+Člen 16 Merila in informacije za določene GSO
---+Article 16 1.
---+Article 16 2.
---+Article 16 3.

Člen 16 Merila in informacije za določene GSO

Člen 16

Merila in informacije za določene GSO

1.  Pristojni organ ali Komisija na svojo pobudo lahko izdela predlog o merilih in zahtevanih informacijah, ki morajo biti izpolnjene za prijavo, z odstopanjem od člena 13, za dajanje v promet nekaterih vrst GSO kot proizvodov ali v proizvodih.

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2.   ►M6  Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 29a za dopolnitev te direktive z določitvijo meril in zahtevanih informacij iz odstavka 1, pa tudi ustreznih zahtev za povzetek dokumentacije, po posvetovanju z ustreznim znanstvenim odborom. Merila in zahtevane informacije so take, da zagotavljajo visoko raven varnosti za zdravje ljudi in okolje ter temeljijo na znanstvenih dokazih, ki so na voljo za tako varnost, in na izkušnjah, pridobljenih pri sproščanju primerljivih GSO. ◄

Zahteve iz člena 13(2) se nadomestijo z zahtevami, sprejetimi v skladu s prvim pododstavkom, in uporabi se postopek iz člena 13(3), (4), (5) in (6) ter členov 14 in 15.

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3.  Komisija da pred sprejetjem delegiranih aktov na podlagi odstavka 2 predlog na voljo javnosti. Javnost lahko Komisiji sporoči pripombe v 60 dneh. Komisija te pripombe skupaj z analizo posreduje strokovnjakom iz člena 29a(4).

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1. Pregled

,
Article 16 1.
A competent authority, or the Commission on its own initiative, may make a proposal on criteria and information requirements to be met for the notification, by way of derogation from Article 13, for the placing on the market of certain types of GMOs as or in products.
Article 16 2.
►M6  The Commission is empowered to adopt delegated acts in accordance with Article 29a in order to supplement this Directive by establishing the criteria and information requirements referred to in paragraph 1, as well as any appropriate requirements for a summary of the dossier, after consultation of the relevant Scientific Committee. The criteria and information requirements shall be such as to ensure a high level of safety of human health and the environment and shall be based on the available scientific evidence concerning such safety and on experience gained from the release of comparable GMOs. ◄

The requirements set out in Article 13(2) shall be replaced by those adopted in accordance with the first subparagraph, and the procedure set out in Article 13(3), (4), (5) and (6) and Articles 14 and 15 shall apply.
Article 16 3.
Before adopting delegated acts pursuant to paragraph 2, the Commission shall make the proposal available to the public. The public may make comments to the Commission within 60 days. The Commission shall forward any such comments, together with an analysis, to the experts referred to in Article 29a(4).

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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