Substance Information Exchange Forums (SIEFs) are operational and critical for data-sharing and the subsequent preparation of joint registration dossiers. A SIEF is established when companies have agreed that their substance is the same. The time remaining to fulfill the tasks for a SIEF is short, especially for registrants needing to submit for the deadline of Dec. 1, 2010. According to the European Chemicals Agency (ECHA), this deadline accounts for more than 55,000 SIEFs, while 146,000 substances have been preregistered.1
Steps to take before registration include the following, and must be completed at least two months before the respective registration deadline due to registration approval specifics:1,2
▪ Identification of SIEF formation facilitator (SFF)
▪ Agreement on the sameness of the substance
▪ Selection of a lead registrant (LR)
▪ Agreement on operational rules for the SIEF and cost splitting
▪ Compilation and sharing of existing data
▪ Determination of data gaps
▪ Generation of new data; initiation of testing (Annex VII, VIII) or preparation of test proposals (Annexes IX, X)
▪ Preparation of Chemical Safety Report (CSR)
▪ Joint Submission (JS) and payment of the registration fee by the LR
▪ Acceptance of LR dossier by ECHA
▪ Submission of SIEF member dossiers
▪ Payment of registration fee by individual members
Registrants are required to jointly submit information on intrinsic properties of the substance, its classification and labeling, and, if applicable, on testing proposals. Contrary to the SFF, the selection of a LR is a provision of the REACH Regulation. The LR acts with the agreement of the other SIEF members and submits the joint registration dossier to the ECHA. Separately and individually, the other registrants submit their company-specific, administrative information on the following:
▪ The legal entity identity
▪ The substance identity
▪ Information on manufacture and on use(s) with tonnage
▪ Limited exposure information for quantities of 1-10 tonnes
If an agreement among SIEF members is reached, the CSR and guidance on safe use of the substance can also be jointly submitted. CSRs are required for registration bands of >10 tonnes and consist of an Exposure Scenario (ES), an exposure estimate and a risk characterization. For hazardous chemicals, the ES will have to be annexed to the SDS.
The technical dossier of the joint submission (JS) needs to be compiled, according to the requirements of the REACH Annexes VI– X. Annex VI disseminates the provisions of Article 10 (REACH) as information to be submitted for general registration purposes. The Annexes VII to X describe the requirements on physicochemical, toxicological and ecotoxicological studies and where detailed, robust summaries are demanded for key studies.3 The extent of the requirements depends on the tonnage of the substance to be registered as shown here:
▪ 1-10 tonnes; Annex VII
▪ 10-100 tonnes; Annex VII and VIII
▪ 100-1000 tonnes; Annex VII, VIII, IX
▪ >1000 tonnes; Annex VII, VIII, IX, X
Annex VII lists 14 physicochemical datapoints, from melting point to self-ignition temperature, and five toxicological and two ecotoxicological datapoints with specific adaptation rules based on the prerequisites of the substance properties. Annex VIII lists eight more toxicological and three more ecotoxicological datapoints with adaptation rules. Each following annex lists more datapoints that are all, according to the respective tonnage band, required additionally to the preceding annexes.
As laid down in Annex XI, before new tests are carried out to determine the properties listed in Annexes VII-X, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read: across approach) shall be assessed. Annex XI also ruled that testing may be omitted based on the exposure scenarios developed in the CSR. An amendment of the REACH Regulation addressing exposure-based waiving was published in February 2009.4 If further testing is required, consider for the dossiers preparation schedule that some tests may take up to 12 months.
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.
• 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.
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.