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

31 Cognis Deutschland GmbH & Co. KG Postfach 13 01 64 40551 Düsseldorf DEUTSCHLAND Henkelstrasse 67 40589 Düsseldorf DEUTSCHLAND Phytosterol esters for the addition to i) milk type products and yoghurt type products; and ii) yellow fat spreads as described by Council Regulation (EC) No 2991/94, excluding cooking and frying fats and spreads based on butter or other animal fat and FSA (2)(UK) Request for an opinion on the substantial equivalence of phytosterols and their esters 23 July 2004 4 August 2004

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. and NFB (3)(FIN) Opinion on the substantial equivalence of plant sterols, phytosterolesters and foods enriched with these (Cognis Deutschland GmbH & Co) 20 April 2005 29 June 2005

Rye bread with added phytosterol esters and/or phytosterols The requirements laid down in Article 2 of the aforementioned Decisions apply. NFB (3)(FIN) Opinion on substantial equivalence for rye bread enriched with Cognis plant sterol ingredient (Cognis Deutschland GmbH & Co) 23 May 2006 9 June 2006

31v Gebr. Woerle GmbH Postfach 18 Enzing 26 5302 Henndorf bei Salzburg ÖSTERREICH 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, 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 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; a container of beverages will not contain more than 3 g of added phytosterols The phytosterol esters are provided by Cognis 6 October 2008 7 November 2008

31w Mills of Crete SA Eth. Veniselou 40 73 200 Souda Crete GREECE rye bread with flour containing ≥ 50 % rye and ≤ 30 % wheat; and with ≤ 4 % sugar but no fat added 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; The phytosterol esters are provided by Cognis 5 December 2008 11 December 2008

31x Valio Ltd PO Box 10 Meieritje 6, Pitäjanmaki FI-00039 Valio Helsinki SUOMI/FINLAND Yellow fat spreads excluding cooking and frying fats and spreads based on butter or other animal fat with added phytosterols 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, 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 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; a container of beverages will not contain more than 3 g of added phytosterols The phytosterols are provided by Cognis 2 December 2008 11 December 2008

31y Viotros SA Block 31 DA 13 Phase B 574 00 Industrial Area of Sindos (Echedoros — Thessaloniki) GREECE 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 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 The phytosterols are provided by Cognis 24 April 2008 30 April 2008

40e R & L Holdings Ltd. P.O. Box 977 Vaitele Apia SAMOA Noni juice (juice of the fruits of Morinda citrifolia) ACNFP (4)(UK) Opinion on substantial equivalence of Noni Juice produced on a number of Pacific Islands considered under Article 5 of the Novel Foods Regulation 17 January 2008 28 January 2008

41 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 (Reducol™) NFB (3)(FIN) Opinion on the substantial equivalence of foods enriched with Reducol™ phytosterols/phytostanols (Forbes Medi-Tech Inc.) of 28 February 2005 22 April 2005 6 June 2005

Rye bread NFB (3)(FIN) Opinion on substantial equivalence for rye bread enriched with REDUCOL™ plant sterol ingredient 12 June 2006 3 August 2006

Cheese products (fat content < 12 g per 100 g) with added phytosterols and/or phytosterol esters Letter of 6 September 2006 by the FSAI (5)concerning the substantial equivalence 3 October 2006 6 November 2006

41l Caseifcio Pinzolo Fiavè Rovereto S.c.r.l. Via A. Degasperi 12/A 38075 Favé (Trento) TN ITALIA Yogurt 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 added phytosterols The phytosterols are provided by Forbes MediTech 3 March 2008 18 March 2008

41m Rupp Käseexport GmbH Krüzastraße 8 6912 Hörbranz ÖSTERREICH 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 phytosterols are provided by Forbes MediTech 7 July 2008 28 October 2008

54 Triple Crown AB Stenslingan 10 SE-182 38 Stockholm SVERIGE Phytosterols to be used in milk type, yoghurt type products ACNFP (4)Opinion on substantial Equivalence of free phytosterols considered under Article 5 of the Novel Foods Regulation 11 November 2005 8 December 2005

Stenslingan 10 SE-182 38 Danderyd SVERIGE Low fat soft cheese/melt cheese (fat content ≤ 12 g per 100 g) and rye bread NFB (3)Opinion on substantial equivalence of a plant sterol ingredient manufactured by Triple Crown company and foods enriched with it (Triple Crown AB) 16 October 2006 7 November 2006

54b Koninklijke ERU Kaasfabrik BV Postbus 7 3440 AA Woerden NEDERLAND Middelandse Zee 7 3446 CG Woerden NEDERLAND 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 phytosterols are supplied by Triple Crown 23 April 2008 14 May 2008

57 Vitae-Caps S.A. Polígono Industrial Torrehierro C/ Gutemberg, 356 45600 Talavera de la Reine (Toledo) ESPAÑA Rice drinks 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); a container of beverages will not contain more than 3 g of added phytosterols/phytostanols AESA (6)Opinion on substantial equivalence for phytosterols and esters of phytosterol from the company VitaeCaps S.A. on the basis of Art. 5 of Regulation (EC) No 258/97 (26 of May of 2008) 25 June 2008 9 July 2008

62 Oy Foodfiles Ltd Niementie 2 L 6 FI-70210 Kuopio SUOMI/FINLAND on behalf of Arboris LLC 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; milk type and fermented milk type products; yoghurt type products; cheese type products; soya drinks and salad dressings and spicy sauces NFB (3)(FIN) Opinion on substantial equivalence for Arboris® sterol AS-2™ plant sterol ingredient and foods enriched with it (Arboris® LLC) 5 April 2006 27 April 2006

rye bread with flour containing ≥ 50 % rye and ≤ 30 % wheat; and with ≤ 4 % sugar but no fat added 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/phytostanols; salad dressings and spicy sauces will be packed as single portions. 7 December 2006 19 February 2007

