Phthalates Restrictions in Toys: Testing Requirements and Compliance Guide
Phthalates in toys are regulated because certain phthalate plasticizers are restricted in children’s products. In the United States, children’s toys and certain child care articles are subject to requirements under the Consumer Product Safety Improvement Act (CPSIA) and 16 CFR Part 1307. In the European Union, applicable phthalate restrictions are established under REACH Annex XVII.

Phthalate testing is particularly relevant to flexible plastics, PVC, synthetic rubber, coatings, printing inks, and other plasticized materials. The required testing scope depends on the destination market, product classification, accessible materials, and applicable regulatory requirements.
A toy containing several flexible plastic components may require multiple material test points. The material composition of the product therefore plays an important role in determining the appropriate phthalate compliance testing program.
What Are Phthalates?
Phthalates are a group of chemicals commonly used as plasticizers, which are substances added to certain plastics and other materials 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 give the material its soft or pliable characteristics.
Phthalate restrictions apply to specific substances and product applications. The applicable limits and testing requirements depend on the market where the toy will be sold.
Why Are Phthalates Restricted in Toys?
Children can have frequent contact with toy materials through handling, mouthing, sucking, and other forms of direct contact.
Regulatory authorities have established restrictions on certain phthalates in toys and child care articles to control exposure to regulated substances.
Phthalate requirements form part of a broader toy chemical safety program that may also address:
- Lead
- Migration of certain elements
- Heavy metals
- Restricted chemicals
- Surface coatings
- Other substances regulated by the destination market
Chemical requirements should be evaluated together with applicable mechanical, physical, flammability, labeling, and other toy safety requirements.
Which Toy Materials May Contain Phthalates?
Phthalate testing is particularly relevant to plasticized materials.
Materials and components that may require assessment include:
- Flexible PVC
- Soft plastic toy components
- Flexible plastic figures
- Plastic dolls
- Inflatable toy materials
- Synthetic rubber components
- Plastic grips and handles
- Flexible cords
- Plasticized coatings
- Certain printing inks
- Soft plastic accessories
A single toy can contain several different materials.
For example, a doll may include a soft plastic head, flexible limbs, rigid plastic accessories, printed clothing, and coated components. These materials can have different compositions and may need to be evaluated separately when determining the testing scope.
For this reason, phthalate testing is commonly assessed at the material or component level.
U.S. Phthalates Requirements 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.
Covered children’s toys and child care articles must not contain concentrations greater than 0.1% (1,000 ppm) of an applicable regulated phthalate in covered accessible plasticized component parts.
The limit applies to each regulated phthalate individually.
Which Phthalates Are Restricted Under CPSIA?
Current U.S. requirements cover eight regulated 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% |
The concentration of each applicable regulated phthalate is evaluated against the 0.1% limit.
Which Products Are Covered by U.S. Phthalate Requirements?
For 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.
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 established before determining the applicable testing and certification requirements.
Which Components Need Phthalates Testing?
The phthalate testing scope is determined by identifying the accessible plasticized components that could contain regulated phthalates.
Potential test materials may include:
- Flexible PVC
- Soft plastic components
- Plasticized rubber
- Certain printed materials
- Flexible coatings
- Plasticized straps or cords
Material composition is important when developing the testing program.
CPSC has issued testing determinations for certain materials that are known not to contain phthalates when applicable conditions are met. These include materials such as untreated or unfinished wood, metal, natural fibers, natural latex, certain mineral products, and paper products. Determinations also exist for certain specified plastics and other materials.
These determinations can affect whether third-party phthalate testing is required for a particular material, while manufacturers remain responsible for ensuring that the finished children’s product complies with applicable requirements.
Phthalates Testing and CPSIA Certification
Children’s products subject to applicable U.S. children’s product safety rules generally require the appropriate third-party testing and certification.
Where third-party testing is required for phthalates, testing must be performed by a CPSC-accepted third-party laboratory for the applicable rule.
The domestic manufacturer or importer uses the applicable test results as part of the basis for issuing a Children’s Product Certificate (CPC).
For toys, the CPC may identify applicable requirements including:
- ASTM F963
- 16 CFR Part 1307 phthalates requirements
- Lead requirements
- Small parts requirements where applicable
- Other applicable children’s product safety rules
The required compliance scope depends on the product, age grading, materials, design, and applicable requirements.
Phthalates and ASTM F963
ASTM F963 forms part of the U.S. mandatory toy safety framework through 16 CFR Part 1250.
Toy compliance may involve ASTM F963 together with other applicable federal children’s product safety requirements.
For toys intended for children 12 years of age and younger, the applicable compliance program may include:
- ASTM F963 requirements
- CPSIA phthalate restrictions
- Lead requirements
- Small parts requirements where applicable
- Tracking labels
- Children’s Product Certificate requirements
Phthalate compliance should therefore be evaluated within the complete U.S. toy testing and certification scope applicable to the product.
EU Phthalates Restrictions for Toys
Toys supplied in the European Union may be subject to phthalate restrictions under REACH Regulation (EC) No 1907/2006, Annex XVII.
REACH restricts several phthalates in plasticized materials used in consumer products, including applicable toys and child care articles. The substances, concentration limits, material scope, and product applications should be evaluated against the applicable REACH entries.
For toys entering the EU market, chemical compliance may involve requirements relating to:
- REACH restricted substances
- Phthalates where applicable
- Migration of certain elements
- Mechanical and physical safety
- Flammability
- CE conformity requirements
- Technical documentation
The testing program should be established according to the toy materials, intended age group, product design, and applicable EU requirements.
