Ensuring Phthalate Compliant Toys: Guide to Phthalates Regulations and Testing
With the growing number of international markets imposing restrictions on phthalates in toys, navigating compliance has become a complex challenge. This guide provides an overview of the relevant regulations governing phthalates in toy products, their requirements and scope, and effective methods for ensuring your toys comply.
Regulations and Standards Governing Phthalates in Toy Products
Phthalates, commonly used in plastic toys to increase flexibility and durability, are an extremely large class of chemicals. Not all phthalate compounds are regulated; different markets may only restrict specific phthalates, adding to the complexity of ensuring compliance. Understanding the key regulations in major markets like the EU and US, as well as emerging restrictions globally, is essential for ensuring your toys meet all necessary safety standards.
European Union
REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation: The EU’s REACH regulation includes specific provisions for phthalates, particularly those on the SVHC (Substances of Very High Concern) Candidate List due to their potential harm to reproductive and endocrine systems. Importers and manufacturers must notify the European Chemicals Agency (ECHA) if SVHCs are present in their products at concentrations exceeding 0.1% weight by weight (w/w). Key phthalates on the SVHC list include:
Butylbenzyl phthalate (BBP)
Di-(2-ethylhexyl) phthalate (DEHP)
Bis(2-ethylhexyl) tetrabromophthalate
Bis(2-methoxyethyl) phthalate
Dibutyl phthalate (DBP)
Dicyclohexyl phthalate (DCHP)
Dihexyl phthalate
Diisobutyl phthalate (DIBP)
Diisopentyl phthalate
Dipropyl phthalate (DPP)
n-pentyl-isopentyl phthalate
Additionally, Annex XVII to REACH imposes restrictions on specific phthalates, listed in Entries 51 and 52, with varying limits based on product type and age group. DEHP, DBP, BBP, and DIBP are restricted to a maximum of 0.1% by weight in consumer products, except for motor vehicles, aircraft, and lab-use measuring devices. For toys and childcare products that might be placed in the mouth by children, DINP, DIDP, and DNOP are restricted to the same 0.1% limit by weight.
Learn more about REACH: Guide to Compliance with EU REACH Regulation for Toys
EU Toy Safety Directive (2009/48/EC): The EU Toy Safety Directive ensures the safety of toys for children under age 14 sold within the European Union. While the Directive itself does not prescribe specific phthalate limits, its guidelines are carried out through relevant harmonized standards and other regulations. In order to comply with the Directive, you must ensure your toys comply with the referenced standards.
Annex II of the Toy Safety Directive prohibits the use of any substance classified in the CLP Regulation (EC) No 1272/2008 as Carcinogenic, Mutagenic, or toxic for Reproduction (CMR) in toys; for example:
Di-(2-ethylhexyl) phthalate (DEHP) – Toxic for Reproduction
Diisobutyl phthalate – Toxic for Reproduction
Bis(2-methoxyethyl) phthalate – Toxic for Reproduction
Dibutyl phthalate (DBP) – Toxic for Reproduction
Diisooctyl phthalate – Toxic for Reproduction
Diisopentylphthalate – Toxic for Reproduction
RoHS (Restriction of Hazardous Substances in Electrical and Electronic Equipment): RoHS regulates the use of certain hazardous materials in electrical and electronic equipment, including electronic toys. As of July 22, 2019, the RoHS Directive includes additional substance restrictions for phthalates, with specific maximum concentration values:
Bis (2-ethylhexyl) phthalate, also known as Di-(2-ethylhexyl) phthalate (DEHP): 0.1%
Butyl benzyl phthalate (BBP): 0.1%
Dibutyl phthalate (DBP): 0.1%
Diisobutyl phthalate (DIBP): 0.1%
North America
US CPSIA (Consumer Product Safety Improvement Act): The US regulatory landscape for phthalates in toys is governed by the CPSIA Section 108 and a subsequent rule, 16 CFR Part 1307. These regulations apply to "children's toys," defined as consumer products designed or intended for use by children 12 years old or younger.
