Understanding CA Prop 65 Phthalates Requirements
California's Proposition 65, also known as “CA Prop 65”, requires businesses to provide their customers with warnings when their products contain chemicals known to cause health problems. Among these regulated chemicals are phthalates, a group of plasticizers for which Prop 65 sets limits on the amount that can be used before a warning label is required.
This article outlines the specifics of CA Prop 65 as it relates to phthalates, offering a clear guide to compliance requirements, the types of phthalates regulated, and the products impacted.
California Proposition 65 Compliance: An Overview
Proposition 65 requires businesses to provide warnings about significant exposures to chemicals that cause cancer, birth defects, or other reproductive harm, unless the level of exposure to the chemical is below the regulatory safe harbor level. These chemicals regulated under Proposition 65 can be found in various everyday products, from household items to workplace tools.
Who It Applies To: Prop 65 applies to all companies with 10 or more employees selling products to consumers in California, including online sales. This wide-reaching regulation impacts manufacturers, packagers, importers, suppliers, and distributors.
Chemicals Covered: The list of chemicals under Prop 65 is extensive, including over 900 substances. Phthalates, a group of chemicals commonly used to make plastics more durable, are a significant part of this list due to their potential health risks.
Why Compliance Matters: Compliance is not only a legal requirement but also a commitment to consumer safety and environmental responsibility. Non-compliance can result in penalties, legal fees, fines of up to $2,500 per day, and damage to your company's reputation.
Read more: Prop 65 Warning Label Requirements: What They Are and How to Comply
Understanding phthalates under Proposition 65 is critical for manufacturers, as non-compliance can lead to substantial consequences.
Phthalates Regulated Under California Prop 65
Under Prop 65, 'safe harbor levels' define specific thresholds for chemicals, including No Significant Risk Levels (NSRLs) for carcinogens and Maximum Allowable Dose Levels (MADLs) for reproductive toxins. These benchmarks are crucial for manufacturers as they dictate the maximum amounts of these chemicals permissible in products without necessitating a Prop 65 warning label.
There are six phthalates included under Proposition 65, listed below along with their established safe harbor level thresholds:
| Chemical Name & Reason for Inclusion on Prop 65 List | NSRL (μg/day) | MADL (μg/day) |
|---|---|---|
| BBP (butyl benzyl phthalate): Exposure to BBP is a concern because it may interfere with the hormonal systems in the body. It has been linked to reproductive issues, including effects on fetal development and fertility. | – | 1200 |
| DBP (di-n-butyl phthalate): DBP is included on the Prop 65 list due to its potential reproductive toxicity. Exposure during pregnancy has been associated with child developmental issues. | – | 8.7 |
| DEHP (di(2-ethylhexyl)phthalate): The inclusion of DEHP on the Prop 65 list is primarily due to its role as a carcinogen and an endocrine disruptor. It may cause reproductive and developmental issues, particularly affecting the male reproductive system. | 310 | 4200 (intravenous) (Adult) 600 (intravenous) (Infant boys, age 29 days - 24 mos.) 210 (intravenous) (Neonatal infant boys, age 0 - 28 days) 410 (oral) (Adult) 58 (oral) (Infant boys, age 29 days - 24 mos.) 20 (oral) (Neonatal infant boys, age 0 - 28 days) |
| DIDP (di-isodecyl phthalate): DIDP is regulated under Prop 65 because of concerns regarding birth defects if exposed during pregnancy, or reproductive harm. | – | 2200 |
| DINP (diisononyl phthalate): DINP is regulated under Prop 65 because it can cause or increase the risk of cancer. | 146 | – |
| DnHP (di-n-hexyl phthalate): DnHP is included for its potential reproductive toxicity. It is believed to impact reproductive health and could contribute to developmental problems in fetuses. | - | 2200 (oral) |
For more information on safe harbor levels, see the California Office of Environmental Health Hazard Assessment website.
These phthalates are commonly found, and thus regulated, in a wide range of products, including but not limited to:
Vinyl flooring
Wire and cable insulations
Wall coverings
Food containers and wrappers
Medical devices
Beauty products like nail polish and hairspray
It's essential for manufacturers to have a clear understanding of the specific phthalates present in their product lines, as well as their concentrations. This understanding is vital for ensuring compliance both with CA Prop 65 and other California or US regulations. For instance, under the California Toxic Toys Bill, certain children's toys and childcare articles manufactured, sold, or distributed in California must not contain more than 0.1% of BBP, DBP, or DEHP. Phthalates testing is a critical tool to ensure compliance.
Ensuring Proposition 65 Compliance with QIMA’s Expertise
Ensuring the safety and compliance of your products begins with accurately identifying the presence of phthalates. QIMA's thorough phthalate testing services and expert guidance are pivotal in this process, offering tailored solutions to meet Prop 65 regulations.
With our comprehensive phthalate testing services and expert regulatory guidance, you can ensure your products comply with Prop 65 regulations. Our testing is customized to meet your unique needs, with protocols designed for your specific product category. We help you get the tests you need when you need them, to help you operate in California – and beyond – with peace of mind.
Contact us today to learn more about how our chemical testing laboratory can assist in keeping your products compliant and your business ahead of regulatory curves.
More Resources
CPSIA Phthalate Restrictions for Children's Products – Learn more about the United States’ CPSIA restrictions on phthalates in products for children.
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