+Člen 25 Zaupnost
---+Article 25 1.
---+Article 25 2.
---+Article 25 3.
---+Article 25 4.
---+Article 25 5.
---+Article 25 6.
---+Article 25 7.
---+Article 25 8.
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Člen 25 Zaupnost
Člen 25 Zaupnost 1. Prijavitelj lahko predloži zahtevo pristojnemu organu, da nekatere dele informacij, predloženih na podlagi te direktive, obravnava kot zaupne, pri čemer priloži preverljivo utemeljitev v skladu z odstavkoma 3 in 6. 2. Pristojni organ oceni zahtevo za zaupnost, ki jo je predložil prijavitelj. 3. Na zahtevo prijavitelja lahko pristojni organ odobri zaupno obravnavo samo v zvezi z naslednjimi informacijami, in na podlagi preverljive utemeljitve, če prijavitelj dokaže, da bi razkritje zadevnih informacij lahko znatno škodilo njegovim interesom:
(a)
informacije iz točk (a), (b) in (c) člena 39(2) Uredbe (ES) št. 178/2002;
(b)
informacije o zaporedju DNK, razen o zaporedjih, ki se uporabljajo za odkrivanje, identifikacijo in količinsko določanje transformacijskega dogodka, ter
(c)
vzorce in strategije žlahtnjenja.
4. Pristojni organ po posvetovanju s prijaviteljem odloči, katere informacije obravnavajo kot zaupne, in prijavitelja obvesti o svoji odločitvi. 5. Države članice, Komisija in ustrezni znanstveni odbori sprejmejo potrebne ukrepe za zagotovitev, da zaupne informacije, sporočene ali izmenjane na podlagi te direktive, niso objavljene. 6. Ustrezne določbe iz členov 39e in 41 Uredbe (ES) št. 178/2002 se smiselno uporabljajo. 7. Ne glede na odstavke 3, 5 in 6 tega člena:
(a)
lahko pristojni organ v primeru, kadar je nujno takojšnje ukrepanje za zaščito zdravja ljudi, zdravja živali ali okolja, kot so izredne razmere, razkrije informacije iz odstavka 3, ter
(b)
se kljub vsemu objavijo informacije, ki so del zaključkov znanstvenih prispevkov, ki so jih pripravili ustrezni znanstveni odbori, ali zaključkov ocenjevalnih poročil in se nanašajo na predvidljive učinke na zdravje ljudi in zdravje živali ali okolje. V tem primeru se uporablja člen 39c Uredbe (ES) št. 178/2002.
8. Če prijavitelj umakne prijavo, države članice, Komisija in ustrezni znanstveni odbori upoštevajo zaupno obravnavo informacij, ki jo je odobril pristojni organ v skladu s tem členom. Kadar je prijava umaknjena, preden pristojni organ odloči o zadevni zahtevi za zaupno obravnavo, države članice, Komisija in ustrezni znanstveni odbori ne objavijo informacij, za katere je bila zahtevana zaupna obravnava.
▼B
1. Pregled
| Naslov |
Regulativa |
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Article 25 1.
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The notifier may submit a request to the competent authority to treat certain parts of the information submitted under this Directive as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.
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Article 25 2.
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The competent authority shall assess the confidentiality request submitted by the notifier.
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Article 25 3.
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Upon request of a notifier, the competent authority may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the notifier to potentially harm its interests to a significant degree:
(a)
items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;
(b)
DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and
(c)
breeding patterns and strategies.
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Article 25 4.
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The competent authority shall, after consultation with the notifier, decide which information is to be treated as confidential and shall inform the notifier of its decision.
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Article 25 5.
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Member States, the Commission and the relevant Scientific Committee(s) shall take the necessary measures to ensure that confidential information notified or exchanged under this Directive is not made public.
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Article 25 6.
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The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.
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Article 25 7.
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Notwithstanding paragraphs 3, 5 and 6 of this Article:
(a)
where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and
(b)
information which forms part of the conclusions of the scientific outputs delivered by the relevant Scientific Committee(s) or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.
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Article 25 8.
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In the event of a withdrawal of the notification by the notifier, Member States, the Commission and the relevant Scientific Committee(s) shall respect the confidentiality as granted by the competent authority in accordance with this Article. Where the withdrawal of the notification takes place before the competent authority has decided on the relevant confidentiality request, Member States, the Commission and the relevant Scientific Committee(s) shall not make public the information for which confidentiality has been requested.
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1.1 Sklici
1.2 Ugotovljene zahteve
1.3 Povezani standardi
2. Ugotovljene zahteve
3. Povezani standardi
- Builddate: 27.03.2021 00:00:00 -Doknr: CELEX:32001L0018
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