Government of Pakistan
Model Customs Collectorate of (Appraisement)
Custom House, Karachi
No. CC-25/2010-(A) Dated: 02.12.2010
PUBLIC NOTICE NO. 06/2010
SUB: CLASSIFICATION DISPUTE FOR (1) CAPSULES SRIEO PHARMA WELL MATON CHOCOLATE BROWN OBLONG (2) SOFT GELS ZHECHEM FOLIC SOFTGELS (3) CAP BOAN HEALTH ORTHROCAP (WHITE OVAL)
The classification aspect of product namely “(1) CAPSULES SIREO PHARAMA WELL MATON CHOCOLATE BROWN OBLONG (2) SOFT GELS ZHECHEM FOLIC SOFTGELS (3) CAP BOAN HEALTH ORTHROCAP (WHITE OVAL)” has been referred to the classification center by the Model Customs Collectorate of Appraisement, Custom House, Karachi, whether the above mentioned products are medicaments of PCT 3003.9010, or vitamins of PCT heading 2936.9000 are suggested by the Honorable High Court of Sindh in C.P. No. 1468/2010 or food Supplements of PCT heading 2106.9090.
2. The product’s constitution/contents as per information and literature provided by the importers are:
i) CAPSULES SIREO PHARMA WELL MATON CHOCOLATE BROWN OBLONG is based Vitamin A Acetate (I million IU/g) 0.605 mg, Vitamin D3 (40 million IU/g) 0.002mg, Natural Vitamin E (1000 IU/g), d-Alpha-Tocopherol, GMO Free) 1.639 mg, Vitamin C (L- Ascorbic Acid) 10.300, Vitamin B1 (Thiamine Hydrochloride) 0.520 mg, Vitamin B2 (riboflavin) 0.520 mg, Vitamin B3 (Nicotinamide) 5.200 mg, Vitamin B6 (Pyridoxine Hydrochloride 0.520 mg Vitamin B2 (riboflavin) 0.520 mg, Vitamin B3 (Nicotinamide) 5.200 mg, Vitamin B6 (Pyriodxine Hydrochloride 0.520 mg, Folic Acid 0.416mg, Vitamin B12 (0.1% cyanocobalamine) 1.040 mgg, Zinc Lactate 14.080 mg, Selenium Yeast 15.150mg, Ferrous Furnarate 17.176 mg. Beeswax 40.00 mg, Soyabean Oil 892.832 mg.
ii) SOFT GELS ZHECHEM FOLIC SOFTGELS is based on folic acid (vitamin B- folic acid 400 mcg).
iii) CAP BOAN HEALTH ORTHROCAP (WHITE OVAL) is based on calcium (as calcium carbonate) 300mg vitamin D-3 (as cholecaiferol) 100IU.
3. Custom House Laboratory reported for all three product as below:
WELL MATON CHOCOLATE BROWN OBLONG
i) The samples received in loose packing under the description with trade name “Wall Maton Chocolate Brown Oblong” the content of capsule on test is found to consist of mainly of multivitamin minerals, wax, fatty substances, pasted in vegetable oil and other additives etc. it is in the form of Chocolate brown along capsule (soft gel).it is stated to be used for the deficiency and to meet the increased requirement of Vitamins and Minerals.
FOLIC SOFTGELS
ii) The sample received in loose packing under the description with trade name “Folic Soft Gel”. The content of capsule on test is found to consist mainly of folic acid (Vitamin B), fatty substances/vegetable oil, glycerin etc. and other additive etc. it is in the form of yellow color spherical small soft gel stated to be used for treatment of megaloblactic and macrocytic anemia’s due to folate deficiency in Red Blood Cell improvement etc.
ORTHROCAP
iii) The sample received is in loose packing under the description with trade name “Ortho Cap” (Capsules). The sample on test is found to be a preparation based on Herbal vegetable essential minerals and calcium compounds, excipients and other additive etc. it is in the form of oval shape white capsule stated to be used for the patients of Gestational hypertension, Osteoporosis, Rickets etc.
