applying one or more of the measures 
set out in points 2 and 3 of Section 1 of Annex IV on measures to manage the risks 
and  pathways  of  quarantine  pests,  the  Commission  shall  amend  that  implementing 
act, as appropriate. 

The  acceptability  of  the  level  of  that  phytosanitary  risk  shall  be  assessed  in 
accordance with the principles set out in Section 2 of Annex IV on principles for the 
management of the risks of pests. Where appropriate, the acceptability of that level 
of  phytosanitary  risk  shall  be  assessed  with  regards  to  one  or  more  specific  third 
countries. 

30 

OJ L 256, 7.9.1987, p. 1. 

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Those  amendments  shall  be  adopted  in accordance  with  the  examination  procedure 
referred to in Article 99(3) of this Regulation. 

On  duly  justified  imperative  grounds  of  urgency  to  address  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  those  amendments  by  immediately  applicable 
implementing acts, in accordance with the procedure referred to in Article 99(4). 

3. 

4. 

A plant, plant product or other object listed in the implementing act provided for in 
paragraph 1 shall not be introduced into the Union territory from the third country, 
concerned by that listing. 

Member States shall notify, through the electronic notification system referred to in 
Article 97, the Commission and other Member States where plants, plant products or 
other objects have been introduced into the Union territory in violation of paragraph 
3. 

The  third  country  from  which  the  plants,  plant  products  or  other  objects  were 
introduced into the Union territory shall be notified.  

Article 41 
Plants, plant products and other objects subject to special and equivalent requirements 

1. 

2. 

The  Commission  shall  adopt  an  implementing  act,  containing  the  plants,  plant 
products  and  other  objects,  and  the  requirements  and,  where  applicable,  the  third 
countries concerned, as set out in Part A of Annex IV to Directive 2000/29/EC. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2) of this Regulation. 

In the list established by that implementing act, those plants, plant products and other 
objects shall be identified by their respective CN code. 

In  case  a  plant,  plant  product  or  other  object  poses  a  phytosanitary  risk  of  an 
unacceptable level by its likelihood to host a Union quarantine pest, and that risk can 
be reduced to an acceptable level by applying one or more of the measures set out in 
points  2  and  3  of  Section  1  of  Annex  IV  on  measures  and  principles  for  the 
management of the risks of pests, the Commission shall amend the implementing act 
referred to in paragraph 1, to include in it that plant, plant product or other object and 
the measures to be applied to it. Those measures, and the requirements referred to in 
paragraph 1, are hereinafter referred to as 'special requirements'.  

Those measures may take the form of specific requirements, adopted in accordance 
with Article 42(1), for the introduction into the Union territory of particular plants, 
plant products or other objects, which are equivalent to special requirements for the 
movement of those plants, plant products or other objects within the Union territory 
(hereinafter: 'equivalent requirements'). 

In case a plant, plant product or other object included in that implementing act does 
not pose a phytosanitary risk of an unacceptable level, or it poses such a risk but that 
risk  cannot  be  reduced  to  an  acceptable  level  by  the  special  requirements,  the 
Commission shall amend that implementing act. 

EN 

52 

   EN 

The  acceptability  of  the  level  of  that  phytosanitary  risk  shall  be  assessed,  and  the 
measures  to  reduce  that  risk  to  an  acceptable  level  shall  be  adopted,  in  accordance 
with  the  principles  set  out  in  Section  2  of  Annex  IV  on  principles  for  the 
management of the risks of pests. Where appropriate, the acceptability of that level 
of  phytosanitary  risk  shall  be  assessed,  and  those  measures  shall  be  adopted,  with 
regards to one or more specific third countries or parts thereof. 

Those  amendments  shall  be  adopted  in accordance  with  the  examination  procedure 
referred to in Article 99(3) of this Regulation. 

On  duly  justified  imperative  grounds  of  urgency  to  address  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 99(4). 

3. 

4. 

A plant, plant product or other object listed in the implementing act provided for in 
paragraph 1 may only be introduced into, or moved within, the Union territory if the 
special requirements, or equivalent requirements, are fulfilled. 

Member States shall notify, through the electronic notification system referred to in 
Article 97, the Commission and other Member States where plants, plant products or 
other  objects  have  been  introduced  into,  or  moved  within,  the  Union  territory  in 
violation of paragraph 3. 

Where  applicable,  the  third  country  from  which  the  plants,  plant  products  or  other 
objects were introduced into the Union territory shall also be notified. 

Article 42 
Setting out of equivalent requirements 

1. 

Equivalent requirements, as referred to in the second subparagraph of Article 41(2) 
shall  be  set  out,  by  means  of  an  implementing  act,  on  request  of  a  particular  third 
country, if all of the following conditions are fulfilled: 

(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  adopted  pursuant  to  Article 
41(1) and (2) in respect of the movement within the Union territory of plants, 
plant products and other objects concerned; 

(b) 

the  third  country  concerned  objectively  demonstrates  to  the  Commission  that 
the  specified  measures  referred  to  in  point  (a)  achieve  the  level  of 
phytosanitary protection referred to in that point. 

Where appropriate, the Commission shall investigate, in the third country concerned, 
and  in  accordance  with  Article  119  of  the  Regulation  (EU)  No  …/….  [Office  of 
Publications,  please  insert  number  of  Regulation  on  Official  Controls],  whether 
points (a) and (b) are fulfilled. 

The implementing acts referred to in paragraph 1 shall be adopted in accordance with 
the examination procedure referred to in Article 99(3). 

2. 

3. 

EN 

53 

   EN 

Article 43 
Information to be provided to travellers, clients of postal services and internet clients 

1. 

2. 

3. 

1. 

Member States and international transport operators shall make information available 
to  passengers  concerning  the  prohibitions,  set  out  pursuant  to  Article  40(3),  the 
requirements,  set  out  pursuant  to  Articles  41(1)  and  42(2),  and  the  exemptions,  set 
out pursuant to Article 70(2), as regards the introduction of plants, plant products and 
other objects into the Union territory. 

That information shall be provided in the form of posters or brochures, which, where 
appropriate, shall be made available through the internet. 

Where  that  information  is  made  available  to  passengers  at  seaports  and  airports,  it 
shall be provided in the form of posters. 

The Commission shall be empowered to adopt an implementing act, setting out those 
posters  and  brochures.  That  implementing  act  shall  be  adopted  in  accordance  with 
the advisory procedure referred to in Article 99(2) of this Regulation. 

The information referred to in paragraph 1 shall be made available by postal services, 
and  by  professional  operators  involved  in  sales  through  distance  contracts,  to  their 
clients through the internet. 

Member  States  shall  annually  submit  to  the  Commission  a  report  summarising  the 
information provided pursuant to this Article. 

Article 44 
Exception from prohibitions and requirements for frontier zones 

By way of derogation from Articles 40(3) and 41(3), Member States may authorise 
the introduction of plants, plant products and other objects into the Union territory, 
where the plants, plant products and other objects fulfil the following conditions: 

(a) 

(b) 

(c) 

(d) 

they  are grown  or  produced in  areas of third countries  in  the vicinity  of their 
border with Member States (hereinafter: 'third country frontier zones'); 

they are introduced into areas of Member States immediately across that border 
(hereinafter: 'Member State frontier zones'); 

they are to be processed in the respective Member State frontier zones in such a 
manner that any phytosanitary risk is eliminated; 

they do not pose any risk of spreading quarantine pests caused by movements 
within the frontier zone. 

Those  plants,  plant  products  and  other  objects  shall  only  move  into  and  within  the 
Member  State  frontier  zones,  and  only  under  the  official  control  of  the  competent 
authority.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, setting out the following: 

EN 

54 

   EN 

(a) 

(b) 

(c) 

the maximum width of third country frontier zones and Member State frontier 
zones,  as  appropriate  for  the  specific  plants,  plant  products  and  other  objects 
individually; 

the maximum distance of the movement of the plants, plant products and other 
objects  concerned  within  the  third  country  frontier  zones  and  Member  State 
frontier zones; and 

the  procedures  concerning  the  authorisation  of  the  introduction  into,  and 
movement  within,  the  Member  State  frontier  zones  of  plants,  plant  products 
and other objects referred to in paragraph 1. 

The width of those zones shall be such to ensure that the introduction and movement 
of those plants, plant products and other objects in the Union territory does not pose 
any phytosanitary risks to the Union territory or parts of it. 

The Commission may lay down, by means of implementing acts, specific conditions 
or  measures  concerning  the  introduction  into  Member  State  frontier  zones  of 
particular plants, plant products and other objects, and specific third countries, which 
are subject to this Article. 

Those acts shall be adopted in accordance with Section 1 of Annex IV on measures 
to manage the risks of quarantine pests and Section 2 of that Annex on principles for 
the management of the risks of pests, taking into account the scientific and technical 
developments. 

Those implementing acts shall be adopted, and as appropriate repealed or replaced, 
in accordance with the examination procedure referred to in Article 99(3). 

Member States shall notify, through the electronic notification system referred to in 
Article  97,  the  Commission  and  the  other  Member  States  where  plants,  plant 
products  or  other  objects  have  been  introduced  into,  or  moved  within,  the  frontier 
zones as referred to in paragraphs 1 and 2 in violation of those paragraphs. 

The  third  country  from  which  the  plants,  plant  products  or  other  objects  were 
introduced into the frontier zone concerned shall also be notified. 

Article 45 
Exception from prohibitions and requirements for phytosanitary transit 

By  way  of  derogation  from  Article  40(3)  and  Article  41(3),  Member  States  may 
authorise the introduction of plants, plant products and other objects into, and their 
passing  through,  the  Union  territory  to  a  third  country  (hereinafter  'phytosanitary 
transit'),  where  those  plants,  plant  products  and  other  objects  fulfil  the  following 
conditions: 

(a) 

they  are  accompanied  by  a  signed  declaration  of  the  professional  operator  in 
control  of  those  plants,  plant  products  and  other  objects  stating  that  those 
plants, plant products or other objects are in phytosanitary transit; 

3. 

4. 

1. 

EN 

55 

   EN 

(b) 

they are packed and moved in such a way that there is no risk of spreading of 
Union quarantine pests during their introduction into, and passing through, the 
Union territory; 

(c) 

they are introduced into, passed through and, without delay, moved out of the 
Union territory under official control by the competent authorities concerned. 

The competent authority of the Member State where those plants, plant products or 
other  objects  are  introduced  into,  or  for  the  first  time  moved  within,  the  Union 
territory  shall  inform  the  competent  authorities  of  all  other  Member  States  through 
which  those  plants,  plant  products  or  other  objects  are  to  be  moved  prior  to  being 
moved out of the Union territory. 

Where so stipulated by the acts adopted pursuant to Article 27(1) and (2) and Article 
29(1) and (2), this Article shall apply accordingly. 

The  Commission  shall  be  empowered,  in  accordance  with  Article  98,  to  adopt 
delegated  acts  setting  out  the  contents  of  the  declaration  referred  to  in  point  (a)  of 
paragraph 1. 

The  Commission  may,  by  means  of  implementing  acts,  adopt  format  specifications 
for the declaration referred to in point (a) of paragraph 1. Those implementing acts 
shall be adopted in accordance with the examination procedure referred to in Article 
99(3). 

Member States shall notify, through the electronic notification system referred to in 
Article  97,  the  Commission  and  the  other  Member  States  where  plants,  plant 
products  or  other  objects  have  been  introduced  into,  or  moved  within,  the  Union 
territory as referred to in paragraph 1 in violation of the provisions of that paragraph. 

The  third  country  from  which  the  plants,  plant  products  or  other  objects  were 
introduced into the Union territory shall also be notified. 

Article 46 
Plants, plant products and other objects used for scientific purposes, trials, varietal 
selection, breeding and exhibitions 

By  way  of  derogation  from  Articles  40(3)  and  41(3),  Member  States  may,  on 
application, authorise the introduction into, and the movement within, their territory 
of plants, plant products and other objects used for scientific purposes, trials, varietal 
selection, breeding and exhibitions, if all of the following requirements are fulfilled: 

(a) 

(b) 

the presence of the plants, plant products or other objects concerned does not 
cause an unacceptable risk of the spread of a Union quarantine pest if adequate 
restrictions are imposed; 

the storage facilities in which those plants, plant products or other objects are 
to  be  kept  and  the  quarantine  stations,  as  referred  to  in  Article  56,  in  which 
they are to be used are appropriate; 

2. 

3. 

4. 

5. 

1. 

EN 

56 

   EN 

(c) 

the scientific and technical qualifications of the personnel by whom the activity 
involving those plants, plant products or other objects is to be carried out are 
appropriate. 

2. 

The competent authority shall assess the risk of the spread of Union quarantine pests 
by the plants, plant products or other objects concerned, as referred to in paragraph 
1(a),  taking  into  account  the  identity,  biology  and  means  of  dispersal  of  the  Union 
quarantine  pests  concerned,  the  activity  envisaged,  the  interaction  with  the 
environment  and  other  relevant  factors  relating  to  the  risk  posed  by  those  plants, 
plant products or other objects. 

It  shall  assess  the  storage  facilities  in  which  those  plants,  plant  products  or  other 
objects  are  to  be  kept,  as  referred  to  in  paragraph  1(b),  and  the  scientific  and 
technical qualifications of the personnel by whom the activity involving those plants, 
plant products or other objects is to be carried out, as referred to in paragraph 1(c). 

On  the  basis  of  those  assessments  the  competent  authority  shall  authorise  the 
introduction of those plants, plant products or other objects into, or their movement 
within, the Union territory if the requirements set out in paragraph 1 are fulfilled. 

3. 

Where an authorisation is granted, it shall include all of the following conditions: 

(a) 

(b) 

(c) 

the plants, plant products or other objects concerned are to be kept in storage 
facilities found to be appropriate by the competent authorities and referred to in 
the authorisation; 

the  activity  involving  those  plants,  plant  products  or  other  objects  is  to  be 
carried out in a quarantine station designated in accordance with Article 56 by 
the competent authority and referred to in the authorisation; 

the  activity  involving  those  plants,  plant  products  or  other  objects  is  to  be 
carried out by personnel whose scientific and technical qualifications are found 
to  be  appropriate  by  the  competent  authority  and  referred  to  in  the 
authorisation; 

(d) 

those  plants,  plant  products  or  other  objects  are  to  be  accompanied  by  the 
authorisation when introduced into or moved within the Union territory. 

4. 

5. 

6. 

The  authorisation  shall  be  limited  to  the  amount  that  is  adequate  for  the  activity 
concerned and shall not exceed the capacity of the designated quarantine station. 

It shall include the restrictions necessary to adequately mitigate the risk of the spread 
of the Union quarantine pests concerned. 

The competent authority shall monitor compliance with the conditions referred to in 
paragraph 3 and the limitation and the restrictions referred to in paragraph 4 and take 
the necessary action in case those conditions, that limitation or those restrictions are 
not complied with. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, laying down detailed rules concerning: 

EN 

57 

   EN 

(a) 

the  exchange  of  information  between  Member  States  and  the  Commission 
concerning the introduction into, and movement within, the Union territory of 
the plants, plant products and other objects concerned; 

(b) 

the assessments and authorisation referred to in paragraph 2; and 

(c) 

the  monitoring  of  compliance,  the  action  in  case  of  non-compliance  and 
notification thereof, as referred to in paragraph 5. 

7. 

Member States shall notify, through the electronic notification system referred to in 
Article  97,  the  Commission  and  the  other  Member  States  where  plants,  plant 
products  or  other  objects  have  been  introduced  into,  or  moved  within,  the  Union 
territory in violation of the provisions of paragraphs 1 to 4. 

Where  applicable,  those  notifications  shall  also  include  the  measures  taken  by  the 
Member  States  on  the  plants,  plant  products  and  other  objects  concerned,  and  the 
whether the introduction into, or movement within, the Union territory of those plant, 
plant  products  or  other  objects  has  been  allowed  after  the  implementation  of  those 
measures. 

Where  applicable,  the  third  country  from  which  the  plants,  plant  products  or  other 
objects were introduced into the Union territory shall also be notified. 

Member  States  shall  annually  submit  to  the  Commission  a  report  summarising  the 
relevant  information  on  the  authorisations  granted  pursuant  to  paragraph  1  and  the 
results of the monitoring referred to in paragraph 5. 

Article 47 
Temporary measures concerning plants for planting  

1. 

The Commission may adopt, by means of implementing acts, temporary measures as 
regards the introduction into, and movement within, the Union territory of plants for 
planting from third countries, where the following conditions are fulfilled: 

(a) 

there is no or little phytosanitary experience as regards trade in the plants for 
planting  concerned  originating  in  or  dispatched  from  the  third  country 
concerned; 

(b)  no  assessment  has  been  carried  out  as  regards  the  phytosanitary  risks  for  the 
Union  territory  in  respect  of  those  plants  for  planting  from  the  third  country 
concerned; 

(c) 

those  plants  for  planting  are  likely  to  pose  phytosanitary  risks  which  are  not 
linked,  or  cannot  yet  be  linked,  to  Union  quarantine  pests  listed  pursuant  to 
Article 5(2) and (3) or pests for which measures have been adopted pursuant to 
Article 29. 

Those implementing acts shall be adopted, and as appropriate repealed or replaced, 
in accordance with the examination procedure referred to in Article 99(3). 

EN 

58 

   EN 

2. 

The  temporary  measures  referred  to  in  paragraph  1  shall  be  adopted  in  accordance 
with Annex III on elements to identify plants for planting which pose phytosanitary 
risks  for  the  Union  territory  and  Section  2  of  Annex  IV  on  principles  for  the 
management of the risks of pests. 

3. 

4. 

5. 

6. 

Those  measures  shall  provide  for  one  of  the  following,  as  necessary  in  the  case 
concerned: 

(a) 

intensive  sampling,  at  the  point  of  introduction,  of  each  lot  of  plants  for 
planting introduced into the Union territory and testing of samples; 

(b)  where  absence  of  the  phytosanitary  risk  cannot  be  ensured  by  intensive 
sampling  and  testing  at  the  introduction  of  the  plants  for  planting  concerned 
into  the  Union  territory,  a  quarantine  period  to  verify  the  absence  of  that 
phytosanitary risk in those plants for planting; 

(c)  where  absence  of  the  phytosanitary  risk  cannot  be  ensured  by  intensive 
sampling  and  testing  at  the  introduction  of  the  plants  for  planting  concerned 
into the Union territory and a quarantine period, prohibition of the introduction 
of those plants for planting into the Union territory. 

The  measures  referred  to  in  paragraph  1  shall  apply  for  a  maximum  of  two  years. 
This period may be prolonged once for a maximum of two years. 

On  duly  justified  imperative  grounds  of  urgency  to  address  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  immediately  applicable  implementing  acts,  in 
accordance with the procedure referred to in Article 99(4). 

