INTERNATIONAL
COUNCIL OF
CHEMICAL
ASSOCIATIONS
03 October 1998
Related information - list of HPV chemicals
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IUCLID Guidance Document
A comprehensive IUCLID Guidance Document (IUCLID 3.1.1) has been prepared by the Fraunhofer Institute of Toxicology and Aerosol Research on behalf of CEFIC and in collaboration with the European Chemicals Bureau
(ECB). The main objectives of this guidance document are:
 To provide a brief overview of the structure of IUCLID and its main features, referring to the technical manuals for more detailed information where appropriate;
 To provide detailed guidance on the entry of study summaries into common and subchapter-specific fields of IUCLID;
 To provide detailed guidance on the preparation of robust study summaries in a harmonized form including the use of (electronic) sample free texts.
This guidance document is intended for use by persons assessing study reports with the view of preparing study summaries using IUCLID, but also for those who use IUCLID data sets as a basis for conducting hazard and risk assessment.
Published December 2000
ICCA HPV Working List (Last updated - 2000/07/01)
Available in:
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MS/Excel 5.0/7.0
- 222 Kb
PDF - 122 Kb
The ICCA TAG formed an HPV Chemical Work Group to manage this Initiative in December 1998. One of the Work Group's first major tasks was to develop the working list of 1,000 chemicals to be included in the Initiative. The criteria for chemicals selected to be on this list include chemicals that are HPV chemicals or
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INTERNATIONAL
COUNCIL OF
CHEMICAL
ASSOCIATIONS otherwise of interest in two or more regions (i.e., US, Europe, or Japan).
A second list of chemicals, Annex A, consists of chemicals that are HPV in only one region, and were nominated by a company, OR, are chemicals that are already in the OECD SIDS Program, OR are EU priority list chemicals (CR
EEC/793/93).
Chemical industry participants are free to include other chemicals that are not on either of the lists described above if appropriate when using a category approach.
The working list and Annex A will be reviewed and updated periodically by the
HPV Chemical Work Group.
Implementing SIDS and The ICCA Initiative: A Workshop Sponsored by CMA and EPA
May 4-5, 2000 - CMA Headquarters, 1300 Wilson Boulevard, Arlington, VA
MS/Word 97 - 30 Kb
Key objectives:
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Learn how the SIDS process really works
 Dialogue with EPA and the experts on creating SIDS documents
Learn what has changed under the "refocused" SIDS program
 Hear views from European and Japanese representatives on overcoming barriers to forming global consortia
 Network with your peers working on HPV implementation
ICCA (HPV) Chemical Tracking System Web site
This site monitors the progress of the global chemical industry’s commitment to
Product Stewardship and Responsible Care by evaluating the voluntary progress of providing hazard assessments on HPV chemicals.
Description of High Production Volume (HPV) Chemical Initiative with 3
Appendices
HTML
List of petroleum products to be excluded from the ICCA initiative because they are being addressed by another group
MS/Excel 5.0/7.0 - 50 Kb
1. Background
The chemical industry (see ICCA Web site ) is, under its world-wide programme on
Responsible Care, committed to the safe management of chemicals throughout their entire life cycle. There are a number of regional and national chemicals management activities established. These activities are based on legal obligations but also on voluntary industry commitments. They include priority- setting, hazard assessment, risk assessment and risk management.
For the "existing chemicals" - chemicals which had already been on the market when
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INTERNATIONAL
COUNCIL OF
CHEMICAL
ASSOCIATIONS regulatory frameworks for new chemical substances were introduced at regional or national level - the availability of the relevant hazard and risk information merits (in spite of significant progress in national and regional programmes) further improvement.
Special concerns are related to HPV-chemicals (chemicals with a production of
> 1000 tonnes a year) because - due to high production - there are associations with higher risk. In 1987 the OECD , with Industry’s support, therefore decided to launch a special programme on HPV chemicals using the advantages of global burden-sharing.
There are 6 basic test-categories which have been internationally agreed for screening
HPV chemicals for toxicity: acute toxicity, repeated dose toxicity, reproductive toxicity, mutagenicity, eco-toxicity and environmental fate (Screening Information
Data Set - SIDS). About 100 substances have been assessed for their hazardous properties under this programme so far; around 275 additional substances are in the programme at present.
The slow progress of national, regional and global programmes on data availability of
HPV-chemicals is causing increasing public concern. The elaboration and publication of lists of "unwanted chemicals" by some countries, environmental groups and also sometimes sectors of industry are the results of the growing public disquiet about the internationally accepted Risk- Based Decision- Making.
2. The Objectives of the Global Initiative
In order to ensure the sustainability of the chemical industry and its business the
ICCA Board strongly recommends its member federations and their companies to establish an efficient and effective process for systematic data gathering and hazard assessment of HPV chemicals within a reasonable time using the existing OECD programme and hence/thereby the advantages of global burdensharing.
