Commission Directive 2008/61/EC of 17 June 2008 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 2000/29/EC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections (Codified version)
Date: 2008-06-17
Institutions: European Commission
Subjects: codification of EU law, parasitology, plant disease, plant health legislation, protected area, protection of plant life, scientific research

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COMMISSION DIRECTIVE 2008/61/EC

of 17 June 2008

establishing the conditions under which certain harmful organisms, plants, plant products and other
objects listed in Annexes I to V to Council Directive 2000/29/EC may be introduced into or moved
within the Community or certain protected zones thereof, for trial or scientific purposes and for
work on varietal selections

(Codified version)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

or moved within the Community or certain protected
zones thereof unless the relevant special requirements
indicated in that Annex are met.

(5)

(6)

(7)

(8)

Having regard to the Treaty
Community,

establishing the European

Having regard to 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
their spread within the Community (1), and in
and against
particular Articles 3(8), 4(5), 5(5) and 13b(4) thereof,

Whereas:

(1)

(2)

(3)

I

Commission Directive 95/44/EC of 26 July 1995 estab-
lishing the conditions under which certain harmful
organisms, plants, plant products and other objects
listed in Annexes
to V to Council Directive
77/93/EEC may be introduced into or moved within
the Community or certain protected zones thereof, for
trial or scientific purposes and for work on varietal
selections (2) has been substantially amended (3). In the
interests of clarity and rationality the said Directive
should be codified.

Under the provisions of Directive 2000/29/EC, harmful
organisms listed in its Annexes I and II, whether singly or
associated with the relevant plants or plant products
to that Directive, may not be
listed in Annex II
introduced into and spread by movement within the
Community or certain protected zones thereof.

Under Directive 2000/29/EC, plants, plant products and
listed in its Annex III may not be
other objects
introduced
into certain
protected zones thereof.

into the Community or

(4)

Plants, plant products and other objects listed in Annex
IV to Directive 2000/29/EC may not be introduced into

(9)

Plants, plant products and other objects listed in Annex
V, Part B to Directive 2000/29/EC coming from third
countries may not be introduced into the Community
unless they comply with the standards and requirements
laid down in that Directive and are accompanied by an
official
such
compliance and are, moreover, inspected on an official
basis for compliance with these provisions.

phytosanitary

certificate

ensuring

However, Articles 3(8), 4(5), 5(5) and 13b(4) of Directive
2000/29/EC provide for those rules not to apply to the
introduction and movement of such harmful organisms,
plants, plant products and other objects,
for trial or
scientific purposes and for work on varietal selections,
at
under
Community level.

conditions which

determined

shall

be

it is necessary to determine the conditions
Therefore,
which must be satisfied in the case of such introductions
or movements, in order to ensure that there is no risk of
harmful organisms spreading.

trade

therein (4)

and
the European Parliament and of

The conditions laid down for material under Council
Regulation (EC) No 338/97 of 9 December 1996 on
the protection of species of wild fauna and flora by
regulating
under Directive
2001/18/EC of
the
Council of 12 March 2001 on the deliberate release
into the environment of genetically modified organisms
and repealing Council Directive 90/220/EEC (5), and
other more specific Community provisions regarding
endangered species of wild fauna
and
genetically modified organisms, are not affected by this
Directive.

and flora

The measures provided for
accordance with
Committee on Plant Health.

the

in this Directive are in
Standing
the

of

opinion

(1) OJ L 169, 10.7.2000, p. 1. Directive as

last amended by
Commission Directive 2007/41/EC (OJ L 169, 29.6.2007, p. 51).
(2) OJ L 184, 3.8.1995, p. 34. Directive as amended by Directive

97/46/EC (OJ L 204, 31.7.1997, p. 43).

(3) See Annex IV, Part A.

(4) OJ L 61, 3.3.1997, p. 1. Regulation as last amended by Commission

Regulation (EC) No 318/2008 (OJ L 95, 8.4.2008, p. 3).

(5) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Directive

2008/27/EC (OJ L 81, 20.3.2008, p. 45).

