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REACH as business case
Sao Paulo 07.07.2008
Dr. Thomas Jostmann
Talking points
• Setting the scene
• Business implications
• Industry cooperation
• Major activities under REACH
• Pre-Registration
• Registration
• Authorization/Restriction
• Role of industry associations
• Opportunities under REACH
• Summary and outlook
REACH – a European exercise or a global mega trend (1)?
Some general remarks:
Risk assessment for chemicals is not a new invention of REACH (Biocides Directive, ICCA HPV, US Challenge…), but
• Shift of „burden of proof“ to evaluate risks from authorities to companies is „shift in paradigm“
• Shared responsibilities between manufacturers and users of chemicals changes transparency in supply chain
• Improved information of downstream users about safe handling of chemicals based on intrinsic properties and exposure information
• „right to know“ for end users and NGOs is changing companiesattitudes towards more transparency to the public
• regulators to challenge substances of high concern
• ban of critical substances if safe use cannot be demonstrated
REACH – a European exercise or a global mega trend (2)?
• REACH entered into force in mid 2007
• US, Canada and Mexico started the CHAMP initiative
• China has introduced a „REACH-type“ regulation for new substances
• UNEP summit on „Strategic approach on international chemicalsmanagement (SAICM)“ in 2006 started a global approach for safemanagement of chemicals
So; REACH is not an isolated initiative of Europe but has somespecifities which are so far unique and may have some immediate business implications!
Business implications
Get clarity about your own role in REACH
Specify your own obligations under REACH:
• Are you selling substances or preparations in Europe?
• Are you a manufacturer / importer or downstream user?
• Will you need to register or „just“ provide information about your ownuse?
• Do you have all information on hand which are necessary to fullfil yourobligations?
• Do you have an overview about your substances / applications fallingunder REACH requirements?
In case you‘re a downstream user make sure that your use is takencare of by your supplier, otherwise your product can not be exported to the EU!
No registration – no market
First immediate business impacts:
First (easy) hurdle is given by the pre-registration.
No Pre-Registration means loss of „phase-in“ Status and by that need to register before entering the market or continuing existing business
Pre-Registration will no be followed by registration:Expiration of respective registration period (depending on tonnage band)
determines end of marketing within Europe.
Registration dossier not complete:If missing infomation will not be provided in due time, ECHA can stop marketing
of corresponding substance.
Specific use is not covered by the registration dossier:Three options:
require either separate DU-registration
Supplier has to update his dossier
Use of substance in this specific application has to be stopped
Each Business Step is affected byREACH?
Core processes
supplier
Data exchange and communication
customers
§
purchasingProduct-safetyt
Production
R&D
Sales offices
authoritiesSIEFS
Substance Data
RegistrationsDocuments
§
Quelle Grafik: Technidata
Starting the communicationchain under REACH
Communication alongthe value chain
competitor
EU
Non-EU
Only Representative
Industry cooperation –sharing expertise
Registration is team work which requires expertise in different areas and planning of available resources
• Organisation within the company• specify data requirements and gaps• collect inhouse information
• Dialogue within various supply chains• identify „intended uses“• collect information about conditions of use
• Cooperation within consortia• evaluate data• identify data information gaps
May be that in-house resources may notsuffice and need to be (re-) activated
Is industry prepared to communicate ?
„European transparency“ is not backed up at global level thus creating an unevenlevel playing field
Dialogue ......increases market transparency...provides market intelligence to
potential competitors...discloses confidential business
information
Supplier
Formulators
Downstream users
Chemical suppliers are used to provide information via SDS to theircustomers but development of exposure scenarios and listing of identified uses needs open dialogue with downstream users !
Is your European customer prepared to „open the books“?
CBI – clarify first before sharing
CBIIUCLID 5: proprietary information can be indicated as
confidential in the registration dossier (Caviat: fees foreach individual CBI)
Exchange of important data / information about usepatterns o specific applications with customers is basedon an SA (Secrecy Agreement) vereinbart.
