Getting Started with REACH-IT
Contents
1. For A example a chemical company may sign up as a company to register the substance it manufactures and as a TPR to get involved in data sharing processes on behalf of another company 3 5 3 Updating REACH IT There are now two central sources of information storing the LEO the IUCLID 5 website and the REACH IT application However there is no automatic synchronisation process between these two sources Therefore when information needs to be updated it has to be done in a consistent way firstin REACH IT then preferably also on the IUCLID 5 website and finally in the IUCLID 5 local application The recommended procedure Figure 8 is the following 1 Update information data in LEO REACH IT 2 Export the LEO file LEOX to the local hard drive and import it into the local IUCLID 5 application 3 Separately update the LEO of the IUCLID 5 website with the same information data Version 1 0 20 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA EC A Part 1 Getting Started with REACH IT a http echa europa eu Figure 8 Update of LEO information IUCLID 5 GECHA REACH IT website IUCLID 5 website IUCLID 5 Local IUCLID 5 application peers eg He HK LEOX A Only official LEO is accepted for REACH IT sign up A LEO created directly in the local IUCLID 5 application cannot be imported into REACH IT 3 6 Other concepts This chapter will be further elaborated as new functi2. 1 3 FAQS DOCUMENT tw ban gas ase ason aste sadso sevyet as sqadgassssnyal an peao andan 24 Version 1 0 3 of 26 October 2008 REACH IT INDUSTRY USER MANUAL VA ECI IA Part 1 Getting Started with REACH IT a http echa europa eu List of figures FIGURE 1 MAIN NAVIGATION RULES IN REACH IT secccessseceenseeeeeenseeeeeensnaeeeensaaeeeeeeseaeeesnseaeeeseseseeeseseeeensesseeenes 6 FIGURE 2 ARCHITECTURE OF REACH IT ie new a aaa on owa ao ou awaa to tad kwa wo nn ww a sonb was sone wes sone wes sone was anae ou susone ves 9 FIGURE 3 STRUCTURE OF REACH IT OPENING PAGE 20k aaa enaaaaasenaaaaatenaaasasenaansasennaasssssnnannassnnansassnnannansnnannanannann 11 FIGURE 4 MESSAGE COLOUR GREEN AND NAVIGATION TOOLS aa kaa kat tata ta aaaaaoanoa anne saasasanneosannesesnannanannsnnnnnnannnanannn 12 FIGURE 5 MESSAGE COLOUR RED ane kk kann en n kk eke n kk n ea kn ki n n A ka 12 FIGURE 6 LEOX GENERATION AND USE WHEN IUCLID 5 IS ALREADY INSTALLED e2ttrsasennaasssannansanannansanannannanannnnnn 19 FIGURE 7 LEOX GENERATION AND USE WHEN IUCLID 5 IS NOT PREVIOUSLY INSTALLED i va aeennnnssssnnnnaasannanaanannnnnn 20 FIGURE 8 UPDATE OF LEO INFORMATION at tt ak kana ata aa aa aa Aa ARANNA ARAA AAAA KAAR AARAA NA RAEAN AANER A 21 List of tables TABLE 1 DIFFERENCES BETWEEN REACH IT AND IUCLID 5 akt tate area aa aa ooaaeaaoaaaaeesasaennossaannaoannnoanaaannnonnaannnonnnnn 10 TABLE 2 DIFFERENT PARTY TYPES ivscecent ka su w ate wan la w to a
3. A When updating information in REACH IT remember to click Save as the system will not ask you if you want to save the changes 2 5 2 Wizard rules When navigating through a wizard e g for sign up process the required actions have to be performed in a particular sequence the one step one form one tab principle applies This means that the user has to type in the required details one tab at a time The Previous and lt Next gt buttons are available at the bottom of the content pane to move from one tab to another Data is saved only after clicking Next Forward navigation is disabled until the current steps have been completed successfully Backward navigation allows the user to change previously saved data except the user ID Version 1 0 13 of 26 October 2008 REACH IT INDUSTRY USER MANUAL Part 1 Getting Started with REACH IT MECHA http echa europa eu 3 DEFINITIONS AND CONCEPTS 3 1 Parties A party may either represent a complex business structure or a simple organised business Companies and Third Party Representative TPR may be complex multi user parties as opposed to Data Holder DH or Interested Party IP who could be simple single user parties Table 2 Different party types Company Entails the Manufacturer Importer Downstream User DU and Only Representative OR Only Representative OR REACH Article 8 have to sign up in REACH IT for each non EU manufacturer they rep
4. IT system The standard way of providing company information in REACH IT is to import the IUCLID LEO Figure 6 However as an alternative a party may enter its information manually when it does not have an IUCLID 5 LEO Figure 7 The IUCLID 5 manual can be consulted http iuclid eu for more details about the use of the software and its installation Version 1 0 18 of 26 October 2008 REACH IT INDUSTRY USER MANUAL VA ECI iA Part 1 Getting Started with REACH IT a http echa europa eu 3 5 2 Signing up in REACH IT As mentioned in the previous chapter there are two different possibilities to sign up depending on whether a party already has a IUCLID 5 LEO i e has installed the IUCLID 5 software locally on its IT environment All details on Step by step Sign up in REACH IT are provided in Part 2 Sign up and account management 3 5 2 1 Local IUCLID 5 is already installed When signing up in REACH IT and being prompted to the administrator possible only for Company and TPR must import lt Browse gt from their local IUCLID 5 software i e from own computer the LEO XML LEOX file created on the IUCLID 5 website and containing the party information company data Figure 6 LEOX generation and use when IUCLID 5 is already installed GECHA REACH IT website IUCLID 5 IUCLID 5 website IUCLIDS Local IUCLID 5 application 3 5 2 2 IUCLID 5 is not yet installed When a party has