By way of derogation from the measures adopted pursuant to paragraph 1, Article 46 
shall apply to the introduction into, and the movement within, the Union territory of 
plants for planting used for scientific purposes, trials, varietal selection, breeding and 
exhibitions. 

Member  States  shall  notify  the  Commission  and  the  other  Member  States  where  a 
plant,  plant  product  or  other  object  has  been  subject  to  the  measures  referred  to  in 
points (a) or (b) of paragraph 2. 

Member  States  shall  notify  the  Commission  and  the  other  Member  States  where, 
following the application of the measures referred to in points (a) or (b) of paragraph 
2, a pest has been found which is likely to pose new phytosanitary risks. 

Member States shall notify, through the electronic notification system referred to in 
Article 97, the Commission and the other Member States where the introduction of a 
plant,  plant  product  or  other  object  into  the  Union  territory  was  refused,  or  its 
movement  within  the  Union  territory  prohibited,  because  the  Member  State 
concerned considered that the prohibition referred to in point (c) of paragraph 2 was 
violated.  Where  applicable,  those  notifications  shall  include  the  measures  taken  by 
the Member States on the plants, plant products and other objects concerned pursuant 
to Article 64(3) of Regulation (EU) No …/… [Office of Publications, please insert 
number of Regulation on Official Controls]. 

EN 

59 

   EN 

Where  applicable,  the  third  country  from  which  the  plants,  plant  products  or  other 
objects  were  dispatched  for  introduction  into  the  Union  territory  shall  also  be 
notified. 

Article 48 
Amendment of Annex III 

The Commission shall be empowered to adopt delegated acts, in accordance with Article 98, 
amending Annex III on elements to identify plants for planting which pose phytosanitary risks 
for the Union territory, as regards the characteristics and origin of those plants for planting, to 
adapt to the developments of technical and scientific knowledge. 

SECTION 2 
MEASURES RELATING TO PROTECTED ZONES 

Article 49 
Prohibition of introduction of plants, plant products and other objects into protected 
zones 

1. 

2. 

The  Commission  shall  adopt  an  implementing  act,  containing  the  plants,  plant 
products and other objects, and the prohibitions and the protected zones concerned, 
as set out in Part B of Annex III to Directive 2000/29/EC. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2) of this Regulation. 

In the list established by that implementing act, the plants, plant products and other 
objects shall be identified by their respective CN code. 

In case a plant, plant product or other object, coming from outside the protected zone 
concerned,  poses  a  phytosanitary  risk  of  an  unacceptable  level  by  its  likelihood  to 
host  a  protected  zone  quarantine  pest,  and  that  risk  cannot  be  reduced  to  an 
acceptable level by applying one or more of the measures set out in points 2 and 3 of 
Section 1 of Annex IV on measures to manage the risks and pathways of quarantine 
pests, the Commission shall amend, as appropriate, the implementing act referred to 
in  paragraph  1,  to  include  in  it  that  plant,  plant  product  or  other  object  and  the 
protected zones concerned. 

In case a plant, plant product or other object included in that implementing act does 
not pose a phytosanitary risk of an unacceptable level, or it poses such a risk but that 
risk can be reduced to an acceptable level by applying one or more of the measures 
set out in points 2 and 3 of Section 1 of Annex IV on measures to manage the risks 
and  pathways  of  quarantine  pests,  the  Commission  shall  amend  that  implementing 
act. 

Those  amendments  shall  be  adopted  in accordance  with  the  examination  procedure 
referred to in Article 99(3) of this Regulation. 

EN 

60 

   EN 

3. 

4. 

5. 

The  acceptability  of  the  level  of  that  phytosanitary  risk  shall  be  assessed  in 
accordance with the principles set out in Section 2 of Annex II on principles for the 
management of the risks of pests. 

A plant, plant product or other object listed in the implementing act provided for in 
paragraph 1 shall not be introduced into the respective protected zone from the third 
country, or area of the Union territory, concerned. 

On  duly  justified  imperative  grounds  of  urgency  to  address  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 99(4). 

Member States shall notify, through the electronic notification system referred to in 
Article  97,  the  Commission  and  other  Member  States  of  any  cases  where  plants, 
plant  products  or  other  objects  have  been  introduced  into,  or  moved  within  the 
protected  zone  concerned,  in  violation  of  the  prohibitions  adopted  pursuant  to  this 
Article. 

Where  applicable,  the  third  country  from  which  the  plants,  plant  products  or  other 
objects were introduced into the protected zone concerned shall also be notified. 

Article 50 
Plants, plant products and other objects subject to special requirements for protected 
zones 

1. 

2. 

The  Commission  shall  adopt  an  implementing  act,  containing  the  plants,  plant 
products  and  other  objects,  the  respective  protected  zones  and  the  requirements,  as 
set out in Part B of Annex IV to Directive 2000/29/EC. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2) of this Regulation. 

In the list established by that implementing act, the plants, plant products and other 
objects shall be identified by their respective CN code. 

In case a plant, plant product or other object, coming from outside the protected zone 
concerned poses a phytosanitary risk of an unacceptable level for that protected zone 
by  its  likelihood  to  host  a  protected  zone  quarantine  pest,  and  that  risk  can  be 
reduced  to  an  acceptable  level  by  applying  one  or  more  of  the  measures  set  out  in 
points  2  and  3  of  Section  1  of  Annex  IV  on  measures  to  manage  the  risks  and 
pathways  of  quarantine  pests,  the  Commission  shall  amend  the  implementing  act 
referred to in paragraph 1, to include in it that plant, plant product or other object and 
the measures to be applied to it. Those measures, and the requirements referred to in 
paragraph 1, are hereinafter referred to as 'special requirements for protected zones'. 

In case a plant, plant product or other object included in that implementing act does 
not  pose  a  phytosanitary  risk  of  an  unacceptable  level  for  the  protected  zone 
concerned,  or  it  poses  such  a  risk  but  that  risk  cannot  be  reduced  to  an  acceptable 
level by the special requirements for protected zones, the Commission shall amend 
that implementing act. 

EN 

61 

   EN 

Those  amendments  shall  be  adopted  in accordance  with  the  examination  procedure 
referred to in Article 99(3) of this Regulation. 

The  acceptability  of  the  level  of  that  phytosanitary  risk  shall  be  assessed,  and  the 
measures  to  reduce  that  risk  to  an  acceptable  level  shall  be  adopted,  in  accordance 
with the principles set out in Section 2 of Annex II on principles for the management 
of the risks of pests. 

On  duly  justified  imperative  grounds  of  urgency  to  address  a  serious  phytosanitary 
risk,  the  Commission  shall  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 99(4). 

3. 

4. 

A plant, plant product or other object listed in the implementing act provided for in 
paragraph 1 may only be introduced into, or moved within, the respective protected 
zone if the special requirements for protected zones are fulfilled. 

Member States shall notify, through the electronic notification system referred to in 
Article 97, the Commission and other Member States where plants, plant products or 
other  objects  have  been  introduced  into,  or  moved  within,  the  protected  zone 
concerned, in violation of the measures adopted pursuant to this Article. 

Where  applicable,  the  third  country  from  which  the  plants,  plant  products  or  other 
objects were introduced into the Union territory shall also be notified. 

Article 51 
Information to be provided to travellers, clients of postal services and internet clients as 
regards protected zones 

Article 43 concerning information to be provided to travellers, clients of postal services and 
internet  clients  shall  apply  accordingly  as  regards  the  introduction  of  plants,  plant  products 
and other objects from third countries into protected zones. 

Article 52 
Exception from prohibitions and requirements for frontier zones as regards protected 
zones 

Article  44  concerning  the  exceptions  from  prohibitions  and  requirements  for  frontier  zones 
shall  apply  as  regards  the  plants,  plant  products  and  other  objects  listed  pursuant  to  Article 
49(1) and (2) and Article 50(1) and (2) with regard to protected zones bordering third country 
frontier zones. 

Article 53 
Exception from prohibitions and requirements for phytosanitary transit as regards 
protected zones 

Article  45  concerning  the  exceptions  from  prohibitions  and  requirements  for  phytosanitary 
transit  shall  apply  accordingly  as  regards  the  plants,  plant  products  and  other  objects  listed 
pursuant to Article 49(1) and (2) and Article 50(1) and (2) with regard to phytosanitary transit 
through protected zones. 

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Article 54 
Plants, plant products and other objects used for scientific purposes, trials, varietal 
selection, breeding and exhibitions as regards protected zones 

By way of derogation from the prohibitions and requirements provided for in Articles 49(3) 
and 50(3), Article 46 shall apply as regards the plants, plant products and other objects listed 
pursuant to Article 49(1) and (2) and Article 50(1) and (2) with regard to the introduction into 
and the movement within protected zones of plants, plant products and other objects used for 
scientific purposes, trials, varietal selection, breeding and exhibitions. 

SECTION 3 
OTHER MEASURES CONCERNING PLANTS, PLANT PRODUCTS AND OTHER OBJECTS 

Article 55 
General requirements for packaging and vehicles 

1. 

2. 

Packaging material used for plants, plant products or other objects, referred to in the 
implementing acts adopted pursuant to Articles 27(1) and (2), 29(1) and (2), 40(1), 
41(1) and (2), 47(1), 49(1) and 50(1) and moving into or within the Union territory, 
shall be free from Union quarantine pests.  

The  same  shall  apply  to  vehicles  transporting  such  plants,  plant  products  and  other 
objects. 

The  packaging  material  referred  to  in  paragraph  1,  other  than  wood  packaging 
material, shall cover the plants, plant products and other objects concerned in such a 
way that, during their movement into or within the Union territory, there is no risk of 
spreading of Union quarantine pests. 

The vehicles referred to in paragraph 1 shall, as appropriate, be covered or closed in 
such a way that, during their movement into or within the Union territory, there is no 
risk of spreading of Union quarantine pests. 

3. 

Paragraphs  1  and  2  shall  apply  to  protected  zones  also  as  regards  the  respective 
protected zone quarantine pests. 

Article 56 
Designation of quarantine stations 

1. 

Member States shall designate in their territory quarantine stations for plants, plant 
products,  other  objects  and  pests,  or  authorise  the  use  of  designated  quarantine 
stations in other Member States, provided that those stations fulfil the requirements 
set out in paragraph 2. 

The  competent  authority  may,  in  addition,  on  request,  designate  a  facility  as  a 
quarantine station provided that it fulfils the requirements set out in paragraph 2. 

2. 

Quarantine stations shall meet the following conditions: 

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(a) 

they provide physical isolation of the plants, plant products and other objects to 
be  kept  in  quarantine  and  ensure  they  cannot  be  accessed  or  removed  from 
those stations without consent of the competent authority; 

(b)  where the activities carried out in the quarantine stations concern plants, plant 
products  or  other  objects,  they  provide  suitable  growing  or  incubation 
conditions conducive for the development on those plants, plant products and 
other objects of signs and symptoms of quarantine pests; 

(c) 

(d) 

(e) 

(f) 

they  have  surfaces  of  smooth  and  impervious  material  allowing  effective 
cleaning and decontamination; 

they have surfaces resistant to deterioration and to attack by insects and other 
arthropods; 

they  have  irrigation,  sewage  and  ventilation  systems  which  exclude  the 
transmission or escaping of quarantine pests; 

they have systems for sterilisation, decontamination or destruction of infested 
plants, plant products and other objects, waste and equipment before removal 
from the stations; 

(g) 

they provide for protective clothing and shoe covering; 

(h) 

they  have,  if  appropriate,  systems  for  de-contamination  of  personnel  and 
visitors upon exit of the station; 

(i) 

(j) 

a definition of the tasks of those stations, and the conditions under which they 
shall carry out those tasks, is available; 

a sufficient number of suitably qualified, trained and experienced personnel is 
available. 

Member States shall communicate a list of the designated quarantine stations in their 
territory to the Commission and the other Member States upon request. 

Article 57 
Operation of quarantine stations 

The  person  responsible  for  the  quarantine  station  shall  monitor  that  station  and  the 
immediate vicinity of that station for the presence of quarantine pests. 

Where such a pest is found to be present, the person responsible for the quarantine 
station  concerned  shall  take  the  appropriate  action.  It  shall  notify  the  competent 
authority of that presence and of that action. 

The  person  responsible  for  the  quarantine  station  shall  ensure  that  personnel  and 
visitors  wear  protective  clothing  and  shoe  covering  and,  where  appropriate,  are 
subject to decontamination upon leaving that station. 

The person responsible for the quarantine station shall keep records on the following 
points: 

3. 

1. 

2. 

3. 

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(a) 

the personnel employed; 

(b) 

the visitors accessing the station; 

(c) 

the plants, plant products and other objects entering and leaving the station; 

(d) 

the place of origin of such plants, plant products and other objects; 

(e)  observations  concerning  the  presence  of  pests  on  such  plants,  plant  products 

and other objects. 

Those records shall be kept for three years. 

Article 58 
Supervision of quarantine stations and revocation of designation 

The  competent  authority  shall  organise  audits  or  inspections  of  the  quarantine 
stations,  at  least  one  per  year,  to  verify  whether  those  stations  meet  the  conditions 
referred to in Article 56(2) and Article 57. 

The  competent  authority  shall  revoke  the  designation  referred  to  in  Article  56(1) 
without delay where: 

(a) 

(b) 

following an audit or inspection, it appears that that quarantine station fails to 
fulfil the conditions referred to in Article 56(2) or Article 57; 

the person responsible for that quarantine station fails to take appropriate and 
timely remedial action. 

Article 59 
Release of plants, plant products and other objects from quarantine stations 

Plants, plant products and other objects shall only leave the quarantine stations, upon 
authorisation by the competent authorities, if it is confirmed that they are free from 
Union quarantine pests, or, where applicable, protected zone quarantine pests. 

Competent  authorities  may  authorise  the  movement  of  plants,  plant  products  and 
other objects from the quarantine stations to other quarantine stations or to any other 
locations  only  if  measures  are  taken  to  ensure  that  no  Union  quarantine  pests,  or, 
where applicable, protected zone quarantine pests, are spread in the area concerned. 

Article 60 
Movement out of the Union territory 

Where  the  movement  of  a  plant,  plant  product  or  other  object  out  of  the  Union  is 
governed  by  a  phytosanitary  agreement  with  a  third  country,  that  movement  shall 
comply with that agreement. 

Where the movement of a plant, plant product or other object out of the Union is not 
governed  by  a  phytosanitary  agreement  with  a  third  country,  that  movement  shall 

1. 

2. 

1. 

2. 

1. 

2. 

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take place in accordance with the phytosanitary rules of the third country into which 
that plant, plant product or other object is to be moved. 

3. 

Where  the  movement  of  a  plant,  plant  product  or  other  object  out  of  the  Union  is 
neither  governed  by  a  phytosanitary  agreement  with  a  third  country  nor  by  the 
phytosanitary rules of the third country into which that plant, plant product or other 
object is to be moved, the requirements for movement of plants, plant products and 
other  objects  within  the  Union  territory,  as  set  out  in  the  list  referred  to  in  Article 
41(1) and (2), shall apply.  

Those requirements shall, however, not apply where they concern a pest that fulfils 
either of the following conditions: 

(a) 

(b) 

it  is  recognised  by  that  third  country  as  being  present  in  its  territory  and  not 
under official control; 

it can be reasonably assumed that it does not qualify as a quarantine pest with 
respect to the territory of that third country. 

Chapter V 
Registration of professional operators and traceability 

Article 61 
Official register of professional operators 

1. 

The competent authority shall keep and update a register containing the professional 
operators  who  carry  out  the  activities,  listed  in  the  second  subparagraph,  in  the 
territory  of  the  Member  State  concerned,  and  are  covered  by  one  of  the  following 
points:  

(a) 

they are professional operators whose activities concern plants, plant products 
or other objects covered by an implementing act provided for in Articles 27(1), 
(2) or (3), 29(1), (2) or (3), 40(1), 41(1) or (2), 47(1), 49(1) or 50(1), or subject 
to the provisions of Articles 43(1) or (2), 44(1), 45(1), 51, 52 or 53;  

(b) 

they  are  professional  operators  within  the  meaning  of  Article  3(6)  of 
Regulation  (EU)  No  …/….  [Office  of  Publications,  please  insert  number  of 
Regulation on plant reproductive material law]. 

This paragraph shall apply as regards the following activities: 

(a)  planting; 

(b)  growing; 

(c)  production; 

(d) 

introduction into the Union territory; 

(e)  movement within the Union territory; 

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2. 

3. 

(f)  movement out of the Union territory; 

(g)  producing  and/or  making  available  on  the  market  in  the  meaning  of  Article 
3(5)  of  Regulation  (EU)  No  …/….  [Office  of  Publications,  please  insert 
number of Regulation on plant reproductive material law]; 

(h) 

sales through distance contracts. 

That  register  shall  be  referred  to  as  'the  register'.  Professional  operators  registered 
pursuant  to  points  (a)  and  (b)  of  the  first  subparagraph  shall  be  referred  to  as 
'registered operators'. 

A  professional  operator  may  be  registered  in  the  register  of  a  competent  authority 
more  than  once,  provided  that  each  registration  is  linked  to  different  premises, 
collective warehouses and dispatching centres as referred to in Article 62(2)(d). For 
each of those registrations, the procedure of Article 62 shall apply. 

Paragraph 1 shall not apply to a professional operator covered by one or more of the 
following points: 

(a) 

(b) 

it  supplies  exclusively  small,  as  appropriate  to  the  plants,  plant  products  and 
other  objects concerned,  quantities of plants, plant products and other objects 
to final users, by other means than sales through distance contracts; 

its  professional  activity  concerning  plants,  plant  products  and  other  objects  is 
limited to transporting such plants, plant products or other objects for another 
professional operator; 

(c) 

its  professional  activity  exclusively  concerns  the  transport  of  objects  of  all 
kinds using wood packaging material. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, setting out one or more of the following:  

(a) 

further  categories  of  professional  operators  to  be  exempted  from  the 
application  of  paragraph  1,  where  that  registration  would  constitute  a 
disproportionate administrative burden for them compared to the phytosanitary 
risk of their professional activities;  

(b)  particular requirements for the registration of certain categories of professional 

operators; 

(c) 

the maximum figure for small quantities of particular plants, plant products or 
other objects as referred to in point (a) of the first subparagraph. 

Article 62 
Procedure of registration 

1. 

Professional  operators  falling  within  the  scope  of  points  (a)  or  (b)  of  the  first 
subparagraph  of  Article  61(1)  shall  submit  an  application  to  the  competent 
authorities for inclusion in the register. 

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2. 

