FAQs: Bans on Phthalates in Children's Toys

November 15, 2011

What are phthalates?

Phthalates are chemical plasticizers that are often used in the production of many types of plastics. Phthalates most often, but not always, are used to make plastics softer and/or more pliable.

 

What is the ban on phthalates?

Congress has permanently banned three types of phthalates: DEHP, DBP, and BBP1 in any amount greater than 0.1 percent (computed for each phthalate individually) in: (1) children's toys, and (2) any child care article that is designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help children age 3 and younger with sucking or teething.

Congress has also banned on an interim basis three additional phthalates: DINP, DIDP, and DnOP2 in any amount greater than 0.1 percent (computed for each phthalate individually) in: (1) any children's toy that can be placed in a child's mouth, and (2) any child care article that is designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help children age 3 and younger with sucking or teething.

Note that the "interim banned" phthalates limits apply to children's toys that can be placed in a child's mouth whereas the permanent ban applies to any children's toy.

A discussion of the definitions of children's toys and child care articles is covered below.

This document refers to both bans as the "ban on phthalates."

The U.S. Consumer Product Safety Commission (CPSC or the Commission) is also required to convene a chronic hazard advisory panel (CHAP) on phthalates, which is discussed in more detail below.

 

Where can I find the law describing the ban on phthalates?

The law that makes children's toys and certain child care articles subject to the ban on certain phthalates can be found in section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) (pdf), Pub. L. No. 110-314, 122 Stat. 3016 (August 14, 2008). Additional requirements on the ban on phthalates were added in section 5 of Public Law No. 112-28 (August 12, 2011), which amended the CPSIA.

 

What are the important dates for businesses to comply with the ban on phthalates?

Compliance with the ban on phthalates for children's toys and certain child care articles:

If you are a manufacturer, importer, or private labeler of children's toys and certain child care articles, you must continue to comply with the ban on phthalates.

Third Party Testing:

If you are a manufacturer, importer, or private labeler of children's toys and certain child care articles, you must test your products manufactured after December 31, 2011 for compliance with the ban on phthalates. The Commission will require third party testing for those products on January 1, 2012. The required testing must be conducted by an accredited third party laboratory3 whose accreditation is accepted by the CPSC.4

As explained more fully below, third party testing is required for all plasticized component parts in a children's toy or child care article and is not required for certain materials known not to contain phthalates. Third party testing is also not required for inaccessible component parts of a children's toy or child care article.

Certification:

After a product is tested for compliance with the ban on phthalates, the manufacturer, private labeler, or importer must issue a Children's Product Certificate5 in which it certifies, in writing, that the children's toy or child care article complies with the ban on phthalates.

The effective dates and other details of testing and certification requirements are detailed in the "notice of requirements" (pdf).

 

Is this requirement to third party test and certify retroactive?

No. The requirement to third party test and certify all covered children's toys will only be enforced by the Commission for those children's toys and child care articles manufactured on or after January 1, 2012.

 

What child care articles are covered by the ban on phthalates?

Covered child care articles are those which are designed or intended by the manufacturer for a child age three years old or younger to facilitate sleeping or feeding or to help the child in sucking or teething. The definition was provided by Congress in the CPSIA and, at this time, the Commission has not issued further interpretive guidance.

However, the staff has interpreted items such as children's sleepwear, infant and toddler bottles, sippy cups, utensils, bibs, pacifiers, and teethers to be child care articles covered by the ban on phthalates. The staff determinations have not been approved by the Commission and the Commission may review and/or supersede the staff guidance and determinations.

 

What children's toys are covered by the ban on phthalates?

For purposes of the ban on phthalates, 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 by the child when the child plays."

Any determination as to whether a particular product is designed or intended for use by a child 12 years of age or younger during play will be made after consideration of the following factors:

  • Whether the intended use of the product is for play, including a label on the product if such statement is reasonable.
  • Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by the ages specified.
  • Whether the product is commonly recognized by consumers as being intended for use by a child of the ages specified.
  • The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.

In addition, as part of the staff's proposed approach, the CPSC staff looks to the definition of "children's toy" in the ASTM F963-08 children's toy safety standard for guidance. The CPSIA made ASTM F963-08 a mandatory CPSC standard on February 10, 2009. ASTM F963-08 excludes certain types of children's toys. For further guidance on the types of children's toys that are covered by the ban on phthalates, you may review the Commission's draft guidance (pdf), which is still in effect.

 

What is a children's toy that can be placed in a child's mouth?

Congress has stated that a "children's toy" means a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays.

A children's toy can be placed in a child's mouth if any part of the children's toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the children's product can only be licked, it is not regarded as able to be placed in the mouth. If a children's toy or part of a children's toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth.

At present, the Commission has not issued any additional information on interpreting these definitions. The definitions provided in the statute are found in section 108(e) of the CPSIA. For further guidance on the types of children's toys that can be placed in a child's mouth, you may review the Commission's draft guidance (pdf), which is still in effect.