5. USER MANUAL JA EC j A Part 1 Getting Started with REACH IT of http echa europa eu Figure 3 Structure of REACH IT opening page L eT Contact GECHA de iy Login banner You are connected as provoosj on behalf of CompanyTest Preferences Logout Home Company You have 7 unread message s in your message box Pre registration Pre SIEF The Functional menu on the left hand side displays the current functionalities available to the user signed up in the system The Top banner displays the lt Contact gt link that points to the ECHA website page where you will be able to send a question to ECHA helpdesk on any aspect of REACH The Login banner displays the profile of the user currently connected lt User gt and lt Organisation gt names The lt Preferences gt and lt Logout gt functionalities are also available from this banner The Navigation links tabs banner displays links and tabs related to the current functionality The links indicate where the user is within the application They are navigable so the user can return to the parent pages up to the home page The tabs help the user navigate by structuring the complex information of the present page o In Website terms breadcrumbs are site paths created to mark progress when navigating through the site and they also show how to navigate back to where you started from o A global navigation breadcru
6. based application 1 Client server application Unique central system installed at ECHA 2 Stand alone application Decentralised system installed locally Restricted to REACH Regulation Used globally and for other regulatory purposes in addition to REACH e g OECD High Production Volume chemicals programme HPV EU Biocides legislation etc Application where dossiers are submitted Application which captures and stores information by users on chemicals for various regulatory purposes globally Multi party system where Industry and Each installation is essentially a single party system Authority parties co exist 2 3 2 REACH IT Requirements To be able to use REACH IT the user to be will require A computer with internet connection preferably broadband to support the submission of large dossier files A standard browser either Internet Explorer IE 6 x or higher or Firefox 2 0 or higher Adobe Acrobat Reader latest version to read submission reports and invoices A The REACH IT application has been tested with IE 6 0 IE 7 0 and Firefox 2 0 2 4 ECHA REACH IT General Layout REACH IT is available via the Internet at https reach it echa europa eu Once a user account has been created all REACH IT pages contain fixed sections from which links and menus are accessible The REACH IT webpage is structured as given in FIGURE 3 below Version 1 0 10 of 26 October 2008 REACH IT INDUSTRY
7. ka mas wa ge wo da w ye ye da po gu we s fa ye ga w ga ge ye da we ya ge w ge agen ae ya kage w eee da fase 7 2 1 BACKGROUND ai 7 2 2 WHO USES REACH TP cccccccconononononanonononononnccnnnononononnnancnnnnnnn neante Annn none nan nn nnnn nono nn anar nn arcano nnnaancnanancnns 8 2 2 1 AUTHOBITIES 222 La ne ae nordica 8 2 2 2 INDUSTRY ui de ce pita taa tin tat ata re A n a e w m a tete Dre e e w ect en n ae 8 2 2 3 THE GENERAL PUBLIC AND OTHER INTERESTED PARTIES bi ttvveeeooooooooouoeeoooooeooooooooeeseoooooououoeeoeseoouoon 8 2 3 REACH Ti ARGHTEC TURE te ia dada 8 2 3 1 LINK BETWEEN REACH IT AND IUCLID 5 Lilieeeeeooooooooeeeeooooooooooeoasoooeoooooououoeeoooooeoooooaoaaseoeoeoonoonnnn 9 2 3 2 REACHEIT REQUIREMENTS siria daa kaj rin lt m ly kt e m a n rt e a a bi ra kn 10 2 4 ECHA REACH IT GENERAL LAYOUT L0lieeeeeeooootoeeeeeooooeooooaoeeeooeeooooouoeoaeeooooooooooeseoeeoeoouoonaseneooeoooononnaann 10 2 5 O NINO eee eeeeoeoeoouoeeseeoeoeoooooeseooeoeoooooeseoeeoeoooooonoeneooeoeooooooasaneooeoooonnnnenn 12 2 5 1 GENERAL RULES 000bttaaeaeeeoooottoauaasseaveoooooooneaeseeooosuoasaoseeoooooonoaasoueveuoououanssonsesooouoneansoosonsooonanssoosene 13 2 5 2 WIZARD RULES eka A tan cs ce bann te on Aa e ka a e e nt A ane e e SA RO ae ewo ene ae ko pea 13 3 DEFINITIONS AND CONCEPTS o cccocconcoccococnnnononanaroncnnananananancnncananananan cn rr ncnnnnanana nan rrnnan anna rn nnmnnn nanna 14 3 1 PARTES St arcas 14 3 2 USERS a oak at aa tk a
8. not installed IUCLID 5 locally in its IT environment it is recommended to sign up directly in REACH IT and subsequently to install IUCLID 5 locally The party information is therefore entered manually into the REACH IT system which provides a company UUID and a LEOX This LEO can be exported from REACH IT and saved locally by the user and will be used for the installation of IUCLID 5 in the party s IT environment This means that for the download of the IUCLID 5 application from the IUCLID 5 website the steps 1 to 3 should be ignored During the subsequent installation procedure of IUCLID 5 when asked for the import of the LEOX the user shall select the LEOX created in REACH IT Version 1 0 19 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA EC A Part 1 Getting Started with REACH IT http echa europa eu Figure 7 LEOX generation and use when IUCLID 5 is not previously installed IUCLID 5 LEON ECHA IUCLID 5 website REACH IT website LEOX IUCLID 5 Local IUCLID 5 application It is possible to sign up with the same OR company information name address etc but A the company UUIDs that the OR represents cannot be identical Chapters 3 5 and 3 2 1 and 3 2 2 One LEO UUID MUST be created per represented non EU manufacturer It is allowed for the same Legal Entity to sign up as different parties into REACH IT These parties are therefore completely separate and their UUID CANNOT be shared
