The country of origin marking of three breast pump accessory kits

N361654June 15, 2026MAR-2:OT:RR:NC:N4:422
CATEGORY: MarkingMs. Hyeyeon LeeShinhan Customs Services Co. Ltd704, Nonhyeon-ro, Gangnam-guSeoul 06052South KoreaRE: The country of origin marking of three breast pump accessory kitsDear Ms. Lee:This is in response to your letter dated
May 20, 2026
requesting a ruling on whether the proposed marking ofthree breast pump accessory kits described below is an acceptable country of origin marking. Product photosand descriptions were submitted for our review. Item numbers were not provided.The items concerned are three breast pump accessory kits as follows:Luna Resupply KitNB Resupply KitCollection KitEach kit contains five components: a breast shield, a silicone valve, a backflow protector, a feeding bottle,and an airflow tube. They are all packaged together in a polyethylene (PE) bag. In your submission, youstated that all components of each kit are made in South Korea except for the airflow tube. The airflow tubeis made in China and imported into South Korea for inclusion in the accessory kit. Each bag is labeled with asticker, or printed inside the bag, or printed in ink on the retail packaging as “Made in Korea.” The airflowtube is marked “Made in China” and secured with adhesive tape.In your request, you inquired if the country of origin marking would be “Made in Korea,” and the airflowtube may be excepted from individual marking.When determining the country of origin for purposes of marking, the substantial transformation analysis isapplicable. The test for determining whether a substantial transformation will occur is whether an articleemerges from a process with a new name, character or use, different from that possessed by the article priorto processing. See Texas Instruments Inc. v. United States, 69 C.C.P.A. 151 (1982). In order to determinewhether a substantial transformation has occurred, CBP considers the totality of the circumstances and makessuch determinations on a case-by-case basis.
CBP has stated that a new and different article of commerce is an article that has undergone a change incommercial designation or identity, fundamental character, or commercial use. A determinative issue is theextent of the operations performed and whether the materials lose their identity and become an integral partof the new article. This determination is based on the totality of the evidence. See National Hand Tool Corp.v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).In determining whether the combining of parts or materials constitutes a substantial transformation, thedeterminative issue is the extent of operations performed and whether the parts lose their identity and becomean integral part of the new article. Belcrest Linens v. United States, 573 F. Supp. 1149 (Ct. Int’l Trade 1983),aff’d, 741 F.2d 1368 (Fed. Cir. 1984). Assembly operations that are minimal or simple, as opposed tocomplex or meaningful, will generally not result in a substantial transformation. Factors which may berelevant in this evaluation may include the nature of the operation (including the number of componentsassembled), the number of different operations involved, and whether a significant period of time, skill,detail, and quality control are necessary for the assembly operation. If the manufacturing or combiningprocess is a minor one which leaves the identity of the article intact, a substantial transformation has notoccurred. Uniroyal, Inc. v. United States (“Uniroyal”), 3 CIT 220, 542 F. Supp. 1026 (1982), aff’d 702 F. 2d1022 (Fed. Cir. 1983).Although we agree that the essential character of each kit is imparted by the South Korean component, theplastic bottle, a substantial transformation does not occur to the breast pump accessory kits at issue. In thiscase, most components of each kit are manufactured in South Korea. The airflow tube component ismanufactured in China and imported into South Korea for inclusion in the accessory kit. All components arecombined and packaged together into a retail accessory kit. No additional manufacturing processes areperformed on the airflow tube after importation into South Korea other than inclusion in the retail packaging.The South Korean and Chinese components retain their separate identities when combined together. Thus,the combining process of components is a minor one, which leaves the identity of the article intact, asubstantial transformation has not occurred.The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unlessexcepted, every article of foreign origin (or its container) imported into the United States shall be marked in aconspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) willUnited Statespermit, in such a manner as to indicate to the ultimate purchaser in the the English name of thecountry of origin of the article.Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirementsand exceptions of 19 U.S.C. 1304. Section 134.41(b), Customs Regulations (19 CFR 134.41(b)), mandatesthat the ultimate purchaser in the United States must be able to find the marking easily and read it withoutstrain. Section 134.1(d), defines the ultimate purchaser as generally the last person in the United States whowill receive the article in the form in which it was imported. If an imported article is to be sold at retail in itsimported form, the purchaser at retail is the ultimate purchaser. In this case, the ultimate purchasers of thebreast pump accessory kits are the consumers who purchase the kits at retail.Accordingly, the breast pump accessory kits must be marked to specify the country of origin of eachcomponent, for example “Breast shield, silicone valve, backflow protector, and feeding bottle made in Korea,airflow tube made in China,” or its equivalent.The holding set forth above applies only to the specific factual situation and merchandise description asidentified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.Additionally, we note that the material facts described in the foregoing ruling may be subject to periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Dana L. Giammanco at [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division