Phthalates are a family of chemicals based on esters of phthalic anhydride. They are used as softening agents in plastics (polyvinyl chloride or PVC being the primary one) and as additives to personal and health care items like shampoos and cosmetics. They are named by the alcohol used to form the ester and vary in molecular weight according to the alcohol used.
Though phthalates have been used for over 40 years in a broad range of industrial and consumer items including textiles, flooring products, medical devices, electrical insulation, children’s toys, food closures, and hoses; recent concerns have been voiced over their safety in certain applications. In particular, some phthalate esters have been alleged to disrupt hormones and pose a reproductive health risk particularly to boys.
The manufacturers and users of phthalates have disputed the adverse health findings associated with these concerns over phthalate safety. Further information on these issues is available from the phthalate manufacturers and on several web sites:
Regardless of the disputed nature of the actual public health threat posed by phthalates, their use is now regulated in several specific areas. Due to this, manufacturers and sellers of phthalate containing products need to stay up to date on their regulatory responsibilities.
The EU banned the use of 6 phthalate esters in toys and children’s products that might be potentially placed in the mouth, at levels greater than 0.1% of the total object weight on January 16, 2007. The phthalates subject to this regulation are:
The EU has also applied limitations to the use of these phthalates in general food contact applications (packaging and closures) and medical device applications. In addition, several phthalates have been listed as “Substances of Very High Concern” (SVHC) requiring reporting of their content in articles exported into the EU under the REACH regulations:
Manufacturers contemplating export of phthalate containing compounds or articles to EU members should acquaint themselves with the specifics of these and other EU regulatory requirements.
United States overview:
In the United States, on August 14, 2008 the Consumer Product Safety Improvement Act (CPSIA) incorporated regulation of phthalate esters as components of children’s toys and child care articles for children under the age of 12 that could be “placed in the mouth”.
For CPSIA purposes, the following phthalates were permanently banned at levels greater than 0.1%:
The CPSIA also imposed an interim ban on the use of the following phthalates at levels greater than 0.1% pending the results of further CPSC (Consumer Product Safety Commission) review:
The CPSIA also contains a number of other provisions regulating other chemical content of toys, prohibition of the sale of non-compliant materials after February 10, 2009, analysis requirements, and other standards. Anyone engaged in production or sale of toys or child care products should thoroughly acquaint themselves with all the provisions of this legislation.
The complete CPSIA document is available at: www.cpsc.gov/cpsia.pdf
The states of California, Washington, and Vermont have also enacted legislation similar to the CPSIA. Other states have similar legislation pending, so manufacturers of regulated children’s products should be aware of local regulatory concerns as well.
As in the EU, there are further limitations on the use of phthalates (and other plastic additives) in food, closure, and medical device applications under FDA regulations.
First, an assessment should be made as to whether a product is actually subject to regulation. Manufacturers should read the EU, CPSIA, FDA, and other regulatory documents to establish their liability in this regard. The majority of phthalate containing applications are not currently subject to these regulatory requirements.
In general, the EU and CPSIA regulations on toys and child care products specify the specific banned phthalates and maximum allowable concentrations. Though these regulations restrict the use of many of the more common phthalates, a number of phthalate esters and isomers are not subject to regulation. This allows relatively broad latitude in reformulation of regulated articles to achieve compliance.
Development of truly “phthalate free” products, containing no detectable content of phthalates is also possible. However, the choice of a suitable phthalate substitute is severely limited since many “non-regulated” phthalates and phthalate isomers may contain trace quantities of regulated phthalates as contaminants (though below the limits set in EU and CPSIA regulations).
MarChem, is one of the leading suppliers of PVC Plastisol compounds in the United States. We are involved in the development of a broad range of PVC Plastisol products, including materials used in the production of toys, child care products, medical devices, food contacting products, and the entire spectrum of other regulated and non-regulated applications.
If you are a fabricator or user of PVC Plastisol compounds containing phthalates, and have questions about the regulatory status of your product, MarChem will provide the answers that you need.
MarChem has PVC Plastisol manufacturing and technical support laboratories at four locations servicing the United States and export markets. We will work with you to develop PVC Plastisols designed specifically for your manufacturing process and regulatory requirements.
Contact us for an assessment of your requirements and a cost and performance effective resolution.
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