Phthalate Plasticisers : Update on Eco-profiles /Perceptions

1
Phthalate Plasticisers Update on Eco-profiles
/Perceptions

• David Cadogan
• VinylSUM
• Loughborough University
• 11 May 2006

2
Outline

• Ecoprofiles Risk assessments and risk reduction
• New legislation - Toys, food contact materials,
  medical devices
• Trends in plasticiser consumption
• Summary

3
Risk Assessments / Risk Reduction

• DBP, DINP and DIDP Risk Assessments and Risk
  Reduction Strategies published in Official
  Journal on 13 April 2006
• Human health risks
• DBP No consumer risks including cosmetics. Risk
  to workers assuming worst case exposure OEL to
  be set by SCOEL
• DIDP Theoretical risks for children via toys
  Toy legislation
• DINP No risks in any current use Toy
  legislation due to difference of opinion between
  RAR and CSTEE
• Environmental risks
• DBP Possible risk to vegetation near some
  processing plants - Extra monitoring data on
  exhaust air
• DINP and DIDP No risks

4
Risk Assessments / Risk Reduction

• DINP and DIDP - Two versatile high volume
  phthalates
• Finally perceived as being Risk Free following
  revision of legislation for use in toys
• For both health and environmental effects
• Can be used in all applications except toys and
  childcare articles which can be put in the
  mouth
• Not hazardous - not classified CMR or Dangerous
  to the Environment
• Large shift in consumption to DINP and DIDP

5
Risk Assessments / Risk Reduction

• BBP and DEHP risk assessments to be completed via
  written procedure during Q2-3 2006. Publication
  in 2006
• Human health risks
• BBP few, if any, risks anticipated
  Consumption falling rapidly
• DEHP
• Workers OEL needed
• Children via toys New legislation
• Haemodialysis and long term transfusion in
  children / neonates - Request opinion of expert
  medical committee
• DEHP Possibly children living near some
  processing plants Agree Marketing and Use
  Directive to control DEHP emissions

6
Risk Assessments / Risk Reduction

• Environmental risks
• BBP Possible risk to water and sediment near
  processing plants - Fish study and processing
  plant emission data
• DEHP Risks only seen for default emission levels
  from hypothetical plants. No risks when using
  real emission data which are 1000 times lower.
• General population via the environment - Kemi
  want to ban DEHP in all outdoor applications.
  Commission not convinced no risk identified.
  Biomonitoring shows no risks to man at regional
  level

7
Total Human Exposure - Biomonitoring

• Using latest, most reliable conversion factors
  (Angerer 2004)
• The 95th percentile DEHP exposure levels are
• 17µg/kg bw/day 85 German subjects aged 7-64 (Koch
  et al, 2003)
• 9.5µg/kg bw/day 2772 US subjects aged gt 6 (US CDC
  2005)
• 10 µg/kg bw/day 305 UK subjects aged 18-70
  (Anderson et al 2001)
• DEHP may pose a risk in certain scenarios but in
  general no sweeping reduction of DEHP usage is
  needed
• Using the highest exposure the MOS for the
  various effects range from 280 to 1700

8
Outdoor Emissions - Misperceptions

• Emissions from outdoor articles based on long
  term studies on roofing sheets
• Emissions from other materials estimated by
  adjusting for thickness, surface area and service
  life. Very reliable
• Biodegradation occurs at surfaces - especially
  buried cables
• Very little difference between level of emissions
  from indoor and outdoor applications
• Least reliable assumption high level of abraded
  particles with plasticiser freely available. Six
  times the emissions from articles in use. This
  leads to call for ban on DEHP in outdoor uses.

9
Toys and Childcare Articles

• Permanent measures agreed by Parliament in July
  2005, ratified by Council on 22 November and
  published in the Official Journal on 27 December
  2005
• DBP, BBP and DEHP banned in all toys and
  childcare articles
• DINP, DIDP and DNOP banned in toys and childcare
  articles which can be put in the mouth
• National legislation to be enacted from 16
  January 2007
• Entirely political decision ignoring science
  based risk assessments
• A range of alternative plasticisers available
  citrates, etc.

10
Food Contact Materials

• New legislation is expected to come into force in
  the EU during Q4 2006
• EFSA Scientific Panel has re-examined the
  phthalate toxicity data and published TDI values.
  DBP reduced by a factor of 5. Others not changed.
• Two types of phthalate applications under
  discussion
• Repeat use (hoses, tubing, conveyer belts etc)
• Single use (cap seals and closures)
• DEHA and polymeric plasticisers will continue to
  be used in a wide range of food contact
  applications

11
Food Contact Materials

• In practical terms the new legislation will mean
• Repeat Use
• BBP, DINP and DIDP all food types SML based
  on full TDI
• DEHP only aqueous SML based on 50 TDI
• DBP - only aqueous SML based on 50 new TTDI -
  too low
• Single Use
• BBP, DINP and DIDP aqueous only SML based on
  full TDI
• DEHP - only aqueous SML based on 50 TDI -
  gradual phase out
• Phthalates may continue to be used as technical
  support agents in polyolefins for contact with
  all foods provided they meet residual
  concentration and SML requirements.

