(Extract from ECHA, Guidance in a nutshell, Registration data and dossier handling, 2009)
REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. The European Chemicals Agency (ECHA) administers the scheme. REACH places the responsibility on industry to manage the risks that chemicals may pose to human health and the environment. All manufacturers and importers of chemical substances, whether neat, components of chemical mixtures or incorporated into produced articles from which they can be released, must identify and manage risks linked to the substances they manufacture and market and provide appropriate safety information down the supply chain to their users. Therefore, manufactures or importers have to collect or generate data on their substances and assess how risks to human health and the environment can be controlled by applying and recommending suitable risk management measures. To this end, so-called exposure scenarios need to be developed in certain cases and communicated in an annex to the safety data sheet in order to enable actors down the supply chain to comply with the conditions for safe use set out in them. The summary of the collected data and the corresponding chemical safety assessment (including exposure scenarios, if applicable) is required to be submitted to ECHA in a registration dossier.
There are two key central concepts in REACH that go beyond the former chemical control schemes:
The basic definition of a substance is a very broad one which includes not only potentially hazardous industrial chemicals, but every type of chemical substance manufactured in or imported into the EEA. It therefore also includes substances which are already closely regulated by other legislation or which typically cause no or only minimal risk to human health and the environment. For these and other reasons there are some complete or partial exemptions from REACH requirements, e.g. for: radioactive substances; intermediates; waste; substances used in medicinal products, food or feedingstuffs; substances in Annex IV and V; polymers; etc.
Unless explicitly exempted from its scope, REACH requires registration substances with ECHA if they are manufactured or imported at 1 tonne per year or more by submission of a dossier including physicochemical, toxicological and ecotoxicological information. As of 1 June 2008, new substances (so-called ‘non-phase-in’ substances) have to be registered before being manufactured or imported, but substances that are already on the EEA market (i.e. ‘phase-in’ substances that have been ‘pre-registered’) benefit from transitional arrangements that allow them to be registered by set deadlines depending on their tonnage and/or hazardous properties (i.e. CMRs or R50/53). The deadlines are presented in figure below.