ASTM D4236-16 Standard Practice for Labeling Art Materials for Chronic Health Hazards

The standard "ASTM D4236-16 Standard practice for labeling art materials for chronic health hazards" developed by the American Society for Testing and Materials (ASTM) describes standard procedures for developing precautionary labels for art materials based on information available to the scientific and medical communities to provide chronic health hazards and precautionary guidelines. This procedure relates to hazards known to be associated with a product or product component when present in a physical form, volume, or concentration that toxicologists believe may cause chronic adverse health effects.

This standard applies only to art materials packaged in sizes suitable for individual users or persons participating in groups of any age and does not apply to products appropriately labeled for known chronic health hazards.

Labeling decisions must take into account reasonably foreseeable use or abuse. Precautionary labeling responsibility lies with the manufacturer or repackager who markets the materials for arts or crafts use.

This standard also does not prescribe tests to determine whether a substance or product has adverse chronic health effects. Labels must include signal word warnings, lists of potential chronic hazards, names of long-term hazardous ingredients, instructions for safe use, lists of sensitive ingredients, sources of information, label contents and product dimensions, and other supplemental information.

For the purposes of this standard, the following terms and definitions apply:

• An analytical laboratory is a laboratory with personnel and apparatus capable of performing quantitative or qualitative analyses of art materials, which can provide information used by a toxicologist in evaluating potentially hazardous substances.
• An art material or art material product is any raw or processed material or manufactured product marketed or represented by a manufacturer or repackager that is intended and suitable for users as defined herein.
• Bioavailability is the degree to which a substance can be absorbed in a biologically active form.
• Chronic adverse health effects are persistent toxic effects that develop over time from a single, prolonged, or repeated exposure to a substance.
• Chronic health hazards are a health risk to humans resulting from exposure to a substance that can cause chronic adverse health effects.
• A label is a representation of written, printed or graphic material immediately on any art material product.
• A producer is a person or organization that produces, processes or imports an art material.
• A repackager is a person or organization that obtains materials from manufacturers and places them, without modification, into containers designed to be sold to users as art materials.
• A sensitizer is a substance that is known to cause chronic adverse health effects in a significant number of individuals who are repeatedly exposed to the same substance through an allergic process.
• Toxic applies to any substance that is likely to cause personal injury or illness to humans through ingestion, inhalation, or skin contact.

To comply with this voluntary practice, companies that manufacture or repackage art materials must submit the art material product formulation or reformulation to a toxicologist for review. This review must comply with this standard. The toxicologist must keep the product formulation confidential.

Unless otherwise agreed to in writing by the manufacturer or repackager, no one other than the toxicologist shall have access to the formulation. However, the toxicologist shall provide the patient's physician with confidential information necessary to diagnose or treat exposure or accidental ingestion.

To comply with this standard, the manufacturer or repackager shall, upon recommendation by a toxicologist, adopt precautionary labeling based on generally accepted, well-established evidence that an ingredient is known to cause chronic adverse health effects.

To comply with this standard, labeling must parallel, comply with, and include, to a minimum, labeling practices prescribed by U.S. regulations and must not detract from required acute toxicity warnings.

To comply with this standard, the manufacturer or repackager must provide generic formulation information for distribution to poison control centers through a poison exposure management information source or provide a 24-hour toll-free telephone number for poison control centers.

Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, our organization also provides testing services defined in the standard “ASTM D4236-16 Standard practice for labeling art materials for chronic health hazards” with its trained and expert staff and advanced technological equipment.