REACH - Views from a Downstream User

REACH - Views from a
Downstream User
perspective
Robert Walker
Society of Motor Manufacturers and Traders (SMMT)
UK REACH Competent Authority
National event, 16 October 2007, Edinburgh
Overview
• About the SMMT
• The scale of REACH, threat to all
business, respond accordingly
• Auto sector cooperation and the AIG:
Automotive Industry Guideline on REACH
• REACH is not ‘too hard’ – AIG one pager
• Case studies, resulting actions as DU etc.
About the SMMT
• Society of Motor Manufacturers and Traders, the
trade association for the UK automotive industry
• 500 member companies: all the major vehicle
manufacturers, component and material
suppliers, power train providers, designers
• Manufacturing turnover £47 billion, >10% of UK
exports, supporting around 800,000 jobs
• Active on REACH for 5 years
Understand the scale of REACH
•
Substance withdrawals/ restrictions can
stop production (yours & rest of chain)
• 5-10% economic withdrawal
• Reformulation means retesting downstream
•
End of Life Vehicle (ELV) Directive restricted
4 substances. REACH likely to control ~1500
Ź Your customers (& theirs’) need assurance
you have REACH under control
Ź Budget and allocate resources accordingly
Task Force-REACH
In preparation for REACH
all the major vehicle manufacturers
European, Japanese and Korean
and
the automotive supply chain
with SMMT (UK),VDA (Germany)
and AIAG (USA)
representing VMs and suppliers
…formed TF-REACH
and drafted the AIG (Annex A: list of manufacturers represented)
About the AIG
• Automotive Industry Guideline (AIG) aims to:
– Avoid duplication/confusion in supply chain
– Harmonise the sector's response to REACH
– Establish a common schedule & external
communication strategy
– Address sector’s obligations, expectations
• Based on Orgalime guide (engineering sector)
• Download AIG free: www.acea.be/reach (& updates)
• AIG is global: English, Japanese, more to follow
Automotive Industry Guideline on REACH (AIG)
Chapter 1 - Intro: REACH and the
Automotive Industry
•
•
•
•
•
Requires immediate/ongoing action: OEMs/suppliers
Importance of pre-registration
Importance of “only representative” option
Obligations on industry, registration
Need for communication up/down the whole
supply chain (data, uses, control measures for
safe use etc)
• Need for each player in supply chain to have a
Strategic Action Plan
Automotive Industry Guideline on REACH (AIG)
Chapter 2: Definitions/acronyms
Manufacturer/Importer
Downstream
user: uses a
substance, either Downstream User
Formulator 1
on its own or in a
preparation, in
his industrial or
Formulator 2
professional
activities. Not a
Industrial User
Professional User
manufacturer,
importer,
distributor nor a
(non-professionl)
Distributor
Consumer
consumer
Automotive Industry Guideline on REACH (AIG)
Chapter 3: Important deadlines
S et up of Agency
2007
A u th o riza tio n
In fo rm a tio n in th e
s u p p ly c h a in (T itle IV )
R e g is tra tio n
(T itle II)
R E A C h e n te rs
in to fo rc e
D o w n s tre a m
u s e rs
o b lig a tio n
(T itle V )
P u b lic a tio n
o f C a n d id a te
L is t
2 n d V e rs io n o f
P rio rity L is t fo r
A u th o riz a tio n
R e s tric tio n s
(T itle IX )
N o tific a tio n o f
S V H C ´s
p re s e n t in
a rtic le s 6
m o n th a fte r
in c lu s io n in
c a n d id a te lis t
3 rd V e rs io n o f
P rio rity L is t fo r
A u th o riz a tio n
L is t o f P re R e g is te re d
S u b s ta n c e s
2009
2008
1 st V e rs io n o f
P rio rity L is t fo r
A u th o riza tio n
2010
2011
2013
2018
˜
1 .6 .
2007
1 .6 .
2008
1 .1 2 .
2008
1 .6 .
2009
1 .1 2 .
