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From formula to bottle

Updated

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Unusually, you cannot finish the compliance check without knowing the container size.

One: methacrylic acid, as a percentage

More than 5 percent weight to volume in a single retail package. Weight-to-volume is a specific basis, so the figure has to be computed that way rather than taken from a weight-for-weight batch sheet.

Two: the acetonitrile figure, which is a mass

The glue remover trigger is expressed per container rather than as a concentration, so the calculation is the strength multiplied by the fill volume and it has to be redone for every size you sell.

Three: decide the format, knowing one exemption is a format

A pen-like applicator holding no free liquid is outside the methacrylic acid requirement. A bottle of the same product is inside it. That is a genuine design choice with a regulatory consequence.

Four: if a threshold is crossed, the packaging has to perform

16 CFR 1700.15 asks for not less than 85 percent child-resistant effectiveness without a demonstration and 80 percent after one, and for the packaging to keep working in actual contact with the substance and across the openings and closings customary for its size.

Which is a real ask for a nail product

A polish or a treatment is opened and closed many times, and the solvents attack liner materials. Effectiveness after contact and after repeated use is the part a datasheet will not tell you.

Five: label it as a cosmetic where it is one

A polish, a cuticle oil and a treatment are cosmetics, with ingredients declared in descending order of predominance. A remover sold on its solvent content may also need the hazard statements in 16 CFR 1500.14.

Keep the calculations, per size

The methacrylic percentage and the acetonitrile mass, computed for each fill volume you offer, with the date. Adding a size reopens both, and that is the specific thing that gets forgotten.

Two of the five answers are per size

Which makes the compliance file a table rather than a page. A range of three fill volumes is three acetonitrile calculations, and the one added last is the one nobody runs.

References

16 CFR 1700.14(a)(29), Methacrylic acid. Liquid household products containing more than 5 percent methacrylic acid by weight to volume in a single retail package require special packaging, except products applied by an absorbent material contained inside a dispenser such as a pen-like marker, provided no free liquid is within the device and the acid will emerge only through the tip under any reasonably foreseeable conditions of use. law.cornell.edu
16 CFR 1700.14(a)(18), Glue removers containing acetonitrile: household glue removers in a liquid form containing more than 500 mg of acetonitrile in a single container. law.cornell.edu
16 CFR 1700.14(a)(15) on solvents for paint or other similar surface-coating material at 10 percent or more benzene, toluene, xylene or petroleum distillates under 100 SUS, and 16 CFR 1700.15, the poison prevention packaging standards: the packaging must keep working in actual contact with the substance and across the openings and closings customary for its size, at not less than 85 percent child-resistant effectiveness without a demonstration and 80 percent after one. law.cornell.edu
21 CFR 701.3, the cosmetic ingredient declaration, which requires ingredients in descending order of predominance on the label of a cosmetic in package form. law.cornell.edu
Written from federal regulation and from measured catalog data, not from a salon. Whether a formula crosses 5 percent methacrylic acid or 500 mg of acetonitrile is a question about your formula and your container size, and the percentages here are the test rather than the answer. Nothing on these pages certifies a package as child-resistant.