CELEX: 52013PC0267
Language: en
Date: 2013-05-06
Title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on protective measures against pests of plants

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		52013PC0267
		
			Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on protective measures against pests of plants /* COM/2013/0267 final - 2013/0141 (COD) */
			
				
		
		
			
			   	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/EC[1], 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. 
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, 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) 882/2004[3]). 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 modifications[4].
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 consultant[6]. 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 evaluation[7] was presented in a second
conference on 28 September 2010 including stakeholders, the 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 Groups[8] 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 page[9] 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
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 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 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 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.
Schematic representation of the various
types of pests in the proposal, the decision process for their qualification
and the measures required against them.
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.
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.
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. 
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 Committee[10],

Having regard to the opinion of the
Committee of the Regions[11],

Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       Council Directive
2000/29/EC of 8 May 2000 on protective measures against the introduction into
the Community of organisms harmful to plants or plant products and against
their spread within the Community[12]
sets out a plant health regime.
(2)       On 21 November 2008, the
Council invited the Commission to proceed to an evaluation of that plant health
regime[13].
(3)       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.
(4)       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 phytosanitary risks posed by those pests and the reduction of those risks
to an acceptable level.
(5)       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.
(6)       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.
(7)       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 territory
as a whole, a restricted list of such pests, hereinafter 'priority pests',
should be established.
(10)     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.
(11)     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. 
(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 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
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
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)     It is appropriate to
provide for the replacement of plant passports and of phytosanitary
certificates.
(49)     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 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.
(55)     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.
(56)     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.
(57)     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.
(58)     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.
(59)     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.
(60)     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.
(61)     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.
(62)     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.
(63)     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.
(64)     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.
(65)     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.
(66)     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.
(67)     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.
(68)     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.
(69)     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.
(70)     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.
(71)     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, 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 powers[16].
(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 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-rollers[17] and Council Directive 69/466/EEC
of 8 December 1969 on control of San José Scale[18] 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 Disease[19], Council Directive 93/85/EEC
of 4 October 1993 on control of Potato Ring Rot[20], 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/EC[22]
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,
HAVE ADOPTED THIS REGULATION:
Chapter I
Subject matter, scope and definitions
Article 1
Subject matter and scope
1.           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.
2.           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)         
an addition to Annex I of one or more territories
that are referred to in Article 355(1) of the Treaty;
(b)         
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;
(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;
(3)          '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; 
(4)          'other object' means any
material or object, other than plants or plant products, capable of harbouring
or spreading pests, including soil or growing medium;
(5)          '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];
(6)          '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;
(7)          '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: 
(a)         
planting;
(b)         
growing;
(c)         
production;
(d)         
introduction into, and movement within, and out
of the Union territory;
(e)         
making available on the market;
(8)          '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;
(9)          '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)                   
its identity is established, within the meaning
of point (1) of Section 1 of Annex II;
(b)                   
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; 
(c)                   
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;
(d)                   
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
(e)                   
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.
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).
Article 5
Prohibition of
introduction and movement of Union quarantine pests
1.           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.
2.           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).
3.           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.
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)         
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;
(b)         
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 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)         
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;
(b)         
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;
(c)         
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)         
the pest is to be kept in storage facilities found
to be appropriate by the competent authorities and referred to in the
authorisation;
(b)         
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;
(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.
4.           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.
5.           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.
6.           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
1.           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.
2.           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.
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. 
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)         
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; 
(b)         
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;
(c)         
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. 
2.           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. 
3.           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.
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.
Article 14
Notification of imminent
dangers 
1.           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.
2.           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
1.           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.
2.           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.
3.           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.
4.           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. 
Article 16
Eradication of Union
quarantine pests
1.           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.
2.           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.
3.           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.
4.           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 
1.           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)         
all plants showing signs or symptoms indicating
possible infestation by that pest; 
(c)         
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.
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.
4.           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.
5.           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.
6.           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 
1.           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).
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.
