Thai FDA Drafts New Import Exemption Rules for the Hazardous Substances It Regulates

Thai FDA has circulated a new draft notification that would replace both of the notifications currently governing when a hazardous substance under its jurisdiction can be imported into Thailand without going through the full compliance process the Hazardous Substances Act B.E. 2535 (1992) otherwise requires. The draft, titled the Notification of the Ministry of Public Health regarding the Import Exemption from Compliance with the Hazardous Substances Act, B.E. 2535 (1992), of Hazardous Substances under the Responsibility of the Food and Drug Administration, was reported in early July 2026 and would supersede the exemption notifications currently in force from 2005 and 2025.

For a company that has already built its Thai compliance program around full registration and licensing, this draft does not change that core obligation. What it changes is the narrow set of circumstances in which a hazardous substance can cross the Thai border at all without triggering that obligation in the first place, which matters most to companies moving small quantities for reasons other than ordinary commercial sale.

What the draft actually exempts

The draft sets out specific, narrow scenarios in which an FDA-regulated hazardous substance can be imported without the registration and license the Act would otherwise require. These include personal-use shipments, occasional imports outside the ordinary course of a commercial supply chain, imports for exhibition purposes, and transfers to agencies that already operate under recognized international compliance standards, along with transfers to government ministries, the Thai Red Cross Society, or United Nations agencies. Each of these categories already exists in some form under the current 2005 and 2025 notifications; the draft's function is to consolidate, and in places refine, the criteria, conditions, and documentation each one requires.

A new category: foreign film and commercial production

The one genuinely new addition is an exemption for hazardous substances imported for the production of foreign films or commercials in Thailand. Thailand's film production industry regularly brings in specialty chemical products for effects, props, or set requirements that would otherwise sit under Thai FDA's hazardous substance jurisdiction, and this exemption appears designed to remove a compliance friction point that had no clean answer under the existing notifications without either an ad hoc exemption request or a full registration effort disproportionate to a short production shoot.

The condition that runs through every exemption

Every scenario in the draft carries the same underlying condition: the imported hazardous substance cannot be for sale. An exemption removes the registration and license burden precisely because the substance is not entering ordinary Thai commerce, and the moment that condition fails, whatever compliance gap the exemption filled reopens. A company that imports a product under one of these exemption categories and later diverts any part of it into a commercial sale channel has stepped outside the exemption entirely and back into the full registration and licensing framework it was never engineered to satisfy.

How the approval process works

An importer seeking to rely on one of these exemptions still needs Thai FDA approval before the shipment moves, and the draft channels that approval through Thai FDA's electronic submission network as the default route. Where the network cannot process a particular submission, the draft provides that documentation can instead be filed directly at the Food and Drug Checkpoint where the importation actually takes place, keeping a physical fallback available rather than leaving an importer with no path forward if the digital system is unavailable at the relevant port of entry. This structure mirrors the approach Thailand has taken elsewhere in its hazardous substance framework, where the electronic system is the default channel but a physical alternative remains available rather than making digital access a hard precondition for compliance.

The exemption itself is not self-executing. An importer cannot simply decide a shipment qualifies under one of the draft's categories and proceed; approval has to be obtained before the goods move, which means a company planning to rely on an exemption needs to build the approval step into its shipping timeline in the same way it would budget time for an ordinary registration-based import declaration. Treating an exemption category as something that can be asserted after the fact, if a shipment is ever questioned, rather than confirmed in advance, defeats the purpose of the exemption process entirely.

What this signals about the direction of travel

Read alongside the digitization already delivered under Ministerial Regulation No. 5 (B.E. 2568/2025) for Type 3 permit applications, this draft continues a pattern of Thai FDA consolidating and modernizing its hazardous substance procedures rather than leaving them scattered across notifications issued decades apart. Replacing a 2005 notification and a 2025 notification with a single current text also reduces the risk that an importer relies on an outdated criterion that a more recent, narrower notification has already superseded, which has historically been a real source of confusion in this area given how the underlying exemption rules have been amended piecemeal over time.

Why replacing two notifications with one matters operationally

The 2005 notification and the 2025 notification it sits alongside were not written against the same regulatory backdrop. The older text predates the GHS labeling requirements that have applied to hazardous substances since 2013, predates the digitization of Type 3 permit processing under Ministerial Regulation No. 5, and predates the current fee schedule set under the Ministerial Regulation on Hazardous Substance Fees, B.E. 2552. A company relying on an exemption criterion sourced from the older 2005 text without checking whether the 2025 notification, or now this draft, has already narrowed or restructured it runs a real risk of citing an exemption basis that no longer matches current practice, even where the underlying exemption category itself, personal use, exhibition purposes, and so on, has existed in some form for years. Consolidating both into a single current text removes that layered-history problem for anyone approaching the exemption framework for the first time.

What happens if an exemption is used incorrectly

An importer relying on an exemption category who is later found to have sold the imported substance, or otherwise moved it outside the personal-use, exhibition, or institutional-transfer purpose the exemption was granted for, has not committed a labeling or documentation error. They have imported a hazardous substance without the registration and license the Act otherwise requires for that activity, which is exactly the unlicensed-activity exposure covered in detail in DeeMED's guide to penalties and enforcement risk under the Act. Treating an import exemption as a shortcut around registration, rather than as a narrow carve-out for genuinely non-commercial movement, is the single most consequential way a company could misuse this draft once it takes effect.

What foreign companies should do now

This is currently a draft, not yet a final, effective notification, so a company should not restructure an existing import process around it before it is formally issued in the Government Gazette. What a foreign company can usefully do now is identify whether any of its own Thailand-bound shipments have historically relied on an exemption category, rather than full registration, and flag those shipments for a fresh compliance check once the final notification text is published, since the specific documentation and criteria attached to each exemption category are exactly the kind of detail that can shift between a draft and its final form. A company that has never previously relied on an exemption category, and instead already holds full registration and licensing for everything it moves across the Thai border, is largely unaffected by this draft either way, since nothing in it touches the underlying registration and licensing obligation itself.

DeeMED tracks Thai FDA's hazardous substance rulemaking as part of our Hazardous Substances regulatory consulting work, and we will confirm the final notification's effective date and any changes from this draft once it is formally published.