Austria | BCH-NR2-AT-102345 | 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)
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BCH-NR2-AT-102345-2   |   PDF   |   Print   |  
last updated: 27 Sep 2011
General Information


Federal Ministry of Health (BMG), Federal Ministry of Science and Research (BMWF), Federal Ministry of Agriculture, Forestry, Environment and Water Management (BMLFUW), Austrian Agency for Health and Food Safety (AGES)
EN

11 Sep 2007
27 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
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
Yes
EN
Yes
EN
More than 10
EN
Yes
EN
The EU biosafety framework as reported by the European Commission (EC) is directly or indirectly applicable to Austria. The EU-Regulations as referenced by the EC are directly applicable, the relevant EU-Directives have been transposed into Austrian legislation. <br />The Austrian Gene Technology Act regulates the application of GMOs in agriculture and medicine in a general way. It is in force since 1995 and was amended several times. The Act transposes the European Directive for the deliberate release and the placing on the market of GMO products, as well as the EU Directive concerning contained use of GMOs. Implementation of the Austrian Gene Technology Act is supported by a number of ordinances established at the federal level. <br />To implement measures for Co-existence of GM crops and non-modified crops the 9 federal provinces ("Bundesländer") introduced specific regulations, which apply within their territories. <br />An overview on the Austrian legal framework is provided at <a href="http://www.biosafety.at/index.php?id=3849&L=1">http://www.biosafety.at/index.php?id=3849&amp;L=1</a> (<a href="http://www.biosafety.at/en/regulations/austrianregulations">http://www.biosafety.at/en/regulations/austrianregulations</a>); a brief description of the framework is available at: <a href="http://bmg.gv.at/home/">http://bmg.gv.at/home/</a> Path: Schwerpunkte/Gentechnik/Fachinformation_Allgemeines: Description_of_Austrian_Regulations_on_Genetic_Engineering<br />
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Article 5 – Pharmaceuticals
Yes
EN
Yes
EN
The EU framework for medical products as outlined by the submission of the European Commission also applies for Austria. The relevant provisions of Directive 2001/18/EC are transposed into Austrian law by the Austrian Gene Technology Act. For further information see <a href="http://www.biosafety.at/index.php?id=3849&L=1">http://www.biosafety.at/index.php?id=3849&amp;L=1</a> (<a href="http://www.biosafety.at/en/regulations/austrianregulations">http://www.biosafety.at/en/regulations/austrianregulations</a>)
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Article 6 – Transit and Contained use
Yes
EN
Yes
EN
Yes
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The EU framework as outlined by the submission of the European Commission also applies for Austria. The relevant provisions of Directive 2001/18/EC are transposed into Austrian law by the Austrian Gene Technology Act. For further information see <a href="http://www.biosafety.at/index.php?id=3849&L=1">http://www.biosafety.at/index.php?id=3849&amp;L=1</a> (<a href="http://www.biosafety.at/en/regulations/austrianregulations">http://www.biosafety.at/en/regulations/austrianregulations</a>)
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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
No
EN
No
EN
None
EN
None
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Further details on the implementation of Articles 7-10 in Austria and the other EU-Member-States are outlined in the submission of the European Commission with regard to the EU regulatory framework.
