Data Submission Manual 5: How to complete a - ECHA - Europa

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Data Submission Manual Figure 34: "Annex 1" status - Classification entry fields If the field "Status" indicates "67/548/EEC self classification" or "other:" then information must be provided for all the endpoints (Figure 35). Figure 35: "Self classification" or "Other" status - Classification entry fields and reason for not classifying Version: 3.1 38
Part 05 - How to complete a technical dossier for registrations a PPORD notifications 4.2.3.2. Labelling for section 2.2 Release date: February 2013 39 If at least one classification has been indicated for an endpoint, then at least one "Risk phrase" must be indicated. A "Safety phrase" should also normally be provided in this case (Figure 36). Figure 36: Risk phrases For dossiers of isolated intermediates, this "Labelling" block will not be checked for completeness. 4.2.4. Section 2.3 – PBT assessment Section 2.3 on the PBT assessment is a new section that has been introduced in IUCLID 5.4. It consists of an endpoint summary, and endpoint study records. Although the new fields related to the PBT assessment are not currently subject to TCC, registrants of tonnages above 10 tonnes are encouraged to complete them already now in the best possible manner with information from the CSR. This way you may avoid updating your dossier at a later stage. If you are required to provide a CSR, then in order for your dossier to be accepted for processing, i.e. pass the Business Rules check, at least an endpoint summary has to be created (by right clicking on the section number) and a choice has to be made in the drop-down list "PBT assessment: overall result". If "PBT assessment does not apply" is selected, a justification should be provided in the free text field. PBT assessment is currently not subject to TCC. The above rule applies also to member registrants who are required a CSR and for whom the lead is not providing it on their behalf. 4.3. Section 3 - Manufacture, use and exposure This chapter contains information on how to provide data in IUCLID 5 on the technological processes used, estimated quantities, site(s), information on mixtures, life cycle description, uses advised against and exposure. Each topic will be presented in a separate chapter.
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EUROPEAN CHEMICALS AGENCY ANNANKATU
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Data Submission Manual 5: How to complete a - ECHA - Europa

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