What's the HS Code for "Infant Formula"?

HQ H268218 March 17, 2016 OT:RR:CTF:TCM H268218 MAB CATEGORY: Classification TARIFF NO.: 1901.10.6000/.7500 Mr. Sean T. Murray Miller & Company P.C. 4929 Main Street Kansas City, MO 64112 RE: Classification of Enfamil Ready-to-Use Infant formula Dear Mr. Murray: This is in reply to your request submitted on June 2, 2015, to the Director, National Commodity Specialist Division, Customs and Border Protection (CBP), seeking a binding ruling concerning the classification of Enfamil infant formula under the Harmonized Tariff Schedule of the United States (HTSUS). In addition, you requested confidential treatment of certain specific information. Your request was forwarded to our office for reply. We have also considered the information presented in your correspondence dated June 17, 2015 and July 13, 2015, along with an email to staff of the National Commodity Specialist Division, dated July 22, 2015. FACTS: The merchandise, known as Enfamil infant formula, is a ready-to-use liquid formula for infants from birth to 12 months old packed in an 8-fl oz. sealed plastic bottle. The product is said to provide complete and balanced nutrition for infants’ first full year. It is composed of 82.7% water, 6.3% fluid skim milk (or 1.8% milk solids), 5.9% lactose, 3.2% vegetable oils blend, and less than 1%, each, of a variety of ingredients including galacto-oligosaccharide syrup, whey protein concentrate (80% protein), certain vitamins, minerals, prebiotics, and DHA, a fatty acid. The lactose ingredient is produced from whey. The average moisture content in the lactose is 4.95% and the solids content is 95.05%. ISSUE: Whether the infant formula is a food preparation of goods of headings 0401 to 0404 (milk and whey, etc.) and therefore classified in heading 1901, Harmonized Tariff Schedule of the United States (HTSUS), or a food preparation not elsewhere specified or included of heading 2106, HTSUS? LAW AND ANALYSIS: Classification under the Harmonized Tariff Schedule of the United States (HTSUS) is made in accordance with the General Rules of Interpretation (GRI). GRI 1 provides that the classification of goods shall be determined 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. The tariff provisions at issue are the following: 1901 …; Food preparations of goods of heading 0401 to 0404, not containing cocoa or containing less than 5 percent by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included: 1901.10 Preparations for infant use, put up for retail sale: Other: Other: Infant formula containing oligosaccharides: 1901.10.6000 Described in additional U.S. note 2 to this chapter and entered pursuant to its provisions 1901.10.7500 Other * * * * * 2106 Food preparations not elsewhere specified or included: 2106.90 Other: Other: Other: Other: Other: 2106.90.99 Other: Other: 2106.90.9990 Canned * * * * * When interpreting and implementing the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, while neither legally binding nor dispositive, provide a guiding commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. CBP believes the ENs should always be consulted. See T.D. 89-90, 54 Fed. Reg. 35127, 35128 (August 23, 1989). The ENs to heading 1901 state, in pertinent part, the following: The preparations of this heading may be distinguished from the products of headings 0401 to 0404 in that they contain, in addition to natural milk constituents, other ingredients not permitted in the products of those earlier headings. Thus heading 1901 includes, for example: Preparations in powder or liquid form used as infant food or for dietetic purposes and consisting of milk to which secondary ingredients (e.g., cereal, groats, yeast) have been added; Milk preparations obtained by replacing one or more constituents of milk (e.g., butyric fats) by another substance (e.g., oleic fats). The ENs to Chapter 4 state, in pertinent part, the following: This Chapter does not cover: Products obtained from whey, containing by weight more than 95% lactose, expressed as anhydrous lactose, calculated on the dry matter (heading 17.02); The ENs to heading 1702 (other sugars) state, in pertinent part, the following: Lactose (also known as milk sugar) … which occurs in milk and is produced commercially from whey. This heading covers both commercial and chemically pure lactose. Such products must contain by weight more than 95% lactose, expressed as anhydrous lactose, calculated on the dry matter. … Products obtained from whey and containing 95% or less by weight of lactose, expressed as anhydrous lactose, calculated on the dry matter, are excluded (generally heading 0404)…. Lactose is used extensively, in milk, in the preparation of infant foods; it is also used in confectionery, in jam-making or in pharmacy. The ENs to heading 21.06 state, in pertinent part, the following: Provided that they are not covered by any other heading of the Nomenclature, this Heading covers: Preparations for use, either directly or after processing (such as cooking, dissolving or boiling in water milk, etc.), for human consumption. You assert that the Enfamil infant formula meets all the requirements of heading 1901 in that it is a food preparation, of a good or goods of headings 0401 – 0404, that is not elsewhere specified or included, and contains less than 5% of cocoa. In regard to the requirement that it contains goods of headings 0401 to 0404, you emphasize that the infant formula includes the following milk products: skim milk (1.8% milk solids, wherein you factor out the liquid content), lactose (6.0%), and whey protein concentrate (0.8%), which together constitute 8.6 percent of the product. You explain that “[m]ilk and cream, not concentrated or containing added sugar or other sweetening matter” are classified in headings 0401 - 0404. You cite Note 1 to HTS Chapter 4 that “milk” is defined as “full cream milk or partially or completely skimmed milk.” In your calculation, in addition to the skim milk, you have included the lactose ingredient (which is 95.05 percent lactose by dry weight). Also, you state that the whey protein concentrate (0.8%) is covered by heading 0404. You therefore argue that the Enfamil infant formula with a (corrected) total percentage of 8.5 percent of milk solids of headings 0401 to 0404 should be classified in subheading 1901.10 “…as preparations for infant use, put up for retail sale.” Specifically, you argue that the Enfamil should be classified in 1901.10.6000/.7500, because its milk solids content is below 10% by weight, and it contains lactose and a galacto-oligossaccharides syrup, which are both oligosaccharides. We note that the classification