What are phthalates?

Phthalates are high production volume chemicals used primarily as plasticizers in polyvinylchloride (PVC) products. There are several different kinds of phthalates, but all of them are used to make hard plastic more soft and flexible. Some common phthalates are: dibutyl phthalate (DBP), diisobutyl phthalate (DIBP), butyl benzyl phthalate (BBP), di-n-pentyl phthalate (DnPP), di (2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DnOP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP).

What are the risks of phthalates?

A number of phthalates are known or suspected endocrine disruptors, including the most common phthalate: di-exylhethyl phthalate (DEHP). Endocrine disruptors are toxins that interfere with the normal activities of the endocrine system, which regulates hormone levels in the body.In addition to this, Phthalates have been shown to cause a variety of effects in laboratory animals;

particularly their adverse effects on development of the reproductive system in males. These effects include infertility, decreased sperm count, cryptorchidism, hypospadias and other reproductive tract defects and are referred to as the phthalate syndrome.

Where are phthalates found?

Phthalates are nearly ubiquitous in modern society, found in plasticised products such as, among other things, toys, food packaging, coated leathers, raincoats, shower curtains, vinyl flooring, wall coverings, lubricants, adhesives, detergents, nail polish, hair spray and shampoo.

What legislation relates to phthalates and what are the limits?

REACH

Annex XVII REACH restricts DEHP, DBP and BBP in concentrations greater than 0.1% by weight of the plasticised material in toys and childcare articles.  It also restricts DINP, DIDP and DNOP in concentrations greater than 0.1% by weight of the plasticised material in toys and childcare articles which can be placed in the mouth by children.

On the European Commission website there is a document which has been published on questions and agreed answers on the implementation of Annex XVII of REACH. In this document it states that “different restrictions are applied to each of the two groups of phthalates. The limit value of 0.1% should therefore be applied for each group of phthalates combined, i.e. the concentration of DEHP, DBP and BBP combined should not be higher than 0.1% and the concentration of DINP, DIDP and DNOP combined should also not be higher than 0.1%.”

CALIFORNIA PROPOSITION 65

The Office of Environmental Health Hazard assessment (OEHHA) states that Proposition 65 applies to all products not just children’s products and is intended to provide information to Californian citizens on exposure any of the 800+ chemicals listed which are known to cause cancer, birth defects or other reproductive harm. 

The following phthalates are listed under Proposition 65:

- Di(2-ethylhexyl) phthalate (DEHP)

- Butyl benzyl phthalate (BBP)

- Di-n-butyl phthalate (DBP)

- Di-isodecyl phthalate (DIDP)

- Di-n-hexyl phthalate (DnHP)

Under Proposition 65, significant exposure to any one of these named phthalates would require a warning prior to the exposure. ”Safe harbor levels”for DEHP, DBP, and DnHP have been established which indicate when a Proposition 65 warning is required.

CPSIA

CPSIA Section 108 on products containing certain phthalates states that three phthalates, DEHP, DBP, and BBP, have been permanently prohibited by Congress in concentration of more than 0.1% in “children’s toys”or “child care articles.”

Three additional phthalates, DINP, DIDP, and DnOP, have been prohibited pending further study and review by a group of outside experts and the Commission. This interim prohibition applies to child care articles or toys that can be placed in a child’s mouth or brought to the mouth and kept in the mouth so that it can be sucked or chewed that contains a concentration of more than 0.1% of the above phthalates.