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Baby Changing Products Business Guidance and Small Entity Compliance Guide

Federal law requires that baby changing products comply with the Safety Standard for Baby Changing Products under 16 CFR part 1235 (Effective June 26, 2019), which incorporates by reference ASTM F2388-21 Standard Consumer Safety Specification for Baby Changing Products for Domestic Use, and with additional requirements, including those of the Consumer Product Safety Improvement Act of 2008 (CPSIA). 

Manufacturers and importers of baby changing products must have the products tested to the requirements under the Standard and additional requirements (such as lead) by a CPSC-accepted, third party laboratory. Manufacturers and importers must certify in a Children's Product Certificate that the products comply with the Standard and the additional requirements. These requirements are discussed in more detail below and at: www.cpsc.gov/BusinessEducation.
 

What is a baby changing product?

The term “baby changing product,” as defined in ASTM F2388-21, includes (1) changing tables, (2) changing table accessories, (3) add-on changing units, and (4) contoured changing pads. (These four terms are defined in more detail below.)

Note, only products defined as “baby changing products” under ASTM F2388 are subject to this standard—flat, non-contoured changing mats that are typically included with a diaper bag, for example, are not covered under this definition, and therefore, are not subject to this standard.

  • Changing Table: an elevated, freestanding structure generally designed to support and retain a child with a body weight of up to 30 lbs. (13.6 kg) in a horizontal position for the purpose of allowing a caregiver to change the child’s diaper. Changing tables may convert from or to other items of furniture, such as, but not limited to, a dresser, desk, hutch, bookshelf, or play yard, may have pull-out or drop-down changing surfaces, and they may provide storage for diapers and diaper products.

  • Changing Table Accessory: an accessory that attaches to a crib or play yard designed to convert the product into a changing table, typically having a rigid frame with soft fabric or mesh sides or bottom surface, or both.

  • Add-On Changing Unit: a rigid addition to or separate product used with an item of furniture that provides barriers to prevent the infant from rolling off the product during a diaper change.

  • Contoured Changing Pad: a changing pad designed for use on an elevated surface that incorporates barriers to prevent a child from rolling off the changing surface and that often consists of synthetic-covered foam with contoured edges.

 

What is the purpose of the Baby Changing Product Standard?

The Standard seeks to minimize injuries to children from normal use and reasonably foreseeable misuse or abuse of baby changing products. Specifically, this Standard attempts to minimize injuries and fatalities to children due to: (1) falls from changing tables, (2) failure of structural or mechanical components, (3) instability and entrapment in openings in the table structure, and (4) suffocation.
 

Where can I find the Baby Changing Products Standard?

The Standard is published in the Code of Federal Regulations at 16 CFR part 1235. The Standard incorporates by reference ASTM F2388-21.
 

What are the specific requirements for baby changing products in ASTM F2388-21?

ASTM F2388-21 contains requirements for baby changing products concerning:

  • Sharp points and edges;

  • small parts;

  • surface coatings;

  • wood parts;

  • openings;

  • toys;

  • threaded fasteners;

  • protective components;

  • scissoring, shearing, and pinching;

  • structural integrity;

  • stability;

  • barriers;

  • retention of contoured changing pads and add-on changing units;

  • entrapment in shelves and in enclosed openings;

  • self-folding steps;

  • restraint systems;

  • warnings and labels; and

  • instructional literature.

The specific requirements and descriptions of the tests for baby changing products are in ASTM F2388-21, which can be purchased from ASTM.

What are the additional requirements for baby changing products required by the Consumer Product Safety Improvement Act?

Baby changing products are subject to requirements for surface coatings, lead content, small parts, testing and certification, registration cards, and tracking labels. These requirements are discussed below and at: www.cpsc.gov/cpsia:

  • Surface Coating: Baby changing products may not be painted with paint that contains more than 0.009 percent (90 ppm) lead.

  • Lead Content: Baby changing products cannot contain greater than 100 ppm (0.01 percent) of total lead content in any accessible component part.

  • Phthalate Content Limits: Plasticized components of baby changing products that facilitate sleeping or feeding of children under 3 must not contain more than 0.1 percent of the following eight specified phthalates: di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP).

  • Testing and Certification: Baby changing products, like all products that are designed or intended primarily for children 12 years of age or younger, must be tested by a CPSC-accepted, third party laboratory for compliance with applicable children's product safety regulations, including the Baby Changing Products Standard. Based on that testing, a domestic manufacturer (or importer) of baby changing products must issue a Children's Product Certificate indicating that the product complies with those regulations.

  • Registration Forms: Each manufacturer of a baby changing table must (1) provide a postage-paid consumer registration form with each product, and (2) keep records of consumers who register their products with the manufacturer. In addition, manufacturers must add permanent markings to the product that state: (3) the manufacturer's name and contact information, (4) the model name and number of the product, and (5) the date of manufacture on each such product.

  • Tracking Labels: Baby changing products must have a tracking label or other distinguishing permanent mark affixed to the product and its packaging. The tracking label shall be a permanent distinguishing mark on the product and its packaging, to the extent practicable, and must contain certain basic information, including: (1) the name of the manufacturer or private label, (2) the location and date of manufacture, and (3) cohort information, such as a batch or run number.

If the information required to be marked on the product (by the tracking label requirement and the registration rule) is duplicative the markings on the product may be combined to satisfy both requirements. Note: the tracking label must also be  on the product's packaging.


Where can I find additional information?

For more information on the requirements for baby changing products, contact the U.S. Consumer Product Safety Commission’s:

  • Office of Compliance (for specific enforcement inquires): e-mail: section15@cpsc.gov; telephone: (800) 638-2772.

  • Small Business Ombudsman (for general assistance understanding and complying with CPSC regulations): e-mail: Please use our Contact Form, which is the best way to get a fast response; telephone: (888) 531-9070.

To obtain copies of ASTM F2388-21, contact ASTM International at: www.astm.org or via telephone: (610) 832-9585.

 


This communication has been prepared for general informational purposes only.  This summary document does not, and is not intended to, constitute legal advice nor does it replace or supersede a manufacturer’s obligations to comply with all applicable laws, regulations, standards, or bans enforced by CPSC. This communication has not been reviewed or approved by the Commission, and does not necessarily represent their views. Any views expressed in this communication may be changed or superseded by the Commission.

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