of the lactose ingredient affects the classification of the infant formula. Lactose is a disaccharide derived from milk containing glucose and galactose units. The lactose ingredient you use to make the infant formula is produced from whey wherein the average moisture content is 4.95%. As such, it contains 95.05% lactose on the dry matter. Note (4) to Chapter 4, states that this Chapter does not cover: Products obtained from whey, containing by weight more than 95% lactose, expressed as anhydrous lactose, calculated on the dry matter (heading 1702); Thus, the lactose ingredient is classified in heading 1702, HTSUS, as a sugar, rather than heading 0404, HTSUS, as a product obtained from whey. Therefore, the lactose cannot be included in a calculation of percentage of goods of headings 0401 to 0404, HTSUS. The revised total of goods of headings 0401 to 0404, HTSUS, is 7.1% (6.3 % liquid skim milk in addition to 0.8% of whey protein concentrate). The pertinent question becomes whether or not 7.1% of goods of headings 0401 to 0404 is enough to classify the infant formula in heading 1901, HTSUS, as a food preparation of goods of milk and whey. Ready-to-feed milk-based infant formulas classified in heading 1901 contain varying amounts of milk powder, or skim milk powder, or milk and whey powder, or whey protein powder and skim milk powder, or fluid skim milk with whey powder. See B85238, dated May 5, 1997 (classifying a ready-to-feed infant formula with 23.6% fluid skim milk, 6.2% whey and a concentrate infant formula with 47% fluid skim milk, 12% whey); HQ 950299, dated December 30, 1991 (classifying an infant formula with 5.23% demineralized whey protein powder, 1.8% milk powder), N245270, dated August 23, 2013 (classifying an infant formula with 22% nonfat goat milk powder), NY 815447, dated November 1, 1995 (classifying an infant powder with 35.1% milk, a liquid concentrate with 8.2% milk, a powder with 25.9% milk, a concentrate with 14.8% milk and whey, a ready-to-feed infant formula with 7.56% milk and whey, and a ready-to-feed infant formula with 4.2% milk. The instant Enfamil infant formula (6.3% fluid skim milk and 0.8% whey protein concentrate) falls within the range cited in previous rulings. Therefore, it is properly classified under heading 1901, HTSUS. Heading 2106 provides for food preparations not elsewhere specified or included.  The EN to heading 2106 states this heading covers “preparations for use, either directly or after processing … for human consumption.” Customs has previously classified infant formulas in heading 2106. In most of these rulings, the infant formulas were not milk-based, i.e., they contained no milk or milk products. See, HQ 950917, dated May 11, 1992 (classifying a lactose-free infant formula in ready-to-use form in subheading 2106.90.9990); NY B85383, dated May 23, 1997 (classifying a soy-based formula in ready-to-use form in subheading 2106.90.9990). On May 4, 2010, CBP classified a ready-to-feed milk-based infant formula in heading 2106 in N102047. The product is described as follows: The product is a ready-to-feed shelf-stable infant formula, for children up to 12 months or age, in bottles containing 8 fluid ounces, six bottles in a shrink-wrapped cardboard tray. The formula is composed of approximately 85 percent water, 6 percent lactose, 3 percent fat blend, 2 percent nonfat dried milk, one percent whey protein concentrate, and less than one percent, each, vitamin premix, nutrient premix, nucleotide premix, ascorbic acid, potassium bicarbonate, potassium hydroxide, ferrous sulfate, and carrageenan. The instant Enfamil infant formula uses 6.1% liquid skim milk and 0.8% whey protein concentrate. The infant formula in ruling N102047 uses 2% nonfat dried milk (skim milk powder) and 1% whey protein concentrate. Since the Enfamil infant formula contains more than double the amount of milk-based products than the infant formula in N102047, they are not analogous. Therefore, the Enfamil infant formula here is not properly classified in heading 2106. As noted above, the instant Enfamil infant formula is classified in heading 1901, HTSUS. We do not need to resort to the “basket” provision, heading 2106, which provides only for products not specified elsewhere. Because the milk content is below 10% by weight (7.1%) and it contains a galacto-oligosaccharides syrup which is a oligosaccharide, at the 10-digit level, the Enfamil infant formula is classified in subheading 1901.10.6000/.7500, HTSUS, which provides for “Food preparations of goods of headings 0401 to 0404 … preparations for infant use put up for retail sale … Other: Infant formula containing oligosaccharides: Described in additional U.S. note 2 to this chapter and entered pursuant to its provisions … Other.” HOLDING: By application of GRI 1, the Enfamil infant formula is classified in heading 1901, HTSUS, which provides for “Food preparations of goods of heading 0401 to 0404…” It is specifically provided for in subheading 1901.10.6000, HTSUSA (Annotated), which provides for “Preparations for infant use put up for retail sale … Other: Infant formula containing oligosaccharides: Described in additional U.S. note 2 to this chapter and entered pursuant to its provisions.” The 2015 column one general rate of duty is 17.5% ad valorem. If the quantitative limits of Additional U.S. Note 2 to Chapter 19 are reached, then the classification will shift to subheading 1901.10.7500, HTSUSA, and is dutiable at the rate of $1.035/kg, plus 14.9% ad valorem. 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. We note that you currently produce the infant formula in the United States for exportation. It’s our understanding that you sought this prospective ruling because the infant formula might be returned to the United States for testing. When returned, the infant formula could be eligible for a duty-free entry under subheading 9801.00.1095, HTSUSA (Annotated), which provides for products of the U.S. that are returned after having been exported, without having been advanced in value or improved in condition by any process of manufacture or other means while abroad upon compliance with the documentary requirements of section 10.1, CBP Regulations (19 C.F.R. §10.1). Sincerely, Ieva K. O’Rourke, Chief Tariff Classification and Marking Branch

