7th, August,2023
The Chief Manager, Business Intelligence & Analysis
Kenya Revenue Authority
Times Towers
Nairobi, Kenya
Dear Madam,
REF: Application for Guidance for the HS Classification for Andolex C Lozenges Honey/Lemon
We are the authorized Importers and Distributors of the above-mentioned product supplied by iNova Pharmaceuticals. We are writing to request for guidance on the tariff classification of Andolex C Lozenges Honey/Lemon. The request is done pursuant to the profiling and targeting sections, message indicating that the product should be classified in HS Code 1704.90.00. The consignment was imported vide entry number 23NBOIM407978267. We classified the product in HS code 3004.90. Below please find the legal notes to be considered as well as the implications of the legal notes. Our comments on the relevant legal notes are enclosed in a text box. The most important legal notes are underlined.
Description of Product
ANDOLEX-C LOZENGES HONEY/LEMON contains Benzydamine hydrochloride 3.00mg & Cetylpyridinium chloride 1.33mg and is prescribed for the relief of minor infections and painful conditions of the mouth and throat.
Benzydamine, is a drug available as the hydrochloride salt, is a locally acting nonsteroidal anti-inflammatory drug with local anaesthetic and analgesic properties for pain relief and anti-inflammatory treatment of inflammatory conditions of the mouth and throat.
Cetylpyridinium chloride (CPC) is a cationic quaternary ammonium compound that has antiseptic properties and kills bacteria and other microorganisms.
This product has been registered with the Pharmacy & Poisons Board as a therapeutic product for the treatment of the above-mentioned medical conditions (see attached retention certificate).
Therefore ANDOLEX-C LOZENGES HONY/LEMON is generally prescribed by registered medical practitioner, dentist, or a pharmacist upon diagnosis of the above-mentioned medical conditions – see attached package insert, section 3 which describes how to take Andolex C Lozenges Honey/Lemon as your doctor or pharmacist have told you.
This product is therefore a medicament as opposed to other OTC products which may be purely for oral or dental hygiene, and which are available even in the supermarkets whereas ANDOLEX-C LOZENGES HONEY/LEMON is not available from the supermarkets.
What is Benzydamine hydrochloride
Benzydamine (also known as Tantum Verde and branded in some countries as Maxtra Gargle, Difflam and Septabene), available as the hydrochloride salt, is a locally acting nonsteroidal anti-inflammatory drug (NSAID) with local anaesthetic and analgesic properties for pain relief and anti-inflammatory treatment of inflammatory conditions of the mouth and throat. It falls under class of chemicals known as indazole.
What is Cetylpyridinium chloride
Cetylpyridinium chloride (CPC) is a cationic quaternary ammonium compound used in some types of mouthwashes, toothpastes, lozenges, throat sprays, breath sprays, and nasal sprays. It is an antiseptic that kills bacteria and other microorganisms. It has been shown to be effective in preventing dental plaque and reducing gingivitis. It has also been used as an ingredient in certain pesticides.
What is Isomalt?
Isomalt is a sugar substitute, a mixture of the two disaccharide alcohols 1,6-GPS and 1,1-GPM. It is used primarily for its sugar-like physical properties. It has little to no impact on blood sugar levels and does not stimulate the release of insulin. It is classified in heading 29.40.
What is Sucralose?
Sucralose is an artificial sweetener and sugar substitute. The majority of ingested sucralose is not broken down by the body, so it is noncaloric It is produced by chlorination of sucrose, selectively replacing three of the hydroxy groups—in the C1 and C6 positions of fructose and the C4 position of glucose—to give a 1,6-dichloro-1,6-dideoxyfructose–4-chloro-4-deoxygalactose disaccharide.
Legal Notes and WCO Rulings to be Considered.
Chapter 17: Sugars and sugar confectionery: Explanatory Notes(EN)
1.- This Chapter does not cover :
(b) Chemically pure sugars (other than sucrose, lactose, maltose, glucose and fructose) or other products of heading 29.40; or
(c) Medicaments or other products of Chapter 30.
GENERAL
The Chapter does not include :
(d) Chemically pure sugars (other than sucrose, lactose, maltose, glucose and fructose), and aqueous solutions thereof (heading 29.40).
