EU Regulatory Framework on Registration, Evaluation and Authorization of Chemicals (REACH)

Target

Improvement of the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry
Enterprises that manufacture or import more than one ton of a chemical substance per year will be required to register it in a central database, and to communicate and take adequate measures to control the identified risks
More information and communication through the supply chain
Evaluation of some substances by Member States
Authorization only for very high concern substances
REACH information requirements relate to production volumes, uses and properties of the chemicals

Feb 2001: White Paper published
May 2003: Internet consultation launched 20th May 2003, early notice to WTO Members
29 Oct 2003: Draft REACH regulation adopted by Commission
21 January 2004: Notified under the TBT Agreement (G/TBT/N/EEC/52)
Today: Still under discussion in European Parliament and Council of Ministers (still subject to modification)

Approximately 30 000 substances are estimated to be registered (including transported intermediates)
Many of these substances are manufactured and/or imported by more than one company, so there is the potential for many more registrations to be received only those substances manufactured or imported in volumes starting at 1 ton
It is not possible for the EC to provide a list of all substances
Substances exempted from the present legislation: Annex II reproduces the list of substances exempt from the obligation to register under the present Existing Substances Regulation (Reg.793/93). See also paragraph 2.1.4.
Substances that fulfill certain criteria: Annex III provides a more general list of criteria for exemptions from the obligation to register. The criteria in Annex III are taken from experience in the operation of the present New Substances Directive (Dir. 67/548/EEC)
The use of some substances regulated by other legislation are exempted (see Art. 4(1))
Substances manufactured or imported in volumes < 1 ton do not need to be registered
All substances of very high concern will be subject to authorization. Examples of substances that will be subject to authorization are:

All REACH provisions equally apply to EU and non-EU-producers and the system is expected to affect equally EU and non-EU producers in a completely non-discriminatory way
The current legislation distinguishes between so-called "existing" and "new" chemicals, based on the cut-off date of 1981. All chemicals that were put on the market before 1981 are called "existing" chemicals. In 1981, they numbered 100,106. Chemicals introduced after 1981 are termed "new" chemicals
Registration is the basis of REACH
Uses of substances in product- or process-oriented R&D do not need to be registered for up to 5 years, renewable for a further 5 years (For substances used in medicinal products, the maximum total exemption is 15 years)
The REACH threshold for registration (1 tonne/year) is much higher than the current 10 kg threshold for new substances
The costs of registering a new substance will be significantly lower than the current cost of notification
Registration will be quicker than the current notification, thus reducing the time to market
The requirements for authorization should encourage companies to increase their search for safer substitutes
The discrimination of new substances versus existing substances will come to an end

As a result of the position of SME's in the value-added chain, most chemicals will already be registered when they are utilized by downstream users
When assessing risks, manufacturers and importers must address the uses identified by downstream users
Cost reduction and a high level of chemical safety for down stream users
Downstream users who wish to keep their uses secret can choose to do their own risk assessments

Downstream users of chemicals will get relevant information on the safe use of each chemical substance they buy
Closer contacts with suppliers; ability to ensure better protection of workers
Safer products for consumers and the environment