Annex II_IUCLID5 PPORD Manual - REACH-CLP
Contents
1. 1 5 Joint submission Ha Add maA 1 6 Sponsors 1 7 Suppliers Other IT system identifiers 1 8 Recipients Flags IT system ID Remarks 1 9 Product and p ted 5 2 Classification and Labelling 3 Manufacture us dexp H 4 Physical and chemical properties 5 Environmental fate and pathways H 6 Ecotoxicological Information 7 Toxicological information Ha Add 8 Analytical methods H 9 Residues in food and feedingstuffs H 10 Effectiveness against target organisms H 11 Guidance on safe use 12 Literature search 13 Assessment Reports Information Modification history Sy Access Consultation 4 Attachments Annotations Validation e Where a PORD application has been accepted in more than one EU country the notifier of the corresponding PPORD should indicate each PORD identifier number and country 1 4 Analytical information e Double click on 1 4 Analytical information and press 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 pressing 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 and appropr2. il a Remarks 7 1 8 Recipients i 1 9 Product and process oriented res Be 2 Classification and Labelling Fef 2 0 GHs nf 4 2 2 DSD DPD 3 Manufacture use and exposure 4 Physical and chemical properties 5 Environmental fate and pathways 6 Ecotoxicological Information 7 Toxicological information e 8 Analytical methods 11 Guidance on safe use 12 Literature search Sol 13 Assessment Reports Document IUCLIDS_substance doc 522 5 KB q information e The information screen will appear Click on the tab Attachments Information ii information Modification history Type w Substance UUID 1UCS 9c725e97 d88f 4817 a29c Sfd7373ebdd0 Dossier UUID 0 Sealed Copy protected Subset of original e To add an attachment press the Edit item button right click on the white left field and select Ada Remarks Last modified Size b o 52 e The system will ask you to save the working document Accept and the browsing box will appear Select the file to attach and click Open ME Select files to add f Look In C New Folder EIRE E IUCLIDS_sut ibstance doi a IUCLIDS_substance2 doc File Name IUCLIDS_substance doc Open Cancel e Write remarks on the file if you wish and press Save the attached file will appear D Information CO Information ix J Modification history
3. 7 Ace sE C Consultation Attachments i jie IUCLIDS_substance doc 522 5 KB Remarks Last modified Size b on e Repeat the previous steps to attach more files The maximum size for all the combined attachments is 20 megabytes Bt irs ET pray F pea Aa EL F Ta anaE ee Fa onsuliation Attachments Annotations c Validatie Last modified 2007 02 05 Size b 535 040 53 e Once the necessary attachments have been added to the Substance dataset press the Minimise button to go back to the Substance dataset B information a Nah ena a ary AMSA Dios ee Ly tion Modification history GC 5 IUCLIDS_substance doc 522 5 KB Remarks BW IUCLIDS_substance2 doc 522 5 KB Last modified 2007 02 05 Size b 535 040 Creating the updated dossier The procedure is exactly the same as for creating and exporting a new dossier However when you arrive at the screen of Additional administrative information during the creation of the dossier see point 5 of this manual step 6 you must tick the box Is the dossier an update e If the update is made as a result of a request or decision from the ECHA tick the box Further to a request decision from regulatory body and then press the T button under this section Use the box called decision number to indicate the number of the request or the dec
4. Set password Remarks e Now go to Assign Legal entities and press the button A query window will appear Type the name of the official Legal entity you want to assign and press Search 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 IUCLID Download web site can be assigned to a user Legal entity name CompanyB ton cum Show only active values Address Companys Helsinki name CompanyB eu Bakerstreet 1 123456 He Number of results 1 1 e Right click on the Legal entity you want to assign If the tick box for Active trade partner is not checked click on active trade partner to activate it Then press Assign 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 IUCLID Download web site can be assigned to a user Legal entity name CompanyB wem o S P E _ Showonly active values Search a Companyb Helsinki jname Companyb eu Bakerstreet 1 125456 He sw Print table EA Copy table mm Active trade partner Number of results 1 1 e Press 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 AE IUCLID 5 Warning e The next time you log in IUCLID 5 as that us
5. Descriptic 00 6835 7 retinol 66 26 68 C20H3S00 01 2286 5 retinyl palm 9 81 2 Ca6Hb002 04 155 8 retinaldehy 116 31 4 C40H2Z680 04 6844 2 retinyl acet 127 47 9 C22HS5202 250 3635 2 retinyl prop 7069 42 53 C235Hs402 435 6876 1 retinyl pival 20559 05 1 C25Hs80 2 269 43535 6 retinyl hept 36641 44 5 Cern42o2 Number of results Assign 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 pick list proposed under the No EC information available section Wo EC information available wsuneaon 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 when available CAS number and CAS name when available IUPAC name Molecular formula Molecular weight SMILES notation Structural formula File Edit Go Window Help Plugins C2 6 E 2 e eS Bl 4 ie iw E navigation n Query results Query 4m Reference substance Retinoline General information Reference substance name petinoline a EC
6. Classification E R2 Explosive Risk of explosion by shock friction fire or other sources of ignition Explosivenes E R3 Explosive Extreme risk of explosion by shock friction fire or other sources of ignition Oxidising properties R1 Explosive when dry Flammability Y R16 Explosive when mixed with oxidising substances Thermal stability Y R18 In use may form flammable explosive vapour air mixture R19 May form explosive peroxides Acute toxicity Y asa R4 Forms very sensitive explosive metallic compounds Acute toxicity irreversible w 2 damage after single exposure E R44 Risk of explosion if heated under confinement Repeated dose toxicity Y Irritation Corrosion Y o The second box of each property allows you to explain the reason why the substance is not classified even where data Is available Classification Se Pick list Reason for Classification 3 no classification Select avalue for i p as Explosiveness Explosiveness Y i p Oxidising properties Y TEITI Flammability Y Thermal stability Y data lacking inconclusive EC EL Acute toxicity v conclusive but not sufficient for classification Acute toxicity irreversible v damage after single exposure Repeated dose toxicity Y Irritat
7. Trade names flag P Synonyms SMILES notation Molecular formula InChl i Show only active values Contact person Person flags p Organisation Department Title e Highlight the Reference substance from the results and click Assign 24 Find the reference substance Reference substance name PPORD Reference substance CAS number EC Inventory EC name EC number CAS mame IUPAC name Synonyms SMILES notation CAS number Molecular formula Inchi T Showonly active values Search Name umbry Remarks Last UE PPORD Reference substance f IUC5 5b3b1bf5 0 2008 ee __ New E Assig Close ew O assiog J Sose Note It is possible that the Reference substance exists but you have not set it as Active In this case untick the Show only active values tick box to display both the Reference substances marked as active and inactive Right click on the non activated substance you want to assign Click on active trade partner to activate it Then press Assign lf you cannot find your Reference substance because it has not been created yet o Click on New to create a new Reference substance 25 Find the reference substance Reference substa
8. interned ates RESCH Recistration on site isolated intermediates above 1 todne REACH Registration transported isolated intermediates 1 1000 tonnes RESCH Registration transperted isolated intermediates abawe 1030 tones hote The dossiertern plate if usedto determ ne which substance endpoints wil be selected ay default The selectiod can Ee rod fied manually in a subsequent step o ths dossier creation 8 8 0 8 G jack ieta finish _gancel_ select adcssisr template 46 Note the dossier template selection helos to determine which IUCLID 5 section and endpoint studies will be part of your dossier O O Step 2 Define the filters Every item that matches these filters will be taken into account for the Dossier The Select all buttons allow you to select all possible items at once 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 PPORD notification appear ticked as only these documents will appear in your dossier The relevant sections suggested by IUCLID 5 for the creation of a PPORD dossier appear checked by default p Dossier creation wizard Verify the selected parts of sections 1 to 3 or deselect as appropriate Dossier template REACH PPORD Q i Substance Select the parts which should be included v 1 2 Composition v 1 3 Identifiers 1 4 Analytical
