+Člen 8 Dovoljenja
---+Article 8 1.
---+Article 8 2.
---+Article 8 3.
---+Article 8 4.
---+Article 8 5.
---+Article 8 6.
---+Article 8 7.
---+Article 8 8.

Člen 8 Dovoljenja

Člen 8

Dovoljenja

1.  Države članice z odstopanjem od omejitev iz točk (a), (b), (c), (d), (f) in (g) člena 7(1) in ob upoštevanju odstavka 2 tega člena uvedejo sistem dovoljenj, ki ustanovam omogoča raziskave o invazivnih tujerodnih vrstah, ki zadevajo Unijo, ali njihovo ohranjanje ex-situ. Kadar se pri varstvu človekovega zdravja ni mogoče izogniti uporabi proizvodov, pridobljenih iz invazivnih tujerodnih vrst, ki zadevajo Unijo, lahko države članice v njihov sistem dovoljenj vključijo tudi znanstveno proizvodnjo in poznejšo uporabo v zdravstvene namene.

2.  Države članice pooblastijo svoje pristojne organe za izdajo dovoljenj iz odstavka 1 za dejavnosti, ki se izvajajo v zaprtem sistemu in izpolnjujejo vse naslednje pogoje:

(a) invazivna tujerodna vrsta, ki zadeva Unijo, je zaprta v zaprtem sistemu v skladu z odstavkom 3, v katerem se jo tudi obravnava;

(b) dejavnost izvaja ustrezno usposobljeno osebje, kakor določijo pristojni organi;

(c) prevoz do zaprtega sistema in od njega se opravi pod pogoji, določenimi v dovoljenju, ki onemogočajo pobeg invazivne tujerodne vrste;

(d) če so invazivne tujerodne vrste, ki zadevajo Unijo, živali, se označijo oziroma se njihova identifikacija omogoči na drug način, če je to ustrezno, pri tem pa se uporabijo postopki, ki ne povzročajo bolečine, stiske ali trpljenja, ki se jim da izogniti;

(e) nevarnost pobega, širjenja ali premestitve se učinkovito obvladuje glede na identiteto, biologijo in način razpršitve vrste, predvideno dejavnost in zaprti sistem, interakcijo z okoljem in druge zadevne dejavnike;

(f) zagotovljen je sistem stalnega nadzora, pri čemer prosilec pripravi načrt ukrepov v primeru morebitnega pobega ali širjenja, vključno z načrtom odstranitve. Načrt ukrepov v primeru pobega odobri pristojni organ. Če pride do pobega ali širjenja, se načrt ukrepov začne izvajati takoj, dovoljenje pa se lahko začasno ali trajno odvzame.

Dovoljenje iz odstavka 1 se omeji na število invazivnih tujerodnih vrst ali osebkov, ki ne presega zmogljivosti zaprtega sistema. Vključuje omejitve, ki so potrebne za zmanjšanje možnosti pobega ali širjenja zadevne vrste. Dovoljenje mora spremljati invazivno tujerodno vrsto, za katero je bilo izdano, ves čas med njenim posedovanjem, vnosom in prevozom znotraj Unije.

3.  Šteje se, da so osebki zaprti v zaprtem sistemu, če so izpolnjeni naslednji pogoji:

(a) osebki so fizično izolirani in ne morejo pobegniti ali se širiti, niti jih ne morejo iz sistema, v katerem so zaprti, premestiti nepooblaščene osebe;

(b) s protokoli o čiščenju, ravnanju z odpadki in vzdrževanju je zagotovljeno, da osebki ali deli, ki so sposobni razmnoževanja, ne morejo pobegniti, se širiti, niti jih ne morejo premestiti nepooblaščene osebe;

(c) premestitev osebkov iz sistemov, odprava, uničenje ali humana izločitev je izvedena tako, da se onemogoči njihova propagacija ali razmnoževanje zunaj sistemov.

4.  Ko prosilec zaprosi za dovoljenje, predloži vsa potrebna dokazila, da lahko pristojni organ oceni, ali so izpolnjeni pogoji iz odstavkov 2 in 3.

5.  Države članice pooblastijo svoje pristojne organe, da kadar koli začasno ali trajno odvzamejo dovoljenje, če se pojavijo nepredvideni dogodki, ki imajo škodljive vplive na biotsko raznovrstnost ali povezane ekosistemske storitve. Vsak odvzem dovoljenja mora biti znanstveno utemeljen, če so znanstveni podatki še nezadostni, pa mora biti utemeljen z načelom previdnosti ob ustreznem upoštevanju nacionalnih upravnih predpisov.

