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Child resistance

What the standard asks for

Updated

On this page8
The standard is short, and most of it is about proving a package behaves rather than describing how it is built.

It is written as performance, not design

1700.15 sets out what packaging has to achieve to count as special packaging within the meaning of the Act, and leaves the construction to you. There is no approved list of closures, which is why a supplier calling something child-resistant is a starting point and not a finding.

The effectiveness specifications

Tested by the method in 1700.20, special packaging must show not less than 85 percent child-resistant effectiveness without a demonstration, and not less than 80 percent after a demonstration of the proper means of opening. Those are population figures from a protocol, not bench impressions.

Adults have to be able to open it

The same test method addresses adult use, which is the tension in every child-resistant package: too stiff and the customer decants it into something unlabeled, which is a worse outcome than the one the rule was written for.

No reuse

Special packaging for substances subject to those paragraphs shall not be reused. If part of your proposition is a refillable bottle, check which paragraph you are under before the marketing is written.

Restricted flow, where it applies

Where a paragraph calls for it, the package must be one from which no more than 2 milliliters can be obtained when inverted, opened and squeezed or activated once. That is a specific number and it shapes the orifice, not the label.

Sample packages go to the Commission

The manufacturer or packer must provide the Commission with a sample of each type of special packaging, with the labeling for each size and for any noncomplying package. It is an obligation with an address attached, so treat it as part of the launch rather than an afterthought.

Performance standards cut both ways

Because nothing is prescribed, there is no part number that discharges the obligation, and equally no construction is ruled out if it performs. That is more freedom than a design standard would give and more responsibility, and the responsibility is the half people underestimate.

References

16 CFR 1700.15, Poison prevention packaging standards. Paragraph (a) requires the packaging to keep working in actual contact with the substance and across the openings and closings customary for its size and contents; (b) sets child-resistant effectiveness at not less than 85 percent without a demonstration and 80 percent after one; (c) forbids reuse; (d) restricts flow to 2 milliliters per activation. law.cornell.edu
16 CFR 1700.14, Substances requiring special packaging, under the Poison Prevention Packaging Act regulations. Paragraph (a)(3) covers liquid preparations over 5 percent methyl salicylate; (a)(7) illuminating preparations at 10 percent petroleum distillates; (a)(31) and (a)(32) hazardous substances, and drugs and cosmetics, at 10 percent or more hydrocarbons by weight and under 100 SUS at 100 F, each with an exemption for packages whose only non-child-resistant access is a spray device. law.cornell.edu
Written from federal regulation, not from a formulation bench. Whether a given formula crosses a threshold in 16 CFR 1700.14 is a question about your formula, and the percentages here are the test rather than the answer. Anything on these pages is a starting point and not clearance for a specific product.