2010
1 .6 .
2011
P re R e g is tra tio n
Preregistration
1 June 1 Dec 2008
R e g is tra tio n o f:
P h a s e -in s u b s ta n c e s a b o v e 1 0 0 0 t/a &
C M R , R 5 0 /5 3 a b o ve 1 0 0 t/a & S u b s ta n c e s fo r A u th o riz a tio n
R e g is tra tio n o f:
P h a s e -in s u b s ta n c e s a b o v e 1 0 0 t/a
R e g is tra tio n o f:
P h a s e -in s u b s ta n c e s a b o v e 1 t/a
R e g is tra tio n o f n o n p h a s e -in s u b s ta n c e s a n d n o t p re -re g is te re d
s u b s ta n c e s a b o v e 1 to n b e fo re m a n u fa c tu rin g / im p o rtin g / p u ttin g
o n th e m a rk e t
Automotive Industry Guideline on REACH (AIG)
1 .6 .
2013
1 .6 .
2018
Chapter 4: How to comply - a
step-by-step process
Do you use substances/preparations
in your industrial processes?
• Flow chart 1: Registration of
substances/in preparations
• Flow chart 2: Authorisation
• Flow chart 3: Registration of
substances intended to be
released from articles
no
Make substance inventory to verify!
See AI Guideline 3
yes
Are the substances/
substances in preparations
exempted from registration?
Do you use substances
See AI Guideline 2
Supply
of substance
in the of
EU
on their own/in preparations
identified
as substances
no
will(SVHC)?
no longer(Art.
be 57)
possible
Very high concern
No further
no
• Only representative
(“no data – no market”):
Requirement *1
will act as importer
You
may re-consider
Make substance
inventory
to verify! alternative
Does your non
and has to register
outside
the EU/notify the
Guideline
3
Do you import substances See AI supplier
EU supplier
the substance (Art.6)
Agency of your interest for the
yes
yes
/preparations
have an only
• You are a
yes (Art. 28.4 and 28.5)
substance
From outside the EU?
representative
downstream user:
See AI Guideline 5
See AI Guideline 4
Only (Art.8)
representative
In the• EU?
check whether your
Do you import SVHC/
Does your non
will act as importer yes
yes
Preparations containing SVHC
use will be covered.
EU supplier
From outside
no the EU?
no and has to apply for
no have an only
See AI Guideline 5
Authorisation.
See AI Guideline 4
representative
• You are DU: make
Do you
produce
articles in or import articles into the EU
Is there
an alternative
in the EU? (Art. 8)
sure your use will Will the supplier pre-register/
Is there an
thatno
intentionally
substances under normal
yes
no
supplier
in the release
EU
alternative supplier be included in the
register the substance/substances
no
and
foreseeable conditions of use?
who will
pre-register/
application for
no (Art. 28)
in preparations
in the EU?
register?
yes
authorisation.
Is the substance orMake
your inventory
use generally
No further
of articles to verify!
yes
See AI Guideline 10
Exempted from authorisation?
See AI Guideline 3 Requirement *1
no
(Art. 2, Art. 56.3 to 56.6)
Is there an
yes
alternative supplier
yes
In the EU?
no
yes
yes
• You act as importer of substance /
No further
Makeof
inventory
of substances
Is your use / category
uses
yes
preparation and may have to pre-register
*1
No further
intentionally
released from theRequirement
article:
nocover your use
Will the supplier
specifically
exempted
from
/ register the substance on its own / in
no authorisation?
Requirements *1
Are
exempted from registration?
in his registration file? (Art. 37)
(Art.
58.2)
Is there
anthey
alternative
preparation (Art. 6)
See
AIcover
Guidelines 2 and 3
supplier
who
will
yes
• If SVHC: Check AIG Flow chart 2
no
• You act as importer of
your use? no
substance/preparation.
