1. 

Mr Xavier Mirepoix was charged with importing from the Netherlands for sale in France a consignment of onions treated with maleic hydrazide, a pesticide whose use is not authorized by French legislation. In the ensuing criminal proceedings the tribunal de police [Local Criminal Court], Dijon, referred the following question to the Court of Justice for a preliminary ruling:

‘Article 6 of the Order of 20 July 1956 prohibits the sale of fruit and vegetables which, before or after harvesting, have been subjected to unauthorized pesticidai or chemical treatment and has the effect of prohibiting the importation into France of onions from, among other countries, the Netherlands which have been treated with tried and tested substances facilitating their preservation, including maleic hydrazide the use of which as a germination inhibitor is apparently authorized in the other Member States of the Community. Is the said Article 6 a measure having an effect equivalent to a restriction on imports within the meaning of Article 30 of the EEC Treaty’ (Judgment of 4 February 1985).

Once again, therefore, the Court is being asked to interpret the provisions of the Treaty concerning the free movement of goods and, more particularly, the principle embodied in the first sentence of Article 36 whereby ‘prohibitions or restrictions on imports ... justified on grounds of the protection of health and life of humans ...’ are considered lawful. The Court will have to determine whether that principle applies to national rules which generally prohibit — though authorize the administration to allow in individual cases — the sale of foodstuffs which have been treated with pesticides and have been imported from other Member States in which such foodstuffs may be lawfully marketed.

2. 

In order to gain a better insight into the question, some information is necessary on the pesticide concerned on the provisions regulating its use in France and on the Comunity rules concerning pesticides.

Maleic hydrazide is a synthetic chemical product belonging to the group of presticides which regulate growth. If applied to the leaves of plants, it penetrates the tissues during active growth, including the bulbs and tubers. The product leaves a residue behind for a sufficiently long period to ensure that the plant lies dormant and germination is arrested. In the treatment of onions, the substance is used from two to four weeks before the harvest.

The relevant French rules are clear. Article 6 of the Order of 20 July 1956 on the sale of fruit and vegetables provides as follows:

‘It shall be prohibited to sell fruit and vegetables which have been subjected:

The system for authorizing substances containing poisons intended for nonmedical purposes is set out in Article R 5149 et seq of the Public Health Code. Toxic substances are classified in Table A; Article R 5158 provides that their use ‘for the destruction of parasites harmful to agriculture shall be prohibited in relation to all crops and harvests in respect of which their use has not been authorized by order of the Minister of Agriculture’. By Ministerial Order of 31 July 1968, maleic hydrazide was included in Table A. Accordingly, that substance may not be used without specific authorization which, it would appear, had not been granted prior to the material events.

I now turn to the relevant Community rules. Those rules, which at present fall short of seeking to achieve harmonization, are of two kinds: those which concern the legality of sale and those which determine the maximum permitted level of chemical residues in foodstuffs. The first set of rules includes Council Directive No 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (Official Journal 1979, L 33, p. 36), which merely prohibits the disposal of particularly dangerous pesticides, although hydrazide is not listed in the annex to the directive. The second set of rules includes Council Directive No 76/895/EEC of 23 November 1976 (Official Journal 1976, L 340, p. 26), as subsequently amended by Directive No 82/528/EEC of 19 July 1982 (Official Journal 1982, L 234, p. 1). That directive fixes maximum levels for certain pesticide residues in and on fruit and vegetables, but Annex II which contains a list of substances in respect of which residues are premissible within certain specified limits, does not include maleic hydrazide.

However, it should be noted that on 12 November 1981 the Commission proposed, on the basis of the studies carried out by the Committee on Pesticides, that the substance in question should be included in the said annex and established a maximum level of 10 mg per kg in the case of onions. The proposal is still being examined by the Council (Official Journal 1982, C 95, p. 6).

3. 

In the proceedings before the Court, written observations have been submitted by the French Government, the Government of the Federal Republic of Germany and the Commission. Mr Mirepoix submitted observations only during the oral procedure.

The French and German Governments consider that the contested system is lawful under Community law. It came into being as a result of the fact that the harmonization hitherto achieved in the sphere of pesticides was only rudimentary, and was based on the exception referred to in the first sentence of Article 36 of the EEC Treaty. According to those governments, that view is supported by the judgment of 19 September 1984 in Case 94/83, Officier van Justitie v Heijn [1984] ECR 3263. That case was also concerned with a pesticide, namely vinchlozoline, which was found to be present in a consignment of apples. The importer had been charged with infringing the Netherlands rules on maximum pesticide residues permissible in foodstuffs and had contended before the national court that the apples found in its stock with residues of vichlozoline (a substance in respect of which the level of residue allowed is zero) had come from Italy where they had been legally marketed. The prohibition of their disposal was therefore contrary to the provisions of the EEC Treaty on the free movement of goods.

