European Chemicals Agency Luxembourg Sept. 30 th 2008

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1 European Chemicals Agency Luxembourg Sept. 30 th 2008 ECHA s IT Tools for Pre-registration Eduardo Vencesla

2 Agenda ECHA Mission and Challenges REACH The REACH Context and the RIPS ECHA Support IT Tools IUCLID XML Format, IUCLID 5 and REACH-IT Data for pre-registration and how to do it Other ECHA Support Services Websites and Helpdesk

3 Agenda ECHA Mission and Challenges REACH The REACH Context and the RIPS ECHA Support IT Tools IUCLID XML Format, IUCLID 5 and REACH-IT Data for pre-registration and how to do it Other ECHA Support Services Websites and Helpdesk

4 ECHA Our Mission Manage and carry out technical, scientific and administrative aspects of Registration, Evaluation, Authorisation and restriction of Chemicals centrally instead of 27 MSCA. No rule-makers. Ensure consistency at Community level Provide the best possible scientific/technical advice on questions relating to REACH Provide guidance and advice for stakeholders Publish Guidance & explanatory documents Run helpdesk on REACH, IUCLID 5 and REACH-IT Make information on chemicals publicly accessible

5 ECHA Challenges in Finalise by 1 June 2008 the preparatory actions to be ready for the entry into operation: REACH-IT System Organisation including committees Internal work processes 2. Demonstrate efficient functioning of the REACH operations by end 2008 Pre-registration (list published by 1 st January 2009) Registration PPORD notification

6 The REACH context (1) Art. 77 stipulates that the Agency shall: establish and maintain databases for all registered substances, the C&L inventory and the harmonised C&L list and make information publicly available free of charge, over the Internet Obligation towards registrants - Art. 111 specifies: The Agency shall specify formats and make them free of charge, and software packages and make them available on its website for any submissions to the Agency For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID

7 Agenda ECHA Mission and Challenges REACH The REACH Context and the RIPS ECHA Support IT Tools IUCLID XML Format, IUCLID 5 and REACH-IT Data for pre-registration and how to do it Other ECHA Support Services Websites and Helpdesk

8 The REACH context (2) REACH Implementation Projects (RIPs): RIP 1: Process descriptions RIP 2: Development of IT systems (IUCLID 5 & REACH-IT) RIP 3: Guidance Documents for industry RIP 4: Guidance Documents for authorities RIP 5/6: Preparation for start-up of Agency Our aim is to develop guidance to help fulfil the obligations under REACH in close collaboration with all stakeholders

9 The REACH context (3) RIP2 covers: Formats & software for submission of data to Agency: IUCLID 5 (e.g. for registration dossiers), web applications (e.g. for pre-registration or specific DU dossiers) Databases in the Agency: Information on all registered substances: IUCLID 5 data repository Dissemination: REACH-IT dissemination Others: Pre-registration information, C&L inventory, Community Rolling plans IT support for all tasks carried by the Agency Agency portal, Workflow system, Link with Payment system, etc.

10 Agenda ECHA Mission and Challenges REACH The REACH Context and the RIPS ECHA Support IT Tools IUCLID XML Format, IUCLID 5 and REACH-IT Data for pre-registration and how to do it Other ECHA Support Services Websites and Helpdesk

11 ECHA Support IT Tools IUCLID 5 XML FORMAT Article 111 REACH Regulation IUCLID 5 XML format For Pre-registration purposes only The Agency shall specify formats and make them free of charge For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID The files to be submitted to the ECHA for pre-registration need to follow a specific XML format described by a set of XML schema definition files (xsd files). Users of the IUCLID 5 preregistration plugin do not have to worry about the details of this format as it is automatically produced by the plugin.

12 ECHA Support IT Tools IUCLID 5 IUCLID 5 (International Uniform Chemical Information Database) is the software for companies to store data on chemicals and prepare their registration dossiers for submission to the Agency via REACH-IT. The IUCLID 5 pre-registration plug-in IUCLID 5 also includes the IUCLID 5 pre-registration plug-in that is an extension of the IUCLID 5 application. It adds the functionality to create single and bulk pre-registration XML files in a format that can be submitted to the ECHA. Users can enter the required data manually or extracting it from their existing IUCLID 5 data sets.

