INTERNATIONAL WORKSHOP ON REACH - THE NEW
EUROPEAN COMMUNITY REGULATION ON CHEMICALS
REACH – State of Play Today
Mathias Berner
Partner, Sales Director
7th of April 2009, Brasilia
Copyright © 2008 REACHLAW Ltd. All rights reserved.
Agenda
1. REACHLaw Introduction
2. Basic REACH concepts & terminology
3. The complexity of REACH
4. Current Status of REACH
5. SIEF and Consortia Strategy
6. Cost Estime for REACH
7. Authorization
8. Conclusions
Copyright © 2008 REACHLAW Ltd. All rights reserved.
REACHLaw Introduction
Copyright © 2008 REACHLAW Ltd. All rights reserved.
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
Our Service Model
Non-EU Countries
EU
M
SIEF
Non EU Industry
Associations
OR
Consortium LR
Consortium
DH
REACHLaw Ltd
Brussels
REACHLaw Ltd
Helsinki, Finland
Non–EU Manufacturers
Own subsidiaries
&
Partners for
on site support
and additional competencies
ECHA
Process development
&
Confidential Information
Management
EU
EU
Manufacturers
Manufacturers
Importers
(→ DU)
Downstream Users
(EU Market)
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
Partners
Customers
Our customers: > 200 major manufacturers in 25
countries with around 2000 substances
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
Copyright © 2008 REACHLAW Ltd. All rights reserved.
Comment to the Presentation
The presentation is built on previous REACH
knowledge and only a very concise summary
and key terms will be repeated
What is REACH?
 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 to register?
 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.
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?
Milestones
Pre-Registration preparations ongoing
1000 t/y,
CMR 1&2
R50/53
100 - 1000 t/y
1 - 100 t/y
2007
Dec 1
2010
2008
In Force
June 1, 2007
2009
June1
2013
June 1
2018
TODAY’S FOCUS
Pre-Registration (June 1 – December 1 2008)
Dec 1
2008
Evaluation, SDS & Down Stream User Data maintenance
Evaluation, SDS & Down Stream User…
Evaluation…
2010
2011
2012
2013 2014
2015
2016
2017
2018
2019
Terminology
 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
The complexity of REACH
Copyright © 2008 REACHLAW Ltd. All rights reserved.
The context/concept/paradigma of REACH
(Background:Scope of our risk analysis)
EU - customers
7.
Independent
importers
Your OR /
subsidiiary
4.
1c.
New counterparts
ECHA, SIEF,
Consortia....
6.
EU – supplier
Substance A
5.
EU
Scope: topics to be covered
Non-EU
Independent
Non - EU
Manufacturer
1b.
3.
Your company
Your
company
(Group)
Group
1a.
2.
Non-EU
Non-EU
suppliers
suppliers
1a. Appointing Parties, substances, legal entities
1b. Appointment Process
1c. Appointed Party (OR)
2. Independent non-EU suppliers
3. Indirect export
4. Independent EU importers
5. Potential EU suppliers, re-import
6. New ”REACH counterparts/liabilities/risks”
7. New liabilities against your customers
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
TECHNICAL WORK IN REACH
ORGANIZING EXISTING DATA
SHARING THE EXISTING DATA
TESTING REQUIREMENTS
EVALUATION OF THE DATA QUALITY
IDENTIFICATION OF DATA GAPS
GENERATION OF NEW DATA
PREPARATION OF TESTING PROPOSALS
CHEMICAL SAFETY ASSESSMENT CSA
HAZARD ASSESSMENT
(HA)
Dangerous or
PBT, vPvB
EXPOSURE ASSESSMENT
(EA)
RISK CHARACTERISATION (RC)
FINAL
EXPOSURE
SCENARIO (ES)
PREPARATION AND CHECK OF CSR
DOCUMENTATION IN CHEMICAL SAFETY REPORT (CSR)
Starting point
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
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
Copyright © 2008 REACHLAW Ltd. All rights reserved.
Some statistics: pre-SIEF’s
Percentage of preNo of Pre-SIEFS in SIEF covered by
No of Participants range
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
Low cost?
High cost?
If > 1000 ton and no existing consortia -> major difficulty in
registering on time
Which substances will be affected 20092010 (=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
players
Key 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
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
1
Leading
2
Involved
3
Passive
4
Dormant
Position
My position
(please indicate the
appropriate cell)
This is a substance of high strategic
importance for my company and I
have available resource to (co) lead
and drive registration to completion
My company is registering and may
be actively involved. My company
will receive a SIEF progress report,
an invoice* and an invitation to
comment
My company has the intention to
register this substance. My company
will receive a SIEF progress report
and an invoice*
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.
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
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 & ecotoxicological 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
Copyright © 2008 REACHLAW Ltd. All rights reserved.
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-Consortium
Study
If successful
Consortium
Authorisation Service –
Providing Evidence of Adequate
Control to ECHA
Copyright © 2008 REACHLAW Ltd. All rights reserved.
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
Copyright © 2008 REACHLAW Ltd. All rights reserved.
5%
SIEF
70-80%
Data
Big variation
Oil industry: Total average cost estimate 100.000 to 200.000
euro/substance
10%
ECHA
10%
Consulting
Pre-registration service
1-2%
Registration service
Cost components of Registration phase
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 potential
Registrants
Total
Information
gap
> 10
X
0
0
X
0
X
X
0
X
100
X
0
0
0
X
0
X
X
1000
0
0
0
0
0
X
0
0
x
ECHA Fees
STANDARD FEES
Individual
Submission
Fee for
substances
in the range
of 1 to 10
tonnes
Joint
Submission
REDUCED FEES FOR SMEs
Medium
Medium
Enterprise
Enterprise
(Individual
(Joint
Submission) Submission)
Small
Enterprise
(Individual
Submission)
Small
Enterprise
(Joint
Submission)
Micro
Enterprise
(Individual
Submission)
Micro
Enterprise
(Joint
Submission)
EUR 1 600
Fee for
substances
in the range
of 1 to 10
EUR 1 200 tonnes
EUR 1 120
EUR 840
EUR 640
EUR 480
EUR 160
EUR 120
EUR 4 300
Fee for
substances
in the range
of 10 to 100
EUR 3 225 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 11 500
Fee for
substances
in the range
of 100 to
EUR 8 625 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
Fee for
substances
above 1000
EUR 31 000 EUR 23 250 tonnes
EUR 21 700 EUR 16 275 EUR 12 400
EUR 9 300
EUR 3 100
EUR 2 325
Fee for
substances
in the range
of 10 to 100
tonnes
30 000 Substance * 23 250 €/substance = 697 500 000 euro
Conclusions
Copyright © 2008 REACHLAW Ltd. All rights reserved.
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 noncompliant 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 !