H:\sdg\talc\corresp\1993-5 The Cosmetic, Toiletry, and Fragrance Association 1101 17th Street, N .W .

H:\sdg\talc\corresp\1993-5 The Cosmetic, Toiletry, and Fragrance Association 1101 17th Street, N .W .

H:\sdg\talc\corresp\1993-5 The Cosmetic, Toiletry, and Fragrance Association 1101 17th Street, N .W .

It was originally assembled by the Cosmetic, Toiletry and Fragrance Association (CTFA) to utilize in the control of cosmetic talcs.

'The Cosmetic, Toiletry, and Fragrance Association is the national trade association representing the cosmetic, toiletry and fragrance industry in the United States.

The Cosmetic, Toiletry, and Fragrance Association 1101 7th Street, N.W.

The Cosmetic, Toiletry, and Fragrance Association 1101 7th Street, N.W.

He joined the Cosmetic, Toiletry and Fragrance Association as senior toxicologist, and at present he is the Director of Toxicology at CTFA.

He joined the Cosmetic, Toiletry and Fragrance Association as senior toxicologist, and at present he is the Director of Toxicology at CTFA.

Bailey Ph.D. > Page 3 of the talc According to the CTFA specification for cosmetic talc the balance of the talc may consist of other naturally occuring minerals such as calcite chlorite dolomite kaolin and magnesite Prior to the early 1970's there was some concern that talc mined and processed commercially could be contaminated by asbestos or asbestiform minerals Since that time however the cosmetic industry specification for talc has been tightened to virtually eliminate that concern For example a 1977 investigation of 46 talc samples by FDA revealed only 3 to contain asbestos tremolite or anthophyllite and even then the level was only 0.1 or less As mentioned earlier there are no premarket approval requirements under FDCA for cosmetics or their constituent raw materials Accordingly there are no mandated regulatory standards or specifications for the grade of talc that may be used in formulating cosmetic products However the Agency did note in its discussion concerning talc as a Category I skin protectant ingredient for the prevention of diaper rash c.f. 55 FR 25224 June 20 1990 ) that cosmetic talc should contain at least 90 platy talc having flat as opposed to fibrous particles that is free of detectable amounts of fibrous minerals including asbestos Other general talc specifications have been published by the Pharmacopoeia which specifies impurity limits and by the Cosmetic Toiletry and Fragrance Association which now U.S.

Pharmacopoeia, which specifies impurity limits, and by the CTFA (Cosmetic, Toiletry, and Fragrance Association), which now also dictates that there should be no detectable fibrous amphiboles such as asbestiform tremolite.

Pharmacopoeia, which specifies impurity limits, and by the CTFA (Cosmetic, Toiletry, and Fragrance Association), which now also dictates that there should be no detectable fibrous amphiboles such as asbestiform tremolite.

------------------------------- 30 Cosmetics ------------------------------------------ ------- ------- ----- ----------- ---------,------ 30 Correction Fluids ----:-->----- ----------------------------------------------*--------------------- ---30 Electronics ----------- ---------------------- ------------- --------;------- >-------- -------- --------- 30 Floor Coverings----- ------------------ ------------- --------------------------.-------------------------- 30 Leathers------------------ ---------------------------- -------------------------- ---------------- ------- 31 Printing Inks --------------------------- ---------------- -------------------------------------------------- -----31 Roofing -----

Richland, WA 99352, USA (Accepted 16 June 1994) Summary--A review of the literature reveals two primary issues: (1) a weak, but not causal, association of hygienic use of cosmetic talc and ovarian cancer; (2) lung changes in animals exposed to talc aerosol concentrations that resulted in lung overload.

A review of the selected titles reveals two primary issues, namely (I) hygienic use of cosmetic talc and ovarian cancer risk, and (2) health effects of inhaled cosmetic talc.