What Supply Chain Managers need to do to meet effectively comply with REACH ?
By Philip Capel
LogiChem 2011 will be the event's tenth anniversary and an opportunity for the most senior chemical supply chain & global logistics directors from the European chemicals community to come together once again share experiences, make new contacts and benchmark the latest chemical supply chain initiatives.
Not only will LogiChem 2011 be a chance for the chemical industry to reminisce about the last ten years but an opportunity to shape the next decade. To celebrate a decade of LogiChem, there will be an exciting three day programme filled with networking opportunities in our new location, Antwerp.
2. 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
3. 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
4. REACHLaw Ltd today :
World class REACH service provider
Partners
Customers
Our customers: > 200 major manufacturers in more than 30
countries with 2500+ substances
5. 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
6. What is REACH?
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
CLP: Classification, labelling and packaging
7. 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
8. Supply Chain vs REACH
Supply chain manager REACH
Raw materials, Products, Substances, Mixtures,
SKU,s Articles
INCOTERMS, POM (place on the market)
Distributors, Customers, Manufacturer, Importer,
Suppliers, Formulators, Downstream User (OR)
toll-manufacturers,
warehousing
9. 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
10. 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
11. Some implications
Original estimate Pre-registration Current status Key concerns
2.300 How to get the
substances with work done,
Lead Registrant costs ?
6.700
How to get the
substances where
ECHA 9.000 55.000 work started ?
LR needed
(HPV, substances
CMR’s etc) with
2010 deadline 0-46.000 (?)
wrong pre- Which ones ?
registrations
Replacement
0-46.000 (?)
of substances,
substances which
change of
will disappear
processes ?
12. Key concern : Current (=real) status of
REACH work, outcome 2010 ?
13. Availability of chemicals
Substances 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
14. 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
15. Fig. 2: REACH & CLP: Main issues for sourcing
and delivery
Main issues for sourcing:
• availability of raw materials?
Non-EEA EEA • coverage by upstream registrations?
• REACH-SDS and CLP-labels?
• risk of non-compliance mitigated?
Formulator Manufacturer
Consumer
Manufacturer OR
Final professional
user
Your company
Distributor Sour Deli Formulator
EEA supply chain
cing very
Distributor
Main issues for delivery:
• REACH-SDS and CLP-labels?
Article supplier Supplier • exposure scenarios for customer uses?
• risk of non-compliance mitigated?
• Article 33 SVHC communication
16. 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)
17. Supply Chain Communication REACH
Role & 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
18. Main REACH & CLP tasks in the supply chain
for 2010 / early 2011 (simplified)
What REACH Registration CLP Notification CLP Classification, REACH compliant SDS ² REACH REACH Candidate List
& when 30.11.2010 ¹ 3.1.2011- Labeling & Packaging ² Continuous Restrictions for Authorization
(for substances) Continuous Continuous
Who 1.12.2010-
Manufacturer / Required Required Required Required Required Mainly ’early warning
importer of unless only unless only For dangerous system’ (consider phase-
substances (on their representative does for representative registers substances and mixtures out of substance)
own or in mixtures) importer beforehand incl. CLP
Downstream user Not required Not required Required Required Required Mainly ’early warning
of substances (e.g. but check if registration but take over supplier’s For dangerous system’ (consider phase-
formulators and other covers your use and – classification if substances and mixtures out of substance)
professional users) if not - check obligation unmodified
to prepare CSR
Distributor (incl. Not required Not required Required Required Required Mainly ’early warning
retailer) but check if registered but take over supplier’s For dangerous system’ (consider phase-
classification substances and mixtures out of substance)
Article producer / Not required Not required Not required Not required Required REACH Article 33
importer / supplier but check exception for but check exception for but check exception for communication²; SVHC
articles with substances imported articles with articles with substances notification as of
subject to REACH Art.7 substances subject to subject to REACH Art.7 1.6.2011; consider
REACH Art.7 and explosive articles phase-out of substance
¹ Existing (‘phase-in’) substances ≥1,000 tonnes, R 50/53 ≥100 tonnes and CMR cat.1 or 2 ≥ 1 tonne per year
² If supplied downstream in EEA
19. 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
20. Main tasks as distributor
Check if your supplier is going to register
Compliance with restrictions
REACH-compliant SDS
21. 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
22. 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 ?
24. EU importer – registration necessary
Announcement from Shell:
25. 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
26. 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 ” ?
27. REACH is about Strategy
Preregistration
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
28. 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
29. 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
30. 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
32. Need of changes in internal processes
On sourcing side:
”Compliance certificate”
Agreements:
On delivery side:
Information in supply chain
Agreements
….
33. Substance Inventory Managment System
SIMS
Identification & monitoring
Substance volume tracking upstream &
downstream
Internal use mapping
Supply chain communication
Creation of notification documents
35. Substance Inventory Managment System
SIMS
Interface between ERP & EH&S
Electronic eSDS system
Interface with IUCLID5
..
36. REACH SVHC in articles management
indentification & downstream communication
Requirements for substances in Articles
SVHC in Article screening
SVHC Communication in the supply chain
SVHC Candidate list proposals
37. Substance first re-classified as hazardous
and then identified as SVHC – What is the
potential impact on your EU customer?
Cosmetic
Ozone depleting EOL vehicles
Products
substances REACH Directive Young people at Directive
Regulation (EC) Regulation 2000/53/EC work Directive 76/768/EEC
No 2037/2000 1907/2006 1994/33/EC
Chemicals
Seveso II Hazardous Agents Directive
Detergents Directive waste Directive 1998/24/EC
CLP Regulation Directive 96/82/EC Exposure to 91/689/EC
1272/2008/EC 648/2004 carcinogens and
Ecolabel Award mutagens at work IPPC Directive
Biocidal scheme 2004/37/EC 2008/1/EC
Waste Framework Products 1980/2000 DSD / DPD
Directive Directive Export / import Directive VOCD
2006/12/EC & 98/8/EC Biological Regulation 67/548/EEC & Directives
2008/98/EC agents at work 689/2008 1999/45/EC 1999/13/EC
Directive & 2004/42/EC
Aerosol 2000/54/EC
Health and
Dispensers WEEE Directive RoHS Directive
Pregnant and Safety signs at
Directive 2002/96/EC 2002/95/EC
breastfeeding work Directive
75/324/EEC
women at work Water 1992/58/EC
1992/58/EEC Framework Batteries
General Product Directive Directive Plant protection
Ambient air
Safety Directive 2000/60/EC 91/157/EEC Products
Directive
2001/95/EC Protection of Directive
1996/62/EC
mothers 91/414/EEC
Ecolabel EU indicative
Directive Regulation occupational
92/85/EEC PPE
Directive 66/2010 exposure limit
89/686/EEC values Directive
2000/39/EC
38. Other new regulations ?
How to utilize REACH work and experiences
REACH goes global !!!
Turkey
Japan
Others
39. 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.
40. 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
41. 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….
.......
42. 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 ?