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Hazardous Substances

Hazardous substances are those which are:1

  • Toxic.
  • Corrosive.
  • An irritant.
  • A strong sensitizer.
  • Flammable or combustible.
  • Capable of generating pressure through decomposition, heat, or other means and which could cause harm or injury through handling, use, or ingestion by children.
  • Radioactive.
  • A toy or article for use by children that presents an electrical, mechanical, or thermal hazard.

Hazardous substances require special labeling. Most also have some shipping limitations or special requirements.

Soap, Cosmetics & Handcrafted Products

Very few products made or sold by soap and cosmetic handcrafters are hazardous substances. However, there are a few products that might be considered hazardous substances under certain circumstances and therefore would require special labeling and handling:

  • Essential oils with a low flash point (flammable or combustible);
  • Fragrance oils with a low flash point (flammable or combustible);
  • Perfumes with a high percentage of alcohol (flammable or combustible);
  • Products with 2% or more bergamot oil2 (strong sensitizer);
  • Powdered orris root and products containing it3 (strong sensitizer);
  • Sodium or potassium hydroxide (corrosive);
  • Products for children containing small parts or other hazards

Flammable or combustible

The flash point is the lowest temperature at which a substance evaporates enough to flash ignite in the presence of a flame or fire. For example, gasoline evaporates at -40°F and will flash ignite at that temperature; 190 proof Everclear has a flash point of 63°F.

The flash point is used to determine whether substance, such an essential oil, fragrance oil or perfume, is flammable or combustible:4

Flash Point Hazard Level Signal Word
20°F or below Extremely Flammable DANGER
Above 20°F and below 100°F Flammable WARNING or CAUTION
Above 100°F and up to 1F0°F Combustible WARNING or CAUTION

The SDS of any essential oil, fragrance oil or other ingredient you purchase should include the flash point. If you sell the fragrance or essential oil directly, that will determine the flash point of the final product. If you blend ingredients with low flash points

Strong Sensitizer

A strong sensitizer is a substance that can cause increasing sensitivity the more you are exposed to it. Unlike an irritant, which is irritating all the time, a sensitizer you may not be sensitive to it at first but become more sensitive with each exposure.5

Determining whether a product containing powdered orris root or 2% bergamot oil needs hazardous substance labeling is determined on a product-by-product basis.6 For example, for bergamot the factors to be considered might include the percentage of bergamot oil, whether it has had the how the furocoumarins removed, and product will be used and by whom.

Corrosive

Sodium and potassium hydroxide are considered corrosive and are most certainly hazardous substances. A product containing more than 10% sodium or potassium hydroxide requires a signal word of POISON.

Note that soap, even if the formulation calls for more than 10% sodium or potassium hydroxide is NOT a hazardous substance as the sodium or potassium hydroxide is converted into soap and not in the soap in its original form.

Labeling

In the Hazardous Substances Act, the term “hazardous substance” does not apply to cosmetics.7 HOWEVER, failing to reveal material facts about substantial risk from a cosmetic which is or contains a hazardous substance would make the cosmetic misbranded,8,9 (and thus prohibit its being sold).

Hazardous substances are required to have certain cautionary statements on their labels including:10

  • Signal words (e.g., DANGER, WARNING, CAUTION);
  • A statement of the principal hazard(s) (e.g., HARMFUL OR FATAL IF SWALLOWED; FLAMMABLE; SKIN AND EYE IRRITANT);
  • Common or usual name, or chemical name of the hazardous substance;
  • Name and place of business of the manufacturer, packer, distributor, or seller;
  • Precautionary measures to follow;
  • Instructions, when appropriate, for special handling and storage;
  • The statement “Keep Out of the Reach of Children” or its practical equivalent;
  • First-aid instructions, when appropriate.

Text Specifications

  • The required information must be placed on the immediate container which actually contains the substance (the bottle, tube, jar, etc.), as well as on any outer wrapper or package surrounding the immediate container.
  • The signal word and statement of the principal hazard must be placed on the principal display panel (PDP). Other required information may be placed on any panel, but if not on the PDP, the statement: “Read carefully other cautions on the ___ panel” must be placed on the PDP. The information must be placed in a block (with or without a border), separated from other content on the PDP.
  • All required information (except the business name and address) must be placed horizontally, parallel to the base of the product when it is displayed for retail sale.
  • Where the principal display panel is on a lid or cap or other part that may be separated from the immediate container, the required information must also be placed somewhere on the immediate container.
  • The signal word and statement of hazard must be in capital letters. Required wording must be in sharp contrast to the background and cannot be obscured or made inconspicuous by the label design, images, or other labeling or lettering.
  • The minimum text size is based on the size of the principal display panel, as follows:
PDP Area (square inches) 0-2 >2 - 5 >5 - 10 >10 - 15 >15 - 30 >30
Size of lettering, based on the height of capital letter, measured in inches:
Signal word 3 ⁄ 64 1 ⁄ 16 3 ⁄ 32 7 ⁄ 64 1 ⁄ 8 5 ⁄ 32
Statement of hazard 3 ⁄ 64 3 ⁄ 64 1 ⁄ 16 3 ⁄ 32 3 ⁄ 32 7 ⁄ 64
Other cautionary material * 1 ⁄ 32 3 ⁄ 64 1 ⁄ 16 1 ⁄ 16 5 ⁄ 64 3 ⁄ 32

* Size of lettering for other cautionary material is based on the area of the display panel on which such cautionary material appears (not the PDP).

Shipping Restrictions

There are restrictions on shipping hazardous materials; they require special packaging and labeling. The classifications for hazardous materials for shipping purposes are slightly different than the classifications for labeling.

If you are shipping hazardous materials, be sure to check with the shipping company (USPS, UPS or FedEx, for example). Liquid products also may require special handling.

Children’s Products

Children’s products which have small parts require a very similar hazard warning on the label.

1 15 USC 1261(f) – Definition of “hazardous substance”
2 16 CFR 1500.13(e) – Listing of “strong sensitizer” substances
3 16 CFR 1500.13(b) – Listing of “strong sensitizer” substances [link to ]
4 16 CFR 1500.3(c)(6) and 16 CFR 1500.3(a)(14) – Definition of terms
5 15 USC 1261(k) – Definitions
6 Consumer Product Safety Commission. CPSC Staff's Strong Sensitizer Guidance Document.
7 15 USC 1261(f)(2) – Definition of “hazardous substance”
8 16 CFR 1500.81 – Exemptions for food, drugs, cosmetics, and fuels.
9 21 CFR 1.21 – Failure to reveal material facts.
10 16 CFR 1500.121 - Labeling requirements; prominence, placement and conspicuousness.

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