+Artikolu 12 Leġislazzjoni settorali
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Artikolu 12 Leġislazzjoni settorali

Artikolu 12

Leġislazzjoni settorali

1. L-Artikoli 13 sa 24 ma japplikawx għal xi GMO bħal jew fi prodotti sakemm dawn ikunu awtoriżżati minn leġislazzjoni tal-Komunità li tipprovdi għall-istima ta' riskju ambjentali speċifiku li jsir skond il-prinċipji stabbiliti fl-Anness II u fuq bażi ta' informazzjoni speċifikata fl-Anness III mingħajr preġudizzju għal rekwiżiti addizjonali provduti minn leġislazzjoni tal-Komunità msemmija fuq, u għal rekwiżiti dwar stima ta' riskju, tikkettjar, sorveljar kif xieraq, informazzjoni lill-pubbliku u klawżola ta' salvagwardja mill-inqas ekwivalenti għal dik stabbilita f'din id-Direttiva.

2. Sakemm huwa konċernat ir-Regolament tal-Kunsill (KEE) Nru 2309/93, l-Artikoli 13 sa 24 ta' din id-Direttiva ma japplikawx għal xi GMO bħal jew ġewwa prodotti sakemm huma awtoriżżati minn dak ir-regolament sakemm isir stima ta' riskju ambjentali skond il-prinċipji stabbiliti fl-Anness II għal din id-Direttiva u fuq il-bażi ta' tip ta' informazzjoni speċifikata fl-Anness III għal din id-Direttiva mingħajr preġudizzju għal rekwiżiti rilevanti oħra dwar stima ta' riskju, tikkettjar, sorveljar kif xieraq, informazzjoni lill-pubbliku u klawżola ta' salvagwardja provduta minn leġislazzjoni tal-Komunità dwar prodotti mediċinali għall-użu tal-bniedem u veterinarju.

3. Proċeduri li jassiguraw li stima ta' riskju, rekwiżiti dwar stima ta' riskju, tikkettjar, sorveljar kif xieraq, informazzjoni lill-pubbliku u klawżola ta' salvagwardja huma ekwivalenti għal dawk stipulati f'din id-Direttiva jiġu introdotti, fir-regolament tal-Parlament Ewropew u tal-Kunsill. Leġislazzjoni futura settorali bażata fuq dispożizzjonijiet ta' dak ir-regolament għandhom jagħmlu riferenza għal din id-Direttiva. Sakemm jidħol fis-seħħ dak ir-regolament, kwalunkwe GMO bħal jew fi prodotti sakemm huma awtoriżżati minn leġislazzjoni oħra tal-Komunità għandhom jitpoġġew biss fis-suq wara li jiġu aċċettati biex jitpoġġew fis-suq skond din id-Direttiva.

4. Waqt l-evalwazzjoni ta' talbiet għat-tpoġġija fis-suq ta' GMOs riferiti fil-paragrafu 1, il-korpi stabbiliti mill-Komunità skond din id-Direttiva u minn Stati Membri għall-iskop ta' implimentazzjoni ta' din id-Direttiva għandhom jiġu konsultati.

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1. Ħarsa ġenerali

Titlu	Regolamentazzjoni
Article 12 1.	Articles 13 to 24 shall not apply to any GMO as or in products as far as they are authorised by Community legislation which provides for a specific environmental risk assessment carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements provided for by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive.
Article 12 2.	As far as Council Regulation (EEC) No 2309/93 is concerned, Articles 13 to 24 of this Directive shall not apply to any GMO as or in products as far as they are authorised by that Regulation provided that a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II to this Directive and on the basis of the type of information specified in Annex III to this Directive without prejudice to other relevant requirements as regards risk assessment, risk management, labelling, monitoring as appropriate, information to the public and safeguard clause provided by Community legislation concerning medicinal products for human and veterinary use.
Article 12 3.	Procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in this Directive shall be introduced, in a Regulation of the European Parliament and of the Council. Future sectoral legislation based on the provisions of that Regulation shall make a reference to this Directive. Until the Regulation enters into force, any GMO as or in products as far as they are authorised by other Community legislation shall only be placed on the market after having been accepted for placing on the market in accordance with this Directive.
Article 12 4.	During evaluation of the requests for the placing on the market of the GMOs referred to in paragraph 1, the bodies established by the Community under this Directive and by Member States for the purpose of implementing this Directive shall be consulted.

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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