That application shall include the following elements: 

(a)  name, address and contact details of the professional operator; 

(b) 

a  statement  concerning  the  intention  of  the  professional  operator  to  exercise 
each  of  the  activities  referred  to  in  Article  61(1)  concerning  plants,  plant 
products and other objects; 

(c) 

a  statement  concerning  the  intention  of  the  professional  operator  to  carry  out 
each of the following activities: 

(i) 

issuing  of  plant  passports  for  plants,  plant  products  and  other  objects, 
pursuant to Article 79(1); 

(ii)  placing  of  the  mark  on  wood  packaging  material,  referred  to  in  Article 

91(1); 

(iii) 

issuing of any other attestation, as referred to in Article 93(1); 

(iv) 

issuing  of  official  labels  for  plant  reproductive  material,  pursuant  to 
Article 19 of Regulation (EU) No …/…. [Office of Publications, please 
insert number of Regulation on plant reproductive material]; 

(d) 

address of the premises, collective warehouses and dispatching centres used by 
the  professional  operator  in  the  Member  State  concerned  to  carry  out  the 
activities referred to in Article 61(1) for the purpose of the registration; 

(e) 

the genera and species of the plants and plant products, and, where appropriate, 
nature of other objects, concerned by the activities of the professional operator. 

The competent authorities shall register a professional operator where the application 
for registration contains the elements of paragraph 2. 

Registered professional operators shall, where appropriate, submit an application for 
updating  the  data  referred  to  in  points  (a),  (d)  and  (e)  of  paragraph  2,  and  the 
statements referred to in points (b) and (c) of paragraph 2. 

Where the competent authority becomes aware that the registered operator does not 
carry out any more the activities of Article 61(1), or that the registered operator has 
submitted an application no longer complying with the requirements of paragraph 2, 
it  shall  request  that  operator  to  comply  with  those  requirements  immediately  or 
within a specified period of time. 

In case the registered operator does not comply with those requirements within the 
period of time set by the competent authority, the competent authority shall revoke 
the registration of that operator. 

Article 63 
Content of the register 

3. 

4. 

5. 

The register shall contain the elements set out in points (a), (b), (d) and (e) of Article 62(2) 
and the following elements:  

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(a) 

(b) 

(c) 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

31 

the official registration number;  

the two-letter code indicated in norm ISO 3166-1-alpha-231 for the Member State in 
which the professional operator is registered; 

an indication whether the professional operator is authorised for each of the activities 
referred to in point (c) of Article 62(2). 

Article 64 
Availability of information of official registers 

The  Member  State  keeping  the  register  shall,  on  request,  make  the  information  it 
contains available to the other Member States or the Commission.  

The  Member  State  keeping  the  register  shall  make  available,  on  request,  the 
information  referred  to  in  Article  63,  with  the  exception  of  points  (d)  and  (e)  of 
Article 62(2), to any professional operator. 

Article 65 
Traceability 

A professional operator to which plants, plant products or other objects are supplied 
that are subject to prohibitions, requirements or conditions pursuant to Articles 40(1), 
41(1) and (2), 44(1) and (3), 45(1), 46(1) and (3), 47(1), 49(1) and (2), 50(1) and (2), 
52,  53  and  54  shall  keep  a  record  for  each  plant,  plant  product  or  other  object 
supplied, allowing that operator to identify the professional operators supplying it. 

A  professional  operator  supplying  plants,  plant  products  or  other  objects  that  are 
subject to prohibitions, requirements or conditions pursuant to Articles 40(1), 41(1) 
and (2), 44(1) and (3), 45(1), 46(1) and (3), 47(1), 49(1) and (2), 50(1) and (2), 52, 
53 and 54 shall keep a record allowing that professional operator to identify, for each 
plant,  plant  product  or  other  object  it  supplied,  the  professional  operators  whom  it 
was supplied. 

Professional  operators  shall  keep  the  records  referred  to  in  paragraphs  1  and  2  for 
three years from the date on which the plant, plant product or other object concerned 
was supplied to or by them. 

On  request,  they  shall  communicate  the  information  in  the  records  referred  to  in 
paragraphs 1 and 2 to the competent authorities. 

Paragraphs 1 to 4 shall not apply to the professional operators referred to in point (b) 
of Article 61(3). 

ISO 3166-1:2006, Codes for the representation of names  of countries and their subdivisions – Part 1: 
Country codes. International Organisation for Standardization, Geneva. 

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Article 66 
Movements of plants, plant products and other objects within the premises of the 
professional operator 

Professional  operators  shall  have  in  place  traceability  systems  and  procedures  to 
allow  identification  of  the  movements  of  their  plants,  plant  products  and  other 
objects within their own premises. 

The  first  subparagraph  shall  not  apply  to  the  professional  operators  referred  to  in 
point (b) of Article 61(3). 

The information, as identified by the systems and procedures referred to in paragraph 
1,  on  the  movement  of  the  plants,  plant  products  and  other  objects  within  those 
premises shall be made available to the competent authority on request. 

Chapter VI 
Certification of plants, plant products and other objects 

SECTION 1 
PHYTOSANITARY CERTIFICATES REQUIRED FOR THE INTRODUCTION OF PLANTS, PLANT 
PRODUCTS AND OTHER OBJECTS INTO THE UNION TERRITORY 

Article 67 
Phytosanitary certificate for introduction into the Union territory 

A phytosanitary certificate for introduction of plants, plant products and other objects 
into the Union territory shall be a document, issued by a third country, which fulfils 
the conditions of Article 71, has the contents set out in Part A of Annex V, or, where 
applicable,  Part  B  of  Annex  V,  and  certifies  that  the  plant,  plant  product  or  other 
object concerned complies with all of the following requirements: 

(a) 

it is free from Union quarantine pests;  

(b) 

it  complies  with  the  provisions  of  Article  37(1)  concerning  the  presence  of 
Union quality pests on plants for planting; 

(c) 

it complies with the requirements referred to in Article 41(1) and (2); 

(d)  where  applicable,  it  complies  with  rules  adopted  in  accordance  with  the 

provisions adopted pursuant to Article 27(1) and (2) and Article 29(1). 

Where  applicable,  the  phytosanitary  certificate  shall  specify  under  the  heading 
'Additional  Declaration',  and  in  accordance  with  the  implementing  acts  adopted 
pursuant to Articles 41(1) and (2) and 50(1) and (2), which specific requirement is 
fulfilled,  where  there  is  a  choice  between  several  options.  This  specification  shall 
include a reference to the relevant option provided in those acts. 

Where  applicable,  the  phytosanitary  certificate  shall  state  that  the  plants,  plant 
products or other objects concerned comply with phytosanitary measures recognised 

1. 

2. 

1. 

2. 

3. 

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4. 

1. 

as  equivalent,  pursuant  to  Article  42,  to  the  requirements  of  the  implementing  act 
adopted pursuant to Article 41(2). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, amending Parts A and B of Annex V to adapt them to the scientific and 
technical developments and the development of international standards. 

Article 68 
Plants, plant products and other objects for which phytosanitary certificates are 
required 

The  Commission  shall,  by  means  of  an  implementing  act,  establish  a  list  of  the 
plants, plant products and other objects, and the respective third countries of origin or 
dispatch,  for  which  a  phytosanitary  certificate  is  required  for  introduction  into  the 
Union territory. 

That list shall include: 

(a) 

the plants, plant products and other objects listed in Point I of Part B of Annex 
V to Directive 2000/29/EC; 

(b)  plants,  plant  products  and  other  objects  for  which  requirements  have  been 
adopted pursuant to Articles 27(1) and 29(1) concerning their introduction into 
the Union territory; 

(c) 

seeds listed pursuant to Article 37(2); 

(d)  plants,  plant  products  and  other  objects  listed  pursuant  to  Articles  41(1)  and 

(2). 

Points (a) to (d) shall not apply, however, where the act adopted pursuant to Articles 
27(1), 29(1) or 41(1) and (2) requires proof of compliance in the form of an official 
mark, as referred to in Article 91(1), or another official attestation, as referred to in 
Article 93(1). 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2). 

2. 

The Commission shall, by means of an implementing act, amend the implementing 
act referred to in paragraph 1, in the following cases: 

(a)  where  a  plant,  plant  product  or  other  object,  listed  in  that  implementing  act, 

does not fulfil paragraph 1(b), (c) or (d); 

(b)  where  a  plant,  plant  product  or  other  object,  not  listed  in  that  act,  fulfils 

paragraph 1(b), (c) or (d). 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2). 

3. 

The  Commission  may,  by  means  of  an  implementing  act,  amend  the  implementing 
act referred to in paragraph 1, in accordance with the principles set out in Section 2 

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4. 

1. 

of  Annex  IV,  where  there  is  a  risk  that  a  plant,  plant  product  or  other  object,  not 
listed in that act, hosts a Union quarantine pest, or where, for a plant, plant product or 
other object listed in that act, that risk no longer exists. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 99(3). 

By way of derogation from paragraphs 1, 2 and 3, no phytosanitary certificate shall 
be  required  for  the  plants,  plant  products  or  other  objects,  which  are  subject  to 
Articles 44, 45, 46 and 70. 

Article 69 
Plants, plant products and other objects for which phytosanitary certificates are 
required for introduction into a protected zone 

The  Commission  shall,  by  means  of  an  implementing  act,  establish  a  list  of  the 
plants, plant products and other objects, and the respective third countries of origin or 
dispatch,  for  which  a  phytosanitary  certificate  is  required,  in  addition  to  the  cases 
referred to in Article 68 (1), (2) and (3), for their introduction into certain protected 
zones from those third countries. 

That list shall include: 

(a) 

the plants, plant products and other objects listed in Point II of Part B of Annex 
V to Directive 2000/29/EC; 

(b)  plants, plant products and other objects listed pursuant to Article 50(1) or (2). 

Points (a) and (b) shall not apply, however, where the act adopted pursuant to Article 
50(1) or (2) requires proof of compliance in the form of an official mark, as referred 
to in Article 91(1), or another official attestation, as referred to in Article 93(1). 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2).  

2. 

The Commission shall, by means of an implementing act, amend the implementing 
act referred to in paragraph 1, in the following cases: 

(a)  where  a  plant,  plant  product  or  other  object,  listed  in  that  implementing  act, 

does not fulfil paragraph 1(b); 

(b)  where  a  plant,  plant  product  or  other  object,  not  listed  in  that  act,  fulfils 

paragraph 1(b). 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2). 

3. 

The  Commission  may,  by  means  of  an  implementing  act,  amend  the  implementing 
act referred to in paragraph 1, in accordance with the principles set out in Section 2 
of  Annex  IV,  where  there  is  a  risk  that  a  plant,  plant  product  or  other  object,  not 

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4. 

1. 

2. 

listed in that act, hosts the respective protected zone quarantine pest, or where, for a 
plant, plant product or other object listed in that act, that risk no longer exists. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 99(3). 

By way of derogation from paragraphs 1, 2 and 3, no phytosanitary certificate shall 
be  required  for  the  plants,  plant  products  or  other  objects,  which  are  subject  to 
Articles 52, 53, 54 and 70. 

Article 70 
Exceptions for travellers' luggage, clients of postal services and internet clients 

Small  quantities  of  particular  plants,  plant  products  and  other  objects  from  a  third 
country may be exempted from the requirement for a phytosanitary certificate set out 
in  Article  68(1)  and  Article  69(1),  if  they  comply  with  all  of  the  following 
conditions: 

(a) 

they  are  introduced  into  the  Union  territory  as  part  of  travellers'  personal 
luggage, as consignments shipped following sales through distance contracts to 
final  users  (hereinafter:  'internet  clients'),  or  as  shipments  delivered  by  postal 
services to final users; 

(b) 

they are not to be used for professional or commercial purposes; 

(c) 

they are listed pursuant to paragraph 2. 

That exemption shall not apply to plants for planting, other than seeds. 

The Commission shall, by means of implementing acts, list the plants, plant products 
and other objects referred to in paragraph 1 and the third countries concerned, and set 
out  the  maximum  quantity,  as  appropriate,  of  the  plants,  plant  products  and  other 
objects concerned that shall be subject to the exemption of that paragraph and, where 
appropriate,  one  or  more  of  the  risk  management  measures  set  out  in  Section  1  of 
Annex IV. 

That  listing  and  the  setting  out  of  the  maximum  quantity  concerned  and,  where 
appropriate,  the  risk  management  measures  shall  be  decided  on  the  basis  of  the 
phytosanitary risk posed by small quantities of those plants, plant products and other 
objects, in accordance with the criteria set out in Section 2 of Annex IV. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 99(3) of this Regulation. 

Article 71 
Conditions to be fulfilled by a phytosanitary certificate 

1. 

The competent authority shall only accept a phytosanitary certificate accompanying 
plants,  plant  products  or  other  objects  to  be  introduced  from  a  third  country,  if  the 
content of that certificate complies with Part A of Annex V. Where the plants, plant 

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products or other objects are to be introduced from a third country from which they 
do not originate, the competent authority shall only accept a phytosanitary certificate 
complying with Part B of Annex V. 

It  shall  not  accept  that  phytosanitary  certificate  where  the  additional  declaration 
referred to in Article 67(2), where applicable, is not present or not correct, and where 
the statement referred to in Article 67(3), where applicable, is not present. 

2. 

The competent authority shall only accept a phytosanitary certificate if it fulfils the 
following requirements: 

(a) 

it is issued in at least one of the official languages of the Union; 

(b) 

it is addressed to the Union or one of its Member States; 

(c) 

it has been issued no more than 14 days before the date on which the plants, 
plant  products  or  other  objects  covered  by  it  have  left  the  third  country,  in 
which it was issued. 

In  the  case  of  a  third  country  which  is  party  to  the  IPPC,  the  competent  authority 
shall  only  accept  the  phytosanitary  certificates  issued  by  the  official  national  plant 
protection organisation of that third country or, under its responsibility, by a public 
officer who is technically qualified and duly authorised by that official national plant 
protection organisation. 

In the case of a third country which is not party to the IPPC, the competent authority 
shall only accept the phytosanitary certificates issued by the authorities competent in 
accordance  with  the  national  rules  of  that  third  country  and  notified  to  the 
Commission.  The  Commission  shall  inform  the  Member  States  and  the  operators, 
through the electronic notification system referred to in Article 97, pursuant to point 
(a) of Article 131 of the Regulation (EU) No …/…. [Office of Publications, please 
insert number of Regulation on Official Controls], of the notifications received. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  supplementing  the  conditions  for  acceptance  referred  to  in  the  first 
subparagraph, to ensure the reliability of those certificates. 

Electronic phytosanitary certificates shall only be accepted when provided through, 
or  in  electronic  exchange  with,  the  computerised  information  management  system 
referred  to  in  Article  130  of  Regulation  (EU)  No  …/….  [Office  of  Publications, 
please insert number of Regulation on Official Controls]. 

Article 72 
Invalidation of phytosanitary certificate 

Where a phytosanitary certificate has been issued in accordance with Article 67(1), 
(2)  and  (3),  and  the  competent  authority  concerned  concludes  that  the  conditions 
referred  to  in  Article  71  are  not  fulfilled,  it  shall  invalidate  that  phytosanitary 
certificate  and  ensure  that  it  does  not  accompany  any  longer  those  plants,  plant 
products or other objects concerned. In that case, and in respect of the plants, plant 
products  or  other  objects  concerned,  the  competent  authority  shall  take  one  of  the 

3. 

4. 

5. 

1. 

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measures  as  set  out  in  Article  64(3)  of  Regulation  (EU)  No  …/….  [Office  of 
Publications, please insert number of Regulation on Official Controls]. 

2. 

Member States shall notify, through the electronic notification system referred to in 
Article  97,  the  Commission  and  other  Member  States  where  a  phytosanitary 
certificate was invalidated pursuant to paragraph 1. 

The  third  country  which  had  issued  that  phytosanitary  certificate  shall  also  be 
notified. 

SECTION 2 
PLANT PASSPORTS REQUIRED FOR THE MOVEMENT OF PLANTS, PLANT PRODUCTS  
AND OTHER OBJECTS WITHIN THE UNION TERRITORY 

Article 73 
Plant passports 

A  plant  passport  shall  be  an  official  label  for  movement  of  plants,  plant  products  and  other 
objects  within  the  Union  territory  and,  where  applicable,  into  and  within  protected  zones, 
which certifies compliance with all requirements set out in Article 80 and, for movement into 
protected zones, Article 81, and has the content and format set out in Article 78. 

Article 74 
Plants, plant products and other objects for which a plant passport is required for 
movement within the Union territory 

1. 

The  Commission  shall,  by  means  of  an  implementing  act,  establish  a  list  of  the 
plants,  plant  products  and  other  objects,  for  which  a  plant  passport  is  required  for 
their movement within the Union territory. 

That list shall include: 

(a) 

all plants for planting, other than seeds; 

(b) 

the  plants,  plant  products  and  other  objects  listed  in  point  (I)  of  Part  (A)  of 
Annex V to Directive 2000/29/EC; 

(c)  plants,  plant  products  and  other  objects  for  which  requirements  have  been 
adopted  pursuant  to  Article  27(1),  (2)  or  (3)  or  29(1),  (2)  or  (3)  concerning 
their movement within the Union territory; 

(d) 

seeds listed pursuant to Article 37(2); 

(e)  plants, plant products and other objects listed pursuant to Article 41(1) and (2). 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2).  

2. 

The Commission shall, by means of an implementing act, amend the implementing 
act referred to in paragraph 1, in the following cases:  

EN 

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3. 

4. 

1. 

(a)  where  a  plant,  plant  product  or  other  object,  not  listed  in  that  act,  fulfils 

paragraphs 1(c), (d) or (e); 

(b)  where  a  plant,  plant  product  or  other  object  ,  listed  in  that  implementing  act, 

does not fulfil paragraph 1(c), (d) or (e); 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(3). 

The  Commission  may,  by  means  of  an  implementing  act,  amend  the  implementing 
act  referred  to  in  paragraph  1,  in  accordance  with  the  principles  of  Section  2  of 
Annex IV, where there is a risk that a plant, plant product or other object, not listed 
in that act, hosts a Union quarantine pest or where, for a plant, plant product or other 
object listed in that act, that risk no longer exists. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 99(3). 

By way of derogation from paragraphs 1, 2 and 3, no plant passport shall be required 
for the plants, plant products or other objects, which are subject to Articles 44, 45, 46 
and 70. 

Article 75 
Plants, plant products and other objects for which a plant passport is required for 
introduction into, and movement within, protected zones 

The  Commission  shall,  by  means  of  an  implementing  act,  establish  a  list  of  the 
plants,  plant  products  and  other  objects,  for  which  a  plant  passport  is  required  for 
their introduction into certain protected zones. 

That list shall include: 

(a) 

the  plants,  plant  products  and  other  objects  listed  in  point  (II)  of  Part  A  of 
Annex V to Directive 2000/29/EC; 

(b)  other plants, plant products and other objects listed pursuant to Article 50(2). 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2). 

