General
The description of a product as a medicament in Union legislation (other than that relating specifically to classification in the Combined Nomenclature) or in the national legislation of the Member States, or in any pharmacopoeia, is not the deciding factor in so far as its classification in this chapter is concerned.
Additional note 1
1. Herbal medicinal preparations are preparations based on one or more active substances, produced by subjecting a plant or parts thereof to a process such as drying, crushing, extraction or purification.
Active substance means a chemically defined substance, a chemically defined group of substances (for example, alkaloids, polyphenols, anthocyanins) or a plant extract. These active substances must have medicinal properties for the prevention or the treatment of specific diseases, ailments or their symptoms.
2. Homeopathic medicinal preparations are prepared from products, substances or compositions called homeopathic stocks (mother tinctures). The degree of dilution must be indicated (for example, D6).
3. Vitamins or mineral preparations are preparations based on vitamins of heading 2936, on minerals including trace elements and mixtures thereof. They are used to treat or prevent specific diseases, ailments or their symptoms. Such preparations contain a much higher amount of vitamins or minerals, generally at least three times higher than the recommended daily allowance (RDA).
As regards the recommended daily allowance (RDA) for certain vitamins and minerals, see, for example, the table in the Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (OJ L 304, 22.11.2011, p. 58) reproduced below:
| Vitamins and minerals | RDA |
| Vitamin A | 800 μg |
| Vitamin D | 5 μg |
| Vitamin E | 12 mg |
| Vitamin K | 75 μg |
| Vitamin C | 80 mg |
| Thiamin | 1,1 mg |
| Riboflavin | 1,4 mg |
| Niacin | 16 mg |
| Vitamin B6 | 1,4 mg |
| Folic acid | 200 μg |
| Vitamin B12 | 2,5 μg |
| Biotin | 50 μg |
| Pantothenic acid | 6 mg |
| Potassium | 2 000 mg |
| Chloride | 800 mg |
| Calcium | 800 mg |
| Phosphorus | 700 mg |
| Magnesium | 375 mg |
| Iron | 14 mg |
| Zinc | 10 mg |
| Copper | 1 mg |
| Manganese | 2 mg |
| Fluoride | 3,5 mg |
| Selenium | 55 μg |
| Chromium | 40 μg |
| Molybdenum | 50 μg |
| Iodine | 150 μg |
4. Recommended daily allowance (RDA) for adults with a weight of 70 kg, on essential amino acids, according to the joint WHO/FAO/UNU expert Consultation 2007:
| Essential Amino Acid | RDA (mg) |
| Histidine | 700 |
| Isoleucine | 1 400 |
| Leucine | 2 730 |
| Lysine | 2 100 |
| Methionine + Cysteine | 1 050 |
| Cysteine | 287 |
| Methionine | 728 |
| Phenylalanine + Tyrosine | 1 750 |
| Threonine | 1 050 |
| Tryptophan | 280 |
| Valine | 1 820 |
Recommended daily allowance (RDA) for adults with a weight of 70 kg, on essential fatty acids, according to the joint WHO/FAO/UNU expert Consultation 2007.
| Types of essential fatty acids | Name of essential fatty acid | RDA (g) |
| n-3 polyunsaturated fatty acids | linolenic acid (ALA) | 2 |
| long-chain n-3 polyunsaturated fatty acids | EPA plus DHA | 0,25 |
| n-6 polyunsaturated fatty acids | linoleic acid | 10 |
Heading 3004 does not cover, inter alia, food supplements or dietary preparations (see also note 1(a) to this chapter).