16 CFR 1500.14 - Products requiring special labeling under section 3(b) of the act.
(a) Human experience, as reported in the scientific literature and to the Poison Control Centers and the National Clearing House for Poison Control Centers, and opinions of informed medical experts establish that the following substances are hazardous:
(1) Diethylene glycol and mixtures containing 10 percent or more by weight of diethylene glycol.
(2) Ethylene glycol and mixtures containing 10 percent or more by weight of ethylene glycol.
(3) Products containing 5 percent or more by weight of benzene (also known as benzol) and products containing 10 percent or more by weight of toluene (also known as toluol), xylene (also known as xylol), or petroleum distillates such as kerosine, mineral seal oil, naphtha, gasoline, mineral spirits, stoddard solvent, and related petroleum distillates.
(4) Methyl alcohol (methanol) and mixtures containing 4 percent or more by weight of methyl alcohol (methanol).
(5) Turpentine (including gum turpentine, gum spirits of turpentine, steam-distilled wood turpentine, sulfate wood turpentine, and destructively distilled wood turpentine) and mixtures containing 10 percent or more by weight of such turpentine.
(b) The Commission finds that the following substances present special hazards and that, for these substances, the labeling required by section 2(p)(1) of the act is not adequate for the protection of the public health. Under section 3(b) of the act, the following specific label statements are deemed necessary to supplement the labeling required by section 2(p)(1) of the act:
(1)Diethylene glycol. Because diethylene glycol and mixtures containing 10 percent or more by weight of diethylene glycol are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, such products shall be labeled with the signal word “warning” and the statement “Harmful if swallowed.”
(2)Ethylene glycol. Because ethylene glycol and mixtures containing 10 percent or more by weight of ethylene glycol are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, such products shall be labeled with the signal word “warning” and the statement “Harmful or fatal if swallowed.”
(3)Benzene, toluene, xylene, petroleum distillates.
(i) Because inhalation of the vapors of products containing 5 percent or more by weight of benzene may cause blood dyscrasias, such products shall be labeled with the signal word “danger,” the statement of hazard “Vapor harmful,” the word “poison,” and the skull and crossbones symbol. If the product contains 10 percent or more by weight of benzene, it shall bear the additional statement of hazard “Harmful or fatal if swallowed” and the additional statement “Call physician immediately.”
(ii) Because products containing 10 percent or more by weight of toluene, xylene, or any of the other substances listed in paragraph (a)(3) of this section may be aspirated into the lungs, with resulting chemical pneumonitis, pneumonia, and pulmonary edema, such products shall be labeled with the signal word “danger,” the statement or hazard “Harmful or fatal if swallowed,” and the statement “Call physician immediately.”
(iii) Because inhalation of the vapor of products containing 10 percent or more by weight of toluene or xylene may cause systemic injury, such products shall bear the statement of hazard “Vapor harmful” in addition to the statements prescribed in paragraph (b)(3)(ii) of this section.
(4)Methyl alcohol (methanol). Because death and blindness can result from the ingestion of methyl alcohol, the label for this substance and for mixtures containing 4 percent or more by weight of this substance shall include the signal word “danger,” the additional word “poison,” and the skull and crossbones symbol. The statement of hazard shall include “Vapor harmful” and “May be fatal or cause blindness if swallowed.” The label shall also bear the statement “Cannot be made nonpoisonous.”
(5)Turpentine. Because turpentine (including gum turpentine, gum spirits of turpentine, steam-distilled wood turpentine, sulfate wood turpentine, and destructively distilled wood turpentine) and products containing 10 percent or more by weight of such turpentine, in addition to oral toxicity resulting in systemic poisoning, may be aspirated into the lungs with resulting chemical pneumonitis, pneumonia, and pulmonary edema, such products shall be labeled with the signal word “danger” and the statement of hazard “Harmful or fatal if swallowed.”
(6)Charcoal. Charcoal briquettes and other forms of charcoal in containers for retail sale and intended for cooking or heating.