NY A81548 April 22, 1996 CLA-2-19:RR:NC:FC:228 A81548 CATEGORY: Classification TARIFF NO.: 1901.10.1500, 1901.10.3000 Mr. Leonard P. Ruiz Jr. Altra Bio Inc. 4001 Lexington Avenue North Arden Hills, MN 55126 RE: The tariff classification of infant formula from the Netherlands. Dear Mr. Ruiz: In your letters dated February 17, 1996, and March 21, 1996, you requested a tariff classification ruling. Descriptive literature and an ingredients breakdown were submitted with your letters. Morinaga "BF-L" infant formula is a powdered food product composed of 47.8 percent demineralized whey, 17 percent skimmed milk, 9.1 percent palm oil, 8.0 palm kernel oil, 5.7 percent soy bean oil, 4.5 percent lactose, 3.3 percent milk fat, 3.2 percent maltodextrin, and less than 1 percent each of soy lecithin, lactulose, vitamins, minerals, and amino acids. The formula is for infants less than one year of age. The applicable subheading for the infant formula, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.1500, Harmonized Tariff Schedule of the United States (HTS), which provides for food preparations of goods of headings 0401 to 0404...preparations for infant use, put up for retail sale... containing over 10 percent by weight of milk solids...other ...infant formula containing oligosaccharides...described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, these products will be classified in subheading 1901.10.3000, HTS, and dutiable at the rate of $1.156 per kilogram plus 16.6 percent ad valorem. In addition, products of the Netherlands, classified in subheading 1901.10.3000, HTS, will be subject to additional duties based on their value, as described in subheadings 9904.19.01 to 9904.19.09, HTS. 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 Stanley Hopard at 212-466-5760. Sincerely, Roger J. Silvestri Director National Commodity Specialist Division

N245270 August 23, 2013 CLA-2-19:OT:RR:NC:N2:228 CATEGORY: Classification TARIFF NO.: 1901.10.1500; 1901.10.3000 Mr. Shaukat Khan FedEx Trade Networks Transport & Brokerage (Canada), Inc. 7075 Ordan Dr. Mississauga, Ontario L5T 1K6 Canada RE: The tariff classification of infant formula from Holland Dear Mr. Khan: In your letter dated August 16, 2013, you requested a tariff classification on behalf of Hyproca Nutrition North America Inc., Canada. An ingredients breakdown, and label image accompanied your inquiry. Hyproca Nutrition brand Kabrita Goat Milk Toddler Formula with DHA & ARA, OPO & Iron (Kabrita 3 Hanna) is said to be a goat milk-based powder for targeting to children age 12-24 months, consisting of approximately 45 percent lactose, 22 percent nonfat goat milk powder, 19 percent vegetable oils, 9 percent goat whey protein concentrate, 2 percent glucose syrup solids, 1 percent dicalcium phosphate, and less than 1 percent, each, mortierella alpina oil, tricalcium citrate, tricalcium phosphate, crypthecodinium cohnii oil, choline bitartrate, calcium carbonate, vitamin C, choline chloride, taurine, ascorbic acid, ferrous sulfate, inositol, vitamin E acetate, L-carnitine, niacinamide, zinc sulfate, calcium pantothenate, lecithin, thiamine hydrochloride, retinyl acetate, riboflavin, cupric sulfate, manganese sulfate, vitamin B6 hydrochloride, folic acid, vitamin K1, sodium selenite, biotin, vitamin D3, and cobalamine. The product is packed in cans weighing 14 ounces (400 grams), for retail sale. The applicable subheading for the product, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.1500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for food preparations of goods of headings 0401 to 0404 ... preparations for infant use, put up for retail sale ... containing over 10 percent by weight of milk solids ... other ... infant formula containing oligosaccharides ... described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, the product will be classified in subheading 1901.10.3000 HTSUS, and dutiable at the rate of $1.035 per kilogram, plus 14.9 percent ad valorem. In addition, products classified in subheading 1901.10.3000, HTSUS, will be subject to additional duties based on their value, as described in subheadings 9904.19.01 to 9904.19.09, 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 http://www.usitc.gov/tata/hts/. This merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling FDA at 301-575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html. 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 Bruce N. Hadley, Jr. at (646) 733-3029. Sincerely, Myles B. Harmon Acting Director National Commodity Specialist Division

N277186 September 22, 2016 CLA-2-19:OT:RR:NC:N4:228 CATEGORY: Classification TARIFF NO.: 1901.10.1500; 1901.10.3000 Mr. Paul F. Fitzpatrick MIQ Logistics 20 Central Street, Ste. 108 Salem, MA 01970 RE: The tariff classification of infant formula from the Netherlands Dear Mr. Fitzpatrick: In your letter dated July 5, 2016, you requested a tariff classification on behalf of Hyproca Nutrition USA Inc. An ingredients breakdown, and label image accompanied your inquiry. Kabrita non-GMO goat milk baby formula is said to be a goat milk-based powder for targeting to babies age 9-24 months. The baby formula is said to contain 45.6 percent lactose, 21.6 percent nonfat goat milk powder, 19 percent vegetable oils, 9.5 percent goat whey protein concentrate, 1.75 percent minerals, 1.5 percent glucose syrup solids and less than 1 percent each mortierella alpina oil, crypthecodinium cohnii oil, choline bitartrate, vitamins, choline chloride, taurine, inositol, and L-carnitine. The product is packed for retail sale in 14 ounce cans (400 grams) net weight. The applicable subheading for the product, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.1500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for food preparations of goods of headings 0401 to 0404 ... preparations for infant use, put up for retail sale ... containing over 10 percent by weight of milk solids ... other ... infant formula containing oligosaccharides ... described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The general rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, the product will be classified in subheading 1901.10.3000 HTSUS, and dutiable at the rate of $1.035 per kilogram, plus 14.9 percent ad valorem. In addition, products classified in subheading 1901.10.3000, HTSUS, will be subject to additional duties based on their value, as described in subheadings 9904.19.01 to 9904.19.09, 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 https://hts.usitc.gov/current. This merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling FDA at 301-575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html. 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 Bruce N. Hadley, Jr. at bruce.hadleyjr@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division

