PROCESSED CEREAL-BASED FOODS FOR INFANTS AND YOUNG

CHILDREN
Definition:

standard definition
EU foodstuffs for particular nutritional use fulfilling the particular requirements of infants and young
children in good health in the Community and are intended for use by infants while they are being
weaned, and by young children as a supplement to their diet and/or for their progressive adaptation
to ordinary food

CODEX/ processed cereal-based foods intended for feeding infants as a complementary food generally from
PSQCA the age of 6 months onwards, taking into account infants’ individual nutritional requirements, and for
feeding young children as part of a progressively diversified diet, in accordance with the Global
Strategy for Infant and Young Child Feeding and World Health Assembly Resolution

FDA Infant formula means a food which purports to be or is represented for special dietary use solely as a
food for infants by reason of its simulation of human milk or its suitability as a complete or partial
substitute for human milk.
REF: EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006L0125
CODEX: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F
%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B74-
1981%252FCXS_074e.pdf
PSQCA: http://www.puntofocal.gob.ar/notific_otros_miembros/pak45_t.pdf
FDA: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-106#106.3

ESSENTIAL COMPOSITION:

EU STANDARD ESSENTIAL COMPOSITION

UNIT MINIMUM LIMITS/100kcal MAXIMUM LIMITS/100kcal
CEREAL CONTENT 25%
PROTEIN Gram 2 5.5
Sucrose,glucose,glucose
Gram - 7.5 g
CARBOHYDRATES syrups,honey
fructose Gram - 3.75
Gram - 3.3
15 % of the total lipid
lauric acid -
conten
LIPIDS 15 % of the total lipid
myristic acid -
content
linoleic acid Mg 300 1200
MINERALS Sodium Mg - 100
potassium Mg 160
calcium Mg 80 180

1
 Magnesium Mg - 40
Iron Mg - 3
Zinc mg 2
Copper µg - 40
Iodine µg -- 35
maganese Mg - 0.6
Vitamin A (μg) 60 180
Vitamin E (mg) - 3
Vitamin D (μg) - 3
Vitamin C (mg) - 12,5/25
Thiamin (μg) 100 500
Riboflavin (mg) - 0.4
VITAMINS
Niacin mg - 4.5
Vitamin B6 mg -- 0.35
Folic acid (μg) - 50
Vitamin B12 (μg) -- 0.35
Pantothenic acid (mg - 1.5
Biotin (μg) -- 10

Contaminants:

standard contaminants
Processed cereal-based foods and baby foods shall not contain residues of individual
pesticides at levels exceeding 0,01 mg/kg, except for those substances for which specific
levels have been set in Annex VI, in which case these specific levels shall apply
CHEMICAL NAME MAX RESIDUE LEVEL (MG/KG)
Cadusafos 0,006
Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-
methyl (individually or combined, expressed as demeton-S- 0,006
EU methyl)
Ethoprophos 0.008
Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as
0.004
fipronil)
Propineb/propylenethiourea (sum of propineb and
0,006
propylenethiourea)
AFLA TOXINS lower than 1 µg/kg
CODEX/PSQCA DEOXYNIVALENOL (DON) 200µg/kg
LEAD 0.01 MG/KG
FDA RADIONUCLIDES
REF: EU:
https://food.ec.europa.eu/system/files/2021-04/codex_cccf
_14_agenda_item_10a.pdf
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?

2
 uri=CELEX:32006L0125
CODEX:

PACKAGING:

STANDARD

EU

The product shall be packed in

containers which will safeguard
the hygienic and other qualities
of the food.
The containers, including
packaging material, shall be
CODEX/PSQCA made only of substances which
are safe and suitable for their
intended use. Where the Codex
Alimentarius Commission has
established a standard for any
such substance used as
packaging material, that
standard shall apply.

FDA The product shall be packed in

containers which will safeguard
the hygienic and other qualities
of the food.
Equipment and procedures for
thermal processing of infant
formula packaged in
hermetically sealed container.
Container shall be made which
are suitable for intended use,
easily cleanable, withstand with
environment.
Packaging materials should be
non toxic, nor
reactive or absorptive.