3.           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.
4.           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. 
5.           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 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.           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. 
2.           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. 
3.           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.
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.
2.           Member States shall notify
their multi-annual survey programmes upon their establishment to the Commission
and the other Member States. 
3.           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
1.           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. 
2.           Member States shall report
to the Commission and the other Member States by 30 April of each year the
results of the surveys referred to in paragraph 1, which were carried out in
the preceding year.
Article 24
Contingency plans for
priority pests
1.           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.           The contingency plan shall
include the following: 
(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)         
arrangements for recording findings of the
presence of the priority pest concerned;
(e)         
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; 
(f)           
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.
Article 25
Simulation exercises
1.           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.
2.           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.
3.           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.
4.           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
1.           Where the presence of a
priority pest is officially confirmed in the territory of a Member State pursuant
to Article 11(1)(a), 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. 
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.
2.           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.
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. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 99(3).
2.           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'.
3.           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.
4.           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.
5.           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.
6.           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).
7.           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
1.           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.
2.           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. 
3.           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
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). 
2.           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.
3.           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.
4.           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.
5.           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.
6.           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).
7.           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 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. 
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).

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)         
a description of the boundaries of the protected
zone concerned, including maps; and 
(b)         
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 there is no risk of spreading the respective protected zone
quarantine pest within that protected zone.
3.           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
1.           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).
2.           Member States shall notify
the Commission and the other Member States, by 30 April of each year, of
the results of the surveys referred to in paragraph 1, which 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.
2.           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.
3.           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.
4.           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;
(b)         
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;
(c)         
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)                   
its identity is established in accordance with
point (1) of Section 4 of Annex II;
(b)                   
it is present in the Union territory;
(c)                   
it is no Union quarantine pest;
(d)                   
it is transmitted mainly through specific plants
for planting, in accordance with point (2) of Section 4 of Annex II;
(e)                   
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;
(f)                     
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.           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.
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: 
(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 seed[24] 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/EEC[25];
(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/EEC[26];

(e)         
point (b) of Annex II to Council Directive
2002/55/EC of 13 June 2002 on the marketing of vegetable seed[27];
(f)           
point (6) of Annex I to Council Directive
2002/56/EC[28]
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 plants[29] 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).
3.           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.
4.           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.
5.           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.
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.
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
Tariff[30]
(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.
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.           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.
4.           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.           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.
2.           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.
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.           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.
4.           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.
2.           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.
3.           The implementing acts
referred to in paragraph 1 shall be adopted in accordance with the examination
procedure referred to in Article 99(3).
Article 43
Information to be provided
to travellers, clients of postal services and internet clients
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.
2.           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.
3.           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
1.           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)         
they are grown or produced in areas of third
countries in the vicinity of their border with Member States (hereinafter:
'third country frontier zones');
(b)         
they are introduced into areas of Member States immediately
across that border (hereinafter: 'Member State frontier zones');
(c)         
they are to be processed in the respective
Member State frontier zones in such a manner that any phytosanitary risk is
eliminated;
(d)         
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:
(a)         
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;
(b)         
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
(c)         
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.
3.           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).
4.           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
1.           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;
(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.
2.           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.
3.           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.
4.           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).
5.           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
1.           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)         
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;
(b)         
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;
(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)         
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;
(b)         
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;
(c)         
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.           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.
5.           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.
6.           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 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).
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.
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.
3.           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.
4.           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).
5.           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.
6.           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].
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.           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.
2.           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.
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.
3.           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.
4.           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).
5.           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.           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.
2.           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.
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.           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.
4.           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.
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.           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.
2.           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:
(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)         
they have surfaces of smooth and impervious
material allowing effective cleaning and decontamination;
(d)         
they have surfaces resistant to deterioration
and to attack by insects and other arthropods;
(e)         
they have irrigation, sewage and ventilation
systems which exclude the transmission or escaping of quarantine pests;
(f)           
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)           
a definition of the tasks of those stations, and
the conditions under which they shall carry out those tasks, is available;
(j)           
a sufficient number of suitably qualified,
trained and experienced personnel is available.
