Eu risk assessment

EU risk assessment - Lead metal and lead compounds title

European Union Risk Assessment Report

Lead metal

CAS No: 7439-92-1

EINECS No: [click here to insert EINECS No.]

Lead oxide

CAS No: 1317-36-8

EINECS No: [click here to insert EINECS No.]

Lead tetroxide

CAS No: 1314-41-6

EINECS No: [click here to insert EINECS No.]

Lead stabiliser compounds

Dibasic lead phthalate (CAS No: 69011-06-9)

Basic lead sulphate (CAS No: 12036-76-9)

Tribasic lead sulphate (CAS No: 12202-17-4)

Tetrabasic lead sulphate (CAS No: 12065-90-6)

Neutral lead stearate (CAS No: 1072-35-1)

Dibasic lead stearate (CAS No: 12578-12-0)

Dibasic lead phosphite (CAS No: 12141-20-7)

Polybasic lead fumarate (CAS No: 90268-59-0)

Basic lead carbonate (CAS No: 1319-46-6)

Basic lead sulphite (CAS No: 62229-08-7)

CAS No: [click here to insert CAS No.]

EINECS No: [click here to insert EINECS No.]

VOLUNTARY Risk Assessment

Lead Development Association International
Lead metal

CAS No: 7439-92-1

lead oxide

CAS No: 1317-36-8

Lead tetroxide

CAS No: 1314-41-6

lead stabiliser compounds

Dibasic lead phthalate (CAS No: 69011-06-9)

Basic lead sulphate (CAS No: 12036-76-9)

Tribasic lead sulphate (CAS No: 12202-17-4)

Tetrabasic lead sulphate (CAS No: 12065-90-6)

Neutral lead stearate (CAS No: 1072-35-1)

Dibasic lead stearate (CAS No: 12578-12-0)

Dibasic lead phosphite (CAS No: 12141-20-7)

Polybasic lead fumarate (CAS No: 90268-59-0)

Basic lead carbonate (CAS No: 1319-46-6)

Basic lead sulphite (CAS No: 62229-08-7)

EINECS No: [click here to insert EINECS No.]

ENVIRONMENTAL Risk Assessment

Environmental fate (section 3.1.4)

PEC derivation (section 3.1.5-3.1.9)

Draft of April 2008

This report has been prepared by EURAS, ECOLAS and KUL under contract to the

LDAI Lead Risk Assessment Working Group.

Scientific expertise:

Aquatic effects assessment, local exposure assessment, measured regional environmental data (water and sediment), background concentrations (water and sediment):

Patrick Van Sprang, Marleen Vandenbroele, Marnix Vangheluwe, Dagobert Heijerick & Frederik Verdonck

EURAS bvba

Kortrijksesteenweg 302

B-9000 Gent

Belgium

Tel.: ++32 9 241 77 45

Fax: ++32 9 241 77 02

[e-mail]

Terrestrial effects assessment, assessment of secondary poisoning (terrestrial part), measured regional environmental data (soil), background concentrations (soil):

Erik Smolders & Nadia Waegeneers

Katolieke Universiteit Leuven

Laboratory of Soil Fertility and Soil Biology

Kasteelpark Arenberg 20

B-3001 Heverlee

Belgium

Tel: ++32 16 32 96 77

Fax: ++32 16 32 19 97

[e-mail]

Regional/continental releases:

Annick Van Hyfte & Karen Callebaut

ECOLAS NV

Kortrijksesteenweg 302

B-9000 Gent

Belgium

Tel: ++ 32 9 241 77 28

Fax: ++ 32 9 241 77 01

[e-mail]
© Lead Development Association International
All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage or retrieval system without prior permission from the author. This copyright is protected under the law of England and Wales, European Community Law, the Berne Copyright Convention, the Universal Copyright Convention and other relevant international copyright law.

Review country for the risk assessment of lead metal and lead compounds is the Netherlands

Date of Last Literature Search :	[insert year]
Review of report by MS Technical Experts finalised:	[insert month and year]
Final report:	[insert year]

Foreword

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 [phone], email [e-mail]