REACH-IT Praxis und aktueller Stand

Dr. Martin Klöffler 22.11.2007

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REACH-IT• Your Enterprise:• Efforts depending on

– Role: Downstream user (DU) or producer– Size: Depending on small / medium / large enterprises

(SAP Companies)– Organisation: At best central solution (Model roi soleil)?

• Targeting to agreed standards (Definitions, Workflows, formats, even tools?)– Inside your company– In the european industry– ECHA

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Schedule for REACH IT

Pre-Registration

RegistrationPhase I> 1000 t/a or> 100 t/a + R50/53 or cmr

6 months

3 years after REACH c.i.f.

Data Collection,Evaluation

18 months afterREACH c.i.f.

18 months

Registr.Phase II100 – 1000 t/a

Registr.Phase III1 - 100 t/a

6 years afterREACH c.i.f.

REACH-IT Echa

12 months afterREACH c.i.f.

REACH-IT Industry

REACH-IT Industry

REACH-IT Industry

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Where to invest

Your Company ECHA

industryCustomer

SIMS

Questionnaire

SVT

Interface

Supplier

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Some key players• European Union: ECHA und ECB • Cefic

– REACH-IT Groups• SIEF-Project

• VCI– REACH-Fachgruppe

• Fachgruppe Datenmodellierung– Task force Interface IUCLID/EH&S

• TechniData– SVT, IUCLID, REACH-IT-Tools– EH&S data modeling

• SAP– Holistic approach (project study)

• BASF• ReachWay, Trasys, Hemmis, DHL, …

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Substance inventory for REACHoutside EU,

Exempted or registeredNot REACH-relevant

Non-phase-in?

EU phase-inVolume < 1 t/y

REACH relevantIntended / Belated

Registration

REACH Phase I-IIIVolume > 1 t/y

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Substance definition or Impact of RIP 3.10 and 3.2.2

• Get all Phase-in substances with 1 ton/y min!• Requires more detailed definitions compared to

listed substances defined by CAS RN– NLP versus polymers– Naturally occurring substances versus modified

naturally occurring substances (UVCB)

• Demand for a – Investigation on supply chain– more EH&S detailed data model

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The answer: a more refined Substance data model

MaterialsPackaging

powder / bag / drum...

RealSubProduct xyz

FAES C12-14 + 2EO, Na /Water / buffer / additives ...

ChemSub*FAES C12-14

+ 2EO, NaNLP

ListSubCAS-No:

68891-38-3Polymer

SDS

SpecificationRegulatory

report

1:n n:m

1:n

Regulations

1:1 CAS 1:n (LE)

* Pure substance

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The big issues for substances

• Complete Chemical compositions– All manufactured Products– Purchased or imported raw materials– REACH-compositions

• Trade secrets• Substance definitions compliant to RIP 3.10• REACH-Status decisions and tracking

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Pre- Registration

SIEF Dashboard

Read Across

Sameness

Subst. Id. Card

Data Exchange

SIEF Information Pages

Joint Submission (Lead Reg.)

SIEF Member Submission

Pre-SIEFdiscussion

Registration

Cefic’s SIEF IT system - Functional Overview

Potential Registrants

SIEF System boundary

Cost sharing

C&L

Data Gaps

StudiesSIEF Formation

Agency (ECHA)

Industry

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YourCompanySupplier Customer

Downstream In

Downstream Out

Upstream Out

Upstream In

SIEF

SUPPLIERS (UPSTREAM)• Pre-registration• Registration• Uses & Exposure Scenarios

CUSTOMERS (DOWNSTREAM)• Confirmation of Use

Industry questionnaire Up- and downstream user communication

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• In-house database for– Pre-Registration– Registration– SIEF

• Download available by ECHA since June 2007• Installed with major companies• Extensions proposed by CEFIC• Next release in spring 2008

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SVT for Products

Product PReal No 10322

Mat PNo 158009

Raw, Unpacked

PC2 Mat No 337426175 kg drum

PC2 Mat No 30883625 kg hobbock

PC2 Mat No 388991tankcar

EH&S

100% CAS RN XXXXX

Primary Material

NO Primary Material

NO Primary Material

NO Primary Material

contains ChemSub 3958

Primary Substance

Material

OutputAuthority Required Info•Pre-Registration•Registration Phase II •Manufactured 887 tons/year for 2005

Primary Product

Company APlant BCountry C

Orders

Annual volume

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New Tools for your company• ECHA:

– IUCLID 5– REACH-IT workflow system

• Registration, Dossier Admin. + Publishing, Billing, SIEF, CSR,…• Industry

– REACH-Industry portal for SIEF and consortia– REACH-Questionnaire for DU and Manufacturers

• Your Company– REACH-Substance Management (SIMS)– Supply chain tracking– Substance volume tracking (SVT) and REACH status tracking– Reporting

• Registration• CSR = Chemical Safety Report• CSA = Chemical Safety Analysis• ES = Exposure Scenario• Review of substances

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Backup

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Companie’s Decisions for registrationOperational

Relevance EU

Registration

Exemptions & exclusions

Phase-in

Ingredients in chemical compositions

EINECS, ELINCS, EU NLP, Company NLP

Volumes

Upgrading

Decisions upon rules

SVT for LE & Plant

Volume>1

Phase I-III

CMR, R50/53,….

REACHInventory

Pre-registration

ExpertDecisions

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SAP EH&S: REACH

The interfaceInitial load pre-reg sub

Update major biological Endpoints

Update administrative &

PC data

SAP EH&S:Non REACHSubstances

IUCLID 5

IUCLID 4