Citation: 2006 Eur. Food & Feed L. Rev. 17 2006
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EFFL 112006 Free Movement of Enriched Foodstuffs and Food Supplements 17
Free Movement of Enriched Foodstuffs and
Food Supplements in the European Union
BarbaraKlaus*
Especially in the food sector the establishing of a common market has been one of
the most noticeable achievements of the European Union so far.But it is also true
that the free movement offoodstuffs has not yet totally been realised.The present
articleaims to provide an overview of the principles offree movement offoodstuffs
in the European Union and the connected rightsfor economic operatorsin the food
sector, with particularregard to the manufacture and the marketing of enriched
foodstuffs andfood supplements.
I. Introduction
As is known, one of the European Community's
main tasks is to promote the economic activities of
the Member States by abolishing the existing
obstacles to the free movement of goods (see Art. 3,
para. 1 lit. c) and Art. 28-30 of EC Treaty). In this
regard, the free movement of foodstuffs in the
European Union is a very important economic aspect.
Differences between the food laws of the single
Member States may impede the free movement
of foodstuffs by creating unequal conditions for
competition. Therefore the European legislator is
proceeding in a quite determined way to harmonise
national food legislation and to establish
common concepts, principles and procedures in
this sector. For example, the adoption of Regulation
(EC) No. 178/2002 laying down the general
principles and requirements of food law and food
safety and establishing the European Food Safety
Authority1
means a very important step towards a
uniform European Food Law. This regulation indeed
has been followed by the adoption of numer*
Dr. Barbara Klaus is lawyer in the firm of meyer//meisterernst in
the Italien office in Milan: klaus@meyer-meisterernst.com.
1 Official Journal, 2002, L 31, p. 1; to this regard see also "Guidance
on the implementation of articles 11, 12, 16, 17, 18, 19
and 20 of Regulation (EC) No. 178/2002 on general food law.
Conclusions of the Standing Committee on the Food Chain and
Animal Health of 20 December 2004", available on the Internet:
http://europa.eu.int/comm/food/food/foodIaw/gu idance/
guidance rev 7 en.pdf.
2 The protection of consumers isan unwritten ground of justification,
see e.g. Judgment of the Court of 20 February 1979 in
Case 120/78, Rewe, Rec. 1979, p.
64 9
.
3 See Judgment of the Court of 12 July 1973 in Case 2/73,
Geddo/Ente Nazionale Risi, Rec.1 973, p. 865.
ous legal provisions at EU-level. Furthermore the
Court of Justice case law contributes significantly
to the application of the principle of free movement
of goods.
On the other hand, the free movement of foodstuffs
has not yet totally been realised. For, in practice,
numerous trade hurdles still exist. Indeed,
problems are rising again and again especially in
trade with food supplements and enriched foods.
It is therefore important to apply correctly the
principles of free movement of foodstuffs in the
European Union, especially as far as the companies
are concerned, but also for public authority monitoring
bodies.
II.Prohibition of quantitative
restrictions on imports and exports
Quantitative restrictions on imports and exports
between Member States and all measures having
the equivalent effect are prohibited by Art. 28 and
29 of the EC Treaty. Such a prohibition or restriction
on imports, exports or goods in transit may
only be allowed if justified on specific grounds (e.g.
protection of health and life of humans, animals or
plants or defence of consumer interests, 2
Art. 30 of
EC Treaty).
First of all, that means, that between the Member
States generally, all measures are forbidden, which
restrain (totally or partially) imports, exports or
goods in transit3
(quantitative restrictions). Furthermore,
national trading rules which are capable of
hindering, directly or indirectly, actually or potentially,
intra-community trade, are prohibited beFree
Movement of Enriched Foodstuffs and Food Supplements 1 17EFFL 112006
1 8-reMvmn fErchdFosuf n od upeet FL120
cause they are considered as measures having effect
equivalent to quantitative restrictions of imports.4
In the food sector, technical rules are particularly
likely to constitute barriers to the free movement of
foodstuffs, for example, rules relating to the composition
of the product, 5
its safety,6
the labelling,
presentation and advertising of the product,7
its
sales name8
and its packaging.9
Equally, national
measures are forbidden, which have as their specific
object or effect the restriction of patterns of
exports and thereby the establishment of a difference
in treatment between the domestic trade of a
Member State and its export trade in such a way as
to provide a particular advantage for national production
or for the domestic market of the state in
question at the expense of the production or of the
trade of other Member States (measures having
equivalent effect as quantitative restrictions).
