Thailand Unveils the Draft Regulations for Infant Formula, Follow-up Formula, Formula for Young Children, and Infant Formula for Special Medical Purposes

On September 25, 2024, Thailand Food and Drug Administration (Thai FDA) consulted on the exposure drafts of three MOPH Notifications regarding infant formula, infant formula for special medical purposes, follow-up formula and formula for young children. Specifically, all three draft covers supervision, quality standards, nutrient contents, ingredients requirements, containers, labeling and claims of the above-mentioned formulas. Any comments can be sent back before October 31, 2024.

The three draft notifications under consultation are:

Some requirements in the three Notifications are in common, for example:

Supervision

These infant formula and young children formula food (including infant formula for special medical purposes) are all supervised as specifically-controlled food, which means that product registration is required for market access.

Quality standard

• The components and formula should have been proven safe, appropriate, and supportive enough for the growth and development of infants and young children;

• Powdered products shall have a crumbly, powdery or dry texture without clumping together. After mixing them into liquid form, they should have homogeneous texture without the formation of a floating layer.

• The contaminants in the products should be compliant with MOPH Notification regarding Standard for Contaminants in Food.

• No hormones or antibiotics in the products.

Nutrient contents

• The energy value and the contents of protein, carbohydrates, fat, vitamins and minerals of those products are specified in the corresponding draft regulations. The varieties and dosage of vitamins and mineral are detailed in the attachment of the drafts.

Ingredient requirements

• All ingredients and food additives used must be gluten-free.

• Partially hydrogenated oils and fats cannot be used.

• Generally speaking, the addition of ingredients other than those mentioned in the regulations must be approved by Thai FDA.

Containers

• The containers used to packaging products must be sealed containers whose quality following MOPH Notification regarding Food Container, Specification of Quality or Standards of Plastic Containers, Feeding Bottles and Milk Containers for Infants and Young Children as the case may be.

Labeling

• The mandatory labeling items include:

1. Product name (with the source of protein indicated)

2. Food registration number

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

4. Food quantity in metric system

5. Nutrition facts
   

6. Manufacture date

7. Expiry date

8. Recommendation for storage

9. Preparation method

10. Warning statements

• The labeling content must be in Thai, while foreign language is allowed to be included.

• The products cannot be indicated with any nutritional or health claims.

Certainly, there are also differences for the specific requirements among infant formula, infant formula for special medical purposes, follow-up formula, and formula for young children. For instance,

• The varieties and dosage of vitamins and minerals are varied among different products.

• Warning statements are different.

• Formula for special medical purposes should be additionally indicated with osmotic pressure in units of osmolality or osmolarity, or acid-base balance.

The regulations will enter into force after 180 days since the promulgation of the finalized version. Stakeholders will be given a 30-month grace period after that. It is noteworthy that these proposed changes signify a great optimization for the regulation framework of infant and young children formula food. At present, formula food for infants and young children are regulated under an umbrella notification named MOPH Notification No. 157 Re: Infant foods and Follow-up Formula Foods for Infants and Young Children and its amendments. Besides, currently Thailand has no regulation exclusive for infant formula for special medical purposes.