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Guidance for SIEF-Member Registrants (Joint-Submissioners) who will submit a co-registration dossier.

The aim of this document is to help ensure that companies can successfully submit a dossier under the REACH Regulation 1907/2006 through REACH-IT, and in particular to explain the initial checks that are made by REACH-IT to determine whether the dossier can be accepted for further processing. Basically, the joint registration process involves the following steps: File import Legal entity check Completion of IUCLID data file TCC check on IUCLID file Dossier creation TCC on dossier Dossier export Submission of dossier on REACH IT

Pre-requisites: Be member of the relevant joint submission Functional IUCLID platform version 5.2.0 or 5.2.2

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A. File import

Open IUCLID and log in to get to main screen. Click on import. Note: the iz5 file will only be imported properly in a iuclid version 5.2.0. or 5.2.2.

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Step 1: select the import file on your computer and select the overwrite mode: The default option is shown on the screen. If you have not created the substance yet e.g. zinc metal, the import will occur no

matter the overwrite mode If you have already created a substance and you import a file with same name,

the import will occur only if: o You select the overwrite mode “always” (but it will also overwrite your

data) o You change beforehand the name of the substance in your system;

contents can the subsequently be copied between files Step 2: the system verifies the contents. Step 3: select the endpoints you want to import (select all) and finish. Your substance‟s sections 1, 3 and 11 should be filled.

B. Legal entity check In the process of creating a dataset, creating a dossier and submitting it, there are three instances where the legal entity needs to be indicated. To avoid any ambiguity, you have to ensure that all these legal entities are the same. If you have not yet defined your legal entity and linked site(s), please do so beforehand from the main screen‟s relevant sections.

1. The substance dataset is linked to a specific IUCLID legal entity. This must be the same as the REACH-IT legal entity from which the dossier will be submitted.

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How to find the legal entity linked to the substance dataset?

a. Click on “Substance” in the IUCLID main screen

b. 189B

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c. Choose the substance in question from the query list

d. In the upper menu of the section tree, select Reach registration member of a joint submission general case or intermediate – this defines your “template”

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e. In section 1.1, substance identification, click on the blue arrow on the right end side of the “Legal entity” field

f. 191BIn the “Information” field, under the “Information” tab, you can find the UUID of the legal entity associated with this substance. The information tab is visible at the bottom of the screen and can be enlarged with the mouse.

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2. Dossier Creation: When creating the dossier you must ensure that you use an IUCLID user Account for the legal entity which corresponds with the submitting legal entity in REACH-IT. This legal entity is visible at the bottom of IUCLID 5 screen, in the status bar. The substance dataset is linked to a specific IUCLID legal entity.

This legal entity is defined in the legal entity section (main screen, upper left corner). Click and select the legal entity to see its information. This must be the same as the REACH-IT legal entity from which the dossier will be submitted.

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3. 61BHow to find the submitting legal entity in REACH-IT? a. When logged in, point to “Company” and click on “View”

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b. The second row in the “General information” field contains the UUID of the submitting legal entity

If the 3 UUIDs are not the same, the dossier will be rejected

C. IUCLID 5 preparation

On IUCLID main screen, click on the substance icon, select the substance you want to work on and open the file. In the upper menu of the section tree, select Reach registration member of a joint submission general or intermediate

Now open the General information section in the menu.

4. General information, Section 1.1 – identification of both the substance and the

submitting company Role in the supply chain: Please note that 216Bif “Manufacturer” is selected, a production site in section 3.3 “Sites” must be provided.

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Contact person: Should be filled with contact data (does not especially have to correspond to the contact defined in REACH IT to pass the checks)

5. Section 1.2 – composition Companies should check if their product is covered by the composition defined in the Lead Dossier which is given as reference. As this section is company specific, it can be changed. Each company can add its own composition, additives, different impurities provided they do not change the classification given by the lead registrant‟s dossier. For details on the composition registered by the LR, please refer to “Substance Identification Profile”, provided with the co-submission package. Information is also available on websites www.reach-zinc.eu and www.reach-cadmium.eu.

