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: 21CFR700

 

  Page 175-180

 

         TITLE 21--FOOD AND DRUGS

 

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

 

 PART 700--GENERAL--Table of Contents

 

          Subpart B--Requirements for Specific Cosmetic Products

 

 700.10  Shampoo preparations containing egg as one of the ingredients.

 700.11  Cosmetics containing bithionol.

 700.13  Use of mercury compounds in cosmetics including use as

           skinbleaching agents in cosmetic preparations also regarded as

           drugs.

 700.14  Use of vinyl chloride as an ingredient, including propellant of

           cosmetic aerosol products.

 700.15  Use of certain halogenated salicylanilides as ingredients in

           cosmetic products.

 700.16  Use of aerosol cosmetic products containing zirconium.

 700.18  Use of chloroform as an ingredient in cosmetic products.

 700.19  Use of methylene chloride as an ingredient of cosmetic products.

 700.23  Chlorofluorocarbon propellants.

 700.25  Tamper-resistant packaging requirements for cosmetic products.

 

     Authority: Secs. 201, 301, 502, 505, 601, 602, 701, 704 of the

 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 352, 355, 361,

 362, 371, 374).

 

     Source: 39 FR 10054, Mar. 15, 1974, unless otherwise noted.

 

 Subpart B--Requirements for Specific Cosmetic Products

 

 Sec. 700.10   Shampoo preparations containing eggs as one of the

           ingredients.

 

     The present views of the Food and Drug Administration concerning the

 status of shampoo preparations containing egg as one of the ingredients

 are as follows:

     (a) An article designated as ``egg shampoo'' should contain one egg

 (or the equivalent amount of dried whole egg) in that quantity of the

 article which would be used in one shampooing of the hair.

     (b) An article that contains less than one egg per ``shampoo''

 should not be referred to as an ``egg shampoo'' and the word ``egg''

 should not be used as part of the name of the article. At the present

 time, the Food and Drug Administration is not raising objection to the

 marketing of an article containing less than one egg per ``shampoo,''

 provided the word ``egg'' does not appear in the name of the article,

 the reference to the egg ingredient, such as ``plus egg,'' appears in a

 subordinate position on the label and is in type which is substantially

 reduced in size in comparison with the title of the article, and the

 reference to the presence of egg reveals the amount of the egg

 ingredient.

     (c) In the case of an article containing less than 2 percent egg,

 the amount of egg is so small as to be insignificant, and it is

 therefore considered that it would be misleading for the labeling to

 make any mention of the presence of egg in such a product.

 

 Sec. 700.11   Cosmetics containing bithionol.

 

     (a) Bithionol has been used to some extent as an antibacterial agent

 in cosmetic preparations such as detergent bars, shampoos, creams,

 lotions, and bases used to hide blemishes. New evidence of clinical

 experience and photopatch tests indicate that bithionol is capable of

 causing

 

   Page 176

 

 photosensitivity in man when used topically and that in some instances

 the photosensitization may persist for prolonged periods as severe

 reactions without further contact with sensitizing articles. Also, there

 is evidence to indicate that bithionol may produce cross-sensitization

 with other commonly used chemicals such as certain halogenated

 salicylanilides and hexachlorophene. It is, therefore, the view of the

 Food and Drug Administration that bithionol is a deleterious substance

 which may render any cosmetic product that contains it injurious to

 users. Accordingly, any cosmetic containing bithionol is deemed to be

 adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic

 Act.

     (b) Regulatory proceedings may be initiated with respect to any

 cosmetic preparation containing bithionol shipped within the

 jurisdiction of the act after March 15, 1968.

 

 Sec. 700.13   Use of mercury compounds in cosmetics including use as

           skinbleaching agents in cosmetic preparations also regarded as

           drugs.

