WASHINGTON, DC – AUGUST 13, 2009 – The US Consumer Product Safety Commission (CPSC) reversed its March 2009 policy on phthalates testing, now requiring the 0.1 percent concentration limit to apply to each plasticized component part as opposed to the entire children’s toy or child care article as a whole.  The CPSC’s new guidance, however, does not address key issues such as inaccessible component parts and whether companies may rely on results from prior tests that were conducted in accordance with the March 2009 policy.

By way of background, Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) permanently prohibits the sale of any children’s toy or child care article containing concentrations of more than 0.1 percent of the following phthalates: di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP).  The CPSIA also prohibits, on an interim basis, the sale of any children’s toy that can be placed in a child’s mouth or a child care article containing concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP).  In March of 2009, CPSC staff issued a testing method that recommended either testing the entire homogenized product to determine the overall phthalate concentration, or weighing and testing individual components and averaging out the phthalate concentrations across the entire product. After considering comments to this testing method, however, the Commission stated it now believes that the phthalate limits should apply to each individual component, although phthalate testing should be limited to only those plastic parts or other product parts that could conceivably contain phthalates (“plasticized components parts”).  According to the Commission, testing component parts, as opposed to the entire product, to the phthalates limits will provide more protection to children, may reduce the testing costs for manufacturers in certain circumstances, and will align the federal government’s approach with the requirements in other jurisdictions, such as California.

According to CPSC, manufacturers are responsible for deciding whether their products or components must be tested for phthalates because they should know what materials are used in their products.  To guide manufacturers in their analysis, CPSC offers the following examples of materials that may contain phthalates:

• Polyvinyl chloride (PVC) and related polymers, such as polyvinylidene chloride (PVDC) and polyvinyl acetate (PVA).  According to CPSC, these materials should always be tested.

• Soft or flexible plastics, except polyolefins.

• Soft or flexible rubber, except silicone rubber and natural latex.

• Foam rubber or foam plastic, such as polyurethane (PU).

• Surface coatings, non-slip coatings, finishes, decals, and printed designs.

• Elastic materials on apparel, such as sleepwear.

• Adhesives and sealants.

• Electrical insulation.

CPSC also explained that the following materials do not normally contain phthalates and, thus, might not require testing or certification:

• Unfinished metal.

• Natural wood, except for coatings and adhesives added to wood.

• Textiles made from natural fibers, such as cotton or wool, except for printed decorations, waterproof coatings or other surface treatment, back coatings, and elastic materials (especially sleepwear).

• Textiles made from common synthetic fibers, such as polyester, acrylic, and nylon, except for printed decorations, waterproof coatings or other surface treatments, and elastic materials.  Any textiles containing PVC or related polymers, however, must be tested.

• Polyethylene and polypropylene (polyolefins).

• Silicone rubber and natural latex.

• Mineral products such as play sand, glass, and crystal.

Finally, CPSC staff developed a new method to test component parts for the restricted phthalates.  The general approach under this new test method is to grind the sample to a powder by cryogenic milling, dissolve it completely in tetrahydrofuran, precipitate any PVC polymer with hexanes, filter and then dilute the solution with cyclohexane, and analyze by Gas Chromatography-Mass Spectrometry (GC-MS) with selective ion monitoring (SIM).

Companies are encouraged to submit comments on the new guidance.  Comments may address issues such as accessible and inaccessible component parts, retroactivity, and reliance on previous agency guidance. 

Related documents:

• Statement of Policy: Testing of Component Parts with Respect to Section 108 of the Consumer Product Safety Improvement Act

• Test Method: CPSC-CH-C1001-09.2, Standard Operating Procedure for Determination of Phthalates

Please contact any of the individuals below if you have questions regarding this new policy.

Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939

James R. Ravitz
ravitz.james@arentfox.com
202.857.8903

Scott A. Cohn
cohn.scott@arentfox.com
212.484.3984

Robert G. Edwards, PhD
edwards.robert@arentfox.com
202.857.6346

Amy S. Colvin
colvin.amy@arentfox.com
202.857.6338