What is ingredient permissibility, and why does it differ by market?

Ingredient permissibility is one of the most fundamental concepts in food and supplement compliance, and one of the most misunderstood. Brands regularly assume that because an ingredient is freely available in supplements in their home market, it's permitted everywhere. It isn't. And the gap between what's permitted in Australia, Singapore, Indonesia, the EU, and the US is wider than most people expect.

What ingredient permissibility means

Every market has a framework that determines which ingredients can be used in food supplements, and under what conditions. 'Permitted' typically means one or more of:

• On a positive list: The ingredient is explicitly listed as allowed, often with maximum daily intake levels and purity specifications.

• Not on a negative/prohibited list: Some frameworks operate on the basis of 'permitted unless prohibited,' where the default is allowed and specific ingredients are banned.

• Specifically approved: Some ingredients require individual evaluation and approval before use, regardless of whether a general positive or negative list exists.

The framework type determines the compliance risk. Positive-list markets (South Korea, China, Japan to a significant extent) mean that anything not on the list is not permitted. Negative-list markets (US under DSHEA, some aspects of EU food supplements) mean the bar is lower, but prohibited substances are strictly enforced.

Why the same ingredient can be permitted in one market and not in another

Different safety assessment processes. Each regulatory authority evaluates ingredients against its own evidence standards. An ingredient that has been through sufficient evaluation in one jurisdiction may not have been formally reviewed in another. The absence of review often means the absence of permission in positive-list markets.

Different risk thresholds. Regulatory authorities make different judgments about acceptable risk levels for the same ingredient. A botanical extract at a dose considered safe under EU food supplement rules may be restricted in Indonesia or Malaysia because those authorities have set lower maximum levels.

Different classification of the ingredient itself. Some ingredients are classified as medicines in certain markets and as food ingredients in others. Melatonin is a clear example: OTC supplement in the US, regulated medicine in the UK and parts of Europe.

Traditional use considerations. Markets with strong traditional medicine systems (China, India, South Korea, Japan) have frameworks that reflect those traditions. Foreign ingredients with no traditional use history face more scrutiny.

Trade and geopolitical factors. Permitted ingredient lists are updated over time based on new evidence, political decisions, and regulatory policy shifts. An ingredient permitted when a brand first entered a market may later be restricted.

Common permissibility issues by market

Australia (TGA): Generally permissive for the complementary medicine category, but specific dose levels matter. The Permitted Indications Determination links permitted doses to permitted claims.

Indonesia (BPOM): Positive list-based for health supplements. Proprietary botanical blends with ingredients common in Western markets frequently include components not on the BPOM positive list.

Malaysia (NPRA): Similar positive-list approach for natural health products. High-dose botanical extracts and newer functional ingredients are the most common issues.

European Union: Food supplements operate under Directive 2002/46/EC for vitamins and minerals (with positive lists and maximum levels) and, for botanicals, a patchwork of national rules since no EU-harmonised botanical list exists.

United States (DSHEA): Dietary supplement ingredients marketed before October 1994 have grandfathered status. New dietary ingredients (NDIs) require pre-market notification with evidence of safety. One of the most permissive major markets, but enforcement against prohibited and unsafe ingredients is real.

South Korea (MFDS): Strictly positive-list. Only MFDS-recognised functional ingredients can carry health function claims. Ingredients not on the list can be used in ordinary food but cannot support any health function statement.

Practical implications

For any brand taking a product to a new market, ingredient permissibility screening is the first step: before formulation is finalised, before the dossier is assembled, before a launch date is committed to.

The questions to answer for each target market: Is each ingredient on the permitted list, or not on the prohibited list? Is the dose within permitted maximum levels? Does any ingredient require individual approval or specific documentation? Are any excipients, processing aids, or capsule components affected?

Finding a permissibility issue after a product is manufactured means reformulation, retesting, and a delayed launch. Finding it at the screening stage costs a supplier change.

Taama's ingredient permissibility screening covers 18 markets, checking every ingredient in your formulation against the permitted lists and maximum levels for each target market. See what we cover