902 KAR 45:060. Cosmetic packaging and labeling.

 

      RELATES TO: KRS Chapter 217

      STATUTORY AUTHORITY: KRS 194.050, 217.125

      NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 217 authorizes the Cabinet for Human Resources to regulate the misbranding of cosmetics. The purpose of this administrative regulation is to establish uniform labeling requirements for packaged cosmetics.

 

      Section 1. General Package Requirements. (1) A requirement contained in this administrative regulation that any word, statement, or other information appear on the label shall not be considered to be complied with unless the word, statement, or information also appears on the outer container or wrapper of the retail package of the article, or the information is easily legible by the transparency of the outer wrapper or container.

      (2) If a consumer commodity is marketed in a multiunit retail package bearing the mandatory label information required by this administrative regulation and the unit containers are not intended to be sold separately, the net weight placement on the containers shall be waived if the units are in compliance with this administrative regulation.

 

      Section 2. Cosmetic Package. (1) As used in this administrative regulation, a package is a container or wrapper enclosing a cosmetic for use in the delivery or display to retail purchasers, excluding:

      (a) Shipping containers or wrappings used solely for the transportation of a cosmetic in bulk or in quantity to manufacturers;

      (b) Shipping containers or outer wrappings used by retailers to ship or deliver a cosmetic to retail customers if containers and wrappings bear no printed matter pertaining to any particular commodity; and

      (c) Containers used for tray pack displays in retail establishments.

      (2) Transparent wrappers or containers that do not bear written, printed, or graphic matter obscuring the label information required by this administrative regulation are exempt from cosmetic package requirements.

 

      Section 3. Principal Display Panel. (1) The principal display panel for cosmetics in package form shall be the part of a label most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

      (2) The principal display panel shall be large enough to accommodate all the label information clearly and without obscuring designs, vignettes, or crowding.

      (3) If packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel.

      (4) To obtain uniform type size in declaring the quantity of contents of all packages of substantially the same size, the area of the principal display panel shall be:

      (a) In the case of a rectangular package, with one (1) entire side considered to be the principal display panel side, the product of the height times the width of that side.

      (b) In the case of a cylindrical or nearly cylindrical container, forty (40) percent of the product of the height of the container times the circumference.

      (c) In the case of any other shape of container, forty (40) percent of the total surface of the container.

      (5) If the container presents an obvious principal display, panel such as the top of a triangular or circular package, the area of the principal display panel shall consist of the entire top surface.

      (6) In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars.

      (7) For cylindrical or nearly cylindrical containers, information required to appear on the principal display panel shall appear within that forty (40) percent of circumference most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

 

      Section 4. Statement of Identity. (1) The principal display panel of a cosmetic in package form shall bear as a principal feature a statement of the identity of the commodity.

      (2) A statement of identity shall be in terms of:

      (a) The common or usual name of the cosmetic;

      (b) A descriptive name or, if the nature of the cosmetic is obvious, a fanciful name understood by the public to identify the cosmetic; or

      (c) An illustration or vignette representing the intended cosmetic use.

      (3) The statement of identity shall:

      (a) Be presented in bold type on the principal display panel;

      (b) Be in a size reasonably related to the most prominent printed matter on the panel; and

      (c) Be in lines generally paralleled to the base on which the package rests as it is designed to be displayed.

 

      Section 5. Name and Place of Business of Manufacturer, Packer, or Distributor. (1) The label of a cosmetic in package form shall distinctly specify the name and place of business of the manufacturer, packer, or distributor.

      (2) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be satisfied in the case of a corporation only by the actual corporate name, which may be preceded or followed by the name of the division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. For an individual, partnership or association, the name under which the business is conducted shall be used.

      (3) If the cosmetic is not manufactured by the person whose name appears on the label, the name shall include a phrase that reveals the connection that person has with the cosmetic; such as "Manufactured for _________", "Distributed by _________".

      (4) The statement of the place of business shall include the street address, city, state, and zip code. The street address may be omitted if it is shown in a current city directory or telephone directory. For nonconsumer packages, the zip code shall appear either on the label or the labeling (including the invoice).

      (5) If a person manufactures, packs, or distributes a cosmetic at a place other than the principal place of business, the label may state the principle place of business instead of the actual place where the cosmetic was manufactured, packed, or is to be distributed, unless the statement would be misleading.

 

      Section 6. Declaration of Net Quantity of Contents. (1) The label of a cosmetic in package form shall bear a declaration of the net quantity of contents by weight, measure, numerical count, or a combination of numerical count and weight or measure.

