Code of Federal Regulations

  Title 21, Volume 7, Parts 600 to 799

  Revised as of April 1, 1996

 From the U.S. Government Printing Office via GPO Access

  CITE: 21CFR701

 

  Page 180-192

 

         TITLE 21--FOOD AND DRUGS

 

 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

 

 PART 701--COSMETIC LABELING

 

       Subpart A--General Provisions

 

 Sec.

 701.1  Misbranding.

 701.2  Form of stating labeling requirements.

 701.3  Designation of ingredients.

 701.9  Exemptions from labeling requirements.

 

     Authority: Secs. 201, 502, 601, 602, 603, 701, 704 of the Federal

 Food, Drug, and Cosmetic Act (21 U.S.C. 321, 352, 361, 362, 363, 371,

 374); secs. 5, 6 of the Fair Packaging and Labeling Act (15 U.S.C. 1454,

 1455).

 

     Source: 39 FR 10056, Mar. 15, 1974, unless otherwise noted.

 

       Subpart A--General Provisions

 

 Sec. 701.1   Misbranding.

 

     (a) Among representations in labeling of a cosmetic which render

 such cosmetic misbranded is a false or misleading representation with

 respect to another cosmetic or a food, drug, or device.

     (b) The labeling of a cosmetic which contains two or more

 ingredients may be misleading by reason (among other reasons) of the

 designation of such cosmetic in such labeling by a name which includes

 or suggests the name of one or more but not all such ingredients, even

 though the names of all such ingredients are stated elsewhere in the

 labeling.

 

 Sec. 701.2   Form of stating labeling requirements.

 

     (a) A word, statement, or other information required by or under

 authority of the Act to appear on the label may lack that prominence and

 conspicuousness required by section 602(c) of the Act by reason (among

 other reasons) of:

     (1) The failure of such word, statement, or information to appear on

 the part or panel of the label which is

 

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 presented or displayed under customary conditions of purchase;

     (2) The failure of such word, statement, or information to appear on

 two or more parts or panels of the label, each of which has sufficient

 space therefor, and each of which is so designed as to render it likely

 to be, under customary conditions of purchase, the part or panel

 displayed;

     (3) The failure of the label to extend over the area of the

 container or package available for such extension, so as to provide

 sufficient label space for the prominent placing of such word,

 statement, or information;

     (4) Insufficiency of label space (for the prominent placing of such

 word, statement, or information) resulting from the use of label space

 for any word, statement, design, or device which is not required by or

 under authority of the Act to appear on the label;

     (5) Insufficiency of label space (for the prominent placing of such

 word, statement, or information) resulting from the use of label space

 to give materially greater conspicuousness to any other word, statement,

 or information, or to any design or device;

     (6) Smallness or style of type in which such word, statement, or

 information appears, insufficient background contrast, obscuring designs

 or vignettes, or crowding with other written, printed, or graphic

 matter.

     (b)(1) All words, statements, and other information required by or

 under authority of the Act to appear on the label or labeling shall

 appear thereon in the English language: Provided, however, That in the

 case of articles distributed solely in the Commonwealth of Puerto Rico

 or in a Territory where the predominant language is one other than

 English, the predominant language may be substituted for English.

     (2) If the label contains any representation in a foreign language,

 all words, statements, and other information required by or under

 authority of the Act to appear on the label shall appear thereon in the

 foreign language.

     (3) If the labeling contains any representation in a foreign

 language, all words, statements, and other information required by or

 under authority of the Act to appear on the label or labeling shall

 appear on the labeling in the foreign language.

 

 Sec. 701.3  Designation of ingredients.

 

     (a) The label on each package of a cosmetic shall bear a declaration

 of the name of each ingredient in descending order of predominance,

 except that fragrance or flavor may be listed as fragrance or flavor. An

 ingredient which is both fragrance and flavor shall be designated by

 each of the functions it performs unless such ingredient is identified

 by name. No ingredient may be designated as fragrance or flavor unless

 it is within the meaning of such term as commonly understood by

 consumers. Where one or more ingredients is accepted by the Food and

 Drug Administration as exempt from public disclosure pursuant to the

 procedure established in Sec. 720.8(a) of this chapter, in lieu of label

 declaration of identity the phrase ``and other ingredients'' may be used

 at the end of the ingredient declaration.

