Classifying herbal medicines
This guide will help you understand the classification of herbal medicines, in order to determine the custom duty rates and non-tariff measures applicable to your products.
This guidance covers a range of products that may be referred to as
- herbal medicines or medicaments
- homeopathic and herbal remedies
- supplements, food and dietary
- tonics
Herbal medicines are classified according to
- their purpose - whether they're medicinal or for general health and well-being
- their contents and additives
- the way in which they're made up - for example for retail sale or in measured doses for a specific use
Generally these products are covered in one of the following chapters of the tariff
- Chapter 21 - for food preparations like herbal teas or dietary supplements
- Chapter 22 - for drinks with added ingredients like vitamins - for example fortified tonic wines
- Chapter 29 - for vitamins and similar organic compounds that are separately defined
- Chapter 30 - for herbal medicinal preparations for both humans and animals
- Chapter 23 - for animal feed supplements
Some products may however be classified elsewhere, for example in Chapter 7, Chapter 8, Chapter 9, Chapter 12, Chapter 13 or Chapter 19.
Defining herbal medicines, supplements and tonics
When you're classifying medicinal preparations for the purposes of the Tariff, in particular Chapter 30, you may come across certain terms and abbreviations. Some examples are listed below.
Terms used when referring to medicaments
- active substance - a chemically defined substance, a chemically defined group of substances, such as alkaloids, polyphenols or anthocyanins, or a plant extract, all of which must have medicinal properties to prevent or treat specific diseases and ailments, or their symptoms
- excipient - a non-nutritional substance (like magnesium stearate) added during the production of tablets
- herbal medicinal preparations - these are preparations based on one or more active substances (see above) and obtained from a plant, or parts of a plant, by a process such as drying, crushing, extraction or purification
- homeopathic medicinal preparations - these are prepared from products, substances or compositions called 'homeopathic stocks' or 'mother tinctures', which are diluted, for example in alcohol or water and where the degree of dilution must be shown (for example D6).
- provitamin - a vitamin precursor that's converted by the body into active form as a vitamin
- vitamins or mineral preparations - these are preparations based on vitamins that are covered under heading code 2936, or based on minerals, including trace elements, and mixtures of minerals. They're used to treat or prevent specific diseases or ailments - or their symptoms. This type of preparation contains a much higher amount of vitamins or minerals, generally at least three times higher than the recommended daily allowance (see above).
- RDA - the recommended daily allowance of a vitamin or mineral needed by the body to remain healthy
The following table from the Annex to Council Directive 90/496/EEC - (amended by Directive 2008/100/EC) - on nutrition labeling of foodstuffs sets out the RDA for a range of vitamins and minerals.
Vitamins |
RDA |
Minerals |
RDA |
Vitamin A |
800 micrograms |
Potassium |
2 grams |
Vitamin D |
5 micrograms |
Chloride |
800 milligrams |
Vitamin E |
12 milligrams |
Calcium |
800 milligrams |
Vitamin K |
75 micrograms |
Phosphorous |
700 milligrams |
Vitamin C |
80 milligrams |
Magnesium |
375 milligrams |
Thiamin |
1.1 milligrams |
Iron |
14 milligrams |
Riboflavin |
1.4 milligrams |
Zinc |
10 milligrams |
Niacin |
16 milligrams |
Copper |
1 milligram |
Vitamin B6 |
1.4 milligrams |
Manganese |
2 milligrams |
Folic Acid |
200 micrograms |
Fluoride |
3.5 milligrams |
Vitamin B12 |
2.5 micrograms |
Selenium |
55 micrograms |
Biotin |
50 micrograms |
Chromium |
40 micrograms |
Pantothenic Acid |
6 milligrams |
Molybdenum |
50 micrograms |
Iodine |
150 micrograms |
|
|
Miscellaneous food preparations
Products that don't treat, cure or prevent diseases or ailments are generally classified under heading code 2106 as food preparations not elsewhere specified or included.
