Thailand Infant Formula Regulation

1. Definition & classification

In Thailand, infant formula food refers to food products that are manufactured to contain suitable food substances in sufficient quantity for feeding infant and children. It could be classified as the following two types:

Infant foods:

Food aimed for feeding infant aged between one day and twelve months in lieu of mother’s milk.

Follow-up formula foods for infants and young children:

Food aimed for feeding infant aged from six months to twelve months or children from one day old till three years old. (quoted from Notification No. 157 article No. 3)

It is noteworthy that there is a product type named “modified milk for infants and young children” in Thailand. Their technical requirements are almost the same with infant foods and follow-up formula foods for infants and young children, except modified milk shall contain the requisite composition of cow’s milk (not less than 60% of the weight), and its carbohydrate in lactose form should be not less than 50% of the weight of the total carbohydrate.

2. Competent authority

Ministry of Public Health (MOPH)

MOPH takes charge of food safety, quality and importation through standard setting and management, labeling, advertisement and its packaging.

The National Food Commission

The National Food Commission is responsible for the formulation of national policy direction and strategies covering all dimensions of food

3. Regulatory framework

4. Market access permission

In Thailand, infant food and follow-up formula food products are categorized as specially controlled food, which means that the products must be registered with Thai FDA for market access. The registration requires a detailed analysis of the product, manufacturing process, and ingredients. Corresponding product requirements are specified in ministerial notification (No. 156 & No. 157).

Here are the required documents for infant formula registration in Thailand:

• The complete formula (w/w, w/v, v/v) under the letterhead of the manufacturer

• Product Information

• Food manufacturing process under the letterhead of the manufacturer

• Finished product’s specification

• Analysis report

• Ingredient (raw material)’s specification

• Product label (original and in color)

• Packaging material’s specification

• Good Manufacturing Practice Certificate issued by the government of the country of origin (or HACCP or equivalent ISO quality system certificate, which has been legalized by the Thai embassy in the country of manufacturing)

• Free Sale Certificate issued by the manufacturer or importer and legalized by the Thai embassy in the country of manufacturing

5. Compliance requirements

5.1  Ingredients

According to MOPH notification No. 156 and No. 157, the following substances are prohibited to be added in infant formula foods:

• Hormone or anti-biotics

• Radiated ingredients

• Preservatives

• Toxic substances

• Food colors, food odor and food flavoring substances (However, it is allowed to add flavor and odor as approved by Food and Drug Administration in follow-up formula foods for infants and young children)

In addition, enterprises cannot use sugar, honey and any other sweeteners except lactose or carbohydrates other than sugars which has equal or less sweetness than lactose (mentioned in MOPH notification No. 287).

While producing infant foods and follow-up formula foods for infants and young children, the use of food additives other than food preservatives shall follow MOPH notification governing food additives.

5.2 Nutrient composition

Article No. 5 and No.6 in MOPH notification No. 157 specified the energy value range and nutrient level (including protein, fats, vitamins and minerals) in infant foods and follow-up formula foods for infants and young children. Please read MOPH notification No. 157 for the details.

Notes: If the infant formula product is designed for babies with abnormal digestion or abnormal assimilation or allergic to certain kinds of food, the varieties of food ingredients and their corresponding contents shall be approved by the Food and Drug Administration.

5.3 Processing technique

Infant formula food products shall be homogenized and sterilized by heat (UHT or other process approved). Notably, radiation is forbidden in production.

5.4 Label

“MOPH notification No. 367 Re: Labeling of Prepackaged Foods” applies to infant formula products. MOPH notification No. 157 details the labeling requirements.

The following are the mandatory labeling items of infant foods and follow-up formula foods for infants and young children. They must be indicated in Thai, but may contain foreign language.

• Name of food

• Food recipe’s registration number

• Name and location of the manufacturer or of the person repacking the food for sale

• Quantity of food in metric system

• Ingredient list and nutrition labeling

• Manufacture date

• Expiry date

• Recommendation for storage

• Preparation method (if any)

• Warning statements, including: “Breastfeeding is  superior for infant feeding for complete nutrition value”, “Modified milk for infant should be used according to the advice of a doctor, nurse or nutritionist”, “Inappropriate preparation may harm infants”. They shall be displayed in consecutive order and be on the same surface of the package the same box. (mentioned in MOPH notification No. 308)

5.4 Advertising

To meet international recommendations for breastfeeding, on April 4, 2017, Thailand passed the “Control of Marketing of Infant and Young Child Food Act” to restrict the marketing of food for infants and young children. Manufacturers, importers and distributors are prohibited from:

• Advertising food products for infants and young children in a way that may cause families to believe they are better than breast milk or necessary

• Claiming any nutritional or health benefits for infants and young children on food labels

• Giving discount coupons, offering tie-in-sales, product samples or gifts

• Offering gifts, money incentives or other benefits to public health personnel

• Organizing meetings, trainings or seminars of food products for infants and young children for public health service agencies or their personnel

• Donating food for infants or children to public health service agencies or their personnel, except to those who have specific diseases or with abnormal physical conditions that require supplementation

• Demonstrating or sponsoring a demonstration of food products for infants or young children in healthcare facilities or any other venues with the goal of encouraging or promoting the consumption of these products, except when such activities are conducted for medical purposes or for the benefits of treating infants or young children

* Global Food Compliance Service

We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.

 Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.

Our Services

• Food Ingredient Review

• Label Review

• Product Registration

• Regulatory Consultation

• Monitoring, Training and customized report

Please feel free to contact us via food@chemlinked.com if you need any help.