Five questions. Four are about paperwork and one is about the bottle, which is the right proportion for this category.
One: are you in scope?
Are you marketing or representing the substance as suitable for creating visual or graphic art, and are you packaging it in sizes for individual users or a small group? Two yeses puts you inside 16 CFR 1500.14(b)(8) as a producer or repackager.
Not a supplier’s assurance and not a safety data sheet. A toxicologist review of the current composition, with the seven matters in paragraph (D) taken into account, and a date on it for the five-year clock.
Three: does the label carry what the rule requires?
Signal word in bold capitals at least as large as the chronic hazard statement, hazards in descending severity, hazardous components named, handling instructions, sensitizers listed, an information source, and where chronic labeling applies a US address, a telephone number and the not-for-children statement.
On the product wherever practical, otherwise the individual package, a point-of-purchase sign, separate literature or a bid response. And it goes nowhere at all if the review behind it has not happened.
Five: what does the liner face, and for how long?
Name the binder and the solvent, name the liner, and get the supplier’s tested position in writing. Then keep a filled sample and look at it at one, three and six months.
And file the criteria
A written description of how you determine chronic hazard potential, plus a list of the materials needing warning labels, submitted to the Commission’s Division of Regulatory Management. It is an obligation with an address, and it is easy to miss.
Then put two dates in the calendar
The five-year toxicologist review, and a periodic check with the supplier and the toxicologist for new hazard information, which has twelve months to reach the label from the date of discovery. Nothing in the product will remind you.
References
16 CFR 1500.14(b)(8), which reproduces ASTM D-4236 as a regulation under the Labeling of Hazardous Art Materials Act, 15 U.S.C. 1277, effective November 18, 1990. Paragraph (b)(8)(i)(A)(2) limits it to art materials packaged in sizes intended for individual users or a small group; (b)(8)(ii)(A) defines art material by what the producer or repackager markets it as, and excludes FIFRA economic poisons and FDCA drugs, devices and cosmetics.
law.cornell.edu16 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.edu16 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.edu16 CFR 1500.14(b)(8)(i)(C)(7), the statement of conformance: "Conforms to ASTM Practice D-4236", "Conforms to ASTM D-4236", or "Conforms to the health requirements of ASTM D-4236". It should appear on the product wherever practical, and may otherwise sit on the individual package, a point-of-purchase display or sign, separate explanatory literature, or a response to a formal request for bid.
law.cornell.edu16 CFR 1500.14(b)(8)(ii)(C), (D) and (E): describe the criteria used in writing and submit that description and a list of art materials needing hazard warnings to the Commission’s Division of Regulatory Management; carry the US name, address and telephone number and a statement that the material is inappropriate for use by children where chronic labeling applies; and get new hazard information onto labels within 12 months of discovery.
law.cornell.edu16 CFR 1700.14,
Substances requiring special packaging. Paragraph (a)(15) covers prepackaged liquid solvents for paints and similar surface-coating materials containing 10 percent or more benzene, toluene, xylene or petroleum distillates with a viscosity under 100 SUS at 100 F.
law.cornell.edu 