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Complying with the CPSIA Phthalates Requirements: CPSC Seeks Public Input on Draft Guidance Document


Yesterday, the Consumer Product Safety Commission ("CPSC") issued a draft guidance document addressing the phthalates requirements in Section 108 of the new Consumer Product Safety Improvement Act of 2008 ("CPSIA"). The phthalates provision prohibits the sale, manufacture or importing of certain children's toys and child care articles if they contain more than 0.1% of specified phthalates as of February 10, 2009.

The CPSC issued the draft guidance document to seek public comment on the Agency's approach for determining which products will be subject to the phthalates limits, and on how such an approach could be applied to particular product classes. The draft guidance provides proposed examples and exclusions of items under each category of product subject to Section 108.

Children's Toys
The draft document proposes excluding some products from the "children's toy" category, such as bicycles, ordinary children's books, sporting equipment (including balls used for sports but not general purpose balls or toy versions of sporting equipment), and arts and crafts materials. In addition, the draft guidance proposes that the CPSC consider the following factors in its determination as to whether a product is a "children's toy":

  1. Whether the intended use of the product is for play, including a label on the product if such statement is reasonable.
  2. Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by the ages specified.
  3. Whether the product is commonly recognized by consumers as being intended for use by a child of the ages specified.
  4. The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.

Toys That Can Be Placed in a Child's Mouth
The draft guidance document defines toys that can be placed in a child's mouth as those where "any part of the toy can actually be brought to the mouth and kept in the mouth . . . so that it can be sucked and chewed" or where "any part of the toy is less than 5 cm in any dimension." The CPSC would consider inflatable toys in their deflated state, unless they are permanently inflated by the manufacturer, rather than inflated by the consumer.

Child Care Articles
With respect to the "child care articles" category, the draft document proposes four criteria for evaluating whether a product meets this category, and is thereby subject to the phthalate limits:

  1. Whether the intended use of the product is to facilitate sleeping, feeding, sucking, or teething, including a label on the product if such statement is reasonable.
  2. Whether the product is intended for use by children age 3 or younger.
  3. Whether the product is a primary or secondary facilitator of sleeping, feeding, sucking, or teething. In other words, does it facilitate the process for the child directly or indirectly through the parent/caregiver.
  4. Whether the product is commonly recognized by consumers as being intended to facilitate sleeping, feeding, sucking, or teething.

The guidance document mentions consideration of "the level of involvement or proximity of the child and the product during the feeding, sleeping, sucking, or teething processes" in determining whether a product is a "child care article." Products that are used directly in the mouth by the child (e.g., pacifiers and teethers), as well as products that have direct contact with the child, but may or may not have direct mouth contact (e.g., bibs, high chairs, baby blankets), would be considered primary products subject to Section 108.

Products that are used by a parent, but do not have any contact with a child (e.g., bottle warmers, breast pumps), would be excluded from the "child care articles" category under this approach.

The guidance document further proposes that multi-function products such as swings, bouncers, strollers will generally be considered secondary products and not subject to the regulation; however, manufacturers who advertise their products as facilitating sleep may be subject to Section 108.

The CPSC's draft phthalates guidance is intended to help manufacturers, importers, retailers and consumers determine which products CPSC will consider to be subject to the phthalates limits. Until the guidance is finalized, CPSC announced that it intends to focus its phthalate enforcement efforts primarily on those products most likely to post a risk of exposure to children, particularly:

  • bath toys,
  • small, plastic toys (especially those made of polyvinyl chloride) for young children that can be put in the mouth,
  • teethers,
  • rattles, and
  • pacifiers.

The Commission requests written comments on its draft phthalates guidance from all interested parties. Comments are due 30 days after the document is published in the Federal Register.

Consumer Product Safety Commission Draft Guidance Document [PDF]

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