Home

What is a registration dossier?

1. Melting freezing point at 101 325 Pa Key value for chemical safety assessment Discussion A BISIA BIB PR IPR ATR RR BHAA 1 y ormal gt Agency FB a IB UIEFBSRBSIEE f 2g Attached document s fig ada Wat Boa Moveup Move down g an end point study record D ormaldehyde A al Development Foundatio ed Hong Kong Hong Kong Scroll File Edit Go Window Help cro CO lHulZalsl 30 2 Be a A down and E E ore add data Complete a faf E al rieidas K a Administrative Data 7i 0 Related Information H 1 General Information p 2 Classification and Labelling Select Create dossier from the Purpose flag 5 robust study summary used for classification yo as shortcut menu from a substance H 4 Physical and chemical properties Data waiving 5 H 5 Environmental fate and pathways Justification for i 6 Ecotoxicological Information data waiving O r Cate or m od u e B 6 1 Aquatic toxicity l t 6 1 1 Short term toxicity to fish Study result type 4 A Study period w ethano i ethano li r 6 1 2 Long term toxicity to fish Reliability a S w metha
2. O Thank you CMA Testing and Certification Your Reliable Quality Solution Partner Laboratories BR BABE HE
3. State form of the substance ure rties Remarks Related composition Classification Physical hazards Hazard statement Reason for no classification Explosives data lacking Flammable gases data lacking Flammable aerosols 4 G4 id data lacking Oxidising gases data lacking Gases under pressure data lacking Flammable liquids data lacking Flammable solids data lacking Self reactive substances data lacking and mixtures Pyrophoric liquids O LOLOLOLOUL data lacking Pyrophoric solids data lacking y Type v Substance q IUC5 f0e72e5e 37a3 45d3 9325 e7ed1d69ec80 48 CMA Industrial Development Foundation Limite v al esting pDoratories HAE IRE A gt ding DSD DPD information E IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong File Edit Go Window Help i Oo E E Section tree Complete es Toxicity to reproduction data lacking fertility 0 Related Information Toxicity to reproduction gt data lacking H 1 General Information development z 2 Classification and Labelling Toxicity to reproduction data lacking j 9 2 1 GHS breastfed babies 1 1 2 2 DSD DPD Environment data lacking 3 Manufacture use and exposure 4 Physi
4. se p Dossier creation wizard Enter additional administrative information concerning your dossier Query results Dossier template REACH Registration member of a joint submission general case Query gt w ethanol CMA Industrial Developme Name given by user w forma CMA Industrial Developme w formaldehyde CMA Industrial Deve Dossier submission remark w paraffin waxes CMA Industrial Deva amp Sodium CMA Industrial Developmet Type of submission Information provided by the lead on behalf of the member s C Chemical safety report C Guidance on safe use Review by an assessor Tonnage band als On site isolated intermediates tonnage band Transported isolated intermediates tonnage band Submission update oO Is the submission an update Registration dossier specific information Phasca im 3 V1170 The phase in status is mandatory DossierRecreationinfo phaseinstatus oO V1180 The tonnage band is mandatory DossierRecreationinfo tonnageband B 3 5 8 8 G 8 Bi Nex Enisi Cancel Enter administrative information Information 8 CMA Industrial Development Foundation Limite v IUCLID 5 2 0 File Edit Go Window Help CO Ha zs lt one craton wizard As appropriate select the checkbox for Copy protect Query results REACH Registration member
5. 14 Request for Information T Ez Ej amp i i amp TT eae Mutagenicity Genetic Toxicity data lacking IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong DEAR Eile Edit Go Window Help GOl Hul alol a ze al Toxicity to reproduction vi data lacking fertility Toxicity to reproduction l a M data lacking development Toxicity to reproduction q data lacking breastfed babies Environment z data lacking Labelling Use up arrow Indication of danger before adding next Risk phrases Safety phrases 51 2 keep locked up and out of reach of children Code Add a newitem Additional text Specific concentration limits formation E a yae 8 Type Substance q UUID IUCS f0e72e5e 37a3 45d3 9325 e7ed1d69ec80 a E AA inctarete ist Navainnmant Eriemnsatines I iniisa wl Information Modification history fy Access Consultation Attachments Annotations cj Validation A Testing d Certification boratories oe ey i 1 BE G IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong DAR Eile Edit Go Window Help SO elu 4 alal i a Query esits section
6. 7 2 reliable with restrictions 3 not reliable V 4 not assignable v any other v no realiability defined o 8855528 Your Reliable Q Select flags j IN CMA Testing and Certification Laboratories PS Br ABE HH o gt p Export assistant Verify the default settings or select other checkbox in order to specify the detail level to be included in the export file Dossier template Complete Detail level of endpoint fields Select the detail level Basic level All fields excluding confidential test material information All fields including confidential test material information amp B 8 8 8 G 8 8 sme Cae Your Reliable Select field level CMA Testing and Certification Laboratories Feit Fal IRER D tps Export assistant Verify the selected parts of sections 1 to 3 or deselect as appropriate Dossier template REACH Registration above 1000 tonnes x Substance P Select the parts which should be included Select all L 1 2 Composition A 1 3 Identifiers 1 4 Analytical information 1 5 Joint submission 1 6 Sponsors 1 7 Suppliers BSI NSE SE DBB DBE 1 8 Recipients 1 9 Product and process oriented research and development 2 1 GHS 2 2 DSD DPD y 3 1 Technological process 3 2 Estimated quantities 3 3 Sites 3 4 Form
7. CMA Testing and Certification Laboratories HA SIRE Hb ee Member dossier O gt Use the TCC plug in on your substance dataset gt Use Dissemination and Fee calculation plug in on dossier gt Run the TCC plug in again on your dossier Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EIRE gt Submit O gt Before submitting members have to join the joint submission in REACH IT gt Members can submit as soon as the lead has passed business rules e Members can follow the status of the lead dossier in REACH IT oa BRECHA tegen Sasons socs 1er large mes IUCLID i5z Dossier submission Your Reliable Quality Solution Partne1 CMA Testing and Certification Laboratories HA EIRE Hb What if member fails business rules o gt Most critical step in your registration process e Prepare your submission in advance of the deadline gt In case of a business rule failure e Your dossier is not accepted for processing e You will be informed through a message in REACH IT with details on the failure and instructions Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE hb n For all submissions company size gt SMEs benefit from a fee reduction in both the REACH and CLP regulations gt Company size will determine the invoice e Also o
8. Department a Title Composition ID L 2783d77d f5f8 4c8b a3ab 5237d0ba61a9 r First name Last name dues in food and feedingstuffs Phone d Effectiveness against target organisms 11 Guidance on safe use cow 12 Literature search 13 Assessment Reports 14 Request for Information Mobile q Fax Constituents E mail 5 Environmental fate and pathways 6 Ecotoxicological Information Impurities t 7 Toxicological information 8 Analytical methods 9 Residues in food and feedingstuffs Additives Add S u bstance E 10 Effectiveness against target organisms coo 11 Guidance on safe use t f m t 12 Literature search J u rl y n O r a IO n 13 Assessment Reports 14 Request for Information Address Address Postal code Town Region State Country Remarks formation Modification history Gy Access 7 Consultation Attachments Annotations c Validation Type Substance 4 Type 6 Substance UUID IUC5 4342bd9b 92e0 478e ab99 3023bc9c8c26 Dossier UUID 0 UUID IUC5 f0e72e5e 37a3 45d43 9325 e7ed1d69ec80 i Sealed Copy pro
9. EZ ethanol CMA Industrial Development Found w forma CMA Industrial Development Found formaldehyde CMA Industrial Development paraffin waxes CMA Industrial Developmen Please open a document Dossier templates available for a substance Complete Biocides Active ingredients Biocides Biocidal products Biocides Substances of concern CLP notification CLP Regulation CLH dossier Endpoints information OECD harmonised templates OECD SIDS REACH Annex XV Restriction REACH Annex XW SWHC REACH Application for authorisation REACH Downstream user report REACH Inquiry REACH Notification of substance in article REACH PPORD REACH Registration 1 10 tonnes physicochemical requirements REACH Registration 1 10 tonnes standard requirements REACH Registration 10 100 tonnes REACH Registration 100 1000 tonnes REACH Registration above 1000 tonnes REACH Registration member of ajoint submission general case REACH Registration member of ajoint submission intermediates REACH Registration on site isolated intermediates above 1 tonne REACH Registration transported isolated intermediates 1 1000 tonnes REACH Registration transported isolated intermediates above 1000 tonnes REACH Substance Evaluation Query CMA Industrial Developmet 1 Select tonnage e g REACH registration 100 1000 tonnes Bose oe Right click gt select create do
