(1)

On 21 September 2000 Karl Fazer Ltd made a request to the competent authorities of Finland to place foods with added phytosterols on the market as novel foods or novel food ingredients.

(2)

On 29 January 2001 the competent authorities of Finland issued their initial assessment report.

(3)

In their initial assessment report, Finland’s competent food safety assessment body came to the conclusion that the phytosterols/phytostanols are safe for human consumption.

(4)

The Commission forwarded this initial assessment report to all Member States on 13 March 2001.

(5)

Within the 60-day period laid down in Article 6(4) of the Regulation, reasoned objections to the marketing of the products were raised in accordance with that provision.

(6)

The Scientific Committee on Food (SCF) in its opinion ‘General view on the long-term effects of the intake of elevated levels of phytosterols from multiple dietary sources, with particular attention to the effects on β-carotene’ of 26 September 2002 indicated that there was no evidence of additional benefits at intakes higher than 3 g/day and that high intakes might induce undesirable effects and that it was therefore prudent to avoid plant sterol intakes exceeding 3 g/day.

(7)

Furthermore, the SCF, in its opinion on applications for approval of a variety of plant sterol enriched foods of 5 March 2003, reiterated its concerns about cumulative intakes from a wide range of foods with added phytosterols. However, at the same time the SCF confirmed with regard to the application of Oy Karl Fazer Ab that the addition of phytosterols to a wide range of bakery products was safe.

(8)

In order to meet the concerns on cumulative intakes of phytosterols/phytostanols from different products Oy Karl Fazer Ab consequently agreed to reduce the original application to rye bread.

(9)

Commission Regulation (EC) No 608/2004 of 31 March 2004 (2) concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters ensures that consumers receive the information necessary in order to avoid excessive intake of additional phytosterols.

(10)

The Standing Committee on the Food Chain and Animal Health has not given a favourable opinion; the Commission therefore submitted a proposal to the Council on 22 August 2005 in accordance with Article 5(4) of the Council Decision 1999/468/EC (3), the Council being required to act within three months.

(11)

However, the Council has not reacted within the required time-limit; a Decision should now be adopted by the Commission,