Guidance documents

1. This section contains all the relevant guidance documents developed by Eurometaux, the Nickel Consortia and ECHA.

This includes general guidance documents to help DU read and understand the GES, how to demonstrate compliance, and obligation of DU under REACH. Also included here are Ni specific guidance documents for assessing site specific environmental and occupational exposure.

 

Guidance drafted by Eurometaux

• Exposure Scenario Guidance for DU-mmies (Version 1-May 2011)
  

This guidance is intended for DU of chemical substances and all other persons who will have to read a generic exposure scenario (GES) to check whether it covers their uses. It explains all the relevant sections of the GES, while providing general and metal specific tips on how to check compliance.

 

Guidance drafted by the Nickel REACH Consortia

• Particle size distribution and speciation guidance

This guidance document is for helping companies assess their compliance with the GES for workers. It provides the proper guidance for companies that wish to incorporate site-specific data on particle size distribution and/or chemical composition of the workplace nickel exposure into the description of the site-specific exposure scenario. 

• Tiered approach for site-specific exposure assessment of Ni in the environment (Version 1, 2011)

This guidance helps companies assess their compliance with the GES for the environment. It illustrates a tiered approach and provides the proper tools to scale the GES to site-specific conditions. Practical examples are provided with a focus on the freshwater compartment, the driver of the environmental section of the GES.  

• Indirect exposure of Ni to Man Via the Environment

This guidance helps companies assess their compliance with local air exposure concentrations at neighbouring populations to the site. A tiered approach is presented for determining local predicted air concentrations, starting from the application of a generic tools (DU Scaling tool) to more site-specific refined tools.   

 

Guidance and fact sheets drafted by ECHA

Click here to access the ECHA website section and banner for Downstream Users (available in 22 EU languages)

• ECHA Guidance for Downstream Users (January 2008)

This document provides guidance on the requirements of DU under REACH. It provides to DU its roles and obligations under REACH, while also providing guidance on a range of REACH processes, including some technical methods that DU can make use of.    

• Guidance factsheet for Downstream users (April 2008)

This document summarises key aspects of the Downstream Users Guidance (above).

• Fact Sheet on Safety Data Sheets and Exposure Scenarios

This fact sheet documents the obligations of DU concerning specifically the safety data sheets and compliance with the exposure scenarios. Additional links for more information and support from ECHA are provided.  

 

Nickel environmental risk assessment fact sheets

These fact sheets are specific to the environmental section of the European Union’s Existing Substances Risk Assessment of Nickel (EU RA). They are intended to assist the reader in understanding the complex environmental issues and concepts presented in the EU RA by summarizing key technical information and providing guidance for implementation. The environmental sections of the REACH dossiers (effects assessment and exposure and risk characterization) are based on information in the EU RA. Currently, five fact sheets are available for the following topics:

1. Data Compilation, Selection, and Derivation of PNEC values for the Freshwater Compartment
2. Data Compilation, Selection, and Derivation of PNEC values for the Soil Compartment 
3. Data Compilation, Selection, and Derivation of PNEC values for the Marine Aquatic Compartment 
4. Incorporation of Bioavailability in the Aquatic Compartment 
5. Incorporation of Bioavailability in the Terrestrial Compartment