1
0
All these measures, generally, are forbidden
between Member States, even if they may apply
without distinction both to domestic products and
to products from other Member States.1
1
Ill. Principle of mutual recognition
1. Ingeneral
The rules explained above has been interpreted and
applied also by the European Court of justice.
Already in 1979, in the famous case Cassis de
Dijon,1
2 which involved German legislation on the
minimum alcohol content of fruit liqueurs, the
Court of justice laid down the principle of mutual
recognition. According to this concept, a product
(e.g. a foodstuff) which is lawfully manufactured
and/or marketed in one Member State (or in Turkey
or in an EFTA State that is a contracting party to
the Agreement on the European Economic Area 1
3)
must be accepted in the other Member States even
though it is not in line with the domestic rules
(e.g. technical rules regarding the composition, the
labelling and presentation, the packaging). Only in
certain circumstances when it is necessary to satisfy
mandatory requirements (e.g. protection of public
health and consumer rights) Member States may
forbid the marketing of those imported products
provided that they do not guarantee an equivalent
level of protection.
However, it is important to emphasise that
the principle of mutual recognition is only applicable
when rules are not harmonised. When a matter
is regulated by Community Law any national
measure relating thereto must be assessed in the
light of the specific harmonising measure and not
by Art. 28-30 of the EC Treaty.14
In other words,
when there are uniform Community rules, Member
States shall not, for reasons related to their
composition, manufacturing specifications, presentation
or labelling, prohibit or restrict trade in
foodstuffs which comply with Community Law.
4 See Judgment of the Court of 11 July 1974 in Case 8/74, Dassonville,
Rec. 1974, p. 837; The European Court of justice confirmed
this case law in numerous judgments, see for example Judgment
of the Court of 23 September 2003 in Case C-192/01, Commission
v Denmark, Rec. 2003, p. 1-9693; Judgment of the Court of
29 April 2004 in Case C-387/99, Commission/Germany, Rec.
2004, p. 1-3751.
5 See Judgment of the Court of 14 July 1988 inCase C-90/86, Zoni,
Rec. 1988, p.4285; Judgment of the Court of 5April 2001 in
Case C-123/00, Bellamy, Rec. 2001, p. 1-2795.
6 See Judgment of the Court of 24 October 2002 inCase
C-121/2000, Hahn, Rec. 2002, p. 1-
9193
.
7 See Judgment of the Court of 15 July 2004 inCase C-239/02,
Douwe Egberts, Rec. 2004, p. 1-7007.
8 See Judgment of the Court of 5 December 2000, Case C-448/98,
Guimont, Rec. 2000, p. 1-10663.
9 See Judgment of the Court of 10 November 1982 inCase 261/81,
Rau/De Smedt, Rec. 1982, p. 3961.
10 See Judgment of the Court of 8 November 1979 in Case 15/79,
Groenveld, Rec. 1979, p.3409; Judgment of the Court of 9 June
1992 inCase C-47/90, Delhaize, Rec. 1992, p. 1-3669; Judgment
of the Court of 16 May 2000 in Case C-388/95, Rioja,
Rec. 2000, p. 3123; Judgment of the Court of 20 May 2003 in
Case C-108/01, Prosciutto di Parma, Rec. 2003, p.1-5121;
Judgment of the Court of 20 May 2003 inCase C-469/00, Ravil,
Rec. 2003, p. 5053; see also on this topic; Klaus/Meyer, Qualitdtsprodukte
auf dem Siegeszug oder: die Entwicklung der
EuGH-Rechtsprechung zum Schutz der Ursprungsbezeichnungen
bis zu den neuen Urteilen ,,Prosciutto di Parma" und
,,Grana Padano", Deutsche Molkerei Zeitung 2003, Heft 22, 23,
24; Capelli/Klaus, La tutela delle indicazioni geografiche nell'ordinamento
comunitario e in quello internazionale, Diritto
Comunitario e degli Scambi Internazionali 2004, p. 191.
11 See Judgment of the Court of 21 June 2001 inCase C-30/99,
Commission/Ireland, Rec. 2001, p. 4619.
12 See Judgment of the Court of Judgment 20 February 1979 in Case
120/78, Rewe, Rec. 1979, p. 649; see also Commission's interpretative
communication on facilitating the access of products to
the markets of other Member States: the practical application of
mutual recognition (Official Journal, 2003, C 265, p. 2).
13 To this regard see point 2.2. of Commission's interpretative communication
on facilitating the access of products to the markets
of other Member States: the practical application of mutual
recognition, cit. above.
14 See, in particular, Judgment of the Court of 13 December 2001
in Case C-324/99, DaimlerChrysler AG, Rec. 2001 p. I-9897.
