REACH is intended to replace the current system in which chemical substances are covered by a patchwork of different directives and regulations. The regulation applies to manufacturers, importers, distributors and downstream users.
REACH came into force in June 2007 and the registration process will take place over a period of 11 years. The final deadline is 1 June 2018.
REACH applies a common system for new and for existing substances. Under this system the burden of proof for evaluating substances is transferred from the authorities to industry.
REACH does not apply to all substances and there are partial or complete exemptions provided, e.g. for wastes or radioactive materials, which are covered under other legislation. Exemptions are also provided for materials that inherently pose minimal risk or where it is considered that registration would be inappropriate or unnecessary.
The main requirements under REACH are summarised below.
Manufacturers and importers must register substances, in accordance with the timetable set out for existing substances, or prior to being placed on the market for new substances. For quantities >1 tonne, a technical dossier must be prepared. For quantities >10 tonnes, a chemical safety report is required.
The European Chemical Agency (ECHA) and/or the Health and Safety Authority (HSA) evaluate the data provided during the registration process and may authorise or restrict materials based on their findings.
This is required for the use or placing on the market of substances of very high concern (i.e. carcinogens, mutagens and materials classes as toxic for reproduction (CMR); materials that are persistent, bioaccumulative and toxic (PBT); and materials that are very persistent and very bioaccumulative (vPvB)), as well as materials that are potentially dangerous to health or the environment and used in dispersive form.
The authorities will prepare a list of substances requiring authorisation. For materials on this list, a separate authorisation is required for each use. Restrictions may be placed on the manufacture, placing on the market or use of certain substances where there is an unacceptable risk to health or the environment. If necessary, the authorities can place a prohibition on these activities.
Most companies using chemicals will qualify under the REACH regulation as a downstream user of registered substances. As the downstream user, a company must demonstrate that the substances are used in a safe manner.
Byrne Ó Cléirigh provides comprehensive consultation and advice on REACH and its implications for chemical substances in industry.