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RAPID RESPONSE SERVICE - FREQUENTLY ASKED QUESTIONS ON REACH AND PRE-REGISTRATION

https://www.chemnet.com   Nov 24,2008
In addition to the questions highlight in the News Alert of 19 November (ECHA/PR/08/47) ECHA has identified further 7 commonly asked questions for which answers are already available on the ECHA website. During the first week, the rapid response service has answered almost 900 questions. This special service for pre-registrants will be available until 1 December.


1. Can I pre-register on paper, via e-mail or through the information request web forms on ECHA’s website?



Unfortunately, the European Chemicals Agency cannot accept pre-registrations on paper, by e-mail or through the information request web forms on ECHA’s website.



In accordance with Article 111 of Regulation (EC) No 1907/2006 the European Chemicals Agency specifies and makes available the formats that can be used by Member States, manufacturers, importers, distributors, or downstream users in their submissions to the Agency. The format for the submission of pre-registrations specified by the Agency is REACH-IT. Therefore, the only channel which can be used for pre-registering a phase-in substance is the REACH – IT system. REACH-IT is a web-based application.



To pre-register, you have to sign up to the REACH-IT portal on the ECHA website at:
http://echa.europa.eu/reachit/portal_en.asp



2. How do I pre-register a substance if I cannot find this substance in EINECS?



We advise you to first verify the phase-in status of your substance as defined in Article
3(20) of the REACH Regulation, since only phase-in substances can be pre-registered.



You can find more information on this issue in Section 1.7 of the Guidance on registration
http://reach.jrc.it/docs/guidance_document/registration_en.htm



In case your substance fulfils the definition of phase-in substance, you can pre-register it by using CAS number and CAS name or only its chemical name.



More information is available in Section 1.36 and 1.37 in the Pre-registration Q&A
document at
http://echa.europa.eu/doc/pre-registration/pre_reg_qa_en.pdf.



3. I manufacture and import the same substance. I signed up in REACH-IT as a company and pre-registered the tonnage of my substance I manufacture. How can I now pre-register the same substance as importer?



If your company consists only of one legal entity you shall sign up in REACH-IT only one time and when submitting the pre-registration add up the tonnages manufactured and imported when determining the tonnage band and the registration deadline.



In case you decide not to add up the tonnage of the manufactured and imported substance, you may sign up in REACH-IT as company twice. In that case it is not possible to use the same Legal Entity Object (LEO) having the same company UUID for multiple accounts, but you may use the same company identification information (name, VAT, address, etc.). You may consider adding a numerical or other identifier to your company name when signing up in REACH-IT, to facilitate the management of different legal entity accounts.



4. Do I have to pre-register a substance previously notified in accordance with
Directive 67/548/EEC by other manufacturers?



A notification under Directive 67/548/EC is nominal so that only the notifier benefits from being considered registered. Any other parties manufacturing or importing the substance but who have not notified it, do have (pre)registration obligations unless they may benefit from one of the exemptions in the REACH Regulation.



Previously notified substances are non-phase in substance under REACH. You do not need to pre-register them but you have to inquire and then submit a registration dossier as soon as the quantity of the substance manufactured or imported reaches 1 tonne per year.



For more information on notified substances we would like to refer you to section 6.3.6 of the Frequently Asked Questions on REACH: http://echa.europa.eu/reach/faq_en.asp



5. One of our pre-registration was submitted, but it is not on ECHA's intermediate list of pre-registered substances. Why?



We would like to clarify that the published list is only an intermediate list of pre-registered chemical substances. ECHA decided to release this intermediate list as an additional service to allow Downstream Users of chemicals a possibility to determine whether substances of their interest are already pre-registered. As required by Article 28 of the REACH Regulation the final list will be published by 01 January 2009. The list will comprise all phase-in substances pre-registered within the time period starting on 1 June 2008 and 01 December 2008.



Your substances might be missing from the intermediate list of pre-registered substances as some submissions required further examination by the Agency and potentially, clarification by companies.



6. Do I have to pre-register a substance that has already been pre-registered by another party?



In accordance with Art 6(1) of REACH, a registration shall be submitted to the Agency by all manufacturers or importers established in the European Community for all substances they manufacture or import in quantities of 1 tonne or more per year (unless they are explicitly exempted from the scope of registration by other provisions of the Regulation).



7. What documentation will I need to provide to the REACH Enforcement Authorities to prove my manufacturing/importation tonnage?



In accordance with Article 125 and Article 126 of the REACH Regulation the enforcement of the REACH Regulation lies in the remit of the Member States. Therefore we would suggest that you contact the relevant national authorities of your EU distributors:
http://echa.europa.eu/reach/helpdesk/nationalhelp_contact_en.asp

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