Art materials law

The toxicologist review

Updated October 2026

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The duty The test What the toxicologist must take into account And four more things Then the labeling follows from the advice Poison control needs a route in And it is not a one-time exercise References

The determination is not yours to make. The rule assigns it to a toxicologist and lists what they must weigh.

The duty

The producer or repackager shall submit art material product formulations or reformulations to a toxicologist for review. Unless otherwise agreed in writing, no one other than the toxicologist shall have access to the formulation, except that they may give a patient’s physician what is needed to treat an exposure.

The test

An art material is considered to have the potential for producing chronic adverse health effects if any customary or reasonably foreseeable use can result in a chronic hazard. That is a broad test and it is applied to the product as people will actually use it.

What the toxicologist must take into account

The current chemical composition, supplied by an analytical laboratory or an industrial chemist; well-established knowledge of the chronic toxicity of each component and of the whole formulation; the physical and chemical form, bioavailability, concentration and amount of each component.

And four more things

Reasonably foreseeable uses, determined by consulting users and people experienced with the material such as teachers, or by market studies; known synergism and antagonism between components; chronic effects of decomposition or combustion products; and the opinions of regulatory agencies and scientific bodies.

Then the labeling follows from the advice

Upon advice given by a toxicologist, and based on generally accepted, well-established evidence that a component is known to cause chronic adverse health effects, the producer or repackager shall adopt precautionary labeling in the form the rule sets out.

Poison control needs a route in

The producer or repackager shall supply a poison exposure management information source with the generic formulation information for dissemination to poison control centers, or shall provide poison control centers with a 24-hour cost-free telephone number.

And it is not a one-time exercise

A toxicologist must review formulations and associated labels as necessary but at least every five years, against the then-current scientific knowledge. A formulation that was fine in 2021 has to be looked at again.

References

16 CFR 1500.14(b)(8)(i)(C) and (D), on the producer or repackager’s duties: submit the formulation to a toxicologist, supply a poison exposure management information source or a 24-hour cost-free telephone number to poison control centers, and have formulations and labels re-reviewed at least every 5 years. Paragraph (D) lists the seven matters the toxicologist must take into account. law.cornell.edu

16 CFR 1500.14(b)(8)(i)(E), (F) and (G), on labeling practices: the signal word WARNING in bold capitals at least as large as the chronic hazard statement, chronic hazards grouped in descending severity, chronically hazardous components named prominently, safe handling instructions, and a list of sensitizing components. law.cornell.edu

Written from federal regulation and from measured catalog data, not from a formulation bench. Whether a specific product needs chronic hazard labeling is a toxicologist’s determination and the rule says so; nothing here substitutes for that review. Anything on these pages is a starting point.