Certification and Registration
16 CFR Part 1307: Phthalates in Children’s Products
Category:
CPC
What are phthalates?
Phthalates are chemical plasticizers commonly used in plastics. They are most often—though not always—added to make plastics softer or more flexible.
What are the regulations prohibiting phthalates?
Under the CPSIA, any children’s toy or child care article containing any of the following phthalates at more than 0.1% is prohibited:
● Di(2-ethylhexyl) phthalate (DEHP).
●Dibutyl phthalate (DBP).
●Benzyl butyl phthalate (BBP).
●Diisononyl phthalate (DINP).
●Diisobutyl phthalate (DIBP).
●Dipentyl phthalate (DPENP).
●Dihexyl phthalate (DHEXP), and
●Dicyclohexyl phthalate (DCHP).
Applicable Standards
16 CFR 1307 Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates
Which children’s toys are covered by the ban?
For this ban, “children’s toys” means “consumer products that are designed or intended by the manufacturer for use in play by children aged 12 years or younger.”
To determine whether a product is designed or intended for play by children 12 or younger, consider:
● Whether the product’s intended use is for play, including any labeling that reasonably claims such use.
● Whether packaging, display, promotion, or advertising represents the product as suitable for a particular age.
● Whether consumers widely perceive the product as intended for children of a specific age.
● The age‑determination guidelines issued by CPSC staff in September 2002 and any subsequent guidelines.
● Also, CPSC staff refer to the definition of “children’s toy” in ASTM F963 (which became mandatory under the CPSIA on February 10, 2009) for further guidance.
Which child care products fall under the ban?
Covered child care products are those that manufacturers design or intend to promote sleep, feeding, or to assist with sucking or teething. The CPSIA provides this definition; the Commission has not yet issued further guidance.
However, CPSC staff have interpreted items such as children’s sleepwear, infant feeding bottles, sippy cups, tableware, bibs, pacifiers, and toothbrushes as child care articles covered by the ban. This staff interpretation has not been approved by the Commission, which may review or supersede it.
Which components are subject to the ban? Does it apply to non‑contact parts?
The phthalate ban applies to any plasticized component of a children’s toy or child care article, and to any other component made from materials that may contain phthalates. Non‑contact components are excluded. A component is considered non‑contact if it is enclosed by a sealed cover or housing and will not become exposed under reasonably foreseeable conditions of use and misuse (including swallowing, biting, breaking, or aging).
Does every component need to be tested?
No. The Committee has stated that materials known to be phthalate‑free need not be tested or certified, provided they have not been treated with or contaminated by substances that may contain phthalates.
The following materials do not require testing for phthalate compliance, if untreated or uncontaminated:
●Unprocessed/unfinished wood.
●Metal.
●Natural fibers; and
● Natural latex and mineral products.
● Other examples of materials that do not require testing and certification include paper products (paper, cardboard, liners and media, as well as pulp).
Testing and Certification
Manufacturers, importers, and private‑label brands must comply with the phthalate ban and have their products tested by a CPSC‑accredited laboratory.
All plasticized components require third‑party testing, but certain known phthalate‑free materials are exempt, including (but not limited to) man‑made wood products (particleboard, hardwood plywood, or medium‑density fiberboard – see 16 CFR §1252.3(c)), untreated raw synthetic fibers (polyester, nylon, polyurethane/spandex, viscose rayon, acrylic/modacrylic, and natural rubber latex – see 16 CFR §1253.2(c)). Also, third‑party testing is not required for non‑accessible parts or for products made from seven plastics combined 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 that require phthalate testing, manufacturers, private‑label brands, or importers must provide a Children’s Product Certificate (CPC) demonstrating compliance with the ban.
The U.S. market has strong demand for infant and child products, yet regulatory oversight is stringent.SATISFY can provide compliance guidance for infant and child products – please contact SATISFY customer service for more details.
Related Information
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