+Artikolu 6 Proċedura ta' awtoriżżazjoni standard
---+Article 6 1.
---+Article 6 2.
---+Article 6 2a.
---+Article 6 3.
---+Article 6 4.
---+Article 6 5.
---+Article 6 6.
---+Article 6 7.
---+Article 6 8.
---+Article 6 9.

Artikolu 6 Proċedura ta' awtoriżżazjoni standard

Artikolu 6

Proċedura ta' awtoriżżazjoni standard

1.  Mingħajr preġudizzju għall-artikolu 5, kwalunkwe persuna trid, qabel ma tirrilaxxja b'mod intenzjonat GMO jew tagħqid ta' GMOs, tagħti notifika lil awtorità kompetenti ta' Stat Membru li fit-territorju tiegħu se jsir ir-rilaxx.

2.  In-notifika riferita fil-paragrafu 1 tinkludi:

(a) 

dossier tekniku li jagħti l-informazzjoni speċifikata fl-Anness III neċessarja biex isir stima ta' riskju ambjentali ta' rilaxx intenzjonat ta' GMO jew tagħqid ta' GMOs, in partikolari:

(i) 

informazzjoni ġenerali inkluża informazzjoni fuq impjegati u taħriġ,

(ii) 

informazzjoni dwar il-GMO(s),

(iii) 

informazzjoni dwar il-kondizzjonijiet ta' rilaxx u l-ambjent potenzjali li qiegħed jirċievi,

(iv) 

informazzjoni fuq l-interazzjonijiet bejn GMO(s) u l-ambjent,

(v) 

pjan għal sorveljar skond il-partijiet rilevanti tal-Anness III biex tidentifika effetti ta' GMO(s) fuq is-saħħa tal-bniedem jew fuq l-ambjent,

(vi) 

informazzjoni fuq kontroll, metodi ta' rimedji, trattament ta' skart u pjanijiet ta' rispons għal emerġenza,

(vii) 

sommarju tad-dossier;

(b) 

stima ta' riskju ambjentali u l-konklużjonijiet meħtieġa fl-Anness II, taqsima D, flimkien ma riferenza bibliografika u indikazzjonijiet tal-metodi użati.

▼M7

2a.  In-notifika msemmija fil-paragrafu 1 għandha tiġi sottomessa b'konformità ma' formati standard ta' data, fejn jeżistu skont il-liġi tal-Unjoni.

▼B

3.  In-notifikant jista' jirreferi għal informazzjoni jew riżultati minnn notifiki li kienu mgħotija qabel minnn notifikanti oħra, sakemm l-informazzjoni, data u riżultati mhumiex kunfidenzjali jew dawn in-notifikanti taw il-kunsens tagħhom bil-miktub, jew jistgħu jipprovdu informazzjoni addizjonali li huwa jikkonsidra rilevanti.

4.  L-awtorità kompetenti tista' taċċetta li rilaxx ta' l-istess GMO jew ta' tagħqid ta' GMOs fuq l-istess post jew f'postijiet differenti għall-istess skop u f'perijodu definit jistgħu jiġu notifikati b'notifika waħda.

5.  L-awtorità kompetenti għandha tagħrraf id-data ta' riċevuta ta' notifika u, wara li tkun kunsidrat, fejn xieraq, xi osservazzjonijiet minn Stati Membri oħra li saru skond l-Artikolu 11, tirrispondi bil-miktub lin-notifkant f'90 ġurnata mir-riċevuta ta' notifika billi jew:

(a) 

tindika li hi sodisfatta li n-notifika hija konformi ma' din id-Direttiva u li r-rilaxx jista' jipproċedi; jew

(b) 

tindika li r-rilaxx ma josservax il-kondizzjonijiet ta' din id-Direttiva u li għalhekk in-notifika ma ġietx aċċettata.

6.  Għal għan li tikkalkula il-perijodu ta' 90 ġurnata msemmi fil-paragrafu 5, ma jittieħidx akkont ta' xi perijodi ta' żmien li matulhom l-awtorità kompetenti:

(a) 

qed tistenna informazzjoni ulterjuri li tista' tkun talbet minn għand in-notifikant, jew

(b) 

qed tiżvolġi inkjesta pubblika jew konsultazzjoni skond l-Artikolu 9; din l-inkjesta pubblika jew konsultazzjoni ma ttawwalx il-perijodu ta' 90 ġurnata msemmi fil-paragrafu 5 b'iktar minn 30 ġurnata.

7.  Jekk l-awtorità kompetenti titlob informazzjoni ġdida trid simultajament tagħti r-raġunijiet tagħha talli għamlet hekk.

8.  In-notifikant jista' jipproċedi bir-rilaxx biss meta jkun irċieva l-kunsens bil-miktub ta' l-awtorità kompetenti, u konformi ma' kwalunkwe kondizzjonijiet rikjesti f'dan il-kunsens.

9.  L-Istati Membri għandhom jassiguraw li ebda materjal li ġej minn GMOs li huma deliberament rilaxxati skond il-parti B ma jitpoġġa fis-suq, kemm-il darba ma jkunx skond il-parti C.

1. Ħarsa ġenerali

,
Article 6 1.
Without prejudice to Article 5, any person must, before undertaking a deliberate release of a GMO or of a combination of GMOs, submit a notification to the competent authority of the Member State within whose territory the release is to take place.
Article 6 2.

The notification referred to in paragraph 1 shall include:

(a) 

a technical dossier supplying the information specified in Annex III necessary for carrying out the environmental risk assessment of the deliberate release of a GMO or combination of GMOs, in particular:

(i) 

general information including information on personnel and training,

(ii) 

information relating to the GMO(s),

(iii) 

information relating to the conditions of release and the potential receiving environment,

(iv) 

information on the interactions between the GMO(s) and the environment,

(v) 

a plan for monitoring in accordance with the relevant parts of Annex III in order to identify effects of the GMO(s) on human health or the environment,

(vi) 

information on control, remediation methods, waste treatment and emergency response plans,

(vii) 

a summary of the dossier;

(b) 

the environmental risk assessment and the conclusions required in Annex II, section D, together with any bibliographic reference and indications of the methods used.
Article 6 2a.
The notification referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist under Union law.
Article 6 3.
The notifier may refer to data or results from notifications previously submitted by other notifiers, provided that the information, data and results are non confidential or these notifiers have given their agreement in writing, or may submit additional information he considers relevant.
Article 6 4.
The competent authority may accept that releases of the same GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.
Article 6 5.

The competent authority shall acknowledge the date of receipt of the notification and, having considered, where appropriate, any observations by other Member States made in accordance with Article 11, shall respond in writing to the notifier within 90 days of receipt of the notification by either:

(a) 

indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed; or

(b) 

indicating that the release does not fulfil the conditions of this Directive and that notification is therefore rejected.
Article 6 6.

For the purpose of calculating the 90 day period referred to in paragraph 5, no account shall be taken of any periods of time during which the competent authority:

(a) 

is awaiting further information which it may have requested from the notifier, or

(b) 

is carrying out a public inquiry or consultation in accordance with Article 9; this public inquiry or consultation shall not prolong the 90 day period referred to in paragraph 5 by more than 30 days.
Article 6 7.
If the competent authority requests new information it must simultaneously give its reasons for so doing.
Article 6 8.
The notifier may proceed with the release only when he has received the written consent of the competent authority, and in conformity with any conditions required in this consent.
Article 6 9.
Member States shall ensure that no material derived from GMOs which are deliberately released in accordance with part B is placed on the market, unless in accordance with part C.

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
  • Builddate: 27.03.2021 00:00:00 -Doknr: CELEX:32001L0018
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