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
CODEX:

Minimum Maximum
S.NO. NUTRIENTS Unit
/100Kcal /100Kcal

1. Cereal 25%

2. Proteins

2.1. Protein free liquids g 2 5.5

2.2. Rusks and Biscuits g 1.5 5.5

3. Carbohydrates

3.1. Glucose, sucrose, glucose syrup, g 7.5

honey (Protein free liquids)

3.2. Fructose (Rusks and Biscuits) g 3.75

3.3. Glucose, sucrose, glucose syrup, g 5

honey (Protein free liquids)

3.4. Fructose (Rusks and Biscuits) g 2.5

4. Lipids g 4.5

4.1. Linoleic acid mg 300 1200

2
 4.2. Lauric acid 15% of the total lipid
content

4.3. Myristic acid 15% of the total lipid

content

5. Minerals

5.1. Sodium mg 100

5.2. Calcium (Protein free liquids) mg 80

5.3. Calcium (Rusks and Biscuits) mg 50

6. Vitamins

6.1. Vitamin B1 (thiamin) µg 50

6.2. Vitamin A µg 60 80

6.3. Vitamin D µg 1 3

PSQCA

Minimu Maximu S. Minimu Maximu

S.NO Uni m m NO. NUTRIENT Uni m m
NUTRIENTS
. t S t
/100Kcal /100Kcal /100Kcal /100Kcal

6. Minerals
Cereals 25% and Trace
1.
Elements

Protein g 1.8 3 6.1. Iron mg 0.45

2.
Lipids g 4.4 6 6.2. Calcium mg 50
3.
20% of 6.3. Phosphoru mg 25
Lauric acid g total fatty s
3.1.
acids

3
 20% of 6.4. Magnesiu mg 5
Myristic acids total fatty m
3.2.
acids

3% of 6.5. Sodium mg 20
Trans fatty
total fatty
3.3. acids
acids

Phospholipids mg 300 6.6. Chloride mg 50 60

3.4.
Linoleic Acid mg 300 6.7. Potassium mg 60 160
3.5.
α-Linolenic 6.8. Manganes µg 1 180
mg 50
3.6. acid e

Carbohydrate 6.9. Iodine µg 10

s (Lactose and g 9 14
4.
Glucose)

6.10 Selenium µg 1
Vitamins
5. .

µg 6.11 Copper 19) µg 35

Vitamin A RE 60 180 .
5.1. 10)

µg 6.12 Zinc mg 0.5

Vitamin D3 1 2.5
5.2. 11)
.

mg 7. Other
α- Substances
Vitamin E 0.5 13)
5.3. TE
12)

Vitamin K µg 4 7.1. Choline mg 7

5.4.
7.2. Myo- mg 4
Thiamin µg 60
5.5. Inositol

Riboflavin µg 80 7.3. L-Carnitine mg 1.2

5.6.
Niacin14) µg 300
5.7.
Vitamin B6 µg 35
5.8.
Vitamin B12 µg 0.1
5.9.

4
 Pantothenic
5.10. µg 400
acid

5.11. Folic acid µg 10

5.12. Vitamin C15) mg 10

5.13. Biotin µg 1.5

Optional Ingredients:

Minimum Maximum GUL

S.NO. NUTRIENTS Unit
/100Kcal /100Kcal

1. Taurine mg 12

% of fatty 0.5
2. Docosahexaenoic Acid 20)
acids

3. Fluoride µg 100

FDA

Nutrients Unit of measurement Minimum level Maximum level

Protein Grams 1.8 4.5

Fat Do. 3.3 6.0

Percent calories 30 54

Linoleic acid Milligrams 300

Percent calories 2.7

Vitamins

Vitamin A International Units 250 750

Vitamin D Do. 40 100

Vitamin E Do. 0.7

Vitamin K Micrograms 4

5
Thiamine (Vitamin B1) Do. 40

Riboflavin (Vitamin B2) Do. 60

Vitamin B6 Do. 35

Vitamin B12 Do. 0.15

Niacin1 Do. 250

Folic acid (Folacin) Do. 4

Pantothenic acid Do. 300

Biotin2 Do. 1.5

Vitamin C (Ascorbic acid) Milligrams 8

Choline2 Do. 7

Inositol2 Do. 4

Minerals

Calcium Do. 60

Phosphorus Do. 30

Magnesium Do. 6

Iron Do. 0.15 3.0

Zinc Do. 0.5

Manganese Micrograms 5

Copper Do. 60

Iodine Do. 5 75

Selenium Do. 2 7

Sodium Milligrams 20 60

Potassium Do. 80 200

Chloride Do. 55 150

6
 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
MAX RESIDUE LEVEL
CHEMICAL NAME
(MG/KG)
Cadusafos 0,006
Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-
EU methyl (individually or combined, expressed as demeton-S- 0,006
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
The product shall be prepared with special care under good manufacturing practices,
so that residues of those pesticides which may be required in the production, storage
or processing of the raw materials or the finished food ingredient do not remain, or, if
PSQCA technically unavoidable, are reduced to the maximum extent possible
The product shall be free from residues of hormones, antibiotics as determined by
means of agreed methods of analysis and practically free from other contaminants,
especially pharmacologically active substances.
The products covered by this Standard shall comply with the Maximum Levels of the
General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995). 5.2
The products covered by this Standard shall comply with the maximum residue limits
for pesticides and/or veterinary drugs established by the Codex Alimentarius
Commission
CODEX DEOXYNIVALENOL (DON) 200µg/kg
LEAD 0.02 MG/KG
EU:
https://food.ec.europa.eu/system/files/2021-04/codex_cccf
REF: _14_agenda_item_10a.pdf
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?
uri=CELEX:32006L0125

MICROBOLOGY:

STANDARD MICROBILOGY

CODEX/ A microbiological criterion is a risk management metric which indicates the acceptability of
a food, or the performance of either a process or a food safety control system following

7
PSQCA the outcome of sampling and testing for microorganisms, their toxins/metabolites or
markers associated with pathogenicity or other traits at a specified point of the food chain.

the products covered by the provisions of this Standard be prepared and handled in
accordance with the appropriate sections of the General Principles of Food Hygiene (CXC
1-1969), and other relevant Codex texts such as Codes of Hygienic Practice and Codes of
Practice.

The products should comply with any microbiological criteria established in accordance
with the Principles and Guidelines for the Establishment and Application of Microbiological
Criteria Related to Foods (CXG 21-1997)

FDA

MICRO/PESTICIDES

standard

EU However, in the case of a small number of pesticides or metabolites of pesticides

even a maximum residue level of 0,01 mg/kg might, under worst-case intake
conditions, allow infants and young children to exceed the ADI. This is the case for
pesticides or metabolites of pesticides with an ADI lower than 0,0005 mg/kg body
weight.

Maximum residue levels of pesticides set out in relevant Union law, in particular
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23
February 2005 on maximum residue levels of pesticides in or on food and feed of
plant and animal origin (1), should apply without prejudice to specific provisions
set out in this Regulation and delegated acts adopted pursuant to this Regulation.

The use of pesticides can lead to pesticide residues in food that is covered by this
Regulation. Such use should, therefore, be restricted as much as possible, taking
into account the requirements of Regulation (EC) No 1107/2009 of the European
Parliament and of the Council of 21 October 2009 concerning the placing of plant
protection products on the market (2). However, a restriction on, or a prohibition
of, use would not necessarily guarantee that food covered by this Regulation,
including food for infants and young children, is free from pesticides, since some
pesticides contaminate the environment and their residues can be found in such

8
 food. Therefore, the maximum residue levels in such food should be set at the
lowest achievable level to protect vulnerable population groups, taking into
account good agricultural practices as well as other sources of exposure, such as
environmental contamination

Restrictions on and prohibitions of certain pesticides equivalent to those currently

established in the Annexes to Directives 2006/125/EC and 2006/141/EC should be
taken into account in delegated acts adopted pursuant to this Regulation. Those
restrictions and prohibitions should be updated regularly, with particular attention
to be paid to pesticides containing active substances, safeners or synergists
classified in accordance with Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures (3) as mutagen category 1A or 1B,
carcinogen category 1A or 1B, toxic for reproduction category 1A or 1B, or
considered to have endocrine-disrupting properties that can cause adverse effects
in humans.

CODEX/PSQCA PIC IN MOBILE

FDA Microorganism n1 Sample size M value

2
Cronobacter spp. 30 10 g (grams) 0.
2
Salmonella spp. 60 25 g 0.
1
Number of samples.

2
None detected.

REFRENCE

FILLING

EU

CODEX/PAQCA PSQCA: In the case of products in ready-to-eat form, the fill of container
shall be:

9
 (i) not less than 80% v/v for products weighing less than 150 g (5 oz.);

(ii) not less than 85% v/v for products in the weight range 150-250 g (5-8
oz.); and

(iii) not less than 90% v/v for products weighing more than 250 g (8 oz.) of
the water capacity of the container. The water capacity of the container is
the volume of distilled water at 20° C which the sealed container will hold
completely filled.

FDA

ADDITIVES:

1. THICKENERS:

ADDITIVE STANDARD INS/ E-NO. Maximum Level in 100ml Conditions For Use
of product ready for
consumption
Guar Gum PSQCA INS 412 0.1 g in liquid formulas
containing hydrolysed
protein
CODEX 0.2g
FDA GRAS
EU E-414 10,000 mg/l or mg/kg only processed cereal
(0.1gm) based foods and baby
foods
Carob bean PSQCA INS 410 0.1 g in all types of infant
gum (Locust formula
bean gum) CODEX 0.2g
FDA GRAS
EU E-410 10,000 mg/l or mg/kg only processed cereal-
(0.1gm) based foods and baby
foods
Distarch INS1412 PSQCA PSQCA
phosphate E-1412 CONDITION 1:0.5 g CONDITION 1: singly or
CONDITION 2: 2.5 g in combination with
Acetylated INS 1414 soy-based infant
distarch E-1414 formula only
Phosphate CONDITION 2: singly or

