What is REACH?
REACH stands for Registration, Evaluation, and Authorisation of Chemicals. It is the new EU Chemical legislation which came into force on 1 June 2007. The aim of REACH is to improve the protection of human health and the environment by identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. TEPPFA plays a coordinating role in preparing its industry members for the legislation.
The European Commission’s (EC) White Paper of 2001 on a ‘future chemical strategy’ proposed a system that requires chemicals manufactured in quantities of greater than 1 tonne to be ‘registered’, those manufactured in quantities greater than 100 tonnes to be ‘evaluated’, and certain substances of high concern (for example carcinogenic, mutagenic and toxic to reproduction - CMR’s) to be ‘authorised’.
The EC adopted its proposal for a new scheme to manage the manufacture, importation and supply of chemicals in Europe on in October 2003. This proposal eventually became law once the European Parliament officially approved its final text of REACH. It came into force on 1 June 2007.
A requirement is to collect, collate and submit data to the European Chemicals Agency (ECHA) on the hazardous properties of all substances (except Polymers and non-isolated intermediates) manufactured or imported into the EU in quantities above 1 tonne per year. Certain substances of high concern, such as carcinogenic, mutagenic and reproductive toxic substances (CMRs) will have to be authorised.
Chemicals will be registered in three phases according to the tonnage of the substance:
More than 1000 tonnes a year, or substances of highest concern, must be registered in the first 3 years;
100-1000 tonnes a year must be registered in the first 6 years;
1-100 tonnes a year must be registered in the first 11 years.
In addition, industry should prepare risk assessments and provide controls measures for using the substance safely to downstream users.
Evaluation provides a means for the authorities to require registrants, and in very limited cases downstream users, to provide further information.
There are two types of evaluation: dossier evaluation and substance evaluation:
Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are avoided, and to check the compliance of registration dossier with the registration requirements.
The relevant authorities perform substance evaluation when there is a reason to suspect that a substance presents a risk to human health or the environment (e.g. because of its structural similarity to another substance). Therefore, all registration dossiers submitted for a substance are examined together and any other available information is taken into account.
The REACH proposal sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorisation requirement.
This authorisation requirement ensures that risks from the use of such substances are either adequately controlled or justified by socio-economic grounds, having taken into account the available information on alternative substances or processes.
The Regulation enable restrictions of use to be introduced across the European Community where this is shown to be necessary. Member States or the Commission may prepare such proposals.
Manufactures and/or importers should develop risk reduction measures for all known uses of the chemical including downstream uses. Downstream users such as plastic pipe producers should provide detail of their uses to their suppliers. In cases where downstream users decide not to disclose this information, they need to have their own CSR.
European Chemicals Agency
The European Chemicals Agency (ECHA) is managing the technical and administrative aspects of the REACH system at Community level. The Agency, located in Helsinki, is the central coordinating body and will be operational in 2008.
REACH Key Dates: