What Supply Chain Managers need to do

to meet effectively comply with REACH ?

Philip Capel, European Sales Director REACHLaw Ltd

Copyright © 2008 REACHLAW Ltd. All rights reserved.

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

Partners

Customers

Our customers: > 200 major manufacturers in more than 30

countries with 2500+ substances
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
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

 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 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
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
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 ?
Key concern : Current (=real) status of
REACH work, outcome 2010 ?
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
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
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
 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 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
 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
 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 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
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 management
indentification & 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?
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
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 !