9. e Double click on 2 1 GHS e Press the Edit item button Ei and then the Add button to display the fields where the information on the C amp L can be specified 36 N Section wee General information C Not classified ba REACH PPORD i M ma SN 4 Implementation A M 5 Environmental fate and pathways J 5 1 Stability Classification so 5 1 1 Phototransformation in air Physical hazards bie Remarks 3 Manufacture use and exposure 4 Physical and chemical properties 5 1 2 Hydrolysis e 5 1 3 Phototransformation in wate Es i 5 1 4 Phototransformation in soil Explosives M ls 5 Hazard statement Reason for no classification 5 2 Biodegradation 4 Flammable gases amp 5 3 Bioaccumulation B 5 v E 5 4 Transport and distribution Flammable aerosols a M q M X M B 5 5 Environmental data 6 Ecotoxicological Information 5 6 Additional information an environ oxidizinggases SIT If Salko i Gases under pressure a M alf a H 7 Toxicological information oo 8 Analytical methods Flammable liquids q M a a M 11 Guidance on safe use 12 Literature search Femmabiesoias SAL a Ji So 13 Assessment Reports SS a S and mixtures Substances and mixtures Pyrophoric liquids a M Q M a M Prophork soits k aS and mixtures which in contact with water alr alr e
10. reach europa local reach secure company dossiers submission submit_dossier_intro Faces x gt IG gt Getting Started Q Latest Headlines PortableApps com R PortableApps com News ECHA Home gt Submit Dossier Intro gt Confirm Dossier Submission Company Confirm Dossier Submission Dossier type Process and Product Oriented Research and Development PPORD Submission type External dossier eatiheation Dossier file name CADocuments and Settings u07069 Desktop PPORDdossier1 j6z Joint subm Company name ChemicalCompany1 Organization Name ChemicalCompany1 Inventories Invoice Contact Name David Smith Raw data Purchase Order Large file access code Confirm submission Cancel submission e Your dossier has now been submitted The submission number generated for this submission is specified in the next screen REACH IT Completed Submission Mozilla Firefox File Edit Yiew History Bookmarks Tools Help z i http s reach pslb 04 reach europa local reach secure company dossiers submission submit_dossier_confirmation faces gt e Google Ke Ed Getting Started R Latest Headlines PortableApps com R PortableApps com News ECHA Home gt Submit Dossier Intro gt Dossier Submission Successful Pre SIEF Process and Product Oriented Research and Development PPORD notification submission You are connected as on beha
11. 9 of the IUCLID 5 Substance dataset can be provided as an exact or approximate tonnage or as a tonnage range It is however important to provide as specific tonnage as possible 35 o You can also add in the remarks field additional information you consider relevant for the PPORD notification dossier such as the Research and Development programme This information can be provided as an attachment document using the button here you can only attach one file if you wish to attach several files please use the procedure described in this manual under Attach several files as additional information in point 7 Updating a dossier Product and process oriented research and development y a sl Reaction mass PPORD m Name Reaction mass PPORD Medicinal product for human or veterinary use Substance not placed on the market Estimated quantity ls E Metric tonnes v Remarks R amp D program is in attached file Document Section 2 Classification and Labelling The available information on the classification and labelling C amp L for your substance should be reported in Section 2 2 DSD DPS of the IUCLID 5 Section tree in accordance with Directive 67 548 EEC Note however that from the 1 December 2010 the C amp L will have to be reported in Section 2 1 GSH of the IUCLID 5 Section tree in accordance with the Global Harmonised System 2 1 Global Harmonised System
12. External Dossier External dossiers Internal dossiers Here you can submit a PPORD notification dossier If you want to create your notification dossier online please use the Internal dossier submission tool click on the tab Internal dossiers on this webpage Process and Product Oriented Research and Development PPORD notification submission Please pick here using the Browse button the file which contains your dossier your file should have been created using IUCLID 5 and have the extension i5z File name CADocuments and Settings u07069 Desktop PPORDdossierl i52z Browse Access code for large files Dossier file cannot exceed the maximurn size of 20 MBytes If you would like to submit files larger than this limit please request a one time access code using the following link request access code The Agency will check your request and may grant your upload by sending this one time access code to your personal message box This process may take up to 24 hours Please note that in case you submit a dossier exceeding 20 Mbytes without specifying an access code your dossier submission will fail If you have an access code for a large dossier please enter it here Large file access code Invoices e Click on Confirm submission 59 REACH IT Submit External Dossier Mozilla Firefox File Edit View History Bookmarks Tools Help Google SJ k v E tt http s reach pslb 04
13. address name 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 IUCLIDS Microsoft Internet Explorer provided by ECHA File Edit Yiew Favorites Tools Help Q sex gt B a Search 5 Favorites E2 A te a rel 33 Address El http fecbwbiuS jrc itfindex php fuseaction home showAddLeox2 amp type private i Go IUCLIDS Bal EUROPEAN COMMISSION Home IUCLID 5 Project Get IUCLID 5 Get Support Pre Registration News About Us Welcome name surname usernamel Logout English en 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 Company B Department Regulatory affairs Title Mr First name Name Last name Surname Phone number 123456769 Mobile number 050123456789 Fax number 129876543 i E Mai
14. by user Dossier submission remark Type of submission Submission update iis the submission an update Last submission number Reason for updating Further to a request decision from regulatory body Spontaneous update gt 8 5 8 8 8 a Enter administrative information e A window informs about the success of the import When pressing the View dossier button the dossier will be displayed You can nowviewthe dossier or close this wizard L View dossier Close wizard 48 6 EXPORTING APPORD DOSSIER The PPORD dossier needs to be exported in order to be sent to the ECHA via REACH IT e Inthe main screen click in the dossier icon or in view J T 2 Open sa Print Expor b Create dossier Delete Delete Thr e The 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 press next Export assistant Annotation can be included into the export file amp Annotation export gt export without annotations _ export with all related annotations C export only related annotations 8 8 lt Back A E Cancel Additional export documents 49 In the next screen press the disk icon enter the name of your dossier and specify the location where you want
15. 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 hitp 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 http iuclid eu Click on the Get IUCLID 5 tab and sign in with your username and password You will then see the following screen A UCLIDS Microsoft Internet Explorer provided by ECHA File Edit View Favorites Tools Help we Q sxx K gt x a EA no Search JY Favorites amp 2 s gt m rel 33 Address ES http ecbwbiuS jrc itfindex php Fuseaction home login amp type public Welcome Steven Buchanan StevenBuchanan Logout IVCLID 5 E INTERNATIONAL UNIFORM CHEMICAL INFORMATION DATABASE English en M pa 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 IUCLIDS 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 cr
16. inventory ia Anue gr EC name retinol No EC information available Justification M Reference substance information a CAS information CAS number 68 26 8 q Te O O IUPAC name Description O OOOO A For the structural formula go to Structural formula under Molecular and structural information and press the Add button You can then upload an image file with the structural formula Molecular and structural information Molecular formula Molecular weight range SMILES notation Inch Structural formula al Inform ation Remarks jig Load ia in My Computer Open Ed C wo7102 Image preview a My Network Places C My Network Places C Shortcut to general on s echa vpsv O4Data 0 File Mame Files of Type Images gif jpg jpeg prgy 3 CREATING A SUBSTANCE DATASET To create a PPORD notification 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 erar eee eee Substance P i Create and update substance related information gee MES es New Update if e Type the name of your substance for which you are conducting PPORD activities on The name can be anything but it i