 

     (a) Mercury-containing cosmetic preparations have been represented

 for many years as skin-bleaching agents or as preparations to remove or

 prevent freckles and/or brown spots (so-called age spots). Preparations

 intended for such use are regarded as drugs as well as cosmetics. In

 addition to such use as skin-bleaching agents, mercury compounds have

 also been widely used as preservatives in cosmetics such as hand and

 body creams and lotions; hair shampoos, hair sets and rinses, hair

 straighteners, hair coloring, and other preparations; bath oils, bubble

 bath, and other bath preparations; makeup; antiperspirants and

 deodorants; and eye-area cosmetics.

     (b) The toxicity of mercury compounds is extensively documented in

 scientific literature. It is well known that mercury compounds are

 readily absorbed through the unbroken skin as well as through the lungs

 by inhalation and by intestinal absorption after ingestion. Mercury is

 absorbed from topical application and is accumulated in the body, giving

 rise to numerous adverse effects. Mercury is a potent allergen and

 sensitizer, and skin irritation is common after topical application.

 Cosmetic preparations containing mercury compounds are often applied

 with regularity and frequency for prolonged periods. Such chronic use of

 mercury-containing skin-bleaching preparations has resulted in the

 accumulation of mercury in the body and the occurrence of severe

 reactions. Recently it has also been determined that microorganisms in

 the environment can convert various forms of mercury into highly toxic

 methyl mercury which has been found in the food supply and is now

 considered to be a serious environmental problem.

     (c) The effectiveness of mercury-containing preparations as skin-

 bleaching agents is questionable. The Food and Drug Administration has

 not been provided with well controlled studies to document the

 effectiveness of these preparations. Although mercurial preservatives

 are recognized as highly effective, less toxic and satisfactory

 substitutes are available except in the case of certain eye-area

 cosmetics.

     (d) Because of the known hazards of mercury, its questionable

 efficacy as a skin-bleaching agent, and the availability of effective

 and less toxic nonmercurial preservatives, there is no justification for

 the use of mercury in skin-bleaching preparations or its use as a

 preservative in cosmetics, with the exception of eye-area cosmetics for

 which no other effective and safe nonmercurial preservative is

 available. The continued use of mercurial preservatives in such eye-area

 cosmetics is warranted because mercury compounds are exceptionally

 effective in preventing Pseudomonas contamination of cosmetics and

 Pseudomonas infection of the eye can cause serious injury, including

 blindness. Therefore:

     (1) The Food and Drug Administration withdraws the opinion expressed

 in trade correspondence TC-9 (issued May 13, 1939) and concludes that

 any product containing mercury as a skin-bleaching agent and offered for

 sale as skin-bleaching, beauty, or facial preparation is misbranded

 within the meaning of sections 502(a), 502(f)(1) and (2), and 502(j),

 and may be a new drug without approval in violation of section 505 of

 the Federal Food, Drug, and Cosmetic Act. Any such preparation

 

   Page 177

 

 shipped within the jurisdiction of the Act after January 5, 1973 will be

 the subject of regulatory action.

     (2) The Food and Drug Administration withdraws the opinion expressed

 in trade correspondence TC-412 (issued Feb. 11, 1944) and will regard as

 adulterated within the meaning of section 601(a) of the Act any cosmetic

 containing mercury unless the cosmetic meets the conditions of paragraph

 (d)(2) (i) or (ii) of this section.

     (i) It is a cosmetic containing no more than a trace amount of

 mercury and such trace amount is unavoidable under conditions of good

 manufacturing practice and is less than 1 part per million (0.0001

 percent), calculated as the metal; or

     (ii) It is a cosmetic intended for use only in the area of the eye,

 it contains no more than 65 parts per million (0.0065 percent) of

 mercury, calculated as the metal, as a preservative, and there is no

 effective and safe nonmercurial substitute preservative available for

 use in such cosmetic.

 

 Sec. 700.14   Use of vinyl chloride as an ingredient, including

           propellant of cosmetic aerosol products.

