1995L0044 — EN — 20.08.1997 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONDIRECTIVE95/44/EC
of26July1995
establishing the conditions under which certain harmful organisms, plants, plant products and
other objects listed in AnnexesI to V to Council Directive 77/93/EEC may be introduced into ormoved within the Community or certain protected zones thereof, for trial or scientific purposes
andforworkonvarietal selections
(OJ L 184, 3.8.1995, p. 34)
Amended by:
Official Journal
No page date
►M1Commission Directive 97/46/EC of 25 July 1997 L 204 43 31.7.1997
Corrected by:
►C1Corrigendum, OJ L 91, 12.4.1996, p. 78 (95/44/EC)
▼B
COMMISSIONDIRECTIVE95/44/EC
of26July1995
establishingtheconditionsunderwhichcertainharmfulorganisms,
plants,plantproductsandotherobjectslistedinAnnexesItoVtoCouncil Directive 77/93/EEC may be introduced into or movedwithin the Community or certain protected zones thereof, for trial
orscientific purposesandforworkonvarietal selections
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976
on protective measures against the introduction into the Community of
organisms harmful to plants or plant products and against their spreadwithin the Community(
1), as last amended by Commission Directive
95/4/EC(2), and in particular Articles3 (7) (e), 4 (5), 5 (5) and 12
(3c), thereof,
Whereasunder the provis ionsof Directive 77/93/EEC, harmful organ-
isms listed in its Annexes I and II, whether singly or associated with
the relevant plants or plants products listed in Annex II to the said
Directive, may not be introduced into and spread by movement withinthe Community or certain protected zonesthereof;
Whereas under the same Directive, plants, plant products and other
objetslis ted in itsAnnex III, may not be introduced into the Commu-nity or into certain protected zonesthereof;
Whereas also plants, plant products and other objects listed in Annex
IV to the said Directive, may not be introduced into or moved within
the Community or certain protected zonesthereof unles sthe relevant
special requirements indicated in the said Annex are met;
Whereas plants, plant products and other objects listed in Annex V,
Part B to the said Directive coming from third countries may not beintroduced into the Community unless they comply with the standardsand requirementslaid down in the s aid Directive and are accompaniedby an official phytosanitary certificate ensuring such compliance andare, moreover, inspected on an official basis for compliance with these
provisions;
Whereas, however, Articles 3 (7) (e), 4 (5), 5 (5) and 12 (3c) of the
said Directive provide for those rules not to apply to the introductionand movement of such harmful organisms, plants, plant products andother objects, for trial or scientific purposes and for work on varietalselections, to certain conditions which shall be determined at Commu-nity level;
Whereas therefore, it is necessary to determine the conditions 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;
Whereas, however, the conditions for such introductions of potato
breeding material have already been determined by Commission Deci-sion 80/862/EEC(
3), as last amended by Decision 91/22/EEC(4), and
are therefore not affected by thisDirective; whereasfurthermore, theconditions for such introductions of soil and growing medium origi-
nating in third countrieshave als o already been determined by
Commission Decision 93/447/EEC(
5), asamended by Decis ion 94/9/
EC(6), and are therefore not affected by thisDirective;
Whereasthe conditionslaid down for material under Council Regula-
tion (EEC) No 3626/82 of 3 December 1982 on the implementation in1995L0044 — EN — 20.08.1997 — 001.001 — 2
(1) OJ No L 26, 31. 1. 1977, p. 20.
(2) OJ No L 44, 28. 2. 1995, p. 56.
(3) OJ No L 248, 19. 9. 1980, p. 25.
(4) OJ No L 13, 18. 1. 1991, p. 21.
(5) OJ No L 209, 20. 8. 1993, p. 32.
(6) OJ No L 7, 11. 1. 1994, p. 15.
▼B
the Community of the Convention on international trade in endangered
species of wild fauna and flora(1), as last amended by Commission
Regulation (EC) No 558/95(2), and under Council Directive 90/220/
EEC of 23 April 1990 on the deliberate release into the environment
of genetically modified organisms(3), as amended by Commission
Directive 94/15/EEC(4), and other more specific Community provisions
regarding endangered species of wild fauna/EC and flora and geneti-cally modified organisms, are not affected by this Directive;
Whereasthe meas uresprovided for in thisDirective are in accordance
with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. Member States shall ensure that for any activity for trial or scien-
tific purposes and for work on varietal selections, hereinafter referredto as ‘the activities’, which would involve the use of harmful organ-isms, plants, plant products and other objects pursuant to Article 3 (7)(e), 4 (5), 5 (5) or 12 (3c) of Directive 77/93/EEC, hereinafter referred
to as ‘the material’, an application shall be submitted to the responsible
official bodiesprior to the introduction into, or movement within, anyMember State or relevant protected zonesthereof, of any s uch material.