9. role will be assigned by default if no role has been assigned at user creation A The functionalities available in the Functional menu depend on the user profile i e a Company user will not have the same menu as a TPR user Depending on the organisation of the party company or TPR or other different reader and or normal user accounts can be created by the administrator 3 2 2 User account management User Management entails the following tasks creating a user assigning adding removing roles updating party information managing user security features such as password reset access blocking and unblocking A It is not possible to assign one identical user to different companies One user account belongs to one party only A Account management tasks can only be performed by users with the Administrator role e All the information provided during sign up can be modified later by the Company Manager Administrator role except the initially entered User ID The data which can be edited include General information Billing information and Contacts include their creation deletion and modification 3 3 Message box All REACH IT users user levels 1 to 3 have their own Message Box folder where they can access internal messages addressed to them their group users with the same role or their party The messages handled in the internal message box are generated by the REACH IT application and delivered into th
10. 0 6 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA ECH A Part 1 Getting Started with REACH IT a http echa europa eu lt Contact gt in the top right corner of the REACH IT opening page Figure 3 takes you to the ECHA Helpdesk website page where you will be able to send a question on any aspect of REACH including REACH IT 2 WHAT IS REACH IT 2 1 Background The central IT system which will underpin the requirements of the REACH regulation EC no 1907 2006 hereafter REACH is called REACH IT The aim of REACH IT is To ensure that the REACH processes in the European Chemicals Agency ECHA or Agency the Member States Competent Authorities MSCAs the Industry and other stakeholders are supported by appropriate IT system s and corresponding interfaces and so that other requirements from the legislation such as Articles 77 tasks of the Agency and 111 format and software for submission of information to the Agency are met The REACH IT system is a central system running in ECHA REACH IT has three fundamental groups of parties for which it provides appropriate functionalities Industry homepage this is the place where a company can for example sign up pre register substances obtain contact details of other companies having pre registered the same substance submit registrations download invoices and view the status of submitted registrations and payments In addition it allows dossier preparation e g notific
11. A EC i A Part 1 Getting Started with REACH IT 4 http echa europa eu The ECHA website has a dedicated menu for REACH IT http www echa europa eu reachit en asp which also provides various training materials and up to date information 4 1 2 ECHA REACH IT Helpdesk The ECHA Helpdesk is the main source of information for any further questions on REACH IT IUCLID 5 and the REACH legislation e See ECHA website FIRST It handles the customers questions in a standardized and timely manner in order to guarantee high quality resolutions Contact forms are available via http echa europa eu about contact_en asp The REACH IT and IUCLID 5 web forms shall only be used for request of technical support with the tools 4 1 3 FAQs document Different FAQ documents are developed by ECHA as a result of compiling the questions arriving at the ECHA REACH IT helpdesk They can be found at http echa europa eu reachit reachit faq en asp but also on the inquiry and registration web pages Version 1 0 24 of 26 October 2008 REACH IT INDUSTRY USER MANUAL A ECH A Part 1 Getting Started with REACH IT http echa europa eu Version 1 0 25 of 26 October 2008 European Chemicals Agency Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 6861 80 Fax 358 9 6861 8210 http echa europa eu info echa europa eu
12. AECHA http echa europa eu REACH IT INDUSTRY USER MANUAL Part 1 Getting Started with REACH IT For latest news and most up to date information please consult the ECHA website REACH IT INDUSTRY USER MANUAL A EC A Part 1 Getting Started with REACH IT a i l http echa europa eu Reference ECHA 08 B 08 EN Issue date 27 October 2008 Language English If you have questions or comments in relation to this document please send those quote the reference and issue date using the information request form to ECHA helpdesk The information request form can be accessed in the REACH helpdesk section of the ECHA website at http echa europa eu reach helpdesk echahelp en asp Version 1 0 2 of 26 October 2008 REACH IT INDUSTRY USER MANUAL VA ECI iA Part 1 Getting Started with REACH IT a http echa europa eu TABLE OF CONTENTS 1 HOW TO USE THIS INDUSTRY USER MANUAL ccccccccconcnnnnonococconananonannoconcananananancnnonnnnnannana ro neneman nna 5 1 1 OBJECTIVE A e n n e an EASE 5 1 2 STRUCTURE rad a e aa sn Ca a ea e e e atan ka Ce made 5 1 3 CONVENTIONS eki bi kt sote uann oka obi ad a den ras aime it aii 5 1 3 1 ICONS a l Se ta e a D da an e ak Ba t ea ede 5 1 3 2 TEXT CONVENTION S bw at aou ai caved kabwa e a dd aa bes a 5 1 3 3 BUTTONS LINKS a a na sue kinbe di tea po onon eee on etant 6 1 3 4 Leal tk a a tar Clan ee n ba E 6 2 WHAT IS REACHT siccsczi sib es odyo tn an deta ga se ga sw condo w pa
