New EU chemicals regulation
The new EU chemicals regulation, REACH, requires that chemical substances on their own, in preparations and those which are intentionally released from articles have to be registered to the European Chemicals Agency (ECHA). REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on June 1st 2007 to streamline and improve the former legislative framework on chemicals of the EU. It replaces about 40 pieces of legislation with a streamlined and improved Regulation. The regulation applies to substances manufactured in, or imported to the EU in annual quantities of 1 tonne or more per company, unless the regulation indicates otherwise.
The obligation to register applies from June 1st 2008. The chemicals currently on the EU market which meet the definition of phase-in substances should be pre-registered between June 1st and December 1st 2008. Companies who pre-register their substances can benfit from extended registration deadlines. The deadline depends on the tonnage band and the hazardous properties of the substance. The deadlines are:
- 30 November 2010
- 31 May 2013 or
- 31 May 2018
Pre-registration requires only limited data and there is no fee associated to it.
When you start preparing for REACH you should first know what roles your company may have in relation to its substances. The following roles are relevant for pre-registration:
- Manufacturer / importer of substances
- Producer / importer of articles
- Only representative
- Downstream user
- Distributor
- Data holder
You need to know all chemical substances your company manufactures, imports and/or uses. Establishing this knowledge is a critical step in getting ready for REACH. You may compile your inventory using any solution that suits your company size, commercial activity and information systems.
A pre-registration can be only carried out electronically via the REACH-IT portal on the ECHA website, where you need to sign-up and create an account for your company. To ensure an easy submission of your files please ensure that you have all necessary information in hand before you enter the REACH-IT pre-registration module.
The REACH-IT module will allow a pre-registrant to see who else has pre-registered the same substance. The information is displayed on a substance specific pre-Substance Information Exchange Forum (SIEF) page. This page provides general information on the substance and company specific information.
Companies who have pre-registered a substance will automatically become listed on the pre-SIEF page of this substance. ECHA will publish by 1 January 2009, a list of pre-registered substances on its website. The list will comprise of all substances that have been pre-registered by 1 December 2008. A SIEF is a forum to share data and other information on a given substance. Participants in a SIEF are free to organize themselves in consortia or other forms of agreements.
When potential registrants in a SIEF have shared and assessed the available data they will prepare the common parts of their registration file, a so called joint submission. The other parts of their registration file will have to be submitted separately.
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