     (b) The declaration of ingredients shall appear with such prominence

 and conspicuousness as to render it likely to be read and understood by

 ordinary individuals under normal conditions of purchase. The

 declaration shall appear on any appropriate information panel in letters

 not less than \1/16\ of an inch in height and without obscuring design,

 vignettes, or crowding. In the absence of sufficient space for such

 declaration on the package, or where the manufacturer or distributor

 wishes to use a decorative container, the declaration may appear on a

 firmly affixed tag, tape, or card. In those cases where there is

 insufficient space for such declaration on the package, and it is not

 practical to firmly affix a tag, tape, or card, the Commissioner may

 establish by regulation an acceptable alternate, e.g., a smaller type

 size. A petition requesting such a regulation as an amendment to this

 paragraph shall be submitted pursuant to part 10 of this chapter.

     (c) A cosmetic ingredient shall be identified in the declaration of

 ingredients by:

     (1) The name specified in Sec. 701.30 as established by the

 Commissioner for that ingredient for the purpose of

 

   Page 182

 

 cosmetic ingredient labeling pursuant to paragraph (e) of this section;

     (2) In the absence of the name specified in Sec. 701.30, the name

 adopted for that ingredient in the following editions and supplements of

 the following compendia, listed in order as the source to be utilized:

     (i) CTFA (Cosmetic, Toiletry and Fragrance Association, Inc.)

 Cosmetic Ingredient Dictionary, Second Ed., 1977 (available from the

 Cosmetic, Toiletry and Fragrance Association, Inc. 1110 Vermont Ave.

 NW., Suite 800, Washington, DC 20005, or available for inspection at the

 Office of the Federal Register, 800 North Capitol Street, NW., suite

 700, Washington, DC 20408), which is incorporated by reference, except

 for the following deletions and revisions:

     (a) The following names are not adopted for the purpose of cosmetic

 ingredient labeling:

 

 Acid Black 58

 Acid Black 107

 Acid Black 139

 Acid Blue 168

 Acid Blue 170

 Acid Blue 188

 Acid Blue 209

 Acid Brown 19

 Acid Brown 30

 Acid Brown 44

 Acid Brown 45

 Acid Brown 46

 Acid Brown 48

 Acid Brown 224

 Acid Orange 80

 Acid Orange 85

 Acid Orange 86

 Acid Orange 88

 Acid Orange 89

 Acid Orange 116

 Acid Red 131

 Acid Red 213

 Acid Red 252

 Acid Red 259

 Acid Violet 73

 Acid Violet 76

 Acid Violet 99

 Acid Yellow 114

 Acid Yellow 127

 Direct Yellow 81

 Solvent Black 5

 Solvent Brown 43

 Solvent Yellow 63

 Solvent Yellow 90

 

     (b) The following names are adopted for the purpose of cosmetic

 ingredient labeling, provided the respective monographs are revised to

 describe their otherwise disclosed chemical compositions, or describe

 their chemical compositions more precisely, and such revised monographs

 are published in supplements to this dictionary edition by July 18,

 1980.

 

 Acid Black 2

 Benzophenone-11

 Carbomer 934

 Carbomer 934P

 Carbomer 940

 Carbomer 941

 Carbomer 960

 Carbomer 961

 Chlorofluorocarbon 11S

 Dimethicone Copolyol

 Disperse Red 17

 Pigment Green 7

 Polyamino Sugar Condensate

 SD Alcohol (all 27 alphanumeric designations)

 Sodium Chondroitin Sulfate

 Synthetic Beeswax

 

     (c) The following names are adopted for the purpose of cosmetic

 ingredient labeling until January 19, 1981.

 

 Amphoteric (all 20 numeric designations)

 Quaternium (all 49 numeric designations)

 

     (ii) United States Pharmacopeia, 19th Ed., 1975, and Second

 Supplement to the USP XIX and NF XIV, 1976. (Copies are available from

 the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway,

 Rockville, MD 20852, or available for inspection at the Office of the

 Federal Register, 800 North Capitol Street, NW., suite 700, Washington,

 DC 20408.)

     (iii) National Formulary, 14th Ed., 1975, and Second Supplement to

 the USP XIX and NF XIV, 1976. (Copies are available from the U.S.

 Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD

 20852, or available for inspection at the Office of the Federal

 Register, 800 North Capitol Street, NW., suite 700, Washington, DC

 20408).

