Subdivision 4 – General labelling and packaging requirements
11 Representations of food as infant formula product
A food must not be represented as an infant formula product unless it complies with this Standard.
12 Prescribed names
‘Infant Formula’ and ‘Follow-on Formula’ are prescribed names.
13 Requirement for a measuring scoop
(1) A package of infant formula product in a powdered form must contain a scoop to enable the use of the infant formula product in accordance with the directions contained in the label on the package.
(2) Subclause (1) does not apply to single serve sachets, or packages containing single serve sachets of an infant formula product in a powdered form.
14 Required warnings, directions and statements
(1) The label on a package of infant formula product must include the following warning statement –
(a) in the case of infant formula product in powdered form –
‘Warning – follow instructions exactly. Prepare bottles and teats as directed. Do not change proportions of powder except on medical advice. Incorrect preparation can make your baby very ill’; and
(b) in the case of concentrated infant formula product –
‘Warning – follow instructions exactly. Prepare bottles and teats as directed. Do not change proportions of concentrate except on medical advice. Incorrect preparation can make your baby very ill’; and
(c) in the case of ‘ready to drink’ infant formula product –
‘Warning – follow instructions exactly. Prepare bottles and teats as directed. Do not dilute or add anything to this ‘ready to drink’ formula except on medical advice. Incorrect preparation can make your baby very ill’.
(2) The label on a package of infant formula product must include directions for the preparation and use of the infant formula product which include words and pictures instructing –
(a) that each bottle should be prepared individually; and
(b) that if a bottle of made up formula is to be stored prior to use, it must be refrigerated and used within 24 hours; and
(c) that potable, previously boiled water should be used; and
(d) where a package contains a measuring scoop, that only the enclosed scoop should be used; and
(e) that formula left in the bottle after a feed must be discarded.
(3) Subject to subclause (4), the label on a package of infant formula product must contain the following warning statement –
‘Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice.’;
under a heading that states –
‘Important Notice’ or any word or words having the same or similar effect.
Division Subdivision 4 - Australia New Zealand Food Standards Code - Standard 2.9.1 - Infant Formula Products - General labelling and packaging requirements | Zoe
(4) Subclause (3) does not apply to infant formula products for metabolic, immunological, renal, hepatic or malabsorptive conditions.
(5) The label on a package of an infant formula product must contain statements indicating that –
(a) the infant formula product may be used from birth, in the case of infant formula; and
(b) the infant formula product should not be used for infants aged under 6 months in the case of follow-on formula; and
(c) except in the case of packages of pre-term formula, it is recommended that infants over the age of 6 months should be offered foods in addition to the infant formula product.
15 Print and package size
(1) Where an infant formula product is in a package having a net weight of more than 500 g, the statements required by subclauses 14(1), (3) and 26(1) must be in size of type of no less than 3 mm.
(2) Where an infant formula product is in a package having a net weight of 500 g or less the statements required by subclauses 14(1), (3) and 26(1) must be in size of type of no less than
1.5 mm.
16 Declaration of nutrition information
(1) The label on a ‘ready to drink’ infant formula product must include a statement, which may be in the form of a table, that contains the following information –
(a) the average energy content expressed in kJ per 100 mL; and
(b) the average amount of protein, fat and carbohydrate expressed in g per 100 mL; and
(c) the average amount of each vitamin, mineral and any other nutritive substance permitted by this Standard expressed in weight per 100 mL; and
(d) when added, the average amount of –
(i) a combination of inulin-type fructans and galacto-oligosaccharides; or
(ii) inulin-type fructans; or
(iii) galacto-oligosaccharides
expressed in weight per 100 mL.
(2) The label on a powdered or concentrated form of infant formula product must include a statement, which may be in the form of a table that contains the following information –
(a) the average energy content expressed in kJ per 100 mL of infant formula product that has been reconstituted according to directions; and
(b) the average amount of protein, fat and carbohydrate expressed in g per 100 mL of infant formula product that has been reconstituted according to directions; and
(c) the average amount of each vitamin, mineral and any other nutritive substance permitted by this Standard expressed in weight per 100 mL of infant formula product that has been reconstituted according to directions; and
(d) a declaration –
(i) of the weight of one scoop in the case of powdered infant formula; and
(ii) of the proportion of powder or concentrate required to reconstitute the formula according to directions; and
(e) when added, the average amount of –
(i) a combination of inulin-type fructans and galacto-oligosaccharides; or
(ii) inulin-type fructans; or
(iii) galacto-oligosaccharides
expressed in weight per 100 mL when the product is reconstituted in accordance with directions.
Note: Editorial note:
Note: As a guide to how nutrition information may be presented, see the Guidelines for Infant Formula Products at the end of this Standard. These Guidelines do not form part of the legally binding Standard.
17 Date marking and storage instructions
(1) Paragraphs 2(1)(c) and (d) of Standard 1.2.5 do not apply to this Standard.
(2) A label on a package of infant formula product must contain storage instructions covering the period after it is opened.
Note: Editorial note:
Note: The full range of climatic conditions that exist in Australia and New Zealand may need to be considered when determining valid and appropriate storage instructions.
18 Statement of protein source
The label on a package of infant formula product must contain a statement of the specific source, or sources, of protein in the infant formula product immediately adjacent to the name of the infant formula product.
Note: Editorial note:
Note: Standard 1.2.2 requires that all food be labelled with its name. The requirement in clause 18 of this Standard applies only to the name on the label on the product in accordance with the requirement in Standard 1.2.2.
19 Statement on dental fluorosis
(1) An infant formula product must comply with subclause (2) where it contains –
(a) more than 17 µg of fluoride per 100 kJ prior to reconstitution, in the case of powdered or concentrated infant formula product; or
(b) more than 0.15 mg of fluoride per 100 mL, in the case of ‘ready to drink’ formula.
(2) The label on a package of infant formula product referred to in subclause (1) must contain statements –
(a) indicating that consumption of the formula has the potential to cause dental fluorosis; and
(b) recommending that the risk of dental fluorosis should be discussed with a medical practitioner or other health professional.
20 Prohibited representations
(1) The label on a package of infant formula product must not contain –
(a) a picture of an infant; or
(b) a picture that idealises the use of infant formula product; or
(c) the word ‘humanised’ or ‘maternalised’ or any word or words having the same or similar effect; or
(d) words claiming that the formula is suitable for all infants; or
(e) information relating to the nutritional content of human milk; or
(f) subject to clause 28, a reference to the presence of any nutrient or nutritive substance, except for a reference to a nutrient or nutritive substance in –
(i) accordance with clause 30 – Claims relating to lactose free formula or low lactose formulas; or
(ii) the statement of ingredients in accordance with Standard 1.2.4 – Labelling of Ingredients; or
(iii) the nutrition information statement in accordance with clause 16 of this Standard – Declaration of nutrition information; or
(g) subject to Division 3, a representation that the food is suitable for a particular condition, disease or disorder.
(2) Subject to clause 28, the label on a package of infant formula product must not contain a reference to inulin-type fructans or galacto-oligosaccharides except for a reference to either substances in –
(a) the statement of ingredients in accordance with Standard 1.2.4 – Labelling of Ingredients; or
(b) the nutrition information statement in accordance with clause 16 of this Standard – Declaration of nutrition information.
Note: Editorial Note:
Note: Division 3 relates to Infant Formula Products for Special Dietary Use. Clause 28 permits labelling which varies from this clause.