10. Subject Creation Date Expire Date Recipient cane Sl Check Failed 40 09 2010 11 09 User The related submission report Download submission report Full details on the outcome of the Completeness Check and its impact on your application can be found in the Communications which is available in REACH IT under the menu Home gt Submitted Dossiers gt Dossier Details under the tab Annotations This communication can be viewed in REACH IT by selecting the Annotations tab from the dossier details page CMA Testing and Certification Laboratories FTES Be HE RD i Your Reliable Quality Solution Partner Checklist 2 Technical completeness gt How should you react after a TCC failure e Ensure that you correct all the sections that were indicated as failing in the communication letter e Run the TCC tool plug in e Contact relevant helpdesk for assistance if needed e Resubmit the complete dossier before the deadline set by ECHA Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EIRE gt Checklist 3 Receiving the registration gt ECHA will issue the registration number when e Your dossier is considered technically complete and e The fee payment has been received in full gt You will receive the Decision letter containing your registration number through REACH IT Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EI
11. TT ss Pe eee S wanmi F Ssn k 7 H i 5 D i i j CMA Testing and Certification Laboratories Your Reliable Quality Solution Partner CMA Testing and Certification be Laboratories RAS IRER OOO Implementation and Support Programme to deal with the EU Regulation on Registration Evaluation Authorization and Restriction of Chemicals REACH TID SDF Project Ref No D09 002 006 IUCLID 5 WORKSHOP 17t December 2010 ere CMA Testing Mee HES ot ee Am oe SRhEMBHSS and Certification Taal HONG KONG _ ya a The Chinese Manufacturers Laboratories N WU SCIENCE amp R Association of Hong Kong AARRE PD TECHNOLOGY E m aR HE CMA Testing and Certification Your Reliable Quality Solution Partner Laboratories ic al IRER gt pagenda gt Preparing a registration dossier with IUCLID 5 Your Reliable Quality Solution Partner s CMA Testing and Certification Laboratories HA SIRE hb panat is a registration dossier gt Dossier Definition amp Characteristics e a copy of selected data elements from the different IUCLID elements such as Substance Template Category Reference substance Legal entity CMA Testing and Certification Laboratories HA SIRE Hb Your Reliable Quality Solution Partner pom t is a registration dossier gt Dossier Definition amp Characteristics
12. gt This enables the automatic treatment of your payment once it has been received by ECHA Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EIRE gt Checklist 1 Invoicing and fee payment OO gt Prepare your accounting department for ECHA s invoices e You can create ECHA as a client in your accounting system before receiving ECHA s invoices gt Updated Frequently Asked Questions on invoicing and payments are available in our website e They contain detailed advice for registrants and their accounting department on ECHA s invoicing and management of payments CMA Testing and Certification Laboratories HA EIRE gt Your Reliable Quality Solution Partner Checklist 2 Technical completeness gt Use TCC tool plug in before submitting your dossiers e TCC tool also includes most of business rules checks e Run the tool on your substance dataset e But also after creating your dossier BV gt Same tool is used at ECHA to check your dossiers Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE gt Checklist 2 Technical completeness gt In case of completeness check failure e You will receive a message in REACH IT e The message links to a letter with detailed list of failures and instructions on how to resubmit e ECHA will set a reasonable deadline e You remain legally on the market
13. co 8 Analytical methods Tonnage used for tonnes year 9 Residues in food and feedingstuffs research purposes a T Lj Information J Modification history Gy Access 77 Consultation Attachments Annotations Validation Type Substance q IUC5 f0e72e5e 37a3 45d3 9325 e7ed1d69ec80 a 38 CMA Industrial Develnnment Foundatinn limite w Limmurhan 1 2 a UUID CMA Testing and Certification Laboratories Your Reliable Quality Solution Partner Pc AR EH gt ow to report identified uses _ Identified uses RS Information on uses Uses by workers in industrial settings Flags IU number Identified u G 3 Manufacture use and exposure C 3 1 Technological process sional work ers Identified u Process cat Environmen Substance s Market sect Sector of en Subsequent Article cate Ex gical information cal methods 9 Residues in food and feedingstuffs uma st ng and Certification l off CMA Industrial Development Foundation Limite kimmvch Your Reliable Quality Solution Partner amp Laboratories BP Be ABE HH o gt eee Sections 4 13 substance endpoint data O e The Sections 4 1
14. d 2010 07 21 23 20 13 308 148 0 CONCAWE Paraffin waxes and Hydrocarbon w 2010 07 21 23 20 13 265 144 0 CONCAWE Hydrocarbon waxes petroleum c 2010 07 21 23 20 13 265 126 2 CONCAWE Hydrocarbon waxes petroleum a 2010 07 21 23 20 13 292 640 4 CONCAWE Paraffin waxes petroleum acid tr 2010 07 21 23 20 13 295 457 8 CONCAWE Paraffin waxes petroleum low m 2010 07 21 23 20 13 308 141 2 CONCAWE Paraffin waxes petroleum low m 2010 07 21 23 20 13 v v v INCAWE Paraffin waxes and Hydrocarbon we 2010 07 21 0 13 265 154 5 CONCAWE Paraffin waxes petroleum hydrot 2010 07 21 23 20 13 265 163 4 CONCAWE Hydrocarbon waxes petroleum h 2010 07 21 23 20 13 308 140 7 CONCAWE Paraffin waxes petroleum carbo 2010 07 21 23 20 13 265 145 6 CONCAWE Paraffin waxes petroleum clay tr 2010 07 21 23 20 13 295 458 3 CONCAWE Paraffin waxes and Hydrocarbon w 2010 07 21 23 20 13 e Bee Gee ee Oe ee 8 not exported because of filter settings a partially exported reduced information completely exported x cannot be exported error CMA Testing and Certification Your Reliable Seeaegceagrgeesr L lt seck J Cxer gt J Emish _ Limb Laboratories Select documents to be exported ne N HARIR EHD p Export assistant Select the folder and specify the name of
15. t e 11 Guidance on safe use 12 Literature search H 13 Assessment Reports 3 Manufacture use and exposure 4 Physical and chemical properties CMA Testing and Certification Laboratories AAR IRER D CMA Testing and Certification Laboratories Your Reliable Quality Solution Partner Your Reliable Quality Solution Partner MATRE D a me reating the lead dossier gt Critical elements dataset e Legal entity e Substance composition e Endpoint study records e Chemical safety report and guidance on safe use gt Use the TCC plug in on your substance dataset e You will be alerted of any lack of data e t also checks most of the business rules Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EIRE gt a n geating the lead dossier gt Create your dossier e Tonnage band of joint submission dossier template e Own tonnage band indicated in dossier header Basis for invoice Dossier header Tonnage band s of the lead registrant Dossier template Tonnage band Between 100 to 1000 tonnes year f tonnage band Version 2010 07 14 Transported isolated intermediates Name given by user Test tonnage band gt Use Dissemination and Fee calculation plug in on dossier gt Also run again the TCC plug in on your dossier CMA Testing and Certification Laboratories HA EIRE Hb Your Reliabl
16. 16 Completeness rules version 2 0 9 1 q u a 2 8 stack J cance J TCC result Piagins CMA Testing and Certification Laboratories HA EIRE hb V ting a E f i A o m ries Your Reliable Quality Solution Partner RS SARE d Your rr a Lead versus member dossier Lead versus member dossier gt Lead dossier Lead Member e All the requirements for the highest tonnage band within the quam 6 c GEE scion vee joint submission REACH Registration above 1000 tonnes af REACH Registration member of ajoint subi X M M paea i LEAD and the MEMBER 0 Related Information 1 General Information e e 2 Classification and Labelling e e H 0 Related Information a H 1 General Information gt Mem ber dossier 2 Classification and Labelling e Only limited information needed identification of company er ki m hvironmental fate an athwvay s and substance and information on manufacture and uses B a He 7 Toxicological information e Other information included in the dossier will be regarded 8 Analytical methods H 11 Guidance on safe use as an opt out 12 Literature search H 13 Assessment Reports E 3 Manufacture use and exposure E 4 Physical and chemical properties H H 5 Environmental fate and pathways me 6 Ecotoxicological Information H 7 Toxicological information 8 Analytical methods
17. 27 09 2010 15 51 O Show Yes Business Rules Check passed 27 09 2010 16 44 O Show No File under examination 79 Registration reg 27 09 2010 13 10 Delete Moe Message box folder Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EIRE Hb Checklist 1 Invoicing and fee payment OO gt Invoice will be sent once dossier has been accepted e Initial payment due date is indicated in invoice e f payment not received due date will be automatically extended gt Use Fee calculation plug in before submitting your dossiers gt Make arrangements with your accounting department CMA Testing and Certification Laboratories HA BE gt Your Reliable Quality Solution Partner Checklist 1 Invoicing and fee payment o gt Registration number cannot be issued before payment is received gt Ensure payment is made within extended due date e Otherwise the registration will be rejected Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories MARRE H Checklist 1 Invoicing and fee payment O gt Ensure a quick confirmation that the payment is successful by following these best practices e Reference number invoice number in the free text payment message field gt 8 digits e Single payment one invoice per payment transaction e SEPA Single Euro Payments Area payment e Pay exactly the invoiced amount
