Ref. Ares(2014)78291 - 15/01/2014

How does industry prepare forpre-registration
Watze de Wolf
DuPont Coordination Center, Brussels , Belgium

REACH Workshop- Final countdown to pre-registration
and registration of chemicals
Monday 14 April 2008, Brussels - Belgium

2Outline• What has industry done to prepare
for pre-registration and registration –an example• Inventory• Substance identity• IUCLID 5 downloads• SIEF planning• Communication in the supplychain• What have industry associations
done to inform companies, inparticular SMEs, about preregistration?
4/14/2008 REACh Workshop, Brussels - Belgium

3Product Compositional Data
EINECS, ELINCS
Polymer, NLP

REACH deals with substances• Tens of thousands of substances

Industry works primarily with products• Millions of products• Use of products in products• Product safety driven

REACH requires the development ofapproaches to deal with substances inproducts
Kevlar

4/14/2008 REACh Workshop, Brussels - Belgium• Substance inventories

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Understand your organisational structure
REACH deals with Legal Entities• Country specific boundaries

Industry often works with business units• No geographical boundaries - across Europe• Within one country a Business Unit can own multiple Legal Entities• Multiple Business Units can work within one Legal Entity

4/14/2008 REACh Workshop, Brussels - Belgium

5Develop your substance inventory• A “real-time” or “as-is” reflection of substances one
is dealing with
• More than one purpose:• Starting point for pre-registration• Starting point for classification and labelling inventory• Support Operations• etc.

Compositional data

• Create and maintain lists of substancesthat are:inventory• Imported into the EU• Manufactured in the EU• Used as a Downstream User in the EU• no volume cut-off

Transactional data

4/14/2008 REACh Workshop, Brussels - Belgium

Inventory system should include Legal Entity &Substance Volume Tracking

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Build your pre-registration list
• Extract from the inventory a list of substances thathave to be pre-registered:• import into EU• manufacture in the EU• current and expected annual tonnage above 1
ton per legal entity
Compositional data

inventory

Transactional data

4/14/2008 REACh Workshop, Brussels - Belgium

Pre-registration data

• Information is a starting point to set up a systemthat supports pre-registration for REACHcompliance7Populate internal pre-registration database
The following fields could be filled-out:
 IUPAC name of the substance CAS number of the substance EINECS number of the substance The tonnage band and the envisaged deadline
 Redefinition of a substance in relationship to CAS or EINECS entries

 The legal entity information

 Footnote – Substance read-across is an approach to fill
information gaps. The information gap filling strategy ispreferably decided upon within the SIEF
4/14/2008 REACh Workshop, Brussels - Belgium

8Submit pre-registration information to Helsinki

Internal databaseXMLAs of 1 June 2008

4/14/2008 REACh Workshop, Brussels - Belgium

9Plan for pre-registrant activities
Pre-registration• CAS or EINECS-identifier• Access to Legal Entity contact information‘Information exchange’ on:• Chemical identity• Volume of production (tonnage band)• Hazard information?
• Uses (in registration consortia)?
• Exposure data (in registration consortia)?

Potential risk of:• Infringements of anti-competition law• Loss of Intellectual Property and CBI (Confidential Business Information)
4/14/2008 REACh Workshop, Brussels - Belgium10Prepare for Substance ID• First step following pre-registration• Objective: agree on sameness of substance• Pre-registration list
• CAS or EINECS-identifier• Guidance on substance ID (RIP3.10)• Well-defined substances• Mono-constituent substances• Multi-constituent substances• Substances with Unknown or Variable composition,
Complex reaction products or Biological materials (=UVCBs)
4/14/2008 REACh Workshop, Brussels - Belgium

11Prepare for data sharing
Data sharing• One of the first steps following the birth of the SIEF
• Legal requirement to inform other pre-registrants in theSIEF of available data

What?
• Identify information one owns (or may have access to)• Collect test reports• Prepare (robust) study summaries in IUCLID 5• Assess quality of the information• For Klimisch 1 and 2 studies: determine costs

4/14/2008 REACh Workshop, Brussels - Belgium

12Prepare for registration – IUCLID 5• Create internal IT-architecture• Download IUCLID 5• Build capacity and capability withbusiness, technical and regulatory
personnel• Develop substance identification• Gather information on manufactureand use• Create (robust) study summaries ofown hazard data
• Store relevant information

4/14/2008 REACh Workshop, Brussels - Belgium

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Communicate with your supply chain

Supplier
Downstream users• Pre-registration is necessary to be able tocontinue business• No data, no market• Avoid “Panic pre-registration”• Late pre-registration
4/14/2008 REACh Workshop, Brussels - Belgium

14Make use of industry awareness actions• Information bulletins• Newsletters• Fact sheets• Interpretations• Guidance/guidelines• Workshops• Seminars• Trainings• …………

4/14/2008 REACh Workshop, Brussels - Belgium

15Be Aware of REACH!
• Inventory of substances• Pre-register manufactured or imported substances• REACH-IT tool from ECHA
• release ASAP, together with guidance• companies need time to experience and train

Ferocactus wislizeni• proof of pre-registration -> pre-registration number• No need for ‘panic pre-registration’ by multiple players in the same
supply chain• consider late pre-registration possibility• Prepare for SIEF discussions and information exchange

Beyond being a regulatory complianceissue, REACH is a business issue
4/14/2008 REACh Workshop, Brussels - Belgium