REACH How do we deal with it

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REACHHow do we deal with it?

• Zoran Gavric, March 2007

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Overview roles and responsibilities

• European Chemical Agency / EC determines
• Legislation
• Guidelines
• Manufacturers, importers and downstream users
  comply to legislation and carry it out according
  to guidelines while paying attention to
• Clearly described roles responsibilities
• Mandatory consortia
• Defined and mandatory communication in the value
  chain
• End Users enjoy the safe show

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Sara Lees role in REACH

• mainly a Downstream User (DU)
• we use chemicals produced by others
• also an Importer (I)
• when we buy raw materials from suppliers outside
  the EU
• or buy (semi)finished products/articles or
  packaging components outside the EU

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Sara Lee as Downstream User

• Mandatory obligations for downstream users
• May only use registered substances
• Substances must be registered for their specific
  use by manufacturers/importers
• Must assist manufacturers in registration
• Provide info on use, tonnage and exposure
  scenarios
• Contribute to collecting data, testing
• Provide extended Safety Data Sheets to customers
  (further downstream users and end users)
• Share safety information
• Describe Risk Management Measures

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EU situation (SaraLee as Downstream user)
Manufacturer (Supplier)
Client (SaraLee)
RM Extended Safety Data Sheet with Exposure
Scenarios

• Inventory of all our chemicals and their use
  (product/application)

Our Use Covered?
Clients can inform the supplier about their use
(identified uses) Goal To insure
pre-registration and to cover their use (SDS)
Check / Implementation of Risk Management Measures
Yes

• Inventory of all suppliers (Manufacturers) of our
  chemicals (RM)

• Dialogue with the suppliers (Manufacturers) of
  our chemicals (RMs). Check the intention to
  pre-register/register and to cover our use.

Business secret (IPR)?
No
Yes
Develop your own CSR2
Inform Central Authority1
No
1 Not required for chemicals lt 1 t/jr 2 Chemical
Safety Report
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Example of how to approach the inventory

• Company system finds tonnage by adding up all
  tonnages with this formulation, making a
  distinction between substances imported by the
  Company and substances supplied by the EU M/I
• Buyers list and database used to include
  tonnages in a spreadsheet
• System sums up total tonnage of e.g. substance A
  with a split over formulations in previous table
  (b) and adds up columns for different kinds of
  substance A sources etc

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Sara Lee as Importer

• Mandatory obligations for Importers
• Importing implies the same duties as
  manufacturing
• Imported substances must be registered in the
  same way as those manufactured in EU
• Registration mandatory when gt 1 t/y imported in
  the EU
• Perform Chemical Safety Assessment (gt 10 t/y) and
  prepare Chemical Safety Report
• Registration costs/fees

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Import from outside the EU
Case 1
EU
Non EU
Case 2
Case 3
EUManufacturer
LocalManufacturer
SaraLee
SaraLee / 3rd party
OnlyRepresentative
LocalManufacturer(REACH proof)
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Import from outside EU (Factors crucial for
success)

• Accurate and reliable inventory of chemicals and
  their local suppliers
• Timely analysis of the situation and start of the
  dialogues with the suppliers
• Awareness of the importance of REACH and its
  impact throughout all business units involved
  (but also our suppliers)
• Adapt business strategy on time to avoid problems
  and overcome gaps (eliminate non-REACH proof
  suppliers on time, insure availability of REACH
  proof RMs and sustainability of the
  products)Cheapest non-EU supplier will under
  REACH not always result in the cheapest solution

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Expected impact on Sara Lee

• Erosion of allowed substances (less resources)
• Low turnover does not support registration
  investments
• Decreased number of manufacturers
• Outside EU gt non-REACH proof suppliers
• Extra documentation
• Much more extensive Safety Data Sheets
• Mandatory data sharing with suppliers (tonnage,
  exposure scenarios..)
• Contribution to Registration Dossier
• More demand on the IT system
• To answer the questions like How many tones of
  an ingredient in an article XYZ do we import in
  the EU?How many tones of ingredient X from the
  supplier Y did we use in product Z this year?
• Increased costs
• Registration fees
• More expensive chemicals (??? Someone has to pay
  for the costs)
• Administrative costs
• So be prepared!!!

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REACH timeline
SIEFs
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REACH implementation

• REACH implementation team (Procurement,
  operations, supply chain and regulatory)
• REACH implementation support and maintenance
• Inventory system (dig. information management
  system)

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Contact details

• Zoran GavricManger Safety Environment and
  Regulatory AffairsSara Lee Household Body Care
  ResearchFruitweg 25 2525KG Den Haage-mail
  zoran.gavric_at_saralee.comtel 070-3303764