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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
Yes
EN
More than 10
EN
More than 10
EN
More than 10
EN
Yes, always
EN
Yes, always
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For a description of the comprehensive regulatory framework of the EU, which is applicable in Austria, see the respective submission of the European Commission. Decisions for authorisition of LMOs-FFP are taken at the EU-level and authorise the use of these LMOs-FFP in all EU-member states, including Austria.<br />Austria itself has taken national decisions to introduce safeguard measures for some LMOs to prohibit the cultivation and in some cases the import and placing on the market of LMOs according to Directive 2001/18/EC and the respective provisions of the Austrian Gene Technology Act. These measures are based on concerns about the conclusions of the risk assessments conducted at the EU-level for these applications. For an overview on these decisions see: <a href="http://www.biosafety.at/index.php?id=3848&L=1">http://www.biosafety.at/index.php?id=3848&amp;L=1</a> (<a href="http://www.biosafety.at/en/decisions/safeguard-measures">http://www.biosafety.at/en/decisions/safeguard-measures</a>)
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Article 12 – Review of decision
Yes
EN
No
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No
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None
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Article 13 – Simplified procedure
No
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No
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None
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Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
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The Austrian government did not enter into any bilateral, regional or multilateral agreements. <br />The EU has determined as per Article 14(4) and 9 (2) (c) that it relies on its existing legislative framework for intentional movements of GMOs within the European Union and for imports of GMOs into the European Union. This decision has been communicated to other Parties through the Biosafety Clearing-House.<br />
EN
Article 15 – Risk assessment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes, always
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Yes, always
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More than 10
EN
Yes, always
EN
Yes, always
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Decisions with regard to release and placing on the market of LMOs are taken on an EU level according to its regulatory framework and are binding for all EU Member States, including Austria. This biosafety framework mandates to conduct a comprehensive risk assessment prior to decision making. For further information see the respective submission of the European Commission.<br />By its legal definition the justifications of national safeguard measures which are based on concerns about the conclusions of the EU-wide risk assessment of certain LMOs do not require a full risk assessment themselves.<br />
EN
Article 16 – Risk management
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
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For further information on risk management see the submission of the European Commission concerning Article 16.
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Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
No
EN
Never
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Article 18 – Handling, transport, packaging and identification
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Article 19 – Competent National Authorities and National Focal Points
Yes
EN
Yes
EN
Yes, more than one
EN
Yes
EN
Yes, all information
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Yes
EN
Yes
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information not available
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information available and 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 and in the BCH
EN
Yes
EN
Yes
EN
Yes, always
EN
No
EN
n/a
EN
Yes
EN
The Austrian BCH focal point is regularly coordinating its activities with the national focal points from the other EU member states, with the BCH focal point of the European Community and with the SCBD secretariat. Relevant information is on the one hand submitted to the BCH central portal and on the other hand available at the national BCH in German and English language (<a href="http://www.biosafety.at/">http://www.biosafety.at/</a>). <br />Advice and help by the SCBD staff concerning technical questions regarding operation of the BCH is thankfully acknowledged.<br />
EN
Article 21 – Confidential information
Yes
EN
Yes, always
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For further information regarding confidential information see the respective submission of the European Commission.
EN
Article 22 – Capacity-building
No
EN
Yes
EN
Bilateral channels
EN
No
EN
Yes
EN
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • 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
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Taking into account risks to human health
No
EN
No
EN
No
EN
Yes
EN
Austria has contributed to various capacity building initiatives (some funded by GEF) in the field of biosafety for the effective implementation of the Protocol.
EN
Article 23 – Public awareness and participation
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
None
EN
For further information regarding EU-wide implementation of Article 23 see the respective submission of the European Commission. In the current reporting period no applications for deliberate release of LMOs which require national consultation and participation activities were filed in Austria.
EN
Article 24 – Non-Parties
No
EN
Yes
EN
No
EN
Yes, always
EN
Yes, always
EN
n/a
EN
For further information regarding Article 24 implementation see the respective submission of the European Commission, since all imports were authorised according to the EU biosafety framework.
EN
Article 25 – Illegal transboundary movements
Yes
EN
Yes
EN
Never
EN
For further information regarding measures concerning illegal transboundary movement of LMOs see the respective submission of the European Commission.
EN
Article 26 – Socio-economic considerations
No
EN
Yes
EN
Discussions on the consideration of socio-economic aspects of LMO use are ongoing both at the national level and in coordination with the respective activities of other EU member states and the European Commission. For further information regarding EU level activities see the submission of the European Commission.
EN
Article 27 – Liability and Redress
Yes
EN
Yes
EN
For further information see the respective submission of the European Commission.