LABELLING:

3
STANDARD

CODEX/FDA 8.1.1 The requirements of the General Standard for

the Labelling of Prepackaged Foods (CXS 1-1985),
the Guidelines on Nutrition Labelling (CXG 2-1985)
and the Guidelines for Use of Nutrition and Health
Claims (CXG 23-1997) apply to this Standard. With
specific reference to Section 7 of the General
Standard for the Labelling of Prepackaged Foods
national jurisdictions may further restrict the use Of
pictorial devices.
1. Any indication required in the labelling should be
made in the appropriate language(s) of the country
in which the product is sold.
2. The name of the food: The name of the food shall
be "Dry Cereal for Infants (and/or Young Children)",
"Rusks for Infants (and/or Young Children)" or
"Biscuits (or "Milk Biscuits") for Infants (and/or
Young Children)" or "Pasta for Infants (and/or
Young Children)", or any appropriate designation
indicating the true nature of the food, in accordance
with national legislation.
3. List of ingredients: A complete list of ingredients
shall be declared on the label in descending order of
proportion except that in the case of added
vitamins and minerals, these may be arranged as
separate groups for vitamins and minerals,
respectively, and within these groups the vitamins
and minerals need not be listed in descending order
of proportion
The specific name shall be declared for ingredients
and food additives. In addition, appropriate class
names for these ingredients and additives may be
included on the label.
4. Declaration of nutritive value: The declaration of
nutrition information shall contain the following
information which should be in the following order:
a) The energy value, expressed in kilocalories (kcal)
and kilojoules (kJ), and the amount of protein
carbohydrate and fat expressed in grammes (g) per
100 g or 100 ml of the food as sold, and where
appropriate, as per specified quantity of the food as
suggested for consumption
b) The average amount of each vitamin and mineral
for which specific levels are defined in section 3.6
and 3.7 expressed in numerical form per 100g or

4
100 ml of the food as sold and, where appropriate,
as per specified quantity of the food as suggested
for consumption
c) Any other nutritional information required by
national legislation.
5. Date marking and storage instructions: The date
of minimum durability (preceded by the words
"best before") shall be declared by the day, month
and year in uncoded numerical sequence except
that for products with a shelf-life of more than
three months, the month and year will suffice. The
month may be indicated by letters in those
countries where such use will not confuse the
consumer. In the case of products requiring a
declaration of month and year only, and the shelf
life of the product is valid to the end of a given year,
the expression "end (stated year)" may be used as
an alternative
8.5.2 In addition to the date, any special conditions
for the storage of the food shall be indicated if the
validity of the date depends thereon.
Where practicable, storage instructions shall be in
close proximity to the date marking.
6. Information for utilization: Directions as to the
preparation and use of the food, and its storage and
keeping before and after the container has been
opened, shall appear on the label and may also
appear on the accompanying leaflet.
For products covered by 2.1.1, directions on the
label shall state “Milk or formula but no water shall
be used for dilution or mixing” or an equivalent
statement.
When the product is composed of gluten-free
ingredients and food additives, the label may show
the statement “gluten-free”1.
The label shall indicate clearly from which age the
product is recommended for use. This age shall not
be less than six months for any product. In addition,
the label shall include a statement indicating that
the decision when precisely to begin
complementary feeding, including any exception to
six months of age, should be made in consultation
with a health worker, based on the individual
infant’s specific growth and development needs.
Additional requirements in this respect may be
made in accordance with the legislation of the
country in which the product is sold.
7. Additional requirements:

5
 The products covered by this standard are not
breast-milk substitutes and shall not be presented
as such.

EU The labelling may bear:

(a) the average quantity of the nutrients set
out in Annex IV when such declaration is
not covered by the provisions of paragraph
1(d), expressed in numerical form, per 100 g
or 100 ml of the product as sold and, where
appropriate, perspecified quantity of the
product as proposed for consumption.
(b) in addition to numerical information,
information on vitamins and minerals
shown in Annex V, expressed as a
percentage of the reference values given
therein, per 100 g or 100 ml of the product
as sold, and where appropriate, per
specified quantity of the product as
proposed for consumption, provided that
the quantities present are at least equal to
15 % of the reference values.

FDA (a) The labeling of infant formulas, as defined

in section 201(z) of the Federal Food,
Drug, and Cosmetic Act, shall bear in the
order given, in the units specified, and in
tabular format, the following information
regarding the product as prepared in
accordance with label directions for infant
consumption:

(1) A statement of the number of fluid

ounces supplying 100 kilocalories (in case of
food label statements, a kilocalorie is
represented by the word “Calorie”); and

(2) A statement of the amount, supplied by

100 kilocalories, of each of the following
nutrients and of any other nutrient added by
the manufacturer:

