The tariff classification of CosmoDerm( human base collagen implant and CosmoPlast( human base collagen implant

N003355 December 14, 2006 CLA-2-33:RR:E:NC:2:240 CATEGORY: Classification TARIFF NO.: 3304.99 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive Irvine, CA 92612 RE: The tariff classification of CosmoDerm( human base collagen implant and CosmoPlast( human base collagen implant Dear Ms. Fuller: In your letter dated November 13, 2006, you requested a tariff classification ruling. CosmoDerm( and CosmoPlast( are dermal fillers approved for the correction of facial wrinkles, acne scars, and other soft tissue contour deficiencies, as well as for the restoration of the lip border. CosmoDerm( collagen implant is composed of highly purified human-base collagen that is dispersed in a phosphate-buffered physiological saline and 0.3 percent lidocaine. CosmoDerm(human base collagen implant is available in two forms CosmoDerm(1 and CosmoDerm(2. Both forms are marketed in six single 1.0 ml disposable syringes with six sterile ADG( needles and two standard 30G needles. CosmoDerm(1 contains 35 mg/mL of the purified human-base collagen, whereas CosmoDerm(2 contains almost twice the collagen concentration. CosmoDerm( collagen implant, administered by a physician, is injected into the collagen layer just below the surface of the skin, and is used to fill unwanted lines, wrinkles, and restore the border of the lip. CosmoPlast( collagen implant is composed of cross-linked purified human-base collagen that is dispersed in a phosphate-buffered physiological saline, pH 7.2 and 0.3 percent lidocaine. CosmoPlast( is marketed in six single 1.0 ml disposable syringes with six sterile ADG( needles and two standard 30G needles. CosmoPlast( collagen implant, administered by a physician, is indicated to treat skin depressions that require a stronger regiment. You recommend that the classification of both products falls in 3004.90, HTSUS, which provides for Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. Merchandise is classifiable under the Harmonized Tariff Schedule (HTS) in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that classification shall be determined according to the terms of the headings and any relative Section or Chapter Notes. The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) are the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTS. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 August 23, 1989). The Explanatory Notes to heading 3304 (A)(3) page 619 provides, in part, for “Other beauty or make-up preparations and preparations for the care of the skin (other than medicaments), …and injectable intracutaneous gels for wrinkle elimination and lip enhancement (including those containing hyaluronic acid)” (emphasis added). A product similar to the instant merchandise was reviewed by the Harmonized System Committee 30th Session (November 2002) at the World Customs Organization. A classification opinion was written on: “An injectable intracutaneous gel put up in measured doses in packings for retail sale; in a box containing a 1 ml syringe of colourless glass and a needle in blister pack; in two dosages 0.4 or 0.7 ml. It is used for wrinkle correction and lip enhancement via injection into the skin or lips. The gel is supplied in glass syringes and consists of: water (1 ml), sodium chloride (9 mg), hyaluronic acid (20 mg), sodium phosphate monobasic, and sodium phosphate dibasic. Hyaluronic acid is biosynthetically produced by bacterial fermentation and stabilized.” The injectable intracutaneous gel put up in measured doses in packings for retail sale was classified in heading 3304, which provides for Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparation. Classification in heading 3004 was precluded. The applicable subheading for CosmoDerm( collagen and CosmoPlast( collagen implant will be 3304.99, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations: Other. 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 the ruling, contact National Import Specialist Stephanie Joseph at 646-733-3268. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division