6.  Komisija z izvedbenimi akti določi obliko dokumenta, ki predstavlja dokazilo za dovoljenje, ki ga izdajo pristojni organi države članice. Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 27(2). Države članice uporabijo to obliko za dokument, ki je priložen dovoljenju.

7.  Države članice za vsa dovoljenja, izdana v skladu z odstavkom 1 tega člena, brez odlašanja na spletu objavijo vsaj:

(a) znanstveno in domače ime invazivne tujerodne vrste, ki zadeva Unijo, za katero je bilo izdano dovoljenje;

(b) število ali količino zadevnih osebkov;

(c) namen, za katerega je bilo izdano dovoljenje, in

(d) oznake kombinirane nomenklature, kot so določene v Uredbi (EGS) št. 2658/87.

8.  Države članice zagotovijo, da preglede opravljajo njihovi pristojni organi, da bi zagotovili, da ustanove izpolnjujejo pogoje iz teh izdanih dovoljenj.

1. Pregled

,
Article 8 1.
By way of derogation from the restrictions set out in points (a), (b), (c), (d), (f) and (g) of Article 7(1), and subject to paragraph 2 of this Article, Member States shall establish a permit system allowing establishments to carry out research on, or ex-situ conservation of, invasive alien species of Union concern. Where the use of products derived from invasive alien species of Union concern is unavoidable to advance human health, Member States may also include scientific production and subsequent medicinal use within their permit system.
Article 8 2.

Member States shall empower their competent authorities to issue the permits referred to in paragraph 1 for activities carried out in contained holding that fulfil all of the following conditions:

(a) 

the invasive alien species of Union concern is kept in and handled in contained holding in accordance with paragraph 3;

(b) 

the activity is to be carried out by appropriately qualified personnel as laid down by the competent authorities;

(c) 

transport to and from contained holding is carried out under conditions that exclude escape of the invasive alien species as established by the permit;

(d) 

in the case of invasive alien species of Union concern that are animals, they are marked or otherwise effectively identified where appropriate, using methods that do not cause avoidable pain, distress or suffering;

(e) 

the risk of escape or spread or removal is effectively managed, taking into account the identity, biology and means of dispersal of the species, the activity and the contained holding envisaged, the interaction with the environment and other relevant factors;

(f) 

a continuous surveillance system and a contingency plan covering possible escape or spread is drawn up by the applicant, including an eradication plan. The contingency plan shall be approved by the competent authority. If an escape or spread occurs, the contingency plan shall be implemented immediately and the permit may be withdrawn, temporarily or permanently.

The permit referred to in paragraph 1 shall be limited to a number of invasive alien species and specimens that does not exceed the capacity of the contained holding. It shall include the restrictions necessary to mitigate the risk of escape or spread of the species concerned. It shall accompany the invasive alien species to which it refers at all times when those species are kept, brought into and transported within the Union.
Article 8 3.

Specimens shall be considered to be kept in contained holding if the following conditions are fulfilled:

(a) 

the specimens are physically isolated and they cannot escape or spread or be removed by unauthorised persons from the holdings where they are kept;

(b) 

cleaning, waste handling and maintenance protocols ensure that no specimens or reproducible parts can escape, spread or be removed by unauthorised persons;

(c) 

the removal of the specimens from the holdings, disposal or destruction or humane cull is done in such way as to exclude propagation or reproduction outside of the holdings.
Article 8 4.
When applying for a permit, the applicant shall provide all necessary evidence to allow the competent authority to assess whether the conditions set out in paragraphs 2 and 3 are fulfilled.
Article 8 5.
Member States shall empower their competent authorities to withdraw the permit at any point in time, temporarily or permanently, if unforeseen events with an adverse impact on biodiversity or related ecosystem services occur. Any withdrawal of a permit shall be justified on scientific grounds and, where scientific information is insufficient, on the grounds of the precautionary principle and having due regard to national administrative rules.
Article 8 6.
The Commission shall adopt, by means of implementing acts, the format of the document serving as evidence for the permit issued by the competent authorities of a Member State. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). Member States shall use that format for a document accompanying the permit.
Article 8 7.

For all permits issued in accordance with paragraph 1 of this Article, Member States, shall, without delay, make publicly available on the internet at least the following:

(a) 

the scientific and common names of the invasive alien species of Union concern for which the permit has been issued;

(b) 

the number or the volume of specimens concerned;

(c) 

the purpose for which the permit has been issued; and

(d) 

the codes of Combined Nomenclature as provided by Regulation (EEC) No 2658/87.
Article 8 8.
Member States shall ensure that inspections are carried out by their competent authorities to ensure that the establishments comply with the conditions set out in those permits issued.

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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