Data Submission Manual 2
Contents
1. 2 CHA http echa europa eu Data Submission Manual 2 How to Prepare and Submit an Inquiry Dossier Release 1 2 For latest news and most up to date information please consult the ECHA website Reference ECHA 08 B 03 EN Date 15 December 2008 Language English If you have questions or comments in relation to this document please send those to ECHA helpdesk by using the information request form The information request form can be accessed in the REACH helpdesk section of the ECHA website at http echa europa eu reach helpdesk echahelp en asp Table of Contents l GAL TIN TS ea tae E et iub dites 4 Creating additional official Legal Entity cressoni a 4 Downloading an official Legal entity and importing it into IUCLID 5 7 Appointing a third party representative ss 11 REFERENCE SUBSTANCES arrainen a Re tale 12 Querying updating Reference substances in your inventory 12 Creating a Reference SUDSEIdCG scs a D deter ebur M id nn 15 CREATING A SUBSTANCE DATASET uio Sor Rue BUR o aerea uae eh voee 19 Assigning a third party representative 1f applicable 21 ENTERING INFORMATION IN THE SUBSTANCE DATASET 23 IUCLID Section t General TnfOFTaLIOT scc cose reato obo anota fone utes ete 24 IUC LEID Section TI Identicat lolo ovp com savers buta nan 24 UC TID Section 1 2 Compositions eei um tenance c CIR E a 21 IUCLID Section 1 3 Identifi2. Information a rT zi ar I E al Information Type a Substance n UUIG ILc4 e553758c afBl 32c3 aab5 4fbe54dc3077 Dossier UUID 0 TT Sealed Copy protected Subset of original e To add an attachment click the Edit item button right click the white left field and select Add 36 Li Information ormatic tion V Attachments i Remarks Last modified Size b in e he system will ask you to save the working document Accept and the browsing box will appear Select the file to attach and click Open Select files to add A Looki i a C ez IUCLIDS substance de a IUCLIDS_substanceZ doc File Name IUCLIDS substance doc e Write remarks on the file if you wish and click Save the attached file will appear B Information Consultation S Attachments ll Remarks Last modified Size b 0 e Repeat the previous steps to attach more files 37 tion X Attachments Annotations ILICLIDS substance 5 KE E ILICLIDS substancez doc 522 5 KB Last modified 2007 02 05 Size b 535 040 e Once the necessary attachments have been added to the Substance dataset click the Minimise button to visualise the Substance dataset entry data pane B Information E t tz Attachments IUCLIDS substance doc 522 5 KB B IUCLIDS_substanceZ doc 522 5 KB Last modified 2007 02 05 see
3. e A query dialog appears Search for your Reference substance gt O al sls a e EVE d substance ME Query Ea Query results Sectiontree Substance Find the reference substance Chemical na ut 4 0 Related Information 1 General Information Legalent Reference substance name ethanol ma 1 1 Identification 1 2 Composition 1 1 3 Identifiers Third pa EC name 7 1 4 Analytical information 7 1 5 Joint submission 1 6 Sponsors CH p 1 7 Suppliers Ch i Third party flag CAS number EC Inventory EC number Role in the Role fla CAS number CAS name 1 8 Recipients Ro 7 1 9 Product and process oriented rest IUPAC name H 2 Classification and Labelling Reference s E 3 Manufacture use and exposure cass H 4 Physical and chemical properties SMILES notation H 5 Environmental fate and pathways H 6 Ecotoxicological Information Type ese Molecular formula H 7 Toxicological information Compositig nchi s Analytical methods H 9 Residues in food and feedingstuffs ong m 10 Effectiveness against target organisms LI Show only active values search 11 Guidance on safe use Trade name E 12 Literature search Trade names fl 9 13 Assessment Reports BB Number of results Assign Close
4. tate Sn E Ww E e substance e Create and update reference substance related information Referenc poe 12 e f during the installation of IUCLID 5 you have chosen to download and install the Reference substance inventory you will have approximately 70 000 Reference substances stored in your computer A warning will appear indicating that the default query limit is 500 items If you answer Yes the query for all Reference substances will be skipped the next time you update the inventory If you answer No IUCLID will retrieve the full list of Reference substances the next time you choose to update the Reference substance inventory Either way you will be redirected to the Reference substances screen Query limit reeched The query Get all reference substances has returned 66400 tems This exceeds the maximum number of S00 items Skip the query the next timc Never ask again e Click the Query button File Edit Co Window Help Plugins O O a LJ LH r Gg a j Please open a document n e A dialog box will appear Select Find Reference substances from the Select query picklist File Edit Go Window Help Plugins vu ed uisi Select query result type WE Reference substance Select query Get all reference substances Find reference substances Get all reference substances e Type the search criteria for the substance you are looking f
5. 38 5 CREATING AN INQUIRY DOSSIER On the IUCLID 5 Task Panel select Update from Substance e All available substances are displayed select the substance for which you want to create the Inquiry dossier e Right click a substance in the query results list From the pop up menu select Create Dossier j O LESEN Query results Please open Query SP ethanol 8 ethanol ethanol 1 ECHA Of A Open Enter Testl ethanol ethanol 64 j Ea Print Export OM Delete Delete e he Dossier creation wizard is displayed e Step 1 Select the Dossier template Complete ease open a document p Dossier creation wizard Select a dossier template which meets your specific requirements regulatory programme type of dossier tonnage band member of a joint submission etc Substance Dossier templates available for a substance Biocides Active ingredients Biocides Biocidal products Biocides Substances of concern Endpoints information REACH Annex XV Authorisation REACH Annex XV C amp L harmonisation REACH Annex XV Restriction REACH Application for authorisation REACH C amp L notification REACH C amp L notification member of a joint submission REACH Downstream user report REACH Notification of substance in article REACH PPORD REACH Registration 1 10 tonnes physicochemical requirements REACH Registration 1 10
6. Finland JP gt Third party flags p Third party 2 Role in the supply chain Role flags jP Legal entity name E Role Manufactur Town Reference substance Country h Official legal enti v A Type of substance v Show only active values Search x Composition Origin Trade names Trade names flag P Number of results New Assign Bj Ada J e Using the search criteria search for the third party you wish to assign to your Substance dataset e Highlight it from the list presented and click the Assign button 21 Query i 0 LL Official legal entity r v Show only active values Address IS ECHA Finland Finland Number of results 1 1 e Athird party has now been assigned to your inquiry 22 4 ENTERING INFORMATION IN THE SUBSTANCE DATASET Once you have created a Substance dataset for your substance that has been assigned to the Legal entity of the inquirer you can enter data on the substance in this dataset The information required to be included in the Substance dataset is described in the REACH regulation Article 26 1 and the associated Data Sharing guidance available on the ECHA website http reach jrc it quidance en htm Note also that further information on the description of substances in IUCLID 5 is available in the Guidance for Identification and Naming of substances under REACH