3.           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
1.           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.
2.           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.
3.           The person responsible for
the quarantine station shall keep records on the following points:
(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
1.           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.
2.           The competent authority
shall revoke the designation referred to in Article 56(1) without delay where:
(a)         
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;
(b)         
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
1.           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.
2.           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
1.           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.
2.           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 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)         
it is recognised by that third country as being
present in its territory and not under official control;
(b)         
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;
(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'.
2.           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.
3.           Paragraph 1 shall not
apply to a professional operator covered by one or more of the following
points:
(a)         
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;
(b)         
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.
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.
3.           The competent authorities
shall register a professional operator where the application for registration
contains the elements of paragraph 2.
4.           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.
5.           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
The register shall contain the elements set
out in points (a), (b), (d) and (e) of Article 62(2) and the following
elements: 
(a)          the official registration number;

(b)          the two-letter code indicated in
norm ISO 3166-1-alpha-2[31]
for the Member State in which the professional operator is registered;
(c)          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
1.           The Member State keeping
the register shall, on request, make the information it contains available to
the other Member States or the Commission. 
2.           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
1.           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.
2.           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.
3.           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.
4.           On request, they shall
communicate the information in the records referred to in paragraphs 1 and 2 to
the competent authorities.
5.           Paragraphs 1 to 4 shall
not apply to the professional operators referred to in point (b) of Article
61(3).
Article 66
Movements of plants, plant
products and other objects within the premises of the professional operator
1.           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).
2.           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
1.           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).
2.           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.
3.           Where applicable, the
phytosanitary certificate shall state that the plants, plant products or other
objects concerned comply with phytosanitary measures recognised as equivalent,
pursuant to Article 42, to the requirements of the implementing act adopted
pursuant to Article 41(2).
4.           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
1.           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 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).
4.           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
1.           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
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).
4.           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
1.           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.
2.           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
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.
3.           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.
4.           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.
5.           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
1.           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 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: 
(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).
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).
4.           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
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
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).
3.           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).
4.           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.           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.
2.           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.
3.           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 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.
4.           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.
5.           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
1.           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.
2.           Plant passports may,
however, be issued by the competent authorities where a registered operator
requests so.
3.           Authorised operators shall
only issue plant passports in the premises, collective warehouses and
dispatching centres referred to in Article 62(2)(d).
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)                   
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) and (2); and
(e)                   
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.           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.
2.           The examination shall be
carried out by the authorised operator, or, where applicable under Article
79(2), by the competent authorities. 
3.           The examination shall
fulfil the following conditions:
(a)         
it shall be carried out frequently, at
appropriate times and taking into account the risks involved;
(b)         
it shall be carried out at the premises,
collective warehouses and dispatching centres referred to in Article 62(2)(d);
and
(c)         
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.
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).
4.           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;
(b)         
it has in place systems and procedures enabling
it to fulfil its obligations concerning traceability pursuant to Article 65 and
66.
2.           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 
1.           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.
2.           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
1.           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).
2.           The phytosanitary risk
management plan shall cover, where appropriate in the form of instruction
manuals, at least the following:
(a)         
the information required under Article 62(2)
concerning the registration of the authorised operator;
(b)         
the information required under Article 65(3) and
66(1) concerning the traceability of plants, plant products and other objects;
(c)         
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;
(d)         
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;
(e)         
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;
(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).
3.           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 
1.           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.
2.           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
1.           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.
2.           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:
(a)         
the identity of the plants, plant products or
other objects concerned is guaranteed; and
(b)         
the plants, plant products or other objects
concerned continue to comply with the requirements referred to in Articles 80
and 81.
4.           Where a plant passport is
issued pursuant to paragraphs 1 or 2, the examination referred to in Article 82(1)
shall not be required.
5.           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 
1.           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.
