MAR-2:OT:RR:NC:N4:422
Ms. Hyeyeon Lee
Shinhan Customs Services Co. Ltd
704, Nonhyeon-ro, Gangnam-gu
Seoul 06052
South Korea
RE: The country of origin marking of three breast pump accessory kits
Dear Ms. Lee:
This is in response to your letter dated May 20, 2026 requesting a ruling on whether the proposed marking of
three breast pump accessory kits described below is an acceptable country of origin marking. Product photos
and descriptions were submitted for our review. Item numbers were not provided.
The items concerned are three breast pump accessory kits as follows:
1. Luna Resupply Kit
2. NB Resupply Kit
3. Collection Kit
Each 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, you
stated that all components of each kit are made in South Korea except for the airflow tube. The airflow tube
is made in China and imported into South Korea for inclusion in the accessory kit. Each bag is labeled with a
sticker, or printed inside the bag, or printed in ink on the retail packaging as “Made in Korea.” The airflow
tube 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 airflow
tube may be excepted from individual marking.
When determining the country of origin for purposes of marking, the substantial transformation analysis is
applicable. The test for determining whether a substantial transformation will occur is whether an article
emerges from a process with a new name, character or use, different from that possessed by the article prior
to processing. See Texas Instruments Inc. v. United States, 69 C.C.P.A. 151 (1982). In order to determine
whether a substantial transformation has occurred, CBP considers the totality of the circumstances and makes
such 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 in
commercial designation or identity, fundamental character, or commercial use. A determinative issue is the
extent of the operations performed and whether the materials lose their identity and become an integral part
of 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, the
determinative issue is the extent of operations performed and whether the parts lose their identity and become
an 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 to
complex or meaningful, will generally not result in a substantial transformation. Factors which may be
relevant in this evaluation may include the nature of the operation (including the number of components
assembled), 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 combining
process is a minor one which leaves the identity of the article intact, a substantial transformation has not
occurred. Uniroyal, Inc. v. United States (“Uniroyal”), 3 CIT 220, 542 F. Supp. 1026 (1982), aff’d 702 F. 2d
1022 (Fed. Cir. 1983).
Although we agree that the essential character of each kit is imparted by the South Korean component, the
plastic bottle, a substantial transformation does not occur to the breast pump accessory kits at issue. In this
case, most components of each kit are manufactured in South Korea. The airflow tube component is
manufactured in China and imported into South Korea for inclusion in the accessory kit. All components are
combined and packaged together into a retail accessory kit. No additional manufacturing processes are
performed 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, a
substantial transformation has not occurred.
The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless
excepted, every article of foreign origin (or its container) imported into the United States shall be marked in a
conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will
permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the
country of origin of the article.
Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements
and exceptions of 19 U.S.C. 1304. Section 134.41(b), Customs Regulations (19 CFR 134.41(b)), mandates
that the ultimate purchaser in the United States must be able to find the marking easily and read it without
strain. Section 134.1(d), defines the ultimate purchaser as generally the last person in the United States who
will receive the article in the form in which it was imported. If an imported article is to be sold at retail in its
imported form, the purchaser at retail is the ultimate purchaser. In this case, the ultimate purchasers of the
breast 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 each
component, 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 as
identified 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 the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform 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 periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Dana L. Giammanco at [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division