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(10)

This Directive should be without prejudice to the obli-
gations of the Member States relating to the time-limits
for transposition into national law of the Directives set
out in Annex IV, Part B,

Article 2

1. Member States, on receipt of the application referred to in
Article 1, shall approve the activities concerned, if it is estab-
lished that the general conditions laid down in Annex I are
satisfied.

HAS ADOPTED THIS DIRECTIVE:

Article 1

1. Member States shall ensure that for any activity for trial or
scientific purposes and for work on varietal selections, here-
inafter referred to as ‘the activities’, which would involve the
use of harmful organisms, plants, plant products and other
objects pursuant
to Article 3(8), 4(5), 5(5) or 13b(4) of
Directive 2000/29/EC, hereinafter referred to as ‘the material’,
an application shall be submitted to the responsible official
bodies prior to the introduction into, or movement within,
any Member State or relevant protected zones thereof, of any
such material.

The application referred to in paragraph 1, shall specify at

2.
least the following:

(a)

the name and address of the person responsible for the
activities;

(b) the scientific name or names of the material, including the

harmful organism concerned, where appropriate;

(c)

the type of material;

(d) the quantity of material;

(e)

the place of origin of the material, with appropriate docu-
mentary evidence for material to be introduced from a third
country;

(f)

and objectives of

the duration, nature
activities
envisaged, including, at least, a resumé of the work and a
specification for trial or scientific purposes or work on
varietal selections;

the

(g) the address and description of the specific site or sites for
quarantine containment and, where appropriate, for testing;

(h) the place of first storage or of first planting, as appropriate,
after the material has been officially released, where appro-
priate;

(i)

the proposed method of destruction or
treatment of
material on completion of the approved activities, where
appropriate;

(j)

the proposed point of entry into the Community for
material to be introduced from a third country.

Member States shall withdraw the said approval at any time if it
is established that the conditions laid down in Annex I cease to
be met.

Following the approval of

the activities referred to in
2.
paragraph 1, Member States shall approve the introduction
into or movement within the Member State or
relevant
protected zones of the material referred to in the application,
is accompanied in all cases by a
provided that such material
letter of authority for such introduction or movement of
harmful organisms, plants, plant products and other objects
scientific purposes and for work on varietal
for
referred to as a ‘letter of authority’,
selections, hereinafter
conforming to the model set out in Annex II and issued by
the responsible official body of the Member State in which the
activities are to be undertaken, and

trial or

(a)

in the case of material originating in the Community:

(i) where the place of origin is in another Member State,
the accompanying letter of authority shall be officially
endorsed by the Member State of origin for movement
of
containment
conditions; and

the material

quarantine

under

(ii) for those plants, plant products and other objects listed
the
in Annex V, Part A to Directive 2000/29/EC,
material shall also be accompanied by a plant passport
issued in accordance with Article 10 of Directive
2000/29/EC, on the basis of the examination carried
that Directive
out pursuant
for
to Article 6 of
laid down therein,
compliance with the provisions
other than those relating to any harmful organism in
respect of which the activities have been approved under
the first subparagraph of paragraph 1 of this Article.
The plant passport
following
is moved under Directive
statement:
2008/61/EC’.

‘This material

contain the

shall

In cases where the address of the specific site or sites for
quarantine containment is located in another Member
State, the Member State responsible for issuing the plant
passport shall issue a plant passport only on the basis of
information regarding the approval referred to in the
first
this Article
received officially from the Member State responsible
for the approval of the activities, and on the assurance
that quarantine containment conditions shall be applied
during movement of the material; and

subparagraph of paragraph 1 of

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(b) in the case of material introduced from a third country:

(i) Member States shall ensure that the letter of authority is
issued on the basis of appropriate documentary evidence
as regards the place of origin of the material; and

(ii) for plants, plant products and other objects listed in
Annex V, Part B to Directive 2000/29/EC the material
shall also be accompanied wherever possible by a phyto-
sanitary certificate issued in the country of origin in
Directive
accordance
2000/29/EC, on the basis of the examination carried
that Directive
out pursuant
for
to Article 6 of
compliance with the provisions
laid down therein,
other than those relating to any harmful organism in
respect of which the activities have been approved under
the first subparagraph of paragraph 1 of this Article.

