REACH Update: SIEF Tasks and Registration Requirements

By: Annelie Struessmann, PhD, CONUSBAT

Posted: June 10, 2009

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A prerequisite for the dossier preparation is the International Uniform Chemical Information Database (IUCLID) 5 software, which can be downloaded from the ECHA Web site.⁵ IUCLID 5 allows the user to enter, manage, store and exchange information on intrinsic and hazard properties of chemical substances. The software is compatible with various chemical legislation frameworks apart of REACH, such as the OECD High Production Volume Program. For a registration under REACH, the IUCLID 5 dossier must be submitted to ECHA via the REACH-IT platform.

Key Summary:
• More than 55,000 substances need to be registered by the first registration deadline of Dec. 1, 2010.
• The registration dossiers should be completed well before the respective registration deadline because of the specifics of the registration approval process.
• SIEFs have to complete more than ten different tasks until registration.
• Registrants must submit the technical registration dossier with information on intrinsic properties and classification and labeling jointly.
• The Joint Submission is done by the Lead Registrant.
• Separately and individually, other registrants submit  their company-specific administrative information.
• Upon agreement within the SIEF, the Chemical Safety Report (CSR) can also be jointly submitted.
• The requirements of the technical dossier are staggered depending on the tonnage manufactured or imported.
• The REACH Annexes VII–X specify physicochemical, toxicological and ecotoxicological datapoints that must be submitted for registration.
• Before new tests are carried out, all available in vitro, in vivo, historical human data, data from valid (Q)SARs and from structurally related substances (read: across approach) must be assessed.
• For the dossier preparation, IUCLID 5 software must be used.
• The submission of the dossier to ECHA is done via the REACH-IT platform.

Further questions? Go to C&T magazine online's REACH Round Table.

References
1. ECHA Second Stakeholders' Day, available at: http://echa.europa.eu/news/events/2nd_stakeholders_day_en.asp  (May 27, 2009)
2. CEFIC - Gantt chart on SIEF timing, available at: http://cefic.org/files/Downloads/gantt_chart_SIEF.xls
3. OECD Manual for investigation of HPV Chemicals, 2008; available at: http://www.oecd.org/dataoecd/39/6/41332719.pdf  
4. COMMISSION REGULATION (EC) No 134/2009; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:046:0003:0005:EN:PDF  
5. IUCLID 5 Software, available at: http://iuclid.echa.europa.eu/

Readers are reminded that the text of the REACH Regulation (EC) No 1907/2006 is the only authentic legal reference. The information in this column does not constitute legal advice.