18 1 Free Movement of Enriched Foodstuffs and Food Supplements EFFL 112006
EFFL 112006 Free Movement of Enriched Foodstuffs and Food Supplements 19
2. Application of the principle of mutual
recognition for the marketing
As far as enriched foodstuffs and food supplements
are concerned, their manufacturing and marketing
has only partially been harmonised at EU level.
With regard to the enrichment of foods (despite
of the use of food additives, an argument not considered
by the present explanations) there are only
specific harmonised rules on certain substances
that may be added for specific nutritional purposes
to dietary foodstuffs. The Directive 91/32-i/EEC on
infant formulae and follow-on formulae1 5
and the
Directive 9 6/5 /EC on processed cereal-based foods
and baby foods 1
6 include positive lists of nutritional
substances that may be added to the foods intended
for infants and young children up to three
years of age covered by these two specific directives.
Furthermore, Directive 200/I 5/EC1 7
applies
to all other dietary food groups that are covered by
Council Directive 89 /39 8/EEC 18
on foodstuffs intended
for particular nutritional uses. The use of
the substances in Directive 2001/1 5 /EC is permitted
15 Commission Directive 91/321/EEC of 14 May 1991 on infant
formulae and follow-on formulae (Official Journal 1991, L175,
p. 35).
16 Commission Directive 96/5/EC on processed cereal-based foods
and baby foods for infants and young children (Official Journal
1996, L 49, p. 17).
17 Commission Directive 2001/15/EC of 15 February 2001 on substances
that may be added for specific nutritional purposes in
foods for particular nutritional uses (Official Journal 2001, L 52,
p. 19).
18 Council Directive 89/398/EEC of 3 May 1989 on the approximation
of the laws of the Member States relating to foodstuffs intended
for particular nutritional uses (Official Journal 1990, L 275,
p. 42).
19 COM (2003) 671 final.
20 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 (Official Journal
2002, L 183, p. 51).
21 The Court of Justice has revealed no factor of such a kind as to
affect the validity of Directive 2002/46/EC, see Judgment of the
Court of12 July 2005 in Case C-154/04, Alliance for Natural
Health and others, as yet unpublished; to this regard see also
Capelli/Klaus, La direttiva sugli integratori alimentari e conforme
al diritto comunitario, nota alIa sentenza della Corte di giustizia
del 12 luglio 2005 nei procedimenti riuniti C-154/04 e C-155/04
(Alliance for Natural Health ed altri), Diritto Comunitario e degli
Scampi Internazionali, 2004, p. 437.
22 See Decreto ministeriale of 17 February 2005 (published in
Gazzetta Ufficiale No. 54 of 7 March 2005).
23 Maximum amounts of vitamins and minerals present in food
supplements are going to be set at Community level taking in
account the criteria established in Art. 5 of Directive
2002/46/EC.
for either all foods for particular nutritional uses
covered by the directive or only foods for special
medical purposes. The lists include the following
categories of nutrients: vitamins, mineral substances,
amino acids and other nitrogen compounds,
choline and inositol. Anyway, there are no specific
uniform rules on the enrichment of foodstuffs for
common use as yet. At the moment, there is only a
proposal for a regulation of the European Parliament
and of the Council on the addition of vitamins
and minerals and of certain other substances
to foods.19
For this reason, the principle of mutual
recognition is still applicable to the marketing of
enriched foodstuffs for common use.
As far as food supplements are concerned, Directive
2002/46/EC,2 0
as a first stage, has only laid
down specific common rules regarding the labelling,
presentation and advertising of food supplements
as well as rules for vitamins and minerals
used as ingredients of food supplements. Indeed, in
order to ensure a high level of protection for consumers,
only vitamins and minerals in the forms
listed in Directive 2002/46/EC may be used for the
manufacture of food supplements in the European
Union (Art. 4, para. 1 Directive 2002/46/EC).
2 1
Anyway,
it is important to emphasise that until 31 December
2009, Member States may allow the use (in
their territory) of vitamins and minerals not listed
in Directive 2002/46/EC provided that (a) the substance
in question has been used in one or more
food supplements marketed in the Community on
the date of entry into force of this Directive (12 July
2002) and (b) the European Food Safety Authority
has not given an unfavourable opinion in respect of
the use of that substance, or its use in that form,
in the manufacture of food supplements (Art. 4,
para. 6 Directive 2002/46/EC). Several Member
States (for example Italy22
) have adopted lists of
those (forms of) vitamins and minerals still allowed
in food supplements manufactured and marketed
in their territory. Therefore, also as far as the use of
vitamins and minerals in food supplements is concerned,
at the moment different national rules still
exist. Furthermore, harmonised maximum and minimum
amounts of vitamins and minerals present
in food supplements per daily portion of consumption
as recommended by the manufacturer are still
missing at EU level.23
In addition, no specific rules
have been laid down by Community Law for
other nutrients than vitamins and minerals or substances
with a nutritional or physiological effect
Free Movement of Enriched Foodstuffs and Food Supplements 1 19EFFL 112006
20 FreMvmn-fErcedFosuf n odSupeet FL120
that might be present in food supplements (e.g.
