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Inappropriate Phthalates Testing Should Be Avoided Pending CPSC Clarification of Rules
This information is courtesy of the Toy Industry Association (TIA).
Concerns about chaotic testing of toys to determine compliance with as yet to be implemented phthalate restrictions under the Consumer Product Safety Improvement Act of 2008 (CPSIA) have prompted TIA to issue this bulletin clarifying, to the extent currently possible, issues that have emerged related to attempts to apply future phthalate requirements to toy products.
Phthalate Ban Under CPSIA
Section 108 of CPSIA, prohibits the manufacture, import, distribution, or sale of children's toys or child care articles containing more than 0.1% of benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), or di-(2-ethylhexyl) phthalate (DEHP), on products manufactured after February 10, 2009. Subsection 108(b)(1) further prohibits, on an interim basis, the manufacture, import, distribution, or sale of certain "children's toys that can be placed in a child's mouth" or child care articles containing more than 0.1% of diisodecyl phthalate (DIDP), diisononyl phthalate (DINP), or di-n octylphthalate (DnOP), pending the determination of a Chronic Hazard Advisory Panel (CHAP). The purpose of the CHAP will be to review the potential effects on children's health of all phthalates and phthalate alternatives in children's toys and child care articles. In doing so, the CHAP will consider the cumulative effects of exposure to multiple phthalates from all sources. The CHAP will recommend to the Commission whether to continue the interim ban and whether additional bans on phthalates or phthalate alternatives are needed. As recently as 2003, the CPSC determined after convening a CHAP review that DINP as used in toys did not present a health hazard.
Limited Only to Certain Toys and Child Care Articles
Subsection 108(e) defines ''children's toy'' as "a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays." Further qualification is provided in that a toy is considered a "toy that can be placed in a child's mouth"…"if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the children's product can only be licked, it is not regarded as able to be placed in the mouth. If a toy or part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth."
A ''child care article'' is defined as "a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething." Please note that manufacturer's intent is given great deference in determining which child care articles fall within the scope of this requirement. Also note that Congress used the term "facilitate" as opposed to "used to" connoting a narrower scope of products in the regulated category.
Status of Final Rules
The CPSC staff has yet to define final rules that will determine the scope of enforcement of this ban. Ultimately it is expected that a rational implementing rule will be developed by CPSC. The expectation is that enforcement will be similar to existing regulation under EU requirements when compatible. In the interim, there has been a rush to sometimes indiscriminately test all "children's products" regulated under the Act, without a full realization that the phthalates ban applies to a very narrow range of toys and childcare articles; NOT all children's products.
Concurrent with the adoption of a phthalate standard Congress also adopted ASTM F-963-07 (version e1) as a mandatory regulation which also defines the scope of products considered "toys". In addition TIA has become aware of erroneous information being perpetuated to expand the scope of such testing to children's products clearly excluded from the scope of the Standard. This has required the CPSC staff to issue advisory opinions or responses to inquiries that make it clear that items such as traditional sporting goods, footwear, apparel are not subject to phthalate restrictions. Comments on CPSC's implementation of test standards for phthalates are due January 12, 2009.
Indiscriminate Testing Is Inappropriate
We have also become aware of indiscriminate and sometimes inappropriate testing of toys and child care articles for phthalates. This has occurred both with products not within the scope of regulated products and for products not yet subject to the Standard. Phthalate testing tends to be very expensive and, when misdirected, results in the inappropriate allocation of scarce resources and an unjustified increase in the cost of goods available for sale to consumers.
Phthalates were primarily used in some but not all PVC ("Vinyl") formulations. They are used as plasticizers, added primarily to vinyl to increase its flexibility and in certain liquid paints and adhesives to increase flexibility. Generally they are intentionally added in very high amounts to insure great flexibility in the Vinyl. Given their nature and function, they are not intentionally added in the formulation of hardened materials or plastics such as Styrene, ABS, Polypropylene, Polyethylene and Silicon commonly used to make many toys and child care articles. Therefore indiscriminate testing of such materials, when they are not used in the manufacture process of such materials is inappropriate. Testing of materials which do not contain added phthalates is unnecessary. By analogy, the CPSC staff has stated that there is no requirement to test for lead in paint, if no paint is used. A similar approach should be urged for materials which inherently do not contain the restricted phthalates, for products within the scope of the ban and that are manufactured after February 10, 2009.
In addition, some laboratories have applied phthalate testing to components parts of products. As distinct from the lead requirements under Section 101, Section 108 of the Act does not treat components as distinct from the whole product or mandate separate component part testing. A common sense approach in this regard is required, particularly if the product part cannot be mouthed as specified in the criteria for toys.
Material Data Sheets and Resin Supplier Certifications
Until the CPSC issues clarifying rules, members are urged to review their material specifications and formulations so as to avoid the requirement for unnecessary indiscriminate phthalate testing on an enormous variety of hard plastics and alternative vinyl plastics which do not inherently contain the restricted phthalates. Also many reputable laboratories provide an initial hardness screening process to avoid needless testing of toys for phthalates.
Toy Industry Association is providing ongoing info to its members on CPSIA and compliance. For information on TIA membership please contact Laura Quartuccio at lquartuccio@toyassociation.org or visit toyassociation.org.
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