Cosmetics requirement for the tattoo in toys

3.1.19 cosmetics—any article intended or likely to be rubbed, sprinkled, or sprayed on, introduced onto, or otherwise applied to the human body for cleansing, beautifying, promoting or enhancing attractiveness, or for altering appearance.

 

4.3.4 Cosmetics—Cosmetics shall conform to the requirements of the Federal FDCA as codified in 21 CFR. The regulations applicable to cosmetics are stated in 21 CFR 700 through 740. The color additive regulations applicable to
cosmetics are found in 21 CFR 73, 74, 81, and 82.

4.3.4.1 In addition, cosmetics intended for use by children under 8 years of age shall meet all requirements of this specification and the FHSA regulations, notwithstanding the exclusions of 16 CFR 1500.81 and 1500.3 (b) (4) (ii).

 

4.3.6 Cosmetics, Liquids, Pastes, Putties, Gels, and Powders—The purpose of this requirement is to minimize the risk associated with the lack of cleanliness, shelf life, and contamination of cosmetics, liquids, pastes, putties, gels, and
powders used in toys (excluding art materials). It sets standards for cleanliness and the ability to withstand extended shelf life or contamination, or both, during use without microbiological degradation.

4.3.6.1 Water used in the manufacturing and filling of toys shall be prepared according to the bacteriological standards for USP Purified Water. (Warning—The various methods for producing purified water each present different potentials for contaminating the final product. Purified water produced by distillation is sterile, provided that the production equipment is suitable and sterile. On the other hand, ion-exchange columns and reverse osmosis units require special attention in that they afford sites for microorganisms to foul the system and contaminate the effluent. Frequent monitoring may thus be called for, particularly with the use of these units following periods of
shutdown of more than a few hours.)

4.3.6.2 The formulations of these products used in toys shall be such that they are not subject to microbial degradation during shelf life or reasonably foreseeable use.

 

4.3.6.3 The cleanliness of these products used in toys and their ingredients shall be determined in accordance with 8.4.1.  Formulations used to prevent microbial degradation shall be evaluated in accordance with8.4.2.

4.3.6.4 Formulations of cosmetics shall be evaluated for potential microbiological degradation in accordance with8.4.2

 

8.4Tests for Cleanliness and Preservative Effectiveness:

8.4.1Cleanliness of Materials—The cleanliness of cosmetics, liquids, pastes, putties, gels, and powders used in toys (excluding art materials) shall be determined using the methods in USP 24 <61> Microbial Limits Tests or the most current edition of the U.S. Pharmacopeia.15 Another method may be substituted provided it has been properly validated as giving equivalent or better results, as specified in USP 24 <61> or the most current edition of the U.S. Pharmacopeia. In conjunction with the chosen test method, the limits for determining the cleanliness of materials will consist of the most current guidelines for cosmetics set forth by the Cosmetic, Toiletry, and Fragrance Association (CTFA).

8.4.2Preservative Effectiveness—The formulations of cosmetics used in toys shall be evaluated for the potential microbiological degradation, or they shall be tested for microbial control and preservative effectiveness using the methods and limits in USP 24 <51> Antimicrobial Effectiveness Testing or the most current edition of the U.S. Pharmacopeia.