17. need to re type again all your substance data e Inthe main screen go to Tasks and press Update under Substance e Select from the list the substance for which you wish to submit new information and double click on it Now click on the tab Section tree and go to the relevant section that you wish to update Edit the necessary sections by pressing the Edit item button Query results Section tree 0 Related Information 1 General Information p 1 1 Identification 1 2 Composition 1 3 Identifiers 1 4 Analytical information i 1 8 Recipients rs 1 9 Product and process oriented rest 2 Classificatigy and Labelling E 2 1 GHS 7 2 2 DSD DPD e 3 Manufacture use and exposure 3 3 Sites H 4 Physical and chemical properties Estimate Attaching files as additional information e At the bottom of the Substance dataset screen a window called Information is minimised by default Press the H button to maximise it 51 Rueryrestits section tree Product and process oriented research and development REACH PPORD 0 Related Information 1 General Information 1 1 Identification 0 1 2 Composition 7 1 3 Identifiers 1 4 Analytical information Medicinal product for human or veterinary use C Substance not placed on the market Estimated quantity
18. number The number or identifier of the PORD notification corresponding to the PPORD to be notified to the ECHA should be specified in the ID field This number should be a unique identifier of the PORD that was provided by the MS CA Finally the country where the PORD notification was made should be indicated in the Remarks field It is recommended that the name of the country is given in English language i e Austria Belgium Bulgaria Cyprus Czech Republic Germany Denmark Estonia Finland France United Kingdom Greece Hungary Ireland Italy Lithuania Luxembourg Latvia Malta Netherlands Poland Portugal Romania Spain Sweden Slovenia or Slovakia For instance a PORD notification made in Germany which was attributed the number 4567 07 by the German MS CA should be reported as follows E Regulatory programme identifier Edit the regulatory programme identifier kis ID 4567 r07 OF Cancel By pressing OK in the Regulatory programme identifier window the PORD notification number will appear in the list of regulatory identifiers 32 Query results Section tree identiiers Regulatory programme identifiers EY j Flags Regulatory programme Remarks H 0 Related Information S 1 General Information 7 1 1 Identification 1 2 Composition j other PORD 4567 07 Germany a t gt 1 4 Analytical information
19. or enter an asterisk in one of the boxes and press enter to see all the available Legal entities 34 Name Remarks Legal entity name PPORD Town Country Official legal entity M v Show only active values E mail e E7 PPORD customer i Number of results 171 New Select the Legal entity of your customer from the list and press Assign Note that you will not be able to do so if you did not check the box Active trade partner during the creation of the Legal entity where you stored the information of your customer You may also provide additional information in the Remarks field You have now assigned one customer to the Substance dataset To report more than one customer for the PPORD reiterate the procedure described above as many times as needed 1 9 Product and process oriented research and development In the Substance dataset section tree double click on 1 9 Product and process oriented research and development Then press the Edit item button Ei By pressing the IP button you can now include the following information o a name for the PPORD activities for which the notification is prepared o the estimated quantity of your substance You must report the estimated quantity of the substance to be manufactured imported or used in the production of an article for the purpose of PPORD for the calendar year of the notification This estimation to be documented in section 1
20. A eel i Specific effect Route of exposure Effects on or M 7 M 7 via lactation Specific target organ toxicity single anti STOT single exp cat 2 Hazard statement Reason for no classification peal i STOT single exp c M a M N M Affected organs Route of exposure Specific target organ toxicity repeated R J p Hazard statement Reason for no classification Is Ie Specific target organ toxicity repeated P For Labelling you will find a pick list where you can state the Signal word in your labelling Labelling Signal word ME Pick list x Hazard statements Z Additional precautionary statements no signal word Additional labelling requirements C cme Press the button next to Hazard statements Additional precautionary statements Additional labelling requirements Specific concentration limits and Notes to access the pick up lists from which you can select the labelling 39 Hazard statements Hazard statements H301 Toxic if swallowed Aduiliveial eat Addilional precaulionary slalemenls EE Ce Na Precautionary statement p g Keep out of reach of children Additional text Additional labelling requirements E a E Additiona
21. Annex II IUCLID5 manual for the preparation of PPORD notification dossiers Index INTRODUCTION meer metres ety me ie ne time ere te eRe net ie ene ea eae mee ane eer 3 ls 2 ssl 7 lt M ol 0 cc nee ene re one ne ee eA oe eae ee eee See eee eee 4 Creating additional official Legal entity ccscccsscccsseccessecesseceeseeeeeseeeesseeesseeens 4 Downloading an official Legal entity and importing it into IUCLID 5 8 Creating a Legal entity for customers to be listed in a PPORD notification 12 2 REFERENCE SUBSTANCE Srann es ee ete 13 Querying updating Reference substances in your inventory ssesesseeessesesseeess 13 Creating a Reference substance 0 eee ccccccessccsececsseccesseecessecessescesssceesescesesseeseseneaees 16 3 CREATING A SUBSTANCE DATASET zuriena tical aS 20 4 ENTERING INFORMATION IN THE SUBSTANCE DATASET cccccecseseseteees 23 SECON Ts Genra ATOR MAGN oe E E E EE 23 1 1 identificalo N seana A anes 23 1 2 COMPOSI OM eecninesnea an a a a a hasten osedots 28 1 3 NCSU VENI GUS ash sacred iar gases aa doianesae ahabteast aialeaieideaen 30 1 4 Analytical information 3 355 oss dates tie teeceedaciarcce eA on eae aes 33 19 RECIDIEDIS ages eich secre tances eed icc eon eine eigenen 34 1 9 Product and process oriented research and development 35 Section 2 Classification and Labelling cece ccsscccsssccesseccsssecessecesssecesseeesteeeessees 36 2 1 Global Ha
22. Gel all reference substances has relurned 66600 lems IMs xceeds the Maximum number of SUU tems Skip the query the next time Never ask again Foxes LJ e Press the Query button File Edit Go Window Help Plugins oer D p Query resus pam Please open a document ar e A dialog box will appear Select Find Reference substances from the Select query pick list File Edit Go Window Help Plugins 2eogl HeR azals Select query result type 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 for and press Search You can use the asterisk as a wild card For example to get all the substances starting by phenol you would type phenol To get all the substances ending in amine you would type amine note that only 2 000 results will be shown p Query Select query result type W Reference substance Select query Find reference substances Query specific fields Reference substance name CAS number EC Inventory PO searen cancer e Double click on the Reference substance to display the related data SE IUCLID 5 File Edit Go Window Help Plugins COGlUH ZA S OH H R10 O18 Navigation o UC Query results Query gt E ethacridine 7 ethoxyacridine 3 9 diami Ple
23. Internet lt 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 on the Next button Z IUCLIDS Microsoft Internet Explorer provided by ECHA File Edit View Favorites Tools Help Q sec amp x a A Search P Favorites gA GS Se jw rel 33 Address Ea http ecbwbiuS jrc itfindex php Fuseaction home showAddLeox amp type private v Go L IUCLID 5 Ba EUROPEAN COMMISSION Home IUCLID 5 Project Get IUCLID 5 Get Support Pre Registration News About Us Welcome name surname usernamel Logout English en User Info Download LEO Creation Your LEOS 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 Company name CompanyB IUCLID 4 PIN if available DUNS number 963852741 VAT number BE0999999999 Organisation information Legal entity contact Phone number 123456789 Fax number 129876543 E Mail
