The tariff classification of enzyme preparations imported in bulk from Germany

N257529 December 22, 2014 CLA-2-35:OT:RR:NC:2:235 CATEGORY: Classification TARIFF NO.: 3507.90.7000 Ms. Debra Stern Sandler, Travis & Rosenberg, P.A. 1000 NW 57th Court, Suite 600 Miami, FL 33126 RE: The tariff classification of enzyme preparations imported in bulk from Germany Dear Ms. Stern: In your letter dated September 19, 2014, you requested a tariff classification ruling on behalf of Roche Diagnostics Operations, Inc. We apologize for the delay as the information was sent to our laboratory for anlaysis. The first product called R1, consists of N-Tris(hydroxymethyl)methyl-3-aminopropanesulfonic acid (TAPS) buffer, creatinase, sacrosine oxidase, ascorbate oxidase, catalase, 2,4,6-triiodo-3-hydroxybenzoic acid (HTIB), detergents and preservative. According to our laboratory, R1 consists of a mixture of enzymes with other chemical substances. The second product, SR which you state is also known as R2, consists of N-Tris(hydroxymethyl)methyl-3-aminopropanesulfonic acid (TAPS) buffer, creatininase, peroxidase, 4-aminophenazone, potassium hexacyanoferrate (II), a detergent, and a preservative. According to our laboratory, SR consists of a mixture of enzymes with other chemical substances. You state that R1 and SR will be imported separately in 10 liter bulk containers rather than together in measured amounts in a diagnostic kit. Subsequent to importation, they will be used to make up an enzymatic colorimetric assay for the determination of creatinine concentration in human serum, plasma and urine on COBAS INTEGRA systems. The applicable subheading for the R1 and SR imported in bulk will be 3507.90.7000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Enzymes; prepared enzymes not elsewhere specified or included: Other.” The rate of duty will be free. 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 on World Wide Web at http://www.usitc.gov/tata/hts/. In your letter you suggest classification under subheading 3822.00.5090 which provides for "Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 30.02 or 30.06: Other: Other." You believe that both products, R1 and SR, are properly classifiable as diagnostic reagents of heading 3822, even when imported separately in bulk form. In their condition as imported, neither R1 nor S2 contain all of the necessary components to perform the assay for creatinine. By themselves, they are not capable of being used for the detection of creatinine in human serum and do not undergo an observable or measurable change. Based upon the forgoing, R1 and SR are precluded from heading 3822 and will be classified elsewhere. This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.gov. This ruling is being issued under the provisions of Part 177 of the Customs 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 Heading 3507, contact National Import Specialist Paul Hodgkiss at [email protected]. If you have any questions regarding Heading 3822, contact National Import Specialist Judy Lee at [email protected]. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division