+Artikolu 8 Permessi
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---+Article 8 8.

Artikolu 8 Permessi

Artikolu 8

Permessi

1.  Permezz ta’ deroga mir-restrizzjonijiet stipulati fil-punti (a), (b), (c), (d), (f) u (g) tal-Artikolu 7(1), u soġġett għall-paragrafu 2 ta' dan l-Artikolu, l-Istati Membri għandhom jistabbilixxu sistema ta’ permessi li tippermetti li l-istabbilimenti jagħmlu riċerka dwar, jew il-konservazzjoni ex situ ta', speċijiet aljeni invażivi li huma sors ta' tħassib għall-Unjoni. Fejn l-użu ta' prodotti derivati minn speċijiet aljeni invażivi li huma sors ta' tħassib għall-Unjoni ma jistax jiġi evitat fl-avvanz tas-saħħa tal-bniedem, l-Istati Membri jistgħu wkoll jinkludu l-produzzjoni xjentifika u l-użu mediċinali sussegwenti fi ħdan is-sistema tagħhom tal-permessi.

2.  L-Istati Membri għandhom jagħtu s-setgħa lill-awtoritajiet kompetenti tagħhom biex joħorġu l-permessi msemmija fil-paragrafu 1 għal attivitajiet li jsiru f'faċilità kkonfinata li jissodisfaw il-kondizzjonijiet kollha li ġejjin:

(a) l-ispeċi aljena invażiva li huma sors ta' tħassib għall-Unjoni tinżamm u tiġi ttrattata f'faċilitajiet ikkonfinati skont il-paragrafu 3;

(b) l-attività ssir minn persunal bi kwalifiki adatti kif stabbilit mill-awtoritajiet komptenti;

(c) it-trasport lejn u mill-faċilità kkonfinata jsir f'kondizzjonijiet li jeskludu l-ħarba ta' speċijiet aljeni invażivi kif stabbilit mill-permess;

(d) fil-każ ta’ speċijiet aljeni invażivi li huma sors ta' tħassib għall-Unjoni li huma annimali, dawn jiġu mmarkati jew inkella jiġu identifikati b'mod effettiv, skont il-każ, bl-użu ta’ metodi li ma jikkawżawx uġigħ, tensjoni jew tbatija li jkunu evitabbli;

(e) ikun ġestit b'mod effettiv ir-riskju tal-ħarba jew ta' tixrid jew ta' tneħħija, b'kont meħud tal-identità, il-bijoloġija u l-mezzi tat-tixrid tal-ispeċijiet, l-attività u l-faċilità kkonfinata maħsuba, l-interazzjoni mal-ambjent u fatturi rilevanti oħra;

(f) jitfasslu mill-applikant sistema ta' sorveljanza kontinwa u pjan ta' kontinġenza li jkopri l-ħarba jew it-tixrid possibbli, inkluż pjan għall-qerda. Il-pjan ta' kontinġenza għandu jiġi approvat mill-awtorità kompetenti. Jekk isseħħ ħarba jew iseħħ tixrid, għandu jiġu implimentat minnufih il-pjan ta' kontinġenza u l-permess jista' jiġi rtirat fuq bażi temporanja jew permanenti.

Il-permess imsemmi fil-paragrafu 1 għandu jkun limitat għal għadd ta' speċijiet aljeni invażivi u eżemplari li ma jaqbiżx il-kapaċità tal-faċilità kkonfinata. Huwa għandu jinkludi r-restrizzjonijiet meħtieġa għall-mitigazzjoni tar-riskju tal-ħarba jew tat-tixrid tal-ispeċi kkonċernata. Huwa għandu jakkumpanja l-ispeċijiet aljeni invażivi li għalihom ikun qed jirriferi l-ħin kollu meta dawk l-ispeċijiet jinżammu, jiddaħħlu jew jiġu ttrasportati fl-Unjoni.

3.  L-eżemplari għandhom jitqiesu bħala li qed jinżammu f'faċilitajiet ikkonfinati jekk ikunu sodisfatti l-kondizzjonijiet li ġejjin:

(a) l-eżemplari ikunu fiżikament iżolati u ma jistgħux jaħarbu jew jinxterdu jew jitneħħew minn persuni mhux awtorizzati mill-faċilitajiet fejn jinżammu;

(b) il-protokolli tat-tindif, tal-ġestjoni tal-iskart u tal-manteniment għandhom jiżguraw li l-ebda eżemplar jew parti riproduċibbli ma jkunu jistgħu jaħarbu, jinxterdu jew jitneħħew minn persuni mhux awtorizzati;

(c) it-tneħħija tal-eżemplari mill-faċilitajiet, ir-rimi jew il-qerda jew il-qtil b'mod mhux krudili jsir b'tali mod li jeskludi l-propagazzjoni jew ir-riproduzzjoni barra mill-faċilitajiet.

4.  Meta japplika għall-permess, l-applikant għandu jipprovdi l-evidenza neċessarja kollha biex jippermetti li l-awtorità kompetenti tivvaluta jekk il-kondizzjonijiet stabbiliti fil-paragrafi 2 u 3 humiex sodisfatti.

5.  L-Istati Membri għandhom jagħtu s-setgħa lill-awtoritajiet kompetenti tagħhom sabiex jirtiraw il-permess fi kwalunkwe mument, fuq bażi temporanja jew permanenti, jekk iseħħu ġrajjiet mhux mistennija b'impatt negattiv fuq il-bijodiversità jew is-servizzi relatati tal-ekosistema. Kwalunkwe rtirar ta' permess għandu jkun ġustifikat b'raġunijiet xjentifiċi u, fejn l-informazzjoni xjentifika tkun insuffiċjenti, minħabba l-prinċipju ta' prekawzjoni u b'konsiderazzjoni dovuta għar-regoli amministrattivi nazzjonali.

6.  Il-Kummissjoni għandha tadotta, permezz ta' att ta' implimentazzjoni, il-format tad-dokument li jservi bħala evidenza għall-permess maħruġ mill-awtoritajiet kompetenti ta' Stat Membru. Dawk l-atti ta’ implimentazzjoni għandhom jiġu adottati f’konformità mal-proċedura ta’ eżami msemmija fl-Artikolu 27(2). L-Istati Membri għandhom jużaw dak il-format għal dokument li jakkumpanja l-permess.

7.  Għall-permessi kollha maħruġa skont il-paragrafu 1 ta' dan l-Artikolu, l-Istati Membri għandhom, mingħajr dewmien, jagħmlu dan li ġej disponibbli fuq l-internet għall-pubbliku:

(a) l-ismijiet xjentifiċi u komuni tal-ispeċijiet aljeni invażivi li huma sors ta' tħassib għall-Unjoni li jkun inħarġilhom permess;

(b) l-għadd jew il-volum tal-eżemplari kkonċernati;

(c) l-għan li għalih ikun maħruġ il-permess; u

(d) il-kodiċijiet tan-Nomenklatura Magħquda kif previsti fir-Regolament (KEE) Nru 2658/87.

8.  L-Istati Membri għandhom jiżguraw li l-awtoritajiet kompetenti jagħmlu ispezzjonijiet biex jiżguraw li dal-istabbiliment jikkonforma mal-kondizzjonijiet stabbiliti f'dawk il-permessi maħruġin.

1. Ħarsa ġenerali

,
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 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
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