24. address Address Postal code Town PPORD site town Region State Country w Phone 0987654321 Fax E mail ppordusesite companyname net Web site e Press Save You have now created a site for the PPORD notifier Legal entity Assigning a site e In the section tree of the substance dataset double click on 3 3 Sites and press the Edit item button e Press the button to display the fields for your production or use site e Press the button and a pop up window with all the sites assigned to your Legal entity will appear Select the site and press ok 44 Sites _ Production site _ Use site p Select a site reference e Tick the box below the Site field to indicate if it is a production or use site e f you need to indicate more production or use sites press the TP button and repeat the procedure described above Sections 4 to 13 Although not compulsory in sections 4 to 13 of IUCLID 5 it is possible to provide additional information about a substance in a PPORD dossier such as information on physico chemical toxicological or ecotoxicological properties and guidance on safe use The procedure on how to provide this information is thoroughly described in the IUCLID 5 guidance documents available at http iuclid eu 45 5 CREATING APPORD DOSSIER On the IUCLID 5 Task Panel select Update from Substance e All available S
25. aerosols q IS Oxidizing gases mz IS Gases under pressure S Flammable liquids Ne Flammable solids yj Self reactive substances and mixtures a Pyrophoric liquids lhe Pyrophoric solids Ihe Ma be h enale nm asch ee ee Hazard statement Reason for no classification ti conclusive but not sufficient for classification Lox Cancel iw iw b e W Pick list le f data lacking les inconclusive d w Lg f lhd Once completed press fl to save the changes For the fields of Carcinogenicity Germ cell mutagenicity Specific organ target toxicity single and Specific organ target toxicity repeated button in order to display the boxes you you will need to press the need to complete 38 Germ cell mutagenicity D avs Hazard statement Reason for no classification muta cat 1A Germ cell mutagenicity muta cat 1A A M may cause genetic M inconclusive A M Route of exposure Carcinogenicity 3 a gt carc cat 2 Hazard statement Reason for no classification Carcinogenicity carc cat 2 A M suspected of causi M conclusive but not sufficient for class M Route of exposure Hazard statement Reason for no classification Reproductive toxicity repr cat 14 A M suspected to dama s M data lacking
26. al entities created on the IUCLID web site for which a central management of company identifiers UUID is available it enables to subsequently identify the company in a unequivocally manner In general companies owning and or submitting the data or the dossiers should be official Legal entities non official Legal entities created directly in IUCLID 5 for which there is no central management on the IUCLID web site of company identifiers These should be used only in cases where an unequivocally identification of companies is not critical e g for reporting information on a non EU manufacturer It is however recommended to use as much as possible the official Legal entities obtained from the IUCLID web site or directly from the companies owning them For exemption under REACH due to PPORD the manufacturer or importer or producer of articles must notify the European Chemicals Agency ECHA of certain information in particular his own contact details and those of his customers 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 PPORD notifier either the manufacturer or importer or producer of articles for the substance on which the PPORD activity takes place For the PPORD customers it is recommended to also get from them or create on their behalf on the IUCLID 5 web site official Legal entities for a better management of the contact details The
27. ase open a document W ethacridine lactate 2 hydroxypropanoic E ethambutol 2 2 ethane 1 2 diyldiiming W ethane ethane 74 84 0 E ethane 1 2 diol ethylene glycol 107 2 ww ethane 1 2 disulphonic acid compound E ethane 1 2 disulphonic acid compound wy ethane 1 2 dithiol ethane 1 2 dithiol ea ethane 1 2 diyl palmitate ethane 1 2 di w ethane 1 2 diylbis dichloromethylsilane sai ethanesulphonic acid ethanesulfonic aci w ethanesulphonyl chloride ethanesulfony Ti ethanethin athanethin IEP w ethaverine hydrochloride 1 3 4 dietho ea ethenzamide 2 ethoxybenzamide 938 Ea ethiazide 6 chloro 3 ethyl 3 4 dihydro sai ethinamate 1 ethynylcyclohexyl carbam Ea ethinylestradiol 17 ethynylestra 1 3 5 W ethion 0 0 0 0 tetraethy 5 5 methyle Ea ethionamide 2 ethylpyridine 4 carboth E ethisterone 17 hydroxypregn 4 en 20 w ethoate methyl 2 ethylamino 2 0x E ethoheptazine ethyl 1 methyl 4 phenyl bs 3 ethomoxane hydrochloride N 6 ethox sf ethosuximide 3 ethyl 3 methylpyrrolid a B information n W Ej s 2 Win wW 2 Mic gt C4 Cri y p IUCLIOD 5 4 untitle e Check the data on the Reference substance To update add any information on the Reference substance press the Edit item button i in the toolbar on the top of the screen edit the information on the Reference substance and save the changes Creating a Reference substance lf you do not find
28. bed above under points 5 and 6 of the manual 55 8 SUBMITTING APPORD DOSSSIER TO ECHA The submission of a PPORD notification dossier prepared using IUCLID 5 should be submitted to the ECHA using REACH IT by the PPORD notifier For this purpose you will need go to the REACH IT website sign up unless already done as the notifier of the PPORD i e the manufacturer or importer or producer of articles for the substance on which the PPORD activity takes place and submit the PPORD notification dossier REACH IT will be available starting 1 June 2008 Sign up procedure If you do not have an account in REACH IT follow the instructions in this section e Click on sign up as a company z a Help AECHA _ Reach lT Welcome to REACH IT i t hla REACH IT provides an online platform to submit data and dossiers pre registration registration C amp L notification an chemicals It also allows the Agency and lv the dossiers The Agency will also use REACH IT to make non confidential information on chemicals accessible to public on its website ember States authorities to review What can you do If you already have an account you may login to the system Sp eg ee e 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 F
29. bility in organic solvents a A 4 18 Storage stability and reactivit 4 19 Stability thermal sunlight m oo 4 20 pH Sensitisation a 4 21 Dissociation constant H 4 22 Viscosity Carcinogenicity a l 4 23 Additional physico chemical i ae 5 Environmental fate and pathways S 5 1 Stability ol 5 1 1 Phototransformation in a 5 1 2 Hydrolysis 5 1 3 Phototransformation in H 5 1 4 Phototransformation in s E 5 2 Biodegradation P Oxidising properties Y Flammability Y Thermal stability Y P 2 P Acute toxicity ro Acute toxicity irreversible w damage after single exposure v v P P Repeated dose toxicity Irritation Corrosion Mutagenicity Genetic Toxicity a Toxicity to reproduction a fertility Toxicity to reproduction O N development Toxicity to reproduction a breastfed babies P P A A P P EO O O O EO O E0 Ww 6O ED EO O LO EO EO ED EO ED Eo EO v 40 e For every hazardous property there are two boxes with pick lists o The first one allows you to choose the classification in the pick list that opens when you press a hal button there are several options for classification ATP last update ME Select picklist values Remarks Select a value for Explosiveness Classification
30. cedure Signing up as a company is a simple process You will be guided through the following 5 steps O O User account Create your REACH IT user account Company information Provide general information on your company For consistency we recommend you to import the LEO created in the IUCLID 5 website which was linked to the substance for which the IUCLID 5 PPORD notification dossier was made Billing information Provide billing details for your company Contacts In this screen you can select the contact person for the PPORD dossier you intend to submit You can select among all the users from your Legal entity who have an account in REACH IT including yourself Validation Check the information you have provided and modify if necessary Login to REACH IT Once you have completed the sign up procedure you may login to REACH IT e Click on the link home to go back to the homepage 57 REACH IT Conclusion Mozilla Firefox File Edit View History Bookmarks Tools Help a ie X x G Gt B http s reach pslb 04 reach europa localfreach public signup register_4_validation faces amp G s00ale gt Getting Started amp Latest Headlines PortableApps com PortableApps com News ECHA i Company sign up gt Conclusion Your company and its first user account have been successfully crea
