European Heath, Safety

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European Heath, Safety Environmental Legislation

• (Incorporating REACh)

Robert Stubbs Group Technical Director Polartech
STLE Meeting, Chicago February 2008
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European Heath, Safety Environmental Legislation

• (or how I tried to kill off the European
  lubricants industry in one easy lesson)

Robert Stubbs Chairman Health Environment
Committee - UEIL
STLE Meeting, Chicago February 2008
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Union Indépendante de Lindustrie Européene des
Lubrifiants

• Created in 1963
• Originally based in Paris, moved to Brussels in
  2005
• Secretariat based at offices of Essencia
• Representative of Independent Lubricant Companies
  in Europe

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EU Associations
UK Lubricants AssociationProduct Stewardship
Group
VSI - Verband Schmierstoff Industrie
UEIL Health Environment Committee
Fedechimica
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EU Countries

• Pre 2004 EU Member Countries
• Austria Belgium
• Denmark Finland
• France Germany
• Greece Ireland
• Italy Luxembourg
• Portugal Spain
• Sweden The Netherlands
• United Kingdom

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EU Countries

• Current EU Member Countries
• 2004 members plus
• Cyprus The Czech Republic
• Estonia Hungary
• Latvia Lithuania
• Malta Poland
• Slovakia Slovenia

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UK Future in Europe?
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UK Future in Europe?
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UK Future in Europe?
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UK Future in Europe?
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Content

• Current Significant Issues
• REACh
• GHS
• Other MWF Related Issues

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REACh - EU Chemicals Policy

• Some potential consequences
• adverse effect on international competitiveness
• adverse effect on availability of imports into
  Europe
• unavailability of a number of current raw
  materials
• forced product reformulations
• simplification of product ranges
• reduced product developments and innovations

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REACh

• 1 June 2008 30th November 2008
• a six month pre-registration notification
  period for
• existing (phase-in) substances

Phase-In substances their actual registration
will be organised according to three phase-in
periods spanning 11 years as shown.

• Registration
• 1 - 10 t
• Phase-in Substances

• Registration
• gt 1t CMRs
• gt 100 t Environmentally
• Hazardous R50/53
• gt 1000 t Phase-In Substance

• Registration
• 100 - 1000 t
• Phase-in Substances

• Registration
• 10 - 100 t
• Phase-in Substances

Set-Up of European Chemicals Agency
Pre-registration All Phase-In Substances
1st June 1st June 1st December
30th November 31st
May 31st May 2007
2008 2008
2010
2013 2018
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REACh

• Registration Key Points
• Only a legal entity in the EU can register
  chemicals
• A non-EU manufacturer-
• Is not automatically an importer unless he has a
  registered company in the EU to import and
  register its substances
• Can appoint another legal entity in the EU to act
  as his Only Representative in fulfilling all
  the importers obligations
• Can leave it to individual (non-affiliated)
  importers to do their own individual
  registrations of his products

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REACh

• Registration Key Points
• Substances made by multiple EU manufacturers
  and/or imported by multiple importers will have
  multiple registrations (1 registration for each
  manufacturer/importer)
• A Registration remains proprietary to the
  registering company
• Substances manufactured and registered in the EU
  and exported to a non-EU company need not be
  registered again when imported back into the EU

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REACh

• Pre-Registration Phase-in Substances
• Pre-Registration is very important it allows a
  manufacturer/importer to continue supplying an
  existing substance up until its registration
  deadline
• Pre-registration is an indication of intent, not
  a commitment, to register
• Manufacturers need to pre-register all substances
  produced
• Importers need to pre-register all non-EU
  manufactured substances imported, including all
  substances in mixtures/preparations

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REACh

• Pre-Registration Phase-in Substances
• Information needed for Pre-registration-
• Substance name/identification
• Potential registrant details (or 3rd party
  representative)
• Deadline for registration (depends on tonnage)
• Information on similar substances (for
  read-across)

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Implications for US Companies
Simple Example
Apple Additives Inc.
Sun Additives Inc.
Apple Additives Europe
?
?
Additive Mars Moon Star
Additive Pear Orange Lemon
Acme Oil EU
Acme Oil Inc.
?
?
?
Product Acme MWF
??

• Sun Additives Inc. makes Additive Mars and
  supplies it to Acme Oil Inc.
• Apple Additives Inc. makes Additive Pear and
  supplies it to Acme Oil Inc.
• Additive Mars contains components Moon Star
  Additive Pear contains Orange Lemon
• Acme Oil Inc. mixes Additive Mars and Additive
  Pear to make Product Acme MWF
• Acme Oil Incs affiliate, Acme Oil EU, imports
  Product Acme MWF and supplies it to end users

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Implications for US Companies
Simple Example
Apple Additives Inc.
Sun Additives Inc.
Apple Additives Europe
?
?
Additive Mars Moon Star
Additive Pear Orange Lemon
Acme Oil EU
Acme Oil Inc.
?
?
?
Product Acme MWF
??