7. This information can then be re used in other datasets without having to retype the information The Reference substance inventory is directly maintained by you in your local installation To extend the number of entries in your Reference substance inventory we recommend you to download the ca 70 000 pre filled Reference substances from the IUCLID 5 web site and import them to your local installation unless already done so during the IUCLID 5 installation These pre defined Reference substances have been prepared to improve data quality and minimise data entry In addition you should also download an EC inventory from the IUCLID 5 web site unless already done during the IUCLID 5 installation This inventory consists of a list of substance identities which is based on a combination of the following EU inventories EINECS ELINCS and NLP list When creating a new Reference substance with an EC number you can minimise data entry and ensure data quality by extracting the data from the EC inventory In this section of the manual you will find the procedure to be followed for searching updating and creating the Reference substances to be assigned to your substance directly from the main task panel Note that it is also possible to create a Reference substance directly from the Substance dataset Chapter 4 Querying updating Reference substances in your inventory e Click Update under Reference substance on the main task panel
8. We 5 Environmental fate and pathway amp M 6Ecot ological Information 2 7 To logical inform ing Add sanay method 2 Resta food and feeding Pice 5 aga arget organism 2 e 11 Cuid Safe izute tarch 134 ment Repor Sur n x s ann informaron Modification history Cy Access 7 Consuhation Atachments Annotations jj Validation e n the Regulatory programme identifiers select Add to edit the list of identifiers A pop up window entitled Regulatory programme identifier appears on the screen Ouereng Q Section tree Identifiers Regulatory programme identifiers Flags Regulatory programme iD Remarks We O Related Information 3 1 Ceneral information 111 identification _ 1 2 Composition gt 1 4 AnaNtical information X 1 5 joint submission E Regulatory programme identifier 1 6 Sponsors Add areguiatory programme identifier 17 Supplier 0 ftem identifiers oriented rest ipients Flags IT syste 19 Product and p d se fication and Labelling E M 3 Manufacture use and exposure p E 4 Physical and chemical properties S Environmental fate and parmsys Regulatory programme 6Ecotoxicological Information ID 7 Toxicological information 4 Add A V SAnatical method Remarks Bo 9Reriduet in food and feedingrtuff 10 Effectiveness against target organism t amp b 11Cuidance on safe use 12 Literature searc n Information Modification history C
9. e Highlight the Reference substance from the result list and click Assign 24 Find the reference substance Reference substance name ethanol CAS number EC Inventory EC name EC number L CAS number CAS name ILIPA C name Synonyms LLIL SMILES notation Molecular formula InChl _ Show only active values Search Name UUID Remarks Last modification RR E d New Css DD ce Close Note It is possible that the Reference substance already exists but you have not set it as Active In this case untick the Show only active values checkbox to display both the Reference substances marked as active and inactive Right click the non activated substance you want to assign Click the Active trade partner to activate it Then click Assign e f you cannot find your Reference substance because it has not been created yet o Click New to create a new Reference substance Query x Find the reference substance Es Reference substance name ethan CAS number EC Inventory EC name EC number CAS number CAS name IUPAC name Sy ony tts SMILES notatian Molecular formula In c hl Show only active values Remarks Last modification 25 o You will be redirected to the Reference substance assistant o Typ
10. x a Le s Search Se Favorites a gt lg rel 33 Address FT http Jecbwbius jrc it index php Fuseaction home login amp type public Welcome Steven Buchanan StevenBuchanan Logout IUCLID 5 INTERNATIONAL UNIFORM CHEMICAL INFORMATION DATABASE English en v M Bd EUROPEAN COMMISSION Home IUCLID 5 Project Get IUCLID 5 Get Support Pre Registration News About Us User Info Download LEO Creation Your LEOs Welcome to IUCLID5 In the restricted area you can manage your account information download the IUCLID software or updated packages create new Legal Entity Objects LEOs and browse through your previously created LEOs User Info Download Create new LEO Your LEOs Legal notice amp 8B Internet e Click Create new LEO IUCLID5 Microsoft Internet Explorer provided by ECHA File Edit View Favorites Tools Help Ay Q sxx K gt ix a yo Search Se Favorites o A te aj Mz lad Fel Address d http ecbwbius jrc it index php fuseaction home showAddLeox amp Eype private INTERNATIONAL UNIF RM CHEMICAL INFORMATION DATABASE English en v Bal EUROPEAN COMMISSION Home IUCLID 5 Project Get IUCLID 5 Get Support Pre Registration News About Us e uw Welcome Steven Buchanan StevenBuchanan Logout User Info Download LEO Creation Your LEOs Legal Entity Object LEO Creation 4 Legal entity can be an individual an industrial or commercial organisation
11. ECHA website http echa europa eu to access REACH IT e n REACH IT click on sign up as a company ias Contact Help an IL it 2 CHA Welcome to REACH IT D o REACH IT provides an online platform to submit data and dossiers pre registration registration C amp L notification on chemicals It also allows the Agency and Member States authorities to review the dossiers The Agency will also use REACH IT to make non confidential information on chemicals accessible to public on its website What can you do If you already have an account you may login to the system Sign up as a company Sign up as a Data Holder Register as an interested third party Register as a third party representative Need help with REACH IT or with this site REACH IT Frequently Asked Questions FAQ The REACH legal text e Contact information e Site ma e Search the site Related links e Public REACH information on chemicals Information about REACH on the Europa website e n the following page you will be required to accept the terms and conditions in order to proceed with the sign up procedure If you agree with the terms and conditions click on accept Contact Help 9 11 GECHA __ Rgaci Company sign up Terms and conditions Mn signing up as a company is a simple process You
12. Print 2008 03 04 E Delete Delete e The Export assistant will ask you if you wish to include your annotations in the dossier Normally select Export without annotations unless you have included relevant information as annotations in your Dossier and click the next button 1 Export assistant 1 Annotation can be included into the export file 2 Annotation export export without annotations C export with all related annotations export only related annotations aA EE Back Next gt INE Cancel Additional export documents 42 e n the next step specify the location where you want to store your Dossier by clicking the t button p Export assistant Select the folder and specify the name of the export file AS appropriate select the checkbox for Copy protect and or Seal Note the finish button is enabled when afile name has been entered and all dossier information has been collected in the background Depending onthe dossier and your system this may take some time Specify the export file Remarks P Select the destination for the export file sous Dwar 3 BELL S BS G3 System C amp Data D amp DVD RAM Drive CC File Name Inquiry Dossier Files of Type ibz IUCLID 5 data exchange container x Cenc Si Pad Rack i Ala st B m i Cancal e Now click the Finish button The Dossier has now been exported to the location you specified a con
