CELEX: 62001CJ0095
Free movement of goods
Articles 28 EC and 30 EC
Prohibition on marketing foodstuffs to which vitamins and minerals have been added
Justification
Proportionality

By judgment of 19 February 2001, received at the Court on 27 February 2001, the Tribunal de grande instance de Paris (Regional
Court, Paris) referred to the Court for a preliminary ruling under Article 234 EC a question on the interpretation of Articles
28 EC and 30 EC.
That question was raised in the course of criminal proceedings against Mr Greenham and Mr Abel, joint directors of NSA France
SARL (hereinafter
NSA France), whose seat is in Paris (France), which distributes foodstuffs from NSA International, a company established in the United
Kingdom.
Legal background
Community legislation
It is common ground that at the time of the facts which gave rise to the main proceedings there were no provisions of Community
legislation laying down the conditions under which nutrients, such as vitamins and minerals, could be added to foodstuffs
for daily consumption.
As regards foodstuffs intended for particular nutritional uses, some are now covered by directives adopted by the Commission
under 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 (OJ 1989 L 186, p. 27).
National legislation
Article L. 213-1 of the French Code de la consommation (Consumer Code), in the version applicable to the main proceedings
provides that: Anyone, whether or not a party to the contract, who by any means or conduct whatsoever, even through a third party, deceives
or attempts to deceive a contracting party:
1.
as to the nature, type, origin, material qualities, composition or content in active principles of any goods,
2.
as to the quantity of items delivered or as to their identity by delivering goods other than those specified as the subject-matter
of the contract, or
3.
as to fitness for use, the risks inherent in the product's use, the checks made, the methods of use or the precautions to
be taken
shall be liable to imprisonment for two years or to a fine of FRF 250 000 or to both.
The French legislation applicable to the marketing of food supplements and foodstuffs for daily consumption fortified with
vitamins, minerals and other nutrients such as amino-acids is the Decree of 15 April 1912 laying down administrative regulations
for implementing the Law of 1 August 1905 to prevent deception in the sale of goods and adulteration of foodstuffs relating
to victuals, and particularly meat, prepared meat products, fruit, vegetables, fish and preserved foods.
Article 1 of the Decree, as amended by Decree No 73-138 of 12 February 1973 (JORF of 15 February 1973, p. 1728), provides:
It shall be an offence to possess with a view to sale, to put on sale or to sell any goods or foodstuffs intended for human
consumption to which chemical products have been added other than those whose use has been declared lawful by orders made
jointly by the Minister for Agriculture and Rural Development, the Minister for the Economy and Finance, the Minister for
Industrial and Scientific Development and the Minister for Public Health, on the advice of the Conseil supérieur d'hygiène
publique de France (French Public Health Authority,
the CSHPF) and the Académie nationale de médecine (National Academy of Medicine).
Decree No 99-242 of 26 March 1999 (JORF of 28 March 1999, p. 4653) amended the Decree of 15 April 1912 by substituting the
advice of the Agence française de sécurité sanitaire des aliments (French Food Safety Agency,
AFSSA) for that of the CSHPF and the Académie nationale de médecine.
Article 1 of Decree No 91-827 of 29 August 1991 on foodstuffs intended for particular nutritional uses (JORF of 31 August
1991, p. 11424) provides: Foodstuffs are regarded as being intended for particular nutritional uses if, as a result of their particular composition
or of a particular process in their manufacture, they are clearly different from foodstuffs for daily consumption, are suitable
for the stated nutritional purpose and are marketed in such a way as to indicate that they fulfil that purpose.
Article 3 of the same decree reads as follows: Joint orders made by the ministers responsible for consumer affairs, agriculture and health after obtaining the opinion of
the [CSHPF], shall determine:
(a)
The list and conditions for use of substances with a nutritional purpose, such as vitamins, minerals, amino acids and other
substances, which it is lawful to incorporate in foodstuffs intended for particular nutritional uses, as well as the standards
of purity which are applicable to those substances;
...
Decree No 97-964 of 14 October 1997 (JORF of 21 October 1997, p. 15266), which supplements the Decree of 15 April 1912, defines,
for the first time, food supplements as
products intended to be ingested in addition to the daily diet, in order to compensate for an actual or presumed insufficiency
of daily intake.
The main proceedings and the question referred for a preliminary ruling
Mr Greenham and Mr Abel were prosecuted for having committed, in the course of 1998, two offences relating to the sale of
foodstuffs.
First, they were charged with having displayed and put on sale allegedly adulterated foodstuffs by marketing products (food
supplements
Juice Plus + vegetable mixture and
Juice Plus + fruit mixture) to which had been added the substance coenzyme Q10, a nutrient whose addition is not authorised in France for human consumption,
and vitamins in quantities exceeding that of the recommended daily intake or exceeding the safety limits laid down by the
CSHPF.