2.           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
1.           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.
2.           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.
3.           Where paragraphs 1 and 2
apply, the professional operator concerned shall retain the invalidated plant
passport for three years.
4.           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.
5.           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
1.           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.
2.           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.
3.           The mark shall only be
applied by a professional operator authorised in accordance with Article 92.
4.           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)         
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);
(b)         
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.
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)         
it exclusively uses wood from treatment facilities
operated by a registered operator authorised pursuant to paragraph 1;
(b)         
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.
3.           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.
4.           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
1.           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).
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;
(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).
3.           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 
1.           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.
2.           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)         
a plant passport, as referred to in Article 73,
accompanying the plant, plant product or other object concerned;
(b)         
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.
3.           The phytosanitary
certificate for export shall contain the elements set out in Part A of Annex
VIII.
4.           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.
5.           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).
6.           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
1.           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)         
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;
(b)         
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.
3.           The provisions of Article 94(2),
concerning the information sufficient to certify compliance with the
requirements of the third country concerned, shall apply accordingly.
4.           The phytosanitary
certificate for re-export shall contain the elements set out in Part B of Annex
VIII.
5.           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.
6.           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).
7.           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
1.           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.

2.           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.
3.           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.
4.           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.
5.           The Commission shall be
empowered to adopt delegated acts, in accordance with Article 98, setting out
the contents of the pre-export certificate. 
6.           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).
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.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.
2.           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.
3.           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 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.
4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.
5.           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
1.           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.
2.           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.
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 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)     they concern Union quarantine pests
not known to occur in the Union territory, listed pursuant to Article 5(2) of
Regulation (EU) No […]/[…]*;
(b)     they concern priority pests listed
pursuant to Article 6(2) of Regulation (EU) No […]/[…]*;
(c)     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):
'(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)     they concern Union quarantine pests
not known to occur in the Union territory, listed pursuant to Article 5(2) of
Regulation (EU) No […]/[…]*;
(b)     they concern priority pests listed
pursuant to Article 6(2) of Regulation (EU) […]/[…]*;
(c)     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 […]/[…]*.
*          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.           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].
2.           Article 97(2) shall apply from
the date when the systems referred to in Article 97(1) are established.
3.           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                       For
the Council
The President                                                 The
President
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.           Guadeloupe
2.           French
Guiana
3.           Martinique
4.           Réunion
5.           Saint-Martin
6.           Mayotte
7.           Ceuta
8.           Melilla
9.           The
Canary Islands
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)         
the pest is not known to be present in the
territory in question, except in a limited part of it;
(c)         
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.
(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)      hosts of the pest and, where
relevant, vectors for transmission of the pest are available;
(ii)      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;
(e)         
effects on street trees, parks and public and
private green;
(f)           
effects on native plants, biodiversity and
ecosystem services;
(g)         
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;
(h)         
changes to producer costs or input demands, including
control costs and costs of eradication and containment;
(i)           
effects on producer profits that result from
changes in production costs, yields or price levels;
(j)           
changes to domestic or foreign consumer demand
for a product resulting from quality changes;
(k)         
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.
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)          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.
(b)          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 flora[32] and Directive 2009/147/EC of the European
Parliament and of the Council of 30 November 2009 on the conservation of wild
birds[33];
(ii)     major and permanent increases of the
use of plant protection products on the crops concerned.
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.
(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;
(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)           
effects on producer costs or input demands,
including control costs and costs of eradication and containment;
(j)           
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.
As regards points (i) to (m), indirect effects
within and outside the endangered area shall be taken into account.
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.
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, plant products, premises, land, water, soil,
growing media, facilities, 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;
(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.
(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.
