銆€銆€of 31 March 2004
銆€銆€authorising the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
銆€銆€(notified under document number C(2004) 1243)
銆€銆€(Only the English text is authentic)
銆€銆€(2004/333/EC)
銆€銆€THE COMMISSION OF THE EUROPEAN COMMUNITIES,
銆€銆€Having regard to the Treaty establishing the European Community,
銆€銆€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,
銆€銆€Whereas:
銆€銆€(1) On 2 November 2001 Archer Daniels Midland Company (ADM) made a request to the competent authorities of the Netherlands for placing phytosterols and phytosterol esters on the market.
銆€銆€(2) On 13 December 2001 the competent authorities of the Netherlands issued their initial assessment report.
銆€銆€(3) In their initial assessment report, the Netherlands' competent food assessment body came to the conclusion that the phytosterols/stanols are safe for human consumption.
銆€銆€(4) The Commission forwarded the initial assessment report to all Member States on 5 March 2002.
銆€銆€(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.
銆€銆€(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. Furthermore, the SCF, in its opinion on an application from ADM for approval of plant sterol-enriched foods of 4 April 2003, came to the conclusion that the addition of phytosterols is safe, provided that the daily consumption does not exceed 3g.
銆€銆€(7) 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.
銆€銆€(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
銆€銆€HAS ADOPTED THIS DECISION:
銆€銆€Article 1
銆€銆€Foods and food ingredients as described in Annex 1 with added phytosterols/phytostanols as specified in Annex 2, hereinafter called the products, may be placed on the market in the Community.
銆€銆€Article 2
銆€銆€The products shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3g (in case of one portion per day) or a maximum of 1g (in case of three portions per day) of added phytosterols/phytostanols.
銆€銆€Salad dressings shall be packed as single portions.
銆€銆€The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.
銆€銆€Article 3
銆€銆€This Decision is addressed to Archer Daniels Midland Company, 4666 Faries Parkway, Decatur, IL. 62526-5666, USA.
銆€銆€Done at Brussels, 31 March 2004.
銆€銆€For the Commission
銆€銆€David Byrne
銆€銆€Member of the Commission
銆€銆€(1) OJ L 43, 14.2.1997, p. 1.
銆€銆€(2) OJ L 97, 1.4.2004, p. 44.
銆€銆€ANNEX 1
銆€銆€Products referred to in Article 1
銆€銆€Yellow fat spreads, as defined by Council Regulation (EC) No 2991/94(1), excluding cooking and frying fats and spreads based on butter or other animal fat.
銆€銆€Salad dressings including mayonnaise.
銆€銆€Milk type products such as semi skimmed and skimmed milk type products, possibly with the addition of fruits and/or cereals, fermented milk type products such as yoghurt, soya drinks, and cheese type products (fat content <= 12 g per 100 g), where the milk fat and/or protein has been partly or fully replaced by vegetable fat or protein.
銆€銆€(1) OJ L 316, 9.12.1994, p. 2.
銆€銆€ANNEX 2
銆€銆€Specifications of phytosterols and phytostanols for the addition to foods and food ingredients
銆€銆€Definition:
銆€銆€Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and stanols or esterified with food grade fatty acids.
銆€銆€Composition (with GC-FID or equivalent method):
銆€銆€< 80 % a-sitosterol
銆€銆€< 15 % a-sitostanol
銆€銆€< 40 % campesterol
銆€銆€< 5 % campestanol
銆€銆€< 30 % stigmasterol
銆€銆€< 3 % brassicasterol
銆€銆€< 3 % other sterols/stanols
銆€銆€Contamination/Purity (GC-FID or equivalent method)
銆€銆€Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 % of the phytosterol/phytostanol ingredient.