12
Medical Applications

• SCMPMD Opinion of September 2002 concluded that
  no specific recommendation could be made to limit
  the use of DEHP in any particular patient group
• We must await the Opinion of the new Scientific
  Committee on Emerging and Newly Identified Health
  Risks (SCENIHR) mid 2006
• It is possible that the three applications which
  pose a risk according to the DEHP RAR will move
  from DEHP to alternatives such as ATBC, DINCH,
  trimellitates or polymeric plasticisers.
• However this sector is conservative and reluctant
  to change away from plasticisers which have given
  no adverse effects in patients

13
European Plasticiser Consumption - Trends
1999
2005
Source ECPI, 2004
14
Plasticisers The Way Forward

• The family of phthalates satisfy the performance,
  health and safety requirements of the vast
  majority of applications.
• Classification and labelling has resulted in a
  move to DINP and DIDP
• Alternatives to phthalates already exist or are
  being developed for certain applications
• Food contact materials, medical devices, toys and
  childcare articles
• Low migrating plasticisers polymerics and
  trimellitates
• Lower animal toxicity adipates, citrates,
  terephthalates, DINCH, acetylated glycerol esters

15
Summary

• Risk assessments finally published DINP and
  DIDP
• Biomonitoring data very helpful in risk
  assessment and reduction
• New legislation and classification causes move
  away from hazardous plasticisers to continue
• There will be moves to new plasticisers in
  certain applications
• There is still a very strong future for flexible
  PVC

16
Adverse Effects on Human Health

• ECPI position is
• No evidence of any phthalate having an adverse
  effect on human health
• 20 year follow-up study on 242 low birth weight
  individuals (high DEHP exposure in intensive
  care) showed no effects on male fertility
• Adolescents exposed to DEHP via ECMO as neonates
  show no adverse effects on growth or sexual
  maturity
• Adverse effects are only seen in rodent studies
• Adverse effects not seen in non-human primates
• However - There are now two studies claiming to
  see effects in humans

17
Swan et al, EHP, May 2005

• Looks for link between anogenital distance (AGD)
  in male infants and level of mothers exposure to
  phthalates during pregnancy
• First attempt to make such a link in humans hence
  few historical data and no established procedures

18
Swan et al, EHP, May 2005

• Level of maternal phthalate exposure
• Only one urine sample taken at variable times
  late in pregnancy
• Measure levels of phthalate breakdown products in
  urine
• Studies by Hauser et al (2004) and Hoppin et al
  (2002) indicated that repeated measurements are
  necessary

19
Swan et al, EHP, May 2005

• Measurement of AGD in boys
• Poor planning. AGD changes rapidly with age but
  they measured at ages ranging from 2 28 months
  therefore need extensive regression analysis
  may be the cause of the variation in AGI.
• This is the second published study. In first one
  (Salazar-Martinez et al, 2004) 45 boys measured
  at 6 hours old. No regression analysis needed.

20
Swan et al, EHP, May 2005

• Authors attempt to make their case stronger than
  it is
• Authors claim correlation between AGI and
  metabolites of DEP, DBP, DIBP and BBP.
• No correlation with MEHP but weak correlation
  with secondary metabolites of DEHP - not logical
• Strong correlation with MEP contrary to many
  other studies
• Statistical Assessment Service (STATS) say that
  no phthalate had a statistically significant
  correlation between metabolite level in mothers
  urine and low AGI in the baby.
• US NTP panel of 11 toxicologists requested more
  data from Swan but it was not available and they
  have concluded that the findings are unsound

21
Main et al, EHP, September 2005

• Investigate link between phthalate levels in
  breast milk and undescended testes / reproductive
  hormone levels in male infants
• No correlation between undescended testes and
  phthalate levels
• A link proposed between some phthalate
  metabolites and some hormone levels
• Independent statisticians agree that there is no
  real correlation.
• The authors discount results which do not fit
  their hypothesis as being random findings
• The lack of a link between MEHP and hormone
  levels is said to be due to the limited number
  of samples in the study

22
Main et al, EHP, September 2005

• Main study - summary
• Independent statisticians agree that there is no
  real correlation.
• Study rejected by EU Member States Experts in
  DEHP Risk Assessment
• US CERHR Expert Panel concerns
• Hormone ratios not relevant
• Incorrect statistical treatment
• Confounding factors not addressed
• Contamination via breast pumps