Chemical Supply Chain
description
Transcript of Chemical Supply Chain
Copyright © 2008 REACHLAW Ltd. All rights reserved.
What Supply Chain Managers need to do to meet effectively comply with REACH ?
Philip Capel, European Sales Director REACHLaw Ltd
Topics to be covered
� Introductions
� Current status of REACH
� The role of supply chain in REACH and key responsibilities
� Alternative strategies
� Future of REACH and impact on supply chain
� Conclusions & summary
REACHLaw’s 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
Key capabilities of REACHLaw:
Industry knowledge, Legal REACH knowledge, Chemistry,
Close Cooperation with ECHA and Helsinki REACH Centre, Independence
REACHLaw Ltd today : World class REACH service provider
Our customers: > 200 major manufacturers in more than 30 countries with 2500+ substances
Customers
Partners
Topics to be covered
� Introductions
� Current status of REACH
� The role of supply chain in REACH and key responsibilities
� Alternative strategies
� Future of REACH and impact on supply chain
� Conclusions & summary
� REACH is the new chemical legislation in the EU
affecting the sale and manufacture of all
chemicals unless specifically exempted
� REACH (and CLP) are in force NOW!
� No registration – no EU market
What is REACH?
CLP: Classification, labelling and packaging
REACH is complex
� REACH text is 849 pages
� Difficult to understand
� New and unclear definitions
� IT tools are still under development
� Processes are unclear
� Responsibilities unclear (Commission, National, ECHA, Enforcement)
� Guidances more than 20.000 pages (still in development)
Failure to comply may lead to halt of production and eventuel criminal penalties
For a company it is an exercise in knowledge management
Supply Chain vs REACH
Supply chain manager
� Raw materials, Products, SKU,s
� INCOTERMS,
� Distributors, Customers, Suppliers, Formulators, toll-manufacturers, warehousing
REACH
� Substances, Mixtures, Articles
� POM (place on the market)
� Manufacturer, Importer, Downstream User (OR)
Different Actors in the REACH Supply Chain
“Only representatives” established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers
ECHA Statistics : pre-registrations
� Total number of pre-registrations
� 2,750,000 pre-registrations
� 65,000 companies signed up in REACH-IT
� 146,000 different substances pre-registered
� Volume about 15 x expected by ECHA
� Number of pre-registrations to be safe ?
� Non-EU pre-registrations ?
� Importers ?
� Our conclusion: Far fewer ”real” registrants involved as the work really gets going
Some implications
ECHA 9.000(HPV,
CMR’s etc)
55.000
substances with
2010 deadline
2.300substances with Lead Registrant
6.700substances where
LR needed
0-46.000 (?)wrong pre-
registrations
0-46.000 (?)substances which
will disappear
How to get the work done,
costs ?
How to get the work started ?
Which ones ?
Replacement
of substances, change of
processes ?
Original estimate Pre-registration Current status Key concerns
Key concern : Current (=real) status of REACH work, outcome 2010 ?
Availability of chemicalsSubstances not covered currently� 2010 deadline, no progress yet
� A huge risk: no registration
� Only solution: Industry must take the responsibility and some major manufacturer must show up as Lead Registrant, otherwise no registration
Topics to be covered
� Introductions
� Current status of REACH
� The role of supply chain in REACH and key responsibilities
� Alternative strategies
� Future of REACH and impact on supply chain
� Conclusions & summary
Fig. 2: REACH & CLP: Main issues for sourcing and delivery
Non-EEA EEA
Manufacturer
Distributor
Formulator
Article supplier
OR
Manufacturer
Your company
Supplier
Consumer
Final professional user
Distributor
EE
A s
upply
chain
FormulatorSourcing
Delivery
Main issues for sourcing:• availability of raw materials?• coverage by upstream registrations?• REACH-SDS and CLP-labels?• risk of non-compliance mitigated?