Very many items are classified under this heading code, including
- mixtures of plants, or parts of plants, with other ingredients, like plant extracts. These mixtures are not consumed in this form, but are used to make herbal teas and infusions. They may have a particular purpose, for example to be used as a laxative, purgative or diuretic, or to relieve flatulence. Others claim to provide relief from ailments or to promote general health or well-being.
- mixtures of ginseng extract with other ingredients to make ginseng tea or drink
- food or dietary supplements that are based on substances like plant extracts, fruit concentrates, honey or fructose and that contain added vitamins - the packaging of these preparations often indicates that they're beneficial in maintaining general health or well-being
Although many products like vitamins are usually classified under this heading, it's important to take into account
- the actual contents of the product
- how the product is made up, presented or labelled
These may mean that a product is classified under a different heading. For example vitamins that are mixed with water and other ingredients and are ready for immediate consumption as drinks or tonics are not covered under heading code 2106. Instead they're covered in Chapter 22.
Tonics and liquid food supplements
Chapter 22 covers tonics and liquid food supplements that are meant for immediate consumption. These preparations contain added vitamins or iron compounds and are designed to maintain general health or well-being. This type of product is generally covered under one of the following heading codes
- heading code 2202 - non-alcoholic beverages
- heading code 2205 - aromatised wines
- heading code 2206 - mixtures of fermented beverages, mixtures of fermented beverages with non-alcoholic beverages and other fermented beverages
- heading code 2208 - spirituous beverages including products like tonic wine fortified with herbal extracts and/or vitamins, and liquid herbal remedies with a basis of distilled alcohol - these are included under this heading even if they're meant to be taken in very small quantities
Provitamins and vitamins
Separately defined organic compounds, like vitamins, are covered in Chapter 29. But to be covered in this chapter they must comply with strict conditions that specify the additives that are allowed. These compounds can be dissolved in water or in some other solvent, but the solution must be used only because it's required for safety reasons or for transport purposes. Stabilisers, such as anti-caking agents, can also be added, but only to preserve the compound or for transport purposes.
So if for example an essential trace element like chromium picolinate is prepared as a dietary supplement in the form of tablets or capsules, it would not be covered in this chapter. This is because the added ingredients, like binder, the capsule shell and excipients, haven't been added just for the purposes of preservation or transport. This type of product is covered in Chapter 21 under heading 2106.
Heading 2936 specifically cover
- provitamins
- vitamins
- derivatives used mainly as vitamins
- mixtures of provitamins, vitamins and vitamin derivatives
Certain specified additives, such as antioxidants, are allowed provided that the amount added is just enough for the vitamins to be preserved or transported.
For classification purposes it's very important that anything added to a compound doesn't make the resulting product particularly suitable for a specific use rather than for general use. For example if vitamins are prepared as food supplements in the form of tablets, capsules or caplets then they're not classified under heading code 2936. Because of the way they're presented, with an intended daily dosage, they're considered to be suitable for a specific use. They're also excluded from this heading code because the purpose of the additives is for more than just preserving or transporting the vitamins. The additives are there to give the product a convenient and easy to use form.
Herbal medicinal preparations
Herbal medicinal preparations, or medicaments, are covered in Chapter 30 under heading codes 3003 and 3004. These include preparations used (either internally or externally) to treat or prevent human or animal diseases or ailments. Products that maintain general health and well-being are specifically excluded from this chapter.
If a medicinal preparation is made up into measured doses, like ampules, syringes or capsules, then these must be classified under heading code 3004.
This heading code also specifically covers the retail sale of
- herbal and homeopathic medicinal preparations
- certain preparations containing vitamins, minerals, essential amino acids or fatty acids
These products must include certain information for consumers on their labels or packaging, or on the accompanying user directions. This information must show
- the specific diseases, ailments or deficiencies (or their symptoms) for which the product is to be used
- the concentration of the active substances that the product is based on
- the dosage
- mode of application
The level of vitamins and minerals in these products must be much higher than the recommended daily allowance (RDA) of these substances for just maintaining general health or well-being.