Units of
Nutrients measurements
Protein grams
Fat Do
Carbohydrate Do

6
 Water Do
Linoleic acid milligrams
Vitamins:
Vitamin A International Units
Vitamin D Do
Vitamin E Do
Vitamin K micrograms
Thiamine (Vitamin Do
B1)
Riboflavin (Vitamin Do
B2)
Vitamin B6 Do
Vitamin B12 Do
Niacin Do
Folic acid (Folacin) Do
Pantothenic acid Do
Biotin Do
Vitamin C (Ascorbic milligrams
acid)
Vitamin C (Ascorbic Do
acid)
Vitamin C (Ascorbic Do
acid)
Minerals:
Calcium milligrams
Phosphorus Do
Magnesium Do
Iron Do
Zinc Do
Manganese micrograms
Copper Do
Iodine Do
Selenium Do
Sodium milligrams
Potassium Do
Chloride Do
(b) In addition the following apply:

(1) Vitamin A content may also be declared

on the label in units of microgram retinol
equivalents, vitamin D content in units of
micrograms cholecalciferol, vitamin E
content in units of milligram alpha-
tocopherol equivalents, and sodium,
potassium, and chloride content in units of

7
millimoles, micromoles, or milliequivalents.
When these declarations are made they shall
appear in parentheses immediately following
the declarations in International Units for
vitamins A, D, and E, and immediately
following the declarations in milligrams for
sodium, potassium, and chloride.

(2) Biotin, choline, and inositol content shall

be declared except when they are not added
to milk-based infant formulas.

(3) Each of the listed nutrients, and the

caloric density, may also be declared on the
label on other bases, such as per 100
milliliters or per liter, as prepared for infant
consumption.

(4) One of the following statements shall

appear on the principal display panel, as
appropriate:

(i) The statement “Infant Formula With

Iron”, or a similar statement, if the product
contains 1 milligram or more of iron in a
quantity of product that supplies 100
kilocalories when prepared in accordance
with label directions for infant
consumption.

(ii) The statement “Additional Iron May

Be Necessary”, or a similar statement, if
the product contains less than 1 milligram
of iron in a quantity of product that
supplies 100 kilocalories when prepared in
accordance with label directions for infant
consumption.

(5) Any additional vitamin may be declared

at the bottom of the vitamin list and any
additional minerals may be declared
between iodine and sodium, provided that
any additionally declared nutrient:

(i) Has been identified as essential by the

8
 Food and Nutrition Board of the Institute
of Medicine through its development of a
Dietary Reference Intake, or has been
identified as essential by the Food and
Drug Administration through a Federal
Register publication; and

(ii) Is provided at a level considered in

these publications as having biological
significance, when these levels are known.

Directions for use: In addition to the applicable

labeling requirements, the product label shall
bear:

(a) Under the heading “Directions For

Preparation and Use”, directions for:

(1) Storage of infant formula before and

after the container has been opened,
including a statement indicating that
prolonged storage at excessive temperatures
should be avoided;

(2) Agitating liquid infant formula before

opening the container, such as “Shake Well
Before Opening”;

(3) “Sterilization” of water, bottle, and

nipples when necessary for preparing infant
formula for use;

(4) Dilution of infant formula, when

appropriate. Directions for powdered infant
formula shall contain the weight and volume
of powdered formula to be reconstituted.

(b) In close proximity to the “Directions for

Preparation and Use” a pictogram depicting
the major steps for preparation of that infant
formula, such as (for a concentrated formula):

9
(c) A “Use by ______” date, the blank to be
filled in with the month and year selected by
the manufacturer, packer, or distributor of the
infant formula on the basis of tests or other
information showing that the infant formula,
until that date, under the conditions of
handling, storage, preparation, and use
prescribed by label directions, will:

(1) when consumed, contain not less than the

quantity of each nutrient, as set forth on its
label; and

(2) otherwise be of an acceptable quality

(e.g., pass through an ordinary bottle
nipple).

(d) The statement “Add Water” or “Do Not

Add Water”, as appropriate, to appear on the
principal display panel of concentrated or
ready-to-feed infant formulas. In close
proximity to the statement “Add Water”, a
symbol such as

10
if the addition of water is necessary. The
symbol shall be placed on a white background
encircled by a dark border.

(e) A warning statement beneath or in close

proximity to the “Directions For Preparation
and Use” that cautions against improper
preparation or use of an infant formula, such
as “THE HEALTH OF YOUR INFANT
DEPENDS ON CAREFULLY FOLLOWING
THE DIRECTIONS FOR PREPARATION
AND USE”.

(f) A statement indicating that parents should

consult their physicians about the use of infant
formulas, such as “USE AS DIRECTED BY
A PHYSICIAN”.

11