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COMMUNICATION IN THE SUPPLY CHAIN
Mercedes Viñas
European Affairs Manager
European Association of Chemical Distributors (FECC)
CEPI REACH Workshop
30 January 2008
Introduction
Communication in the supply chain
• CSA and ES
CEFIC-FECC-DUCC approach
FECC MEMBERSHIP
National Associations: 17
Company Members: 29
ALGOL OY AB HSH Chemical Distribution Group
AVANTEC IMCD Group
AZELIS KRAHN CHEMIE GmbH
BANG & BONSOMER NORDMANN RASSMANN GmbH
BIESTERFELD OMYA AG
BRENNTAG HOLDING GmbH ORKA d.o.o.
BTC Europe PENTA CHEMIKALIEN GmbH
CALDIC BV QUIMIDROGA S.A.
CAMPI Y JOVE QUIMITECNICA.COM
C.H. ERBSLÖH KG R2 Group A/S
DIPOL Chemical International Inc, SAFECHEM EUROPE GmbH
EIGENMANN & VERONELLI SpA TENNANTS DISTRIBUTION Ltd.
GROLMAN GROUP UNIVAR Europe Ltd
Harke Group WARWICK INTERNATIONAL GROUP
Aug. HEDINGER GmbH & Co. KG
Associate Members: 9
LATEST FECC ACTIVITIES ON REACH
Observer seat at REACH CA
Presentation to the ECHA, Feb. 2007
Participation in Commission REACH workshops
REACH Implementation Projects (RIPs):
3.1: Registration and Overall Guidance
3.2: Chemical Safety Assessment and Report
3.4: Data and cost sharing
3.5: Downstream users obligations
3.6: GHS
LATEST FECC ACTIVITIES ON REACH
Joint CEFIC-FECC position on communication
in the supply chain.
Position paper and amendments on GHS
Simplification of the Use Descriptor
Comments on the Fee Regulation
Guidance on Only Representative
Annexes review
Monitor upcoming projects: industry portal,
baseline study, etc.
Cooperation with other stakeholders
CEFIC, Businesseurope, DUCC, EuroCommerce, etc.
LATEST FECC ACTIVITIES ON REACH
FECC information to the Members on REACH:
Monthly REACH section in Newsletter and regular e-
mails with updates and latest information.
Standard reply to customers
“How to get prepared for REACH” leaflet
Exemptions and Key dates in REACH
REACH and cosmetics, food and pharma
FECC Seminar on REACH Implementation for
Chemical Distributors, 20 November 2007
REACH session in Annual Congress, Budapest June
2008
COMPLEX SUPPLY CHAINS
REACH will affect the entire supply chain
STORAGE
MANUFACTURE
FORMULATION
PROFESSIONAL/
RE-PACKAGING INDUSTRIAL USER
DISTRIBUTION
CONSUMER
TRANSPORT
REACH & CHEMICAL DISTRIBUTORS
REACH will make the chemical distributors play a
crucial role in the chemicals supply chain.
Producers
Properties of Information
substances and on uses of
Distributors
safe uses substances
(SDS, ES,
RMM…)
Downstream users
REACH & CHEMICAL DISTRIBUTORS
Chemical Distributors may have different roles in
REACH…
Importer: import into the EU a substance or a
substance in a preparation in 1 or more
tonnes/year
Distributor: only stores and places on the
market a substance, on its own or in a
preparation, for third parties
Downstream user: uses a substance, either on
its own or in a preparation, in the course of his
industrial or professional activities, e.g.
formulation, dilution, re-packaging, etc
REACH & CHEMICAL DISTRIBUTORS
…which entails different obligations.
IMPORTER: Pre-register and Register
imported substances or substances in
preparation > 1 t/y
DISTRIBUTOR: Make sure information is
passed up and down in the supply chain
DOWNSTREAM USER: communication of
information on own uses upstream or carry
out use assessment
REACH: What should we do now?
Start getting prepared!
Identify who will be responsible within company, get
to know REACH, etc. > Make sure you receive regular
info!
Inventory of all substances & substances in
preparations you import/distribute/handle: check
substance identity and exemptions!
Identify for each substance your role in REACH:
Manufacturer/Importer, Distributor or Downstream user
Be aware of the obligations and prepare and
implementation plan
Be aware of the deadlines!!