2. The application referred to in paragraph 1, shall specify at least
the following:
— the name and address of the person responsible for the activities,
— the scientific name or names of the material, including the harmful
organism concerned, where appropriate,
— the type of material,
— the quantity of material,
— the place of origin of the material, with appropriate documentary
evidence for material to be introduced from a third country,
— the duration, nature and objectivesof the activitiesenvis aged,
including at least, a resumé of the work and a specification for trialfor scientific purposes or work on varietal selections,
— the address and description of the specific site or sites for quaran-
tine containment and, where appropriate, for testing,
— the place of first storage or of first planting, as appropriate, after the
material hasbeen officially releas ed, where appropriate,
— the proposed method of destruction or treatment of material on
completion of the approved activities, where appropriate,
— the proposed point in entry into the Community for material to be
introduced from a third country.
Article 2
1. Member Stateson receipt of the application referred to in Article
1 shall approve the activities concerned, if it is established that the
general conditions laid down in Annex I are satisfied.
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.
2. Following the approval of the activitiesreferred to in paragraph 1,
Member Statess hall approve the introduction into or movement within
the Member State or relevant protected zones, of the material referred
to in the application, provided that such material is accompanied in allcases by a letter of authority for such introduction or movement of1995L0044 — EN — 20.08.1997 — 001.001 — 3
(1) OJ No L 384, 31. 12. 1982, p. 1.
(2) OJ No L 57, 15. 3. 1995, p. 1.
(3) OJ No L 117, 8. 5. 1990, p. 15.
(4) OJ No L 103, 22. 4. 1994, p. 20.▼M1
▼B
▼B
harmful organisms, plants, plant products and other objects of trial for
scientific purposes and for work on varietal selections, hereinafterreferred to asa ‘letter of authority’, conforming to the model s et out
in Annex II and issued by the responsible official body of the Member
State in which the activitiesare to be undertaken and,
(a) the case of material originating in the Community:
(i) where the place of origin isin another Member State, the s aid
accompanying letter of authority shall be officially endorsed bythe Member State of origin for movement of the material under
quarantine containment conditions; and
(ii) for those plants, plant products and other objects listed in
Annex V, Part A to Directive 77/93/EEC, the material shall
also be accompanied by a plant passport issued in accordance
with Article 10 of Directive 77/93/EEC, on the basis of theexamination carried out pursuant to Article 6 of that Directivefor compliance with the provisions laid down therein, otherthan those relating to any harmful organism in respect of whichthe activites have been approved under the first subparagraph
of paragraph 1. The plant passport shall contain the following
statement: ‘This material is moved under Directive 95/44/EC’.
In cases where the address of the specific site or sites for quar-
antine containment islocated in another Member State, the
Member State responsible for issuing the plant passport shallissue a plant passport only on the basis of informationregarding the approval referred to in the first subparagraph ofparagraph 1 received officially from the Member State respon-
sible for the approval of the activities, and on the assurance
that quarantine containment conditionss hall be applied duringmovement of the material; and
(b) in the case of material introduced from a third country;
(i) Member States shall ensure that the said letter of authority is
issued on the basis of appropriate documentary evidence as
regardsthe place of origin the material; and
(ii) for plants, plant products and other objects listed in Annex V,
Part B to Directive 77/93/EEC the material shall also be
accompanied wherever possible by a phytosanitary certificateissued in the country of origin in accordance with Article 7 ofDirective 77/93/EEC, on the basis of the examination carriedout pursuant to Article 6 of that Directive for compliance with
the provisions laid down therein, other than those relating to
any harmful organism in respect of which the activities havebeen approved under the first subparagraph of paragraph 1.
The certificate shall, under ‘Additional declaration’, contain the
following indication: ‘Thismaterial isimported under Directive95/44/EC’. The relevant harmful organism or organisms shallalso be specified, where appropriate.
