Hong Kong Infant Formula Regulation

Legislation system

The legislation of infant and young children formula in Hong Kong is based on the Codex Alimentarius standards. The aim is to ensure that the legislation system is in line with the international standards and that the products could provide enough nutrients for infant and young children.

Relevant Competent Authorities

  • Food and Health Bureau (FHB)
  • Food and Environmental Hygiene Department (FEHD)
  • Center for Food Safety (CFR)
  • Trade and Industry Department

Relevant Regulations

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 range specified in the Amendment Regulation
  • A maximum level is also set for taurine if it is added to infant formula
  • The ratio of linoleic acid to -linolenic acid must be at least 5:1 and not more than 15:1.
  • The ratio of calcium to phosphorus must be at least 1:1 and not more than 2:1.
  • The combined content of lauric acid and myristic acid must not exceed 20% of the total content of fatty acids.
  • The content of trans fatty acids must not exceed 3% of the total content of fatty acids.
  • The content of erucic acid must not exceed 1% of the total content of fatty acids 11
  • The content of vitamin E must in any case not be less than 0.5 mg -TE/g polyunsaturated fatty acids, as adapted to the number of fatty acid double bonds in the formula using the following factors of equivalence
  • If there is any docosahexaenoic acid (DHA) added:

    • the content of arachidonic acid must not be less than that of DHA; and
    • the content of eicosapentaenoic acid must not exceed that of DHA.

Other recommended nutritional requirements for infant formula

  • For equal energy value, the formula contains an available quantity of each essential and semi-essential amino acid at least equal to that contain in the reference protein (Essential and semi essential amino acids contents in breast milk as defined in Annex I of CODEX STAN 72- 1981).
  • The content of phospholipids does not exceed 300mg/100kcal (72mg/100kJ).
  • If there is added DHA, its content does not exceed 0.5% of total fatty acid.
  • Fluoride should not be added to infant formula.

Nutritional composition requirement for follow-up formula

It is recommended that follow-up formula should fulfill the nutritional composition requirements set out by the jurisdiction or country where the product is originated or the nutritional composition requirements as set out in Codex Standard for Follow-up Formula (CODEX STAN 156-1987).

Nutrition labelling requirement for infant formula and follow-up formula infants and young children:

  • Infant formula must bear labels with the energy value and content of 29 nutrients (i.e. “1+29)
  • If the fluoride content of the product in a reconstituted or per serving basis exceeds the maximum level stipulated in the concerned Codex standard, the formula must be marked or labelled with a statement—

    • (i) Indicating that consumption of the formula may cause dental fluorosis; and
    • (ii) Recommending that the risk of dental fluorosis should be discussed with a medical practitioner or health professional.
  • Follow-up formula must label the energy value and content of 25 nutrients (“1+25”)

Labeling Language

Nutrition label can be written in English, Chinese (simplified or traditional) or in both languages. However, the nutrition label must be in both English and Chinese languages if both languages are used in the marking or labelling of the infant formula, follow-up formula

Nutrition and health claim of infant formula

In Jan 2015, Hong Kong FHB, FEHD and CFS released a consultation document regarding the nutrition and health claims on infant formula, follow-up formula, etc. Two of the overarching principles it proposed are:

  • nutrition claims (i.e. nutrient content claims and nutrient comparative claims) should be prohibited in infant formula; and
  • Reduction of disease risk claims should be prohibited in formula products;

Marketing of infant and young children formula

According to the HK Code of Marketing,

  • Manufacturers and distributors (M&Ds) should not launch any education and information dissemination activities for breastfeeding and formula milk feeding and nutrition;
  • M&Ds should not carry out any promotional activities involving formula milk and formula milk related products;
  • Public promotion such as advertising and sample distribution of food products for infants and young children is allowed but not in health care facilities.

In terms of the labeling, the Code does not allow health and nutrition claims for infant formula. It allows health claims but not nutrition claims for follow-up formula.

Importers Qualification

As all importers of powdered formula must register with the Director of Food and Environmental Hygiene in accordance with the Food Safety Ordinance (Cap. 612). Trade and Industry Department (TID) would issue Export License to those importers of food who hold a valid registration with Food and Environmental Hygiene Department (FEHD) listed at (i) and (ii) as below:

  • Registered as a food importer for powdered formula under Food Safety Ordinance (Cap.612) with a valid food importer registration number; or
  • Exempted under section 4(3)(a) of Cap. 612 with a valid food importer registration (notice of exemption) exemption number