Introduction
Communication in the supply chain
• CSA and ES
CEFIC-FECC-DUCC approach
What is an exposure scenario?
A description of safe use by describing:
Conditions of use
Risk Management Measures (RMM)
ES covers all activities and processes within the value
chain:
Production: chemical synthesis of the substance and
use as intermediate
Formulation: mixing and blending into a preparation
Industrial, professional use
Consumer exposure and private use
Service life
Waste Life stage
Steps in the development ES
Obtain the current Conditions of Use
Tentative Exposure Scenario
COMMUNICATION
Carry out CSA
COMMUNICATION
Draft Exposure Scenario (risk = controlled)
Supply chain communication
Final Exposure Scenario
Include in CSR and publish as Annex to e-SDS
Elements of an Exposure Scenario
Elements of an Exposure Scenario
Set of standard core information on conditions of use contained in an Exposure Scenario (Draft)
1. Short title of Exposure Scenario[1] Water soluble solvent MANUFACTURE AND
FORMULATION in Industrial and professional use
2. Description of activities/process(es) • Use in a continuous systems with process sampling
covered in the Exposure Scenario • Formulating via batch processes
• Dis/charging
• Filling of containers
• Use as laboratory agent (for QA purposes).
3.Operational conditions Process is carried out under room temperatures at
atmospheric conditions
3.1 Duration and frequency of use for >4 hrs/day, 200 days per year
which the RMM ensure adequate control
of risk
3.2 Max amount used
Concentration 100% v/v
Temperature Room temperature, unless handled in a closed system
4. Physical form of product Liquid
5. Product specifications (Concentration See section 2 of SDS
or percentage of substance in preparation
or article applied)
Elements of an Exposure Scenario
6. Risk management
measures determining
exposure
Occupational measures Use in closed system:
following the hierarchy of W7.01 Closed dosing, transfer, sampling and application
Directive 98/…; impact of system including connectors
single options or Apply local exhaust ventilation
combination of options on W15 ex2 Ventilated process enclosures or
exposure to be quantified; W15 ex3 Fume cupboard or
options to be phrased as W17 ex1 Local Exhaust Ventilation - with captor hood or
instructions W18 ex1 Local Exhaust Ventilation - with receptor hood
for dust
In case of skin contact:
CW29.01 Use Protective Gloves - Chemical resistant (see
for more detail on type of glove section 8)
In case of eye contact:
CW31.02 Use Goggles - Not specified
General RMM’s
W27.02 Personal hygiene
W27.01 Apply General good hygiene and housekeeping
Elements of an Exposure Scenario
Environment related measures; impact of single To be developed
options or combination of options on exposure to be
quantified; options to be phrased as instructions;
Consumer related measures Not applicable
7. Waste related measures needed to ensure For worker protection see RMM’s as defined
adequate control of risk at the different life cycle for Manufacture and Formulation
stages (including articles at the end of service life
8a Prediction of exposure resulting from the Predicted worker inhalatory exposure based
conditions as described above on ECETOC TRA:
For closed systems : 0.5 ppm
For batch processes: 1.8 ppm
For discharging: 3 ppm
For Filling containers:0.6 ppm
For use as lab agent: 0.1 ppm
Worker dermal exposure is not predicted as the
exposure should be minimized to prevent irritation
effects.
8 b Derived control thresholds none
9. Set of variables which together indicate safe ECETOC TRA scenario’s :
use -closed continuous process
-batch process
-dis/charging
-filling
-use as lab agent
USE AND IDENTIFIED USE
Use: any processing, formulation, consumption, storage, keeping,
treatment, filling into containers, transfer from one container to another,
mixing, production of an article or any other utilization.
Identified use: substance on its own or in a preparation, or a use of a
preparation that is intended by an actor in the supply chain, including his
own use, or that is made known to him in writing by an immediate DU.
Descriptor system (RIP 3.2 – Expected approval in March)
Sectors of Use, 22 options. Example: SU1 Agriculture,
forestry, fishery
Product Category, 39 options. Ex.: PC1 Adhesives
Process Category, 20+ options. Ex.: PROC1 use in closed
systems, no likelihood of exposure
Article Category,
Not intended release 20, options. Ex.: AC02 Passenger cars
and motor cycles
Intended release (in development)
Identified use (Example)
Substance X is used in building and
construction work (SU19) and in the
general public domain (SU22) in
Coatings and Paints, Fillers, Putties,
Thinners (PC9) by professional spraying
outside industrial settings and/or
applications and roller or brushing
application (PROC)
Introduction
Communication in the supply chain
• CSA and ES
CEFIC-FECC-DUCC approach
Workflow for the Use and Exposure
communication throughout the supply chain
Aim: avoid flood of questionnaires
Based on the RIP 3.2-2 Technical guidance on
preparing CSR and “Arona Workshops”
Work conducted in close cooperation between
CEFIC and FECC. DUCC also joined.
