OT:RR:NC:N3:140
Ying Wang
Concord & Sage P.C.
1360 Valley Vista Dr., Suite 140
Diamond Bar, CA 91765
RE: The country of origin and marking of a hand sanitizer
Dear Ying Wang:
In your letter dated December 4, 2025, you requested a country of origin ruling on a hand sanitizer for duty
and marking purposes on behalf of your client, Cosmax (Xiamen) Import & Export Co., Ltd.
The subject product is described as a hand sanitizer in gel form used to gently cleanse the skin. The product
is packaged in a plastic bottle with a screw cap.
The hand sanitizer contains 62 percent alcohol. The other ingredients consist of water, glycerin, acrylates,
T-butyl alcohol, aminomethyl propanol, aloe barbadensis leaf extract, tocopheryl acetate, denatonium
benzoate, FD&C Yellow No. 5 and FD&C Blue No. 1. The alcohol that comprises 62 percent of the product
will be sourced from Vietnam, and the other ingredients will be sourced from various countries including
Vietnam, Malaysia, the United States, and India.
The raw materials will be sent to either Malaysia or Vietnam. There, they will be weighed, homogenized, and
blended under controlled conditions to produce a stable bulk, and then combined with high shear mixing
operations using a mixing machine. The formulation will then be bulk tested for pH, microbial content, and
stability. After testing, the bulk formulation will be sent to China. In China, it will be diluted with water,
followed by the addition of colorants and fragrance, then subjected to high-shear homogenization. The
product will then be filled into retail containers, labeled, and packaged in cartons for export to the United
States. All packaging materials originate in China.
Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every
article of foreign origin 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. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to
know by an inspection of the marking on the imported goods the country of which the goods is the product.
The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by
knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should
influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940).
Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the
country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP
Regulations (19 CFR 134.1(b)), defines “country of origin” as the country of manufacture, production, or
growth of any article of foreign origin entering the United States. Further work or material added to an article
in another country must effect a substantial transformation in order to render such other country the “country
of origin” within the meaning of the marking laws and regulations.
A substantial transformation occurs when, as a result of manufacturing process, a new and different article
emerges, having a distinct name, character or use, which is different from that originally possessed by the
article or material before being subjected to the manufacturing process. See United States v.
Gibson-Thomsen Co., Inc., 27 C.C.P.A. 267 (C.A.D. 98) (1940).
You suggest that the country of origin is either Malaysia or Vietnam where the ingredients are sent to be
weighed, homogenized, and blended to produce the stable bulk. We disagree. In this case, we find that the
processing of the alcohol with the other ingredients does not result in a substantial transformation. Therefore,
it is our opinion that the country of origin of the hand sanitizer will be determined based on the alcohol
component sourced from Vietnam, which imparts the identity of the finished hand sanitizer. Accordingly, the
country of origin of the subject hand sanitizer will be Vietnam.
In your letter you state, “It is proposed that the retail container be marked as ‘Product of Malaysia’ or
‘Product of Vietnam.’ Alternatively, the company is considering marking the product ‘Product of
Malaysia/Bottled in China’ or ‘Product of Vietnam/Bottled in China.’ If a U.S. address appears on the
packaging, the origin marking will be stated in close proximity and comparable size in accordance with 19
C.F.R. §134.46.” We find that marking the retail container as “Product of Vietnam” or “Product of
Vietnam/Bottled in China” is acceptable.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are
administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and
Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by
visiting their website at www.fda.gov.
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 Merari Ortiz at [email protected].
Sincerely,
(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division