NY 815447 November 1, 1995 CLA-2-19:R:N2:228 815447 CATEGORY: Classification TARIFF NO.: 1901.10.1500; 1901.10.3000; 1901.10.6000; 1901.10.7500 Mr. James J. Kelly Barthco International, Inc. 7575 Holstein Avenue Philadelphia, PA 19153 RE: The tariff classification of infant formulas from Canada and Ireland Dear Mr. Kelly: In your letters dated September 5, 1995 and September 27, 1995, on behalf of Wyeth-Ayerst Laboratories, Philadelphia, PA, you requested a tariff classification ruling. Ingredients breakdowns were submitted with your first letter. Samples of U.S.-manufactured products were submitted with earlier correspondence. The samples were examined and disposed of. "Bonamil" and "SMA" infant formulas are produced in powder, liquid concentrate, and ready-to-feed forms. Bonamil powder consists of 36.8 percent lactose, 35.1 percent milk, 27.5 percent oil blend, and .6 percent vitamins and minerals. Bonamil liquid concentrate is 75.9 percent water, 9 percent lactose, 8.2 percent milk, 6.6 percent oil blend, and .3 percent vitamins and minerals. Bonamil ready-to-feed contains 87.6 percent water, 4.7 percent lactose, 4.2 percent milk, 3.4 percent oil blend, and .1 percent vitamins and minerals. SMA powder is composed of 45.6 percent lactose, 27.2 percent oil blend, 25.9 percent milk, and .3 vitamins and minerals. SMA concentrate is 76.1 percent water, 14.8 percent milk and whey, 6.6 percent oil blend, 2.1 percent lactose, and .4 percent vitamins and minerals. SMA ready-to-feed contains 87.8 percent water, 7.56 percent milk and whey, 3.4 percent oil blend, one percent lactose, and .2 percent vitamins and minerals. The powder products are packaged in cans holding one pound, net weight, the concentrate in cans holding 13 fluid ounces, and the ready-to-feed formulas in cans holding one quart. The applicable subheading for the Bonamil powder, SMA powder, and SMA concentrate, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.1500, Harmonized Tariff Schedule of the United States (HTS), which provides for food preparations of goods of headings 0401 to 0404...preparations for infant use, put up for retail sale... containing over 10 percent by weight of milk solids...other...infant formula containing oligosaccharides...described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, these products will be classified in subheading 1901.10.3000, HTS, and dutiable at the rate of $1.187 per kilogram plus 17.1 percent ad valorem. In addition, products of Ireland, classified in subheading 1901.10.3000, HTS, will be subject to additional duties based on their value, as described in subheadings 9904.19.01 to 9904.19.09, HTS. The applicable subheading for the Bonamil ready-to-feed, Bonamil concentrate, and SMA ready-to-feed, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.6000, Harmonized Tariff Schedule of the United States (HTS), which provides for food preparations of goods of headings 0401 to 0404... preparations for infant use, put up for retail sale... other...infant formula containing oligosaccharides...described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, these products will be classified in subheading 1901.10.7500, HTS, and dutiable at the rate of $1.187 per kilogram plus 17.1 percent ad valorem. In addition, products of Ireland, classified in subheading 1901.10.7500, HTS, will be subject to additional duties based on their value, as described in subheadings 9904.19.01 to 9904.19.09, HTS. This ruling is being issued under the provisions of Section 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 Stanley Hopard at 212-466-5760. Sincerely, Roger J. Silvestri Director National Commodity Specialist Division

HQ 950299 December 30, 1991 CLA-2 CO:R:C:F 950299 LPF CATEGORY: Classification TARIFF NO.: 1901.10.0000, 9904.02.01 Mr. Klaske de Jonge Marketing Manager Nutricia-Loma Linda, Inc. 11503 Pierce Street Riverside, CA 92505 RE: Classification of Nutrilon Premium infant formula in heading 1901 and subject to dairy quota in heading 9904 Dear Mr. de Jonge: This is in response to your letter of August 21, 1991, submitted on behalf of Nutricia-Loma Linda, Inc. Your inquiry requests the proper classification of Nutrilon Premium infant formula under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA). A sample was not submitted with your request for a binding ruling. FACTS: The product, Nutrilon Premium, is a nutritionally complete cow's milk-based infant formula containing 87.43 percent demineralized water, 5.23 percent demineralized whey protein powder, 1.85 percent skimmed milk powder, 1.72 percent lactose and various amounts of vegetable oils, vitamins and minerals. This product will be packaged in 200 milliliter (6.8 ounce) glass bottles for use in clinical trials. The article is imported from the United Kingdom. ISSUE: Whether the infant formula is classified in heading 1901, HTSUSA, as a food preparation of goods of headings 0401 to 0404 (specifically, milk and whey) not containing cocoa powder; heading 2106, HTSUSA, as a food preparation not elsewhere specified or included; or in heading 2202, HTSUSA, as sweetened or flavored water or another nonalcoholic beverage. -2- LAW AND ANALYSIS: The General Rules of Interpretation (GRI's) taken in their appropriate order provide a framework for classification of merchandise under the HTSUSA. The majority of imported 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 GRI's may then be applied. The Explanatory Notes to the Harmonized Commodity Description and Coding System, which represent the official interpretation of the tariff at the international level, facilitate classification under the HTSUSA by offering guidance in understanding the scope of the headings and GRI's. Upon review of the various HTSUSA chapters, it appears that the infant formula is potentially classified in either chapter 22, 21 or 19. Chapter 22 provides for beverages, spirits and vinegar. The Explanatory Notes explain that the products of Chapter 22 constitute a group quite distinct from the foodstuffs covered by the other HTSUSA chapters. Chapter 22 includes products falling into four main groups: water and other non- alcoholic beverages; fermented alcoholic beverages; distilled alcoholic liquids and beverages; and vinegar. For tariff purposes, a beverage is a product which is drinkable in its condition as imported. Strohmeyer & Arpe Co. v. United States, 28 CCPA 34, C.A.D. 121. However, this does not indicate that all potable liquids are necessarily considered beverages under the HTSUSA. The delineation of the main groups of products which constitute a beverage in Chapter 22 corroborates this point. If we attempted to classify the product as a beverage in Chapter 22, heading 2202 would appear to be the appropriate provision. It provides for waters, including mineral and aerated waters, with sugar, sweetening matter or flavored