In all cases Member State shall ensure that the material is held under
quarantine containment conditionsduring the s aid introduction ormovement, and is moved directly and immediately to the site or sitesspecified in the application.
3. The responsible official body shall monitor the approved activ-
ities and shall ensure that:
(a) the quarantine containment conditionsand other general conditions
specified in accordance with Annex I are complied with throughout
the duration of the activities, by examination of the premises andactivitiesat appropriate times ;
(b) the proceduress et out below are followed according to the type of
approved activities:
(i) for plants, plant products or other subjects intended for release
from quarantine:
— the plants, plant products or other objects shall not be
released without approval by the responsible official body,hereinafter referred to as‘official releas e’. Prior to official1995L0044 — EN — 20.08.1997 — 001.001 — 4
▼B
release the plants, plant products or other objects shall have
been subject to quarantine measures including testing, andmust 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 isnot lis ted inDirective 77/93/EEC,
— the quarantine measures including testing shall be carried
out by scientifically trained staff of that body or of any offi-cially 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 organismsas specified in the first indent, and any other plants, plantproductsor other objectswith which they have been in
contact or which may have become contaminated shall be
destroyed or subjected to an appropriate treatment or quar-antine measure aimed at eradicating the relevant harmfulorganisms; the provisions of (ii), second indent shall applyaccordingly.
(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 contamined during the activities:
— the material (including the harmful organisms and any
contamined material) and any other plants, plant products
or other objectswith which it hasbeen in contact or which
may have become contamined shall be destroyed, sterilizedor otherwise treated in a manner to be specified by theresponsible official body, and
— the premises and facilities at which the activities in ques-
tion have been undertaken shall be sterilized or otherwise
cleaned, as necessary, in a manner to be specified by the
responsible official body;
(c) any contamination of the material by harmful organisms listed in
Directive 77/93/EEC and any other harmful organism considered a
risk to the Community by the responsible official body anddetected during the activity shall be notified immediately to theresponsible official body by the person responsible for the activ-ities, along with notification of any event resulting in the escape
of the abovementioned organisms into the environment.
4. Member States shall ensure that for activities utilizing plants,
plant productsand other objectslis ted in Annex III to Directive 77/93/EEC and not covered by Part A, SectionsI to III of Annex III tothis Directive, appropriate quarantine measures including testing shallbe carried out. These quarantine measures shall be notified to the
Commission and to the other Member States. The details of such quar-
antine measures shall be completed and inserted in Annex III to thisDirective 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 quantities, of
the introductionsand movementsof material approved under thisDirective during the preceding period of one year ending on 30 June,and of any contamination by harmful organisms of such material,which hasbeen confirmed under the quarantine meas uresincludingtesting carried out under Annex III, during the same period.
2. Member States shall cooperate administratively through the
authorities established or designated pursuant to Article 1 (6) of Direc-tive 77/93/EEC, with regard to the provision of details of thequarantine containment conditions and measures imposed for activitiesapproved under thisDirective.1995L0044 — EN — 20.08.1997 — 001.001 — 5
▼B
Article 4
1. Member States shall bring into force the laws, regulations or
administrative provisions necessary to comply with this Directive on 1
February 1996. They shall immediately inform the Commission
thereof.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such referenceat the time of their official publication. The procedure for such refer-ence shall be adopted by Member States.
2. Member States shall immediately communicate to the Commis-
sion all provisions of national law which they adopt in the field
covered by this Directive. The Commission shall inform the other
Member Statesthereof.
Article 5
ThisDirective s hall enter into force on the 20th day following its
publication in the Official Journal of the European Communities .
Article 6
This Directive is addressed to the Member States.1995L0044 — EN — 20.08.1997 — 001.001 — 6
▼B
ANNEX I
1. For the purposes of Article 2 (1) of this Directive the following general
conditionss hall apply:
— the nature and objectivesof the activitiesfor which the material isto 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 77/93/
EEC,
— the quarantine containment conditionsof the premis esand facilitiesat 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 isadequate for the approved activitiesand in any cas e 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
activitiesare to be undertaken, s hall have been examined and approved
by the responsible official body.