• Sun Additives Inc. cannot register Moon Star
  because it is not a Company in the EU
• Apple Additives Inc. cannot register Orange
  Lemon because it is not a Company in the EU
• Apple Additives Europe cannot register Orange
  Lemon for Apple Additives Inc. either because it
  is not the manufacturer/importer of the
  substances Orange Lemon

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Implications for US Companies
Simple Example
PRODUCT Acme MWF Total Registration Cost for Acme
Oil EU Qty
4 substances 1 10
tonnes/yr each component
48,000 10 100 tonnes/yr each component
460,000 100 1000 tonnes/yr each
component 1,150,000
Apple Additives Inc.
Sun Additives Inc.
Apple Additives Europe
?
?
Additive Mars Moon Star
Additive Pear Orange Lemon
Acme Oil EU
Acme Oil Inc.
?
?
?
Product Acme MWF
??

• Acme Oil EU has to register substances Moon,
  Star, Orange, and Lemon
• To do this, Acme Oil Inc. has to get the full
  composition details of Additive Mars and Additive
  Pear from it suppliers and pass it to Acme Oil EU

confidentiality
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Implications for US Companies
Apple Additives Europe now makes Additive Pear
for Apple Additives Inc.
PRODUCT Acme Oil Total Registration Cost for Acme
Oil EU is now Qty
2
substances 1 10 tonnes/yr each component
24,000 10 100 tonnes/yr each component
230,000 100 1000 tonnes/yr each
component 575,000
Apple Additives Inc.
Sun Additives Inc.
Apple Additives Europe
?
Additive Pear Orange Lemon
?
?
Additive Mars Moon Star
Additive Pear
Acme OIL EU
Acme OIL Inc.
?
?
?
Product Acme Oil
??

• Sun Additives Inc cannot register Moon Star
  because it is not a Company in the EU
• Apple Additives Europe has to register Orange
  Lemon as the EU manufacturer
• Acme Oil EU now only has to register substances
  Moon Star
• To do this, Acme Oil Inc. still has to get the
  full composition details of Additive Mars from
  its supplier and pass it to Acme Oil EU

confidentiality
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Implications for US Companies

• Prepare For Pre-registration (Phase-in
  Substances)
• Identify the substances and products you use /
  distribute / manufacture that are traded in the
  EU identify data gaps
• Consider whether any of these substances may be
  substances of very high concern that could be the
  subject of authorization
• Start establishing communications channels with
  your suppliers your customers in the EU
• Discuss approaches to be taken in relation to
  registration and information sharing

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Implications for US Companies

• Prepare For Pre-registration (Phase-in
  Substances)
• Non-EU manufacturers need to be prepared to
  provide detailed information on substances
  contained in their products so that EU-based
  importers can comply with their obligations
• Analyze commercial implications of REACH
• Familiarize yourself with the thousands of pages
  of official guidance that are being developed so
  you can follow them where they are relevant to
  your business

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REACh Reaction Products

• Reaction Products in Metalworking Fluids
• A complex area
• In-situ reaction products are normally
  registerable
• There are some exemption criteria for incidental
  reactions
• Uncertainty over relevance to neutralisation of
  fatty acids
• Chemistry is often complex with several different
  salts produced
• UKLA have developed a set of criteria to assess
  exemption status
• Endorsed by UEIL
• Not prescriptive, responsibility remains with
  manufacturer
• Ongoing

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REACh Reaction Products

• Reaction Products in Greases
• Range of reaction products is more limited
• Soaps are intentionally formed and are essential
  to the structure
• No uncertainty about the need to register
• Consortium has been formed to help with
  registration
• Many complex legal issues, but making progress
• Each company shares costs for data sets relevant
  to them

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REACh

• How China is Helping Its Manufacturers
• Chinese government has set up an office (CCCMC)
  in Helsinki to act as the Only Representative
  for Chinese manufacturers
• CCCMC is reported to have 4000 member Chinese
  companies
• CCCMC will undertake REACH registrations for
  Chinese firms and will protect their legitimate
  interests
• All Chinese manufacturers of the same chemical
  substance will be able to benefit by sharing a
  single registration
• China Chamber of Commerce of Metals, Minerals
  Chemical Importers and Exporters

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GHS

• Implementation timetable of GHS in the EU
• Complicated will result in a mixture of
  classifications and labels up until 2015
• Timetable - different rules for substances and
  mixtures
• Dual classification system for substances
  mandatory from 2010 to 2015

