Phthalates Restrictions in Toys: Testing Requirements and Compliance Guide

Phthalates restrictions in toys limit the use of certain plasticizing chemicals in children’s products because of potential health risks associated with exposure. These requirements are particularly important for toys containing flexible plastics, vinyl, synthetic rubber, coatings, printing inks, and other plasticized materials.

For manufacturers and importers, phthalate compliance depends on the destination market, product classification, accessible materials, and applicable regulations. In the United States, children’s toys and certain child care articles are subject to restrictions under the Consumer Product Safety Improvement Act (CPSIA) and 16 CFR Part 1307. In the European Union, restrictions on several phthalates are established through REACH Annex XVII.

Testing requirements also vary by market. A toy containing several flexible plastic components may require multiple material test points, while materials known not to contain phthalates may not require the same laboratory evaluation.

Understanding where phthalates may occur, which substances are restricted, and how laboratories determine the testing scope helps manufacturers manage toy compliance before products enter the market.

What Are Phthalates?

Phthalates are a group of chemicals commonly used as plasticizers, substances added to plastics to increase flexibility, softness, and durability.

They have historically been used in materials such as:

• Polyvinyl chloride (PVC)
• Flexible plastics
• Synthetic rubber
• Plastic coatings
• Printing inks
• Adhesives
• Soft plastic accessories

A flexible plastic toy, for example, may contain plasticizers that help provide its soft or pliable characteristics.

Phthalate restrictions focus on particular substances and product applications. The regulatory requirements depend on the market where the toy will be sold.

Why Are Phthalates Restricted in Toys?

Children may have greater exposure to toy materials through frequent hand-to-mouth behavior, mouthing, sucking, and prolonged contact with products.

Regulators have therefore established restrictions on certain phthalates in children’s toys and child care articles.

For manufacturers, phthalate compliance forms part of a broader chemical safety program that may also include requirements for:

• Lead
• Heavy metals
• Migration of certain elements
• Restricted chemicals
• Surface coatings
• Other substances regulated under national or regional legislation

Chemical requirements should be evaluated together with the mechanical, physical, flammability, and labeling requirements applicable to the toy.

Which Toy Materials May Contain Phthalates?

Phthalate testing is particularly relevant to plasticized materials.

Examples may include:

• Flexible PVC
• Soft plastic toy components
• Plastic dolls
• Inflatable toys
• Flexible plastic figures
• Plastic grips and handles
• Synthetic rubber components
• Flexible cords
• Plasticized coatings
• Certain printing inks
• Soft plastic accessories

A single toy can contain several different materials.

For example, a doll may contain a soft plastic head, flexible arms, hard plastic accessories, printed clothing, and coated components. Each material needs to be evaluated according to its composition and applicable regulatory requirements.

This is why phthalate testing scope is generally determined at the material or component level.

U.S. Phthalates Restrictions for Toys

In the United States, phthalate restrictions for children’s toys and child care articles are established under Section 108 of the CPSIA and 16 CFR Part 1307.

The U.S. Consumer Product Safety Commission (CPSC) prohibits covered children’s toys and child care articles containing concentrations greater than 0.1% (1,000 ppm) of a regulated phthalate in an accessible plasticized component. The concentration limit applies to each regulated phthalate individually.

Which Phthalates Are Restricted Under CPSIA?

The current U.S. restrictions cover eight phthalates:

Phthalate	Abbreviation	Maximum Concentration
Di-(2-ethylhexyl) phthalate	DEHP	0.1%
Dibutyl phthalate	DBP	0.1%
Benzyl butyl phthalate	BBP	0.1%
Diisononyl phthalate	DINP	0.1%
Diisobutyl phthalate	DIBP	0.1%
Di-n-pentyl phthalate	DPENP	0.1%
Di-n-hexyl phthalate	DHEXP	0.1%
Dicyclohexyl phthalate	DCHP	0.1%

CPSC guidance confirms that children’s toys and child care articles containing more than 0.1% of any regulated phthalate in covered accessible plasticized components are prohibited.

What Products Are Covered by U.S. Phthalate Requirements?