such as amino acids, essential, fatty acids, fibre and
various plants and herbal extracts).2 4
As these specific
matters are not yet completely regulated by
Community Law, the principle of mutual recognition
is still applicable.
3. Extent of the principle of mutual
recognition
a. In general
Especially in the food sector, Member States have
always tried and still try to hinder the access of
foodstuffs (e.g. food supplements or enriched food)
manufactured and/or marketed in other Member
States into the domestic marked claiming that these
products do not fulfil the national (safety) requirements
and are not equal to the level of protection
that they guarantee their own citizens (human
health and consumer rights). Indeed, in those situations,
often national authorities refuse to allow a
product to be placed on the market or order its withdrawal
from the market, obliging the economic
operator to refrain from marketing the product in
that Member State. The result is uncertainty, which
can act as an important barrier to gaining access to
that market. Therefore, it is very important that economic
operators as well as national authorities
know to what extent products legally manufactured
and marketed in a Member State may be commercialised
in another Member State even if they do
not fulfil all the national rules of that state.
In following the extent of the principle of mutual
recognition according to the Court of Justice case
law and the Commission's interpretation 25
will be
synthesised.
b. Verification of the equivalence of the level of
protection of the imported product
The economic operators' right to commercialise
their products legally manufactured and marketed
in one Member State also in the others is not an
absolute right. The Member State of destination has
the right to verify if the level of protection of the
product (e.g. a food supplement or an enriched
foodstuff) imported from another Member State is
equivalent to that provided by its own national
rules.2 6
This supervision must be based on objective
and non-discriminatory criteria which are
known in advance. 2 7
Consequently, the criteria
should be duly published or easily available and the
supervision should be exercised in the framework
of a procedure that is as short, effective and inexpensive
as possible.
For example, in order to be able to verify if the
imported foodstuff conforms to the rules of the
Member State of origin, the authorities of the
Member State of destination may ask the economic
operator to provide the relevant technical information
as well as some product samples. Obviously, if
the economic operator has proof of the conformity
such as a written confirmation from an authority of
the Member State of origin, it would be useful for it
to be transmitted to the relevant authority of the
Member State of destination. On the other hand,
national authorities of the Member State of destination,
generally may not impose the official attestation
of conformity as a condition for marketing
the relevant product on the domestic market.28
Furthermore, it cannot duplicate controls which
have already been carried out in the context of
other procedures, either in the same State, or in
another Member State.2 9
Rather, according to that
Court of Justice case law, the following must be
taken into account:30
(a) the checks carried out by a
24 Not later than 12 July 2007, the Commission shall submit to the
European Parliament and the Council a report on the advisability
of establishing specific rules, for those kinds of substances
used in food supplements (Art. 4, para. 8 Directive 2002/46/CE).
25 Commission's interpretative communication on facilitating the
access of products to the markets of other Member States: the
practical application of mutual recognition, cit. above.
26 See also point 4. of the Commission's interpretative communication
on facilitating the access of products to the markets of other
Member States: the practical application of mutual recognition,
cit. above.
27 See in particular Judgment of the Court of 22 January 2002 in
Case C-390/99, Canal Satelite Digital, Rec. 2002, p. 1-607.
28 See Judgment of 8 May 2003 in Case C-14/02, ATRAL, Rec.
2003, p. 1-4431. Such a restriction of free trade would only be
justified, if covered by one of the exceptions provided for in
Art. 30 ECTreaty or one of the overriding requirements recognised
by the case-law of the Court and, in either case, it must be
appropriate for securing the attainment of that objective and not
go beyond what is necessary in order to attain it.
29 See in particular Judgment of the Court of 22 January 2002 in
Case C-390/99, Canal Sat~lite Digital, cit. above. However, the
Member State of destination may always carry out additional
tests, but at its own expense, see in particular Judgment of the
Court of 16 November 2000, in Case C-217/99,
Commission/Belgium Rec. 2000, p. 1-10251.
