Applicant Description of Food or Food Ingredient Scientific Evidence Notification Transmission to Member States

27a Dr. L. Nyberg Skånemejerier S-205 03 Malmö Yoghurt type products with added phytosterols a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols; a container of beverages will not contain more than 3 g of phytosterols/phytostanols. The phytosterols are provided by Teriaka (Diminicol) 26 August 2005 8 September 2005

31 Dr Horst Messinger Cognis Deutschland GmbH & Co. KG Postfach 13 01 64 D-40551 Düsseldorf Henkelstrasse 6 D-40589 Düsseldorf Plantsterols and plantsterol esters for the addition to yellow fat spreads (excluding cooking and frying fats and spreads based on butter or other animal fat), salad dressings including mayonnaise and milk type products as specified by Commission Decision 2004/333/EC, spicy sauces as specified by Comission Decision 2004/334/EC and milk based fruit drinks as specified by Commission Decision 2004/336/EC. a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols; a container of beverages will not contain more than 3 g of phytosterols/phytostanols; spicy sauces will be packed as single portions. NFB (1) (FIN) Opinion on the substantial equivalence of foods enriched with plant sterols and phytosterol esters (Cognis Deutschland GmbH & Co) 20 April 2005 29 June 2005

31d Dr. R. Keller MIFA AG Frenkendorf Rheinstraβe 99 CH–4402 Frenkendorf Yellow fat spreads with added phytosterol esters a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols The phytosterol esters ingredient is the one that was notified by Cognis. 30 May 2005 29 June 2005

31e Mr. F. Meindl Nöm AG Vöslauer Straße 109 A–2500 Baden Milk type products with added phytosterols a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols; a container of beverages will not contain more than 3 g of phytosterols/phytostanols The phytosterol esters ingredient is the one that was notified by Cognis. 2 September 2005 9 September 2005

31f Mr. M._A. García Baquero LÁCTEAS GARCIA BAQUERO S.A. Polígno industrial ‘Alces’ 22-23 E-13600 Alcázar de San Juan Cheese type products with added phytosterols a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols The phytosterol esters ingredient is the one that was notified by Cognis. 22 July 2005 8 September 2005

39 Mr David Backstrom Resort Health Products Noni Maui Nutrition & Cosmetics 211, Napoko Place Kulu Maui 96790 Hawai USA Noni juice (juice of the fruits of Morinda citrifolia) Opinion of the AFSSA (F) (2) on assessment of the substantial equivalence of a Hawaiian noni juice with another noni juice authorised by the Decision of 5 June 2003 of the European Commission's Scientific Committee on Food 28 January 2005 22 February 2005

40 Mr Gerhard Stemmler Herbex Ltd. P.O.Box 516 17 Vesi Crescent Waiyavi Lautoka Fidji Islands Noni juice (juice of the fruits of Morinda citrifolia) ACNFP (3) (UK) Opinion on substantial equivalence of Noni Juice produced on a number of Pacific Islands considered under Article 5 of the Novel Foods Regulation 11 January 2005 11 February 2005

40a Mr W. G. Brull Royal Noni (Fiji) Limited P.O.Box 5842 Lautoka Fiji Islands Noni juice (juice of the fruits of Morinda citrifolia) ACNFP (3) (UK) Opinion on substantial equivalence of Noni Juice produced on a number of Pacific Islands considered under Article 5 of the Novel Foods Regulation 15 April 2005 25 April 2005

40b Mr. Alexander Litterst Blütenweg 17 d-78351 Bodmann-Ludwigshafen on behalf of Tauro Tukaroa Sunline Noni Ltd. Rarotonga P.O. Box 295 Cook Islands Noni juice (juice of the fruits of Morinda citrifolia) ACNFP (3) (UK) Opinion on substantial equivalence of Noni Juice produced on a number of Pacific Islands considered under Article 5 of the Novel Foods Regulation 2 June 2005 29 June 2005

40c Mr Ken Newton C.C.K. Trading Ltd. P.O. Box 3043 Apia Samoa Noni juice (juice of the fruits of Morinda citrifolia) ACNFP (3) (UK) Opinion on substantial equivalence of Noni Juice produced on a number of Pacific Islands considered under Article 5 of the Novel Foods Regulation 25 May 2005 29 June 2005

40d Mr. Bradley J. Stafford Cook Islands Noni Marketing Ltd. P.O.Box 184 Rarotonga Cook Islands Noni juice (juice of the fruits of Morinda citrifolia) ACNFP (3) (UK) Opinion on substantial equivalence of Noni Juice produced on a number of Pacific Islands considered under Article 5 of the Novel Foods Regulation 29 September 2005 20 October 2005

