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

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Data Submission Manual 4.3.3. Section 3.3 - Sites As specified in section 1.1.3 of Annex VI of REACH, the location of the registrant’s production and own use site(s) must be provided, as appropriate. To provide a site, a new block should be created in section 3.3 by clicking on the green cross button (Figure 39). Every created site block must have a site linked to it. To do so one should click on the chain button (Figure 39). Figure 39: Site entry field Each created site block must be complete, i.e. contain a linked site with a complete contact address. The following fields in the Contact address must be filled in: "Site name", "Address", "Postal code", "Town" and "Country" (Figure 40). Figure 40: Contact address Version: 3.1 42
Part 05 - How to complete a technical dossier for registrations a PPORD notifications Release date: February 2013 43 In addition, for all registration dossiers, if "Sites" is provided, then each site must be linked under "Manufacture/own use(s)" in section 3.3 to at least one use identified in section 3.5. Only uses reported in the tables "Manufacture", "Formulation" and "Uses at industrial sites" can be related to a site (Figure 41). If you indicated in IUCLID 5 section 1.1 that your "Role in the supply chain" is (also) "Manufacturer", then you must provide at least one site related to the manufacture of the substance in section 3.3. To indicate a site as manufacture site, you must create a link from "Manufacture/own use(s)" to at least one reported manufacture in the table "Manufacture" of section 3.5. Links to the table "Manufacture" are identified with the letter "M" (Figure 41). Figure 41: Linking the uses If the box "Manufacturer" is ticked in IUCLID 5 section 1.1 "Identification", then at least one manufacture site must be provided by linking to a manufacture use in section 3.5 (Figure 41). Special note for PPORD dossiers: if the "Role in the supply chain" in section 1.1 contains "Manufacturer", then at least one site must be provided in section 3.3. Every site block must have a site linked to it. To do so one should click on the chain button (Figure 39). For each site the fields "Address", "Postal code", "Town" and "Country" must be filled in (Figure 40). The block "Manufacture/own use(s)" is not subject to TCC in case of a PPORD dossier. For substances/dossiers migrated from an older version of IUCLID 5 (version 5.3 or older), the migrated values in the heading of the block "Manufacture/own use(s)" ("Production site", "Production/Use site" and "Use site") are also valid. Please note, that in case these migrated values are edited, they automatically get removed from your IUCLID 5.4 dataset and new uses need to be linked to that block according to the instructions above (Figure 41). Note that in IUCLID 5, sites are connected to legal entities. If you change the legal entity in section 1.1 "Identification" of the substance dataset, any site(s) linked in section 3.3 that belonged to that legal entity will be removed from the substance dataset. After changing the legal entity in section 1.1, you need to go to section 3.3 and manually link the appropriate sites of the new legal entity.
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Data Submission Manual 5: How to complete a - ECHA - Europa

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