Consortia; in each consortium in with Evonik Degussa is actively participating CBI is covered in the contract(contract examples by Cefic, Redeker)
REACH Subgroups
SVT (Substance Volume Tracking)SVT (Substance Volume Tracking)ContractsContractsTrainingTrainingRisk
AssessmentRisk
AssessmentAgency contactsAgency contacts
IUCLID 5IUCLID 5Cost sharingCost sharingMarketingMarketingCSRCSRSubstance-identificationSubstance-
identification
REACH-BaseREACH-BaseCompetitorCompetitorCustomer Questionnaire
Customer Questionnaire
Standard-dossier
Standard-dossierChecklistsChecklists
DRIP (TeamDoc)
DRIP (TeamDoc)Data SharingData SharingPurchasing
(Feedstock)Purchasing (Feedstock)eSDSeSDSData-
collectionData-
collection
IT-ToolsIT-ToolsConsortiaConsortiaCommuni-cation
Communi-cation
Risk evaluation
Risk evaluation
Pre-Registration
Pre-Registration
REACH Implementation Working Group (CES, BUs, IT, LE, PR …)
Subgroups within Evonik to prepare for REACH
Preparatory steps (1)
Cost calculation (1)
Pre-Registration (internal costs)
- Information gathering (Art. 28)- IT for pre-registration (IUCLID 5-Modul, REACH-IT, own IT-solution)
Registration (internal costs)
- List of substances, intermediates, on-site, transported, tonnage band- Evaluation of available data, identification of data gaps, costs for necessary
studies- Generaton of registration dossier- Generation of eSDS- Generation of exposure scenario(s)- Generation of CSR (chemical safety report)
Registration costs (only direct costs)Cost evaluation by VCI ( 2007)
Cost evaluation by KPMG (2005)
Cost includes :Tests, Registration dossier incl. internal administration, CSR etc.not included:Waiving, existing data (e.g. for phase-in substances), registration fees
1 – 10 t/a ca. 10.000 – 30.000 €10 – 100 t/a ca. 100.000 – 200.000 €100 - 1.000 t/a ca. 300.000 – 700.000 €> 1.000 t/a Up to ca. 3 Mio €
1 – 10 t/a 14.602 €
10 – 100 t/a 162.723 €100 - 1.000 t/a 282.097 €> 1.000 t/a 323.163 €
Preparatory steps (2)
Cost calculation (2)
Registration (external costs)
- Registration fees ECHA (registration / CBI protection / PPORD / etc.)- Consultant
Kosten IT
- IUCLID 5, own systems (e.g. SAP EH&S modul, SDS software)
Registration fees: new (1)
Tonnage band Full base fee
Joint Submission
Medium sized (single)
Medium sized (joint)
1 – 10 t 1600 Euro 1200
Euro
1120
Euro
840
Euro10 – 100 t 4300 Euro 3225
Euro
3010
Euro
2258
Euro
100 t – 1000 t 11500 Euro
8625
Euro
8050
Euro
6038
Euro> 1000 t 31000
Euro23.250
Euro
21700
Euro
16275
Euro
Version 10/2007
Registration fees: new (2)
Tonnage band Small sized
Small sized (joint)
Micro sized (single)
Micro sized (joint)
1 – 10 t 640 Euro 480
Euro
160
Euro
120
Euro10 – 100 t 1720 Euro 1290
Euro
430
Euro
323
Euro
100 t – 1000 t 4600 Euro 3450
Euro
1150
Euro
863
Euro> 1000 t 12400
Euro9300
Euro
3100
Euro
2325
Euro
Stand: 10/2007
Get in touch with your supplier
Check your supplier situation in order to prepare for any changeswhich may occur in the course of REACH registration
Supplier questionnaire
“Will you pre-register the substance you’re supplying?”
“Will you register the substance and – if yes- when?”
