Supply chain communication

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Supply chain communication

• Tatjana Humar Juric, M.Sc.
• Semira Hajrlahovic Mehic, LL.M.

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CONTENT

• Overview of information
• Communication DOWN the supply chain
• Communication UP the supply chain
• Importers and Non - Community companies
• Guidance, FAQ

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Basic framework under REACH
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OVERVIEW

• REACH TITLE IV
• Information in the supply chain Articles 31-36
• Actors suppliers
• Communication Instruments
• SDS
• CSR/Exposure scenario

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Actors

• Supplier of S/P(mix.) means any
• Manufacturer M
• Importer I
• downstream user DU or
• distributor D placing on the market a substance,
  on its own or in a preparation, or a preparation
• Producer P of articles
• Consumer C

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Actor's roles

• Different roles in supply chain
• REACH majority of obligations apply to M/I
• Non-EU manufacturers do not have direct
  obligations under REACH
• Importer established within the Community, needs
  to comply with REACH

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GOALS of Supply Chain Communication

• Safety use of substance/preparation/article
• Risk managment (to lower the risk)
• To pass on information received from supplier to
  customers
• M/I of substances should supply the information
  on risk managment to other professionals such as
  DS or D
• P/I of articles should supply information on the
  safe use of articles to industrial and
  professional users, and consumers on request.

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Risk manegment Risk characterisation under
REACH

• Estimation of incidence and severity of adverse
  effects likely to occur in a population/ecosystem
  due to exposure to a substance
• Addressing several potential toxic effects and
  human (sub)populations, and considering each
  (sub)populations exposure by relevant exposure
  routes
• Focus on most critical effect (with consideration
  of time scale)
• Quantitative or qualitative provisons

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Risk manegment main goal
Environmental risk characterisation

Risk controlled if lt1
Human risk characterisation
RCR intake or concentration/DNEL or DMEL
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• Informing of users
• 
  CHEMICAL SAFETY REPORT
• 
  
  (prof. users)
• SAFETY DATA SHEET
• (prof. users,
  DU, distrib.)
• LABELL
• (all users)
• - - - - - - - - - - - - - - - - - -
  extent of information, tonage.

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• Chemical Safety Report (CSR)and
• Safety Data Sheet (SDS)
• informing of users
• risk manegment

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Communication DOWN the supply chain (1)

• SDS OBLIGATORY for transmitting safety info on
  S/P DOWN the supply chain
• S/P meets the criteria for classification as
  dangerous-hazardous
• Substance is PBT or vPvB
• Substances to be included in Annex XIV
  (substances subject to authorisation)

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Safety Data Sheet-SDS (1)

• REACH Regulation (Art.31, Annex II)
• Provides safety information on all classified
  chemicals and information from the relevant
  Chemical Safety Report (CSR) down the supply
  chain
• Exceptions
• not hazardous preparations (mixtures)
• chemicals e.g. metals in massive form, alloys,
  compressed gases
• (Annex VI, 67/548/EEC)
• Enable users to take the necessary measures
  relating to protection of human health and safety
  at the workplace, and protection of the
  environment.

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SDS (2)

• Information provided by SDS shall
• Meet the requirements set out in Directive
  98/24/EC on the protection of the health and
  safety of workers from the risks related to
  chemical agents at work
• Enable the employer to determine whether any
  hazardous chemical agents are present in the
  workplace, and to assess any risk to the health
  and safety of workers arising from their use

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SDS (3)

• Format is given in Annex II of REACH
• Official language of MS where S/P is placed on
  the market
• Free of charge in paper or electronically
• Enforcement MS Competent Authorities

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SDS (4)

• On request also for preparation not classified as
  dangerous but containing certain dangerous or
  very high concern substances (authorisation
  candidates, PBT, vPvB)
• No SDS obligations for
• S/P for general public (as well as a sufficient
  info is provided )
• Articles

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SDS (5) the content

• IDENTIFICATION OF THE S/P AND OF THE
  COMPANY/UNDERTAKING
• HAZARDS IDENTIFICATION
• COMPOSITION/INFORMATION ON INGREDIENTS
• FIRST AID MEASURES
• FIRE-FIGHTING MEASURES
• ACCIDENTAL RELEASE MEASURES
• HANDLING AND STORAGE
• EXPOSURE CONTROLS/PERSONAL PROTECTION
• PHYSICAL AND CHEMICAL PROPERTIES
• STABILITY AND REACTIVITY
• TOXICOLOGICAL INFORMATION
• ECOLOGICAL INFORMATION
• DISPOSAL CONSIDERATIONS
• TRANSPORT INFORMATION
• REGULATORY INFORMATION
• OTHER INFORMATION
• ANNEX (information from
  CSR!)

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SDS (6)- new under REACH

• Exposure Scenarios (including use and exposure)
  in an annex to the SDS
• The information on uses of S in SDS must be
  consistent with the ES in the annex, indicating
  which uses are covered by the single ES
• Results from hazard assessments the should be
  incorporated into the SDS.
• SDS for Substances of Very High Concern subject
  to Authorisatin (SVHC Candidate list )
• Structure changes (sections 2 and 3)
• Additional info (registration No., e-mail
  address..)

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• What is a Chemical Safety Report (CSR)?
• Document, which details the process and the
  results of Chemical Safety Assesment (CSA)
• - CSR shall be
• completed for all substances subject to
  registration in accordance with in quantities of
  10 tonnes or more per year per registrant
• conducted in accordance with paragraphs 2 to 7 of
  Art.14 and with Annex I of REACH for
• either each substance on its own or
• in a preparation or
• in an article or a group of substances.

