Standards working group aims to clarify nickel-free label in dental products manufacturing
April 07, 2014
By Jean Williams, ADA News staff
An International Organization for Standardization working group wants manufacturers to modify labels that proclaim a dental product nickel-free even as potentially harmful trace amounts remain in metal materials.
To that end, the working group seeks to clarify and redefine the term "nickel-free" in a revision of ISO 22674 Dentistry Metallic Materials, which allows manufacturers to employ the term if a product contains less than 0.1 percent nickel.
"One of the difficulties in defining nickel-free is that when extracting metals from their ores, nickel can be a naturally occurring impurity," said Spiro Megremis, Ph.D., assistant director, research and laboratories, ADA Division of Science. "The allergic reaction to nickel can vary from patient to patient and even very minute amounts of nickel may cause a reaction in some patients, while being harmless to others."
The working group's revision to the standard would mean manufacturers must account for trace amounts of nickel in metal alloys with a label change, including the statement "nickel free: contains less than 0.1 percent nickel."
"This is similar to packaging that is seen on food products that don't have peanuts listed in their ingredients but contain the warning 'made in a facility that processes peanuts,'" Dr. Megremis said.
For more information, contact firstname.lastname@example.org. ISO 22674 Dentistry Metallic Materials can be obtained through the ADA e-catalog at ADAcatalog.org.