 

Does the ban on phthalates apply to inaccessible parts?

No. Inaccessible component parts are excluded from the ban on phthalates. Presently, a component part is not accessible if that part is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product. (Reasonably foreseeable use and abuse of the product includes swallowing, mouthing, breaking, or other children's activities, and the aging of the product.) In the next year, the Commission will provide further guidance on how to interpret "inaccessibility." For future updates on this issue and other regulatory issues that may affect you, it is recommended that you sign up for the CPSIA email list.

 

Does every component part of every children's toy and child care article need to be tested?

No. The Commission has stated that it is unnecessary to test and certify materials that are known not to contain phthalates or to certify that phthalates are absent from materials that are known not to contain phthalates.

The following materials do not require testing for compliance with the ban on phthalates, provided that they have not been treated or adulterated by a substance that may contain phthalates:

  • Untreated/unfinished wood;
  • Metal;
  • Natural fibers; and
  • Natural latex and mineral products.

Additional examples of materials that do not require testing and certification include paper products (paper, paperboard, linerboard and medium, and pulp).

 

Can I rely upon a supplier that certifies that its component parts comply with the ban on phthalates?

Yes, provided that certain conditions are satisfied. First, not all children's products are required to be tested for phthalates. The Commission has issued a statement of policy (pdf) on the testing of component parts with respect to the ban on phthalates which provides guidance on what types of materials used in a children's product must be tested. This statement of policy remains in effect.

Second, the Commission has issued a rule regarding testing component parts. To the extent that a children's product is required to be third party tested for phthalates, you can rely upon the test results or a certification from a component part supplier if the requirements in our regulation at 16 CFR part 1109 are met. That rule requires that in order to rely upon test results or a certification from a supplier, you must use due care to ensure that the tests results or the certificate is valid, and be given access to the underlying documentation, such as test results and attestations regarding how the testing was conducted and by whom. Generally, certifications of a component part must satisfy the requirement for a children's product certificate, and must be based on the results of testing from a laboratory whose accreditation has been accepted by the CPSC.

More information is available about component part testing

 

For which age groups (i.e., the product's intended users) is third party testing and certification required for the ban on phthalates?

All children's toys intended or designed primarily for children 12 years of age and younger must be subjected to third party testing for the three permanently banned phthalates (DEHP, DBP, and BBP) by an accredited laboratory whose accreditation has been accepted by the CPSC.

Children's toys intended or designed primarily for children 12 years of age and younger that can be placed in a child's mouth must also be subjected to third party testing for the three interim banned phthalates (DINP, DIDP, and DnOP) by an accredited laboratory whose accreditation has been accepted by the CPSC.

Child care articles intended or designed primarily for children 3 years of age and younger must be subjected to third party testing by an accredited laboratory whose accreditation has been accepted by the CPSC.

The manufacturer, importer, or private labeler must issue a written certification based on the results of the third party testing, as described further below.

 

What are the test methods for the ban on phthalates accepted by the Commission?

The two test methods currently approved by the Commission are:

Test Method: CPSC-CH-C1001-09.3 - Standard Operating Procedure for Determination of Phthalates, April, 1, 2010 [PDF]

Alternate Phthalates Test Method: GB/T 22048-2008, children's toys and Children's Products-Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic, issued on June 16, 2008 ("Chinese Test Method").

 

If I have already tested my product for compliance with the ban on phthalates, must I now re-test my product because of the lab accreditation process?

The Commission, in approving the "notice of requirements", set forth the criteria for those laboratories seeking acceptance of their accreditation to test for compliance with the ban on phthalates. The Commission has a list [LINK] of those laboratories now accepted by the CPSC and that must use be used to test for compliance with the ban on phthalates.

If you previously tested your product for compliance with the ban on phthalates, you may not need to re-test your product again if certain conditions are satisfied.

First, the testing must have been performed by an ISO/IEC 17025-accredited third party testing laboratory.

Second, for tests conducted using the CPSC Test Method, the test must have been conducted on or after July 27, 2009. The Commission has chosen July 27, 2009, because it is the date the Commission posted a test method for testing component parts for phthalates on the Commission website: (http://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.2.pdf.). The test method was updated on April 1, 2010, to the current method (http://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.3.pdf.). The Commission will accept phthalates content certifications if the product was tested using either CPSC-CH-C1001-09.2 or CPSC-CH-C1001-09.3. For tests conducted using the Chinese Test Method, the test must have been conducted on or after June 18, 2008. The Commission has chosen June 18, 2008, because that is the date that the Chinese Test Method was issued.