The pressures on the industry arising from the public anxiety are different in different regions, and the risk assessment and risk management of specific substances have, in general, to be carried out at regional or national level. The common element at the global level in the industry response is data- gathering and hazard assessment. The
ICCA initiative on HPV chemicals is intended to deal with that common element effectively by achieving burden-sharing and avoiding duplication of efforts. This programme will also provide the basis for strengthening and accelerating the risk assessment of existing chemicals at national and regional level. The ICCA Board stresses the following prerequisites for the proposed initiative:
 The initiative should take into account all of the 4,100 chemicals included in the OECD HPV list. Priority will be on substances of high concern (e.g. for chemicals with wide disperse uses or the potential for extensive human exposure). Identification of these chemicals will be made after consultation with OECD. After listing up chemicals, the initiative will start to keep consistency with OECD/SIDS mechanism. It is estimated that around 1000
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INTERNATIONAL
COUNCIL OF
CHEMICAL
ASSOCIATIONS chemicals will be included in this initial phase.
 SIDS data are to be regarded as a basis for the testing process, but in practice there will be situations where fewer or more tests will be necessary. Certain chemicals may need reduced testing, or none at all, depending on their characteristics and the amount of information available. Others may require testing beyond SIDS requirements because of specific applications or exposure situations. Companies or consortia should validate the data and explain why deviation from the SIDS package is necessary. For efficiency, the programme must also include "intelligent testing", e.g. making use of scientifically valid concepts such as QSAR.
 The aim is to complete the SIDS information packages for the priority chemicals by the end of 2004. While making this commitment, ICCA invites
OECD Governments and the appropriate Inter-Governmental organisations to accelerate the SIDS assessment process, which results in a hazard assessment.
 Having completed this programme, OECD-type hazard assessments of a significant portion of the world’s chemical production will be available.
 Hazard assessment is a necessary but insufficient basis for management actions. However, the hazard assessment information will produce valuable data for prioritisation and possible acceleration of risk assessments by
Governments at the regional or national level as well by Industry. Under conditions to be clarified, OECD should accept hazard and/or risk assessments already completed in regional or national programmes.
 To be of the greatest value, the publicly available information collected should be contained in a single database repository. ICCA is prepared to discuss the establishment of such a repository with other interested stakeholders.
 All companies belonging to ICCA are called upon to join this Global Initiative.
Some detailed mechanisms for determining the companies which become responsible for the testing must be defined. One of the useful ideas is: The companies involved in the production or handling of HPV chemicals on the priority list should nominate a company taking the lead in the data gathering and testing. The priority list of HPV chemicals should name the involved companies as well as the lead company for public awareness.
 Companies producing or handling priority list chemicals should commit themselves to making promptly available any significant, new information regarding adverse health or environmental effects.
 Flexibility will be required to achieve the goal of this initiative, since each
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INTERNATIONAL
COUNCIL OF
CHEMICAL
ASSOCIATIONS country has its own social system for securing chemical safety. The responsibility for data gathering and testing is not necessarily placed solely on chemical companies. The public authority can also contribute to data gathering and testing. It is important to achieve the objectives of the global initiative by desirable co-operation between chemical companies and public authorities.
 ICCA will focus on chemicals produced by companies which belong to their member associations. However, ICCA encourages allied associations to work on chemicals of their constituency and to co-operate with ICCA.
 ICCA members are recommended to consider working closely with stakeholders when establishing a chemicals management programme in their country or region.
 The Work Programme should be managed by the ICCA Secretariat under the direct responsibility of ICCA/TAG (Technical Affairs Group). It should be promoted, monitored and reported by ICCA/TAG under the auspices of OECD in close contact with ICCA member federations.
3. Outlook
This ICCA initiative on chemicals management based on Product Stewardship will contribute to both a continuous, internationally co-ordinated improvement of society’s knowledge of chemicals and the proper management of health, safety and environmental risks posed by existing chemicals within an appropriate time frame.
The global initiative of ICCA will be subject to discussion with authorities in the established procedures of the OECD. Furthermore, ICCA encourages the dialogue on the initiative with all committed stakeholders in order to meet public needs and concerns.
ICCA expects that information provided by industry and the hazard assessment outcome will be considered by OECD Member Countries, by international bodies
(e.g. UNEP, OSPAR), by regional bodies (e.g. the EU under its Regulation on
Existing Chemicals) and the public as an internationally accepted and harmonised basis for further steps of chemicals management: the risk assessment and if necessary the identification of the appropriate and most efficient and cost-effective risk reduction option. With that, duplication of work and also differences in interpretation of scientific data will be avoided.
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