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)
  |  
BCH-NR2-RO-102640-3   |   PDF   |   Print   |  
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
None
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
EN
Article 15 – Risk assessment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
No
EN
Yes, always
EN
No
EN
More than 10
EN
No
EN
Yes, always
EN
- Romania , as part of the EU, has implemented a comprehensive system of risk assessment&nbsp; according with the provisions of 2001/18/EC Directive. Accordingly, all notification for experimental purposes or placing on the market, shall contain a risk assessment with aims, to identify and evaluate, on a case by case basis, the potential adverse effects of the GMO, both direct and indirect, immediate or delayed, on human health and the environment. <br /><br />- This assessment conducted on a “case by case” basis in accordance with the procedures laid down in EU and national legislation, is carried out firstly by the notifier and then evaluated by the national scientific advisory technical bodies that support decisions taken by ministries responsible for GMO’s management. In Romania the Biosafety Commision is the scientific advisory body with consultative role in the decision making process taken by NEPA.<br /><br />Romania issued the Ministerial Order No 1.829/2007 for the approval of the guidance notes regarding the risk assessment on the environment and human health due to deliberate release and placing on the market of GMOs, which supplements Annex No 2 to EGO 43/2007 ( transposing 2001/18/EC Directive).<br /><br />Please also see the EU common report
EN
Article 16 – Risk management
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
No
EN
Please the EU common report<br />
EN
Article 17 – Unintentional transboundary movements and emergency measures
No
EN
Yes
EN
Yes
EN
Never
EN
Joint Order No 1160/2902/2010 of MEF and NCA on the approval on the control procedure regarding the import, export and transit of genetically modified organisms&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; ]
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes, to some extent
EN
Yes
EN
In Romania is in force the legislation transposing the EU legislative provisions regarding the handling, transport, packaging and identification of GMOs.<br /><br />Please also see the EU common report<br />
EN
Article 19 – Competent National Authorities and National Focal Points
Yes
EN
Yes
EN
Yes, more than one
EN
No
EN
Yes, some information
EN
Yes
EN
Yes
EN
Competent national authorities:<br /><br />- Ministry of Environment and Forests (through NEPA and NEG&nbsp; acting under the MEF)<br /><br />-National Sanitary Veterinary and Food safety Authority: LMOs-FFP<br /><br />- National Customs Authority under Ministry of Public Finances: border control
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available but only partially available in the BCH
EN
Information available but not in the BCH
EN
Information not available
EN
Information available but only partially available in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Information available but not in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Yes
EN
Yes
EN
Yes, in some cases
EN
No
EN
No
EN
Article 21 – Confidential information
Yes
EN
Yes, always
EN
Please see the EU common report
EN
Article 22 – Capacity-building
No
EN
No
EN
No
EN
Yes
EN
  • Institutional capacity
  • Risk assessment and other scientific and technical expertise
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
Yes
EN
Yes
EN
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
No
EN
No
EN
Article 23 – Public awareness and participation
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes, to a limited extent
EN
More than 5
EN
Please see the EU common report<br />&nbsp; <br />The national legislation includes provisions regarding public consultation and public information in the decision making process regarding deliberate release into environment of LMOs.<br /><br />All the notifications are published on JRC and NEPA's websites.<br /><br />Public information at the national level is performed in cooperation with the county environmental agencies, functioning under NEPA.<br /><br />All the risk assessments submitted by the notifiers and the summary decisions taken by the competent authority are published on the NEPA's site: <a href="http://www.anpm.ro/Mediu/biosecuritate-12">http://www.anpm.ro/Mediu/biosecuritate-12</a> <br /><br />If necessary, public debates are organized during the authorization procedure for experimental release and placing on the market of LMOs.<br /><br />Romania is also Party to Aarhus Convention.
EN
Article 24 – Non-Parties
No
EN
Yes
EN
No
EN
Yes, always
EN
No
EN
n/a
EN
Article 25 – Illegal transboundary movements
Yes
EN
No
EN
Never
EN
Penalty measures in cases of infringement of provisions regarding transboundary movements are foreseen in the national legislation.
EN
Article 26 – Socio-economic considerations
Only in some cases
EN
Yes, to a limited extent
EN
Article 27 – Liability and Redress
Yes
EN
Yes
EN
Romania signed the Nagoya Supplementary Protocol on 11 May 2011, the ratification process is ongoing.
EN
Article 33 – Monitoring and reporting
Yes
EN
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (Not applicable)
Other information
Re: Q. 14 -<br />&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; <br />Romania signed the Cartagena Protocol on Biosafety in 2000 and ratified it in 2003 (Law 59/2003). In 2007 Romania adhered to the EU, consequently its legislation has been developed in order to align with EU requirements.&nbsp; (see EU common report).<br /><br />This report updates the Romanian's first national report on the implementation of the Cartagena Protocol and supplements the EC common report with some information, according to the specific situation at the national level .<br />&nbsp; &nbsp; &nbsp;&nbsp; <br />The report has been prepared by&nbsp; the Ministry of Environment and Forests (MEF) as the central public authority for the environmental protection in Romania and competent authority under the Cartagena Protocol.<br /><br />The following authorities with responsibility in biosafety issues - decision making process, inspection and control, were involved in gathering the data used as a basis for the report:<br /><br />-National Environmental Protection Agency (NEPA)&nbsp; - acting under the MEF is the competent authority for issuing the authorizations for placing on the market and for the experimental activities involving genetically modified organisms. Also, for issuing imports consents.<br /><br />-National Environmental Guard (NEG) - operates under MEF as the control and inspection body; together with MARD is responsible for controlling the cultivation of genetically modified crops.<br /><br />- Ministry of Agriculture and Rural Development (MARD) - At central level has the responsibility for drafting legislation and maintaining the national registry of GM growers; for national monitoring of GM seed certification and supervision and control activity of Regional Inspectorate for Seeds and Planting Material Quality; for coordination of GMO inspections and control activity of CDAs (County Divisions for Agriculture)<br /><br />-National Sanitary Veterinary and&nbsp; Food Safety Authority (NSVFSA) - provides scientific advice in the field of GMOs through the Scientific Council; performs official controls in the field of traceability and labelling of GMOs on the entire food and feed chain, with the exception of primary production; performs qualitative and quantitative analysis of GMO food and feed.<br /><br />- National Customs Authority (NCA)&nbsp; - operates under the Ministry of Public Finances as the law enforcement body; applies customs policies beeing responsible with customs control
EN
Comments on reporting format
- some difficulties encountered completing the pre-definite format
EN
Survey on indicators of the Strategic Plan (2014)
2001 or earlier
EN
10 per year or more
EN
Yes
EN
n/a
EN
Yes
EN
One or more
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
One or more
EN
The socio economic implications of the deliberate release into environment are tacking into account into decision macking process, according with the provisions of the Ordinance no 43/2007 on the deliberate release and placing on the market of the genetically modified organisms, approved by the Law 247/2009. Additionaly, partial studies on socio-economic considerations were proposed to be conducted in the future in the areas of Romania were GMOs are cultivated.
EN
Yes
EN
10 or more
EN
10 or more
EN
10 or more
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
One or more
EN
One or more
EN
Yes
EN
One or more
EN
One or more
EN
No
EN
Yes
EN
Yes
EN
  • National website
  • Public hearings
National website
EN
3 or more
EN
One or more
EN
Yes
EN
Yes
EN
5 or more
EN
One or more
EN
  • National website
One or more
EN
No
EN
No
EN
One or more
EN