For purposes of the CPSIA phthalate requirements, a children’s toy is a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use while playing.

A child care article is a consumer product designed or intended to facilitate sleeping or feeding for children aged three and younger, or to help them with sucking or teething.

Examples of products that may fall within these requirements include:

• Plastic toys
• Dolls
• Inflatable toys
• Bath toys
• Teething products
• Soft plastic figures
• Toy accessories
• Certain children’s feeding products
• Pacifiers and related child care articles

Product classification should be confirmed before determining the applicable testing requirements.

Which Components Need Phthalates Testing?

Not every component of a toy automatically requires phthalates testing.

The first step is identifying accessible plasticized component parts that could contain regulated phthalates.

Examples may include:

• Flexible PVC
• Soft plastic components
• Plasticized rubber
• Certain printed materials
• Flexible coatings
• Plasticized straps or cords

CPSC has determined that some materials do not require phthalate testing when they have not been treated or adulterated with substances that could contain phthalates. Examples include untreated or unfinished wood, metal, natural fibers, natural latex, certain mineral products, and paper products. Certain engineered wood products, fibers, and specified plastics also have testing determinations under CPSC regulations.

These testing determinations do not remove the manufacturer’s obligation to ensure that the finished product complies with applicable phthalate limits.

Phthalates Testing and CPSIA Certification

Children’s toys subject to U.S. children’s product safety rules generally require third-party testing and certification.

For phthalates, testing must be performed by a CPSC-accepted third-party laboratory where third-party testing is required. The domestic manufacturer or importer then uses the applicable test results to support the Children’s Product Certificate (CPC).

The CPC identifies the applicable children’s product safety rules with which the product complies. CPSC’s example CPC for toys specifically includes 16 CFR Part 1307 for phthalates among the applicable rules.

Manufacturers and importers should therefore consider phthalate testing as part of the broader U.S. toy compliance program alongside applicable ASTM F963, lead, small parts, tracking label, and other requirements.

Phthalates and ASTM F963

ASTM F963 is the mandatory toy safety standard incorporated into U.S. federal requirements through 16 CFR Part 1250.

ASTM F963 contains a section addressing phthalates, although CPSC’s statutory phthalate requirements under 16 CFR Part 1307 remain an important part of children’s toy compliance. CPSC identifies phthalates separately among the rules that may require third-party testing and certification.

For toys intended for children 12 years of age and younger, manufacturers and importers should therefore assess the complete applicable compliance scope, including:

• ASTM F963
• CPSIA phthalate restrictions
• Lead requirements
• Small parts requirements where applicable
• Tracking labels
• Children’s Product Certificate requirements

Our ASTM F963 Toy Safety Standard guide explains the broader U.S. toy safety requirements.

EU Phthalates Restrictions for Toys

Toys supplied in the European Union may also be subject to phthalate restrictions under REACH Regulation (EC) No 1907/2006, particularly Annex XVII.

Several phthalates are restricted in plasticized materials used in consumer products, including toys and child care articles. Product-specific restrictions and the scope of individual substances should be reviewed against the current REACH requirements when preparing toys for the EU market.

Manufacturers supplying toys to Europe should evaluate chemical compliance alongside applicable EN71 requirements and the EU Toy Safety Directive.

A typical EU toy compliance program may therefore involve:

• EN71 mechanical and physical testing
• EN71 flammability testing
• EN71-3 migration of certain elements
• REACH restricted substance assessment
• Phthalate testing where applicable
• CE conformity requirements
• Technical documentation

The applicable chemical testing program depends on the toy materials and current regulatory requirements.

Phthalates Testing for Different Toy Types

Different toy categories present different levels of phthalate risk because their material composition varies.

Plastic Toys

Plastic toys may contain both rigid and flexible plastic components.

Flexible plastics require particular attention because plasticizers may be used to achieve the desired softness or flexibility.

Examples include:

• Flexible toy figures
• Plastic dolls
• Bath toys
• Inflatable toys
• Soft plastic accessories

Plush Toys

The textile fabric of a plush toy may present relatively little phthalate concern, although other components can require assessment.