13. SER MANUAL JA ECH A Part 1 Getting Started with REACH IT a http echa europa eu This file will be processed by the system without manual intervention from the potential registrant For this reason it is only possible to pre register in bulk substances that are identified by an EC number EINECS or NLP number In case of multi constituent substances this constraint does not apply to the substance itself but to each of its constituents which must be identified by an EC number EINECS or NLP number If similar substances are specified they must also be identified by an EC number Part 4 of the industry user manual IUM covers online pre registrations submitted in REACH IT whereas the Data Submission Manual 6 also available on the ECHA website covers bulk pre registration The REACH IT pre registration module follows the principles set up in the Guidance for identification and naming of substances under REACH It enables to pre register substances which are either 1 Well defined substances i e substances with a defined qualitative and quantitative composition that can be sufficiently identified These substances may be either eMono constituent substances or eMulti constituent substances 2 UVCB substances Substances of Unknown or Variable composition Complex reaction products and Biological materials To facilitate the description of a phase in substance in REACH IT during the pre registration process a general id
14. about the information submitted e g in pre registration or registration These contacts can be used to specify a contact person for a pre registration and dossier created online If no contact is specified ECHA will use the company general contact information A The Contacts are not connected to User accounis Therefore they do not have a REACH IT message box nor access to the company pages in REACH IT There are four predefined contact types General Dossier supervision Invoice manager Joint submission It is suggested to synchronise the User accounts and the contacts Some users may have specific roles assigned to them and could be contacted for questions pertaining to that specific role e g the invoice manager has his her own User account to download invoices and could also be listed in the contact list as invoice manager to be contacted when additional information is needed by ECHA about invoices 3 5 Legal Entity Object 3 5 1 Use of IUCLID 5 for REACH IT management IUCLID 5 plays a central role in the IT environment of all organisations dealing with chemical data submission for REACH but also for other regulatory programmes such as the OECD HPV programme or EU Biocides TABLE 1 IUCLID is also mentioned in the REACH legislation REACH article 111 as the format to use for data collection dossier preparation and dossier submission From the IUCLID 5 website http iuclid eu companies EU Member States
15. and any other interested party can obtain the IUCLID installation kit and download the IUCLID 5 software locally Once installed the local IUCLID 5 software is the essential tool to capture and store submit and exchange data on chemical substances Before downloading the software each party is requested to sign up on the IUCLID 5 website by providing a number of information on its Legal Entity including contact details This information is managed centrally so no duplicate entry may exist In particular each Legal Entity is uniquely identified by a Universal Unique Identifier UUID Legal Entity information i e contact details provided by the party and UUID assigned by the central system is stored in a so called Legal Entity Object LEO Version 1 0 17 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA ECH A Part 1 Getting Started with REACH IT a http echa europa eu This LEO must be downloaded from the IUCLID 5 website to be able to install the IUCLID 5 application in a local environment In the IUCLID 5 software this LEO is designed as an official LEO i e a LEO obtained from the IUCLID 5 website vs created locally in the application itself This official LEO may be imported to REACH IT via an XML file The main information contained in the LEO is the company UUID which will be used during the REACH IT sign up so that a company may be identified by the same UUID locally in IUCLID 5 and in the central REACH
16. ation of classification and labelling Examples of users of the Industry homepage manufacturers importers third party representatives Only Representatives downstream users Agency workflow this part of REACH IT supports the day to day work in the regulatory process management of ECHA and in the MSCAs for activities such as registration evaluation authorisation restriction and classification and labelling of substances Users of the Agency workflow Agency staff MSCA staff Dissemination website the public website is for publication of non confidential registration dossier data and other relevant data such as the classification and labelling inventory and the authorisation numbers decisions database The dissemination website will fulfil the requirements laid down in the legislation for dissemination of data Examples of users of the dissemination site general public consumer and environmental non governmental organisations NGOs Industry users Version 1 0 7 of 26 October 2008 REACH IT INDUSTRY USER MANUAL YA ECI i A Part 1 Getting Started with REACH IT http echa europa eu 2 2 Who uses REACH IT REACH IT is to be used by so called parties which represent participants to the system Parties are categorised in three groups each having access to specific functionalities 2 2 1 Authorities REACH IT will provide specific support to ECHA and MSCA staff for following the dossiers submitted by industry car
17. e user s Message box folder The type of messages sent by REACH IT concerns submission reports registration numbers decisions on a dossier etc Due to their confidential nature they are not sent via standard e mails The Message Box folder has a fixed and standard structure and contains all incoming messages as long as they are not moved to another of the following sub folders the User folder which may contain messages addressed personally to the user but also related to his her role the Organisation folder which may contain a copy of the messages addressed to his her party and the Role folder which may contain a copy of the messages addressed to his her role Version 1 0 16 of 26 October 2008 REACH IT INDUSTRY USER MANUAL VA ECI iA Part 1 Getting Started with REACH IT a http echa europa eu A These default folders are meant to help the user sorting and archiving messages They are identical for all users and cannot be renamed 3 4 Contacts The REACH IT application allows the administrator to include Contacts and to link them to the Party e g in the accounting department or in the registration team This is an optional step during the sign up process The list of contacts stored in REACH IT can be viewed as an address book phone and or email information to be solely used by ECHA for the purpose of contacting the company without using the REACH IT system to obtain further details
