+Člen 6 Standardni postopek odobritve
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---+Article 6 2.
---+Article 6 2a.
---+Article 6 3.
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---+Article 6 6.
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---+Article 6 8.
---+Article 6 9.

Člen 6 Standardni postopek odobritve

Člen 6

Standardni postopek odobritve

1.  Brez poseganja v člen 5 mora vsaka oseba, preden začne z namernim sproščanjem GSO ali kombinacije GSO, predložiti prijavo pristojnemu organu države članice, na katere ozemlju bo prišlo do sproščanja.

2.  Prijava iz prvega odstavka vključuje:

(a) 

tehnično dokumentacijo, ki daje informacije iz Priloge III, potrebne za opravljanje ocene tveganja za okolje pri namernem sproščanju GSO ali kombinacije GSO, zlasti:

(i) 

splošne informacije, vključno z informacijami o osebju in njegovi usposobljenosti,

(ii) 

informacije v zvezi z GSO,

(iii) 

informacije v zvezi s pogoji sproščanja in potencialnega prejemnega okolja,

(iv) 

informacije o medsebojnem vplivanju GSO in okolja,

(v) 

načrt spremljanja skladno z ustreznimi deli Priloge III za določitev učinkov GSO na zdravje ljudi ali okolje,

(vi) 

informacije o nadzoru, metodah sanacije, ravnanju z odpadki in načrtih ukrepov za primer nesreče,

(vii) 

povzetek dokumentacije;

(b) 

oceno tveganja za okolje in zaključke, zahtevane v Prilogi II, oddelek D, skupaj z morebitnimi bibliografskimi sklici ter navedbami uporabljenih metod.

▼M7

2a.  Prijava iz odstavka 1 se predloži v standardnih oblikah zapisa podatkov, če te v skladu s pravom Unije obstajajo.

▼B

3.  Prijavitelj se lahko sklicuje na podatke ali rezultate iz prejšnjih prijav, ki so jih predložili drugi prijavitelji, pod pogojem, da te informacije, podatki in rezultati niso zaupni ali da so ti prijavitelji dali pisno privoljenje, ali lahko predloži dodatne informacije, za katere meni, da so pomembne.

4.  Pristojni organ lahko privoli, da se sproščanja istega GSO ali kombinacije GSO na istem mestu ali različnih mestih za isti namen in v določenem obdobju, prijavijo v eni sami prijavi.

5.  Pristojni organ potrdi datum prejema prijave in potem, ko je proučil, kjer je to primerno, morebitne pripombe drugih držav članic po členu 11, prijavitelju pisno odgovori v 90 dneh od prejema prijave z:

(a) 

navedbo, da se je prepričal, da je prijava v skladu s to direktivo in da se lahko prične s sproščanjem; ali

(b) 

navedbo, da sproščanje ne izpolnjuje pogojev te direktive in se prijava zato zavrne.

6.  Za izračun 90 dnevnega obdobja iz odstavka 5 se ne upoštevajo obdobja, v katerih pristojni organ:

(a) 

čaka na dodatne informacije, ki jih je morda zahteval od prijavitelja; ali

(b) 

ugotavlja javno mnenje ali se posvetuje z javnostjo v skladu s členom 9; to ugotavljanje javnega mnenja ali posvetovanje z javnostjo ne podaljšata 90-dnevnega roka iz odstavka 5 za več kot 30 dni.

7.  Če pristojni organ zahteva nove informacije, mora hkrati navesti razloge za to.

8.  Prijavitelj lahko prične s sproščanjem samo, ko prejme pisno odobritev pristojnega organa, in samo pod pogoji, zahtevanimi v tej odobritvi.

9.  Države članice zagotovijo, da se noben material, ki izhaja iz GSO, namerno sproščenih po delu B, ne da v promet, če ni v skladu z delom C.

1. Pregled

,
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 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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