and other non- alcoholic beverages, not including fruit or vegetable juices. Pursuant to GRI 1, we classify the product according to the terms of the heading. The product is not merely a water as described in 2202, since it contains milk, whey and a substantial number of vitamins. Thus, it must either fit the description of an "other non-alcoholic beverage" or be classified elsewhere. The Explanatory Notes to 2202 explain that the heading covers non- alcoholic beverages such as: lemonade, orangeade and cola; tamarind nectar; and certain other beverages ready for consumption, such as those with a basis of milk and cocoa. -3- The infant formula is not an "other non-alcoholic beverage." Heading 2202 is limited and is not intended to include all drinkable liquids without a certain alcoholic content. The Explanatory Notes to 2202 recognize such a limitation by specifying that 2202 does not cover "non-alcoholic beverages" classified in other headings such as 2009 (vegetable juices) or 2201 (waters). In addition, the Explanatory Notes specify types of "non-alcoholic beverages" included in 2202 , inter alia, "certain" other beverages ready for consumption. Thus, other drinkable liquids that apparently could qualify as "other non- alcoholic beverages" actually may be classifiable in other headings and sometimes in other chapters. The subject product is not merely a beverage, that is, liquid for drinking, generally without consequence to the amount ingested, but rather is a vital food and nutrient source for an infant. With its high milk, protein and vitamin content the product would be purchased in order to provide sustenance for and maintain the health and well-being of an infant. Food is defined as a "material...used in the body of an organism to sustain growth, repair, and vital processes and to furnish energy; also: such food together with supplementary substances (as minerals, vitamins and condiments)." Webster's Ninth New Collegiate Dictionary 480 (1990). Therefore, although the product is milk based, it is best described as a food preparation. Although the product will be imported for clinical trials at medical centers, this does not indicate that the product is classifiable in chapter 30 as a pharmaceutical product. Note 1(a) to Chapter 30 explains that the chapter does not cover fortified foods or food supplements. Likewise the Explanatory Notes to headings 3003 and 3004, providing for medicaments, exclude food preparations or supplements containing nutritional or medicinal substances either to increase the product's nutritional value or to maintain health or well-being without indicating use for the prevention or treatment of any disease or ailment. Although the information, from the inquirer, describes the product as a nutritional formula, it does not indicate that the product is used to prevent or treat any diseases or ailments. Thus, we must classify the product in a heading providing for a food preparation rather than for a beverage or pharmaceutical product. -4- Heading 1901 provides for food preparations of goods of headings 0401 to 0404, not containing cocoa powder not elsewhere specified or included, while heading 2106 provides for food preparations not specified or included elsewhere. The Explanatory Notes to heading 1901 explain that products included in this heading contain, in addition to natural milk constituents (milk enriched in vitamins or mineral salts), other ingredients not permitted in the products of headings 0401 to 0404. Headings 0401 and 0404 provide for milk and whey, respectively. In addition, the Explanatory Notes provide that 1901 includes preparations in powder or liquid form used as infant food and consisting of milk to which secondary ingredients have been added. Having determined that heading 1901 provides for the product, since two of its primary ingredients are milk and whey, there is no need to resort to the "basket" provision, heading 2106, which provides only for products not specified elsewhere. As between the two headings, the former appropriately and specifically provides for the product as opposed to the latter. Because it is possible to classify this product by the terms of heading 1901 in accordance with GRI 1, it is not necessary to determine essential character as set forth in GRI 3(b) for mixtures. Even if the product is considered a mixture, GRI 1, would still apply since food preparations in heading 1901 include mixtures. The 200 milliliter (6.8 ounce) bottles are considered retail size. In addition, we are assuming that the product will be used in clinical trials in order to undergo merchandising tests. For these reasons, the infant formula is put up for retail sale and classifiable in subheading 1901.10.0000. HOLDING: The Nutrilon Premium infant formula is classifiable in subheading 1901.10.0000 HTSUSA, as "[m]alt extract;...food preparations of goods of headings 0401 to 0404, not containing cocoa powder..., not elsewhere specified or included: Preparations for infant use, put up for retail sale." The general column one rate of duty is 17.5 percent ad valorem. -5- Because the product is subject to quota quantity restrictions in subheading 9904.02.01, an import license issued to the importer by the United States Department of Agriculture, will also be required at the time such merchandise is entered for consumption into the United States. Questions regarding licensing procedures and applications for license to import products subject to dairy quotas should be addressed to: Foreign Agricultural Service U.S. Dept. of Agriculture-Room 5531 Import Policies & Trade Analysis Division Washington, D.C. 20250-1000 (202) 720-5270 Sincerely, John Durant, Director Commercial Rulings Division 6 cc: AD NY Seaport 2 cc: CIE 1 cc: NIS John Maria