Article

13(1)

with

of

shall, under

following indication:

‘Additional declaration’,
The certificate
‘This material
contain the
is
imported under Directive 2008/61/EC’. The relevant
harmful organism or organisms shall also be specified,
where appropriate.

have been found free by such measures from any
harmful organism, unless it
is identified as one
which is known to occur in the Community and
is not listed in Directive 2000/29/EC,

— the quarantine measures, including testing, shall be
carried out by scientifically trained staff of that body
or of any officially approved body, and shall be
carried out in accordance with the provisions laid
down in Annex III to this Directive for the plants,
plant products and other objects specified,

— any plants, plant products or other objects which
have not been found free, by such measures, from
harmful organisms as specified in the first indent,
and any other plants, plant products or other
objects with which they have been in contact or
which may have become contaminated shall be
destroyed or subjected to an appropriate treatment
or quarantine measure aimed at eradicating the
relevant harmful organisms; the provisions of (ii),
second indent shall apply accordingly;

In all cases Member States shall ensure that the material is held
under quarantine containment conditions during the said intro-
duction or movement, and is moved directly and immediately
to the site or sites specified in the application.

(ii) for all other material (including harmful organisms), at
the end of the duration of the approved activities, and
for all material found to be contaminated during the
activities:

The responsible official body shall monitor the approved

3.
activities and shall ensure that:

(a)

the quarantine containment conditions and other general
conditions
specified in accordance with Annex I are
complied with throughout the duration of the activities,
by examination of the premises and activities at appropriate
times;

(b) the following procedures are applied according to the type

of approved activities:

(i) for plants, plant products or other objects intended for

release from quarantine:

— the material (including the harmful organisms and
any contaminated material) and any other plants,
plant products or other objects with which it has
been in contact or which may have become
contaminated shall be destroyed,
sterilised or
otherwise treated in a manner to be specified by
the responsible official body, and

— the premises and facilities at which the activities in
question have been undertaken shall be sterilised or
otherwise cleaned, as necessary, in a manner to be
specified by the responsible official body;

— the plants, plant products or other objects shall not
be released without approval by the responsible
‘official
official body, hereinafter
release’. Prior to official release,
the plants, plant
products or other objects shall have been subject
to quarantine measures, including testing, and must

referred to as

(c) any contamination of the material by harmful organisms
listed in Directive 2000/29/EC and any other harmful
organism considered a risk to the Community by the
responsible official body and detected during the activity
shall be notified immediately to the responsible official
body by the person responsible for the activities, along
with notification of any event resulting in the escape of
such organisms into the environment.

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for activities utilising
4. Member States shall ensure that
plants, plant products and other objects listed in Annex III to
Directive 2000/29/EC and not covered by Part A, Sections I, II
and III of Annex III to this Directive, appropriate quarantine
including testing, shall be carried out. These qua-
measures,
rantine measures shall be notified to the Commission and to
the other Member States. The details of
such quarantine
measures shall be completed and inserted in Annex III to this
Directive once the necessary technical information is available.

Article 3

1.
Before 1 September each year, Member States shall send
to the Commission and to the other Member States a list, with
the introductions and movements of material
quantities, of
approved under this Directive during the preceding period of
one year ending on 30 June, and of any contamination by
such material, which has been
harmful organisms of
confirmed under the quarantine measures,
including testing,
carried out under Annex III during the same period.

authorities

established

2. Member States shall cooperate administratively through
the
to
Article 1(4) of Directive 2000/29/EC, with regard to the
provision of details of the quarantine containment conditions
and measures
this
Directive.

imposed for activities approved under

designated

pursuant

or

in the field covered by this Directive. The Commission shall
inform the other Member States thereof.

Article 5

Directive 95/44/EC, as amended by the Directive listed in
Annex IV, Part A,
is repealed, without prejudice to the obli-
gations of the Member States relating to the time-limits for
transposition into national
in
law of
Annex IV, Part B.

the Directives set out

References to the repealed Directive shall be construed as
references to this Directive and shall be read in accordance
with the correlation table in Annex V.

Article 6

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

This Directive is addressed to the Member States.

