NY N002961 - The tariff classification of ZYDERM collagen implant and ZYPLAST collagen implant - United States International Trade Commision Rulings

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NY N002961

December 4, 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 ZYDERM collagen implant and ZYPLAST collagen implant

Dear Ms. Fuller:

In your letter dated November 6, 2006, you requested a tariff classification ruling.ZYDERM collagen implant is composed of a highly purified bovine dermal collagen that is dispersed in a phosphate-buffered saline containing 0.3 percent lidocaine. ZYDERM collagen implant is available in two strengths: ZYDERM1 and ZYDERM2. ZYDERM1 contains 35-mg/ml bovine dermal collagen, whereas, ZYDERM2 contains 65-mg/ml bovine dermal collagen. Both forms are packaged in ready to use sterile disposable syringes with an ADG needle of 1 mm exposure length. ZYDERM collagen implant, administered by a physician, is injected into the dermis for the correction of contour deficiencies of this soft tissue. After injection, the implant undergoes syneresis, and as the saline is lost, the suspended collagen condenses into a soft cohesive network of fibers. This network of fibers is responsible for restoring skin contour.

ZYPLAST collagen implant is composed of highly purified bovine dermal collagen that is lightly cross-linked with glutaraldehyde and dispersed in a phosphate-buffered physiological saline containing 0.3 percent lidocaine. ZYPLAST collagen implant is packaged in a 35-mg/ml sterile disposable syringe with an ADG needle of 2 mm exposure length. ZYPLAST collagen implant, administered by a physician, is injected into mid to deep dermal tissues for correction of contour deficiencies. After injection, the suspended collagen forms a soft cohesive network of fibers, which is responsible for restoring contour.

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”. Classification in heading 3004 is precluded.

The applicable subheading for ZYDERM collagen implant and ZYPLAST 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,

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