4. Safety Requirements
4.1 Material Quality—Toys may be made from new or
reprocessed materials and shall be visually clean and free from
infestation. The materials shall be assessed visually by the
unaided eye rather than under magnification. If reprocessed
materials are used, they must be refined so that the level of
hazardous substances conforms to the requirements of 4.3.1.
4.2 Flammability—Materials other than textiles (excluding
paper) used in toys shall not be flammable, as defined under 16
CFR 1500.3 (c) (6) (vi) under the Federal Hazardous Substances
Act (FHSA). For testing purposes, any textile fabrics
used in toys should comply with 16 CFR 1610. A test
procedure for testing flammability of toys, which is an interpretation
of 16 CFR 1500.44, is contained in Annex A4.
4.3 Toxicology:
4.3.1 Hazardous Substances—Toys or materials used in
toys shall conform to the FHSA and to the regulations
promulgated under that act. Exemptions to this act for certain
types of toys are given in 16 CFR 1500.85. The regulations
define limits for substances that are toxic, corrosive, an irritant,
sensitizer or pressure generating, and radioactive, flammable,
and combustible materials. Testing references for hazardous
substance content are given in 8.2. It should be noted that
specific states may have hazardous substances regulations that
are more restrictive than the Federal regulations.
4.3.2 Manufacturing and Packaging of Food—All food
products supplied with toys shall be manufactured and packaged
in compliance with 21 CFR 110, which is concerned with
the sanitation practices for the manufacture, processing, packaging,
or holding of human food.
4.3.3 Indirect Food Additives—Toy components intended to
be used in contact with food, such as toy cooking utensils, shall
conform to the applicable requirements of the Food, Drug and
Cosmetic Act (FDCA), specifically 21 CFR 170 through 189.
4.3.3.1 Toys in Contact with Food—Toys comprising components
intended to be used in contact with food, such as toy
cooking utensils and toy tableware shall meet the requirements
of 6.7 for instructional literature.
4.3.3.2 Ceramicware, Lead, and Cadmium
Contamination—Ceramic toy components intended or likely to
hold food, such as a porcelain tea set, shall conform to the
applicable requirements of the FDCA, Section 402 (a) (2) (c),
and FDA Compliance Policy Guides.
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).
4.3.4.2 The requirements from the Food and Drug Administration
(FDA) will therefore be additive to those existing for
children’s products.
4.3.5 Paint and Similar Surface-Coating Materials—Paint
and other similar surface-coating materials applied to toys shall
comply with the lead content provisions of 16 CFR 1303,
issued under the Consumer Product Safety Act (CPSA).
4.3.5.1 The regulation prohibits the use of paints or similar
surface-coating materials that contain lead or lead compounds
and in which the lead content (calculated as lead metal [Pb]) is
in excess of 0.06 % (600 ppm) of the weight of the total
nonvolatile content of the paint or the weight of the dried paint
film.
4.3.5.2 In addition, surface-coating materials shall not contain
compounds of antimony, arsenic, barium, cadmium, chromium,
lead, mercury, or selenium, of which the metal content
of the soluble material is in excess of the levels by weight of
the contained solids (including pigments, film solids, and
driers) given in Table 1. The analytical results obtained should
be adjusted in accordance with the test method in 8.3.4.3 prior
to comparing them to the values in Table 1 to determine
conformance. The soluble level shall be determined by dissolving
the contained solids (dried film including pigments, film
solids, and driers) as specified in 8.3.
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
TABLE 1 Maximum Soluble Migrated Element in ppm (mg/kg)
Toy Material
Antimony,
(Sb)
Arsenic,
(As)
Barium,
(Ba)
Cadmium,
(Cd)
Chromium,
(Cr)
Lead,
(Pb)
Mercury,
(Hg)
Selenium,
(Se)
60 25 1000 75 60 90 60 500
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.
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