Case C-316/03: Reference for a preliminary ruling by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of that Court of 3 July 2003 in the administrative proceedings between Orthica BV against Bundesrepublik Deutschland, represented by the Federal Ministry of Consumer Protection, Nutrition and Agriculture; Intervener: the representative of the public interest at the Oberverwaltungsgericht für das Land Nordrhein-Westfalen
Date: 2003-11-15
Institutions: Court of Justice
Subjects: Germany, consumer protection, food supplement, foodstuffs legislation, interpretation of the law, intra-EU trade, medicinal product, public health

15.11.2003

EN

Official Journal of the European Union

C 275/25

IV.

a)

In so far as the term ‘health risk’ is relevant to
the questions in sections II or III, or to other
applicable Community law, such as Articles 28
and 30 EC: Is the relevant threshold the ‘upper
safe level’ or should it be reduced, say, because
the substances in question are also ingested
with food and/or because — at least where
they are taken long-term — regard may have
to be had to the various consumer groups and
their different sensitivities? How are the words
‘reference intakes for the population’ within the
meaning of Article 5 of the Food Supplements
Directive to be defined?

b)

Is it an infringement of Community law for the
specialist authorities to have a discretion under
national
law to determine (individual) upper
safe levels and any (individual) reductions that
is subject to only limited review by the courts?

V.

a)

If a product may be marketed in at least one
other Member State as a foodstuff, is the fact
that there is no ‘nutritional need’
for that
product in Germany significant in terms of the
freedom to market the product in Germany?

VI.

b)

If so, is it compatible with Community law
for the authority to have a discretion under
national
law that is subject to only limited
review by the courts?

If in regard to the questions posed in section III the
Court confirms the judgment in van Bennekom and
there is no incompatibility in this case with the
requirements of health protection, how can the
request for marketing authorisation be successfully
pursued? Can a decision of general application under
Paragraph 47a of the LMBG be refused, without
Community law being infringed, on the basis that
in the German classification system a product is
medicinal, whereas it can be marketed as a foodstuff
in the Member State where it was manufactured? Is
it compatible with Community law, and in particular
Articles 28 and 30 EC, not to apply the rule in
Paragraph 47a of the LMBG to such medicinal
products analogously? If not, can the German State,
without thereby infringing Community law, evade
an obligation which a German court intends to
impose on it to adopt a decision of general appli-
cation under Paragraph 47a of the LMBG (applied
analogously) if it, or the authority responsible for
food but not medicines, objects that because in
the German classification system the product is
medicinal no decision of general application under
Paragraph 47a of the LMBG (analogously) may be
adopted,

a)

because the body competent to adopt decisions
of general application under Paragraph 47a of
the LMBG is not competent for medicines also,

b)

because the product is not authorised as a
medicine?

VII.

If the Court declines itself to reply to the questions
posed in section A, may the national court then
direct questions on the classification of products or
indeed scientific or methodological questions to the
European Food Authority and to what extent are
any guidelines provided by that authority binding
on the national court?

Reference for a preliminary ruling by the Oberverwal-
tungsgericht für das Land Nordrhein-Westfalen by order
of that Court of 3 July 2003 in the administrative
proceedings between Orthica BV against Bundesrepublik
Deutschland, represented by the Federal Ministry of
Consumer Protection, Nutrition and Agriculture; Inter-
vener: the representative of the public interest at the
Land Nordrhein-
für
Oberverwaltungsgericht
Westfalen

das

(Case C-316/03)

(2003/C 275/42)

the Court Registry on 24 July 2003,

Reference has been made to the Court of
Justice of the
European Communities by order of the Oberverwaltungsge-
richt für das Land Nordrhein-Westfalen (Higher Administrative
Court for the Land of Nordrhein-Westfalen) of 3 July 2003,
for a
received at
preliminary ruling in the administrative proceedings between
Orthica BV against Bundesrepublik Deutschland, represented
by the Federal Ministry of Consumer Protection, Nutrition and
Agriculture; Intervener: the representative of the public interest
at
für das Land Nordrhein-
the Oberverwaltungsgericht
Westfalen on the following questions:

A.

1.

Is the contested product

‘OPC 85’

a foodstuff (perhaps in the form of a food sup-
plement) or a medicinal product? Is this finding
binding on all the Member States?

2.