Main issues for delivery:• REACH-SDS and CLP-labels?• exposure scenarios for customer uses?• risk of non-compliance mitigated?• Article 33 SVHC communication
REACH and CLP (Classification Labelling and Packaging)
REACH
� All chemical substances must be registered by manufacturer or importer
unless exempted
� Requires an extensive technical dossier including tox/ ecotox data and uses
� Only applies to volumes above 1 ton per year
CLP
� Derived from the GHS UN to be implemented in EU
� Requires notification of hazard classification and labelling by manufacturer
and importer
� Re-labelling, re-packaging by suppliers of hazardous substances and
mixtures
� Applies to all substances and mixtures regardless of volume (very limited
exemptions)
Supply Chain Communication REACHRole & Responsibilities
Registrants duty of communication
� As a part of Registration Dossier collect info on uses
� Provide SDS to customer
Downstream Users
� Communicate new info on hazardous properties
� Duty to identify apply & use recommend RMM
� Report info to ECHA
Distributors
� To pass the info on next actor in supply chain
Article suppliers
� Info on SVHC in articles acc to Art.33
Main REACH & CLP tasks in the supply chain for 2010 / early 2011 (simplified)
¹ Existing (‘phase-in’) substances ≥1,000 tonnes, R 50/53 ≥100 tonnes and CMR cat.1 or 2 ≥ 1 tonne per year² If supplied downstream in EEA
What
& when
Who
REACH Registration
30.11.2010 ¹
CLP Notification
3.1.2011-
CLP Classification,
Labeling & Packaging ²
(for substances)
1.12.2010-
REACH compliant SDS ²
Continuous
REACH
Restrictions
Continuous
REACH Candidate List
for Authorization
Continuous
Manufacturer /
importer of
substances (on their
own or in mixtures)
Required
unless only
representative does for
importer
Required
unless only
representative registers
beforehand incl. CLP
Required Required
For dangerous
substances and mixtures
Required Mainly ’early warning
system’ (consider phase-
out of substance)
Downstream user
of substances (e.g.
formulators and other
professional users)
Not required
but check if registration
covers your use and –
if not - check obligation
to prepare CSR
Not required Required
but take over supplier’s
classification if
unmodified
Required
For dangerous
substances and mixtures
Required Mainly ’early warning
system’ (consider phase-
out of substance)
Distributor (incl.
retailer)
Not required
but check if registered
Not required Required
but take over supplier’s
classification
Required
For dangerous
substances and mixtures
Required Mainly ’early warning
system’ (consider phase-
out of substance)
Article producer /
importer / supplier
Not required
but check exception for
articles with substances
subject to REACH Art.7
Not required
but check exception for
imported articles with
substances subject to
REACH Art.7
Not required
but check exception for
articles with substances
subject to REACH Art.7
and explosive articles
Not required Required REACH Article 33
communication²; SVHC
notification as of
1.6.2011; consider
phase-out of substance
Main tasks as an importer/ manufacturer
� Registration (substances on their own or in mixtures): Has
your non-EU supplier appointed an OR,
� Compliance with restrictions
� CLP by 1.12.2010 for substances
� C&L notification (unless supplier-OR has registered using CLP) first deadline: 3 January 2011
� REACH-compliant SDS update required to include CLP classification & labeling starting 1.12.2010
� Outlook: Authorisation, substance will be permanently under inspection, creates a strong pressure to substitute
Main tasks as distributor
� Check if your supplier is going to register
� Compliance with restrictions
� REACH-compliant SDS
Main tasks as article producer/importer/supplier
� Check if your supplier is going to register
� Main issue: Article 33 have a system in place to
track SVHC and communicate downstream
� Compliance with restrictions
� Check registration and notification obligation acc.
to REACH Article 7
Key concerns – grouping of issues
� Supply chain management concerns
1. Availability of chemicals after 2010 (sourcing) 1. Substances not covered currently by REACH work,?
2. Certain Uses not covered according to ECHA Use Discriptor System
3. Current (real) status of REACH work, outcome 2010
2. Other new regulations, obligations for supply chain (delivery side)
3. Structural changes in the market (both sourcing and delivery)
4. Need of internal process updates (both sourcing and delivery)
� Technical concerns in supply chain
1. CLP and REACH: how implement at same time ?
2. Need of updating IT support ?
Structural changes in the market ?
Solution ?
You must survive regulations…
or ???
EU importer – registration necessary Announcement from Shell:
Topics to be covered
� Introductions
� Current status of REACH
� The role of supply chain in REACH and key responsibilities
� Alternative strategies
� Future of REACH and impact on supply chain
� Conclusions & summary
Availability of chemicals ?Impacts ?� What will happen with substances, which will not be
registered on time ?
� No manufacture ?
� No import ?
� Enforcement ?
� By local authorities ?
� Different approaches ?
� ”Unequal markets ” ?
REACH is about StrategyPreregistration
� Phase in status important
� Future development substances
� Future importer status
� Operations : future production decision
Registration
� Which consortia to join?
� Do you want to have a leader position?
� Do you need to take a leader position?
Rethinking your supply chain
� Buying EU vs non EU
� Discontinuing products
� Reformulation products
� Excluding applications
Imported substances from non-EU countries - Background
� Many importers have made pre-registrations for
substances they import from non-EU countries
� Note: Many EU manufacturers act also as importers when they buy raw materials for their
own manufacture
� To register or not ?