41 Dr David Stewart Forbes Medi-Tech Inc. 750 West Pender Street Vancouver B.C. V6C 2T8 Canada Foods listed in Article 1 of Commission Decision 2000/500/EC and in annex 1 of Commission Decisions 2004/333/EC, 2004/334/EC, 2004/335/EC and 2004/336/EC (yellow fat spreads, salad dressings, fermented milk type products, soya drinks, cheese type products, yoghurt type products, spicy sauces, milk based fruit drinks) with added phytosterols/ phytostanols (ReducolTM) NFB (1) (FIN) Opinion on the substantial equivalence of foods enriched with ReducolTM phytosterols/phytostanols (Forbes Medi-Tech Inc.) of 28 February 2005 22 April 2005 6 June 2005

41a Timo Keski-Kasari Juustoportti Oy Meijeritie 3 FIN-61600 Jalasjärvi Yoghurt type products with added phytosterols/phytostanols (ReducolTM) The yoghurt type products shall be presented in conformity with the provisions of Article 2 of Commission Decisions 2004/334/EC — 2004/336/EC NFB (1) (FIN) Opinion on the substantial equivalence of foods enriched with ReducolTM phytosterols/phytostanols (Forbes Medi-Tech Inc.) of 28 February 2005 10 May 2005 30 June 2005

41b Dr. Gilles Nassy Novandie 19, rue de la République F-76153 Maromme Cedex Yoghurt type products and other dairy products with added phytosterol esters (ReducolTM) The yoghurt type products and other diary products shall be presented in conformity with the provisions of Article 2 of Commission Decision 2004/845/EC. The phytosterol esters ingredient is the one that was authorised by Commission Decision 2004/845/EC. In addition, the yoghurt type products and other dairy products containing this phytosterol esters ingredient were already notified by Forbes Medi Tech (see No 41). 27 May 2005 29 June 2005

41c Ms N. Carrolo Pingo Doce Distribuição Alimentar S.A. Rua Actor António Silva, 7 Aparto 52022 P-1649-033 Liboa Milk based beverages with added phytosterols a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols; a container of beverages will not contain more than 3 g of added phytosterols The phytosterols are the same as authorised by Commission Decision 2004/845/EC 17 June 2005 4 July 2005

41d Mr D. Dobbins Robert Wisemans & Sons Limited 159 Glasgow Road East Kilbride Glasgow G74 4PA United Kingdom Milk based beverages with added phytosterols a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols; a container of beverages will not contain more than 3 g of added phytosterols The phytosterols are the same as authorised by Commission Decision 2004/845/EC 27 June 2005 26 July 2005

41f Mr C Swire Fayrefield Foods Ltd. Englesa House Barthomley Road Crewe, Cheshire CW1 UF United Kingdom Yellow fat spreads with added phytosterols, exluding cooking and frying fats and spreads based on butter or other animal fat a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols The phytosterols are the same as authorised by Commission Decision 2004/845/EC 13 July 2005 3 August 2005

41g Dr. Walter Link Walter Rau Lebensmittelwerke GmbH & Co. KG Münsterstr. 9-11 D-49171 Hilter Yellow fat spreads with added phytosterols, exluding cooking and frying fats and spreads based on butter or other animal fat a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols The phytosterols are provided by Forbes MediTech 15 November 2005 7 December 2005

42 Dr David Stewart Forbes Medi-Tech Inc. 750 West Pender Street Vancouver B.C. V6C 2T8 Canada Foods listed in Article 1 of Commission Decision 2000/500/EC and in annex 1 of Commission Decisions 2004/333/EC, 2004/334/EC, 2004/335/EC and 2004/336/EC (yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks, cheese type products, yoghurt type products, spicy sauces, milk based fruit drinks) with added plant sterol esters NFB (1) (FIN) Opinion on the substantial equivalence of Forbes plant sterol esters with authorised plant sterol esters (Forbes Medi-Tech) of 28 February 2005 22 April 2005 6 June 2005

43 Dr David Stewart Forbes Medi-Tech Inc. 750 West Pender Street Vancouver B.C. V6C 2T8 Canada Foods listed in Article 1 of Commission Decision 2000/500/EC and in annex 1 of Commission Decisions 2004/333/EC, 2004/334/EC, 2004/335/EC and 2004/336/EC (yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks, cheese type products, yoghurt type products, spicy sauces, milk based fruit drinks) with added phytosterols/phytostanols (Phyto-S-SterolsTM) NFB (1) (FIN) Opinion on the substantial equivalence of Phyto-S-SterolTM with authorised phytosterols/phytostanols (Forbes Medi-Tech Inc.) of 4 November 2004 20 Mai 2005 6 June 2005

