REACH - the new EU Regulation for Chemicals
Are you getting ready for REACH? The EU's new regulatory regime for chemicals entered into force on 1 June 2007. The Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation impose significant new duties on the producers, importers and downstream users of chemicals. In the future, chemicals will only be available for specific uses for which an appropriate risk assessment has been undertaken and where suitable measures are in place to protect both people and the environment.
Register here to stay informed of IOM's REACH seminars and services. There is more information on our Wake up to REACH page.
- ECHA's NAVIGATOR Tool (Sept 2007)
- Guidance available from the ECHA (updated March 2008)
- Latest guidance available and draft Fees Regulation (Feb 2008)
Registration, Chemical Risk Assessment, Exposure Scenarios and more
Producers and importers need to register each chemical that they supply for specified purposes. Safety data sheets must have the standard health and safety information for the chemical and a description of the specified uses.
The mandatory Chemical Safety Assessment - CSA - must address the human health and environmental hazards associated with the substance.
The regulation outlines the toxicological and human health data that are required for the assessment. These data are to be used to develop Derived No Effects Levels (DNELs) for human health effects and Predicted no Effect Concentrations (PNECs) for environmental effects.
Exposure scenarios that arise during manufacture of the chemical and during the specified uses must be described and levels of exposure assessed. It is not yet clear how scenarios should be defined, but further guidance is currently being developed.
The chemical risk assessment must demonstrate that exposures remain below the DNELs. Authorisation will need to be sought for specified uses for chemicals that the new European Chemicals Agency identifies as being of very high concern such as carcinogens, mutagens, reproductive toxins or are very persistent or bioaccumulative. For substances such as some carcinogens, where there is no threshold for effects, authorisation of specified uses will require a social and economic analysis to demonstrate that the risks are adequately managed. Suppliers will also be forced to explore the use of substitute chemicals.
Downstream users who use chemicals in manufacturing their products, for cleaning or other purposes, will need to be sure that the chemicals they use are registered for their uses. If their supplier decides not to register a chemical for that specific use, they may wish consider seeking registration as a downstream user. The data requirements will be the same as for suppliers but the application will be narrower.
How IOM Consulting can help you... Tailored Consultancy for REACH
We can help you find a way through these complex regulations by:
- Reviewing what implications REACH may have for your particular business;
- Providing guidance on how to ensure compliance that is specifically tailored for SMEs as well as providing services to major suppliers or users of chemicals;
- Helping to identify and characterise relevant exposure scenarios;
- Undertaking exposure modelling and/or measurement to inform the risk assessment process;
- Reviewing the available toxicological, exposure and human health information and its suitability for inclusion in the risk assessment process;
- Deriving DNELs and undertaking appropriate risk assessment
- Assisting in the development of substitution plans and the analysis of alternatives to support applications for authorisations; and
- Advising on data gaps and helping you fill them
Some Technical guidance is now available and the rest is expected before the end of 2007 and we can help you through this new regulatory process even as REACH comes into force. We have already reviewed human health and toxicological information and exposure data for major actors in the metals industry and advised on the likely additional requirements of REACH. We are actively involved in collecting exposure data for the petrochemical industry and the metals industry in preparation for REACH. We are also involved in the development of appropriate generic models and databases to assist exposure assessment for a wide range of chemicals and in the preparation of guidance under the REACH Implementation Programmes (RIP).
IOM has extensive experience supporting industry associations through the Existing Substances risk assessment process that preceded REACH. This experience remains highly relevant and has included:
- measurement surveys of workplace exposure in various industries;
- reviews of toxicological data where the evidence for adverse effects was equivocal;
- developing and improving models for the prediction of workplace exposure by inhalation or skin contact.
