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Introduction
Indonesia's National Agency of Drug and Food Control (BPOM) issued Regulation No. 10 in 2024, focusing on the labeling of natural medicines, quasi-medicines, and health supplements. This regulation will take effect on January 01, 2025. Accurate labeling is essential for consumer safety and informed choices, ensuring transparency and providing necessary information.
Key Definitions
- Natural Medicines: Products derived from natural sources like plants, minerals, and animals, used for their therapeutic properties. Examples include herbal remedies and homeopathic treatments.
- Quasi-Medicines: Products with medicinal attributes not fully meeting drug criteria, such as antiseptics, disinfectants, and preventive treatments.
- Health Supplements: Products supplementing the diet with nutrients like vitamins, minerals, and amino acids, enhancing overall well-being and addressing nutritional deficiencies.
Food Additive Regulations
The document titled "Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia No. 10 Tahun 2024" outlines regulations on food additives, focusing on the use, labeling, and safety assessments required for these substances.
- Scope of Regulation: Applies to all food products containing additives, ensuring they meet safety and quality standards.
- Safety Assessment: Manufacturers must conduct thorough safety assessments of food additives before approval for use in food products.
- Labeling Requirements: Clear guidelines inform consumers about the presence of food additives in products, enhancing transparency.
- Compliance and Enforcement: The regulation outlines the responsibilities of food producers and monitoring processes by BPOM to ensure compliance.
- Public Health Protection: The regulation aims to protect public health by ensuring food additives used in the market are safe for consumption.
Affected Products:
- Processed Foods: Products using various additives for preservation, flavor enhancement, or texture improvement.
- Beverages: Products using additives to stabilize flavors or colors, including soft drinks and fruit juices.
- Confectionery: Sweets and candies with artificial colors and preservatives.
- Snacks: Chips, crackers, and other snacks utilizing additives for flavor and shelf-life extension.
- Dairy Products: Items like cheese and yogurt containing stabilizers or emulsifiers.
Labeling Requirements
General Labeling Requirements:
- Product Name: Clearly states the product’s nature.
- List of Ingredients: Complete list of ingredients in descending order of weight or volume.
- Allergen Information: Clearly indicates any allergens.
- Nutritional Information: Displays nutritional facts, including calorie count and dietary information.
- Net Weight/Volume: States the net weight or volume of the product.
- Manufacturer Information: Includes the name and address of the manufacturer or distributor.
- Country of Origin: Specifies the country of origin for imported products.
- Expiration Dates: Includes expiration or best-before dates.
- Storage Instructions: Mentions any specific storage conditions necessary.
- Clear and Legible Presentation: Ensures the label is easy to read with clear and indelible printing.
Primary and Secondary Packaging:
- Primary Packaging: Must carry all essential information, ensuring it remains available even if the outer packaging is discarded.
- Secondary Packaging: Should meet Regulatory requirements, ensuring consistency and clarity.
Language and Format: Labels must use the Indonesian language, Arabic numerals, and Latin letters for universal readability.
Optional Details:
- Halal Certification: Important in Indonesia for consumers following Islamic dietary laws.
- Alcohol Content: Relevant for those avoiding alcohol for health or religious reasons.
Special Cases:
- Imported Products: Must adhere to local labeling regulations to meet the same standards as domestic products.
- Products with Limited Packaging Space: Special guidelines ensure essential information is conveyed even with limited space.
Compliance and Enforcement: BPOM oversees compliance with these labeling regulations through regular inspections and assessments to ensure products meet established standards.
Penalties for Non-compliance:
- Fines and Recalls: Non-compliance may result in fines and product recalls.
- License Suspension: Continuous non-compliance can lead to the suspension of manufacturing or import licenses.
Conclusion
Indonesia's new labeling regulations for natural medicines, quasi-medicines, health supplements, and food additives are crucial for ensuring consumer safety and transparency. Adherence to these guidelines fosters consumer trust and protects public health. Freyr, as a global Regulatory expert, assists manufacturers in navigating these regulations, ensuring compliance and market entry in Indonesia with services such as end-to-end Regulatory support, safety assessment, and compliance management. These regulations ensure access to safe, effective, and accurately labeled products, building a reputation for quality and reliability that benefits both the market and public health.
