May 17, 2023
Child-resistant (C-R) packaging, also referred to as "special packaging," is used to reduce the risk of poisoning in children via the ingestion of potentially hazardous items including certain prescription and over-the-counter (OTC) medications, pesticides, and household chemicals. The U.S. Consumer Product Safety Commission (CPSC) has the authority to regulate C-R packaging via the Poison Prevention Packaging Act1 (PPPA) which became effective in 1972.
According to the PPPA, “The term "special packaging" means packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.”
Below are some commonly asked questions about C-R packaging requirements.
- What products require C-R packaging?
The complete list of substances requiring C-R packaging can be found in 16 CFR §1700.14. Specific examples of products available OTC and requiring C-R packaging include:
- Iron-containing drugs and dietary supplements
- Methyl salicylate
- OTC switch drugs
- What are the certifications that C-R packaging must meet?
C-R packaging must meet the performance specifications outlined in 16 CFR §1700.15. Information regarding performance specifications is available at the CPSC website.
- How are products tested to determine if they are child-resistant?
Panels of 50 children (42-51 months) are tested sequentially following division into three age categories (42-44 months; 45-48 months; 49-51 months). The testing period is 10 minutes and children are instructed on how to open the package and that they may use their teeth. The parameters required for passing the C-R test are outlined in 16 CFR § 1700.20(a)(2)(iii). If test results are inconclusive, additional testing involving one or more groups of 50 children each is required. A maximum of 200 children may be tested.
- How are products tested to determine if they are senior-friendly?
A panel of 100 senior adults (50-70 years) tested individually, is given five minutes to open and, if reclosable, to properly close the C-R package. If they cannot open this C-R package in five minutes they are screened to determine their ability to open and close two non C-R packages in one minute. In order to pass this test, 90 percent of the adults tested must be able to open and properly close the package during both the five-minute and one-minute tests.
- Is unit dose packaging considered to be child-resistant?
Any package (including blisters or pouches) containing a substance regulated under the PPPA must meet C-R standards regardless of package type. A failure for unit dose packaging is defined as occurring when a child opens or gains access to more than eight individual units or the number of units representing a toxic amount, whichever is less.
- What factors does the CPSC consider when establishing the need for C-R packaging?
According to the PPPA, CPSC must consider the following factors:
- Reasonableness of the standard;
- Available scientific, medical, and engineering data concerning special packaging and childhood accidental ingestions, illness, and injury caused by household substances;
- Manufacturing practices of industries affected by the PPPA; and
- The nature and use of the household substance.
- Are there any exceptions to the C-R packaging requirement under the PPPA?
For a product subject to C-R standards under the PPPA, a manufacturer or distributor may package an OTC product in a single non C-R size provided that they also supply the product in popular-sized packages complying with C-R packaging requirements. The non C-R package must also state "This package for households without young children"; (or “Package Not Child-Resistant” for small packages). See 16 CFR §1700.5 for more information.
1Codified at 15 U.S.C. §§ 1471−1477