30 See point 4.1. of the Commission's interpretative communication
on facilitating the access of products to the markets of other
Member States: the practical application of mutual recognition,
cit. above.
20 1 Free Movement of Enriched Foodstuffs and Food Supplements EFFL 112006
EFFL 112006 Free Movement of Enriched Foodstuffs and Food Supplements 21
competent authority in the Member State of origin;
(b) the technical or scientific analyses or laboratory
tests already carried out in a State of origin and
granted by an inspection or certification body legally
established there. The Member State of destination
will have the right to require additional tests
only under certain circumstances.
3 1
On the basis of the information obtained on the
product in question, the competent authority of the
Member State of destination may examine if and to
what extent its national technical rules must apply
to the imported product. If these data prove that the
level of protection is equivalent to that of the
Member State of destination, the marketing of that
product shall not be hindered. The technical rules to
which the product in question do not conform may
only be applied if necessary and proportional to protect
legitimate objectives such as consumer protection
and public health. Otherwise, national authorities
are obliged not to apply these technical rules to
a product coming from another Member State. To
this regard it is important to remember that, if the
Member State of destination decides that the product
should be refused access to its market, it shall:32
(a) inform the economic operator in writing of those
elements of the national technical rules which, in its
opinion, prevent the marketing of the product in
31 See point 4.1. of the Commission's interpretative communication
on facilitating the access of products to the markets of other
Member States: the practical application of mutual recognition,
cit. above.
32 See point 4.3. of the Commission's interpretative communication
on facilitating the access of products to the markets of other
Member States: the practical application of mutual recognition,
cit. above.
33 See for example Judgment of the Court of 23 February 1988 in
Case 216/84, Commission/France, Rec. 1988, p. 793; Judgment
of the Court of 14 July 1988 inCase 407/85, Drei Glocken
GmbH, Rec. 1988, p. 4233.
34 Judgment of the Court of 20 February 1979 in Case 120/78,
Rewe, cit. above.
35 Judgment of the Court of 17 March 1983 in Case 94/82, Kikvorsch,
Rec. 1983, p. 947.
36 Judgment of the Court of 19 February 1981 in Case 130/80, Kelderman,
Rec. 1981, p.527.
37 Judgment of the Court of 9 December 1981 inCase 193/80,
Commission/Italy, Rec. 1981, p. 3019; see also Judgment of the
Court of 15 December 1985 in Case 281/83, Commission/Italy,
Rec. 1985, p. 3397.
38 Judgment of the Court of 14 July 1988 in Case 407/85, Drei
Glocken GmbH, Rec. 1988, p. 4233; see also Judgment of the
Court of 14 July 1988 in Case 90/86, Zoni, Rec. 1988, p. 4285.
39 Judgment of the Court of 12 March 1987 in Case 178/84, Coin
mission/Germany, Rec. 1987, p. 1227; see also Judgment of the
Court of 12 March 1987, Case 176/84, Commission/Greece,
Rec. 1987, p.
1 1 9 3
.
question in the Member State of destination; (b)
prove the grounds for which the technical rule must
be imposed on the product to the economic operator;
(c)invite the economic operator to submit any
comments and duly take into account these comments
in the final decision; (d) notify the decision
restricting the marketing of the product to the
economic operator stating the methods of appeal;
(e) notify or inform the Commission of this decision.
In any case, the decision to refuse the access of a
foodstuff (e.g. food supplement or enriched food)
legally manufactured and/or marketed in another
Member State, must conform to the principle of
free movement of goods laid down in Art. 28-30 EC
Treaty as interpreted by the European Court of
Justice. To this regard, in the following, some examples
will be given.
c. National measures destined to protect
consumers' interests (misleading)
As far as national measures destined to protect consumers'
(economic) interests are concerned, according
to the Court of Justice case law, the prevention
from being misled may easily be ensured by appropriate
information on the label and/or the packag-
ing.33
Therefore, according to the Court of Justice
case law, the following national measures hindering
the free movement of foodstuffs may for example
not be justified on the grounds of consumer interests:
(a) the fixing of a minimum alcohol content
for alcoholic beverages intended for human consumption;
34
(b) the prohibition of the marketing of
any beer the acidity of which exceeds a certain
level, unless that beer is produced by processes traditionally
used in that part of the community to
obtain sour beer;35
(c) national rules which require
the quantity of dry matter in bread to fall within
specified sets of limits;36
(d) national legislation
which prohibits the marketing and importation of
vinegars of agricultural origin other than those
originating in the acetic fermentation of wine and
which restricts the designation "vinegar" to winevinegar;
3 7
(e) the extension to imported products of
a prohibition on the sale of "pasta" made from common
wheat or from a mixture of common wheat
and durum wheat; 38
(f) the restriction of the
German designation "Bier" (and its equivalents in
the languages of the other Member States) to beers
manufactured in accordance with the rules in force
in Germany;3 9
(g) national rules prohibiting cocoa
Free Movement of Enriched Foodstuffs and Food Supplements 1 21EFFL 112006
22 FreMvmn-fErcedFosuf n odSupeet FL120
and chocolate products which comply with the
requirements as to the minimum content laid down
in Council Directive 7 3 /24 1/EEC of 24 July 1973
from being marketed in Italy under the name used
in the Member State of production, and by requiring
that those products may only be marketed
under the name chocolate substitute; 40
(h) prohibition
of any statement alluding to sugar in the
labelling of artificial sweeteners; 41
(i) general prohibition
of references to health or slimming;42
(j)
legislation prohibiting the marketing of margarine
or edible fats where each block or its external packaging
does not have a particular shape (e.g. the
shape of a cube).
