L 2404 Official Journal of the European Communities 8.9.2001 COMMISSION REGULATION (EC) No 1777/2001 of 7 September 2001 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomencla- ture and on the Common Customs Tariff THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EEC) No 265887 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ('), as last amended by Commission Regulation (EC) No 1230/2001 (3, and in particular Article 9 thereof, Whereas: 1) To ensure uniform application of the Combined Nomen- clature annexed to the said Regulation, it is necessary to make a distinction between: 1. on the one hand, herbal medicinal preparations and preparations based on various active substances, amongst others, vitamins, minerals, essential amino acids or fatty acids, for therapeutic or prophylactic uses in human or animal medicine, consisting of mixed or unmixed products, put up in measured doses or in forms or packings for retail sale, which could be classified in Chapter 30 as medicaments of heading 3004, and 2. on the other hand, preparations for special dietary uses including preparations used for particular nutri- tional uses, and food supplements used for main- taining health or well-being, which are generally clas- sifiable in Chapter 21 as food preparations of heading 2106. It has been noted that the classification of certain types of food or medicinal preparations designated for specific medicinal purposes presents difficulties due to the absence of clear definitions in the Combined Nomencla- ture. It is necessary to consider that certain medicinal prepara- tions known as homeopathic medicinal products, for human beings or animals, are prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing proce- dure described in various officially recognised pharma- copoeias, with respect to human beings, in accordance with Article 1 of Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/ 65/EEC and 75/319/EEC on the approximation of provi- sions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal prod- ucts (}), and with respect to animals, in accordance with Article 1 of Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/ 851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down addi- tional provisions on homeopathic veterinary medicinal products (4). Preparations used for particular nutritional uses and preparations for special dietary uses are products specifi- cally made up or prepared to fulfil the dietetic needs corresponding to a special physical or physiological condition in accordance with Article 1(2) of Council Directive 89/398/EEC of 3 May 1989 on the approx- imation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (%), whereas food supplements are preparations generally based on vitamins, essential amino acids or fatty acids and minerals. A distinction between, on the one hand, preparations used for particular nutritional uses or dietetic uses which could contribute to maintaining health or well-being and, on the other hand, herbal medicinal preparations or preparations based on various active substances including certain homeopathic preparations which could help to prevent or treat diseases or specific ailments can be established. With regard to products put up for retail sale, the criteria for the distinction can be established on the basis of verifiable technical specifications generally given on the label, on packaging or on the accompa- nying user directions, for example, the presence of active substances, dosage and mode of application. It seems appropriate to create a list of mandatory criteria laid down in an additional note to Chapter 30 of the Combined Nomenclature, which covers pharmaceutical products. The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Commiittee, HAS ADOPTED THIS REGULATION: Article 1 Chapter 30 of the Combined Nomenclature annexed to Regula- tion (EEC) No 2658/87 is hereby amended as follows. 0] 0] 0] L 297, 13.10.1992, p. 8. L 297, 13.10.1992, p. 12. L 186, 30.6.1989, p. 27.