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GHS
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Other MWF Related Issues
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Short Chain C10 - C13 - SCCPs
Mandatory Labelling for all SCCPs R40 (Category
3 Carcinogen) R50/53 (Dangerous for the
Environment). Not allowed in MWFs.
Cancer label mandatory only for C12, 60
Chlorine. Some suppliers may voluntarily label
other SCCPs. All SCCPs subject to Toxic Release
Inventory requirements.
All SCCPs declared as Toxic. All SCCPs subject
to National Pollution Release requirements.
OSPARCOM EUROCHLOR
Agreed to phase out SCCPs in MWFs by 2000
No longer used within European Metalworking Fluid
Industry
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Medium Chain C14 - C17 - MCCPs
Imminent Mandatory Labelling. Voluntary
environmental labelling in the UK. Awaiting final
ratification for mandatory EC Classification
Cancer label not required. Not subject to Toxic
Release. US suppliers seem to be adopting
environmental classification for international
transport
Proposal to include ALL chlorinated paraffins as
Toxic.
EUROCHLOR
Partial agreement on voluntary environmental
labelling
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Medium Chain C14-17 - MCCPs Labelling
Mandatory labelling proposal currently being
discussed. Environmental labelling R64 May
cause harm to breast-fed babies.
Generic Oil Comp.London, UK Tel. [phone]
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Long Chain C18 - LCCPs
No current Mandatory or Voluntary Labelling. Some
calls for more detailed risk assessments/studies.
Cancer label not required. Not subject to Toxic
Release Inventory requirements.
Proposal to include ALL chlorinated paraffins as
Toxic.
EUROCHLOR
No labelling issues currently being considered
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Boric Acid / Borates

• Mandatory Labelling Proposal
• Category 2 Reproductive Toxin
• Possible implementation date is late 2009
• ONLY APPLIES to BORIC ACID, boric oxide and 3
  specific inorganic borates (including borax)
• ONLY APPLIES if products contain 5.5 or more of
  BORIC ACID (the boric oxide/prescribed borates
  have different s)
• DOES NOT APPLY to other boron compounds (e.g.
  borate esters) or products containing less than
  5.5 unreacted boric acid

• Industry has strongly contested any
  classification on the basis that the animal test
  results are not relevant to humans - a need to
  include consideration of normal handling and use

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Boric Acid / Borates
7000
Rat NOEL Reversible Testicular Effects (7000 mg
boric acid)
Rat NOAEL Reversible Developmental Effects (3300
mg boric acid)
Human LOAEL Vomiting and Diarrhoea Effects
(2000 mg boric acid)
Maximum possible human exposure (occupational
exposure - 162 mg boric acid)
Intake from litre of wine (25 - 35 mg boric acid)
Average daily intake from diet (6 -17 mg boric
acid)
Maximum dermal exposure (4 mg boric acid)
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Boric Acid / Borates

• Effects will not occur under normal handling and
  use
• No effects on reproduction in US Borax Mine and
  Production workers, the highest known
  occupationally exposed workers (to total borate
  dusts of 19.7 mg boric acid/m3). Estimated
  exposure (from blood and urine) was 162 mg boric
  acid/day (28 mg B/day)
• No effects on reproduction in a Turkish
  population exposed occupationally and to
  naturally high boron levels
• Physical properties prevent high dust levels
  forming - dusts are visible at 10 mg/m3
• Dermal absorption is extremely low in humans
  0.266 0.125 boric acid

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Formaldehyde

• International Agency for Research on Cancer The
  World Health Organisation
• Reclassified Formaldehyde from
• Group 2A (probably carcinogenic to humans)
• to
• Group 1 (known human carcinogen)
• Possible Consequences
• Classification labelling - discussion started
• More stringent workplace controls
• Restrictions on use

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Formaldehyde

• Metalworking Fluids
• In many countries, Formalin (formaldehyde
  solution) is not used in MWFs
• Large proportion of MWFs are protected by
  biocidal actives that are formaldehyde
  releasers
• Many MWF formaldehyde release biocides are
  defined discrete chemical molecules with their
  own toxicological data packages
• Effect of more stringent workplace controls
  impact observed in French marketplace

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BPD - Product Authorisation Scheme

• Biocidal actives and biocidal preparations
• Metalworking Fluid Preservatives ARE included
• Metalworking Fluids themselves ARE NOT generally
  included
• Biocidal System Cleaners/Treatments ARE included
• Manufactured Biocidal Actives being dealt with
  first
• Prescribed timetable for authorisation according
  to type
• 2007 start of review of MWF biocidal actives
• 2008 - 2009 completion of review of MWF biocidal
  actives
• From 2008 ? PREPARATIONS need to be registered
  or withdrawn as and when the actives in them
  complete their review

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In Summary

• REACh
• Overview
• Implications for USA Suppliers
• MWF Reaction Products
• GHS
• Other MWF Related Issues
• Chloroparaffins
• Boric Acid
• Formaldehyde
• BPD

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Thank you for your attention
For further information please visit www.polartec
h.com or contact rstubbs_at_polartech.com
Design by Peter Richards Content by Roy Beardmore
Rob Stubbs