Official Journal of the European Union

C 55/3

(Case C-383/07)

(Reference for a preliminary ruling - Regulation (EC) No 258/97 - Article 1(1) to (3) - Novel foods and novel food ingredients)

(2009/C 55/03)

Language of the case: German

Referring court

Parties to the main proceedings

Applicant: M-K Europa GmbH & Co. KG

Defendant: Stadt Regensburg

Joined party: Landesanwaltschaft Bayern

Re:

Reference for a preliminary ruling — Bayerischer Verwaltungsgerichtshof — Interpretation of Article 1(2)(d) and (e) and (3) of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ 1997 L 43, p. 1) — Novel character of a food marketed in a limited geographical area of the Community (San Marino) shortly before the entry into force of the regulation when the food is manufactured from ingredients the habitual human consumption of which is disputed or can be established only by reference to a non-member country (Japan) — Obligation to subject a food to a control

Operative part of the judgment

1.Importation of a food product into San Marino before the entry into force of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients is not a relevant factor for assessing whether that product meets the requirement relating to human consumption to a significant degree within the European Community within the meaning of Article 1(2) of that regulation.

2.The fact that all the individual ingredients of a food product meet the requirement laid down in Article 1(2) of Regulation No 258/97, or have a safe history, cannot be regarded as sufficient for that regulation not to apply to the food product concerned. In order to decide whether that food product should be classified as a novel food within the meaning of Regulation No 258/97, the competent national authority must proceed on a case-by-case basis, taking into account all the characteristics of the food product and of the production process.

3.The fact that all of the algae contained in a food product within the meaning of Article 1(2)(d) of Regulation No 258/97 meet the requirement relating to human consumption to a significant degree within the European Community, within the meaning of Article 1(2) of that regulation, is not sufficient for that regulation not to apply to that product.

4.Experience regarding the safety of a food product existing exclusively outside Europe is not sufficient to establish that the product concerned falls within the category of food products ‘having a history of safe food use’ within the meaning of Article 1(2)(e) of Regulation No 258/97.

5.It is not incumbent upon an undertaking to initiate the procedure laid down in Article 13 of Regulation No 258/97.

(1) OJ C 283, 24.11.2007.