copyright © 2008 reachlaw ltd. all rights reserved. international workshop on reach - the new...

Copyright © 2008 REACHLAW Ltd. All rights reserved.

INTERNATIONAL WORKSHOP ON REACH - THE NEW EUROPEAN COMMUNITY REGULATION ON CHEMICALS

REACH – State of Play Today

Mathias BernerPartner, Sales Director

7th of April 2009, Brasilia


Agenda

1. REACHLaw Introduction2. Basic REACH concepts & terminology3. The complexity of REACH4. Current Status of REACH5. SIEF and Consortia Strategy6. Cost Estime for REACH7. Authorization8. Conclusions


REACHLaw Introduction

Our mission

REACHLaw Ltd

exists exclusively to provide full set of REACH services and timely solutions to its clients

by

offering unique combination of expertise in REACH, legal, chemistry, environmental and business

Introductions:Our Executive Team & skills

Mr Lasse Kurkilahti, Partner and Chairman of the Board, former CEO and President of Kemira Ltd, also former Chairman of Finnish Chemical Industry Association, MSc in Business Admistration

Mr Lasse Musakka, Partner and CEO, MSc in Economics

Mr Mathias Berner, Partner and Sales Director, D.Sc. (Tech)

Mr Riku Rinta-Jouppi, Partner and Chief Legal Council, MA Law, MSc in Bioinformation Technology

Mrs Ying Zhu, Partner and COO, PhD in Bio Chemistry, MBA

Mr Jouni Honkavaara, Partner, CFO and CMO, MSc , MBA

> 40 specialists in REACH/EU competition law, chemistry, toxicology and business

Key capabilities of REACHLaw: Chemical Industry, business and legal REACH knowledge, Chemistry,

Close Co-operation with ECHA and Helsinki REACH Centre, Independence

Consortium

EU Manufacturers

Our Service Model

Non-EU Countries

REACHLaw LtdHelsinki, Finland

Process development&

Confidential InformationManagement

ECHA

Importers(→ DU) Downstream Users

(EU Market)

Consortium

M

LR

DH

OR

EU

Non EU IndustryAssociations

Non–EU Manufacturers

Own subsidiaries&

Partners for on site support

and additional competencies

SIEF

EU Manufacturers

REACHLaw LtdBrussels

Some of Our Partners> China

> Huateng www.hthitech.com CPCIA www.cpcia.org.cn > India

> Dynamic Orbits www.dynamicorbits.com> Russia

> Petrofinn www.petrofinn.com> Thailand

> Pro-Application Service www.proapplication.com> USA

> ChemRisk www.chemrisk.com

Latin America

CIQyP & MOURAO ENRIQUE ASSOCIADOS

With the support of: ABIQUIM, ANIQ, ASIQUR, ASIQUIM, ASOQUIM.

AUSTRALIA

Pamir Consulting www.pamirconsulting.com

REACHLaw Ltd today : global, world class REACH service provider

Our customers: > 200 major manufacturers in 25 countries with around 2000 substances

Customers

Partners

Examples on our REACH service packages

Services for Manufacturers Registration Service Package

Service/outsourcing/Third party agreement model for EU manufacturers and subsidiaries of non-EU manufacturers

Only Representative model for non-EU manufacturers

Service Package for Late Arrivals Sourcing and Supply Chain Strategies: REACH Risk Analysis

Services for Lead registrants & Consortia Pre-Consortium Study for Consortia Formation Lead Registrant Support Service Package Consortium Support Service Package

Services for Downstream users Downstream User Registration Package Exposure Scenarios


Basic REACH concepts & terminology

The presentation is built on previous REACH knowledge and only a very concise summary

and key terms will be repeated

Comment to the Presentation

REACH is the new chemical legislation in EU affecting the sale and manufacture of all chemicals unless specifically exempted

REACH is in Force NOW! No (pre)-registration – no Market

What is REACH?

All substances – on their own, in preparations or articles (if intended to be released)

manufactured or imported in quantities of 1 tonne or more per year

unless they are explicitly exempted from the scope of registration, notably Annex IV, V.