(A) Because inhalation of the carbon monoxide produced by burning charcoal indoors or in confined areas may cause serious injury or death, containers of such products packaged before November 3, 1997, shall bear the following borderlined statement:
WARNING: Do Not Use for Indoor Heating or Cooking Unless Ventilation Is Provided for Exhausting Fumes to Outside. Toxic Fumes May Accumulate and Cause Death
(B) For bags of charcoal packaged before November 3, 1997, the statement specified in paragraph (b)(6)(i) of this section shall appear within a heavy borderline in a color sharply contrasting to that of the background, on both front and back panels in the upper 25 percent of the panels of the bag at least 2 inches below the seam, and at least 1 inch above any reading material or design elements in type size as follows: The signal word “WARNING” shall appear in capital letters at least three-eighths inch in height; the remaining text of the warning statement shall be printed in letters at least three-sixteenths inch in height.
(A) Because inhalation of the carbon monoxide produced by burning charcoal indoors or in confined areas can cause serious injury or death, containers of such products packaged on or after November 3, 1997, shall bear the following borderlined label.
(B) Except as provided in paragraph (b)(6)(ii)(C) of this section, the following requirements apply to bags of charcoal subject to paragraph (b)(6)(ii)(A) of this section. The label specified in paragraph (b)(6)(ii)(A) of this section shall appear within a heavy borderline, in a color sharply contrasting to that of the background, on both the front and back panels in the upper 25 percent of the panels of the bag, and with the outer edge of the borderline at least 2.54 cm (1 inch) below the seam and at least 2.54 cm (1 inch) above any other reading material or design elements. The signal word “WARNING” shall be in bold capital letters in at least 7.14 mm ( 9/32 inch) type. The remaining text of the warning statement shall be in at least 4.763 mm ( 3/16 inch) type. The phrase “CARBON MONOXIDE HAZARD” shall be in bold. This phrase and the word “NEVER” shall be in all capital letters. The lettering shall have a strokewidth-to-height ratio of 1:6 to 1:8. The label shall be at least 50.8 mm (2 inches) high and 147.5 mm (5 13/16 inches) wide. The label's lettering, spacing between the bottom of the letters of one line and the top of the letter of the next line, and pictogram shall have the size relation to each other and to the remainder of the label shown in paragraph (b)(6)(ii)(A) of this section.
(C) For bags of charcoal subject to paragraph (b)(6)(ii)(A) of this section that are 6 inches or less wide, the minimum label height may be reduced to 38 mm (1.5 inches) and the minimum width may be reduced to 139.7 mm (5.5 inches). The signal word “WARNING” shall be in capital letters in at least 6.32 mm (0.249 inch) type. The remaining text of the warning shall be in at least 4.23 mm (0.166 inch) type. All other requirements of paragraphs 6(b)(ii) (A) and (B) of this section shall apply to these bags.
(7)Fireworks devices. Because of the special hazards presented by fireworks devices if not used in a certain manner, the following listed fireworks devices shall be labeled as indicated:
(iii)Spike and handle cylindrical fountains.
(v)Rockets with sticks.
On the front and back panels:
On the side, front, back, top, or bottom panel.
(ix)Mines and shells.
(x)Whistles without report.
(xi)Toy smoke devices and flitter devices.
(xv)Labeling - General. Any fireworks device not required to have a specific label as indicated above shall carry a warning label indicating to the user where and how the item is to be used and necessary safety precautions to be observed. All labels required under this section shall comply with the requirements of § 1500.121 of these regulations. (See also § 1500.17(a) (3), (8) and (9); § 1500.83(a)(27); § 1500.85(a)(2); and part 1507).
The Labeling of Hazardous Art Materials Act (“LHAMA”), 15 U.S.C. 1277 ( Pub. L. 100-695, enacted November 18, 1988) provides that, as of November 18, 1990, “the requirements for the labeling of art materials set forth in the version of the standard of the American Society for Testing and Materials [“ASTM”] designated D-4236 that is in effect on [November 18, 1988] * * * shall be deemed to be a regulation issued by the Commission under section 3(b)” of the
(i)ASTM D-4236 -
(1) This section describes a procedure for developing precautionary labels for art materials and provides hazard and precautionary statements based upon knowledge that exists in the scientific and medical communities. This section concerns those chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist (see paragraph (b)(8)(i)(B)(11) of this section) has the potential to produce a chronic adverse health effect(s).
