[Title 21 CFR 73.2396]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES]
[Subchapter A - GENERAL]
[Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION]
[Subpart C - Cosmetics]
[Sec. 73.2396 - Lead acetate.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  1
  1996-04-01
  1996-04-01
  false
  
  73.2396
  Sec. 73.2396
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
    GENERAL
    LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
    Cosmetics
  


Sec. 73.2396  Lead acetate.

    (a) Identity. The color additive lead acetate is the trihydrate of 
lead (2+) salt of acetic acid. The color additive has the chemical 
formula Pb (OOCCH3)2.3H2O).
    (b) Specifications. Lead acetate shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Water-insoluble matter, not more than 0.02 percent.
pH (30 percent solution weight to volume at 25 deg. C), not less than 
4.7 and not more than 5.8.
Arsenic (as As), not more than 3 parts per million.
Lead acetate, not less than 99 percent.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. The color additive lead acetate may be 
safely used in cosmetics intended for coloring hair on the scalp only, 
subject to the following restrictions:
    (1) The amount of the lead acetate in the cosmetic shall be such 
that the lead content, calculated as Pb, shall not be in excess of 0.6 
percent (weight to volume).
    (2) The cosmetic is not to be used for coloring mustaches, 
eyelashes,

[[Page 334]]

eyebrows, or hair on parts of the body other than the scalp.
    (d) Labeling requirements. (1) The label of the color additive lead 
acetate shall conform to the requirements of Sec. 170.25 of this 
chapter, and bear the following statement or equivalent:

    Wash thoroughly if the product comes into contact with the skin.

    (2) The label of the cosmetic containing the color additive lead 
acetate, in addition to other information required by the act, shall 
bear the following cautionary statement, conspicuously displayed 
thereon:

    CAUTION: Contains lead acetate. For external use only. Keep this 
product out of children's reach. Do not use on cut or abraded scalp. If 
skin irritation develops, discontinue use. Do not use to color 
mustaches, eyelashes, eyebrows, or hair on parts of the body other than 
the scalp. Do not get in eyes. Follow instructions carefully and wash 
hands thoroughly after each use.

    (e) Exemption for certification. Certification of this color 
additive for the prescribed use is not necessary for the protection of 
the public health and therefore batches thereof are exempt from the 
certification requirements of section 721(c) of the act.

[45 FR 72117, Oct. 31, 1980]