MV CEPI 300108.ppt - Europulp by pengxiang

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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

								
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