(2) This section applies exclusively to art materials packaged in sizes intended for individual users of any age or those participating in a small group.
(3) Labeling determinations shall consider reasonably foreseeable use or misuse.
(4) Manufacturers or repackagers may wish to have compliance certified by a certifying organization. Guidelines for a certifying organization are given in paragraph (b)(8)(i)(H) of this section.
(B) Descriptions of Terms Specific to This Standard. (1) Art material or art material product - any raw or processed material, or manufactured product, marketed or represented by the producer or repackager as intended for and suitable for users as defined herein.
(2) Users - artists or crafts people of any age who create, or recreate in a limited number, largely by hand, works which may or may not have a practical use, but in which aesthetic considerations are paramount.
(3) Chronic adverse health effect(s) - a persistent toxic effect(s) that develops over time from a single, prolonged, or repeated exposure to a substance. This effect may result from exposure(s) to a substance that can, in humans, cause sterility, birth defects, harm to a developing fetus or to a nursing infant, cancer, allergenic sensitization, damage to the nervous system, or a persistent adverse effect to any other organ system.
(4) chronic health hazard(s) (hereafter referred to as “chronic hazard”) - a health risk to humans, resultant from exposure to a substance that may cause a chronic adverse health effect.
(5) Analytical laboratory - a laboratory having personnel and apparatus capable of performing quantitative or qualitative analyses of art materials, which may yield information that is used by a toxicologist for evaluation of potentially hazardous materials.
(6) Label - a display of written, printed, or graphic matter upon the immediate container of any art material product. When the product is unpackaged, or is not packaged in an immediate container intended or suitable for delivery to users, the label can be a display of such matter directly upon the article involved or upon a tag or other suitable labeling device attached to the art material.
(7) Producer - the person or entity who manufactures, processes, or imports an art material.
(8) Repackager - the person or entity who obtains materials from producers and without making changes in such materials puts them in containers intended for sale as art materials to users.
(9) Sensitizer - a substance known to cause, through an allergic process, a chronic adverse health effect which becomes evident in a significant number of people on re-exposure to the same substance.
(11) Toxicologist - an individual who through education, training, and experience has expertise in the field of toxicology, as it relates to human exposure, and is either a toxicologist or physician certified by a nationally recognized certification board.
(12) Bioavailability - the extent that a substance can be absorbed in a biologically active form.
(C) Requirements. (1) The producer or repackager of art materials shall submit art material product formulation(s) or reformulation(s) to a toxicologist for review, such review to be in accordance with paragraph (b)(8)(l)(D) of this section. The toxicologist shall be required to keep product formulation(s) confidential.
(2) Unless otherwise agreed in writing by the producer or repackager, no one other than the toxicologists shall have access to the formulation(s); except that the toxicologists shall furnish a patient's physician, on a confidential basis, the information necessary to diagnose or treat cases of exposure or accidental ingestion.
(3) The producer or repackager, upon advice given by a toxicologist in accordance with paragraph (b)(8)(i)(D) of this section and based upon generally accepted, well-established evidence that a component substance(s) is known to cause chronic adverse health effects adopt precautionary labeling in accordance with paragraph (b)(8)(i)(E) of this section.
(4) Labeling shall conform to any labeling practices prescribed by federal and state statutes or regulations and shall not diminish the effect of required acute toxicity warnings.
(5) The producer or repackager shall supply a poison exposure management information source the generic formulation information required for dissemination to poison control centers or shall provide a 24-hour cost-free telephone number to poison control centers.
(6) The producer or repackager shall have a toxicologist review as necessary, but at least every 5 years, art material product formulation(s) and associated label(s) based upon the then-current, generally accepted, well-established scientific knowledge.
