delivered on 25 February 1986 (*1)

Mr President,

Members of the Court,

1.After samples had been taken of a consignment of a ‘special primary preparation’ called ‘Phénix’ used in the manufacture of cakes and pastries, which was imported from Germany by Kampfmeyer-France SARL, the French antifraud authorities found that it contained an emulsifying additive, ‘E 475’, not referred to on the packaging, which, however, bore the words ‘conforms to French legislation’ followed by the list of ingredients.

Since the use of that emulsifier in foodstuffs was not permitted in France, criminal proceedings were brought against Kampfmeyer-France SARL in the person of its manager, Claude Müller, before the tribunal correctionnel [Petty Sessional Court], Strasbourg, which inter alia imposed a fine. The importer appealed against the conviction relying on the provisions of Council Directive 74/329/EEC of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (Official Journal 1974, L 189, p. 1) and the provisions of Article 30 of the EEC Treaty.

The cour d'appel [Court of Appeal] Colmar is unsure whether those provisions apply in view of the prohibition in France on the use of the additive E 475. It has therefore submitted the following two questions to the Court:

(1)‘(1) Is the effect of Council Directive No 74/329 of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs to prevent a Member State from prohibiting the use of one of the substances listed in Annex 1 thereto, and, if not, in what circumstances may such a prohibition be permitted under Community law?

(2)May a Member State which has properly prohibited the use of one of the substances listed in Annex 1 prevent the importation and marketing in its national territory of a product containing such a substance manufactured in another Member State in conformity with Community legislation on grounds other than those set out in Article 8 (4) of the Directive of 18 June 1974 without infringing Article 30 of the Treaty of Rome?’

2.Article 1 of the French Decree of 15 April 1912 (JORF of 29 June 1912) prohibits the offer for sale of foodstuffs ‘containing chemical additives ... other than those the use of which is declared lawful’ by inter-ministerial orders made ‘after consultation with the Conseil supérieur d'hygiène publique de France and the Académie nationale de médecine’. That prohibition has been extended to imported products.

A circular of 8 August 1980 (JORF of 25 September 1980, NC p. 8544) sets out the conditions for making ‘applications for authorization to use substances intended to be added to foodstuffs (additives and processing aids)’; it specifies what such applications must contain, having regard in particular to the needs of users and consumers, the specific properties of the additives and their harmlessness.

The principle of the French legislation is thus that all additives are prohibited other than those which are expressly authorized. Such a system is thus similar to that applied in Belgium which was the subject of the recent judgment of the Court in Case 247/84 Ministère public v Léon Motte [1985] ECR 3887 (see in particular paragraph 6 thereof). As in that case, it is thus necessary to point out that the question of interpretation in the present case does not concern the ban on the use of additive E 475 in foodstuffs but the question whether national legislation based on the principle that the use of an additive is banned unless it is previously authorized is compatible with Community law.

The question to be examined is therefore whether, in view of the provisions of Directive No 74/329 or, if they do not apply, of Articles 30 and 36 of the EEC Treaty, a Member State may maintain such a ban even when it has not had to take a decision with regard to an application for authorization to use the additive in question.

3.There is no doubt that Directive 74/329 allows Member States to maintain such a ban and to reject an application for authorization.

Like the three other basic directives on additives — Council Directive of 23 October 1962 on colouring matters (Official Journal, English Special Edition 1959-1962 p. 279), Council Directive 64/54 of 5 November 1963 on preservatives (Official Journal, English Special Edition 1963-1964, p. 99) and Council Directive 70/357 of 13 July 1970 on antioxydants (Official Journal, English Special Edition 1970 (II), p. 429) — the directive on emulsifiers is intended to further the approximation of national laws whose disparities may hinder the free movement of foodstuffs and creat conditions of unfair competition. The harmonization must give priority first of all to ‘the protection of public health’, then to ‘the protection of the consumer against falsification’ and, ‘so far as health protection allows’, to ‘economic and technological needs’ (third recital).