31. e that the substance for which the PPORD dossier is submitted is rightful in order to proceed further with the submission e Click on Proceed to continue Home gt Submit Dossier Intro Registration notification submission Here you can initiate the subrnission process for registration notification dossiers or reports or their updates To submit an update you should use the EF same process as for the first submission of your dossier report The updated version should contain all previously submitted valid information and the updated one please refer to relevant guidance documents Phase in Information praia cata Select dossier type Product and P ocess Orientated Research and Development PPORD notification jM Registration fi Purchase Order p acknowledge that e In the following screen and under the external dossiers section select the IUCLID 5 PPORD notification dossier to be submitted Click on Browse select the corresponding PPORD file and click on submit dossier e Note that if your file is exceptionally large gt 20Mbytes you will need to request an access code from the ECHA that should be reported in this screen before clicking on submit request pe Search Help GECHA each ie You are connected as on behalf of ChemicalCompany Home gt Submit Dossier Intro gt Submit
32. eated LEOS User Info Download Create new LEO Your LEOs Legal notice Internet e Click on Create new LEO Z IUCLIDS Microsoft Internet Explorer proyided by ECHA File Edit View Favorites Tools Help ae Q sxx sc E gt x B JO Search JY Favorites amp A un 3 lc rel 33 Address ES http fecbwhbius jrc it index php fuseaction home show ddLeox amp kype private IUCLID INTERNATIONAL UNIFORM CHEMICAL INFORMATION DATABASE English en N v Eco Links Welcome Steven Buchanan StevenBuchanan Logout Bal EUROPEAN COMMISSION Home IUCLID 5 Project Get IVCLID 5 Get Support Pre Registration News About Us User Info Download LEO Creation Your LEOs 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 z Organisation information General IUCLID 4 PIN if available DUNS number Company name 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 v Done
33. er 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 HAGG ECHA SAT Espoo f Finland 38 EUROPEAN COMMISSION European Chemica 8 ChemicalCompany1 Helsinki Finland f CompanyB Helsinki Finland E HAGG ECHA SAT Espoo Finland h Creating a Legal entity for customers to be listed in a PPORD notification The Legal entity of the PPORD customers can be created directly from IUCLID 5 as non official Legal entity For further information please consult the IUCLID 5 End User manual available on the IUCLID 5 web site However it is recommended instead to get from the customers or create on their behalf on the IUCLID web site official Legal entities for a better management of the contact details To create and or import the official Legal entity of the PPORD customer follow the procedure described above Note that you do not need to assign the official Legal entity of the PPORD customers to your user account 2 REFERENCE SUBSTANCES To correctly identify the substance in a PPORD notification dossier it is important to understand the concept of substance Substance dataset and Reference substance in IUCLID 5 The PPORD notifica
34. f the research activities for which the PPORD notification dossier is prepared correspond to a PORD notification expiring on 1 June 2008 it is recommended that you report the corresponding PORD notification number as follows e Open the section 1 3 of the IUCLID 5 substance dataset by double clicking on 1 3 Identifiers and press the Edit item button 30 Query results Section tree Complete 4 E 0 Related Information 1 General Information 0 1 1 Identification e A 1 6 Sponsors 0 1 7 Suppliers I 1 8 Recipients i D 1 9 Product and process oriented res ae 2 Classification and Labelling H H 3 Manufacture use and exposure p e 4 Physical and chemical properties H 5 Environmental fate and pathways ae 6 Ecotoxicological Information 7 Toxicological information oA 8 Analytical methods oe 9 Residues in food and feedingstuffs He 10 Effectiveness against target organism m e 11 Guidance on safe use 12 Literature search i 13 Assessment Reports Identifiers Regulatory programme identifiers Regulatory programme Remarks Cie ae Other IT system identifiers iF Delete Remarks IT system 8 Delete Information T Information Ey Access 4 Consultation Attachments Annotations g Validation In the Regulatory programme identifiers select Add to edit the list of ident
35. iate Analytical information F Analytical methods iysvis spectra IR spectra NMR spectra and spectral data e Optical activity See attached file 33 Results of analysis Provide the analytical results used to characterise the substance such as spectral data UV IR NMR MS etc chromatographical data etc For each analysis press the Add button and enter the analysis type the tested substance the method used and any remark you consider relevant For every analysis you can also attach one file by pressing the button HPLC chromatography Tested substance Reaction mass PPORD commercial Method used See attached file Analysis type HPLC chromatography TRT a x Remarks 1 8 Recipients This section can be used to indicate the identity of all the customers involved in the PPORD activity including their names and addresses If you have not already imported the Legal entities of your customers or created them in IUCLID 5 please refer to the point 1 of this manual In the section tree of your Substance dataset double click on section 1 8 Recipients Press the Edit item button 4 Press the Add button A new box where you can enter the identity of your customer will appear Recipients Name ri Remarks y R2 e Press the Z button and the dialog to look for the Legal entities will appear Search your customer
36. ifiers A new window entitled Regulatory programme identifier appears on the screen Complete ale ed E 0 Related Information 1 General Information jon 9 1 1 Identification 1 2 Composition D 1 3 Identifiers O 1 4 Analytical information 0 1 5 Joint submission O 1 6 Sponsors gt 1 7 Suppliers O 1 8 Recipients i O 1 9 Product and process oriented res 2 Classification and Labelling 3 Manufacture use and exposure 4 Physical and chemical properties aS e e E 5 Environmental fate and pathways p e ae oe 6 Ecotoxicological Information 7 Toxicological information 8 Analytical methods 9 Residues in food and feedingstuffs pe 10 Effectiveness against target organism 11 Guidance on safe use 12 Literature search 13 Assessment Reports Identifiers Regulatory programme identifiers Regulatory programme Remarks p Regulatory programme identifier Add aregulatory programme identifier ID a Remarks 4 OK Cancel amp Information information Attachments Annotations Validation 31 In the new Regulatory programme identifier complete the fields as follows Other should first be selected as regulatory programme PORD should then be specified as the regulatory program in the subsequent field to clarify that the identifier to be provided corresponds to a PORD notification
37. 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 on New under Reference substance e Type 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 MC Reference substance assistant Create a new reference substance Reference substance name Retinoline Active reference substance e Select the Finish button the Reference Substance is created and an empty Reference substance section appears Click on the Edit item button Reference substance Retinoline m General information Reference substance name Retinoline i EC inventory Mo EC information available psiteion Reference substance information CAS information D T e fthe Reference substance is listed in the EC inventory EE IM A o Assign that entry by pressing 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 E Query Find information in the EC inventory Search EC number CAS number Molecular f
38. information 1 5 Joint submission 1 6 Sponsors 1 7 Suppliers 1 8 Recipients 1 9 Product and process oriented research and development 2 1 GHS 2 2 DSD DPD Ki lt lt I CJ Be i E 3 1 Technological process 3 2 Estimated quantities 3 3 Sites lt LJ LJ 3 4 Form inthe supply chain 3 5 Identified uses and exposure scenarios Pirin eu 3 6 Uses advised against 3 8 Exposure estimates 3 9 Biocidal information 3 7 Waste from production and use A 3 10 Application for authorisation of uses Required Optional Not required g 2 e B B GB w lt Back Next gt Cancel Select parts to filter Step 4 Select the level of detail for your endpoint study records Detail level of endpoint fields Select the detail level Basic level All fields excluding confidential test material information a All fields including confidential test material Information 47 o Step 5 check all related objects to ensure they will be part of your dossier Legal entity Reference substance s and endpoints o Step 6 If necessary enter additional administrative information concerning your dossier in case you are submitting an update of the dossier please see Updating a dossier in section 7 of this manual p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH PPORD Name given
