Nigel Sarginson_PVC Plasticizers Global Regulatory

Vinyl SA 2014
October 22, 2014
PVC Plasticizers: Global
Regulatory Developments and
Implications for the Future
Nigel Sarginson, Reach, Product Stewardship and Regulatory Affairs
This presentation includes forward-looking statements. Actual future conditions (including economic conditions, energy demand, and energy supply) could differ materially due to changes in technology,
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www.plasticisers.org
Wide Range of Benefits to Society
Safely and cost effectively
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Benefits of Flexible PVC
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•
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•
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Durability and long life of products made with flexible PVC
Energy Efficiency
Electrical Safety
Physical Safety
Lifesaving equipment and devices
Hygiene and prevention of bacterial infections
Easy and low cost maintenance
Environmental and resource conservation
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Flexible PVC stands for:
•Performance (Durability)
•Value (Cost effectiveness)
•Conservation (Resources, Environment)
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EU and Member State Regulation
Member States drive the REACH process and have own initiatives
French National
Endocrine Strategy
Danish National
Phthalates Strategy
Swedish Non-toxic
Environment Strategy
REACH Candidate List and Authorisation
Producers
REACH SVHC Roadmap (ECHA ED Expert Group)
EU
Customers / Downstream users
REACH CoRAP Substance Evaluation
Brand holders
Other EU regulation: RoHS, Medical Devices, Toys, Food contact
Retailers / Consumers
Endocrine Disrupter Roadmap (Biocides/Pesticides) – Impact Assessment
Criteria
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Not all phthalates are the same
•
Low molecular weight (LMW)
High molecular weight (HMW)
DEHP, BBP, DBP
C3 to C8 alcohol + Phthalic Anhyd.
Cat 1B Reproductive Agents
Risk reduction required
REACH Candidate List
Fertility effects
Likely Endocrine Disrupters
DINP & DIDP
C9 & C10 Alcohol + Phthalic Anhyd.
Not CMR
Not classified and labelled
No risk reduction required
Not Endocrine disrupters
PVC+DINP, DIDP: safe, flexible, durable, cost effective, can be recycled
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ECHA recommends Authorisation for DEHP for three
companies to supply for PVC applications
• September 2014 – ECHA Risk Assessment and Socio-Economic
Analysis Committees are recommending Authorisation
• For DEHP supply for use in PVC applications
• Formulation of DEHP in compounds, dry-blends and plastisol formulations
• Industrial use in polymer processing by calendering, spread coating,
extrusion, injection moulding to produce PVC articles
• Except erasers, sex toys, small household items (<10cm) that can be
swallowed by children, clothing intended to be worn against the bare skin
• Existing restrictions in toys, cosmetics and mixtures for the general public
remain in place
• Three companies are Authorised to supply: Arkema, Zak and Deza
• Time limited 4 years: Re-authorisation required in 2019
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ECHA recommends Authorisation for recycling for three
companies
• Formulation of recycled soft PVC containing DEHP in compounds and
dry-blends.
• Industrial use of recycled soft PVC containing DEHP in polymer
processing by calendering, extrusion, compression and injection
moulding to produce PVC articles
• Seven year Authorisation period. Re-authorisation required in 2022.
• Three companies: Vinyloop Ferrara, Stena Recycling and Plastic
Planet.
• European Commission to officially confirm all Authorisations
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DINP and DIDP are safe for use
in all current applications
ECHA concludes that DINP and DIDP are
safe for use in all current applications (*)
In-depth evaluation of all hazard and
exposure data during a four year process
•
Review of all available studies regarding DINP
and DIDP
Public consultation and RAC (Risk Assessment
Committee) opinion on the draft report
Final Report of 370 pages
“No additional risk management measures are
needed to reduce the exposure of children and
adults to DINP and DIDP” (**)
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European Commission confirms ECHA
conclusions (Jan 2014)
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(*) “Evaluation of new scientific evidence concerning DINP and DIDP (In
relation to entry 52 of Annex XVII to REACH Regulation (EC) No 1907/2006),
Final Review Report August 2013.”
“Absence of any further risks”
“Tasks called for by the review clause are
satisfied and fully completed.”
(**) While maintaining existing precautionary restrictions for toys that can be placed in
the mouth
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Mature regions shift to High Molecular Weight
kTa
2000
Other
plasticizers
1500
Other
phthalates
LMW
1000
HMW
500
0
USA and Western Europe plasticizer consumption
Source: IHS Chemical Economics Handbook 2013 report - Plasticizers
Regulatory Scrutiny of Other Plasticisers
• REACH Substance Evaluation Process
• CoRAP – Community Rolling Action Plan
• Three year rolling plan / Updated annually
• Member States take the lead
• Plasticisers included
• DEHA / DPHP / DIUP / DTDP / L911P / L11P
• French National Endocrine Strategy
• DINCH and DOTP being evaluated (re: replacement
of classified LMW phthalates)
• US CPSC CHAP recommending evaluation of other
plasticisers
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Regulatory Developments in the
US and Asia
• US TSCA – development of reference doses (safe limits)
• US CPSC CHAP report – evaluation of plasticisers in toys
and childcare articles
• LMW phthalates restricted in all toys and childcare articles
• Recommending that restrictions on DIDP be lifted
• Recommending that restrictions on DINP in toys and
childcare articles be maintained
• Recommending evaluation of other plasticisers
• California Proposition 65
• Australia’s NICNAS evaluations – DINP safe for use in all
toys and childcare articles
• China – toy regulation, ecolabels for articles
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REACH – SVHC 2020 Roadmap
• Intent is to give some predictability to companies as to which
substances will be included in the REACH Candidate List
• Substances of Potential Concern included in a list for a Risk
Management Options Analysis
• 80 substances on first list – for which Member States are carrying
out Risk Management Options Analysis – can lead to proposals for:
• REACH Candidate List
• Restriction
• Classification and Labelling
• Occupational Exposure Limit
• No action
• DINCH and DOTP included on the list with France responsible for
RMOA
• http://www.echa.europa.eu/web/guest/addressing-chemicals-of-concern/substances-of-potentialconcern/svhc-roadmap-implementation-plan/pact
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Global Regulatory Developments –
Conclusions and Implications
• REACH represents a paradigm change for the supply
chain
• All key substances will be subject to regulatory scrutiny
• Other regulations around the globe requiring substance
evaluations
• Substances which have been reviewed by regulators
and found to be safe, offer security for the future
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Shaping Tomorrow Together
FLEXIBLE VINYL VALUE CHAIN
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