What to register?

How to Register?

1. Independent, professional Only Representative

2. Own legal entity (subsidiary in the EU) as registrant

3. (Importer in the EU as OR/registrant)

4. (Test laboratories)

5. (Multinational companies)

6. (Non-EU Government affiliates)

When to Register?

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 20192007

In ForceJune 1, 2007

1000 t/y,CMR 1&2R50/53

100 - 1000 t/y

1 - 100 t/y

Pre

-Re

gis

tra

tion

(Ju

ne

1 –

De

cem

be

r 1

20

08

)Evaluation, SDS & Down Stream User Data maintenance

Evaluation, SDS & Down Stream User…

Evaluation…

June12013

June 12018

Dec 12010

Dec 12008Milestones

Pre

-Re

gis

tra

tion

pre

pa

ratio

ns

on

go

ing

TODAY’S FOCUS

SIEF = Substance Information Exchange Forum All pre-registered substances are automatically part of the (pre)SIEF. After sameness of the substances is agreed the SIEF officially starts Purpose of SIEF: agree on CLP and data sharing

Consortia “Voluntary” Formalized co-operation between companies

Terminology


The complexity of REACH

The context/concept/paradigma of REACH (Background:Scope of our risk analysis)

Non-EUsuppliers

Your companyGroup

EU – supplierSubstance A

Your OR /subsidiiary

Independent importers

EU

Non-EU

Your company(Group)

Independent Non - EU

Manufacturer

Non-EUsuppliers

1c.

1a.

2.

3.

4.

EU - customers

5.

1b.Scope: topics to be covered

1a. Appointing Parties, substances, legal entities1b. Appointment Process1c. Appointed Party (OR)2. Independent non-EU suppliers3. Indirect export4. Independent EU importers5. Potential EU suppliers, re-import6. New ”REACH counterparts/liabilities/risks”7. New liabilities against your customers

New counterpartsECHA, SIEF, Consortia.... 6.

7.

Comments to REACH risk analysis Understand all REACH relationships very well Especially Focus on

Supply chain issues Pressure created by your customers in EU

Liabilities arising from REACH

HAZARD ASSESSMENT (HA)

RISK CHARACTERISATION (RC)

DOCUMENTATION IN CHEMICAL SAFETY REPORT (CSR)

EXPOSURE ASSESSMENT (EA)

FINAL EXPOSURE

SCENARIO (ES)

Dangerous or PBT, vPvB

IDENTIFICATION OF DATA GAPS

TESTING REQUIREMENTS

PREPARATION OF TESTING PROPOSALS

PREPARATION AND CHECK OF CSR

CHEMICAL SAFETY ASSESSMENT CSA

SHARING THE EXISTING DATA

EVALUATION OF THE DATA QUALITY

GENERATION OF NEW DATA

ORGANIZING EXISTING DATA

TECHNICAL WORK IN REACH

If substance is not hazardous, only data for physicochemical properties required (Annex III)

When there is an information gap which cannot be filled by any non-testing method, registrant has to take action

- Annexes VII or VIII : generate new information - Annexes IX or X : prepare a testing proposal

Starting point

Tests needed (1/4)

Tests Needed (2/4)

Tests Needed (3/4)

Tests Needed (4/4)

Conclusions on technical requirements There is an incredible workload coming towards

substance with the 2010 deadline Numerous tests have either to be performed (Annex VII-

VIII) or testing proposals submitted (Annex IX-X) Requires completely new interactions between

competitors (NOTE: Competition LAW!)

How is the industry coping with this?

European Chemical Industry Council (CEFIC) Alert 4.3.2009 A key warning to companies is that in practice, they should aim to submit

lead registration dossiers by June 2010 - six months before the deadline - to be on the safe side. This is so that it can undergo a technical completeness check and secure registration - after the registration fee has been paid - in time so that all other members of the substance information exchange forum (SIEF) that are sharing data in that dossier can refer to it.

