REACH USA 2008SOCMA CEC
How to Implement a REACH-Proof System in a Company!
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Evonik Degussa GmbH
Shaun Clancy
Friday 16 May 2008
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About Evonik Degussa GmbH
As an industrial group with three business sectors.
Evonik is a new name announced on September 12, 2007
Evonik Industries
Chemicals
Real EstateEnergy
2006 sales: €10,1 billionEmployees: about 32000
2006 sales: €2,6 billionEmployees: about 4600
2006 sales: €0,4 billionEmployees: About 500
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Elements of REACH: Scope (2)
STRUCTURE
Elements of REACH (scope, R&D, articles)
Time frame
Roles under REACH
Evonik Degussa´s REACH Project
Implementing REACH
Where do we stand today?
Useful helpdesks
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What means REACH?
REGISTRATION
EVALUATION
AUTHORISATION and RESTRICTION of
CHEMICALS
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Elements of REACH: Scope (1)
Scope:
REACH is valid for all substances, being manufactured or imported in
amounts exceeding 1 ton/year
BUT:
Completely exempt from REACH:
•Radioactive substances
•Non-isolated intermediates
•Substances under customs control
•Waste (according to 75/442/EC)
•Subject to transportation regulation
•Defence
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Elements of REACH: Scope (2)
Scope:
Exempt only from registration, evaluation and information duties:
•Annex IV: e.g.: water, starch, vitamin A, glucose….
•Annex V: e.g.: by-products, hydrates, natural substances……
•Polymers (from registration and evaluation, not from authorisation!)
•Re-imported, already registered substances
•Substances already regulated (e.g. Medical products, foodstuff,
Biocides, feedstuff….)
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Elements of REACH: R&D
Special exemptions for R&D-substances
Substances of product- and process oriented R&D are exemptedfor a period of 5 years.
The Agency may extend the five-year exemption by a further maximum of five years (5+5).
The manufacturer/importer shall notify the Agency of some basic information (manufacturer, substance identity, C&L, amount, customer)
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Elements of REACH: Articles
Articles
Substances in articles have to be registered only if:
- The substance in the article exceeds 1 metric ton/year per manufacturer and
- The substance is intended to be released under normal or foreseeable conditions
cartridge
mobile
tyre
pen
No intended release intended release
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REACH-Time frame (pre-registration, registration)
Registration: CMR 1+2; R 50/53 > 100 mt/a; Substances > 1,000 mt/a
Registration: Substances 100 - 1,000 mt/a
+ 12 months: Start of pre-registration/registration period
End of pre-registration period
+ 3,5 years:
+ 6 years:
+ 11 years: Registration: Substances 1 - 100 mt/a
+ 18 months:
Pre-registration required for utilizing the transition periods for phase-in substances
Start of transition periods for registration of pre-registered substances (Art. 21)
1 June 2007
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2009 2010 2011 2012 2013 2014 2015 2016 20172007 2008 2018
Registration acc. REACH (incl. evaluation + authorisation)
Subsequent requirements
3,5 years
11 years
6 years
5 years (+ 5 years prolongation possible)
ChemG
Transition period
Authorisation
Pre-registration of phase-in-substances
Registration of phase-in-substances
Inventory of Classification & labelling ofSubstances placed on the market
• substances >1000 t/a substances R50/R53 and >100 t/a CMR, categories 1 and 2, >1 t/a
• substances >100 – 1000 t/a
• substances 1 – 100 t/a
Registration of non-phase-in-substances
01.06.07 – REACHeffective
01.06.08 – opening of Europ. Chemicals Agency
Dossier evaluation by the Agency
30.11.08 - end of pre-registration
31.05.09 - presentation of Candidate list (every 2 years)
Registration of R&D-substances
Time frame of REACH (all parts)
missing pre-registration means registration as Non-Phase-in-substance
0,5 years
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Registrant: Means the manufacturer or the importer of a substance or the
Manufacturer or importer of an article submitting a registration for a substance.
Manufacturer: Means any natural or legal person established within the
Community who manufactures a substance within the EU.
Importer: Means any natural or legal person established within the EU who is
responsible for import of substances into the EU.