� Business decision based on several issues
� Cost, benefit for your business, independence
Imported substances from non-EU countries - alternatives
� If you register, in most case you will be ”Regular
Registrant
� Especially if you are ”true” importer
� REACHLaw Registration Services available
� If you don’t register you need to know if your
suppliers are REACH-compliant
� REACHLaw Supply Chain Audit Services
Topics to be covered
� Introductions
� Current status of REACH
� The role of supply chain in REACH and key responsibilities
� Alternative strategies
� Future of REACH and impact on supply chain
� Conclusions & summary
Substance Volume Tracking
Need of changes in internal processes
� On sourcing side:
� ”Compliance certificate”
� Agreements:
� On delivery side:
� Information in supply chain
� Agreements
� ….
Substance Inventory Managment System SIMS
� Identification & monitoring
� Substance volume tracking upstream &
downstream
� Internal use mapping
� Supply chain communication
� Creation of notification documents
Substance Inventory Managment System SIMS (only IT can manage it)
Substance Inventory Managment System SIMS
� Interface between ERP & EH&S
� Electronic eSDS system
� Interface with IUCLID5
� ..
REACH SVHC in articles managementindentification & downstream communication
� Requirements for substances in Articles
� SVHC in Article screening
� SVHC Communication in the supply chain
� SVHC Candidate list proposals
Substance first re-classified as hazardous and then identified as SVHC – What is the potential impact on your EU customer?
Health and Safety signs at
work Directive 1992/58/EC
Seveso II Directive96/82/EC
Detergents
Directive648/2004
CosmeticProducts
Directive76/768/EEC
REACH Regulation1907/2006
Biocidal Products
Directive 98/8/EC
Ecolabel Award
scheme 1980/2000
Young people at work Directive
1994/33/EC
Biological
agents at work Directive
2000/54/ECAerosolDispensers
Directive 75/324/EEC
EOL vehiclesDirective
2000/53/EC
Export / import
Regulation 689/2008
Pregnant and
breastfeedingwomen at work
1992/58/EEC
VOCD
Directives 1999/13/EC
& 2004/42/EC
IPPC Directive 2008/1/EC
DSD / DPD
Directive 67/548/EEC &
1999/45/EC
ChemicalsAgents Directive
1998/24/EC
Hazardous waste Directive
91/689/EC
Plant protection
Products Directive
91/414/EEC
Ambient air
Directive 1996/62/EC
Batteries Directive
91/157/EEC
RoHS Directive
2002/95/EC
WEEE Directive
2002/96/EC
Water Framework
Directive 2000/60/EC
General Product Safety Directive
2001/95/EC
CLP Regulation
1272/2008/EC
Ozone depleting substances
Regulation (EC)
No 2037/2000
EcolabelRegulation
66/2010
Protection of mothers
Directive 92/85/EEC PPE
Directive 89/686/EEC
Waste Framework
Directive 2006/12/EC &
2008/98/EC
EU indicative occupational
exposure limit
values Directive 2000/39/EC
Exposure to carcinogens and
mutagens at work 2004/37/EC
Other new regulations ?
How to utilize REACH work and experiences
� REACH goes global !!!
� Turkey
� Japan
� Others
Other new regulations ?
� Solution: Global Regulatory Monitoring
� Amendments to REACH and CLP Regulation
� REACHLaw will report the latest amendments to the REACH and CLP regulation with an explanation and of the possible business effect if any.
� SVHC monitoring service
� Authorization and Restriction processes
� Enforcement of REACH
� REACHLaw will report on the REACH Implementation projects initiated by the Forum and provide information on Forum meetings, resolutions and actions taken.
Topics to be covered
� Introductions
� Current status of REACH
� The role of supply chain in REACH and key responsibilities
� Alternative strategies
� Future of REACH and impact on supply chain
� Conclusions & summary
REACH (and CLP) go global – using registration to meet other regulatory requirements
� We have not seen the real impact of REACH yet !
� New regulations coming, affect….
� .......
Top key concerns – Conclusions
� Supply chain management concerns
1. Availability of chemicals after 2010 (sourcing)
2. Other new regulations, obligations for supply chain (delivery side)
3. Structural changes in the market (both sourcing and delivery)
4. Need of internal process updates (both sourcing and delivery)
� Technical concerns in supply chain
1. CLP and REACH: how implement at same time ?
2. Need of updating IT tools ?
Questions ?
� Thank You !