+Airteagal 8 Ceadanna
---+Article 8 1.
---+Article 8 2.
---+Article 8 3.
---+Article 8 4.
---+Article 8 5.
---+Article 8 6.
---+Article 8 7.
---+Article 8 8.

Airteagal 8 Ceadanna

Airteagal 8

Ceadanna

1.  De mhaolú ar na srianta a leagtar amach i bpointí (a), (b), (c), (d), (f) agus (g) d’Airteagal 7(1), agus faoi réir mhír 2 den Airteagal seo, cuirfidh na Ballstáit córas ceadanna ar bun lena bhféadfaidh bunaíochtaí taighde, nó caomhnú ex-situ a dhéanamh ar speicis choimhthíocha ionracha is ábhar imní don Aontas. I gcás ina bhfuil úsáid na dtáirgí a eascraíonn ó speicis choimhthíocha ionracha is ábhar imní don Aontas dosheachanta le sláinte an duine a chur ar aghaidh, féadfaidh na Ballstáit freisin an táirgeadh eolaíoch agus an leas íocshláinte ina dhiaidh sin a áireamh laistigh dá córas ceadanna.

2.  Tabharfaidh na Ballstáit de chumhacht do na húdaráis inniúla na ceadanna dá dtagraítear i mír 1 a eisiúint le haghaidh gníomhaíochtaí a dhéantar faoi choimeád imshrianta a chomhlíonann gach ceann de na coinníollacha seo a leanas:

(a) coimeádtar agus láimhseáiltear an speiceas choimhthíoch ionrach is ábhar imní don Aontas faoi choimeád imshrianta i gcomhréir le mír 3;

(b) beidh an ghníomhaíocht le cur i gcrích ag pearsanra a bheidh cáilithe go hiomchuí faoi mar leagann na húdaráis inniúla iomchuí síos;

(c) beidh iompar chuig ionad coimeádta imshrianta agus uaidh faoi dhálaí a eisiann éalú na speiceas coimhthíoch ionrach faoi mar a bhunaítear iad leis an gcead;

(d) i gcás gur ainmhithe iad na speicis choimhthíocha ionracha is ábhar imní don Aontas, marcáiltear iad nuair is iomchuí nó sainaithnítear ar shlí éifeachtach eile iad agus úsáidfear modhanna nach gcuireann pian, anacair nó fulaingt inseachanta faoi deara;

(e) déanfar an riosca éalaithe nó leata a bhainistiú go héifeachtach, agus cuirfear san áireamh céannacht, bitheolaíocht agus modhanna scaipthe an speicis, an ghníomhaíocht agus an coimeád imshrianta atá beartaithe, an t-idirghníomhú leis an timpeallacht agus tosca ábhartha eile;

(f) tarraingeofar suas córas faireachais leanúnaigh agus plean teagmhasach chun go gcumhdófaí éalú nó leathadh a d’fhéafadh a tharlú, lena n-áirítear plean don díothú. Déanfaidh an t-údarás inniúil an plean teagmhais a fhormheas. I gcás ina dtarlaíonn éalú nó leathadh, cuirfear chun feidhme an phlean teagmhais láithreach agus féadfar an cead a tharraingt siar, ar bhonn sealadach nó buan.

Teorannófar an cead dá dtagraítear i mír 1 do líon ar leith speiceas agus eiseamal ionrach nach mó ná cumas an ionaid coimeádta imshrianta. Áireofar ann na srianta is gá chun riosca éalaithe nó leata an speicis lena mbaineann a mhaolú. Coimeádfar i gcónaí é leis na speicis choimhthíocha ionracha dá dtagraíonn sé nuair a bhíonn na speicis sin á gcoimeád, agus á dtabhairt isteach san Aontas agus á n-iompar laistigh den Aontas.

3.  Measfar go bhfuil eiseamail á gcoimeád faoi choimeád imshrianta má chomhlíontar na coinníollacha seo a leanas:

(a) tá eiseamail scartha amach go fisiceach agus ní féidir leo éalú ná leathadh ná ní féidir le daoine neamhúdaraithe iad a thógáil as na saoráidí ina bhfuil siad á gcoimeád;

(b) áiritheoidh prótacail um ghlanadh, um láimhseáil dramhaíola agus um chothabháil nach bhféadfaidh aon eiseamail ná codanna inatáirgthe éalú, leathadh nó nach féidir le daoine neamhúdaraithe iad a thógáil as na saoráidí;

(c) déantar na heiseamail a thógáil as na saoráidí nó a dhiúscairt nó a dhíothú nó a dhealú go daonnachtúil ar bhealach chun iomadú nó atáirgeadh lasmuigh de na saoráidí a eisiamh.

4.  Nuair a dhéanfaidh an t-iarratasóir iarratas ar chead, déanfaidh sé gach fianaise is gá a sholáthar chun go bhféadfaidh an t-údarás inniúil measúnú a dhéanamh an bhfuil na coinníollacha dá dtagraítear i mír 2 agus i mír 3 á gcomhlíonadh.

5.  Tabharfaidh na Ballstáit de chumhacht dá n-údaráis inniúla an cead a tharraingt siar tráth ar bith, go sealadach nó go buan, má tharlaíonn imeachtaí gan choinne a bhfuil drochthionchar acu ar an mbithéagsúlacht nó ar sheirbhísí gaolmhara éiceachórais. Déanfar bonn cirt a thabhairt maidir le haon chead a aistarraingt ar bhonn eolaíoch agus, i gcás nach leor an fhaisnéis eolaíoch, ar bhonn phrionsabal an réamhchúraim agus aird chuí á tabhairt ar rialacha náisiúnta riaracháin.

6.  Glacfaidh an Coimisiún, trí bhíthin gníomhartha chur chun feidhme, formáid an doiciméid atá mar fhianaise ar an gcead a d’eisigh údaráis inniúla Ballstáit. Déanfar na gníomhartha cur chun feidhme sin a ghlacadh i gcomhréir leis an nós imeachta scrúdúcháin dá dtagraítear in Airteagal 27(2). Úsáidfidh na Ballstáit an fhormáid sin do dhoiciméad a bheidh ag gabháil leis an gcead.

7.  I gcás gach cead a eisíodh i gcomhréir le mír 1 den Airteagal seo, cuirfidh na Ballstáit ar fáil go poiblí ar an idirlíon, gan mhoill, na nithe seo a leanas ar a laghad:

(a) ainmneacha eolaíocha agus coitianta an speicis choimhthígh ionraigh is ábhar imní don Aontas ar eisíodh an cead ina leith;

(b) líon nó méid na n-eiseamal lena mbaineann;

(c) an cuspóir dár eisíodh an cead; agus

(d) na cóid den Ainmníocht Chomhcheangailte chuirtear ar fáil le Rialachán (CEE) Uimh. 2658/87.

8.  Áiritheoidh na Ballstáit go ndéanfaidh a n-údaráis inniúla cigireachtaí chun a áirithiú go gcomhlíonfaidh na bunaíochtaí na coinníollacha a leagadh amach sna ceadanna sin a eisíodh.

1. Forbhreathnú

,
Teideal Rialáil
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 Tagairtí

1.2 Ceanglais aitheanta

1.3 Caighdeáin ghaolmhara

2. Ceanglais aitheanta

Ceanglais
Foinse Ceanglas

3. Caighdeáin ghaolmhara

Caighdeáin
Foinse Ceanglas
  • Builddate: 14.12.2019 00:00:00 -Doknr: CELEX:32014R1143
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