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Two entries

The pump exemption

Updated

On this page8
A regulation that says how much ethanol a pump may deliver per stroke. There is nothing else like it in this library.

The four conditions

A nonremovable pump dispenser. At least 7 percent on a weight-to-weight basis of mint or cinnamon flavoring oils. No more than 0.03 grams of absolute ethanol dispensed per pump actuation. And less than 15 grams of ethanol in a single unit.

Nonremovable is the first and hardest

It means a dispenser a user cannot unscrew to reach the liquid, which is the same logic as the spray-device exemption in the diffuser property. A screw-on pump leaves the neck underneath as access.

The dose per actuation is a metering specification

0.03 grams of absolute ethanol per stroke. That is a performance figure for the pump, tied to the alcohol concentration of your formula, and it is the pump manufacturer who can speak to it.

The flavoring condition is doing a job too

At least 7 percent mint or cinnamon flavoring oils by weight. A strongly flavored product is unpleasant to drink in quantity, which is plainly the point, and it is a formulation condition inside a packaging exemption.

And a cap on the unit

Less than 15 grams of ethanol in a single unit, which limits how large the exempt format can be. So the exemption describes a small, strongly flavored, pump-metered product rather than a family bottle.

All four, not three

The sentence is conjunctive. A nonremovable pump on a weakly flavored product, or a well-flavored product in a screw-cap bottle, is not exempt, and partial satisfaction gets you nothing.

Which is why the format decision comes first

If the exemption is the plan, the pump and the flavor level are design inputs from the start. Retrofitting a nonremovable pump onto a bottle chosen for appearance is not a change you can make late.

References

16 CFR 1700.14(a)(22), Mouthwash. Preparations containing 3 g or more of ethanol in a single package require special packaging, except products with nonremovable pump dispensers containing at least 7 percent weight-to-weight mint or cinnamon flavoring oils, dispensing no more than 0.03 grams of absolute ethanol per actuation, and containing less than 15 grams of ethanol in a single unit. The paragraph defines mouthwash to include mouthrinses, oral antiseptics, gargles, fluoride rinses, anti-plaque rinses and breath fresheners, and to exclude throat sprays and aerosol breath fresheners. law.cornell.edu
16 CFR 1700.15, Poison prevention packaging standards: not less than 85 percent child-resistant effectiveness without a demonstration and 80 percent after one, with the packaging required to keep working in actual contact with the substance and across the openings and closings customary for its size and contents, and not to be reused. law.cornell.edu
Written from federal regulation and from measured catalog data, not from a formulation bench. Whether a product crosses the ethanol or fluoride thresholds is a calculation about your formula and your fill, and whether a pump satisfies the exemption is a question for the pump manufacturer. Nothing here certifies a package.