SAFEGUARDS | HardgoodsNO. 066/21
California Proposition 65 (Prop 65) is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, a ballot initiative passed overwhelmingly by Californian residents in November 1986. It requires the state to publish a list of chemicals that are known to cause cancer, birth defects and/or reproductive harm. The list was first published in 1987 and has evolved to include approximately 900 chemicals.
In Prop 65, one important provision for companies doing business in California is to provide a clear and reasonable warning before knowingly and intentionally exposing anyone to a listed chemical. Unless exempt, businesses have 12 months to comply with this requirement once a chemical is listed.
N-Nitrosodiethylamine (NDEA, CAS 55-18-5) is a chemical known to cause cancer and has been on the Prop 65 list of chemicals since October 1987. Sources/uses of this chemical may include lubricant additives, stabilizer in plastics and as a by-product from the manufacture of elastomeric materials.
In a 2015 Prop 65 settlement, a reformulation of no more than 10 ppb (parts per billion) NDEA in condoms was agreed between the parties named in the settlement (SafeGuardS 6/16).
In April 2021, two 60-day notices of violation were issued to businesses for failing to provide a clear and reasonable warning for NDEA exposure from a variety of latex resistance bands used for exercise.
The 60-day notice of violation is a legal document served to businesses which have allegedly violated Prop 65 warning requirements. It usually results in settlement negotiations, which may result in the two parties having a settlement agreement with reformulation or defined concentration requirements.
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