CPSC Testing Burden Reduction Workshop

April 3, 2014 | Rockville, Maryland

Proposals and Rationales for Exemptions from 

Phthalate Certification Testing

Presented by: 

Alan P. Kaufman

Senior Vice-President, Technical Affairs
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Toy Industry Association (TIA)

 Trade association for North American-based manufacturers, importers, 

licensors and toy retailers (regular members)

 Associate members include inventors, designers, testing labs

 Formed in 1916

 Long History of Dedication to Child Safety

 Over 750 members

 Members represent approx 85% of the U.S. market
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Toy Industry Association

Toy Companies, Licensors, Inventors and Designers, Manufacturers Reps, Retailers
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A Snapshot of the U.S. Toy Industry

Average price of a toy is less than US$9.00

US$22+ Billion in direct toy sales (2013)

An estimated 3 Billion+ units sold each year

Estimated 512,775 FTE toy industry jobs in the United States

Total annual economic impact of US$69 Billion
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Overview

Industry is not seeking any relief 

regarding compliance, but only

relief from testing which does not 

advance safety
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Overview

 TIA has provided information to CPSC on this topic several 

times previously, but today will present proposals and 

additional data

• Proposal to revise definition of “accessible”

• Proposal to screen materials based on rigidity

• Proposal to test/exclude materials based on 

composition

• Rationale

– Evidence from process knowledge/process controls

– Evidence from review of material producer-supplied bills of 

substance

– Evidence from absence by test
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Proposal 1: Revise definition of “accessible” 

materials

 Current definition of accessibility based on 16CFR 

1500.48/49

 This test method developed for sharp point/edges based on 

ability to touch them

 Inappropriate for phthalates, where alleged hazard is oral 

exposure 

 Suggest language similar to ASTM F963 Heavy elements 

section: 

 Toys and parts of toys which, due to their inaccessibility, size, mass, function, or 

other characteristics, cannot be sucked, mouthed or ingested are not subject to 

this requirement.
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Proposal 2: Utilize rigidity as initial means to 

exclude materials from phthalate testing

 Phthalates are added to materials for plasticization, 

i.e. to make them flexible

 Rigid materials will not contain appreciable 

amounts of restricted phthalates

 Shore hardness is excellent proxy for rigidity 

 Propose exclusion of rigid materials, defining these 

as exhibiting Shore “A” Hardness of 90 or greater
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Why Even Some Flexible Materials Don’t Require 

Routine Testing: Considerations

– Most materials listed as not requiring routine testing utilize petroleum and/or natural gas as 

feedstocks; these will not contain regulated phthalates

– Polylactic acid produced from corn starch;

– Resin producers tightly control extraneous materials to assure quality and safe reactor 

operation 

– Polyolefins (polyethylene, polypropylene, polybutene, propylene-ethylene copolymers, 

ethylene-butene copolymers, ethylene-hexene copolymers, ionomers, et al) are flexible, but 

not through use of plasticizers; flexibility is obtained in polymerization by manipulating 

molecular weight and degree of branching of polymer chains, and selection of copolymers. 

Phthalates are not compatible/miscible with these materials

– Thermoplastic polyesters (PETE, PBT, PCT, PCTA, PCTG) are flexible, but despite the name, do 

not contain phthalates

– Styrenics (GPS, MIPS, HIPS, SHIPS, ABS, SBR) do not utilize plasticizers to obtain physical 

properties-this is accomplished by altering MW, alloying or copolymerizing with acrylonitrile 

and/or butadiene. Phthalates will attack and degrade these materials if present

– Some materials are plasticized (nylon 11/12, cellulosics), but not with regulated phthalates
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Proposal 3: Exclusions based on Composition

