Japan Releases Draft Guidelines for Food Products in Tablet and Capsule Form

Target food

Processed foods in the form of tablets, capsule, powdered, liquid, and similar formats in which "Natural Extracts" are used as ingredients.

"Natural Extracts" refers to substances that are obtained by fractionation, purification, concentration, drying, chemical reactions, or other processes using natural materials or extracts derived from natural sources, resulting in variations in the original composition and proportions compared to their natural states, or are chemically synthesized.

Target operator

• Enterprises engaged in the manufacturing, processing, sales, import, etc., of natural extracts and similar substances used as ingredients in tablets, capsules, and similar food products.

• Enterprises engaged in the manufacturing, processing, sales, import, etc., of tablets, capsules, and similar food products in which natural extracts are used as raw materials.

Raw material voluntary Self-inspection points

1. Enterprises shall gather information on the eating experience of the target ingredients and the products in which they are used as raw materials. Considering societal norms, consumption patterns, and intake quantities, enterprises shall to determine if sufficient eating experience exists.

2. If safety cannot be adequately ensured based on eating experience, enterprises shall conduct a literature search to collect information on safety and toxicity regarding the target ingredients and the raw materials used in the manufacturing, then evaluate the safety based on this information.

3. If safety cannot be ensured based on eating experience and information gathered, enterprises shall conduct safety tests on the target ingredients to ensure their safety.

Guidelines for Good Manufacturing Practice (GMP) of Food Products in Tablet and Capsule Form (Draft)

Target food

Processed foods and their ingredients in the form of tablets, capsule, powdered, liquid, and similar formats in which "Natural Extracts and the Like" are used as ingredients.

Target operator

• Enterprises engaged in the manufacturing or processing of food products such as tablets, capsules, etc., in which natural extracts and similar substances are used as raw materials.

Importers shall confirm with the manufacturing company of the products to be imported that the products were manufactured under proper manufacturing process control. Enterprises shall also create documents containing product information (ingredients, manufacturing location, etc.) and storage methods, etc., aiming to ensure an equivalent level of quality with products manufactured in Japan.

Others

The draft provides a more specific description in accordance with the specified ingredient's Good Manufacturing Practice (GMP) and clarifies the overall process. In addition to GMP, attention should be given to hygiene management in accordance with the Food Sanitation Act.