      (a) The declaration shall be in terms of fluid measure if the cosmetic is liquid, or in terms of weight if the cosmetic is solid, semisolid, or viscous, or a mixture of solid and liquid.

      (b) If there is a firmly established, general consumer usage and the trade custom of declaring the net quantity of a cosmetic by numerical count, linear measure, or measure of area, it may be used.

      (c) If there is a firmly established, general consumer usage and trade custom of declaring the contents of a liquid cosmetic by weight, or a solid, semisolid, or viscous cosmetic by fluid measure, it may be used.

      (2) Statements of weight shall be in terms of avoirdupois pound and ounce. Statements of fluid measure shall be in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid ounce subdivision thereof and shall express the volume at sixty-eight (68) degrees Fahrenheit.

      (3) If the declaration by numerical count, linear measure, or measure of area does not give accurate information as to the quantity of cosmetic in the package, it shall be combined with a statement by weight, measure, size of the individual units, or the total weight or measure of the cosmetic that will give the information.

      (4) The declaration may contain common or decimal fractions.

      (a) A common fraction shall be in terms of halves, quarters, eighths, 16ths, or 32nds.

      (b) If there exists a firmly established, general consumer usage and trade custom of employing different common fractions in the net quantity declaration of a particular commodity, it may be used.

      (c) A common fraction shall be reduced to its lowest terms.

      (d) A decimal fraction shall not be carried out to more than two (2) places.

      (e) A statement that includes small fractions of an ounce shall permit smaller variations than a statement that does not include small fractions of an ounce.

      (5) The declaration shall be located on the principal display panel of the label; packages bearing alternate principal display panels shall have the declaration duplicated on each principal display panel.

      (a) The principal display panel of a cosmetic marketed in a "boudoir-type" container, including decorative cosmetic containers of the "cartridge," "pill box," "compact," or "pencil" variety, and those with a capacity of one-fourth (1/4) ounce or less, may be considered to be a tear-away tag or tape affixed to the decorative container and bearing the mandatory label information, but the type size of the declaration shall be governed by the dimensions of the decorative container; and

      (b) The principal display panel of a cosmetic marketed on a display card to which the immediate container is affixed may be considered to be the display panel of the card, but the type size of the declaration shall be governed by the dimensions of the display card.

      (6) The declaration shall appear as a distinct item on the principal display panel, and shall be:

      (a) Separated by at least a space equal to the height of the lettering used in the declaration from other printed label information appearing above or below the declaration and by at least a space equal to twice the width of the letter "N" of the style of type used in the quantity of contents statement from other printed label information appearing to the left or right of the declaration; and

      (b) Placed within the bottom thirty (30) percent of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed, except:

      1. On packages having a principal display panel of five (5) square inches or less, the requirement for placement within the bottom thirty (30) percent of the area of the label panel shall not apply; and

      2. In the case of a cosmetic that is marketed with both outer and inner retail containers bearing the mandatory label information, and the inner container is not intended to be sold separately, the net quantity of contents placement requirement of this section applicable to the inner container is waived.

      (7) The declaration shall accurately reveal the quantity of cosmetic in the package exclusive of wrappers and other material, except:

      (a) In the case of cosmetics packed in containers designed to deliver the cosmetic under pressure, the declaration shall state the net quantity of the contents that will be expelled if the instructions for use as shown on the container are followed. The propellant is included in the net quantity declaration; and

      (b) In the case of a package which contains the integral components making up a complete kit, and is designed to deliver the components in the manner of an application (for example, a home permanent wave kit), the declaration may state the net quantity of the contents in nondescriptive terms of the number of applications available in the kit if the instructions for use as shown on the container are followed.

      (8) The declaration shall appear in obvious and easily legible boldface print or type in distinct contrast, by typography, layout, color, embossing, or molding, to other matter on the package; except a declaration of net quantity blown, embossed, or molded on a glass or plastic surface shall be permissible if all label information is formed on the surface. Requirements of legibility shall include:

      (a) The ratio of height to width of the letter shall not exceed a differential of three (3) units to one (1) unit (no more than three (3) times as high as it is wide).

      (b) Letter heights pertain to upper case or capital letters. If upper and lower case or all lower case letters are used, it is the lower case letter "o" or its equivalent that shall meet the minimum standards.

      (c) If fractions are used, each component numeral shall meet one-half (1/2) the minimum height standards.

