Decision 2006/58 - 2006/58/EC: Commission Decision of 24 January 2006 authorising the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients pursuant to Regulation 258/97 (notified under document number C(2006) 42) - Main contents
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official title
2006/58/EC: Commission Decision of 24 January 2006 authorising the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2006) 42)| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2006/58 |
| Original proposal | COM(2005)340  |
| CELEX number i | 32006D0058 |
| Document | 24-01-2006 |
|---|---|
| Publication in Official Journal | 03-02-2006; OJ L 118M , 8.5.2007,OJ L 31 p. 18-20 |
| Effect | 24-01-2006; Entry into force Date notif. |
| End of validity | 31-12-9999 |
| Notification | 24-01-2006 |
3.2.2006 |
EN |
Official Journal of the European Union |
L 31/18 |
COMMISSION DECISION
of 24 January 2006
authorising the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document number C(2006) 42)
(Only the Finnish and Swedish texts are authentic)
(Text with EEA relevance)
(2006/58/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,
Whereas:
(1) |
On 24 September 2001 Pharmaconsult Oy Ltd (formerly MultiBene Health Oy Ltd) made a request to the competent authorities of Finland for placing phytosterols on the market. |
(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, |
HAS ADOPTED THIS DECISION:
Article 1
Foods and food ingredients as described in Annex I with added phytosterols/phytostanols as specified in Annex II, hereinafter called the products, may be placed on the market in the Community.
Article 2
The products shall be presented in such a manner that they can be easily divided into portions that contain either...
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