13 ECHA Support IT Tools REACH-IT Central IT system of the European Chemicals Agency that supports the implementation of the REACH legislation It includes: A web portal for submission and consultation of information by industry A workflow system for full control of all tasks triggered by REACH Central database of all information necessary to manage the system (REACH-IT database): identification and status of dossiers, decisions, A dissemination system for publishing non-confidential data on the Agency website Integration mechanisms with other Agency systems, in particular IUCLID 5, but also payment, reporting systems, s

14 Agenda ECHA Mission and Challenges REACH The REACH Context and the RIPS ECHA Support IT Tools IUCLID XML Format, IUCLID 5 and REACH-IT Data for pre-registration and how to do it Other ECHA Support Services Websites and Helpdesk

15 ECHA Support IT Tools DATA FOR PRE-REGISTRATION Following Chapter 3 (Article 28) of the REACH Regulation: In order to benefit from the transitional regime provided for in Article 23, each potential registrant of a phase-in substance (> 1 tonne/year), shall submit all the following information to the Agency: a) the name of the substance as specified in section 2 of Annex VI, including its EINECS and CAS number or, if not available, any other identity codes; for which the available information is relevant for the application of sections 1.3 and 1.5 of Annex XI. b) his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in section 1 of Annex VI; c) c) the envisaged deadline for the registration and the tonnage band

16 ECHA Support IT Tools PRE-REGISTRATION There are two possibilities to submit pre-registration informationtoecha viareach-it: by direct encoding of the information in the REACH-IT website (On-line pre-registration made one by one) by submitting pre-registration XML files prepared separately in IUCLID 5 or with any software following the IUCLID 5 XML pre-registration format. This option allows companies to do bulk submissions

17 ECHA Support IT Tools IUCLID 5 DEMO

18 Agenda ECHA Mission and Challenges REACH The REACH Context and the RIPS ECHA Support IT Tools IUCLID XML Format, IUCLID 5 and REACH-IT Data for pre-registration and how to do it Other ECHA Support Services Websites and Helpdesk

19 ECHA Support Websites /iuclid Concise overall guidance IT based Navigator tool Detailed technical guidance Pre-registration Prepare dossiers for submission

20 ECHA Support IT Tools SOME RECOMMENDATIONS REACH-IT FAQ /reachit/reachit_faq_en.asp Invoices and payments in REACH-IT (#1 to #14) Modifying / Deleting / Deactivating a Pre-registration (#19 - #27) Only Representatives and Third Party Representatives (#21 - #22) UUID syncronisation IUCLID 5 website and REACH-IT (#30) Find all information on pre-registration at /pre-registration_en.asp and /reachit/pre-registration-it_en.asp

21 ECHA Support Information PRE-REGISTRATION Resources: Practical Steps guide tells users how pre-registration works and it is published on the ECHA website in 22 EU languages Other resources for pre-registration: At - Guidance on IUCLID 5 Pre-registration plug-in, specially chapter REACH pre-registration Questions and Answers (Release 3) At - Guidance for identification and naming of substances under REACH specially sections 3.2 & Guidance on Data-sharing specially chapters 3 & 4

22 ECHA Support Helpdesk Operational since 1 st June 2007 for registrants and MSCAs Coordination of the REACH National Helpdesks Network where each EU Member State is the 1 st point of contact for industry Publishes FAQs in REACH, IUCLID 5 and REACH-IT ECHA chairs and ensures the Secretariat of the REACH HelpNet, represented by the REACH helpdesk correspondents network (REHCORN) Aim of the network: achieve consistent and harmonised advice to stakeholders across EU Tools: REACH Helpdesk Exchange Platform (RHEP Tool) IT platform for daily cooperation, discussion on Q&A Contains a reference database of Q&A

23 ECHA Support Helpdesk STATISTICS 29/10/2008 IUCLID incidents since June 2007 (2) registered users downloads ( standalone distributed) LEOs created (GER, UK, FRA, ) (48) REACH Advice incidents since November 2007 (10) REACH-IT incidents since June 2008 (15) signs-up (+403 Third Party Representatives) (34) pre-registrations (GER, UK, NL, ITA, ) (314) submissions received 366 PPORDs, 324 Inquiries

24 ECHA Support Helpdesk REACH Questions By Geographic Region By Type EU 48% Europe - other 9% Latin America 2% North America 9% Oceania 0% (blank) 7% Africa 0% Request for information 16% Related EU Legislation 3% Registration dossier 4% Restriction 2% Scope of regulation 13% Substance ID 5% Notification on substances in articles 2% Process 4% other 6% Authorisation 1% EEA - non EU 1% Asia 24% Registration 34% Pre-Registration 10%

25 Thank you for your attention!