The timeline also indicates that already: SIEF formation facilitators should have been identified; codes reflecting the role companies will play within SIEFs should have been communicated; and agreement on the sameness of a substance represented by the SIEF should have been achieved. For many SIEFs this will not have happened--it is understood that only 10% of pre-SIEFs had a potential formation facilitator lined up via the pre-registration process.

EU Response on REACH and costs


Current status of REACH

Some statistics: pre-SIEF’s

No of Participants

No of Pre-SIEFS in range

Percentage of pre-SIEF covered by consortia

1000-4999 138 ?500-999 287 ?200-499 1114 ?100-199 2006 ?75-99 1290 ?50-74 2733 ?25-49 9734 ?10-24 35439 ?1-9 94428 ?Grand Total 147169 0

If > 1000 ton and no existing consortia -> major difficulty in registering on time

High cost?

Low cost?

Which substances will be affected 2009-2010 (=deadlines for registration)

30.000

Current status:Types of SIEF’s (according to our experiences from 2000 Pre-SIEFs) Type of SIEF Activities/status Characteristics Dominating

playersKey issues

1. ”Dormant” No progress, major type so far

No leading manufacturer

No one so far Leading must show up, others can just wait

2. ”Mess” Playground for commercial service providers

No real leading manufacturer having industrial interest

No one so far Leading must show up,

3. ”Nominal” Low activity in SIEF, leading has taken to role

Major work done in existing consortia

Large USA/EU based manufacturers

Cost sharing issues, membership in consortium

4. ”Fighting” Discussions dominated by one manufacturer

Major work done by the leading company (no consortium)

One large manufacturer

Cost sharing mechanism

5. ”Real” No existing examples

Major work done by SIEF

No one Role in SIEF depending on existing data

CEFIC tried to help

Chemistry making a world of difference

European Chemical Industry Council – Cefic aisbl Avenue E. van Nieuwenhuyse 4 B - 1160 Brussels Belgium Tel: +32 2 676 72 11 Fax: +32 2 676 73 01 [email protected] www.cefic.org

Deadline is within 2 weeks after the sending of the letter but no later than 1st of March 2009 if the earliest registration deadline in the SIEF is 30 November 2010. Assignment of SIEF codes is not static and may change over time No assignment of code will mean default code 4 (please note that these codes can be changed at any time by contacting the SFF).

SIEF Code Position

My position (please indicate the

appropriate cell) 1 Leading

This is a substance of high strategic importance for my company and I have available resource to (co) lead and drive registration to completion

2 Involved

My company is registering and may be actively involved. My company will receive a SIEF progress report, an invoice* and an invitation to comment

3 Passive

My company has the intention to register this substance. My company will receive a SIEF progress report and an invoice*

4 Dormant

My company has no intention to register nor to spend money. My company will receive no communications and no invoice (besides mandatory data sharing).

* Invoice will include the data needed for the corresponding registration and any additional management compensation according to cost sharing system agreed in the entire SIEF.

Why so slow progress – major reason ?

Big ones not taking the lead, especially non-EU manufacturers Pre-registration, basic challenges

Major tasks Substance identification (chemistry) Knowledge about & interpretation of REACH regulation (legal) Volume calculation REACH-IT

Registration, completely new challenges Pre-SIEF , SIEF and consortia formation: Who should take the leading position,

what it means, how to cooperate in SIEF / Consortia, cost sharing etc (legal & business)

Later: Evaluation of data, new research (toxicological & eco-toxicological tasks)

Current status: Pre-SIEFs have started, but…

We (= our customers) have made pre-registrations for around 2.000 substances

Less than 200 Pre-SIEFs are running…

Reason to be worried ??


SIEF and Consortia Strategy

Immediate Actions needed Products in over 1000 t category or CMR’s are in very real danger of

missing the 2010 deadline if no one is taking the lead What is the pre(SIEF) status? Data availability? SIEF distribution?

But first, let’s understand the individual role...

Our Categorization - first understand the status

Next Step: (pre)SIEF status What is the status of the pre-SIEF?

Is it progressing Based on the pre-SIEF lisiting are there other major

manufacturers Who is the SIEF Formation Facilitator? ECHA will not assist in this process!

