BPOM food category 13.0 covers processed food for special nutritional purposes. On the regulatory text, the category follows who a product is formulated for, such as infants, young children, people with medical conditions or people on controlled diets, and not its physical format.
A nutritional shake, a bar and an enriched powder can share the same format and still follow different regulatory pathways.
Category 13.0 brings tighter rules than conventional packaged food: narrower claim options, mandatory label statements and, for medical-purpose foods, restricted sales channels.
This guide is for regulatory affairs teams, formulation scientists and brand owners handling food and beverage product registration in Indonesia. It covers the legal basis for category 13.0, claim limits, the registration route and the checks to make before a dossier is compiled.
Note: this article sets out the reading of Product Registration Indonesia (PRI) and is not an official BPOM ruling. Confirm the category for a specific formula with a qualified regulatory adviser.
What Is BPOM Food Category 13.0?
BPOM food category 13.0 is the processed food category for special nutritional purposes under PerBPOM 13/2023 (Peraturan BPOM, a BPOM regulation). It covers foods formulated for a defined consumer: infants, young children, people with medical conditions or people on weight-control diets, whatever the format.
The Legal Basis for Category 13.0
PerBPOM 13/2023: Where the Category Sits
PerBPOM 13/2023 on Food Categories, published in Berita Negara 2023 No. 428, revoked PerBPOM 34/2019. Article 5 paragraph 2 letter m lists category 13.0, titled processed food for special nutritional purposes. Under Article 2, packaged processed food sold at retail must meet the requirements of its assigned category.
PerBPOM 1/2018: Detailed Supervision
Detailed supervision sits in PerBPOM 1/2018 on Supervision of Processed Food for Special Nutritional Purposes, as amended by PerBPOM 24/2019 and PerBPOM 24/2020. Article 1 defines these products as processed food formulated specially for nutritional needs arising from a physical or physiological condition, disease or disorder.
The regulation labels these products PKGK, short for Pangan Olahan untuk Keperluan Gizi Khusus. Article 6 requires producers to apply CPPOB (Cara Produksi Pangan Olahan yang Baik, meaning good processed food production practices) and HACCP (Hazard Analysis and Critical Control Point), with adult special-diet foods excused from HACCP.
Article 17 adds a gateway. A PKGK type that the regulation does not yet cover needs written approval from the Head of BPOM before it can be marketed. For a novel formulation, the category question can become an assessment request with its own supporting data.
PerBPOM 1/2018 is under revision. BPOM circulated a draft revision in December 2024 and reopened public consultation in January 2026. As of 3 November 2026, PRI has found no issued revision, so the 2018 text, as amended, remains the working basis.
The Two Groups Inside Category 13.0
PerBPOM 1/2018 sorts these products into two groups. Special-diet foods (PDK, Pangan Olahan untuk Diet Khusus) serve particular physical or physiological conditions. Foods for special medical purposes (PKMK, Pangan Olahan untuk Keperluan Medis Khusus) support diet management for people with certain diseases or disorders.
| Group | Formulated for | Examples named in Article 2 (as amended) |
|---|---|---|
| Special-diet food (PDK) | A particular physical or physiological condition | Infant formula, follow-up formula, growth formula, complementary foods (MP-ASI), snack foods for children, drinks for pregnant or lactating mothers, sports foods, weight-control foods |
| Food for special medical purposes (PKMK) | Diet management of people with a particular disease or disorder | Foods for diabetes, chronic kidney disease, chronic liver disease, inborn errors of metabolism, cow’s milk protein allergy, infant lactose intolerance, malabsorption, inflammatory bowel disease, malnutrition, premature infants, human milk fortifier and ketogenic diets |
Each group spans infants, children and adults. Source: PerBPOM 1/2018, Articles 1 and 2, as amended by PerBPOM 24/2019 and 24/2020.
The examples follow Article 2 as amended by PerBPOM 24/2020, which brought in snack foods for children and further PKMK types. Group placement drives the label statements and sales channels discussed next.
Label Statements and Sales Channels
Article 12 requires special-diet foods to display a bold instruction to consult a health professional. Article 13 requires PKMK to carry a bold statement that a doctor’s prescription is required. Article 16 limits PKMK sales to pharmacies, hospital pharmacies and puskesmas (community health centres), except government nutrition programmes (paragraph 2).
How Category 13.0 Is Decided: Start With the Consumer
PRI has no category 13.0 file to draw on, so this reading is interpretive. Article 1 of PerBPOM 1/2018 defines each product type by condition, disease or disorder and never ties a definition to a product form. On that text, format cannot be the test for category 13.0.
PRI’s casework on neighbouring categories points the same way. A nutrition company asked about a powdered drink with live cultures, and BPOM still requested a postbiotic formula assessment although a similar product was already approved. Three category routes were open, and they differed sharply in feasibility.
Ten dry herb-soup mixes reviewed by PRI looked like ordinary food until an ingredient check moved the whole set into the natural medicine regime. The pattern repeats across categories: the regime follows the formulation and intended use, so a product’s shape on the shelf offers no safe shortcut.
In our reading, the intended consumer tends to surface first in the brief, artwork and marketing copy, well before the formula is final. A line such as ‘suitable from 12 months’ can pull a general drink mix toward category 13.0, so the brief needs the same review as the recipe.
Claim Rules for Category 13.0 Products
Claims are supervised under PerBPOM 1/2022 on Supervision of Claims on Processed Food Labels and Advertisements, issued by BPOM. For category 13.0 products the regulation narrows what may be said, and in some cases bars claims altogether. Three provisions matter most for infant, child and medical-purpose foods.
Complementary Food (MP-ASI) Claims: Article 7
Complementary foods (MP-ASI, Makanan Pendamping Air Susu Ibu) may carry only five claim types under Article 7: nutrient content, comparison, no added sugar, gluten and nutrient function.
