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Disclosed by a report by Malaysia Competition Commission (MyCC), the local infant formula (IF) industry in Malaysia is dominated by multinational players due to high capital investment and stringent regulatory requirements. In 2017, multinational players such as Danone Dumex, Mead Johnson Nutrition, Abbott, Nestle, Dutch Lady, Fonterra, Abbott Laboratories and Wyeth Nutrition collectively occupied about 90% share of the revenue of infant formula market. The local infant formula market is also dependent on the importation of raw materials such as dairy ingredients due to insufficient domestic supply of raw materials and limited numbers of local manufacturers.
Seeing the opportunities in Malaysian infant formula market, this article mainly provides analysis on regulatory requirements to help stakeholders export infant formula products to Malaysia.
1. Overall procedures of exporting IF to Malaysia
The overall trading procedure is summarized below. Besides satisfying infant formula product standards, stakeholder intending to sell IF to Malaysia should register as a user of Food Safety Information System of Malaysia (FoSIM). If products claim halal or organic, enterprises should also obtain relevant certificates. Other required documents for customs include customs import declaration, commercial invoice, bill of lading, packing list and certificate of origin.
Source: Food Safety and Quality Division, Ministry of Health Malaysia
2. How to make product compliance
Baby formula is subject to the supervision of special purpose food in Malaysia, which includes infant formula (for infants aged 0-12 months), follow-up formula (for infants aged 6 months to 3 years), and special formula (infant or follow-up formula for special dietary or medical purposes).
Food Act 1983 and Food Regulations 1985 are two major regulations in Malaysia that pertain to the safety, product standards and labeling of food products. Regulation 389 of Food Regulations 1985 details the requirements and standards for infant formula products’ nutrient level, optional ingredients, food additives, etc.
As for product label, in addition to following the labeling requirements for general foods, infant formula is subject to further detailed provisions. For example, it is forbidden for infant formula products to
l indicate words like “humanised” or “maternalised”;
l claim such formula is enriched or vitaminised;
l display any claim of superiority of the product to breast milk;
l display any picture or graphics of infants, babies, parts of infants or babies, mothers, feeding bottles or teats. (For the purposes of illustrating the preparation methods of the follow-up formula, graphics can be used.)
Check ChemLinked Food-Pedia: Malaysian Baby Formula Regulation for more info.
3. Concerning organic/halal certificate
Both organic and halal certificates for infant formula are voluntary and are often acquired as an added value, especially in a Muslim-majority country.
3.1 Halal certificate
Halal products must ensure the product at every stage, from raw materials to processing and transportation be halal.
All imported infant formula intending to certify halal must obtain a Halal Certificate issued by JAKIM (The Halal Department Division under the Department of Islamic Development Malaysia) or be certified as Halal by the foreign halal certification body recognized by JAKIM (List of recognized foreign halal certification bodies).
Related Malaysian standards include:
l MS 1500:2009 Halal Food — Production, Preparation, Handling and Storage — General Guidelines
l MS 1500:2019 Halal Food — General Requirements (Third Revision)
Read ChemLinked Food-Pedia:Malaysian Halal Food Regulation for more info.
3.2 Organic certificate
Only products conforming to the requirements specified in the Malaysian Standards “MS 1529: The Production, Processing, Labelling and Marketing of Plant-Based Organically Produced Foods” can be claimed as organic. Besides, for such products, at least 70% of food ingredients should be organic. Stakeholders shall submit applications for organic certificate to the Ministry of Health.
Click Guideline for Malaysian Organic Food Certification Scheme for details.
4. Marketing
After selling infant formula to Malaysia, there’s another issue worth attention—marketing. The marketing of infant formula in Malaysia is strictly governed by the Code of Ethics for the Marketing of Infant Foods and Related Products, which aims to uphold the supremacy of breast milk and encourage breastfeeding.
Based on the Code, manufacturers and distributors of infant/follow-up formula shall
l not market, promote, or advertise any designated products in such a way as to a) challenge or undermine the supremacy of breast milk; or b) compete in any way with breast milk;
l not provide samples of infant/follow-up formula, etc.
l not advertise or promote infant/follow-up formula in the health care system, child care centers, retail outlets or on the mass media;
l not conduct any activity that involves infants, young children, pregnant women or mothers of infants or young children for the purpose of promoting products;
l not permit company personnel to have direct or indirect contact with pregnant women, parents of infants, members of their families or child-care providers for the purpose of promoting designated products, etc.
Check Food Act 1983, Food Regulations 1985 and the Code of Ethics for more details, or contact ChemLinked for more regulatory consultation service.
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