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Law, Regulation or Guideline
Record information and status
Record ID
104464
Status
Published
Date of creation
2012-11-27 13:25 UTC (german_bch@bvl.bund.de)
Date of last update
2017-07-06 10:36 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:47 UTC (ursula.monnerjahn@bmel.bund.de)

This document is also available in the following languages:
General Information
Country
  • Germany
Jurisdiction
  • Germany
Title of document
General position statement of the Central Committee on Biological Safety (ZKBS) on frequently carried out genetic engineering operations based on the criteria of comparability: Genetic engineering operations with Sindbis virus and Semliki Forest virus expression systems
Legislative details
Type of document
  • National Guideline
Subject areas
  • Contained use
  • Risk assessment and management
Types of LMOs addressed
  • Viruses
Brief description of the document including objective and scope:
Position statement of the Central Committee on Biological Safety (ZKBS) on the risk assessment of genetic engineering operations with Sindbis virus and Semliki Forest virus expression systems according to German Genetic Engineering Act.
Date of entry into force
2017-05-30
Document details
Document text
DE
6790-10-50_SIN-SFV-Vektor_Version Mai 2017_de.pdf (250 KB)
6790-10-50_SIN-SFV-Vektor_Version Mai 2017_de
Unofficial documents
EN
6790-10-50_SIN SFV Vector_update May 2017_en.pdf (257 KB)
6790-10-50_SIN SFV Vector_update May 2017_en
Amendments
This is an amendment of the position statement of the Central Committee on Biological Safety (ZKBS) from 2007 on the risk assessment of genetic engineering operations with Sindbis virus and Semliki Forest virus expression systems according to German Genetic Engineering Act. To prevent an interchange of the formerly and updated version only the latest and most current version of 2017 is provided here. The updated version is a complete position statement on its own.
Regulatory contact information
Contact person
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Berlin
Germany, 10117
Phone:+49-(0)3018-445-6500
Fax:+49-(0)3018-445-6099
Email:german_bch@bvl.bund.de
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Additional Information
Additional Information
The Central Committee on Biological Safety (ZKBS - Zentrale Kommission für die Biologische Sicherheit) is an expert scientific committee made up of 20 members and 20 deputy members, who represent different specialist areas or spheres of corporate interest. Its offices are based at the Federal Office of Consumer Protection and Food Safety (BVL - Bundesamt für Verbraucherschutz und Lebensmittelsicherheit). Its members and deputy members are appointed by the Federal Ministry for Food, Agriculture and Consumer Protection (BMELV - Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz) for three years. The ZKBS evaluates genetically modified organisms (GMOs) for possible risk potential, assigns genetic engineering operations to a biosafety level and recommends suitable safety measures. The german federal states obtain ZKBS position statements for genetic engineering operations in safety categories 3 and 4 and for operations in a lower safety category, whose classification is not clear. The ZKBS also evaluates approval applications for releases and for the placing of GMOs on the market and also issues a report to the BVL. An activity report is published annually.