If the Court of Justice concludes that the product in
question is medicinal, but that in those Member
States where it has hitherto been regarded as a
foodstuff it should continue to be a foodstuff, that
raises problems for the referring Chamber such as
those underlying the questions in B VI, in conjunc-
tion with those in B III. Reference is made to those
questions and the observations thereon and an
answer is requested.

C 275/26

EN

Official Journal of the European Union

15.11.2003

B.

In the event that — as has been the case hitherto — the
questions posed in section A above are to be answered
not by the Court of Justice but by the national courts, the
replies are,
in this Chamber’s view, needed to the
following questions:

I.

a)

b)

Is the contested product to be classified accord-
ing to the first and second paragraphs of
Article 2, in conjunction with point (d) of the
third paragraph of Article 2 of Regulation (EC)
No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down
the general principles and requirements of food
law, establishing the European Food Safety
Authority and laying down procedures in mat-
ters of food safety (OJ 2002 L 31, p. 1, ‘the
Basic Regulation’), or — once the period for
transposition expires on 31 July 2003 —
according to Directive 2002/46/EC of
the
European Parliament and of the Council of
10 June 2002 on the approximation of the
laws of the Member States relating to food
supplements (OJ 2002 L 183, p. 51, ‘the Food
Supplements Directive’), and if so according to
which parts of the directive?

If the first and second paragraphs of Article 2,
in conjunction with point
(d) of the third
paragraph of Article 2 of the Basic Regulation
applies, the following question arises: is it the
case that it is no longer the product’s main
(objective) purpose that is the decisive factor,
but rather that a product which meets the
criteria for both a food and a medicine is,
legally speaking, always — and only — a
medicinal product? How material
for these
purposes is the type of product and how
material the individual product?

II.

a) How is the term ‘pharmacological effect’, which
is critical for the purposes of classification,
inter alia, under the first and second paragraphs
of Article 2, in conjunction with point (d) of
the third paragraph of Article 2 of the Basic
Regulation, to be defined for the purposes
of Community law? In particular, does the
definition include a requirement that there be a
health risk?

b) Now that Directive 2001/83/EC of the Euro-
pean Parliament and of the Council of 6 Nov-
ember 2001 on the Community code relating
to medicinal products for human use has,
by the second sentence of Article 1(2)
(on
‘functional’ medicinal products), introduced the
term ‘physiological functions’, the further ques-
tion arises as to the meaning of that term and
its relation to the term ‘pharmacological effect’.

III. Does the view expressed by the Court of Justice in
Case 227/82 van Bennekom [1983] ECR 3883,
paragraph 39 on the general classification of vitamin
preparations, in which it said that it must be possible
to import a product that may be marketed as a food

in the Member State in which it was manufactured
by the granting of a marketing authorisation if, even
though it is regarded as a medicine in the Member
State of import, a marketing authorisation is com-
patible with the requirements of health protection,
also apply to the product at issue here, and does the
Court of Justice adhere to its view in the light of
subsequent Community law?

IV.

a)

In so far as the term ‘health risk’ is relevant to
the questions in sections II or III, or to other
applicable Community law, such as Articles 28
and 30 EC: Is the relevant threshold the ‘upper
safe level’ or should it be reduced, say, because
the substances in question are also ingested
with food and/or because — at least where
they are taken long-term — regard may have
to be had to the various consumer groups and
their different sensitivities? How are the words
‘reference intakes for the population’ within the
meaning of Article 5 of the Food Supplements
Directive to be defined?

b)

Is it an infringement of Community law for the
specialist authorities to have a discretion under
national law to determine (individual) upper
safe levels and any (individual) reductions that
is subject to only limited review by the courts?

V.

a)

If a product may be marketed in at least one
other Member State as a foodstuff, is the fact
that there is no ‘nutritional need’ for that
product in Germany significant in terms of the
freedom to market the product in Germany?

b)

If so, is it compatible with Community law
for the authority to have a discretion under
national
law that is subject to only limited
review by the courts?

VI.