2. 

The  Commission  may,  by  means  of  an  implementing  act,  amend  the  implementing 
act referred to in paragraph 1, in the following cases:  

(a)  where  a  plant,  plant  product  or  other  object,  not  listed  in  that  act,  fulfils 

paragraph 1(b); 

(b)  where  a  plant,  plant  product  or  other  object  ,  listed  in  that  implementing  act, 

does not fulfil paragraph 1(a) or (b). 

That  implementing  act  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 99(2). 

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76 

   EN 

3. 

4. 

The  Commission  may,  by  means  of  an  implementing  act,  amend  the  implementing 
act referred to in paragraph 1, and in accordance with the principles of Section 2 of 
Annex IV, where there is a risk that a plant, plant product or other object, not listed 
in that act, hosts the respective protected zone quarantine pest, or where, for a plant, 
plant product or other object listed in that act, that risk no longer exists. 

That  implementing  act  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 99(3). 

By way of derogation from paragraphs 1, 2 and 3, no plant passport shall be required 
for the plants, plant products or other objects, which are subject to Articles 52, 53, 54 
and 70. 

Article 76 
Exception for final users 

No plant passport shall be required for the movement of small, as appropriate to the plants, 
plant  products  and  other  objects  concerned,  quantities  of  plants,  plant  products  or  other 
objects to a final user. 

The Commission shall be empowered to adopt delegated acts, in accordance with Article 98, 
setting  out  the  maximum  figure  for  small  quantities  of  particular  plants,  plant  products  or 
other objects. 

Article 77 
Exceptions for movements within and between the premises of a professional operator 

No  plant  passport  shall  be  required  for  the  movements  of  plants,  plant  products  and  other 
objects within and between the premises of the same professional operator. 

Article 78 
Content and format of the plant passport 

1. 

2. 

3. 

The plant passport shall take the form of a distinct label, which shall be printed on 
any  suitable  substrate,  provided  that  the  plant  passport  is  kept  separate  from  any 
other information or label which may also be indicated on that substrate. 

The plant passport shall be clearly legible and indelible. 

The  plant  passport  for  movement  within  the  Union  territory  shall  contain  the 
elements set out in Part A of Annex VI. 

The plant passport for introduction into, and movement within, a protected zone shall 
contain the elements set out in Part B of Annex VI. 

In the case of plants for planting produced, or made available on the market, in the 
meaning of Article 3(5) of Regulation (EU) No …/…. [Office of Publications, please 
insert number of Regulation on plant reproductive material law], as pre-basic, basic 
or  certified  material  in  the  meaning  of  Article  10  of  that  Regulation,  the  plant 
passport  shall  be  included,  in  a  distinct  form,  in  the  official  label  produced  in 

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77 

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accordance  with  Article  22  of  that  Regulation,  or,  where  applicable,  in  the  master 
certificate issued in accordance with Article 122(1) of that Regulation. 

Where  this  paragraph  applies,  the  plant  passport  for  movement  within  the  Union 
territory shall contain the elements set out in Part C of Annex VI. 

Where this paragraph applies, the plant passport for introduction into, and movement 
within, a protected zone shall contain the elements set out in Part D of Annex VI. 

The Commission shall be empowered to adopt, pursuant to Article 98, delegated acts 
amending  Parts  A,  B,  C  and  D  of  Annex  VI,  to  adapt  those  elements,  where 
applicable, to scientific and technical developments. 

Within one year from the entry into force of this Regulation, the Commission shall 
adopt, by means of implementing acts, the format specifications of the plant passport 
for movement within the Union territory and the plant passport for introduction into, 
and movement within, a protected zone, as regards the plant passports referred to in 
the  first  and  second  subparagraphs  of  paragraph  2  and  in  the  second  and  third 
subparagraphs  of  paragraph  3.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 99(3). 

Where  the  nature  of  particular  plants,  plant  products  or  other  objects  so  requires, 
specific size specifications may be set out for them. 

Article 79 
Issuance by authorised professional operators and competent authorities 

Plant passports shall be issued by registered operators, authorised, in accordance with 
Article  84,  by  the  competent  authorities  to  issue  plant  passports,  hereinafter 
'authorised operators', under the supervision of the competent authorities. 

Authorised operators shall issue plant passports only for the plants, plant products or 
other objects for which they are responsible. 

Plant  passports  may,  however,  be  issued  by  the  competent  authorities  where  a 
registered operator requests so. 

Authorised  operators  shall  only  issue  plant  passports  in  the  premises,  collective 
warehouses and dispatching centres referred to in Article 62(2)(d). 

4. 

5. 

1. 

2. 

3. 

Article 80 
Substantive requirements for a plant passport for movement within the Union territory 

A  plant  passport  shall  be  issued  for  movement  within  the  Union  territory  for  a  plant,  plant 
product or other object only where it fulfils the following requirements: 

(a) 

(b) 

EN 

it is free from Union quarantine pests; 

it  complies  with  the  provisions  of  Article  37(1)  concerning  the  presence  of  Union 
quality pests on plants for planting; 

78 

   EN 

(c) 

(d) 

(e) 

it complies with the requirements referred to in Article 41(1) and (2);  

where  applicable,  it  complies  with  rules  adopted  in  accordance  with  the  provisions 
adopted pursuant to Article 27(1) and (2) and Article 29(1) and (2); and 

where applicable, it complies with measures adopted by the competent authorities for 
the  eradication  of  Union  quarantine  pests  pursuant  to  Article  16(1)  and  the 
eradication  of  pests  provisionally  qualifying  as  Union  quarantine  pests  pursuant  to 
Article 28(1). 

Article 81 
Substantive requirements for a plant passport for movement into and within a protected 
zone 

1. 

A  plant  passport  shall  be  issued  for  introduction  into,  and  movement  within,  a 
protected zone for a plant, plant product and other object only where it fulfils all of 
the requirements of Article 80, and in addition the following requirements: 

(a) 

it is free from the respective protected zone quarantine pest; and 

(b) 

it complies with the requirements referred to in Article 50(1) and (2). 

2. 

Where Article 33(2) applies, the plant passport referred to in paragraph 1 shall not be 
issued. 

Article 82 
Examinations for plant passports 

1. 

2. 

3. 

A plant passport may only be issued for plants, plant products and other objects for 
which  a  meticulous  examination  in  accordance  with  paragraphs  2,  3,  and  4  has 
shown that they fulfil the requirements of Article 80, and, where applicable, Article 
81. 

Plants,  plant  products  and  other  objects  may  either  be  examined  individually  or  by 
representative  samples.  The  examination  shall  also  cover  the  packaging  material  of 
the plants, plant products or other objects concerned. 

The examination shall be carried out by the authorised operator, or, where applicable 
under Article 79(2), by the competent authorities.  

The examination shall fulfil the following conditions: 

(a) 

(b) 

(c) 

it shall be carried out frequently, at appropriate times and taking into account 
the risks involved; 

it  shall  be  carried  out  at  the  premises,  collective  warehouses  and  dispatching 
centres referred to in Article 62(2)(d); and 

it  shall  be  made  by  visual  examination  and,  in  the  case  of  suspicion  of  the 
presence  of  a  Union  quarantine  pest  or,  in  case  of  a  protected  zone,  the 
protected zone quarantine pest concerned, by sampling and testing. 

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79 

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4. 

That  examination  shall  take  place  without  prejudice  to  any  specific  examination 
requirements or measures adopted in accordance with Article 27(1), (2) or (3), 29(1), 
(2) or (3), 41(1) and (2), and 50(1) and (2). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  setting  out  detailed  measures  concerning  visual  examination,  sampling 
and  testing,  and  the  frequency  and  timing  of  the  examinations,  referred  to  in 
paragraphs 1, 2 and 3, with regard to specific plants, plant products and other objects, 
on  the  basis  of  the  particular  phytosanitary  risks  they  may  present.  Those 
examinations shall, where appropriate, concern certain plants for planting belonging 
to the categories referred to in Article 12(1) of Regulation (EU) No …/… (Office of 
Publications,  please  insert  number  of  Regulation  on  the  production  and  making 
available on the market of plant reproductive material), and, where appropriate, shall 
be carried out for any of the elements, as appropriate, set out in Part D of Annex II to 
that Regulation.  

Where the Commission adopts such a delegated act for specific plants for planting, 
and those plants for planting are subject to certification schemes pursuant to Article 
20(1) of Regulation (EU) No …/…. [Office of Publications, please insert number of 
Regulation  on  the  production  and  making  available  on  the  market  of  plant 
reproductive  material],  the  respective  examinations  shall  be  combined  in  a  single 
certification scheme. 

When  adopting  those  delegated  acts,  the  Commission  shall  take  into  account  the 
technical and scientific knowledge and developments.  

Article 83 
Attaching of the plants passports 

Plant  passports  shall  be  attached  by  the  authorised  operators,  or,  where  so  applicable  under 
Article 79(2), by the competent authorities, to each lot of the plants, plant products and other 
objects concerned before they are moved within the Union territory pursuant to Article 74 or 
into or within a protected zone pursuant to Article 75. Where such plants, plant products or 
other objects are moved in a package, bundle or container, the plant passport shall be attached 
to that package, bundle or container. 

Article 84 
Authorisation of professional operators to issue plant passports  

1. 

The  competent  authority  shall  grant  an  authorisation  to  a  professional  operator  to 
issue  plant  passports  (hereinafter  'the  authorisation  to  issue  plant  passports')  where 
that professional operator complies with the following conditions: 

(a) 

it possesses the necessary knowledge to carry out the examinations referred to 
in Article 82 concerning the Union quarantine pests, protected zone quarantine 
pests  and  Union  quality  pests  that  could  affect  the  plants,  plant  products  and 
other  objects  concerned,  and  concerning  the  signs  of  the  presence  of  those 
pests and the symptoms caused by them, the means to prevent the presence and 
spread of those pests, and the means to eradicate them; 

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2. 

1. 

2. 

1. 

2. 

(b) 

it  has  in  place  systems  and  procedures  enabling  it  to  fulfil  its  obligations 
concerning traceability pursuant to Article 65 and 66. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  setting  out  qualification  requirements  to  be  fulfilled  by  the  professional 
operators in order for them to comply with the conditions of paragraph 1(a).  

Article 85 
Obligations of authorised operators  

Where an authorised operator intends to issue a plant passport, it shall identify and 
monitor the points of its production process, and the points concerning the movement 
of  plants,  plant  products  and  other  objects  by  that  operator,  which  are  critical  as 
regards  compliance  with  the  rules  adopted  pursuant  to  Article  27(1),  (2)  and  (3), 
Article 29(1), (2) and (3), Article 37(1), Article 41(3), Article 80 and Article 82, and, 
where applicable, Article 33(2), Article 50(3) and Article 81.  

It shall keep records concerning the identification and monitoring of those points. 

The authorised operator referred to in paragraph 1 shall provide appropriate training 
to its personnel involved in the examinations referred to in Article 82, to ensure that 
that personnel possesses the necessary knowledge to carry out those examinations. 

Article 86 
Phytosanitary risk management plans 

The  competent  authority  may  approve,  as  appropriate,  phytosanitary  risk 
management plans of authorised operators, setting out the measures implemented by 
those operators to fulfil the obligations set out in Article 85(1). 

The phytosanitary risk management plan shall cover, where appropriate in the form 
of instruction manuals, at least the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

the information required under Article 62(2) concerning the registration of the 
authorised operator; 

the  information  required  under  Article  65(3)  and  66(1)  concerning  the 
traceability of plants, plant products and other objects; 

a  description  of  the  production  processes  of  the  authorised  operator  and  its 
activities  as  regards  movement  and  sales  of  plants,  plant  products  and  other 
objects; 

an analysis of the critical points referred to in Article 85(1) and the measures 
taken by the authorised operator to mitigate the phytosanitary risks associated 
with those critical points; 

the procedures in place and actions foreseen in the case of suspicion or findings 
of  quarantine  pests,  the  recording  of  those  suspicion  or  findings  and  the 
recording of the actions taken; 

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3. 

1. 

2. 

1. 

2. 

(f) 

the  roles  and  responsibilities  of  the  personnel  involved  in  the  notifications 
referred to in Article 9(1), the examinations referred to in Article 82(1), and the 
issuance of plant passports pursuant to Article 79(1), Article 88(1) and (2) and 
Article 89; 

(g) 

the training provided to the personnel referred to in point (f). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, amending the elements referred to in paragraph 2. 

Article 87 
Withdrawal of authorisation  

Where the competent authority becomes aware that an authorised operator does not 
comply  with  Article  82(1),  (2),  (3)  or  (4)  or  Article  84(1),  or  that  a  plant,  plant 
product  or  other  object,  for  which  that  professional  operator  has  issued  a  plant 
passport,  does  not  comply  with  Article  80  or,  where  applicable,  Article  81,  that 
authority  shall  without  delay  take  the  measures  necessary  to  ensure  that  non-
compliance with those provisions does not continue. 

Where the competent authority has taken measures in accordance with paragraph 1, 
other  than  the  withdrawal  of  the  authorisation  to  issue  plant  passports,  and  non-
compliance continues, that authority shall without delay withdraw that authorisation. 

Article 88 
Replacing a plant passport 

An  authorised  operator  which  has  received  a  lot  of  plants,  plant  products  or  other 
objects, for which a plant passport has been issued, or the competent authority acting 
on  request  of  a  professional  operator,  may  issue  a  new  plant  passport  for  that  lot, 
replacing the plant passport initially issued for that lot, provided that the conditions 
of paragraph 3 are fulfilled. 

Where a lot of plants, plant products or other objects, for which a plant passport has 
been issued, is divided into two or more lots, the authorised operator responsible for 
those  new  lots,  or  the  competent  authority  acting  on  request  of  a  professional 
operator,  shall  issue  a  plant  passport  for  each  new  lot  resulting  from  the  division, 
provided that the conditions set out in paragraph 3 are fulfilled. Those plant passports 
shall replace the plant passport issued for the initial lot. 

Where  two  lots,  for  each  of  which  a  plant  passport  has  been  issued,  are  combined 
into  a  single  lot,  the  authorised  operator  responsible  for  that  new  lot,  or  the 
competent authority acting on request of a professional operator, shall issue a plant 
passport for that lot. That plant passport shall replace the plant passport issued for the 
initial lots, provided that the conditions in paragraph 3 are fulfilled. 

3. 

A  plant  passport,  as  provided  for  in  paragraphs  1  and  2,  may  only  be  issued  if  the 
following conditions are fulfilled: 

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(a) 

(b) 

the  identity  of  the  plants,  plant  products  or  other  objects  concerned  is 
guaranteed; and 

the plants, plant products or other objects concerned continue to comply with 
the requirements referred to in Articles 80 and 81. 

Where  a  plant  passport  is  issued  pursuant  to  paragraphs  1  or  2,  the  examination 
referred to in Article 82(1) shall not be required. 

Following the replacement of a plant passport referred to in paragraphs 1 and 2, the 
authorised operator concerned shall retain the replaced plant passport for three years. 

In  case  a  plant  passport  is  issued  by  the  competent  authority  to  replace  a  plant 
passport,  the  professional  operator,  on  whose  request  it  is  issued,  shall  retain  the 
replaced plant passport for three years. 

Article 89 
Plant passports replacing phytosanitary certificates  

By way of derogation from Article 82, where a plant, plant product or other object, 
introduced into the Union territory from a third country, which for movement within 
the  Union  territory  requires  a  plant  passport  pursuant  to  the  implementing  acts 
referred  to  in  Article  74(1)  and  75(1),  such  a  passport  shall  be  issued  where  the 
checks  pursuant  to  Article  47(1)  of  Regulation  (EU)  No  …/….  [Office  of 
Publications, please insert number of Regulation on Official Controls]concerning the 
introduction  of  the  respective  plant,  plant  product  or  other  object  have  been 
completed satisfactorily. 

Following the issuance of a plant passport referred to in paragraph 1, the authorised 
operator issuing that plant passport shall, where applicable, retain the phytosanitary 
certificate for three years. 

Where  point  (c)  of  Article  95(2)  applies,  that  phytosanitary  certificate  shall  be 
replaced by a certified copy of it. 

Article 90 
Obligation to remove the plant passport 

The professional operator which has under its control a lot of plants, plant products 
or  other  objects,  shall  remove  the  plant  passport  from  that  lot,  in  case  it  becomes 
aware that any of the requirements of Articles 78 to 82, 84 or 85 are not fulfilled. 

The  professional  operator  shall  invalidate  that  plant  passport  by  drawing  a  clearly 
visible and indelible diagonal red line over it. 

In  case  the  professional  operator  fails  to  comply  with  paragraph  1,  the  competent 
authorities  shall  remove  the  plant  passport  from  the  lot  concerned  and  shall 
invalidate that plant passport by drawing a clearly visible and indelible diagonal red 
line over it. 

4. 

5. 

1. 

2. 

1. 

2. 

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   EN 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

Where paragraphs 1 and 2 apply, the professional operator concerned shall retain the 
invalidated plant passport for three years. 

Where  paragraphs  1  and  2  apply,  the  professional  operator  concerned  shall  inform 
accordingly  the  authorised  operator,  or  competent  authority,  who  issued  the 
invalidated plant passport. 

Member States shall notify, through the electronic notification system referred to in 
Article  97,  the  Commission  and  other  Member  States  where  a  plant  passport  was 
removed and invalidated pursuant to paragraph 2. 

SECTION 3 
OTHER ATTESTATIONS 

Article 91 
Marking of wood packaging material 

The  mark  attesting  that  wood  packaging  material  has  been  treated  against  Union 
quarantine  pests  and  protected  zone  quarantine  pests,  in  accordance  with  a  method 
established pursuant to Article 27(1) or (2), Article 29(1) or (2), Article 41(1) or (2) 
or Article 50(1) or (2), shall contain the elements set out in Annex VII. 

The  Commission  shall  be  empowered,  in  accordance  with  Article  98,  to  adopt 
delegated  acts  amending  Annex  VII  to  adapt  that  mark  to  the  development  of 
international standards. 

The mark shall only be applied by a professional operator authorised in accordance 
with Article 92. 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format 
specifications of the mark referred to in paragraph 1. Those implementing acts shall 
be adopted in accordance with the examination procedure referred to in Article 99(3). 

Article 92 
Authorisation and supervision of professional operators applying the mark of wood 
packaging material in the Union territory 

1. 

An authorisation to apply the mark referred to in Article 91(3) shall be granted to a 
registered operator provided that it fulfils the following conditions: 

(a) 

(b) 

it  possesses  the  necessary  knowledge  to  carry  out  the  treatment  of  the  wood 
packaging material required pursuant to the acts referred to in Article 91(1); 

it  operates  appropriate  facilities  to  carry  out  that  treatment  (hereinafter: 
'treatment facilities'). 

