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Law, Regulation or Guideline
Record information and status
Record ID
103673
Status
Published
Date of creation
2012-07-06 11:41 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 15:46 UTC (ursula.monnerjahn@bmel.bund.de)

This document is also available in the following languages:
General Information
Country
  • Germany
Jurisdiction
  • Germany
Title of document
Position statement of the Central Committee on Biological Safety (ZKBS) on the risk assessment of influenza viruses
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 influenza viruses. In general, Directive 2000/54/EC of the European Parliament and the Council allocates influenza viruses (genus A, B and C) to risk group 2. Contrarily, the ZKBS recommends to assign the following subtypes and strains of influenza-A-viruses to risk group 3 since these are associated with a severe course of disease in humans or fowl, or with an increased pandemic potential due to the lack of immunity in the population:
- the variant of subtype H1N1 that caused the Spanish Flu in 1918
- highly pathogenic avian influenza viruses (HPAIV)
- novel avian influenza A virus of subtype H7N9
- non-contemporary influenza A viruses of the subtype H2N2
Moreover, the ZKBS recommends some additional safety measures for genetic engineering operations with these viruses.
Date of entry into force
2015-11-30
Document details
Document text
EN
6790-05-02-29_Influenzaviren_Version November 2015_de.pdf (23 KB)
6790-05-02-29_Influenzaviren_Version November 2015_de
Unofficial documents
EN
6790-05-02-29_influenza_update November 2015_en.pdf (20 KB)
6790-05-02-29_influenza_update November 2015_en
Amendments
This is an amendment of the position statement of the Central Committee on Biological Safety (ZKBS) on the risk assessment of influenza viruses from 2005. To prevent an interchange of the formerly and updated version only the latest and most current version of 2015 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) 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 office is based at the Federal Office of Consumer Protection and Food Safety (BVL). Its members and deputy members are appointed by the Federal Ministry for Food, agriculture and Consumer Protection (BMELV) for three years. The ZKBS evaluates 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.