If in regard to the questions posed in section III the
Court confirms the judgment in van Bennekom and
there is no incompatibility in this case with the
requirements of health protection, how can the
request for marketing authorisation be successfully
pursued? Can a decision of general application under
Paragraph 47a of the LMBG be refused, without
Community law being infringed, on the basis that
in the German classification system a product is
medicinal, whereas it can be marketed as a foodstuff
in the Member State where it was manufactured? Is
it compatible with Community law, and in particular
Articles 28 and 30 EC, not to apply the rule in
Paragraph 47a of the LMBG to such medicinal

15.11.2003

EN

Official Journal of the European Union

C 275/27

products analogously? If not, can the German State,
without thereby infringing Community law, evade
an obligation which a German court intends to
impose on it to adopt a decision of general appli-
cation under Paragraph 47a of the LMBG (applied
analogously) if it, or the authority responsible for
food but not medicines, objects that because in
the German classification system the product is
medicinal no decision of general application under
Paragraph 47a of the LMBG (analogously) may be
adopted,

because the body competent to adopt decisions
of general application under Paragraph 47a of
the LMBG is not competent for medicines also,

a)

b)

2.

If the Court of Justice concludes that the product in
question is medicinal, but that in those Member
States where it has hitherto been regarded as a
foodstuff it should continue to be a foodstuff, that
raises problems for the referring Chamber such as
those underlying the questions in B VI, in conjunc-
tion with those in B III. Reference is made to those
questions and the observations thereon and an
answer is requested.

B.

In the event that — as has been the case hitherto — the
questions posed in section A above are to be answered
not by the Court of Justice but by the national courts, the
replies are,
in this Chamber’s view, needed to the
following questions:

because the product is not authorised as a
medicine?

I.

a)

VII.

If the Court declines itself to reply to the questions
posed in section A, may the national court then
direct questions on the classification of products or
indeed scientific or methodological questions to the
European Food Authority and to what extent are
any guidelines provided by that authority binding
on the national court?

Reference for a preliminary ruling by the Oberverwal-
tungsgericht für das Land Nordrhein-Westfalen by order
of that Court of 7 July 2003 in the administrative
proceedings between Orthica BV against Bundesrepublik
Deutschland, represented by the Federal Ministry of
Consumer Protection, Nutrition and Agriculture; Inter-
vener: the representative of the public interest at the
Land Nordrhein-
für
Oberverwaltungsgericht
Westfalen

das

(Case C-317/03)

(2003/C 275/43)

the Court Registry on 24 July 2003,

Reference has been made to the Court of Justice of the
European Communities by order of the Oberverwaltungsge-
richt für das Land Nordrhein-Westfalen (Higher Administrative
Court for the Land of Nordrhein-Westfalen) of 7 July 2003,
received at
for a
preliminary ruling in the administrative proceedings between
Orthica BV against Bundesrepublik Deutschland, represented
by the Federal Ministry of Consumer Protection, Nutrition and
Agriculture; Intervener: the representative of the public interest
at
für das Land Nordrhein-
the Oberverwaltungsgericht
Westfalen on the following questions:

A.

1.

Is the contested product

‘Acid Free C-1000’

a foodstuff (perhaps in the form of a food sup-
plement) or a medicinal product? Is this finding
binding on all the Member States?

Is the contested product to be classified accord-
ing to the first and second paragraphs of
Article 2, in conjunction with point (d) of the
third paragraph of Article 2 of Regulation (EC)
No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down
the general principles and requirements of food
law, establishing the European Food Safety
Authority and laying down procedures in mat-
ters of food safety (OJ 2002 L 31, p. 1, ‘the
Basic Regulation’), or — once the period for
transposition expires on 31 July 2003 —
according to Directive 2002/46/EC of
the
European Parliament and of the Council of
10 June 2002 on the approximation of the
laws of the Member States relating to food
supplements (OJ 2002 L 183, p. 51, ‘the Food
Supplements Directive’), and if so according to
which parts of the directive?

If the first and second paragraphs of Article 2,
in conjunction with point
(d) of the third
paragraph of Article 2 of the Basic Regulation
applies, the following question arises: is it the
case that it is no longer the product’s main
(objective) purpose that is the decisive factor,
but rather that a product which meets the
criteria for both a food and a medicine is,
legally speaking, always — and only — a
medicinal product? How material
for these
purposes is the type of product and how
material the individual product?

How is the term ‘pharmacological effect’, which
is critical for the purposes of classification,
inter alia, under the first and second paragraphs
of Article 2, in conjunction with point (d) of
the third paragraph of Article 2 of the Basic
Regulation, to be defined for the purposes
of Community law? In particular, does the
definition include a requirement that there be a
health risk?

b) Now that Directive 2001/83/EC of the Euro-
pean Parliament and of the Council of 6 Nov-
ember 2001 on the Community code relating
to medicinal products for human use has,
by the second sentence of Article 1(2) (on
‘functional’ medicinal products), introduced the

b)

II.

a)