Lead in Toys: Regulations Governing Lead in Children's Products
Recent years have seen a rise in the number of children's products recalled due to high lead content. In 2022, the highest children’s product recall year since 2013, nineteen children's products sold in the US were found to exceed maximum allowable lead limits, resulting in their recall. Global lead restrictions are stringent, and understanding the regulations of your destination market is critical to protecting children and your brand reputation.
This article will review global lead regulations for toys, detailing the key requirements, who they apply to, and how to achieve compliance through effective testing. You'll gain a clear understanding of how to safeguard your products and ensure they meet all necessary safety standards.
Background information: Beyond “Safe Enough”: The Importance of Lead Testing in Children’s Toys
Regulations and Standards that Restrict Lead in Toys
There are numerous regulations worldwide that restrict lead in toys and other children’s products. These regulations are designed to minimize children's exposure to lead, thereby reducing the risk of lead poisoning. Here are some of the primary regulations that you must adhere to in the EU, US, and beyond.
European Union
REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation: The European Chemicals Agency (ECHA)has included lead on their Candidate List of Substances of Very High Concern (SVHCs), meaning companies that produce or import articles containing lead exceeding a concentration of 0.1% weight by weight must notify ECHA.
Additionally, under Entry 63 of REACH Annex XVII, the total lead content in articles and accessible parts that can be mouthed by children (smaller than 5 centimeters or with detachable parts of that size) cannot exceed 0.05% by weight. However, an exception exists if it can be proven that the lead release rate is below 0.05 μg/cm² per hour (equivalent to 0.05 μg/g/h) and for coated items, the coating demonstrably prevents exceeding this limit for at least two years under normal or foreseeable use. It's important to note that currently there are no official methods to determine lead release rates.
In May 2023, Entry 63 was updated to include new restrictions limiting lead to less than 0.1% in PVC polymer and copolymer articles.
Learn more about REACH’s impacts on toys: Guide to Compliance with EU REACH Regulation for Toys
EU Toy Safety Directive (2009/48/EC): The EU Toy Safety Directive sets limits on the amount of lead permissible in various toy materials to ensure children's safety. Specifically, it stipulates that:
Lead content in dry, brittle, powder-like or pliable toy materials must not exceed 2 milligrams per kilogram.
For liquid or sticky toy materials, the allowable lead limit is even stricter, at 0.5 milligrams per kilogram.
For materials that can be scraped off toys, the directive permits a maximum lead content of 23 milligrams per kilogram.
RoHS (Restriction of Hazardous Substances in Electrical and Electronic Equipment): RoHS imposes strict limits on lead and its compounds in all electrical and electronic products, including electrical and electronic toys. Specifically, the directive restricts lead content to no more than 0.1% by weight. This limit applies to each homogeneous material within a product, rather than to the product or part as a whole.
United States
US CPSIA (Consumer Product Safety Improvement Act): The CPSIA sets stringent lead content limits for products designed for children under 12 manufactured in or imported into the United States to ensure their safety. The CPSIA mandates lead testing to demonstrate compliance with the regulations. Noncompliance can lead to civil penalties of up to $100,000 per violation.
Total Lead Content: Section 101 of the CPSIA mandates that all children's products (age 12 and under), with a few exceptions, must not exceed 100 ppm (parts per million) of lead in parts of the product accessible to children.
Total Lead Exemptions and Considerations:
Certain products have exceptions, such as bicycles, which are allowed a higher lead limit of 300 ppm.
The total lead content limits exclude components of a children's product that a child cannot access during normal and reasonably foreseeable use and abuse. However, paint, coatings, and electroplating don't count as barriers for lead accessibility.
Unadulterated materials like gemstones, wood, and specific textiles are generally exempt from mandatory testing, as they are assumed not to contain lead in their natural state.
Used children's products are not subject to these regulations.
Electronic components within electronic toys may have specific lead limits outlined in separate regulations (16 C.F.R. § 1500.88).
Learn more about CPSIA lead exemptions: CPSIA Exemption List for Lead and Phthalates in Children's Toys
Lead in Paint and Coatings: Under 16 C.F.R. part 1303, all children's products must not contain a concentration of lead greater than 0.009 percent (90 parts per million) in paint or any similar surface coatings.
Read more about CPSIA compliance: CPSIA: Stricter Standards, Stronger Enforcement
California Proposition 65 (Cal Prop 65): Prop 65 identifies lead and lead compounds as chemicals known to cause cancer, birth defects, and reproductive toxicity. Under this law, businesses must provide warnings to consumers about products that may expose them to more than 0.5 micrograms of lead per day.
Other Global Regulations
Canada Consumer Product Safety Act (CCPSA): The Consumer Products Containing Lead Regulations under the Canada Consumer Product Safety Act (CCPSA) set a total lead limit of no more than 90 mg/kg for accessible parts of children's toys.
Japan Toy Safety Standard (ST 2016), Part 3: This standard specifies that for rubber pacifiers and toys made of PVC / polyethylene, the lead content must be ≤ 1 µg/ml. Additionally, lead in paint coatings on the body or components of toys must not exceed 90 mg/kg.
Japan Food Sanitation Law (JFSL): The JFSL targets toys likely to come into direct contact with children's mouths, including pacifiers, bottles, nipples, rattles, clay, masks, origami, building blocks, toy phones, and dollhouse toys. This law mandates that lead content in toy coatings must be 90 µg/g or less. Compliance with Sections IV and V of the JFSL, verified through laboratory testing, is mandatory for applicable children's products before they can enter the Japanese market.
This list of regulations is not exhaustive and is subject to change as lead restrictions tighten. Staying up-to-date on evolving restrictions is crucial for continued compliance.
Ensuring Your Toys Comply with Lead Regulations
Ensuring compliance with lead regulations in toys primarily involves thorough testing. There are two main methods for measuring lead content:
Concentration by Weight: This method sets a maximum allowable percentage of lead by weight in a material, such as 0.01% (US Federal requirement for lead in substrate).
The regulations of your market help determine which testing method will provide the most relevant information. Additionally, some regulations mandate specific testing procedures to ensure compliance. It's essential to understand which methods apply to your products and the markets you are targeting.
Partnering with a toy testing laboratory and regulatory expert like QIMA can help you determine the appropriate tests for your product type and ensure compliance with all relevant regulations. With our expertise, 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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