For that purpose the directive envisages two stages :

—‘as a first stage, ... the establishment of a single list of emulsifiers, stabilizers, thickeners and gelling agents which may be authorized by the Member States for the treatment of foodstuffs... ’ (fourth recital);

—‘during a second stage’, the Council must decide on conditions for the use of each of the agents or in other words the foodstuffs to which they may be added and the conditions under which they may be added (sixth recital and Article 4).

During the first stage, the directive prohibits the Member States from authorizing the use of additives not expressly listed in Annex I thereto. On the other hand, it in no way requires them to authorize the use of every additive referred to therein. In this regard, the title of the directive, the wording of the fourth recital of its preamble and Annex I are unambiguous: it is a question only of drawing up a list of agents ‘which may be used in foodstuffs’. That literal interpretation is confirmed by Article 2 (1) which states that ‘Member States shall authorize the use as emulsifiers, stabilizers, thickeners and gelling agents in foodstuffs intended for human consumption, of only those substances listed in Annex I... ’. The initial purpose of the directive is therefore solely to require the Member States to refrain from doing something.

However, since the Council has still not adopted the measures needed to pass to the second stage of harmonization, the Member States must for the time being determine not only the foodstuffs to which the additives may be added but also the conditions under which they may be used.

Does the latitude which they are thus given still allow them to maintain a ban on use? Unlike the three other directives on additives, which in giving such latitude prohibit the Member States (in respectively Articles 1 (2), 2 (2) and 9) from completely excluding the use of one of the additives listed in their annexes, Directive 74/329 contains no provision of that kind.

In Kampfmeyer's view, the absence of such a provision cannot be interpreted as giving the Member States freedom to impose a general and absolute ban without impairing the effectiveness of the directive.

That argument must be rejected. In its judgment in Case 88/79 Ministère public v Grunert [1980] ECR 1827 and in Case 108/80 Ministère public v Kugelmann [1981] ECR 433 the Court placed a token limit on the right of the Member States to regulate the use of additives based on the express proviso in Articles 2 (2) and 9 of the directives on preservatives and antioxydants. Consequently, it must be recognized that, in the absence of a provision of the same kind in Directive 74/329, there is nothing to prevent a Member State from maintaining a complete ban on the use of one of the additives listed in Annex I, such as the ban imposed by the national legislation in question. As far as those additives are concerned, the reservation cannot be inferred from the provisions or the scheme of the directive but must be inferred from the general interim powers retained by the Member States during the first stage of harmonization as a result of the Council's inaction.

As regards the directive's effectiveness at the first stage of the approximation of laws envisaged by the directive, this clearly resides in the prohibition imposed on the Member States preventing them from authorizing any additive not mentioned in Annex I. In addition, the Member States are bound by the provisions of the directive each time when, following an application, for example, they authorize the use of one of the additives referred to in Annex I. In such a case, the harmonization for which it provides, even though embryonic, has the following two effects.

First, a Member State which intends to withdraw authorization which it has granted is now required to observe the Community procedure for temporarily suspending the authorization to use a particular additive; the Council, acting unanimously, may then decide to impose a permanent ban (Article 5 of the directive). A Member State must follow that Community procedure in order to prohibit the use of an additive previously authorized.

Secondly, the directive provides that the Member States may not prohibit the importation of an additive listed in Annex I ‘for the sole reason that they consider the labelling inadequate’ if it satisfies the conditions laid down in the directive itself (Article 8 (4)).

Obviously, those provisions, let us remember, apply only to additives listed in Annex I, the use of which has been authorized by a Member State; the directive, as applied at present, allows the Member State to maintain any previous prohibition.

4.In the present state of Community law, it must therefore be recognized that Directive 74/329 does not affect the power of Member States to maintain a ban on use within their territory unless previous authorization of use has been granted.

However, if the prohibition is extended to foodstuffs imported from another Member State where the use of the additive is lawfully authorized, the Member States' discretion is limited by the rules of Community law on the free movement of goods.

According to established case-law, such a ban on use may hinder directly or indirectly, actually or potentially, intra-Community trade and may thus constitute a measure having an effect equivalent to a quantitative restriction on imports prohibited by Article 30 of the EEC Treaty. However, if based on the need to protect human health, it may be justified under the derogating provisions contained in Article 36 of the EEC Treaty if the requirements thereof are observed (Case 53/80 Officier van Justitie v Koninklijke Kaasfabriek Eyssen BV [1981] ECR 409; Case 174/82 Sandoz BV[1983] ECR 2445; Case 227/82 van Bennekom [1983] ECR 3883; Case 247/84 Motte cited above).