HQ W967962 November 15, 2006 CLA-2 RR:CTF:TCM 967962ptl CATEGORY: Classification TARIFF No.: 1901.10.3500; 1901.10.4000 Port Director U.S. Customs and Border Protection Area Port of Jacksonville 2831 Talleyrand Avenue Jacksonville, FL 32206 RE: Protest 1803-05-100005; Cerelac Dear Port Director: The following is our decision on the above-referenced protest filed by counsel against your classification, under the Harmonized Tariff Schedule of the United States, (HTSUS), of a product identified as Cerelac in subheadings 1901.10.3500 and 1901.10.4000, HTSUS, which are the in-quota and over-quota subheadings that provide for “food preparations of goods of headings 0401 to 0404, not containing cocoa or containing less than 5 percent by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included: preparations for infant use, put up for retail sale: containing over 10 percent by weight of milk solids.” Counsel contends that the products should be classified in 1901.90.4200, HTSUS, which provides for “food preparations of flour, groats, meal, starch or malt extract, not containing cocoa … food preparations of goods of headings 0401 to 0404 … described in additional U.S. note 10 to chapter 4.” The entries were made on January 20, 2004, and the entries were liquidated on November 26, 2004. The protest was received by CBP on February 22, 2005. FACTS: The merchandise under protest is described by counsel as being a wheat cereal with milk. Its percentage ingredient composition is: wheat flour, 47%, nonfat milk and milk, 28%, sugar (refined), 13%, butter oil, caramel color (liquid), corn oil, vitamins, minerals, and flavor, 12%. The ingredients are combined in a simple mixing process. The product is sold to consumers in cylindrical canisters containing approximately 500 grams (17.6 ozs.), by weight, of powder. The product is intended to be consumed as a beverage. The preparation instructions on the can instruct the consumer to add 1 cup of cold milk to 3 tablespoons of Cerelac, plus optional fruit of preference to make a “Delicious Shake.” Counsel states Cerelac is intended to be consumed soon after being mixed with milk, that the mixed product is not designed to be stored. However, that information is not contained on the label. Information on the Cerelac label submitted by counsel is printed in both English and Spanish and reveals the merchandise is a product of Venezuela. The label contains the standard nutrition label and list of ingredients, along with a Nestle statement that the Cerelac is a cereal prepared with wheat flour, milk and vitamins and minerals and what benefits those ingredients are said to provide to the consumer, and the claim that “Nestle Cerelac shakes are ideal for the entire family at breakfast, lunch or as a nutrition supplement.” We note that the preparation instructions tell the consumer to use 3 tablespoons of Cerelac, while the nutrition information tells the consumer that the serving size is 2 tablespoons. On the front of the label, adjacent to the product name, there is a triangle with the number “12” and the words “meses en adelante/months or older” inside. The label depicts a smiling bear cub-like character, dressed in children’s shirt and overalls, holding a glass of what is presumed to be prepared Cerelac and offering it to the viewer. The goods were entered on January 20, 2004, and classified by the importer as dairy products provided for in US Note 10 to Chapter 4, classified in subheading 1901.90.4200, HTSUS, and since they were a product of Venezuela, they were eligible for duty free treatment under the GSP. At liquidation on November 26, 2004, CBP reclassified the goods in subheadings 1901.10.3500 and 1901.10.4000, HTSUS, which are the in-quota and over-quota subheadings that provide for “food preparations of goods of headings 0401 to 0404, not containing cocoa or containing less than 5 percent by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included: preparations for infant use, put up for retail sale: containing over 10 percent by weight of milk solids … Dairy products described in additional U.S. note 1 to chapter 4.” Through counsel, the importer filed a protest against this reclassification on February 22, 2005. Counsel’s Application for Further Review was approved by the port in reliance of counsel’s claim that “facts are alleged and legal arguments presented which were not considered at the time of the original ruling” and the matter was referred to this office for decision. ISSUE: Whether Nestle Cerelac is classified as a food preparation of goods of headings 0401 to 0404, for infant use, in subheading 1901.10, or in subheading 1901.90, the provision for “Other” articles. 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: Malt extract; food preparations of flour, groats, meal, starch or malt extract, not containing cocoa or containing less than 40 percent by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included; food preparations of goods of headings 0401 to 0404, not containing cocoa or containing less than 5 percent by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included: 1901.10 Preparations for infant use, put up for retail sale: Containing over 10 percent by weight of milk solids: * * * Other: Dairy products described in additional U.S. note 1 to chapter 4: 1901.10.3500 Described in additional U.S. note 10 to chapter 4 and entered pursuant to its provisions 1901.10.4000 Other 2/ * * * 1901.90 Other: * * * Other: Dairy products described in additional U.S. note 1 to chapter 4: Dairy preparations containing over 10 percent by weight of milk solids: * * * 1901.90.4200 Described in additional U.S. note 10 to chapter 4 and entered pursuant to its provisions There are two outstanding rulings issued by CBP (then “Customs”) that classify Cerelac. HQ 955752, dated November 29, 1994, classified a product identified as “Nestle Cerelac” composed of 54% wheat flour, 23% sucrose, 21% milk, 1% salt, and 1% lisin. HQ 956315, also dated November 29, 1994, classified a product identified as “Nestle Cerelac Farinha Lactea” composed of 50% wheat flour, 26.5% milk solids, 13% sugar, with the balance consisting of corn oil, iron, calcium, vanillin, and vitamins. Both rulings classified the Cerelac product in subheading 1901.10, HTSUS. Counsel attempts to distinguish the Cerelac under consideration from the Cerelac that was previously classified by CBP. He first states that because neither ruling was issued to Nestle USA, Nestle USA is not bound by them. He then contends that the earlier rulings “involved products from the Portuguese and Ecuadorian markets,” whereas the product under consideration “is made for the U.S. market.” Next, counsel argues that the earlier rulings “turned on whether the items were essentially wheat or essentially milk.” Counsel further argues that because the Cerelac does not contain the requisite nutrition to qualify it as a complete or partial substitute for human milk, it cannot be classified as an infant formula according to U.S. Food and Drug Administration (FDA) standards. We do not agree with counsel’s contentions. While the instant Cerelac and that considered previously by CBP do not have the exact composition, they are all composed primarily of the same ingredients with slightly differing percentages. They are all packed for retail sale in canisters and all are intended to make a wheat and milk beverage/shake. All the products bear the name “Nestle Cerelac.” Although counsel claims the products classified in HQ 956315 and HQ 955752 were not formulated for the United