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California Proposition 65: Reformulation of Chemicals in Consumer Products

Multiple settlements have been reached for a range of products containing Proposition 65 (Prop 65) chemicals. Many of these agreements allow a Prop 65 warning as an alternative.

 

California 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 or reproductive harm. First published in 1987 and updated at least once per year, the list 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. Failure to provide a warning may result in lawsuits.

 

In this communication, we summarize multiple recent settlements involving a variety of consumer goods containing the following chemicals:

 

Bisphenol A (BPA)

 

Table 1. Reformulation of BPA in consumer goods

 

Entry Scope Unless stated, reformulation/warning for BPA
1
  • Computer cases
  • Safety glasses
  • Warning
2
  • Pill splitters
  • ≤ 3 μg (wipe test), otherwise warning
3
  • Socks designed for female shoes whose composition includes spandex and ≥ 51% polyester
  • ≤ 10 ppm (BPA must not be replaced with other bisphenols (BPAF, BPAP, BPB, BPE, BPF, BPP, BPS and BPZ))

 

 

Lead

 

Table 2. Reformulation of lead consumer goods

 

Entry Scope Reformulation/warning for lead
1
  • Antique brass shoehorns
  • Ceramic pitchers
  • Decorative trays
  • Gravy boats
  • Keychains
  • Laser pet toy products
  • Mug and lid sets (dinnerware)
  • Oil bottles (kitchenware)
  • Ornament mug products
  • Wind chime products
  • ≤ 1 μg (NIOSH 9100), otherwise warning
2
  • Bronze fittings
  • ≤ 100 ppm, and ≤ 1.0 μg (NIOSH 9100), otherwise warning
3
  • Butter dishes
  • Any decoration, colored artwork, designs and/or marking on the surface of the product: ≤ 90 ppm
  • Any surface: ≤ 1 μg (NIOSH 9100)
  • Any decorations: ≤ 25 ppm
  • Otherwise warning
4
  • Ceramic fragrance warmers with exterior designs
  • Ceramic trays with surface designs
  • Any colored artwork, designs and/or marking on the exterior surface of the product: ≤ 90 ppm
  • Any surface: ≤ 1 μg (NIOSH 9100
  • Otherwise warning
5
  • Ceramic soap dispensers
  • Ceramic trays
  • Ceramic vases (decoration items)
  • Critter baths (ceramic bath houses for pets)
  • Jewelry holders
  • Napkin holders
  • ≤ 4 μg (NIOSH 9100), otherwise warning
6
  • Ceramic teacups with exterior designs
  • Colored artwork, designs and/or marking on the exterior surface of the product: ≤ 90 ppm
  • Any surface: ≤ 1 μg (NIOSH 9100)
  • Any decorations located in the upper 20 mm of a product (lip and rim area): ≤ 25 ppm
  • Otherwise warning
7
  • Ceramic toothbrush holders with exterior designs
  • Any decoration, colored artwork, designs and/or marking on the surface of the product: ≤ 90 ppm
  • Any surface: ≤ 1 μg (NIOSH 9100)
  • Otherwise warning
8
  • Glass bottles with exterior decorations
  • Any exterior surface: ≤ 90 ppm
  • Any surface: ≤ 1 μg (NIOSH 9100)
  • Otherwise warning
9
  • Glass nail polish bottles with exterior decoration
  • Any decoration, description, artwork and/or design on the exterior surface: ≤ 25 ppm
  • Any exterior surface: ≤ 0.5 μg (NIOSH 9100)
  • Otherwise warning
10
  • Metal and glass boxes
  • Metal and glass brush holders
  • Any accessible component: ≤ 90 ppm
  • Any surface: ≤ 1.0 μg (NIOSH 9100)
  • Otherwise warning
11
  • Pet bowls
  • Any decoration, colored artwork, designs and/or marking on the surface of the product: ≤ 90 ppm
  • Any surface: ≤ 1 μg (NIOSH 9100)
  • Any decorations: ≤ 25 ppm
  • Otherwise warning
12
  • Snare wire products
  • Warning
13
  • Stoneware mugs with exterior designs
  • Any decoration, colored artwork, designs and/or marking on the surface of the product: ≤ 90 ppm
  • Any surface: ≤ 1 μg (NIOSH 9100)
  • Any decorations located in the upper 20 mm of a product (lip and rim area): ≤ 25 ppm
  • Otherwise warning
14
  • Whisk set products
  • ≤ 90 ppm, otherwise warning

 

 

One or more phthalates

 

Table 3. Reformulation of consumer goods containing one or more phthalates

 

