Directive 2001/18/EC of the European Parliament and of the Council of 12 Márta 2001 maidir le orgánaigh ghéinmhodhnaithe a scaoileadh isteach sa chomhshaol d’aon ghnó agus lena n-aisghairtear Treoir 90/220/CEE ón gComhairle [1] Bunús dlí

Ealaín. 114 CFAE – “Dlíthe a chomhfhogasú” (Treoir maidir leis an margadh inmheánach)

1.1.2 Cuspóir

Chun na dlíthe a chomhfhogasú, rialacháin agus forálacha riaracháin an Bhallstáit (ealaín. 1)

Chun sláinte an duine agus an comhshaol a chosaint (ealaín. 1)

Treoir 90/220/CE agus a raon feidhme a shoiléiriú (aithris 2 agus 3)

Modheolaíocht choiteann a bhunú chun measúnuithe riosca comhshaoil ​​a dhéanamh (aithris 20)

1.1.3 Raon feidhme

  1. Clúdaithe:
  • Activities: Eisiúint d’aon ghnó sa chomhshaol chun aon chríche eile seachas chun é a chur ar an margadh agus a chur ar an margadh (ealaín. 4)
  • Object(s): GMOanna, mar nó i dtáirgí (ealaín. 4)
  1. Sainmhínithe a bhaineann le raon feidhme:
  • Deliberate release: "any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment” (ealaín. 2(3))
  • Placing on the market: "making available to third parties, cibé acu mar mhalairt ar íocaíocht nó saor in aisce” (ealaín. 2(4))
  • GMO: "an organism, cé is moite de dhaoine, ina ndearnadh an t-ábhar géiniteach a athrú ar bhealach nach dtarlaíonn go nádúrtha trí chúpláil agus/nó trí athchuingniú nádúrtha” (ealaín. 2(2))
  • Díolúintí:
  • Organisms obtained through the techniques listed in Annex I B (ealaín. 3.1)
  • The carriage of GMOs by rail, bóthar, uiscebhealach intíre, farraige nó aer (ealaín. 3.2)
  • Certain GMOs as medicinal and other products authorised under EU legislation (ealaín. 5, 12.1, 12.2)
  1. Meicníocht(s) le haghaidh díolúintí amach anseo: /

1.1.4 Príomh-mheicníocht rialála(s)

Nós imeachta comhchuibhithe údaraithe maidir le scaoileadh d’aon ghnó sa chomhshaol chun aon chríche seachas chun é a chur ar an margadh (Cuid B: ealaín. 5 go 11)

  • The applicant notifies the CA of the MS within whose territory the release is to take place and supplies the information determined by art. 6.2. (ealaín. 6.1)
  • The CA consults the public and notifies other MS through the Commission. Aontaíonn nó diúltaíonn an ÚD don iarratas laistigh 90 laethanta fála bunaithe ar ERA. (ealaín. 6.3 go 6.9)
  • A differentiated procedure is possible for GMOs meeting the requirements in Annex V (ealaín. 7)
  • In the case of an unfavourable decision, féadfaidh an t-iarratasóir dul i muinín achomharc riaracháin faoin gcreat intíre.

Nós imeachta comhchuibhithe údaraithe chun iad a chur ar an margadh (Cuid C: ealaín. 12 go 24) [2]

  • The applicant notifies the CA of the MS within whose territory the placing on the market is to take place for the first time and supplies the information determined by art. 13.2. (ealaín. 13)
  • Within 90 laethanta, déanann an ÚD réamh-mheasúnú agus cuireann sé an tuarascáil mheasúnaithe ar aghaidh mar aon leis an iarratas chuig CAanna na mBallstát agus chuig an gCoimisiún.[3] I gcás tuairisc mheasúnaithe dhiúltach, diúltófar don iarratas. (ealaín. 14)
  • Within 60 laethanta ó dháta scaipeadh na tuarascála measúnaithe, féadfaidh na CAanna agus an Coimisiún barúlacha a thabhairt nó agóid a dhéanamh. Tá saincheisteanna gan réiteach le réiteach laistigh de 105 laethanta tar éis dháta an chúrsaíochta. Ceadófar an t-iarratas mura bhfuil aon agóidí, ná saincheisteanna gan réiteach ag deireadh na bhfrámaí ama faoi seach. (ealaín. 15)
  • In the case of objections or unresolved outstanding issues, déanann an Coimisiún agus an Coiste inniúil measúnú ar an sainchomhad agus glacfar cinneadh laistigh de 120 laethanta i gcomhréir leis an nós imeachta scrúdúcháin atá leagtha síos san ealaín. 5, 10 agus 11 den Rialachán (AE) Uimh 182/2011 [4] [5] (ealaín. 30(2)). (ealaín. 18)
  • In the case of an unfavourable decision, féadfaidh an t-iarratasóir dul i muinín achomharc os comhair na gcúirteanna Eorpacha.
  • A simplified procedure is possible for the deliberate release for any other purpose than for placing on the market of certain genetically modified plants [6] (ealaín. 6(5) jº Cinneadh 94/730/CE ón gCoimisiún)

[1] http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32001L0018

[2] Rialachán (CE) Uimh 1829/2003 provides for a single procedure for the placing of the market of a GMO that concerns food or feed, thus merging the procedures set out in Directive 2001/18/EC and in the Regulation. The single procedure under Directive 2001/18/EC for the placing on the market has not been used since the entry into force of the Regulation.

[3] In practice, these documents are only sent to the Commission, which in turn forwards these to the CAs of the MS. Refer to: http://ec.europa.eu/food/plant/gmo/new/authorisation/cultivation/index_en.htm

[4] Cf. supra, chapter “Commission implementing acts”

[5] The Directive refers to art. 5, 7 agus 8 of Decision 1999/468/EC but this act has been repealed by Regulation (AE) Uimh 182/2011. According to the old provisions, if no qualified majority can be reached on the Commission proposal in the Committee, it is submitted to the Council.

The Council decides within 3 months after referral of the proposal. If it fails to reach a majority to consent to the proposal, the Commission will re-examine it. The Commission in turn may amend the proposal and re-submit it to the Council, which again has 3 months to reach a qualified majority.

[6] The simplified procedure provides for a single notification dossier for more than one release of genetically modified plants which have resulted from the same recipient crop plant species but which may differ in any of the inserted/deleted sequences or have the same inserted/deleted sequence but differ in phenotypes.