Is child resistant packaging child proof?

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 .

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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 §.14. Specific examples of products available OTC and requiring C-R packaging include:

• Acetaminophen
• Aspirin
• Diphenhydramine
• Ibuprofen
• Iron-containing drugs and dietary supplements
• Imidazolines
• Methyl salicylate
• Mouthwash
• Naproxen
• 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 §.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 § .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 §.5 for more information.

1Codified at 15 U.S.C. §§ &#;

This guide provides an overview of special child-resistant and senior-friendly packaging (for simplicity, referred to as CRP) &#; what types are available and which companies manufacture and test CRP. Photographs of the CRP also are included. This information has been compiled by CPSC staff. It has not been reviewed or approved by, and may not reflect the views of the Commission.

NOTE: THE CPSC DOES NOT APPROVE, CERTIFY, OR ENDORSE ANY SPECIFIC CRP.

During the years CRP has been used to package drugs, cosmetics, and household chemicals, the number of children who have died from ingesting toxic household substances has declined significantly. 

Both CPSC and the U.S. Environmental Protection Agency (EPA) require the use of this packaging with certain products. The CPSC administers the Poison Prevention Packaging Act of (PPPA), 15 U.S.C. §§ -. Regulations issued under the PPPA provide for CRP of many harmful household products. This helps prevent children under the age of five years old from gaining access to those household products that could cause serious illness or injury. 

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), section 25 (c)(3), the EPA sets standards for the packaging of pesticides and/or devices to protect children and adults from serious illness or injury resulting from accidental ingestion or contact with these pesticides or devices. 

This guide describes a variety of CRP. Packages are designated as CRP strictly on the basis of data supplied by manufacturers and are included here with the permission of those manufacturers. Packaging designated CRP is used as the primary packaging. Using these packages as the secondary packaging would not comply with the PPPA. 
 

How to Use the CRP Indices

To access CRP descriptions and photographs, use the indexes listed below. 
The three indices (with links) include:

To contact a CRP manufacturer included in this guide, click here. This list will be updated periodically upon request of CRP manufacturers. 
To contact a firm that has conducted tests or plans to conduct tests on CRP in accordance with the PPPA, click here. This list will also be updated periodically.
To contact a consultant who represents that he/she can provide services in CRP development or manufacture in accordance with the PPPA, click here. This list will also be updated periodically.

ASTM Classifications

• ASTM Type I Reclosable Packaging Continuous Thread Closure 
• ASTM Type II Reclosable Packaging Lug Finish Closure 
• ASTM Type III Reclosable Packaging Snap Closure 
• ASTM Type IV Unit Non Reclosable Packaging Flexible (Strip/Pouch) 
• ASTM Type VII Aerosol Packages 
• ASTM Type VIII Non Reclosable Packaging Semi Rigid (Blister) 
• ASTM Type IX Dispensers (Not Intended To Be Removed) 
• ASTM Type X Box Or Tray Package 
• ASTM Type XI Reclosable Packaging Flexible 
• ASTM Type XIII Reclosable Packaging Semi Rigid (Blister)

The ASTM classifications are extracted, with permission, from D-09, Standard Classification of Child Resistant Packages, copyright

ASTM International 
100 Barr Harbor Drive 
West Conshohocken, PA .

Important Note

This is not a comprehensive listing of all CRP available or all CRP that can be used for products regulated under the PPPA. CPSC staff has not certified or verified the manufacturers' test data on child-resistance or senior adult use effectiveness. THE CPSC DOES NOT APPROVE, CERTIFY, OR ENDORSE ANY SPECIFIC CRP, OR USE OF ANY SPECIFIC SPECIAL CLOSURE WITH A SPECIFIC CONTAINER OR SUBSTANCE, OR THE COMPANIES LISTED THAT MANUFACTURE, DEVELOP, AND/OR TEST CRP. It is the responsibility of the packager to select CRP that is suitable for the substance to be packaged and its intended use.

Additions/Corrections

If you would like additional CRP to be included in this guide, please send at least 2 samples of the CRP, the manufacturer&#;s permission, and a copy of the full protocol laboratory testing report. If you would like to correct errors or omissions, send us your suggestions and the basis for your comments. Any corrections or additions will be verified first with the company involved. 
Please address all correspondence to:

John W. Boja, Ph.D.

Compliance Officer

Office of Compliance and Field Operations

U.S. Consumer Product Safety Commission

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Note: This booklet is a joint undertaking of the CPSC and the EPA. A version of this guide is also posted on the EPA&#;s website at www.epa.gov. The EPA maintains its own lists of CRP manufacturers and CRP testing firms. Please address corrections for the EPA lists to:

Attention: Lisa Pahel 
Environmental Protection Agency 
Office of Pesticide Programs (P) 
Registration Division; Fungicide & Herbicide Branch 
Pennsylvania Ave., N.W. 
Washington, DC  
(703) 347  
Fax: (703) 308  
: 

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