A number of Prop 65 settlement agreements and judgments have been reached for phthalates in a range of products. Many of these allow a Prop 65 warning as an alternative.
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. This unique right-to-know law requires the state to publish a list of chemicals that are known to cause cancer, birth defects and/or reproductive harm.
Companies operating in California must provide ‘a clear and reasonable warning’ before knowingly and intentionally exposing anyone to a listed chemical. This provision becomes effective 12 months after a chemical has been listed.
Phthalates are a ubiquitous family of synthetic chemicals that are found in a diverse variety of products. They are primarily used as a plasticizer in polymer and rubber materials. They can also be used as dispersion agents, enteric coatings, emulsifying agents, gelling agents, solubilizers (solvents), stabilizers or viscous control agents.
Among the list of approximately 900 chemicals are six phthalates known to the state of California to cause cancer, birth defects, other reproductive harm or a combination of these toxicities. These six phthalates are:
A number of Prop 65 settlements have been reached for phthalates in a wide range of products. These include DIY, tools and hardware, home furnishings and housewares, sports and leisure items, bags and accessories, and electrical and electronic accessories. Many of these settlements agreed to reformulate all six (Prop 65) phthalates in their products and allowing a warning as an alternative.
Highlights of these settlements and judgments are summarized in Table 1. It is noteworthy that the parties in entry 7 agreed to reformulate di-n-octyl phthalate, a phthalate that is currently not in the Prop 65 list of chemicals as part of the settlement for earwax removal kits. This settlement agreement did not provide the acronym or CAS number for di-n-octyl phthalate.
The acronym for di-n-octyl phthalate (CAS 117-84-0) is commonly DNOP. This chemical is regulated in certain children’s products by some jurisdictions in the US, including California (Phthalates in Products for Young Children), Oregon (High Priority Chemicals of Concern for Children’s Health (HPCCCHs), Vermont (Chemicals of High Concern to Children, CHCCs) and Washington (CHCCs).
It is also interesting to note that the parties in entry 9 agreed to reformulate the content of four phthalates, or their releasable forms, using a modification of the NIOSH 9100 method, with a warning as an alternative.
| Entry | Scope | Reformulation/Warning for Phthalates |
|---|---|---|
| 1 | Binder clip grip materials | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 2 | Binders with clear vinyl/plastic coverings | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 3 | Cases used to carry small objects and made of or having components made of vinyl/PVC or other plastic | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 4 | Circuit tester cords/insulated electrical wires | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 5 | Coated utility and storage hooks | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 6 | Cosmetic bags | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 7 | Earwax removal kits | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP, DnHP and DNOP otherwise warning |
| 8 | First aid kits | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 9 | Fishing lures | ≤ 50% each of BBP, DEHP, DIDP and DINP or By modification of NIOSH 9100: ≤ 270 μg/cm² BBP, ≤ 160 μg/cm² DEHP, ≤ 1000 μg/cm² DIDP, ≤ 90 μg/cm² DINP, otherwise warning |
| 10 | Floating pool thermometers | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 11 | Football equipment bags | < 0.1% each of DBP, DEHP, DIDP and DINP |
| 12 | Gloves with vinyl/PVC components | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 13 |
| ≤ 0.1% each of DBP, DEHP and DINP otherwise warning |
| 14 | Handbags, totes, cosmetic bags and purses | ≤ 1000 ppm each of DIDP and DINP otherwise warning |
| 15 |
| ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 16 | Jump ropes | ≤ 0.1% each of DBP, DEHP and DINP otherwise warning |
| 17 | Keychains | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 18 | Math essentials kits | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 19 | Phone cords | ≤ 1000 ppm each of DEHP and DINP otherwise warning |
| 20 | Plastic hat products | ≤ 1000 ppm each of DEHP and DINP otherwise warning |
| 21 | Plastic purse | ≤ 1000 ppm each of DEHP, DIDP and DINP otherwise warning |
| 22 | Rubber hair roller sets and/or clear plastic bags and cases | ≤ 0.1% each of DEHP and DINP otherwise warning |
| 23 | Soft balls with vinyl, plastic, or other faux leather cover materials | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 24 | Storage or packaging cases made in whole or in part with vinyl or PVC for bedding products | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 25 | Tile mallets | ≤ 1000 ppm each of DIDP and DINP otherwise warning |
| 26 | Tool grips | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 27 | Tool pouches with vinyl/PVC components | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 28 | Vinyl/PVC audio cords | ≤ 0.1% each of DEHP and DINP |
| 29 | Vinyl/PVC greenhouse covers | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 30 | Vinyl/PVC hoses | < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 31 | Vinyl toiletry bags | ≤ 1000 ppm each of DEHP and DINP otherwise warning |
| 32 | Vinyl/PVC waterproof storage bags, cases and accessories | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 33 | Vinyl storage bags associated with hair rollers | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
| 34 | Vertical toggle clamps | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
| 35 | PASS | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP otherwise warning |
Table 1
A Prop 65 settlement is a consent agreement between the parties named in the settlement and a party not named in a settlement is not bound by that settlement.
Through its 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 DIY products, electrical and electronics, hardgoods products, juvenile products, and textile & toy products. For further information, please visit our website.
For enquiries, please contact:
Hingwo Tsang
Global Information and Innovation Manager
t: (+852) 2774 7420
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