43
d. National measures destined to protect
consumer health
As is known, non-harmonised national measures
designed to protect consumer health still exist. It is
important to emphasise that in the absence of harmonisation,
Member States have the right to decide
on the level of protection of human health and life
they wish to guarantee.44
However, in these cases,
the Member States may apply their safety requirements
to imported products which are legally manufactured
and/or marketed in another Member
State only when specific criteria are fulfilled. First
of all such national measures have to be necessary
and appropriate to protect human health. Therefore,
national authorities, which invoke the need of
40 Judgment of the Court of 16 February 2003 in Case C-14/00,
Commission/Italy, Rec. 2003, p. 1-513; see also Judgment of the
Court of 16 February 2003 inCase C-12/00, Commission/Spain,
Rec. 2003, p.1-459; see to this regard Klaus, Wann d~irfen
Schokoladeerzeugnisse auch tatsdchlich unter dem Namen
"Schokolade" vermarktet werden?- Beitrag zum Urteil des
EuGH, 16. Januar 2003, C-14/00, DLR 2003, p. 365.
41 Judgment of the Court of 12 December 1990 inCase C-241/89,
SARPP, Rec. 1990, p. 1-4695.
42 See Judgment of the Court of 23 January 2003 in Case
C-221/00, Commission/Austria, Rec. 2003, p. 1-1007; Judgment
of the Court of 23 January 2003 inJoined Cases C-421/00,
C-426/00 and C-1 6/01, Sterbenz, Haug, e.a., Rec. 2003,
p. 1-1065; Judgment ofthe Court of 15 July 2004 in Case
C-239/02, Douwe Egberts, cit. above.
43 See Judgment of the Court of 10 November 1982 in Case
261/81, Rau/De Smedt, cit. above; see also Judgment of the
Court of 13 March 1984 in Case 16/83, Prantl, Rec. 1984,
p. 1299; Judgment of the Court of 4 December 1986, inCase
1 79/85, Commission/Germany, ECR 1986, p. 3879.
44 See for example Judgment of the Court of 5 February 1981 in
Case 53/80, Eyssen, Rec. 1984, p. 409; Judgment of the Court of
14 July 1983 in Case 174/82, Sandoz, Rec. 1983, p. 2445;
Judgment of the Court of 6 June 1984 in Case 97/83, Melkuni,
such a safety measure, shall demonstrate, on the
basis of scientific data available and the most recent
results of international research, that a certain foodstuff
or food ingredient pose a real risk to consumer
health and that state intervention is therefore necessary
to avert these risks.45
Furthermore, it must
be shown that human health may not be protected
equally effectively by less restrictive intra-Community
trade measures. In this context, it is necessary
to assess the protection provided by alternative
measures. The necessary risk assessment shall be
carried out on the common criteria set out by
Art. 14 of Regulation (EC) No. 178/2oo2.
With regard to correct risk management, it is
important to emphasise that the criterion of nutritional
need of the population of a Member State
requiring or not the addition of nutrients to the
foodstuffs concerned, may only play a role where
this addition may pose a real risk to public health.
On the other hand, the judgment of the Member
States relating to the protection of public health is
particularly autonomous where it is shown that
there is still uncertainty in the current state of scientific
research, such as certain nutrients (e.g. vitamins),
which are not generally harmful in them-
selves.46
However there may be risks in cases of
excessive consumption (precautionary principle).
