MAR-2:OT:RR:NC:N3: 135
Tobias Bachofner
Institut Straumann AG
Peter Merian-Weg, 12 Basel 4002 Switzerland
RE: The country of origin marking of an angled abutment
Dear Mr. Bachofner:
This is in response to your letter, dated January 23, 2024, requesting a ruling on whether your proposed marking described below is an acceptable country of origin marking. Representative images of both current and proposed product labels of an angled abutment were submitted with your letter for review. Supplemental information including an image and video of the product packaged in retail form was provided by email, dated January 26 and January 29, 2024.
You state that your company exports dental implants and dental prosthetics, packaged in retail form, from Switzerland to the US-subsidiary. These products will then be sold to US customers, mainly dentists, dental technicians, and dental organizations, without repacking. They may be manufactured in Switzerland or other European countries (such as France and Germany). You plan to change the country of origin marking on the product labels.
The angled abutment is packed in the tray of a three-panel (one middle and two side panels) PET blister. The two side panels of the blister are foldable for logistical reasons. Both the current and proposed labels are affixed to the blister on the three panels.
One side panel label contains a QR code, the name and description of the product in English, date, a Straumann logo, a catalogue number symbol accompanied by number, and a batch code symbol accompanied by batch code. The other side panel contains three discrete sections of the label. The first and second sections are identical to each other including a catalogue number symbol accompanied by number, a batch code symbol accompanied by batch code, and the image logo of Straumann. The third section on the right of the bottom panel displays a symbol of an authorized representative in the European Community, a symbol consisting of “EC” “IMP” in individual boxes, the image logo of Straumann, and the representative’s name and address – “Etkon GmbH Lochhamer Schlag 6 DE-82166 Gräfelfing, Germany.”
The middle panel of the blister has the largest label section with the marking under consideration located on the bottom portion. The left column of the label section displays the product’s name and description in five different languages, the product quantity, the patent website, a symbol of instructions for use and website. The lower middle column contains four symbols representing single use only, prescription only, CE marking with reference number, and non-sterile. The right column contains Straumann logos, a medical device symbol, a catalogue number symbol accompanied by number, a batch code symbol accompanied by batch code, a date of manufacture symbol accompanied by date, and a country of origin symbol (in the shape of an inverted raindrop), followed by the ISO country code, such as “CH.” The bottom of the label section is printed on a green background with a symbol and the shipper’s name of and address - “Institut Straumann AG Peter Merian-Wg 12 CH-4002 Basel Switzerland.” You confirm that the shipper’s name and address remain the same but may or may not correspond to the manufacturer’s address since some products could be manufactured in other European countries. The current label used is identical except it has the phrase “Made in Switzerland.”
You ask whether it is acceptable country of origin marking if you forego the use of “made in xxx” for marking the country of origin on the product label and instead use a symbol indicating country of origin, accompanied by the official ISO country code, such as “CH,” or, alternatively, only spell out the country of origin, such as “Switzerland,” without an ISO code.
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 U.S. 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 U.S. the English name of the country of origin of the article.
As provided in section 134.41(b), Customs Regulations (19 CFR 134.41(b)), the country of origin marking is considered conspicuous if the ultimate purchaser in the U.S. is able to find the marking easily and read it without strain.
With regard to the permanency of a marking, section 134.41(a), Customs Regulations (19 CFR 134.41(a)), provides that as a general rule marking requirements are best met by marking worked into the article at the time of manufacture. For example, it is suggested that the country of origin on metal articles be die sunk, molded in, or etched. However, section 134.44, Customs Regulations (19 CFR 134.44), generally provides that any marking that is sufficiently permanent so that it will remain on the article until it reaches the ultimate purchaser unless deliberately removed is acceptable.
In Headquarters Ruling Letter (“HRL”) 735083, dated August 5, 1993, CBP determined that “‘NL’” is not an acceptable abbreviation for the Netherlands because it does not unmistakably indicate the country of origin to the ultimate purchaser.” Also, see HRL 562240, dated February 4, 2002 (denial of “AU” for Australia). Accordingly, using a symbol indicating the origin, accompanied by the official ISO country code, such as “CH,” is not an acceptable marking to indicate the country of origin of the product.
You also suggest the alternative marking – spelling out just the country of origin (e.g. “Switzerland,”) on the label. The phrase “made in” or “product of” is required in the case where the name of any locality other than the country or locality in which the article was manufactured appears on the article or its container and may mislead or deceive the ultimate purchaser. Section 134.46, CBP Regulations (19 C.F.R. 134.46), requires that in any case in which the words “United States,” or “American,” the letters “U.S.A.,” any variation of such words or letters, or the name of any city or locality in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced, appears on an imported article or its container, there shall appear, legibly and permanently, in close proximity to such words, letters, or name, and in at least a comparable size, the name of the country of origin preceded by “Made in,” “Product of,” or other words of similar meaning.
The purpose of Section 134.46 is to prevent the possibility of misleading or deceiving the ultimate purchaser as to the actual origin of the imported goods. In this case, we find that the name and address of the authorized representative in the European Community and the shipper’s name and address when it differs from the name and address of the manufacturer are potentially misleading to the ultimate purchaser as to the country of origin of the good and trigger the special marking requirements of 19 CFR 134.46. The company names and addresses on the label therefore should be accompanied by a statement which includes the name of the actual country of origin preceded by “Made in,” “Product of,” or other words of similar meaning in close proximity and in lettering of comparable size. Hence, the proposed marking of the label of the angled abutment in either case, described above, is not an acceptable country of origin marking pursuant to 19 U.S.C. 1304 and 19 CFR 134.
Customs has previously ruled that in order to satisfy the close proximity requirement of this regulation, the country of origin marking must appear on the same side(s) or surface(s) on which the name of the locality other than the country of origin appears. See Headquarters Ruling Letter (“HQ”) 708994, dated April 24, 1978. Although the two side panels of the blister are foldable for logistical reasons, they can be easily folded back to be a flat surface. Therefore, the three panels of the blister can be considered on the same side or surface. If the name of the country of origin preceded by “Made in,” “Product of,” or other words of similar meaning is marked in the location of the proposed origin marking and is in lettering of comparable size with the shipper’s address and the representative address, it will meet the special marking requirements of 19 CFR 134.46.
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 Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division