+Artikolu 5
---+Article 5 1.
---+Article 5 2.
---+Article 5 3.
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Artikolu 5
Artikolu 5 1. L-Artikoli 6 sa 11 ma japplikawx għal sustanzi mediċi u komposti għall-użu tal-bniedem li jikkonsisti, jew li fih, GMO jew tagħqid ta' GMOs sakemm ir-rilaxx intenzjonat tagħhom għal skop ieħor ħlief dak li jitpoġġa fis-suq huwa awtoriżżat mill-leġislazzjoni tal-Komunità li tipprovdi:
(a)
għal stima ta' riskju speċifiku ambjentali skond l-Anness II u fuq il-bażi ta' tip ta' informazzjoni speċifikata fl-Anness III mingħajr preġudizzju għal rekwiżiti addizjonali provduti minn din il-leġislazzjoni;
(b)
għal kunsens espliċitu qabel ir-rilaxx;
(ċ)
għal pjan ta' sorveljar skond il-parti rilevanti ta' l-Anness III, bil-ħsieb li tikxef l-effetti ta' GMO jew GMOs fuq is-saħħa tal-bniedem jew fuq l-ambjent;
(d)
f'manjiera xierqa għal rekwiżiti dwar trattament ta' oġġetti ġodda ta' informazzjoni, informazzjoni lil pubbliku, informazzjoni fuq ir-riżultati ta' rilaxxi, u skambju ta' informazzjoni għall-inqas ekwivalenti għal dik li hemm f'din id-Direttiva u fil-miżuri li ttieħdu skond dan.
2. Stima ta' riskji għal ambjent preżentati minn dawn is-sostanzi u komposti ssir b'ko-ordinazzjoni ma awtoritajiet nazzjonali u tal-Komunità msemmija f'din id-Direttiva. 3. Proċeduri li jassiguraw konformità tal-istima ta' riskju speċifiku ambjentali u ekwivalenti mad-dipożizzjonijiet ta' din id-Direttiva jridu jiġu provduti f'din il-leġisalzzjoni, li trid tirreferi għal din id-Direttiva. 1. Ħarsa ġenerali
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Regolamentazzjoni |
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Article 5 1.
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Articles 6 to 11 shall not apply to medicinal substances and compunds for human use consisting of, or containing, a GMO or combination of GMOs provided that their deliberate release for any purpose other than that of being placed on the market is authorised by Community legislation which provides:
(a)
for a specific environmental risk assessment in accordance with Annex II and on the basis of the type of information specified in Annex III without prejudice to additional requirements provided for by the said legislation;
(b)
for explicit consent prior to release;
(c)
for a monitoring plan in accordance with the relevant parts of Annex III, with a view to detecting the effects of the GMO or GMOs on human health or the environment;
(d)
in an appropriate manner for requirements relating to treatment of new items of information, information to the public, information on the results of releases, and exchanges of information at least equivalent to those contained in this Directive and in the measures taken in accordance therewith.
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Article 5 2.
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Assessment of the risks to the environment presented by such substances and compounds shall be carried out in coordination with the national and Community authorities mentioned in this Directive.
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Article 5 3.
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Procedures ensuring conformity of the specific environmental risk assessment and equivalence with the provisions of this Directive must be provided for by the said legislation, which must refer to this Directive.
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1.1 Referenzi
1.2 Rekwiżiti identifikati
1.3 Standards relatati
2. Rekwiżiti identifikati
3. Standards relatati
- Builddate: 27.03.2021 00:00:00 -Doknr: CELEX:32001L0018
- EULAW -
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