      (9) The declaration shall be in letters and numerals in a type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications:

      (a) Not less than one-sixteenth (1/16) inch in height on packages the principal display panel has an area of five (5) square inches or less.

      (b) Not less than one-eighth (1/8) inch in height on packages the principal display panel has an area of more than five (5) but less than twenty-five (25) square inches.

      (c) Not less than three-sixteenths (3/16) inch in height on packages the principal display panel has an area of more than twenty-five (25) but less than 100 square inches.

      (d) Not less than one-fourth (1/4) inch in height on packages the principal display panel has an area of more than 100 square inches, except not less than one-half (1/2) inch in height if the area is more than 400 square inches.

      (10) If the declaration is blown, embossed, or molded on a glass or plastic surface rather than by printing, typing, or coloring, the lettering sizes specified in subsection (9)(a) through (d) of this section shall be increased by one-sixteenth (1/16) of an inch.

      (11) On packages containing less than four (4) pounds or one (1) gallon and labeled in terms of weight of fluid measure:

      (a) The declaration shall be expressed both in ounces with identification by weight or by liquid measure and, if applicable (one (1) pound or one (1) pint or more), followed in parentheses by a declaration in pounds for weight units, with the remainder in terms of ounces or common or decimal fractions of the pound (see example set forth in subsection (14)(a) and (b) of this section), or in the case of liquid measure, in the largest whole unit (quarts, quarts and pints, or pints, as appropriate) with the remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see example in subsection (14)(c) and (d) of this section). Net weight or fluid measure of less than one (1) ounce shall be expressed in common or decimal fractions of the respective ounce and not in drams.

      (b) The declaration may appear in more than one (1) line.

      1. The term "net weight" shall be used if stating the net quantity of contents in terms of weight.

      2. The terms "net" or "net contents" for fluid measure or numerical count is optional.

      3. Avoirdupois ounce may be distinguished from fluid ounce through association of terms; for example, "net wt. 6 oz." or "6 oz. net wt." and "net contents 6 fl. oz." or "6 fl. oz."

      (12) On packages containing four (4) pounds or one (1) gallon or more and labeled in terms of weight or fluid measure, the declaration shall be expressed in pounds for weight units with the remainder in terms of ounces or common or decimal fractions of the pound. Fluid measure shall be expressed in the largest whole unit (gallons, followed by common or decimal fractions of a gallon) or by the next smaller whole unit or units (quarts or quarts and pints) with the remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see example in subsection (14) of this section).

      (13) The declaration shall not include a term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the cosmetic in the container, such as "giant pint" and "full quart."

      (14) Examples.

      (a) A declaration of one and one-half (1 1/2) pounds weight shall be expressed as "Net wt. 24 oz. (1 lb. 8 oz.)", "Net wt. 24 oz. (1 1/2 lb.)", or "Net wt. 24 oz. (1.5 lb.)."

      (b) A declaration of three-fourths (3/4) pound avoirdupois weight shall be expressed as "Net wt. 12 oz."

      (c) A declaration of one (1) quart liquid measure shall be expressed as "Net contents 32 fl. oz. (1 qt.)."

      (d) A declaration of one and three-fourths (1 3/4) quarts liquid measure shall be expressed as "Net contents 56 fl. oz. (1 qt. 1 1/2 pt.)" or "Net contents 56 fl. oz. (1 qt. 1 pt. 8 oz.)", but not in terms of quart and ounce such as "Net contents 56 fl. oz. (1 qt. 24 oz.)."

      (e) A declaration of two and one-half (2 1/2) gallons liquid measure shall be expressed in the alternative as "net contents 2 gal. 2 qt.", not as "2 gal. 4 pt."

      (15) For quantities, the following abbreviations shall be used (periods and plural forms are optional): weight, wt.; gallon, gal,; square, sq.; quart, qt.; fluid, fl.; pint, pt.; yard, yd.; ounce, oz.; feet or foot, ft.; pound, lb.; inch, in.

      (16) On packages labeled in terms of linear measure, the declaration shall be expressed both in terms of inches and, if applicable (one (1) foot or more), the largest whole units (yards, yards and feet, feet). The declaration in terms of the largest whole units shall be in parentheses following the declaration in terms of inches and the remainder shall be in terms of inches or common or decimal fractions of the foot or yard; for example, "86 inches (2 yd. 1 ft. 2 inches)," "90 inches (2 1/2 yd.)" "30 inches (2.5 yd.)".