(e) Medicaments containing sugar (Chapter 30).
| The EN extract quoted above informs us that chapter 17 does not cover medicaments containing sugar or other products of chapter 30. Such products remain classified in chapter 30. Benzydamine hydrochloride and Cetylpyridinium chloride are the ingredients that impart the medicinal properties. Please take note that isomalt is classifiable in heading 29.40 and is therefore excluded from chapter 17 as per sub note (b) quoted above. Sucralose is a derivative of sucrose and is also excluded from chapter 17. |
WCO Decisions for Subheading 1704.90
Application of GIRs 1 and 6. Adoption : 2019
Adoption : 2022
Analysis of WCO Decisions 10,11,12
| The three WCO decisions clarify that the principal ingredient of products that are to be classified in subheading 1704.90 should be essentially sugars of chapter 17, with essential oils and others as the other ingredients. None of the products in the rulings contain pharmacologically active ingredients. The sugar substitutes isomalt and sucralose are excluded from classification in chapter 17. |
Section VI 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.
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 as 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. |
Chapter 30:Pharmaceutical products: Explanatory Notes
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.
.
| Note that all goods of chapter 29 are considered as unmixed goods. Heading 30.04 covers Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses. All the ingredients in the instant product, namely, Benzydamine hydrochloride, Cetylpyridinium chloride, Isomalt, Sucralose are classifiable in chapter 29. Their preparations are therefore not excluded from classification in chapter 30. |
Heading 30.03 Explanatory Notes
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.
On the other hand, the heading covers preparations in which the foodstuff or the beverage merely serves as a support, vehicle, sweetening agent or a processing or technical aid for the medicinal substances (e.g., in order to facilitate ingestion).
| Heading 30.03 ENs clarify the type of products classifiable in 30.04. They are 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. The lozenges satisfy this condition. |
Heading 30.04 Explanatory Notes
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.
On the other hand, even if no indications are given, unmixed products are to be regarded as being put up for retail sale for therapeutic or prophylactic use if they are put up in a form clearly specialised for such use.
| Heading 30.04 covers unmixed products. All the ingredients in the lozenges are classifiable in heading 29. Their preparations are therefore not excluded from classification in heading 30.04. |
This heading includes pastilles, tablets, drops, etc., of a kind suitable only for medicinal purposes, such as those based on sulphur, charcoal, sodium tetraborate, sodium benzoate, potassium chlorate or magnesia.
| Heading 30.04 covers pastilles. This term fully describes the lozenges. The definition of a pastille is : A pastille is a type of sweet or medicinal pill made of a thick liquid that has been solidified and is meant to be consumed by light chewing and allowing it to dissolve in the mouth |
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However, preparations put up as throat pastilles or cough drops, consisting essentially of sugars (whether or not with other foodstuffs such as gelatin, starch, or flour) and flavouring agents (including substances having medicinal properties, such as benzyl alcohol, menthol, eucalyptol, and tolu balsam) fall in heading 17.04.
| Heading 30.04 note above clarifies that the pastilles to be classified in heading 17.04 are those that contain sugars of heading chapter 17, and not products of chapter 29(Isomalt, Sucralose). Pastilles containing sugars of heading 17.04, foodstuff and essential oils as the active ingredients are to be classified in heading 17.04. |
Throat pastilles or cough drops containing substances having medicinal properties, other than flavouring agents, remain classified in this heading when put up in measured doses or in forms or packings for retail sale, provided that the proportion of those substances in each pastille or drop is such that they are thereby given therapeutic or prophylactic uses.
| Heading 30.04 note above informs us that pastilles with medicinal properties remain classified in this heading. The Andolex C Lozenges Honey/Lemon contains Benzydamine hydrochloride and Cetylpyridinium chloride as the active ingredients. The two products have medicinal properties as described in the introduction. |
The heading also covers the following products, provided they are put up as prescribed in paragraph (a) or (b) above :
(1)Organic surface-active products and preparations, with active cation (e.g., quaternary ammonium salts), having antiseptic, disinfectant, bactericidal or germicidal properties.
| Note that the ingredient, Cetylpyridinium chloride, is a quaternary ammonium salt. It is cationic and has antiseptic, disinfectant, bactericidal or germicidal properties. |
| From our assessment, the Andolex C Lozenges Honey/Lemon, 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 |
We here by enclose copies of the following documents for your reference and favourable consideration.
Thanking you for your valued consideration.
Yours faithfully,
Janron Consult
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