13. Save button You have now created a production site linked to the Legal entity Assigning a site e n the section tree of the Substance dataset double click 3 3 Sites and click the Edit item button e Create a new repeatable block clicking the 1 button The fields where the information on the production site can be specified are now displayed e Click the button to link the Sites assigned to your Legal entity will appear Select the site and click the Ok button 33 e Tick the Production site checkbox e f you need to indicate more production sites click the button and repeat the procedure described above IUCLID 5 Section 13 Assessment Reports Use this section to attach the information requirements which would require new studies to be carried out Art 26 1 c and d To do this you first need to complete the Inquiry information requirements form available on the ECHA website http echa europa eu download it and save it You then need to attach it in IUCLID 5 as part of the Substance dataset as follows e Right click section 13 Assessment Reports and select New endpoint study record 34 Query results E section tree id 0 Related Information 3 4 1 General Information 1 1 Identification 1 2 Composition 1 3 Identifiers 1 4 Analytical information 2 1 1 5 Joint submission L6 Sponsor
14. This guidance is also available on the ECHA website To retrieve the Substance dataset you have already created click Update under Substance in the main task panel and select your substance from the list by double clicking it note to facilitate the retrieval of your Substance dataset you may either use the filtering system by typing the name or part of it of the substance in the query field or use the query system by clicking the Query button ME ethanol ECHA Oy Helsinki Finland IUCLID 5 File Edit Go Window Help Plugins Ogle hh fet Navigation Query results M2 Section tree Substa Chemic ethanol e Legal enti A ethanol ECHA Oy Helsinki Finland a Testl ethanol ethanol 64 17 5 ECHA Leg MEN Once the substance is displayed in the data entry pane expand the section tree by clicking the Section tree tab and proceed to complete the necessary sections Double click in each section to display it and click the Edit item button in the upper part of the screen to complete the fields Thir File Edit Go Window Help Plugins f h T Query results Q amp Section tree Sub 23 IUCLID 5 Section 1 General information IUCLID 5 Section 1 1 Identification Name of the substance e In Reference substance click the Z button to assign a Reference substance to your substance Reference substance
15. discussions with other manufacturers importers or where relevant downstream users the third party representative must have an official Legal entity created in IUCLID 5 and he must sign up in REACH IT During the sign up in REACH IT he must import the LEO created in IUCLID 5 into REACH IT For further information on how to assign a TPR to your inquiry please refer to Chapter 3 of this manual 11 2 REFERENCE SUBSTANCES To correctly identify the substance you wish to inquire about it is important to understand the concept of substance Substance dataset and Reference substance in IUCLID 5 The inquiry dossier is prepared for a substance a substance is defined under Article 3 1 of the REACH Regulation In IUCLID 5 the information related to that substance such as the identity of the substance its composition etc should be specified in the Substance dataset created for that substance To insert information on the identity of your substance and its constituents in the Substance dataset you will need to use the concept of Reference substance A Reference substance is nothing more than a link to the identity of a chemical The concept of a Reference substance enables you to store identification information on a given substance or a given constituent of a substance such as chemical names EC name CAS name IUPAC name synonyms etc identity codes e g EC number CAS number molecular and structural information in a central place
16. in the adjacent box type Inquiry In the Remarks field type In accordance with Art 26 1 c and d attach the list of information requirements that would require me to conduct new studies Alternatively if you have no information requirements that would require new studies to be conducted in the Remarks field type No information requirements requiring new studies to be conducted In the document field click the button and the Add button that appears You may be requested to save at this stage which you should do You can then attach the document You do not need to attach this 35 form if you have no information requirements requiring new studies to be conducted Additional information Information requiremnts which would require new studies lalfields Administrative Batale _A A AR_ R Type of report aie CT Remarks In accordance with Art 26 1 c and d attach the list of information requirements that would require me to conduct new studies a Es Document Discussion ADIs IiPA dE VOR IDEA 7 NE CE ES EJ BHAA 1 y bomu hono Je driers Attaching files as additional information e At the bottom of the Substance dataset screen a window called Information is minimised by default Click the H button to maximise it 38 HAGCC FCHA SAT 7 Fennn 7 Finland l e h e The information screen will appear Click the tab Attachments
17. including SMEs a university a research organisation a partnership non exhaustive enumeration Edit here the data about a Legal entity for which you have already created a LEO Organisation information General IUCLID 4 PIN if available Company name DUNS number VAT number Organisation information Legal entity contact Phone number Fax number E Mail address Legal entity web site Street Street 2 Postal code City Town Region County Country other Done Internet IL e Complete as many of the fields as possible In addition to the Company name it is important that in the Organisation information Legal entity contact block the following fields are completed o Phone and or Fax number o E mail address o Street o Postal code o City Town o Country e Click the Next button Z IUCLID5 Microsoft Internet Explorer provided by ECHA File Edit View Favorites Tools Help Q see x E Search Se Favorites M wi lag rel 33 Address L3 http Jecbwbius jrc it index php Fuseaction home showAddLeox amp type private vi Go L Welcome name surname usernamel Logout English en By EUROPEAN COMMISSION Home IUCLID 5 Project Get IUCLID 5 Get Support Pre Registration News About Us User Info Download LEO Creation Your L
18. 0 0 0 0 tetraethyl S S methyle TE ethionamide 2 ethylpyridine 4 carboth w ethisterone 17 hydroxypregn 4 en 20 W ethoate methyl S 2 ethylamino 2 0x TE ethoheptazine ethyl 1 methyl 4 phenyl w ethomoxane hydrochloride N 8 ethox TE ethosuximide 3 ethyl 3 methylpyrrolidi Bi information fm 2 Win CENT I38 073407 EN 7 14 e Check the data on the Reference substance To update add any information on the Reference substance click the Edit item button in the toolbar on the top of the screen edit the information on the Reference substance and save the changes Creating a Reference substance If you do not find in your Reference substance inventory the Reference substance you need you can create it following this procedure e In the main screen go to inventories and click New under Reference substance ence nce related information e ype the name of the Reference substance in the Reference substance assistant pop up window The box Active Reference substance should be checked as only Reference substances marked as active can be used during the creation of a Substance dataset Reference substance assistant Create anew reference substance Reference substance name Retinoline 4 Active reference substance Finish Cancel e Select the Finish button the Reference substance is created and an empty Reference substance section appears Clic