As far as national measures regulating the use of
nutrients or of substances with a nutritional or
physiological effect in food supplements and in
foodstuffs for common use are concerned, partially
Rec. 1984, p. 2367; Judgment of the Court of 10 December
1985 in Case 247/84, Motte, Rec. 1985, p. 1-3887; Judgment of
the Court of 8April 1992 inCase C-95/89, Commission/Italy,
Rec. 1992, p. 1-4545; Judgment of the Court of 16 July 1992 in
Case C-344/90, Commission/France, Rec. 1992, p. 1-4719;
Judgment of the Court of 24 October 2002 inCase C-121/00,
Hahn, Rec. 2002, p.1-9193; Judgment of the Court of 23 September
2003 in Case C-1 92/01, Commission/Denmark,
Rec. 2003, p. 1-9693; Judgment of the Court of 5 February 2004
in Case C-24/00, Commission/France, Rec. 2004, p. I-1277;
Judgment of the Court of 5 February 2004 inCase C-95/01,
Greenham e Abel, Rec. 2004, p. 1-1333; Judgment of the Court
of 5 February 2004 in Case C- 24/00, Commission/France, cit.
above; Judgment of the Court of 2 December 2004 inCase
C-41/02, Commission/Netherlands, Rec. 2004, p. 1-11375.
45 See for example Judgment of the Court of 23 September 2003 in
Case C-192/01, Commission/Denmark, cit. above; Judgment of
the Court of 5 February 2004 inCase C-24/00, Commission/
France, cit. above; Judgment of the Court of 2 December 2004
in Case C-41/02, Commission/Netherlands, cit. above.
46 See for example Judgment of the Court of 23 September 2003 in
Case C-192/01, Commission/Denmark, cit. above; Judgment of
the Court of 5 February 2004 inCase C-24/00, Commission/
France, cit. above; Judgment of the Court of 2 December 2004
in Case C-41/02, Commission/Netherlands, cit. above.
22 1 Free Movement of Enriched Foodstuffs and Food Supplements EFFL 112006
EFFL 112006 Free Movement of Enriched Foodstuffs and Food Supplements 23
they still differ considerably. In particular, some
Member States require prior authorisation for the
marketing of foodstuffs enriched with such substances.
It is important to emphasise that, for food
supplements, the requirement of authorisation
would not be lawful anymore because Directive
2002/46/EC, which has harmonised the general
requirements of the manufacturing and marketing
of food supplements, only allows the prior notification
(see Art. 1o of Directive 2002/46/EC). With
regard to the enrichment of foodstuffs for common
use (e.g. with nutrients such as vitamins and minerals),
where uniform Community rules at the
moment do exist, according to the Court of Justice
case law the requirement of prior authorisation for
foodstuffs, that are legally manufactured and/or
marketed in another Member State, is justified only
under very strict conditions:47
(a) the prior authorisation
procedure must be readily accessible and
capable of being completed within a reasonable
time; (b) that procedure shall be expressly provided
for in a measure of general application which is
binding on the national authorities; (c) if the procedure
leads to a refusal, that decision must be open
to challenge before the courts; (d) a prohibition of
marketing the foodstuff is only justified where the
existence of the risk to public health can be shown.
For example, the Court of Justice has declared the
following national measures regulating the use of
certain substances do not conform to EU Law due
to not establishing that such foodstuffs entail a real
risk to consumer health and/or failing to fulfill the
47 See Judgment of the Court of 5 February 2004 in Case C-95/01,
Greenham eAbel, cit. above; Judgment of the Court of 5 February
2004 in Case C-24/00, Commission/France, cit. above.
48 Judgment of the Court of 11 May 1989 inCase 52/88, Commission/Belgium,
Rec. 1989, p. I-1137; Judgment of the Court of 11
July 1984 in Case 51/83, Commission/Italy, Rec. 1984, p. 2793.
49 Judgment of the Court of 19 June 2003 in Case C-420/01, Commission/Italy,
Rec. 2003 p. 1-6445.
50 Judgment of the Court of 23 September 2003 in Case C-192/01,
Commission/Denmark, cit. above.
51 Judgment of the Court of 5 February 2004 in Case C-24/00,
Commission/France, cit. above.
52 Judgment of the Court of 5 February 2004 in Case C-270/02,
Commission/Italy, Rec. 2004, p. I-1559.
53 Judgment of the Court of 2 December 2004 in Case C-41/02,
Commission/Netherlands, cit. above.
54 Judgment of the Court of 29 April 2004, inCase C-1 50/00,
Commission/Austria, cit. above.