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.* 
II. Additional Declaration
[Enter text here]
III. Disinfestation and/or Disinfection Treatment
Date ________ Treatment ___________ Chemical (active
ingredient)______________________ 
Duration and temperature________________________________________________________ 
Concentration_________________________________________________________________ 
Additional information___________________________________________________________ 
___________________________________________________________________________ 
                                                         Place
of issue_____________________________________ 
(Stamp of Organization) ________    Name of authorized
officer___________________________ 
                                                         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
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 || ¨ || *certified true copy || ¨ 
of which is attached to this certificate;
that they are
 *packed || ¨ || *repacked || ¨ 
in
 *original || ¨ || *new || ¨ 
containers, that based on the
 *original phytosanitary certificate || ¨ 
and
 *additional inspection || ¨ 
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 || ¨ || boxes 
II. Additional Declaration
[Enter text here]
III. Disinfestation and/or Disinfection Treatment
Date ________ Treatment ___________ Chemical (active
ingredient)______________________ 
Duration and temperature________________________________________________________ 
Concentration_________________________________________________________________ 
Additional information___________________________________________________________ 
___________________________________________________________________________ 
                                                         Place
of issue_____________________________________ 
(Stamp of Organization) _______      Name of authorized
officer___________________________ 
                                                         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
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)         
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;
(d)         
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;
(e)         
the letter 'C.', followed by the lot number of
the plant, plant product or the other object concerned;
(f)           
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;
(e)         
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;
(f)           
the letter 'C.', followed by the lot number of
the plant, plant product or the other object concerned;
(g)         
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;
(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.
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)          on its left hand, the logo of the
IPPC;
(b)          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.
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;
(b)         
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;
(c)         
the words 'Declared name and address of
consignee', followed by the declared name and address of the consignee;
(d)         
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;
(e)         
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;
(f)           
the words "Declared means of
conveyance", followed by the declared means of conveyance of that
consignment;
(g)         
the words "Declared point of entry", followed
by the declared point of entry into the country of destination of that
consignment;
(h)         
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;
(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 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.';
(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)         
the words "Chemical (active
ingredient)", followed by the active ingredient of the chemical used for
the treatment referred to in point (m);
(o)         
the words "Duration and temperature", followed
by the duration and, where applicable, temperature of that treatment;
(p)         
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)          
the word "Additional information", followed
by any additional information that the competent authority wishes to include in
the certificate;
(s)          
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)         
the words 'Name and signature of authorised
officer', followed by the name and signature of the officer issuing and signing
the phytosanitary certificate;
(v)         
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.
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;
(b)         
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;
(c)         
the words 'Declared name and address of
consignee', followed by the declared name and address of the consignee;
(d)         
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;
(e)         
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;
(f)           
the words "Declared means of
conveyance", followed by the declared means of conveyance of that
consignment;
(g)         
the words "Declared point of entry", followed
by the declared point of entry into the country of destination of that
consignment;
(h)         
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;
(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:
'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 ……………….
 ¨ || *original || ¨ || *certified true copy of which is attached to this certificate, 
–              
that they are
 ¨ || *packed || ¨ || *repacked 
in
 ¨ || *original || ¨ || *new containers, 
–              
that based on the
 ¨ || *original phytosanitary certificate 
and
 ¨ || *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)         
the words "Chemical (active
ingredient)", followed by the active ingredient of the chemical used for
the treatment referred to in point (m);
(o)         
the words "Duration and temperature", followed
by the duration and, where applicable, temperature of that treatment;
(p)         
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)          
the word "Additional information", followed
by any additional information that the competent authority wishes to include in
the certificate;
(s)          
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)         
the words 'Name and signature of authorised
officer', followed by the name and signature of the officer issuing and signing
the phytosanitary certificate;
(v)         
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.