EN
Article 33 – Monitoring and reporting
Yes
EN
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (Not applicable)
Other information
Comments on reporting format
Survey on indicators of the Strategic Plan (2014)
2001 or earlier
EN
Respective funding was provided by the Federal Ministry of Agriculture, Forestry, Environment and Water Management (BMLFUW)
EN
None
EN
Yes
EN
Coordination is provided by the competent authorities, Federal Ministry of Health (BMG) and Federal Ministry of Agriculture, Forestry, Environment and Water Management (BMLFUW)
EN
100,000 USD or more
EN
No
EN
Funding is provided on an annual basis
EN
None
EN
Yes
EN
Yes
EN
Yes
EN
Guidance documents developed at the EU level are used. For details pls. refer to the response by the European Commission.
EN
Yes
EN
Guidance for risk assessement is developed by cooperation between EU Member States and EU-level institutions.
EN
Yes
EN
For details see http://bmg.gv.at/cms/home/attachments/0/8/6/CH1052/CMS1196158149332/cms1201531756840_forschungsbericht_band_4-2007.pdf
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Respective EU-level regulation applies, for details pls. refer to the response by the European Commission.
EN
Yes
EN
In addition to participation in EU-level activities, Austrian experts conducted national research projects addressing the issue: for details pls. see http://bmg.gv.at/home/Schwerpunkte/Gentechnik/Fachinformation_Allgemeines/Studie_Assessing_Socio_Economic_Impacts_of_GMOs and http://www.umweltbundesamt.at/fileadmin/site/publikationen/REP0354.pdf
EN
50 or more
EN
see http://bmg.gv.at/home/Schwerpunkte/Gentechnik/Fachinformation_Allgemeines/Studie_Assessing_Socio_Economic_Impacts_of_GMOs and http://www.umweltbundesamt.at/fileadmin/site/publikationen/REP0354.pdf
EN
Further discussion and coordination on the development of criteria on how to take into account socio economic considerations in LMO decision making are necessary.
EN
Yes
EN
Enforcement is coordinated and implemented by the Federal Ministry of Health (BMG).
EN
10 or more
EN
10 or more
EN
10 or more
EN
Yes
EN
2 national reference laboratories operated by government agencies (AGES and EAA) were established.
EN
Yes
EN
Technical guidance documents developed at the EU-level are used. For details pls. refer to the response by the European Commission.
EN
No
EN
Yes
EN
100 or more
EN
Customs officers were trained to enforce the national regulations, e.g. concerning the Austrian safeguard measures on specific LMOs (http://www.biosafety.at/ms/biosafety/en/enbiosafety_natdecisions/enbiosafety_decision1/)
EN
10 or more
EN
Above number concerns staff at the 2 natl. reference laboratories.
EN
Yes
EN
Several laboratories available, including 2 natl. reference laboratories.
EN
5 or more
EN
5 or more
EN
No
EN
Yes
EN
EU-level and natl. regulations concerning environmental liability apply.
EN
Yes
EN
Specific regulation according to the Austrian Gene Technology Act is available, http://bmg.gv.at/home/Schwerpunkte/Gentechnik/Rechtsvorschriften_in_Oesterreich/Anhoerungsverordnung
EN
  • National website
  • Newspaper
  • Public hearings
National website
EN
http://bmg.gv.at/home/Schwerpunkte/Gentechnik/, tp://www.umweltbundesamt.at/umweltsituation/gentechnik/, http://www.biosafety.at/ms/biosafety/en///
EN
None
EN
None
EN
Yes
EN
Yes
EN
5 or more
EN
For additional published information see e.g. http://www.umweltbundesamt.at/umweltsituation/gentechnik/gentechnik_termine/.
EN
One or more
EN
Publications available e.g. from http://bmg.gv.at/home/Service/Publikationen_bestellen/, http://www.umweltbundesamt.at/aktuell/publikationen/publikationsliste/?pub_category_id=19
EN
  • National website
None
EN
Yes
EN
Activities are coordinated by the Federal Ministry of Health (BMG).
EN
Federal Ministry of Health (BMG) at natl. level.
EN
Yes
EN
Declaration of the Austrian government regarding the natl. biosafety policy.
EN
5 or more
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Available from http://bmg.gv.at/home/Service/Publikationen_bestellen/.
EN