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REACH Update: SIEF Tasks and Registration Requirements
By: Annelie Struessmann, PhD, CONUSBAT
Posted: June 10, 2009
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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.