 REACH is a new European Union regulation concerning the registration, evaluation, authorisation and restriction of chemicals. It came into force on 1 June 2007 and replaces a number of European Directives and Regulations with a single system.
Some 30,000 chemicals currently in use (e.g. acids, metals, solvents, surfactants, glues) have to be pre-registered at the European Chemicals Agency (ECHA) between 1 June and 1 December 2008.
Aims of REACH
- To provide a high level of protection of human health and the environment from the use of chemicals.
- To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)
- To allow the free movement of substances on the EU market.
- To enhance innovation in and the competitiveness of the EU chemicals industry.
- To promote the use of alternative methods for the assessment of the hazardous properties of substances i.e. QSAR and read across.
A major part of REACH is the requirement for manufacturers or importers of substances to register them with a central European Chemicals Agency (ECHA). A registration package will be supported by a standard set of data on that substance. The amount of data required is proportionate to the amount of substance manufactured or supplied.
If you do not register your substances, then the data on them will not be available and as a result, you will no longer be able to manufacture or supply them legally, i.e. no data, no market!
Requirements
The new registration requirements cover substances supplied in quantities above one tonne per year. For substances of very high concern there is now an authorisation requirement.
Registration
A technical dossier and a chemical safety report will need to be prepared, recording a chemical safety assessment of the substance that is being registered.
For any one substance, a single set of information on its intrinsic properties is produced and can be shared by all those companies that manufacture or supply that substance. The companies will work together to get an agreement on information sharing through a Substance Information Exchange Forum (SIEF), the details of how this information is shared is the responsibility of the businesses involved.
Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.
The information contained in the chemical safety assessment must be passed down the supply chain, and all chemical safety assessments and registrations must be implemented and kept up to date.
Evaluation
There are two types of evaluation: dossier and substance. The new Chemicals Agency will carry out dossier evaluations, while competent authorities within member states will carry out substances evaluations.
Authorisation
Authorisation for substances of very high concern will be granted by competent authorities if the risks of a substance are under "adequate control". The industry will be required to make efforts to find safer substitute substances as part of the authorisation process.
Smaller businesses – many of the substances subject to REACH registration are supplied by smaller businesses. There are special provisions to help SME low tonnage suppliers, including reduced information requirements and delayed registration. For more information on REACH and to find out whether these regulations affect you, click here. |