 

     (a) Vinyl chloride has been used as an ingredient in cosmetic

 aerosol products including hair sprays. Where such aerosol products are

 used in the confines of a small room, as is often the case, the level of

 vinyl chloride to which the individual may be exposed could be

 significantly in excess of the safe level established in connection with

 occupational exposure. Evidence indicates that vinyl chloride inhalation

 can result in acute toxicity, manifested by dizziness, headache,

 disorientation, and unconsciousness where inhaled at high

 concentrations. Studies also demonstrate carcinogenic effects in animals

 as a result of inhalation exposure to vinyl chloride. Furthermore, vinyl

 chloride has recently been linked to liver disease, including liver

 cancer, in workers engaged in the polymerization of vinyl chloride. It

 is the view of the Commissioner that vinyl chloride is a deleterious

 substance which may render any cosmetic aerosol product that contains it

 as an ingredient injurious to users. Accordingly, any cosmetic aerosol

 product containing vinyl chloride as an ingredient is deemed to be

 adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic

 Act.

     (b) Any cosmetic aerosol product containing vinyl chloride as an

 ingredient shipped within the jurisdiction of the Act is subject to

 regulatory action.

 

  39 FR 30830, Aug. 26, 1974

 

 Sec. 700.15   Use of certain halogenated salicylanilides as ingredients

           in cosmetic products.

 

     (a) Halogenated salicylanilides (tribromsalan (TBS,3,4',5-

 tribromosalicylanilide), dibromsalan (DBS,4'5-dibromosalicylanilide),

 metabromsalan (MBS, 3,5 - dibromosalicylanilide) and 3,3',4,5'-

 tetrachlorosalicylanilide (TCSA)) have been used as antimicrobial agents

 for a variety of purposes in cosmetic products. These halogenated

 salicylanilides are potent photosensitizers and cross-sensitizers and

 can cause disabling skin disorders. In some instances, the

 photosensitization may persist for prolonged periods as a severe

 reaction without further exposure to these chemicals. Safer alternative

 antimicrobial agents are available.

     (b) These halogenated salicylanilides are deleterious substances

 which render any cosmetic that contains them injurious to users.

 Therefore, any cosmetic product that contains such a halogenated

 salicylanilide as an ingredient at any level for any purpose is deemed

 to be adulterated under section 601(a) of the Federal Food, Drug, and

 Cosmetic Act.

     (c) Any cosmetic product containing these halogenated

 salicylanilides as an ingredient that is initially introduced into

 interstate commerce after December 1, 1975, that is not in compliance

 with this section is subject to regulatory action.

 

  40 FR 50531, Oct. 30, 1975

 

 Sec. 700.16  Use of aerosol cosmetic products containing zirconium.

 

     (a) Zirconium-containing complexes have been used as an ingredient

 in cosmetics and/or cosmetics that are also drugs, as, for example,

 aerosol antiperspirants. Evidence indicates that certain zirconium

 compounds

 

   Page 178

 

 have caused human skin granulomas and toxic effects in the lungs and

 other organs of experimental animals. When used in aerosol form, some

 zirconium will reach the deep portions of the lungs of users. The lung

 is an organ, like skin, subject to the development of granulomas. Unlike

 the skin, the lung will not reveal the presence of granulomatous changes

 until they have become advanced and, in some cases, permanent. It is the

 view of the Commissioner that zirconium is a deleterious substance that

 may render any cosmetic aerosol product that contains it injurious to

 users.

     (b) Any aerosol cosmetic product containing zirconium is deemed to

 be adulterated under section 601(a) of the Federal Food, Drug, and

 Cosmetic Act.

     (c) Any such cosmetic product introduced in interstate commerce

 after September 15, 1977 is subject to regulatory action.

 

  42 FR 41376, Aug. 16, 1977

 

 Sec. 700.18   Use of chloroform as an ingredient in cosmetic products.

 

     (a) Chloroform has been used as an ingredient in cosmetic products.

