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Dokument 32008L0061
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)
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)
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)
OJ L 158, 18.6.2008, s. 41—55
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) This document has been published in a special edition(s)
(HR)
Již není platné, Datum konce platnosti: 13/12/2019; Repealed by 32019R0829
Vztah | Akt | Poznámka | Týká se podcelku | od | do |
---|---|---|---|---|---|
Zrušení | 31995L0044 |
Vztah | Akt | Poznámka | Týká se podcelku | od | do |
---|---|---|---|---|---|
Zrušeno | 32019R0829 | 14/12/2019 |
18.6.2008 |
EN |
Official Journal of the European Union |
L 158/41 |
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,
Having regard to the Treaty establishing the European Community,
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 and against their spread within the Community (1), and in particular Articles 3(8), 4(5), 5(5) and 13b(4) thereof,
Whereas:
(1) |
Commission Directive 95/44/EC of 26 July 1995 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I 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. |
(2) |
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 listed in Annex II to that Directive, may not be introduced into and spread by movement within the Community or certain protected zones thereof. |
(3) |
Under Directive 2000/29/EC, plants, plant products and other objects listed in its Annex III may not be introduced into the Community or into certain protected zones thereof. |
(4) |
Plants, plant products and other objects listed in Annex IV to Directive 2000/29/EC may not be introduced into or moved within the Community or certain protected zones thereof unless the relevant special requirements indicated in that Annex are met. |
(5) |
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 phytosanitary certificate ensuring such compliance and are, moreover, inspected on an official basis for compliance with these provisions. |
(6) |
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, under conditions which shall be determined at Community level. |
(7) |
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. |
(8) |
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 trade therein (4) and under Directive 2001/18/EC of the European Parliament and 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 flora and genetically modified organisms, are not affected by this Directive. |
(9) |
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health. |
(10) |
This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex IV, Part B, |
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, hereinafter 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.
2. The application referred to in paragraph 1, shall specify at 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 documentary evidence for material to be introduced from a third country; |
(f) |
the duration, nature and objectives of the activities envisaged, including, at least, a resumé of the work and a specification for trial or scientific purposes or work on varietal selections; |
(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 appropriate; |
(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. |
Article 2
1. Member States, on 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 activities referred to in 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, provided that such material is accompanied in all cases by a letter of authority for such introduction or movement of harmful organisms, plants, plant products and other objects for trial or scientific purposes and for work on varietal selections, hereinafter referred to as a ‘letter of authority’, 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
(a) |
in the case of material originating in the Community:
|
(b) |
in the case of material introduced from a third country:
|
In all cases Member States shall ensure that the material is held under quarantine containment conditions during the said introduction or movement, and is moved directly and immediately to the site or sites specified in the application.
3. The responsible official body shall monitor the approved 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:
|
(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. |
4. Member States shall ensure that for activities utilising 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 measures, including testing, shall be carried out. These quarantine 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 quantities, of the introductions and movements of material approved under this Directive during the preceding period of one year ending on 30 June, and of any contamination by harmful organisms of such material, which has been confirmed under the quarantine measures, including testing, 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(4) of Directive 2000/29/EC, with regard to the provision of details of the quarantine containment conditions and measures imposed for activities approved under this Directive.
Article 4
Member States shall immediately communicate to the Commission all provisions of national law which they adopt 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 obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex IV, Part B.
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.
Article 7
This Directive is addressed to the Member States.
Done at Brussels, 17 June 2008.
For the Commission
The President
José Manuel BARROSO
(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).
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:
|
(b) |
further quarantine measures according to the specific biology and epidemiology of the type of material involved and the activities approved:
|
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 selections
ANNEX III
QUARANTINE MEASURES INCLUDING TESTING ON PLANTS, PLANT PRODUCTS AND OTHER OBJECTS INTENDED FOR RELEASE FROM QUARANTINE
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
1. |
The plant material, as appropriate, shall be subjected to appropriate therapy procedures as laid down in FAO/IPGRI Technical Guidelines. |
2. |
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:
|
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 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 procedures as laid down in FAO/IPGRI Technical Guidelines. |
2. |
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:
|
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. |
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 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:
|
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. |
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:
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:
|
PART B
For plants, plant products and other objects listed in Annexes II and IV to Directive 2000/29/EC
1. |
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. |
2. |
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) 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).
ANNEX IV
PART A
Repealed Directive with its amendment
(referred to in Article 5)
Commission Directive 95/44/EC |
|
Commission Directive 97/46/EC |
PART B
List of time-limits for transposition into national law
(referred to in Article 5)
Directive |
Time-limit for transposition |
95/44/EC |
1 February 1996 |
97/46/EC |
1 January 1998 |
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)(a) |
Article 1(2), second indent |
Article 1(2)(b) |
Article 1(2), third indent |
Article 1(2)(c) |
Article 1(2), fourth indent |
Article 1(2)(d) |
Article 1(2), fifth indent |
Article 1(2)(e) |
Article 1(2), sixth indent |
Article 1(2)(f) |
Article 1(2), seventh indent |
Article 1(2)(g) |
Article 1(2), eighth indent |
Article 1(2)(h) |
Article 1(2), ninth indent |
Article 1(2)(i) |
Article 1(2), tenth indent |
Article 1(2)(j) |
Articles 2 and 3 |
Articles 2 and 3 |
Article 4(1) |
— |
Article 4(2) |
Article 4 |
— |
Article 5 |
Article 5 |
Article 6 |
Article 6 |
Article 7 |
Annexes I, II and III |
Annexes I, II and III |
— |
Annex IV |
— |
Annex V |