Food Compliance
Intelligence & Solutions
Hong Kong Infant Formula Regulation
Sep 19, 2022
Jerry Wang
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CONTENTS

1. Definition & classification 

As per Food and Drugs (Composition and Labeling) (Amendment) (No.2) Regulation 2014,

  • Infant formula refers to:

a) a product that, according to its descriptions or instructions for use, is intended for consumption as a substitute for human breast milk that is specially manufactured to satisfy, by itself, the nutritional requirements of persons of any age up to and including 12 months until the introduction of appropriate complementary feeding (even if it is also claimed in the descriptions or instructions, if applicable, to be suitable for consumption by persons of any age over 12 months); or

b) a product marked or labelled as "infant formula" or "嬰兒配方產品", or with any other words of similar meaning;

  • Follow-up formula refers to:

a) a product that, according to its descriptions or instructions for use, is represented as a replacement for human breast milk or infant formula; and intended for consumption as a liquid element in a progressively diversified diet by persons of any age from 6 months to under 36 months (even if it is also claimed in the descriptions or instructions, if applicable, to be suitable for consumption by persons of any other age); or

b) a product marked or labelled as "follow-up formula" or "較大嬰兒及幼兒配方產品", or with any other words of similar meaning.

2. Competent authority 

Competent authority

Responsibility

Center of Food Safety (CFS)

CFS is the food safety authority of the Hong Kong government. Its mission is to ensure that food is safe and fits for consumption through tripartite collaboration among the government, food merchant, and consumers.

Food and Environmental Hygiene Department (FEHD)

FEHD is responsible for implementing territory-wide policies of food safety control and enforcing the food legislation.

3. Market access approval 

Food importers, through close liaison with exporting countries, are responsible for ensuring that food items comply with the local legislation. To help ensure food hygienic standards, importers are encouraged to obtain health certificates issued by the issuing entities of countries of origin to accompany their imports, which certify that the food products are fit for human consumption. Any person who carries on food importation/distribution business shall register with Director of Food and Environmental Hygiene (DFEH) as a food importer/food distributor.

4. Product compliance 

4.1 Product requirements 

Food and Drugs (Composition and Labeling) (Amendment) (No.2) Regulation 2014 stipulates the nutritional composition requirement for infant formula. Infant formula must contain energy and 33 nutrients (i.e. "1+33"), and the level of energy and each nutrient must fall within the specified range.

4.2 Label 

The labeling of infant formula is supervised as prepackaged food. It shall comply with food labeling provisions stated in Cap. 132W Food and Drugs (Composition and Labeling) Regulations.

Besides, Food and Drugs (Composition and Labeling) (Amendment) (No.2) Regulation 2014 stipulates the nutrition labeling requirement for infant formula and follow-up formula.

  • Infant formula must label the energy value and the content of 29 nutrients (i.e. "1+29"). If the fluoride content of the product in a reconstituted or the served basis exceeds the maximum level stipulated in the Amendment Regulation (exceeding 100 μg per 100 kilocalories or 24 μg per 100 kilojoules), the formula must be marked or labelled with a statement associated with dental fluorosis.

  • Follow-up formula must label the energy value and the content of 25 nutrients (i.e. "1+25").

4.3 Guidance 

Stakeholders may follow the following guidance released by CFS for the compliance: