REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals. It came into force on 1st June 2007 and replaced a number of European Directives and Regulations with a single system.
The Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) is based on the United Nations’ Globally Harmonised System (GHS) and its purpose is to ensure a high level of protection of health and the environment, as well as the free movement of substances, mixtures and articles.
Scope and exemptions:
REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne or more per year. Generally, it applies to all individual chemical substances on their own, in preparations or in articles (if the substance is intended to be released during normal and reasonably foreseeable conditions of use from an article).
Some substances are specifically excluded:
- Radioactive substances
- Substances under customs supervision
- The transport of substances
- Non-isolated intermediates
- Waste
- Some naturally occurring low-hazard substances
Some substances, covered by more specific legislation, have tailored provisions, including:
- Human and veterinary medicines
- Food and foodstuff additives
- Plant protection products and biocides
Other substances have tailored provisions within the REACH legislation, as long they are used in specified conditions:
- Isolated intermediates
- Substances used for research and development
Manufacturers/Importers:
Businesses that manufacture or import (from outside the EU) 1 tonne or more of any given substance each year are responsible for registering a dossier of information about that substance with the European Chemicals Agency. Because substances in articles also count (if these substances are intended to be released during use), it’s possible that some manufacturers/importers of such articles will be registrants.
The registrant directs downstream users in the appropriate risk management measures for any particular use of the substance and responds to other actors on other aspects of REACH. Registrants of phase-in substances should have pre-registered them between 1st June and 30th November 2008 to benefit from the phased registration deadlines. Late pre-registration is now only available to first time importers/manufacturers.
Downstream users:
Downstream users include any business using chemicals, which probably includes most businesses in some way. Companies that use chemicals have a duty to use them in a safe way, and according to the information on risk management measures that should be passed down the supply chain. There is also an opportunity to pass information about use back to registrants so that this can be taken account of when assessing the risks of chemical used.
Downstream users may need to supply risk assessment and risk management measures to the European Chemicals Agency if they don’t want their supplier to know about how they use the chemicals. Some users may also be importers and have a duty to register.