States markets, pre-importation classification rulings were sought from CBP. Those rulings were issued for products that were going to be introduced into the United States market. It has been CBP policy to classify products with substantially similar ingredients in the same tariff subheadings. Counsel’s statement that the earlier rulings turned on whether the items were of wheat or milk demonstrates a misreading of those rulings. Both rulings clearly state that CBP considered milk to be the essential character of the product. In both rulings, after discussing factors weighed in determining essential character of a product, CBP stated: “We are aware that milk is one of the basic food products for infants and that Cerelac provides this necessary food product for infants with the addition of wheat flour. We conclude that the milk solids constitutes [sic] the essential character of Cerelac.” These rulings also determined that although the product may “also be for use by adolescents and adults,” its principal use was as a food preparation for infants. Counsel has provided portions of FDA regulations relating to infant formula and argues that because the instant product does not satisfy the criteria set forth therein, the Cerelac cannot be classified as an infant formula or a product for infant use. We initially note that CBP is not classifying Cerelac as an infant formula, but as a preparation for infant use. This forces us to review how the term “infant” has been interpreted for tariff purposes. Despite its frequent use, the word is not defined in the tariff. The closest the tariff comes to defining the term is not by the age of the child, but by its size. In chapter 61, note 6(a), and chapter 62, note 4(a), “babies garments and clothing accessories” are defined by the child’s body height, e.g., “not exceeding 86 centimeters.” Although the application of these definitions is limited to headings 6111 and 6209, respectively, there are numerous CBP rulings which indicate that, for tariff purposes, the term “infant” is interpreted to mean children up to two years of age. In HQ 088575, dated May 31, 1991, the tariff classification of a child’s hat and bib set was determined pursuant to GRI 3. However, in describing the product, the ruling stated that it was “sized for infants 0 to 24 months,” and was used “to form a costume for an infant.” HQ 952285, dated August 10, 1992, discussed the scope of the chapter 61 and 62 notes regarding babies’ garments, and declared that the height requirements of those notes “translated into the existing commercial size range of 0-24 months.” In HQ 959527, dated October 9, 1996, an article being classified was described as being “an infant’s pram suit [that] will fit young children not exceeding 86 cm in body length.” The ruling states, “Customs has interpreted and applied this based on age 0 to 24 months. We note that 2 years and up is the age range for children’s garments.” In New York Ruling NY I83817, dated July 29, 2002, the issue is whether “the hat is for ‘infants (babies)’ or ‘toddlers.’ … Hats are normally labeled and marketed from 0 to 24 months as infant’s hats, and from 2 years to 3 years as toddler hats.” From commentary in the above rulings, it is clear that CBP has considered the term “infant” to include children up to 2 years of age as far as apparel is concerned. In prior rulings CBP has classified Cerelac with pictures of babies on the container as infant food. The instant container of Cerelac has a picture of a “cute” bear cub. Both pictures can be considered “appropriate” for products intended for the infant – young child market. In fact, when one considers that the preparation instructions on the subject product tell the customer to add milk and the instructions for the earlier classified Cerelac products tell the user to add water, one could say that the product under consideration is more appropriate for younger consumers in that it provides more fresh food nutrients. Accordingly, we have determined that the product Nestle Cerelac cereal with milk has milk as its essential character, is a type of food product which is principally used as an infant food, and is properly classified in subheading 1901.10.35 and 1901.10.40, HTSUS. HOLDING: Nestle Cerelac, cereal with milk, is classified in subheadings 1901.10.3500 and 1901.10.4000, HTSUS, which are the in-quota and over-quota subheadings that provide for “food preparations of goods of headings 0401 to 0404, not containing cocoa or containing less than 5 percent by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included: preparations for infant use, put up for retail sale: containing over 10 percent by weight of milk solids … Dairy products described in additional U.S. note 1 to chapter 4.” The 2004 duty rate for the product entered under quota was 17.5% per kilo. The over quota rate was $1.035/kg plus 14.9%. 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. The protest should be DENIED in accordance with the above decision. In accordance with the Protest/Petition Processing Handbook (CIS HB, January 2002, pp. 18 and 21), 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 in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of the decision the Office of Regulations and Rulings will make the decision available to CBP personnel, and to the public on the CBP Home Page on the World Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution. Sincerely, Myles B. Harmon, Director Commercial and Trade Facilitation Division

NY B85238 May 5, 1997 CLA-2-19:RR:NC:2:228 B85238 CATEGORY: Classification TARIFF NO.: 1901.10.1500; 1901.10.3000; 1901.10.6000; 1901.10.7500; 2106.90.9990 Mr. Ray Maggio Wyeth Nutritionals International 145 King of Prussia Road Radnor, PA 19087 RE: The tariff classification of infant formulas from Canada Dear Mr. Maggio: In your letter dated April 23, 1997 you requested a tariff classification ruling. Copies of three product labels, and ingredients breakdowns for four items were submitted with your letter. The products are liquid infant formula preparations, two described as milk-based, and two as soy-based, in ready-to-feed and concentrated form, heat processed and packed in cans containing 385 milliliters. The milk-based, ready-to-feed formula is composed of 66 percent water, 23.6 percent fluid skim milk, 6.2 percent whey, 3.4 percent oil, .7 percent lactose, and .1 percent "micro nutrients." The milk-based concentrate formula is made from 47 percent fluid skim milk, 33 percent water, 12 percent whey, 6.6 percent oil, 1.4 percent lactose, and .19 percent micro nutrients. The soy-based ready-to-feed formula consists of 86.9 percent water, 6.9 