PART 1250—SAFETY STANDARD FOR TOYS

Chapter II—Consumer Product Safety Commission › Subchapter B—Consumer Product Safety Act Regulations

§ 1250.1 Scope.

This part establishes a consumer product safety standard for toys.

§ 1250.2 Requirements for toy safety.

(a) Each toy must comply with all applicable provisions of ASTM F963-23 (incorporated by reference, see § 1250.10).

(b) Pursuant to section 106(a) of the Consumer Product Safety Improvement Act of 2008, section 4.2 and Annex 5 or any provision of ASTM F963 that restates or incorporates an existing mandatory standard or ban promulgated by the Commission or by statute or any provision that restates or incorporates a regulation promulgated by the Food and Drug Administration or any statute administered by the Food and Drug Administration are not part of the mandatory standard incorporated in paragraph (a) of this section.

§ 1250.4 Requirements for water beads.

(a) Scope and purpose. This section establishes performance and labeling requirements for water bead toys and toys containing water beads to minimize the risk of children ingesting, inserting, aspirating, and choking on water bead toys. The provisions of this part are intended to eliminate or adequately reduce the risk of injury and death to children from water bead toy hazards. This section adds requirements for water bead toys in addition to the requirements of § 1250.2.

(b) Definitions. In addition to the definitions in ASTM F963-23 (incorporated by reference, see § 1250.10), the following definitions apply for purposes of this section:

Aspiration hazard means a hazard caused by a child inhaling a water bead whereby the water bead can become lodged in the respiratory tract and can potentially cause death or injury.

Choking hazard means a hazard cause by a child attempting to swallow a water bead whereby the water bead can become lodged in the throat and can potentially cause death or injury.

Ingestion hazard means a hazard caused by a child swallowing a water bead whereby the water bead can become lodged in the digestive tract and can potentially cause death or injury.

Insertion hazard means a hazard caused by a child putting a water bead in the ear canal or nasal passage of the body and can potentially cause death or injury.

Water bead means a various shaped liquid absorbent polymer, composed of materials such as, but not limited to, polyacrylamide and polyacrylate, which expands when soaked in liquid.

(c) Performance requirements. In addition to the requirements of § 1250.2, all water bead toys and toys containing water beads within the scope of the rule must meet the performance requirements in this section to minimize the risk of children ingesting, inserting, aspirating, and choking on water beads.

(1) Size limit requirements. Water beads as received or water beads removed from a toy, which fit entirely inside the small parts cylinder in their dehydrated (pre-expanded) state as shown in figure 1 to this paragraph (c)(1) (16 CFR 1501.4) shall, after expansion, remain whole while completely passing through the funnel test gauge as shown in figure 2 to this paragraph (c)(1) or sieve test gauge as shown in figure 3 to this paragraph (c)(1), under its own weight, when tested in accordance with the following test procedure:

Figure 1 to Paragraph (c)(1)—Small Parts Cylinder

Figure 2 to Paragraph (c)(1)—Funnel Test Gauge. Material: Polytetrafluorethylene (PTFE)

Figure 3 to Paragraph (c)(1)—Sieve Test Gauge. Material: Polytetrafluorethylene (PTFE)

(i) Condition the water bead or toy containing the water bead, at 20 ± 5 °C (68 ± 9 °F) and at a relative humidity of 40-65 percent for a minimum of seven hours prior to the test.

(ii) If the water bead is partially expanded, or contained within a toy and partially expanded, remove the water bead for testing and allow 120 hours to dehydrate before confirming the water bead fits entirely inside the small parts cylinder in its dehydrated state.

(iii) Submerge the water bead under a test bath of deionized water maintained at 37 ± 2 °C (98.6 ± 3.6 °F) for the duration of immersion, without agitation. For water beads that exhibit positive buoyancy, place weight(s) (with mass just sufficient to achieve complete submersion) atop the water bead. Care should be taken to minimize contact of the water bead with the sides or bottom of the container.

(iv) Maintain submersion for 72 hours, measuring the water bead dimensions at 6 hours, 24 hours, 48 hours and 72 hours duration. If the greatest expansion was observed at 72 hours of submersion, proceed to immediately test the expanded water bead. If the greatest expansion was observed at another time interval, condition and submerge a new water bead per paragraphs (c)(1)(i) through (iii) of this section for the time interval at which the greatest expansion was observed. Then immediately test the expanded water bead.

(v) Place the expanded water bead on the surface of the funnel or sieve gauge as applicable in the orientation least likely to pass through the funnel or sieve gauge opening and observe if the expanded water bead is able to completely pass through the funnel or sieve gauge opening. The expanded water bead shall remain whole and completely pass through the funnel or sieve gauge opening.