      (17) On packages labeled in terms of area measure, the declaration shall be expressed in terms of square inches and, if applicable (one (1) square foot or more), the largest whole square unit (square yards, square yards and square feet, square feet). The declaration in terms of the largest whole units shall be in parentheses following the declaration in terms of square inches and the remainder shall be in terms of square inches or common or decimal fractions of the square foot or square yard; for example, "158 sq. inches (1 sq. ft. 14 sq. inches)".

      (18) This section shall not prohibit supplemental declarations at locations other than the principal display panel describing in nondeceptive terms the net quantity of contents.

      (a) Supplemental declarations shall not include any term of weight, measure, or count that tends to exaggerate the amount of the cosmetic contained in the package; for example, "giant pint" and "full quart."

      (b) Dual or combination declarations, as provided for in subsections (1), (3), and (11) of this section (for example, a combination of net weight plus numerical count), shall not be regarded as a supplemental declaration and shall be located on the principal display panel.

      (19) A separate statement of the net quantity of contents in terms of the metric system shall not be regarded as a supplemental declaration. A statement in terms of the metric system of weight or measure may also appear on the principal display panel or on other panels.

      (20) The declaration shall express an accurate statement of the quantity of contents of the package. Reasonable variations caused by loss or gain of moisture during the course of good distribution practice or by unavoidable deviations in good manufacturing practice will be recognized.

 

      Section 7. Prominence of Required Statements. (1) A word, statement, or other information required may lack prominence pursuant to KRS Chapter 217 by reason of:

      (a) Failure of a word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;

      (b) Failure of a word, statement, or information to appear on two (2) or more parts or panels of the label, each having sufficient space, and designed to render it likely to be, under customary conditions or purchase, the part or panel displayed;

      (c) Failure of the label to extend over the area of the container or package available for the extension to provide sufficient label space for the prominent placing of a word, statement, or information;

      (d) Insufficient label space, for the prominent placing of a word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required to appear on the label;

      (e) Insufficient label space, for the prominent placing of a word, statement, or information, resulting from the use of label space to give materially greater distinction to any word, statement, or information, or to any design or device; or

      (f) Smallness or style of type in which a word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.

      (2) Words, statements, and other information required to appear on the label or labeling shall appear in the English language. Articles distributed solely in a territory where the predominant language is one other than English, the predominant language may be substituted for English.

      (3) If the label contains any representation in a foreign language, all words, statements, and other information required pursuant to KRS 217.035 to appear on the label or labeling shall appear in the foreign language.

 

      Section 8. Exemptions. (1) Except as provided by subsections (2) and (3) of this section, a cosmetic that is to be processed, labeled, or repacked at an establishment other than where originally processed or packed, shall be exempt, during the time of introduction into commerce and the time in the establishment, from the labeling requirements of KRS 217.085(1) and 217.095(2) if:

      (a) The person who introduced the shipment or delivery into commerce is the operator of the establishment where the cosmetic is to be processed, labeled, or repacked; or

      (b) If the person is not the operator, the shipment or delivery is made to the establishment under a written agreement; signed by and containing the post office address of the person and operator; and containing the specifications for the processing, labeling, or repacking, of the cosmetic in the establishment that will insure, if the specifications are followed, that the cosmetic will not be adulterated or misbranded upon completion of processing, labeling, or repacking. The person and the operator shall each keep a copy of the agreement until two (2) years after the final shipment or delivery of the cosmetic from the establishment. If requested, copies shall be made available to the cabinet for inspection.

      (2) An exemption of a shipment or other delivery of a cosmetic pursuant to subsection (1)(a) of this section shall, at the beginning of removing the shipment or delivery, or any part thereof, from the establishment, become void ab initio if the cosmetic comprising the shipment, delivery, or part is adulterated or misbranded when removed.

      (3) An exemption of a shipment or other delivery of a cosmetic pursuant to subsection (1)(b) of this section shall become void ab initio with respect to the person who introduced the shipment or delivery into commerce upon refusal by the person to make available for inspection a copy of the agreement, as required.

      (4) An exemption of a shipment or other delivery of a cosmetic pursuant to subsection (1)(b) of this section shall expire:

      (a) At the beginning of removing the shipment or delivery, or any part thereof, from the establishment if the cosmetic comprising the shipment, delivery, or part is adulterated or misbranded when removed; or

      (b) Upon refusal by the operator of the establishment where the cosmetic is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required. (1 Ky.R. 547; eff. 3-12-75; Am. 20 Ky.R. 2203; eff. 3-14-94.)