44 Reinhard Bursian Trisana GmbH Diemendorf 8 D-82327 Tutzing Noni juice (juice of the fruits of Morinda citrifolia) BVL (4) Opinion on the substantial equivalence, in accordance with Article 3(4) of Regulation (EC) No 258/97, of juice from the Morinda citrifolia L. fruit produced by Trisana GmbH to the ‘Noni-Saft’ (juice from the Morinda citrifolia L. fruit) produced by Morinda Inc., which is approved as a novel food ingredient in accordance with Regulation (EC) No 258/97 Dated 14 September 2004 but wrongly addressed, therefore received only on 2 May 2005 29 June 2005

45 Mr. L. Sita Granarolo S.p.a. Via Cadriano, 27/2 I-40127 Bologna Fermented milk (yoghurt) type products with added phytosterols a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols; a container of beverages will not contain more than 3 g of phytosterols/phytostanols. The phytosterols are provide by the company Triple Crown and the FSA (5) has delivered an opinion that the phytosterols are substantially equivalent ‘Opinion on the substantial equivalence of a free phytosterol ingredient’ 5 August 2005 16 August 2005

46 Ms M. Weinzierl Princesse de Mogador Kellerstr. 11 D-81667 München 2 Notifications concerning Argan oil (oil from Argania spinosa L.) AFSSA (2) (F) Opinion concerning the evaluation of the substantial equivalence of argan oil (Argania spinosa L.) with other edible oils 23 May 2005 and 5 July 2005 26 July 2005

47 Mr G. Martin Mi GmbH Postfach 2535 CH-6342 Baar Mi EU ltd. c/o EAC Business Sevices Ltd. Cariocca Business Park 2 Sawley Road Manchester M40 8BB United Kingdom Noni juice (juice of the fruits of Morinda citrifolia ACNFP (3) Opinion on substantial equivalence of Noni juice considered under Article 5 of the Novel Foods Regulation 28 June 2005 25 July 2005

48 Ms N. Hanlon Kerry Foods Tralee Road, Listowel Co. Kerry Ireland Yellow fat spreads as defined by Council Regulation (EC) No. 2991/94, excluding cooking and frying fats and spreads based on butter or other animal fat a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols The FSAI (6) (IRL) provided an opinion that the foods are substantially equivalent to those authorised by Commission Decisions 2004/333/EC, 2004/334 EC and 2004/336. 15 June 2005 4 July 2005

49 Mr M. Gebauer Homann Feinkost GmbH & Co Bahnhofstrasse 4 D-49197 Dissen Salad dressings and mayonnaises with added phytosterols a portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols; the foods will be packed as single portions. The phytosterols are the same as authorised by Commission Decision 2004/333/EC 5 July 2005 3 August 2005

50 Mr M Werner NCT Nord Trading GmbH Albert-Schweitzer-Str. 20 D-85375 Neufahrn b.Freising Noni juice (juice of the fruits of Morinda citrifolia) BVL (4) Opinion concerning the substantial equivalence, in accordance with Article 3(4) of Regulation (EC) No. 258/97, of juice of the fruit of the species Morinda citrifolia L. of NCT Nord Trading GmbH and Dynamic Health Laboratories Inc. with the ‘Noni juice’ (juice of the fruit of the species Morinda citrifolia L.) of the company Morinda Inc, which has been approved as a novel food ingredient in accordance with Regulation (EC) No. 258/97 19 May 2005 19 September 2005

51 Mr Bruce Burwick Dynamic Health Labortories Inc. 110 Bridge Street USA-Brooklyn New York 11201 Noni juice (juice of the fruits of Morinda citrifolia) BVL (4) Opinion concerning the substantial equivalence, in accordance with Article 3(4) of Regulation (EC) No. 258/97, of juice of the fruit of the species Morinda citrifolia L. of NCT Nord Trading GmbH and Dynamic Health Laboratories Inc. with the ‘Noni juice’ (juice of the fruit of the species Morinda citrifolia L.) of the company Morinda Inc, which has been approved as a novel food ingredient in accordance with Regulation (EC) No. 258/97 27 September 2005 10 October 2005

52 Dr. Dirk Cremer Degussa Food Ingredients GmbH Lisa-Meitner-Strasse 34 D-85345 Freising Foods listed in annex 1 of Commission Decisions 2004/333/EC, 2004/334/EC, 2004/335/EC and 2004/336/EC (yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks, cheese type products, yoghurt type products, spicy sauces, milk based fruit drinks) with added plant sterol esters NFB (1) (FIN) Opinion on Substantial equivalence in the case of Cholestatin™ IP phytosterol/phytostanol ingredient (Degussa Food Ingredients GmbH) 27 September 2005 13 October 2005

53 Mr Boujima Boujia ARGANINE Argan-Öl e.K. D-86938 Schondorf Argan Oil (Oil from Argania spinosa) AFSSA (2) (F) Opinion concerning the evaluation of the substantial equivalence of argan oil (Argania spinosa L.) with other edible oils 17 October 2005 24 November 2005