HS 300213 Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale

Quick Answer: Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale, imported under HS 300213 enter the UK at 0.00%, the EU at 0.00%, and the US at Free under the MFN rate. This classification covers substances like antigens and antibodies that are intended for medical or veterinary use but are not yet prepared for direct administration to patients. They are typically supplied in bulk for further processing. Importers and customs brokers should verify specific product composition and intended use to ensure correct classification. According to CustomTariffs data, these products generally benefit from duty-free entry across major trading blocs, simplifying trade for bulk biological materials.

What Are the Import Duty Rates?

🇬🇧 United Kingdom

Code MFN Preferential Unit
3002130000 0.00 %

🇪🇺 European Union (TARIC)

Code MFN Preferential Unit
3002130000 0.00 %

🇺🇸 United States (HTSUS)

Code MFN Preferential Unit
30021300 Free
3002130090 ["kg"]
3002130010 ["kg"]

Duty rates sourced from the USITC (US International Trade Commission) Harmonized Tariff Schedule (HTS) (accessed 2/22/2026), EU TARIC – DG TAXUD (Directorate-General for Taxation and Customs Union) (accessed 2/22/2026), and UK Trade Tariff – HMRC (His Majesty's Revenue and Customs) (accessed 2/22/2026).

Data compiled and presented by HSRates.

How to Classify This HS Code?

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What products does HS 300213 cover?

This subheading covers immunological products that are unmixed and not presented in measured doses or in forms or packings for retail sale, as defined by the World Customs Organization (WCO) Harmonized System Nomenclature. This includes substances such as antigens and antibodies, whether or not derived from human or animal sources, intended for prophylactic or diagnostic use, but which have not yet been prepared for direct administration to patients or for sale to the general public. Official definitions from sources like the USITC Harmonized Tariff Schedule (HTS) and the EU TARIC database confirm this scope.

What falls outside HS 300213?

The following products are excluded from HS 300213: immunological products that are mixed, put up in measured doses (e.g., single-use vials or pre-filled syringes), or specifically packaged for retail sale. Also excluded are finished pharmaceutical preparations of heading 3004, vaccines, and blood fractions. For instance, a ready-to-inject vaccine for influenza, even if unmixed, would be classified elsewhere, typically under 3002.20, due to its preparation for direct administration.

What are common classification mistakes for HS 300213?

A common error is misinterpreting the "unmixed" and "not put up in measured doses or in forms or packings for retail sale" criteria. Importers may incorrectly classify a product as unmixed when it contains stabilizers or excipients that constitute a mixture for the purposes of the HS, or they may classify a product intended for laboratory diagnostic kits as being for retail sale. Adherence to General Interpretative Rule 1 and Section VI of the HS Nomenclature is crucial.

How should importers classify products under HS 300213?

The correct procedure for classifying products under HS 300213 involves a thorough review of the product's composition, presentation, and intended use. Importers and customs brokers must consult the WCO HS Explanatory Notes, the relevant national tariff schedule (e.g., USITC HTS, EU TARIC), and any available laboratory analyses. Key considerations are whether the product is a single immunological substance and if it is prepared for direct administration or retail sale.

How is the duty calculated for products under HS 300213?

A batch of unpurified monoclonal antibodies for research, weighing 500 grams and declared at a customs value of $10,000 USD, would attract a US duty of $350.00. This is calculated using the USITC Harmonized Tariff Schedule's Most Favored Nation (MFN) rate of 3.5% ad valorem, applied to the declared customs value ($10,000 USD × 0.035 = $350.00). This specific rate is found under HTSUS subheading 3002.13.0000.

Which trade agreements reduce duties for HS 300213?

Several free trade agreements may reduce the applicable duty rate for HS 300213, including the United States-Mexico-Canada Agreement (USMCA), which can result in a duty rate of Free for qualifying goods originating from Canada or Mexico. Additionally, the Generalized System of Preferences (GSP) may offer duty-free entry for eligible products from certain developing countries. To claim these preferences, a valid USMCA Certificate of Origin or a GSP Form A, as required by the importing jurisdiction, must be presented.

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FAQ

What are the typical import duty rates for HS code 300213, and how can preferential rates be accessed?

For HS code 300213, 'Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale,' the Most Favored Nation (MFN) duty rate in the United States is 0.00% ad valorem. In the European Union, under TARIC, the rate is also 0.00%. The United Kingdom's Trade Tariff also lists this classification as Free. To access preferential rates under trade agreements, importers must provide a valid Certificate of Origin and ensure the goods meet the rules of origin specified in the relevant agreement. For example, under the USMCA, qualifying products may benefit from reduced or eliminated duties.

What are the key classification criteria for goods under HS code 300213?

HS code 300213 covers immunological products that are 'unmixed.' This means the product consists of a single active immunological substance or a mixture of identical substances, not combined with other active principles. Crucially, these products must not be 'put up in measured doses or in forms or packings for retail sale.' This excludes finished pharmaceutical products ready for patient administration, such as vaccines in single-dose vials or diagnostic kits packaged for consumer use. The WCO's Explanatory Notes to Chapter 30 provide detailed guidance on distinguishing between bulk immunological preparations and those ready for retail.

What documentation is typically required when importing goods classified under HS 300213?

When importing immunological products under HS code 300213, standard import documentation is required, including a commercial invoice, packing list, and bill of lading or air waybill. Additionally, depending on the importing country's regulations and the specific nature of the product, a Certificate of Analysis (CoA) may be necessary to verify the product's composition and quality. Health authorities in the importing country might also require import permits or licenses, especially for biological materials. Importers should consult the specific requirements of their national customs authority and relevant health ministries.

How is the import duty calculated for HS code 300213, and can you provide a numerical example?

Since HS code 300213 generally carries a 0.00% ad valorem duty rate in major markets like the US, EU, and UK, the calculated duty is typically zero. An ad valorem duty is calculated as a percentage of the value of the imported goods. For example, if a shipment of immunological products classified under HS 300213 has a declared customs value of $10,000 USD and the MFN duty rate is 0.00%, the duty calculation would be: 0.00% of $10,000 = $0.00. Therefore, no duty would be payable on this shipment based on the standard tariff.

Which common trade agreements significantly impact the duty rates for HS code 300213, and what are the implications?

While HS code 300213 often has a 0.00% MFN duty rate, trade agreements can still be relevant for ensuring continued duty-free status and streamlining customs procedures. Agreements like the USMCA (United States-Mexico-Canada Agreement) or the EU's trade agreements with various countries often reaffirm duty-free treatment for products within Chapter 30. The implications are primarily related to compliance with rules of origin to prove the goods originate from a partner country, thereby qualifying for preferential treatment. This avoids the need to pay duties even if a non-preferential rate were applicable, and it can also simplify customs declarations and reduce the risk of audits related to duty payments.