+Članak 16. Mjerila i informacije za određene GMO-e
---+Article 16 1.
---+Article 16 2.
---+Article 16 3.

Članak 16. Mjerila i informacije za određene GMO-e

Članak 16.

Mjerila i informacije za određene GMO-e

1.  Nadležno tijelo ili Komisija na svoju inicijativu mogu dati prijedlog o zahtjevima vezanima uz mjerila i informacije koje se moraju zadovoljiti u prijavi, odstupanjem od članka 13., za stavljanje na tržište određenih vrsta GMO-a kao proizvoda ili sastojka proizvodâ.

▼M3

2.   ►M6  Komisija je ovlaštena, nakon savjetovanja s relevantnim znanstvenim odborom, donijeti delegirane akte u skladu s člankom 29.a radi dopune ove Direktive utvrđivanjem mjerila i zahtjeva u vezi s informacijama iz stavka 1., kao i svih odgovarajućih zahtjeva u vezi sa sažetkom dosjea. Mjerila i zahtjevi u vezi s informacijama moraju biti takvi da osiguravaju visoku razinu sigurnosti zdravlja ljudi i okoliša i moraju se temeljiti na raspoloživim znanstvenim dokazima u vezi s tom sigurnosti i na iskustvima stečenima uvođenjem usporedivih GMO-a. ◄

Zahtjevi navedeni u članku 13. stavku 2. zamjenjuju se zahtjevima usvojenima u skladu s prvim podstavkom, a primjenjuje se postupak utvrđen u članku 13. stavcima 3., 4., 5. i 6. i člancima 14. i 15.

▼M6

3.  Prije donošenja delegiranih akata iz stavka 2. Komisija stavlja prijedlog na raspolaganje javnosti. Javnost može dati komentare Komisiji u roku od 60 dana. Komisija sve takve komentare, popraćene analizom, prosljeđuje stručnjacima iz članka 29.a stavka 4.

▼B

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 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi

3. Povezani standardi

Standardi
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