California Proposition 65 Reformulation of Phthalates in Consumer Products
SAFEGUARDS | Consumer Products NO. 059/17
A number of Prop 65 settlement agreements involving phthalates have been reached for a wide variety of products. The parties agreed to reformulate or to provide a Prop 65 warning. Two settlements also include DIBP as part of their requirements.
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 the second half of 2016, there has been an increase in the number of settlements requiring the reformulation of phthalates and/or providing a Prop 65 warning label in a wide range of products. Highlights of these settlement agreements are summarized in Table 1. A Prop 65 settlement is a consent agreement between the parties named only in the settlement. Any party not named in a settlement is not bound by the terms of such settlement.
It is important to note that two of these settlement agreements listed in Table 1 (entries 4 and 8) resulted in the reformulation of phthalates to include DIBP, a substance that is currently not on the Prop 65 list of chemicals. DIBP is commonly known as diisobutyl phthalate (CAS 84-69-5). These settlement agreements did not provide the chemical name or CAS number for DIBP.
Table 1. Settlement agreements for phthalates
|Entry||Product||Reformulation for phthalates/warning|
|1||Crimpers with vinyl grips||≤ 1000 ppm each of DBP, DEHP, DINP, DIDP and DnHP|
||≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP|
|3||Gloves||≤ 1000 ppm each of DEHP and DINP otherwise warning|
|4||Hanger hooks covered with vinyl (in whole or in part)||≤ 1000 ppm each of DBP, DEHP, DIBP, DIDP, DINP and DnHP|
|5||Sink mats||≤ 0.1% each of DEHP and DBP|
||< 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP|
|7||Squeegees with vinyl/PVC blades||≤ 1000 ppm DEHP, DIDP and/or DINP|
|8||Vinyl coated utility hooks||≤ 1000 ppm each of DBP, DEHP, DIBP, DIDP, DINP and DnHP|
|9||Vinyl covers||≤ 1000 ppm DEHP, DIDP and/or DINP|
|10||Vinyl/PVC cutting mats||< 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP|
||≤ 1000 ppm DEHP, DIDP and/or DINP|
|12||Vinyl/PVC tool grips||< 0.1% each of DEHP and DINP|
|13||Vinyl/PVC washer bases (suction cups used in sinks)||≤ 1000 ppm DEHP, DIDP and/or DINP|
Table 2. Definitions
|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.
For enquiries, please contact:
Global Hardlines Information and Innovation Manager
t: +852 2774 7420
Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!
© SGS Group Management SA - 2017 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.