Secondly, they were prosecuted for having misled consumers, in particular as to the material quality of the products, by marketing
meal substitutes
Juice Plus + Lite, chocolate and vanilla flavour which do not comply with the regulatory requirements applicable with regard to Commission Directive 96/8/EC of 26 February
1996 on foods intended for use in energy-restricted diets for weight reduction (OJ 1996 L 55, p. 22), particularly because
of an energy rating lower than the threshold set by the regulations and a deficiency of certain minerals.
The charges were based on two samples taken on 23 March 1998 by the Directorate-General for Competition, Consumers and Prevention
of fraud from foodstuffs marketed in France by NSA France.
Before the referring court, the defendants in the main proceedings argued, first, that the foodstuffs in question were already
lawfully marketed in the other Member States of the European Union when they took up their posts, and, secondly, that coenzyme
Q10 is permitted in, among others, Spain, Italy, Germany and the United Kingdom.  Therefore, the French authorities could
not prohibit the free movement and the marketing of those foodstuffs in France.
Since it considered that the outcome of the proceedings before it required an interpretation of Articles 28 EC and 30 EC,
the Tribunal de grande instance de Paris decided to stay the proceedings and to refer the following question to the Court
for a preliminary ruling: Must Articles 28 and 30 of the Treaty be interpreted as prohibiting a Member State from preventing the free movement and marketing
of a food supplement lawfully sold in another Member State?
The question referred
Observations submitted to the Court
The defendants in the main proceedings maintain that national legislation such as that at issue in the main proceedings, which
precludes the free marketing of food supplements lawfully marketed in another Member State although no serious health risk
has been proved, constitutes a measure having equivalent effect to a quantitative restriction, contrary to Articles 28 EC
and 30 EC.
They submit that the French authorities have been unable to prove that the national legislation is necessary in order to avoid
a serious risk to public health and that it cannot be replaced by a measure which is less restrictive of intra-Community trade,
such as labelling.
In addition, they argue that, contrary to the requirements of Community law, traders cannot obtain authorisation to market
those food supplements by a readily accessible procedure which can be completed within a reasonable time.
The French Government submits that a system prohibiting marketing without authorisation is compatible with Community law if
it meets certain requirements laid down thereby.  The authorisation procedure must be readily accessible, capable of being
completed within a reasonable time and permit refusals to be challenged before the courts.
It points out that in the main case no application for authorisation was submitted by NSA France, which, indeed, deliberately
proceeded to market the products in question without having previously submitted an application which could have been examined
by the French authorities.
The Greek Government submits that the mere fact that a particular food supplement is freely marketed in other Member States
is not sufficient for its marketing to be permitted automatically in the Member State concerned without undergoing the authorisation
procedure provided for for that purpose by the rules in force in that Member State.  The relevant national provisions can
and should lay down certain conditions for authorising the marketing of food supplements, whether they are produced in the
Member State concerned or imported from another Member State.  Such conditions can consist of a procedure for prior authorisation.
Whilst refraining from taking a position on the question referred, the Spanish Government observes that under its own food
legislation none of the products which are the subject of the question referred is regarded as a foodstuff and that, therefore,
they cannot be marketed freely on the Spanish foodstuffs market.  Moreover, the addition of coenzyme Q10 is not provided for
in that legislation.
The Commission submits that the addition to foodstuffs of a particular nutrient allowed in another Member State must be permitted
in a product imported from that State provided that, taking account of the results of international scientific research and
the nutritional habits in the Member State where it is imported, the nutrient does not pose a risk for public health.
According to the Commission, it is for the national court to decide whether the competent authorities of the Member State
concerned have evaluated the risks relating to the nutrients in question, thus enabling them to decide whether the legislation
relating to such nutrients is necessary for the effective protection of public health.
With regard to the main proceedings, it states that the referring judgment gives no indication as to either the safety limits
fixed by the CSHPF for the consumption of vitamins or how those limits were established.
In relation to coenzyme Q10, the Commission submits that no information has been produced concerning the public health risks
which the addition of that nutrient to a foodstuff could entail.
Reply of the Court
By its question, the referring court is asking, in essence, whether Articles 28 EC and 30 EC must be interpreted as meaning
that they preclude a Member State from prohibiting the marketing without prior authorisation of foodstuffs lawfully manufactured
and marketed in another Member State, if nutrients such as vitamins or minerals have been added thereto other than those whose
use has been declared lawful in the first Member State.
