دستگاه ضدعفونی با نور UVC: استریلیزر حرارتی ۸۴۱۹ نیست، «سایر دستگاه‌های برقی» ۸۵۴۳ است

OT:RR:CTF:EMAIN H343962 SKK

Center Director Machinery Center of Excellence and Expertise U.S. Customs and Border Protection 109 Shiloh Dr., Suite 300 Laredo, TX 78045 ATTN: Derrick M. Logan, Import Specialist; Bernard Ash, Supervisory Import Specialist

Dear Center Director:

This is in response to an Application for Further Review (“AFR”) of Protest No. 1703-23-115544, filed on April 17, 2023, by Liviliti Health Products Corp (“Protestant”). The AFR is against U.S. Customs and Border Protection’s (“CBP”) classification under the Harmonized Tariff Schedule of the United States (“HTSUS”) of the “Paptizer UVC Sanitizer.” No sample was provided for examination.

The AFR was forwarded to this office for review.

The merchandise at issue in Protest No. 1703-23-115544 is identified as the Liviliti Paptizer UVC 1 Sanitizer (“Paptizer”). The primary function of the Paptizer is to sanitize certain medical equipment. The subject device is comprised of a plastic enclosure containing 40 individual UVC LED lights, heating element, temperature sensor, fan, and various control electronics. The Paptizer measures 11.89 x 10.59 x 6.06 inches and weighs 4.29 pounds. Items to be sanitized are placed in the machine’s cavity and subjected to UVC light and heat for the prescribed cycle time. Heat is used to dry items after washing and to maintain optimal conditions (i.e., humidity and temperature) for sanitized storage.

UVC LED sanitizers use ultraviolet C (UVC) light to disinfect equipment and other objects. The Paptizer user manual describes the device’s three operating modes as follows: [Footnote 2: Modes 2 and 3 are designed for use in clinical settings.]

• “Fast Sanitize” Mode (cycle time 3 minutes).

• “Auto” Mode (cycle time 1-24 hours) “Fast Sanitize” mode followed by 60-minute “Smart Drying” cycle using internal fan and temperature control features. Sensors determine whether additional drying time is needed. Once drying is complete, the Paptizer switches to “Sanitized Storage,” which uses low light UVC LEDs.

• “Fast Sanitize + Sanitized Storage” Mode (cycle time 1-24 hours)

See https://www.liviliti.com/_files/ugd/2a5b17_f9d44e46778445bcad4d88c487ad2059.pdf (site last visited December 1, 2025).

The subject merchandise was entered under heading 8419, specifically subheading 8419.20.00, HTSUS, which provides for “[M]achinery, plant or laboratory equipment, whether or not electrically heated (excluding furnaces, ovens and other equipment of heading 8514), for the treatment of materials by a process involving a change of temperature such as heating, cooking, roasting, distilling, rectifying, sterilizing, pasteurizing, steaming, drying, evaporating, vaporizing, condensing or cooling, other than machinery or plant of a kind used for domestic purposes; instantaneous or storage water heaters, nonelectric; parts thereof: Medical, surgical or laboratory sterilizers. The subject entries were liquidated on March 17 and March 24, 2023 under heading 8543, specifically subheading 8543.70.98, HTSUS, which provides for “[E]lectrical machines and apparatus, having individual functions, not specified or included elsewhere in this chapter; parts thereof: Other machines and apparatus: Other: Other.”

Whether the subject device is properly classified under heading 8419, HTSUS, as an electrical machine for the treatment of materials by a process involving a change of temperature, or under heading 8543, HTSUS, as an electrical machine or apparatus, having an individual function, not specified or included elsewhere in this chapter?

This matter is protestable under 19 U.S.C. 1514(a)(2) as a decision on classification. The protest was timely filed on April 17, 2023, within 180 days of liquidation, pursuant to 19 U.S.C. 1514(c)(3). Further Review of Protest No. 1703-23-115544 is properly accorded pursuant to 19 CFR § 174.24(b), as this protest is alleged to involve questions of law or fact that have not been ruled upon by the Commissioner of CBP or his designee or by the customs courts.

Classification under the HTSUS is in accordance with the General Rules of Interpretation (“GRIs”). GRI 1 provides that the classification of goods will be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. If a good cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 will then be applied in order. GRI 6 provides that classification of goods at the subheading level will be determined according to the terms of those subheadings and any related subheading notes and, mutatis mutandis, to the preceding GRIs on the understanding that only subheadings at the same level are comparable.

The following HTSUS provisions are under consideration:

8419 Machinery, plant or laboratory equipment, whether or not electrically heated (excluding furnaces, ovens and other equipment of heading 8514), for the treatment of materials by a process involving a change of temperature such as heating, cooking, roasting, distilling, rectifying, sterilizing, pasteurizing, steaming, drying, evaporating, vaporizing, condensing or cooling, other than machinery or plant of a kind used for domestic purposes; instantaneous or storage water heaters, nonelectric; parts thereof

Note 2(A)(v) to Chapter 84, HTSUS, provides that heading 8419 does not cover “[M]achinery, plant or laboratory equipment, designed for mechanical operation, in which a change of temperature, even if necessary, is subsidiary.”