Article 7

Done at Brussels, 17 June 2008.

Article 4

Member
shall
Commission all provisions of national

immediately

States

communicate
to the
law which they adopt

For the Commission
The President

José Manuel BARROSO

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ANNEX I

1. For the purposes of Article 2(1) of this Directive the following general conditions shall apply:

— the nature and objectives of the activities for which the material is to be introduced or moved shall have been
examined by the responsible official body and found to comply with the concept of trial or scientific purposes and
for work on varietal selections provided for under Directive 2000/29/EC,

— the quarantine containment conditions of the premises and facilities at the site or sites at which the activities are to
be undertaken shall have been inspected for compliance with the provisions laid down in point 2 and approved by
the responsible official body,

— the responsible official body shall limit the quantity of material to an amount that is adequate for the approved
activities and in any case the amount shall not exceed quantities which have been determined having regard to
available quarantine containment facilities,

— the scientific and technical qualifications of the personnel by whom the activities are to be undertaken shall have

been examined and approved by the responsible official body.

2. For the purposes of point 1, the quarantine containment conditions of the premises and facilities at the site or sites at
which the activities are to be undertaken shall be sufficient to ensure a safe handling of the material such that any
harmful organisms of concern are contained and the risk of spreading such harmful organisms eliminated. For each
activity specified in the application, the risk of spread of the harmful organisms held under quarantine containment
conditions shall be determined by the responsible official body, having regard to the type of material and the activity
envisaged, and to the biology of the harmful organisms, the means of their dispersal, the interaction with the
environment and other relevant factors relating to the risk posed by the material concerned. As a result of the
assessment of the risk, the responsible official body shall consider and lay down as appropriate:

(a)

the following quarantine measures concerning the premises, facilities and working procedures:

— physical

isolation from all other plant/harmful organism material,

including consideration of control of

vegetation in surrounding areas,

— designation of a contact person responsible for the activities,

— restricted access to the premises and facilities and to the surrounding area, as appropriate, to named personnel

only,

— appropriate identification of the premises and facilities indicating the type of activities and the personnel

responsible,

— maintenance of a register of

the activities performed and a manual of operating procedures,

including

procedures in the event of escape of harmful organisms from containment,

— appropriate security and alarm systems,

— appropriate control measures to prevent the introduction into and the spread within the premises of harmful

organisms,

— controlled procedures for sampling and for transfer between premises and facilities, of the material,

— controlled waste, soil and water disposal, as appropriate,

— appropriate hygiene and disinfection procedures and facilities for personnel, structures and equipment,

— appropriate measures and facilities for disposal of experimental material,

— appropriate indexing (including testing) facilities and procedures; and

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(b) further quarantine measures according to the specific biology and epidemiology of the type of material involved

and the activities approved:

— maintenance in facilities with separate chamber ‘double door’ access to personnel,

— maintenance under negative air pressure,

— maintenance in escape-proof containers with appropriate mesh size and other barriers e.g. water barrier for

mites, closed soil containers for nematodes, electric insect traps,

— maintenance in isolation from other harmful organisms and material, e.g. viruliferous plant food material, host

material,

— maintenance of material for breeding in breeding cages with manipulation devices,

— no interbreeding of the harmful organisms with indigenous strains or species,

— avoidance of continuous culture of the harmful organisms,

— maintenance under conditions that strictly control the multiplication of the harmful organism, e.g. under an

environmental regime such that diapause does not occur,

— maintenance in such a way that no spread by propagules can occur, e.g. air streams should be avoided,

— procedures to check the purity of cultures of the harmful organisms for freedom from parasites and other

harmful organisms,

— appropriate control programmes for the material to eliminate possible vectors,

— for in vitro activities, handling of the material under sterile conditions: equipping the laboratory for the

performance of aseptic procedures,

— maintenance of harmful organisms spread by vectors under conditions such that there is no spread via the

vector e.g. controlled mesh size, containment of soil,

— seasonal isolation to ensure the activities are done during periods of low plant health risk.

