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.
Pre-registration has to be carried out electronically on the REACH-IT portal of the ECHA Web site. The portal will be launched by June 1, 2008. The three options for submission are online pre-registration, by manually compiling the data required on the REACH-IT portal; IUCLID 5 pre-registration, by entering substance data in IUCLID 5; and XML pre-registration, by entering substance data in an IT system that creates an extensible mark-up language (XML) file in the required format. For pre-registrants, submitting information on only a few substances that are not currently using IUCLID 5, an on-line pre-registration via REACH-IT may be the preferred option. For companies pre-registering many substances, the plug-in or the XML options may be most practical as they allow the submission of pre-registration information of several substances in one single file.
The first step is to create an account for the company, either directly in REACH-IT or by uploading it from IUCLID 5. To do so, the company needs to supply a company ID, invoicing information for use during registration and the contact persons within the company.
The first user of a company who signs up becomes the account manager of the company in REACH-IT, but additional user accounts can be created. The substance data file for pre-registration can be prepared either by manually compiling the data required or by entering the substance data in the IUCLID 5 pre-registration plug-in, or in the XML pre-registration file. The links for the software downloads are given below. It is important, however, that before submission of a pre-registration, the reviewed annexes and other information newly published by the ECHA be carefully read.
Key Summary:
• On June 1, 2008, the ECHA will start managing all activities for registration, evaluation, authorization and restriction of chemical substances in Europe.
• The pre-registration phase is June 1—Dec. 1, 2008.
• Pre-registration requires limited information and no fee applies.
• A fee will apply for regular registration.
• Further costs for REACH will derive from testing of substances, administration of SIEFs and consortia and experts' services.
• Pre-registration can be deactivated.
• Several important information documents for pre-registration are still not available, including Annexes IV and V.
• Pre-registration has to be carried out electronically on the REACH-IT portal.
• The portal will be launched by June 1, 2008.
• The three options for pre-registration are REACH-IT Online, IUCLID 5 and XML.
• The first step is to create an account for a company.
• The IUCLID 5 pre-registration plug-in and the XML pre-registration software are already available.
• Before submission of a pre-registration, the reviewed annexes and other information newly published by the ECHA should be carefully read.
Next months’ topic: Pre-SIEFS, SIEFs and Actual Status for Consortia Formation
Further questions?
Go to C&T Online's REACH Round Table
Additional Useful Information
Pre-registration Guide (hands-on guide):
https://echa.europa.eu/doc/pre-registration/080403%20ECHA-08-B-01-EN_PracticalSteps-web.pdf
New Guidance Documents on REACH:
Guidance on registration (update)--April 29, 2008
Guidance on Socio-Economic Analysis - Restrictions (update)--May 13, 2008
REACH IT Workshop, Brussels:
http://ec.europa.eu/enterprise/reach/events_en.htm
IUCLID 5 Pre-registration Plug-in:
http://ecbwbiu5.jrc.it/index.php?fuseaction=home.preregistrationPlugin&type=public
Pre-Registration XML Format:
http://ecbwbiu5.jrc.it/index.php?fuseaction=home.preregistrationFormat&type=public
Readers are reminded that the text of the REACH Regulation (EC) No 1907/2006 is the only authentic legal reference. The information in this document does not constitute legal advice.
-Annelie Struessmann, PhD
CONUSBAT
