REACH update from IOM
Guidance available from the ECHA
The European Chemical Agency has published Guidance on REACH that is intended to assist businesses in their preparations for REACH
Links to the guidance available as of September 2008 are provided below:
For further information on how IOM can assist you and your business with REACH, visit REACH at IOM and ECHA guidance on REACH
- Identifying and naming substances
- Pre-registration – not yet published, but Chapter 3 in the guidance on Data Sharing addresses pre-registration.
- Registration (updated 24 September 2008)
Part 1: Registration tasks and obligations; Part 2: Preparation of the Registration Dossier. - Information requirements and chemical assessment (updated 29 May 2008)
- Downstream Users (Published Jan 2008)
- Data Sharing
- Monomers and Polymers (updated 29 May 2008)
- SR&D and PPORD (updated 18 Feb 2008)
(Specific provisions for substances manufactured, imported or used in scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD)). - Substances in articles
Identification of producers and importers’ obligations. - Intermediates (updated 18 Feb 2008)
- Classification, Packaging & Labelling substances and mixtures – not yet published
- Classification and Labelling notification – not yet published
- Preparing the Chemical Safety Report
- IUCLID (International Uniform Chemical Information Database - version 5)
How to use the IT system that underpins REACH to prepare dossiers. - Preparing an application for authorisation – not yet published
How to prepare an application for authorisation of use of substances identified as being of very high concern by the ECHA includes the analysis of alternatives, development of a substitution plan and how third parties may prepare and submit information on alternatives. - Socio-economic impact analysis (relevant to applying for authorisation) – not yet published
- Frequently Asked Questions (updated 11 June 2008)
Covers FAQs concerning REACH, the guidance documents and the Agency. - Frequently Asked Questions on Fee regulation(updated 8 August 2008)
Covers FAQs relating to invoices and payments in REACH-IT and technical issues.
The European Chemical Agency is also developing and publishing Guidance on REACH to assist competent authorities in their roles. Business may wish to refer to this guidance in order to inform their preparations for REACH:
- Priority setting for evaluation (updated 11 August 2008)
Guidance for the Agency and the Member States Competent Authorities on prioritising of dossiers, testing proposals or substances for evaluation. - Dossier & Substance Evaluation
Evaluation tasks to be performed by the Authorities. - Harmonised Classification and Labelling
How Member States Competent Authorities can prepare a dossier for a Harmonised Classification and Labelling proposal. - Identifying substances of very high concern
How the authorities can prepare an Annex XV dossier to identify a substance of very high concern. - Annex XIV (Substances subject to authorisation) (updated 11 August 2008)
How the authorities will decide if a substance of very high concern should be subject to authorisation. - Restrictions (updated 5 May 2008)
How the authorities can prepare an Annex XV dossier to propose a restriction under REACH.
The European Chemicals Agency has also published several Fact Sheets. These Fact Sheets provide a structured overview of the REACH Guidance documents published by the Agency. The following Fact Sheets are available:
- Substance Identification
- Downstream Users
- Requirements for substance in articles
- Data Sharing
- Registration
- Information Requirements and Chemical Safety Assessment (Part A, introduction to the guidance document)
- Information Requirements and Chemical Safety Assessment (Part D, Exposure Scenario Building)