COMMUNICATION IN THE SUPPLY CHAIN

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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
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• Introduction
• Communication in the supply chain
• CSA and ES
• CEFIC-FECC-DUCC approach

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FECC MEMBERSHIP
National Associations 17 Company Members
29 ALGOL OY AB AVANTEC AZELIS BANG BONSOMER
BIESTERFELD BRENNTAG HOLDING GmbH BTC Europe
CALDIC BV CAMPI Y JOVE C.H. ERBSLÖH KG DIPOL
Chemical International Inc, EIGENMANN
VERONELLI SpA GROLMAN GROUP Harke Group Aug.
HEDINGER GmbH Co. KG Associate Members 9
HSH Chemical Distribution Group IMCD Group
KRAHN CHEMIE GmbH NORDMANN RASSMANN GmbH OMYA
AG ORKA d.o.o. PENTA CHEMIKALIEN GmbH
QUIMIDROGA S.A. QUIMITECNICA.COM R2 Group A/S
SAFECHEM EUROPE GmbH  TENNANTS DISTRIBUTION
Ltd. UNIVAR Europe Ltd WARWICK INTERNATIONAL
GROUP
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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

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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.

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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

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COMPLEX SUPPLY CHAINS
REACH will affect the entire supply chain
STORAGE
MANUFACTURE
FORMULATION
PROFESSIONAL/ INDUSTRIAL USER
RE-PACKAGING
DISTRIBUTION
CONSUMER
TRANSPORT
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REACH CHEMICAL DISTRIBUTORS

• REACH will make the chemical distributors play a
  crucial role in the chemicals supply chain.

Producers
Information on uses of substances
Properties of substances and safe uses (SDS, ES,
RMM)
Distributors
Downstream users
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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

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REACH CHEMICAL DISTRIBUTORS

• which entails different obligations.
• IMPORTER Pre-register and Register imported
  substances or substances in preparation gt 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

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REACH What should we do now?

• Start getting prepared!
• Identify who will be responsible within company,
  get to know REACH, etc. gt 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!!
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• Introduction
• Communication in the supply chain
• CSA and ES
• CEFIC-FECC-DUCC approach

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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

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Steps in the development ES

• Obtain the current Conditions of Use
• Tentative Exposure Scenario
• Carry out CSA
• Draft Exposure Scenario (risk controlled)
• Supply chain communication
• Final Exposure Scenario
• Include in CSR and publish as Annex to e-SDS

COMMUNICATION
COMMUNICATION
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Elements of an Exposure Scenario
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Elements of an Exposure Scenario
Set of standard core information on conditions of use contained in an Exposure Scenario (Draft) Set of standard core information on conditions of use contained in an Exposure Scenario (Draft)
1. Short title of Exposure Scenario1 Water soluble solvent MANUFACTURE AND FORMULATION in Industrial and professional use
2. Description of activities/process(es) covered in the Exposure Scenario Use in a continuous systems with process sampling 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 which the RMM ensure adequate control of risk gt4 hrs/day, 200 days per year
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 or percentage of substance in preparation or article applied) See section 2 of SDS

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Elements of an Exposure Scenario
6. Risk management measures determining exposure
Occupational measures following the hierarchy of Directive 98/ impact of single options or combination of options on exposure to be quantified options to be phrased as instructions Use in closed system W7.01 Closed dosing, transfer, sampling and application system including connectors Apply local exhaust ventilation W15 ex2 Ventilated process enclosures or W15 ex3 Fume cupboard or W17 ex1 Local Exhaust Ventilation - with captor hood or 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 RMMs W27.02 Personal hygiene W27.01 Apply General good hygiene and housekeeping
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Elements of an Exposure Scenario
Environment related measures impact of single options or combination of options on exposure to be quantified options to be phrased as instructions To be developed
Consumer related measures Not applicable
7. Waste related measures needed to ensure adequate control of risk at the different life cycle stages (including articles at the end of service life For worker protection see RMMs as defined for Manufacture and Formulation
8a Prediction of exposure resulting from the conditions as described above Predicted worker inhalatory exposure based on ECETOC TRA For closed systems 0.5 ppm For batch processes 1.8 ppm For discharging 3 ppm For Filling containers0.6 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 use ECETOC TRA scenarios -closed continuous process -batch process -dis/charging -filling -use as lab agent
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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)

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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)

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• Introduction
• Communication in the supply chain
• CSA and ES
• CEFIC-FECC-DUCC approach

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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

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WORK FLOW
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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

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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

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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
• Speed up the feedback to DUs, Suppliers .. and
  M/I

Each level is responsible!
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Thank you for your attention! www.fecc.org
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Back-up slides
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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)
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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

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ES FOR PREPARATIONS