Ministero della Salute v Coordinamento delle associazioni per la difesa dell'ambiente e dei diritti degli utenti e dei consumatori (Codacons) and Federconsumatori.

• Jurisdiction: European Union
• Court: Court of Justice (European Union)
• Writing for the Court: Timmermans
• ECLI: ECLI:EU:C:2005:129
• Date: 03 March 2005
• Docket Number: C-132/03
• Procedure Type: Reference for a preliminary ruling

OPINION OF ADVOCATE GENERAL

LÉGER

delivered on 3 March 2005 (1)

Case C-132/03

Ministero della Salute

v

Coordinamento delle associazioni per la difesa dell’ambiente e dei diritti degli utenti e consumatori (Codacons), Federconsumatori

(Reference for a preliminary ruling from the le Consiglio di Stato (Italy))

(Regulation (EC) No 49/2000 – Labelling of foodstuffs produced from certain genetically modified organisms – Mandatory statement to that effect – Not required in the case of adventitious contamination not exceeding 1% – Extent of exclusion – Foodstuffs for infants and young children)

1. Must foodstuffs for infants and young children bear labelling stating that the foodstuffs have been produced from certain genetically modified organisms (‘GMOs’) if, as a result of adventitious contamination, the foodstuffs contain material derived from such organisms in proportions not exceeding 1%?

2. That, in essence, is the question referred by the Consiglio di Stato (Italy) in the context of proceedings in which the legality of a ministerial decree is in issue.

3. With this question, the Court is called upon to clarify the scope ratione materiae of certain provisions of Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC, (2) as amended by Commission Regulation No 49/2000 of 10 January 2000. (3)

I – Legal framework

A – The Community legislation

4. Numerous measures of secondary law have been adopted with regard to the labelling of foodstuffs. Some of them apply to all foodstuffs and thus have general and horizontal effect, while others apply only to certain foodstuffs and therefore constitute specific measures.

1. General legislation on the labelling of foodstuffs

5. General legislation on the labelling of foodstuffs has been in existence since the adoption of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer. (4)

6. In the words of the third recital in the preamble, the purpose of this directive was to enact Community rules of a general nature applicable horizontally to all foodstuffs put on the market.

7. Accordingly, Article 3 of the said directive laid down the principle that the labelling of foodstuffs was to show a number of particulars, which were exhaustively listed, including a list of ingredients.

8. However, this principle was subject to a number of modifications. Article 4 of the directive allowed Community provisions applicable to specified foodstuffs to derogate from the requirement to include certain particulars on the labelling, including the requirement for a list of ingredients, (5) or, conversely, allowed such provisions to require additional particulars to those exhaustively listed in Article 3 of the directive. (6) Article 4 also allowed the Member States to lay down such labelling requirements where there were no Community measures to that effect, subject to compliance with certain conditions. (7)

9. All these provisions of Directive 79/112 were restated in essence by Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. (8) This is the directive which was in force when the decree of the Minister of Health No 371 of 31 May 2001 (9) was published on 16 October 2001, which is the relevant date, in the context of the main proceedings, for assessing the legality of the said decree.

2. Special measures on the labelling of foodstuffs

10. Pursuant to Article 4 of Directive 79/112, a specific measure was adopted for foodstuffs for infants and young children and another for foodstuffs produced from GMOs.

(a) Measures on the labelling of foodstuffs for infants and young children

11. Article 7(1) of 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 (10) provides that Directive 79/112 applies to the products referred to in Article 1 of Directive 89/398, which include products for infants and young children (in good health).

12. Article 3(1) of Directive 89/398 lays down the principle that the nature or composition of the products concerned must be such that the products are appropriate for the particular nutritional use intended. In this connection, Article 4(1) envisages the adoption of specific directives for the foodstuffs covered by Directive 89/398, in particular with regard to their nature or composition, the quality of raw materials and the labelling of such foodstuffs.

13. Two specific directives were adopted on the basis of Article 4(1):

– Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae, (11) and

– Commission Directive 96/5/EEC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children. (12)

14. Article 3(1) and (2) of Directive 91/321 provides that infant formulae and follow-on formulae are to be manufactured from protein sources defined in the annexes to that directive and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data. In the same way, Article 5(1) adds that only certain substances (listed exhaustively in Annex III to the directive) may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy their nutritional requirements. (13) It is stated that the purity criteria for these substances will be stipulated at a later stage.

15. On the same lines, Article 6(1) of Directive 91/321 requires infant formulae and follow-on formulae to contain no substance in such quantity as to endanger the health of infants. In this connection, it is envisaged that, where necessary, the maximum levels of any such substance will be stipulated at a later date.

16. In addition to the provisions concerning the production and composition of foodstuffs for infants, Directive 91/321 provides, in Article 7(2), that the labelling of such foodstuffs must show a number of particulars in addition to those laid down by Directive 79/112. (14) The additional particulars relate to the vitamin content, content of proteins, lipids and glucides, and the energy value and instructions for use of such foodstuffs.

17. All those provisions were in substance repeated by Directive 96/5 with regard to processed cereal-based foods and foods for infants (of less than 12 months) and young children (of one to three years of age).

18. Directives 91/321 and 96/5 were amended by Directives 1999/50/EC (15) and 1999/39/EC (16) respectively. The latter were adopted on the basis of Article 6 of Directive 91/321 and Article 6 of Directive 96/5 respectively, pursuant to the precautionary principle. (17) They added to the said Article 6 provisions concerning pesticides in order to limit their presence in foodstuffs for infants and young children. (18)

(b) Rules on the labelling of foodstuffs produced from GMOs

19. The basic rules concerning the labelling of foodstuffs produced from GMOs were laid down by Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms.(19)

20. The main aim of those rules was to set up a common procedure for the marketing for the first time, on the Community market, of products containing or made from GMOs. In the framework of this procedure, the trader concerned was required to inform the Member State in question of his proposal to place such a product for the first time on the Community market from the territory of that State. The notification was to include the proposed labelling of the product, indicating the presence of GMOs among other mandatory particulars. This mandatory statement was then to be shown on the labelling once the marketing decision was taken if, following an appraisal of its harmlessness, the product was deemed not to be harmful to human health or to the environment. (20)

21. These provisions of Directive 90/220 were very largely repeated by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. (21)

22. The labelling requirements of Regulation No 258/97 became applicable to certain specified products irrespective of the date on which they were placed on the market (that is to say, before or after the said regulation came into force). (22)

23. Regulation No 1813/97, which was adopted for that purpose, was repealed and replaced by Regulation No 1139/98. The question referred relates to the latter regulation, as amended, and seeks to clarify its scope ratione materiae.

24. On the same lines as Regulation No 1813/97, Regulation No 1139/98 applies (in the words of Article 1(1)) to foods and food ingredients which are to be delivered as such to the final consumer and are produced, in whole or in part, from genetically modified soya beans covered by Decision 96/281 or from genetically modified maize covered by Decision 97/98.

25. Article 2(1) of Regulation No 1139/98 lays down the principle that the foodstuffs falling within the scope of the regulation are subject to additional specific labelling requirements. These are set out in Article 2(3) and aim to ensure that the consumer is informed as to the origin of the ingredients from which the foodstuffs concerned are made, by including (in the list of ingredients required by Directive 79/112 or in relation to it) words such as ‘produced from genetically modified soya’ or ‘produced from...