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 27(1) || ─ 
 Article 2 || Article 27(1)(d) || ─ 
 Articles 3, 4 and 5 || Article 27(1)(c) || ─ 
 Article 6 || Article 27(1)(e) || ─ 
 Article 7 || ─ || ─ 
 Article 8 || Article 8 || ─ 
 Article 9 || Article 31(1) || ─ 
 Articles 10 and 11 || Article 27(1)(c) || ─ 
 Articles 12 and 13 || ─ || ─ 
 Council Directive 93/85/EEC || This Regulation || Regulation (EU) No …/…. [Office of Publications, please insert number of Regulation on Official Controls] 
 Article 1 || Article 27(1) || ─ 
 Article 2 || Article 27(1)(f) || ─ 
 Article 3 || Article 9 || ─ 
 Articles 4 to 8 || Article 27(1)(a), (b) and (c) || ─ 
 Article 9 || ─ || ─ 
 Article 10 || Article 8 || ─ 
 Article 11 || Article 31(1) || ─ 
 Article 12 || Article 27(1) || ─ 
 Articles 13 to 15 || ─ || ─ 
 Annexes I to V || 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) || ─ 
 Article 2 || Article 27(1)(f) || ─ 
 Article 3 || Article 9 || ─ 
 Article 4 to 7 || Article 27(1)(a), (b) and (c) || ─ 
 Article 8 || ─ || ─ 
 Article 9 || Article 8 || ─ 
 Article 10 || Article 31(1) || ─ 
 Article 11 || Article 27(1) || ─ 
 Articles 12 to 14 || ─ || ─ 
 Annexes I to VII || 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 || Article 27(1) || ─ 
 Articles 2 and 3 || Article 27(1) and (2) || ─ 
 Articles 4 to 8 || Article 27(1)(f) || ─ 
 Articles 9 to 13 || Article 27(1) and (2) || ─ 
 Article 14 || Article 8 || ─ 
 Article 15 || Article 31(1) || ─ 
 Article 16 || Article 27(1) || ─ 
 Article 17 || Article 99 || ─ 
 Articles 18 to 20 || ─ || ─ 
 Annexes I to IV || 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 3 
 Article 1(5) and (6) || ─ || ─ 
 Article 2(1)(a) || Article 2(1) || ─ 
 Article 2(1)(b) || Article 2(2) || ─ 
 Article 2(1)(c) || ─ || ─ 
 Article 2(1)(d) || Article 2(3) || ─ 
 Article 2(1)(e) || Article 1(1) || ─ 
 Article 2(1)(f) || Article 73 || ─ 
 Article 2(1)(g) || ─ || Articles 3, 25 and 36 
 Article 2(1)(h) || Articles 32 to 35 || ─ 
 Article 2(1)(i), first subparagraph || Article 71 || Article 4 
 Article 2(1)(i), second subparagraph || ─ || Articles 4 and 19 
 Article 2(1)(i), third subparagraph || ─ || Article 129 
 Article 2(1)(j) || ─ || Article 2(28) 
 Article 2(1)(k) || ─ || Article 3 
 Article 2(1)(l) || ─ || Article 3 
 Article 2(1)(m) || ─ || Article 3 
 Article 2(1)(n) || ─ || Article 3 
 Article 2(1)(o) || Article 2(6) || ─ 
 Article 2(1)(p) || ─ || Article 2(26) 
 Article 2(1)(q) || ─ || ─ 
 Article 2(1)(r) || ─ || Article 2(48) 
 Article 2(2) || Article 2(2), second subparagraph || ─ 
 Article 3(1) || Article 5(1) || ─ 
 Article 3(2) and (3) || Articles 5(1), 37(1) and 41(3) || ─ 
 Article 3(4) || ─ || ─ 
 Article 3(5) || Article 32(2) and 50(3) || ─ 
 Article 3(6) || Articles 5(2) and 32(3) || ─ 
 Article 3(7) || Articles 5(3), 27(1) and 37(1) || ─ 
 Articles 3(8) and (9) || Articles 8, 46 and 54 || ─ 
 Article 4(1) || Article 40(1) || ─ 
 Article 4(2) || Article 49(1) || ─ 
 Article 4(3) || ─ || ─ 
 Article 4(4) || ─ || ─ 
 Article 4(5) || Articles 8, 46 and 54 || ─ 
 Article 4(6) || Article 44 || ─ 
