Ask Dr REACH: What information do I need to pre-register?
QUESTION: "What information is required for pre-registration of substances under REACH?" The questioner represents a multinational speciality chemicals firm based in Germany.
ANSWER:
For pre-registration, Article 28 of the REACH Regulation specifies the following data are needed:
(a) the name of the substance as specified in Section 2 of Annex VI, including its EINECS and CAS number or, if not available, any other identity codes;
(b) the registrant’s name and address and the name of the contact person and, where appropriate, the name and address of the [third party] representing him in accordance with Article 4 as specified in section 1 of Annex VI;
(c) the envisaged deadline for the registration and the tonnage and;
(d) the name(s) of substance(s) as specified in section 2 of Annex VI, including their EINECS and CAS number or, if not available, any other identity codes, for which the available information is relevant for the application of Sections 1.3 [on application of quantitative structure-activity relationship (QSAR) techniques] and 1.5 [on application of substance grouping and read-across techniques] of Annex XI.
RIP 3.4 gives some insights as to what information may be accessible to other companies (that have pre-registered). It is rather unclear what e-mail addresses will be used for different communications, especially as this may be made available to other pre-registrants. At this point it is important to consider using a ‘third party representative’ where anonymity may be desired – e.g. for confidentiality reasons.
It would seem that there are different ways to pre-register via the REACH IT system. Either you manually type in the substances (via EINECS, CAS number, name) or files are uploaded. We are waiting for the precise IT format for IUCLID5 to be made available as an add-on.
Companies are eagerly awaiting the final template for pre-registration data. It may be advisable, for flexibility, to include a few extra blank fields to any pre-registration database under development in case the REACH IT system allows extra data points to be entered.
Steffen Erler
Legal Disclaimer: The information contained in this communication follows a technical interpretation of REACH to serve as a thought-starter for discussions; it does not constitute legal or any other form of advice. Note that technical aspects are subject to review and references should be checked for updates. The legal text of the REACH Regulation must serve as the basis for REACH compliance and it may be advisable to seek legal and/or other expert advice on any given issue. The author and Chemical Watch accept no liability whatsoever with regard to the use of information contained in this communication.
Further information: http://echa.europa.eu/news/workshop_en.html