18. entification scheme is applied regardless of the substance type mono or multi constituent substance or UVCB and method online or via a XML file The scheme defines a cascade of several identification levels from the preferred ones i e EC number to the less preferred ones i e chemical name such as follows All substances or constituents of a substance should whenever possible be identified using an EC number EINECS or NLP number If this is not applicable because the substance is not included in the EC Inventory the substance or constituent should be identified by providing its CAS number and CAS name If the CAS information does not exist either the substance or constituent can be identified by providing one or more chemical names Contact information needs to be provided for each pre registered substance since it will be used to bring together the manufacturers and importers of the same substance for data sharing purposes If the applicant does not specify dedicated contact information during pre registration the contact information provided during company sign up will be displayed to others pre registering the same substance Alternatively a potential registrant may prefer to hand over his her data sharing obligations to a TPR TPRs need to sign up in REACH IT and communicate their UUID outside the REACH IT system to their clients before their clients pre register If a TPR is assigned to a pre registration his contact in
19. formation provided during sign up will be communicated to the other potential registrants even if a company contact person was specified within the related pre registration Version 1 0 22 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA EC A Part 1 Getting Started with REACH IT http echa europa eu 3 6 2 Notified substances REACH Article 24 imposes that substances that have been notified under the New Chemicals legislation 67 548 EEC are to be considered registered and shall be assigned a registration number Consequently the administrative details of the substances notified listed in the New Chemical Database have been migrated to REACH IT The owner of the notification Domestic manufacturer importer or former sole representative under Dir 67 548 EEC SR or newly appointed Only Representative OR may receive upon successful claim a registration and a submission number for any notified substance they own The claimant MUST be part of the company that owns the notified substance or be mandated by this company to act on its behalf either a domestic Manufacturer or an Importer or a Sole representative under Directive 67 548 EEC or a newly appointed Only Representative to claim a registration number As soon as the owner of the notification has successfully claimed a registration number for his notified substance all other provisions of the Regulation will follow The notifier will have to fulfill the dutie
20. ia ak a ok tt m a e ek ba e k a 14 3 2 1 USER ROLES wi onet oua kou ba E kitan ici 15 3 2 2 USER ACCOUNT MANAGEMENT bb lttteeeeeeooooooaoaeeeeeoeoeoouoaoeseooeoeoooooeseueeoeooooooeoeaoeoeooooooooesenesoeoooononnenn 16 3 3 MESSAGE BON Mai te O In e ra ro ake e a e a ta dei den 16 3 4 CONTACTS aE E ds an A w Da o ae A 17 3 5 LEGAL ENTITY OBJECT wscccccssceccsevvascccteceddcuutvancenctedaddcavnadecsusivuavesuesdndevusvaivaddenaddsuslusavesvencadduvesaavectecacdas 17 3 5 1 USE OF IUCLID 5 FOR REACH IT MANAGEMENT oocccccccnncnococcnnnonononnnancnnnnnonononnarnnanononennanccnncnnnnnnnns 17 3 5 2 SIGNING UP IN REACH IT 0lliiieeeoooooootoaeaaeeeeoeoooogooeoeoesoeoooaeeaeeoeoeooooooesooeooeoooooaoeoseoeseoouoooasoaeeoeon 19 3 5 3 UPDATING REACH IT 0 Lbiiaeeeeeoeooteaeeaeeeeoooooosoeeeeseoooooooeeeeseoooeoouoeoeseooeoeoooooaoeaeeoeoeooooooasoneeoeoooononaen 20 3 6 OTHER CONCERTS titit ava dra tt tit de tt on a tw akl pk tie e ar kd eta ata e e a a ki kra Oe 21 3 6 1 PRESHEGISTRA TO Nat n e e tn kt aa 21 3 6 2 NOTIFIED SUBSTANCES kt e a aAA Dee a n de an 23 4 HOW TO GET SUPPORT occccnanccccccoconconononononannnnnnanannncnnnnnnnnnanan rn cr nnnn nn anan an rn cr nnan annee meme anar anar arca rra nananananas 23 4 1 1 ECHAWEBSITE tra reta dead eta kab tea S k ele e kr cena detecte en 23 4 1 2 ECHA REACH IT HELPDESK kb tb tt ttte tete aa aa aa aa aa aa aaa aaa aa aaa aaa aaa aaa aaa aaa aaa aaa aa nn nono nn nn nn nn nn nn nn nn nn nr REEERE n 24 4
21. l l 1 Expo 1 A dossier i database l l L Industry REACH IT workflow REACH IT functions database aS Public database Exchange Line complete or partial info Other functions menos Export database dossier Disseminate Authority user IUCLID 5 application REACH IT incorporates various data flows such as Sign up Internal message and Payment data flows IUCLID 5 functions and UI 2 3 1 Link between REACH IT and IUCLID 5 IUCLID 5 is the software application developed for and provided to Industry free of charge to capture and store data on users own substances in their local IT environment and submit these data in the correct format to ECHA For more information on IUCLID 5 see the IUCLID 5 website at http iuclid eu Figure 2 also shows the link between REACH IT and IUCLID 5 and indicates that IUCLID 5 is to be used by all parties as a separate application to prepare the dossiers e g registrations When parties are signed in dossiers exported from IUCLID 5 may be loaded into REACH IT to be submitted to ECHA 0 The REACH IT and IUCLID 5 applications are completely decoupled and are not meant to replace each other Table 1 Version 1 0 9 of 26 October 2008 REACH IT INDUSTRY USER MANUAL VA ECI iA Part 1 Getting Started with REACH IT a http echa europa eu Table 1 Differences between REACH IT and IUCLID 5 REACH IT IUCLID 5 Web
