Before selling a product, it is important to consider the specific hazards that can occur during the normal and reasonably foreseeable use, damage, or abuse of the product. Some hazards may be so significant that the product should not be offered for sale. Other hazards may be addressed by a clear and conspicuous warning.
As a general rule, manufacturers and importers of children’s products are required to issue a written Children’s Product Certificate (CPC) certifying compliance with all applicable children’s product safety rules based upon the passing test results of third party testing.
Similarly, manufacturers and importers of certain general use products (i.e., non-children’s products) for which consumer product safety rules apply, must certify in a written General Certificate of Conformity (GCC) that their products comply with those applicable rules, based on testing or a reasonable testing program. Periodic testing may also be required to ensure continued product compliance after certification testing.
When considering what product safety standards may apply, consider some of these common requirements:
- Drawstrings: Due to risk of strangulation, the CPSC prohibits drawstrings at the hood and neck area of children’s upper outerwear in sizes 2T to 12. In addition, the CPSC drawstring standard places three requirements on drawstrings at the waist and bottom of children’s upper outerwear in sizes 2T to 16.
- Small Parts:
- Products intended for children under 3 cannot include small parts.
- For products intended for use by children who are at least 3 but less than 6 that have small parts must have a warning “Choking Hazard – Small parts - Not for children under 3 yrs” prominently displayed on the product packaging.
- Any toy or game that requires a cautionary statement about the choking hazard associated with small parts must bear that cautionary statement in the product’s advertising, if the advertising provides a direct means to purchase or order the product.
- Additional statements are required on latex balloons (or toys or games that contain a latex balloon), small balls (or toys or games intended for use by children ages 3 to 8 that contain a small ball), and marbles (or toys or games intended for children ages 3 to 8 that contain a marble). Products that are intended for children under 6 years of age must also comply with the Small Parts Regulations under the Federal Hazardous Substances Act (FHSA).
- Sharp Points or Edges: Products intended for use by children under 8 years of age must not contain sharp points or edges. The CPSC’s regulations apply to products with points or edges exposed during intended use or through foreseeable damage or misuse of a product.
- These regulations do not apply to toys that by their nature include functional sharp points or edges, such as toy sewing kits or toy scissors, as long as each such toy is conspicuously, legibly, and visibly labeled as having such points or edges. Further, these regulations do not apply to other, non-toy items having functional sharp points, such as ball point pens.
- Toys with functional sharp points or edges should be clearly and conspicuously labeled, e.g., “WARNING: This product has sharp edges that may cut or puncture. Handle with care.”
- Total Lead Content and Lead in Paint and Other Similar Surface Coatings: The CPSC enforces two limits related to lead in children’s product.
- Pursuant to the Consumer Product Safety Information Act (CPSIA), the majority of children’s products may not contain more than 100 ppm of total lead content in accessible parts. “Accessible parts” does not include component parts that are not accessible to a child through normal and reasonably foreseeable use and abuse of the product.
- In addition, with a few limited exceptions, all children’s products, including toys and some furniture, must not contain a concentration of lead greater than 90 ppm in paint or any similar surface coatings.
- Phthalates (Children’s Toys and Childcare Articles): Six types of phthalates are currently banned for use in children’s toys and certain child care articles. Phthalates are chemical plasticizers that are often used in the production of many types of plastics, certain inks, paints, and other products.
- Electronically- and Battery-Operated Toys and Other Products Intended for Use by Children: All electronically operated toys and other electronically operated products intended for use by children must meet requirements of the CPSC regulations enforcing the FHSA. For the purposes of these regulations, an electronic toy is one which is intended to be powered by electrical current from nominal 120-volt branch circuits. These regulations do not apply to toys or other products powered by circuits of 30 volts r.m.s. or less, articles used primarily by adults and only incidentally by children, or video games.
- Certification (Children’s Products): All children’s products must be tested by a CPSC-accredited third-party laboratory for compliance with applicable children’s product safety requirements. Testing must occur initially, periodically, and if a material change is made to the product which does or could affect the product’s ability to comply with applicable product children’s safety requirements. Manufacturers and importers of children’s products must then certify, in a written Children’s Product Certificate, based on these test results, that their children’s products comply with applicable children’s product safety requirements.
