Plasticizers Regulatory Update

February 2014

Scott Boito

Eastman Chemical Company

2014 2013 2015 2012

CPSC DINP, DIDP,

DnOP Interim Ban

decision based on

CHAP delayed

until 2014

EPA Chemical

Action Plan

DEHP, DBP, BBP,

DIBP, DIDP, DINP,

DnPP, DnOP

Adoption delayed

US and EU Plasticizer Regulatory Timeline

REACH DEHP, DBP,

BBP, DIBP

Non-authorized

SVHC “Sunset”

OSHA

CLP GHS

Classification

& Labeling

mandatory

EPA DfE DEHP, DBP, BBP,

DIBP, DIDP, DINP,

DnPP, DnOP

Design for the

Environment

Alternatives

Assessment

EPA EDSP

DOP test

orders due

FTC

“Green

Guides” released

“Phthalate-free”

defined

EPA EDSP2

Tier 1 testing

of DOP from

2014 to 2016

ECHA CoRAP evaluations

Di-C9-11P, DnUP, Di-

C7-9P, DUP, DEP, Di-

C11-14P

WHO/UNEP Endocrine

Disruptors

report DINP included

Danish EPA

and MOH DEHP

alternatives

review in

Medical Devices

California Safer Consumer

Products

Regulations A REACH-like

regulation

ECHA Confirmation

of ban on

DINP and

DIDP in toys

Walmart “Retailer

Regulation”

to force out

several

chemicals in

products

California DINP

added to

Prop 65 list

ECHA CoRAP

evaluation DPHP

DEHP has the most immediate limitations in the market.

1. Identified as an SVHC under REACH.

2. Currently in the “Authorization” process a. We expect very few exemptions (authorized uses) to be approved after

Feb 2015.

b. Medical devices are the biggest exception due to different regulations covering them.

3. Identified as an Endocrine Disruptor in Europe and we are awaiting test orders under TSCA for the EDSP here.

4. Introduced to California Prop 65 in 1988.

5. Consumption in Europe is down to about 20% of peak in 1998, and US consumption is falling annually.

DEHP Activities

DINP is coming under increased scrutiny.

1. World Health Organization identified DINP as an endocrine disruptor in their Feb 2013 report.1

2. Danish EPA identified DINP as an endocrine disruptor in their Phthalate Strategy report in July 2013.2

3. ECHA reaffirmed the ban on DINP in childhood articles late 2013. 3 US CHAP report expected to confirm the same in 2014.

4. California listed DINP on Prop 65 on 20 Dec 2013.4

5. Danish EPA has spoken publicly about nominating DINP to the CoRAP list in 2014 for evaluation as an SVHC.

6. European and US flooring companies are running away from DINP as a result of those issues.

DINP Activities

DPHP was flying under the radar until October 2013 when it was nominated to the CoRAP list for evaluation in 2016 by Germany. Can’t find the reasoning, though, since it’s not “classified” under the new

GHS rules.

We are not aware of any issues with the toxicity of DPHP, but the CoRAP evaluation will be key.

DPHP Activities

DEHT has been evaluated as a DEHP alternative in medical devices by the European SCENIHR committee twice.5

Updated report to publish in March.

DEHT has been evaluated as a DEHP alternative in medical devices by the Danish government.6

Report to publish in March.

DEHT has been independently evaluated under the GreenScreen alternatives assessment protocol as an alternative to phthalates and it received the highest score of all evaluated plasticizers.7

DEHT will be evaluated as a replacement for DEHP in medical tubing and bags under the European Pharmocopoeia in 2014.8

DEHT is already being used in some medical devices.9

DOTP (DEHT) Activities

REACH – View of Phthalate Plasticizers

Phthalate Esters: Alkyl Group Carbon Number

C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 C13

DMP DEP DMeOEP DBP DPP DnHP DiHP DEHP DINP DIDP DUP DTDP

CoRAP SVHC SVHC SVHC SVHC SVHC SVHC CoRAP

DiBP DPHP

SVHC CoRAP

DAP BBP PIPP DHNUP (C7-C11)

CoRAP SVHC SVHC SVHC

DIPP C6-C8, C7 Rich C9-C11

SVHC SVHC CoRAP

Benzyl C7-C9 C11-C13

CoRAP CoRAP

Where is DEHT?

We cannot see DEHT appearing on this list because it has

been shown not to be an SVHC or an endocrine disruptor.

Chemical Alternatives Assessments

These assessments are being used and cited more frequently by NGOs promoting substitutions of “toxic” chemicals with safer alternatives.

In every case they are only considering hazard – not exposure – because that’s easier and it meets their goals.

The good news for Eastman 168TM is that it looks very good in the phthalate-alternatives group. Currently ranking a 3DG out of 4 using the GreenScreen protocol,

highest of all evaluated plasticizers in the GC3 project.

Dinch at 2 and DINP at 1.