10
 Phosphated PSQCA/CODEX/ INS 1413 in combination in
distarch EU E-1413 hydrolyzed protein
Phosphate and/or amino acid-
Hydroxypropyl INS 1440 based infant formula
starch only

CODEX: 6gm CODEX:

singly or in
combination
EU: 50,000 mg/l or mg/kg EU:
(0.5gm) only processed cereal-
Exception: Hydroxypropyl based foods and baby
starch foods
Carrageenan PSQCA INS 407 0.03 g in regular milk and
soy-based liquid infant
formula only
0.1 g in hydrolyzed protein-
and/or amino acid-
based
liquid infant formula
only
Acylated CODEX 6g singly or in
Distarch combination
adipate EU E-1422 50,000 mg/l or mg/kg only processed cereal-
(0.5gm) based foods and baby
foods
Distarch CODEX 6g Singly or in
glycerol combination
Acetylated di CODEX 6g Singly or in
starch glycerol combination
Non-Amidated CODEX 1g in canned fruit-based
Pectin baby food only
FDA GRAS
EU E-440 10,000 mg/l or mg/kg only processed cereal
(0.1gm) based foods and baby
foods

2. EMULSIFIERS:

ADDITIVE STANDARD INS/ E-NO. Maximum Level in 100ml of Conditions For Use
product ready for
consumption
Lecithins PSQCA INS: 322 0.5g In all types of infant
formula
CODEX 0.5g
EU E-322 10,000 mg/l or mg/kg In all types of baby

11
 (0.1gm) foods, cereal based
foods
FDA GRAS

Mono and Di PSQCA INS:471 0.4g In all types of infant

glycerides formula
CODEX 0.15g
EU E-471 5,000 mg/l or mg/kg In all types of baby
(0.05gm) foods, cereal based
foods

3. Acidity Regulators

ADDITIVE STANDARD INS/ E-NO. Maximum Level in 100ml of Conditions For Use
product ready for
consumption
Sodium Hydroxide PSQCA INS: 524 0.2g singly or in
combination and
within the limits for
sodium, potassium and
calcium in section
3.1.3 (e) in
all types of infant
formula
EU E-524 Quantum Satis Only for pH
adjustment
FDA GRAS
Sodium Hydrogen PSQCA INS:500ii PSQCA: 0.2gm PSQCA: singly or in
Carbonate CODEX CODEX: Limited by GMP combination and
Sodium Carbonate PSQCA INS:500i PSQCA: 0.2gm within the limits for
CODEX E-500 CODEX: Limited by GMP sodium, potassium and
EU EU: Quantum Satis calcium in section
FDA FDA: GRAS 3.1.3 (e) in
Potassium PSQCA INS: 525 PSQCA: 0.2gm all types of infant
Hydroxide EU E-525 EU: Quantum Satis formula
FDA FDA: GRAS EU: Only as Rising
Potassium Hydrogen PSQCA INS: 501ii PSQCA: 0.2gm Agent
Carbonate CODEX CODEX: Limited by GMP
Calcium Hydroxide PSQCA INS: 526 PSQCA: 0.2gm PSQCA: singly or in
EU E-526 EU: Quantum Satis combination and
within the limits for
sodium, potassium and
calcium in section
3.1.3 (e) in

12
 all types of infant
formula
EU: Only for pH
adjustment
Calcium Carbonate CODEX INS: 170 i CODEX: Limited by GMP
FDA FDA: GRAS/GMP
L(+) Lactic Acid PSQCA INS: 270 PSQCA: Limited by GMP in EU: Only for pH
CODEX E-270 all types of infant formula adjustment
EU CODEX: 0.2gm
FDA EU: Quantum Satis
FDA: GRAS
Citric Acid PSQCA INS: 330 PSQCA: Limited by GMP in Only for pH
EU E-330 all types of infant formula adjustment
FDA CODEX: 0.5 g
EU: Quantum Satis
FDA: GRAS/GMP

Sodium Salt (NOT CODEX 0.5g and within the e limit

SPECIFIC) for sodium in Section 3.1.3
Sodium Di Hydrogen PSQCA INS: 331i
Citrate FDA
PSQCA: Limited by GMP in
Trisodium Citrate INS: 331 iii all types of infant formula
FDA: GRAS/GMP
Potassium Citrate INS: 332

Acetic Acid CODEX INS: 260 0.5gm

FDA FDA: GRAS

PACKAGING:

STANDARD

EU

CODEX/PSQCA 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 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.

13
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:

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, 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

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 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
numerical form per 100g or 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

14
 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:

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

15
 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
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

16
 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 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:

17
 (i) Has been identified as essential by the 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):

18
(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

if the addition of water is necessary. The symbol shall be placed on a white

19
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”.

20