Case C-211/03: Reference for a preliminary ruling by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of that Court of 7 May 2003 in the administrative proceedings between HLH Warenvertriebs GmbH and Bundesrepublik Deutschland; Intervener: The representative of the public interest at the Oberverwaltungsgericht für das Land Nordrhein-Westfalen
Date: 2003-08-23
Institutions: Court of Justice
Subjects: Germany, consumer protection, food supplement, interpretation of the law, marketing, medicinal product, product designation

C 200/8

EN

Official Journal of the European Union

23.8.2003

The Commission's analysis ignored its obligation, before
claiming overpayment or overfinancing had occurred, to
take into account the actual costs of the eligible projects
and the actual matching co-funding and the correct
exchange calculations from the Irish authorities before
Ireland breached the 75 % ESF
determining whether
funding limit.

is submitted that

It
the Commission to
the failure of
accept the Applicant's explanations in this case amounts
to a breach of a fundamental rule of law relating to the
operation of the structural funds and the principles iden-
tified by the Commission in the context of the Decision.

It is submitted that the approach adopted by the Commis-
sion is out of all proportion to the result intended to be
achieved having regard to the ongoing efficacy of
the
projects in issue and the nature of the project beneficiary.
Such an approach effectively amounts to the imposition
of a penalty in circumstances where the beneficiary is
innocent of any wrongdoing.

it is submitted that the Commission's approach
legal certainty and

the principles of

Finally,
fails
to respect
legitimate expectations.

2.

3.

4.

Reference for a preliminary ruling by the Oberverwal-
tungsgericht für das Land Nordrhein-Westfalen by order
that Court of 7 May 2003 in the administrative
of
proceedings between HLH Warenvertriebs GmbH and
Bundesrepublik Deutschland; Intervener: The representa-
tive of the public interest at the Oberverwaltungsgericht
für das Land Nordrhein-Westfalen

(Case C-211/03)

(2003/C 200/14)

Justice of

the
Reference has been made to the Court of
European Communities by order of
the Oberverwaltungsge-
richt für das Land Nordrhein-Westfalen (Higher Administrative
Court for the Land of Nordrhein-Westfalen) of 7 May 2003,
received at the Court Registry on 15 May 2003, for a preli-
minary ruling in the administrative proceedings between HLH
Warenvertriebs GmbH and Bundesrepublik Deutschland; Inter-
vener: The representative of the public interest at the Oberver-
waltungsgericht
für das Land Nordrhein-Westfalen (Higher
Administrative Court for the Land of Nordrhein-Westfalen) on
the following questions:

condition in which it is imported the determining
factor?

3.

4.

that

If the Court of Justice concludes that the product in
in those Member
question is medicinal, but
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.

If ‘Lactobact omni FOS’ is a foodstuff (food supple-
ment), is it then a novel food within the meaning of
Regulation (EC) No 258/97 of the European Parlia-
ment and of
the Council of 27 January 1997
concerning novel foods and novel food ingredients
‘the Novel Foods Regulation’)?
(OJ 1997 L43, p. 1,
What is the relationship between the various legal
bases?

B

In the event that — as has been the case hitherto — the
questions (as to classification) posed in section A above
are to be answered not by the Court of Justice but by the
national courts, guidance is none the less sought on how
correctly to resolve the questions in A 2 from a Commu-
nity law standpoint,
in so far as Community law is
applicable.

In addition the following questions arise:

I

a)

in

of

the

with

Article

to be

Regulation

contested product

conjunction
(3)(d),

Is
classified
according to Article 2, subparagraphs (1) and
2,
(2),
subparagraph
(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
establishing the European Food Safety
law,
in
Authority
and laying down procedures
‘the
matters of food safety (OJ 2002 L31, p. 1,
Basic Regulation’), or — once the period for
transposition expires on 31 July 2003 —
according to Directive 2002/46/EC of
the
the Council of
European Parliament and of
10 June 2002 on the approximation of
the
laws of
the Member States relating to food
‘the Food
supplements (OJ 2002 L 183, p. 51,
Supplements Directive’), and if so according to
which parts of the directive?

A.

1.

Is the contested product

‘Lactobact omni FOS’

b)

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

2.

it

Is
that,
relevant when classifying the product
according to the directions for use, it is intended to
is the
be dissolved in water or

in yoghurt? Or

(1) and (2),

subparagraphs

in
If Article 2,
conjunction with Article 2, subparagraph (3)(d),
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
legally speaking, always — and
medicine is,
only — a medicinal product? How material for
these purposes is the type of product and how
material the individual product?

23.8.2003

EN

Official Journal of the European Union

C 200/9

II

How is the term ‘pharmacological effect’, which is
inter alia,
critical for the purposes of classification,
under Article 2,
in
subparagraphs
conjunction with Article 2, subparagraph (3)(d) of
the Basic Regulation, to be defined for the purposes
of Community law?

(1) and (2),

In particular, does the definition include a require-
ment that there be a health risk?

III Does the view expressed by the Court of Justice in
Case C-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 compa-
tible with the requirements of health protection, also
apply to probiotic products of the kind 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?

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, subject
only to review by the courts?

V

a)

b)

If a product may be marketed in at least one
other Member State as a foodstuff,
is the fact
that the competent German authority essentially
says that in Germany that there is no ‘nutri-
tional need’ for that product significant in terms
of
the product as a
foodstuff (food supplement) in Germany?

the freedom to market

authority

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

law that

to have

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
is
in the German classification system a product

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
evade an obligation to act intended by a German
court
to adopt a decision of general application
under Paragraph 47a of the LMBG (applied analo-
gously) without
there being any infringement of
it, or the authority responsible
Community law if
for food but not medicines, objects that no decision
of general application under Paragraph 47a of the
LMBG (analogously) may be adopted because in the
German classification system a product is medicinal,

a)

the body competent

on the ground that
to
adopt decisions of general application under
Paragraph 47a of the LMBG is not competent
for medicines also,

b)

because the product
medicine?

is not authorised as a

VII

If as a result of the Court's replies it transpires that
the product
(including,
in question is a foodstuff
possibly, a food supplement) but is in any event not
a medicine, questions will arise for the Chamber on
the on the applicability of the Novel Foods Regula-
tion, which takes precedence over Paragraph 47a of
the LMBG, and the effect of which may be to
remove any interest in legal protection in this case.
The Chamber therefore asks:

How is the phrase ‘which have not hitherto been
used for human consumption to a significant degree’
in Article 1(2) of the Novel Foods Regulation to be
interpreted? Is it sufficient that the Netherlands Offi-
cial Gazette of 16 February 1995 declared trading in
a probiotic similar to the contested product called
Ecologic 316 to be permissible and that, according to
the invoice of 20 May 1996 a delivery of Ecologic
326 was made to the applicant, or alternatively what
are the minimum requirements that must be met in
order for there to have been use to a significant
degree hitherto for the purposes of Article 1(2) of
is the starting
the Novel Foods Regulation? What
point for interpreting the words ‘not hitherto’?

VIII

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? Can (or must) such guidelines be
reviewed by the Community judicature alone or by
the referring national court also?