1 / 20

EU REACH Regulation

EU REACH Regulation. Data Management under REACH. Agenda. IUCLID 5 IUCLID 5 – The European Data Base set up of IUCLID 5 How to get started disadvantages of IUCLID 5 missing existencials how to make it work

chacha
Télécharger la présentation

EU REACH Regulation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. EU REACH Regulation Data Management under REACH

  2. Agenda IUCLID 5IUCLID 5 – The European Data Baseset up of IUCLID 5How to get starteddisadvantages of IUCLID 5missing existencialshow to make it work Any Own Data Base?Why having your own data baseother internal requirementsthe design principles for your data baseThreads the “Multi Constituent Substance”-issue GeneralGeneral Requirements Types of REACH-Data REACh and its data needsdata for pre-registrationpre registration in EXCEL?how to get data to the EChAwhat happens after pre-Registration?Data for full Registration

  3. General Requirements • Data need to be collected also from multiple sites • Data must linked and grouped to provide information • Data must be stored safely in a central spot • Data must be maintained • Access must be granted to those who need and • those who don’t must be securely excluded • IP must be protected and kept internally • Data growth needs must be considered from the very beginning

  4. Types of REACH-Data • Primary data = data that are subject to reports to authorities directly • Secondary Data = data that are not direct reportables but will appear elsewhere under REACH, e.g. in the MSDS’s or supply chain communication or SEIFs.

  5. Data for pre-registration • Required by REACH - substance ID: EC number (EINECS = European Inventory of Existing Commercial Chemical Substances), name - Contact details of authorized representative (real person) - tonnage band - planned latest registration (linked to tonnage band) - reference substances - CAS-number (not listed in requirements list but mandatory under IUCLID)

  6. Pre-Registration in Excel?

  7. How to get the data to EChA • EChA runs an internet site REACH-IT which is the only portal for information transfer between EChA and the client (Data, messages, etc) • Each client will have its own web space within REACH-IT which cannot be accessed by anyone • REACH-IT will also be the information exchange platform for the SIEFs

  8. What happens after pre-Registration? • Data will have to be forwarded to EChA in an acceptable file format (actually only XML-files are accepted) • January 1st 2009 the EChA will publish a list with chemicals and the relevant SIEFs (Substance Information Exchange Forum) • SIEFs will have to form and allocate roles and responsibilities • SIEFs to start work on pulling together the dossiers for registration working dead lines down

  9. Data for full Registration Additional documents : • SVHC evaluation • reports on toxicity testing across the pathways of the product • Registration Dossier/Substance Safety Report • descriptions of use from customers, distributors and end-users • exposure description and risk asessment of the chemical • exposure scenarios • limiting values (PNECs, DNELs, etc) • ....

  10. The data pool

  11. IUCLID 5 – The EU Data Base IUCLID is the given Data Base from EC • Available as Server-Based- and • Stand-Alone-Version • Required to create technical dossiers • Could be set up to also cover multiple legal entities/sites It looks like there is no alternative to IUCLID 5

  12. Set-Up of IUCLID 5 Multiple server installations for one group of entities single server installation Multiple stand alone installations for a group of entities single stand alone installation

  13. How to get started • Register at IUCLID web site • Create a LEO (legal entity object) and download LEO-file • Download installation files for IUCLID • Download European Inventory files • Download reference substance files • Install IUCLID, create new user, new entity, new site, new substance….

  14. Disadvantages of IUCLID 5 • Very many data fields – high work load for maintenance and data input • The concept of user set-up does not allow individual write/read-access: all users will see all data of all legal entities connected to the relevant IUCLID installation!!! • Actually there is no query tool – search for data is difficult • No option to create a literature list for a particular chemical substance • Import-/Export-capabilities allow only XML-file-format after special treatment (rename *.xml to *.i5d, then zip to *.i5z, then import…) • Completeness check missing to a large extend • Data entry not as self-explaining as could be assumed from GUI • …

  15. Missing existencials • IUCLID is not designed to also cover most part of secondary data • import-/export interface to link IUCLID 5 to other data base systems • Data hand over format to e.g. MSDS system, R&D-System and others • Completeness check for technical dossiers • Extend user administration functionality (e.g. to also set read functionality)

  16. How to make it work Picture taken from presentation„BDI REACh-Workshop“, by Dr. Manuela Cremer, BASF Aktiengesellschaft

  17. Why having your own data base? There is good reason to use the opportunity compiling a powerful chemicals data base: • Recovery of data about local, regional and global chemicals consumption • Grouping supplier information to allow top down view from global level down to local • Recovery and centralization of data about any products that fall under the category “Chemical Product” • If wanted expand data mining, hosting and maintaining to all kind of related research-, development-, testing- and business data of our products • ….

  18. Other internal requirements/ Use the opportunity install a powerful chemicals data base that can e.g. be used for: • Recovery of data about local, regional and global chemicals consumption • Grouping supplier information • Recovery and centralization of data about any products affected by REACH • Implement data mining, hosting and maintaining to all kind of related business data (research-, development-, testing- and market data of your products) Basically: set up a professional Product Stewardship Tool

  19. The Design Principles for a Data Base • Compliance: ensure a sustaining proper use of the data base by making it be easy and comfortable to use and to access. • Robustness: Self explaining data fields, comfortable walk-through, set-up of user rights and secure save/deletion processes to make it’s use by individuals with a broad variety of PC-skills safe Safety • Availability: Available and accessible 24/7 for all affected sites • Flexibility: Built to cover your actual needs, flexible enough to allow adaption to your future needs

  20. Thank You For Your Attention Please Feel Free To Ask Any Questions

More Related