The PPPA requires several household substances to be packaged in special packaging, also referred to as child-resistant/senior-friendly packaging. The purpose of the PPPA is to protect children under 5 from poisonings and deaths that can occur when children access the contents of containers with hazardous products.
The requirements for special packaging are codified at 16 CFR part 1700.
“Special packaging” is defined as a package that is significantly difficult for children under 5 to open (a.k.a. child-resistant) but is relatively easy for an adult to open (a.k.a. senior-friendly or adult-friendly). For a package to be child-resistant, at least 85% of tested children must not be able to open the package during the first 5 minutes of the test, and at least 80% of tested children must not open the packaging during the full 10 minutes of the test. For a package to be adult-friendly, at least 90% of adults must be able to open a package within 5 minutes and, if applicable, properly resecure a second package within 1 minute. The protocols to be followed for testing children and adults can be found at 16 CFR § 1700.20.
There are some additional requirements for special packaging that may apply: (1) the package must continue to effectively function for the life of the product; (2) the package must not be rendered ineffective due to interference or reacting with the enclosed substance; (3) the package must not be re-used; and (4) the package must include a restricted-flow mechanism. These requirements are outlined at 16 CFR § 1700.15, and the applicability of each requirement is stated explicitly under each regulated substance listed at: 16 CFR § 1700.14.
The PPPA allows CPSC to set rules requiring special packaging for certain household substances if the CPSC determines:
- That those substances present a risk of serious injury or illness to children under 5 years of age who are able to open packages of such substances and possibly drink, eat, or handle its contents; and
- That technology exists or can be developed to produce special packaging for such substances, the packaging can be used with modern mass production and assembly techniques, and the packaging will adequately protect the integrity of the substance and not interfere with intended storage or use of the substance.
A “household substance” is defined as a substance:
- that is customarily produced or distributed for consumption or use, or customarily stored, by individuals in or about the household; and,
- that is
- a “hazardous substance,” as defined in section 2(f) of the Federal Hazardous Substances Act, 15 U.S.C. § 1261(f);
- a “food,” “drug,” or “cosmetic,” as defined in section 201 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321; or,
- a substance intended for use as fuel (heating, cooking, or refrigeration system) when stored in a portable container.
The list of substances that require special packaging can be found at 16 CFR § 1700.14. CPSC adds new substances or updates the requirements from time to time; therefore, we recommend that you check periodically for new or revised rules.
Yes. Except for prescription drugs and drain cleaners containing 10% or more sodium/potassium hydroxide, firms may package one size of a regulated product in conventional packaging. To take advantage of this option, firms must also provide popular sizes of the regulated product in special packaging and must label the conventional package with the statement: “This package for households without young children” or, for small packages, “Package not child resistant.” For more information, see: 16 CFR § 1700.5.
The test protocols for the various tests (child test, senior-adult test, and younger-adult test) are outlined at 16 CFR § 1700.20. As long as these test protocols are followed, anyone can conduct the tests. If you choose not to test a package yourself, CPSC has compiled a list of testing facilities that have informed CPSC that they conduct such testing. CPSC has also compiled a list of consultants who have informed CPSC that they can provide services related to the development or manufacture of special packaging in accordance with the PPPA. Note that CPSC does not approve, certify, or endorse any firm/consultant or their services.
Due to key differences in the test methods, CPSC does not accept alternative tests when certifying to the special packaging requirements.
Due to the extraordinary circumstances caused by the SARS-CoV-2 (COVID-19) pandemic, CPSC staff issued a notice of enforcement discretion on June 25, 2020, which allows for certain deviances from the regulation:
- Acceptance of alternative test methods (ISO 8317, ISO 14375, EN 632, CSA Z76.1, CSA Z76.2)
- Use of transparent barriers between tester and test subjects, and between children
- Use of single site (site restriction noted in the protocols applies to zip codes instead)
- Use of resecuring data to support compliance to child test
Packages that initiated testing during the enforcement discretion period do not need to be retested once the enforcement discretion period ends.
The enforcement discretion ended as of June 30, 2022. Any packages initiating testing for compliance to the special packaging requirements after June 30, 2022, are no longer allowed the deviances noted above.
CPSC does not perform pre-market approval of special packaging. Note that CPSC does not approve, certify, or endorse any specific package or design.
Special packaging is not intended for children and, therefore, special packaging does not require third-party testing under the Consumer Product Safety Improvement Act (CPSIA); however, certificates of compliance are still required. Certification of a special package must be done by the manufacturer of the end product. The manufacturer must ensure that the packaging meets the requirements of the special package under 16 CFR § 1500.15 and generate a General Certificate of Conformity (GCC) for the end product. More information is available our GCC business guidance page.
As long as the protocols outlined in 16 CFR § 1700.20 are followed, anyone can perform the test to determine if a package is considered special packaging. CPSC is aware of firms that conduct tests in accordance with 16 CFR § 1700.20 and has compiled a list of such firms. Note that CPSC does not approve, certify, or endorse any particular testing facility or its services.
According to the PPPA, the manufacturer of the end product is responsible for ensuring or certifying that the end product meets the special packaging requirements. Note that the manufacturer of an empty package is not considered the manufacturer of the end product and would not be considered the responsible party. Under the PPPA, the entity that fills the package with the regulated substance is considered the manufacturer.
Yes. CPSC does not prohibit the use of special packaging for unregulated substances.
As long as the tested package adequately reflects the package being used in the end product, retesting or recertification is not required. If there is reason to believe the effectiveness of the package has changed, the manufacturer should retest and recertify. CPSC staff recommends that retesting and recertification be conducted whenever there is a change in the packaging material, a change in the manufacturing process, a different substance will be inserted, or a different combination of closure and package is used. CPSC staff also recommends that retesting and recertification be conducted when incident reports and/or complaints are received or when a manufacturing or materials defect becomes evident.
The practice of testing intervals of package sizes, as opposed to every single size, is commonly referred to as bracket testing. The PPPA does not specifically address bracket testing, nor does CPSC provide any guidance on the subject; however, CPSC staff may accept bracket testing if the manufacturer is able to make an informed determination (based on other testing of similar products, trends, or information from other manufacturers) on how certain sizes will perform.
CPSC staff generally recommends testing the two extremes (e.g., the smallest and largest sizes) along with some intervals between the extremes (e.g., if you have 5 different sizes you should test the 1st, 3rd, and 5th sizes). If the compliance of a certain size that did not undergo the full testing was ever to be called into question, CPSC staff would evaluate the rationale and supporting information used to certify that size.
The Child Nicotine Poison Preventing Act (CNPPA), Pub. L. No. 114-116, requires liquid nicotine to use special packaging as of July 26, 2016. More information is available on our liquid nicotine packaging business guidance page.
Section 3 of Reese’s Law, H.R. 5313, requires button cell or coin batteries use special packaging as of February 12, 2023. More information is available on our button cell and coin batteries business guidance page.