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%.”

CALIFORNIAPROPOSITION 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.

The Consumer Product Safety Improvement Act (CPSIA), enacted in 2008, effectively bans the presence of various phthalates in children's products, limiting their content to 1000 ppm. However, growing concern and publicity has prompted most brand-name manufacturers and retailers to ban this class of chemicals - used to plasticise (soften) plastics and coatings - from all of their products.

In February 2009, the Consumer Product Safety Commission (CPSC) published its Standard Operating Procedure for Determination of Phthalates.

The Leather Research Laboratory offers testing to this exact procedure, so call us today to initiate testing and compliance certification for your range of leathers or leather products.

The specific phthalates that are restricted are:

1) di(2-ethylhexyl) phthalate (DEHP)

2) dibutyl phthalate (DBP)

3)benzyl butyl phthalate (BBP)

4)Diisononyl phthalate (DINP)

5)Diisodecyl phthalate (DIDP)

6)Di-n-octyl phthalate (DnOP)

Regulations

Candidate List (SVHC List) under REACH Regulation: 14 phthalates

REACH Annex XVII: 6 phthalates

OEKO-TEX® Standard 100: 15 phthalates

US Consumer Product Safety Improvement Act (CPSIA): 6 phthalates

US Prop 65: 6 phthalates

China GB 6675 Safety of Toys: 6 phthalates

China GB 24613 Limit of Harmful Substances in Coatings for Toys: 6 phthalates

CanadaSOR/2011-298: 6 phthalates

EU Commission Regulation (EU) No 10/2011 for food contact materials: 8 phthalates

The 6th batch of Inedible Substance List issued by Health Ministry of China: 17 phthalates

Taiwan’s Ministry of Health and Welfare: 6 phthalates

China GB/T 21911 Determination of Phthalate Esters in Foods: 16 phthalates

China GB/T 21928 Determination of Phthalate Esters in Food Plastic Packaging Materials: 16 phthalates

China GB/T 22048 Determination of Certain Phthalate Esters in Toys and Children’s Products: 6 phthalates

What are phthalates and what is phthalates testing?

PTS Testing Service are experts in phthalates testing. Phthalates are high production volume chemicals used primarily as plasticizers in polyvinylchloride (PVC) and Polyurethane (PU) products. There are several different kinds of phthalates, but all of them are used to make hard plastic more soft and flexible.

The risks…

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.

Why you need phthalates testing?

Phthalates are heavily regulated globally. 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.

PTS Testing Service can provide 23 kinds of phthalates detection :