It is not disputed that the application to foodstuffs imported from another Member State in which the additive in question could be lawfully authorized of legislation based on the principle that an additive is prohibited unless previously authorized, such as the legislation in question, constitutes an obstacle to trade contrary to the principle laid down in Article 30 of the Treaty. Since, as has already been emphasized, the harmonization achieved by the directive is incomplete, assessment of the compatibility of that legislation with Community law will ultimately depend solely on the scope of the derogation in Article 36 of the Treaty (Case 247/84 Motte paragraphs 16 and 17). The Court's case-law has set narrow limits within which such a ban must remain in order to be justified.

After stating that, as far as additives are concerned, ‘only a small degree of Community harmonization has been achieved and that harmonization reveals great prudence on the part of the Community legislature regarding the potential harmfulness of such substances’, in view in particular of the uncertainties which may still exist ‘in the present state of scientific research’ the Court, following a line of cases, held that:

‘... it is for the Member States, in the absence of harmonization, to decide what degree of protection of the health and life of humans they intend to assure, having regard however to the requirements of the free movement of goods within the Community’ (Case 247/84 Motte cited above, paragraphs 18 and 19, my emphasis).

However legitimate may be a Member State's concern to ensure, in order to mitigate the absence of uniform rules, ‘the protection of health and life of humans’ referred to in Article 36 of the EEC Treaty, the. Member State must observe ‘the principle of proportionality which underlies the last sentence of Article 36 of the Treaty’ (Sandoz, at paragraph 18), according to which ‘prohibitions or restrictions shall not... constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States’.

More particularly, to be justified under Article 36 a prohibition on use without prior authorization must be based, on the one hand, on an assessment of the need which the additive meets, which may be technological, economic, organoleptic or even psychological, and, on the other hand, on ‘a scientific evaluation of the risk... for human health’, which would arise from the use of the additive. Furthermore, it should be restricted ‘to what is necessary to attain the legitimate aim of protecting health’ so that ‘authorizations to market such products should be granted when they are compatible with that aim’ (Motte, paragraphs 21, 22 and 23).

Finally, the Court has also stated that, where an application for prior authorization is made, the Member State must show ‘in each instance’ that all the conditions for the application of Article 36, as described, are satisfied (Case 174/82 Sandoz paragraph 21 et seq.; Case 227/82 van Bennekom, paragraph 40).

In my view, in order to comply with the requirements of Article 36, a ban as so delimited in the case-law of the Court must in the first place allow manufacturers and traders to obtain marketing authorization. If the ban could not be changed by means of a procedure to obtain authorization, the Member State would be freed from its obligation to prove with regard to each foodstuff that the additive is dangerous or has no usefulness, which are the essential conditions for the application of Article 36 of the EEC Treaty. In the second place, irrespective of the technological or other need that the additive meets, the ban must be based on the existence of a risk to human health. On the other hand, authorization must always be granted if the use of the additive satisfies both tests of usefulness and harmlessness (Motte, paragraph 24).

Since they are not of equal importance, there must be an order of priority between those two tests. The protection of human health is the prime requirement which needs to be satisfied. The logic of Article 36 and the third recital of the preamble to the directive require it. What is more, the Court has interpreted the term ‘need’ widely and takes it to mean not only technological or organoleptic needs but also economic or psychological needs. Although the existence of a ‘real need’ may suffice (Motte, paragraph 24), the safety test which must be applied owing to a possible risk to human health must be the summa conditio for any decision regarding imports.

5.Let us now consider the facts of the present case in the light of the case-law of the Court.

As we know, additive E 475 cannot be used in French territory or therefore imported as such or in a foodstuff, if its use has not been previously authorized; authorization will be granted only if there is a real need for the additive and it entails no risk to health.

However, where this emulsifier is concerned, the application of those two tests must be considered in the light of the findings of the Scientific Committee for Food set up by Commission Decision No 74/234 of 16 April 1974 (Official Journal 1974, L 136, p. 1).