The Court held that since the substance in question was not covered by Community rules Member States were ‘in principle authorized to make regulations regarding the maximum permissible level of residues of that pesticide, bearing in mind however that the scope of that authorization is limited by the Treaty, and in particular, by the last sentence of Article 36’. Although pesticides are necessary to agriculture they are dangerous; that factor, together with the fact that the quantities absorbed by the consumer in the form of residues on foodstuffs can neither be predicted nor controlled justifies the adoption of strict measure. Accordingly, ‘in so far as the... Community rules do not cover certain pesticides, Member States may regulate the presence of residues of those pesticides on foodstuffs in a way which may vary from one country to another according to the climatic conditions [and] the normal diet of the population In that context, they may permit different levels of the same pesticide in respect of different foodstuffs. The authorities of the importing ... State are however obliged to review the ... level if it appears ... that the reasons which led to its being fixed have changed, for example, as a result of the discover of a new use for such and such a pesticide’ (paragraphs 14, 15, 16 and 18 of the decision). The German Government infers from those words that, in view of the present state of harmonization in the Community and of scientific knowlege, the Member States are empowered to adopt different rules in respect of the use of maleic hydrazide. That power is not affected either by the fact that scientists have determined the maximum quantity of that substance which may be ingested daily or by the fact that certain States authorize its use.

4. 

The Commission takes the opposite view. It too refers to the Heijn judgment but points out that, although in that case the national rules specified the maximum permissible level of the pesticide in question, the system under consideration in this case prohibits the sale of fruit and vegetables subjected in the exporting State to treatment which is unauthorized in the importing State, with the result that onions may not contain any maleic hydrozide whatsoever. Moreover, in the commission's view, the French rules are in breach of the principle of proportionality. Unlike the rules considered by the Court in the Heijn case, the rules in this case do not provide for the possibility of reviewing the reasons for the prohibition in the light of new international scientific knowledge or, consequently, of laying down permissible levels of residues at least in respect of imported products.

That being so, the commission states that, in adopting rules concerning the use of a given pesticide, the Member States cannot allow themselves to be guided solely by the aim of the protection of health. Instead, they must strike a balance between that requirement, which entails the use of the lowest possible level of toxic substances, and the technical and economic interests of agricultural production. Accordingly, the interests of health protection must be deemed to prevail only where the national authorities are confident that the use of that pesticide entails a risk higher than that generally accepted by them in quantifying the permissible level of various pesticide residues. If their decisions are to be in conformity with the Community rules, it is insufficient for those authorities to adopt a passive attitude by shifting on to the importer the burden of proving that the treatment is harmless. They must, on the contrary, play an active role by keeping abreast of developments in scientific research and of the measures adopted in Member States which allow the treatment.

For his part, Mr Mirepoix has argued, along the same lines as the Commission, that the French rules are disproportionate with regard to the requirement of health protection.

5. 

Recast in terms which are more consistent with the wording of Article 177, the question submitted by the tribunal de police, Dijon, seeks to ascertain whether it is lawful under Community law to adopt national rules which prohibit, in the absence of administrative authorization, the sale of foodstuffs treated with a pesticide the use of which is forbidden. The national court therefore requires a ruling to enable it to decide whether that prohibition may also be applied to imported products or whether it is incompatible with the provisions of the Treaty and with the rules of secondary legislation concerning the free movement of goods.

Viewed in those terms, the problem is not not new, but has already been dealt with by the Court, not only in the aforesaid Heijn case, but also in a number of decisions given in the 1980's (judgments of 12 June 1980 in Case 88/79, Grunert [1980] ECR 1827; 5 February 1981 in Case 108/80, Kugelmann [1981] ECR 433; 5 February 1981 in Case 53/80, Kaasfabriek Eyssen [1981] ECR 409; 17 December 1981 in Case 272/80, Frans-Nederlandse Maatschappij voor Biologische Producten [1981] ECR 3277; 14 July 1983 in Case 174/82, Sandoz [1983] ECR 2445; 30 November 1983 in Case 227/82, Van Bennekom [1983] ECR 3883; 6 June 1984 in Case 97/83, Melkunie [1984] ECR 2367, and 10 December 1985 in Case 247/84, Motte [1985] ECR 3887). Leaving aside the specific features of those cases, that body of case-law — which reconciles the free movement of foodstuffs with the protection of health where the foodstuff concerned contains substances the harmfulness of which is scientifically uncertain and national systems have not been harmonized in full — constitutes a valid basis for answering the question submitted for preliminary ruling. Let me say at once that, in my view, the arguments advanced by the Frnch and German Governments in support of the view that the contest rules are lawful are largely substantiated by that case-law. On the other hand, in the light of the principles established by the Court, the argument put forward by the Commission and by Mr Mirepoix cannot be considered well founded.

