The U.S. Consumer Product Safety Commission (CPSC) published a final rule in the Federal Register (86 FR 33022) establishing a mandatory safety standard for infant sleep products: the Safety Standard for Infant Sleep Products (16 CFR part 1236), incorporating by reference ASTM F3118-17a. (ASTM F3118- 17a can be viewed free of charge as a read-only document at: https://www.astm.org/products- services/reading-room.html.) The rule will be effective for products manufactured on or after June 23, 2022.
ASTM F3118-17a, Standard Consumer Safety Specification for Infant Inclined Sleep Products, is intended to address hazards from falls, positional asphyxia, and obstruction of nose and mouth by bedding. CPSC’s final rule (also, ISP rule) makes significant modifications to the introduction, scope, performance, and testing requirements of ASTM F3118-17a, to further reduce the risk of injury associated with infant sleep products, both flat and inclined.
Additionally, infant sleep products have been identified as durable infant or toddler products and are subject to the consumer registration requirement found at 16 CFR part 1130. Manufacturers and importers of infant sleep products must certify in a Children's Product Certificate (CPC) that their infant sleep products comply with the mandatory standard and any additional CPSIA requirements, after the infant sleep products have been tested for compliance at a CPSC- accepted, third party laboratory. These requirements are discussed below and in CPSC’s Regulatory Robot.
Please see this CPSC Letter to Retailers and Sellers of Infant Sleep Products for additional information.
This rule establishes a category of durable infant or toddler products called “infant sleep products,” which are all products marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age, and that are not already subject to one of CPSC’s mandatory standards for infant sleep:
- 16 CFR part 1218—Safety Standard for Bassinets and Cradles
- 16 CFR part 1219—Safety Standard for Full-Size Baby Cribs
- 16 CFR part 1220—Safety Standard for Non-Full-Size Baby Cribs
- 16 CFR part 1221—Safety Standard for Play Yards, or
- 16 CFR part 1222—Safety Standard for Bedside Sleepers.
Infant sleep products that are not already subject to one of CPSC’s mandatory standards for infant sleep include products such as: infant inclined sleep products, in-bed sleepers, baby boxes, compact/travel bassinets, and infant travel tents. Additionally, if a product name implies the product is for use as an infant sleep product, such as use of the terms “bed,” “bassinet,” or “crib,” but the product does not already comply with one of CPSC’s mandatory standards for infant sleep, the product falls within the scope of the Infant Sleep Products rule.
The purpose of the standard is to address infant sleep products not already covered by a sleep product regulation and to reduce deaths associated with known infant sleep hazards, including, but not limited to, fall hazards, asphyxiation and suffocation, obstruction of nose and mouth by bedding, and inclined sleep surfaces. In response to incident data compiled by CPSC, the new standard addresses: (1) fall hazards, (2) asphyxiation and suffocation, and (3) obstruction of nose and mouth by bedding.
The final rule requires that “infant sleep products,” which are defined as products marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age, and that are not covered by a CPSC sleep standard, comply with the Safety Standard for Bassinets and Cradles, 16 CFR part 1218.
Infant sleep products subject to 16 CFR part 1236 must also conform to the definition of a “bassinet/cradle,” as indicated in the standard. Please see our bassinets and cradles business education page for more information on how to comply with that standard.
In addition to complying with 16 CFR part 1218, infant sleep products, must also meet requirements related to the angle of the seat back/sleep surface intended for sleep. Specifically, infant sleep products must be tested to confirm the seat back/sleep surface angle is 10 degrees or less from horizontal, per the test method described below:
- If applicable, place the product in the manufacturer's recommended highest seat back/sleep surface angle position intended for sleep.
- Place the hinged weight gage-infant in the product and position the gage with the hinge centered over the seat bight line and the upper plate of the gage on the seat back/sleep surface. Place a digital protractor on the upper torso/head area lengthwise.
Infant sleep products also need to comply with other mandatory federal requirements, including those specified by the Consumer Product Safety Improvement Act of 2008 (CPSIA), discussed below.
Infant sleep products are subject to requirements for surface coatings, lead, testing and certification, registration cards, and tracking labels under the CPSIA. These requirements are discussed below and at: www.cpsc.gov/BusinessEducation:
- Surface Coating Limit: Infant sleep products must not be painted with paint that contains more than 90 ppm (0.009 percent) lead.
- Lead Content Limit: Infant sleep products must not contain greater than 100 ppm (0.01 percent) of total lead content in any accessible component part.
- Phthalate Content Limits: Plasticized components of infant sleep products must not contain more than 0.1 percent of the following eight specified phthalates: di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), 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: Infant sleep 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 the Safety Standard for Infant Sleep Products, as well as all other applicable children’s product safety rules, such as lead paint and lead content. Based on that testing, a domestic manufacturer (or importer) of infant sleep products must issue a Children's Product Certificate (CPC) specifying each applicable rule and indicating that the product complies with those rules.