The  Commission  shall  be  empowered,  in  accordance  with  Article  98,  to  adopt 
delegated  acts  amending  the  requirements  for  authorisation,  where  appropriate  in 
view of the development of scientific and technical knowledge. 

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The authorisation shall be granted by the competent authority on application. 

2. 

By  way  of  derogation  from  paragraph  1,  the  authorisation  referred  to  in  that 
paragraph  may  be  granted,  concerning  the  marking  of  wood  packaging  material 
entirely  composed  of  treated  wood,  where  the  registered  operator  fulfils  all  of  the 
following conditions: 

(a) 

(b) 

it  exclusively  uses  wood  from  treatment  facilities  operated  by  a  registered 
operator authorised pursuant to paragraph 1; 

it  ensures  that  the  wood  used  for  that  purpose  can  be  traced  back  to  those 
treatment facilities; 

(c)  where  applicable  pursuant  to  Articles  27(1)  and  (2),  29(1)  and  (2),  41(1)  and 
(2) and 50(1) and (2), it exclusively uses wood referred to in point (a) which is 
accompanied by a plant passport. 

The  competent  authority  shall  supervise  the  professional  operators  authorised 
pursuant  to  paragraph  1,  to  verify  and  ensure  that  they  treat  and  mark  wood 
packaging material in accordance with Article 91(1) and fulfil the conditions set out 
in paragraphs 1 and 2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, supplementing the requirements set out in this paragraph concerning the 
supervision of professional operators by the competent authority. 

Where the competent authority becomes aware that a professional operator does not 
comply with the requirements referred to in paragraphs 1, 2 or 3, that authority shall 
without delay take the measures necessary to ensure that non-compliance with those 
provisions does not continue. 

Where the competent authority has taken those measures, other than the withdrawal 
of  the  authorisation  referred  to  in  paragraph  1,  and  non-compliance  continues,  that 
authority shall without delay withdraw the authorisation referred to in paragraph 1. 

Article 93 
Attestations other than the mark of wood packaging material 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  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 as form of proof of the 
implementation of measures adopted pursuant to Article 27(1) or (2), Article 29(1) or 
(2), Article 41(1) or (2) or Article 50(1) or (2). 

3. 

4. 

1. 

2. 

Those  delegated  acts  may  also  set  out  requirements  concerning  one  or  more  of  the 
following: 

(a) 

the  authorisation  of  professional  operators  as  regards  the  issuance  of  the 
official attestations referred to in paragraph 1; 

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(b) 

the  supervision  by  the  competent  authority  of  the  professional  operators 
authorised pursuant to point (a); 

(c) 

the withdrawal of that authorisation referred to in point (a). 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format 
specifications of the attestations referred to in paragraph 1. Those implementing acts 
shall be adopted in accordance with the examination procedure referred to in Article 
99(3). 

SECTION 4 
EXPORT OF PLANTS, PLANT PRODUCTS AND OTHER OBJECTS FROM THE UNION TERRITORY 

Article 94 
Phytosanitary certificate for export  

Where for the export of a plant, plant product or other object from the Union territory 
to  a  third  country,  a  phytosanitary  certificate  is  required  by  the  rules  of  that  third 
country  (hereinafter:  'phytosanitary  certificate  for  export'),  that  certificate  shall  be 
issued by the competent authority, at the request of the professional operator which 
has under its control the plant, plant product or other object to be exported. 

The phytosanitary certificate for export shall be issued provided that the information 
available  is  sufficient  to  certify  compliance  with  the  requirements  of  the  third 
country  concerned.  That  information  may  originate,  where  applicable,  from  one  or 
more of the following elements: 

(a) 

(b) 

a  plant  passport,  as  referred  to  in  Article  73,  accompanying  the  plant,  plant 
product or other object concerned; 

the  mark  of  wood  packaging  material  as  referred  to  in  Article  91(1),  or  the 
attestation referred to in Article 93(1); 

(c) 

the information included in the pre-export certificate referred to in Article 96; 

(d)  official  information  included  in  the  phytosanitary  certificate  as  referred  to  in 
Article 67, where the plant, plant products or other object concerned has been 
introduced into the Union territory from a third country; 

(e)  official  inspections,  sampling  and  testing  of  the  plant,  plant  product  or  other 

object concerned. 

The phytosanitary certificate for export shall contain the elements set out in Part A of 
Annex VIII. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  amending  Part  A  of  Annex  VIII  to  adapt  it  to  scientific  and  technical 
developments and the development of international standards. 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format 
specifications  of  the  phytosanitary  certificate  as  referred  to  in  paragraph  1.  Those 

3. 

1. 

2. 

3. 

4. 

5. 

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6. 

1. 

implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 99(3). 

Electronic  phytosanitary  certificates  for  export  shall  only  be  valid  when  provided 
through, or in electronic exchange with, the computerised information management 
system  referred  to  in  Article  130  of  Regulation  (EU)  No  …/….  [Office  of 
Publications, please insert number of Regulation on Official Controls]. 

Article 95 
Phytosanitary certificate for re-export 

Where  a  plant,  plant  product  or  other  object  originates  in  a  third  country  and  has 
been  introduced  into  the  Union  territory  from  that,  or  another,  third  country,  a 
phytosanitary  certificate  for  re-export  may  be  issued  instead  of  the  phytosanitary 
certificate for export. 

The phytosanitary certificate for re-export shall be issued by the competent authority 
at the request of the professional operator which has under its control the plant, plant 
product or other object to be exported. 

2. 

The  phytosanitary  certificate  for  re-export  shall  be  issued  provided  that  all  of  the 
following conditions are complied with: 

(a) 

(b) 

the  plant,  plant  product  or  other  object  concerned  has  not  been  grown, 
produced  or  processed  in  the  Member  State  from  which  it  is  exported  to  the 
third country concerned; 

the plant, plant product or other object concerned has not been exposed to any 
risk of infestation with quarantine pests, listed as such by the third country of 
destination, during storage in the Member State from which it is to be exported 
to that third country; 

(c)  where  available,  the  phytosanitary  certificate  accompanying  the  plant,  plant 
product  or  other  object  concerned  from  the  third  country  of  origin,  or  a 
certified copy of it, is attached to the phytosanitary certificate for re-export. 

The  provisions  of  Article  94(2),  concerning  the  information  sufficient  to  certify 
compliance  with  the  requirements  of  the  third  country  concerned,  shall  apply 
accordingly. 

The phytosanitary certificate for re-export shall contain the elements set out in Part B 
of Annex VIII. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  98,  amending  Part  B  of  Annex  VIII  to  adapt  it  to  scientific  and  technical 
developments and the development of international standards. 

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format 
specifications  of  the  phytosanitary  certificate  as  referred  to  in  paragraph  1.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 99(3). 

3. 

4. 

5. 

6. 

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7. 

1. 

2. 

3. 

4. 

5. 

6. 

Electronic phytosanitary certificates for re-export shall only be valid when provided 
through, or in electronic exchange with, the computerised information management 
system  referred  to  in  Article  130  of  Regulation  (EU)  No  …/….  [Office  of 
Publications, please insert number of Regulation on Official Controls]. 

Article 96 
Pre-export certificates 

The Member State from which the plants, plant products and other objects referred to 
in  Article  94(1)  are  exported  and  the  Member  State  in  which  the  plants,  plant 
products  and  other  objects  were  grown,  produced  or  processed,  shall  exchange 
information as necessary for issuing, without delay, the phytosanitary certificate for 
export.  

The  exchange  of  information  referred  to  in  paragraph  1  shall  take  the  form  of  a 
harmonised  document  (hereinafter  'pre-export  certificate'),  in  which  the  Member 
State, in which the plants, plant products and other objects were grown, produced or 
processed,  attests  compliance  of  those  plants,  plant  products  or  other  objects  with 
specific phytosanitary requirements concerning one or more of the following: 

(a) 

the  absence  of  particular  pests  in  the  plants,  plants  products  or  other  objects 
concerned;  

(b) 

the origin of the plants, plant products or other objects concerned; 

(c) 

the  phytosanitary  procedures  applied  to  the  production  or  processing  of  the 
plants, plant products or other objects concerned. 

The pre-export certificate shall be issued, on request of the professional operator, by 
the  Member  State  in  which  the  plants,  plant  products  or  other  objects  were  grown, 
produced or processed, while those plants, plant products or other objects are on the 
premises of the professional operator concerned. 

The  pre-export  certificate  shall  accompany  the  plants,  plant  products  and  other 
objects  concerned  during  their  movement  within  the  Union  territory,  unless  the 
information  contained  in  it  is  exchanged  between  the  Member  States  concerned  by 
electronic means. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article 98, setting out the contents of the pre-export certificate.  

The  Commission  shall  adopt,  by  means  of  implementing  acts,  the  format 
specifications of the pre-export certificate. Those implementing acts shall be adopted 
in accordance with the examination procedure referred to in Article 99(3). 

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Chapter VII 
Supporting measures by the Commission 

Article 97 
Establishment of electronic notification system 

1. 

The  Commission  shall  establish  an  electronic  system  for  the  submission  of 
notifications by the Member States. 

That system shall be connected to and compatible with the computerised information 
management  system  referred  to  in  Article 130(1)  of  Regulation  (EU)  No  …/…. 
[Office of Publications, please insert number of Regulation on Official Controls]. 

2. 

Where  the  notification  concerns  the  presence  of  a  pest  in  plants,  plant  products  or 
other  objects  introduced  into,  officially  presented  for  introduction  into,  or  moved 
within, the Union territory, the notification referred to in paragraph 1 shall contain a 
reference to the plants, plant products and other objects concerned, the nature of the 
non-compliance and the measures taken. 

Where the notification concerns the presence of a pest in the territory of a Member 
State,  other  than  in  a  plant,  plant  product  or  other  object  introduced  into,  officially 
presented for introduction into, or moved within, the Union territory, the notification 
referred to in paragraph 1 shall contain a reference to the plants, plant products and 
other  objects  concerned, the name of the pest, the location and GPS coordinates of 
that presence, and the measures taken. 

Chapter VIII 
Final provisions 

Article 98 
Exercise of the delegation 

1. 

2. 

3. 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The  delegation  of  power  referred  to  in  Articles  1(2),  7(1)  and  (2),  8(6),  11(3),  20, 
22(3),  25(4),  30,  32(4),  34(1),  38,  44(2),  45(3),  46(6),  48,  61(3),  67(4),  71(4),  76, 
78(4), 82(4), 84(2), 86(3), 91(2), 92(1) and (3), 93(1), 94(4), 95(5) and 96(5) shall be 
conferred on the Commission for an indeterminate period of time from the entry into 
force of this Regulation. 

The  delegation  of  power  referred  to  in  Articles  1(2),  7(1)  and  (2),  8(6),  11(3),  20, 
22(3),  25(4),  30,  32(4),  34(1),  38,  44(2),  45(3),  46(6),  48,  61(3),  67(4),  71(4),  76, 
78(4), 82(4), 84(2), 86(3), 91(2), 92(1) and (3), 93(1), 94(4), 95(5) and 96(5) may be 
revoked  at  any  time  by  the  European  Parliament  or  by  the  Council.  A  decision  of 
revocation shall put an end to the delegation of the power specified in that decision. 
It  shall  take  effect  the  day  following  the  publication  of  the  decision  in  the  Official 

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4. 

5. 

1. 

2. 

Journal of the European Union or at a later date specified therein. It shall not affect 
the validity of any delegated acts already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

A delegated act adopted pursuant to Articles 1(2), 7(1) and (2), 8(6), 11(3), 20, 22(3), 
25(4),  30,  32(4),  34(1),  38,  44(2),  45(3),  46(6),  48,  61(3),  67(4),  71(4),  76,  78(4), 
82(4), 84(2), 86(3), 91(2), 92(1) and (3), 93(1), 94(4), 95(5) and 96(5) shall enter into 
force only if no objection has been expressed either by the European Parliament or 
the Council within a period of two months of notification of that act to the European 
Parliament  and  the  Council  or  if,  before  the  expiry  of  that  period,  the  European 
Parliament  and  the  Council  have  both  informed  the  Commission  that  they  will  not 
object. That period shall be extended by two months at the initiative of the European 
Parliament or the Council. 

Article 99 
Committee procedure 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Plants,  Animals, 
Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council. That committee shall be a committee within 
the meaning of Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  4  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result when, within the time-limit for delivery 
of  the  opinion,  the  chair  of  the  committee  so  decides  or  a  simple  majority  of 
committee members so requests. 

3. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result when, within the time-limit for delivery 
of  the  opinion,  the  chair  of  the  committee  so  decides  or  a  simple  majority  of 
committee members so requests. 

4. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU)  No 
182/2011, in conjunction with Article 5 thereof shall apply. 

Article 100 
Penalties 

The Member States shall lay down the rules on penalties applicable to infringements of this 
Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are  implemented.  The 
penalties provided for must be effective, proportionate and dissuasive. 

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The  Member  States  shall  notify  those  provisions  to  the  Commission  by  ……  [Office  of 
Publications, please insert date of application of this Regulation] at the latest and shall notify 
them without delay of any subsequent amendments affecting them. 

Article 101 
Repeals 

1. 

Directive 2000/29/EC is repealed. 

The following acts are also repealed: 

(a)  Directive 69/464/EEC; 

(b)  Directive 69/466/EEC; 

(c)  Directive 74/647/EEC ; 

(d)  Directive 93/85/EEC; 

(e)  Directive 98/57/EC; 

(f)  Directive 2007/33/EC. 

2. 

References to those repealed acts shall be construed as references to this Regulation 
and shall be read in accordance with the correlation table set out in Annex IX hereto. 

Article 102 
Amendment of Regulation (EU) […]/2013 
[Office of Publications, please insert number of Regulation laying down provisions for the 
management of expenditure relating to the food chain, animal health and animal welfare, and 
relating to plant health and plant reproductive material] 

Regulation  (EU)  No  [.…]/2013  [Office  of  Publications,  please  insert  number  of  Regulation 
laying down provisions for the management of expenditure relating to the food chain, animal 
health  and  animal  welfare,  and  relating  to  plant  health  and  plant  reproductive  material]  is 
amended as follows: 

(1) 

In Article 1, point (e) is replaced by the following: 

'(e)  on protective measures against pests of plants;' 

(2) 

In Article 17(1), points (a), (b) and (c) are replaced by the following: 

'(a)  measures  to  eradicate  a  pest  from  an  infested  area,  taken  by  the  competent 
authorities  pursuant  to  Article  16(1),  27(1)  or  29(1)  of  Regulation  (EU)  No 
[…]/[…]  of  the  European  Parliament  and  of  the  Council  [on  protective 
measures against pests of plants]*; 

(b)  measures to contain a priority pest, listed pursuant to Article 6(2) of Regulation 
(EU)  No  […]/[…]*,  against  which  Union  containment  measures  have  been 
adopted  pursuant  to  Article  27(2)  or  Article  29(2)  of  that  Regulation,  in  an 

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infested  area  from  which  that  priority  pest  cannot  be  eradicated,  where  those 
measures  are  essential  to  protect  the  Union  territory  against  further  spread  of 
that  priority  pest.  Those  measures  shall  concern  the  eradication  of  that  pest 
from  the  buffer  zone  surrounding  that  infested  area  in  case  its  presence  is 
detected in that buffer zone; 

(c) 

prevention measures taken against the spread of a priority pest, listed pursuant 
to  Article  6(2)  of  Regulation  (EU)  No  […]/[…]*,  against  which  Union 
measures have been adopted pursuant to Article 27(3) or Article 29(3) of that 
Regulation,  where  those  measures  are  essential  to  protect  the  Union  territory 
against further spread of that priority pest. 

* 

OJ  L  …,  …….,  p.  …'  [Office  of  Publications,  please  insert  this  footnote,  referring  to  the 
present  Regulation,  in  Regulation  (EU)  No  [.…]/2013  laying  down  provisions  for  the 
management of expenditure relating to the food chain, animal health and animal welfare, and 
relating to plant health and plant reproductive material] 

(3) 

Article 18 is amended as follows: 

(a) 

In the first paragraph, points (a) and (b) are replaced by the following: 

'(a) 

(b) 

(c) 

they  concern  Union  quarantine  pests  not  known  to  occur  in  the  Union 
territory,  listed  pursuant  to  Article  5(2)  of  Regulation  (EU)  No 
[…]/[…]*; 

they  concern  priority  pests  listed  pursuant  to  Article  6(2)  of  Regulation 
(EU) No […]/[…]*; 

they  concern  pests,  not  listed  as  Union  quarantine  pests,  which  are 
covered  by  a  measure  adopted  by  the  Commission  pursuant  to  Article 
29(1) of Regulation (EU) No […]/[…]*. 

* 

OJ  L  …,  …….,  p.  …'  [Office  of  Publications,  please  insert  this  footnote,  referring  to  the 
present  Regulation,  in  Regulation  (EU)  No  [.…]/2013  laying  down  provisions  for  the 
management of expenditure relating to the food chain, animal health and animal welfare, and 
relating to plant health and plant reproductive material] 

(b)  The second paragraph is replaced by the following: 

'For  measures  fulfilling  the  condition  laid  down  in  point  (c)  of  the  first 
paragraph,  the  grant  shall  not  cover  costs  incurred  after  the  expiry  of  the 
measure  adopted  by  the  Commission  pursuant  to  Article  29(1)  of  Regulation 
(EU) No […]/[…]*. 

* 

OJ  L  …,  …….,  p.  …'  [Office  of  Publications,  please  insert  this  footnote,  referring  to  the 
present  Regulation,  in  Regulation  (EU)  No  [.…]/2013  laying  down  provisions  for  the 
management of expenditure relating to the food chain, animal health and animal welfare, and 
relating to plant health and plant reproductive material] 

(4) 

Paragraph 1 of Article 19 is amended as follows: 

(a)  The following point (ca) is inserted after point (c): 

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'(ca)  costs  incurred  by  Member  States  for  compensation  to  the  operators 
referred  to  in  Article  2(7)(a),  (b)  and  (c)  of  Regulation  (EU)  […]/[…]* 
for  the  value  of  the  destroyed  plants,  plant  products  or  other  objects 
subject  to  the  measures  referred  to  in  Article  16  of  that  Regulation,  as 
regards priority pests, listed pursuant to Article 6(2) of that Regulation; 

* 

OJ  L  …,  …….,  p.  …'  [Office  of  Publications,  please  insert  this  footnote,  referring  to  the 
present  Regulation,  in  Regulation  (EU)  No  [.…]/2013  laying  down  provisions  for  the 
management of expenditure relating to the food chain, animal health and animal welfare, and 
relating to plant health and plant reproductive material] 

(b)  Point (d) is replaced by the following: 

'(d) 

in  exceptional  and  duly  justified  cases,  taking  into  account  the  Union 
added  value  of  the  measures,  the  costs  incurred  in  carrying  out  other 
necessary measures than those referred to in points (a) to (ca), provided 
that such measures are set out in the grant decision referred to in Article 
35(3).' 