2. For the purposes of paragraph 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 quar-
antine 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 inter-
action with the environment and other relevant factorsrelating to the ris k
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, asappropriate, to named pers onnel 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 mate-
rial,
— appropriate indexing (including testing) facilities and procedures; and
(b) further quarantine measures according to the specific biology and epide-
miology of the type of material involved and the activitiesapproved,
— maintenance in facilitieswhich s eparate chamber ‘double door’
access to personnel,
— maintenance under negative air pressure,
— maintenance in espace-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. viruliferousplant food material, hos t material,
— maintenance of material for breeding in breeding cageswith manipu-
lation devices,
— no interbreeding of the harmful organisms with indigenous strains or
species,
— avoidance of continuous culture of the harmful organisms,1995L0044 — EN — 20.08.1997 — 001.001 — 7
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— maintenance under conditionsthat s trictly 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,
— proceduresto check the purity of culturesof the harmful organis ms
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 condi-
tions: 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.1995L0044 — EN — 20.08.1997 — 001.001 — 8
▼B
ANNEX II
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 selections1995L0044 — EN — 20.08.1997 — 001.001 — 9
▼C1
1995L0044 — EN — 20.08.1997 — 001.001 — 10
▼B
ANNEX III
QUARANTINE MEASURES INCLUDING TESTING ON PLANTS,
PLANT PRODUCTS AND OTHER OBJECTS INTENDED FOR
RELEASEFROMQUARANTINE
PART A
For certain plants, plant products and other objects listed in Annex III to
Directive 77/93/EEC
Section I: Plants of Citrus L., Fortunella Swingle, Poncirus Raf. and their
hybrids, other than fruit and seeds
1. The plant material, as appropriate, shall be subjected to appropriate therapy
proceduresaslaid down in FAO/IPGRI Technical Guidelines .
2. The plant material, following the therapy procedurescarried out in 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 conditionslaid 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 rele-
vant harmful organisms listed in Directive 77/93/EEC, on arrival and
subsequently, at appropriate times, during the period of the indexing proce-
dures.
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,
indicator plants, including Citrus sinensis (L.) Osbeck, C. aurantifolia
Christm. Swing, C. medica L.,C. reticulata Blanco and Sesamum L., in
order to detect at least the following harmful organisms:
(a) Citrusgreening bacterium
(b) Citrusvariegated chloros is(c) Citrusmos aic virus(d) Citrus tristeza virus (all isolates)(e) Citrusvein 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 proceduresaccording to point 1.
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 fas as possible, the identity of the harmful organ-
isms 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
1. The plant material, as appropriate, shall be subjected to appropriate therapy
proceduresaslaid down in FAO/IPGRI Technical Guidelines .
2. The plant material, following the therapy procedurescarried out in 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 conditionslaid down in Annex I. Plant material1995L0044 — EN — 20.08.1997 — 001.001 — 11
▼B
intended for approval for official release shall be held under conditions
conducive to a normal for signs and symptoms of harmful organisms
including all relevant harmful organisms listed in Directive 77/93/EEC, 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 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 organ-
isms:
(a) Arabismos aic 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 MalusMill:
(i) where the plant material originatesfrom a country which isnot 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 appro-
priate, indicator plantsfor 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, indi-
cator plantsfor the detection of at leas t 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., asappropriate for each Prunus species:
(i) where the plant material originatesfrom a country which isnot 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 appro-
priate, indicator plantsfor 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, indi-
cator plantsfor the detection of at leas t 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 mycoplasm1995L0044 — EN — 20.08.1997 — 001.001 — 12
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(g) Peach yellowsmycoplas m
(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 PyrusL. 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 neces-
sary, to determine as far as possible, the identity of the harmful organisms
causing the signs and symptoms.
Section III: Plants of Vitis L., other than fruits
1. The plant material shall be subjected, as appropriate, to appropriate therapy
procedures, as laid down in FAO/IPGRI Technical Guidelines.
2. The plant material, following the therapy procedurescarried out in 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 conditionslaid 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 77/93/EEC, 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 originatesin a country which isnot known to be
free of the following harmful organisms:
(i) Ajinashika disease
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 vegeta-
tion.
(ii) Grapevine stunt virus
The testing shall use appropriate indicator plants, including the vine
variety Campbell Early, and observation shall take place during oneyear.
(iii) Summer mottle
The testing shall use appropriate indicator plants, including the vine
varieties Sideritis, Cabernet-Franc and Mission.
