+Artikolu 20 Sorveljar u maneġġjar ta' informazzjoni ġdida
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Artikolu 20 Sorveljar u maneġġjar ta' informazzjoni ġdida

Artikolu 20

Sorveljar u maneġġjar ta' informazzjoni ġdida

1.  Wara t-tpoġġija fis-suq ta' GMO bħal jew fi prodott, in-notifikant jassigura li sorveljar u rappurtaġġ fuqha jsiru skond il-kondizzjonijiet speċifikati fil-kunsens. Ir-rapporti ta' dan l-issorveljar jingħataw lill-Kummissjoni u lil awtoritajiet kompetenti ta' Stati Membri. Fuq il-bażi ta' dawn ir-rapporti, skond il-kunsens u fil-qafas għal pjan ta' sorveljar speċifikat fil-kunsens, l-awtorità kompetenti li rċeviet in-notifika oriġinali tista' tadatta il-pjan ta' sorveljar wara l-perijodu ta' l-ewwel sorveljar.

2.  Jekk saret disponibbli informazzjoni ġdida, minn dawk li jużaw jew sorsi oħra, dwar riskji ta' GMO(s) għas-saħħa tal-bniedem jew l-ambjent wara li jingħata l-kunsens bil-miktub, in-notifikant għandu immedjatament jieħu l-miżuri biex jipproteġi s-saħħa tal-bniedem u l-ambjent, u jinforma lill-awtorità kompetenti b'dan kollu.

Ma' dan, in-notifikant għandu jirrevedi l-informazzjoni u kondizzjonijiet speċifikati fin-notifika.

3.  Jekk issir disponibbli informazzjoni lill-awtorità kompetenti li jista' jkollha konsegwenzi għar-riskji ta' GMO(s) lis-saħħa tal-bniedem jew l-ambjent, jew skond ċirkostanzi deskritti fil-paragrafu 2, immedjatament tibgħat l-informazzjoni lill-Kummissjoni u lil awtoritajiet kompetenti ta' l-Istati Membri l-oħra u tista' tuża d-dispożizzjonijiet fl-Artikoli 15(1) u 17(7) fejn xieraq, meta l-informazzjoni ssir disponibbli qabel il-kunsens bil-miktub.

Meta l-informazzjoni ssir disponibbli wara li jingħata l-kunsens, l-awtorità kompetenti għandha fi żmien 60 ġurnata wara li tirċievi l-informazzjoni ġdida, tibgħat ir-rapport ta' stima u tindika jekk u kif il-kondizzjonjijiet ta' kunsens għandhom jiġu emendati jew il-kunsens għandu jiġi mitmum lill-Kummissjoni li, fi żmien 30 ġurnata minn meta tirċievi dan, tibgħatha lil awtoritajiet kompetenti ta'l-Istati Membri l-oħra.

Kummenti jew oġġezzjonijiet raġjunati biex tpoġġi aktar GMO fis-suq jew fuq il-proposta biex temenda il-kondizzjonijiet tal-kunsens, għandhom fi żmien 60 ġurnata wara ċirkolazzjoni tar-rapport ta' stima tibgħathom immedjatament lil awtoritajiet kompetenti kollha.

L-awtoritajiet kompetenti u l-Kummissjoni jistgħu jiddiskutu xi kwistjonijiet li għadu ma ntlaħaqx ftehim dwarhom, bil-għan li jilħqu ftehim fi żmien 75 ġurnata mid-data ta' ċirkolazzjoni ta' rapport ta' stima.

Fl-assenza ta' xi oġġezzjoni raġjunata minn Stat Membru jew mill-Kummissjoni fi żmien 60 ġurnata wara d-data ta' ċirkolazzjoni ta' l-informazzjoni l-ġdida jew ta' kwistjonjiet li mhux riżolti jiġu solvuti fi żmien 75 ġurnata, l-awtorità kompetetni li ppreparat ir-rapport temenda l-kunsens kif propost, tittrasmetti l-kunsens emendat lin-notifikant u tinforma lill-Istati Membri oħra u lill-Kummissjoni b'dan fi 30 ġurnata.

4.  Biex tassigura trasparenza tagħha, ir-riżultati ta' sorveljar li sar skond il-parti Ċ tad-Direttiva għandu jsir pubblikament disponnibli.

1. Ħarsa ġenerali

,
Titlu Regolamentazzjoni
Article 20 1.
Following the placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent. The reports of this monitoring shall be submitted to the Commission and the competent authorities of the Member States. On the basis of these reports, in accordance with the consent and within the framework for the monitoring plan specified in the consent, the competent authority which received the original notification may adapt the monitoring plan after the first monitoring period.
Article 20 2.
If new information has become available, from the users or other sources, with regard to the risks of the GMO(s) to human health or the environment after the written consent has been given, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof.

In addition, the notifier shall revise the information and conditions specified in the notification.

Article 20 3.
If information becomes available to the competent authority which could have consequences for the risks of the GMO(s) to human health or the environment, or under the circumstances described in paragraph 2, it shall immediately forward the information to the Commission and the competent authorities of the other Member States and may avail itself of the provisions in Articles 15(1) and 17(7) where appropriate, when the information has become available before the written consent.

When the information has become available after the consent has been given, the competent authority shall within 60 days after receipt of the new information, forward its assessment report indicating whether and how the conditions of the consent should be amended or the consent should be terminated to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Comments or reasoned objections to further placing on the market of the GMO or on the proposal for amending the conditions of the consent shall, within 60 days following the circulation of the assessment report, be forwarded to the Commission which shall immediately forward them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

In the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the new information or if outstanding issues are resolved within 75 days, the competent authority which prepared the report shall amend the consent as proposed, shall transmit the amended consent to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

Article 20 4.
So as to ensure its transparency, the results of the monitoring carried out under part C of the Directive shall be made publicly available.

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors Rekwiżit

3. Standards relatati

Standards
Sors Rekwiżit
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