GC3 Report on Phthalate Alternatives

Back up slides

REACH Update

REACH: Registration, Evaluation, Authorization of CHemicals in the EU.

REACH Currently has 152 Chemicals identified as SVHC candidates (including 11 phthalates) The next step would be to “promote” verified SVHCs as Candidates for

Authorization under Annex XIV of REACH (14 on the authorization list so far).

ECHA stated recently that they see about 440 total SVHC candidates proposed by 2020.

Authorization application deadline for DEHP, DBP, DIBP, and BBP was August 2013. “Sunset” (ban) date for non-authorized uses is February 2015. ECHA released most of the dossiers in Nov.

No reason to expect any major authorizations as a result.

ECHA ban on DINP and DIDP in toys

Late-August 2013 ECHA confirmed that the ban on use of DINP and DIDP in toys and childcare articles is permanent.1

They performed an open review of the ban from 2008 and accepted comments and reviewed the latest data and studies.

Ultimately they stated that adverse effects from exposure to young children by mouthing items containing DINP and DIDP could not be ruled out, so the ban was confirmed.

One of our largest global customer’s R&D rep said this: “The train has left the station for DINP and DIDP”.

World Heath Organization (WHO)

Issued updated Endocrine disruptors report in February 2013.2

Report includes DINP in the list of phthalates suspected to be endocrine disrupting chemicals (EDCs).

Table 2.1 shows effects on different organs, etc.

Nothing distinguishes which effects are from which phthalates.

Danish EPA Phthalate Strategy

Denmark is continuing to push the boundaries in Europe, even defying ECHA’s RAC and SEAC to move forward with the ban on 4 phthalates in 2015 for all uses except medical.

They recently published their strategy document outlining where they will be pushing.3

DINP named as an Endocrine Disruptor at high exposure levels.

Early 2014 they are finalizing their review of DEHP alternatives in medical devices. 10 identified alternatives and again Eastman 168 appears to be one of

the best alternatives.

Their goal is to be able to push phthalates out of medical devices sooner than the current 2020 timeframe for the rest of EU.

SCENIHR DEHP in medical devices review

Related to both the faux-Life Cycle Analysis from the NGO “PVCfreeBloodBag” and the upcoming review of DEHP for Authorization under REACH.

I expect the SCENIHR review to show positive results for DEHP in most medical applications, but reiterating their 2008 conclusion (similar to FDA’s) that “at-risk” populations should be supplied with non-phthalate or non-PVC alternatives. Several alternatives were evaluated in their 2008 report.4

New draft report due out in March 2014 (revised).

European Pharmacopoeia

There was a data call-in late last year for suggestions to replace DEHP in blood bags, IV bags, and IV tubing. Related to the SVHC status of DEHP.

The review process is well behind schedule, so actual updates to EP are at least a year away.

DEHT and Dinch will be evaluated as replacements for DEHP in these applications.

Under the 2008 CPSIA law, DEHP, DBP, and BBP were permanently banned for toys and childcare articles.

DINP, DIDP, and DnOP were temporarily banned for use in toys and childcare articles, subject to further review.

The CHAP is performing that review and an alternatives assessment for all six of the phthalates.

Report expected sometime in early-2014 and expected to permanently ban DINP for toys and other children's products.

Updates from June 2013 indicate some movement but no official timelines have been given. In the internal peer-review process now.

Publication in 2014 is probable.

CPSC Chronic Hazard Advisory Panel (CHAP)

References

1. WHO State of the science of endocrine disrupting chemicals - 2012, as viewed on 3 September 2013.

2. Danish EPA Phthalate Strategy, as viewed on 3 September 2013.

3. Evaluation of new scientific evidence concerning DINP and DIDP, as viewed on 3 September 2013.

4. Chemical Listed Effective December 20, 2013 as Known to the State of California to Cause Cancer: Diisononyl Phthalate (DINP), as viewed on 31 January 2014.

5. The Safety of Medical Devices Containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk, as viewed on 31 Jan 2014.

6. Danish EPA Evaluates Alternatives to DEHP in Medical Devices, as viewed on 31 January 2014.

7. Chemical Hazard Assessments of Alternative Plasticizers for Wire & Cable Applications, as viewed on 31 January 2014.

8. Pharmeuropa 25.1, Reference: PA/PH/Exp. 16/T (10-11) 10-15 ANP, as viewed on 31 January 2014.

9. The New Formula, as viewed on 31 January 2014.

Glossary

REACH – Europe’s Registration, Evaluation, and Authorization of Chemicals.

ECHA – European Chemicals Agency enforcing REACH.

CoRAP – Community Rolling Action Plan (the Evaluation part of REACH).

Authorization – Under Reach, the mechanism to try to exempt a substance’s use from a ban.

SVHC – Substance of Very High Concern

EDSP – US EPA’s Endocrine Disruptor Screening Program.

Thank You!

Any Questions?