6. Section 1.3 – identifiers One identifier should always be provided. Even if it is a “green” section in IUCLID, your dossier will not pass without the identifier. For most, the identifier will be the pre-registration number; for some (late pre-registrants), it will be an inquiry number (to be selected from drop-down menu). Title can be selected from the menu; number is to be encoded in the ID box by the co-submissioner.

7. Section 1.4 – Analytical information Both qualitative and quantitative chemical analyses are necessary to insure sameness of substance. As previously advised, each registrant is in principle responsible for deciding how they are going to satisfy this Analytical Data requirement. There may be several possible approaches. Below is a suggested Zn and Cd REACH Consortium best practice procedure that you may wish to follow:

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You should obtain:

XRD (X-Ray Diffraction), for substance characterization ICP (Inductively Coupled Plasma) or XRF (X-Ray Fluorescence) for

quantitative elemental analysis. The Lead Registrant‟s XRD from Outotec report is provided indicatively. Note: The elemental analysis should not be restricted to just the registered substance [if mono-constituent], but will be typically for all elements present in the substance > 1% w/w, and those present > 0.1% w/w if an element is classified as hazardous (or other possible limit if it is the case, e.g. Cd sulphate > 0.01%w/w).

8. Section 1.5 – Joint submission This section, although indicated in red, is not to be filled by the JS. The information of the Joint Submission is completely derived from REACH-IT (the joint submission name must be provided in REACH-IT while uploading the dossier) and any information in Section 1.5 is not taken into account. It is important to note that the consistency of any information in this section of IUCLID will not be verified against the information derived from REACH-IT.

9. Section 2 – Classification & Labelling This section should not be modified in a co-submission (please refer to substance identity extracted from CSR provided separately). In case of a Joint Submission this information will be provided by the lead and is not expected to be in the member dossier, unless in the case Section 2 is part of the information for which an opt-out applies.

10. Section 3.1 – Technological process Basic technological process, discussed in the working groups is provided in the IUCLID file. Optionally, the co-submissioners that have (a) specific process(es) can add it (them) in this section by adding supplementary blocks.

11. Section 3.2 – Estimated quantities [not mandatory for intermediates] Indicate here the estimated production/imports quantity in tonnes per calendar year or multi-yearly average. Only total tonnage (manufactured/imported) is mandatory, do not bother to fill in the details. Note that for registration of substance under REACH regulation (EC 1907/2006) the quantities have to be considered in the calendar year of the registration [ = estimate]. As indicated, we suggest reporting “0” for all the fields indicated (see screenshot) and just fill total tonnage section with manufactured and/or imported tonnage.

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12. Section 3.3 – Sites This section is a repeatable block section, which offers the possibility to list all sites where the Substance is produced and/or used. This is done by creating for each site a link with the relevant information stored in the Legal entity site inventory. The minimum data required is town / city and the country, where the site is located. Please note that in the case of an importer no information is required in this section, however, if a site is provided, the same requirement applies.

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To link a site to a legal entity, just click on the starred icon and select a legal entity owner.

13. Section 3.4 – Form in the supply chain [section not available for intermediates] By default, “available as a substance” box is selected.

14. Section 3.5 – identified uses The full list of identified uses in the Lead dossier is provided. If the co-submissioners have specific and/or confidential uses, they should fill additional lines in the relevant fields (industrial, professional or consumer).

15. Section 3.6/3.7 – uses advised against and waste from prod. and uses Default entries are made depending on the substances. If present, the uses advised against are in the LR dossier and this section should not be touched by the co-submissioners. A generic phrase is used for the waste.

16. Section 11 – Guidance on safe use The lead registrant and sometimes additional MSDSs information is provided. It is advised to leave this section by the LR as it is. It is possible however to add the information of your own MSDS as a new study record.

17. Section 13 – Assessment reports In this section, you will append the Part A of the CSR, duly filled and signed. Just click right on section 13, select new endpoint study record. Then fill as shown in screen below: type of report other: part A of CSR, then append the document by clicking on the paper clip.