     (iv) Food Chemicals Codex, 2d Ed., 1972; First Supplement, 1974, and

 Second Supplement, 1975, which are incorporated by reference. Copies are

 available from the Center for Food Safety and Applied Nutrition, Food

 and Drug Administration, 200 C St. SW., Washington, DC 20204, or

 available for inspection at the Office of the Federal Register, 800

 North Capitol Street, NW., suite 700, Washington, DC 20408.

     (v) USAN and the USP dictionary of drug names, USAN 1975, 1961-1975

 

   Page 183

 

 cumulative list. (Copies are available from the U.S. Pharmacopeial

 Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, or

 available for inspection at the Office of the Federal Register, 800

 North Capitol Street, NW., suite 700, Washington, DC 20408.)

     (3) In the absence of such a listing, the name generally recognized

 by consumers.

     (4) In the absence of any of the above, the chemical or other

 technical name or description.

     (d) Where a cosmetic product is also a drug, the declaration shall

 first declare the active drug ingredients as required under section

 502(e) of the Federal Food, Drug, and Cosmetic Act, and shall then

 declare the cosmetic ingredients.

     (e) Interested persons may submit a petition requesting the

 establishment of a specific name for a cosmetic ingredient pursuant to

 part 10 of this chapter. The Commissioner may also propose such a name

 on his own initiative.

     (f) As an alternative to listing all ingredients in descending order

 of predominance, ingredients may be grouped and the groups listed in the

 following manner and order:

     (1) Ingredients, other than color additives, present at a

 concentration greater than 1 percent, in descending order of

 predominance; followed by

     (2) Ingredients, other than color additives, present at a

 concentration of not more than 1 percent, without respect to order of

 predominance; followed by

     (3) Color additives, without respect to order of predominance.

 Ingredients specified in paragraph (f)(2) of this section may be

 included with those specified in paragraph (f)(1) of this section and

 listed in descending order of predominance.

     (g) A declaration of ingredients may include an ingredient not in

 the product if the ingredient is identified by the phrase ``may

 contain'' and:

     (1) It is a color additive added to some batches of the product for

 purposes of color matching; or

     (2)(i) The same declaration of ingredients is also used for other

 products similar in composition and intended for the same use, including

 products which may be assortments of products similar in composition and

 intended for the same use; and

     (ii) Such products are ``shaded'' products, i.e., those falling

 within the product categories identified in Sec. 720.4 (c)(3), (7) and

 (8)(v) of this chapter; and

     (iii) All products sharing the common declaration of ingredients are

 sold by the labeler under a common trade name or brand designation, and

 no trade name or brand designation not common to all such products

 appears in the labeling of any of them; and

     (iv) The ingredient is a color additive.

     (h) As an alternative to a declaration of color additive ingredients

 for each product, the color additives of an assortment of cosmetic

 products that are sold together in the same package may be declared in a

 single composite list in a manner that is not misleading and that

 indicates that the list pertains to all the products.

     (i) As an alternative to the declaration of ingredients specified in

 paragraph (b) of this section, the declaration of ingredients may appear

 in letters not less than \1/16\ of an inch in height in labeling

 accompanying the product, as for example, on padded sheets or in

 leaflets, if the total surface area of the package is less than 12

 square inches. This paragraph is inapplicable to any packaged cosmetic

 product enclosed in an outer container, e.g., a folding carton. In

 addition, this paragraph is applicable only to cosmetic products meeting

 one of the following requirements:

     (1) The cosmetic products are held and displayed for sale in tightly

 compartmented trays or racks of a display unit. The holder of the

 labeling bearing the declaration of ingredients shall be attached to the

 display unit; or

     (2) The cosmetic products are ``shaded'' products, i.e., those

 falling within the product categories identified in Sec. 720.4 (c)(3),

 (7) and (8)(v) of this chapter, and are held for sale in tightly

 compartmented trays or racks. The holder of the labeling bearing the

 declaration of ingredients shall be attached to a display chart bearing

 samples of the product shades, which is displayed to purchasers. Such a

 display chart shall be of such construction and design as to permit its

 continuous use

 

   Page 184

 

 as a display, such as on a counter, and shall be designed for the

 primary purpose of displaying samples of the shades of the products.