“’What are the specific use patterns”
“Can you describe the exposure situation during application (Scenario)”
Risk CommunicationProcess flow
Manufacturer/Importer
ES/UEC
ES/UEC
ES/UEC
Formulator I
Downstream user
Formulator II Identified use
Identified use
Identified use
Data CSA CSRES/UEC
Check
Check
Check
ECHA
Substances of very high concern will need special treatment
Check the toxicological or ecotoxicological properties of your substance:
CMRs class 1 & 2 are already today not allowed for end use products. UnderREACH is will be necessary to apply for an authorization to cover the use in industrial applications
PBTs and vPvBs are under severe scrutiny by European regulators and maydissapear from the market in the midterm run.
Sensitizers are going to be subject for authorization, criteria not yet clear
Endicrine disrupters are in the focus
All substances which have such intinsic properties will qualify for authorization, whichmay be given under certain restrictions and timely limitations
A list of substances which will disappear from the market midterm
First list of candidates for authorization has been published by ECHA: Update everytwo years
Anthracene
4,4'- Diaminodiphenylmethane
Dibutyl phthalate
Cyclododecane
Cobalt dichloride
Diarsenic pentaoxide
Diarsenic trioxide
Sodium dichromate, dihydrate
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
Bis (2-ethyl(hexyl)phthalate) (DEHP)
Hexabromocyclododecane (HBCDD)
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
Bis(tributyltin)oxide
Lead hydrogen arsenate
Triethyl arsenate
Benzyl butyl phthalate
Pre-Registration
Pre-Registration (1)
Aim: Overview about all relevant substances, possible data sharing and avoidance of unnecessary animal testing, formation of SIEFs,
Pre-registration (and registration) required for each legal entity
Just one submission number and one pre-registration number per combination substance / legal entity
When?: 1. June 2008 – 1. December 2008 (only limited possibility to extend this period)
Who is affected?: Manufacturers and importers
How to do it?: XML-File based on own IT tools, via REACH-IT (online), via IUCLID 5
Actual Problems: Bulk upload not yet available
Pre-Registration (2)
List I: Agency publishes substance list on 1. January 2009
Substance names, CAS-/EINECS-No./intended registration period
List II: Only for manufacturers and importers
Name of Manufacturer/Importer, Adress (-> for SIEF)
Important impact of pre-registration:
If manufacturer / importer does not pre-register his substance in due
time, production / import has to be stopped immediately after expiration of pre-
registration period Substance becomes Non-Phase-in-Substance!
Phase-in-Substance (Art.20):
• Substance is listed in EINECS
• Substance produced in the EU but not marketed within the last 15 years (e.g. intermediates, R&D, Export)
• NLP: definition has been changed (limited to period 1981 - 1993 , Art 3, 20c)
• Monomers in polymers
Non-Phase-in-substance: new substance
Pre-Registration (3)REACH-IT
Workflow-System of ECHA called „REACH-IT“ with some shortcomings
- Launched on 1st June 2008
- Not all functionalities available (e.g.no bulk-upload). Planned availability earlyJuly
- manual online-pre-registration of substances is possible
- PPORD and „Early-Bird-Registrations“ actually only per e-mail/CD-ROM
- Disconnect in „Messaging system“: Informations via mail-box of REACH-IT will not be passed on to own mailing systems.
- Invoices for registration fees of ECHA cannot be downloaded from REACH-IT (one exemption: Firefox)
-> associations are in permanent contact with ECHA to solve problemsin due time.
Pre-Registration (4)REACH-IT
Actual situation in REACH-IT (18.6.2008)1851 legal entities registered
170 Third Party Representatives (TPR) nominated
9555 Pre-registrations already sucessfully done (2% with mistakes)
169 PPORD (but: no template available so far)
43 Inquiries
5 Full-Registrations (but: very often without any standardized templates)
18 Registrations for intermediates (template problems)
16 Proposals for SVHC from member states
What to do right now?