18. 4 11 Flash point 4 12 Auto flammability 4 13 Flammability 4 14 Explosiveness 4 15 Oxidising properties 4 16 Oxidation reduction potent 4 17 Stability in organic solvents 4 18 Storage stability and reacti 4 19 Stability thermal sunlight 4 20 pH 4 21 Dissociation constant 4 22 Viscosity 4 23 Additional physico chemic te 5 Environmental fate and pathways He 6 Ecotoxicological Information ae 7 Toxicological information 8 Analytical methods 9 Residues in food and feedingstuff ae 10 Effectiveness against target orga co 11 Guidance on safe use 12 Literature search Endpoint summary Boiling point Administrative Data Short description of key information Boiling poi w BP end point summary ees Z EEIP4 Attached document s if Delete 2 Move up Move down Information Type Endpoint summary Qa UUID IUC5 797ad8a8 16db 4438 8c67 237439d97533 q l g CMA Industrial Development Foundation Limite kimmychan ena E IUCLID 5 2 0 File Edit Go Window Help moos andadmimistanior E me Your Click template aE CMA Inducteis Navalanmant Foundation limite w ort template IUCLID 5 2 0 File Edit Go Window Help GOml He FE S 4 B Rna o heey resis Please open a document Query W Open Enter Se Print Delete Delete Right click and select ex
19. e Stored in the IUCLID 5 database e Read only snapshot of underlying data Cannot be edited e Unique identification number Dossier UUID in addition to original UUIDs of each individual record e Print to HTML feature e Export feature CMA Testing and Certification Laboratories HASIE A gt Your Reliable Quality Solution Partner ALLEL is a registration dossier gt Dossier Definition amp Characteristics e Administrative Information Name of the Dossier user defined Dossier submission remark e Type of submission e Specific information for Dossier registration e Ownership protection option Prevents Dossier ESRs ESSs records from being copied CMA Testing and Certification Laboratories HAE IRE A gt Your Reliable Quality Solution Partner What is a registration dossier Requirements are defined in Art 10 of the REACH proposal gt Technical dossier company identity amp substance identity manufacture amp uses guidance on safe use C amp L exposure information if applicable e study summaries robust study summaries proposals for testing e various statements gt Chemical safety report gt 10 tonnes CMA Testing and Certification Your Reliable Quality Solution Partner Laboratories BR BABE HR 0 hapaa Layer gt IUCLID 5 Raw Data Dossier data Annotations e Multiple data layers in IUCLID 5 ENTERING Data FREEZING Data COMM
20. of ajoint submission general case Query E w ethanol CMA Industrial Developme Ownership protection settings w forma CMA Industrial Developme o Copy protect exported endpoint study records summaries and additional information w formaldehyde CMA Industrial Deve This setting prevents the documents from being copied w paraffin waxes CMA Industrial Dewg amp Sodium CMA Industrial Developmer a a a 0 8 8 8 P Cee e CEmism Ownership protection o e D ee p Your 4 CMA Industrial Development Foundation Limite v Accessing the dossier from the front E IUCLID 5 2 0 File Edit Go Window Help Cola E IUCLID 5 2 0 Eile Edit Go Window Help allr RA BA NS B e s ae Dossier header Dossier template Name REACH Registration member of ajoint submission general case Version 2010 02 10 of CMA Industrial Develop gundation Lim Name given by user abc Dossier subject Name a Sodium CMA Industrial Development Foundation Limited Hong Kang Hong Kang a PIAA Substance Publicname x itting legal entity FM CMA Industrial Development Foundation Limited Hong Kong Hong Kong a PEIA l nfo rm ati O n er creation date time 2010 11 25 12 38 54 CST Dossier submission remark y Dossier access _ used in category Type of submission v Joint submission Data sel
21. protected Subset of original Sealed Copy protected Subset of original CMA Testing and Certification 3 CMA Industrial Development Foundation Limite v rtification Laboratories Your Laboratories fic Fa RE R b RA RIRE H b IUCLID 5 2 0 ethanol CMA Industrial Development Foundation Limited Hong Kong Hong Kong File Edit Go File Edit Go Window Help CO luual alal Navigation mr forma s evelopment Foundation Limited Hong Kong RE section tree Substance composition Complete Ea 0 Related Information Ge 1 General Information _ 0 1 4 Identification 0 L2 Composition Brief description 0 1 3 Identifiers 1 4 Analytical information H 0 1 5 Joint submission 4 fa D 1 6 Sponsors Degree of purity 0 1 7 Suppliers pP C 1 8 Recipients _ 1 1 9 Product and process oriented rese z zj 2 Classification and Labelling 3 Manufacture use and exposure H 4 Physical and chemical properties He He Window Help lopment Foundation Limited Hong Kong Hong K Contact person Person flags al Information ication and Labelling ture use and exposure nd chemical properties ental fate and pathways blogical Information sgical information Organisation Click on section tree to add substance properties Name
22. the export file As appropriate select the checkbox for Copy protect and or Seal Dossier template Complete Specify the export file Ownership protection settings m Copy protect exported endpoint study records summaries and additional information This setting prevents the documents from being copied Seal exported endpoint study records summaries and additional information This setting prevents the documents from being modified Remarks B 8 0 8 G a 0 O Enter file name NS See A KAJ EESBUEWER E GER UAE ESE Your Reliabl Cancel CMA Testing and Certification Laboratories PS Br ABE HH o gt gt Advanced tools CMA Testing and Certification Laboratories Your Reliable Quality Solution Partner MERRE HD dvanced Tools e Templates e Categories e Plug ins e Bulk Export Plug in e Migration tool Pre registration Plug in e SNIF Migration tool e Query Plug in e Helpsystem Plug in e CSR Plug in Technical Completeness Tool Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories AAR IRER D EUCLID 5 2 0 File Edit Go Window Help COfl HHR BZAl S RB B HR B GS moos and adinisistauols vo ae mplates New template need access A Testing d Certification boratories CMA Industrial Development Foundation Limite x 0
23. tree j Complete q EJ z yat al Development Foundation Limited Hong Kong 0 Related Information 1 General Information 2 Classification and Labelling D 2 1 GHs i 0 2 2 DSD DPD 3 Manufacture use and exposure C 3 1 Technological process 3 2 Estimated quantities 0 3 3 Sites Imported tonnes year E 3 4 Form in the supply chain 0 3 5 Identified uses 0 3 6 Uses advised against O 3 7 Waste from production and use 0 3 8 Exposure estimates 0 3 9 Biocidal information JP icen Eu REACH Year ee Add tonnage Manufactured tonnes year information Details on tonnages Tonnage for own use tonnes year Tonnage imported in article tonnes year tage gt y Tonnage used as intermediate under aT 0 3 10 Application for authorisation of u strictly controlled conditions transported z E 10 Effectiveness against target organisms Remarks 11 Guidance on safe use so 12 Literature search soo 13 Assessment Reports i 14 Request for Information E 4 Physical and chemical properties Tonnage used as intermediate under G 5 Environmental fate and pathways strictly controlled conditions on site sannesivear 6 Ecotoxicological Information Tonnage used in the 7 Toxicological information production of articles tonnes year
24. used for MSDS v not used for MSDS B B 5 8 8 0 8 8 Select flags CMA Testing and Certification Laboratories AAR IRER D poort Step 4 p Export assistant Verify default settings or clear checkboxes for properties for which the information shall not be exported Dossier template Complete Purpose flag Deselect all V key study v supporting study weight of evidence disregarded study K K K no purpose flag selected Data waiving Deselect all V study technically not feasible v study scientifically unjustified v exposure considerations v other justification V no data waiving selected amp B 8 5 8 G a 8 Your Reliable seecrass CMA Testing and Certification Laboratories PPS Sr AGE HH o gt xport Step 5 p Export assistant Verify default settings or clear checkboxes for properties for which the information shall not be exported Dossier template Complete Study result type Deselect all experimental result V experimental study planned V estimated by calculation v read across based on grouping of substances category approach read across from supporting substance structural analogue or surrogate 7 QSAR V any other v no data V no study result type selected Reliability Deselect all V 1 reliable without restriction
25. 1 5 Joint submission 0 1 6 Sponsors D 1 7 Suppliers Additives 0 1 8 Recipients 1 9 Product and process oriented rese 2 Classification and Labelling 3 Manufacture use and exposure 3 x P 5 Environmental fate and pathways 6 Ecotoxicological Information ae He G 4 Physical and chemical properties ee p e 7 Toxicological information 13 Assessment Reports 14 Request for Information Reference substance i y l so 8 Analytical methods Function 3 m E 9 Residues in food and feedingstuffs Typical concentration fH 10 Effectiveness against target organisms 7 co 11 Guidance on safe use Concentration range x zj y H 12 Literature search Remarks a _ this additive is considered relevant for the classification and labelling of the substance Use arrows to expand and contract sections tion a C information Modification history Ty Access 7 Consultation Attachments Annotations Validation Type Substance UUID IUCS5 f0e7 2e5e 37a3 45d3 9325 e7ed1d69ec80 Dossier UUID 0 Sealed Copy protected __ Subset of original 3E CMA Industrial Development Foundation Limite Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories ic al IRER
