HS 293712 Insulin and its salts

Insulin and its salts (HS 2937.12) generally benefit from very low or zero import duty rates in many major trading blocs due to their critical medical application. For example, under the Harmonized Tariff Schedule of the United States (HTSUS), the Most Favored Nation (MFN) duty rate for 2937.12.00.00 is 0.00% ad valorem. Similarly, the EU TARIC and UK Global Tariff also list a 0.00% ad valorem duty rate for goods classified under HS 2937.12. However, it is crucial to verify the specific duty rate for the country of importation, as some nations may apply different tariffs. For instance, certain developing economies might apply a duty rate of up to 10% ad valorem to protect domestic industries or for revenue purposes, although this is less common for essential medicines like insulin. Always consult the official tariff schedule of the importing country.

Classification under HS 2937.12 is primarily based on the chemical identity of the substance. This heading specifically covers 'Insulin and its salts.' Insulin is a peptide hormone produced by the pancreas, crucial for glucose regulation. Its salts refer to chemically modified forms where insulin is combined with an acid or base to form a salt, often to improve stability or absorption (e.g., insulin zinc suspension). The key criterion is that the product must be chemically identifiable as insulin or a salt thereof, falling under the broader Chapter 29 for 'Organic chemicals' and specifically Section VI for 'Products of the Chemical or Allied Industries.' Products that are insulin analogues (modified forms of insulin with altered amino acid sequences) or formulations containing insulin (e.g., pre-filled pens) are generally classified here, provided the active pharmaceutical ingredient (API) is insulin or its salt. The WCO Explanatory Notes for Chapter 29 provide further guidance on the chemical identity and purity requirements for classification.

Yes, beyond standard customs documentation (commercial invoice, packing list, bill of lading/air waybill), the importation of insulin and its salts (HS 2937.12) typically requires strict regulatory approvals due to its nature as a pharmaceutical product. Importers must generally comply with the regulations of the national health authority, such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the EU, or the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This often includes: 1. Product Registration: The specific insulin product must be registered and approved for use in the importing country. 2. Import Licenses: A specific import license or permit may be required from the health authority. 3. Good Manufacturing Practice (GMP) Certificates: Evidence that the manufacturing facility adheres to GMP standards. 4. Certificate of Analysis (CoA): Detailing the purity, potency, and quality of the specific batch. 5. Cold Chain Documentation: As insulin is temperature-sensitive, documentation proving maintenance of the cold chain during transit is often mandatory. Customs brokers should confirm all specific national regulatory requirements prior to shipment.

Given that the MFN duty rate for HS 2937.12 is often 0.00% ad valorem in many major economies (e.g., US, EU, UK), the direct impact of preferential trade agreements on duty rates for this specific HS code is frequently negligible, as there is no duty to reduce further. However, trade agreements can still be relevant by: 1. Solidifying Zero Duties: They often bind the zero-duty rate, providing long-term predictability and preventing future imposition of duties. 2. Rules of Origin: While not impacting the duty rate directly, understanding the Rules of Origin (ROO) within agreements (e.g., USMCA, EU-Japan EPA, UK-EU TCA) is crucial for claiming preferential treatment for other goods in the same shipment or for future policy considerations. 3. Non-Tariff Barriers: Trade agreements often include provisions aimed at streamlining regulatory processes, harmonizing standards, or improving customs procedures, which can indirectly facilitate the trade of sensitive products like insulin by reducing non-tariff barriers, even if the tariff itself is zero. Importers should always verify if their specific product qualifies under the ROO of any applicable free trade agreement (FTA) to ensure compliance, even if the duty rate is already zero.