What is REACH?
The European Commission has developed a new EU Chemicals Policy, REACH [Registration, Evaluation, and Authorisation of Chemicals], that replaces in a single regulation the current EU legislation (ie. Existing Substances Regulation [ESR], Notification of new Substances [NONS], and Marketing and Use Directive) for supply of chemicals to the EU market. It came into force in June 2007.
REACH requires Member States of the European Union to appoint competent authorities to manage the domestic aspects of the legislation, and to liaise with European Chemicals Agency (ECHA). In the UK, the Competent Authority is the Health and Safety Executive (HSE), working with the Environment Agency and other government departments. HSE has set up a helpdesk to support UK business in the run-up to REACH coming into force, which can be accessed by phone on 0845 408 9575 or by email to UKreachca@hse.gsi.gov. The HSE also has a REACH information page on its website, where has published fact sheets on REACH which are free to download. It has also recently added case studies designed to help stakeholders understand how they might fit into REACH, by reflecting the experience of the types of questions asked of the CA helpdesk.
The new regulation requires:
Registration of chemical substances manufactured or imported and associated requirements for information and communication in the supply chain;
Evaluation of the information supplied and safety in use of selected substances by Member States [MSs];
Authorisation for CHemicals of high concern, based on health (eg. carcinogens and mutagens) or environmental hazards (eg. persistent and bioaccumulative);
Restrictions at EU-level triggered by other concerns;
A centralised European agency (in Helsinki) to manage the system.
REACH introduces some fundamental changes from the current legislation. There is a new responsibility for manufacturing companies (and those importing into the EU) to demonstrate that the substances they produce can be used safely both on their own premises and by their customers (called Downstream Users [DUs]), throughout the entire life cycle of the substance. The principle is 'no data, no market'.
One of the main objectives of the new legislation is that dangerous substances (manufactured or imported in quantities above a certain tonnage) will have to be used under demonstrated safe conditions for workers, consumers and the environment. This requires a chemical safety report [CSR] to be prepared and identification of appropriate Risk Management Measures [RMM] by the manufacturer or importer [M/I]. Hazard assessment of the chemical and identification of Exposure Scenarios [ES] are essential elements in complying with these requirements. For REACH, the term 'Exposure Scenario' is currently defined as "the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment". The ES in essence contains practical handling guidance for the substance.
A number of REACH Implementation Projects [RIPs] are currently underway and through one of these, the Commission is developing the general framework of ESs and guidance on the implementation in practice. This requires an interaction between M/Is and DUs to understand in full how the substance under consideration is used and what RMMs are, or should be, in place. This is an essential step to produce effective and transparent ESs and to assist with their successful implementation. The resulting ESs will be communicated to DUs as appendices to the safety data sheet.
Many other organisations in addition to BOHS and HSE have useful websites on REACH, some of which are listed below. Please note that BOHS can not be held in any way responsible for the content of any of these.
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REACH and the existing health and safety at work legislation
REACH is not intended to change any of the existing provisions such as the Chemical Agents Directive [CAD] and the Carcinogens Directive, or the COSHH regulations in the UK. However, there is a requirement for DUs to comply with the RMMs recommended in the ESs by the M/I/supplier, as a minimum. This may cause difficulty for the chemical user in interpreting the RMMs to take into account site specific considerations associated with their process or operation. There is an obvious overlap between the duties under COSHH to assess risks to health and apply Principles of Good Control Practice, and the production of ESs and RMMs under REACH. Further consideration and guidance may be needed on how these legislative arrangements will work in tandem.
REACH will be applied progressively, starting with the most hazardous (carcinogens, mutagens, reprotoxins) and the greatest tonnage on the EU market, so that it will be some years before it is fully applied. However, as the most hazardous materials have to be registered within three years of the entry into force of the legislation, there will be a need for work on ESs for these materials in the near future.
In addition, REACH (at least in its current form) does not cover health issues such as process-generated hazards (eg. welding fume, wood dust) so that even when fully in force it will not cover all workplace health concerns.
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The role for Occupational Hygienists
The role of BOHS