Japan Expands Food Labeling Scope for Food for Special Dietary Uses

On May 19, 2023, the Consumer Affairs Agency of Japan amended the labeling requirements for Food for Special Dietary Uses (FOSDU). According to the amendment, enterprises now can apply for FOSDU labels for oral rehydration solution (ORS) products. The label review criteria are as follows.

1. Major contents revealed by the amendment

Scope

ORS product can apply for FOSDI labels only for dehydration caused by diarrhea and vomiting due to infectious gastroenteritis. If the ORS product is intended for other purposes, an individual application should be submitted.

Specification

1. ORS can be used to replenish water and electrolytes for dehydration caused by diarrhea and vomiting due to infectious gastroenteritis. (For powdered products, they shall meet the specifications after being prepared)

2. Nutrient content standard:

Mandatory labeling

1. Characters that mean “「経口補水液」(oral rehydration solution) ”.

2. Use only when instructed by doctor for dehydration caused by diarrhea and vomiting due to infectious gastroenteritis.

3. Information on precautions, etc. when ingesting

4. The statement:

(1) It is suitable as an ingredient for dietary therapy, and taking it in large quantities will not cure the disease.

(2) It is recommended to consult and instruct a doctor, registered dietitian, etc. before use.

(3) If you are instructed by doctor to limit sodium or potassium intake, be sure to consult and instruct your doctor before use.

5. Sodium (converted to salt equivalent), potassium, chlorine, glucose, molarity ratio (sodium: glucose) and osmotic pressure of the product per package and per 100 mL.

2. What Is Food for Special Dietary Uses (FOSDU) ?

Definition

Food for Special Dietary Uses (FOSDU) refers to food that are approved/permitted to display that it is appropriate for special dietary uses.

Categories

There are five categories of FOSDU.

Labeling

FOSDU must be labeled with the following information, as prescribed in the Ministerial Ordinance under the Health Promotion Law.

• Product name

• Use by date or date of minimum durability

• Methods to preserve

• Name and address of the manufacturer

• Specified permission/approval mark

• Permitted/approved phrase for display

• Amount of nutrient (including energy value) in the food

• Name of food materials and food additives

• Instruction for consumption, preparation, and preservation if necessary

• Name of the approved entity and its address, in a case that manufacturer is different from those who were approved.