 Article 5(1) || Article 40(3) || ─ 
 Article 5(2) || Article 49(3) || ─ 
 Article 5(3) || Articles 40(2) and 49(2) || ─ 
 Article 5(4) || Articles 51 and 70 || ─ 
 Article 5(5) || Articles 8, 46 and 54 || ─ 
 Article 5(6) || Article 44 || ─ 
 Article 6(1) to (4) || Article 82(1), (2) and (3) || ─ 
 Article 6(5), first and second subparagraphs || 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) || Articles 61 and 65 || ─ 
 Article 6(7) || 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 76 || ─ 
 Article 6(9) || Article 62 || ─ 
 Article 10(1) || Articles 78(3), 80, 81 and 82 || ─ 
 Article 10(2) || Articles 74, 75 and 76 || ─ 
 Article 10(3) || Article 88 || ─ 
 Article 10(4) || Article 82(4) || ─ 
 Article 11(1) || Article 82(1) || ─ 
 Article 11(2) || ─ || ─ 
 Article 11(3) ||  ─ || Article 19(d) 
 Article 11(4) || Article 87 || ─ 
 Article 11(5) || Article 87 || ─ 
 Article 12(1) || ─ || Articles 43, 134, 135 and 136 
 Article 12(2) || Articles 65(3), 88(5) and 90(2) || Article 4(1)(g) and (h) 
 Article 12(3) || ─ || Article 115 
 Article 12(4) || 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 47 
 Article 13a(2) || ─ || Article 52 
 Article 13a(3) || Article 71 || ─ 
 Article 13a(4) || Article 71 || ─ 
 Article 13a(5) || ─ || Articles 50 and 52 
 Article 13b(1) || ─ || Article 63 
 Article 13b(2) || ─ || Article 49 
 Article 13b(3) || ─ || Article 46 
 Article 13b(4) || ─ || Article 46 
 Article 13b(5) || ─ || Article 46 
 Article 13b(6) || ─ || ─ 
 Article 13c(1)(a) || ─ || Article 55 
 Article 13c(1)(b) || Article 61 || ─ 
 Article 13c(1)(c) || ─ || Article 54, 55 and 56 
 Article 13c(2)(a) || ─ || Article 47 
 Article 13c(2)(b) || ─ || Article 51 
 Article 13c(2)(c) || ─ || Article 51 
 Article 13c(2)(d) || ─ || Article 51 
 Article 13c(2)(e) || ─ || Article 49, 50 and 51 
 Article 13c(2)(f) || ─ || Article 47 
 Article 13c(3) || ─ || Articles 55 and 130 
 Article 13c(4) || ─ || Articles 55, 58 and 62 
 Article 13c(5) || ─ || ─ 
 Article 13c(6) || Article 89 || ─ 
 Article 13c(7) || Article 72 || Articles 134, 135 and 136 
 Article 13c(8) || Articles 40(4), 41(4), 49(5), 50(4) and 97 || Article 130 
 Article 13d(1) || ─ || Articles 77 and 78 
 Article 13d(2) || ─ || Article 79 
 Article 13d(3) || ─ || Articles 79 and 83 
 Article 13d(4) || ─ || Article 80 
 Article 13d(5) || ─ || Articles 78 and 79 
 Article 13d(6) || ─ || ─ 
 Article 13d(7) || ─ || ─ 
 Article 13e || Articles 94 and 95 || ─ 
 Article 14 || 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) || ─ 
 Article 15(1) || Article 41(2), first subparagraph || ─ 
 Article 15(2) || Article 41(2), second subparagraph || ─ 
 Article 15(3) || Article 67(3) || ─ 
 Article 15(4) || ─ || ─ 
 Article 16(1) || 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 || ─ || ─ 
 Article 16(3) || Article 29 || ─ 
 Article 16(4) || Articles 27(1), 29(1) and 47(1) || ─ 
 Article 16(5) || Articles 27(6), 29(6) and 47(4) || ─ 
 Article 18 || Article 99 || ─ 
 Article 20 || ─ || ─ 
 Article 21(1) || ─ || Article 115(1) and (2) 
 Article 21(2) || ─ || Article 115(4) 