19. 50123456 7590 Fax 12093876543 E mail name surnamedcoampnayB eu Address Bakerstreet 1 Address Postal code 125456 Town Helsinki F F F F F F F F Region State Country Finland mM Remarks IUCLID 5 Section 1 2 Composition e Double click section 1 2 Composition and click the Edit item button e Click the Add button e Write the name and a brief description of your substance Ethanol amp i4 X Mame Ethanal Brief description Manacanstituent substance x m e Complete the Degree of purity section The degree of purity to be specified should correspond to the purity of the main constituent s of the substance The drop down list box allows you to pick symbols or units from a picklist and the boxes allow you to type numbers In this part you can give the normal range of purity for the substance For instance a substance with purity between 95 98 w w will be given as shown below Degree of purity ee ee e Open the constituents repeatable block by clicking the Add button oF e Assign a Reference substance to the newly created constituent by clicking the button as described above Search for the appropriate 27 Reference substance and add it by selecting it and clicking Assign Create the Reference substance you need if it was not created in advance e Indicate the typical concentration and the concentration range for eve
20. Biocidal products Biocides Substances of concern Endpoints information REACH Annex XV Authorisation REACH Annex XV C amp L harmonisation Downstream u 20 Therefore IUCLID 5 marks all sections in green meaning it suggests they are optional The sections that should be completed as a minimum for inquiry are sections 1 1 1 2 1 3 1 4 3 3 and 13 The detail required to complete each of these sections is explained later in this manual Assigning a third party representative if applicable If you wish to appoint a TPR to deal with discussions with other manufacturers importers or where relevant downstream users you will need to get from the TPR or create on their behalf on the IUCLID 5 web site an official Legal entity You would then need to import the TPR official LEO into your local IUCLID installation using the procedure described under Downloading an official Legal entity and importing it into IUCLID 5 The procedure to assign the official Legal entity to your Substance dataset is as follows e Click the ug button next to the third party as circled in the screenshot below e A query dialog appears e Ensure the Official Legal entity and Show only active values checkboxes are checked 0 Substance ethanol ECHA Oy Helsinki Finland Substance identification Chemical name ethanol L Pe Legal entity flags iu Legal entity 3 ECHA Oy Helsinki
21. EOs Legal Entity Object LEO Creation 4 Legal entity can be an individual an industrial or commercial organisation including SMEs a university a research organisation a partnership non exhaustive enumeration Edit here the data about a Legal entity for which you have already created a LEO Organisation information General IUCLID 4 PIN if available Company name 5 CompanyB DUNS number 963852741 VAT number BE0999999999 Organisation information Legal entity contact Phone number 1123455789 Fax number 4129876543 E Mail address Iname CompanyB eu Legal entity web site http www companyb eu Street Bakerstreet 1 Street 2 Postal code 123456 City Town Helsinki Region County Country Finland Fl v e In the Organisation Information Contact Person complete as many of the fields as possible In particular it is important that the following fields are completed o Organisation o First Name o Last Name o Phone and or mobile and or fax number o E mail address o Street o Postal code o City Town and or Region County o Country IUCLID5 Microsoft Internet Explorer provided by ECHA File Edit View Favorites Tools Help Q sx lt E A Search Sf Favorites 2 C3 n ate Address http ecbwbius5 jrc itfindex php fuseaction home showAddLeox2 amp type private IUCLID S E EUROPEAN COMMISSION Home IUCLIDS Proj
22. Home IUCLID 5 Project Get IUCLID 5 Get Support English en x Pre Registration News About Us User Info Download LEO Creation Your LEOs Your LEOS sc wn dm UUID Country Address Edit LEOX Name oid IUC5 0eb52fic e5if 4a77 a4ea Finland Helsinki Bakerstreet Edit Gowland 2059480a94d3 FI 1 EL Legal notice e Click the Download link You will download a Legal entity Object or LEO that contains the information of your official Legal entity However it is still not linked to your local IUCLID 5 installation e n the main task panel of IUCLID 5 click Import Note this import procedure applies to Legal entities other than your own one under which you have executed the installation process of IUCLID 5 e Use the browser window to select the new LEO you created p Import assistant x Please select the iSz file to be imported Verify content carefully before importing ve Select the import file Ovenarite mode never if newer than existing always ask user B B Cancel Select import file e Click the Next button in the following windows A confirmation message will appear Click the Finish button p Import assistant Please select the i5zfile to be imported Verify content carefully before importing Document Endpoint Last modification Compared to data Validation v SH CompanyB 2008 04 18 21 0 28 Cema ee Cie Prepare the impor
23. a etc For each analysis click the 4 button to add a new repeatable block and enter the analysis type the test substance the method used and any remark you consider relevant For each analysis you can also attach one file by clicking the button Results of analysis Analysis type Tested substance Method used Remarks 31 IUCLID 5 Section 3 Manufacture use and exposure IUCLID 5 Section 3 3 Sites as appropriate Use this section to indicate the Site where production of your substance takes place First you should create those Sites in the relevant section of the main task panel Creating a Site e On the main task panel click New under Legal entity site e The Site assistant will appear Type the name of your site p Site assistant Create anew site B a Set name e Assign the Legal entity of the notifier to the Site and click the Finish button p Site assistant Create 4 new site Legal entity owner n CompanyB Helsinki f Fin m m lt Back Hex Finish Cancel Set legal entity e he Legal entity screen will appear Indicate the address of your Site as well as the contact details and other IT identifiers 32 Other IT system identifiers u Flags IT syst em ID Re m arks fig Add Contact address Address flags p PEE 4m e Click the