- Product and Outer Package Labeling Requirements: Durable infant or toddler products, such as infant sleep products, must be permanently marked with specific labeling information, including tracking labels, on the product and on the packaging.
- Product Registration Card Requirement: In addition, durable infant or toddler products are required to have additional product markings and a product registration card attached to the product. This chart summarizes the specific labeling and registration requirements that durable infant and toddler products must meet.
It depends on the product design, among other factors. In determining whether products are subject to the ISP rule, the Commission will consider relevant factors set forth in the ISP rule, including, but not limited to, marketing and advertising; labeling; product design; and consumer usage. Products that are mainly for infant (0 – 5 months of age) sleep, based on the product’s design, cannot be labeled as not intended for infant sleep to avoid meeting the requirements of the ISP rule.
Knowledge that consumers are using a product that was initially marketed and intended for sleep for infants from 0 to 5 months of age, but then remarketed as not intended for sleep for infants from 0 to 5 months of age, may be evidence that your product is subject to one of the five existing mandatory sleep product standards, or the new ISP rule. This knowledge would be considered along with the factors discussed above.
The “infant loungers” category of products encompasses a broad range of products.
In determining whether products are subject to the ISP rule, the Commission will consider relevant factors set forth in the ISP rule, including, but not limited to, marketing and advertising; labeling; product design; and foreseeable consumer use or misuse.
Products that already meet an existing rule for infant sleep (full-size cribs, bassinets, play yards, bedside sleepers, and non-full-size cribs) are not subject to the ISP rule. The ISP rule is a baseline for previously unregulated sleep products and for firms interested in developing a new sleep product for infants 0 to 5 months of age. A product intended for infant sleep must meet the requirements of an existing rule for infant sleep (full-size cribs, bassinets, play yards, bedside sleepers, and non-full-size cribs) or meet the ISP rule, meaning the product has a sleep surface angle of 10 degrees or less and meets the requirements of 16 CFR part 1218, Safety Standard for Bassinets and Cradles, including conforming to the definition of a “bassinet.”
Yes, if marketed or intended as a bassinet or travel bassinet for infants of an age that includes infants 0 to 5 months old, a combination diaper bag/changing area/travel bassinet must meet the ISP rule. The ISP rule requires that all infant sleep products that do not already meet one of CPSC’s existing five infant sleep regulations (full-size cribs, bassinets, play yards, bedside sleepers, and non-full-size cribs) meet the ISP rule. Additionally, the product may also be in scope of 16 CFR part 1235, Safety Standard for Baby Changing Products.
It depends on the intended use, marketing, and design of the tent. An after-market product may be subject to the ISP rule in certain circumstances, including, but not limited to, a product that could provide a sleeping accommodation and that is marketed and intended for infants up to 5 months of age.
Crib wedges, sleep positioners, and sleep wedge pillows are out of scope of the ISP rule. These products could be considered “medical devices” under the FDA’s jurisdiction, depending on the marketing claims being made. Regardless of jurisdiction, neither CPSC nor FDA recommends using a crib wedge, sleep positioner, or sleep wedge pillow for infant sleep because these products have been associated with infant suffocation.
Unless a product already meets one of the five existing CPSC mandatory rules cited above, a product marketed or intended for infant sleep with an advertised age range that includes infants up to 5 months of age, is within the scope of the ISP final rule. For example, an infant sleep product advertised for infants 0- 6 months or 0-9 months could be within the scope of the rule, as well as an infant sleep product advertised for infants 3-12 months, 0+, or a product advertised for “newborns” or “all infants.”
Multiuse products with different use modes must meet the applicable regulation for each use while in that mode, as specified in many CPSC regulations for children’s products. The product’s marketing, instruction manuals, and labeling must be clear and contain all required warnings on the product and in the instructions that are applicable to each intended use. If any intended use is marketed for sleep for infants up to 5 months, then the product, in that mode, is required to meet the ISP rule, if not already subject to one of the following CPSC’s mandatory standards (Full-Size Cribs (16 CFR part 1219), Non- Full-Size Cribs (16 CFR part 1220), Play Yards (16 CFR part 1221), Bedside Sleepers (16 CFR part 1222), and Bassinets and Cradles (16 CFR part 1218)).
Section II.B of the preamble to the final rule (86 FR at 33025) explains which products are excluded from the ISP rule: “[P]roducts with inclined or adjustable seat back positions that are covered by other CPSC standards, such as infant bouncer seats, strollers, handheld carriers, frame carriers, and infant swings, are excluded from the scope of the ASTM infant inclined sleeper standard, and they are also excluded from the scope of the final rule, unless the product is specifically marketed for infant sleep for an infant up to 5 months of age.” If such a product’s packaging, marketing materials, inserts, or instructions indicate that the product is for sleep, or includes pictures of sleeping infants, then CPSC will consider the product to be marketed for sleep. Moreover, such products must fully comply with the applicable regulations for those product categories, including the warnings. Any product advertised for “attended” or “supervised” sleep must comply with the ISP rule, if not already subject to one of the following CPSC’s mandatory standards (Full-Size Cribs (16 CFR part 1219), Non-Full-Size Cribs (16 CFR part 1220), Play Yards (16 CFR part 1221), Bedside Sleepers (16 CFR part 1222), and Bassinets and Cradles (16 CFR part 1218)). Some products, for example, infant and toddler rockers (i.e., rocker seats), are not currently subject to a mandatory regulation under section 104 of the Consumer Product Safety Improvement Act (CPSIA).
