CLA-2 RR:CFT:TCM W968424ptl
Ms. Susan Blancato
Vice President
Genotec Nutritionals, Inc.
450 Commack Road
Deer Park, NY 11729
RE: Enzogenol® Pine Bark Extract
Dear Ms. Blancato:
This is in response to your letters dated June 19 and July 31, 2006, to the Customs and Border Protection, National Commodity Specialist Division, in New York, requesting a binding ruling on the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of a product you refer to as Enzogenol® Pine Bark Extract from the bark of the Pinus radiata tree. Your letters were forwarded to this office for response.
FACTS:
The product is said to be manufactured from screened fresh bark from the Pinus radiata tree that has been reduced by milling to a uniform size. The milled bark is then placed in an extraction vessel and extracted for a set period of time with pure hot water. This process results in a liquor and a residue. Non-soluble suspended particles are then separated from the liquor using decanting and separating techniques. Among the materials you provided is a description of the process that is utilized. That process states that the filtered liquor is then further processed by either ultra-filtration, reverse osmosis, or a combination of both
processes. This stage is to fractionate the dissolved components in the filtrate by molecular size and shape. Both the reverse osmosis unit and the ultra-filtration unit are fitted with membranes with micropores sized according to pre-determined cut-off molecular sizes. The purpose of these steps is to allow the capture of the desired proanthocyanidins, along with similar sized dissolved compounds, in a concentrated solution. The proanthocyanidins are then recovered from the concentrated solution by removing the water by either freeze drying or reverse osmosis. The resultant product is brown colored crystalline flakes which contain all the desired proanthocyanidins.
In your submission, you suggest classification of the Enzogenol® Pine Bark Extract in subheading 1302.19.9040, HTSUS, which provides for “vegetable saps and extracts, other, other, other.” The product will be imported in bulk. After importation, the powder will be put in capsules and sold to the consumer as a food supplement.
ISSUE:
What is the classification of Enzogenol® Pine Bark Extract?
LAW AND ANALYSIS:
Merchandise is classifiable under the HTSUS in accordance with the General Rules of Interpretation (GRIs). The systematic detail of the HTSUS is such that most goods are classified by application of GRI 1, that is, according to the terms of the headings of the tariff schedule and any relative Section or Chapter Notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs may then be applied in order.
In understanding the language of the HTSUS, the Harmonized Commodity Description and Coding System Explanatory Notes may be utilized. The Explanatory Notes (ENs), although not dispositive or legally binding, provide a commentary on the scope of each heading of the HTSUS, and are the official interpretation of the Harmonized System at the international level. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The HTSUS subheadings under consideration are as follows:
1302 Vegetable saps and extracts; pectic substances, pectinates and pectates; agar-agar and other mucilages and thickeners, whether or not modified, derived from vegetable products:
Vegetable saps and extracts:
* * *
1302.19 Other:
* * *
Other
* * *
1302.19.9040 Other . . . . .
3824 Prepared binders for foundry molds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included:
* * *
Other:
* * *
Other.
We note that the product under consideration, Enzogenol® extract, has been described by the importer as being produced using a standard extraction process whereby the desired components of New Zealand grown pine bark are removed from the powdered bark. Product information you provided states that the Enzogenol® extract is prepared by extraction of fresh pine bark with an aqueous solution. The extract is then dried and standardized to a proanthocyanidin content of 76 - 87%. Additional flavonoids may also be present in concentrations of between 10 – 15%. These are types of oxygen-containing vegetable pigments, of a class generally referred to as “flavonoids” that are believed to have antioxidant properties that offer positive health benefits. The process of standardizing an extract is one which purifies it of undesirable components that naturally occur in the article (in this instance, the pine bark) from which the extract has been obtained.
The process that has been used to obtain the concentrations of proanthocyanidins in the Enzogenol® extract is extremely elaborate and specially designed to remove the specifically target components from the whole plant (bark) concentrate.
The subheading you have proffered for classification of the product is subheading 1302.19.9040.
The EN 13.02 states, in pertinent part, the following:
(A) Vegetable saps and extracts.
