PHTHALATES – FACT SHEET

International Coatings Product Compliance

Unless otherwise specified, all International Coatings standard ink product formulas manufactured after January 1, 2009 now comply with the U.S. Consumer Product Safety Improvement Act of 2008 (CSPIA) regarding lead and phthalate content and the Consumer Product Safety Act, Title 16 CFR Part 1303, regarding restrictions on heavy metals.* 

Introduction and Phthalate Information Sources

International Coatings recognizes that there is considerable interest in the new CSPIA regulations, particularly as they apply to phthalates and how they affect the apparel screen printing industry.  The following information provides an overview of what phthalates are, in what and how they are used, why they are of concern and what is meant by being ‘phthalate compliant’.  Much of the information in this fact sheet comes from the Phthalate Esters Panel and the Phthalate Information Centre Europe.  You can access these organizations and learn more about phthalates by visiting their web sites - www.phthalates.org (Phthalate Ester Panel) and www.phthalates.com (Phthalate Information Centre Europe).

What are Phthalates?

Phthalates (pronounced THAL-ates) are organic chemicals derived from oil.  They are the most commonly used plasticizers in the world.  Phthalates have been in use for about 50 years, primarily to make polyvinyl chloride (PVC) soft and flexible.  Phthalates look like clear vegetable oil and have little or no smell. The benefits they bring to products include not just flexibility, but durability, longevity and low cost.

Phthalates are always incorporated with other materials into an end product.  They are most commonly blended with PVC resins, pigments and additives to produce everything from textile screen print inks, to PVC flooring and cable sheathing, to life-saving medical devices.  Not all phthalates are used as plasticizers for PVC.  Phthalates keep nail polish from chipping, make perfume linger longer, or make tool handles strong and more resistant to breaking. Others are used to enhance the performance of many other materials, including adhesives, sealants, and paint pigments.

Types of Phthalates

Phthalate esters are by far the most widely produced plasticizers worldwide. Both ortho-phthalate and terephthalate acids can be reacted with an alcohol to produce phthalate esters, which may be used as plasticizers. In practice, terephthalates are more commonly used in the USA than elsewhere. 

Phthalate esters are manufactured from alcohols such as methanol and ethanol (C1/C2) up to iso-decanol (C13), either as a straight chain molecule or with some branching. This large variety of phthalate molecules provides a wide range of different properties for different uses.

Health and Environmental Effects

Because phthalates are so widely used, they have undergone extensive testing for possible health and environmental effects.  They are among the most widely researched of all chemical substances. Research findings and current assessments of the health and environmental effects of phthalates indicate that they do not pose a conclusive risk to human health or the environment.

Phthalates do not persist in the environment; they biodegrade readily. They do not accumulate in animals or humans; inside the body, they break down quickly and are excreted. Most importantly, in their long history of use, there is not one known case of them ever having caused anyone any demonstrable harm. To the contrary, they are important and often unique components of many of today’s life saving medical devices.

So why are phthalates of concern?  Despite its long record of successful use, some issues have been raised in recent years about possible human health effects. These are based on results of studies that showed some adverse health effects in rodents, at much higher exposures than normally would be encountered by people.  Most attention has centered on ortho-phthalates and the finding that high doses of some of these phthalates can interfere with normal sexual development in male rodents. Sexual development in rodents happens rapidly and shortly before birth. High doses of some phthalates administered to pregnant rats shortly before they gave birth suppressed levels of testosterone, a male hormone key to sexual development in the male fetuses, and interfered with the development of male reproductive organs. However, there were also lower doses at which there were no effects, and even these "no effect doses" were far above those that any human being would be exposed to under any realistic scenario. 

The major phthalates in commerce today have not been shown to interfere with or mimic either the estrogen or androgen receptors when tested in laboratory animals. That is, they neither activate the male or female hormone receptors nor prevent activation by natural hormones.

To learn more about the health and environmental effects of phthalates, visit www.phthalates.org.  Links are provided on the site to more detailed discussions, government reports, industry filings with regulatory agencies, and other relevant Web sites.

Phthalate Compliance

Over the past several years, a number of federal, state and international laws have been enacted that restrict the use of certain ortho-phthalates.  These laws target toys and certain child care articles used by infants and children.  There is some question as to whether and how these laws apply to children’s clothing, in particular clothing printed with plastisol textile inks containing phthalate plasticizers.  To minimize uncertainty, several major retailers have decided to require compliance of all textile articles to the new phthalate restrictions.  

What is required to be ‘Phthalate Compliant’?  Products comply if they do not contain more than 0.1% of any of the six phthalates restricted or banned by the new state and federal laws.  These six phthalates are:

DEHP (Di-2-ethylhexyl phthalate)
DBP (Dibutyl phthalate)
BBP (Benzyl butyl phthalate)
DINP (Di-isononyl phthalate)
DIDP (Di-isodecyl phthalate)
DnOP (Di-n-octyl phthalate)

To be clear, the laws do not restrict or ban the use of all phthalates, just the six named above.  In fact, only three of the six phthalates above are banned by the federal government unconditionally – DEHP, DBP, BBP.  Use of the other three is restricted on an interim basis pending further scientific investigation.

What are ‘Phthalate-Free’ inks? 

Phthalate-Free inks or compounds do not contain phthalate based plasticizers.

What are PVC-Free & Phthalate-Free inks? 

These are inks or compounds that do not contain PVC (Polyvinyl Chloride) resins or phthalate based plasticizers.

* International Coatings standard ink products contain less than 90 ppm by weight of lead.   Unless otherwise specified, International Coatings standard ink products are no longer formulated with the following six restricted phthalates nor are they intentionally added to these inks as part of the manufacturing process: DEHP (Di-2-ethylhexyl phthalate), DBP (Dibutyl phthalate), BBP (Benzyl butyl phthalate), DINP (Di-isononyl phthalate), DIDP (Di-isodecyl phthalate), and DnOP (Di-n-octyl phthalate). 
  
The information provided is believed to be accurate based on the scientific data supplied to International Coatings by its suppliers and is presented in good faith. The information presented is intended only as a source of information and given without guarantee and does not constitute a warranty.  Since the conditions under which this information may be applied are beyond its control, International Coatings can assume no liability for the result of the application.  It is incumbent upon the users of International Coatings products to satisfy themselves that any end products derived meet all applicable regulatory requirements since International Coatings does not control the handling, processing or final use of the above products.  Users should also independently determine, prior to use, the suitability of International Coatings products for their specific applications.  No warranty, expressed or implied is given.