Review country for the risk assessment of lead metal and lead compounds is the Netherlands
Date of Last Literature Search :
Review of report by MS Technical Experts finalised:
[insert month and year]
In response to a request from the European Commission to “start preparing the initial
assessments for substances on the EU working list as these were considered as Community priorities in the context of the industry voluntary initiatives for high production volume chemicals” the lead industry committed to undertake a Voluntary Risk Assessment (VRA) for lead metal, lead monoxide, lead tetraoxide, poly-basic lead fumerate, basic lead sulphate, basic lead carbonate, tetrabasic lead sulphate, dibasic lead phosphite, dibasic lead stearate, neutral lead stearate, dibasic lead phthalate, tetrabasic lead sulphate and basic lead sulphite. This initiative was endorsed by the EU Competent Authorities in 2001. Yearly summaries on progress were presented at the CA meetings.
This comprehensive VRA dossier took four years to draft before being submitted to the EU’s Technical Committee on New and Existing Substances (TCNES) for review, with the whole process managed by the Lead Development Association International. It was compiled in co-operation with expert consultants from EBRC and the International Lead Zinc Research Orgainisation for human health and from EURAS, ECOLAS and the Catholic University if Leuven for the environment. It is based on the principles of Regulation 793/93, 1488/94 and the detailed methodology laid down in the revised Technical Guidance Document on Risk Assessment for New and Existing Substances. Methodological experiences gained through other metal Risk Assessments were incorporated as appropriate. Additional up to date scientific information was integrated into the assessment where scientifically relevant. A broad cross section of the European lead industry and its downstream users were fully involved in the process and submitted a significant amount of proprietary data.
To ensure the transparency and quality of the dossier submitted to TCNES, the initial draft RA reports were refined by incorporating inputs from the Reviewing Country (Netherlands) and the independent peer review panels.
A single dossier covers the assessments for lead metal and the lead compounds, with
substance specific aspects provided where relevant. For the base data compilation, extensive literature searches were performed for each substance. Data gaps were filled with analogous data, where relevant, or by additional testing where possible. Where the information was either unnecessary for the lead risk assessment, or impossible to obtain, waiving for testing and/or justification to support derogation is discussed. Some remaining data gaps were identified and will be tackled as a follow-up to this report.
The draft risk assessment report was reviewed by TCNES between 2005 and 2008 and, based on the comments received, the report was significantly amended. Separate TCNES Opinions on the health and environmental parts of the report were prepared by the ECB and endorsed by TCNES. These Opinions summarise the views of TCNES on this report.
This Draft Risk Assessment Report and its appendices (the “Report”) is the property of the member companies of the Lead Reach Consortium companies. A full list of those companies is available upon request from the Lead Development Association International.
This Report is protected by the laws of copyrights in England and Wales, European Community Law, the Berne Convention the Universal Copyright Convention and other relevant international copyright.
Industries/companies or any other legal entity wishing to use all or any part of this Report and/or their appendices, for any purpose (including without limitation any regulatory purpose such as for EU REACH registrations) MAY NOT DO SO without having previously contacted the Lead Development Association International (acting as secretariat for the Lead Reach Consortium) and agreed in writing appropriate terms of access and paid the appropriate licence fee.
In order to avoid possible misinterpretations or misuse of the findings in this draft, anyone wishing to cite or quote any part of this report, or use its related appendices, is advised to contact Lead Development Association International beforehand.
Contact details of the responsible:
Dr Andy Bush, Lead Development Association International, 17a Welbeck Way, London, W1G 9YJ, United Kingdom. Tel +44 (0) 207 499 8422, email firstname.lastname@example.org