The heading covers saps and extracts (vegetable products usually obtained by natural exudation or by incision, or extracted by solvents), provided that they are not specified or included in more specific headings of the Nomenclature.
CBP has consistently held that extensive processing of an extract based article which transforms it from a raw material into an article ready for use as, or in, some more specialized product will render it ineligible for classification in heading 1302. (See HQ 960607, dated July 31, 1998, citing HQ 953679, dated February 3, 1994)
Discussing the criteria for classification of standardized extracts and their eligibility for classification in heading 1302, HTSUS, CBP stated in HQ 967972, dated March 2, 2006:
However, there appears to be a limit on the degree and extent of purification that can occur for the product to remain in heading 1302. For instance, EN 13.02, explicitly excludes certain refined extracts of opium, quassia amare, papaw juice, and cashew nut shell liquid, once the refining process concentrates a certain group of chemical compounds to a particular point. Hence, poppy straw concentrates containing more than 50% alkaloids are excluded from heading 1302. Likewise, quassin, a chemical compound extracted and refined from the quassia amara shrub is classified in Chapter 29. Papain enzyme, once purified from the extraction process of papaw juice, is classified as an enzyme of Chapter 37. And polymers extracted and refined from cashew nut shell liquid are classified in Chapter 39 as polymers.
In HQ 967972, CBP continued: “Following the reasoning in our prior rulings, and the tenet that we must classify goods as imported, we note that the leucoanthocyanin consists of over 90% mixtures of oligomeric proanthocyanidins (OPCs) and the silymarin consists of at least 80% of isomers of silymarin. Therefore, silymarin and leucoanthocyanin are relatively pure chemical products and cannot be classified simply as extracts.”
Here, with the product Enzogenol®, we have a product that has been highly extracted and standardized so that it contains the desired constituent of
the raw pine bark, proanthocyanidin, in concentrations of 76% or greater to the exclusion of other constituents. The extraction procedure involves taking filtered liquor and then further processing it by either ultra-filtration, reverse osmosis, or a combination of both processes. This is to fractionate the dissolved components in the filtrate by molecular size and shape. Both the reverse osmosis unit and the ultra-filtration unit are fitted with membranes with micropores sized according to pre-determined cut-off molecular sizes. The purpose of these steps is to allow you to create a product that contains a high concentration of the desired components of the starting material to the exclusion of unwanted components. This processing results in an article that does not include all constituents of the starting material in their relative proportions. Thus, the Enzogenol® has been processed to become a dietary supplement, clearly a specialized, not general, purpose. As such, it is not an extract classified in heading 1302, HTSUS.
The product, as described above, it has been highly processed to achieve a concentration of dimers, other oligomers, and polymers of procyanidin. This processing has resulted in what is a mixture of chemicals. If the Enzogenol® consisted of a single oligomer, it would be a product of Chapter 29, HTSUS, which covers pure chemical products. However, it is not. Mixtures of chemicals not provided for elsewhere in the tariff are classified in Chapter 38, HTSUS, which provides for “Miscellaneous Chemical Products.” Within Chapter 38, we turn to subheading 3824, HTSUS, which provides for “chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products).” Because of the composition of the product, we turn to subheading 3824.90.28, HTSUS, which provides for "Prepared binders for foundry molds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Mixtures containing 5 percent or more by weight of one or more aromatic or modified aromatic substances: Other." We consider this the correct classification for Enzogenol® because that product is purified from the plant matter well beyond that of an extract, yet it does not contain a separate chemically defined compound, or isomers of such a compound, as necessary for classification in Chapter 29, HTSUS.
HOLDING:
Enzogenol®, an extract of New Zealand pine bark, is classified in subheading 3824.90.2800, HTSUS, which provides for "Prepared binders for foundry molds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Mixtures containing 5 percent or more by weight of one or more aromatic or modified aromatic substances: Other." The column 1, general rate of duty under the 2006 HTSUS is 6.5% ad valorem, with reference to headings in Chapter 99, HTSUS.
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 the World Wide Web at www.usitc.gov.
Sincerely,
Gail A. Hamill, Chief
Tariff Classification and Marking Branch