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D. Technical Completeness Check (TCC) on substance Before creating the dossier, you should run a TCC on the substance:

- Go back to substance list, click right on the substance name and select “run TCC” or select it in the plug-in menu

- Go to step 2 and select “member of a JS” - Indicate tonnage band of the JS => either “registration dossier over 1000T” or “intermediates transported > 1000T”

- Then indicate your own tonnage band - Guidance of safe use and CSR are provided by the LR (by default) - Press then next, and finish and if ok, you should get the 2nd screen hereafter

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E. Dossier creation

Step 1 In the substance list, click right on the substance for which you want to create a dossier and select “create dossier” Choose then the right template:

- Reach registration member of a joint submission – general case or - Reach registration member of a joint submission – intermediates

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1. Complete a dossier Header, JS member, initial submission

Step 2

For a REACH dossier all boxes should be ticked (or default values should be used)

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Step 3

Select all parts that should be included => Zn and Cd REACH Consortia advise to deselect 1.6, 1.7, 1.8, 3.8 and 3.9. For intermediates, sections 3.2 and 3.4 are not mandatory Step 4 Include third option: “all fields- including test material information” Step 5 Gives the list of all items exported

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Step 6

1) Enter name of joint submission (see list of names in Annex 1) 2) No specific remark 3) Information provided by the lead:

a. Tick chemical safety report (not available for intermediates) b. Guidance on safe use (not available for intermediates)

4) YOUR relevant tonnage band for the registration a. For pure substances OR b. For intermediates

PLEASE NOTE THAT YOU SHOULD CHOSE THE MOST SIGNIFICANT TONNAGE FOR YOUR COMPANY: MORE THAN ONE OPTION WILL LEAD TO MULTIPLE INVOICING

5) Registration dossier specific information [your info]: a. Phase-in b. Please note that if you make a confidentiality request, you pay extra per

endpoint you want to keep confidential.

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6) Specific information for intermediates a. Tick 1st box and add in the appearing new box the following text:

“Strictly controlled conditions are ensured by:

⁰ The substance is rigorously contained by technical means during the whole lifecycle including

manufacture, purification, cleaning/maintenance of equipment, sampling, analysis, loading and

unloading of equipment or vessels, waste disposal or purification and storage

⁰ Procedural and control technologies shall be used that minimise emission and any resulting

exposure

⁰ Only properly trained and authorised personnel handles the substance

⁰ For cleaning/maintenance, special procedures such as system purging and washing before

opening devices

⁰ Procedures, control technologies for accidents and waste

⁰ Substance-handling procedures well documented and strictly supervised.”

b. Tick 2nd box confirming intermediate is used in accordance with the

conditions set out in the article 18(4)

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Step 7 Copy-protect your dossier if you wish to (strongly advised). Step 8 Finish... Before submitting the dossier, please run a TCC on the dossier (see procedure for substance above in the IUCLID preparation chapter, and select “dossier” instead of “substance” in the drop-down menu)

F. Dossier export In the main menu, click on the dossier icon. Select the dossier to export, click right and then “export”.

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Chose “Export with all related annotations” and click next

Chose then a place to save it and a name and finish.

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G. Dossier submission

1. Step 1 – starting a dossier submission

To start the dossier submission, go to the <Registration/notification> menu, and click on <Submit registration / notification>.

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2. Step 2 – Selecting a dossier type Select the appropriate dossier type from the

<Dossier type> drop-down menu.

3. Submitting a Registration dossier

Choose “registration” or “registration of transported isolated intermediate” when relevant. Purchase Order: Where needed, fill in with the appropriate reference to be used by ECHA during the generation of the invoice related to your submission (not mandatory).

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Declaration: Click the checkbox related to the statement agreement (entirely reported here below), for registration submissions (registration dossier, or registration dossier of transported intermediates. Opt-in confidentiality: do not tick

4. Uploading dossier file For any dossier type described in Step 2, the dossier upload page opens (Figure 12). Fill in the mandatory fields (*) related to the file name and the CAPTCHA text.

Click on <Browse> to open a dialogue box which allows you to select the dossier file you want to upload (Figure 13). Your substance file must have already been created in IUCLID 5 and have the extension „.i5z‟ Finally, submit

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Verify your data and confirm submission

The dossier submission successful page opens after you confirm the submission. It shows a confirmation message and provides your submission number. An internal message is simultaneously sent to your REACH-IT Message box. (remark: not that confirmation should state registration submission and not C&L notification, only screenshot available)

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