Monitor Agency website
no
Is the substance
• You may have to apply for
and priority list (Art. 58.3)
yes
Do you produce articles containing substance of
included in the candidate
list (liable
an authorisation and cannot
no
Is the substance present in article
for possible inclusion of
very high concern (SVHC) in the EU or
no
for authorisation)? (Art. 57 and 59)
benefit from an authorisation
No further
substance in candidate list.
in quantity over 1 tonne per
import them from outside the EU?
granted to an actor up the
Requirements *1
year? (Art. 7.1)
• Carry out producer/importer
your own chemicalper
safety
supply chain for that use.
yes
report (Art. 37.4, Annex XII)
• Identify, apply and where
suitable
recommend
risk
Make inventory of articles to verify!
no
Follow closely comitology
See
AI Guideline
10
Is
the
substance
Check exemptions! yes
management measures communicated to you in safety
Procedure prior to inclusion
listedto
in the
annex
XIV? (Art. 38)
• Report
Agency
data sheet or in information communicated to you in
Of substance in Annex XIV. Ask the supplier of yes
• Identify, apply and where suitable
accordance with Article 32.
the substance to
yes risk management
no
recommend
See AI Guideline 5
Has the substance in the article
Register, orIdentify
do so SVHC in articles:
Do youmeasures
use a substance
in accordance yes
Notify the Agency within
(Art.Already
37.5).
• If substance of very high concern (SVHC):
been pre-registered
by yourself.
Has the substance in article
with the
of authorisation
3 month of first supply
Seeconditions
AI Guideline
6 for that use?
Check AIG Flow chart 2
(Between June
granted to an actor up
been1already registered
(Art. 66.1).
• If SVHC: Check AIG Flow chart 2
and for that use? (Art. 7.6)
your supply chain? (Art. 56.2)
See AI Guideline 10
yes
December 1, 2008.)
No further
Requirement *1
yes
no
yes
no
Notify the Agency within 3 months
of first supply (Art. 66.1).
Obligations may occur, no
AIthe
Guideline
•See
Ask
supplier10of the substanceif to
pre-register,
SVHC
is added to
yes
or you have to register the substance
(Art.list:
7.1)
candidate
therefore
according to transition periods (Art. 23).
*1 Only for this Flow chart; Check also AIG Flow charts 1, 3 and 4 for further possible obligations.monitor Agency website
• If non phase-in substance or not
andpre-registered
priority list (Art. 58.3).
substance, register before manufacturing/importing/
Until then, present law
RECOMMENDATIONS:
putting
on the
market.
on restriction of use
• Please be aware that authorisation may cause substance withdrawal
from the
market.
AI Guideline
7 Please consider
of SVHC
applies.
• Application for authorisation must include an analysis of alternativesSee
(Article
62.4 REACH).
Article
62.4 REACH at
If SVHC,
check AIG Flow chart 2
an early stage, especially if the use of the substance is critical to •your
processes.
No further
Requirement *1
no
yes
Does the article contain SVHC present
in the candidate list in concentration of
above 0.1% weight by weight? (Art. 33)
no
yes
You may no longer use the
Has the sunset date been reached?
yes
Has the substance in the article
substance unless the request
*1 Only for this Flow chart; Check also AIG Flow charts 2, 3 and 4 for further possible obligations.
No further
Is the substance present in article
been already registered for an authorisation
Apply for an authorisation
no
Requirements *1
no
in quantity over 1 tonne per
yes
for that use? (Art. 7.6) has been made at least
for your own use.
RECOMMENDATIONS:
Do you wish to keep your use
producer/importer per year?
18 months before the sunset
See AI Guideline 10
• Start your substance inventory NOW.
confidential?
date
and
the
decision
• Start communicating with suppliers EARLY: to ensure continuous supply of a substance, be PRO-ACTIVE, don’t waitno
until the
is
still
pending
(Art.
56.1).
no
supplier has registered the substance you are using in processes to no
start communicating!
yes
• Make sure the substance you use will be pre-registered. In case the substance you use has notWill
been
pre-registered,
you have intended
Is apply
the substance
your
supplier
no
no
Is there
alternative
Is the substance of very high
No further
the possibility to notify the Agency of your interest in that
substance.