4. The importers are of the view that Capsules Sireo Pharma Well Maton Chocolate Brown Oblong are multivitamins and minerals and the other substances used therein are preparation for preserving the multivitamins and to make them easy to swallow and some ingredients are parts of the soft gel in which these multivitamins are stuffed. These multivitamins are from natural source and have prophylactic and therapeutic use to meet the deficiency of the vitamins and minerals in the body. According to them, Soft Gel Zhechem Folic Softgels is a Folic acid based on B-Complex vitamin needed to form healthy cells, especially red blood cells. It contains fatty substance vegetable oil and other additives which are used to make them easy to swallow and some ingredients are parts of the soft gel in which these multivitamins are stuffed. These multivitamins are from natural source and have prophylactic and therapeutic use which is used for the treatment of magaloblastic and macrocytic anemia’s due to folate deficiency in the red blood cells improvement. Whereas Cap Boan Health Orthrocap (While Oval) composed of calcium carbonate 750 mg with Vitamin D3 100 IU and is used to prevent or treat negative calcium balance (e.g. osteoporosis) and to restore the depleted maternal calcium reserve during pregnancy, lactation, during childhood prophlaxis of rickets. They have pointed that the subject goods do not contain any food stuff, therefore, cannot be considered as food preparation, thus not classifiable under PCT Heading 21.06 in support of their contention they cited Custom House Laboratory’s report. They contended that all the three subject products in measured doses and have been mentioned with their formulation for prophylactic and therapeutic properties, therefore, the same are classifiable under PCT heading 3004.5000.
5. On the other hand, the staff of MCC (Appraisement) stated that the importer filed GD for clearance of the goods under heading 3003.9010. However, certificate of origin and B/L describes PCT heading 3004.90 and 3004.9010 respectively. None of these classifiable under heading 2106.9000. Moreover, the literature and samples provided by the importer clearly reveals that the impugned product is not covered by the definition of medicaments as given in the Explanatory Notes to heading 30.03 vide page VI-3000-2.
“Medicaments consisting of two or more constituent which have been mixed together for therapeutic and prophylactic uses not put up in measured doses or in forms of packing for retail.”
6. It is clearly mentioned in the Foot Note of the PCT 3003 that food supplements for general health and well being are excluded even they contain vitamins and mineral salts. It reads as under:-
“The provisions of the heading text do not apply to foodstuffs or beverages such as dietetic, diabetic or fortified foods, tonic beverages or mineral waters (natural or artificial), which fall to be classified under their own appropriate headings. This is essentially the case as regards food preparations containing only nutritional substances. The major nutritional substances in food are proteins, carbohydrates and fats Vitamins and mineral salts also play a part in nutrition.
Similarly foodstuffs and beverages containing medicinal substances are excluded from the heading if those substances are added solely to ensure a better dietetic balance to increase the energy –giving or nutritional value of the product or to improve its flavor, always provided that the product retains its character of a foodstuff or a beverage.”
7. Further, no specific definition of oriental medicines is given in the Explanatory Notes. However, the definition available on the internet is as under:
Oriental Medicine (Traditional): This is a sophisticated form of medicine that is comprised of many systematic techniques and method, including acupuncture, herbal medicine, acupressure, gigong, and oriental massage. The most striking characteristic of oriental medicine is its emphasis on diagnosing disturbance of …., or vital energy and sensitivity of body parts.
8. The test reports of the impugned products clearly shows that these are consisting of natural ingredients derived from botanical origin and mixed with manmade vitamins, minerals and other ingredients like glycerin and vegetable oil etc. Therefore, it constitutes nutritional preparation/formulation used as food supplement and to reduce deficiencies of different minerals and vitamins in the body. Further it does not possess any curative effect against a particular disease. Therefore, it cannot be termed as medicament of chapter 30 which covers only product having an active ingredient against a particular ailment (with the exception that nutritional preparations for intravenous administration only, i.e., by injection and drip into a vein) therefore, by virtue of Note 1(a) to chapter 30 (page VI-30-1) the nutritional preparations which are for oral administration are excluded from chapter 30 and is classifiable under PCT 2106.9090.