Downstream user: Means any natural or legal person established within the EU,
other than the manufacturer or the importer, who uses a substance, either on its own or in
a preparation in the course of his industrial or professional activities.
- Distributor: Distributor is not a downstream user.
- Consumer: Consumer is not a downstream user.
- Re-importer: Re-importer is a downstream user.
.
Roles under REACH (1)
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Import: Means the physical introduction into the customs
territory of the EU.
Who is an importer?
This definition is still under discussion! Some explanation:
Importer is the entity that pays the import duties (to be discussed). Please note
that the person responsible for the physical introduction into the EU customs
territory is not necessarily the person responsible for the customs clearance.
The responsibility for import depends on many factors such as who orders,
who pays, who is dealing with the customs formalities, but this might not be
conclusive on its own.
Possibility of using an Only Representative (OR). This option provided for in
Art 8 will be very relevant for multinational companies with major production
sites outside the EU.
Roles under REACH (2)
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Steering Committee•Board/Head of ESHQ
Evonik Degussa´s REACH – Project
• Overall project coordination
• Central monitoring (pre-registration data, Group-wide processing status)
• Communication: current status of implementation (nat./internat. associations)
• Management of REACH Implementation Working Group
• Support for subgroups
• Definition and controlling of milestones
• Inclusion of Regions, Procurement, and Marketing
• Development of approaches and proposals
• SG1: Substance identification, checklists, data requirements
• SG2: Standard dossiers, CSR, exposure scenarios, categories
• SG3: Questionnaires, training, procurement, raw materials, authorization letters
• SG4: Establishment of consortia (agreements), preparation of SIEF
• SG5: System environment, IUCLID. REACH-IT, SuRe, data recording, volume
• Sponsoring
Tasks and responsibilities
Project team
•Degussa Corporate ESHQ
REACH Implementation Working Group
5 Subgroups (SG)
SG
1:
Pre
-reg
istr
ati
on
SG
2:
Evalu
ati
on
SG
3:
Com
mu
nic
ati
on
SG
4:
Con
sort
ia
SG
5:
IT T
ools
• Coordination and decision-making body for all REACH-relevant questions
• Determination of joint approaches
• Interpretation of the REACH Regulation (clearing)
• Harmonization of decentralized activities (to avoid duplication of work)
Authorized officers of the business units
(primarily product safety), IT, LI, PR …
ObjectivesPreparation, organization, tools, cost, clearinghouse, technical questions
Business Units
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Evonik Degussa´s REACH - Project
Degussa REACH Implementation Working Group (assigned Jan/2006)
REACH Subgroups (assigned Nov. 2006)
Pre-registration Evaluation Communication Consortia IT tools
Pre-registration Risk assessment Procurement (checklist)
Data sharing Internal IT (SuRe, EH&S etc.)
Checklist (for Product safety)
Registration dossier
Marketing, sales Costs of studies, values
Degussa REACH-Base
Substance identification
Form of CSR (standard)
Survey, questionnaires
Competitors, contracts
Volume thresholds (SVT)
IT (Agency) CSR, ES, UEC.. Training (intern. customers..)
Contacts, letter of acc.
