Keywords

Summary



Keywords

1. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Regulation No 258/97 – Scope

(Art. 299 EC; European Parliament and Council Regulation No 258/97, Art. 1(2))

2. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Regulation No 258/97 – Scope

(European Parliament and Council Regulation No 258/97, Art. 1(2))

3. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Regulation No 258/97 – Scope

(European Parliament and Council Regulation No 258/97, Art. 1(2)(e))

4. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Regulation No 258/97 – Scope

(European Parliament and Council Regulation No 258/97, Art. 13)

Summary

1. Importation of a food product into San Marino before the entry into force of Regulation No 258/97 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. San Marino is not a Member State of the Community. Nor is that State one of the territories to which the EC Treaty applies under Article 299 EC.

(see paras 16-17, operative part 1)

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 concerning novel foods and novel food ingredients, 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.

Thus, 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.

(see paras 30, 32, operative part 2-3)

3. 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 concerning novel foods and novel food ingredients.

(see para. 38, operative part 4)

4. It is not incumbent upon an undertaking to initiate the procedure laid down in Article 13 of Regulation No 258/97 concerning novel foods and novel food ingredients.

Without prejudice to any procedures that may be implemented in the Member State concerned in accordance with the provisions of the applicable national law, the comitology procedure laid down in Article 13 of that regulation involves exclusively the opinion of the Committee, where the matter has been referred to it by the Chairman either on his own initiative or at the request of the representative of a Member State, a decision taken by the Commission where the measures envisaged are in accordance with that opinion, and lastly, if those measures are not in accordance with the opinion of the Committee, a Council vote adopted by a qualified majority.

(see paras 41-43, operative part 5)