5th August,2023
The Chief Manager, Business Intelligence & Analysis
Kenya Revenue Authority
Times Towers
Nairobi, Kenya
Dear Madam,
REF: Application for Advance Ruling for EUCARBON Tablets
We are writing on behalf of our principal, Austell Pharmaceuticals (Pty) Ltd, to request for a HS classification, advance ruling, for EUCARBON Tablets. The application is done ,as per section 248(A) of EACCMA. Our proposed HS Classification is 3004.90.00
The structure of the application consists of:
Description of EUCARBON Tablets
The EUCARBON Tablets contains Vegetable Charcoal (carbo ligni plv.) 180 mg, Rhubarb dry extract 25 mg, Senna folium powder 105 mg, which constitute the active ingredients. The excipients are acacia, fennel oil, peppermint oil, heavy kaolin, starch, sucrose, and talc. It contains sugar(sucrose)
The product is classified as a lubricant and faecal softener. The properties of this product are traditionally being attributed to the plant material it contains. Eucarbon is a traditional remedy for the symptomatic relief of constipation as a stool softener.
Please refer to the Patient Information Leaflet and the Product Sample for more information
What is Vegetable Charcoal
Active vegetable charcoal comes from coconut bark, bamboo, or plant residues. It has been used since antiquity for its purifying properties. It was used in particular to decontaminate and detoxify the body and especially the digestive tract. It absorbs impurities, bad toxins, germs but also intestinal gas.
What is Rhubarb dry extract?
Rhubarb root is the common name for the root of either of two species of rhubarb plant, known in Latin.
as Rheum palmatum L. and Rheum officinale Baillon, or their hybrids. The dried, comminute root may also be put in a solvent to dissolve compounds and obtain an extract. Rhubarb root preparations are standardised to.
contain a defined amount of anthraquinones, which are substances linked with medicinal activity. Rhubarb root preparations may also be found in combination with other herbal substances in some herbal medicines.
The anthraquinones, stimulate bowel movements, encouraging the bowels to empty. They also alter the absorption of water and salt from the bowels. This increases the amount of water in the material in the gut and so softens it and allows it to pass along the gut more easily.
What is Senna folium powder?
Senna leaf is the common name for the leaf of the plant Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl). Senna leaf preparations that are obtained by drying and comminuting (reducing into tiny pieces) the leaves. The dried, comminuted leaves may also be put in a solvent (such as ethanol) to dissolve compounds and form an extract. All senna leaf preparations are standardised to contain a defined amount of anthraquinones, which are substances linked with the activity of senna leaf.
| The EUCARBON tablet is a composite preparation containing pharmacologically active ingredients. The active charcoal is classifiable in heading 38.02 while the senna leaf extracts and rhubarb root are classified in heading 1211. We will analyse products of headings 1211 and 3802 when they are put up as medical preparations. |
Chapter 12: Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit; industrial or medicinal plants; straw and fodder
Notes.
4.- Heading 12.11 applies, inter alia, to the following plants or parts thereof : basil, borage, ginseng, hyssop, liquorice, all species of mint, rosemary, rue, sage and wormwood.
Heading 12.11 does not, however, apply to :
(a) Medicaments of Chapter 30.
(b) Perfumery, cosmetic or toilet preparations of Chapter 33; or
(c) Insecticides, fungicides, herbicides, disinfectants, or similar products of heading 38.08.
GENERAL
The seeds and fruits covered by the heading may be whole, broken, crushed, husked, or shelled. They may also have undergone heat treatment designed mainly to ensure better preservation (e.g., by inactivating the lipolytic enzymes and eliminating part of the moisture), for the purpose of de‑bittering, for inactivating antinutritional factors or to facilitate their use. However, such treatment is permitted only if it does not alter the character of the seeds and fruits as natural products and does not make them suitable for a specific use
| The senna leaf and rhubarb root extracts are classifiable in heading 12.11 if they have not undergone any processing that makes them suitable for specific use. In the product under consideration the two products have been prepared further for specific use as medicaments. Note that the heading covers medicinal plants. The heading excludes products of chapter 30. |
Heading 12.11 Explanatory Notes
12.11 ‑ Plants and parts of plants (including seeds and fruits), of a kind used primarily in perfumery, in pharmacy or for insecticidal, fungicidal, or similar purposes, fresh, chilled, frozen or dried, whether or not cut, crushed or powdered.