22. ly being developed 2 3 REACH IT Architecture The REACH IT system is composed of two distinct applications Figure 2 The main application includes all the modules necessary to the core business of REACH It supports the main functions available to the authenticated parties i e Industry ECHA and MSCA The main application also filters out confidential information prior to dissemination The dissemination application is designed so that non confidential data can be kept in a separate database It supports the consulting and downloading of public data by non authenticated parties i e parties who do not need to sign up in REACH IT and get credentials e g the general public and other interested parties A The REACH IT main application and the dissemination application are physically distinct Version 1 0 8 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA ECH A Part 1 Getting Started with REACH IT 4 http echa europa eu applications with separate servers databases and sub networks Figure 2 below provides an overview of the REACH IT interactions between ECHA and the Industry It shows the applications their main internal modules and their relationships as well as the most important data and interactions flows Figure 2 Architecture of REACH IT Industry IUCLID 5 application EA rt Agency REACH IT Invoice on line functions and submission consultation etc payment l l
23. may sign up as of January 2009 in REACH IT only if they want to be included in pre SIEF SIEF this is voluntary not compulsory User accounts from a TPR DH and or IP in REACH IT must be separated from Company accounts and have to sign up as a different party 3 2 Users Version 1 0 October 2008 14 of 26 REACH IT INDUSTRY USER MANUAL JA ECH A Part 1 Getting Started with REACH IT a http echa europa eu A user is a generic term and is equivalent to an applicant or a registrant In this IUM different user types exist with different roles Under REACH IT a person may be associated to different user roles A Users are authenticated in REACH IT by a username and a password Parties are responsible for their own user or Account management see chapter 3 5 and Part 2 3 2 1 User Roles The very first user is created at sign up see chapter 3 5 and Part 2 and is called Company manager with an Administrator role see below Subsequent users are created by the first user who is able to add new users to the registered party Assigning roles to users enables to set a level of permissions access over the data A By default the Administrator role is assigned to the very first user created during sign up who can in turn create users and assign roles A The user s credentials and access rights will differ depending upon the party it belongs to and upon his her role in the party The possible roles fo
24. mb link appears at the very top of the banner This breadcrumb allows navigation to higher levels in the site see also Figure 4 o The current navigation breadcrumb tabs shows where you are in the present page see also Figure 4 A Functionalities which are made available to a user depend on his her party type and user role The Page content varies depending on the selected functionality and action and contains also the Message area which displays messages in response to an action performed by the user Positive messages confirming a positive outcome will be highlighted in green Figure 4 Global navigation e n ai Version 1 0 Current naviaation October 2008 REACH IT INDUSTRY USER MANUAL JA ECH A Part 1 Getting Started with REACH IT a http echa europa eu Figure 4 Message colour green and navigation tools Home gt Contacts Company Information Billing information Contacts Add new contact Select First Name Last Name Phone Email Contact Type s No Records Found Error messages will be highlighted in red Figure 5 to inform the user of mistakes or errors occurring in the page e g mandatory fields left empty incorrect format etc and also of the corrective steps to take Figure 5 Figure 5 Message colour red Login Please provide your login information to enter REACH IT is marked win an asterisk are mandatory User ID Password Enter the text shown Forgo
25. n oi a in lana 14 TABLE 3 POSSIBLE ROLES FOR PARTY USERS ae ennan aa aa anan aa aaa saaeaaosasssasasososssessooosonosasssanosososoosnosonososasansnosnnannnnnonnn 15 Version 1 0 4 of 26 October 2008 REACH IT INDUSTRY USER MANUAL VA ECI iA Part 1 Getting Started with REACH IT a http echa europa eu 1 HOW TO USE THIS INDUSTRY USER MANUAL 1 1 Objective This Industry User Manual IUM serves as the reference manual for all REACH IT functionalities which are or will be available to the Industry This IUM is meant for any Industry user who needs to use REACH IT to submit or consult data The different REACH IT users will be described in chapter 3 Definitions and concepts As more functionality becomes available additional or updated parts of this IUM will be released and made available on the ECHA website http www echa eu 1 2 Structure This IUM is divided into different parts covering the many aspects of REACH IT For ease of use as some topics are more relevant than others to different users the different parts will be released separately on the ECHA website presenting also the IUM table of content Part 1 Getting Started with REACH IT introduces the background of REACH IT and the definitions and concepts which are critical to know before proceeding further with the other parts Part 2 and followings cover the step by step instructions of REACH IT from sign up to login search or other features The step by step instr