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Model Letter of Authority for the introduction and/or movement of harmful organisms, plants, plant products
and other objects for trial or scientific purposes and for work on varietal selections

ANNEX II

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ANNEX III

QUARANTINE MEASURES INCLUDING TESTING ON PLANTS, PLANT PRODUCTS AND OTHER OBJECTS
INTENDED FOR RELEASE FROM QUARANTINE

1.

2.

PART A

For certain plants, plant products and other objects listed in Annex III to Directive 2000/29/EC

Section I: Plants of Citrus L., Fortunella Swingle, Poncirus Raf. and their hybrids, other than fruit and seeds

The plant material, as appropriate, shall be subjected to appropriate therapy procedures as laid down in FAO/IPGRI
Technical Guidelines.

The plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected to indexing
procedures in its entirety. All plant material including indexing plants, shall be held at the approved facilities under
the quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release
shall be held under conditions conducive to a normal cycle of vegetative growth and be subjected to visual
inspection for signs and symptoms of harmful organisms including all relevant harmful organisms listed in
Directive 2000/29/EC, on arrival and subsequently, at appropriate times, during the period of
the indexing
procedures.

3.

For the purposes of point 2, the plant material shall be indexed for harmful organisms (tested for and identified)
according to the following procedures:

3.1. The testing shall use appropriate laboratory methods and, where appropriate,

including Citrus
sinensis (L.) Osbeck, C. aurantiifolia Christm. Swing, C. medica L., C. reticulata Blanco and Sesamum L., in order to
detect at least the following harmful organisms:

indicator plants,

(a) Citrus greening bacterium

(b) Citrus variegated chlorosis

(c) Citrus mosaic virus

(d) Citrus tristeza virus (all isolates)

(e) Citrus vein enation woody gall

(f)

Leprosis

(g) Naturally spreading psorosis

(h) Phoma tracheiphila (Petri) Kanchaveli & Gikashvili

(i)

Satsuma dwarf virus

(j)

Spiroplasma citri Saglio et al.

(k) Tatter leaf virus

(l) Witches' broom (MLO)

(m) Xanthomonas campestris (all strains pathogenic to Citrus).

3.2. For diseases such as Blight and Blight-like for which there are no short-term indexing procedures the plant material
must be subjected upon arrival to shoot-tip grafting onto seedling stock grown under sterile culture as set out in
FAO/IPGRI Technical Guidelines, and the resulting plants subjected to therapy procedures according to point 1.

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4.

1.

2.

The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of
harmful organisms have been observed shall be subjected to an investigation including testing where necessary, to
determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

Section II: Plants of Cydonia Mill., Malus Mill., Prunus L. and Pyrus L. and their hybrids and Fragaria L.,

intended for planting, other than seeds

The plant material, as appropriate, shall be subjected to appropriate therapy procedures as laid down in FAO/IPGRI
Technical Guidelines.

The plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected to indexing
procedures in its entirety. All plant material including indexing plants, shall be held at the approved facilities under
the quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release
shall be held under conditions conducive to a normal cycle of vegetative growth and be subjected to visual
inspection for signs and symptoms of harmful organisms including all relevant harmful organisms listed in
the indexing
Directive 2000/29/EC, on arrival and subsequently, at appropriate times, during the period of
procedures.

3.

For the purposes of point 2 the plant material shall be indexed for harmful organisms (tested for and identified)
according to the following procedures:

3.1. In the case of Fragaria L., irrespective of the country of origin of the plant material, the testing shall use appropriate
laboratory methods and, where appropriate, indicator plants, including Fragaria vesca, F. virginiana and Chenopodium
spp. for the detection of at least the following harmful organisms:

(a) Arabis mosaic virus

(b) Raspberry ringspot virus

(c) Strawberry crinkle virus

(d) Strawberry latent ‘C’ virus

(e) Strawberry latent ringspot virus

(f)

Strawberry mild yellow edge virus

(g) Strawberry vein banding virus

(h) Strawberry witches' broom mycoplasm

(i) Tomato black ring virus

(j) Tomato ringspot virus

(k) Colletotrichum acutatum Simmonds

(l)

Phytophthora fragariae Hickman var. fragariae Wilcox & Duncan

(m) Xanthomonas fragariae Kennedy & King.