It must be observed at the outset that, while the main proceedings concern charges relating both to food supplements and to
meal substitutes, the question referred covers only food supplements to which have been added coenzyme Q10, whose addition
is not authorised in France, and vitamins in quantities exceeding the safety limits laid down by the CSHPF or exceeding the
recommended daily intake.
The free movement of goods between Member States is a fundamental principle of the EC Treaty which finds its expression in
the prohibition, set out in Article 28 EC, of quantitative restrictions on imports between Member States and all measures
having equivalent effect.
The prohibition set out in Article 28 EC on measures having an effect equivalent to restrictions covers all commercial rules
enacted by the Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community
trade (see in particular Case 8/74
Dassonville
[1974] ECR 837, paragraph 5, and Case C-192/01
Commission
v
Denmark
[2003] ECR I-0000, paragraph 39).
The file of the main proceedings seems to indicate that they concern foodstuffs imported from another Member State where they
are lawfully manufactured and/or marketed.  It is, however, for the national court, which alone has jurisdiction to determine
and evaluate the facts in the proceedings before it, to check that such is the case and that the rules and principles flowing
from the free movement of goods are indeed to be applied to those proceedings (see, to that effect, Case C-107/97
Rombi and Arkopharma
[2000] ECR I-3367, paragraph 72).
National rules such as those at issue in the main proceedings, which prohibit the marketing of foodstuffs to which nutrients
have been added, such foodstuffs being lawfully manufactured and/or marketed in the exporting Member State but prohibited
in the importing Member State, or which require that such substances have been previously included on a national list provided
for for that purpose in order that the marketing of the foodstuffs to which they have been added may be authorised, can be
justified, as a measure having equivalent effect to a quantitative restriction within the meaning of Article 28 EC, in so
far as they comply with the requirements of Article 30 EC, as interpreted by the Court.
First, such rules must make provision for a procedure enabling economic operators to have a nutrient included on the national
list of authorised substances.  The procedure must be one which is readily accessible and can be completed within a reasonable
time, and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts (see to that effect
Case C-344/90
Commission
v
France
[1992] ECR I-4719, paragraph 9, and today's judgment in Case C-24/00
Commission
v
France
[2004] ECR I-0000, paragraph 26).
Secondly, an application to obtain the inclusion of a nutrient on the national list of authorised substances may be refused
by the competent national authorities only if such substance poses a genuine risk to public health (see
Commission
v
Denmark
, cited above, paragraph 46).
It is of course for the Member States, in the absence of harmonisation and to the extent that there is still uncertainty in
the current state of scientific research, to decide on the level of protection of human health and life they wish to ensure
and whether to require prior authorisation for the marketing of foodstuffs, taking into account the requirements of the free
movement of goods within the Community (see
Commission
v
Denmark
, cited above, paragraph 42).
That discretion relating to the protection of public health is particularly wide where it is shown that there is still uncertainty
in the current state of scientific research as to certain nutrients, such as vitamins, which are not as a general rule harmful
in themselves but may have special harmful effects solely if taken to excess as part of the general diet, the composition
of which cannot be foreseen or monitored (see Case 174/82
Sandoz
[1983] ECR 2445, paragraph 17, and
Commission
v
Denmark
, cited above, paragraph 43).
However, in exercising their discretion relating to the protection of public health, the Member States must comply with the
principle of proportionality.  The means which they choose must therefore be confined to what is actually necessary to ensure
the safeguarding of public health; they must be proportionate to the objective thus pursued, which could not have been attained
by measures less restrictive of intra-Community trade (see
Sandoz
, paragraph 18, and
Commission
v
Denmark
, paragraph 45).
Furthermore, since Article 30 EC provides for an exception, to be interpreted strictly, to the rule of free movement of goods
within the Community, it is for the national authorities which invoke it to show in each case, in the light of national nutritional
habits and in the light of the results of international scientific research, that their rules are necessary to give effective
protection to the interests referred to in that provision and, in particular, that the marketing of the products in question
poses a real risk to public health (see to that effect
Sandoz
, paragraph 22, Case 227/82
Van Bennekom
[1983] ECR 3883, paragraph 40, and
Commission
v
Denmark
, paragraph 46).
A prohibition on the marketing of foodstuffs to which nutrients have been added must therefore be based on a detailed assessment
of the risk alleged by the Member State invoking Article 30 EC (see
Commission
v
Denmark
, paragraph 47).
A decision to prohibit the marketing of a fortified foodstuff, which is in fact the most restrictive obstacle to trade in
products lawfully manufactured and marketed in other Member States, can be adopted only if the alleged real risk for public
health appears to be sufficiently established on the basis of the latest scientific data available at the date of the adoption
of such decision.  In such a context, the object of the risk assessment to be carried out by the Member State is to appraise
the degree of probability of harmful effects on human health from the addition of certain nutrients to foodstuffs and the
seriousness of those potential effects (see
Commission
v
Denmark
, paragraph 48).