     (j) The holder of labeling bearing a declaration of ingredients and

 used in accordance with paragraph (i) of this section shall be attached

 to the display unit or chart and shall meet one of the following

 conditions:

     (1) The labeling is on the front of the display unit or chart and

 can be read in full by a purchaser facing the display unit or chart

 under customary conditions of retail sale; or

     (2) The labeling is on the front of the display unit or chart, is

 partially visible, and is accompanied by a conspicuous notice on the

 front of the display unit or chart describing the location of such

 labeling in letters not less than \3/16\ of an inch in height, e.g.,

 ``Ingredient lists above'', that can be read by a purchaser facing the

 display unit or chart under customary conditions of retail sale, or by

 the notice required by provisions in paragraph (k)(3) of this section,

 if conspicuous at all times; or

     (3) The labeling is on a side of the display unit or chart, but not

 on the top, back, or bottom, and is accompanied by a conspicuous notice

 on the front of the display unit or chart describing the location of

 such labeling in letters not less than \3/16\ of an inch in height,

 e.g., ``Ingredient lists located on right side of display'', that can be

 read by a purchaser facing the display unit or chart under customary

 conditions of retail sale.

     (k) Any use of a display unit or chart bearing labeling under the

 provisions of paragraph (i) of this section shall meet the following

 requirements:

     (1) All articles of labeling bearing ingredient declarations and

 used in conjunction with any one display unit or chart shall be

 identical and shall declare the ingredients of all products sold in

 conjunction with the display unit or chart for which the ingredient

 declaration is made pursuant to paragraph (i) of this section.

     (2) Any display unit or chart intended for such use shall be shipped

 together with the labeling intended to be attached to it.

     (3) Every display unit or chart and/or labeling system shall be

 designed so that the words ``Federal law requires ingredient lists to be

 displayed here'' in letters not less than \3/16\ of an inch in height

 (i) become conspicuous when no ingredient declarations are displayed and

 when the last list has been taken, or (ii) are conspicuous at all times

 adjacent to the place where ingredient declarations are to be attached.

     (4) Any labeling containing a declaration of ingredients which

 reflects a formulation change and not shipped accompanying a display

 unit or chart shall be dated. Whenever any formulation change is made,

 and the labeling containing the declaration of ingredients is thereby

 required to be used in conjunction with products of both the old and new

 formulations, the labeling shall declare the ingredients of both the old

 and new formulations separately in a way that is not misleading and in a

 way that permits the purchaser to identify the ingredient declaration

 applicable to each package, or which clearly advises the purchaser that

 the formulation has been changed and that either declaration may be

 applicable.

     (5) Sufficient copies of the declaration of ingredients shall be

 provided with each shipment of a cosmetic so that a purchaser may obtain

 a copy of the declaration with each purchase. Display units and

 replacement labeling for display units shall be accompanied by

 instructions to the retailer, which when followed will result in

 compliance with the requirements of this section. Copies of the

 declaration accompanying refills shall be attached to the specific

 refill items to which they pertain, or shall be packed with the specific

 refill items to which they pertain, in a container that does not contain

 other cosmetic products.

     (6) The firm whose name appears on a product pursuant to Sec. 701.12

 shall promptly mail a copy of the declaration of ingredients to any

 person requesting it.

     (7) The display unit or chart shall be designed and located such

 that the labeling is easily accessible to a purchaser facing the display

 unit or chart under customary conditions of retail sale.

     (l) The provisions of this section do not require the declaration of

 

   Page 185

 

 incidental ingredients that are present in a cosmetic at insignificant

 levels and that have no technical or functional effect in the cosmetic.

 For the purpose of this paragraph, incidental ingredients are:

     (1) Substances that have no technical or functional effect in the

 cosmetic but are present by reason of having been incorporated into the

 cosmetic as an ingredient of another cosmetic ingredient.

     (2) Processing aids, which are as follows:

     (i) Substances that are added to a cosmetic during the processing of

 such cosmetic but are removed from the cosmetic in accordance with good

 manufacturing practices before it is packaged in its finished form.

     (ii) Substances that are added to a cosmetic during processing for

 their technical or functional effect in the processing, are converted to

 substances the same as constituents of declared ingredients, and do not

 significantly increase the concentration of those constituents.

     (iii) Substances that are added to a cosmetic during the processing

 of such cosmetic for their technical and functional effect in the

 processing but are present in the finished cosmetic at insignificant

 levels and do not have any technical or functional effect in that

 cosmetic.

