CLA-2:RR:CR:GC 965396 HEF

Port Director
U.S. Customs Service
477 Michigan Ave.
Suite 200
Detroit, MI 48226

RE: Protest 3801-01-100303; fish oil capsules

Dear Port Director:

This is our decision on Protest 3801-01-100303 filed against your classification under the Harmonized Tariff Schedule of the United States (HTSUS), of five types of fish oil capsules. The entries were liquidated on March 2, 2001, and the protest timely filed on May 4, 2001.

FACTS: The samples submitted are five types of Omega 3 capsules identified as Omega 3 TG Balanced Health (A8914), Omega 3 EPA/DHA TG Heart Health (A8919), Omega 3 DHA TG Brain Health (A8920), Omega 3 DHA TG Mother’s Health (A8921), and Omega 3 EPA Joint Health (A9693). Each product consists of a gelatin capsule filled with approximately 99 percent fish oil, with added vitamin E.

Protestant submitted a letter describing the manufacturing process for the fish oils dated June 23, 2000. The starting material is crude fish oil, which can originate from a variety of fish species, including sardines, anchovies, or menhaden. When purchased by the importer, the crude oil has been refined to remove solid material, but has not been deodorized, distilled or further concentrated. The manufacturing process performed in Canada includes deodorization, ethylation, distillation, re-esterification, further distillation, bleaching, filtration, mixing, drumming, soft-gel encapsulation, drying and packaging. The mixing operation includes the addition of mixed tocopherols from Canada and natural vitamin E from the United States. According to the protestant, the glyceride content of the oils upon entry into the United States is 90 percent triglycerides, 7 percent diglycerides and 2 percent mono-glycerides. There are also 2-3 milligrams of mixed tocopherols.

The protestant contends that classification of these products should be in subheading 1516.10, HTSUS, as animal fats and oils and their fractions. You classified the products in subheading 2106.90.9998, HTSUS, as food preparations not elsewhere specified or included.

Samples were submitted to the Customs Laboratory for analysis. The laboratory reports (#NY 2 2000 21310, #NY 2 2000 21311, #NY 2 2000 21312, #NY 2 2000 21313, and #NY 2 2000 21278) all dated October 27, 2000, state that the samples are a mixture of glycerides (mono-, di-, triglycerides).


Whether the subject merchandise constitutes animal fats and oils and their fractions, classifiable in subheading 1516.10, HTSUS, or whether they fall into the basket provision, heading 2106, HTSUS, which provides for food preparation not elsewhere specified or included.


Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that articles are to be classified by the terms of the headings and relative Section and Chapter Notes. For an article to be classified in a particular heading, the heading must describe the article, and not be excluded therefrom by any legal note. In the event that 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 understanding the language of the HTSUS, the Harmonized Commodity Description and Coding System Explanatory Notes (ENs) may be utilized. ENs, though not dispositive or legally binding, provide commentary on the scope of each heading of the HTSUS, and are the official interpretation of the Harmonized System at the international level. Customs believes the ENs should always be consulted. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The HTSUS provisions under consideration are as follows:

1516 Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinized, whether or not refined, but not further prepared: 1516.10.00 Animal fats and oils and their fractions

* * *

2106 Food preparations not elsewhere specified or included: 2106.90 Other: [Other: Other: Other: Other:] 2106.90.99 Other: 2106.90.9998 Other The introductory language of EN 2106 states: “Provided that they are not covered by any other heading of the Nomenclature, this heading covers: [a list of exemplars follows]” [Emphasis in original]. Therefore, before classifying the products in Chapter 21, we must first determine whether they can be classified in any other heading.

The General ENs to Chapter 15, page 117, state in part: (A) This Chapter covers: (1) Animal or vegetable fats and oils, whether crude, purified or refined or treated in certain ways (e.g., boiled, sulphurised or hydrogenated).

The ENs on page 118, define the term “animal or vegetable fats and oils” as “esters of glycerol with fatty acids (such as palmitic, stearic and oleic acids).” These glycerol esters are known as triglycerides. Hawley’s Condensed Chemical Dictionary (Van Nostrand Reinhold, 1993), defines a triglyceride as “Any naturally occurring ester of a normal acid (fatty acid) and glycerol. The chief constituents of fats and oil….” The ENs on page 119, further provide that fats and oils of Chapter 15 may also be subjected to refining processes: “These headings cover crude fats and oils and their fractions, as well as those which have been refined or purified, e.g., by clarifying, washing, filtering, decolourising, deacidifying or deodorizing.” EN 1516 describes re-esterified fats and oils:

(B) Inter-esterified, re-esterified or elaidinized fats and oils. (2) Re-esterified fats and oils (also called esterified fats and oils) are triglycerides obtained by direct synthesis from glycerol with mixtures of fatty acid or acid oils from refining. The arrangement of the fatty acid radicals in the triglycerides is different from that normally found in natural oils.