26. 2 45 53 CST Restriction of specific regulatory purposes EU BPD EU PPP EU REACH CA CEPA CA PCPA JP CSCL OECD HPVC US EPA HPVC US FIFRA US TSCA other Confidentiality CBI IP no PA Dossier creation date 2010 11 25 12 38 54 CST Dossier creation comment Created the dossier Dossier template R_JS_MBER i Dossier template version 2010 02 10 16 33 13 CST not printed because of filter settings i partially printed reduced information Dossier abc completely printed EJ cannovbeprintea terran uuID IUCS 252 7a26 c2 fb 4cff 8174 60f07b829495 Dossier UUID UCS 252c7a36 c2fb 4cff 8174 60f07bS39495 B A lt Back Author kimmy CMA Industrial Development Foundation Limited Hong Kong Hong Kong Select documents for printing Date 2010 11 25 12 38 54 CST Remarks Created the dossier E information eo Dossier header 3E CMA Industrial Deveinnment Fnundatinn imite w imepurhan Luo dw of Dossier template and Certification Name REACH Registration member of a joint submission general case on Laboratories Y ou version 2010 02 10 a gt N Your Reliable Quality Solution Partner ey ee S ee A Fi PED 458 HE Pv gt Import Export CMA Testing and Certification Laboratories HA EIRE gt Your Reliable Quality Solution Partner im port Export gt Import Export e Export e Import e Migration tool CMA Testing and Certification Laboratories HA EIRE Hb Your Reliable Qualit
27. 3 of IUCLID represent the format of the Technical Dossier as defined by Article 10 of REACH legislation e The Dossier must include the information specified in the Annexes VII to XI of REACH CMA Testing and Certification Laboratories HA EIRE Hb Your Reliable Quality Solution Partner ndpoints gt An ENDPOINT is an information requirement of data point regarding a substance Physico chemical properties Environmental date and behavior Ecotoxicological information Toxicological information Other specific information e g effectiveness against a target organism Additional information is provided like Guidance on safe use Information on literature search Attachment e g assessment reports Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE hb ndpoints e Section 4 Physico chemical properties melting poin density vapour pressure etc e Section 5 Environmental fate and pathways Stability biodegradation bioaccumulation transport and distribution information monitoring information e Section 6 Ecotoxicological information aquatic and terrestrial toxicity biological effects degradation products Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories MARRE H e Section 7 Toxicological information toxicokinetics acute toxicity genetic toxicity carcinoge
28. 9ec80 Dossier UUID 0 Sealed Copy protected Subset of original ff CMA Industrial Development Foundation Limite Your Reliable Quality Solution Partner kimmvrhan CMA Testing and Certification Laboratories AAR IRER D Eile Edit Go Window Help CO lWual2 alel S naviostion GE OE Section tree lg Complete Ea 0 Related Information B 1 General Information io be 1 1 Identification 1 2 Composition 0 1 3 Identifiers 1 4 Analytical information 0 1 5 Joint submission 0 1 6 Sponsors O L7 Suppliers 1 8 Recipients H D 1 9 Product and process oriented rese H 2 Classification and Labelling amp 3 Manufacture use and exposure E 4 Physical and chemical properties 5 Environmental fate and pathways 6 Ecotoxicological Information a 7 Toxicological information o 8 Analytical methods amp 9 Residues in food and feedingstuffs H 10 Effectiveness against target organisms 11 Guidance on safe use 12 Literature search 13 Assessment Reports 14 Request for Information Industrial Development Foundation Limited Hong Kan Suppliers LF Manufacturer Importer Formulator Name Remarks Only representation informa
29. Certification Your Reliable Quality Solution Partner Laboratories RAS IRE FA O echnical Completeness Tool aC IUCLID 5 2 0 Eile Edit Go Window Help Plugins GOnl Ha BOl S RB H mee nd N ENU i P D ch ih p j gt 9 Technical completeness check kad A The European Chemical Agency ECHA has developed this plug in to assist legal entities in verifying the Technical Completeness Chec x TCC of a dossier or a substance dataset according to Article 9 3 or 20 2 of the REACH Regulation Select document to check w Sodium CMA Industrial Development Foundation Limited Hong Kong Hong Kang p gt IRA LO PPORD notification a a Other dossier template UeiVariteries Phase in definition not applicable to PPORD notifications Phase in substance O Non phase in substance im Fee waiving not applicable to PPORD notifications at OyvYes No Submission update indicate reason for submission update if applicable Is the submission an update Spontaneous update ISJ ahd SISA a ms B Version check failed Press to configure B B B lt Back Next gt Finist Cancel Define check options Plugins na V Certification 3E CMA Industrial Development Foundation Limite v a atories O echnical Completeness Tool p Technical completeness check The European Chemical Ag
30. E 1 General Information i 2 Classification and Labelling i Jj 2 1 GHS if Highlight relevant information for tonnage band 2 2 DSD DPD amp 3 Manufacture use and exposure 0 3 1 Technological process _ 3 2 Estimated quantities im 3 3 Sites GB 3 4 Form in the supply chain 0 3 5 Identified uses 0 3 6 Uses advised against Details on tonnages E a 3 Tonnage for own use tonnes year 3 7 Waste from production and use Pod D 3 8 Exposure estimates Tonnage imported in article tonnes year m ae f 23 Pipeipal itoro e a Tonnage used as intermediate under 3 10 Application for authorisation of u strictly controlled conditions transported fonhesivear Ga 4 Physical and chemical properties Tonnage used as intermediate under H 5 Environmental fate and pathways strictly controlled conditions on site BOOKER Ean 6 Ecotoxicological Information Tonnage used in the 7 Toxicological information production of articles tonnes year 8 Analytical methods Tonnage used for H 9 Residues in food and feedingstuffs research purposes tonnessyeare H 10 Effectiveness against target organisms Remarks a coe 11 Guidance on safe use co 12 Literature search 13 Assessment Reports i 14 Request for Information 4 Information Modification history Type v Subs
31. ENTING Data Annotation layer CMA Testing and Certification Your Reliable Quality Solution Partner Laboratories AAR IRER D a Ba ata Layer gt IUCLID Data Layers e Raw Data Layer It s where the information is stored All the information entered into IUCLID5 is stored here and can be here modified deleted or updated e Dossier Layer It contains read only data The Dossier is a snapshot of a subset of the raw data selected by the user Dossiers cannot be modified CMA Testing and Certification Laboratories HA EIRE gt Your Reliable Quality Solution Partner o D ata Layer gt IUCLID Data Layers e Annotations All data objects can have annotations attached The annotations are stored on a separate layer and each annotation cannot exist on its own i e it needs a parent object like an endpoint study or a substance e XML Both data and dossiers can be exported in XML format by using IUCLID5 This happens in particular when Submitting Dossiers to the ECHA exchanging data between SIEF members Exported IUCLID5 files have the extension i5z which is just a compressed collection of XML files CMA Testing and Certification Laboratories amp HAE IRE A gt Your Reliable Quality Solution Partner C reating Dossier gt Creating a Dossier Create substance legal entit i 2 i Section 1 Section 2 M E a General info C amp L acre us
32. Note The dossier template is used to determine which endpoi modified manually in a subsequent step of the expor 8 5 8 8 8 2 8 Select a dossier template CMA Industrial Development Foundation ation Your Reliable Quality Solution Partner VA Laboratories Te IE h ort template AG IUCLID 5 2 0 File Edit Go Window Help Gomutan Inventories fa noos and adiiiisistiauol A ae Your Import template tl CMA Inductrial Navalonmant Foundation Limite w d data from template p IUCLID 5 2 0 Sodium CMA Industrial Development Foundation Limited Hong Kong Hong Kong File Edit Go Window Help ment Foundation Limited Hong Kang Hong Kong Templates Inherit Endpoint study records and summaries inherited from the following templates are only available in read only within this substance Modifications to the inherited data are only possible by going back to the template 1 exposure properties f 7 d gt Goto linktarget emplates will be copied into the substance Select templates in substance selection Click add highlight tree assign E information a Information UUID 1UC5 a88c2691 20be 4bb4 a2a6 ee01fd17656e q i ation Ei CMA Industrial Development Foundation Limite w Your R a pematcgories e A chemical category is a group of chemi
33. RE Hb Checklist 3 Receiving the registration RECHA ropean Chemicals Agency CompanyName Helsinki Today Street Street2 PostalCode Town Country Submission date SubmissionDate Submission number SubmissionNumber Decision number CommunicationNumber DECISION ON YOUR REGISTRATION UNDER REGULATION EC NO 1907 2006 Dear Sir Madam In accordance with Article 20 2 of Regulation EC No 1907 2006 the REACH Regulation the European Chemicals Agency ECHA has concluded the completeness check of your registration dossier for SubstanceName This registration by CompanyName includes a substance in quantities TonnageBand a transported isolated intermediate according to Article 15 of the REACH Regulation in quantities TOSIiTonnageBand an on site isolated intermediate according to Article 17 of the REACH Regulation in quantities OSIiTonnageBand The registration was considered complete The registration number for this registration ReferenceNumber The registration date for this registration ReferenceDate This registration entitles you to manufacture import this substance or if relevant use in the production of articles If however you have been informed by ECHA that a previous registrant has requested a 4 A Testing month extension of your waiting period you may only start to manufacture import or use the substance Certification Your Relial 4 months from the date of this decision orat