24. b site of company identifiers These should be used only in cases where an unequivocal identification of companies is not critical e g for reporting information on a non EU manufacturer It is however recommended to use as often as possible the official Legal entities obtained from the IUCLID web site or directly from the companies owning them A potential registrant under REACH must submit to the European Chemicals Agency ECHA certain information in particular his own contact details Therefore you will be required if you have not already done so to create on the IUCLID 5 web site an official Legal entity for the potential registrant The creation of an official Legal entity takes place during the installation and downloading of IUCLID 5 for more details on how to download and install IUCLID 5 refer to http iuclid eu Additional official Legal entities can be created in the IUCLID 5 web site and imported into your IUCLID 5 installation If the official Legal entity you wish to link to the substance is a different Legal entity as the one specified during the IUCLID 5 installation you will need to create this official Legal entity Creating additional official Legal entity e Go to hitp iuclid eu Click the Get IUCLID 5 tab and sign in with your username and password You will then see the following screen 23 IUCLID5 Microsoft Internet Explorer provided by ECHA File Edit View Favorites Tools Help E Q ex v a gt
25. ce substance L Type of substance 3 e H e c Composition Origin Trade names e IUCLID 5 also offers the possibility of highlighting sections that are suggested for completion to assist in the preparation of various types of dossiers However this feature is not currently available for an inquiry dossier therefore click the button and select Complete from the picklist ethanol ECHA Oy Helsinki Finland IUCLID 5 File Edit Go Window Help Plugins GO laal4 alsl 2a F B amil Substance ethanol ECHA Oy Helsinki Finland Query results section tree e Substance identification p LU NENNEN 3 ew G e 0 Related Information Gi List 2 i 0 1 Templates Select an item O di 0 2 Categories 0 3 Mixtures H 1 General Information t e 3 PAA i use di RENE T c Ew 4 Physical and chemical properties m 5 Environmental fate and pathways t e 6 Ecotoxicological Information A 7 Toxicological information 8 Analytical methods H H 9 Residues in food and feedingstuffs t e 10 Effectiveness against target organisms 24 11 Guidance on safe use n 7 o 12 Literature search 13 Assessment Reports wm Trade names Trade names flag p Name e Complete is a generic template and not specific to inquiry omplete Biocides Active ingredients Biocides
26. d click active trade partner to activate it Then click Assign NE Query Unassigned Search for legal entities to be assigned to the user MR Note Only official entities LEO that have been created on and downloaded from the IUCLID Download web site can be assigned to a user Legal entity name CompanyB to CS C Show only active values Search Address f CompanyB Helsinki jname Com panybeu sw Print table EA Copy table Ba Active trade partner Number of results 1 1 e Click the Save button to save the changes This change will only be active the next time you log in so you may need to re initialise IUCLID 5 10 E IUCLID 5 Warning e he next time you log into IUCLID 5 as that user the new Legal entity will be assigned to your user account e Where you have assigned more than one official Legal entity to the same user you may switch between them by clicking on the name of the Legal entities at the bottom of the main screen The substances and dossiers created will by default be associated to the entity selected in this box H GG ECHA SAT Espoo Finland 38 EUROPEAN COMMISSION European Chemica 48 ChemicalCompany1 Helsinki Finland E CompanyB Helsinki Finland 38 HAGG ECHA SAT Espoo Finland 2 Appointing a third party representative If you wish to appoint a third party representative TPR to deal with
27. e relevant sections for inquiry are 1 2 1 3 as appropriate 1 4 and 3 3 Dossier creation wizard ferify the selected parts of sections 1 to 3 or deselect as appropriate Jossier template Complete a Substance Select the parts which should be included m 1 2 Composition 1 3 Identifiers 1 4 Analytical information K K IDR DBD i 1 5 Joint submission 1 6 Sponsors 1 7 Suppliers 1 6 Recipients 1 9 Product and process oriented research and development ZEISGEIS 2 2 DSD DPD 3 1 Technological process 3 2 Estimated quantities 3 3 Sites 3 4 Form in the supply chain HELE B BEBDBDBEBDEDEDEDEDBDEEI 3 5 Identified uses and exposure scenarios 3 6 Uses advised against 3 7 Waste from production and use 3 8 Exposure estimates 3 9 Biocidal information 3 10 Application for authorisation of uses Required Optional Not required 9 3 E1 3 E3 3 id lt Back Next gt Cancel Select parts to filter e Step 4 check that all related objects will be part of your Dossier Legal entity Reference substance s and endpoint study record s e Step 5 In the field Name type the substance name the inquiry relates to and in the Dossier submission remark field type Inquiry dossier If your inquiry is as a result of an update of your registration due to a tonnage band increase A
28. e the name of the Reference substance you need to create and click the Finish button p Reference substance assistant Create a new reference substance Reference substance name ethanol Y Active reference substance Finish Cancel o To specify the information on the new Reference substance click the blue arrow button Reference substance T Ethanol 1 EC number EC name MM gMdMgdgeetbte0 o You will be redirected to the screen for the new Reference substance Complete all the possible fields as described in the chapter 2 Creating a Reference substance o Click the Save button o Click button to go back to the substance save when requested e Fil in manually all the fields again you should complete as many as possible e he buttons next to the fields Composition and Origin allow you to choose from picklists e The button Add allows you to create additional repeatable blocks where to add trade names Contact person Although the contact details of your company are specified in the Legal entity you can also indicate the information details of the contact person for that specific substance Complete as many of the fields as possible 26 Contact person Person flags p Organisation CaompanyB Department Regulatory affairs Title Mr First name First Mame Last name Last Mame Phone 1234567890 Mobile 0
29. ect GetIUCLIDS GetSupport Pre Registration News AboutUs J 3 Elo Welcome name surname usernamei Logout English en iw User Info Download LEO Creation Your LEOs Organisation information Contact Person Enter data about the person that will act as primary contact for the Legal Entity Organisation Department Title First name Last name Phone number Mobile number Fax number E Mail address Street Street 2 Postal code City Town Region County Country Company B Regulatory affairs Surname 4123456788 4050123456789 4129876543 iname companyB eu Bakerstreet 1 1123456 Helsinki Finland FI v Exit from LEO Creation Press Submit for creation of the Legal Entit For subsequent downloading of the Legal Entity XML file LEOX please go to section Your LEOs e Click the Submit button e You have now created your official Legal entity Downloading an official Legal entity and importing it into IUCLID 5 e Click the Get IUCLID 5 tab from the IUCLID 5 home page and click Your LEOs link IUCLID5 Microsoft Internet Explorer provided by ECHA File Edit View Favorites Tools Help Q sack z 2 ix a f5 J gt Search Sie Favorites ER axing ee jw Las rel 33 Address EES http ecbwbius jrc it index php Fuseaction home yourLeoxs amp type private IUCLID 5 Bd EUROPEAN COMMISSION