(7) Statement of Conformance - “Conforms to ASTM Practice D-4236,” or “Conforms to ASTM D-4236,” or “Conforms to the health requirements of ASTM D-4236.” This statement may be combined with other conformance statements. The conformance statement should appear whenever practical on the product; however, it shall also be acceptable to place the statement on one or more of the following:
(i) The individual product package,
(ii) a display or sign at the point of purchase,
(iii) separate explanatory literature available on requirements at the point of purchase,
(iv) a response to a formal request for bid or proposal.
(D) Determination of Labeling. (1) 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.
(2) In making the determination, a toxicologist(s) shall take into account the following:
(i) Current chemical composition of the art material, supplied by an analytical laboratory or by an industrial chemist on behalf of a manufacturer or repackager.
(ii) Current generally accepted, well-established scientific knowledge of the chronic toxic potential of each component and the total formulation.
(iii) Specific physical and chemical form of the art material product, bioavailability, concentration, and the amount of each potentially chronic toxic component found in the formulation.
(iv) Reasonably foreseeable uses of the art material product as determined by consultation with users and other individuals who are experienced in use of the material(s), such as teachers, or by market studies, unless such use information has previously been determined with respect to the specific art material(s) under review.
(v) Potential for known synergism and antagonism of the various components of the formulation.
(vi) Potentially chronic adverse health effects of decomposition or combustion products, if known, from any reasonably foreseeable use of the hazardous art material product.
(vii) Opinions of various regulatory agencies and scientific bodies, including the International Agency for Research on Cancer and the National Cancer Institute, on the potential for chronic adverse health effects of the various components of the formulation.
(3) Based upon the conclusion reached in conformance with review determinations set forth herein, the toxicologist(s) shall recommend precautionary labeling consistent with paragraph (b)(8)(i)(E) of this section.
(E) Labeling Practices - (1) Signal Word. (i) When a signal word for an acute hazard(s) is mandated and a chronic hazard(s) exists, the signal word shall be that for the acute hazard.
(ii) When only a chronic hazard(s) exists, the signal word WARNING shall be used.
(iii) The signal word shall be prominently visible and set in bold capitals in a size equal to or greater than the statement of potential chronic hazards.
(2) List of Potentially Chronic Hazards - Potentially chronic hazards, as determined under the procedures of paragraph (b)(8)(i)(D) of this section, shall be stated substantially in accordance with the statements listed in paragraph (b)(8)(i)(F) of this section. Potentially chronic hazards noted shall be those that are clinically significant and that might be expected with any reasonably foreseeable use of the art material. The hazards should be grouped in the order of relative descending severity.
(3) Name of Chronically Hazardous Component(s) - All components and known decomposition products of the formulation with a potential for chronic hazards, as determined under the procedures of paragraph (b)(8)(i)(D) of this section, shall be listed prominently. Generically equivalent names may be used.
(4) Safe Handling Instructions - Appropriate precautionary statements as to work practices, personal protection, and ventilation requirements shall be used substantially conforming with those listed in paragraph (b)(8)(i)(G) of this section.
(5) List of Sensitizing Components - To protect users from known sensitizers found within art materials, each label shall contain a list of those sensitizers present in sufficient amounts to contribute significantly to a known skin or respiratory sensitization.
(6) Combined Statement - If an art material contains more than one component capable of causing a chronic adverse health effect, or if a single chemical can cause several different chronic adverse health effects, the potential effects may be combined into one statement.
(7) Information Sources - The precautionary label shall contain a statement identifying a source for additional health information substantially in conformance with one of the phrases listed below:
(i) For more health information - (24 hour cost-free U.S. telephone number),
(ii) Contact a physician for more health information, or
(iii) Call your local poison control center for more health information.
(8) Labeling Content, Product Size - Any art material product in a container larger in size than one fluid ounce (30 ml) (if the product is sold by volume) or one ounce net weight (28 g) (if the product is sold by weight) shall have full precautionary labeling, as described in paragraph (b)(8)(i) (E) of this section. Any art material product in a container equal to or smaller than one fluid ounce or one ounce net weight shall have a label that includes a signal word in conformance with paragraph (b)(8)(i)(E)(1) of this section and a list of potentially harmful or sensitizing components in conformance with paragraphs (b)(8)(i)(E) (3) and (5) of this section.