6. 

In the first place, it should be pointed out that the present case and the Heijn case do not exhibit the differences alleged by the Commission. Admittedly, in this case, the national rules prohibit any treatment involving the use of maleic hydrazide and hence directly preclude the presence of residues of that substance in foodstuffs. It is equally certain, however, that the legislation reviewed by the Court in the Heijn case achieved the same result by providing that the maximum permissible level of vinchlozoline was zero. In other words, the reference by the French and German Governments to the rules which the court laid down in that case is entirely pertinent.

7. 

The problem in this case, therefore, lies in ascertaining whether the contested rules can be justified in the light of the first sentence of Article 36, and in particular, whether they are proportionate to the requirement of health protection.

In the first place, the possibility that residues of maleic hydrazide may not be present in foodstuffs treated with that substance, as the Commission has argued, must be ruled out. In reply to a question put to it by the Court, the Commission itself stated that for each combination of pesticide and foodstuff a lower limit is set for the purposes of analysis, which is defined as the minimum concentration of residue which can be identified, by a standard method of analysis, as being present in the product with a satisfactory degree of accuracy; the level of pesticide residues is regarded as zero where it falls below that limit. With regard to the level of maleic hydrazide residues in onion, the Commission stated that the limit is at present 1 mg per kg. Tests carried out in various countries have shown that, even after several months, the level of maleic hydrazide residues present in onions is in excess of the limit laid down. The Commission therefore comes to the conclusion that it is unlikely that onions treated with maleic hydrazide in accordance with accepted agricultural practice and marketed as fresh onions contain no residues of that pesticide in excess of the specified limit.

Moroeover, I would point out that, in view of the present state of international scientific knowledge, doubts persist as to whether the pesticide under consideration is dangerous and, more particularly, as to the permissible level of residues of that pesticide in foodstuffs. It is true that, according to the studies hitherto carried out, the residue of maleic hydrazide present in onions treated with sodium or potassium salts is 10 mg. per kg. (Opinion of 12 July 1984 of the Scientific Committee on Pesticides), whilst the maximum quantity that maybe ingested daily is 0 to 1 mg per kg (1984 Report of the Joint Committee of FAO/WHO experts). However, as the German Government emphasizes on the basis of paragraph 13 of the Court's judgment in the Kaasfabriek Eyssen case and paragraph 19 of its judgment in the Sandoz case, those findings do not constitute a comprehensive and final assessment of that substance, in particular because the adoption of a maximum quantity that may be ingested daily does not mean that the consumption of minimal quantities is entirely harmless. That quantity has been calculated on the basis of experiments carried out on animals, the results of which are not automat5ically transferable to man. Furthermore, the maximum daily quantity permitted is based on an examination of the substance carried out in isolation. The effect of maleic hydrazide in conjunction with other substances present in foodstuffs, and in the environment, cannot be accurately assessed.

Nor can it besaid that the contested system contravenes the principle of proportionality inasmuch as it fails to provide for the possibility of a review to take account of scientific progress. In that regard I would point out that: (a) as a matter of law the system allows for exceptions to the prohibition by means of administrative authorization (Article 6 of the Order of 20 July 1956) and (b) as a matter of fact, as the French Government has stated in reply to a question from the Court, the French Committee responsible for determining the toxic effects of pesticides used in agriculture delivered a favourable opinion on maleic hydrazide on 17 September 1985 and the competent authorities are at present considering the possibility of authorizing its use. The Commission's assertion is therefore without foundation. France's conduct appears to be in keeping with the obligation, imposed by the Court in its judgments in Heijn and Motte (paragraphs 18 and 20 respectively), to subject the assessment of the risks involved to a continuous review on the basis of the results achieved by international research institutions.

8. 

In the light of all the foregoing considerations, I suggest that the question submitted by the tribunal de police, Dijon, by judgment of 4 February 1985 in criminal proceedings against Xavier Mirepoix should be answered as follows:

Having regard to the present state of the Community rules on foodstuffs treated with pesticides, the provisions of the Treaty and the rules of secondary legislation governing the free movement of goods must be interpreted as meaning that a Member State is not precluded from adopting measures which, on grounds of the protection of health within the meaning of Article 36 of the Treaty, prohibit pesticidai treatment unless it is authorized by the administration. However, in applying those measures to products imported from another Member State in which they were legally marketed, the national authorities must, in assessing the risk to human health, take account of the results of international scientific research and, in particular, of the studies carried out by the Community's Scientific Committee on Pesticides.