Phthalates Testing for Different Types of Toys
The likelihood that phthalate testing will be relevant varies according to the materials used in the toy.
Plastic Toys
Flexible plastic components require particular attention because plasticizers may be used to produce softness or flexibility.
Examples include:
- Flexible toy figures
- Soft plastic dolls
- Bath toys
- Inflatable toys
- Soft plastic accessories
Rigid and flexible plastics within the same toy may have different formulations and should be assessed accordingly.
Plush Toys
The textile body of a plush toy may have a different phthalate risk profile from plasticized components attached to the product.
Components that may require assessment include:
- Plastic eyes
- Flexible accessories
- Printed coatings
- Plastic labels
- Decorative plastic components
The bill of materials and product construction should be reviewed when establishing the testing scope.
Dolls and Action Figures
Dolls and action figures can contain several material types, including:
- Soft plastic heads
- Flexible limbs
- Rigid plastic bodies
- Coatings
- Clothing
- Accessories
Relevant plasticized components should be identified individually during the compliance review.
Electronic Toys
Electronic toys can contain flexible plastic materials in:
- Cable insulation
- Buttons
- Soft grips
- Flexible decorative components
- Other plasticized parts
Chemical requirements continue to apply to relevant toy materials regardless of the product’s electrical functions.
Inflatable Toys
Inflatable toys frequently use flexible plastic materials. Material formulation is therefore an important consideration when determining whether phthalate testing is required.
How is Phthalate Testing Scope Determined?
The testing scope should be based on the materials present in the finished product and the requirements of the destination market.
The assessment generally considers:
- Destination market
Identify whether U.S., EU, or other market requirements apply. - Product classification
Confirm the type of toy, intended age group, and other relevant product characteristics. - Material composition
Review the materials, components, coatings, printing, and accessories used in the product. - Accessibility
Determine which materials fall within the applicable regulatory scope. - Material differences
Identify different formulations, colors, coatings, or components that may require separate assessment. - Existing supporting information
Review applicable material declarations, previous reports, supplier information, and other technical documentation.
A multi-material toy can therefore require a different number of test points from a simple product made from one relevant flexible plastic material.
What Affects Phthalates Testing Cost?
The cost of phthalate compliance testing is influenced by the number of materials requiring laboratory analysis and the applicable regulatory scope.
Factors can include:
- Number of plasticized materials
- Different material formulations
- Number of colors
- Coatings and printing
- Product variants
- Destination market
- Applicable regulatory requirements
- Number of required test points
For example, a toy containing one relevant flexible plastic material may have a simpler testing scope than a doll containing several flexible plastics, printed coatings, and accessories.
Providing product photographs, a bill of materials, and available material information can help the laboratory determine the appropriate testing scope before quotation.
Common Reasons Toys Fail Phthalates Testing
Phthalate failures can result from material selection and changes within the supply chain.
Use of Restricted Plasticizers
A plastic material may contain a regulated phthalate above the applicable concentration limit.
Changes in Raw Material Suppliers
Changing suppliers can introduce a different material formulation even when the component appears visually identical.
Uncontrolled Recycled Materials
Recycled plastics can contain substances originating from previous material streams when their composition is not adequately controlled.
Material Substitution During Production
A factory may substitute a material because of cost, availability, or production requirements. The replacement material may have a different chemical composition.
Previous Reports That Do Not Represent Current Materials
A previous test report may not represent a new supplier, formulation, color, coating, or component.
Incomplete Material Testing
Results for one material do not automatically establish compliance for other materials with different compositions.
How to Reduce Phthalate Compliance Risks
Phthalate compliance should be considered during material selection and supplier control, before finished products are submitted for laboratory testing.
Useful controls include:
- Define restricted substance requirements in supplier specifications
- Obtain material information from suppliers
- Maintain approved material lists
- Control changes to plastic formulations
- Review supplier declarations and supporting test reports
- Identify relevant plasticized components
- Conduct risk-based laboratory testing
- Retest after significant material or supplier changes
- Maintain traceability between tested materials and production materials
These controls help ensure that the materials represented by laboratory testing remain consistent with those used in production.
Phthalates Testing vs EN 71-3 Testing
Phthalates testing and EN 71-3 testing address different chemical requirements.
Phthalate testing determines the concentration of applicable regulated phthalate plasticizers in relevant materials.
EN 71-3 evaluates the migration of specified elements from toy materials under the conditions defined by the standard.
For example, a flexible plastic component may require assessment for applicable phthalate restrictions, while painted, pigmented, or other relevant toy materials may also require EN 71-3 testing.
A toy testing program can therefore include both phthalate testing and EN 71-3 testing when both requirements apply.
How to Determine Whether a Toy Needs Phthalates Testing
The testing decision should begin with four questions:
- Which market will the toy be sold in?
- What materials and components are used?
- Which materials are accessible and fall within the applicable regulatory scope?
- Does the product contain plasticized materials subject to applicable phthalate restrictions?
The broader toy testing program should then be established according to the product category, age grading, materials, construction, and destination market.
For products containing flexible plastics, PVC, synthetic rubber, coatings, printing, or other potentially plasticized materials, material information should be reviewed before finalizing the laboratory testing scope.
Phthalate compliance begins with identifying the destination market and the plasticized materials used in the toy. Review the product’s material composition, determine which components fall within the applicable restrictions, and establish the required laboratory testing scope before production materials or suppliers are changed.
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