Safety of Children's Toy Laser Products
This guidance addresses children's toy laser products, defined as products primarily used as toys manufactured, designed, intended, or promoted for novelty or visual entertainment use by children under 14 years of age. It excludes laser products used in professional or academic settings.
What You Need to Know? 👇
What are the FDA’s current emission limits for children’s toy laser products?
FDA recommends that children’s toy laser products stay within FDA Class I or IEC Class 1 emission limits to minimize risk. These limits ensure safety even during long-term direct viewing by children.
How does FDA determine if a laser product qualifies as a children’s toy?
FDA considers promotion/advertising targeting children, sales location (toy stores), product graphics with cartoon characters, and whether it’s designed for novelty or visual entertainment use by children under 14.
Why are children’s toy lasers regulated differently from other laser products?
Children’s toy lasers are particularly susceptible to unsafe use. Children and supervising adults may not recognize dangers, and retinal injuries from laser exposure may go unnoticed since they’re not immediately evident.
What certification requirements apply to toys containing laser components?
The entire toy must be certified as a laser product unless the laser-emitting parts are removable and can function independently when separated. Removable laser systems require separate certification based on their emission class.
How do FDA and CPSC authorities overlap for children’s toy laser products?
FDA regulates radiation-emitting electronic products under sections 531-542 of the FD&C Act, while CPSC regulates toys under consumer safety laws. Both authorities complement each other to minimize risks.
What labeling recommendations does FDA provide for compliant children’s toy lasers?
FDA recommends IEC Class 1 designation labeling to clearly advise purchasers that products minimize risk and have been manufacturer-certified. This indicates the product doesn’t require higher-class laser safety controls or warnings.
What You Need to Do 👇
Recommended Actions
- Ensure laser emissions do not exceed FDA Class I or IEC Class 1 limits
- Implement appropriate labeling including IEC Class 1 designation
- Obtain necessary product certification for entire toy or removable laser components
- Review product marketing, sales channels, and features to determine if product qualifies as children’s toy
- Incorporate appropriate safety features, warnings, and instructions
- Ensure compliance with both FDA and CPSC regulations
- Consider potential misuse scenarios by children in product design
- Document compliance with Federal Performance Standards for Laser Products
Key Considerations
Human Factors
- Products should consider that children may use lasers in unsafe or uncontrolled manner
- Retinal injuries may go unnoticed and unreported
- Products should consider supervision by adults who may not recognize dangers
Labelling
- IEC Class 1 designation labeling is recommended
- Promotion, advertising, labeling, packaging, and product graphics should be considered in determining if product is a children’s toy
Safety
- Must comply with Federal Performance Standards for Laser Products
- Emission levels should not exceed FDA Class I or IEC Class 1 limits
- Entire toy needs certification unless laser-emitting parts are removable
- Should incorporate safety features, warnings, and instructions for safe use
Other considerations
- Location of product sales (e.g., toy stores) helps determine if product is a children’s toy
- Purpose and features of product indicate intended use by children
- Products are subject to both FDA and CPSC regulations
Relevant Guidances 🔗
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
- Laser Products - Performance Standards and Safety Requirements
Related references and norms 📂
- IEC 60825-1:2007: Safety of laser products
- 21 CFR 1040.10 and 1040.11: Federal Performance Standards for Laser Products