9. The departmental representative also contended on the contrary chapter 21 covers miscellaneous edible preparations, heading 21.06 covers products, inter-alia, foods preparations not elsewhere specified or included provided that they are not covered by any other heading of the nomenclature. The Explanatory Notes vide page VI-2106-3 includes
“Product consisting of mixture of plants or parts of plants (including seeds of fruits) of different species or consisting of plants or part of plants (including seeds of fruit) of a single or of different species mixed with other substances such as one or more plants, extracts, which are not consumed as such, but which are of a kind used for making herbal infusion or herbal teas (e.g. these having laxative, purgative, divertic or calmative properties) including products which are claimed to offer relief from aliments or contribute to general health and well being.”
10. That the World Custom Counsel has also classified, herbal life vitamins and mineral supplements, multivitamins tonic presented in soft gelatin capsules and vitamins and minerals supplements containing vitamins and mineral sources combined with herbs, in capsules or tables form etc., under heading 2106.9000 vide W.C.O. ruling for harmonized system. For the foregoing reasons Customs is of the opinion that all impugned products fall under PCT heading 2106.9090.
11. The Committee has examined the classification issue in depth and considered the following headings for the purpose of classification of the impugned goods:
i) 29.36
ii) 21.06
iii) 30.03
iv) 30.04
12. PCT heading 29.36 covers pro vitamins and vitamins natural or reproduced by synthesis (including natural concentrative), derivatives thereof used primarily as vitamins and intermixture of the foregoing, whether or not any solvent Note 1(a) to Chapter 29 describes that except where the context otherwise requires, the heading of Chapter 29 apply only to separate chemically defined compounds whether or not containing impurities. The goods imported are deliberate mixtures (preparations) and not a separate compound and as such fall outside the ambit of Chapter 29. Therefore, the classification under heading 29.36 is ruled out. PCT heading 30.03 is relevant only when the goods are not put up in measured doses or in the forms or packing for retail sale. The goods are presented in the form of capsules and hence they are not classifiable under heading 30.03 or any of its sub-heading. The committee observed that crux of the issue involved is whether the goods are food preparations of heading 21.06 or medicaments of heading 30.04 (i.e. product consisting of mixed or unmixed product for therapeutic or prophylactic uses, put up in measured doses or in forms or packing for retails sale).
13. The term “Food” has been defined in the Webster’s New World Dictionary as below:-
“Any substances taken into or assimilated by a plant or animal to keep it alive and enable it to grow and repair tissues;
Anything that nourishes or stimulates; whether helps something to keep active grow”
14. PCT heading 21.06 covers “Food Preparation not elsewhere specified or included”. For example sauces are classifiable under heading 21.03 and food preparations of flavor under heading 19.01. The product of heading 21.03 and 19.01 though constitute “Food preparation” but will not attract classification under heading 21.06. This heading excludes the product of heading 30.03 and 30.04 (i.e. medicaments) vide Note 1(f) to Chapter 21 of the Tariff.
15. PCT heading 30.03/ 30.04 covers medicaments consisting of product for therapeutic or prophylactic uses. However foods or beverages (such as dietetic, diabetic, tonics beverages and mineral waters) other than nutritional preparation for intravenous administration are excluded from these headings and fall for classification under heading 21.06 vide Note 1(d) to Chapter 30 of the Tariff.
16. At page VI-3004-3 of the Explanatory Notes to Harmonized System, it has been explained under heading 30.04 that food stuff and beverage containing medical substance are excluded from heading 3004, if those substances have been added solely to ensure a better dietetic balance, to increase the energy giving or nutritional of the product or to improve its flavor, always provided that the product retains its character of a food stuff or beverage. At the same page VI-3004-3 of the Explanatory Notes the following two examples have been cited for exclusion of product from heading 30.04. Such products have been classified under heading 21.06.