Entry Scope Reformulation/warning for one or more phthalates
1
  • Pet food bowls
  • < 0.1% DBP, otherwise warning
2
  • Bath pillows
  • Car sun visor organizers with clear plastic window
  • Fender holders with adjuster
  • < 0.1% DEHP, otherwise warning
3
  • Bed air mattress
  • Bike beam attachments
  • Electronic abs stimulators
    • (includes electronic muscle stimulators)
  • Neck cooling tubes
  • Shoe charms
  • Support belts with reflector
  • Throw ropes
  • Video and audio recorders
  • Vinyl/PVC door hangers
  • Wakeboard ropes
  • Waterproof phone cases
  • ≤ 0.1% DEHP, otherwise warning
4
  • High heeled shoes
  • ≤ 0.1% each of DEHP and DINP
5
  • Choral folders
  • Sandbag weights
  • Sitz baths with tubing and water bag
  • Waterproof phone pouches
  • ≤ 0.1% DINP, otherwise warning
6
  • Exercise ball covers
  • PVC curtains (workstation curtains)
  • < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP
7
  • Novelty pillows with vinyl pouch windows
  • ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP
8
  • Vinyl-coated cables
  • Vinyl/PVC sheeting and associated parts (plastic zipper door kits)
  • < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP, otherwise warning

 

 

Lead and phthalates

 

Table 4. Reformulation of consumer goods containing lead and phthalates

 

Entry Scope Reformulation/warning for lead and phthalates
1
  • Valves (carbon dioxide valve fill stations for paintball guns)
  • < 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP
  • ≤ 90 ppm Lead
  • ≤ 1.0 μg Lead (NIOSH 9100)

  • Otherwise warning

 

 

Chromium (VI) Compounds

 

Table 5. Reformulation of chromium (VI) compounds in consumer goods

 

Entry Scope Reformulation/warning for lead and phthalates
1
  • Leather belts
  • Leather gun holsters
  • Tool belts
  • Leather welding aprons
  • Warning

 

 

Perfluorooctanoic acid (PFOA)

 

Table 6. Reformulation of PFOA in consumer goods

 

Entry Scope Unless stated, reformulation/warning for PFOA
1
  • Backpack coolers
  • Contains no intentionally added PFOA, otherwise warning
2
  • Cases
  • Hats
  • Jackets
  • Contains no intentionally added 1) PFOA and 2) fluorinated ingredient that causes PFOA to be in the product, including but not limited to C9-15 fluoroalcohol phosphate, otherwise warning
3
  • Hunting vests
  • Nonstick fry pans
  • Products alleged to contain PFOA:
  • < 100 ppm total organic fluorine (TOF) and no intentionally added PFOA, otherwise warning
4
  • Tablecloths
  • Warning for intentionally added PFOA
5
  • Ponchos
  • Umbrellas
  • Warning for PFOA

 

 

Cocamide diethanolamine (cocamide DEA) and diethanolamine (DEA)

 

Table 7. Reformulation of cocamide DEA or DEA in consumer goods

 

Entry Scope Reformulation/warning for cocamide DEA or DEA
1
  • Face and neck mask products
  • Facial exfoliator products
  • Hand soap products
  • Lotions
  • Pain relief creams
  • Sunscreen products
  • < 10 ppm reporting limit for DEA by LC/MS/MS or ICP-MS, otherwise warning
2
  • Facial sprays
  • Styling gels
  • < 2.0 ppm reporting limit for DEA by LC/MS/MS or ICP-MS, otherwise warning
3
  • Gel products (blemish control gel)
  • Skincare products, ingrown hair and skin soothers, cleansers and cream mask products
  • < 10 ppm reporting limit for DEA by LC/MS/MS, ICP-MS or GC-FID, otherwise warning
4
  • Hair cream products
  • < 10 ppm reporting limit for DEA by LC/MS/MS or ICP-MS
5
  • Mask sheets
  • < 2.2 ppm reporting limit for DEA by LC/MS/MS or ICP-MS, otherwise warning
6
  • Moisturizing gels
  • < 200 ppm reporting limit for DEA by LC/MS/MS or ICP-MS, otherwise warning
7
  • Moisturizing lotions
  • < 50 ppm reporting limit for DEA by LC/MS/MS or ICP-MS, otherwise warning
8
  • Shampoos
  • Cocamide DEA not detectable or below the reporting limit (lowest concentration at which cocamide DEA can be detected) by LC/MS/MS or ICP-MS, otherwise warning
9
  • Skin moisture/cream products
  • < 0.1 ppm reporting limit for DEA by LC/MS/MS or ICP-MS, otherwise warning

 

 

_________________________________________________________________________________________________________________________________________

 

 

A Prop 65 settlement is a consent agreement between the parties named in the settlement and parties not named in the settlement are not bound by it.

 

It is important to note that California has recently revised its Prop 66 warning requirements.

 

Abbreviations

 

Entry Abbreviation Phthalate CAS
1 BBP Butyl benzyl phthalate 85-68-7
2 DBP Di-n-butyl phthalate 84-74-2
3 DEHP Di(2-ethylhexyl)phthalate 117-81-7
4 DIDP Di-isodecyl phthalate 68515-49- 1/26761-40-0
5 DINP Diisononyl phthalate ---
6 DnHP Di-n-hexyl phthalate 84-75-3

 

Companies doing business in California, USA, need to be aware of and comply with Proposition 65.

 

Disclaimer: The information provided is for technical and general information purposes only and offers no legal advice. The information is no substitute for professional legal advice to ensure compliance with the applicable laws and regulations.

 

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