     (m) In the event that there is a current or anticipated shortage of

 a cosmetic ingredient, the declaration required by this section may

 specify alternatives to any ingredients that may be affected. An

 alternative ingredient shall be declared either (1) immediately

 following the normally used ingredient for which it substitutes, in

 which case it shall be identified as an alternative ingredient by the

 word ``or'' following the name of the normally used ingredient and any

 other alternative ingredient, or (2) following the declaration of all

 normally used ingredients, in which case the alternative ingredients in

 the group so listed shall be listed in expected descending order of

 predominance or in accordance with the provisions of paragraph (f) of

 this section and shall be identified as alternative ingredients by the

 phrase ``may also contain''. This paragraph is inapplicable to any

 ingredient mentioned in advertising, or in labeling other than in the

 declaration of ingredients required by this section.

     (n) In the event that the shortage of a cosmetic ingredient

 necessitates a formulation change, packages bearing labels declaring the

 ingredients of the old formulation may be used if the revised ingredient

 declaration appears (1) on a firmly affixed tag, tape, card, or sticker

 or similar overlabeling attached to the package and bearing the

 conspicuous words ``new ingredient list'' in letters not less than \1/

 16\ of an inch in height, or (2) on labeling inside an unsealed package

 and the package bears the conspicuous words, on a sticker or similar

 overlabeling, ``new ingredient list inside'' in letters not less than

 \1/16\ of an inch in height.

     (o) The ingredients of products that are similar in composition and

 intended for the same use may be declared as follows:

     (1) The declaration of ingredients for an assortment of such

 products that are sold together in the same package, e.g., eyeshadows of

 different colors, may declare the ingredients that are common to all the

 products, in a single list in their cumulative order of predominance or

 in accordance with the provisions of paragraph (f) of this section,

 together with a statement, in terms that are as informative as

 practicable and that are not misleading, declaring the other ingredients

 and identifying the products in which they are present. The color

 additive ingredients of all the products in such an assortment, whether

 or not common to all the products, may be declared in a single composite

 list following the declaration of the other ingredients without

 identifying the products in which they are present.

     (2) The ingredients of an assortment of such products that are sold

 together in the same package, e.g., eyeshadows of different colors, may

 be declared in a single list in their cumulative order of predominance

 or in accordance with the provisions of paragraph (f) of this section,

 if the package is designed such that it has a total surface area

 available to bear labeling of less than 12 square inches. For the

 purpose of this paragraph, surface area is not available

 

   Page 186

 

 for labeling if physical characteristics of the package surface, e.g.,

 decorative relief, make application of a label impractical.

     (3) The declaration of ingredients for such a product that is

 individually packaged and bears a label that is shared with other

 products pursuant to the provisions of paragraph (g)(2) of this section,

 e.g., one lipstick in a line of lipsticks, may declare the ingredients

 that are common to all such products, in a single list in their

 cumulative order of predominance or in accordance with the provisions of

 paragraph (f) of this section, together with a statement, in terms that

 are as informative as practicable and that are not misleading, declaring

 the other ingredients in such products, and identifying the products in

 which they are present. The color additive ingredients shall be declared

 in accordance with the provisions of paragraph (g) of this section.

     (4) The declaration of ingredients for an assortment of such

 cosmetic products that bears a label that is shared with other products

 pursuant to the provisions of paragraph (g)(2) of this section, e.g.,

 one of several compacts in a line of compacts, may declare the

 ingredients that are common to all such products, in a single list in

 their cumulative order of predominance or in accordance with the

 provisions of paragraph (f) of this section, together with a statement,

 in terms that are as informative as practicable and that are not

 misleading, declaring the other ingredients in such products and

 identifying the products in which they are present. The color additive

 ingredients shall be declared in accordance with the provisions of

 paragraph (g) of this section.

     (p) As an alternative to the declaration of ingredients in letters

 not less than \1/16\ of an inch in height, letters may be not less than

 \1/32\ of an inch in height if the package is designed such that it has

 a total surface area available to bear labeling of less than 12 square

 inches. For the purpose of this paragraph, surface area is not available

 for labeling if physical characteristics of the package surface, e.g.,

 decorative relief, make application of a label impractical.

     (q) The inside containers in a multiunit or multicomponent retail

 cosmetic package are not required to bear a declaration of ingredients

 when the labeling of the multiunit or multicomponent retail cosmetic

 package meets all the requirements of this section and the inside

 containers are not intended to be, and are not customarily, separated

 from the retail package for retail sale.