(c)  The following second subparagraph is added: 

'For the purposes of point (ca) of the first subparagraph, the compensation shall 
not  exceed  the  market  value  of  the  plants,  plant  products  or  other  objects 
immediately before they were destroyed and the salvage value, if any, shall be 
deducted from the compensation.' 

(5) 

Article 20 is amended as follows: 

(a) 

In the first paragraph, points (a) and (b) are replaced by the following: 

'(a) 

(b) 

(c) 

they  concern  Union  quarantine  pests  not  known  to  occur  in  the  Union 
territory,  listed  pursuant  to  Article  5(2)  of  Regulation  (EU)  No 
[…]/[…]*; 

they  concern  priority  pests  listed  pursuant  to  Article  6(2)  of  Regulation 
(EU) […]/[…]*; 

they concern pests not listed as Union quarantine pests which are covered 
by  a  measure  adopted  by  the  Commission  pursuant  to  Article  29(1)  of 
Regulation (EU) No […]/[…]*. 

* 

OJ  L  …,  …….,  p.  …'  [Office  of  Publications,  please  insert  this  footnote,  referring  to  the 
present  Regulation,  in  Regulation  (EU)  No  [.…]/2013  laying  down  provisions  for  the 
management of expenditure relating to the food chain, animal health and animal welfare, and 
relating to plant health and plant reproductive material] 

(b)  The third paragraph is replaced by the following: 

'For  measures  fulfilling  the  condition  laid  down  in  point  (c)  of  the  first 
paragraph,  the  grant  shall  not  cover  costs  incurred  after  the  expiry  of  the 
measure  adopted  by  the  Commission  pursuant  to  Article  29(1)  of  Regulation 
(EU) No […]/[…]*. 

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* 

OJ  L  …,  …….,  p.  …'  [Office  of  Publications,  please  insert  this  footnote,  referring  to  the 
present  Regulation,  in  Regulation  (EU)  No  [.…]/2013  laying  down  provisions  for  the 
management of expenditure relating to the food chain, animal health and animal welfare, and 
relating to plant health and plant reproductive material] 

Article 103 
Entry into force and application 

1. 

2. 

3. 

This  Regulation  shall  enter  into  force  on  the  twentieth  day  following  that  of  its 
publication in the Official Journal of the European Union. 

It shall apply [Office of Publications, please insert date counting 36 months from the 
entry into force]. 

Article 97(2) shall apply from the date when the systems referred to in Article 97(1) 
are established. 

The acts referred to in points (a), (d), (e) and (f) of Article 101(1) shall be repealed 
on 31 December 2021. In case of conflict between the provisions of those acts and 
the provisions of this Regulation, the provisions of this Regulation shall prevail. 

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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ANNEX I 

Territories for which, for the purpose of this Regulation, references to third countries 
shall be read as references to third countries and to those territories, and for which 
references to the Union territory shall be read as references to the Union territory 
without those territories, as referred to in Article 1(2) 

The territories of: 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

Guadeloupe 

French Guiana 

Martinique 

Réunion 

Saint-Martin 

Mayotte 

Ceuta 

Melilla 

The Canary Islands 

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ANNEX II 

Criteria for the qualification of pests according  
to their risk to the Union territory 

SECTION 1 
CRITERIA TO IDENTIFY PESTS WHICH QUALIFY AS A QUARANTINE PEST, AS REFERRED TO IN 
ARTICLES 3, 7(1) AND 28(2) 

(1) 

Identity of the pest 

The taxonomic identity of the pest shall be clearly defined or, alternatively, the pest 
shall have been shown to produce consistent symptoms and to be transmissible. 

The taxonomic identity of the pest shall be defined at species level or, alternatively, a 
higher  or  lower  taxonomic  level,  where  that  taxonomic  level  is  scientifically 
appropriate based on its virulence, host range or vector relationships. 

(2) 

Presence of the pest in the territory in question 

One or more of the following conditions shall apply: 

(a) 

the pest is not known to be present in the territory in question; 

(b) 

(c) 

the  pest  is  not  known  to  be  present  in  the  territory  in  question,  except  in  a 
limited part of it; 

the  pest  is  not  known  to  be  present  in  the  territory  in  question,  except  for 
scarce, irregular, isolated and infrequent presences in it. 

Where  points  (b)  or  (c)  apply,  the  pest  shall  be  considered  to  be  distributed  to  a 
limited extent. 

(3) 

Capability of entry, establishment and spread of the pest in the territory in question 

(a)  Capability of entry 

The pest shall be considered capable of entry into the territory in question, or, 
if present, into the part of that territory where it is distributed to a limited extent 
(hereinafter:  'endangered  area'),  either  by  natural  spread,  or  if  all  of  the 
following conditions are fulfilled: 

(i) 

it  is  associated,  as  regards  plants,  plant  products  or  other  objects  which 
are moved into the territory in question, with those plants, plant products 
and other objects in the territory where they originate or from where they 
are moved into the territory in question; 

(ii) 

it survives during transport or storage; 

(iii) 

it may be transferred to a suitable host plant, plant product or other object 
in the territory in question. 

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(b)  Capability of establishment 

The  pest  shall  be  considered  capable  of  perpetuating  its  presence  for  the 
foreseeable future (hereinafter: 'establishment') in the territory in question, or, 
if present, the part of that territory where it is distributed to a limited extent, if 
all of the following conditions are fulfilled: 

(i) 

(ii) 

hosts of the pest and, where relevant, vectors for transmission of the pest 
are available; 

the decisive environmental factors are favourable for the pest concerned 
and,  where  applicable,  its  vector,  enabling  it  to  survive  periods  of 
climatic stress and complete its life cycle; 

(iii)  cultivation  practices  and  control  measures  applied  in  that  territory  are 

favourable; 

(iv) 

the  survival  methods,  reproductive  strategy,  genetic  adaptability  of  the 
pest and its minimum viable population size support its establishment. 

(c)  Capability of spread 

The  pest  shall  be  considered  capable  of  territorial  spread  in  the  territory  in 
question,  or,  if  present,  the  part  of  that  territory  where  it  is  distributed  to  a 
limited extent, if one or more of the following conditions is fulfilled: 

(i) 

the environment is suitable for natural spread of the pest;  

(ii)  barriers to natural spread of the pest are insufficient; 

(iii)  commodities or conveyances allow for movement of the pest; 

(iv)  hosts and, where relevant, vectors of the pest are present; 

(v)  natural  enemies  and  antagonists  of  the  pest  are  not  present  or  not 

sufficiently capable to suppress the pest.  

(4) 

Potential economic, social and environmental impact 

The  entry,  establishment  and  spread  of  the  pest  in  the  territory  in  question,  or,  if 
present, the part of that territory where it is distributed to a limited extent, shall have 
unacceptable economic, social and/or environmental impacts for that territory, or the 
part of that territory where it is distributed to a limited extent, as regards one or more 
of the following points: 

(a) 

crop losses in terms of yield and quality; 

(b) 

costs of control measures; 

(c) 

costs of replanting and losses due to the necessity of growing substitute crops; 

(d) 

effects on existing production practices; 

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(e) 

effects on street trees, parks and public and private green; 

(f) 

effects on native plants, biodiversity and ecosystem services; 

(g) 

(h) 

(i) 

(j) 

(k) 

effects  on  the  establishment,  spread  and  impact  of  other  pests,  due  to  the 
capacity of the pest concerned to act as a vector for other pests; 

changes to producer costs or input demands, including control costs and costs 
of eradication and containment; 

effects on producer profits that result from changes in production costs, yields 
or price levels; 

changes to domestic or foreign consumer demand for a product resulting from 
quality changes; 

effects  on  domestic  and  export  markets  and  prices  paid,  including  effects  on 
export  market  access  and  likelihood  of  phytosanitary  restrictions  imposed  by 
trading partners; 

(l) 

resources needed for additional research and advice; 

(m)  environmental and other undesired effects of control measures; 

(n) 

effects on Natura 2000 or other protected areas; 

(o) 

changes  in  ecological  processes  and  the  structure,  stability  or  processes  of  an 
ecosystem,  including  further  effects  on  plant  species,  erosion,  water  table 
changes, fire hazards, nutrient cycling; 

(p) 

costs of environmental restoration; 

(q) 

effects on food security; 

(r) 

effects on employment; 

(s) 

effects on water quality, recreation, tourism, animal grazing, hunting, fishing. 

As  regards  points  (a)  to  (g),  direct  effects  on  hosts  in  the  endangered  area  shall  be 
taken into account. Those effects shall be assessed taking account of the range of the 
host  species,  and  on  the  basis  of  the  types,  amount  and  frequency  of  the  damage 
suffered by those host species. 

As regards points (h) to (s), indirect effects within and outside the endangered area 
shall be taken into account. 

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SECTION 2 
CRITERIA TO IDENTIFY UNION QUARANTINE PESTS WHICH QUALIFY AS A PRIORITY PEST AS 
REFERRED TO IN ARTICLES 6(1) AND 7(2) 

A  Union  quarantine  pest  shall  be  considered  to  have  most  severe  economic,  social  or 
environmental impact for the Union territory, if its entry, establishment and spread fulfils one 
or more of the following points:  

(a) 

(b) 

Economic  impacts:  the  pest  has  the  potential  to  cause  major  losses  in  terms  of  the 
direct and indirect effects referred to in point (4) of Section I for crops with a total 
annual production value for the Union territory of at least EUR 1 billion. 

Social  impacts:  the  pest  has  the  potential  to  cause  one  or  more  of  the  following 
effects: 

(i) 

a  significant  employment  decrease  in  the  agriculture,  horticulture  of  forestry 
sector concerned; 

(ii) 

risks to food security or food safety; 

(iii) 

the  disappearance  of,  or  permanent  large-scale  damage  to,  main  tree  species 
growing or cultivated in the Union territory. 

(c) 

Environmental  impacts:  the  pest  has  the  potential  to  cause  one  or  more  of  the 
following effects: 

(i) 

effects on species and habitats listed under the provisions of Council Directive 
92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild 
fauna and flora32 and Directive 2009/147/EC of the European Parliament and of 
the Council of 30 November 2009 on the conservation of wild birds33; 

(ii)  major  and  permanent  increases  of  the  use  of  plant  protection  products  on  the 

crops concerned. 

32 
33 

OJ L 206, 22.7.1992, p. 7. 
OJ L 20, 26.1.2010, p. 7. 

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SECTION 3 
CRITERIA FOR A PRELIMINARY ASSESSMENT TO IDENTIFY PESTS WHICH PROVISIONALLY 
QUALIFY AS A UNION QUARANTINE PEST REQUIRING TEMPORARY MEASURES AS REFERRED TO IN 
ARTICLES 21(1), 28(1), 29(1) AND 30  

SUBSECTION 1 
CRITERIA FOR A PRELIMINARY ASSESSMENT TO IDENTIFY PESTS WHICH PROVISIONALLY 
QUALIFY AS A UNION QUARANTINE PEST REQUIRING TEMPORARY MEASURES AS REFERRED 
TO IN ARTICLE 28(1)  

(1) 

Identity of the pest 

The pest shall meet the criterion defined in point (1) of Section 1. 

(2) 

Presence of the pest in the Member State´s territory 

The  pest  is  not  previously  known  to  be  present  in  the  territory  of  a  Member  State. 
Based  on  the  information  available  to  that  Member  State,  the  pest  is  also  not 
previously  known  to  be  present  in  Union  territory,  or  is  considered  to  fulfil  the 
conditions set out in points (b) or (c) of point (2) of Section 1 as regards the Union 
territory.  

(3) 

Probability  of  establishment  and  spread  of  the  pest  in  the  Union  territory,  or  the 
specific part(s) of the Union territory where it is not present  

Based on the information available to the Member State, the pest meets the criteria 
defined in points (3)(b) and (c) of Section 1 as regards its territory and, to the extent 
possible for the Member State to assess this, the Union territory. 

(4) 

Potential economic, social and environmental impact of the pest 

Based  on  the  information  available  to  the  Member  State,  the  pest  has  unacceptable 
economic,  social  and/or  environmental  impacts  as  regards  its  territory  and,  to  the 
extent possible for the Member State to assess this, the Union territory, if it would 
establish and spread in that territory, as concerns one or several of the areas defined 
in point (4) of Section 1. 

Those  impacts  shall  include  at  least  one  or  more  of  the  direct  effects  listed  under 
point (4)(a) to (g) of Section 1. 

SUBSECTION 2 
CRITERIA FOR A PRELIMINARY ASSESSMENT TO IDENTIFY PESTS WHICH PROVISIONALLY 
QUALIFY AS A UNION QUARANTINE PEST REQUIRING TEMPORARY MEASURES AS REFERRED 
TO IN ARTICLE 29(1)  

(1) 

Identity of the pest 

The pest shall meet the criterion defined in point (1) of Section 1. 

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(2) 

Presence of the pest in the Union territory 

The pest is not previously known to be present in Union territory or is considered to 
fulfil the conditions set out in points (b) or (c) of point (2) of Section 1 as regards the 
Union territory.  

(3) 

Probability  of  establishment  and  spread  of  the  pest  in  the  Union  territory,  or  the 
specific part(s) of the Union territory where it is not present  

Based on the information available to the Union, the pest meets the criteria defined in 
points (3)(b) and (c) of Section 1 as regards the Union territory. 

(4) 

Potential economic, social and environmental impact of the pest 

Based  on  the  information  available  to  the  Union,  the  pest  has  unacceptable 
economic,  social  and/or  environmental  impacts  as  regards  the  Union  territory,  if  it 
would establish and spread in that territory, as concerns one or several of the areas 
defined in point (4) of Section 1. 

Those  impacts  shall  include  at  least  one  or  more  of  the  direct  effects  listed  under 
point (4)(a) to (g) of Section 1. 

SECTION 4 
CRITERIA TO IDENTIFY PESTS WHICH QUALIFY AS A UNION QUALITY PEST AS REFERRED TO IN 
ARTICLE 36 AND 38 

(1) 

Identity of the pest 

The pest shall meet the criterion defined in point (1) of Section 1. 

(2) 

Probability of spread in the Union territory of the pest 

The spread of the pest shall be assessed to take place mainly via specific plants for 
planting,  rather  than  via  natural  spread  or  via  movement  of  plant  products  or  other 
objects.  

That assessment shall include, as appropriate, the following aspects: 

(a) 

the number of life cycles of the pest on the concerned hosts; 

(b) 

the biology, epidemiology and survival of the pest; 

(c)  possible natural, human-assisted or other pathways for transmission of the pest 
to  the  concerned  host  and  pathway  efficiency,  including  mechanisms  of 
dispersal and dispersal rate; 

(d) 

secondary infestation and transmission of the pest from the concerned host to 
other plants and vice versa; 

(e) 

climatological factors; 

(f) 

cultural practices before and after harvest; 

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(g) 

soil types; 

(h) 

susceptibility of the concerned host and relevant stages of host plants; 

(i) 

presence of vectors for the pest; 

(j) 

presence of natural enemies and antagonists of the pest; 

(k)  presence of other hosts susceptible to the pest; 

(l) 

prevalence of the pest in the Union territory; 

(m) 

intended use of the plants. 

(3) 

Potential economic, social and environmental impact of the pest 

Infestations of the plants for planting referred to in point (2) with the pest shall have 
an unacceptable economic impact on the intended use of those plants as regards one 
or more of the following points: 

(a) 

crop losses in terms of yield and quality; 

(b) 

extra costs of control measures; 

(c) 

extra costs of harvesting and grading; 

(d) 

costs of replanting; 

(e) 

losses due to the necessity of growing substitute crops; 

(f) 

effects on existing production practices; 

(g) 

effects on other host plants at the place of production; 

(h) 

effects  on  the  establishment,  spread  and  impact  of  other  pests,  due  to  the 
capacity of the pest concerned to act as a vector for those other pests; 

(i) 

(j) 

effects on producer costs or input demands, including control costs and costs of 
eradication and containment; 

effects on producer profits that result from changes in production costs, yields 
or price levels; 

(k) 

changes to domestic or foreign consumer demand for a product resulting from 
quality changes; 

(l) 

effects on domestic and export markets and prices paid; 

(m)  effects on employment. 

As  regards  points  (a)  to  (h),  direct  effects  on  hosts  in  the  endangered  area  shall  be 
taken into account. Those effects shall be assessed on the basis of the types, amount 
and frequency of the respective damage. 

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As regards points (i) to (m), indirect effects within and outside the endangered area 
shall be taken into account. 

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ANNEX III 

Elements to identify plants for planting which pose phytosanitary risks for the Union 
territory, as referred to in Articles 47(2) and 48 

Plants for planting from third countries shall be considered likely to pose phytosanitary risks 
for the Union territory, as referred to in Article 47(1), where those plants for planting fulfil at 
least  three  of  the  following  conditions,  including  at  least  one  of  the  conditions  provided  in 
points (1)(a), (b) and (c): 

(1) 

Characteristics of the plants for planting 

(a)  They  belong  to  a  plant  genus  or  family  known  to  commonly  host  pests 
regulated as quarantine pests in the Union territory or in third countries. 

(b)  They belong to a plant genus or family known to commonly host polyphagous 
pests,  or  monophagous  pests  known  to  have  major  impact  to  plant  species 
grown  in  the  Union  territory  which  have  major  economic,  social  or 
environmental importance to the Union territory. 

(c)  They  belong  to  a  plant  genus  or  family  known  to  commonly  harbour  pests 
without  signs  and  symptoms  of  those  pests,  or  with  a  latent  period  for  the 
expression of those signs or symptoms of at least three months, implying that 
the presence of pests on those plants for planting is likely to be missed during 
official  controls  at  introduction  into  the  Union  territory,  without  recourse  to 
sampling and testing or submission to quarantine procedures. 

(d)  They are grown outdoors in the third countries of origin. 

(e)  They  are  not  treated  with  generic  plant  protection  products  prior  to  or  during 

shipment. 

(f)  They  are  not  subject  to  official  export  controls  and  certification  in  the  third 

country of origin. 

(g)  They  are  not  shipped  in  closed  containers  or  packaging,  or  when  shipped  in 
such  a  way,  the  shipments  because  of  their  size  cannot  be  opened  in  closed 
premises  for  purposes  of  official  controls  at  introduction  into  the  Union 
territory. 

(2) 

Origin of the plants for planting 

(a)  They originate from, or are moved from, a third country which is the source of 
frequent notifications of interceptions of quarantine pests not listed pursuant to 
Article 5(2). 