CPSIA Section 108: This section establishes a permanent ban on three specific phthalates in children's toys and childcare articles in concentrations above 0.1%:
Di-(2-ethylhexyl) phthalate (DEHP)
Dibutyl phthalate (DBP)
Benzyl butyl phthalate (BBP)
16 CFR Part 1307: This more recent rule expands the initial restrictions set by CPSIA Section 108. It prohibits the use of all the following phthalates in children's toys and childcare articles at concentrations greater than 0.1%:
The three originally banned phthalates (DEHP, DBP, BBP)
Diisononyl phthalate (DINP)
Diisobutyl phthalate (DIBP)
Di-n-pentyl phthalate (DPENP)
Di-n-hexyl phthalate (DHEXP)
Dicyclohexyl phthalate (DCHP)
Read more about CPSIA compliance: CPSIA: Stricter Standards, Stronger Enforcement
California Proposition 65 (Cal Prop 65): This proposition requires businesses to warn consumers about potential exposures to chemicals known by the State of California to cause cancer, birth defects, or other reproductive harm. Six specific phthalates fall under this category:
Di-n-hexyl phthalate (DnHP)
Diisodecyl phthalate (DIDP)
Diisononyl phthalate (DINP)
Di(2-ethylhexyl)phthalate (DEHP)
Dibutyl phthalate (DBP)
Butyl benzyl phthalate (BBP)
Proposition 65 doesn't ban these phthalates, but it does require warnings if they are present above certain threshold levels. Learn more: Understanding CA Prop 65 Phthalates Requirements
Other California regulations do ban phthalates in toys. For example, the California Toxic Toys Bill prohibits the manufacture, sale, or distribution in California of children's toys and childcare articles containing more than 0.1% of:
Butyl benzyl phthalate (BBP)
Dibutyl phthalate (DBP)
Di(2-ethylhexyl)phthalate (DEHP)
Canada Phthalates Regulation (SOR/2016-188): This regulation under Canada’s Consumer Product Safety Act establishes limits on specific phthalates found in children's toys and childcare articles. It applies to toys designed or intended for use by children under 14 years old, as well as childcare articles, such as those for relaxation, sleep, hygiene, feeding, sucking, or teething, that are intended for children under four years old.
Under this regulation, the vinyl material in any part of a toy or childcare article must not contain more than 0.1% (1,000 mg/kg) of these three phthalates:
Di(2-ethylhexyl) phthalate (DEHP)
Dibutyl phthalate (DBP)
Benzyl butyl phthalate (BBP).
For any part of a toy or childcare article that a child under four could reasonably mouth, the vinyl material must not contain more than 0.1% (1,000 mg/kg) of these three phthalates:
Diisononyl phthalate (DINP)
Diisodecyl phthalate (DIDP)
Di-n-octyl phthalate (DNOP)
This list of regulations is not exhaustive and is subject to change as phthalate regulations tighten globally. Staying up-to-date on evolving restrictions is crucial for continued compliance.
Ensuring Phthalate-Compliant Toys
Verifying your toys meet phthalate regulations requires phthalate testing. You may choose to test for specific chemicals of concern or opt for a comprehensive analysis covering all regulated phthalates.
It's important to understand that restrictions such as those above are based on two main methods:
Concentration by weight: This sets a maximum allowable percentage, often 0.1% by weight of the material.
The appropriate testing method depends on several factors, including the type of toy and the destination market's specific regulations. Consulting with a testing lab and regulatory expert like QIMA can help you determine the most suitable tests for your products and ensure they comply with your target market's requirements. Read more: Phthalates Testing Methods: How to Identify Phthalates in Products
At QIMA, our expertise in global phthalates regulations and laboratory toy testing ensures that your toys are tested accurately and thoroughly, meeting all relevant safety requirements. By collaborating with us, you can confidently determine the specific tests needed for your products, ensuring compliance and safeguarding consumer trust.
Contact us to learn more about our toy testing services, or book a test today.
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