30. ers 1f applicable sss 20 IUCLID Section 1 4 Analytical information 31 IUCLID Section 3 Manufacture use and exposure 32 IUCLID Section 3 3 Sites as appropriate 32 IUCLID Section 15 Assessment Reports edet A S s 34 Attaching files as additional information esses 36 CREATING AN INQUIRY DOSSIER tite Ep EE EE UR 39 EXPORTING AN INQUIRY DOSSIER ehe np Lente ha HERES 42 WPDA TING Fe DOSSIERS tette nectit eer ap eto amine tatus 44 Updatns fhe TnEOU fidt EOEL uiuere eder Edo iore oen en dates 44 SUBMITTING AN INQUIRY DOSSIER TO ECHA eene 45 Step 1 Company sign up in REACH IT eeeeeesesseseeeeeernnneneeenennn nnns 45 Step 2 Submitting an IUCLID 5 inquiry dossier eeseeeeeee 46 INTRODUCTION The purpose of this manual is to assist in the preparation of an inquiry dossier using IUCLID 5 The manual assumes that IUCLID 5 has been installed and that you have a user account assigned to the Legal entity created during the installation of IUCLID 5 If IUCLID 5 has not yet been installed please consult the IUCLID 5 web site available at http iuclid eu On this web site you can download the software free of charge and also find more comprehensive guidance about the use of IUCLID 5 This manual provides a stepwise approach for the preparation and submission of an inquiry dossier Step 1 Creating the
31. ext amended to explain how to indicate the inquiry is based on Article 35 12 2 Text amended to read as follows Step 5 In the field Name please type the substance name the inquiry relates to and in the Dossier submission remark field type Inquiry dossier If your inquiry is as a result of an update of your registration due to a tonnage band increase Article 12 2 of the REACH Regulation in this field type Inquiry as a result of an update of a registration If your substance is a non phase in substance legally on the market before June 2008 see 9th of June ECHA press release ECHA PR 08 12 available on the ECHA website at http echa europa eu news press en asp in the Dossier submission remark field type Inquiry dossier for non phase in substance legally on the market before June 2008 n this field you must also give a justification as to why such placing on the market was considered lawful Text deleted in reference to submission using temporary procedures European Chemicals Agency Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 6861 80 Fax 358 9 6861 8210 http echa europa eu info echa europa eu
32. firmation message will appear p Export completed Export process report 1 Export of 6 document s and 0 annatation s completed 2 6 document s was were exported successfully Q document s was were skipped 00 00 3 Export successful 43 7 UPDATING A DOSSIER Updating the information lf you need to submit further information on your inquiry Dossier be it as a result of missing information lack of quality or inability to verify the substance identification you do not need to re type again all your substance data e Inthe main screen go to tasks and click Update under Substance A3 E YE AE 4 Gs e E DEN H Create and update substance related information A Tr VEU DU PAT NI ir E e Select from the list the substance for which you wish to submit new information and double click it From the Substance dataset tree view select the section s that you wish to update Edit the necessary sections by clicking the Edit item button T Navigation EX Query results ME Section tree Query To create and export the Dossier please refer to Chapter 5 and 6 of this manual 44 8 SUBMITTING AN INQUIRY DOSSIER TO ECHA Step 1 Company sign up in REACH IT If you do not have an account in REACH IT refer to the Industry User Manual Part 2 in http echa europa eu reachit createaccount it en asp or follow the instructions in this section e Go to the
33. id CAS number CAS name 3724 52 5 IUPAC name cyclopentane 1 2 3 4 tetracarboxylic acid Typical concentration ca ww 42 Ke Concentration range gt v 41 lt v 42 w w Remarks e Follow the same procedure to complete the impurities and additives fields 28 Impurities p Reference substance Typical concentration Concentration range Remarks Additives je Reference substance Function Typical concentration Concentration range Remarks IUCLID 5 Section 1 3 Identifiers if applicable v v y RR x In this section you can add identifiers for other regulatory programmes or IT systems In particular if the substance for which you are submitting an inquiry has previously been subject to a product and process orientated research and development PPORD notification or is an inquiry based on Article 12 2 of the REACH Regulation it is recommended that you report the PPORD notification number or notification number or registration number e Open the section 1 3 of the IUCLID 5 Substance dataset by double clicking on 1 3 Identifiers from the tree view and click the Edit item button 29 Identifiers lt Regulatory programme identifiers Flags Regulatory programme iD Remarks H Add Other IT system identifiers Flags IT system 10 Remarks i ro ted re o 2cCuassf d Labelling 3 Manuf ute and export oh 4 Physical and chemical properties
34. information available section Mo EC information available e Complete as far as possible the remaining fields of the Reference substance When completing the information for your Reference substance the following information should be submitted for all the known constituents and impurities EC number and EC name if available CAS number and CAS name if available IUPAC name Description specify any additional information relevant for the description of the Reference substance in this field Molecular formula if a molecular formula cannot be derived from the Reference substance a justification should be indicated in the Remarks field at the bottom of the screen Molecular weight range if applicable SMILES notation if applicable InChl when available if applicable Structural formula if applicable File Edit Go Window Help Plugins ocog Wuuilzialse ve evimese m fet Navigation Zr Reference substance Retinoline 4 pa Query results a SHEN General information tinoline ES EC inventory Heu No EC information available www lt E Reference substance information Pa CAS information CAS number 68 26 8 A 7 ee Description BEEN lcciodliid aac J For the structural formula go to Structural formula under Molecular and structural information and click the Add button You can then upload an image fi
35. k the Edit item button 15 Reference substance Retinoline General information LHS Oo EC inventory Mo EC information available wsiteeion TE Reference substance information CAS information m D e f the Reference substance is listed in the EC inventory o Assign that entry by clicking the button The query dialog appears in which EC inventory entries can be searched o Search using any of the criteria listed such as the EC name of the substance Again you can use as a wild card b Query Find information in the EC inventory EC number e u 583 7 EISE 04 155 6 204 544 2 e3 0 363 2 ed3 876 1 209 433 6 Number of results EC name retinal retinyl palm retinaldehy retinyl acet retinyl prop retinyl piwal retinyl hept CAS number Malecular f 58 25 8 M dq 116 31 4 l27 47 9 7 69 42 3 C2 0H300 C36H600 z Ca2 H28o0 Ca22H3202 C23H3402 0559 05 1 cC25H3802 Babdl1 44 5 C2z7H4202 Dezcriptic 16 o Highlight from the list the entry that matches your Reference substance o Click the Assign button The information for this Reference substance will be included in your new Reference substance e f your Reference substance is not in the EC inventory select a justification from the picklist proposed under the No EC
36. le with the structural formula IUPAC name Molecular and structural information ML Open E Molecular formula mt io ee amp 9 E BIS 1 2 Molecular weight range EE P Gane Image preview SMILES notation C2 My Network Places My Metwork Places 5 Shortcut to general on s echa vpsv O4Data Ww 7 EN Structural formula F bond enam 0 0 0 0 0 0 Remarks EN Files of Type Images gif pg Jpeg png 3 Inform ation 18 3 CREATING A SUBSTANCE DATASET To create an inquiry dossier in IUCLID 5 you need first to create a Substance dataset A Substance dataset is the repository of data which is used as a basis to create the dossier to be submitted to the ECHA e On the IUCLID 5 Task Panel under Tasks select New from Substance d NET Create and update substance related information ae Ea teer ica z is ye ice een A e 1r AA Je A te e Type the name of your substance for which you wish to inquire about The name can be anything but it is logical to use an identifier that you are familiar with such as a trade name or chemical name p Substance assistant Create a new substance Chemical name ethanol mm Nea Set name dum NEST ar S FREE e Click the Next button Select the Legal entity to be assigned to the Substance dataset p Substance assistant Create a new substance Legal enti
