WRITTEN QUESTION E-1534/99

by Jan Mulder (ELDR) to the Council

(8 September 1999)

Subject: Application of Regulation 258/97 (novel foods and novel food ingredients)

As the Council will be aware, a number of products (including margarine, halvarine and cheese) to which stanols have been added to reduce cholesterol levels have recently been marketed in the United Kingdom under the trade name Benecol. The manufacturer of these new products refers to the authorisation previously granted and the marketing in Finland of a margarine product also with added stanols, as a result of which, it claims, Regulation 258/97(1) (novel foods and novel food ingredients) does not apply.

1. Does the Council consider that the Commission, in assessing products previously marketed and which are covered by Regulation 258/97, should be aware of the content and scope of the authorisation granted in the Member State in question? Is there a difference depending on whether the authorisation relates to a product or to an ingredient?

2. Can the Council investigate whether the Commission, in assessing whether Regulation 258/97 applies to the original Benecol margarine product or the cholesterol-reducing ingredient, had the authorisation at its disposal? What information did the authorisation contain concerning the difference between product and ingredient?

3. What quantitative criteria is the marketing of a given product required to meet in order for Regulation 258/97 not to apply because the product or ingredient has been used for human consumption to a significant degree within the Community?

4. What qualitative criteria is a product required to meet if, on the basis of the previous marketing of a product, Regulation 258/97 does not apply to it? Is this product required to have the same composition as the product which has been marketed to a significant degree or may the composition be modified, and if so, to what extent? May the ingredient occurring in the original product be included in other products without Regulation 258/97 applying? What criteria should be used to answer these questions?

5. Does the Council consider that the Commission can investigate to what extent the margarine, halvarine and cheese products currently being marketed in the UK differ from the original margarine product? If not, under what obligation is the Commission to investigate?

6. Can the Council indicate whether the Commission has been asked formally or informally for an opinion on whether Regulation 258/97 does not apply to the new Benecol products? If so, what was this opinion and on what was it based?

(1) OJ L 43, 14.2.1997, p. 1.

Reply

(2 December 1999)

The Council would remind the Honourable Member that the Treaty of Amsterdam confirmed that consumer policy is an area to which the European Community can and must bring added value. Article 153(1) of the Treaty establishing the European Community defines the Community's objectives in that connection, in particular having regard to its links with health policy and with promoting the right of consumers to information.

In that context, and more particularly with respect to the questions raised, the Council would inform the Honourable Member that Regulation No 258/97 applies to foods and food ingredients placed on the market before it entered into force only if they have not hitherto been used for human consumption to a significant degree within the Community (Article 1(2) of the Regulation). In such cases, the initial assessment procedure laid down in Article 6 applies.

It is for the Commission, and more particularly the Standing Committee for Foodstuffs (cf. Article 1(3) of the Regulation), to determine by committee procedure whether a type of food or food ingredient falls within the scope of the Regulation, and to lay down (in principle on a case-by-case basis) the qualitative criteria attached to each such type of food or food ingredient in order to determine whether it is covered by the Regulation.

It should also be emphasised that Article 1 of Regulation No 258/97 makes no distinction between foods and food ingredients, and this applies in particular when it comes to identifying the content and scope of approval in the Member State concerned.

Finally, the Council would suggest that the Honourable Member contact the Commission directly regarding those questions which have not been answered, as they are within its field of competence.