The Commission and the defendant in the main proceedings have pointed out that in its report on emulsifiers, stabilizers, thickeners and gelling agents (Opinion delivered on 30 November 1978, p. 30) the Scientific Committee for Food described the technological benefits of emulsifier E 475, especially in bakery products. They argue that precisely those needs account for the legalisation of its use in pastry products in the Federal Republic of Germany.

The same report contained a toxicological evaluation of emulsifier E 475. It appears that the acceptable daily human intake above which there may be a danger to health ought not to exceed 25 mg per kilogram of bodyweight. That established degree of harmfulness corresponds with the results of scientific research in international organizations. That limit has in fact been adopted in German legislation.

Can those findings lead to the irrefutable presumption that additive E 475 is both useful and harmless, as the defendant in the main proceedings and the Commission appear to suggest? I do not think so. However thorough its research may be, the findings of the Scientific Committee for Food do not remove all the uncertainties. That situation arises not only because of the consultative nature of that body but also — and this is a direct consequence— because of the existence of different national laws due to different eating habits in the Member States (Motte, paragraph 24).

Let me say again: only the enactment of Community legislation defining uniformly the foodstuffs for which the addition of E 475 meets a real need and laying down the maximum levels of E 475 to be permitted in foodstuffs would deprive the Member States of their responsibilities in the matter. That is why, unlike the Commission, I take the view that the inclusion of additive E 475 in Annex I to Directive 74/329 prohibits the Member States only from banning the importation of foodstuffs for the sole reason that they contain the additive.

The research undertaken by the international organizations and by the Scientific Committee for Food could constitute a solid foundation for any application for authorization to market additive E 475 which the Member State could not reject except by showing that, having regard to French eating habits, the additive meets no real need and, even if the daily acceptable intake is not exceeded, constitutes a danger to health (Motte, paragraph 24).

The Commission has also suggested that the Member State in question has more appropriate means of protecting human health, namely requiring every importer to make a declaration prior to importation enabling the national authorities to deal in good time with any danger that is revealed. For reasons similar to those put forward by Mr Advocate General Mancini in the Motte case, that argument must be rejected. Such a course of action is appropriate only in appearance, for the legitimate concern to protect human health must lead the national authorities to conduct a thorough examination of foodstuffs which are declared for importation because they contain the prohibited additive.

Finally, in view of the considerations set out above, the Commission's argument based on Directive 79/112 on the approximation of the laws of the Member States relating to the labelling of foodstuffs (Official Journal 1979 No L 33, p. 1) is irrelevant. Article 15 (2) contains an express reservation regarding non-harmonized national provisions justified on grounds of, inter alia, the protection of public health.

6.What does this review mean as far as the national court is concerned?

Two types of cases are possible: an action against the Member State's refusal to grant the authorization requested by a trader, or criminal proceedings brought for fraudulent importation, as in the present case; whichever type of proceedings is considered, the Member State is under an obligation, subject to review by the national courts, to prove in each case that the ban on the marketing of imported products accords with the provisions of Article 36 of the EEC Treaty, as interpreted by the Court.

7.I propose that the following answers should be given to the questions referred to the Court by the cour d'appel, Colmar:

(1)At the present stage of its application, Directive 74/329 does not affect the right of the Member States to maintain legislation banning the use in foodstuffs without prior authorization of an additive listed in Annex I.

(2)The provisions of Directive 74/329, in particular Articles 5 and 8, are binding on every Member State in respect of any additive in Annex I whose use it has previously authorized.

(3)National legislation prohibiting the use in foodstuffs without prior authorization of an emulsifying additive listed in Annex I to the Directive, such as E 475, is

(i)in principle incompatible with the provisions of Article 30 of the EEC Treaty when applied to imported goods, but

(ii)may be justified with regard to the requirements laid down in Article 36 of the EEC Treaty if the Member State shows in each case that, in view of national eating habits and the results of international and Community scientific research, the prohibited substance presents a risk to human health, even if it meets a particular need.

(4)It is for the national court to check whether that condition is satisfied having regard to the criteria which led to the ban.

*1) Translated from the French.