Vaccines to be subdivided under a new heading; INN implementation to increase practical impact on APIs.
The HS2028, effective January 1, 2028, is an amendment package (299 sets of amendments) compiled by the WCO (World Customs Organization). A distinctive feature is that it explicitly cites “health and pandemic response,” alongside the environment, as a rationale for the amendments. EU explanatory documents also highlight “vaccines and health-related groups (addressing needs underscored by the pandemic)” as a primary objective of these changes.
According to the WCO, the HS2028 Article 16 Recommendation will be formally adopted at the end of 2025, published in January 2026, and enter into force on January 1, 2028. (WCO)
This article organizes the expected impacts on corporate practices regarding APIs, pharmaceutical formulations, vaccines, and healthcare-related products, focusing exclusively on high-reliability primary information.

1. Key Highlight: Human Vaccines Expected to be Subdivided Under an “Independent Heading”
In the current HS, vaccines for human medicine are consolidated into a single subheading, meaning all types of vaccines fall under the same classification. The WTO has explicitly stated that this structure hindered policy responses (targeted tariffs and measures) and statistical monitoring during the pandemic. (WTO)
In response, a joint initiative by the WHO, WCO, and WTO has reported a policy to implement the following revisions in HS2028: (WTO)
- Establishment of a new Heading 30.07: “Vaccines for human medicine.”
- Creation of seven categories under this new heading.
- Subdivisions covering a total of 36 named vaccines for specific diseases.
The WTO reports that the wording for this proposal has been approved by the WCO’s HS Review Sub-Committee and has progressed to the stage of submission to the HSC (HS Committee). (WTO) Furthermore, the WCO has announced that the HS2028 amendment recommendation package was provisionally adopted at the HSC meeting in March 2025, marking the conclusion of negotiations. (WCO)
Given this trajectory, it is reasonable to view the subdivision of vaccine classifications as a definitive change occurring in HS2028.
Impact on Corporate Practice:
- Redesign of Item Master Data: Internal codes that previously categorized items simply as “vaccines” may now need to be split by disease type. Attribute management—such as product name, indication, dosage form, and cold-chain requirements—will become critical.
- Strengthened Linkage Between Customs, Statistics, and Regulation: As statistics become more granular, companies must prepare information to explain “why this specific category was chosen” during authorities’ inquiries or internal audits. During the pandemic, the WCO, in cooperation with the WHO, created classification reference materials based on the existing HS to facilitate the cross-border movement of vaccines and related supplies. The HS2028 subdivision is an extension of this effort. (WCO)
2. Changes in Active Pharmaceutical Ingredients (APIs): “Classification Implementation” to Shift Before Code Changes
APIs are fundamentally categorized under Chapter 29 (Organic Chemicals, etc.), while pharmaceutical formulations (medicaments put up in measured doses) fall under Chapter 30. HS2028 will not fundamentally swap this structure.
However, the API sector is entering a phase where “practical impact will increase” due to the following reasons: The WCO announced as an outcome of the 75th HSC session that it has classified 441 items regarding APIs and related substances based on the WHO’s INN (International Nonproprietary Names) list. (WCO)
While this is separate from the HS2028 amendments themselves, it signifies the following for companies:
- There is a strong global demand for the unified application of classification for APIs.
- The organization of classifications based on INN will continue, leading to stricter scrutiny regarding product names and ingredient identification.
The WHO continuously publishes recommended and proposed INN lists, which serve as the common language for pharmaceutical naming and supply chains. (WHO) Even if product names are similar, classification may change based on salts, isomers, derivatives, concentration, or mixed states. In practice, regardless of whether a code itself changes, the frequency of rigorous checks by authorities and customs brokers is expected to increase during the transition to HS2028.
Effective Corporate Preparations (3 Key Points):
- Link INN, CAS, salt form, concentration, and intended use (medicinal vs. research) to the item master.
- Centrally manage evidence for ingredient identification, such as SDS, CoA, specifications, and manufacturing process summaries.
- Maintain records of which HS edition (HS2022 or HS2028) was referenced for the classification.
3. Formulations and Healthcare: Increasing “Granularity for Pandemic Response”
EU explanatory documents cite “vaccines and health-related groups (directly addressing pandemic needs)” as a target of the HS2028 amendments.
While it is difficult to exhaustively list exactly which headings or subheadings will be split for pharmaceutical formulations and healthcare products based solely on currently available primary information (details must be confirmed via the HS2028 legal text and correlation tables), companies can identify “high-risk areas” from a practical perspective. The following areas were prone to becoming bottlenecks during pandemic responses: (WCO)
- Vaccines themselves (lack of classification granularity).
- Consumables for injection/vaccination (needles, syringes, etc.).
- Storage and Transport (cold-chain equipment, etc.).
- Diagnostics and Testing items (reagents, test kits, etc.).
Therefore, for the HS2028 transition, companies should anticipate that classifications and explanatory notes will be adjusted to ensure “healthcare-related items can be tracked for policy and statistical purposes.”
4. Business Practice Checklist
Reducing immediate actions to minimum steps:
- Categorize Target Items into Three Groups:
- Vaccines (Human, Veterinary, Research).
- APIs (Pharmaceutical ingredients with INNs, including biopharmaceutical raw materials).
- Healthcare-related (Diagnostics, vaccination consumables, storage/transport, medical devices).
- Add Data Fields for Vaccines Assuming the “30.07 New Establishment”:
- Prepare attributes capable of withstanding future subdivision, such as disease category and product type.
- Identify connection points between internal statistics, import/export permits, and labeling. (WTO)
- Maintain “Evidence of Ingredient Identification” for APIs:
- Manage INN, CAS, salt form, concentration, use, SDS, CoA, and specifications as a set.
- Always keep a “Classification Rationale Memo” (ensuring traceability for future explanations). (WCO)
- Prepare for Dual Management of HS2022 and HS2028:
- Manage the HS version switchover date (January 1, 2028).
- Maintain history based on Item IDs so that bulk replacement can be performed once correlation tables are released. (WCO)
Summary
The most significant change in the pharmaceutical and healthcare sector under HS2028 is the creation of an independent heading and the subsequent subdivision of human vaccines. The WTO reports progress on a proposal to establish the new Heading 30.07, specifying 7 categories and 36 vaccines. (WTO)
Regarding APIs, the WCO is advancing the classification of numerous substances based on the WHO’s INN list. Even before code changes occur, the “stricter enforcement of classification application” will dictate corporate burden and risk. (WCO) For healthcare-related products, official documents indicate a shift toward making essential pandemic-response supplies traceable for policy and statistics.
The ultimate winning strategy is to conduct an early item inventory: rebuild masters for vaccines assuming increased granularity, and organize ingredient identification and evidentiary trails for APIs. These steps alone will establish a resilient system that “does not stop” during the 2028 transition.







