California Proposition 65 Reformulation of Phthalates in Consumer Products
A number of Prop 65 settlement agreements involving phthalates have been reached for a wide variety of products. The parties agreed to reformulate or provide a Prop 65 warning as an alternative.
SAFEGUARDS | Consumer Products NO. 189/17
California Proposition 65 (Prop 65 ) is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, a ballot initiative passed overwhelmingly by California residents in November 1986. It requires the state to publish a list of chemicals  that are known to cause cancer, birth defects or reproductive harm. The list was first published in 1987 and is updated at least once a year.
Prop 65 places two important provisions  for companies doing business in California. These are:
Providing a clear and reasonable warning before knowingly and intentionally exposing anyone to a listed chemical. Once a chemical is listed, businesses have 12 months to comply with this requirement. The new and revised language for a clear and reasonable warning  will become effective on August 30, 2018.
Prohibiting from knowingly discharging a listed chemical into sources of drinking water. Once a chemical is listed, businesses have 20 months to comply with this requirement
Businesses with less than 10 employees and government agencies are exempt from these 2 provisions. Businesses are also exempt from these provisions if the exposures create no significant risk of cancer, birth defects or other reproductive harm.
The Prop 65 list contains approximately 800 chemicals, including 6 phthalates (BBP, DBP, DEHP, DIDP, DINP and DnHP). These plasticizers are known to the state of California to cause cancer, birth defects, other reproductive harm or a combination of these toxicities.
Products containing phthalates have consistently been targeted  over the years. Since late 2016, there have been a number of Prop 65 settlement agreements requiring the reformulation of phthalates or providing a Prop 65 warning label in a wide variety of products.
Highlights of these settlement agreements are summarized in Table 1.
Table 1. Settlement agreements for phthalates
|Entry||Scope||Reformulation for Phthalates/Warning|
|1||Bolster rolls and wedges||≤ 1000 ppm DINP otherwise warning|
|2||Cosmetic travel cases||≤ 1000 ppm DINP otherwise warning|
|3||Floor mats||≤ 1000 ppm DINP otherwise warning|
|4||ID Badge holders||≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP|
|5||PVC sink stoppers||≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning|
|6||Shampoo hose||≤ 1000 ppm each of DEHP and DINP otherwise warning|
|7||Splash pouches or other vinyl tarps||≤ 1000 ppm DINP otherwise warning|
|8||Sport bags||≤ 1000 ppm each of DEHP and DINP otherwise warning|
|9||Spring clamps with vinyl grips and/or tips||≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP|
|10||Steel hangers, in whole or in part, with grippy materials||≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP|
|11||Vinyl hair caps||≤ 1000 ppm each of DEHP and DINP otherwise warning|
|12||Vinyl medical products such as mats and/or seating and cushions||≤ 1000 ppm each of DEHP and DINP otherwise warning|
|13||Vinyl medical products such as mats and/or seating and cushions||≤ 1000 ppm DIDP otherwise warning|
|14||Vinyl/PVC rainwear||< 0.1% DINP otherwise warning|
Table 2. Definitions
|BBP||Butyl benzyl||85-68-7||DIDP||Di-isodecyl||68515-49-1 / 26761-40-0|
Throughout a global network of laboratories, SGS can offer comprehensive testing, product assessments and consultancy services related to California Proposition 65 to assist your risk management in your supply chain for consumer goods such as DIYs, electrical and electronics, hardgoods products, juvenile products, and textile & toy products. For further information, please visit our website.
While businesses not named in Prop 65 settlements are not legally bound by the agreement, due to the unique nature of Prop 65, it is advisable for companies doing business in California to use settlement reformulation limits as a reference to avoid possible future litigation.
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