34. al Development Found Legal entity flags P Organisation paraffin waxes CMA Industrial Developmen paraffin waxes CMA Industrial Developmen Legal entity 3 CMA Industrial Development Foundation Limited Hong Kong Hong Kong Department amp Sodium CMA Industrial Development Found Third party flags P Title Third party First name ir Add in contact ae details Fax Role in the supply chain Role flags Mobile Role Manufacturer Importer Only representative Downstream user Reference substance Type of substance E mail Address Find reference substance e g using CAS number Address Composition Postal code Origin Town Trade names Region State Trade names flag Country Name Remarks Information E 5 p P X AE Information Modification history fy Access 77 Consultation Attachments Annotations 3 Validation Type Substance q Type Substance UUID IUC5 4342bd9b 92e0 478e ab99 3023bc9c8c26 UUID IUC5 4342bd9b 92e0 478e ab99 3023bc9c8c26 Dossier UUID 0 Dossier UUID 0 Sealed Copy
35. cal and chemical properties 5 Environmental fate and pathways e e e 6 Ecotoxicological Information e e e Mutagenicity Genetic Toxicity data lacking Labelling a ee g Indication of danger 7 Toxicological information 8 Analytical methods 9 Residues in food and feedingstuffs 10 Effectiveness against target organisms Risk phrases 11 Guidance on safe use 12 Literature search oo 13 Assessment Reports so 14 Request for Information Add risk phrases using E E E E S Safety phrases Specific concentration limits Information Type Substance UUID IUC5 f0e72e5e 37a3 45d3 9325 e7ed1d69ec80 isk and Safety phrases Quer resus Section tree Complete a Z 0 Related Information B 1 General Information 2 Classification and Labelling be J 2 1 CHS i 7 2 2 DSD DPD 3 Manufacture use and exposure 4 Physical and chemical properties 5 Environmental fate and pathways e e e 6 Ecotoxicological Information e e e 7 Toxicological information 8 Analytical methods 9 Residues in food and feedingstuffs 10 Effectiveness against target organisms 11 Guidance on safe use 12 Literature search 13 Assessment Reports
36. cals whose physicochemical and toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity e Achemical category is defined by a list of chemicals the category members and by a set of properties and or effects for which experimental and or estimated data are available or can be generated the category endpoints A chemical category can be represented in the form of a matrix e Data gaps in a chemical category can be filled by using various approaches including simple read across trend analysis interpolation and extrapolation and computational methods based on SARs QSARs A CMA Testing and Certification Laboratories HASIE A gt Your Reliable Quality Solution Partner M alegories e Real categories group of similar chemical substances used to identify and fill data gaps across the members of the category e Equivalent substances category used to group chemicals sharing the same information over a number of end points Real Equivalent category Category Endpoint Endpoint Endpoint Your Reliable Quality Solution Partner Substance Substance CMA Testing and Certification Laboratories HA EIRE Hb Bulk export tool O e The purpose of the Bulk Export tool is to allow a set of documents to be exported in bulk With this ply in you can for example export all the substance datasets available i
37. dentiality Select all CBI confidential business information IP intellectual property no PA not public available lt Not confidential Use restricted to selected regulatory programmes Select all EU BPD Biocidal Products Directive 98 8 EC EU PPP Plant Protection Products Directive 91 414 EEC EU REACH Registration Evaluation and Authorisation of Chemicals CA CEPA Existing Substances Program under CEPA CA PCPA Pest Control Products Act JP CSCL Chemical Substances Control Law OECD HPVC HPV Chemicals Programme US EPA HPVC HPV Chemical Challenge Programme US FIFRA Federal Insecticide Fungicide and Rodenticide Act US TSCA Toxic Substances Control Act Any other v No regulatory purpose CMA Testing and Certification Laboratories AAR IRER gt 8 B 5 5 6 G 8 Your Reliable 2 Select data protection flags Ceed ort Step 3 Your Reliable g Export assistant Verify default settings or clear checkboxes for properties for which the information shall not be exported Dossier template Complete Robust study summary Deselect all V robust study summary v not robust study summary Used for Classification Deselect all v used for classification v not used for classification Used for MSDS Deselect all v
38. ducts Act be part of the JP CSCL Chemical Substances Control Law dossier al flag OECD HP C HPV Chemicals Programme US EPA HPVC HPY Chemical Challenge Programme should be selected r US FIFRA Federal Insecticide Fungicide and Rodenticide Act O r the defau It US TSCA Toxic Substances Control Act Any other values should be No regulatory purpose used Dossisr eration vizand Note for a REACH dossier all information should be part of the dossier i e all flags should be selected or the default values should be used B B 5 0 5 5 8 sn Select data protection flags Your Reliable Quality Solution Partner ssier output page 2 IUCLID 5 2 0 File Edit Go Window Help Gogle Query results ethanol CMA Industrial Developme w forma CMA Industrial Developme formaldehyde CMA Industrial Deve w paraffin waxes CMA Industrial Dev amp Sodium CMA Industrial Developme p Dossier creation wizard Select all Confidentiality and Regulatory purpose flags or clear checkboxes for properties for which the information shall not be included into the dossier Dossier template REACH Registration member of a joint submission general case Confidentiality Select all CBI confidential business information IP int
39. e exposure Sections Sections Sections 4 8 9 10 11 13 CMA Testing and Certification Laboratories be KARIE Hb Your Reliable Quality Solution Partner ae reating Dossier gt Adding a new substance e Logon as appropriate user e g technical e Add new substance e Find substance in reference substance inventory e Add physical chemical property data e Add end point study data e Create dossier e Print dossier CMA Testing and Certification Laboratories HA SIRE Hb Your Reliable Quality Solution Partner in contact info aC IUCLID 5 2 0 ethanol CMA Industrial Development Foundation Limited Hong Kong Hong Kong File Edit Go Window Help CO lHe A2El sly Ano Be Navigation i ag Substance ethanol CMA Industrial Development Foundation Limited Hong Kang Hong Kong Query results Sectiontree W Add FE View Query a gt Contact person w ethanol CMA Industrial Development Found Personflags P forma CMA Industrial Development Found File Edit Go COG HR aalal4a Novigation Query resurs se Query Window Help a e eo Can use confidentiality flags if required Substance identification Chemical name ethanol Ea ethanol CMA Industrial Development Found Public name w forma CMA Industri
40. e Quality Solution Partner Oe 7 eate the Joint Submission Object gt Create JSO before submitting the lead dossier gt Easy process Follow the wizard e Identify substance e Give itaname e Select contact person gt Once created you will receive a token Home gt Create Joint Submission gt Success Company Joint Submission Contact Validation Pre registration Pre SIEF The joint submission was successfully created Online dossiers nae ae or Please keep track of the joint submission name and token to be used by other members of the joint submission Name Jointsubmission_silver ion 0 E on Classification and OK Labelling v g nw wheres wy AJWJVERUEBUEWER AE GER UAE ES td Lg eo Cw aeeti ee D istributing the token gt It is the responsibility of the lead to communicate the token to the members of the joint submission e lt has to be done outside REACH IT gt Members need the token to join the joint submission gt Once joined a member does not need the token anymore gt The lead can generate a new token at any time CMA Testing and Certification Laboratories HA SIRE Hb Your Reliable Quality Solution Partner Submit O gt The lead can submit the registration dossier as soon as the joint submission has been created in REACH IT gt The dossier will go through a series of preliminary checks e Virus check e File format validatio
41. ected for opt out Document Section Justification VOOS and adimitsitauoln ae gt Go to link target Information provided by the lead on behalf of the member s Chemical safety report _ Guidance on safe use _ Review by an assessor Your Infor of CMA Industrial Development Foundation Limite v rinting to html G IUCLID 5 2 0 513 Ele Edit go Window Help 2 E E c iProgram Files 1UCLIDSS 2 0 index html lt E tive Search 60 iHe 2 als ae EE ee File Edit View Favorites Tools Help fet ation j E Print to HTML x F 3 3 a v ER 3X E Ive rigy theise etteti dacunfentstorise ect eselecttasiappropriste qi Favorites J5 RNPFB112E Web Image M W Wiktionary the free dictionary W Wikipedia the free encyclo ECHA website Google hif 3 Google Yahoo Hong Kong JERE SE rana Dossier abe a GO mp gt Page gt Safety gt Toos R_JS_MBER Substance Sodium CW 2010 11 25 7 abc Documents selected for printing Print Filter Document Origin Endpoint Last modification v IA CMA Industrial Devel 2010 05 12 11 23 19 CS E ia Substance Sodium 2010 11 25 12 38 54 CS Sodium CMA Indust 2010 10 26 10 56 20 CS Rig ht cl ick gt INTERMATIONAL UNIPORM CHEMICAL INFORMATION DATABASE Printing Date 2010 11 25 1
