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March 2015 Karine Van de Velde ROSC consortium 1

novel REACH consortium for orphan substances March 2015

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Page 1: novel REACH consortium for orphan substances March 2015

March 2015

Karine Van de Velde

ROSC consortium 1

Page 2: novel REACH consortium for orphan substances March 2015

REACH: Registration, Evaluation, Authorisation of CHemicals

2018 deadline 1-100 tonnes

Who will register in the supply chain?

Many more SMEs involved (traders / importers)

High number of substances to be registered (per company)

High cost of REACH dossiers

No (or limited) REACH knowledge in-house (lack of resources)

Cooperation multinationals with SMEs

Languages

Substances nobody looked at / that have no data: ‘orphans’

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ROSC consortium

Page 3: novel REACH consortium for orphan substances March 2015

Make REACH 2018 inventory NOW

Decide in 2015 which substances to register when

Spread costs over 2015-2018

If you have ‘orphan’ substances: start acting now!!= join ‘orphan’ REACH consortium “ROSC”!

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ROSC consortium

Page 4: novel REACH consortium for orphan substances March 2015

Help companies comply with

2018 REACH deadline

by

offering cost efficient tools

Keep more substances on the EU market

Keep more SMEs in business

Facilitate cooperation between SMEs and big players

Offer ‘all-included’ package

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ROSC consortium

Page 5: novel REACH consortium for orphan substances March 2015

All-included package Consortium management

Dossier preparation (including tox / ecotox)

Letter of access: sell REACH access to late-comers

Unique combination of experts in their field ARCHE Consulting

Chemservice

KV Consulting Services BVBA

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ROSC consortium

Page 6: novel REACH consortium for orphan substances March 2015

Grouping ‘orphan’ substances in 1 consortium

Open to organics and inorganics

Only 1 combined but experienced secretariat Experience in consortia management

Industry background (metals and flame retardants)

Keeps cost low (share admin burden)

General part and substance specific part

Use cost efficient tools like Read across / QSAR

Negotiate prices labs

Help companies spread costs over 2015-2018

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ROSC consortium

Page 7: novel REACH consortium for orphan substances March 2015

Check within your supply chain

Which substances do you WANT/NEED to register by

2018?

Make 3 groups of substances:

Registered by someone else

Find out cost to get legitimate access to REACH data

Include in your budgets when you buy access (2015-2018)

Being worked on by a company or industry group

Find out cost to get legitimate access to REACH data

Include in your budgets when you buy access (2015-2018)

‘Orphans’: act now!! Get organized!!

Is the ‘orphan’ ‘ROSC’ consortium an option for you?

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ROSC consortium

Need help making this inventory? Contact us!

Page 8: novel REACH consortium for orphan substances March 2015

Takes time to organize industry Gives time to find most cost efficient solutions Spread costs over 3 years

More feasibile for companies Enables companies to keep more substances on the market as

of May 2018 Very useful for small SME’s struggling with costs + human

resources Very useful for big companies still struggling with dozens of

small substances

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ROSC consortium

Page 9: novel REACH consortium for orphan substances March 2015

Get

consortium

organized

2015Gather

available

data

2015Get more

members

on board

2015

Gather new

data2016

HH and

ENV

assessment

2016Exposure

assessment2016

Risk

evaluation2017

IUCLID /

CSR2017

Industry

approval of

dossiers2017

Planning REACH consortium for ‘orphan’ substances

Lead

Registrant

starts

registering

2018Members

register2018

Sell REACH

registration

access to

non-

members

2018

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ROSC consortium

Page 10: novel REACH consortium for orphan substances March 2015

Provides a broad range of

Regulatory Affairs

services, designed to

assist companies in

preparing for and in

complying with

international and national

chemical control

legislation (like REACH)

with competence in

toxicology, risk

assessments and environ-

mental sciences. Multiple

scientific in-house

disciplines enable broad

issue addressing.

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ROSC consortium

Provides professional and

reliable Consortium

Management services

based on long lasting

experience in the metals

industry.

Main focus is customer

orientation, efficiency,

transparancy,

responsability, and

commitment to an integral

& economic execution.

ARCHE provides

regulatory support to his

clients all over the world.

Our expertise covers

different chemical

legislative frameworks

such as REACH and

CLP/GHS. Next to

preparing registration

dossiers we ensure

companies achieving

compliance and provide

proper training of your

regulatory teams on the

ever evolving aspects of

those chemical legislations

challenging your business.

Page 11: novel REACH consortium for orphan substances March 2015

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ROSC consortium

Combined Competence in:

• Consortia Set-Up & Management

- (including Trustee Accounts, LoA Management, Accounting

capabilities)

• Scientific Expertise (incl. tox, ecotox, read-across, waiving) in

Metals, Organics and Inorganics

• Capability in efficient REACH Dossier Preparation

• Regulatory Affairs know-how and daily experience in communication

with REACH and ECHA

• Capacity in Legal requests

• Multilingual Team (e.g. EN, DE, FR, NL, IT, RUS)

Page 12: novel REACH consortium for orphan substances March 2015

Karine Van de Velde

KV Consulting Services BVBA

Tel: +32 3 297 60 92

Mobile: +32 478 327 562

[email protected]

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ROSC consortium