Prop 65 Phthalates
Phthalates: A Profile
Phthalates are synthetic chemicals most often used as plasticizers. These additives give certain types of plastics, especially polyvinyl chloride (PVC), flexible properties. As such, plasticizers (and thus phthalates) appear often throughout our day-to-day lives; from inflatable products like mattresses and pool toys to insulation for electrical cords, plasticized PVC features heavily in consumer products.
Phthalates also cause a variety of negative health effects in humans if we are exposed to too much on a long-term basis. For that reason, various regulatory initiatives have restricted phthalates’ use.
About Proposition 65
This final provision regarding warnings has become a source of friction between businesses and the state of California. If found to be non-compliant because they provide an inadequate warning, a business may be fined up to $2,500 per day per violation.
The law itself outlines an appropriate warning as a label, prominently affixed to the product or workplace that could expose someone to one or more of the listed chemicals. There are exceptions to the labeling rule, however, in the form of Safe Harbor Levels (SHLs).
Safe Harbor Levels
An SHL is an exposure level below which a listed chemical has negligible or zero effect on human health. These values are derived from research presented to the administering body, California’s Office of Environmental Health Hazard Assessment (OEHHA), by the same trusted sources that alert them to a chemical’s potential danger in the first place.
SHLs are presented as maximum allowable dose levels (MADLs) for reproductive or developmental toxicants and no significant risk levels (NSRLs) for carcinogens.
If a company can prove that their product or workplace does not expose anyone to any listed chemical at a greater dose level than its SHL, they do not need to provide an accompanying warning label. Not every listed chemical has an associated MADL or NSRL, however, and so products containing these chemicals in any detectable amounts must be properly labeled to maintain Prop 65 compliance.
Due to extensive research on their varied negative effects, six phthalates are on the list of chemicals restricted by Prop 65: BBP (Butyl Benzyl Phthalate), DEHP (Di(2-ethylhexyl)phthalate), DIDP (Di-isodecyl Phthalate), DBP (Di-n-butyl Phthalate), DnHP (Di-n-hexyl Phthalate), and DINP (Diisononyl Phthalate).
Some of these compounds are listed as carcinogens, some as developmental hazards, and others as reproductive toxicants. They each have one or more associated SHLs, but they vary wildly from compound to compound — between 8.7 and 4200 micrograms per day.
To determine whether their phthalate-containing product requires a warning label or not, many companies send material samples to Applied Technical Services. We are a testing lab that is well-versed in a variety of chemical analysis methods. With the help of a toxicologist, ATS can help determine whether a product needs to be labeled to maintain compliance due to the presence of Prop 65 phthalates in their chemical makeup.
About Our Prop 65 Phthalates Testing Method: GC/MS
The method that we use to test for phthalates is Gas Chromatography / Mass Spectroscopy (GC/MS). Using this instrumentation, ATS chemists can identify, detect and quantify compounds of interest at the parts per million (ppm) threshold, which yields a more comprehensive result than required by Prop 65.
We are able to achieve these detection limits because of our chemistry team’s experience in performing GC-MS to determine phthalate content according to the relevant standards EPA 8270D and CPSC-CH-C1001-09.3. Our lab is ISO 17025 (A2LA) accredited to perform CPSC-CH-C1001-09.3 for phthalate analysis.
ATS and Compliance Testing
For over 50 years, ATS has delivered testing, inspection, and engineering consulting services of the highest quality. We proudly serve clients from a variety of industries that operate around the world. If your company needs phthalate testing for Prop 65 compliance, send your material sample to ATS — We take a closer look!