26. onalities with related new concepts will be developed and implemented within REACH IT 3 6 1 Pre Registration The pre registration of phase in substances in REACH IT enables manufacturers and importers of such substances to benefit from extended registration deadlines see REACH Regulation 1907 2006 for definitions There are two options to pre register substances by using REACH IT Enter the pre registration information directly online in the REACH IT system data for each phase in substance is encoded manually following a step by step procedure including verifications and final validation at the end of the procedure This procedure requires manual intervention of the potential registrant who is prompted by the system to confirm his her choices Prepare the pre registration information outside of the REACH IT system and store this information in a pre registration file which is then uploaded into the REACH IT system so that the pre registration process can be completed The pre registration file generated outside of the REACH IT system may contain either elnformation on one phase in substance only single pre registration XML file In this case there is no constraint in the way the substance is identified it can be by EC number CAS number and name chemical name or other identifiers or elnformation on several phase in substances bulk pre registration XML file Version 1 0 21 of 26 October 2008 REACH IT INDUSTRY U
27. r party users are given in Table 3 Roles involve activities either related to the party data administrative aspects or to the substance data Table 3 Possible roles for party users 2 eb a x lt a 5 S E p Q oO O Cc so so fas koni o fan 2 fan Ke D D E a L Oo O 7 D 2 a T c E lt D 5 8 5 g amp I 5 ES ge D D 2 BE a a LI y 5 o O D 2 cy en lt jen Cc a ke as a a 9 a as 68 3 Hole O O Oa O I 1 Administrator e e o o e o 2 Normal o o e e 3 Reader o e e full access rights over users accounts and party organisation data such as for pre registration and pre SIEF Version 1 0 15 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA ECH A Part 1 Getting Started with REACH IT a http echa europa eu The administrator user level 1 can add change or delete users from the REACH IT system and furthermore can change information and data pertaining to his party Legal Entity Also the user level 1 can read submit or update information on substances The normal user user level 2 has only read access to data related to the party but cannot change them But the normal user level 2 can submit and update data on substances The reader user user level 3 only has read access to the party and substance data i e can only view data but has no other access rights A Assigning a role is mandatory the Reader
28. resent and submit pre registrations and or dossiers using the appropriate account Third Party Representative TPR Participates to data sharing activities on behalf of a Company REACH Article 4 e g preparation of joint submission by multiple registrants TPR activities are mainly linked with pre registration and pre SIEF Data Holder DH Is a party holding information on pre registered substances and submitting information REACH Article 28 7 e g universities companies manufacturing chemicals in a tonnage of lt 1 tpa trade associations etc Interested Parties IP May participate to certain processes by providing comments e g NGOS which are involved in some of the REACH processes Any party must be signed up into the REACH IT system to get access rights and to be allowed to pre register submit information and or data etc This Sign up operation is performed following a step by step wizard in REACH IT see Part 2 Sign up and Account Management and also Chapter 3 5 for more general concepts It is possible for the same Legal Entity to sign up as different parties into REACH IT but these parties are seen as completely separate and their users are not shared e g a x chemical company may sign up as a Company for a substance it manufactures and must register and may also sign up as Data Holder for other substances it manufactures e g in quantities lt 1 tpa Data holder
29. rying out the evaluation work and communicating with industry and between authorities ECHA is a unique party that represents the Agency MSCA staff is considered as remote users of the REACH IT system and have a view only over the data stored in the system that are relevant for them 2 2 2 Industry REACH IT is to be used for the secure submission of Industry data dossiers and the secure communication of information to Industry such as decision on a dossier registration numbers etc Industry parties may only see and update their own data Industry parties can be subdivided in Chapter 3 1 Company who represents the manufacturer importer downstream user DU and or only representative OR Third Party Representative TPR who participates to data sharing activities on behalf of a company REACH Article 4 Data Holder DH who represents parties holding information on pre registered substances and submitting information REACH Article 28 7 e g trade associations 2 2 3 The general public and other interested parties REACH IT will provide easy access to publicly available data to the general public and interested parties IP In a subsequent step of the development IP will be able to participate to certain processes by providing comments directly via REACH IT e g NGOs that are involved in some of the REACH processes REACH IT will allow easy access and download of publicly available data thanks to search mechanisms current
