REACH Update: Two Weeks Until Pre-registration
Posted: May 20, 2008
June 1, 2008, marks the day when the European Chemicals Agency (ECHA) will start managing all activities for the registration, evaluation, authorization and restriction of chemical substances in Europe. On that date, the pre-registration phase begins and ranges from June 1—Dec. 1, 2008.
Chemicals qualifying for pre-registration are currently marketed in the EU and meet the definition of phase-in substances. With pre-registration, these substances benefit from three extended registration deadlines, depending on their tonnage and hazardous properties. These deadlines are Nov. 30, 2010; May 31, 2013; and May 31, 2018.
Pre-registration only requires limited data and there is no fee associated. A pre-registration file for a substance needs to provide substance identity including EINECS number; CAS number and name of the substance; envisaged deadline and tonnage band for the registration; and the name and contact information of a contact person or third-party representative who will act as the contact point during data sharing. Also provided, when applicable, should be the substance identification of any relevant substances that may facilitate the risk assessment and data sharing of the substance.
A fee will apply for registration, and further costs for REACH will be present in the steps following pre-registration--from testing of substances, administration of SIEFs and consortia, to expert services such as legal, toxicologist, representative and so forth. The extension of the cost will mainly depend on the tonnage and the testing requirements and will range from several thousand Euros to more than one hundred thousand Euros per substance. Decisions for pre-registration and registration have to be based on careful considerations. However, according to the information given during the "REACH IT" workshop held in Brussels in February, pre-registration can be deactivated.
Several important information documents for pre-registration are still not available, including Annexes IV and V of the REACH regulation that contain the exemptions for substances where sufficient information is known or where registration is deemed inappropriate or unnecessary. After reviews, the commission will prepare amendments with the results of the reviews. Also, the ECHA guidance document on pre-registration is not yet available, and the interpretation of important aspects of the "only representative" is currently under revision. According to the information currently available, the review of Annex IV will be finalized by June 1, 2008.