Germany | BCH-NR2-DE-102921 | 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-DE-102921-3   |   PDF   |   Print   |  
published: 16 Dec 2011 last updated: 28 Jan 2016
General Information


EN

01 Jan 2007
16 Dec 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
As a member of the EU the European legislation on genetically modified organisms<br />(GMOs), which has been in place since the early 1990s, is either directly applicable in <br />Germany or has been implemented into German law. The EC has created a comprehensive<br />legal framework and introduced specific legislation on GMOs. Therefore the comprehensive<br />information given in the report of the EU also partly covers the situation in Germany. <br />Germany has fully implemented existing EC-legislation into national law through the<br />German Gentechnikgesetz [Gene Technology Act] and the EG-Gentechnikdurchführungs-<br />gesetz [German law regulating the implementation of the European provisions in the field <br />of GMO].<br /><br />These legal measures are publicly available on the homepage of the German Competent<br />National Authority (BVL) which also hosts the German BCH-homepage (currently under<br />development):<br />-&nbsp; <a href="http://www.bvl.bund.de/cln_027/nn_491818/DE/06_Gentechnik/09_">http://www.bvl.bund.de/cln_027/nn_491818/DE/06_Gentechnik/09_</a><br />BiosafetyClearingHouse/05__RechtlicheGrundlagen/rechtGrundlagen__node.html__nnn=true<br /><a href="http://www.biosafety-bch.de/">http://www.biosafety-bch.de/</a><br /><br />In addition to European legislation German law foresees administrative fines and penalties<br />to ensure compliance with relevant provisions. The Articles 38 and 39 of the German <br />Gentechnikgesetz [Gene Technology Act] as well as the §§ 6 and 7 of the German <br />EG-Gentechnik-Durchführungsgesetz [German Law regulating the implementation of the<br />European provisions in the field of GMOs] include penal provisions that serve to enforce <br />the aims and provisions of the Cartagena Protocol. These provisions penalize behaviours <br />that can contravene the goals of the Cartagena Protocol, for example the deliberate release <br />of a GMO into the environment or the placing on the market of a GMO without the necessary<br /> authorization by the competent authority. Moreover, § 6, 2nd paragraph of the German <br />EG-Gentechnik-Durchführungsgesetz [German Law regulating the implementation of the <br />European provisions in the field of GMOs] penalizes the transboundary movement of living <br />modified organisms carried out in contravention of the relevant German and European laws.
EN
Article 5 – Pharmaceuticals
Yes
EN
Yes
EN
see report of the EU
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
Yes
EN
see report of the EU<br /><br />Transit of specific LMOs might fall under the international legal framework of transport of dangerous goods.
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
No
EN
No
EN
None
EN
None
EN
see report of the EU<br /><br />Applicataions/notificatins regarding the transboundary movement of LMOs for intentional introduction into the enviroment refer, to the German experience&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; &nbsp; to applications regarding the (commercial) use of LMOs. In the EU, decisions on applications with this objective are taken at the EU level among the EU member states, but not in a single EU member state. Information to questions 37-49 regarding the EU level will be delivered from the EU NFP. At the national level, applications regarding the intentional introduction into the environment of LMO used for field trials generally do not originate from a transboundary movement.
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
see report of the EU<br /><br />In the EU, decisions on LMOs-FFP are taken at the EU level among the EU member states, but not in a single EU member state. Information to questions 58-62 regarding the EU level will be delivered from the EU NFP. The EU has developed a comprehensive legal framework on GMOs, which also addresses the import of GMOs intended for direct use for food or feed, or for processing. The EU has declared with reference to Article 14.4 of the Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU.
EN
Article 12 – Review of decision
Yes
EN
Yes
EN
Yes, decision reviewed and changed
EN
Less than 5
EN
In some cases only the notifier
EN
Yes, always
EN
Yes, always
EN
Germany decided to suspend an existing authorisation for the intentional introduction of an LMO into the environment for cultivation at the national level. This decision is subject of a review process.
