WRITTEN QUESTION P-1506/99

by Jan Mulder (ELDR) to the Commission

(1 September 1999)

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

As the Commission will be aware, a number of products (including margarine, halvarine and cheese) to which stanols have been added to lower cholesterol levels have recently been placed on the market in the United Kingdom, the Netherlands, Belgium and Ireland 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. What is the content and scope of the Finnish authorisation of the original Benecol margarine product and does that authorisation relate to a product or an ingredient?

2. Is the composition of the product recently placed on the market in the abovementioned countries the same as that of the product which was marketed in Finland before Regulation 258/97 entered into force?

3. In assessing whether Regulation 258/97 applies to the original Benecol margarine product or the cholesterol-lowering ingredient, did the Commission have the abovementioned authorisation at its disposal and what information was included in the authorisation?

4. 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?

5. What qualitative criteria is a product required to meet in order that, by virtue of the previous marketing of a product, Regulation 258/97 does not apply to it?

6. 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?

7. May the ingredient occurring in the original product also be included in other products without Regulation 258/97 applying?

8. What criteria must be used in answering these questions?

9. Has the Commission investigated to what extent the margarine, halvarine and cheese products currently being placed on the market in the UK differ from the original margarine product? If not, what information on this matter does the Commission have at its disposal?

10. Has the Commission 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.

Answer given by Mr Liikanen on behalf of the Commission

(8 November 1999)

Regulation (EC) 258/97 concerns the placing on the market within the Community of novel foods or novel food ingredients.

In discussions with Member States and on the basis of information provided by them it has been established that none of the products currently marketed under the trade name Benecol contain a novel food ingredient since this was on the market to a significant degree before the entry into force of Regulation (EC) 258/97. Hence the Regulation does not apply.