Latest Documents


  • 25-April-2016

    English

    Application of Good Laboratory Practice Principles to Computerised Systems

    This new Advisory Document replaces the 1995 consensus document on the Application of the Principles of GLP to Computerised Systems. It retains all of the key text from the original 1995 document, but includes new text to reflect the current state-of-the art in this field.

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  • 25-April-2016

    English

    Testing Programme of Manufactured Nanomaterials

    The safety of Manufactured Nanomaterials is an important concern impacting regulatory bodies throughout the world. Due to their size, Manufactured Nanomaterials may require additional testing beyond the standard suite of tests used for other chemicals, to ensure that the impact on human health and the environment is fully understood - download Manufactured Nanomaterials Dossiers or search for Tested Endpoints.

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  • 5-April-2016

    English

    Safety Assessment of Transgenic Organisms in the Environment, Volume 5 - OECD Consensus Documents

    This series represents a compilation of the biosafety consensus documents developed by the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology over the periods 2011-12 (Volume 5) and 2013-15 (Volume 6). Volumes 5 and 6 describe the biology, centres of origin, genetics, hybridisation, production and use, and ecology elements of several crops (sugarcane, cassava, sorghum, common bean, cucurbits) and trees (eucalyptus species). They also provide considerations on pathogenicity factors in assessing the potential adverse health effects of bacteria, and the low level presence of transgenic plants in seed and grain commodities.
    The consensus documents contain information for use during the regulatory assessment of products of modern biotechnology, i.e. transgenic organisms (plants, animals, micro-organisms), when intended for release in the environment. As such, it should be of value to applicants for use of genetically-engineered organisms in agriculture mainly, to regulators and risk assessors in national authorities for their biosafety assessments, as well as the wider scientific community. More information on this OECD programme is found at BioTrack online (www.oecd.org/biotrack).

     

  • 5-April-2016

    English

    Safety Assessment of Transgenic Organisms in the Environment, Volume 6 - OECD Consensus Documents

    This series represents a compilation of the biosafety consensus documents developed by the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology over the periods 2011-12 (Volume 5) and 2013-15 (Volume 6). Volumes 5 and 6 describe the biology, centres of origin, genetics, hybridisation, production and use, and ecology elements of several crops (sugarcane, cassava, sorghum, common bean, cucurbits) and trees (eucalyptus species). They also provide considerations on pathogenicity factors in assessing the potential adverse health effects of bacteria, and the low level presence of transgenic plants in seed and grain commodities.
    The consensus documents contain information for use during the regulatory assessment of products of modern biotechnology, i.e. transgenic organisms (plants, animals, micro-organisms), when intended for release in the environment. As such, it should be of value to applicants for use of genetically-engineered organisms in agriculture mainly, to regulators and risk assessors in national authorities for their biosafety assessments, as well as the wider scientific community. More information on this OECD programme is found at BioTrack online (www.oecd.org/biotrack).
     

  • 1-April-2016

    English

    Draft Guidance and Review Documents/Monographs

    Open for public comment until 13 May 2016, the Guidance Document establishing an Integrated Approach to Testing and Assessment (IATA) for hazard identification of serious eye damage and eye irritation potential of test chemicals aims to provide adequate information for classification and labelling according to the United Nations Globally Harmonised System.

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  • 24-March-2016

    English

    Series on Pesticides

    New pesticides guidance has been finalised that harmonises the way terrestrial field dissipation studies (TFDs) are conducted in different regions of the world.

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    Also AvailableEgalement disponible(s)
  • 18-March-2016

    English, PDF, 1,601kb

    Draft Guidance Document on IATA for Eye Hazard Potential

    The objective of the present Guidance Document (GD) is to establish an Integrated 2 Approach to Testing and Assessment (IATA) for hazard identification of serious eye 3 damage and eye irritation potential of test chemicals (or the absence thereof) that 4 provides adequate information for classification and labelling according to the United 5 Nations Globally Harmonised System (UN GHS, 2015).

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  • 1-March-2016

    English

    Series on Pesticides

    New pesticides guidance has been finalised that harmonises the way terrestrial field dissipation studies (TFDs) are conducted in different regions of the world.

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    Also AvailableEgalement disponible(s)
  • 23-February-2016

    English

    Section 2: Effects on Biotic Systems

    This is a list of the Guidelines for the Testing of Chemicals in Section 2: Effects on Biotic Systems

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  • 23-February-2016

    English

    Publications in the Series on the Safety of Manufactured Nanomaterials

    This document provides background information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level. The information provided in this document captures OECD activities before and after the 15th WPMN meeting (November 2015).

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