42. ellectual property no PA not public available v Not confidential confidentiality options Use restricted to selected regulatory programmes EU BPD Biocidal Products Directive 98 8 EC EU PPP Plant Protection Products Directive 91 414 EEC REACH Registration Evaluation and Authorisation of Chemicals CA CEPA Existing Substances Program under CEPA CA PCPA Pest Control Products Act _ JP CSCL Chemical Substances Control Law OECD HPVC HPV Chemicals Programme US EPA HPVC HPV Chemical Challenge Programme US FIFRA Federal Insecticide Fungicide and Rodenticide Act US TSCA Toxic Substances Control Act C Any other No regulatory purpose Note for a REACH dossier all information should be part of the dossier i e all flags should be selected or the default values should be used Select REACH as output p p B p B g g B lt Back Next gt Finish Cancel Select data protection flags Hags IRE hid gt Creating a Dossier e Make a pre selection of data to be included in the Dossier E Vossier creation seau x Verify the selected parts of sections 1 to 3 or deselect as appropriate Vy h D Dossier template REACH Registration 1 10 tonnes standard requirements ise alidate the Dossier 3 Substance completeness Select the parts which should be
43. ency ECHA has developed this plug in to assist legal entities in verifying the Technical Completeness Check TCC of a dossier or a substance dataset according to Article 9 3 or 20 2 of the REACH Regulation joint Submission O No 8 Yes Role in the Joint submission Member of ajoint submission Tonnage band of the joint submission Registration dossier above 1000 tonnes Tonnage band of the member Tonnage band standard registration Between 100 to 1000 tonnes year M Transported isolated intermediate tonnage band Provided by lead V Guidance on safe use W Chemical Safety Report QO Lead registrant of ajoint submission In general only one dossier type must be selected either in the picklist Registration dossier or in the picklist Intermediate In exceptional case where the registrant would like to submit a combined dossier which would cover a standard registration as well as an intermediate use then an item in both picklists must be selected fe istration dossier Intermediates not applicable not applicabie B e a l lt Back z Back Next gt gt _Einis h B Sancel 1 You Define dossier options u AAR IRER D M Technical Completeness Tool CIUCLID 5 2 0 File Edit Go Window Help Plugins COfml HUM 2 a S 408 gt ans j gt 9 Technical completeness check The European Chemical Agency ECHA ha
44. gt int submission E IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong E BK Eile Edit Go Window Help CO f i He Zalsl ABI ol rial Development Foundation Limited Hong Kong sas wa Query results Section tree P ee e Joint submission Complete 4 v E S y Re RI 3 px E 0 Related Information B 1 General Information 1 1 Identification 0 1 2 Composition 1 3 Identifiers 1 4 Analytical information A C 1 6 Sponsors 7 1 7 Suppliers C 1 8 Recipients C 1 9 Product and process oriented rese 2 Classification and Labelling 3 Manufacture use and exposure 4 Physical and chemical properties 5 Environmental fate and pathways e e e e 6 Ecotoxicological Information e e HE m E E Ezi E 7 Toxicological information F 8 Analytical methods G 9 Residues in food and feedingstuffs H 10 Effectiveness against target organisms feo 11 Guidance on safe use 12 Literature search 13 Assessment Reports 14 Request for Information r General information Joint submission name Remarks Regulatory programme Lead Members JS name only mandatory info Type 4 Substance UUID IUCS f0e72e5e 37a3 45d3 9325 e7ed1d6
45. in the supply chain IBBBRBB 3 5 Identified uses 3 6 Uses advised against 3 7 Waste from production and use IDB 3 8 Exposure estimates SEKI SKIS SSNS 5 3 9 Biocidal information ma 3 10 Application for authorisation of uses C Required 7 Optional 7 Not required v 8 8 8 8 8 G 8 08 amp lt Back Next gt J finch Cancel Select parts to filter Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories AAR IRER D p Export assistant Verify the selected documents or select deselect as appropriate Dossier template Complete Documents selected for export Export Filter Document Origin al Last modification v E QPRF for HC5 SPARC PETROTOX ig ne 2010 07 24 21 58 50 m f E CONCAWE_QPRF_for_HC5_SPARC_PETROTOX_20100 2010 07 21 23 17 36 264 038 1 CONCAWE Paraffin waxes and Hydrocarbon w 2010 07 21 23 20 13 265 134 6 CONCAWE Hydrocarbon waxes petroleum c 2010 07 21 23 20 13 308 143 3 CONCAWE Paraffin waxes petroleum low em 2010 07 21 23 20 13 308 144 9 CONCAWE Paraffin waxes petroleum silicic 2010 07 21 23 20 13 308 142 868 CONCAWE Paraffin waxes petroleum low m 2010 07 21 23 20 13 308 145 4 CONCAWE Paraffin waxes and Hydrocarbon w 2010 07 21 23 20 13 285 095 9 CONCAWE Hydrocarbon waxes petroleum
46. included iv D 1 2 Composition ma v 1 3 Identifiers 4 Ej 1 4 Analytical information m r i KS 1 5 Joint submission C 1 6 Sponsors ma e Enter administrative data optional 1 7 Suppliers 1 8 Recipients D 1 9 Product and process oriented research and development C 2 1 GHS C 2 2 DSD DPD B 3 1 Technological process v v v Ka 0 3 2 Estimated quantities 3 3 Sites C 3 4 Form in the supply chain i fs K 3 5 Identified uses and exposure scenarios sc 8 O 3 6 Uses advised against C 3 7 Waste from production and use ma 3 8 Exposure estimates m lt I lt 3 9 Biocidal information m 3 10 Application for authorisation of uses C Required 7 Optional 7 Not required Your Reliable Quality Solution Partner 8 8 5 8 8 G a Select parts to filter IUCLID 5 2 0 File Edit Go Window Help COglHa e R navano Pace Query results Verify the selected parts of sections 1 to 3 or deselect as appropriate Dossier template REACH Registration member of a joint submission general case Query G Your ethanol CMA Industrial Developme w Substance w forma CMA Industrial Developme Select the parts which should be included formaldehyde CMA Industrial Deve w paraffin waxes CMA Industrial Deve Selec
47. kimmychan beer pa ce typ 53 A G IUCLID 5 2 0 File Edit Go Window Help eate an inherit template OOU alal alae e fet Navigation mis Complete a IS E ee z 3 Template abc G 4 Physical and chemical properties amp 5 Environmental fate and pathways te 6 Ecotoxicological Information Be 7 Toxicological information i 8 Analytical methods 9 Residues in food and feedingstuffs 10 Effectiveness against target organisms 11 Guidance on safe use 12 Literature search 13 Assessment Reports 14 Request for Information Template abc General information Template name abe lon of template Remarks l Legal entity flags P Legal entity CMA Industrial Development Foundation Limited Hong Kong Hong Kong q gt Provides access to sections 4 to 13 a HA BE Rb Add substance data sections 4 E IUCLID 5 2 0 abc File Edit Go Window Help Dak COml HwIZaAalS Aa Re2 Be fet Navigation Section tree Complete St gt Template abc 4 Physical and chemical properties 4 1 Appearance physical state 4 4 2 Melting point freezing point 4 3 Boiling point 8 Boiling poi 4 4 Density 4 5 Particle size distribution GF 4 6 Vapour pressure 4 7 Partition coefficient 4 8 Water solubility 4 9 Solubility in organic solvents 4 10 Surface tension
48. n e Business rules IUCLID i5z Dossier submission Your Reliable Quality Solution Partner What if lead fails business rules O gt Business rules are a set of administrative checks ensuring that ECHA has enough information to be able to process the dossier gt Most critical step in your registration process e Your dossier has to successfully pass before the deadline e Prepare your submission well in advance of the deadline Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EIRE Hb What if lead fails business rules O gt In case of a business rule failure e Your dossier is not accepted for processing e You will be informed through a message in REACH IT with details on the failure and instructions gt The lead will have to modify the dossier accordingly e Follow the instructions in the error message e Consult the specific manual on business rules failures e Contact relevant helpdesk for assistance if needed gt Members will not be able to submit until after the lead has passed business rules seg are Your Reliable Quality Solution Partner Laboratories Te BE h 0 Member dossier O gt Critical elements e Legal entity e Substance composition e Indicate whether lead is submitting CSR on your behalf or not gt Does the lead submit the CSR and or Guidance on Safe use on your behalf Your Reliable Quality Solution Partner
49. n 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 REACH Registration transported isolated intermediates 1 1000 tonnes r 5 x PEES REACH Registration transported isolated intermediates above 1000 tonnes 8 CMA Industrial Development Foundation Limite v kimmychan Note The dossier template is used to determine which substance endpoints will be selected by default The F selection can be modified manually in a subsequent step of the dossier creation CMA Testing and Certification Your Reliable Quality Solution Partner Laboratories Your Reliable Quality Solution Partner RAe IRER gt 8 8 5 5 5 5 a oe ee n Select a dossier template ossier output page 1 CIUCLID 5 2 0 File Edit Go CO l He z a Navigation E Dossier creation wizard F Select a dossier template which meets your specific requirements Query results regulatory programme type of dossier tonnage band member of a joint submission etc ethanol CMA Industrial Developme Substance w forma CMA Industrial Developme w formaldehyde CMA Industrial Deve w paraffin waxes CMA Industrial Devg amp Sodium Window Help File Edit Go Window Help Gogua Query Query results