 Recent information has become available associating chloroform with

 carcinogenic effects in animals. Studies conducted by the National

 Cancer Institute have demonstrated that the oral administration of

 chloroform to mice and rats induced hepatocellular carcinomas (liver

 cancer) in mice and renal tumors in male rats. Scientific literature

 indicates that chloroform is absorbed from the gastrointestinal tract,

 through the respiratory system, and through the skin. The Commissioner

 concludes that, on the basis of these findings, chloroform is a

 deleterious substance which may render injurious to users any cosmetic

 product that contains chloroform as an ingredient.

     (b) Any cosmetic product containing chloroform as an ingredient is

 adulterated and is subject to regulatory action under sections 301 and

 601(a) of the Federal Food, Drug, and Cosmetic Act. Any cosmetic product

 containing chloroform in residual amounts from its use as a processing

 solvent during manufacture, or as a byproduct from the synthesis of an

 ingredient, is not, for the purpose of this section, considered to

 contain chloroform as an ingredient.

 

  41 FR 26845, June 29, 1976

 

 Sec. 700.19  Use of methylene chloride as an ingredient of cosmetic

           products.

 

     (a) Methylene chloride has been used as an ingredient of aerosol

 cosmetic products, principally hair sprays, at concentrations generally

 ranging from 10 to 25 percent. In a 2-year animal inhalation study

 sponsored by the National Toxicology Program, methylene chloride

 produced a significant increase in benign and malignant tumors of the

 lung and liver of male and female mice. Based on these findings and on

 estimates of human exposure from the customary use of hair sprays, the

 Food and Drug Administration concludes that the use of methylene

 chloride in cosmetic products poses a significant cancer risk to

 consumers, and that the use of this ingredient in cosmetic products may

 render these products injurious to health.

     (b) Any cosmetic product that contains methylene chloride as an

 ingredient is deemed adulterated and is subject to regulatory action

 under sections 301 and 601(a) of the Federal Food, Drug, and Cosmetic

 Act.

 

  54 FR 27342, June 29, 1989

 

 Sec. 700.23  Chlorofluorocarbon propellants.

 

     The use of chlorofluorocarbons in cosmetics as propellants in self-

 pressurized containers is prohibited as provided in Sec. 2.125 of this

 chapter.

 

  43 FR 11317, Mar. 17, 1978

 

 Sec. 700.25  Tamper-resistant packaging requirements for cosmetic

           products.

 

     (a) General. Because most cosmetic liquid oral hygiene products and

 vaginal products are not now packaged in tamper-resistant retail

 packages, there is the opportunity for the malicious adulteration of

 those cosmetic products with health risks to individuals who unknowingly

 purchase adulterated products and with loss of consumer confidence in

 the security of cosmetic product packages. The Food and Drug

 Administration has the authority and responsibility under the Federal

 Food,

 

   Page 179

 

 Drug, and Cosmetic Act (the act) to establish a uniform national

 requirement for tamper-resistant packaging of cosmetic liquid oral

 hygiene products or products used vaginally that will improve the

 packaging security and help assure the safety of those products. Such a

 cosmetic product for retail sale that is not packaged in a tamper-

 resistant package or that is not properly labeled under this section is

 adulterated under section 601 of the act or misbranded under section 602

 of the act, or both.

     (b) Requirement for tamper-resistant package. Each manufacturer and

 packer who packages a cosmetic liquid oral hygiene product or vaginal

 product for retail sale shall package the product in a tamper-resistant

 package, if this product is accessible to the public while held for

 sale. A tamper-resistant package is one having an indicator or barrier

 to entry which, if breached or missing, can reasonably be expected to

 provide visible evidence to consumers that tampering has occurred. To

 reduce the likelihood of substitution of a tamper-resistant feature

 after tampering, the indicator or barrier to entry is required to be

 distinctive by design (e.g., an aerosol product container) or by the use

 of an identifying characteristic (e.g., a pattern, name, registered

 trademark, logo, or picture). For purposes of this section, the term

 ``distinctive by design'' means the packaging cannot be duplicated with

 commonly available materials or through commonly available processes.

