What is 16 CFR Part 1307 Certification Testing?

What are Phthalates?

Phthalates are cheMICal plasticizers commonly used in the production of many types of plastics. Phthalates, most commonly (but not always), are used to make plastics softer and/or more flexible.

What are the prohibitions on phthalates?

Pursuant to the requirements of the cpsia, any children’s toy or child care article that contains concentrations of the following phthalates in excess of 0.1% is prohibited.

• BIS(2-ethylhexyl) phthalate (DEHP)

• Dibutyl phthalate (DBP)

• Butyl benzyl phthalate (BBP)

• Diisononyl phthalate (DINP)

• Diisobutyl phthalate (DIBP)

• Di-n-pentyl phthalate (DPENP)

• Di-n-hexyl phthalate (DHEXP); and

• Dicyclohexyl phthalate (DCHP)

Applicable Standard

16 CFR 1307 Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates

Which children’s toys are coveRED by the phthalate ban?

For purposes of the phthalate ban, a "children’s toy" means "a consumer product designed or intended by the manufacturer for use by children 12 years of age or younger during play."

A determination as to whether a product is designed or intended for use by children 12 years of age or younger during play will be made after consideration of the following factors:

• Whether the product’s intended use is for play, including labeling on the product if such a representation is reasonable.

• Whether the product is marketed as suitable for use by persons of the specified age on its packaging, display, promotion, or advertising.

• Whether the product is generally recognized by consumers as intended for use by children of the specified age.

• The Age Determination Guidelines issued by Commission staff in September 2002, and any successor guidelines.

• In addition, CPSC staff references the definition of "children’s toy" in the ASTM F963 Standard Consumer Safety Specification for Toy Safety to provide additional guidance on which types of children’s products constitute "children’s toys." (ASTM F963 was made a mandatory CPSC standard by the CPSIA on February 10, 2009.)

Which child care articles are subject to the phthalate ban?

Covered child care articles are those designed or intended by the manufacturer to facilitate sleeping or feeding, or to assist children with sucking or teething, for use by children 3 years of age or younger. The definition is provided in the CPSIA, and currently, the Commission has not issued further interpretive guidance.

However, CPSC staff has interpreted items such as children’s sleepwear, infant and toddler bottles, sippy cups, tableware, bibs, pacifiers, and toothbrushes as child care articles covered by the phthalate ban. CPSC staff determinations are not approved by the Commission, and the Commission may review and/or supersede staff guidance and determinations.

To which components does the phthalate ban apply? Does it apply to inaccessible parts?

The phthalate ban applies to any plasticized component or any other component of a children’s toy or child care article made from other materials that may contain phthalates. Inaccessible parts of a children’s toy or child care article are not subject to the phthalate ban. A component is considered inaccessible if it is not physically exposed by reason of a sealed covering or casing and will not become physically exposed through reasonably foreseeable use and abuse of the product. (Reasonably foreseeable use and abuse of a product includes swallowing, mouthing, breaking, or other children’s activities, as well as aging of the product.)

Is testing required for every component of every children’s toy and child care article?

No. The Commission has stated that testing and certification are not required for materials known not to contain phthalates.

The following materials do not require testing for compliance with the phthalate ban, provided they have not been treated or adULterated with substances that may contain phthalates:

• Untreated/unfinished wood

• Metals

• Natural fibers; and

• Natural latex and mineral products

• Additional examples of materials not requiring testing and certification include paper products (paper, paperboard, linerboard and medium, and pulp)

Testing and Certification

Manufacturers, importers, and private labelers of children’s toys and child care articles must comply with the regulations prohibiting certain phthalates in such products and must test their products in CPSC-accepted laboratories.

Third-party testing is required for all plasticized components in children’s toys or child care articles, except for certain materials known not to contain phthalates, including but not limited to engineered wood products made of particleboard, hardwood plywood, or medium-density fiberboard (see 16 CFR § 1252.3(c)), and untreated and unadulterated virgin manufactured fibers—polyester (polyethylene terephthalate, PET); nylon; polyurethane (spandex); viscose rayon; acrylic and modacrylic; and natural rubber latex (see 16 CFR § 1253.2(c)). Third-party testing is also not required for inaccessible components of children’s toys or child care articles, or for products made from the following seven plastics with specific additives listed in 16 CFR § 1308.2: 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).

For products requiring phthalate testing, the manufacturer, private labeler, or importer must also issue a Children’s Product Certificate (CPC) certifying that the children’s toy or child care article complies with the phthalate ban.

The U.S. market has a huge demand for infant and children’s products, while regulations governing such products are relatively stringent. JJR LAB can provide compliance guidance for infant and children’s products.