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US FDA to Propose Rule for Children's Toy Laser Safety
On 7 August 2013 the US Food and Drug Administration (FDA) issued a proposed rule to define children’s toy Light Amplification by Stimulated Emission of Radiation (laser) products.
The FDA recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser and the greater the potential to pose serious danger if used improperly.
Under this proposed rule, designation of proper labeling with statements indicating compliance with 21 CFR Subchapter J on the label is highly encouraged.
Safety Hazards of Children’s Laser Toys
The highly-concentrated light emitted from lasers, even those in toy laser products, can be dangerous resulting in serious eye injuries and even blindness, not just to the person using a laser, but to anyone within range of the laser beam when operated unsafely or without certain controls. For laser toys to pose minimum risk to users, the levels of laser radiation or light output must not exceed the emission levels for Class I as defined in the Federal Performance Standard for Laser Products or for Class 1 as defined by the International Electrotechnical Commission (IEC).
Draft Guidance for Children’s Toy Laser Safety
Although most children’s toy laser products would meet the definition of “demonstration laser products” or “surveying, leveling, and alignment laser products” specified in the US Code of Federal Regulations at 21 CFR 1040.10(b)(13)
The Food and Drug Administration (FDA) is particularly concerned about the potential danger to children and those around them, and has issued a draft guidance document (http://www.fda.gov/
Following are examples of children’s toy laser products included in the guidance document:
- Lasers mounted on toy guns that can be used for “aiming”;
- Spinning tops that project laser beams while they spin;
- Hand held lasers used during play as “light sabers”;
- Dancing laser beams projected from a stationary column; and
- Lasers intended for entertainment that create optical effects in an open room.
Manufacturers of laser products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005.
In addition, laser products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040.
About SGS Services for Toys and Juvenile Products
SGS is committed to providing information about developments in the regulations for consumer products as a complimentary service. Throughout a global network of laboratories, SGS is able to provide a wide range of services including electromechanical testing and electrical safety certification (http://www.sgs.com/
Please do not hesitate to contact the SGS experts for further information.
SGS Consumer Testing Services
Technical Manager, Toys - Hardgoods
291 Fairfield AVE
Fairfield, New Jersey 07004
t: + 973-461-7928
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75 000 employees, SGS operates a network of over 1 500 offices and laboratories around the world.