Products with unsafe or faulty packaging can be potentially hazardous for children. That’s why the Consumer Product Safety Commission (CPSC) requires the use of child resistant closures for products such as medications and dietary supplements.
To determine whether packaging is safe and child resistant, clear standards have been established in the United States and abroad with specific safety testing requirements in place. If your product requires child resistant packaging, it’s important to understand these standards and testing requirements.
Child resistant packaging standards
Children’s safety has been central to packaging design since the United States passed packaging legislation in 1970. In the United States, the CPSC is responsible for setting child resistant packaging standards. As of 2021, the CPSC mandated child resistant packaging standard states: “A child resistant package is one that is designed or constructed to be significantly difficult for children under 5 to open or obtain a harmful amount of the contents within a reasonable time.”
It’s important to note the CPSC’s standard does not mean that packaging must be impossible for children to open; rather a child resistant package must remain unopened or closed for at least 85% of children in the first 5 minutes, and for at least 80% of children following the demonstration. This is a significant distinction because it plays a role in US and international testing standards for child resistant packaging.
In addition, the CPSC also states that child resistant packaging should not be difficult for normal adults to open. Together, these standards serve as a guideline for child resistance and safety testing standards. Learn more about the importance of child-resistant packaging.
Understanding testing requirements
Packaging must pass third party certification to ensure it meets required child safety standards. While the US has specific testing requirements, international standards vary. Companies that distribute their product internationally should understand the standards and testing requirements for each country in which they distribute their product.
US child resistant packaging requirements & testing procedures
For packaging to meet the CPSC’s child-resistant standard, it must be subjected to real-world testing with children and adults. Packaging must be tested under normal conditions by a panel of children between 42 to 51 months of age. In order for the packaging to pass child resistant testing, 80% percent of the children tested must not open the package during the full 10 minutes of testing.
Packaging must also be tested under normal conditions by a panel of senior adults between the ages of 50 to 70 years of age with no obvious or overt physical or mental disability.
For seniors, the testing procedure is modified and divided into two steps. First, they are asked to open the child resistant package. Then they are given a second identical package and asked to open it again.
In order for the packaging to pass the senior testing, 90% of participants must be able to open the first package within 5 minutes and the second package within 1 minute. They must also be able to close the package so that it is child resistant again.
International CR Packaging Standards
The International Organization for Standardization (ISO) is the most widely accepted authority for testing standards. The ISO is composed of multiple national standards organizations, with member organizations from across the globe, including:
- American National Standards Institute (ANSI)
- Standards Australia (SA)
- Association Française de Normalisation (AFNOR)
Together, these organizations work to establish international standards for technical, industrial, and commercial purposes, including child resistant packaging. The ISO has established two standards regarding the requirements for this packaging and the testing procedures:
- ISO 8317:2015 explains the required standards and test methods for child resistant packaging. The ISO testing procedure is similar to the procedure established in the US and includes the same age group of children. If they are unable to open the package within 5 minutes, they are given a silent demonstration of how to open it. Following the demonstration, they are then given 5 more minutes to attempt to open the package. A child resistant package must remain unopened or closed in the first five minutes for 85% of children and for at least 80% of children following the demonstration.
- ISO 13127:2012 explains the 10 mechanical tests that can be conducted using machines instead of people. These tests are only used when minor modifications have been made to existing child resistant packaging that have already been tested with a panel of children.
Many countries, especially those within the European Union, recognize ISO testing standards. However, always ensure there are no additional requirements for each country in which you distribute your product. Countries may have requirements in addition to ISO child resistant packaging standards.
Child resistant solutions from Drug Plastics
Drug Plastics understands the unique packaging challenges of the healthcare industries. We are committed to manufacturing high-quality, sustainable plastic packaging that meets modern consumer safety standards. Our child resistant closures meet FDA and CPSC regulations while differentiating your brand from the competition.
Ensuring our products meet child resistant standards
Drug Plastics offers a variety of child resistant closures that work with our bottles to complete your packaging. Our customers can rest easy knowing that our packaging components meet specific FDA regulations: 16 CFR Part 1700.15 and 1700.20.
- SecuRx® child resistant closures are exclusive two-piece, lined bottle closures that can be removed from a bottle by simultaneously pushing down and turning the closure. They’re a popular choice for a variety of pharmaceutical, nutraceutical, and lifestyle products secure and out-of-reach for children, but are still senior-friendly and easy to open for those with limited finger mobility. All SecuRx child resistant closures are manufactured with materials suitable for food packaging applications meeting and are FDA-approved. View our full line of SecuRx closures.
- Our Pop & Click™ Packaging System offers an innovative child resistant closure to help differentiate your brand. The Pop & Click System is an easy-to-use solution for individuals who struggle with traditional child resistant closures, while still meeting CPSC child safety compliance. Our exclusive Pop & Click closures are one-piece closures that use up to 65% less plastic than a comparable 38mm push and turn closure. When you use the entire Pop & Click system, plastic consumption is reduced over a similar cylinder with a push and turn closure, which makes your packaging more sustainable and reduces your carbon footprint.
For more information about our child resistant solutions, contact the DPG team online or speak with someone immediately at 610-632-6315.