 Polyvinyl Chloride (PVC) - excluding rigid grades (>90 Shore 

“A” Hardness) – should be tested

 Thermoset polyurethane (excluding some foams) – should 

be tested

 Polyvinylidene Chloride (PVdC) - excluding rigid grades (>90 

Shore “A” Hardness) – should be tested 

 Chlorinated PVC (CPVC) - excluding rigid grades (>90 Shore 

“A” Hardness) – should be tested

 All of these materials are potentially plasticized with 

restricted orthophthalate esters
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Proposal 3 (cont): Materials which do not require 

certification testing

– Acetal/polyoxymethylene (POM) homopolymer 

– 1,3,5-trioxane, copolymer with 1,3-dioxolane (acetal/polyoxymethylene (POM) 

copolymer) 

– Acrylic (polymethylmethacrylate and polyacrylonitrile) 

– Acrylonitrile butadiene styrene terpolymers (ABS) 

– Butadiene-ethylene resins 

– Butene-ethylene copolymers 

– Ethylene copolymers 

– Ethylene acrylic acid copolymers 

– Ethylene-propylene copolymers 

– Ethylene vinyl acetate copolymers 

– Ethylene vinyl acetate vinyl alcohol copolymers 

– Ionomers 
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Proposal 3 (cont): Materials which do not require 

certification testing

– Polystyrene (crystal and general-purpose (GPS), medium-impact (MIPS), high-impact 

(HIPS), and super-high-impact (SHIPS) grades 

– Polytetramethylene glycol-dimethyl terephthalate-1,4-butanediol copolymer (polyester 

elastomer) 

– Propylene-ethylene copolymers 

– Silicone rubber (pure) 

– Styrene-butadiene copolymers 

– Styrene-butadiene-styrene rubbers (SBS/SBR) 

– Styrene-acrylonitrile copolymers (SAN) 

– Vinylidene chloride/methyl acrylate copolymers 

– CMYK Process Inks (exception: those applied to flexible substrates; inkjet inks)
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Proposal 3 (cont): Materials which do not require 

certification testing

– Liquid crystal polymers (hydroxybenzoic acid copolymers) 

– Nylon/polyamide 

– Olefin thermoplastic elastomers (such as EPDM) 

– Polybutene 

– Polybutylene terephthalate (PBT) 

– Polycarbonate 

– Polyethylene (LLDPE, LDPE, MDPE, HDPE and UHMWPE) 

– Polyethylene terephthalate (PET or PETE) and its variants: PETG (polyethylene 

terephthalate, glycol-modified); PCT (polycyclohexylene dimethylene terephthalate); 

PCTG (polycyclohexylene dimethylene terephthalate, glycol-modified); and PCTA 

(polycyclohexylene dimethylene terephthalate, acid-modified) 

– Polylactic acid 

– Polyphenylene sulfide 

– Polypropylene 
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Rationale: Test, BOM, and BOS Data

SUMMARY OF DATA:

– Testing for regulated phthalates (in some cases, for years) has found them to 

be absent in many plastic materials

– Additionally, TIA members have evaluated bills of material from toy suppliers 

and corresponding bills of substance supplied by resin producers for phthalate 

presence: 

• 600,000+ data points: Automated evaluations against a list of restricted substances 

including the six restricted phthalates -- plus eight additional phthalates (to confirm 

that currently unrestricted phthalates have not been substituted for restricted ones)

• Of the 600,000+ analyses, one or more of the 14 target phthalates were detected in 

samples in only 34 cases: once in phenol-formaldehyde thermoset resin, once in a 

non-polymer liquid formulation, and the balance in PVC.