(b)  They originate from, or are moved from, a third country which is not a member 

of the IPPC. 

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ANNEX IV 

Measures and principles for the management of the risks of pests 

SECTION 1 
MEASURES TO MANAGE THE RISKS OF QUARANTINE PESTS AS REFERRED TO  
IN ARTICLES 16(1), 20, 24(2), 27(4), 28(1), 29(4), 40(2), 41(2), 44(3), 49(2) AND 50(2)  

The management of the risks of quarantine pests shall consist of one or more, as appropriate, 
of the following measures: 

(1) 

Measures  targeting  prevention  and  elimination  of  infestation  of  cultivated  and  wild 
plants 

(a)  Restrictions  as  regards  the  identity,  nature,  origin,  ancestry,  provenance  and 

production history of cultivated plants.  

(b)  Restrictions on the cultivation, harvesting and use of plants. 

(c)  Restrictions on the use of plant products, premises, land, water, soil, growing 

media, facilities, machinery, equipment and other objects. 

(d)  Surveillance,  visual  examination,  sampling  and  laboratory  testing  of  plants, 
land,  water,  soil,  growing  media,  facilities, 

plant  products,  premises, 
machinery, equipment and other objects for the presence of quarantine pests. 

(e)  Surveillance for breakdown or change in the effectiveness of a resistant plant 
species  or  plant  variety  which  relates  to  a  change  in  the  composition  of  the 
quarantine pest or its biotype, pathotype, race or virulence group. 

(f)  Physical, chemical and biological treatment of plants, plant products, premises, 
land,  water,  soil,  growing  media,  facilities,  machinery,  equipment  and  other 
objects, infested or potentially infested with quarantine pests. 

(g)  Destruction of plants, plant products and other objects, infested or potentially 

infested with quarantine pests or for preventive purposes. 

(h) 

Information, data recording, communication and reporting obligations. 

For the purposes of point (b), those measures may include requirements with regard 
to the testing of plant species and plant varieties for resistance to the quarantine pest 
concerned and the listing of plant species and plant varieties found to be resistant to 
the quarantine pest concerned. 

For the purposes of point (f), those measures may include requirements with regard 
to: 

(a) 

the registration, authorisation and official supervision of professional operators 
applying the treatment concerned; 

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(b) 

the issuance of a phytosanitary certificate, plant passport, label or other official 
attestation  for  the  treated  plants,  plants  products  or  other  objects  and  the 
placing of the mark referred to in Article 91(1) following the application of the 
treatment concerned.  

(2) 

Measures targeting consignments of plants, plants products and other objects 

(a)  Restrictions  on  the  identity,  nature,  origin,  provenance,  ancestry,  production 
method, production history and traceability of plants, plant products and other 
objects.  

(b)  Restrictions  on  the  introduction,  movement,  use,  handling,  processing, 
packaging,  storage,  distribution  and  destination  of  plants,  plant  products  and 
other objects. 

(c)  Surveillance,  visual  examination,  sampling,  laboratory  testing  of  plants,  plant 
products  and  other  objects  for  the  presence  of  quarantine  pests,  including 
through subjection to quarantine procedures. 

(d)  Physical, chemical and biological treatment and, where appropriate, destruction 
of plants, plant products and other objects, infested or potentially infested with 
quarantine pests. 

(e) 

Information, data recording, communication and reporting obligations. 

For the purposes of points (a) to (d), those measures may include requirements with 
regard to: 

(a) 

the issuance of a phytosanitary certificate, plant passport, label or other official 
attestation,  including  the  placing  of  the  mark  referred  to  in  Article  91(1)  to 
attest compliance with the provisions referred to in point (a) to (d);  

(b) 

the registration, authorisation and official supervision of professional operators 
applying the treatment referred to in point (d). 

(3) 

Measures targeting pathways for quarantine pests, other than consignments of plants, 
plant products or other objects 

(a)  Restrictions  on  the  introduction  and  movement  of  quarantine  pests  as  a 

commodity. 

(b)  Surveillance,  visual  examination,  sampling  and  laboratory  testing  and  where 

appropriate destruction of commodities of quarantine pests. 

(c)  Restrictions on plants, plant products and other objects carried by travellers. 

(d)  Surveillance,  visual  examination,  sampling  and  laboratory  testing  and  where 
appropriate treatment or destruction of plants, plant products and other objects 
carried by travellers. 

(e)  Restrictions  on  vehicles,  packaging  and  other  objects  used  in  transport  of 

commodities. 

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(f)  Surveillance,  visual  examination,  sampling  and  laboratory  testing  and  where 
appropriate  treatment  or  destruction  of  vehicles,  packaging  and  other  objects 
used in transport of commodities. 

(g) 

Information, data recording, communication and reporting obligations. 

SECTION 2 
PRINCIPLES FOR THE MANAGEMENT OF THE RISKS OF PESTS AS REFERRED TO IN ARTICLES 16(1), 
17(2), 27(4), 28(1), 29(4), 31(1), 37(5), 44(3), 47(2), 68(3), 69(3), 70(2), 74(3) AND 75(3)  

The management of the risks of Union quarantine pests, protected zone quarantine pests and 
Union quality pests shall respect the following principles: 

(1) 

Necessity 

Measures to manage the risk of a pest shall be applied only where such measures are 
necessary to prevent the introduction, establishment and spread of that pest. 

(2) 

Proportionality 

Measures taken to manage the risk of a pest shall be consistent with the risk posed by 
the pest concerned and the level of protection that is required. 

(3) 

Minimal impact 

Measures  taken  to  manage  the  risk  of  a  pest  shall  represent  the  least  restrictive 
measures  available,  and  result  in  the  minimum  impediment  to  the  international 
movement of people, commodities and conveyances. 

(4) 

Non-discrimination 

Measures taken to manage the risk of a pest shall not be applied in such a way as to 
constitute  either  a  means  of  arbitrary  or  unjustified  discrimination  or  a  disguised 
restriction,  particularly  on  international  trade.  They  shall  be  no  more  stringent  for 
third  countries  than  measures  applied  to  that  same  pest  if  present  within  the  Union 
territory,  if  third  countries  can  demonstrate  that  they  have  the  same  phytosanitary 
status and apply identical or equivalent phytosanitary measures. 

(5) 

Technical justification 

Measures taken to manage the risk of a pest shall be technically justified on the basis 
of  conclusions  reached  by  using  an  appropriate  risk  analysis  or,  where  applicable, 
another  comparable  examination  and  evaluation  of  available  scientific  information. 
Those  measures  should  reflect,  and,  where  appropriate,  be  modified  or  removed  to 
reflect new or updated risk analysis or relevant scientific information. 

(6) 

Feasibility 

Measures  taken  to  manage  the  risk  of  a  pest  should  be  such  as  to  allow  that  the 
objective of those measures is likely achieved. 

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ANNEX V 

Contents of phytosanitary certificates for introduction into the Union territory 

PART A 
PHYTOSANITARY CERTIFICATES FOR EXPORT AS REFERRED TO IN ARTICLE 71(1)  

___________________________________________________________________________ 

Model Phytosanitary Certificate 

No. _________________________ 

Plant Protection Organization of _________________________________________________ 

TO: Plant Protection Organization(s) of ___________________________________________ 

I. Description of Consignment 

Name and address of exporter:___________________________________________________ 

Declared name and address of consignee: __________________________________________ 

Number and description of packages: _____________________________________________ 

Distinguishing marks: _________________________________________________________ 

Place of origin: _______________________________________________________________ 

Declared means of conveyance:__________________________________________________ 

Declared point of entry: ________________________________________________________ 

Name of produce and quantity declared: ___________________________________________ 

Botanical name of plants:_______________________________________________________ 

This  is  to  certify  that  the  plants,  plant  products  or  other  regulated  articles  described  herein  have 
been inspected and/or tested according to appropriate official procedures and are considered to be 
free from the quarantine pests specified by the importing contracting party and to conform with the 
current phytosanitary requirements of the importing contracting party, including those for regulated 
non-quarantine pests.  

They are deemed to be practically free from other pests.*  

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II. Additional Declaration 

[Enter text here] 

III. Disinfestation and/or Disinfection Treatment 

Date ________ Treatment ___________ Chemical (active ingredient) ___________________ 

Duration and temperature_______________________________________________________ 

Concentration ________________________________________________________________ 

Additional information_________________________________________________________ 

___________________________________________________________________________ 

(Stamp of Organization) ________ Name of authorized officer _________________________ 

Place of issue ____________________________________ 

Date ___________________________________________ 

(Signature) 

___________________________________________________________________________ 

No financial liability with respect to this certificate shall attach to ____________ (name of Plant 
Protection Organization) or to any of its officers or representatives.* 

* Optional clause 

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PART B 
PHYTOSANITARY CERTIFICATES FOR RE-EXPORT AS REFERRED TO IN ARTICLE 71(1) 

___________________________________________________________________________ 

Model Phytosanitary Certificate for Re-Export 

No. _________________________ 

Plant Protection Organization of _______________________ (contracting party of re-export) 

TO: Plant Protection Organization(s) of ________________ (contracting party(ies) of import) 

I. Description of Consignment 

Name and address of exporter:___________________________________________________ 

Declared name and address of consignee: __________________________________________ 

Number and description of packages: _____________________________________________ 

Distinguishing marks: _________________________________________________________ 

Place of origin: _______________________________________________________________ 

Declared means of conveyance:__________________________________________________ 

Declared point of entry: ________________________________________________________ 

Name of produce and quantity declared: ___________________________________________ 

Botanical name of plants:_______________________________________________________ 

This  is  to  certify  that  the  plants,  plant  products  or  other  regulated  articles  described  above 
________________  were  imported  into  (contracting  party  of  re-export)  ________________  from 
_________________  (contracting  party  of  origin)  covered  by  Phytosanitary  Certificate  No. 
__________________, 

*original  (cid:133)  *certified true copy  (cid:133) 

of which is attached to this certificate; that they are 

*packed  (cid:133)  *repacked  (cid:133) 

in 

*original  (cid:133)  *new  (cid:133) 

EN 

110 

   EN 

 
 
containers, that based on the 

*original phytosanitary certificate 

(cid:133) 

and 

*additional inspection 

(cid:133) 

they  are  considered  to  conform  with  the  current  phytosanitary  requirements  of  the  importing 
contracting party, and that during storage in ______________ (contracting party of re-export), the 
consignment has not been subjected to the risk of infestation or infection. 

*Insert tick in appropriate  (cid:133)  boxes 

II. Additional Declaration 

[Enter text here] 

III. Disinfestation and/or Disinfection Treatment 

Date ________ Treatment ___________ Chemical (active ingredient) ___________________ 

Duration and temperature_______________________________________________________ 

Concentration ________________________________________________________________ 

Additional information_________________________________________________________ 

___________________________________________________________________________ 

(Stamp of Organization) _______  Name of authorized officer _________________________ 

Place of issue ____________________________________ 

Date ___________________________________________ 

(Signature) 

___________________________________________________________________________ 

No financial liability with respect to this certificate shall attach to ____________ (name of Plant 
Protection Organization) or to any of its officers or representatives.* 

* Optional clause 

EN 

111 

   EN 

 
 
 
ANNEX VI 

Plant passports 

PART A 
PLANT PASSPORTS FOR MOVEMENT WITHIN THE UNION TERRITORY AS REFERRED TO IN THE FIRST 
SUBPARAGRAPH OF ARTICLE 78(2)  

(1) 

The  plant  passport  for  movement  within  the  Union  territory  shall  contain  the  following 
elements: 

(a) 

in its upper left hand corner, the words 'Plant Passport'; 

(b) 

in its upper right hand corner, the flag of the European Union; 

(c) 

(d) 

(e) 

(f) 

the  letter  'A.',  followed  by  the  botanical  name  of  the  plant  species  or  taxon 
concerned, in case of plants and plant products, or, where appropriate, the name of 
the object concerned; 

the letter 'B.', followed by subsequently the two-letter code, referred to in point (b) of 
Article 63, for the Member State in which the professional operator issuing the plant 
passport  is  registered,  a  hyphen  and  the  registration  number  of  the  professional 
operator concerned; 

the  letter  'C.',  followed  by  the  lot  number  of  the  plant,  plant  product  or  the  other 
object concerned; 

the letter 'D.', optionally followed by the name of the third country of origin or two-
letter code, referred to in point (b) of Article 63, for the Member State of origin. 

(2) 

The  lot  number  referred  to  in  point  1(e)  may  be  replaced  by  a  reference  to  a  unique 
traceability barcode, hologram, chip or other data carrier, present on the lot. 

PART B 
PLANT PASSPORTS FOR MOVEMENT INTO AND WITHIN PROTECTED ZONES AS REFERRED TO IN THE 
SECOND SUBPARAGRAPH OF ARTICLE 78(2) 

(1) 

The  plant  passport  for  movement  into  and  within  protected  zones  shall  contain  the 
following elements:  

(a) 

in its upper left hand corner, the words 'Plant Passport ─ ZP'; 

(b) 

immediately  underneath  those  words,  the  scientific  name(s)  of  the  protected  zone 
quarantine pest(s) concerned; 

(c) 

in the upper right hand corner, the flag of the European Union; 

(d) 

the  letter  'A.',  followed  by  the  botanical  name  of  the  plant  species  or  taxon 
concerned, in case of plants and plant products, or, where appropriate, the name of 
the object concerned; 

EN 

112 

   EN 

(e) 

(f) 

(g) 

the letter 'B.', followed by subsequently the two-letter code, referred to in point (b) of 
Article 63, for the Member State in which the professional operator issuing the plant 
passport  is  registered,  a  hyphen  and  the  registration  number  of  the  professional 
operator concerned; 

the  letter  'C.',  followed  by  the  lot  number  of  the  plant,  plant  product  or  the  other 
object concerned; 

the letter 'D.', optionally followed by the name of the third country of origin or two-
letter code, referred to in point (b) of Article 63, for the Member State of origin. 

(2) 

The  lot  number  referred  to  in  point  1(f)  may  be  replaced  by  a  reference  to  a  unique 
traceability barcode, hologram, chip or other data carrier, present on the lot. 

PART C 
PLANT PASSPORTS FOR MOVEMENT WITHIN THE UNION TERRITORY, COMBINED WITH A CERTIFICATION 
LABEL, AS REFERRED TO IN THE SECOND SUBPARAGRAPH OF ARTICLE 78(3) 

(1) 

The plant passport for movement within the Union territory, combined in a joint label with 
the  official  label  referred  to  in  Article  19  of  Regulation  (EU)  No  …/….  [Office  of 
Publications, please insert number of Regulation on plant reproductive material law], or 
the  master  certificate  referred  to  in  Article  122  of  that  Regulation,  shall  contain  the 
following elements: 

(a) 

in the upper left hand corner of the joint label, the words 'Plant Passport'; 

(b) 

in the upper right hand corner of the joint label, the flag of the European Union. 

The plant passport shall be positioned in the joint label immediately above, and have the 
same width as, that official label or, where applicable, that master certificate. 

Where point (c), (d), (e) or (f) as referred to in point (1) of Part A is not contained in that 
official label or, where applicable, that master certificate, that point shall be provided in the 
plant passport referred to in the first subparagraph. 

(2) 

Point (2) of Part A shall apply accordingly. 

PART D 
PLANT PASSPORTS FOR MOVEMENT INTO AND WITHIN PROTECTED ZONES, COMBINED WITH A 
CERTIFICATION LABEL, AS REFERRED TO IN THE THIRD SUBPARAGRAPH OF ARTICLE 78(3) 

(1) 

The plant passport for movement into and within protected zones, combined in a joint label 
with  the  official  label  referred  to  in  Article  19  of  Regulation  (EU)  No  …/….  [Office  of 
Publications, please insert number of Regulation on plant reproductive material]  law, or 
the  master  certificate  referred  to  in  Article  122  of  that  Regulation,  shall  contain  the 
following elements: 

(a) 

in the upper left hand corner of the joint label, the words 'Plant Passport ─ ZP'; 

(b) 

immediately  underneath  those  words,  the  scientific  name(s)  of  the  protected  zone 
quarantine pest(s) concerned; 

EN 

113 

   EN 

(c) 

in the upper right hand corner of the joint label, the flag of the European Union. 

The plant passport shall be positioned in the joint label immediately above, and have the 
same width as, that official label or, where applicable, that master certificate. 

Where point (d), (e), (f) or (g) as referred to in point (1) of Part B is not contained in that 
official label or, where applicable, that master certificate, that point shall be provided in the 
plant passport referred to in the first subparagraph. 

(2) 

Point (2) of Part B shall apply accordingly. 

EN 

114 

   EN 

ANNEX VII 

Mark for wood packaging material referred to in Article 91(1) 

The mark applied to wood packaging material pursuant to Article 91(1) shall contain the following 
elements: 

(a) 

(b) 

on its left hand, the logo of the IPPC; 

on its right hand, subsequently the two-letter code, referred to in point (b) of Article 63, for 
the  Member  State  in  which  the  professional  operator  applying  that  mark  is  registered,  a 
hyphen,  the  registration  number  of  the  professional  operator  concerned,  and  the  letters 
'HT'. 

No other information shall be contained within the border of the mark.  

The mark shall not be hand drawn. 