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
Yes
EN
Yes
EN
Yes
EN
Yes, always
EN
Yes, always
EN
More than 10
EN
Yes, always
EN
Yes, always
EN
see report of the EU
EN
Article 16 – Risk management
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
see report of the EU
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
Yes
EN
More than 10
EN
Yes, for every occurence
EN
The affected or potentially affected State
EN
Yes, always
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
No
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
see report of the EU
EN
Article 19 – Competent National Authorities and National Focal Points
Yes
EN
Yes
EN
Yes, one
EN
Yes, all information
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 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 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 available and in the BCH
EN
Information not available
EN
Information not available
EN
Information available and in the BCH
EN
Yes
EN
Yes
EN
Yes, in some cases
EN
No
EN
n/a
EN
Yes
EN
see report of the EU<br /><br />Submission of information is an ongoing process which requires considerable time. Allocation of necessary recources is a function of availablity of recources and current priority of current duties.<br /> <br />In 2007 and 2011 Germany organized 2 meetings of the National Focal Points and Competent National Authorities of the EU Parties to the Cartagena Protocol to exchange views and experiences with regard to the implementation of the requirements of the Cartagena Protocol and the submission of information to the Biosafety Clearing House data base.
EN
Article 21 – Confidential information
Yes
EN
Yes, always
EN
see report of the EU
EN
Article 22 – Capacity-building
No
EN
Yes
EN
Bilateral channels
EN
No
EN
Yes
EN
  • 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
  • Technology transfer
  • Identification of LMOs, including their detection
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
No
EN
No
EN
No
EN
No
EN
Article 23 – Public awareness and participation
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
More than 5
EN
see report of the EU
EN
Article 24 – Non-Parties
No
EN
Yes
EN
Yes
EN
Yes, always
EN
n/a
EN
n/a
EN
see report of the EU
EN
Article 25 – Illegal transboundary movements
Yes
EN
Yes
EN
Never
EN
see report of the EU
EN
Article 26 – Socio-economic considerations
No
EN
Yes, to a limited extent
EN
see report of the EU
EN
Article 27 – Liability and Redress
Yes
EN
Yes
EN
Germany has undertaken initial steps and procedures towards a prompt ratification of this Protocol.
EN
Article 33 – Monitoring and reporting
Yes
EN
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (Not applicable)
Other information
Re: Q. 14- Raification of te Protocol 20. November 2003<br /><br />Re: Q. 138- Regional channels as well
EN
Comments on reporting format
Survey on indicators of the Strategic Plan (2014)
2001 or earlier
EN
10 per year or more
EN
Universities and private entities offer training courses for people(scientiste, technicians) working with GMOs
EN
Yes
EN
n/a
EN
Yes
EN
Has to be seen in relation to the answer to question 4.
EN
10 or more
EN
see report of the EU.
EN
Yes
EN
Yes
EN
Yes
EN
See report of the EU. Has to be seen in relation to the anwer to question 9.
EN
Yes
EN
See report of the EU.
EN
Yes
EN
See contributions to the BCH.
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
See report of the EU.
EN
Yes
EN
See report of the EU.
EN
50 or more
EN
See report of the EU.
EN
Discussion is ongoing, no expressed experience.
EN
Yes
EN
See report of the EU. National emergency measures.
EN
50 or more
EN
10 or more
EN
50 or more
EN
Yes
EN
Yes
EN
relates to question 9 and 10.
EN
Yes
EN
Yes
EN
None
EN
See report of the EU.
EN
50 or more
EN
Due to Germany's federal structure all federal "Länder" provide their expertise in the EU Reference Laboratory Network.
EN
Yes
EN
10 or more
EN
10 or more
EN
No
EN
Yes
EN
See report of the EU.
EN
Yes
EN
See report of the EU. Provisions have been implemented on national level.
EN
  • National website
  • Newspaper
National website
EN
10 or more
EN
See answer to question 4.
EN
10 or more
EN
Yes
EN
Yes
EN
5 or more
EN
100 or more
EN
All information is publicly made available on the homepage of the German Competent National Authority (BVL) which also hosts the German BCH-homepage (currently under development): - http://www.bvl.bund.de/cln_027/nn_491818/DE/06_Gentechnik/09_ BiosafetyClearingHouse/05__RechtlicheGrundlagen/rechtGrundlagen__node.html__nnn=true http://www.biosafety-bch.de/
EN
  • BCH Central Portal
None
EN
Yes
EN
See report of the EU.
EN
Yes
EN
Within the legal framework communication procedures in relation to the assessment and marketing of gmos is implemented
EN
5 or more
EN