 For purposes of this section, the term ``aerosol product'' means a

 product which depends upon the power of a liquified or compressed gas to

 expel the contents from the container. A tamper-resistant package may

 involve an immediate-container and closure system or secondary-container

 or carton system or any combination of systems intended to provide a

 visual indication of package integrity. The tamper-resistant feature

 shall be designed to and shall remain intact when handled in a

 reasonable manner during manufacture, distribution, and retail display.

     (c) Labeling. Each retail package of a cosmetic product covered by

 this section, except aerosol products as defined in paragraph (b) of

 this section, is required to bear a statement that is prominently placed

 so that consumers are alerted to the specific tamper-resistant feature

 of the package. The labeling statement is also required to be so placed

 that it will be unaffected if the tamper-resistant feature of the

 package is breached or missing. If the tamper-resistant feature chosen

 to meet the requirement in paragraph (b) of this section is one that

 uses an identifying characteristic, that characteristic is required to

 be referred to in the labeling statement. For example, the labeling

 statement on a bottle with a shrink band could say ``For your

 protection, this bottle has an imprinted seal around the neck.''

     (d) Requests for exemptions from packaging and labeling

 requirements. A manufacturer or packer may request an exemption from the

 packaging and labeling requirements of this section. A request for an

 exemption is required to be submitted in the form of a citizen petition

 under Sec. 10.30 of this chapter and should be clearly identified on the

 envelope as a ``Request for Exemption from Tamper-resistant Rule.'' The

 petition is required to contain the following:

     (1) The name of the product.

     (2) The reasons that the product's compliance with the tamper-

 resistant packaging or labeling requirements of this section is

 unnecessary or cannot be achieved.

     (3) A description of alternative steps that are available, or that

 the petitioner has already taken, to reduce the likelihood that the

 product will be the subject of malicious adulteration.

     (4) Other information justifying an exemption.

 

 This information collection requirement has been approved by the Office

 of Management and Budget under number 0910-0149.

     (e) Effective date. Cosmetic products covered by this section are

 required to comply with the requirements of this section on the dates

 listed below except to the extent that a product's manufacturer or

 packer has obtained an exemption from a packaging or labeling

 requirement.

     (1) Initial effective date for packaging requirements. (i) The

 packaging requirement in paragraph (b) of this section is

 

   Page 180

 

 effective on Feburary 7, 1983 for each affected cosmetic product (except

 vaginal tablets) packaged for retail sale on or after that date, except

 for the requirement in paragraph (b) of this section for a distinctive

 indicator or barrier to entry.

     (ii) The packaging requirement in paragraph (b) of this section is

 effective on May 5, 1983 for each cosmetic product that is a vaginal

 tablet packaged for retail sale on or after that date.

     (2) Initial effective date for labeling requirements. The

 requirement in paragraph (b) of this section that the indicator or

 barrier to entry be distinctive by design and the requirement in

 paragraph (c) of this section for a labeling statement are effective on

 May 5, 1983 for each affected cosmetic product packaged for retail sale

 on or after that date, except that the requirement for a specific label

 reference to any identifying characteristic is effective on February 6,

 1984 for each affected cosmetic product packaged for retail sale on or

 after that date.

     (3) Retail level effective date. The tamper-resistant packaging

 requirement of paragraph (b) of this section is effective February 6,

 1984 for each affected cosmetic product held for sale on or after that

 date that was packaged for retail sale before May 5, 1983. This does not

 include the requirement in paragraph (b) of this section that the

 indicator or barrier to entry be distinctive by design. Products

 packaged for retail sale after May 5, 1983, as required to be in

 compliance with all aspects of the regulations without regard to the

 retail level effective date.

 

  47 FR 50451, Nov. 5, 1982; 48 FR 1707, Jan. 14, 1983; 48 FR 11427, Mar.

 18, 1983, as amended at 48 FR 16664, Apr. 19, 1983; 48 FR 37624, Aug.

 19, 1983

 

     Effective Date Note: See 48 FR 41579, Sept. 16, 1983, for a document

 announcing an interim stay of the effective date of certain provisions

 in paragraph (e)(3) of Sec. 700.25.