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Welcome to the Website of the Global Initiative on High Production Volume (HPV) Chemicals! 

 

What is the ICCA HPV Chemicals Initiative?

The global chemical industry, through the International Council of Chemical Associations (ICCA), launched a global Initiative on High Production Volume (HPV) chemicals at its Board meeting on 3 October 1998.

Through this commitment, the chemical industry has undertaken to provide, as a first step, harmonised data sets on the intrinsic hazards of and initial hazard assessments for approximately 1,000 HPV substances by the end of 2004. The information, i.e. a Screening Information Data Set Dossier (SIDS Dossier), a SIDS Initial Assessment Report (SIAR) and a SIDS Initial Assessment Profile (SIAP), will be submitted to the OECD for international agreement as part of its refocused HPV Chemicals Programme. The cost of generating data and the work to draft the assessments will be borne by industry – and shared, whenever possible, by companies in international consortia.

The main features of the ICCA HPV Chemicals Initiative are:

·         Voluntary action by the world chemical industry to speed up the process under existing regional and/or global programmes with a clear target date.

·         Globally harmonised, internationally agreed data sets and initial hazard assessments under the refocused HPV Chemicals Programme of the OECD.

·         Elimination of duplication of testing and assessment efforts.

The main expected benefits are:

·         to restore public confidence in chemicals and to foster the reputation of the chemical industry on a global basis;

·         to produce a sound scientific basis for any subsequent voluntary industry action, global, regional and/or national risk assessment, or legislation;

·         to minimise the cost for the industry, and

·         to reduce the number of animals for testing.

ICCA believes that a risk assessment is the basis for decisions on how to manage chemicals. However, experience under the OECD Existing Chemicals Programme has demonstrated that risk assessment is most efficiently carried out on a regional or national level. ICCA has therefore decided to concentrate on the initial hazard assessment as the objective of its Initiative, realising that this is an indispensable input both for the prioritisation of the chemicals subject to risk assessments and for the risk assessment process itself.

In most cases, risk assessment is likely to take place at national or regional level, because of different use situations, regulatory requirements or risk perceptions. However, when international concern is evidenced further consideration of the chemical could be undertaken at the international level. Companies are encouraged to act on their own findings and not wait for regulatory actions.

 

The ICCA HPV Working List (October 2005 update)

To qualify initially for the ICCA Working List of HPV substances, chemicals need to be considered HPV or otherwise of interest in two or more regions (i.e. North America, Europe, or Japan).

However, chemicals that are HPV in only one region and were sponsored by a company because they believe they ought to be supported by international consortia because, for example,

1.      they have been identified as priority chemicals by national and/or regional authorities and which are HPV chemicals in at least one region; or

2.      they are chemicals for which assessments in other programmes had started but got stuck at early stages; or

3.      they fit into a category of chemicals that can be assessed together.

The ICCA HPV Working List is reviewed and updated periodically by the ICCA HPV Task Group. The latest main list dated October 2005 contains 1428 chemicals. It also shows which substances have already been assessed by the SIDS Initial Assessment Meeting (SIAM).

In contrast with past versions, the revised Working List no longer contains an Annex A.  This Annex included HPV chemicals otherwise eligible for the Initiative which already have completed SIDS assessment reports or are undergoing assessments at least as complete under other programmes, particularly risk assessments under the EU Existing Substances Regulation. These chemicals were not eligible for sponsorship under the Initiative. The Annex also included HPV chemicals which were not HPV in at least two regions, but which had been identified as priorities under national programmes or by individual companies.  In contrast to the first group, these chemicals are eligible for sponsorship under the Initiative.  The ICCA HPV Task Group felt that Annex A created confusion because it included chemicals for a wide variety of reasons, some of which were eligible for sponsorship and others not.  The ICCA HPV Task Group will maintain the Annex as an administrative tool for checking eligibility and to respond to questions.

 

How does the Initiative work and why should companies participate?