EN 

115 

   EN 

ANNEX VIII 

Contents of phytosanitary certificates for export and re-export as referred to in Articles 94(3) 
and 95(4) 

PART A 
PHYTOSANITARY CERTIFICATES FOR EXPORT AS REFERRED TO IN ARTICLE 94(3)  

(1) 

The phytosanitary certificate for movement out of the Union territory, for the purpose of 
export to a third country, shall contain the following elements: 

(a) 

the words 'Phytosanitary certificate', followed by subsequently: 

(i) 

the letters 'EU'; 

(ii) 

the two-letter code, referred to in point (b) of Article 63, for the Member State 
in which the professional operator requesting the issuance of the phytosanitary 
certificate for export is registered; 

(iii)  a slash; 

(iv)  a  unique  identification  code  for  the  certificate,  consisting  of  numbers  or  a 
combination of letters and numbers, the letters representing, as applicable, the 
province and district of the Member State where the certificate is issued; 

the words 'Name and address of exporter', followed by the name and address of the 
registered operator requesting the issuance of the phytosanitary certificate for export; 

the words 'Declared name and address of consignee', followed by the declared name 
and address of the consignee; 

the  words  "Plant  protection  organisation  of",  followed  by  the  name  of  the  Member 
State  of  which  the  plant  protection  organisation  issues  the  certificate,  and 
subsequently  the  words  'to  the  plant  protection  organisation(s)  of',  followed  by  the 
name  or,  as  applicable,  names,  of  the  country  or,  as  applicable,  countries  of 
destination; 

the  words  'Place  of  origin',  followed  by  the  place  of  origin  of  the  plants,  plant 
products  or  other  objects  included  in  the  consignment  for  which  the  certificate  is 
issued; 

the  words  "Declared  means  of  conveyance",  followed  by  the  declared  means  of 
conveyance of that consignment; 

the words "Declared point of entry", followed by the declared point of entry into the 
country of destination of that consignment; 

the  words  "Distinguishing  marks:  number  and  description  of  packages;  name  of 
produce;  botanical  name  of  plants",  followed  by  the  number  and  type  of  packages 
included in the consignment; 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

EN 

116 

   EN 

(i) 

(j) 

(k) 

the words "Quantity declared", followed by the quantity of the plants, plant products 
or other objects included in that consignment, expressed by number or weight; 

the words 'This is to certify that the plants, plant products or other regulated articles 
described herein have been inspected and/or tested according to appropriate official 
procedures and aree considered to be free from the quarantine pests specified by the 
importing  contracting  party  and  to  conform  with  the  current  phytosanitary 
requirements  of  the  importing  contracting  party,  including  those  for  regulated  non-
quarantine pests. They are deemed to be practically free from other pests.'; 

the words "Additional declaration", followed by the additional declaration referred to 
in  Article  67(2)  and  the  statement  referred  to  in  Article  67(3)  and,  optionally,  any 
further phytosanitary information relevant to the consignment. If there is insufficient 
space for the whole of the additional declaration, the text is to be continued on the 
back of the form; 

(l) 

the words 'Disinfestation and/or disinfection treatment'; 

(m) 

the  word  "Treatment",  followed  by  the  treatment  that  has  been  applied  to  that 
consignment; 

(n) 

(o) 

(p) 

the  words  "Chemical  (active  ingredient)",  followed  by  the  active  ingredient  of  the 
chemical used for the treatment referred to in point (m); 

the  words  "Duration  and  temperature",  followed  by  the  duration  and,  where 
applicable, temperature of that treatment; 

the  word  "Concentration",  followed  by  the  concentration  of  that  chemical  reached 
during that treatment; 

(q) 

the word "Date", followed by the date on which that treatment was applied; 

(r) 

(s) 

the word "Additional information", followed by any additional information that the 
competent authority wishes to include in the certificate; 

the  words  'Place  of  issue',  followed  by  the  place  of  issuance  of  the  phytosanitary 
certificate; 

(t) 

the word 'Date', followed by the date of issuance of the phytosanitary certificate; 

(u) 

(v) 

the  words  'Name  and  signature  of  authorised  officer',  followed  by  the  name  and 
signature of the officer issuing and signing the phytosanitary certificate; 

the  words  'Stamp  of  organisation',  followed  by  the  official  stamp  of  the  competent 
authority issuing the phytosanitary certificate. 

(2) 

The paper used shall contain the embossed seal of the competent authority that signs the 
certificate. 

EN 

117 

   EN 

PART B 
PHYTOSANITARY CERTIFICATES FOR RE-EXPORT AS REFERRED TO IN ARTICLE 95(4)  

(1) 

The phytosanitary certificate for movement out of the Union territory, for the purpose of 
re-export to a third country, shall contain the following elements: 

(a) 

the words 'Phytosanitary certificate for re-export', followed by subsequently: 

(i) 

the letters 'EU'; 

(ii) 

the two-letter code, referred to in point (b) of Article 63, for the Member State 
in which the professional operator requesting the issuance of the phytosanitary 
certificate for re-export is registered; 

(iii)  a slash; 

(iv)  a  unique  identification  code  for  the  certificate,  consisting  of  numbers  or  a 
combination of letters and numbers, the letters representing, as applicable, the 
province and district of the Member State where the certificate is issued; 

the words 'Name and address of exporter', followed by the name and address of the 
registered  operator  requesting  the  issuance  of  the  phytosanitary  certificate  for  re-
export; 

the words 'Declared name and address of consignee', followed by the declared name 
and address of the consignee; 

the  words  "Plant  protection  organisation  of",  followed  by  the  name  of  the  Member 
State  of  which  the  plant  protection  organisation  issues  the  certificate,  and 
subsequently  the  words  'to  the  plant  protection  organisation(s)  of',  followed  by  the 
name  or,  as  applicable,  names,  of  the  country  or,  as  applicable,  countries  of 
destination; 

the  words  'Place  of  origin',  followed  by  the  place  of  origin  of  the  plants,  plant 
products  or  other  objects  included  in  the  consignment  for  which  the  certificate  is 
issued; 

the  words  "Declared  means  of  conveyance",  followed  by  the  declared  means  of 
conveyance of that consignment; 

the words "Declared point of entry", followed by the declared point of entry into the 
country of destination of that consignment; 

the  words  "Distinguishing  marks:  number  and  description  of  packages;  name  of 
produce;  botanical  name  of  plants",  followed  by  the  number  and  type  of  packages 
included in the consignment; 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

the words "Quantity declared", followed by the quantity of the plants, plant products 
or other objects included in that consignment, expressed by number or weight; 

(j) 

the following text: 

EN 

118 

   EN 

'This is to certify 

– 

that  the  plants  or  plant  products  described  above  were  imported  into 
…….………  (country  of  re-export)  from  ……………….  (country  of  origin) 
covered by phytosanitary certificate No ………………. 

(cid:133)  *original 

(cid:133) *certified true copy of which is attached to this certificate, 

– 

that they are 

(cid:133)  *packed  (cid:133) *repacked 

in 

(cid:133)  *original  (cid:133) 

*new containers, 

– 

that based on the 

(cid:133)  *original phytosanitary certificate 

and 

(cid:133)  *additional inspection, 

they are considered to conform with the current phytosanitary regulation of the 
importing country, and 

– 

that  during  storage  in  ………………  (country  of  re-export)  the  consignment 
has not been subjected to the risk of infestation or infection. 

* 

Insert tick in appropriate boxes', 

in which text the required information shall be filled and the applicable boxes ticked; 

(k) 

the words "Additional declaration", followed by the additional declaration referred to 
in  Article  67(2)  and  the  statement  referred  to  in  Article  67(3)  and,  optionally,  any 
further phytosanitary information relevant to the consignment. If there is insufficient 
space for the whole of the additional declaration, the text is to be continued on the 
back of the form; 

(l) 

the words 'Disinfestation and/or disinfection treatment'; 

(m) 

the  word  "Treatment",  followed  by  the  treatment  that  has  been  applied  to  that 
consignment; 

(n) 

(o) 

(p) 

the  words  "Chemical  (active  ingredient)",  followed  by  the  active  ingredient  of  the 
chemical used for the treatment referred to in point (m); 

the  words  "Duration  and  temperature",  followed  by  the  duration  and,  where 
applicable, temperature of that treatment; 

the  word  "Concentration",  followed  by  the  concentration  of  that  chemical  reached 
during that treatment; 

(q) 

the word "Date", followed by the date on which that treatment was applied; 

EN 

119 

   EN 

(r) 

(s) 

the word "Additional information", followed by any additional information that the 
competent authority wishes to include in the certificate; 

the  words  'Place  of  issue',  followed  by  the  place  of  issuance  of  the  phytosanitary 
certificate; 

(t) 

the word 'Date', followed by the date of issuance of the phytosanitary certificate; 

(u) 

(v) 

the  words  'Name  and  signature  of  authorised  officer',  followed  by  the  name  and 
signature of the officer issuing and signing the phytosanitary certificate; 

the  words  'Stamp  of  organisation',  followed  by  the  official  stamp  of  the  competent 
authority issuing the phytosanitary certificate. 

(2) 

The paper used shall contain the embossed seal of the competent authority that signs the 
certificate. 

EN 

120 

   EN 

ANNEX IX 

Correlation table 

Council Directive 69/464/EEC 

This Regulation 

Regulation (EU) No …/…. [Office 
of Publications, please insert 
number of Regulation on Official 
Controls] 

Article 1 

Article 2 

Articles 3, 4 and 5 

Article 6 

Article 7 

Article 8 

Article 9 

Articles 10 and 11 

Articles 12 and 13 

Article 27(1) 

Article 27(1)(d) 

Article 27(1)(c) 

Article 27(1)(e) 

─ 

Article 8 

Article 31(1) 

Article 27(1)(c) 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Council Directive 93/85/EEC 

This Regulation 

Regulation (EU) No …/…. [Office 
of Publications, please insert 
number of Regulation on Official 
Controls] 

Article 1 

Article 2 

Article 3 

Article 27(1) 

Article 27(1)(f) 

Article 9 

Articles 4 to 8 

Article 27(1)(a), (b) and (c) 

Article 9 

Article 10 

Article 11 

Article 12 

Articles 13 to 15 

Annexes I to V 

─ 

Article 8 

Article 31(1) 

Article 27(1) 

─ 

Article 27(1) 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Council Directive 98/57/EC 

This Regulation 

Regulation (EU) No …/…. [Office 
of Publications, please insert 
number of Regulation on Official 
Controls] 

Article 1 

Article 27(1) 

─ 

EN 

121 

   EN 

Article 2 

Article 3 

Article 27(1)(f) 

Article 9 

Article 4 to 7 

Article 27(1)(a), (b) and (c) 

Article 8 

Article 9 

Article 10 

Article 11 

Articles 12 to 14 

Annexes I to VII 

─ 

Article 8 

Article 31(1) 

Article 27(1) 

─ 

Article 27(1) 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Council Directive 2007/33/EC 

This Regulation 

Regulation (EU) No …/…. [Office 
of Publications, please insert 
number of Regulation on Official 
Controls] 

Article 1 

Articles 2 and 3 

Articles 4 to 8 

Articles 9 to 13 

Article 14 

Article 15 

Article 16 

Article 17 

Articles 18 to 20 

Annexes I to IV 

Article 27(1) 

Article 27(1) and (2) 

Article 27(1)(f) 

Article 27(1) and (2) 

Article 8 

Article 31(1) 

Article 27(1) 

Article 99 

─ 

Article 27(1) 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Council Directive 2000/29/EC 

This Regulation 

Regulation (EU) No …/…. [Office 
of Publications, please insert 
number of Regulation on Official 
Controls] 

Article 1(1), (2) and (3) 

Article 1 

Article 1(4) 

Article 1(5) and (6) 

Article 2(1)(a) 

Article 2(1)(b) 

EN 

─ 

─ 

Article 2(1) 

Article 2(2) 

122 

─ 

Article 3 

─ 

─ 

─ 

   EN 

Article 2(1)(c) 

Article 2(1)(d) 

Article 2(1)(e) 

Article 2(1)(f) 

Article 2(1)(g) 

Article 2(1)(h) 

─ 

Article 2(3) 

Article 1(1)  

Article 73 

─ 

Articles 32 to 35 

Article 2(1)(i), first subparagraph 

Article 71 

Article 2(1)(i), second subparagraph 

Article 2(1)(i), third subparagraph 

Article 2(1)(j) 

Article 2(1)(k) 

Article 2(1)(l) 

Article 2(1)(m) 

Article 2(1)(n) 

Article 2(1)(o) 

Article 2(1)(p) 

Article 2(1)(q) 

Article 2(1)(r) 

Article 2(2) 

Article 3(1) 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

Article 2(6) 

─ 

─ 

─ 

Article 2(2), second subparagraph 

Article 5(1) 

Article 3(2) and (3) 

Articles 5(1), 37(1) and 41(3) 

Article 3(4) 

Article 3(5) 

Article 3(6) 

Article 3(7) 

─ 

Article 32(2) and 50(3) 

Articles 5(2) and 32(3) 

Articles 5(3), 27(1) and 37(1) 

Articles 3(8) and (9) 

Articles 8, 46 and 54 

Article 4(1) 

Article 4(2) 

Article 4(3) 

EN 

Article 40(1) 

Article 49(1) 

─  

123 

─ 

─ 

─ 

─ 

Articles 3, 25 and 36 

─ 

Article 4 

Articles 4 and 19 

Article 129 

Article 2(28) 

Article 3 

Article 3 

Article 3 

Article 3 

─ 

Article 2(26) 

─  

Article 2(48) 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

   EN 

Article 4(4) 

Article 4(5) 

Article 4(6) 

Article 5(1) 

Article 5(2) 

Article 5(3) 

Article 5(4) 

Article 5(5) 

Article 5(6) 

─ 

Articles 8, 46 and 54 

Article 44 

Article 40(3) 

Article 49(3) 

Articles 40(2) and 49(2)  

Articles 51 and 70 

Articles 8, 46 and 54 

Article 44 

Article 6(1) to (4) 

Article 82(1), (2) and (3) 

Article 
subparagraphs 

6(5), 

first 

and 

second 

Article 82(1), (2) and (3) 

Article 6(5), third subparagraph 

Articles 61 and 64  

Article 6(5), fourth subparagraph 

Article 10 

Article 6(5), fifth subparagraph 

Article 76 

Article 6(6) 

Article 6(7) 

Articles 61 and 65 

Article 76 

Article 6(8), first indent 

─ 

Article 6(8), second indent 

Article 53 

Article 6(8), third indent 

Article 82(4) 

Article 6(8), fourth indent 

Articles 62, 65 and 85 

Article 6(8), fifth indent 

─ 

Article 6(8), sixth indent 

Article 6(9) 

Article 10(1) 

Article 10(2) 

Article 10(3) 

Article 10(4) 

Article 11(1) 

Article 11(2) 

EN 

Article 76 

Article 62 

Articles 78(3), 80, 81 and 82  

Articles 74, 75 and 76 

Article 88 

Article 82(4) 

Article 82(1) 

─  

124 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

─ 

   EN 

Article 11(3) 

Article 11(4) 

Article 11(5) 

Article 12(1) 

Article 12(2) 

Article 12(3) 

Article 12(4) 

 ─ 

Article 87 

Article 87 

─  

Article 19(d) 

─ 

─ 

Articles 43, 134, 135 and 136 

Articles 65(3), 88(5) and 90(2) 

Article 4(1)(g) and (h) 

─ 

Article 115 

Articles 41(4) and 90(1) and (5) 

Articles  19(d),  103,  130,  134,  135 
and 136 

Article 13(1) and (2) 

Article 71(5) 

Articles 45 and 89(1)(f) 

Article 13(3) and (4) 

Article 13a(1) 

Article 13a(2) 

Article 13a(3) 

Article 13a(4) 

Article 13a(5) 

Article 13b(1) 

Article 13b(2) 

Article 13b(3) 

Article 13b(4) 

Article 13b(5) 

Article 13b(6) 

Article 13c(1)(a) 

Article 13c(1)(b) 

Article 13c(1)(c) 

Article 13c(2)(a) 

Article 13c(2)(b) 

Article 13c(2)(c) 

Article 13c(2)(d) 

Article 13c(2)(e) 

Article 13c(2)(f) 

─  

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Article 71 

Article 71 

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Article 61 

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Article 47 

Article 52 

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Articles 50 and 52 

Article 63 

Article 49 

Article 46 

Article 46 

Article 46 

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Article 55 

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Article 54, 55 and 56 

Article 47 

Article 51 

Article 51 

Article 51 

Article 49, 50 and 51 

Article 47 

EN 

125 

   EN 

Article 13c(3) 

Article 13c(4) 

Article 13c(5) 

Article 13c(6) 

Article 13c(7) 

Article 13c(8) 

Article 13d(1) 

Article 13d(2) 

Article 13d(3) 

Article 13d(4) 

Article 13d(5) 

Article 13d(6) 

Article 13d(7) 

Article 13e 

Article 14 

Article 15(1) 

Article 15(2) 

Article 15(3) 

Article 15(4) 

Article 16(1) 

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Article 89 

Article 72 

Articles 55 and 130  

Articles 55, 58 and 62 

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Articles 134, 135 and 136 

Articles  40(4),  41(4),  49(5),  50(4) 
and 97 

Article 130 

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Articles 94 and 95 

Articles  5(3)  and  (4),  32(3),  37(2) 
and  (3),  40(2),  41(2),  49(2),  50(2), 
68(2)  and  (3),  69(2)  and  (3),  74(2) 
and (3) and 75(2) and (3) 

Articles 77 and 78 

Article 79 

Articles 79 and 83 

Article 80 

Articles 78 and 79  

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Article 41(2), first subparagraph 

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Article 41(2), second subparagraph  ─ 

Article 67(3) 

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Article 10(1) and (2) and Article 16  ─ 

Article 16(2), first subparagraph 

Article 28 

Article 16(2), second subparagraph 

Article 14(1) 

Article 16(2), third subparagraph 

Article 14(1) 

Article 16(2), fourth subparagraph 

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Article 16(3) 

Article 16(4) 

Article 16(5) 

Article 29 

Articles 27(1), 29(1) and 47(1)  

Articles 27(6), 29(6) and 47(4)  

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EN 

126 

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Article 18 

Article 20 

Article 21(1) 

Article 21(2) 

Article 21(3) 

Article 21(4) 

Article 21(5) 

Article 21(6) 

Article 21(7) 

Article 21(8) 

Article 22 

Article 23(1) 

Article 23(2) 

Article 23(3) 

Article 23(4) 

Article 23(5), first subparagraph 

Article 23(5), second subparagraph 

Article 23(5), third subparagraph 

Article 23(5), fourth subparagraph 

Article 23(5), fifth subparagraph 

Article 23(6), first subparagraph 

Article 23(6), second subparagraph 

Article 23(6), third subparagraph 

Article 23(6), fourth subparagraph 

Article 23(7) 

Article 23(8) 

Article 23(9) 

Article 23(10) 

Article 24(1) 

Article 99 

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Article 97 

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Article 102 

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Article 115(1) and (2) 

Article 115(4) 

Article 115(1) and (3) 

Article 115(1) and (3) 

Articles 117 and 118 

Article 130 

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EN 

127 

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Article 24(2) 

Article 24(3) 

Article 25 

Article 26 

Article 27 

Article 27a 

Article 28 

Article 29 

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Annex I, Part A, Section I 

Article 5(2) 

Annex I, Part A, Section II 

Article 5(2) 

Annex I, Part B 

Article 32(3) 

Annex II, Part A, section I  

Article 5(2) 

Annex II, Part A, Section II 

Article 37(2) 

Annex II, Part B 

Annex III, Part A 

Annex III, Part B 

Annex IV, Part A 

Annex IV, Part B 

Article 32(3) 

Article 40(1) 

Article 49(1) 

Article 41(1) 

Article 50(1) 

Annex V, Part A, Point I 

Article 74(1) 

Annex V, Part A, Point II 

Article 75(1) 

Annex V, Part B, Point I 

Article 68(1) 

Annex V, Part B, Point II 

Article 69(1)  

Annex VI 

Annex VII 

Annex VIII 

Annex VIIIa 

Annex IX 

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Annex VIII 

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128 

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Article 87(2) 

Articles 107 to 110 

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   EN