– These data, in combination with knowledge of material and process, provide 

ample rationale for exemption from routine testing for phthalates
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Rationale: Test, BOM, and BOS Data (cont)

– Evaluated Phthalates:

CASRN Common name Acronym Total

28553-12-0 di-''isononyl'' phthalate DINP 14

117-81-7 bis(2-ethylhexyl) phthalate DEHP 8

84-74-2 dibutyl phthalate DBP 7

85-68-7 benzyl butyl phthalate BBP 4

68515-48-0 1,2-Benzenedicarboxylic acid, di-C8-10-branched DINP 1

117-84-0 dioctyl phthalate DnOP 1

131-11-3 dimethyl phthalate DMP 1

131-18-0 dipentyl phthalate DPP 0

68515-49-1 1,2-Benzenedicarboxylic acid, di-C9-11-branched DIDP 0

84-66-2 diethyl phthalate DEP 0

84-69-5 diisobutyl phthalate DIBP 0

84-75-3 dihexyl phthalate DnHP 0

26761-40-0 di-''isodecyl'' phthalate DIDP 0

3648-21-3 diheptyl phthalate DnHpP 0
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Rationale: Test, BOM, and BOS Data (cont)

CASRN Name Frequency

9003-56-9 ABS 84,919

9002-88-4 PE 56,333

9003-22-9 Pevikon/Bakelite (PVC/phenolic) 46,172

9002-86-2 PVC 46,138

9003-01-4 2-Propenoic acid, homopolymer (polyacrylic acid, carbomer, acrylates polymer) 37,366

24969-26-4 Copolymer of dioxolane and trioxane 34,723

9010-79-1 Ethylene/propylene copolymer 25,344

25054-06-2 Formaldehyde, polymer with cyclohexanone (phenol-formaldehyde resin) 20,741

25038-59-9 PETE 19,982

25608-33-7 Butyl methacrylate methyl methacrylate polymer 17,876

9009-54-5 Polyurethane foam 16,432

9003-55-8 1,3-Butadiene, polymer with styrene 15,270

9002-89-5 Polyvinyl Alcohol 11,595

24937-78-8 EVA 9,839

9003-07-0 PP 8,577

70955-45-2 Rosin, polymer with formaldehyde, glycerol, octylphenol and polymd. rosin 7,341

25038-54-4 Nylon 4,003

26160-89-4

Formaldehyde, polymer with 6-phenyl-1,3,5-triazine-2,4-diamine (benzoguanamineformaldehyde resin) 3,508

9010-94-0

2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, ethenylbenzene and 2-

propenenitrile (ABS-PMMA copolymer) 3,162

9011-14-7 2-Propenoic acid, 2-methyl-, methyl ester, homopolymer (polymethylmethacylate) 3,105

25085-34-1 2-Propenoic acid, polymer with ethenylbenzene (styrene/acrylic acid copolymer) 2,859

various 230 additional polymers 132,000

9004-34-6 wood/cellulose 4830
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Rationale: Test, BOM, and BOS Data (cont)

28553-12-0 PVC

28553-12-0 Phenol formaldehyde resin

117-81-7 PVC

68515-48-0 PVC

68515-48-0 PVC

68515-48-0 PVC

68515-48-0 PVC

68515-48-0 PVC

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

28553-12-0 PVC 

84-74-2 PVC

84-74-2 PVC

84-74-2 PVC

84-74-2 PVC

84-74-2 PVC

84-74-2 PVC

84-74-2 PVC

84-74-2 PVC

85-68-7 PVC

85-68-7 PVC

85-68-7 PVC

85-68-7 PVC

131-11-3 ingredient in non-polymer liquid formulation

117-84-0 PVC
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In Summary

 Accessibility determinations should reflect hazard

 Certain materials, as described here, should always be tested

 Other materials should be exempt from routine certification testing, 

as data from process knowledge and process controls, from review 

of bills of substance, and from evidence related to their absence in 

testing in over 600,000 cases (70,000+ unique materials) indicate 

that this is not necessary to assure compliance.

 Cost to industry to test these materials: $25million +

 Industry is not seeking any relief regarding compliance...but rather 

relief only from testing of certain materials -- which does not 

advance safety and is unwarranted given the nature of these 

materials and their use.
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Thank You!

 Questions?

Al Kaufman

(646) 520-4868

akaufman@toyassociation.org