“Moreover, the products consisting of a mixture of plants or parts of plant or consisting of plants or parts of plants mixed with other substances, used for making herbal infusions or herbal “teas” (e.g. those having laxative, purgative, diuretic or carminative properties), and claimed to offer relief from aliment or contribute to general health and well being, are also excluded from this heading (heading 21.06).
Further, this heading excluded food supplements containing vitamins or minerals salts which are put up for the purpose of maintaining health or well being but have no indication as to
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3004.9010 provided when they conform to the term of main heading (i.e. medicaments having therapeutic or prophylactic uses). However, the products which contribute to the general health and well being are not regarded as “medicament” but termed as “Food Preparation not elsewhere specified or included”. In the written representation furnished before the PCT Committee, the importers reverted from their original claims of classification under heading 3003.9010 meant for “Unani, Ayurvedic or other oriental medicines “ and claimed classification under heading 3004.5000 relevant for “medicaments containing vitamins and other products of heading 29.36”. It is worth mentioned that PCT heading 3004.5000 covers only allopathic medicines.
20. The Committee noticed that the main nutritional ingredients in food preparations are proteins, carbohydrate, fat, vitamins and minerals. The perusal of the literature / Customs laboratory test report reveals that all these products are vitamins preparations containing vitamins and other ingredients. These products are sold on shelf and not under the prescription of a doctor. These products are meant to contribute general health and well being and do not have therapeutic or prophylactic uses, therefore, they contribute “food preparations”.
21. At S.No. 20, 22 and 24 as mentioned below, the Classification Opinion issued by the World Customs Organizations certain products have been classified under heading 21.06 rather than 3004.9010 as they only constitute to general health and well being:
20)- Aloe Vera Tablets, put up for retail sale in a container of plastic (e.g. 60 tablets) consisting of 3% aloe vera powder (containing 0.11% aloin) and excipients: calcium hydrogen phosphate purified talc, magnesium stearate, hypromellose and propylene glycol. Used as nutritional supplement, it is claimed in the product packaging or literature to help build resistance to the common cold and to gave relief from stomach disorders such a constipation and indigestion.
22)- Vitamin-C preparation (500 mg per tablet) put up for retail sale in a container holding 130 tablets, containing ascorbic acid, corn starch, cross linked carboxymethyl cellulose, rose hips, stearic acid, lemon bioflavonoid complex, magnesium stearate and acerola. According to the label, the product is not intended to diagnose, treat, cure or prevent any disease.
24)- Cough Syrup in the form of an aqueous solution of an alcoholic strength by volume of 1.8% vol, put up in a container of 100 ml (130g).The product consist of honey, plant tincture, glucose syrup, invert sugar cherry aroma, rose oil, sodium benzoate and purified water. According to the label, the product is recommended to be used against respiratory catarrhal disease and difficulty of bronchial mucus secretion. The content of active medicinal ingredients is, however, not sufficient to provide a recognizable and clinically proven therapeutic or pro-phylactic effect.
22. In the alphabetical index for H.S. Code 2007 issued by the United Nations Statistical Division-Classification Registry the following identical products were assessed under heading 21.06:
i.) herbal life, vitamin and mineral supplements dietary supplement which is made up in capsules and consists of green tea extract, grape seed extract, pine bark extract, cellulose and magnesium stearate.
ii) Food supplement consisting of a variety of herbs, spices and salts, put up for the purpose of maintaining health or well being.
iv) food supplement, mineral preparation from extracts of botanical plants and containing potassium, iron, magnesium and calcium.
v) Ginkgo Biloba extract, in liquid or capsule form derived from the fresh green leaves of the Ginkgo Biloba tree.
23. Keeping in view of the above, the Classification Committee decided that all the three impugned products namely “(1) capsules sireo pharma well maton chocolate brown oblong (2) soft gels zhechem folic softgels (3) cap boan health orthrocap (white oval)” are correctly classifiable under heading 21.06 (2106.9090) by application of Rule 1 & 6 of the General Rules of Interpretation of Harmonized System.
Signed by
(Gul Rehman)
Additional Collector
Chairman PCT Committee
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