However, if a rocker seat is marketed or intended for infant sleep for an infant 0 to 5 months, it would be subject to the ISP rule.
The factors that CPSC will consider when determining whether a product is in scope are set forth in the ISP rule, as explained in the response to questions above. A product that includes references to sleep, snooze, dream, or nap in the product name, description, and instructions suggests to caregivers that the product is intended for sleep. Accordingly, such products must comply with the ISP rule or another applicable sleep product rule, such as bassinets, cradles, cribs, play yards, or bedside sleepers. A product with pictures of sleeping animals or cartoon figures conveys to caregivers that the product is intended for sleep.
It depends on the product design, among other factors. In determining whether products are subject to the ISP rule, the Commission will consider relevant factors set forth in the ISP rule, including, but not limited to, marketing and advertising; labeling; product design; and consumer usage.
The definition of a “bassinet” referenced above is defined under ASTM F2194-16ε1 and this version of the standard is not mandated by the Commission. However, ASTM F2194-13 (which is incorporated under 16 CFR part 1218) is the version of the ASTM standard that is currently mandated by the Commission, along with the additions and exclusions in 16 CFR part 1218. The definition of a “bassinet/cradle” is defined under ASTM F2194-13 in part as “a small bed . . . supported by free standing legs, a stationary frame/stand, a wheeled base, a rocking base ” The mandatory standard for bassinets does not
specify a minimum height for the legs or frame/stand/base. The requirement to have “free standing legs or a stationary frame/stand/wheeled or rocking base,” and to be raised off the floor, is intended to discourage or prevent use of the product on other, less stable, surfaces, such as elevated surfaces or soft surfaces (e.g., couches and adult beds). CPSC is aware of incidents and fatalities from falls off elevated and soft surfaces involving small, portable, durable infant or toddler products. For infant sleep products, which are intended to be used unattended, the requirement for a stand is intended to address this hazard scenario. Accordingly, an infant sleep product that does not conform to the definition of a “bassinet/cradle” would not meet the requirements of the ISP rule. Staff is working with the ASTM subcommittee for bassinets to specify a requirement for the bassinet stand, whose minimum height should be sufficient to deter placing the product on elevated or soft surfaces and should pass the existing stability requirement in the mandatory standard.
Unless marketed or intended for infant sleep, carriages and strollers are not within the scope of the ISP rule. Carriages and strollers must meet all the requirements of the Safety Standard for Carriages and Strollers, 16 CFR part 1227. However, carriages and strollers and their accessories would be within the scope of the ISP rule if they are marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age. Additionally, as mentioned in a response to a question above, products marketed or intended for “supervised” or “attended” sleep, including napping, could be considered within the scope of the ISP rule. Some carriage and stroller accessories, such as hand-held infant carriers, would also need to comply with the requirements under the mandatory safety standard for Hand-Held Infant Carriers, 16 CFR part 1225.
Baby boxes marketed or intended for infant sleep for 0 to 5 months that do not meet the bassinet standard (including those sold without a stand) would not comply with the ISP rule. The rule requires that all ISPs meet one of CPSC’s five existing mandatory rules for infant sleep, including full-size cribs, non-full-size cribs, play yards, bed-side sleepers, and bassinets and cradles. If the product does not already comply with one of these five sleep standards, the product must comply with the ISP rule, which requires that the product be tested for the sleep surface angle, which must be 10 degrees or less, and comply with the requirements of the bassinet standard, including the requirement that the product have a stand.
The ISP rule states that infant sleep products must comply with ASTM F3118–17a, along with the additions and exclusions outlined in the rule. One of the additions is that infant sleep products shall also meet 16 CFR part 1218, Safety Standard for Bassinets and Cradles, including conforming to the definition of a ‘‘bassinet/cradle.’’ To test this requirement, a third-party testing laboratory would evaluate a product
to ASTM F2194-13, Standard Consumer Safety Specification for Bassinets and Cradles, in conjunction with the additions or exclusions outlined in 16 CFR part 1218.
For more information on the requirements for durable infant or toddler products, specifically infant sleep products, contact the U.S. Consumer Product Safety Commission:
- Visit our Regulatory Robot, designed to guide you through CPSC’s product safety requirements.
- Ask our 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 purchase copies of ASTM F3118-17a, contact ASTM International at: www.astm.org or via telephone: 1-877-909-2786. ASTM F3118-17a can be viewed free of charge as a read-only document
at: https://www.astm.org/products-services/reading-room.html.