1211.20 ‑ Ginseng roots
1211.30 ‑ Coca leaf
1211.40 ‑ Poppy straw
1211.50 ‑ Ephedra
1211.60 ‑ Bark of African cherry (Prunus africana)
1211.90 ‑ Other
This heading covers vegetable products of a kind used primarily in perfumery, in pharmacy or medicine, or for insecticidal, fungicidal, parasiticidal or similar purposes. They may be in the form of whole plants, mosses, or lichens, or of parts (such as wood, bark, roots, stems, leaves, flowers, petals, fruits, and seeds (other than oleaginous fruits and oil seeds classified in headings 12.01 to 12.07)), or in the form of waste resulting, in the main, from mechanical treatment. They remain in the heading whether fresh, chilled, frozen, or dried, whole, cut, crushed, ground, or powdered or (where appropriate) grated or hulled. Products of this heading impregnated with alcohol remain classified here.
| Note that the heading covers vegetable products used primarily in pharmacy and medicine. |
It should also be noted that the following products fall in headings 30.03, 30.04, 33.03 to 33.07 or 38.08, as the case may be :
(a) Products of this heading, unmixed, but put up in measured doses or in forms or packings for retail sale, whether for therapeutic or prophylactic purposes, or put up for retail sale as perfumery products or as insecticidal, fungicidal, or similar products.
(b) Products which have been mixed for use for the purposes described in (a) above.
| Notes a & b are very important in the determination of the classification because it informs us that products of heading 12.11 unmixed, put up in measured doses or in packings for retail sale are to be classified in headings 30.03 or 30.04. Mixed products of this heading put up as medicaments are also to be classified in headings 30.03 or 30.04. |
However, the classification of vegetable products in this heading, by virtue of their being used primarily in pharmacy, does not necessarily imply that they may be regarded as medicaments of heading 30.03 or 30.04 when they are mixed, or unmixed but put up in measured doses or in forms or packings for retail sale. While the term “medicaments” within the meaning of heading 30.03 or 30.04 refers only to products which have therapeutic or prophylactic uses, the broader term “pharmacy” has reference both to medicaments and to products having no therapeutic or prophylactic uses (e.g., tonic beverages, fortified foods, blood‑grouping reagents).
The following products are included in the heading :
Rhubarb (Rheum officinale) : roots.
Senna (Cassia acutifolia and Cassia angustifolia) : pods and leaves.
The botanical names in the list above (which is not exhaustive) are given to assist in the identification of the plants. Mention of the botanical name of a particular species does not necessarily indicate that other species.
of the same plant family are not classified in the heading
.
| Please note that the explanatory note above explicitly confirms that the senna pods and leaves and rhubarb roots are classified in heading 12.11. |
Chapter 38:Miscellaneous chemical products
Notes.
1.‑ This Chapter does not cover :
(e) Medicaments (heading 30.03 or 30.04); or
| Chapter 38 does not cover medicaments as per the note above. Therefore, the instant product even if it contains activated charcoal will not be classified here. |
Heading 38.02 Explanatory Notes
38.02 ‑ Activated carbon; activated natural mineral products; animal black, including spent animal black.
3802.10 ‑ Activated carbon
3802.90 ‑ Other
(A) ACTIVATED CARBON; ACTIVATED NATURAL MINERAL PRODUCTS
Carbon and mineral substances are said to be activated when their superficial structure has been modified by appropriate treatment (with heat, chemicals, etc.) in order to make them suitable for certain purposes, such as decolourising, gas or moisture adsorption, catalysis, ion‑exchange or filtering.
These products fall in two groups :
(I) Products generally characterised by a very large specific surface (of the order of hundreds of square metres per gram), and by the presence of van der Waal’s bonds (physical adsorption) or free chemical bonds saturable by organic or inorganic molecules (chemical adsorption).
These products are obtained by chemical or heat treatment of certain vegetable or mineral substances (clay, bauxite, etc.) in the presence of natural impurities or added foreign matter. This treatment causes a change in the structure of the basic substance, accompanied by an increase in the specific surface, and, in the case of crystalline substances, distortions in the lattice due to the insertion or substitution of atoms with different valencies. The valencies which thus remain free can cause the condensation of protons or electrons on the surface, rendering the product active as a chemical adsorbent, a catalyst or an ion‑exchanger.