3.2. In the case of Malus Mill.:

(i) where the plant material originates from a country which is not known to be free of any of the following

harmful organisms:

(a) Apple proliferation mycoplasm; or

(b) Cherry rasp leaf virus (American),

the testing shall use appropriate laboratory methods and, where appropriate, indicator plants for the detection of
the relevant harmful organisms, and

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(ii) irrespective of the country of origin of the plant material, the testing shall use appropriate laboratory methods

and, where appropriate, indicator plants for the detection of at least the following harmful organisms:

(a) Tobacco ringspot virus

(b) Tomato ringspot virus

(c) Erwinia amylovora (Burr.) Winsl. et al.

3.3. In the case of Prunus L., as appropriate for each Prunus species:

(i) where the plant material originates from a country which is not known to be free of any of the following

harmful organisms:

(a) Apricot chlorotic leafroll mycoplasm;

(b) Cherry rasp leaf virus (American); or

(c) Pseudomonas syringae pv. persicae (Prunier et al.) Young et al.,

the testing shall use appropriate laboratory methods and, where appropriate, indicator plants for the detection of
the relevant harmful organisms; and

(ii) irrespective of the country of origin of the plant material, the testing shall use appropriate laboratory methods

and, where appropriate, indicator plants for the detection of at least the following harmful organisms:

(a) Little cherry pathogen (non-European isolates)

(b) Peach mosaic virus (American)

(c) Peach phony rickettsia

(d) Peach rosette mosaic virus

(e) Peach rosette mycoplasm

(f) Peach X-disease mycoplasm

(g) Peach yellows mycoplasm

(h) Plum line pattern virus (American)

(i) Plum pox virus

(j) Tomato ringspot virus

(k) Xanthomonas campestris pv. pruni (Smith) Dye.

3.4. In the case of Cydonia Mill. and Pyrus L.

irrespective of the country of origin of the plant material, testing by
appropriate laboratory methods, and, where appropriate, indicator plants, for detection of at least the following
harmful organisms:

(a) Erwinia amylovora (Burr.) Winsl. et al.

(b) Pear decline mycoplasm.

4.

The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of
harmful organisms have been observed shall be subject to an investigation including testing where necessary, to
determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

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1.

2.

Section III: Plants of Vitis L., other than fruits

The plant material shall be subjected, as appropriate, to appropriate therapy procedures, as laid down in FAO/IPGRI
Technical Guidelines.

The plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected to indexing
procedures in its entirety. All plant material including indexing plants, shall be held at the approved facilities under
the quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release
shall be held under conditions conducive to a normal cycle of vegetative growth and shall be subjected to visual
inspection for signs and symptoms of harmful organisms including those of Daktulosphaira vitifoliae (Fitch) and of all
other relevant harmful organisms listed in Directive 2000/29/EC, on arrival and subsequently, at appropriate times,
during the period of the indexing procedures.

3.

For the purposes of point 2 the plant material shall be indexed for harmful organisms (tested for and identified)
according to the following procedures:

3.1. Where the plant material originates in a country which is not known to be free of the following harmful organisms:

(i) A j i n a s h i k a d i s e a s e

The testing shall use an appropriate laboratory method. In the event of a negative result, the plant material shall
be indexed on the vine variety Koshu and kept under observation during at least two cycles of vegetation.

(ii) G r a p e v i n e s t u n t v i r u s

The testing shall use appropriate indicator plants, including the vine variety Campbell Early, and observation
shall take place during one year.

(iii) S u m m e r m o t t l e

The testing shall use appropriate indicator plants,
Mission.

including the vine varieties Sideritis, Cabernet-Franc and

3.2. Irrespective of the country of origin of the plant material, the testing shall use appropriate laboratory methods and,

where appropriate, indicator plants for the detection of at least the following harmful organisms:

(a) Blueberry leaf mottle virus

(b) Grapevine Flavescence dorée MLO and other grapevine yellows

(c) Peach rosette mosaic virus

(d) Tobacco ringspot virus

(e) Tomato ringspot virus (strain ‘yellow vein’ and other strains)

(f) Xylella fastidiosa (Well & Raju)

(g) Xylophilus ampelinus (Panagopoulos) Willems et al.