Examples include:

• Plastic eyes
• Printed coatings
• Flexible accessories
• Plastic labels
• Decorative components

The complete bill of materials should be reviewed before determining whether phthalate testing is required.

Dolls and Action Figures

Dolls can contain numerous material types, including soft plastic heads, flexible limbs, rigid plastic bodies, coatings, clothing, and accessories.

Each relevant plasticized component should be considered during the compliance review.

Electronic Toys

Electronic toys may contain flexible plastic components such as:

• Cable insulation
• Plastic buttons
• Soft grips
• Flexible decorative materials
• Battery compartment components

Electrical functionality does not remove the need for chemical compliance assessment.

Inflatable Toys

Inflatable products often use flexible plastic materials, making material composition particularly important when assessing phthalate compliance.

What Affects Phthalates Testing Cost?

Phthalates testing costs depend heavily on the number of materials requiring analysis.

Important factors include:

• Number of plasticized materials
• Number of colors
• Different plastic formulations
• Coatings and printing
• Destination market
• Applicable regulatory requirements
• Number of product variants

For example, a simple toy containing one flexible plastic material may require fewer test points than a multi-colored doll containing several flexible plastics, printed coatings, and accessories.

Before requesting a laboratory quotation, manufacturers should provide clear product photographs and material information so the laboratory can determine the appropriate testing scope.

Use our Toy Testing Cost Calculator to estimate the expected testing scope and laboratory cost for your product.

Common Reasons Toys Fail Phthalates Testing

Phthalate failures often originate in the supply chain.

Using Non-Compliant Plasticizers

A supplier may use a plasticizer that contains a restricted phthalate.

Changing Raw Material Suppliers

A new supplier may provide materials with a different chemical formulation.

Uncontrolled Recycled Materials

Recycled plastics can introduce chemical substances from previous material streams when their composition is not adequately controlled.

Material Substitution During Production

Factories may substitute materials because of cost, availability, or production requirements.

Assuming Previous Test Reports Cover New Materials

A previous test report may not represent a new material, color, supplier, or formulation.

Incomplete Material Testing

Testing one component does not automatically demonstrate compliance for other materials with different compositions.

How to Reduce Phthalates Compliance Risks

Effective phthalate compliance begins before finished products reach the laboratory.

Manufacturers and importers should establish controls throughout product development and production.

Recommended practices include:

• Define restricted substance requirements in supplier specifications.
• Obtain material information from suppliers.
• Control changes to plastic formulations.
• Maintain approved material lists.
• Review supplier declarations and supporting test reports.
• Conduct risk-based testing of plasticized components.
• Retest products after significant material or supplier changes.
• Maintain traceability between tested materials and production materials.

For high-volume toy programs, chemical compliance should form part of the supplier quality management process.

Phthalates Testing vs EN71-3 Testing

Phthalates testing and EN71-3 testing evaluate different chemical hazards.

Phthalates testing determines the concentration of regulated phthalate plasticizers in applicable materials.

EN71-3 evaluates the migration of certain elements from toy materials.

For example, an accessible flexible plastic component may require assessment for phthalates, while painted or pigmented materials may also require EN71-3 testing for migration of certain elements.

A toy can therefore require both types of chemical testing.

How to Determine Whether Your Toy Needs Phthalates Testing

Start by answering four questions:

1. Which market will the toy be sold in?
2. What materials are used?
3. Which materials are accessible?
4. Does the product contain plasticized materials that fall within applicable restrictions?

The complete toy testing program should then be determined according to the product category, age grading, materials, and destination market.

Our guide on How to Determine Which Toy Safety Tests Your Product Needs explains how laboratories establish the broader testing scope.

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Phthalates restrictions require careful control of plasticized materials throughout product development and manufacturing. Manufacturers and importers should identify applicable market requirements, review material composition, control supplier changes, and complete the necessary laboratory testing before market entry.

For products containing flexible plastics, coatings, or other potentially plasticized components, submit the material information to a qualified laboratory for testing scope review before production or shipment

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Frequently Asked Questions