(2) Acrylamide limit requirements. Water beads shall not have more than 325 µg acrylamide extractable from 100 small water beads (defined as <4 mm in all dimensions of the bead prior to hydration) or from one large water bead (defined as ≥4 mm in any dimension of the bead prior to hydration) in the test procedure described in paragraphs (c)(2)(i) through (vi):

(i) To determine the amount of extractable acrylamide in water beads, first place the water beads (one large water bead or 100 small water beads) as received in a container with deionized water that has been pH neutralized.

(ii) Situate the container(s) in a shaker bath that can heat the water beads to 37 °C and shake them at a rate of 30 revolutions per minute (RPM). Leave the water beads untouched for 24 hours.

(iii) Multiple concurrent trials, or sequential repetitions, must be performed to ensure that results are reasonably consistent, given any bead-to-bead variation. For large water beads, perform three trials with one large bead per trial. For small water beads, perform three trials with 100 small beads per trial. Each trial is conducted in a separate container of deionized water that has been pH neutralized.

(iv) Use an extraction container and volume of deionized water so that all water beads remain covered by water for the duration of the extraction period. Because water beads absorb water differently depending on their various sizes, additional tests may need to be conducted before starting the extractions to determine a volume of water that allows for full growth and coverage of the water beads without unnecessarily diluting the concentration of extracted acrylamide. Select containers that will not compress the water beads at any point during the 24-hour extraction period.

(v) Cover the containers to prevent evaporation of the water during the extraction.

(vi) Following the extraction, determine the volume of remaining water for each trial. Analyze the remaining water to determine the mass of extracted acrylamide present using an instrument that can quantitate acrylamide at levels equal to or less than the limit.

(d) Labeling requirements. All water bead toys and packaging of toys containing water beads within the scope of the rule must meet the marking, labeling, and instructional literature requirements in this section to minimize the risk of children ingesting, inserting, aspirating, and choking on water beads.

(1) Requirements for marking and labeling. (i) Water bead toys, packaging of water bead toys, and the container of water beads, if provided, must include the safety alert symbol, signal word, and word message as shown in figure 4 to this paragraph (d)(1)(i).

Figure 4 to Paragraph (d)(1)(i)—Warning for Water Bead Toys and Their Packaging

(ii) Products with contained water beads, such as balls filled with water beads, and the packaging must include the safety alert symbol, signal word, and word message as shown in figure 5 to this paragraph (d)(1)(ii):

Figure 5 to Paragraph (d)(1)(ii)—Warning for Toys With Contained Water Beads and Their Packaging

(iii) Products with contained water beads that do not have packaging must have a hangtag or sticker label with the full warning(s). Multiple products sold in a package or bin must be individually labeled with a hangtag or sticker.

(iv) The warnings shall be in the English language at a minimum.

(v) The warnings shall be conspicuous and permanent on the principal display panel as defined in section 3.1.62 of the version of ASTM F963-23 and in a distinct color contrasting to the background on which it appears.

(vi) The warnings shall conform to ANSI Z535.4-2023 (incorporated by reference, see § 1250.10), sections 6.1-6.4, 7.2-7.6.3, and 8.1, with the following changes:

(A) In sections 6.2.2, 7.3, 7.5, and 8.1.2, of ANSI Z535.4-2023 replace the word “should” with the word “shall.”

(B) In section 7.6.3 of ANSI Z535.4-2023, replace the phrase “should (when feasible)” with the word “shall.”

(C) In ANSI Z535.4-2023, strike the word “safety” when used immediately before a color (for example, replace “safety white” with “white”).

(vii) Certain text in the message panel must be in bold and in capital letters as shown in the example warning labels in figure 4 to paragraph (d)(1)(i) of this section and figure 5 to paragraph (d)(1)(ii) of this section. Text must use black lettering on a white background or white lettering on a black background.

(viii) The message panel text shall appear in sans serif letters and be center or left aligned. Text with precautionary (hazard avoidance) statements shall be preceded by bullet points.

(ix) Multiple precautionary statements shall be separated by bullet points if paragraph formatting is used.

(x) The safety alert symbol ! and the signal word “WARNING” shall appear in sans serif letters and be at least 1/8″ (3.2 mm) high and be center or left aligned. The remainder of the text shall be in characters whose upper case shall be at least 1/16″ (1.6 mm) high.