Article 1 point 17 defines MP-ASI as food given alongside breast milk to babies and children aged six to 24 months, or outside that range on medical indication.
PKMK Claims: Article 8
Article 8 allows PKMK to carry only the claims set by the BPOM regulation that governs PKMK, which in PRI’s reading is PerBPOM 1/2018 as amended. Claim wording for these products therefore starts with that regulation, and the general claim lists of PerBPOM 1/2022 should not be borrowed without checking.
Barred Claims: Article 28
Article 28 letter a bars claims on foods for infants unless the claim is specifically regulated. Letter b bars disease-risk reduction claims on foods for children aged one to three years, with the same exception. Letter g bars any claim that a food prevents, treats or cures disease.
| Product type | Claim rule | Basis |
|---|---|---|
| Complementary food (MP-ASI) | Five claim types only | PerBPOM 1/2022, Article 7 |
| Food for special medical purposes (PKMK) | Claims follow the PKMK regulation | PerBPOM 1/2022, Article 8 |
| Foods for infants | Claims barred unless specifically regulated | PerBPOM 1/2022, Article 28 letter a |
| Foods for children aged 1 to 3 years | Disease-risk reduction claims barred | PerBPOM 1/2022, Article 28 letter b |
| Any processed food | No claim of preventing, treating or curing disease | PerBPOM 1/2022, Article 28 letter g |
Claim rules at a glance. Source: PerBPOM 1/2022.
Registration Route, Timeline and Fee Group
Registration Basis
BPOM food registration is governed by PerBPOM 23/2023 on Processed Food Registration. Per PRI’s guide, approval is generally valid for five years under Article 53 paragraph 1. Imported products carry an ML number and domestic products an MD number, commonly read as Makanan Luar (foreign-made) and Makanan Dalam (domestic).
Timeline and Evidence
In our experience, BPOM food registration for products aimed at infants, pregnant women or people with health conditions follows a higher-risk path, and reviews typically run three to six months or longer. Incomplete labelling or extra laboratory testing can extend that further, so timelines need confirming per formulation.
Composition evidence carries extra weight because nutrient levels are regulated. Reviewers can question a Certificate of Analysis when the laboratory’s accreditation scope does not name the product matrix, a gap explained in PRI’s guide to food testing laboratories. Matching scope to product before sampling saves time.
Fee Group
Fees follow a separate track. PP 15/2026 (Peraturan Pemerintah, a Government Regulation) on BPOM service tariffs groups processed food by type, and PRI’s published reading places nutrition-purpose foods in category 13.0 in a distinct tariff group. The group for each SKU (stock keeping unit) should be confirmed before budgeting.
A Decision Path: Who Is the Product Formulated For?
A short sequence of questions keeps the category decision on track. The questions below follow the order PRI recommends, and any yes answer is a signal to expect category 13.0 and to seek regulatory review before artwork, claims or production plans are fixed.
- Infant under 12 months? If the product is formulated for infants, expect category 13.0 and the strictest claim limits.
- Child under three years? If the product is formulated for young children, expect category 13.0, with disease-risk claims barred under Article 28 letter b.
- Disease or disorder? If the product supports diet management for a medical condition, expect category 13.0 as PKMK.
- Controlled diet? If the product is formulated for a diet such as weight control, expect category 13.0 as a special-diet food (PDK).
- General population? If no defined consumer exists, category 13.0 is unlikely, though an adviser should confirm before the pathway is fixed.
The closing decision is simple to state. Ask who the product is formulated for before choosing a category. If the answer is an infant, a child under three, a person with a medical condition or a weight-control diet, expect 13.0 whatever the format.
Key Acronyms in This Article
- BPOM: Badan Pengawas Obat dan Makanan, Indonesia’s Food and Drug Authority.
- PerBPOM: Peraturan BPOM, a regulation issued by BPOM.
- PP: Peraturan Pemerintah, a Government Regulation.
- PKGK: Pangan Olahan untuk Keperluan Gizi Khusus, processed food for special nutritional purposes.
- PDK: Pangan Olahan untuk Diet Khusus, special-diet food.
- PKMK: Pangan Olahan untuk Keperluan Medis Khusus, food for special medical purposes.
- MP-ASI: Makanan Pendamping Air Susu Ibu, complementary food for babies and young children.
- CPPOB: Cara Produksi Pangan Olahan yang Baik, good processed food production practices.
- HACCP: Hazard Analysis and Critical Control Point.
- ML and MD: number prefixes for imported and domestic processed food, commonly read as Makanan Luar and Makanan Dalam.
- SKU: stock keeping unit, an individual product variant.
- Puskesmas: pusat kesehatan masyarakat, a community health centre.
- PRI: Product Registration Indonesia.
Your Next Step: Settle the Consumer Question Early
Category 13.0 can look demanding, yet it rewards brands that ask the right question first. When the intended consumer is settled early, the category, the claims, the label statements and the registration route fall into a clear order, and launch dates become far easier to protect.
PRI helps brands avoid costly category errors. The team supports category screening, formulation and claim review, label checks and BPOM liaison under its Food & Beverage Product Registration service, so a product enters the right regime before artwork is printed or batches are produced.
Request PRI’s category-screening checklist from the Food & Beverage Registration team. The checklist helps a brand organise the intended consumer statement, ingredient list, draft claims and label artwork, so that a regulatory adviser can review category 13.0 placement on a complete set of facts before any pathway is chosen.
This article is for general education and is not legal advice. Category placement depends on the full formula, intended consumer, claims, process and supporting documents, so every decision should be confirmed with a qualified regulatory adviser before any registration, labelling or marketing step is taken.