REACH IT (Agency)
Flyer/Letter Authorization Standardization SIEF prep. IUCLID 5
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Implementing REACH (1)
Compile an inventory of all substances and preparations that the company handles (CAS, EINECS)
Product Intermediate (“On site”): simple registration (name, company, C&L,
available data, no tests) Intermediate (“transported”): simple registration, under strictly
controlled conditions, beginning with quantities of 1,000 metric tons/year: Annex VII necessary
Polymers (Register monomers!, clarify whether PBT, vPvB) Break preparations down into their individual substances Raw materials as manufacturer, importer, user (break down
according to purchased within the EU, outside the EU) Assign the names/addresses of customers/suppliers to all substances
(important for communication in the supply chain) Assign substances to the tonnage bands (observe deadlines;
“distribute” quantities, if needed) Assign applications (own use, customer)
1st Action: Inventory (done)
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Implementing REACH (2)
Degussa Database
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 onAdd on
Pre-registrationRegistration
2st Action: Develop IT (in progress)
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Implementing REACH (3)
1. Step: Questionnaires (supplier), e.g. Cefic-portal “REACH-LINK”), own IT-Portal
2. Step: Questionnaires (customer), e.g. Cefic-portal “REACH-LINK”), own IT-Portal
Additional limit values, requirements etc.: • DNEL (Derived No Effect Level)• PNEC (predicted no effect concentration) (
http://chimie.ineris.fr/en/index.php/)• PEC (predicted effect concentation) (PEC/PNEC <1)• Exposure scenarios (RIP 3.2-2)• Use and exposure categories (UEC) • Wastewater, water treatment plant
Extended safety data sheets (eSDS)• For the present, change the order of Chapters 2 and 3, and
provide e-mail address. Later, the data listed above.• Necessary to modify all SDS since June 1? No:
3th Action: Information in the Supply Chain
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Implementing REACH (4)
ConclusionThe Chair of Commission Working Group (CWG) concluded that there was consensus that the content, not the format, of the SDS is the priority for the enforcement and that the changes required by REACH; that is, the changed order of Chapters 2 and 3 and the addition of the e-mail address can be introduced when (substantial) changes/updates are made of the SDS. A substantial change could be classification according to GHS or the addition of exposure scenarios. The changes required by REACH should be introduced, however, before the first deadline for registration on December 1, 2010.
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Implementing REACH (5)
Pre-registration All substances in quantities > 1 metric ton/year that will be
manufactured/imported in the future (in 11 years), including intermediates
EINECS substances (substances currently manufactured and imported)
Substances that are manufactured in the EU, but have not been marketed in the 15 years prior to REACH (e.g. intermediates, export products, R&D)
No-longer polymers (NLP) Monomers being part of polymers Substances manufactured and imported earlier (this includes all
substances that could possibly be “revived” again) -> better too many than too few!
Substances from preparations (information from suppliers, check quantities: 0.1% = 1 metric ton of 1,000 metric tons)
All legal entities (LE) within a company must pre-register! Pre-register all strategic or critical raw materials!
4nd Action: Pre-registration
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Implementing REACH (6)
Registration for phase-in substances is staggered.
Phase 1: (Jun. 2008 – Dec. 2010) Substances in quantities > 1,000 metric tons/year CMR substances in quantities > 1 metric ton/year Substances that are extremely toxic to aquatic organisms
and are produced in quantities > 100 metric tons/year
Phase 2: (Jun. 2008 – Jun. 2013) Substances in quantities > 100 metric tons/year
Phase 3: (Jun. 2008 – Jun. 2018) Substances in quantities > 1 metric ton/year
5th Action: Registration
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REACH completely changes the situation for manufacturer and importer
Same data requirement for existing and new substances
In principle, substances > 1 to/year do need:
-pre-registration
-registration (dossier) per Legal Entity
-authorisation (in some cases)
-Depending on tonnage band, distinct data (toxicological, eco-toxicological,
physical-chemical) are required
-Uses must be identified and registered per Legal Entity
-Exposure scenarios must be prepared
-Chemical Safety report must be prepared
-Communication with suppliers and customers must be intensified
-The SDS must be extended (eSDS), e.g. use and exposure categories/exposure
scenarios, uses,
Where do we stand today (1)
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Define your role under REACH
Check, whether you bring substances in amounts > 1to/year into the EU
Check, whether any exemption might be applicable
Seek a partner within the EU (e.g. Only Representative), who will fulfil all
requirements of REACH, e.g. pre-registration, registration dossier, risk
assessment, Chemical Safety Report (CSR), extended Safety Data Sheet,
tracking of amounts brought to EU market etc.
Prepare a registration dossier and use the official IT-tool IUCLID 5
Use the pre-registration phase properly (transition periods!)
Where do we stand today (2)
That means: You as manufacturers from outside the EU have the same duties as manufacturers from inside the EU. Therefore you need to:
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BAuA (Federal Institute for Occupational Safety and Health
www.reach-helpdesk.de
Cefic (European Chemical Industry Council)
www.reachcentrum.org
BDI (German Industry Association):
www.reach.bdi.info/
IUCLID 5 program (for preparation of registration dossier)
http://ecbwbiu5.jrc.it/
ECHA (European Chemicals Agency)
http://echa.europa.eu/
Useful helpdesks
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Thank you very much for your attention!