Testing Services for Phthalate Esters
Phthalate ester plasticizers in consumer products are regulated in the U.S. primarily by the California Proposition 65 product labeling law and by the U.S. Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA) for children’s toys and childcare items. If you’re new to these regulatory programs, see the section below and our pages on CA Proposition 65 and Toy Testing.
Berkeley Analytical tests samples of solid and wet-applied materials and products for their content of regulated phthalate esters (please note that we do not test food, beverage, or dietary supplement samples). We provide phthalate ester testing services to manufacturers, importers, distributors, retailers and their representatives to meet a number of common objectives including:
- Proposition 65 litigation defense,
- Proposition 65 Safe Use Determination (SUD) studies,
- U.S. CPSC CPSIA compliance,
- Manufacturing quality control,
- Supply chain management, and
- Support of “Phthalate Free” product claims
Additionally, we conduct surface wipe testing of plastics for estimation of the migration of phthalate esters due to human contact. These migration studies are only performed under the guidance of the customer’s toxicology consultant in support of an exposure assessment.
Berkeley Analytical is:
- ISO/IEC 17025 Accredited for standard methods CPSC-CH-C1001-09.4 and U.S. EPA Method 8270E and Method 3545A used for the analysis of phthalate content;
- CPSC-Accepted laboratory authorized by CPSC to test children’s products for phthalates
- Annual participant in international inter-laboratory studies for content of phthalates in plastics
As a California laboratory and through our long involvement with Proposition 65, Berkeley Analytical has developed a network of highly qualified professionals who can address a variety of Proposition 65 questions that are beyond the scope of our laboratory testing services. We collaborate on a regular basis with a number of toxicologists and consultants who are knowledgeable with Proposition 65 exposure and risk assessments and who can assist companies in developing Proposition 65 compliance programs and testing strategies for phthalates and other Proposition 65 chemicals. One of the companies we collaborate with is Exponent, a multidisciplinary engineering and science consulting firm. Another is ToxServices, a specialized consultancy that focuses on toxicology, hazard, and risk assessments.
Other Semi-Volatile Organic Compounds (SVOC)
Our laboratory is equipped with state-of-the-art technology for accelerated solvent extraction and high sensitivity GC/MS analysis of a variety of SVOCs in solvent extracts. We apply these techniques and our accredited methods for the analysis of product samples of flexible seating foam, bedding and textiles for their content of halogenated organophosphate flame retardants, such as tris (1,3-dichloro-2-propyl)phosphate (TDCPP), tris (2-chloroethyl)phosphate (TCEP), and tris(2,3-dibromopropyl)phosphate, which are listed in Proposition 65.
Regulation of Phthalate Esters in the U.S.
California Proposition 65
The California Office of Environmental Health Assessment (OEHHA) maintains a Proposition 65 information website. One page is devoted to the six phthalates that are regulated either as chemicals known to cause reproductive toxicity or as carcinogens:
- Butyl benzyl phthalate (BBP) during pregnancy may affect development of the child.
- Di-n-butyl phthalate (DBP) during pregnancy may affect development of the child, and may also harm the male and female reproductive system.
- Di(2-ethylhexyl)phthalate (DEHP) may increase the risk of cancer, and may harm the male reproductive system. Also, exposure to DEHP during pregnancy may affect the development of the child.
- Diisodecyl phthalate (DIDP) during pregnancy may affect the development of child.
- Diisononyl phthalate (DINP) may increase the risk of cancer.
- Di-n-hexyl phthalate (DnHP) may harm the male and female reproductive system.
The requirement to label a product under Proposition 65 depends upon estimated consumer exposures relative to published Safe Harbour values rather than upon a product’s content of phthalates. This makes compliance to the regulation difficult other than by labeling of a product or by elimination of the phthalates of concern from a product.
The OEHHA site recommends avoiding plastics known as polyvinyl chloride (PVC) or vinyl (with recycle code 3) as one way to reduce exposures to phthalates. However, it fails to mention that many responsible manufacturers have switched to alternative PVC plasticizers that are not on Proposition 65 or other lists of highly toxic chemicals.
U.S. CPSC CPSIA Toy and Childcare Item Regulation
The U.S. CPSC administers the Consumer Product Safety Improvement Act (CPSIA), which imposes testing requirements and acceptable levels for lead and phthalate esters in consumer products designed for children, ages 0-12. The final version of the law that went into effect in 2018 prohibits the sale of children’s toys and child care articles that contain concentrations of more than 0.1 percent weight (1000 ppm) of the following eight phthalate esters, evaluated individually:
- Di-(2-ethylhexyl) phthalate (DEHP),
- Dibutyl phthalate (DBP),
- Benzyl butyl phthalate (BBP),
- Diisononyl phthalate (DINP),
- Diisobutyl phthalate (DIBP),
- Di-n-pentyl phthalate (DPENP),
- Di-n-hexyl phthalate (DHEXP or DnHP), and
- Dicyclohexyl phthalate (DCHP).
In order to reduce the testing burden, the CPSC identified certain types of plastic that are not required to be third party tested for the eight prohibited phthalates:
- polypropylene (PP),
- polyethylene (PE),
- high-impact polystyrene (HIPS),
- acrylonitrile butadiene styrene (ABS),
- general-purpose polystyrene (GPPS),
- medium-impact polystyrene (MIPS), and
- super-high-impact polystyrene (SHIPS).
The CPSC also published a revised version of their test method: CPSC-CH-C1001-09.4 – Standard Operating Procedure for Determination of Phthalates.