39. ion f Corrosion Y Sensitisation Liw o fe Ga fal OK Cancel 4 Carcinonenicity e Press the button next to Hazard statements Additional precautionary statements Additional labelling requirements Specific concentration limits and Notes to access the pick lists from which you can select the labelling 41 Code 51 2 keep locked up and out of reac X on S 42 Section 3 Manufacture use and exposure 3 3 Sites You can use this section to indicate the sites where the PPORD activity of the notifier 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 on New under Sites e The Site assistant will appear Type the name of your site AP Site assistant Create a new cite Site name PPORD use site a Next gt Cancel Set name e Assign the Legal entity of the notifier to the site and press Finish p Site assistant Create anew site Legal entity owner Companys f Helsinki f Fin B lt Back ext gt Finish Cancel Set legal entity The Legal entity screen will appear Indicate the address of your site as well as the contact details and other IT identifiers 43 Other IT system identifiers Flags i system ID Wa Add Contact address Address flags P Address PPORD site
40. ision p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH PPORD of submission nission update e ls the submission an update t submission number i on for updating fa Further to arequest decision from regulatory body aa Pl Remarks A _ Spontaneous update 54 lf it is a spontaneous update tick the box Spontaneous update and then press the mP button under this section Click the arrow in the justification box and choose the reason for your update from the pick list p Dossier creation wizard X Enter additional administrative information concerning your dossier Dossier template REACH PPORD of submission ssion update Is the submission an update ubmission number for updating id Further to a request decision from regulatory body v Spontaneous update E p Pick lit x change in company identity change in company role in the supply chain change in composition of the substance change of tonnage band new identified uses o 8 8 8 3 5 B a i _ lt Back y newuses advised against Enter administrative information new knowledge of the risks for human health and or environment Ce The rest of the process for creating and exporting the dossier is identical to the procedure descri
41. l address name companyB eu Street Bakerstreet 1 Street 2 Postal code 123456 City Town Helsinki Region County Country Finland FI v Exit from LEO Creation Press Submit for creation of the Legal Entity For subsequent downloading of the Legal Entity XML file LEOX please go to section Your LEOs e Click on the Submit button You have now created your official Legal entity Downloading an official Legal entity and importing it into IUCLID 5 e Click on the Get IUCLID 5 tab from the IUCLID 5 home page and click on Your LEO link Z UCLID5 Microsoft Internet Explorer provided by ECHA File Edit view Favorites Tools Help Q sak amp x a A s Search 5 Favorites 4 bs oe wj lag rel 33 Address http ecbwbiuS jrc itfindex php Fuseaction home yourLeoxs amp type private v gt Go Welcome name surname usernamel Logout INTERNATION NIFORM CHEM MAT AGASE English en EA EUROPEAN COMMISSION Home IUCLID 5 Project Get IUCLID 5 Get Support Pre Registration News About Us User Info Download LEO Creation Your LEOQs Your LEOS Legabentity UUID Country Address Edit LEOX Name ae IUC5 OebS2fic e51f 4a77 a4ea Finland Helsinki Bakerstreet c t Downoad _ e059480a94d3 FI 1 le Legal notice e Click Download You will download a Legal entity Object or LEO that contains the information of your official Legal entity However it is stil
42. l not linked to your local IUCLID 5 installation e Inthe main task panel of IUCLID 5 click on 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 Please select the 5zfile to be imported Verify content carefully before importing Select the import file Overwrite mode O never G if newer than existing always ask user gt 288 Co j Cn Select import file Press Next in the following windows A confirmation message will appear Press Finish E Im port assistant Please select the i5zfile to be imported Verify content carefully before importing Document Endpoint Last modification Compared to data v 8 Companys 2008 04 16 21 0 o 88 Cege Cine Prepare the import Now you have to assign this new Entity to your user Go to User management in the main task panel Tools and admins tanon In the user management screen select the user to which you want to associate this new official Legal entity File Edit Go Window Help Flugin CO 4H4 2a S 4 RH F B e users Se PPORD notifier amp E PPORD notifier PRPORD notifier last login Never from Nowhere Suspended Super user Login name PPORD notifier Full mame
43. l text a Specific concentration limits concanraton rane e OO CE Hazard categories 2 2 DSD DPD e Press the Edit item button 4 and then the Add button to display Double click on 2 2 DSD PDP the fields to be filled for C amp L aT eT A section tree Classification and Labelling according 67 548 EEC DSD REACH PPORE y R Cnr E E 4 2 S te 4 Physical and chemical properties EEn 4 Appearance physical state col i 4 2 Melting point freezing point 4 3 Boiling point on 0 3 Mixtures a 1 General Information sof 1 1 Identification 0 1 2 Composition 0 1 3 Identifiers eo 1 4 Analytical information 1 8 Recipients i 1 9 Product and process oriented G 2 Classification and Labelling 2 2 DSD DPD General information Name 4 C Not classified sus Index number meree and exposure 3 Sites ATP last update Remarks 4 Lol 4 4 Density Classification e 4 5 Particle size distribution Gran Classification a H 4 6 Vapour pressure oo 4 7 Partition coefficient Explosiveness Y a o 4 8 Water solubility 4 9 Solubility in organic solvents 4 10 Surface tension e 4 11 Flash point H 4 12 Auto flammability oo 4 13 Flammability e 4 14 Explosiveness 4 15 Oxidising properties pe 4 16 Oxidation reduction potential 4 17 Sta
44. lf of ChemicalCompany Company Phase in Information Submission number aoe Your submission has received the following submission number WM120515 28 Please use this number for any subsequent communication concerning this dossier Please note that this number is NOT the reference number for your substance notification or registration number The reference number will be communicated to you after your dossier has passed the completeness check this also includes the payrnent of the fee if appropriate Joint submission As the submission process is not instantaneous and some verifications shall be performed you will be informed at a later time about the status of your dossier by an internal message please consult your message box At any time you can also consult the status of your dossier and the submission report in the menu Registration notification View registration notification and indicating your submission number to retrieve it e Subsequent information on the submission will be communicated as an internal message in the message box of the contact person for the dossier A link to the message box is available on the left 60
45. mits flammable gases oCo co M SS Health hazards Oxidising solids aly a f a r omor EO E ES S S corrosive to metals Hazard statement Reason for no classification i apa co L Bo e For each hazardous property you will find three different pick up menus o The first one allows you to enter the classification Classification Physical hazards Explosives Flammable gases Flammable aerosols Oxidizing gases Gases under pressure Flammable liquids Flammable solids Self reactive substances and mixtures WE Pick list o The second one allows you to enter a hazard statement 37 ssification a0 6S Hazard statement Explosives Flammable gases Flammable aerosols Is JE se OQxidizing gases i Iz Gases under pressure lhe Flammable liquids l Ihe l Flammable solids i Ihe a Sarin A E L tak et a is Del mounn x G Pick list da stable explosive n explosive mass explosion hazard explosive severe projection hazard explosive fire blast or projection hazard fire or projection hazard may explode in fire o The third one allows you to explain the reason why the substance has not been classified classification and hazard statement in accordance with the proposed Classification Physical hazards Explosives Fiammable gases i az Flammable