Furthermore, there are important additional conditions that the specific laboratory performing the test must satisfy for your product's test to be valid. The additional conditions are detailed in the "notice of requirements" in section VI. In sum, if you believe that your tests satisfy the date range(s) set forth above, you should return to the laboratory that performed the testing and seek assurances in writing that they satisfy the other conditions set forth in Section VI of the "notice of requirements." You must satisfy all of the conditions set forth in the "notice of requirements" in order to rely upon prior testing.

 

May a manufacturer use a phthalate that is not banned or an alternative plasticizer in a children's toy or child care article?

The CPSIA has permanently banned DEHP, DBP, and BBP, while DINP, DIDP and DnOP are banned on an interim basis. However, an unbanned phthalate or an alternative plasticizer that is not one of the above banned phthalates may be used in a children's toy or child care article. During the CHAP's study of phthalates required by the CPSIA, an assessment of the interim banned phthalates (DINP, DIDP and DnOP) is being conducted, to include an assessment of the full range of other phthalates and phthalate alternatives for potential health effects.

Manufacturers are still responsible for ensuring that children's products are not considered "hazardous" under the general requirements of the Federal Hazardous Substances Act (FHSA). It is the manufacturer's obligation to ensure that any alternative plasticizer that is used be adequately tested such that the manufacturer is confident it does not pose a risk of injury under normal use or reasonably foreseeable misuse. Children's products that are hazardous or contain a hazardous substance are automatically banned. The Commission has issued chronic hazard guidelines to assist manufacturers in complying with the requirements of the FHSA.

 

What is the CHAP on phthalates?

Congress required the CPSC to convene a phthalates chronic hazard advisory panel (CHAP) composed of scientific experts to study the health effects of the three interim banned phthalates in addition to similar phthalates alternatives. The CHAP is currently examining the possible health effects of phthalates as they act on the body individually and in combination with one another. The CPSC has compiled minutes and other information on the CHAP's activities.

 

Is there the possibility that the interim ban on phthalates may be lifted?

The Commission must issue a final rule, based on the CHAP's report, to determine whether to continue the ban of the three interim banned phthalates in addition to any phthalates alternatives examined by the CHAP. The Commission must conduct a public rulemaking within 180 days of the date when the CHAP delivers its report to the Commission.

The CHAP is still conducting its examination and has not issued its report to the Commission. These FAQs will be updated when the CHAP issues its report. You may subscribe to the CPSIA listserv for additional documents and guidance which will be provided at that time.

 

Is there the possibility that additional bans on phthalates and similar plasticizers may be imposed?

The Commission will be guided by the CHAP's report to determine whether to recommend the addition of certain phthalates alternatives to the list of the phthalate prohibitions. See the answer above for additional explanation.

 

Is the ban on phthalates different than the requirements in the children's toy safety standard?

Yes, children's toys need to be tested for compliance with both sets of requirements. For more information on the children's toy safety standard, please review www.cpsc.gov/children's toysafety.

Product-Specific FAQs

Does the packaging for child care articles and children's toys need to comply with the ban on phthalates?

Packaging is generally not intended for use by children when they play, given that most packaging is discarded and is not used or played with as a children's toy or child care article. However, if the packaging is intended to be reused, or used in conjunction with a child care article or with a children's toy while playing, such as a heavy gauge reusable bag used to hold blocks, it would be subject to the ban on phthalates.

 

Does the ban on phthalates apply to children's shoes or socks?

Shoes and socks are not considered to be children's toys or child care articles. See the Office of the General Counsel advisory opinion.

 

Does the ban on phthalates apply to items such as pool children's toys and beach balls?

Pool children's toys, beach balls, blow up rafts, and inner tubes designed or intended for children 12 years of age or younger would be considered children's toys. Those objects are used by children when playing in a swimming pool or at the beach. Therefore, they would be required to comply with the ban on phthalates.

 

If a cosmetic material is used in a children's toy set which has play value would it be classified as a part of the children's toy and therefore subject to the ban on phthalates?

Yes. If a cosmetic material is included in a children's toy set it is required to meet the requirements of the ban on phthalates. However, cosmetics in general when not packaged with a children's toy are not covered by the ban on phthalates and fall under the jurisdiction of the Food and Drug Administration.

 

Does the ban on phthalates apply to sporting goods?

The category of products known as "sporting goods" can include children's toys but not all sporting goods are children's toys. Indeed, the mandatory ASTM F963-08 children's toy safety standard does not define sporting goods equipment to be a children's toy unless the product is a children's toy version of sporting goods equipment.

However, "children's toy" in section 108 of the CPSIA is defined broadly as a "consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays." Therefore, any determination as to whether a particular sporting goods product would be a children's toy as defined under section 108, and therefore, subject to the ban on phthalates, would be made on a case by case basis after consideration of the following factors:

  • A statement by the manufacturer about the intended use of the product, including a label on the product if such statement is reasonable.
  • Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by of the ages specified.
  • Whether the product is commonly recognized by consumers as being intended for use by a child of the ages specified.
  • The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.