55 Judgment of the Court of 29 April 2004, in Case C-387/99,
Commission/Germany, cit. above.
requirements of a simplified procedure; they therefore
may not be applied to foodstuffs legally manufactured
and/or marketed in another Member
State: (a) the prohibition in Belgium and Italy to
market foodstuffs containing a certain level of gelatine;4
8
(b) the prohibition on the marketing of energy
drinks in Italy containing caffeine in excess of a
certain limit;4 9
(c) the prohibition on marketing of
foodstuffs to which vitamins and minerals have
been added in Denmark;50
(d) the prohibition in
France of marketing certain foodstuffs, such as food
supplements and dietary products containing the
substances L-tartrate and L-carnitine, and confectionery
and drinks to which certain nutrients have
been added;51
(e) the requirement of prior authorisation
in Italy for marketing food products for
sportsmen and women without having shown that
it is necessary and proportionate; 52
(f) the Dutch
administrative practice under which foodstuffs for
everyday consumption fortified with certain vitamins
may be marketed only when they are neither
substitution products nor reconstituted foodstuffs
and only if that enrichment meets a nutritional
need in the population (in addition, without ascertaining
whether those fortified foodstuffs might be
a substitute for foodstuffs already marketed for
which the addition of those nutrients);53
(g) the
German and Austrian administrative practice under
which certain vitamin and mineral nutrient preparations,
which have been lawfully produced and/or
placed on the market as food supplements in other
Member States are classified as medicinal products
where they exceed the daily dose 54
or (Germany)
where the daily dose of such vitamins and minerals
is more than three times that recommended by the
German Gesellschaft ffir Ernahrung.
55
IV.Measures when the principle of free
movement of goods is not respected
There are several measures that can be taken when
Member States do not respect the principle of free
movement of goods.
1. Member State liability for damage
Member States are obliged to make good loss or
damage caused to individuals by breaches of Coin
munity Law for which they can be held responsiFree
Movement of Enriched Foodstuffs and Food Supplements 1 23EFFL 112006
24 FeI oemn fErchdFosufsadFo Splmns FL120
ble.56
Under certain conditions, economic operators,
who suffer damage from hindering their product,
legally manufactured and/or marketed in one
Member State, to be marketed in another Member
State, may ask for the payment of compensation.
2. Requests for a preliminary ruling
(Art. 234 of EC Treaty)
The authorities and courts in each Member State
are responsible for ensuring that Community Law
is properly applied in that country. If a national
court is in any doubt about the interpretation or
validity of a Community Law it may, and sometimes
must, ask the Court of Justice for advice. This
advice is given in the form of a preliminary ruling.
It has to be emphasised, that in the context of
requests for preliminary rulings, the Court of
Justice has no jurisdiction either to apply the EC
Treaty to a specific case or to decide upon the validity
of a provision of domestic law in relation to the
Community Law.5 7
Nevertheless, the Court has the
power to extract from a question imperfectly formulated
by the national court those questions
which alone pertain to the interpretation of Community
Law and may give an abstract answer that
then has to be observed by the national court in its
decision relating to the concrete case.
3. Proceedings for failure to fulfil an
obligation (Art. 226-228 of EC Treaty)
Otherwise, when case law regarding a specific
topic is quite clear, but authorities of one Member
State still do not apply Community Law principles,
economic operators may involve the European
Commission to get that Member State to fulfil its
obligations arising from European Law. Indeed,
when a Member State has failed to fulfil such an
obligation, the Commission or another Member
State can bring the matter before the Court of
Justice (Art. 227-228 EC Treaty). If the Court of
Justice should declare that a Member State has
failed to fulfil its obligations arising from Community
Law, this Member State must set things
right at once. If the Member State concerned fails
to take the necessary measures to comply with the
judgment the Commission may bring the case
again before the Court of Justice and ask for a lump
sum or penalty payment to be paid by that Member
State. However, in case of missing fulfilment of
Community obligations, also the economic operators
have possibilities to act. For example, they can
make a written complaint about this Member State
to the Commission describing the facts of non-fulfilment
and asking the Commission for intervention.
In fact, those complaints and the cooperation
between the economic operators and the Commission
have already led on several occasions to cases
being heard by the Court of Justice, which often
ended with a judgment stating the non-conformity
of certain national measures with Community Law.
56 See Judgment of the Court of 9 November 1995 in Case
C-479/93, Francovich, Rec.1 995, p.1-3843; Judgment of the
Court of 5 March 1996 in Case C-46/93, Brasserie du p~cheur,
Rec.1 996, p.1-1029.
57 Judgment of the Court of 15 July 1964 in Case 6/64,
Costa/E.N.E.L,
Rec. 1964, p.
11 4 1
.
24 1 Free Movement of Enriched Foodstuffs and Food Supplements EFFL 112006