(9) The information described in paragraph (b)(8)(i)(E) of this section must appear on:
(i) The outside container or wrapper, if any, unless it is easily legible through the outside container or wrapper and
(ii) All accompanying literature where there are directions for use, written or otherwise. Where a product that requires warning labels under paragraphs (b)(8)(i) (D) and (E) of this section is packed within a point-of-sale package that obscures the warning statement(s), the point-of-sale package shall carry the signal word conforming to paragraph (b)(8)(i)(E)(1) and the following wording: “Contains: (list hazardous product(s)) that may be harmful if misused. Read cautions on individual containers carefully. Keep out of the reach of children.”
(10) Statements required under paragraphs (b)(8)(i) (D) and (E) of this section must be in the English language and located prominently in conspicuous and legible type in contrast by topography, layout, or color with other printed matter on the label.
(11) Supplemental Information - Where appropriate, more detailed information that relates to chronic hazard(s), such as physical properties, decomposition products, detailed safety instructions, or disposal recommendations, shall be included in supplemental documents, such as Material Safety Data Sheets, technical brochures, technical data sheets etc.
(F) chronic Hazard Statements
(G) Precautionary Statements
(ii) The following shall apply with respect to the standard for art materials set forth in § 1500.14(b)(8)(i).
(A) The term art material or art material product shall mean any substance marketed or represented by the producer or repackager as suitable for use in any phase of the creation of any work of visual or graphic art of any medium. The term does not include economic poisons subject to the
(B) The standard referred to in paragraph (b)(8)(i) of this section applies to art materials intended for users of any age.
(C) Each producer or repackager of art materials shall describe in writing the criteria used to determine whether an art material has the potential for producing chronic adverse health effects. Each producer or repackager shall submit, to the Commission's Division of Regulatory Management,
(D) All art materials that require chronic hazard labeling pursuant to this section must include on the label the name and United States address of the producer or repackager of the art materials, an appropriate United States telephone number that can be contacted for more information on the hazards requiring warning labels under this section, and a statement that such art materials are inappropriate for use by children.
(E) If an art material producer or repackager becomes newly aware of any significant information regarding the hazards of an art material or ways to protect against the hazard, this new information must be incorporated into the labels of such art materials that are manufactured after 12 months from the date of discovery. If a producer or repackager reformulates an art material, the new formulation must be evaluated and labeled in accordance with the standard set forth § 1500.14(b)(8)(i).
(F) In determining whether an art material has the potential for producing chronic adverse health effects, including carcinogenicity and potential carcinogenicity, the toxicologist to whom the substance is referred under the standard described above shall take into account opinions of various regulatory agencies and scientific bodies, including the U.S.
(iii) Pursuant to the LHAMA, the Commission has issued guidelines which, where possible, specify criteria for determining when any customary or reasonably foreseeable use of an art material can result in a chronic hazard. These guidelines include criteria for determining when art materials may produce chronic adverse effects in children and adults, criteria for determining which substances contained in art materials have the potential for producing chronic adverse effects and what those effects are, criteria for determining the bioavailability of chronically hazardous substances contained in art materials when the products are used in a customary or reasonably foreseeable manner, and criteria for determining acceptable daily intake levels for chronically hazardous substances contained in art materials. Because these guidelines apply to hazardous substances in general as well as to hazardous substances in art materials, the guidelines are set forth in § 1500.135 and a definition of “chronic toxicity” is provided in § 1500.3(c)(2)(ii) as part of supplementation of the term “toxic” in section 2(q) of the FHSA.
(iv)Policies and interpretations.
(A) For purposes of enforcement policy, the Commission will not consider as sufficient grounds for bringing an enforcement action under the Labeling of Hazardous Art Materials Act (“LHAMA”) the failure of the following types of products to meet the requirements of § 1500.14(b)(8) (i) through (iii).