IF THE MAJOR MANUFACTURERS WILL NOT TAKE THE LEAD, REGISTRATION DEADLINE WILL BE MISSED

Pre-consortia Study or Lead registrant

Pre-SIEF status

alone

LEAD REGISTRANT

Others in similar position

Pre-ConsortiumStudy

If successful

Consortium


Authorisation Service – Providing Evidence of Adequate

Control to ECHA

Authorization process

Substances Prioritised by ECHA for Authorisation 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) Alkanes,C10-13,chloro (short chain chlorinated paraffins;

SCCPs) Hexabromocyclododecane (HBCDD) and all major

diastereoisomers identified 4,4’-Diamino diphenyl methane (MDA) Bis (2-ethylhexyl) phthalate (DEHP) Benzyl butyl phthalate (BBP) and Dibutyl phthalate (DBP)

ECHA Authorisation Process ECHA consultation now open until 14 April 2009 for

evidence from industry that certain uses for these substances should still be exempted from authorisation

The criteria used are: Intrinsic properties (CRM, PBT, vPvB) Volumes applied Nature of Uses

ECHA Fees For Authorisation


Cost estimtion for REACH

Cost components of Registration phase

DataBig variation

1-2% 10% 5% 70-80% 10%

Oil industry: Total average cost estimate 100.000 to 200.000 euro/substance

Principal model for cost estimate (simplified)

Some major cost factors

1. The exported volume (= data requirement)

2. Your individual data gap (= your missing data)

3. The total data gap (cost for new research)

4. Number of potential registrants sharing the cost

5. Cost sharing mechanism

6. Consortia costs

7. Echa fees

8. External service fees

Data requirement(=studies)

You Other potentialRegistrants

TotalInformation gap

> 10 X00

X0X

X0X

100 X00

0X0

XX

1000 000

00X

00x

ECHA FeesSTANDARD FEES REDUCED FEES FOR SMEs

Individual Submission

Joint Submission

Medium Enterprise (Individual Submission)

Medium Enterprise (Joint Submission)

Small Enterprise (Individual Submission)

Small Enterprise (Joint Submission)

Micro Enterprise (Individual Submission)

Micro Enterprise (Joint Submission)

Fee for substances in the range of 1 to 10 tonnes EUR 1 600 EUR 1 200

Fee for substances in the range of 1 to 10 tonnes EUR 1 120 EUR 840 EUR 640 EUR 480 EUR 160 EUR 120


Fee for substances in the range of 10 to 100 tonnes EUR 3 010 EUR 2 258 EUR 1 720 EUR 1 290 EUR 430 EUR 323


Fee for substances in the range of 100 to 1000 tonnes EUR 8 050 EUR 6 038 EUR 4 600 EUR 3 450 EUR 1 150 EUR 863

Fee for substances above 1000 tonnes EUR 31 000 EUR 23 250

Fee for substances above 1000 tonnes EUR 21 700 EUR 16 275 EUR 12 400 EUR 9 300 EUR 3 100 EUR 2 325

30 000 Substance * 23 250 €/substance = 697 500 000 euro


Conclusions

Conclusions – short term All substances are covered correctly and REACH compliance exists

Enforcements have started and will continue to grow in activity There is not any time to be lost of your deadline is in 2010 and no

consortia exists Be careful of consultant SIEF Formation Facilitators (wrong

interest) Pre-consortium study Lead registrant Are intermediates relevant?

Conclusions – long term REACH is not a short term operational issue but a very stratgic one. It will

effect: Future investments at plants Process changes Supply chain changes (e.g raw material quality)

REACH will be a tool for competition Non-EU suppliers will be divided into compliant vs non-compliant companies

with an economic effect What will happen after 2010?

Will EU buyers prefer to buy from fully REACH compliant suppliers regardless of registration deadline?

Let us not repeat the pre-registration problem…not possible now…

Thank you for your attention !

copyright © 2008 reachlaw ltd. all rights reserved. international workshop on reach - the new...

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