The supplier
Agency shallno
publish on
website the
name
of
thatunder normal and
tofor
be
released
for its
authorisation
your
use?
From AIG
who will apply
concern (SVHC)?
(Art. 57)intended
Requirements *1
substance and, on request, provide your contact details to a potential
registrant (Article 28.5 Reach).
Is the substance
foreseeable conditions of use? Flow
(Art. 7.1)
chart 3
for authorisation
yes
Transition periods for registration will however not be allowed.
to be released under normal and
yes
for your use?
foreseeable conditions
yes
yes of use? (Art. 7.1)
*1
• Flow chart 4: Notification of
substances in articles and
obligation to communicate
No further
Requirement *1
no
Notification obligations under certain conditions and
information
Is the
substancedown
in thethe supply chain
noduty to communicate
may list?
occur.
candidate
(Art. 59)
yes
• No notification needed
• Communicate to article recipient/
to customer upon request to allow
safe use (Art. 33).
See AI Guideline 9
• If SVHC added to Annex XIV,
authorisation might apply.
Check AIG Flow chart 2
You have to register the substance
(Art. 7.1).
Check AIG Flow chart 3
If SVHC added to Annex XIV,
authorisation procedures might apply.
Check AIG Flow chart 2
Check AIG
Flow chart 4
Is the substance
above a concentration of 0.1%
weight by weight?
no
No further Requirement *1
yes
Only for this Flow chart; Check also AIG Flow charts 1, 2 and 4 for further possible obligations.
RECOMMENDATIONS:
Is there a risk of exposure to human and the environment
Article producers/importers should pay attention under which provision of the
REACH
released
substance/substance
preparationno
during
normal
and foreseeable
conditions ofinuse
should be registered:
including disposal? (Art. 7.3)
• If the substance that requires registration is considered as a substance delivered in a container, be registered according to Article 6
REACH. Please note that the container itself may require registration according to Article 3.3yes
REACH.
• If the substance to be registered is considered as a substance in an article, the substance according to Article 7.1 REACH.
• You must notify substance present in article (Art. 7.2)
as of 1 June 2011, 6 months after the substance has
been included in candidate list (Art. 7.7).
See AI Guideline 8
• Communicate to article recipient to allow safe use (Art. 33).
See AI Guideline 9
• If SVHC added to Annex XIV, authorisation might apply.
Check AIG Flow chart 2
• Supply instructions to recipient (Art. 7.3).
• Communicate to article recipient /
customer upon request to allow safe use
(Art. 33).
See AI Guideline 9
*1 Only for this Flow chart; Check also AIG Flow charts 1, 2 and 3 for further possible obligations.
RECOMMENDATIONS
• According to Article 7.2 REACH, the calculation of the 0.1% w/w concentration refers to the article, not at the level of the
homogeneous material.
• Please be aware that according to Article 7.5 REACH, the Agency may require you to register the SVHC under certain conditions.
