+Člen 23 Zaščitna klavzula
---+Article 23 1.
---+Article 23 2.

Člen 23 Zaščitna klavzula

Člen 23

Zaščitna klavzula

1.  Ko ima država članica kot rezultat novih ali dodatnih informacij, ki so postale razpoložljive po datumu odobritve in vplivajo na oceno tveganja za okolje ali ponovno oceno obstoječih informacij na podlagi novega ali dodatnega znanstvenega znanja, podrobne razloge za domnevo, da GSO kot proizvod ali v proizvodu, ki je bil pravilno prijavljen in je prejel pisno odobritev po tej direktivi, predstavlja tveganje za zdravje ljudi ali okolje, lahko ta država članica začasno omeji ali prepove uporabo in/ali prodajo tega GSO kot proizvoda ali v proizvodu na svojem ozemlju.

Država članica zagotovi, da se v primeru resnega tveganja uporabijo nujni ukrepi, kot je prekinitev ali prenehanje dajanja v promet, vključno z obveščanjem javnosti.

Država članica takoj obvesti Komisijo in druge države članice o ukrepih, sprejetih po tem členu, in navede razloge za svojo odločitev, pri čemer dostavi svoj pregled ocene tveganja za okolje in navede, ali in kako je treba spremeniti pogoje odobritve ali odobritev preklicati, ter, kjer je to primerno, nove ali dodatne informacije, na katerih temelji njena odločitev.

▼M3

2.  V 60 dneh po prejemu informacij države članice se sprejme odločitev o ukrepu, ki ga je ta država članica sprejela v skladu z regulativnim postopkom iz člena 30(2). Za izračun 60-dnevnega obdobja se ne upošteva čas, v katerem Komisija čaka dodatne informacije, ki jih je morda zahtevala od prijavitelja, ali pridobiva mnenje znanstvenega-(ih) odbora-(ov), s katerim-(i) se je posvetovala. Čas, v katerem Komisija čaka mnenje znanstvenega-(ih) odbora-(ov), ne sme presegati 60 dni.

Prav tako se ne upošteva čas, ki ga Svet potrebuje za ukrepanje v skladu z regulativnim postopkom iz člena 30(2).

▼B

1. Pregled

,
Article 23 1.
Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.

The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.

The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.
Article 23 2.
Within 60 days of the date of receipt of the information transmitted by the Member State, a decision shall be taken on the measure taken by that Member State in accordance with the regulatory procedure referred to in Article 30(2). For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days.

Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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