The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) constitute the official interpretation of the Harmonized System at the international level. While not legally binding, the ENs provide a commentary on the scope of each heading of the HTS and are thus useful in ascertaining the proper classification of merchandise. It is CBP’s practice to follow, whenever possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89-90, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The EN to heading 84.19 provides, in relevant part:

[T]the heading covers machinery and plant designed to submit materials (solid, liquid or gaseous) to a heating or cooling process in order to cause a simple change of temperature, or to cause a transformation of the materials resulting principally from the temperature change (e.g., heating, cooking, roasting, distilling, rectifying, sterilising, pasteurising, steaming, drying, evaporating, vaporising, condensing or cooling processes). But the heading excludes machinery and plant in which the heating or cooling, even if essential, is merely a secondary function designed to facilitate the main mechanical function of the machine or plant, e.g., machines for coating biscuits, etc., with chocolate, and conches (heading 84.38), washing machines (heading 84.50 or 84.51), machines for spreading and tamping bituminous road-surfacing materials (heading 84.79).

As heading 8543, HTSUS, provides for “[E]lectrical machines and apparatus, having individual functions, not specified or included elsewhere in this chapter; parts thereof,” the initial determination is whether the subject merchandise is prima facie classifiable in heading 8419, HTSUS.

Heading 8419, HTSUS, provides for “[M]achinery, plant or laboratory equipment… for the treatment of materials by a process involving a change of temperature such as … sterilizing….” Note 2(A)(v) to Chapter 84, HTSUS, set forth supra, states that heading 8419, HTSUS, excludes “machinery, plant or laboratory equipment, designed for mechanical operation, in which a change of temperature, even if necessary, is subsidiary.” Therefore, to fall within the scope of heading 8419, HTSUS, the Paptizer must use heat (i.e., a change in temperature) as its primary method of sterilization.

Protestant submits that the subject device uses UVC light to provide radiant energy to break down the DNA cell wall structure of harmful microbes and features “environmental controls that utilize a heating element, fan, temperature control, humidity control, and UVC LEDs in conjunction with one another to achieve proper disinfection efficacy… .” While the Paptizer user manual confirms that UVC light is used in all three modes of operation to eliminate 98% of germs and bacteria, it specifies that heat is only used in “Auto Mode” (to dry items after washing) and in “Sanitizing Storage Mode” (to maintain optimal humidity and temperatures for storage). The user guide further specifies that the device’s peak operating temperature is 40° C, which falls below the 60° C temperature generally required for low-temperature sterilization without chemicals. See https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/low-temperature-sterilization.html (site last visited December 1, 2025)). The foregoing design features indicate that the Paptizer primarily uses UVC light for sterilization (which does not involve a change in temperature), and the use of heat is ancillary to that process. This finding is supported by research indicating that UV sterilization is more efficient in environments with low humidity and at room temperature (see “Shedding a Light on Ultraviolet-C Technologies in the Hospital Environment” at https://pmc.ncbi.nlm.nih.gov/articles/PMC9769028/ (site last visited 8 July, 2025). Accordingly, the subject merchandise is precluded from classification in heading 8419, HTSUS, by application of Chapter 84 Note 2(A)(v).

The subject merchandise is described by heading 8543, HTSUS, in that it is an electrical machine, with an independent function as a sanitization device, that is not provided for in heading 8419, HTSUS, or elsewhere in the Nomenclature. As such, the subject Paptizer is prima facie classified in heading 8543, specifically subheading 8543.70.98, HTSUS, which provides for “[E]lectrical machines and apparatus, having individual functions, not specified or included elsewhere in this chapter; parts thereof: Other machines and apparatus: Other: Other.” See New York Ruling Letter (“NY”) N302623, dated March 6, 2019 (UV CPAP cleaner); NY N025969, dated April 30, 2008 (UV-C Light Sanitizer), and; NY N252928, dated May 13, 2014 (UVC automatic room disinfection system), the foregoing classified under heading 8543, HTSUS.

Lastly, we do not find regarding Protestant’s argument that the Paptizer is not a domestic appliance germane to the instant classification analysis.

By application of GRI’s 1 and 6, the subject merchandise is classified under heading 8543, specifically subheading 8543.70.98, HTSUS, which provides for “[E]lectrical machines and apparatus, having individual functions, not specified or included elsewhere in this chapter; parts thereof: Other machines and apparatus: Other: Other.” The column one, general rate of duty is 2.6 percent ad valorem.

Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 8543.70.98, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. As such, the subject merchandise is covered by heading 9903.88.02, HTSUS, in addition to subheading 8543.70.98, HTSUS, listed above.

This ruling does not address the applicability of any additional duties that may apply to the goods discussed herein. Likewise, duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at www.usitc.gov.

You are instructed to notify the protestant of this decision no later than 60 days from the date of this decision. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to this notification. Sixty days from the date of the decision, the Office of Trade, Regulations and Rulings will make the decision available to CBP personnel and the public on the Customs Rulings Online Search System (CROSS) at https://rulings.cbp.gov/, or other methods of public distribution.

Sincerely, for Yuliya A. Gulis, Director Commercial and Trade Facilitation Division