percent carbohydrate (75 percent corn syrup solids and 25 percent sucrose), 3.5 percent oil, 2 percent soy isolate, and .7 percent micro nutrients. The soy-based concentrate contains 74.8 percent water 13.5 percent carbohydrate, 6.7 percent oil, 3.9 percent soy isolate, and 1.1 percent micro nutrients. The applicable subheading for the milk-based concentrate formula, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.1500, Harmonized Tariff Schedule of the United States (HTS), which provides for food preparations of goods of headings 0401 to 0404...preparations for infant use, put up for retail sale...containing over 10 percent by weight of milk solids... other...infant formulas containing oligosaccharides...described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, the product will be classified in subheading 1901.10.3000 HTS, and dutiable at the rate of $1.126 per kilogram, plus 16.2 percent ad valorem. The applicable subheading for the milk-based ready-to-feed formula, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.6000, HTS, which provides for food preparations of goods of headings 0401 to 0404...preparations for infant use, put up for retail sale...other...other...infant formulas containing oligosaccharides...described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, the product will be classified in subheading 1901.10.7500 HTS, and dutiable at the rate of $1.126 per kilogram, plus 16.2 percent ad valorem. The applicable tariff provision for the soy-based ready to feed and concentrate formulas will be 2106.90.9990, HTS, which provides for food preparations not elsewhere specified or included...other...other...canned. The general rate of duty will be 8.2 percent ad valorem. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR 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 Stanley Hopard at 212-466-5760. Sincerely, Gwenn Klein Kirschner Chief, Special Products Branch National Commodity Specialist Division

NY B85383 May 23, 1997 CLA-2-19:RR:NC:2:228 B85383 CATEGORY: Classification TARIFF NO.: 1901.10.1500; 1901.10.3000; 1901.10.6000; 1901.10.7500; 2106.90.9990 Mr. Ray Maggio Wyeth Nutritionals International 145 King of Prussia Road Radnor, PA 19087 RE: The tariff classification and status under the North American Free Trade Agreement (NAFTA), of infant formulas from Canada; Article 509 Dear Mr. Maggio: In your letter dated May 9, 1997 you requested a ruling on the status of infant formulas from Canada under the NAFTA. Ingredients breakdowns for four items were submitted with your letter. The products are infant formula preparations, in fluid form, two described as milk-based, and two as soy-based, in ready-to-feed and concentrated varieties, heat processed and packed in metal cans containing 385 milliliters. The milk-based, ready-to-feed formula is composed of 66 percent water, 23.6 percent fluid skim milk, 6.2 percent whey, 3.4 percent oil, .7 percent lactose, and .1 percent "micro nutrients." The milk-based concentrate formula is made from 47 percent fluid skim milk, 33 percent water, 12 percent whey, 6.6 percent oil, 1.4 percent lactose, and .19 percent micro nutrients. The soy-based ready-to-feed formula consists of 86.9 percent water, 6.9 percent carbohydrate (75 percent corn syrup solids and 25 percent sucrose), 3.5 percent oil, 2 percent soy isolate, and .7 percent micro nutrients. The soy-based concentrate contains 74.8 percent water 13.5 percent carbohydrate, 6.7 percent oil, 3.9 percent soy isolate, and 1.1 percent micro nutrients. The milk, whey, lactose, and sucrose are products of Canada. The coconut oil in the oil blend is from the Philippines or a neighboring country. The other oils in the blend are products of the United States, as are the soy protein isolate and corn syrup solids. The micro nutrients are from the United States, Europe and Japan. In Canada, the ingredients are blended in accordance with a specific formula, in a proscribed sequence, homogenized, packed in hermetically sealed cans, and sterilized in continuous retorts. The applicable subheading for the milk-based concentrate formula, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.1500, Harmonized Tariff Schedule of the United States (HTS), which provides for food preparations of goods of headings 0401 to 0404...preparations for infant use, put up for retail sale...containing over 10 percent by weight of milk solids... other...infant formulas containing oligosaccharides...described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, the product will be classified in subheading 1901.10.3000 HTS, and dutiable at the rate of $1.126 per kilogram, plus 16.2 percent ad valorem. The applicable subheading for the milk-based ready-to-feed formula, if imported in quantities that fall within the limits described in additional U.S. note 2 to chapter 19, will be 1901.10.6000, HTS, which provides for food preparations of goods of headings 0401 to 0404...preparations for infant use, put up for retail sale...other...other...infant formulas containing oligosaccharides...described in additional U.S. note 2 to this chapter and entered pursuant to its provisions. The rate of duty will be 17.5 percent ad valorem. If the quantitative limits of additional U.S. note 2 to chapter 19 have been reached, the product will be classified in subheading 1901.10.7500 HTS, and dutiable at the rate of $1.126 per kilogram, plus 16.2 percent ad valorem. The applicable tariff provision for the soy-based ready-to- feed and concentrate formulas will be 2106.90.9990, HTS, which provides for food preparations not elsewhere specified or included...other...other...canned. The general rate of duty will be 8.2 percent ad valorem. Each of the non-originating materials used to make these formulas has satisfied the changes in tariff classification required under HTSUSA General Note 12(t)/19.1 and 12(t)21.14. The milk-based formulas, when classified in subheadings 1901.10.1500 and 1901.10.6000, will be entitled to a 1.7 percent ad valorem rate of duty under the NAFTA upon compliance with all applicable laws, regulations, and agreements. The soy-based formulas will be subject to a one percent ad valorem rate of duty under the NAFTA, upon compliance with all applicable laws, regulations, and agreements. This ruling is being issued under the provisions of Part 181 of the Customs Regulations (19 C.F.R. 181). This ruling letter is binding only as to the party to whom it is issued and may be relied on only by that party. 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 Stanley Hopard at 212-466-5760. Sincerely, Gwenn Klein Kirschner Chief, Special Products Branch National Commodity Specialist Division