Time is running fast if not already done it is now high time to prepare for pre-registation.
5 months left to safe your business in Europe!
Actions to prepare for pre-registrations:
• describe / define substance identity• prepare inventory• check feedstock (e.g. ingredients in prep‘s)• decide strategically what to pre-register• who is the registrant in your company
What to do right now (2)?
Actions to prepare for registration
Organisational setup defined (e.g. project structure)Resource planning with additional staff (internal / external) Data gap analysis cost estimation for additional testsCollection of use informationstart communication with customers about exposureConsortia strategy resource managementstrategic management process Plan „B“ for SVHCportfolio management
Registrationmechanisms
Process of risk assessment
Identification and descriptionof use:• Registrants own use• Downstream uses• Entire life cycle (incl. articles & waste)• based on descriptor system
Identification and descriptionof use:• Registrants own use• Downstream uses• Entire life cycle (incl. articles & waste)• based on descriptor system
Exposure scenario
• Exposure determinants• Generic vs. Specific ES• ES for preparations and articles• Derive DNELs and PNECs
Exposure scenario
• Exposure determinants• Generic vs. Specific ES• ES for preparations and articles• Derive DNELs and PNECs
Exposure estimation• measured data (per exposureroute)• modelling
• Occupational health• Environmental exposure• Comsumer exposure• Man indirect via environment
Exposure estimation• measured data (per exposureroute)• modelling
• Occupational health• Environmental exposure• Comsumer exposure• Man indirect via environment
CSA iteration• improve hazard information• improve exposure information• higher tier models• substitute model bymeasurement
CSA iteration• improve hazard information• improve exposure information• higher tier models• substitute model bymeasurement
Safe useUse adviced against
DNEL= derived no effect levelPNEC= predicted no effect concentration
Risk evaluation
There is no „golden“ assessment tool available to evaluate all kinds of exposure; existing tools are
and have…..preset scenariosconservative default valueslimited variability (e.g. in exposure determinants, risk management
measures)complex input structureneed „work-around“ expertise
Occ. ExposureECETOC TRACOSHH/BAuA
Occ. ExposureECETOC TRACOSHH/BAuA
Cons. ExposureConsExpo
EUSESECETOC TRA
Cons. ExposureConsExpo
EUSESECETOC TRA
Env. ExposureEUSES
A/B tables
Env. ExposureEUSES
A/B tables
Without any experience in exposure modelling and basic know-how in risk assessment it will become difficult to judge the validity of themodelling results
OnlyRepresentative
Only representative (OR)
Manufacturers outside of the EU may nominate a “Only Representative”
who can take over all duties for a foreign company not being located within the
EU-
Caution: Definition of OR has been changed
Change from one OR to another is now possible! Update of ECHA. Important: The
previous OR must agree to this change (fix in contract!), otherwise a new Dossier required!
Tonnages of numerous companies of one OR will not be accumulated, but the OR has to
provide a separate Dossier for each registrant.
The OR can cover imports of a Non-EU-Manufacturer, even if the substance has been
traded outside of the EU
Only representative (OR) (2)
The OR will have to take over all activities within the cooperation between companies
SIEF: Definition of sameness of the substance
Negotiation with competitors about scope and structure of SIEF
Data evaluation of own and external data
agreement on cost sharing mechanisms and own contribution
Confidentiality agreements to protect CBI
Consortia cooperation
Contractual issues
Sweat equity contribution
Administrative burden sharing
Agreement on joint and separate activities
Preparation of registration dossier
Information about use and exposure
Role of associations
SIEF-Information exchange forum
Facilitation of inter-company interaction to find cooperation partners
Cefic, VCI, UIC, CIA, FEIQUE and Federchimica have cooperated to form a SIEF-Portal
• System should be ready for use in July (Release 1.0)
• Company owning this system is named REACHLink, the system itself SIEFreach.