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 organ-
isms causing the signs and symptoms.1995L0044 — EN — 20.08.1997 — 001.001 — 13
▼M1
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 proce-
duresaslaid down in FAO/IPGRI Technical Guidelines .
2. Each unit of the plant material, following the therapy procedurescarried out
in 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 conditionslaid 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 rele-
vant harmful organisms listed in Directive 77/93/EEC and potato yellow
vein disease, on arrival and subsequently, at regular intervals until senes-
cence, during the period of the indexing procedures.
3. The indexing proceduresreferred to in point 2 s hall follow the technical
provisions set out in point 5, in order to detect at least the following
harmful organisms:
— Bacteria
(a)Clavibacter michiganensis (Smith) Davis et alssp.sepedonicus
(Spieckermann et Kotthoff) Davis et al;
(b)Pseudomonas solanacearum (Smith) Smith.
— Viruses and virus-like organisms
(a) Andean potato latent virus,
(b) Potato black ringspot virus,
(c) Potato spindle tuber viroid,
(d) Potato yellowing alfamovirus,(e) Potato virusT,(f) Andean potato mottle virus,(g) Common potato viruses A, M, S, V, X and Y (including Y
o,Ynand
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 organ-
isms causing the signs and symptoms.
5. The technical provisions referred to in point 3 shall be as follows:
— Bacteria
1. For tubers, test the heel end of each tuber. The standard sample size
shall be 200 tubers. However, the procedure can be applied conveni-
ently 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. The 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 point 1 and 2, isrecommended.
4. For the material referred to in point 1, the testing method for Clavi-
bacter michiganensis (Smith) Davis et al ssp. sepedonicus
(Spieckermann et Kotthoff) Davis et alshall be the Community
method set out in Annex I to Council Directive 93/85/EEC(1). For
the material referred to in point 2, thistes ting method could be
applied.
5. For the material referred to in point 1, the testing method for Pseu-
domonas solanacearum (Smith) Smith shall be the interim test
scheme set out in the Annex to the Commission decision to be taken
in order to replace the quarantine procedure No 26 for Pseudomonas
solanacearum (Smith) Smith as established by the European and
Mediterranean Plant Protection Organization (EPPO). For the mate-
rial referred to in point 2, thistes ting method could be applied.1995L0044 — EN — 20.08.1997 — 001.001 — 14
(1) OJ No L 259, 18. 10. 1993, p. 1.
▼M1
— Viruses and virus-like organisms, other than potato spindle tuber viroid
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 ishighly recommended.
3. The serological and biological testings 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 infec-
tion. 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
plantswith 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 offi-
cially 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 hasbeen 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.
— Potato spindle tuber viroid
1. For all material, glasshouse grown plants shall be tested, as soon as
they are well established but prior to flowering and pollen produc-
tion. Testing on tuber sprouts/ in vitro plants/small seedlings shall
only be regarded asa preliminary tes t.
2. Sampless hall 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 ºC (preferably at temperatureshigher than 20 ºC) and with at leas t
a 16-hour photo-period.
4. Testing shall be by radioactive or non-radioactive labeled cDNA or
RNA-probes, return-PAGE (with silver staining) or RT-PCR.
5. The maximum bulking rate for probesand return-PAGE is5. Us e of
thisor higher bulking ratesmus t be validated.
PART B
For plants,plantproductsandother objectslisted inAnnexesIIandIVto
Directive 77/93/EEC
1. The official quarantine measures shall include appropriate inspection or
testing for the relevant harmful organisms listed in Annexes I and II to
Directive 77/93/EEC and shall be carried out in respect of the special
requirementslaid down in Annex IV to Directive 77/93/EEC and s hall be
carried out in respect of the special requirements laid down in Annex IV
to Directive 77/93/EEC for specific harmful organisms, as appropriate. In
respect of such special requirements the methods used for the quarantinemeasures shall be those laid down in Annex IV to Directive 77/93/EEC or
other equivalent officially approved measures.
2. The plants, plant products and other objects must be found free, according
to the provisions of paragraph 1, from the relevant harmful organisms speci-
fied in Annexes I, II and IV to Directive 77/93/EEC for the said plants,
plant productsand other objects .1995L0044 — EN — 20.08.1997 — 001.001 — 15
▼B