4.3.6 Cosmetics, Liquids, Pastes, Putties, Gels, Powders,
and Items of Avian Feather Origin—The purpose of this
requirement is to minimize the risks associated with potential
lack of cleanliness, shelf life degradation, and contamination in
use of cosmetics, liquids, pastes, putties, gels, powders, and
items of avian feather origin (example: “marabou” items
derived from poultry feathers) 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 Process water used in the manufacturing and filling
of toys shall comply with the bacteriological standards for USP
Purified Water (USP 35 ) as well as for drinking water
per the EPA standard (40 CFR 141.63); specifically, this
requires a heterotrophic plate count of <10 colony forming
units per milliliter (cfu/ml) and the absence by test of coliform
bacteria.
N OTE 6—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, microfiltration units, 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.
4.3.6.4 Formulations of these products (except avian feather
items) shall be evaluated for potential microbiological degra-
dation in accordance with 8.4.2.
4.3.7 Stuffıng Materials—Loose fillers for stuffed toys shall
be free of objectionable matter originating from insect, bird,
rodent, or other animal infestation and of contaminants, such as
splinters, glass and metal chips to the extent possible in good
manufacturing practice when evaluated in accordance with
8.29.
4.3.8 DEHP (DOP)—Pacifiers, rattles, and teethers shall not
intentionally contain DI (2-ethylhexyl) phthalate (also known
as dioctyl phthalate). To prevent trace amounts of DEHP
(DOP) from affecting analysis, up to 3 % of total solid content
will be accepted in the result, when tested in accordance with
Practice D3421.