• It is compatible with pre-registration functionality of REACH-IT.
• Costs for user of this system: one-time payment of 300.- Euro per LE/Substance/user
• For invited experts: 150.- Euro
• For data holder: 150.- Euro
• Early birds can gain fee reduction of 10% (registration to the system before 31. July)
Contact: Jack Wille, [email protected] [email protected] Alain Renard,
Preparation of standard tools
Evaluation of exposure situation in many standard application is the mostdemanding part in CSA generation.
• Many downstream associations have started to work on their standard exposurescenarios (e.g. detergents, paints, adhesives, …)
• ECETOC is actually refining its tiered risk assessment tool to simplify risk evaluation
• Business Europe is currently developing a standard phrase catalogue to facilitateeSDS generation and standardized communication along the value chain
• Cefic is updating a risk management measures (RMM) library to provide assistence in RMM evaluation and communication
• DU associations prepare calculation tools to enable their membership to evaluatediverging exposure situations
Opportunities under REACH
A REACH registration is a „licence to do business in Europe“
• Customers may ask for covering their specific use in theregistration dossier (=selling point)• Dialogue with customers and downstream users will providebetter inside view about potential product advantages(=customer intimacy)• Conducting special risk assessments for your customer canensure exclusivity (=customer bonding)• Low margin products may be taken off the market (=reductionof complexity)• Screening of SVHC can open business opportunities
Summary
• If you‘re doing business in Europe you better check yourobligations under REACH• Importers do have the same obligations as European manufacturers• Expertise is necessary to conduct a risk assessment – strivefor alliances• Missing deadlines for pre-/registration means loss of business• Your customer will need supply security in order to securehis own business• Manage your own resources (financial & human) to avoidshortages there are no experts anymore on the free market
KONTAKT
Generation of eSDS
Substance on the market
Stoff erfüllt die Einstufungskriteriennach Art. 31.1 und
Art 31.3
SDB erforderlich(ohne Annex)
SDB mit Annex
“Substances of very high
concern” (Art 57 Kriterien)
GenerischesVorgehenmöglich? Generisches ES
(GES (Option)
SektorspezifischesES (Option) detailliertes ES (Option)
kein SDB erforderlich(mögliche Anwendung Art. 32
prüfen)
YesNo
Ja
< 10 jato(zum Zeitpunkt
derRegistrierung)
Ja
Ja
Nein
Nein
Nein
IT Project – REACH-Base (Evonik)
REACH Base
Registration Substances
- Substance name, LE- Registration data
Pre-registration substances
- Substance name, LE
- Little data
Substance Registration Decisions
- Substance name, LE- Decision data (generally,
not in IUCLID 5) - Cost planning
Management Data
- Substance checklists- Endpoint status- Endpoint costs
Front End (Access, Web)IUCLID5 Front End
Evaluations (e.g., Excel, Access, Web)
IUCLID5Add on
Add on Add on
Pre-RegistrationRegistration
10.000 Pre-registrationsBulk-upload aktually not possile250 pre-registrations ready (online)50 Legal entities
. . . . . . . . . .
.
. . . . . . . . . . .
Extended REACH Projekt (2007-2010)– Projektorganisation
REACH Implementation Working Group
Subgroups (SG)
Representatives of Business Units (product safety), IT, LE, PR …
BUs
REACH Assurance Program
- Competence center- Best Practice- SPC (Single Point of Contact)- OFA (One Face to Agency)- internal training- Master IUCLID5 (IT-Tool for
Registration)- Quality check- Proof reading
Project team
Steering committeeBlauth, Dr. Jostmann,
Dr. Rettig, Hetzke
Project teamDr. Wiegand, Dr. Soballa, Dr. Lutz, Rößler
SG1:
Vor
regi
strie
rung
SG2:
Bew
ertu
ng
SG3:
Kom
mun
ikat
ion
SG4:
Kon
sort
ien
SG5:
IT-T
ools