(xi) The safety alert symbol, an exclamation mark in a triangle, when used with the signal word, must precede the signal word. The base of the safety alert symbol must be on the same horizontal line as the base of the letters of the signal word. The height of the safety alert symbol must equal or exceed the signal word letter height. The exclamation mark must be at least half the size of the triangle centered vertically.

(2) Requirements for instructional literature. Instructions shall have the same warning labels that must appear on the product packaging, with similar formatting requirements, but without the need to be in color. However, the signal word and safety alert symbol shall contrast with the background of the signal word panel, and the warnings shall contrast with the background of the instructional literature.

§ 1250.5 Requirements for neck floats.

(a) Scope and purpose. This section establishes performance and labeling requirements for neck floats to reduce the risk of children drowning while using a neck float. The provisions of this part are intended to address the risk of injury and death to children from neck float hazards. This section adds requirements for neck float in addition to the requirements of §§ 1250.1 and 1250.2.

(b) Definitions. In addition to the definitions in ASTM F963-23 (incorporated by reference, see § 1250.10), the following definitions apply for the purposes of this section:

Expected weight capacity means the maximum weight capacity the neck float is rated for, per the manufacturer's recommended use instructions.

Neck float means an article, whether inflatable or not, that encircles the neck, supports the weight of the child by being secured around the neck (such as by fastening, tightening, or other methods), is used as an instrument of play in water environments including sinks, baths, paddling pools, and swimming pools, and is intended for use by children up to and including 4 years of age in water environments including sinks, baths, paddling pools, and swimming pools.

Restraint system means interconnecting components, whether adjustable or not, that are integral to a neck float and are intended to hold the occupant in position relative to the neck float. A restraint system uses fastening mechanisms, such as buckles or Velcro straps, to secure together.

(c) Performance requirements. In addition to any applicable performance requirements from § 1250.1 or § 1250.2, all neck floats within the scope of the rule must meet the performance requirements in this section to reduce the risk of children drowning while using a neck float.

(1) Conditioning procedure. Neck floats shall undergo thermal conditioning in accordance with section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022 (incorporated by reference, see § 1250.10), with modifications provided in paragraphs (c)(1)(i) through (iii) of this section. Following thermal conditioning, a neck float shall undergo exposure conditioning in a chlorinated saltwater bath. The chlorinated saltwater bath shall be prepared by dissolving 32 grams of sodium chloride (NaCl) in 1 liter of aqueous solution containing 2 ppm chlorine at pH 7.0-7.8. The necessary volume of solution at those concentrations shall be prepared to fully submerge the neck float, in darkness and at room temperature (20 ± 2 °C (68 ± 4 °F)) for 8 hours. Lastly, the neck float shall undergo ultraviolet light exposure conditioning in accordance with sections 4.2.1.1-4.2.1.4 of ANSI/APSP/ICC-16 2017 (incorporated by reference, see § 1250.10), with the modifications provided in paragraph (c)(1)(iv) of this section, prior to any testing in accordance with paragraphs (c)(2) through (4) of this section. Any inflatable component(s), if applicable, of the neck float shall be deflated during the conditioning procedure.

(i) The words “Inflatable PFDs” shall be removed and replaced with “Neck floats” in section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022.

(ii) The cold temperature “−30 ± 2 °C” shall be removed and replace with “−10 ± 2 °C” in section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022.

(iii) The words “for two complete cycles,” and the paragraph after item b) “Inflatable PFDs, shall be . . . inflated for (5,0 ± 0.1) min.” shall be removed from section 5.5.4.1 of ANSI/CAN/UL 12402-9:2022.

(iv) The exposure duration for each UV conditioning methods shall be reduced from 720 hours to 180 hours using methods (a) and (b), from 1000 hours to 250 hours using method (c), and from 750 hours to 188 hours using method (d) from sections 4.2.1.1-4.2.1.4 of ANSI APSP ICC-16 2017.

(2) Minimum buoyancy requirements. Neck floats shall demonstrate a minimum upward buoyancy equal to or greater than 30 percent the expected weight capacity of the neck float, and neck floats utilizing inherently buoyant components shall lose no more than 5 percent of their initial buoyancy, when tested in accordance with sections 5.5.9.2-5.5.9.4 of ANSI/CAN/UL 12402-9:2022 with the following additions and exclusions:

(i) The words “PFD” shall be removed and replaced with “neck float.”

(ii) The weight of the cage shall be equal to 1.1 times the expected weight capacity of the neck float, which shall be determined based on either the maximum weight capacity according to the manufacturer's recommended user weight, or the weight given by table 1 to this paragraph (c)(2)(ii) according to the manufacturer's recommended user age, whichever is greater. If the manufacturer's recommended user age falls between two age range options, the older range shall be used.