50. n your IUCLID database at once e Another example is to export in one go all the dossiers for a given substance The user manual can be downloaded from the Get Support Documentation section of the IUCLID website Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE hb pacuery Plug in e The IUCLID 5 Query Tool provides easy access to predefined sets of business relevant information by extending the ways in which data can be queried in the IUCLD 5 database Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE Hb SR Plug in e The IUCLID 5 CSR plug in extracts data from a IUCLID 5 data set or dossier in order to prepare the Chemical Safety Report CSR The detailed user manual can be downloaded from the Get Support Documentation section of the IUCLID website CMA Testing e and Certification Your Reliable Quality Solution Partner Laboratories RA BE Rb echnical Completeness Tool e The aim of the Technical Completeness Check TCC plug in is to enable registrants and PPORD notifiers to check within their IUCLID installation or database the technical completeness of their dossiers or datasets prior a submission to ECHA via REACH IT The plug in also checks that the dossier or substance will be able to pass some of the business rules that can be found in REACH IT CMA Testing and
51. ne CMATCL S Export be Vossier erzation uird ER 6 ort term toxicity to aquati Select a dossier template which meets your specific requirements Short term toxicity to aquatic Rationale for reliability w N m ethylm ethana regulatory programme type of dossier tonnage band member of ajoint submission etc 6 1400 ici a incl deficiencies 6 1 5 Toxicity to aq gae and x Delete Delete 6 1 6 Toxicity to lants oth Data source i f Substance 6 1 7 Toxicit anisms R terence F uatic orga Dossier templates available for a substance Reference type Author Year Title Bibliographic s Testing labora Report no Owner company Company stud aaa FH Ean fa dette moveup BMovedown sea J inser nf Biocides Active ingredients Right click to add Follow the Dossier Creation Wizard Seaside ene Endpoints information end point study pes F that will guide you through the o REACH Application for authorisation REACH C amp L notification oss reference to same study p roces S REACH C amp L notification member of a joint submission a REACH Downstream user report REACH Notification of substance in article REACH PPORD 14 Request for Information e S I t D t pl t a i 7 A M elect a Vossier tempiate SERGE UIE es CEPA Materials and methods x REACH Registration 100 1000 tonnes REACH Registratio
52. ness against target organisms h 11 Guidance on safe use co 12 Literature search i 13 Assessment Reports 14 Request for Information Reference substance LF Function MI q Typical concentration gt gt Concentration range Mi gt X Remarks a this additive is considered relevant for the classification and labelling of the substance on Dossier UUID 0 Type Substance a UUID IUC5 f0e72e5e 37a3 4543 9325 e7ed1d69ec80 C Sealed l Copy protected Subset of original 48 CMA Industrial Development Foundation Limite w Your Reliable Quality Solution Partner C imormarion Modiiestionhistary Sy Access 2 Consultation 5 Attachments Annotations Ti Validation Use reference substance database CMA Testing and Certification Laboratories RAS IRER gt IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong File Go Window Help Edit anding contracting sections E Section vee Complete 0 Related Information G 1 General Information 9 1 2 Identification Constituents L2 Composition co 1 3 Identifiers 0 1 4 Analytical information Impurities O
53. nicity etc e Section 8 Analytical methods data on analytical methods for a substance in different matrixes e g air Soil biological tissues e Section 9 Residues in food and feedingstuffs data on residues in food and feedingstuffs for pesticides and biocides CMA Testing and Certification Laboratories HA EIRE gt Your Reliable Quality Solution Partner ndpoints Section 10 Effectiveness against target organisms only for substances with intended biocide properties Section 11 Guidance on safe use data first aid measures safe use guidance fire fighting measures handling storage and transport measures personal protection etc Section 12 Literature search details on any literature search can be here provided Section 13 Assessment reports the assessment reports are attached to this section Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA EIRE gt Displaying information relevant for afelol band E IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong E BR Eile Edit Go Window Help GCO Hwl Z2 alol a Alaa e all amp Substance formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Koi g ry j TOMASS Query results section tree gt eee e esate quantities Complete gt z ae R23 I 0 Related Information
54. ories em mi BRE Pb Checklist 4 Dissemination o gt Information from your registration dossier will be disseminated on the ECHA website gt Certain information can be claimed confidential gt Confidentiality claims must be justified e Confidentiality Justification Template gt Tools are available to determine which information will be disseminated e Manuals on the ECHA website DSM 15 amp 16 e IUCLID dissemination plug in Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE gt Checklist 5 Updating your registration OOO gt You need to keep your registration updated e Any change in composition of the substance e Change of tonnage band e New identified uses e Changes in the classification and labelling e Etc gt Therefore sufficient REACH resources need to be maintained CMA Testing and Certification Your Reliable Quality Solution Partner a Laboratories RETRED Post submission OOo Receipt ommunication on Submission Dossier cannot be accepted for further processing Virus XML checks Business Rules administrative check of the dossier Invoicing si a E Ss fe SD a E E E a a a lida ace Completeness Check CC i e Technical TCC Financial FCC no no yes yes Dossier Dossier accepted rejected Dossier ond Certification Your Reliable Quality Solution Partner Ss cepted Laboratories RAS IRER gt
55. port B information Please open a document Your oH CMA Industrial Development Foundation Limite v id data from template aF IUCLID 5 2 0 File Edit Go Window Help G0 leb el eals p Export assistant N ation Query results Select a dossier template which meets your specific requirements for exporting the documents Query Dossier templates available for a copy or inherit template Biocides Active ingredients Biocides Biocidal products Biocides Substances of concern CLP notification CLP Regulation CLH dossier Endpoints information OECD harmonised templates OECD SIDS REACH Annex X Restriction REACH Annex X SVHC REACH Application for authorisation REACH Downstream user report REACH Inquiry REACH Notification of substance in article REACH PPORD REACH Registration 1 10 tonnes physicochemical requirements REACH Registration 1 10 tonnes standard requirements REACH Registration 10 100 tonnes REACH Registration 100 1000 tonnes REACH Registration above 1000 tonnes REACH Registration member of ajoint submission general case REACH Registration member of ajoint submission intermediates REACH Registration on site isolated intermediates above 1 tonne REACH Registration transported isolated intermediates 1 10 REACH Registration transported isolated intermediates abo F 8 t t REACH Substance Evaluation O OW expor S eps
56. s developed this plug in to assist legal entities in verifying the Technical Completeness Check TCC of a dossier or a substance dataset according to Article 9 3 or 20 2 of the REACH Regulation 2 eSM a gt Filter Showa with type failure warning Section number Section name Endpoint name Failure description Type gt MVENIONES Section 1 1 Identification At least one role in the supply chain must be selected B TCC failure NB If you are a manufacturer you must also fill in Section 3 1 Technological process and 3 3 Sites including the address of each site i Section 1 1 Identification A reference substance must be provided B TCC failure Section 1 1 Identification Reference substance information is not complete Either Ex TCC failure IUPAC name or EC number or CAS number and CAS name must be provided in the corresponding IUCLID 5 fields It is not enough to provide required information only in the reference substance name Poolside EISi Section 1 1 Identification The reference substance must be updated If you indicate TCC failure a st mono constituent substance in section 1 1 under Type of substance Composition then the molecular formula A molecular weight and structural formula of the reference he substance must be indicated If you indicate multi a constituent substance in section 1 1 under Type of S b m it d i r TCC engine version 5 08 Business rules version 2 0
57. s of concern CLP notification CLP Regulation CLH dossier Endpoints information OECD harmonised templates OECD SIDS REACH Annex XV Restriction REACH Annex XV SVHC REACH Application for authorisation REACH Downstream user report REACH Inquiry REACH Notification of substance in article REACH PPORD REACH Registration 1 10 tonnes physicochemical requirements REACH Registration 1 10 tonnes standard requirements REACH Registration 10 100 tonnes REACH Registration 100 1000 tonnes REACH Registration above 1000 tonnes REACH Registration member of ajoint submission general case REACH Registration member of ajoint submission intermediates REACH Registration on site isolated intermediates above 1 tonne REACH Registration transported isolated intermediates 1 1000 tonnes REACH Registration transported isolated intermediates above 1000 tonnes REACH Substance Evaluation Note The dossier template is used to determine which endpoints will be selected by default The selection can be modified manually in a subsequent step of the export process Your Reliabl 2eoo85o8 Select a dossier template CMA Testing and Certification NA A Laboratories HAE IRE A gt ort Step 2 i X Export assistant x Select all Confidentiality and Regulatory purpose flags or clear checkboxes for properties for which the information shall not be exported Dossier template Complete f N Confi