Companies are responsible for collating and generating data for each of the six basic data categories, which have been agreed by the OECD Member countries for screening HPV chemicals for hazardous properties under the OECD's refocused HPV Chemicals Programme. These are:

·         physical/chemical properties;

·         environmental fate;

·         ecotoxicity;

·         acute toxicity;

·         genetic toxicity;

·         repeat dose, reproductive and developmental toxicity.

These data will be reported in the OECD's SIDS Dossier format

The key information from the SIDS Dossier provides a sound basis for the initial hazard assessment of the chemical. The initial hazard assessments will be presented by the industry consortia to a sponsor country in the form of a draft SIAR. The draft SIAR will then be reviewed by the sponsor country and, once approved forwarded to the OECD for consideration and appropriate action at a SIDS Initial Assessment Meeting (SIAM). The format and content of the SIAR are described in the OECD Guidance Manual (please see http://www.oecd.org/document/7/0,2340,en_2649_34379_1947463_1_1_1_1,00.html).

The prime responsibility for this Initiative lies with the companies producing HPV chemicals. They collect hazard information and, where required, conduct tests needed to supplement existing information. To undertake this work, companies either commit to lead the work for a specific substance or category of substances or to co-sponsor the work, through an international consortium. Such consortia are often formed under the auspices of panels or product sector groups of ICCA member associations.

The costs of data gathering, testing and drafting the initial hazard assessment are borne by companies working in the consortia. Depending on the extent to which the required quality data are available, the data generation costs per substance will vary from zero to approximately EUR/USD 400,000 if no data are available at all. Additional costs are incurred for document development and revision. Sharing the burden in consortia and avoiding overlaps in testing saves the chemical industry in excess of EUR/USD 100 million.

Since the same rules apply in Japan, North America and Europe work will have to be carried out only once, avoiding duplication of work and unnecessary animal testing.

Why should companies participate?

Decisions by companies to participate in the ICCA Initiative, either individually or through consortia are voluntary. However, the following is a list of considerations that should lead a company to reach such a decision:

  1. Industry has declared repeatedly its willingness to respond to public concern about chemicals through its Product Stewardship commitments under Responsible Care.
  2. The chemical industry has an opportunity to take a proactive approach in addressing concerns among the public about chemicals.
  3. The Initiative will improve our knowledge about chemicals and will enable us to better and faster respond to public concerns.
  4. The Initiative delivers globally harmonised, internationally agreed data sets and initial hazard assessments which are recognised under national and regional programmes.
  5. Participation in collection and development of assessment information ensures a role in evaluating that information.
  6. The Initiative offers a way in which the burden of providing harmonised data and an internationally agreed initial hazard assessment is shared among international producers of a chemical.
  7. Non-participants in the Initiative may be viewed more unfavourably by the public or by their customers than companies that have chosen to participate.
  8. National or regional regulatory action could compel the provision of information foreseen under the Initiative, but with more stringent requirements.
  9. Governments may attempt to ban or restrict the use of chemicals if there are no adequate data available.

 

Tracking Progress and Public Access to Information Generated

Confidence and compliance are both tied to the ability of the public to "track" company commitments and progress in the Initiative as it occurs. The ICCA HPV Chemical Tracking System (ICCA TS) is the public's source for monitoring industry progress under the ICCA HPV Chemicals Initiative.

The following elements are being tracked:

·         Commitments by chemical or category of chemicals,

·         Commitments by companies or consortia of companies (with members listed),

·         Statistics on overall commitments

ICCA is in the process of making progress indicators available on the ICCA TS. The ICCA Working List already shows for which chemicals the OECD assessment has been completed, but this will have to be supplemented with information about the stage the assessment of the other chemicals has reached.

For access to the ICCA TS click on
http://www.iccahpv.com/

After assessment by the SIAM and endorsement of the assessment by the OECD Joint Meeting information generated by the ICCA HPV Chemicals Initiative will eventually be made available to the public on the United Nations Environment Programme (UNEP) website. The SIAPs are also available on the OECD Integrated HPV Database (http://cs3-hq.oecd.org/scripts/hpv/).

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