Starting point for the specification of the IT tool
For the management & communication of
“downstream user” (DU) questionnaires
WORK FLOW
Workflow Use & Expose Scenario Communication in supply chain
1 In house review
Collect identified uses Active review of M/I in -house info with key customers
Build tentative ES
3 Check of Info completeness with supply chain
Use ES template (D-1) from
2 RIP 3.2 Guidance Downstream – up tentative ES generation
80 -90% 16
Covered? No Association / SG prepare
Yes tentative ES
17
9
Manufacturer checks
4 M/I to communicate Draft Exp. ES
Run preliminary CSA Scenarios to direct DU for
For uses covered further communication in
supply chain (*) 18
YES CSA
5 Support?
Key DU/Associations 10 Down stream users / Formulators YES
collect and communicate further
To check 13
down the Supply Chain NO
7 M/I will
Comments 11 consider? NO
Yes DU
6 Use D3 template Agree?
M/I
Agree? 12
When DU agrees, No
No DU to inform Supplier
no confirmation
Yes is required about additional
8 use/exposure
Draft Exp Scenario
14 15 19
Final ES with uses covered Communication DU to prepare CSA/CSR
by M/I in registration via ESD Inform Agency
(*) M/I intends to register by (Registration date). Uses that have been communicated
before date x will be included in the Registration process
BASIC PRINCIPLES
The work flow is made of 3 loops for acquiring information
In house
Active review of the preliminary CSA by M/I with key
customers
Completeness check of developed ES with supply chain
Status of the Exposure Scenarios and CSR are changing at
each step distinguishing
Tentative exposure scenarios
Chemical Safety Assessment & Key DU/Associations
Draft Exposure Scenarios
Supply Chain communication
Final Exposure Scenarios
CSR and e-SDS
BASIC PRINCIPLES
Top – Down approach by M/I
Tentative Exposure Scenarios tested with key
customers
Draft ES verified in the supply chain
Feedback system using standard framework
Realistic deadlines for feedback
No feedback needed if agreement
Final Exposure Scenario in e-SDS
Bottom-up input by Associations, Sector groups etc
Impacts on the supply chain communication
The need to harmonise and standardise:
Standard phrasing of ES
Generic ES based on standard descriptors
Standard library of RMM and Conditions of uses
The need to prepare the communication at all levels:
Get all the available ES and CSA developed by national and European
Associations of User Groups
M/I
M/I
Distri Distri
DU Each level is responsible!
DU
DU
Speed up the feedback to DUs, Suppliers ….. and M/I
Thank you for your attention!
www.fecc.org
Back-up slides
CHEMICAL SAFETY ASSESSMENT
A Chemical Safety Assessment (CSA) is required:
As part of Registration dossier when:
• Substance is manufactured/ imported ≥ 10 tonne/year
• Substance is dangerous, PBT or vPvB (*)
And when do I need to have my CSA/CSR ready?
• Registration deadlines for phase-in substances
• 12 months after EIF for non-phase in substances
As part of the application for Authorisation
The CSA is documented in a Chemical Safety Report
(CSR)
The CSR will include exposure scenarios and exposure
assessment
The Exposure Scenarios need to be attached to the SDS
(Mandatory only after deadline for registration has been
reached!) (*) Persistent Bioaccumulative Toxic (PBT)
very Persistent, very Bioaccumulative (vPvB)
CHEMICAL SAFETY ASSESSMENT
The Chemical Safety Assessment should include:
Hazard assessment
• Physicochemical properties
• Human health
• Environmental
PBT and vPvB assessment
• Is the substance or the preparation dangerous (according to
67/548/EEC or 1999/45/EC Directives) or PBT or vPvB ?
Exposure assessment
• The generation of exposure scenario(s) or the generation of
relevant use and exposure categories if appropriate
• Exposure estimation
Risk characterisation
ES FOR PREPARATIONS
