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California Proposition 65 Reformulation of Phthalates in Hearing Protection Products

SafeGuardSAugust 17, 2015

A recent Prop 65 settlement reveals a consent agreement for phthalates in hearing protection products. Reformulated products are to contain less than 0.1% of each of the agreed phthalates, including DINP.

Proposition 65 (Prop 65) [1] is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, a ballot initiative passed overwhelmingly by California residents in 1986. Since its enactment, there have been numerous lawsuits which resulted in the reduction of carcinogenic and reproductive toxicity chemicals through reformulations of consumer products containing such chemicals.

The Prop 65 list contains approximately 850 chemicals that are known to cause cancer, birth defects or other reproductive harm. This list includes six phthalates:

  • Butyl benzyl phthalate (BBP)
  • Di-n-butyl phthalate (DBP)
  • Di(2-ethylhexyl)phthalate (DEHP)
  • Di-isodecyl phthalate (DIDP)
  • Diisononyl phthalate (DINP)
  • Di-n-hexyl phthalate (DnHP)

Phthalates are a group of chemicals that are used in plastics to make them soft and flexible. They are also used as solvents in paints and similar surface coating materials to make them more spreadable.

Over the years, consumer products containing phthalates [2] have been consistently targeted. These include cables, computer accessories, furniture, gloves, lighting equipment, organizers, sports equipment and storage baskets.

On 12 December 2013, diisononyl phthalate (DINP) [3] was added onto the Prop 65 list of chemicals as a chemical known to the state of California to cause cancer. This amendment took effect on 20 December 2013. Since 20 December 2014:

  • Businesses have been required to provide a ‘clear and reasonable warning’ before knowingly and intentionally exposing anyone to DINP.
  • California Attorney-generals, non-governmental organizations, and individuals acting in the public interest have been allowed to begin enforcement actions [4] against businesses that fail to warn consumers about exposure to DINP.

In May 2015, a Prop 65 settlement [5] involving DINP in vinyl / PVC gloves was reached.  Under the terms of the settlement, reformulated vinyl / PVC gloves are to contain less than 0.1% DINP.

In July 2015, a Prop 65 settlement involving DEHP, DINP and DIDP in hearing protection products was reached.  Under the terms of the settlement, reformulated hearing protection products with vinyl / PVC ear cushions or ear plugs are to contain no more than 0.1% (1000 ppm) each of DEHP, DINP and DIDP. 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.

Highlights of the settlement are summarised in Table 1.

Table 1





Hearing protection products containing vinyl / PVC ear cushions or ear plugs

≤ 1000 ppm each of DEHP, DIDP and DINP

Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy for phthalates and other restricted substances in consumer products for California and international markets. Please do not hesitate to contact us for further information.

For enquiries, please contact:

Hing Wo Tsang
Global Toys and Juvenile Products
t: +852 2774 7420

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