Considerations on COM(2005)340 - Authorisation of the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation 258/97 - Main contents
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| dossier | COM(2005)340 - Authorisation of the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ... |
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| document | COM(2005)340  |
| date | January 24, 2006 |
| (2) | On 17 January 2002 the competent authorities of Finland issued their initial assessment report. |
| (3) | In their initial assessment report, Finland’s competent food assessment body came to the conclusion that the phytosterols/stanols are safe for human consumption. |
| (4) | The Commission forwarded the initial assessment report to all Member States on 5 March 2002. |
| (5) | Within the 60-day period laid down in Article 6(4) of the Regulation, reasoned objections to the marketing of the product 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 an application from MultiBene for approval of plant sterol enriched foods of 4 April 2003, reiterated its concerns about cumulative intakes from a wide range of foods with added phytosterols. However, at the same time the SCF confirmed 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 Pharmaconsult Oy consequently agreed to reduce the original application on bakery products exclusively to rye bread. |
| (9) | Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters (2), 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 acted within the required time-limit; a Decision should now be adopted by the Commission, |