(iii) The sentence “If the PFD contains inflatable . . . whichever is less” shall be removed from the first paragraph of section 5.5.9.3 of ANSI/CAN/UL 12402-9:2022. In its place, the following sentence shall be added to the beginning of that section: “Any inflatable component(s), if applicable, of the neck float shall be inflated to an internal air pressure of 0.1 ± 0.01 PSIG.”

(iv) Add “If the neck float contains inherently buoyant components” to the beginning of the third paragraph (“The assembly shall remain . . . recorded as B”) of section 5.5.9.3 of ANSI/CAN/UL 12402-9:2022.

(v) Remove the last two paragraphs “The water temperature . . . immersion period” from section 5.5.9.3 of ANSI/CAN/UL 12402-9:2022.

(vi) Remove the last paragraph “The water temperature . . . and pressure conditions” from section 5.5.9.4 of ANSI/CAN/UL 12402-9:2022.

(3) Restraint system requirements. All restraint systems used to attach the neck float to the body or to connect components of the neck float together shall require the release of the fastening mechanism to have either a double-action release system that requires two distinct, but simultaneous actions to release, or a single-action release system that requires a minimum of 50 N to release. The restraint system shall also comply with the requirements of section 6.4.4 when tested in accordance with section 7.5.1 of ASTM F833-21 (incorporated by reference, see § 1250.10), with the following exclusions:

(i) The sentence “At the . . . 2 in. (51 mm).” of section 6.4.4 of ASTM F833-21 shall be removed.

(ii) [Reserved]

(4) Neck opening test requirement. The neck opening of the neck float shall not admit the passage of a specified head probe when tested in accordance with the following test procedure:

(i) The neck float shall be placed on an elevated platform and positioned directly above and centered about a circular opening in that platform large enough to allow the head probes to fall fully through it. The surfaces of the neck float shall be saturated with baby wash solution, prepared in accordance with section 7.4.1.5 of ASTM F1967-19 (incorporated by reference, see § 1250.10).

(ii) If the neck float includes adjustable restraint straps, then all applicable head probes shall be evaluated at the loosest (largest) setting.

(iii) Any inflatable components of the neck float shall be inflated to an internal air pressure of 0.1 ± 0.01 PSIG.

(iv) A specified head probe, as described in paragraph (c)(4)(vii) of this section, shall then be weighted to mass M1 and positioned in the neck opening. A hanging weight of mass M2 shall then be suspended below the head probe at distance L, where L includes the length between the narrowest and widest circumference of the specified head probe. The choice of specified head probe, mass M1, mass M2, and distance L shall be determined using table 2 to this paragraph (c)(4)(iv) based on the manufacturer's recommended youngest and oldest user age. If the manufacturer's recommended user age falls between two age range options, the younger or older range shall be considered, as is appropriate.

(v) If the neck float's recommended age range could apply to two or more head probes this procedure will be conducted first using the smallest applicable head probe, then repeated using the largest applicable head probe.

(vi) The hanging weight shall be swung for a total of ten 30-second cycles by raising the hanging weight to a 90-degree angle and releasing it. Alternate between a front-to-back swinging direction interval and side-to side interval, relative to the intended position of the neck float user. The 10 alternating swing cycles shall occur consecutively.

(vii) Head probes shall be constructed in accordance with figure 1 and table 3 to this paragraph (c)(4)(vii). Section A-A in figure 1 to this paragraph (c)(4)(vii) demonstrates that the head probe may be hollow for the purposes of adding mass M1, however it is not a requirement of the probe.

(d) Labeling requirements. All neck floats and the packaging of neck floats must meet the marking, labeling, and instructional literature requirements in this section to reduce the risk of children drowning while using a neck float.

(1) Requirements for marking and labeling. (i) Instead of complying with the warning text of section 5.4 of ASTM F963-23, neck floats and the packaging of neck floats must include the safety alert symbol, signal word, and word message as shown in figure 2 to this paragraph (d)(1)(i).

(ii) The warnings shall be in the English language at a minimum.

(iii) The warnings shall be conspicuous and permanent on the principal display panel as defined in section 3.1.62 of the version of ASTM F963-23 and in a distinct color contrasting to the background on which it appears.

(iv) The warnings shall conform to ANSI Z535.4-2023 (incorporated by reference, see § 1250.10), sections 6.1-6.4, 7.2-7.6.3, and 8.1, with the following changes:

(A) In sections 6.2.2, 7.3, 7.5, and 8.1.2, of ANSI Z535.4-2023 replace the word “should” with the word “shall.”