4.

The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of
harmful organisms have been observed shall be subjected to an investigation including testing where necessary, to
determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

Section IV: Plants of stolon- or tuber-forming species of Solanum L. or their hybrids, intended for planting

1.

The plant material, as appropriate, shall be subjected to the therapy procedures as laid down in FAO/IPGRI Technical
Guidelines.

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2.

Each unit of the plant material, following the therapy procedures carried out pursuant to point 1, shall be subjected
to indexing procedures. All plant material, including indexing plants, shall be held at the approved facilities under the
quarantine containment conditions laid down in Annex I. Plant material intended for approval for official release
shall be held under conditions conducive to a normal cycle of vegetative growth and be subjected to visual
inspection for signs and symptoms of harmful organisms including all relevant harmful organisms listed in
Directive 2000/29/EC and potato yellow vein disease, on arrival and subsequently, at regular intervals until
senescence, during the period of the indexing procedures.

3.

The indexing procedures referred to in point 2 shall follow the technical provisions set out in point 5, in order to
detect at least the following harmful organisms:

— B a c t e r i a

(a) Clavibacter michiganensis (Smith) Davis et al. ssp. sepedonicus (Spieckermann et Kotthoff) Davis et al.;

(b) Ralstonia solanacearum (Smith) Yabuuchi et al.

— V i r u s e s a n d v i r u s - l i k e o r g a n i s m s

(a) Andean potato latent virus,

(b) Potato black ringspot virus,

(c) Potato spindle tuber viroid,

(d) Potato yellowing alfamovirus,

(e) Potato virus T,

(f) Andean potato mottle virus,

(g) Common potato viruses A, M, S, V, X and Y (including Yo, Yn and Yc) and potato leaf roll virus.

However, in the case of true seed of potato, the indexing procedures shall be carried out in order to detect at least
the viruses and virus-like organisms listed above at (a) to (e).

4.

The plant material subjected to the visual inspections referred to in point 2 and on which signs and symptoms of
harmful organisms have been observed shall be subjected to an investigation including testing where necessary, to
determine, as far as possible, the identity of the harmful organisms causing the signs and symptoms.

5.

The technical provisions referred to in point 3 shall be as follows:

— B a c t e r i a

1. For tubers, test the heel end of each tuber. The standard sample size shall be 200 tubers. However, the

procedure can be applied for samples with less than 200 tubers.

2. For young plants and cuttings,

including micro-plants, test the lower sections of the stem and, where

appropriate, the roots, for each unit of the plant material.

3. For testing of progeny tubers, or of stem bases for non-tuber forming species, one normal cycle of vegetative

growth after the testing referred to in points 1 and 2, is recommended.

4. For the material referred to in point 1, the testing method for Clavibacter michiganensis (Smith) Davis et al. ssp.
sepedonicus (Spieckermann et Kotthoff) Davis et al. shall be the Community method set out in Annex I to
Council Directive 93/85/EEC (1). For the material referred to in point 2, this testing method could be applied.

5. For the material referred to in point 1, the testing method for Ralstonia solanacearum (Smith) Yabuuchi et al.
shall be the test scheme set out in Annex II to Council Directive 98/57/EC (2). For the material referred to in
point 2, this testing method could be applied.

(1) OJ L 259, 18.10.1993, p. 1. Directive as amended by Commission Directive 2006/56/EC (OJ L 182, 4.7.2006, p. 1).
(2) OJ L 235, 21.8.1998, p. 1. Directive as amended by Commission Directive 2006/63/EC (OJ L 206, 27.7.2006, p. 36).

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— V i r u s e s a n d v i r u s - l i k e o r g a n i s m s , o t h e r t h a n p o t a t o s p i n d l e t u b e r v i r o i d

1. The minimum testing for vegetative material (tubers, young plants and cuttings, including micro-plants) shall
include a serological test done at or near flowering for each of the specified list of harmful organisms other
than potato spindle tuber viroid, and followed by a biological test of material testing negative in the
serological test. For Potato leaf roll virus, two serological tests shall be done.

