Directive 2001/18/EC of the European Parliament and of the Council of 12 3月 2001 遺伝子組み換え生物の環境への意図的な放出と理事会指令90/220 / EECの廃止について [1] 法的根拠

美術. 114 TFEU​​ –「法律の概算」 (内部市場指令)

1.1.2 客観的な

法則を概算するには, MSの規制と管理規定 (美術. 1)

人間の健康と環境を守るために (美術. 1)

指令90/220 / ECとその範囲を明確にする (リサイタル 2 と 3)

環境リスク評価を実施するための共通の方法論を確立する (リサイタル 20)

1.1.3 スコープ

  1. 覆われている:
  • Activities: 市場への投入および市場への投入以外の目的での環境への意図的な放出 (美術. 4)
  • Object(sの): 遺伝子組み換え作物, としてまたは製品で (美術. 4)
  1. スコープ関連の定義:
  • 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” (美術. 2(3))
  • Placing on the market: "making available to third parties, 支払いの見返りか無料か」 (美術. 2(4))
  • GMO: "an organism, 人間を除いて, 交配および/または自然組換えによって自然に発生しない方法で遺伝物質が変更された」 (美術. 2(2))
  • 免税:
  • Organisms obtained through the techniques listed in Annex I B (美術. 3.1)
  • The carriage of GMOs by rail, 道, 内陸水路, 海または空気 (美術. 3.2)
  • Certain GMOs as medicinal and other products authorised under EU legislation (美術. 5, 12.1, 12.2)
  1. 機構(sの) 将来の免除のために: /

1.1.4 主な規制メカニズム(sの)

市場に出す以外の目的での環境での意図的なリリースのための調和された承認手順 (パートB: 美術. 5 へ 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. (美術. 6.1)
  • The CA consults the public and notifies other MS through the Commission. CAは、内のアプリケーションに同意または拒否します 90 ERAに基づく受領日数. (美術. 6.3 へ 6.9)
  • A differentiated procedure is possible for GMOs meeting the requirements in Annex V (美術. 7)
  • In the case of an unfavourable decision, 申請者は、国内の枠組みの下で行政上訴に訴えることができます.

市場に出すための調和された認可手順 (パートC: 美術. 12 へ 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. (美術. 13)
  • Within 90 日, CAは予備評価を実施し、MSおよび委員会のCAに申請書とともに評価レポートを転送します。.[3] 否定的な評価レポートの場合, 申請は却下されます. (美術. 14)
  • Within 60 評価報告書の回覧日からの日数, CAと委員会はコメントまたは異議を唱えることができます. 未解決の問題は、 105 流通日から数日後. 異議がなければ、申請は承認されます, また、それぞれの時間枠の終わりに未解決の未解決の問題もありません. (美術. 15)
  • In the case of objections or unresolved outstanding issues, 委員会と管轄委員会が書類を評価し、内で決定が下されます 120 アートに定められた審査手順に従った日数. 5, 10 と 11 規制の (自分) ノー 182/2011 [4] [5] (美術. 30(2)). (美術. 18)
  • In the case of an unfavourable decision, 申請者は、欧州裁判所に上訴することができます.
  • 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] (美術. 6(5) jº委員会決定94/730 / EC)

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

[2] 規制 (EC) ノー 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 と 8 of Decision 1999/468/EC but this act has been repealed by Regulation (自分) ノー 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.