(B) In section 7.6.3 of ANSI Z535.4-2023, replace the phrase “should (when feasible)” with the word “shall.”

(C) In ANSI Z535.4-2023, strike the word “safety” when used immediately before a color (for example, replace safety white” with “white”).

(v) Certain text in the message panel must be in bold and in capital letters as shown in the example warning labels in figure 2 to paragraph (d)(1)(i) of this section. Text must use black lettering on a white background or white lettering on a black background.

(vi) The message panel text shall appear in sans serif letters and be center or left aligned. Text with precautionary (hazard avoidance) statements shall be preceded by bullet points.

(vii) Multiple precautionary statements shall be separated by bullet points if paragraph formatting is used.

(viii) The safety alert symbol ! and the signal word “WARNING” shall appear in sans serif letters and be at least 1/8” (3.2mm) high and be center or left aligned. The remainder of the text shall be in characters whose upper case shall be at least 1/16” (1.6mm) high.

(ix) The safety alert symbol, an exclamation mark in a triangle, when used with the signal word, must precede the signal word. The base of the safety alert symbol must be on the same horizontal line as the base of the letters of the signal word. The height of the safety alert symbol must equal or exceed the signal word letter height. The exclamation mark must be at least half the size of the triangle centered vertically.

(x) The warning contained within {} “Check for leaks before use. Never use with leaks.” is only required for neck floats utilizing inflatable components.

(2) Requirements for instructional literature. Instructions shall have the same warning labels that must appear on the product and provided separately, as a user manual, with similar formatting requirements, but without the need to be in color. However, the signal word and safety alert symbol shall contrast with the background of the signal word panel, and the warnings shall contrast with the background of the instructional literature. The instructions shall include information on assembly, installation, maintenance, cleaning and use, where applicable. The instructions shall explain how to check for adequate fit of the neck float around the child's neck to prevent slipping through the center opening. For neck floats utilizing inflatable components, the instructions shall include clear directions for testing the neck float for leaks. Any additional instructions provided, that are not required, shall neither contradict nor confuse the meaning of the requirements.

(e) Prohibited stockpiling—(1) Prohibited acts. Manufacturers and importers of neck floats shall not manufacture or import neck floats that do not comply with the requirements of this part between December 15, 2025, and June 15, 2026, at a rate that is greater than 105 percent of the rate at which they manufactured or imported neck floats during the base period for the manufacturer or importer.

(2) Base period. The base period for neck floats is the average monthly manufacturing or import volume within the last 13 months of production immediately preceding December 15, 2025.

§ 1250.10 Incorporation by reference.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the U.S. Consumer Product Safety Commission and at the National Archives and Records Administration (NARA). Contact the U.S. Consumer Product Safety Commission at: Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7479, email cpsc-os@cpsc.gov. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov. The material may be obtained from the following sources:

(a) ASTM International: 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959; telephone (610) 832-9585; www.astm.org.

(1) ASTM F833-21, Standard Consumer Safety Performance Specification for Carriages and Strollers, approved June 15, 2021; into § 1250.5(c).

(2) ASTM F963-23, Standard Consumer Safety Specification for Toy Safety, approved on August 1, 2023; into §§ 1250.2(a), 1250.4(b) and (d), 1250.5(b) and (d).

(3) ASTM F1967-19, Standard Consumer Safety Specification for Infant Bath Seats, approved May 1, 2019; into § 1250.5(c).

(b) National Electrical Manufacturers Association (NEMA): 1300 North 17th Street, Suite 900, Rosslyn, Virginia 22209; (703) 841-3200; www.nema.org.

(1) ANSI Z535.4-2023, American National Standard for Product Safety Signs and Labels (approved December 14, 2023); into §§ 1250.4(d) and 1250.5(d).

(2) [Reserved]

(c) Pool and Hot Tub Alliance (PHTA), 1650 King Street, Suite 602, Alexandria, VA 22314; phone: (703) 838-0083; website: www.phta.org.

(1) ANSI/APSP/ICC-16 2017, American National Standard for Suction Outlet Fitting Assemblies (SOFA) for Use in Pools, Spas and Hot Tubs, approved August 18, 2017; into § 1250.5(c).

(2) [Reserved]

(d) Underwriters Laboratories (UL), 1250 Connecticut Avenue NW, Suite 520, Washington, DC 20036; phone: (202) 296-7840; website: www.ul.com.

(1) ANSI/CAN/UL 12402-9:2022, Standard for Safety for Personal Flotation Devices—Part 9: Test Methods, First Edition, dated January 18, 2022; into § 1250.5(c).

(2) [Reserved]