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 nomenclature and on the Common Customs Tariff
Date: 2001-09-07
Institutions: European Commission
Subjects: Combined Nomenclature, common customs tariff, medical plant, pharmaceutical product, tariff nomenclature

L 240/4

EN

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 2658/87 of 23
July 1987 on the tariff and statistical nomenclature and on the
Common Customs Tariff (1), as last amended by Commission
Regulation (EC) No 1230/2001 (2), 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-

(2)

(3)

ucts (3), 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 (5),
whereas food supplements are preparations generally
based on vitamins, essential amino acids or fatty acids
and minerals.

based on various

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
substances
preparations
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.

active

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
Committee,

(4)

(5)

(6)

(7)

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.

(1) OJ L 256, 7.9.1987, p. 1.
(2) OJ L 168, 23.6.2001, p. 6.

(3) OJ L 297, 13.10.1992, p. 8.
(4) OJ L 297, 13.10.1992, p. 12.
(5) OJ L 186, 30.6.1989, p. 27.

8.9.2001

EN

Official Journal of the European Communities

L 240/5

The following additional note 1 is inserted.

‘Heading 3004 includes herbal medicinal preparations and
preparations based on the following active substances: vita-
mins, minerals, essential amino acids or fatty acids, in pack-
ings for retail sale. These preparations are classified in
heading 3004 if they bear on the label, packaging or on the
accompanying user directions the following statements of:

(a) the specific diseases, ailments or their symptoms for

which the product is to be used;

(c) dosage, and

(d) mode of application.

This heading includes homeopathic medicinal preparations
when they meet the abovementioned conditions of (a), (c)
and (d).

In the case of preparations based on vitamins, minerals,
essential amino acids or fatty acids, the level of one of these
substances per recommended daily dose indicated on the
label must be significantly higher than the recommended
daily intake to maintain general health or well-being.’

Article 2

(b) the concentration of active substance or substances

contained therein;

into force on the 20th day
This Regulation shall enter
following that of its publication in the Official Journal of the
European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 September 2001.

For the Commission

Frederik BOLKESTEIN

Member of the Commission