Table 1. Reformulation of 1,4-dioxane in consumer products
| Entry | Scope | Reformulation/warning for 1,4-dioxane |
| Body wash and hand soap products | ≤ 10 ppm using Headspace GCMS |
SG 01126
Multiple settlements reached for a range of consumer products containing California Proposition 65 (Prop 65) chemicals.
California Prop 65 is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, a ballot initiative passed overwhelmingly by Californian residents in 1986. It requires the state to publish a list of chemicals that are known to cause cancer, birth defects or reproductive harm. First published in 1987 and updated at least once per year, the list has evolved to approximately 900 chemicals.
Under 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. Failure to provide a warning may not only result in lawsuits but also civil penalties of up to USD 2,500 per violation per day.
In this communication, we summarize multiple recent settlements involving a variety of products containing the following chemicals:
Table 1. Reformulation of 1,4-dioxane in consumer products
| Entry | Scope | Reformulation/warning for 1,4-dioxane |
| Body wash and hand soap products | ≤ 10 ppm using Headspace GCMS |
Table 2. Reformulation of bisphenol A (BPA) and bisphenol S (BPS) in consumer products
| Entry | Scope | Reformulation/warning for BPA and BPS |
| Sports bras made primarily of polyester with spandex | ≤ 200 ppb BPA, otherwise warning (defendant must not replace BPA with other bisphenols: BPAF, BPAP, BPB, BPE, BPF, BPP, BPS and BPZ) | |
| Thermal receipt paper/thermal paper | < 100 ppm each of BPA and BPS |
Table 3. Reformulation of diethanolamine (DEA) in consumer products
| Entry | Scope | Reformulation/warning for DEA |
| < 20 ppm, otherwise warning | |
| < 0.1 ppm, otherwise warning | |
| < 2.0 ppm, otherwise warning | |
| < 10 ppm, otherwise warning | |
| < 20 ppm or < 0.1% in any triethanolamine (TEA)-containing ingredient, otherwise warning |
Table 4. Reformulation of lead in consumer products
| Entry | Scope | Reformulation/warning for lead |
| ≤ 100 ppm in brass alloys and ≤ 0.5 μg (NIOSH 9100) on the product's entire surface, otherwise warning | |
| ≤ 1.0 μg (NIOSH 9100), otherwise warning | |
| ≤ 90 ppm, otherwise warning | |
| ≤ 1 μg (NIOSH 9100) on a representative portion of the surface (not a confined area), and ≤ 25 ppm in any decorations located in the upper 20 mm of a product (lip and rim area), otherwise warning | |
| < 100 ppm in each brass component, otherwise warning | |
| ≤ 90 ppm in any accessible exterior metal surface; or ≤ 1.0 μg (NIOSH 9100) on any accessible metal surface, otherwise warning | |
| ≤ 90 ppm and ≤ 1.0 μg (NIOSH 9100), otherwise warning | |
| ≤ 90 ppm in any accessible component and ≤ 1.0 μg (NIOSH 9100) on any surface, otherwise warning | |
| ≤ 90 ppm in any decoration, colored artwork, designs and/or marking on the surface of the product, or ≤ 1 μg (NIOSH 9100), otherwise warning |
Table 5. Reformulation of perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS) in consumer products
| Entry | Scope | Reformulation/warning for PFOA or PFOS |
| Contains no intentionally added 1) PFOS and 2) any fluorinated ingredient that causes PFOS to be present in the product, including but not limited to C9-15 fluoroalcohol phosphate, otherwise warning | |
| Contains no intentionally added 1) PFOA and 2) any fluorinated ingredient that causes PFOA to be present in the product, including but not limited to C9-15 fluoroalcohol phosphate, otherwise warning |
Table 6. Reformulation of consumer products containing one or more phthalates
| Entry | Scope | Reformulation/warning |
| ≤ 10 ppm DBP, otherwise warning | |
| ≤ 0.1% DEHP, otherwise warning | |
| < 0.1% DINP, otherwise warning | |
| < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP, otherwise warning | |
| ≤ 1,000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
It is interesting to note that many of the settlement agreements allow a Prop 65 warning as an alternative to reformulation requirements. Additionally, several settlements require lead content and releasable lead testing using NIOSH 9100 (Ghost wipe test) as part of the reformulation.
A Prop 65 settlement is a consent agreement between the parties named in the settlement and entities not named in the settlement are not bound by its terms.
Stakeholders should be aware California will require the name of at least one chemical on short-form warning labels from January 2028 (SafeGuardS 177/24).
| Entry | Abbreviation | Phthalate | CAS |
| BBP | Butyl benzyl phthalate | 85-68-7 | |
| DBP | Di-n-butyl phthalate | 84-74-2 | |
| DEHP | Di(2-ethylhexyl)phthalate | 117-81-7 | |
| DIDP | Di-isodecyl phthalate | 68515-49-1/26761-40-0 | |
| DINP | Diisononyl phthalate | --- | |
| DnHP | Di-n-hexyl phthalate | 84-75-3 |
Companies doing business in California, USA, need to be aware of and comply with Proposition 65. We provide analytical testing and consultancy services to evaluate your products and guide you toward Prop 65 compliance. Contact us to learn more, or visit our website. In the end, it’s only trusted because it’s tested.
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