37. legal entitiy for the inquirer see Chapter 1 of the manual Step 2 Creating the reference substances related to the inquired about substance see Chapter 2 of the manual Step 3 Creating the substance dataset for the inquired about substance see Chapter 3 of the manual Step 4 Entering information on the inquired about substance see Chapter 4 of the manual l Step 5 Creating an inquiry dossier see Chapter 5 of the manual Step 6 Exporting the inquiry dossier from IUCLID 5 see Chapter 6 of the manual Step 7 Submitting the inquiry dossier to ECHA see Chapter 8 of the manual 1 LEGAL ENTITIES The Legal entities are used in IUCLID 5 to provide contact details on the companies involved in processes under REACH In the case of an inquiry it is necessary to define the Legal entity of the inquirer There are two types of Legal entities that can be created in IUCLID 5 e Official Legal entities are created on the IUCLID web site for which a central management of company identifiers UUID is available it enables you to subsequently identify the company in an unequivocal manner In general companies owning and or submitting the data or the dossiers should be official Legal entities e Non official Legal entities are created directly in IUCLID 5 for which there is no central management on the IUCLID we
38. nd modify if necessary Step 2 Submitting an IUCLID 5 inquiry dossier Please refer to the Industry User Manual Part 6 Dossier Submission available at http echa europa eu reachit manuals_en asp 46 ANNEX I Update of the document I Update of version 1 1 Change made 5 Text amended as follows An inquirer potential registrant under REACH must submit to the European Chemicals Agency ECHA certain information in particular his own contact details Therefore you will be required if you have not already done so to create on the IUCLID 5 web site an official Legal entity for the inquirer potential registrant to be conducted The following text added You can then attach the document You do not need to attach this form if you have no information requirements requiring new studies to be conducted 3 The following text added Alternatively if you have no information requirements that would require new studies to be conducted in the Remarks field type No information requirements requiring new studies 9 40 44 remark field type Inquiry dossier for non phase in substance legally on the market before June 2008 n this field you must also give a justification as to why such placing on the market was considered lawful The following text added If your substance is a non phase in substance legally on the market before June 2008 in the Dossier submission Il Update of version 1 2 Change made T
39. or and click Search You can use the asterisk as a wild card For example to get all the substances starting with phenol you would type phenol To get all 13 the substances ending in amine you would type amine note that only 2000 results will be shown Select query result type Reference substance Select query Find reference substances Query specific fields Reference substance name CAS number EC Inventory EC name EC number CAS number CAS name IUPAC name Synonyms SMILES notation Molecular formula Inch MC IUCLID 5 File Edit Go Window Help Plugins 090 H 4 4 6 A e o 0 mS An TERES Please open a document Query 3 bs ethacridine 7 ethoxyacridine 3 9 diami A w ethacridine lactate 2 hydroxypropanoic 2 bd ethambutol 2 2 ethane 1 2 diyldiimind TH ethane ethane 74 84 0 TH ethane 1 2 diol ethylene glycol 107 2 w ethane 1 2 disulphonic acid compound TE ethane 1 2 disulphonic acid compound MW ethane 1 2 dithiol ethane 1 2 dithiol IE ethane 1 2 diy palmitate ethane 1 2 di TE ethane 1 2 diylbis dichloromethylsilane w ethanesulphonic acid ethanesulfonic aci ethanesulphonyl chloride ethanesulfo LT ethaverine hydrochloride 1 3 4 dietho IE ethenzamide 2 ethoxybenzamide 938 TET ethiazide 6 chloro 3 ethyl 3 4 dihydro w ethinamate 1 ethynylcyclohexyl carbam TE ethinylestradiol 17 ethynylestra 1 3 5 w ethion
40. rticle 12 2 of the REACH Regulation in this field type Inquiry as a result of an update of a registration If your substance is a non phase in substance legally on the market before June 2008 see 9th of June ECHA press release ECHA PR 08 12 available on the ECHA website at http echa europa eu news press en asp type Inquiry dossier for non phase in substance legally on the market before June 2008 in the Dossier submission remark field In this field you must also give a justification as to why such placing on the market was considered lawful 40 p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template Complete Name given by user A Dossier submission remark 98 95 0500 Ens Enter administrative information e A window informs about the success of the import When clicking the View dossier button the Dossier will be displayed T Dossier creation wizard Dossier creation successfully completed You can now viewthe dossier or close this wizard Cases 41 6 EXPORTING AN INQUIRY DOSSIER e The inquiry Dossier needs to be exported in order to be sent to ECHA e n the main screen click in the dossier icon or the view link e Select your inquiry Dossier right click it and select Export COMPLETE Substance 1 2 3 trichloropropz 2008 03 26 BR COMPLETE Subg PCIE TR E 2008 05 13 3 Open Enter R_PPORD Subst 3
41. ry constituent in the same manner as indicated above Constituents y R ca 48 ww A iodocyclopentane iodocyclopentane 1556 18 9 R 7 p LF Reference substance TE A iodocyclopentane iodocyclopentane 1556 18 9 3 2 EC number EC name 216 311 1 liodocyclopentane CAS number CAS name 1556 18 9 liodocyclopentane IUPAC name iodocyclopentane Typical concentration ca LA 48 ET x Concentration range gt x 47 lt x 49 Cup vj Remarks e f you need to specify more than one constituent click the Add button 7 inthe relevant section and more boxes will appear Constituents C ca 48 w w lodocyclopentane lodocyclopentane 1556 18 9 a NM a P Reference substance 117 iodocyclopentane iodocyclopentane 1556 18 9 gt X EC number EC name 216 311 1 liodocyclopentane CAS number CAS name 1556 18 9 IUPAC name liodocyclopentane Typical concentration ca w 48 S w w Concentration range gt w 47 lt 49 S w w Remarks y tlx ca 42 X w w cyclopentane 1 2 3 4 tetracarboxylic acid cyclopentane 1 2 3 4 tetracarboxylic acid 3724 52 5 32 XK P Reference substance rf cyclopentane 1 2 3 4 tetracarboxylic acid cyclopentane 1 2 3 4 tetracarboxylic acid 3724 52 5 gt x EC number EC name 223 074 8 cyctopentane 1 2 3 4 tetracarboxylic ac