(II) Products which generally have a fairly small specific surface (of the order of 1 to 100 m2/g). Although they generally have a high electrical charge density, these products have no marked capacity for adsorption and therefore are not decolourising agents. On the other hand, in aqueous suspension they establish powerful electrostatic interactions with colloids, facilitating or inhibiting their coagulation, and are therefore suitable for use as filtering agents.
Products of this type are also generally obtained by appropriate heat treatment. The presence of alkaline substances during the calcining process sometimes encourages the formation of surface charges.
The heading includes :
(a) Activated carbon. This is usually obtained by treating vegetable, mineral or other carbon (wood charcoal, coconut shell carbon, peat, lignite, coal, anthracite, etc.) at a high temperature in the presence of steam, carbon dioxide or other gases (gas activation), or by dry calcination of cellulosic materials impregnated with solutions of certain chemicals (chemical activation).
Activated carbon is used as a fine powder for decolourising liquids in many industries (sugar or glucose manufacture, oil or wine industry, medicaments, etc.). In the form of grains, it is used for adsorbing vapours (for example, in recovering volatile solvents during dry‑cleaning processes, removing benzene from coal gas), for purifying water or air, as a protection against toxic gases, in catalysis, or for eliminating the accumulation of gas at the electrodes during electrolysis (depolarisation).
| The heading 38.02 explanatory notes above explain the manufacture and properties of activated charcoal. Note the physical adsorption property of the activated charcoal which is an active ingredient of the product. This adsorption property is put to medical uses. Activated charcoal has been shown to significantly reduce the absorption of many ingested toxins when given within the first-hour post-ingestion. Activated charcoal is often used to treat poisoning or overdose and may also treat diarrhoea. |
Chapter 30: Pharmaceutical products: Explanatory Notes(EN)
3.- For the purposes of headings 30.03 and 30.04 and of Note 4 (d) to this Chapter, the following are to be treated :
(a) As unmixed products :
(1) Unmixed products dissolved in water.
(2) All goods of Chapter 28 or 29; and
(3) Simple vegetable extracts of heading 13.02, merely standardised or dissolved in any solvent.
(b) As products which have been mixed :
(1) Colloidal solutions and suspensions (other than colloidal sulphur).
(2) Vegetable extracts obtained by the treatment of mixtures of vegetable materials; and
(3) Salts and concentrates obtained by evaporating natural mineral waters.
| Chapter 30 covers mixed products. Mixed products include vegetable extracts obtained by the treatment of mixtures of vegetable materials. Therefore chapter 30 does not exclude products of vegetable extracts obtained by the treatment of mixtures of vegetable materials put up as medicaments. Heading 12.11 covers plants and parts of plants. The senna pods and leaves, rhubarb roots extracts are the active ingredients in Eucarbon Tablets. |
Heading 30.03 Explanatory Notes(EN)
30.03 – Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale.
3003.90 – Other
This heading covers medicinal preparations for use in the internal or external treatment or prevention of human or animal ailments. These preparations are obtained by mixing together two or more substances. However, if put up in measured doses or in forms or packings for retail sale, they fall in heading 30.04.
The heading includes :
(1) Mixed medicinal preparations such as those listed in an official pharmacopoeia, proprietary medicines, etc., including those in the form of gargles, eye drops, ointments, liniments, injections, counter-irritant and other preparations not falling in heading 30.02, 30.05 or 30.06.
(2) Preparations containing a single pharmaceutical substance together with an excipient, sweetening agent, agglomerating agent, support, etc.
(5) Medicinal compound vegetable extracts including those obtained by treating a mixture of plants.
(6) Medicinal mixtures of the plants or parts of plants of heading 12.11.
| Sub-Notes 5 and 6 of heading 30.03, Explanatory Notes clarifies that heading 3003 includes medicinal compound vegetable extracts as well as medicinal mixtures of plants and parts of plants. Heading 30.03 covers similar products to heading 30.04, with the difference being nonretail sale/retails sale. Therefore heading 30.04 also covers medicinal mixtures of the plants and parts of heading 12.11 but put up in measured doses or for retail sale. |
Heading 30.04 Explanatory Notes(EN)
30.04 – Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale.
3004.90 – Other
This heading covers medicaments consisting of mixed or unmixed products, provided they are :
(a) Put up in measured doses or in forms such as tablets, ampoules (for example, re-distilled water, in ampoules of 1.25 to 10 cm3, for use either for the direct treatment of certain diseases, e.g., alcoholism, diabetic coma or as a solvent for the preparation of injectable medicinal solutions), capsules, cachets, drops or pastilles, medicaments in the form of transdermal administration systems, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use.
