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.