Hence, item (2) describes a process of producing “triglycerides” by direct synthesis from glycerol with mixtures of fatty acids or acid oils. After the inter-esterified, trans-esterified, or re-esterified processes, the products are still fats and oils. They retain the chemical structure of a triglyceride.

The booklet Food Fats and Oils, 8th ed., (The Institute of Shortening and Edible Oils, Inc., Washington, DC, 1999) describes fats and oils on page 1 as: “…chemical units commonly called ‘triglycerides’ resulting from the combination of one unit of glycerol with three fatty acids…Triglycerides are the predominant component of most food fats and oils. The minor components include mono-and diglycerides, free fatty acids, phosphatides, sterols, fatty alcohols, fat soluble vitamins, and other substances.” The same publication on page 2 states that mono-and diglycerides are mono-and diesters of fatty acids and glycerol, which occur naturally in very minor amounts in both animal fats and vegetable oils. Turning to the instant fish oil capsules, the Customs lab reports indicate that the triglyceride levels of each product are not characteristic of a fat or oil. According to the lab analysis, the liquids in each type of capsule are a mixture of glycerides (mono-, di-, and triglycerides) and not a re-esterified triglyceride product. Protestant also indicates that the liquids have a chemical composition of 90 percent triglycerides, 7 percent diglycerides, and 2 percent monoglycerides. While protestant contends that these are normal amounts of di- and monoglycerides for an oil after the reesterification process, Bailey’s Industrial Fats and Oils, 3rd ed., (John Wiley & Sons, Inc., 1996), page 943 states: “The catalyzed reesterification of glycerol with fatty acids to form triglycerides can be readily brought to a stage where no mono- and a relatively small proportion of diglycerides remain.”

The chemical compositions of the subject products have been altered to a point where the merchandise is no longer consistent with the chemical composition of an oil. Too many di- and monoglycerides exist for the substance to be characterized as an oil. Thus, the products are not eligible for classification under heading 1516, HTSUS. See HQ 963166 dated December 11, 2001, wherein Customs found that for merchandise to be considered for classification in heading 1516, the article must be essentially a triglyceride.

Customs has found some fish oils in capsules subject to classification in Chapter 15, HTSUS. However, these products still retain the essential chemical composition and characteristics of oils. These products have only undergone encapsulation and the addition of Vitamin E.

HQ 964014, dated February 8, 2002, classified an encapsulated blend of anchovy and pilchard fish oils that were mixed with Vitamin E in subheading 1515.90.4090, HTSUS. In that case the competing provision was heading 2106, HTSUS. That heading was rejected because the product, despite encapsulation and the addition of Vitamin E, still maintained the essential characteristics of an oil. See also HQ 964015, dated January 31, 2002, and HQ 964804, dated February 19, 2002, which maintain that fish oils capsules are to be classified in Chapter 15 as long as they have not been chemically modified.

For the foregoing reasons, the goods are classified within heading 2106 as food preparations not elsewhere specified or included. In this regard, EN (16) to 2106 states that the heading includes:

[p]reparations, often referred to as food supplements, based [on] extracts from plants, fruit concentrates, honey, fructose, etc. and containing added vitamins.... These preparations are often put up in packagings with indications that they maintain general health or well-being....

Prepared food substances (whether in liquid or solid or capsule form) not elsewhere specified or included under other headings in the HTSUS, containing, for example, plant- and animal-based extracts and prepared specifically for health or nutritional purposes, are classified under heading 2106, HTSUS. In earlier rulings, Customs has classified such substances in Chapter 21. In HQ 084981, issued June 19, 1990, HQ 962323, issued February 3, 2000, and HQ 954142, issued October 5, 1993, Customs classified food preparations used for general health or well-being in heading 2106, HTSUS. Since these products are similarly marketed and no longer maintain the chemical compositions of oils, they are properly classified under GRI 1 in subheading 2106.90.9998, HTSUS, which provides for food preparations not elsewhere specified or included…other.


Under GRI 1, the subject fish oil capsules are classified in subheading 2106.90.9998, HTSUS, as food preparations not elsewhere specified or included…other.

The protest should be DENIED. In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.

Sixty days from the date of the decision the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at, by means of the Freedom of Information Act, and other methods of public distribution.


Myles B. Harmon, Acting Director
Commercial Rulings Division