Preparation for Pre-registration and SIEF Formation: Part 1
REACH offers extended registration deadlines for pre-registered substances. Pre-registration allows companies to continue manufacturing and importing their substances for several years until the registration deadline is reached. The pre-registration phase is from Jun. 1–Dec. 1, 2008; however, it applies only to phase-in substances that meet one of the following criteria:
- they are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
- they were manufactured but not placed on the market at least once within 15 years before REACH entered into force;
- they are no longer polymers according to Article 3(20)REACH.
The pre-registration can be submitted by the manufacturer or the importer of a substance and by the “only” representative of a noncommunity manufacturer. Third party representatives appointed by an EU-manufacturer or importer cannot submit the pre-registration, the manufacturer or importer is responsible for this and must indicate the contact detail of the third party representative in the pre-registration file.
The necessary information for pre-registration includes: substance name including the CAS and EINECS numbers or other identity codes; the name and address of the company and contact person; the envisaged registration deadline depending on tonnage band and nature of the substance; names of other substances that are relevant for quantitative structure-activity relationships (QSARS) or read across approaches.
After the pre-registration phase, the European Chemicals Agency will publish the list of pre-registered substances (in January 2009). This publication does not include the names of pre-registering companies. Companies will know the identity of other pre-registrants of the same substance through the IT system that will be provided for pre-registration.
All manufacturers, importers or "only" representatives that have submitted pre-registration information on the same substance will automatically become participants in the same substance information exchange forum (SIEF). For those EU manufacturers or importers that have appointed a third party representative, this representative will participate in the SIEFs.
REACH-IT is a project that is to deliver the IT for all SIEF procedures and for all further IT tools, which will enable all parties involved in the REACH process to collect, export, submit, receive, evaluate, further treat and view information on chemical substances under the proposed REACH legislation. IUCLID 5 is the software that will normally be used for data collection and dossier preparation.
Key Summary:
- Pre-registration allows companies to continue manufacturing and importing their substances for several years
- Only phase-in substances can be pre-registered
- The information requested for pre-registration is limited, no agency fees apply
Annelie Struessmann, PhD
CONUSBAT
Aachen, Germany
To send the author an inquiry about REACH, contact: [email protected].
