reachlaw introduction
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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. - PowerPoint PPT PresentationTRANSCRIPT
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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
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
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
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
REACHLaw Introduction
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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
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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
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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
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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
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REACHLaw Ltd today : global, world class REACH service provider
Our customers: > 200 major manufacturers in 25 countries with around 2000 substances
Customers
Partners
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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
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
Basic REACH concepts & terminology
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The presentation is built on previous REACH knowledge and only a very concise summary
and key terms will be repeated
Comment to the Presentation
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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?
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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?
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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)
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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
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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
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
The complexity of REACH
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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.
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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
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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
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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
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Tests needed (1/4)
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Tests Needed (2/4)
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Tests Needed (3/4)
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Tests Needed (4/4)
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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?
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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.
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EU Response on REACH and costs
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
Current status of REACH
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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?
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Which substances will be affected 2009-2010 (=deadlines for registration)
30.000
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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
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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.
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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)
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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 ??
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
SIEF and Consortia Strategy
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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...
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Our Categorization - first understand the status
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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
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Pre-consortia Study or Lead registrant
Pre-SIEF status
alone
LEAD REGISTRANT
Others in similar position
Pre-ConsortiumStudy
If successful
Consortium
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
Authorisation Service – Providing Evidence of Adequate
Control to ECHA
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Authorization process
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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)
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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
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ECHA Fees For Authorisation
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
Cost estimtion for REACH
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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
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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
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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 4 300 EUR 3 225
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 11 500 EUR 8 625
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
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Copyright © 2008 REACHLAW Ltd. All rights reserved.
Conclusions
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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?
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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?
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Let us not repeat the pre-registration problem…not possible now…
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Thank you for your attention !