+Artikolu 4 Obbligi Ġenerali
---+Article 4 1.
---+Article 4 2.
---+Article 4 3.
---+Article 4 4.
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Artikolu 4 Obbligi Ġenerali

Artikolu 4

Obbligi Ġenerali

1. L-Istati Membri skond il-prinċipju ta' prekawzjoni jassiguraw li jittieħdu l-miżuri xierqa kollha biex jiġu evitati effetti ħżiena fuq is-saħħa tal-bniedem u l-ambjent li jista' jsir mir-rilaxx intenzjonat jew tpoġġija ta' GMOs fis-suq. GMOs jistgħu jiġu rilaxxati jew jitpoġġew fis-suq intenzjonalment biss in konformità mal-parti B jew mal-parti C rispettivament.

2. Kwalunkwe persuna qabel tissotometti notifika skond parti B jew parti C, għandha tagħmel stima ta' riskju ambjentali. L-informazzjoni li tista' tkun neċessarja biex tagħmel stima ta' riskju ambjentali hija stabbilita fl-Anness III. L-Istati Membri u l-Kummissjoni għandhom jassiguraw li l-GMOs li jkun fihom ġeni li għandhom reżistenza għall-antibijotiċi bl-użu ta' trattament mediku jew veterinarju jittieħdu in konsiderazzjoni meta tagħmel stima ta' riskju ambjentali, bl-idea li tidentifika u ftit ftit telimina dawk l-indikaturi ta' reżistenza antibijotika fil-GMOs li jistgħu jkolhom effetti ħżiena fuq is-saħħa u l-ambjent. Din l-eliminazzjoni għandha issir sal-31 ta' Diċembru 2004 fil-każ ta' GMOs li jitpoġġew fis-suq skond parti C u sal-31 ta' Diċembru 2008 fil-każ ta' GMO awtoriżżati skond parti B.

3. L-Istati Membri u fejn xieraq il-Kummissjoni għandhom jassiguraw li effetti potenzjali ħżiena fuq is-saħħa tal-bniedem u l-ambjent, li jistgħu jseħħu direttament jew indirettament minn trasferiment ta' ġeni minn GMOs għall-organiżmi oħra, huma stmati akkuratament fuq bażi ta' każ b'każ. Din l-istima ssir skond l-Anness II u tieħu akkont ta' l-impatt ambjentali skond in-natura ta' l-organiżmu introdott u l-ambjent li jirċevieh.

4. L-Istati Membri għandhom jappuntaw l-awtorità kompetenti jew awtoritajiet responsabbli għall-osservazzjoni tar-rekwiżiti ta' din id-Direttiva. L-awtorità kompetenti għandha teżamina n-notifikazzjonijiet skond parti B u parti C għall-osservanza tar-rekwiżiti ta' din id-Direttiva u dwar jekk l-istima provduta fil-paragrafu 2 hijiex xierqa.

5. L-Istati Membri għandhom jassiguraw li l-awtorità kompetenti torganiżża spezzjonijiet u miżuri oħra ta' kontroll kif xieraq, biex tassigura konformità ma' din id-Direttiva. Fil-każ ta' rilaxx ta' GMO(s) jew tpoġġija fis-suq bħal jew fi prodotti li għalihom ma ngħatatx awtoriżżazjoni, l-Istat Membru konċernat għandu jassigura li jittieħdu l-miżuri kollha xierqa biex itemm ir-rilaxx jew tpoġġija fis-suq, li jibdew azzjonijiet ta' rimedju jekk neċessarju, u li tinforma lill-pubbliku, lill-Kummissjoni u lill-Istati Membri l-oħra.

▼M2 —————

▼B

1. Ħarsa ġenerali

Titlu	Regolamentazzjoni
Article 4 1.	Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively.
Article 4 2.	Any person shall, before submitting a notification under part B or part C, carry out an environmental risk assessment. The information which may be necessary to carry out the environmental risk assessment is laid down in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall take place by the 31 December 2004 in the case of GMOs placed on the market according to part C and by 31 December 2008 in the case of GMOs authorised under part B.
Article 4 3.	Member States and where appropriate the Commission shall ensure that potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from GMOs to other organisms, are accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with Annex II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.
Article 4 4.	Member States shall designate the competent authority or authorities responsible for complying with the requirements of this Directive. The competent authority shall examine notifications under part B and part C for compliance with the requirements of this Directive and whether the assessment provided for in paragraph 2 is appropriate.
Article 4 5.	Member States shall ensure that the competent authority organises inspections and other control measures as appropriate, to ensure compliance with this Directive. In the event of a release of GMO(s) or placing on the market as or in products for which no authorisation was given, the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States.

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors	Rekwiżit

3. Standards relatati

Standards
Sors	Rekwiżit

Builddate: 27.03.2021 00:00:00 -Doknr: CELEX:32001L0018
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