58. ssier May need to login as admin 2 Click next to continue Note The dossier template is used to determine which substance endpoints will be selected by default The sele be modified manually in a subsequent step of the dossier creation a a 8 S8 5 a B Select a dossier template 4 CMA Industrial Development Foundation Limite w CMA Testing opting and Certification ification e e e a a MA Industrial Development Foundation Limite v kimmvrhali Your Reliable Quality Solution Partner Laboratories Your Kenapie Quality 501uuon Parmer Caboratories RPT Be RE HP D gt PT RE h gt Creating a Dossier e Specify the Confidentiality F ag S a n d R eg u ato ry Select all Confidentiality and Regulatory purpose flags or clear checkboxes P u rpo se F ag S no rd er to Deng WAC tds ean fi Ite th d ata th at y9 j wa nt e CBI confidential business information to be included into the Ba P no PA not public available Dossier panes Use restricted to selected regulatory programmes Note fo r a R EAC H EU BPD Biocidal Products Directive 98 8 EC EU PPP Plant Protection Products Directive 91 414 EEC Dossier al EU REACH Registration Evaluation and Authorisation of Chemicals l nfo rm atio n S h O u id CA CEPA Existing Substances Program under CEPA CA PCPA Pest Control Pro
59. t all amp Sodium CMA Industrial Developmer iv 1 2 Composition v 0 1 3 Identifiers 0 1 4 Analytical information iy C 1 5 Joint submission C 1 6 Sponsors C 1 7 Suppliers C 1 8 Recipients 3 ta 1 9 Product and process oriented research and development 0 2 1 GHS 0 2 2 DSD DPD v C 3 1 Technological process v 0 3 2 Estimated quantities W 0 3 3 Sites V C 3 4 Form in the supply chain iv 0 3 5 Identified uses IY 7 3 6 Uses advised against ivi 3 7 Waste from production and use 7 3 8 Exposure estimates v 3 9 biocidal information C 3 10 Application for authorisation of uses C Required 7 Optional 7 Not required 2 8 3 8 B B O EAS anh cancel Select parts to filter E information CMA Industrial Development Foundation Limite v sier output page 4 IUCLID 5 2 0 File Edit Go Window Help Gogle t Navigation sE Dossier creation wizard Verify the default settings or select other checkbox in order to specify the Query results detail level to be included in the dossier Query Dossier template REACH Registration member of a joint submission general case w ethanol CMA Industrial Developme Detail level of endpoint fields w forma CMA Industrial Developme formaldehyde CMA Industrial Deve r Select the de
60. tail level Basic level All fields excluding confidential test material information All fields including confidential test material information paraffin waxes CMA Industrial Deve amp Sodium CMA Industrial Developmer Note for a REACH dossier all fields should be selected amp 8 8 5 8 8 2 8 Select field level O e A Le 48 CMA Industrial Development Foundation Limite v sier output page 5 aC JUCLID 5 2 0 SEE CO M HE 2 a a sacs creation wizard bg al Verify the selected documents or select deselect as appropriate Query results Dossier template REACH Registration member of ajoint submission general case Query gt w ethanol CMA Industrial Developmen Documents selected for dossier creation w forma CMA Industrial Developme il Origin Endpoint Last modification formaldehyde CMA Industrial Devel i 2010 05 12 11 23 19 CS w paraffin waxes CMA Industrial Deva i se 2010 10 26 10 56 20 CS amp Sodium CMA Industrial Developmer not included because of filter settings fa partially included reduced information completely included go cannot be included error 8 B 8 5 8 8 8 8 Select the documents Your u Di E HE CMA Industrial Development Foundation Limite a S iA ry oh ei b gt AD IUCLID 5 2 0 Eile Edit Go Window Help a
61. tance UUID IUC5S f0e72e5e 37a3 45d3 9325 e7ed1d69ec80 of CMA Industrial Development Foundation Limite gt kimmychan uw ana c tttication Laboratories HAS IRE Hb Your Reliable Quality Solution Partner dding physical and chemical properties IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong File Edit Go Window Help eoOf Hal4 als I B lav e jery results Section tree TO i Ja t freezing point Administrative Data summaries for 4 Tepee H 5 Environmental fate and pathways 6 Ecotoxicological Information H 7 Toxicological information oo 8 Analytical methods 9 Residues in food and feedingstuffs H 10 Effectiveness against target organis 11 Guidance on safe use 0 Related Information a 1 General Information 2 Classification and Labelling 3 Manufacture use and exposure e 4 Physical and chemical properties oo 4 1 Appearance physical state colo B 4 2 Meting FEET pois 3 Melting point freezing point H 4S Bsiling point 4 4 Density A 4 5 Particle size distrib 4 6 Vapour press Right click to add end point property data bo 4 23 Additional physico chemical iri Lalla Short description of key information
62. tected Subset of original Dossier UUID 0 Sealed Copy protected Subset of original CMA Testing E CMA Industrial Development Foundation Limite i and Certification rtner Laboratories JTS amp AE gt and Certification Laboratories Your Reliable Quality Solution Pa TS GE HD Your Reliable Quality Solution Partner ding an additiona constituent Guan E secon ree Degree of purity E IUCLID 5 2 0 formaldehyde CMA Industrial Development Foundation Limited Hong Kong Hong Kong DER Eile Edit Go Window Help SO luul 4 al l ST ial Development Foundation Limited Hong Kong pis a Complete E r I F 0 Related Information a E x 1 General Information o 0 1 1 Identification Constituents C L2 Composition D 1 3 Identifiers gt 1 4 Analytical information Impurities C 1 5 Joint submission C 1 6 Sponsors 0 1 7 Suppliers oo C 1 8 Recipients Additives C 1 9 Product and process oriented rese 2 Classification and Labelling H 3 Manufacture use and exposure amp 4 Physical and chemical properties 5 Environmental fate and pathways E 6 Ecotoxicological Information 7 Toxicological information 8 Analytical methods a 9 Residues in food and feedingstuffs 10 Effective
63. tion Assignment from al non EU manufacturer Other importers Name Agreement Relevant only if the registrant is an OR Bi information 6 Information E 2 Madlfieation storys iy ACCESS 4 Consultation w Substance a WWC5 f0e72eSe 37a3 45d3 9325 e7ed1d69ec80 0 Sealed Copy protected Subset of original 48 CMA Industrial Development Foundation Limite v Your Keliable Quality Solution Partner Testing Certification Laboratories Wit Fal IRER D File Edit Go Window Help CO mfl Ha 4 a amp REVUE Section ree Complete Development Foundation Limited Hong La 3 General information E 0 Related Information E 1 General Information 2 Classification and Labelling 2 1 GHS gt 2 2 DSD DPD 3 Manufacture use and expos 4 Physical and chemical prope 7 Toxicological information 8 Analytical methods amp amp amp i amp con 11 Guidance on safe use 12 Literature search 13 Assessment Reports i 14 Request for Information 5 Environmental fate and pathways e e e 6 Ecotoxicological Information e e e 9 Residues in food and feedingstuffs 10 Effectiveness against target organisms Name C Not classified Implementation
64. wnership voting rights and relationships with other companies contribute to determining a company size e Only Representatives OR should make sure that your registration is in line with the size of the company you represent Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE Hb n For all submissions company size n gt Make sure it is correct in REACH IT before you submit Confirm Dossier Submission Dossier type Registration Dossier file name dossier_ 12657 75456864 j5z Organisation Name a Company size Invoice Contact Name John smith Purchase order REACH 45 236 7 2 Joint submission Related to a joint submission No Joint submission name Confirm submission Cancel submission gt ECHA has the responsibility to check the size of the companies who are eligible for REACH and CLP rebates s CMA Testing and Certification Laboratories HASIE A gt Your Reliable Quality Solution Partner Ganimation of submission select AIl Select None Select Details Read Subject Creation Date C Show No Invoice has been opened oe 29 09 2010 09 59 O Hide Yes Business Rules Check passed 28 09 2010 03 30 Submission number 1m r Dossier Type Registration regular File name et t Download submission report Go to dossier O Show No File under examination mmm mia Registration reg 27 09 2010 16 29 O Show Yes Invoice has been opened
65. y Solution Partner ort gt Import is possible for Substance data Single element e g Legal entity single endpoint Dossiers Reference Substances EC inventory Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE hb O RS rt gt Export is possible for Substance data Single elements e g Legal entity single endpoint Dossiers Reference Substances Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories HA SIRE Hb ort e The Export function consists of a number of steps depending on what is exported e Such steps allow to filter the exported information define its protection level or allow to add comments e Export is possible for a single data set or for a single substance bulk export is not possible e The Export command can be executed in two ways By right clicking on the endpoint record of choice By clicking on the export command on the file menu on the menu bar CMA Testing and Certification Laboratories Your Reliable Quality Solution Partner MERRE H xport Step 1 p Export assistant Select a dossier template which meets your specific requirements for exporting the documents Template Dossier templates available for a copy or inherit template Biocides Active ingredients Biocides Biocidal products Biocides Substance

What is a registration dossier?

Contents

Download Pdf Manuals

Related Search

Related Contents