The heading applies to such single doses whether in bulk, in packings for retail sale, etc.; or
(b) In packings for retail sale for therapeutic or prophylactic use. This refers to products (for example, sodium bicarbonate and tamarind powder) which, because of their packing and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose, etc.) are clearly intended for sale directly to users (private persons, hospitals, etc.) without repacking, for the above purposes.
These indications (in any language) may be given by label, literature or otherwise. However, the mere
indication of pharmaceutical or other degree of purity is not alone sufficient to justify classification in this heading.
Medicaments consisting of mixed products for therapeutic or prophylactic uses and not put up in measured doses or in forms or packings for retail sale are classified in heading 30.03 (see the corresponding Explanatory Note)
| The product satisfies conditions a and b of heading 30.04 explanatory notes extracted above, in the context of: measured doses, for direct treatment of certain diseases, in packings for retail sale for therapeutic use, presence of appropriate indications. Refer to the Patient information Leaflet as well as samples of the product. |
Under the terms of Chapter Note 3, the following are also regarded as unmixed products :
(1) Unmixed products dissolved in water.
(2) All goods of Chapter 28 or 29. Such products include colloidal sulphur and stabilised solutions of hydrogen peroxide.
(3) Single vegetable extracts of heading 13.02, merely standardised or dissolved in any solvent (see the
Explanatory Note to heading 13.02).
| Heading 30.04 covers medicaments consisting of mixed or unmixed products. The definition of unmixed goods includes vegetable extracts obtained by the treatment of mixtures of vegetable materials. Therefore, the products of heading 12.11, put as medicaments for retail sale are included in heading 3004. Vegetable extracts obtained by the treatment of mixtures of vegetable material are defined as unmixed by chapter 30 note 3. |
Section VI: PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES: Explanatory Notes.
2.- Subject to Note 1 above, goods classifiable in heading 30.04, 30.05, 30.06, 32.12, 33.03, 33.04, 33.05, 33.06, 33.07, 35.06, 37.07 or 38.08 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of the Nomenclature.
Note 2. Explanatory Notes
Section Note 2 provides that goods (other than those described in heading 28.43 to 28.46 or 28.52) which are covered by heading 30.04, 30.05, 30.06, 32.12, 33.03, 33.04, 33.05, 33.06, 33.07, 35.06, 37.07 or 38.08 by reason of being put up in measured doses or for retail sale, are to be classified in those headings notwithstanding that they could also fall in some other heading of the Nomenclature. For example, sulphur put up for retail sale for therapeutic purposes is classified in heading 30.04 and not in heading 25.03 or 28.02, and dextrin put up for retail sale as a glue is classified in heading 35.06 and not in heading 35.05.
| The section VI note extracted above rules out classification in any other heading of the nomenclature if a product is put up for therapeutic or prophylactic application(heading 30.04) and is put up in measured doses. Note the reasons: put up in measured doses The instant product is put up in measured doses can be confirmed from the sample provided to KRA. It is correctly classifiable in heading 30.04, therefore the product cannot be classified in any other heading in the nomenclature. |
World Customs Organisation(WCO) Ruling for Subheading 3004.9
Adoption : 2012
| The WCO ruling extracted above supports our assertion that plant extracts put up for therapeutic or prophylactic purpose are to be classified under subheading 3004.90. |
| The products therapeutic attributes described above and in the patient information leaflet is evidence-based with proven clinical studies on the safety, efficacy, and unique mode of action. The clinical trials are available upon request.
All products imported into Kenya will be detailed to HCP (Healthcare Professionals), and will be prescription driven, stock will only be supplied to pharmacies, hospitals and others as approved by the Poisons and Pharmacy Board. Professional medical sales representatives will be trained on the products. The supply model described above is used for all allopathic medicine. |
We hereby enclose copies of the following documents for your reference.
| From our assessment, the EUCARBON Tablets should be classified under heading 30.04 which covers {Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. The specific subheading will be 3004.90.00 |
Our Technical experts will be readily available for any clarification required.
In light of the above, we kindly request you to guide us on the suitable tariff classification for above-mentioned product.
Thanking you for your valued consideration.
Yours faithfully,
Charles Mukangu
Janron Consult
Email: mmc@janronconsult.com
Phone: +254708751955
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