46. n 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 the 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 Reference substance directly from the Substance dataset see point 4 Querying updating Reference substances in your inventory e Click on Update under Reference substance on the main task panel 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 query panel can only show 500 items If you answer Yes this warning will not appear in the future If you answer No you will have the same warning every time you go to the Reference substance inventory Either way you will be redirected to the Reference substances screen Query limit reached The query
47. n installed please consult the IUCLID 5 web site available at http iuclid eu In 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 a PPORD notification dossier Step 1 Creating the Legal entities of the PPORD notifier and its customer s see Section 1 of the manual l Step 2 Creating the Reference substances related to the PPORD substance see Section 2 of the manual Step 3 Creating the Substance dataset for the PPORD substance see Section 3 of the manual Step 4 Entering information on the substance and the PPORD in the Substance dataset see Section 4 of the manual Step 5 Creating a PPORD notification dossier see Section 5 of the manual Step 6 Exporting the PPORD dossier from IUCLID 5 see Section 6 of the manual Step 7 Submiting the PPORD dossier to ECHA via REACH IT see Section 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 For the case of PPORD notifications it is necessary to define the Legal entities of the notifier and its customers There are two types of Legal entities that can be created in IUCLID 5 official Leg
48. nce name PPORD reference O O EC name PEE EC number CAS number i __ _ CAS name Sn IUPAC mame i Synonyms a SMILES notation f Molecular form ula V Show only active values Search UUI Y Remarks tast modification m Humber of results Assign Assign _ le EEE ll Close o You will be redirected to the Reference substance assistant see previous section of the manual o Type the name of the Reference substance you need to create igs sle Manufacturer importer Only representative Downstream user p Reference substance assistant substance Create anew reference substance Reference substance name PPORD reference sub stance Active reference substance Next gt Cancel o To specify the information on the new Reference substance press the blue arrow button 26 Reference substance E PPORD reference substance i i EC number EC name CAS number CAS name o You will be redirected to the screen for the new Reference substance Fill in all the possible fields as shown in point 3 of this manual o Press the Save button o Press button to go back to the Substance save when requested e Fill manually all the other boxes again you should complete as many as possible e The buttons next to the boxes Composition and Origin allow yo
49. nufacture use and exposure H 4 Physical and chemical properties H 5 Environmental fate and pathways H 6 Ecotoxicological Information G Show endpoint study records only H 7 Toxicological information J Show endpoint summaries only 8 Analytical methods 11 Guidance on safe use ily representative C Down 12 Literature search Copy contents to clipboard 13 Assessment Reports Collapse all W Update references W Show endpoint study records and summaries Reference substance Type of substance Composition Mi Origin fs Trade names e IUCLID 5 also offers the possibility of highlighting sections that are suggested for completion to assist in the preparation of a PPORD dossier Click on the button and select REACH PPORD from the pick list 21 amp Sectiontree eel meee is Er e 0 Related Information 0 1 Templates E 0 2 Categories hn a gt O 3 Mixtures kens D 1 1 Identification bie 7 1 2 Composition oof 4 1 3 Identifiers o 3 14 Analytical information 1 8 Recipients bas B 1 9 Product and process oriented rej e 2 Classification and Labelling re 2 1 GHS he hoof 4 2 2 DSD DPD e 3 Manufacture use and exposure Nie D 3 3 Sites REACH Registration 1 10 ches standard requirements REACH Registration 10 100 tonnes REACH Registration 100 1000 tonnes REACH Registration abo
50. 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 in the picture Degree of purity ee ee 28 Open the Constituents repeatable block by pressing the Add button oF e Assign a Reference substance to the newly created Constituent by pressing the AZ button as described above Search for the appropriate Reference substance and add it by selecting it and pressing Assign Create the substance you need if it was not created in advance e Indicate the typical concentration and the concentration range for every constituent in the same manner as indicated for the substance purity Constituents y R P ca 48 win Af iodocyclopentane iodocyclopentane 1556 18 9 R dih x CP Reference substance TE A iodocyclopentane iodocyclopentane 1556 18 9 gt EC number EC name 216 311 1 iodocyclopentane CAS number CAS name 1556 18 9 lt iodocyclopentane IUPAC name iodocyclopentane Typical concentration ca x 48 ETY x Concentration range gt x 47 lt x 49 156 yw x Remarks e f you need to specify more than one constituent click the Add button oF lt O in the relevant section and more boxes will appear Constituents CAS n
51. requently Asked Questions FAQ The REACH legal text Contact information e Site map Search the site Related links Public REACH information on chemicals Information about REACH on the Europa website e In 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 56 Contact Help BECHA 1 J h I Company sign up Terms and conditions signing up as a company is a simple process You will be quidedthrough the following 5 steps b oN User account Information for the first user is required Company information Provide general information on your company Billing information Provide billing details for your company 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 4 Need help with REACH IT or with this site Specific help on company registration e REACH IT Frequently Asked Questions FAQ Legal notice Contact information e Follow the sign up pro
52. rmonised System 0 cc ccccccscccseceeeeeeeeseeeeseeeeseeeeseeens 36 22 Bs BEB oo Jee en ean rE te ee eet rR Ree ATE Og eee 40 Section 3 Manufacture use ANd CXPOSUIE ee ecccccesccessecesseecesseceseecseesseeeeeneeees 43 So NES ee ey ee eee 43 SECCIONS ATO WD sakct hs heehalds cree iiasel ae a catdubiacaiua hiuraseamiatiesubieldat 45 CHEATING AUPPORD DOSSIER eure assstelandecmanttiecsererspaateaanieeannmeiarererien 46 EXPORTING A PPORD DOSSIER reeniri a A eae ae dees 49 UPDATING A DOSSIER rario bier eteicn sts iisian tas ends lecoriel dah aiaeadihebnetiahaleedandles 51 Updating Ihe TORI A TION seisne A NT 51 Attaching files as additional information c cccccccsscccescccessecceesseecessseeeesseeeeesseeeens 51 Creating the updated GOSSET arnasea a E A 54 SUBMITTING A PPORD DOSSSIER TO ECHA 0 occ cccccccssecesssecenseceenseeensees 56 SIGNUP DOC SE WNC acco acon a n eee aacem pa eaencm enue aotearoa 56 Bo a4 6 Bn my Ora ee nearer tee eee eRe er epee eee D7 Submission of a IUCLID 5 PPORD notification dossier c ee ceeecceeseeeeereeeees 58 INTRODUCTION The purpose of this guide is to assist in the preparation of product and process orientated research and development PPORD dossiers using IUCLID 5 The guide 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 bee
53. s logical to use an identifier that you are familiar with such as a trade name or chemical name a CAS number etc p Substance assistant Create a new substance Chemical name PPORD Reaction mass B f Set name e Click the Next button Select the Legal entity to be assigned to the Substance dataset This Legal entity must be the PPORD notifier p substance assistant Create a new substance Legal entity iE CompanyB Helsinki Fin n A lt Back i Finish Set legal entity l Remark if the Legal entity to be linked to the Substance dataset is not available from the pick up list a new Legal entity can be assigned to the user For this purpose please refer to the instruction provided in the Creating an official Legal 20 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 e The section tree of your Substance dataset is displayed in the navigation part of the screen to see the complete tree view press and select expand all from the pop up menu auey resus sectiontree Substance identification Chemical name PPORD Reaction mass 3 L i Leagal entity flags m E 0 Related Information Refresh RS Expand all Ctrl Plus H 1 General Information 2 Classification and Labelling ES 3 Ma