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Format of CSR

• PART A
• 1. Summary of risk management measures2.
  Declaration that risk management measures are
  implemented3. Declaration that risk management
  measures are communicated

• PART B
• 1. Identification of the substance, its
  physical and chemical properties2. Manufacture
  and uses3. Classification and labelling4.
  Environmental fate properties5. Human health
  hazard assessment6. Human health hazard
  assessment of physicochemical properties7.
  Environmental hazard assessment8. PBT and vPvB
  assessment9. Exposure assessment10. Risk
  characterisation

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Goals of Chemical Safety Assessment (CSA)

• To ensure that risks (to workers, consumers and
  the environment) are controlled - identify and
  apply the appropriate measures accordingly
• Shall address all identified uses of the M/I or
  DU
• Develop exposure scenarios if substances are
  classified as dangerous or considered to be a
  PBT/vPvB
• Document the assessment in the chemical safety
  report (CSR), including listing of the exposure
  scenarios, covering Risk Management Measures
  (including CL and down stream consequences)
• To communicate information using the
  SDS

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What is an exposure scenario (ES)?

• describes the conditions under which a substance
  (as such, in a preparation or in an article) or a
  group of substances can be safely used.
• is a major element in the CSA on which the
  exposure assessment and the risk characterisation
  is based
• is an instrument for communicating operational
  conditions of use and risk management measures
  that are suitable to ensure adequate control of
  risk in the supply chain (the ES is integrated
  into the Safety Data Sheet (SDS) system in Annex
  !!).
• shall be developed for both the manufacturers
  own manufacturing process and for identified
  uses including both uses by the manufacturer or
  importer and uses further down the chemical
  supply chain

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• New under REACH
• Any actor in the supply chain who is required to
  prepare a
• CRS shall place the relevant
• Exposure scenario (ES) in an annex to the SDS
• covering identified uses and including specific
• conditions resulting from the application!!

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SDS (8)- update

• New information on hazards becomes available
• Info which may affect the risk management
  measures
• Authorisation has been granted or refused
• Restriction has been imposed
• Access to SDS and other info is given to workers

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Communication DOWN the supply chain (3)

• Supplier of ARTICLES shall inform consumers
  about substances of very high concern contained
  in conc. gt0,1 Also consumer can request such
  information
• Distributor shall pass on info received from
  supplier to costumer to ensure safety use of S/P

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Communication DOWN the supply chain (4)

• If SDS is not required supplier has to
  communicate
• key risk info about S, in particular if the S is
  subject to authorisation or restriction
• Other relevant/available info to enable
  appropriate risk management

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Communication UP the supply chain (1)

• Applies if you are using S/P in the context of
  industrial or professional activities and you do
  not supply further down the chain
• Communicate to your supplier next up the chain

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Communication UP the supply chain (2)

• Communication of
• NEW INFO on hazardous properties that become
  available, regardless of the
• uses concerned
• Any other information that might call into
  question the appropriateness of the risk
  management measures identified in SDS

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Communication UP the supply chain (3)

• Distributors obligation to pass on info received
  to the next actor in the supply chain
• Downstream users
• Have right to make their use known to the
  supplier
• Provide sufficient info to prepare an exposure
  scenario (important for registrants preparing CSR
  including ES)

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DU

• Follow the RM advice and the operational
  conditions of use described SDS received from the
  supplier, including the exposure scenarios
• If relevant, forward the advice to actors further
  down the supply chain
• Obligation to use S according to the conditions
  laid down in the authorisation granted
• Notify to ECHA the use of S subject to
  authorisation

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• DU
• should inform (in writing) suppliers about use of
  a substance ? supplier considers use in relation
  to his registration.
• use be an identified use and have an ES your
  conditions of use, unless the registrant cannot
  support the use.
• Before informing supplier check the use mappings
  prepared by industry association, and/or any
  communication from supplier about the uses he
  intends to cover.
• ECHA has published a Fact Sheet that provides
  background information and further details about
  the DS right to inform their suppliers of the
  use they make of thesubstance (see gudiance!).
• If the substance needs to be registered before 1
  December 2010
• DU must inform the supplier till 30 Nov. 2009!!

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DU

• DU obligations when his use is not covered by the
  SDS-options
• Adapt the conditions of use to those described in
  the SDS
• Implement or recommend ES which includes as a
  minimum the conditions described in the ES
  communicated to him
• Make the use known to the supplier with the aim
  of making it an identified use based on the
  manufacturers CSA
• Perform your own CSA for that particular use and
  record it in a Chemical Safety Report - CSR (if
  the total amount used is 10 t/year or more).
  Notify your use to ECHA
• Switch to another supplier of the substance if
  that supplier covers your specific use in his SDS
  

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Importers and Non - Community companies

• Non Community manufacturers do not have direct
  obligations under REACH
• Non Community manufacturers
• Work with EU importer
• Established or use EU-legal entity
• Use Only representative

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Importers

• Identify which S/P require SDS
• new format, include ES
• submit to costumer
• Identify S subject to restriction/authorisation
  and pass info down the chain
• For articles
• Check if article contains SVHC
• Provide info on safe use (min. name of S)

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3.1 Preparing the registration dossier
3.10 Guidance on substance ID
3.2 Preparing the CSR
RIP-3 REACH Guidance for Industry
3.4 Guidance on data-sharing
3.3 Information requirements
3.7 Guidance on applications for authorisation
3.5 Guidance for downstream users
http//ec.europa.eu/echa/
3.8 Requirements for articles
3.9 Guidance on SEA
3.6 Guidance on CL under GHS
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Thank you!

• Tatjana.Humar-Juric_at_gov.si
• Semira.Mehic_at_gov.si