Romania | BCH-NR2-RO-102640 | Second National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Second National Report on the Implementation of the Cartagena Protocol on Biosafety (NR2)

published: 31 Oct 2011 last updated: 15 Nov 2011
General Information


NEPA, NEG, MARD, NCA, NSVFSA
EN

01 Oct 2007
30 Sep 2011
Party to the Cartagena Protocol on Biosafety
Article 2 – General provisions
A domestic regulatory framework is fully in place
EN
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • Other laws, regulations or guidelines that indirectly apply to biosafety
Yes
EN
Yes
EN
Less than 10
EN
Partially
EN
As a member of the EU since 2007, Romania has transposed the EU legislation on GMOs, which is consistent with the provisions of the Protocol. The main legal measures include:<br /><br />- The EGO No 43/2007 on the deliberate release of the genetically modified organisms, approved by the Law No 247/2009 (transposing 2001/18/EC Directive) <br />-The EGO No 44/2007 on the contained use of genetically modified micro organisms, approved by the Law No 3/2008 (transposing 90/219/EEC Directive, modified through 98/81/EC Directive)<br /><br />-Governmental Decision No 497/2007 on establishing the measures for the implementation of the Regulation of the European Parliament and of the Council No 1946/2003 on transboundary movements of LMOs <br /><br />Romania also created the institutional framework to ensure the enforcement of the EU Regulations:<br /><br />- 1829/2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs. <br /><br />-1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.<br /><br />- 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.<br /><br />Also general provisions have been introduced in the frame law for environmental protection of Romania : Law No 265/2006 on the approval of the EGO no. 195/2005 on the environmental protection, with its modifications and completions.<br /><br />Related legislation:- Order No 237/2006 on the authorization of the genetically modified plant growers.<br /><br />- Order No 471/2006 amending and supplementing Order no.237/2006 on the authorization of the genetically modified plant growers.<br /><br />-Order No 34/2011 approving the Regulation on organization and plant quality control on the import and export of seeds and planting material.<br /><br />-Order No 232/2010 amending and supplementing the Order of Ministry of Agriculture, Forests and rural Development no.631/2006 on the seed quality control&nbsp; and certification by testing non GM varieties and that may be contaminated with GM varieties.<br /><br />- Common Order No 1160/2902/2010 regarding the approval of the control procedure regarding the import, export and transit of the GMOs<br /><br />A list of all legal measures related to genetically modified organisms is available at: <a href="http://www.mmediu.ro/legislatie/biosecuritate.htm">http://www.mmediu.ro/legislatie/biosecuritate.htm</a> <br />&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; <br /><br /><br /><br /><br />&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; ]<br />
EN
Article 5 – Pharmaceuticals
Yes
EN
No
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
Partially
EN
see the EU common report&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; ]
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
More than 10
EN
None
EN
More than 10
EN
More than 10
EN
Yes, always
EN
Yes, always
EN
Yes, always
EN
In some cases only the notifier
EN
Yes, always
EN
  • Approval of the import/use of the LMO(s) with conditions (50)
  • Request for additional relevant information (50)
n/a
EN
Romania applies its national legislative framework transposing the EU legislation instead of the Protocol's advanced informed agreement procedure. This framework is compatible with the provisions of the Protocol.<br /><br />Please see the EU report regarding the import for introduction into environment for cultivation purposes, for which is first needed&nbsp; an authorization. The authorization procedure involves all Member States and is applicable in the EU.<br /><br />For the experimental purposes (field trials), the legal person who intends to introduce GMOs into the environment, must first obtain written authorisation from the Romanian compentent authority.&nbsp; The authorization is issued on a case by case risk assessment basis and is applicable only on the national territory.<br /><br />For the first transboundary movement, the importer is obliged to obtain import consent from the competent authority. The subsequent imports, during the field trials period, have to be notified to the National Environmental Protection Agency, on a yearly base.
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
No
EN
Romania as part of EU, has adopted the Community&nbsp;&nbsp; legal framework on genetically modified organisms, which also addreses the import of LMOs intended for direct use for food or feed or for processing. Implementation of Article 11 of the Protocol is part of the European procedure for market authorisation. Please also see the common EU report.<br />
EN
Article 12 – Review of decision
Yes
EN
No
EN
No
EN
None
EN
Article 13 – Simplified procedure
No
EN
No
EN