(1) Products whose intended general use is not to create art (e.g., common wood pencils, and single colored pens, markers, and chalk), unless the particular product is specifically packaged, promoted, or marketed in a manner that would lead a reasonable person to conclude that it is intended for use as an art material. Factors the Commission would consider in making this determination are how an item is packaged (e.g., packages of multiple colored pencils, chalks, or markers unless promoted for non-art materials uses are likely to be art materials), how it is marketed and promoted (e.g., pencils and pens intended specifically for sketching and drawing are likely to be art materials), and where it is sold (e.g., products sold in an art supply store are likely to be art materials). The products described in this paragraph do not meet the statutory definition of “art material.”
(2) Tools, implements, and furniture used in the creation of a work of art such as brushes, chisels, easels, picture frames, drafting tables and chairs, canvas stretchers, potter's wheels, hammers, air pumps for air brushes, kilns, and molds.
(3) Surface materials upon which an art material is applied, such as coloring books and canvas, unless, as a result of processing or handling, the consumer is likely to be exposed to a chemical in or on the surface material in a manner which makes that chemical susceptible to being ingested, absorbed, or inhaled.
(4) The following materials whether used as a surface or applied to one, unless, as a result of processing or handling, the consumer is likely to be exposed to a chemical in or on the surface material in a manner which makes that chemical susceptible to being ingested, absorbed, or inhaled: paper, cloth, plastics, films, yarn, threads, rubber, sand, wood, stone, tile, masonry, and metal.
(B) For purposes of LHAMA enforcement policy, the Commission will enforce against materials including, but not limited to, paints, crayons, colored pencils, glues, adhesives, and putties, if such materials are sold as part of an art, craft, model, or hobby kit. The Commission will enforce the LHAMA requirements against paints or other materials sold separately which are intended to decorate art, craft, model, and hobby items. Adhesives, glues, and putties intended for general repair or construction uses are not subject to LHAMA. However, the Commission will enforce the LHAMA requirements against adhesives, glues, and putties sold separately (not part of a kit) if they are intended for art and craft and model construction uses. This paragraph (b)(8)(iv)(B) applies to products introduced into interstate commerce on or after August 14, 1995.
(C) Commission regulations at § 1500.14(b)(8)(i)(C)(7) require that a statement of conformance appear with art materials that have been reviewed in accordance with the Commission standard. The Commission interprets this provision to require a conformance statement regardless of the presence of any chronic hazard warnings.
(D) Nothing in this enforcement statement should be deemed to alter any of the requirements of the
(a) The term “certifying organization,” as used in this paragraph, refers to an organization or an institute that, after assuring that all provisions are met, certifies that an art material does conform to the labeling requirements of this practice.
(b) The certifying body may be funded by member manufacturers, but should include users or their representatives, as well as manufacturers' chemists, on its technical and certifying committees.
(c) Representative samples of art materials, labeled as conforming to this section and bought at retail, should be analyzed at random and from time to time by an analytical laboratory to ensure they are the same as the formulation used by the toxicologist(s) for determining labeling requirements.
(d) The methods used by the toxicologist(s) in review and determination of the need and content of precautionary labeling for potentially chronic adverse health effects should be periodically reviewed by an advisory board composed of not less than three or more than five toxicologists, at least one of whom is certified in toxicology by a nationally recognized certification board.
(e) In cases where there is disagreement by participating producers or participating users, with the determination of the toxicologist(s), there should be a method whereby the toxicologist's decision can be presented to the advisory board of toxicologists for arbitration.
- 16 CFR 1500.121 — Labeling Requirements; Prominence, Placement, and Conspicuousness.
- 16 CFR 1500.14 — Products Requiring Special Labeling Under Section 3(b) of the Act.
- 16 CFR 1500.133 — Extremely Flammable Contact Adhesives; Labeling.
- 16 CFR 1500.85 — Exemptions From Classification as Banned Hazardous Substances.
- 16 CFR 1500.83 — Exemptions for Small Packages, Minor Hazards, and Special Circumstances.
- 16 CFR 1112.31 — Who Is Subject to These Audit Requirements?
- 16 CFR 1500.17 — Banned Hazardous Substances.
- 16 CFR 1507.7 — Handles and Spikes.