Report of the OECD Workshop on Sharing Information about New Industrial Chemicals Assessment

187 Pages·2002·0.527 MB·English

by  OECD

General Distribution OCDE/GD(97)33
Report of the OECD Workshop on Sharing Information
about New Industrial Chemicals Assessment
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
Paris
49389
Document complet disponible sur OLIS dans son format d'origine
Complete document available on OLIS in its original format
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OECD Environmental Health and Safety Publications
Series on Testing and Assessment
No. 8
REPORT OF THE OECD WORKSHOP ON SHARING
INFORMATION ABOUT NEW INDUSTRIAL
CHEMICALS ASSESSMENT
Environment Directorate
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
Paris 1997
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Also published in the Series on Testing and Assessment:
No. 1, Guidance Document for the Development of
OECD Guidelines for Testing of Chemicals (1993;
reformatted 1995)
No. 2, Detailed Review Paper on Biodegradability
Testing (1995)
No. 3, Guidance Document for Aquatic Effects
Assessment (1995)
No. 4, Report of the OECD Workshop on
Environmental Hazard/Risk Assessment (1995)
No. 5, Report of the SETAC/OECD Workshop on
Avian Toxicity Testing (1996)
No. 6, Report of the Final Ring Test of the Daphnia
magna Reproduction Test (1997)
No. 7, Guidance Document on Direct Phototrans-
formation of Chemicals in Water (1997)
Guidance Document on Dose Level Selection in
Carcinogenicity Studies (in preparation)
Detailed Review Paper on Aquatic Toxicity Testing
Methods (in preparation)
© OECD 1997
Applications for permission to reproduce or translate all or part of this material should be made
to: Head of Publications Service, OECD, 2 rue André-Pascal, 75775 Paris Cedex 16, France.
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About the OECD
The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental
organization in which representatives of 29 industrialized countries in North America, Europe and the
Pacific, as well as the European Commission, meet to co-ordinate and harmonize policies, discuss issues
of mutual concern, and work together to respond to international problems. Most of the OECD's work is
carried out by more than 200 specialized Committees and subsidiary groups composed of Member
country delegates. Observers from several countries with special status at the OECD, and from
interested international organizations, attend many of the OECD's Workshops and other meetings.
Committees and subsidiary groups are served by the OECD Secretariat, located in Paris, France, which
is organized into Directorates and Divisions.
The Environmental Health and Safety Division publishes complimentary documents in six different
series: Testing and Assessment; Good Laboratory Practice and Compliance Monitoring;
Pesticides; Risk Management; Harmonization of Regulatory Oversight in Biotechnology; and
Chemical Accidents. More information about the Environmental Health and Safety Programme and
EHS publications is available on the OECD’s World Wide Web site (see next page).
This Workshop report was produced within the framework of the Inter-Organization Programme for
the Sound Management of Chemicals (IOMC).
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This publication is available electronically, at no charge.
For the complete text of this and many other Environmental
Health and Safety publications, consult the OECD’s
World Wide Web site (http://www.oecd.org/ehs/)
or contact:
OECD Environment Directorate,
Environmental Health and Safety Division
2 rue André-Pascal
75775 Paris Cedex 16
France
Fax: [phone]
E-mail: [email protected]
The Inter-Organization Programme for the Sound Management of Chemicals (IOMC)
was established in 1995 by UNEP, ILO, FAO, WHO, UNIDO and the OECD (the
Participating Organizations), following recommendations made by the 1992 UN
Conference on Environment and Development to strengthen co-operation and
increase international co-ordination in the field of chemical safety. The purpose of
the IOMC is to promote co-ordination of the policies and activities pursued by the
Participating Organizations, jointly or separately, to achieve the sound management
of chemicals in relation to human health and the environment.
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Foreword
This document contains the report of the OECD Workshop on Sharing Information
about New Industrial Chemicals Assessment. The Workshop, led by the governments of
Australia and Germany, took place at OECD headquarters in Paris on 5-6 February 1996.
Included in this report are the Workshop’s Conclusions and Recommendations, as well as a
summary of discussions, case studies, and perspectives on the sharing of information
presented at the Workshop. Background material and the results of a survey of existing
notification schemes for new industrial chemicals are also included.
Potential notifiers of new industrial chemicals under the various schemes described in
this report are advised to contact the competent authority in the relevant country to discuss
details of how to make a notification.
Derestriction of this document was recommended by the OECD’s Joint Meeting of the
Chemicals Group and Management Committee of the Special Programme on the Control of
Chemicals. It is published on the responsibility of the Secretary-General of the OECD.
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Table of Contents
Executive Summary......................................................................................................11
List of Acronyms...........................................................................................................15
Introduction.....................................................................................................................17
Objectives.......................................................................................................................17
Overview of the Workshop..............................................................................................18
Summary of Presentations and Discussion....................................................................18
Main Features of Existing Schemes..................................................................18
Survey to Identify Possibilities for Sharing Information
on New Industrial Chemicals.............................................................................20
Types of Information Available for Sharing........................................................21
Confidentiality....................................................................................................21
Case Studies and Perspectives on Sharing Information...................................22
An Industry Perspective...............................................................................22
The OECD Pesticide Forum and Exchange of Data Reviews......................21
Sharing of New Chemicals Information in the EU........................................23
The US-Canada Four Corners Agreement..................................................23
The Australian-German Pilot Exchange Programme...................................25
Summary of Discussion.....................................................................................25
Conclusions....................................................................................................................26
Recommendations and Follow-up Work.........................................................................27
Acknowledgments...........................................................................................................28
Annex 1 List of Workshop Participants......................................................................29
(continued next page)
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Annex 2 Summaries of Selected Notification Schemes............................................. 39
Australia....................................................................................................... 41
Canada........................................................................................................ 45
Japan (MHW/MITI)....................................................................................... 49
Japan (ML)................................................................................................... 54
New Zealand................................................................................................ 57
Switzerland.................................................................................................. 61
United States............................................................................................... 65
European Union........................................................................................... 69
Annex 3 Four Corners Agreement between US EPA and the
Canadian Government on International Sharing of
Information on New Chemicals.................................................................... 75
Annex 4 Overview of Responses to the Survey to Identify
Possibilities for Sharing Information about New
Industrial Chemicals Notification and Assessment....................................... 85
Annex 5 Tabulated Summary of the Survey to Identify Possibilities
for Sharing Information about New Industrial Chemicals
Notification and Assessment........................................................................103
Annex 6 Questionnaire to Identify Possibilities for Sharing Information
about New Industrial Chemicals Notification and Assessment....................167
Annex 7 Extracts from the OECD Council Recommendations on the
Exchange of Confidential Data on Chemicals and the List
of Non-Confidential Data.............................................................................181
Annex 8 Members of the Co-ordination Group on Sharing Information
about New Industrial Chemicals..................................................................187
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