2. The minimum testing for true seed shall be a serological test or a biological test if no serological test is
available. Retesting of a proportion of negative samples and testing of borderline results by another method is
highly recommended.

3. The serological and biological testing referred to in points 1 and 2 shall be done on glasshouse grown plants,
sampled from at least two positions on every stem, including a young fully expanded leaflet at the top of each
stem and an older leaflet from a midway position; each stem shall be sampled because of possible non-
systemic infection. In the case of the serological testing, no bulking of leaflets from separate plants shall be
done, unless the bulking rate has been validated for the method of use; leaflets from each stem may however
be bulked to make up the sample from each plant. In the case of the biological testing, the maximum bulking
is up to five plants with inoculation of a minimum of duplicate indicator plants.

4. The appropriate indicator plants to be used for the biological testing referred to in points 1 and 2 shall be
those listed by the European and Mediterranean Plant Protection Organization (EPPO), or other officially
approved indicator plants, which have been shown to detect the viruses.

5. Only material which has been directly tested shall be released from quarantine. Where eye indexing has been
done, only the progeny of the tested eye may be released. The tuber should not be released because of
possible problems with non-systemic infection.

— P o t a t o s p i n d l e t u b e r v i r o i d

1. For all material, glasshouse grown plants shall be tested, as soon as they are well established but prior to
flowering and pollen production. Testing on tuber sprouts/in vitro plants/small seedlings shall only be regarded
as a preliminary test.

2. Samples shall be taken from a fully expanded leaflet at the top of each stem of the plant.

3. All material for testing shall be grown at temperatures not less than 18 °C (preferably at temperatures higher

than 20 °C) and with at least a 16-hour photo-period.

4. Testing shall be by radioactive or non-radioactive labelled cDNA or RNA-probes, return-PAGE (with silver

staining) or RT-PCR.

5. The maximum bulking rate for probes and return-PAGE is 5. Use of this or higher bulking rates must be

validated.

PART B

For plants, plant products and other objects listed in Annexes II and IV to Directive 2000/29/EC

The official quarantine measures shall include appropriate inspection or testing for the relevant harmful organisms
listed in Annexes I and II to Directive 2000/29/EC and shall be carried out in respect of the special requirements laid
down in Annex IV to Directive 2000/29/EC for specific harmful organisms, as appropriate. In respect of such special
requirements the methods used for the quarantine measures shall be those laid down in Annex IV to Directive
2000/29/EC or other equivalent officially approved measures.

The plants, plant products and other objects must be found free, according to the provisions of point 1, from the
relevant harmful organisms specified in Annexes I, II and IV to Directive 2000/29/EC for those plants, plant
products and other objects.

1.

2.

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ANNEX IV

PART A

Repealed Directive with its amendment

(referred to in Article 5)

Commission Directive 95/44/EC

(OJ L 184, 3.8.1995, p. 34)

Commission Directive 97/46/EC

(OJ L 204, 31.7.1997, p. 43)

PART B

List of time-limits for transposition into national law

(referred to in Article 5)

Directive

Time-limit for transposition

95/44/EC
97/46/EC

1 February 1996
1 January 1998

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ANNEX V

Correlation table

Directive 95/44/EC

This Directive

Article 1(1)

Article 1(1)

Article 1(2), introductory sentence

Article 1(2), introductory sentence

Article 1(2), first indent

Article 1(2), second indent

Article 1(2), third indent

Article 1(2), fourth indent

Article 1(2), fifth indent

Article 1(2), sixth indent

Article 1(2), seventh indent

Article 1(2), eighth indent

Article 1(2), ninth indent

Article 1(2), tenth indent

Articles 2 and 3

Article 4(1)

Article 4(2)

—

Article 5

Article 6

Article 1(2)(a)

Article 1(2)(b)

Article 1(2)(c)

Article 1(2)(d)

Article 1(2)(e)

Article 1(2)(f)

Article 1(2)(g)

Article 1(2)(h)

Article 1(2)(i)

Article 1(2)(j)

Articles 2 and 3

—

Article 4

Article 5

Article 6

Article 7

Annexes I, II and III

Annexes I, II and III

—

—

Annex IV

Annex V