REACH A Companys Perspective

1
REACH A Companys Perspective

• Fiona Smith
• Regulatory and Registration Manager

2
Contents

• Lucite International at a Glance
• Impact of REACH at Lucite International
• Preparations for REACH (Internally and
  Externally)
• Business Issues Associated with REACH
• General Business Strategy
• Registering Substances
• Mitigations for Raw Materials
• Lessons Learned
• Challenges Moving Forward

3
Lucite International at a Glance

• Chemical Manufacturing Company
• Successor to acrylics businesses of ICI and
  Dupont with additional strategic acquisitions
  worldwide
• Global leader in the design, development and
  manufacture of acrylic based products
• 17 manufacturing sites around the globe
• Customers in more than 100 different countries

4
Impact of REACH at Lucite (1)

• Manufacture chemicals, preparations, polymers and
  articles
• Sell into industrial, professional, medical,
  dental and consumer markets
• In EU alone over 1600 raw materials
• 600 key
• 65 critical
• Over 3,500 product grades
• As well as manufacturing and selling in the EU,
  we also manufacture globally and import into the
  EU

5
Impact of REACH at Lucite (2)

• Business systems (purchasing, manufacturing and
  sales) very effective but disparate and non
  integrated
• Although registration costs will be significant,
  additional impact could be on manufacturing / RD
• Example 1 - withdrawal of pigment used in sheet
• 3 months RD and product testing
• Example 2 - withdrawal of critical process
  chemical
• Fundamental redesign of manufacturing process
  1-2 yrs effort.

6
Internal Preparations

• Development of REACH legislation closely followed
  for 10 years
• Understand that REACH could bring both compliance
  and business issues
• New function created to drive REACH registration
  and compliance and to lead a cross-functional
  steering group
• REACH Project sponsored by Executive Team

7
External Preparations

• Late 90s/early 2000s
• 2 HPV priority chemicals through EU Existing
  Chemicals Risk Assessment Programme
• Nominated a Category of methacrylate monomers
  within OECD HPV programme to establish category
  approach (read-across, etc.) and data adequacy
• More recently
• Working in trade associations in Europe, US and
  Japan to establish
• Data adequacy and gap analysis
• Assessment of data value
• Downstream use scenarios

8
Key Business Issues Associated with REACH

• Issues associated with data sharing
• Timeframes associated with waiting for consortia
  formation and SIEF
• Value associated with available test data
• Potential rationalisation of products purchased
  and sold
• Legal entity structure needs understanding
• Impact of REACH to be included in business plans
  and owned by the business

9
General Business Strategy

• Build REACH impact into financial plans at
  business level
• Follow guidance on preparations published by both
  CIA and CEFIC
• Discuss REACH implications with contacts up and
  down the supply chain
• Purchasing and sales need guidance
• Tailored questions versus standard letters
  available
• Understand implications associated with legal
  entity structure
• Build auditable systems to collate information
  with view to demonstrate REACH compliance

10
Key Preparations for Registration of Substances

• Commodity chemical substances to register as HPVs
  in first phase-in period
• Compile list of products and understand
  registration obligations (type,
  compositions and volumes) including intermediates
• Review raw materials to highlight imports and
  gain support from suppliers (both EU and non-EU)
• Comprehensive description of downstream markets
  to be included in registration
• LI working with key downstream industries to
  agree use scenarios and control measures for
  inclusion in CSA and CSR

11
Risk Analysis
A detailed risk assessment has been carried out
and some of the key elements addressed through
mitigation plans include

• Loss of a supplier
• Loss of raw material
• Loss of functional element of a material /
  consumable
• Loss of Product
• Loss of particular use of product
• Loss of a customer

12
Supplier Mitigations
13
Lessons Learned

• Ownership of inventory
• Awareness of risks
• The inventory lists are owned by the businesses

• Expertise and resource
• Requirements for each product range

• What is bought, where from and how / where is it
  used
• What is manufactured / imported, how much and
  where they are sold
• Structure of legal entities
• Do not underestimate the time needed to build up
  a complete and robust Inventory of raw material
  and products

• Own use and downstream uses

• Raw material availability
• Product supply continuity

• Timeframes / Resources / Budgets

14
Forward Plan

• Approvals of product assessments
• Compositions / Volumes / Comprehensive
• Extent of REACH requirements
• Confirmation of use scenarios (own and
  downstream)
• Database development and maintenance
• Communications
• Internally to purchasing / manufacturing and
  sales
• Effects on non-EU sites
• Supplier reviews
• Customer support
• Registration related activities
• IUCLID5 download and support
• Trade Groups - Substance Information Exchange
  Forum (SIEF)
• Extended MSDS Requirements
• Develop spend profile for business support

15
Supplier responses range from clear understanding
and support for customers through to
Return to mitigation