 Article 21(3) || ─ || Article 115(1) and (3) 
 Article 21(4) || ─ || Article 115(1) and (3) 
 Article 21(5) || ─ || Articles 117 and 118 
 Article 21(6) || Article 97 || Article 130 
 Article 21(7) || ─ || ─ 
 Article 21(8) || ─ || ─ 
 Article 22 || ─ || ─ 
 Article 23(1) || ─ || ─ 
 Article 23(2) || ─ || ─ 
 Article 23(3) || Article 102 || ─ 
 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 24(2) || ─ || ─ 
 Article 24(3) || ─ || ─ 
 Article 25 || ─ || ─ 
 Article 26 || ─ || ─ 
 Article 27 || ─ || Article 87(2) 
 Article 27a || ─ || Articles 107 to 110 
 Article 28 || ─ || ─ 
 Article 29 || ─ || ─ 
 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 || Article 32(3) || ─ 
 Annex III, Part A || Article 40(1) || ─ 
 Annex III, Part B || Article 49(1) || ─ 
 Annex IV, Part A || Article 41(1) || ─ 
 Annex IV, Part B || 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 VIII || ─ || ─ 
 Annex VIIIa || ─ || ─ 
 Annex IX || ─ || ─ 
[1]               OJ L 169, 10.7.2000, p. 1.
[2]               http://ec.europa.eu/food/plant/plant_health_biosafety/rules/index_en.htm
[3]               OJ L 191, 28.5.2004, p. 1.
[4]               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.
[5]               Taking account of a previous evaluation of the financial
aspects of the regime, completed in 2008.
[6]               Food Chain Evaluation Consortium (FCEC), consisting
of Civic Consulting, Agra CEAS Consulting (project leader), Van Dijk Management
Consultants and Arcadia International. 
[7]               http://ec.europa.eu/food/plant/plant_health_biosafety/rules/index_en.htm
[8]               Advisory Groups on Seeds, Advisory Group on Cotton,
Advisory Group on Floriculture and Ornamentals, Advisory Group on Citrus,
Advisory Group on Potato.
[9]               http://ec.europa.eu/food/plant/plant_health_biosafety/rules/index_en.htm

[10]             OJ C , , p. .
[11]             OJ C , , p. .
[12]             OJ L 169, 10.7.2000, p. 1.
[13]             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.
[14]             OJ L …, ……, p. …
[15]             OJ L …, ……, p. …
[16]             OJ L 55, 28.2.2011, p. 13.
[17]             OJ L 352, 28.12.1974, p. 41–42.
[18]             OJ L 323, 24.12.1969, p. 5–6.
[19]             OJ L 323, 24.12.1969, p. 1–2.
[20]             OJ L 259, 18.10.1993, p. 1–25.
[21]             OJ L 235, 21.8.1998, p. 1–39.
[22]             OJ L 156, 16.6.2007, p. 12–22.
[23]             OJ L …, ……….., p. ….
[24]             OJ L 125, 11.7.1966, p. 2309.
[25]             OJ L 250, 7.10.1993, p. 1.
[26]             OJ L 250, 7.10.1993, p. 9.
[27]             OJ L 193, 20.7.2002, p. 33.
[28]             OJ L 193, 20.7.2002, p. 60.
[29]             OJ L 193, 20.7.2002, p. 74.
[30]             OJ L 256, 7.9.1987, p. 1.
[31]             ISO 3166-1:2006, Codes for the representation of names
of countries and their subdivisions – Part 1: Country codes. International
Organisation for Standardization, Geneva.
[32]             OJ L 206, 22.7.1992, p. 7.
[33]             OJ L 20, 26.1.2010, p. 7.