REACH

Overview

Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) is a European Community Regulation (EC 1907/2006) that became effective on June 1, 2007.  It replaces a number of fragmented European directives and regulations within a single system.  The main objective of REACH is to improve the protection of human health and the environment through:

• collection and sharing of chemical substance data throughout supply chains, and
• authorization or restriction of chemicals of higher concern.

What distinguishes REACH from previous rules are:

• the burden placed on industry to manage the risks from chemicals that they manufacture/import and
• the elevated level of clout given to the administrators of REACH

Here is how the system will be administered:

• Manufacturers and importers will be required to gather information on the properties of their chemical substances and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki, Finland.
• ECHA will act as the central point in the REACH system --- it will manage the databases necessary to operate the system, coordinate the in-depth evaluation of suspicious chemicals, and run a public database in which consumers and professionals can find hazard information.

The ultimate driver for REACH is the authorization or restriction of substances. Substances of very high concern (SVHC) cannot be used or placed on the EU market without a specific authorization, granted from ECHA. In some circumstances restrictions will apply and some substances, based on their risks to humans and the environment, will be banned.

Impacts on U.S. Manufacturers/Exporters

REACH is expected to have world-wide impacts.  When it is fully in force, REACH will require all companies manufacturing/importing chemical substances into the European Union in quantities of one metric tonne (2,205 lbs.) or more per year (or substances already classified as dangerous over 100 tonnes per year) to register these substances with the European Chemicals Agency.  Because REACH applies to some substances that are contained in articles (e.g., autos, batteries, telephones), any company importing goods into Europe could be affected.

Potential registrants (i.e. manufacturers and importers of chemical substances) must “pre-register” these substances by December 1, 2008, in order to benefit from postponed “phase in” deadlines.  These deadlines depend on the classification and quantity of the substance supplied – the deadlines are set out in the timeline below as phases 1, 2 and 3.

Although pre-registering is not mandatory, it is free, and it is an important step in allowing potential registrants much more time before they have to fully register.

The registration process is based on the principle of “one substance, one registration” (OSOR). Consequently, all firms which pre-register the same substance will be encouraged to work together to register the substance which includes the sharing of data.

There are many exemptions from many or all of the provisions of REACH. Some substances being structurally simple and benign are exempted (and listed in the Annexes to the Regulation). Other chemicals or preparations already regulated are exempt from certain provisions such as those in medicinal products or in foods.

Table 1. REACH Timeline

Date	Action
June, 1, 2007	REACH became effective
June, 1, 2007	Pre-registration for existing (‘phase-in’) substances starts Registration for new (‘non phase-in’) substances starts
November 30, 2008	Pre-registration for ‘phase-in’ substances ends
December 1, 2008	Registration for existing substances (that have not been pre-registered) starts
January 1, 2009	List of pre-registered substances published and SIEFs are formed
June 1, 2009	First recommendation of priority substances to be considered for authorization published by ECHA
Phase 1 December 1, 2010	By this date the following pre-registered ‘phase-in’ substances should have been registered when supplied at: ≥ 1,000 tonnes per year (tpy) or; ≥ 100 tpy and classified under CHIP as very toxic to aquatic organisms or; ≥ 1 tpy and classified under CHIP as Cat 1 or 2 carcinogens, mutagens or reproductive toxicants
Phase 2 June 1, 2013	Deadline for registration of substances supplied at ≥ 100 tpa
Phase 3 June 1, 2018	Deadline for registration of substances supplied at ≥ 1 tpa

More Information

• REACH Guidance documents.  Guidance for industry on specific aspects of REACH.