Automotive Industry Guideline on REACH (AIG)
Chapter 5: AI Guidelines
5.1 Roles in the supply chain
5.2 Scope and Exemptions
5.3 Substance Inventory
5.4 Imports of substances/preparations/articles
5.5 Communication obligations along the supply chain
5.6 DU chemical safety report & reporting to ECHA
5.7 Registration of substances in articles
5.8 Notification of substances in articles
5.9 Communication reqts for substances in articles
5.10 Authorisation procedures
5.11 List of RIPs (REACH Implementation Projects)
5.12 Helpdesks and Information tools
5.13 Industry-run helpdesks and Guidance
Automotive Industry Guideline on REACH (AIG)
E.g. AI Guideline 3:
Substance Inventory
To determine your obligations, need inventory:
• Substances/preparations you purchase & use
• Substances/preparations you import
• Substances intended to be released from
articles you produce
• Substances intended to be released from
imported articles
Note: an inventory required for each legal entity
࿼ AIG includes matrix of data required for
each role
Automotive Industry Guideline on REACH (AIG)
E.g. AI Guideline 4: Imports
Imports to the EU of substances/preparations/articles
(with intended release) must be registered by either:
– The “only representative of a non-EU
manufacturer”
OR
– DUs importing the substance, preparation or
article into the EU are ‘importers’ and
responsible for pre- and full registration (for
every one of their legal entities)
࿼ Important to DUs that non-EU suppliers appoint
an ‘only representative’ to minimise burden and
avoid duplication
Automotive Industry Guideline on REACH (AIG)
E.g. AI Guideline 5: Communication
obligations along the supply chain
Company (Customer)
REACHResponsible
Business Unit
1
REACHResponsible
REACHResponsible
Business Unit
2
Business Unit
3
REACHResponsible
Business Unit
n
Company internal communications
REACHRepresentative
Communication
between
companies
REACHRepresentative
Company internal communications
REACHResponsible
Business Unit
1
REACHResponsible
REACHResponsible
Business Unit
2
Business Unit
3
REACHResponsible
Business Unit
n
Company (Supplier)
Automotive Industry Guideline on REACH (AIG)
Chapter 6: Summary of main
obligations & recommendations
One pager with ten steps:
1.
Define contact details for REACH representatives (all
customers and suppliers)
2. Identify substances, preparations & articles in scope
3. " substances intended to be released from articles
4. " substances/preps not already registered for your use
5. " substances not pre-registered by a supplier
6. " SVHCs in articles
7. " imported SVHCs
8. " SVHCs used in EU production
9. " risk management measures in Safety Data Sheet
10. Check the exposure scenarios
Reworked for AIG v.2, with only 8 steps but more detail.
Automotive Industry Guideline on REACH (AIG)
Chapter 6: Summary of main
obligations & recommendations
Automotive Industry Guideline on REACH (AIG)
Annex B: Awareness Letter
Step 1 (Chapter 6), promote REACH awareness via
standard communication letter:
– Recommend using this wording… do not to
request further information at this early stage
– Sets out our expectations: suppliers will
• Pre-Register substances
• Register substances for our uses
• Meet registration deadlines
• Get organised and have procedures for REACH
– Contact details of REACH rep: give yours and
request theirs’
Automotive Industry Guideline on REACH (AIG)
Case studies (from TRW)
• TRW - serves all major vehicle
manufacturers & their suppliers
• Case study 1: Metalworking Fluids
–
–
–
–
Preparation, substances not all identified
Likely SVHC: No
Not critical to business (alternate products are available)
Supplier Location: EU
Ź TRW Role: Downstream User of Preparation
TRW Actions:
•
•
•
•
Send Supplier REACH Awareness and Expectations letters
Inform Supplier of TRW’s uses
Confirm that Supply Chain Pre-Registers substances
Confirm that Supply Chain Registers and includes TRW’s uses
EXAMPLES ONLY!
DU
Communicate:
•Awareness
•Expectations
•Your uses
Check:
•Pre-reg
•Registered
•For your uses
Substance Ditto
importer
(critical)
Ditto
•Follow up
•“Only rep”
•Seek
contingency
supplier
Ditto, plus intended
Article
importer to release
EU
Check anyone
has pre/
registered
substance and
your use
•Follow up
Article
producer
Communicate:
•Awareness
•Not intended release
No pre/full
registration reqd
Info/booking via www.business-sustain.com
Summary
•
•
•
•
•
•
No data, no market. Allocate resources accordingly
Act now
REACH is not ‘too hard’: AIG one pager
AIG is free to download from www.acea.be/reach
Have a REACH rep & a plan (ensure suppliers do too)
Importance of standardised communication, preregistration, ‘only representatives’ and inventory
Thank you for listening
Robert Walker, Technical Manager, SMMT
Email: [email protected] Tel: +44 (0)20 7344 1627