EMEA, European Medicine Evaluation Agency, regulates the drugs, biologicals and medical device for human and veterinary products. REACH, Registration, Evaluation, Authorisation and Restriction of Chemical, is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the chemical substances. The law entered into force on 1 June 2007.
The aim of REACH is to improve and protect human
health as well as environment through the better and earlier identification of
the harmful properties of chemical substances. REACH also works on encourage
innovation and competitiveness of the EU chemicals industry. The benefits
of the REACH system will come gradually, as more and more substances are
entered into REACH.
The REACH Regulation places control on industry
to manage the risks from chemicals and to provide safety information on the
chemical substances. Manufacturers and importers are required to submit the
information on the properties of their chemical substances, which include their
handling and to register the information in a central database run by the
European Chemicals Agency (ECHA) in Helsinki
The Regulation also demands for the advanced
replacement of the most dangerous chemicals with the suitable alternatives. One
of the main reasons for developing and adopting the REACH Regulation was that a
large number of substances have been manufactured and placed on the market in
Europe for many years, sometimes in very high amounts, and yet there is
insufficient information on the hazards that they pose to human health and the
environment. REACH regulations fulfil these information gaps to ensure that
industry is able to assess hazards and risks of the substances, and to identify
and implement the risk management measures to protect humans and the
environment from the chemical exposures.