European Union Risk Assessment Report


Date of Last Literature Search



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Date of Last Literature Search :

2006

Review of report by MS Technical Experts finalised:

April 2008

Final report:

June 2008


LEGAL NOTICE

Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which migh be made of the following information


A great deal of additional information on the European Union is available on the Internet.

It can be accessed through the Europa Server(http://europa.eu.int).


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 copper industry committed to undertake a Voluntary Risk Assessment (VRA) for copper and the copper compounds on the EU working list: Cu, CuO, Cu2O, CuSO4 and Cu2Cl(OH)3. This initiative was endorsed by the EU CAs in 2001. Yearly summaries on progress have been presented at the CA meeting.

This comprehensive VRA dossier has taken four years to complete, with the whole process managed by the European Copper Institute. It was compiled in co-operation with expert consultants from the University of Birmingham/ICON for human health toxicity, from BR. Stern and Associates for human health deficiency, and from Euras/Ecolas 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, e.g. the incorporation of bioavailability for zinc, were incorporated as appropriate. Additional up to date scientific information was integrated into the assessment where scientifically relevant (i.e. the use of bioavailability models for water, sediment and soil, plus information on copper as an essential nutrient). A broad cross section of the European copper industry has been fully involved in the process and has submitted a significant amount of proprietary data.
To ensure the transparency and quality of the dossier, the initial draft RA reports have been refined by incorporating inputs from the Review Country (Italy – Istituto Superiori di Sanità) and independent peer review panels.
For several of the substances under consideration, targeted risk assessments are required under the Biocidal Product Directive (98/8/EC) and the Plant Protection Products Directive (91/414). These dossiers, which have been/will be provided to the competent authorities (France) by the respective end user industry groups, contain confidential information not available to ECI. However, ECI has worked closely with both of these groups in incorporating relevant information to ensure consistency to the extent possible.

A single dossier covers the assessments for copper metal and the copper 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 copper 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.

Since the initial submission of the dossier on 15 May 2005, comments have been received from several Member States. The current version reflects comments made by the Member States in writing and during the TCNES meetings. To ensure the transparency and quality of the dossier, the current version and the responses to Member States comments have been refined in close co-oporation with the Review Country (Italy – Istituto Superiori di Sanità).
The human health and environmental sections of the report have been agreed by TCNES (see TCNES opinions) and sent to SCHER for final review.

This Draft Risk Assessment Report is the responsibility of the European Copper Insitute (ECI). The member companies of the copper industry risk assessment consortium are the owners of the assessment. These companies are listed below.

Industries/companies wishing to use all or part of the Risk Assessment Reports, and/or their appendices, for regulatory purposes such as for EU REACH registrations, EU Biocidal Products Directive Registrations, or EU Plant Protection Product Directive Registrations, are required to contact ECI to agree terms of access.
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 its related appendices, is advised to contact ECI beforehand.
Contact details of the responsible:

Dr. Katrien Delbeke, European Copper Insitute, Tervurenlaan 168, B-1150 Brussels, Belgium. Tel: +32 2 777 7083, e-mail: kmd @eurocopper.org



Ownership

The industry companies that are part of the industry consortium are listed here:









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