Special Dietary Foods (PKGK) Registration in Indonesia

As a regulatory consultant in Indonesia, INSIGHTOF specializes in assisting businesses with the registration of food and beverage products, including Special Dietary Foods (Pangan Keperluan Gizi Khusus – PKGK). Understanding the classification and requirements of PKGK is essential for companies looking to market these products in Indonesia.

Special Dietary Foods (PKGK) refer to processed or specially formulated food products designed to meet specific nutritional needs due to physical/physiological conditions or particular diseases/disorders.

1. Processed Foods for Special Diets
These are processed or specially formulated foods that fulfill specific nutritional requirements based on physical or physiological conditions.

2. Processed Foods for Special Medical Purposes
These foods are specially formulated to provide dietary management for individuals with specific diseases or disorders.

1. Processed Foods for Special Diets (PDK)

PDK for Infants and Children

  • Infant formula (0–6 months)
  • Follow-up formula (6–12 months)
  • Growing-up formula (1–3 years)
  • Complementary foods for breast milk (MP ASI)
  • Snack foods for children

PDK for Adults

  • Special drinks for pregnant and/or lactating women
  • Sports nutrition products
  • Foods for weight management

2. Processed Foods for Special Medical Purposes (PKMK)

PKMK for Infants and Children

  • Foods for patients with metabolic disorders (inborn errors of metabolism)
  • Nutritional support for children at risk of growth failure, undernutrition, or malnutrition
  • Foods for premature infants
  • Human milk fortifiers
  • Foods for infants with cow’s milk protein allergy
  • Ketogenic diet products
  • Foods for malabsorption patients
  • Foods for chronic liver disease patients
  • Foods for inflammatory bowel disease (IBD) patients
  • Foods for infants with lactose intolerance

PKMK for Adults

  • Foods for diabetes patients
  • Foods for chronic kidney disease patients
  • Foods for chronic liver disease patients
  • Nutritional support for malnourished adult patients
  • Foods for patients with metabolic disorders (inborn errors of metabolism)
  • Ketogenic diet products

To comply with Indonesian regulations, PKGK products must include specific labeling information, including:

  1. Product Type
  2. Intended Use
  3. Preparation Instructions
  4. Serving Instructions
  5. Storage Instructions
  6. Warnings
  7. Nutritional Information

Additional Labeling Notes:

  • Processed Foods for Special Diets: Must include the statement:
  • Processed Foods for Special Medical Purposes:
    1. Must be used under a doctor’s prescription.
    2. Not for parenteral use (intravenous administration).
    3. Osmolality and/or osmolarity values must be provided for enteral feeding (via nasogastric tube).

Navigating the regulatory landscape for food and beverage registration in Indonesia can be complex. At INSIGHTOF, we provide expert assistance to ensure your products meet all BPOM (Indonesian National Agency of Drug and Food Control) requirements, allowing you to successfully bring your PKGK products to market.

For more information about PKGK registration, feel free to contact us at marketing@insightof.co.id.

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