42. s 1 7 Suppliers 1 8 Recipients 1 1 9 Product and process oriented resi 2 Classification and Labelling H 3 Manufacture use and exposure QV 4 Physical and chemical properties 5 Environmental fate and pathways M 6 Ecotoxicological Information 7 Toxicological information 8 Analytical methods Er ul E E tt i NL New endpoint study record z e 9 Residues in food and feedingstuffs H 9 1 Preliminary Metabolism in livestod H 9 2 Preliminary Residues in livestock 9 3 Migration of residues into and the 9 4 Expected exposure and proposed 9 5 Additional information on residue E Y 10 Effectiveness against target organisms 10 1 Effectiveness against target orga M 10 2 Efficacy data 11 Guidance on safe use 12 Literature search PH New endpoint study record e A New endpoint study record section appears endpoint study record to Information requirements which would require new studies and click the OK button Create anew endpoint study record Re name the new The endpoint study record will be referenced by its name Confirm the default name given below or change it with a name of your choice T Endpoint record name Information requiremnts which would require new studies A Cancel In the next screenshot shown below from the picklist under Type of report select other and
43. t e Now you have to assign this new entity to your user Go to User management in the main task panel 1001 sinlelsieleellellEstfzii elr e In the user management screen select the user to which you want to associate this new official Legal entity SE IUCLID 5 File Edit Go Window Help Plugins Go0 igmuejzi ze somiii em ng All users madesso Sophia vd Made last login 2008 05 13 10 35 10 EEST from local DE 0 0 0 0 0 0 0 0 0 0 0 0 0 Suspended madesso amp SuperUser Super user Login name madesso OS Full name Sophia vd Made n TTE Remarks e Now go to Assign Legal entities and click the P button A query window will appear Type the name of the official Legal entity you want to assign to the user selected and click the Search button Be sure to uncheck the checkbox Show only active values because newly imported Legal entities are by default marked as inactive SG Query Unassigned Search for legal entities to be assigned to the user Note Only official entities LEO that have been created on and downloaded from the ILICLID Download web site can be assigned to a user Legal entity name CompanyB a LE SE Show only active values Address CompanyB Helsinki name CompanyB eu Bakerstreet 1 123456 He Number of results 1 1 e Right click the Legal entity you want to assign If the checkbox for Active trade partner is not checke
44. tonnes standard requirements REACH Registration 10 100 tonnes REACH Registration 100 1000 tonnes REACH Registration above 1000 tonnes REACH Registration member of a joint submission general case REACH Registration member of a joint submission intermediates REACH Registration on site isolated intermediates above 1 tonne REA CH Registration transported isolated intermediates 1 1000 tonnes REACH Registration transported isolated intermediates above 1000 tonnes v Note The dossier template is used to determine which substance endpoints will be selected by default The selection can be modified manually in a subsequent step of the dossier creation a U BH H H H u Next gt J Cancel Select a dossier template Note The dossier template selection helps to determine which IUCLID 5 section and endpoint studies will be part of your dossier However there is currently not such a template for inquiry and therefore you will need to select the generic Complete template 39 e Step 2 Define the filters Every item that matches these filters will be taken into account for the dossier The Select all button allows you to select all possible items at once e Step 3 See the state full partial of all documents taken into account for the dossier creation At this stage please be sure that all the necessary sections for your inquiry Dossier appear ticked as only these documents will appear in your dossier Th
45. ty d Companys f Helsinki Fin v aA Back Finish Cancel Set legal entity Note If the Legal entity to be linked to the Substance dataset is not available from the picklist a new Legal entity should be assigned to the user For this purpose please refer to the instruction provided in the Creating an official Legal entity and Downloading an official Legal entity and importing it into IUCLID 5 sections above e Click the Finish button You have now created a Substance dataset 19 e The section tree of your Substance dataset is displayed in the navigation part of the screen to see the complete tree view click the button and select expand all from the pop up menu Query resul ts Section tree i ifi i Query results Yr Substance identification Chemical name pporp Reaction mass Ch etnia 0 Related Information 23 Refresh 1 General Information Expand all 2 Classification and Labellin 9 Collapse all EEE ooo Minnie uw H 4 Physical and chemical properties Update references 5 Environmental fate and pathways g Showendpoint study records only 999999 6 Ecotoxicological Information 7 Toxicological information a Showendpoint summaries only 8 Analytical methods LZ Show endpoint study records and summaries 11 Guidance on safe use ly representative 12 Literature search GR Copy contents to clipboard 13 Assessment Reports Ill Referen
46. will be quidedthrough the following 5 steps 1 User account Information for the first user is required 2 Company information Provide general information on your company 3 Billing information Provide billing details for your company 4 Contacts optional Add information about people who may be contact points for SIEFs 5 Validation Check information you have provided and modify if necessary At each step prior to the validation you are allowed to go back to any previous step and change the data you already entered Before going further in the sign up process please read the following terms and conditions Terms and conditions 1 3 Need help with REACH IT or with this site e Specific help on company registration REACH IT Frequently Asked Questions FAQ Legal notice Contact information 45 e Follow the sign up procedure Signing up as a company is a simple process You will be guided through the following 5 steps o User account Create your REACH IT user account o Company information Provide general information on your company For consistency you should import the LEO created in the IUCLID 5 website which was linked to the substance for which the IUCLID 5 inquiry dossier was made See IUM Part 1 o Billing information Provide billing details for your company o Contacts In this screen you can specify contact persons for your company o Validation Check the information you have provided a
47. y Access ConiuMation M Attachments Annotations cj Validation In Regulatory programme identifier box complete the fields as follows REACH PPORD number or notification number NONS or REACH registration number should first be selected as regulatory programme The number should be specified in the ID field e By clicking the OK button in the Regulatory programme identifier window the regulatory identifiers will appear as a list 30 IUCLID 5 Section 1 4 Analytical information e Inthe section tree of your Substance dataset double click the section 1 4 Analytical information and click the Edit item button e Under the Analytical method field describe the analytical methods used to characterise your substance and where appropriate the impurities and additives You can also attach such information by clicking the button note that you can only attach one file in each field e Under the Optical activity field provide information on the optical activity and typical ratio of stereo isomers whenever applicable z e en aout e Substance inquiny f Earapean Chemicals amp gency y Helsinki Jobi rtu Analytical methods and spectral data Spectra pdf f 8 Byte is Optical activity See attached file e Provide the analytical results used to characterise the substance such as spectral data UV IR NMR MS etc chromatographical dat
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