- Flammability: The Flammable Fabrics Act bans the sale of any fabric that does not conform to flammability standards. Standards have been established for the flammability of clothing textiles, vinyl plastic film (used in clothing), carpets and rugs, children’s sleepwear, and mattresses and mattress pads.
General Premarket Considerations
- The CPSC imposes safety requirements on a broad range of consumer products.
- Make sure to consider reasonably foreseeable harms that a product might cause, test for product safety if necessary, and disclose material hazards with a clear and conspicuous warning.
- Use of drawstrings are prohibited in the hood and neck area of children’s upper outerwear in sizes 2T to 12.
- There are restrictions on the use of small parts in children’s products up to the age of six, including prohibiting the use of small parts in products intended for children under three, and requiring certain cautionary statements.
- Products intended for use by children under eight must not contain any sharp points or edges.
- Lead and phthalate restrictions also apply to certain children’s products.
- All children’s products must be tested by a CPSC-accredited third-party laboratory and certified by the manufacturer or importer for compliance with applicable children’s product safety requirements.
- Clothing textiles, vinyl plastic film (used in clothing), carpets and rugs, children’s sleepwear, and mattresses and mattress pads must conform to flammability requirements.
Reporting to the CPSC
Once a product has been distributed into commerce, companies have the obligation to report any potential safety concerns to the CPSC, and potentially conduct a recall.
A manufacturer, retailer, or distributor of a consumer product must report to the CPSC if it obtains information which reasonably supports the conclusion that such product: (1) fails to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard; (2) fails to comply with any other rule, regulation, standard, or ban under this chapter or any other Act enforced by the CPSC; (3) contains a defect which could create a substantial product hazard; (4) creates an unreasonable risk of serious injury or death; or (5) involves an incident in which a child (regardless of age) chokes on a marble, small ball, latex balloon, or other small part contained in a toy or game and that, as a result of the incident, the child dies, suffers serious injury, ceases breathing for any length of time, or is treated by a medical professional.
Failure to fully and immediately report this information may lead to substantial civil or criminal penalties. CPSC civil penalties have generally been on the rise, often exceeding $1 million. To avoid being the subject of a CPSC civil penalty investigation, below are some general tips to keep in mind:
- Companies should develop a compliance program designed to ensure compliance with all applicable product-safety standards, rules, and regulations; have a system in place to maintain and review all safety-related information received about their products; and have a system of internal controls and procedures to ensure timely and accurate reporting.
- If a reporting obligation arises, reporting is required “immediately” (i.e. within 24 hours of obtaining reportable information). While businesses may conduct a reasonably expeditious investigation in order to evaluate the reportability, the investigation and evaluation should not exceed 10 working days unless the company can demonstrate that a longer time is reasonable in the circumstances.
- “Defect” could include any fault, flaw, or irregularity in a consumer product that causes weakness, failure, or inadequacy in form or function.
- A defect could be the result of a manufacturing or production error, or may also arise when product is manufactured exactly in accordance with its design and specifications, but the design of the product, or materials used, results in a defect that presents a risk of injury to the public.
- The primary limitation to the “defect” requirement is that the defect must create a “substantial product hazard.” The CPSA defines “substantial product hazard” as a product defect that “creates a substantial risk of injury to the public.”
- The CPSC will review the following factors to determine whether a defect is serious enough to create a substantial product hazard: (1) pattern of defect; (2) number of defective products distributed in commerce; (3) severity of risk; and (4) likelihood of injury.
- In determining whether a product presents an unreasonable risk of serious injury or death, a company should examine the utility of the product, or the utility of the aspect of the product that causes the risk, the level of exposure of consumers to the risk, the nature and severity of the hazard presented, and the likelihood of resulting serious injury or death.
- The CPSC takes a very broad view of the term “serious injury or death” to include any “significant injury.”
- The requirement that notification occur when a responsible party “obtains information which reasonably supports the conclusion that” its product creates an unreasonable risk of serious injury or death is intended to require companies to report even when no final determination of the risk.
- Report to the CPSC if the company obtains information that reasonably supports the conclusion that a product fails to meet a consumer product safety rule, standard, or ban, contains a defect which could create a substantial product hazard, or creates an unreasonable risk of serious injury or death.