30. s of the REACH registrants including data sharing The substance C amp L data will be included into the C amp L Inventory The non confidential information according to REACH will be disseminated A Only the company users with the normal or administrator roles are authorised to perform a registration number claim Upon successful claim the claimant will be granted One registration number and one submission number per notification if the owner of the notification was a Domestic Manufacturer and or an Importer under Directive 67 548 EEC One registration number and one submission number per non EU manufacturer represented if the owner of the notification was a Sole Representative under Directive 67 548 EEC One registration number and one submission number per non EU manufacturer represented if the owner is a newly appointed Only Representative e After having successfully requested a registration number Industry can request the original SNIF file and the IUCLID 5 migrated file including the confidential information from the Member State Competent Authority MSCA were the substance was notified These operations are not supported by REACH IT 4 HOW TO GET SUPPORT 4 1 1 ECHA Website The ECHA website on http echa europa eu serves as a focal point for REACH related news information and IT tools It is being maintained and continuously updated by ECHA Version 1 0 23 of 26 October 2008 REACH IT INDUSTRY USER MANUAL J
31. t your user iD The lt Enter the text shown gt data field allows the entering of the text that is shown in the CAPTCHA displayed on the screen This is a type of challenge response test to ensure the user is human CAPTCHA stands for Completely Automated Public Turing test to tell Computers and Humans Apart A category of technologies used to ensure that a human is making the O transaction online rather than a computer Random words or letters are displayed in a distorted fashion so that they can be deciphered by people but not by software Users are asked to type in what they see on screen to verify they are in fact human 2 5 REACH IT Navigation Version 1 0 12 of 26 October 2008 REACH IT INDUSTRY USER MANUAL JA EC A Part 1 Getting Started with REACH IT http echa europa eu 2 5 1 General rules REACH IT is a web based application and therefore pages are displayed as web forms Complex information is structured into tabs Data fields are displayed on the left side of the screen and entry fields on the right side of the screen Figure 5 A brief explanation of what the field is about is usually displayed below the data field when applicable e g VAT and D U N S numbers have a specific format and an example is given Mandatory fields are marked with an orange asterisk By default information is presented in read only mode Based on his role see Chapter 3 2 1 the user will be able to switch to the Update mode
32. tables next to a record and are used to select that specific record The links in REACH IT may serve various purposes In pages at the top of the content pane the links are used to go back to information available in previous sections or to jump to the next section In pages above tables the links are used to add records e g add a new contact In tables the links are used to view detailed information on a selected record e The specific link lt Forgot your user ID or password gt is available at the bottom of the Login page The screenshot Figure 1 illustrates the main navigation rules described Figure 1 Main navigation rules in REACH IT Representative registration gt Contacts lt User account i Third Party Representative information contacts Validation Y his step is optional you can skip it by going directly to the Validation page Add new contact gt Select First Name LastName Phone Fax Email Melvin Hobbes 32 2 723 14 11 melvin hobbes che group com _Update Delete The screenshots included in this manual are only for illustrative purposes They may 6 contain dummy entries that should not be considered as valid entries to be used by the users 1 3 4 Help REACH IT currently proposes two help features The blue framed question mark that is situated beside some entry fields in the system moving over this sign displays tips and explanations on the specific entry field Version 1
33. uctions are intended to be as visual as possible so the reader can work easily through screens and examples It is therefore strongly recommended to read this Part 1 chapters 1 to 3 so other parts are more understandable and easier to perform However the IUM as a whole was written to also allow the reader to go directly to the other parts 1 3 Conventions The following conventions will be used throughout this IUM 1 3 1 Icons Icons used in this IUM e Tip points out a handy shortcut or helps to understand something important Remember marks something to keep in mind e g how to handle a particularly tricky part This icon means that what follows is Technical The information is not needed to proceed but it increases the level of understanding O O gt Warning indicates a common pitfall 1 3 2 Text conventions Text between lt gt always describes commands buttons or links that can be found on the screens or in the texts of the REACH IT pages Version 1 0 5 of 26 October 2008 REACH IT INDUSTRY USER MANUAL YA EC A Part 1 Getting Started with REACH IT l http echa europa eu 1 3 3 Buttons amp Links Two types of buttons are used in REACH IT namely action and radio buttons Action buttons are found at the bottom of the content pane of a page and are used to perform basic actions such as Edit Cancel Save etc Radio buttons equivalent to check boxes are found in the first column of
Download Pdf Manuals
Related Search