It is clear that such an assessment of the risk could reveal that scientific uncertainty persists as regards the existence
or extent of real risks to human health.  In such circumstances, it must be accepted that a Member State may, in accordance
with the precautionary principle, take protective measures without having to wait until the existence and gravity of those
risks are fully demonstrated (see to that effect Case C-157/96
National Farmers' Union and Others
[1998] ECR I-2211, paragraph 63).  However, the risk assessment cannot be based on purely hypothetical considerations (see
Case C-236/01
Monsanto Agricoltura Italia and Others
[2003] I-0000, paragraph 106, and
Commission
v
Denmark
, paragraph 49).
At the hearing, the French Government stated that NSA France had been informed by letter of 21 October 1996 that the Opinion
of the CSHPF had not been in favour of the addition of coenzyme Q10 to human food, following an application by another economic
operator for authorisation to place on the market.  According to that Government, the Opinion, dated 11 June 1996, is based
on the absence of nutritional need as regards the addition of coenzyme Q10 and, above all, on the lack of toxicological data
on the effects of that substance.
It also argued at the hearing that the French authorities' reasoning with regard to applications for authorisation concerning
the addition of nutrients to foodstuffs is based on the conclusion that there is no reason to authorise the marketing of a
foodstuff to which have been added such substances, which, even if at present they pose no danger to public health, are none
the less capable of giving rise to such a risk in future, especially as such substances bestow no nutritional benefit.
While it is true that the Court has observed that, in a context of scientific uncertainty, the criterion of the nutritional
need of the population of a Member State can play a role in its detailed assessment of the risk which the addition of nutrients
to foodstuffs may pose for public health, the absence of such a need cannot, by itself, justify a total prohibition, on the
basis of Article 30 EC, on marketing foodstuffs lawfully manufactured and/or marketed in other Member States (see
Commission
v
Denmark
, paragraph 54).
Moreover, as noted in paragraphs 41 to 43 of this judgment, a prohibition on marketing foodstuffs to which nutrients have
been added must be based on a detailed assessment of the real risk to public health alleged by the national authorities invoking
Article 30 EC, established on the basis of the most reliable scientific data available and the most recent results of international
research (see
Commission
v
Denmark
, paragraph 51).
Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency,
inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists
should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (see
Commission
v
Denmark
, paragraph 52).
It is for the referring court to determine whether, in the legal and factual circumstances obtaining in the Member State concerned,
the prohibition on marketing the foodstuffs in question satisfies the requirements of Community law in order that the restriction
on the free movement of goods may be justified.
Having regard to all those considerations, the reply to the question referred must be that Articles 28 EC and 30 EC must be
interpreted as meaning that they do not preclude a Member State from prohibiting the marketing without prior authorisation
of foodstuffs lawfully manufactured and marketed in another Member State, where nutrients such as vitamins or minerals have
been added thereto other than those whose use has been declared lawful in the first Member State, provided that certain conditions
are satisfied. First, the prior authorisation procedure must be readily accessible and capable of being completed within a reasonable time
and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts.  Secondly, refusal to
authorise marketing must be based on a detailed assessment of the risk to public health, based on the most reliable scientific
data available and the most recent results of international research.
Costs
The costs incurred by the French, Greek and Spanish Governments and by the Commission, which have submitted observations to
the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the proceedings
pending before the national court, the decision on costs is a matter for that court.
On those grounds,
THE COURT (Sixth Chamber),
in answer to the question referred to it by the Tribunal de grande instance de Paris by judgment of 19 February 2001, hereby
rules: Articles 28 EC and 30 EC must be interpreted as meaning that they do not preclude a Member State from prohibiting the
marketing without prior authorisation of foodstuffs lawfully manufactured and marketed in another Member State, where nutrients
such as vitamins or minerals have been added thereto other than those whose use has been declared lawful in the first Member
State, provided that certain conditions are satisfied. First, the prior authorisation procedure must be readily accessible
and capable of being completed within a reasonable time and, if it leads to a refusal, the decision of refusal must be open
to challenge before the courts. Secondly, refusal to authorise marketing must be based on a detailed assessment of the risk
to public health, based on the most reliable scientific data available and the most recent results of international research.
Skouris
Gulmann
Puissochet
Macken
Colneric
Delivered in open court in Luxembourg on 5 February 2004.
R. Grass
V. Skouris
Registrar
President
–
Language of the case: French.