54. tance from the list by double clicking on it Substance iden Chemical name Pec egal entity fiags Legal entity F ri Third party flags Third party i Role in the supp Role flags Role M Reference substi Tan nw eal ee we Then open the section tree and proceed to complete the necessary sections Double click in each section to open it and press the Edit item button in the upper part of the screen to complete the fields File Edit to Window Help Plugins fet Navigation a z E Query results Sectiontree Section 1 General information 1 1 Identification 23 Name of the substance e In Reference substance click on the substance to your substance A button to assign a Reference Reference substance e A query dialog appears Search for your Reference substance as described in point 2 of this manual Third party flags p Third party Role in the supply chain Find the reference substance Role flags P Role Manufacturer Importer Only representative Do Reference substance Reference substance name PPORD Reference substance CAS number EC Inventory EC name Type of substance Composition M EC number Origin M CAS number CAS name Trade names IUPAC name
55. ted You may now go to the home page and start working with REACH IT as user OWERTYUIOP You may also keep a trace of your company sign up by exporting your company sign up Click on the myt an hainw ta ovnare vourroamnany in iC iD evehonne forms port button below to export your company in IUCLID exchange format e Login into REACH IT using the user ID and password you specified in your user account Contact Help RECHA Reach Login Please provide your login information to enter REACH IT Fields marked with an asterisk are mandat ory User ID Password Enter the text shown 2 Can t read the text below Try another Sm Submission of a IUCLID 5 PPORD notification dossier e To submit a PPORD notification select on the left side Registration notification gt Submit a registration notification Contact Search Help BRECHA _ Reach S p Ei You are connected as on behalf of ChemicalCompanyt Home Company You have 0 unread message s in your message box Registration notification utilities e In the next screen select the appropriate dossier type Product and Process Oriented Research and Development PPORD notification In 58 addition you are required to acknowledg
56. tion dossier is prepared for a substance as defined under REACH Article 3 1 In IUCLID 5 the information related to that substance such as the identity of the substance its composition classification and labelling tonnage 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 so that the information can be re used in other datasets without having the need to retyping the data 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 I
57. to store it io Window H p Export assistant H H yy Select the folder and specify the name of the export file T AS appropriate select the checkbox for Copy protect and or Seal Query Note the finish button is enabled when afile name has been entered and all dossier information has been collected in the background Depending on the dossier and your system this may take some time i Specify the export file Substance 1 1 i 2 rr OA Ee Remarks 3 C Select the destination for the export file Lookin E Dara p File Name test PPORD dossier y Files of Type i5z IUCLID 5 data exchange container x cancel ubstance L ch I7 T t Substance 1 2 a a mo j Enter file name Now press Finish The dossier has now been exported to the location you specified a confirmation message will appear i AX Export completed Export process report 1 Export of 6 document s and 0 annoatation s completed 2 6 document s was were exported successfully 0 document s was were skipped 00 00 3 Export successful 50 7 UPDATING A DOSSIER Updating the information lf you need to submit further information on your PPORD notification be it as a result of a request for further information or because of the need to update the data sent in your previous application e g to communicate that the number of customers or the tonnage required have changed you do not
58. u to choose from pick lists e The button Add 4 allows you to create boxes 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 2 Contact person Person flags rs Organisation Tom parny E Department Regulatory affairs Title Mr First name First Name Last name Last Name Phone 125456 7890 Mobile 0501254567590 Fax 1209876545 E mail name surname CompnayB eu Address Bakerstreet 1 Address Postal code 125456 Town Helsinki p E P P P P P J P Pa Region f State emne OO O O Remarks 1 2 Composition e Click on section 1 2 Composition and press the Edit item button e Click the Add button e Write the name and a brief description of your substance Reaction mass of iodocyclopentane and cyclopentane 1 2 5 4 tetracarboxylic acid 3 p Mame Reaction mass of iadocyclopentane and cyclopentane 1 2 5 4 tetracarbaoxylic acid Brief description Multiconsituent substance for PPORD a 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 arrow buttons allow you to pick symbols or units from a pick list and the boxes allow you to type numbers In this
59. ubstances are displayed select the substance for which you want to create the PPORD dossier e Right click on a Substance in the query results list From the pop up menu select Create Dossier EEE Le i L gal entity flags PPORD Reaction mass E Create dossier Role flags e The Dossier creation wizard is displayed o Step 1 Select the Dossier template REACH PPORD Dossier creation wizard Select a dossier template waich meets your specific requirements regulaiory programme type of dessier tonnage band member sf ajoit submission etc Substance Dossier templates availakle for a substance Corr plete OECD SIDS Eiocides Active ingredients Elocides borida products Eiocides Substances of concern Endpoints aferm ation RESCH Annex w Authorisation RESCH Annex XV C amp L varnonisetion RESCH Annex XV Restriction REACH Application for aathsrisation RESCH C amp L notification READH C amp L notification nember o ajoin submission REA DH Downstream uze report PES H Metification of sLestance in aricle REA IA PRORD RESCH Recistration 1 20 tonnes physicochemica requirements REACH Recistration 1 20 tonnes standard requirements REACH Recistration 10 100 tonnes RESCH Recistration 100 1000 toanes REA TH Registration above 1000 tonnes REA IH Registration member of a joint submission general case REA TH Registration M mbe af a joint Submission
60. umber CAS name 3724 52 5 IUPAC name cyclopentane 1 2 3 4 tetracarboxylic acid ca 46 nfm lodocyclopentane iodocyclopentane 1556 18 9 R m f fi Reference substance IE iodocyclopentane iodocyclopentane 1556 18 9 I gt IFA EC number EC name 216 311 1 liodocyciopentane CAS number CAS name 1556 18 9 IUPAC name liodocyclopentane Typical concentration ca Y 48 5 usin Concentration range gt v 47 lt Y 49 ate zj Remarks zsdi Zz Ca 42 w w cyclopentane 1 2 3 4 tetracarboxylic acid cyclopentane 1 2 3 4 tetracarboxylic acid 3724 52 5 a Lal Reference substance tf cyclopentane 1 2 3 4 tetracarboxylic acid cyclopentane 1 2 3 4 tetracarboxylic acid 3724 52 5 gt 36 2 EC number EC name 223 074 8 cyclopentane 1 2 3 4 tetracarboxylic acid Typical concentration ca 42 xiaj Concentration range gt 41 lt 42 3 ajay i Remarks 29 e Follow the same procedure to complete the impurities and additives fields Impurities az Reference substance g NA Typical concentration Concentration range v Remarks Additives R i 2 Reference substance 4 B Function Typical concentration Concentration range Remarks v v 1 3 Identifiers In this section you can add identifiers for other regulatory programmes or IT systems In particular i
61. we 1000 tonnes El Downstream user REACH Registration member of a joint submission general case REACH Registration mem ber of a joint submission intermediates ype of substance Aeon er etic Composition w feaa 4 G ieee aea orain o S oi 4 2 Melting point freezing poirt aan J be P 4 3 Boiling point oli 4 4 Density ot 4 5 Particle size distribution Granul ay P 4 6 Vapour pressure SS ee 4 7 Partition coefficient o me 4 8 Water solubility fo Go Trade names Trade names flag e In the section tree the sections IUCLID 5 suggests as necessary for a PPORD dossier will appear marked in red or m The ones that IUCLID 5 consider optional for a PPORD ales are e green It is important to note that this is just for guidance You should refer to the legal text of the REACH regulation to understand fully your requirements 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 PPORD notifier you can enter data on the substance in this dataset The information requirement to be included in the Substance dataset is described in the REACH regulation Article 9 2 and the associated PPORD guidance available on the ECHA website http reach jrc it quidance en htm To retrieve the substance dataset you have already created press Update under Substance in the main task panel and select your subs
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