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EU REACH Regulation

Data Management under REACH

Agenda

GeneralGeneral Requirements

Types of REACH-Data

REACh and its data needsdata for pre-registration

pre registration in EXCEL?

how to get data to the EChA

what happens after pre-Registration?

Data for full Registration

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

Any Own Data Base?Why having your own data base

other internal requirements

the design principles for your data base

Threads the “Multi Constituent Substance”-issue

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

Types of REACH-Data

• Primary dataPrimary data = data that are subject to reports to

authorities directly

• Secondary DataSecondary 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.

Data for pre-registration

Required by REACH

- substance IDsubstance ID: EC number (EINECS = European Inventory of

Existing Commercial Chemical Substances), name

- Contact details of authorized representativeauthorized representative (real person)

- tonnage bandtonnage band

- planned latest registrationlatest registration (linked to tonnage band)

- reference substancesreference substances

- CAS-number (not listed in requirements list but mandatory

under IUCLID)

Pre-Registration in Excel?Substance EC-

NumberCAS tonnage

[mt]registration

dead linereference Substance

Ethanol 200-578-6 64-17-5 200 2013 Methanol

Acetone 200-662-2 67-64-1 90 2018 MEK

Acetyl Salicylic Acid 200-064-1 50-78-2 0,18 none Benzoic Acid

Hexafluoroacetone 211-676-3 684-16-2 4680 2010  

           

Entity Company XYZ

First name of Rep Pauline

Family name of Rep Cartier

Address Somwhere Road

zip-code  123456

City Faraway

Member State Nowhereland

How to get the data to EChA

EChA runs an internet site REACH-IT which is the onlythe only portal for portal for

information transferinformation transfer between EChA and the client (Data, messages,

etc)

Each clientEach client will have its own web spaceits own web space within REACH-IT which

cannot be accessed by anyone

REACH-IT will also be the information exchange platform forinformation exchange platform for the

SIEFsSIEFs

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

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)

• ....

The data pool

...

Legal Entity D

Legal Entity C

Legal Entity B

Legal Entity A

...

Substance D

Substance C

Substance B

Substance A...

Supplier D

Supplier C

Supplier B

Supplier A

Core Data

...

Animal-Tox-Test D

Rat-Tox-Test

Daphnia-Tox-Test

Fish-Tox-Test ...

Product D

Product C

Product B

Product A

...

Penetration Test

Corrosion Test

Mech. Func. Test

Stab. Test A

...

EcoTox-Test D

EcoTox-Test C

EcoTox-Test B

EcoTox-Test A

IUCLID 5 – The EU Data BaseIUCLID 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

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

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….

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-formatonly 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 …

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)

How to make it work

Picture taken from presentation „BDI REACh-Workshop“, by Dr. Manuela Cremer, BASF Aktiengesellschaft

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

– ….

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

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

• 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

Thank You For Your Attention

Please Feel Free To Ask Any Questions