     (r) In the case of cosmetics distributed to the consumers by direct

 mail, as an alternative to the declaration of ingredients on an

 information panel, the declaration of ingredients may appear in letters

 not less than \1/16\ of an inch in height in labeling that accompanies

 and specifically relates to the cosmetic(s) mailed, or in labeling

 furnished to each consumer for his personal use and from which he orders

 cosmetics through the mail, e.g., a direct mail sales catalog or

 brochure, provided all of the following additional requirements are met:

     (1) The declarations of ingredients are conspicuous and presented in

 a way that permits the consumer to identify the declaration of

 ingredients applicable to each cosmetic.

     (2) The package mailed to the consumer is accompanied by a notice

 located on, or affixed to, the top of the package or on top of the

 contents inside the package, or on the face of the package platform

 surrounding and holding the product(s), readily visible to the consumer

 on opening of the package, and provides the following information in

 letters not less than \3/16\ of an inch in height:

     (i) The location of the declarations of ingredients, e.g., in an

 accompanying brochure, or in a sales catalog used for ordering;

     (ii) A statement that a copy of the declaration of ingredients will

 be mailed promptly to any person requesting it; and

     (iii) The name and place of business of the mail order distributor,

     (3) The mail order distributor promptly mails a copy of the

 

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 declaration of ingredients to any person requesting it.

 

  39 FR 10056, Mar. 15, 1974, as amended at 40 FR 8922, Mar. 3, 1975; 40

 FR 18426, Apr. 28, 1975; 42 FR 4718, Jan. 25, 1977; 42 FR 15676, Mar.

 22, 1977; 42 FR 24255, May 31, 1977; 42 FR 46516, Sept. 16, 1977; 42 FR

 61257, Dec. 2, 1977; 45 FR 3577, Jan. 18, 1980; 47 FR 9397, Mar. 5,

 1982; 54 FR 24900, June 12, 1989

 

 Sec. 701.9   Exemptions from labeling requirements.

 

     (a) Except as provided by paragraphs (b) and (c) of this section, a

 shipment or other delivery of a cosmetic which is, in accordance with

 the practice of the trade, to be processed, labeled, or repacked in

 substantial quantity at an establishment other than that where

 originally processed or packed, shall be exempt, during the time of

 introduction into and movement in interstate commerce and the time of

 holding in such establishment, from compliance with the labeling

 requirements of sections 601(a) and 602(b) of the act if:

     (1) The person who introduced such shipment or delivery into

 interstate commerce is the operator of the establishment where such

 cosmetic is to be processed, labeled, or repacked; or

     (2) In case such person is not such operator, such shipment or

 delivery is made to such establishment under a written agreement, signed

 by and containing the post office addresses of such person and such

 operator, and containing such specifications for the processing,

 labeling, or repacking, as the case may be, of such cosmetic in such

 establishment as will insure, if such specifications are followed, that

 such cosmetic will not be adulterated or misbranded within the meaning

 of the act upon completion of such processing, labeling, or repacking.

 Such person and such operator shall each keep a copy of such agreement

 until 2 years after the final shipment or delivery of such cosmetic from

 such establishment, and shall make such copies available for inspection

 at any reasonable hour to any officer or employee of the Department who

 requests them.

     (b) An exemption of a shipment or other delivery of a cosmetic under

 paragraph (a)(1) of this section shall, at the beginning of the act of

 removing such shipment or delivery, or any part thereof, from such

 establishment, become void ab initio if the cosmetic comprising such

 shipment, delivery, or part is adulterated or misbranded within the

 meaning of the act when so removed.

     (c) An exemption of a shipment or other delivery of a cosmetic under

 paragraph (a)(2) of this section shall become void ab initio with

 respect to the person who introduced such shipment or delivery into

 interstate commerce upon refusal by such person to make available for

 inspection a copy of the agreement, as required by such clause.

     (d) An exemption of a shipment or other delivery of a cosmetic under

 paragraph (a)(2) of this section shall expire:

     (1) At the beginning of the act of removing such shipment or

 delivery, or any part thereof, from such establishment if the cosmetic

 comprising such shipment, delivery, or part is adulterated or misbranded

 within the meaning of the act when so removed; or

     (2) Upon refusal by the operator of the establishment where such

 cosmetic is to be processed, labeled, or repacked, to make available for

 inspection a copy of the agreement, as required by such clause.