62b Dale Farm Ltd Shap Road Kendal Cumbria LA9 6NS UNITED KINGDOM Yogurt drinks 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/phytostanols The phytosterols are provided by Arboris 19 September 2008 1 October 2008

80 Lipofoods Calle Issac Peral, 17 08850 Gavà (Barcelona) ESPAÑA 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; products based on milk, such as products based on skimmed and semi — skimmed milk, possibly with the addition of fruits and/or cereals, fermented milk type products, such as yoghurt and cheese type products (fat content ≤ 12 g per 100 g) where the milk fat and or protein has been fully or partly replaced by vegetable fat or protein; milk based fruit drinks; salad dressings and spicy sauces; soya drinks with added phytosterols salad dressings and spicy sauces; soya drinks 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/phytostanols; spicy sauces and salad dressings will be packed as single portions ACNFP (4)Opinion on substantial esquivalence of phytosterols considered under Article 5 of the Novel Foods Regulation (FSA (2)15 February 2007; NFU 632) 16 February 2007 12 March 2007

80a Nöm AG Vöslauer Strasse 2500 Baden ÖSTERREICH Products based on milk, such as products based on skimmed and semi — skimmed milk, possibly with the addition of fruits and/or cereals, fermented milk type products, such as yoghurt 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/phytostanols; The phytosterols are provided by Lipofoods 19 November 2008 1 December 2008

103 SanoVia Im Kühstiefel 19 56653 Wehr DEUTSCHLAND Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by Huilerie F.J. Moog SARL 17 February 2008 17 March 2008

104 ARGANA d.o.o. Rentje 50 SI-4294 Križe SLOVENIJA Arganoil Company 213, Lot Habiba El Oulfa Casablanca MAROC Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by ARGANA d.o.o. and Arganoil Company 17 March 2008 14 April 2008

105 BPF Bioactive Products Faktory ul. Sloneczna 4 95-020 Justynów POLSKA/POLAND Noni juice (juice of the fruits of Morinda citrifolia) IZIZ (8)(PL) has delivered an opinion that the Noni juice to be placed on the market by the company BPF Bioactive Products Factory was substantially equivalent to Noni juice that is already on the market 31 March 2008 16 April 2008

106 Hygieiea Global Building #54,5F 1089 N, Quinzhou Rd Shanghai CHINA Hygieia Europe Postfach 1601 40641 Meerbusch DEUTSCHLAND Glucosamine HCl from Aspergillus niger for use in food supplements FSAI (5)(IRL) Substantial equivalence opinion of GlucosaGreen® branded Glucosamine HCL 3 April 2008 7 May 2008

107 Alga Technologies Ltd. Kibbbutz Ketura D.N. Hevel Eliot 88840 ISRAEL Astaxanthin rich extract from Haematococcus pluvialis ACNFP (4)(UK) Opinion on substantial equivalence of Astaxanthin-rich oleoresin extracted from Haematococcus pluvialis algae considered under Article 5 of the Novel Foods Regulation 14 April 2008 13 May 2008

108 KitoZyme sa Rue Haute Claire 4 Parc Industriel Huats Sarts, Zone 2 4040 Herrstal BELGIQUE/BELGIË Chitosan CSS (9)(B) Opinion No 8319 issued by the Superior Health Council: Substantial equivalence of the chitosan (KiOnutrime-Cs™) 30 April 2008 28 May 2008

109 Thiele Lifestyle Baymex Außenhandelsges. mbH Am Bahnhof 12 94538 Fürstenstein DEUTSCHLAND Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company Thiele Lifestyle 29 April 2008 4 June 2008

110 EZA Natürlich Fair Wenger Straße 5 5203 Köstendorf ÖSTERREICH Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company EZA natürlich Fair 16 June 2008 7 July 2008

111 Hygieiea Global Building #54,5F 1089 N, Quinzhou Rd Shanghai CHINA Hygieia Europe Postfach 1601 40641 Meerbusch DEUTSCHLAND Glucosamine sulphate NaCl from Aspergillus niger for use in food supplements Glucosamine sulphate KCl from Aspergillus niger for use in food supplements FSAI (5)(IRL) Substantial Equivalence Opinion of Glucosamine Sulphate NaCl FSAI (5)(IRL) Substantial Equivalence Opinion of Glucosamine Sulphate KCl 14 August 2008 11 September 2008

112 EFIT Srl Via Bramante 41 05100 Terni TR ITALIA Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company EFIT Srl 11 August 2008 11 September 2008

113 Korzonek Gottfried Kellerstr. 61a 94315 Straubing DEUTSCHLAND Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company Korzonek 21 August 2008 17 September 2008

114 EUROFROID Rue Denis Papin Zone industrielle 24100 Bergerac FRANCE Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company EUROFROID 11 September 2008 1 October 2008

115 ArganEden SARL BP 60331 33164 La Teste Cedex FRANCE Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company ArganEden 1 December 2008 11 December 2008

116 Copram Société de commercialisation des produits alimentaires du Maroc 17 rue Copenhague B.P. 80168 13745 Vitrolles Cedex FRANCE Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company copram 16 December 2008 19 January 2009

118 I.R.B. s.r.l. Istituto di Ricerche Biotecnologiche Via Piave 24/B 36077 Altavilla Vic. NA VI ITALIA Extracts from Ajuga reptans DSPVNSA (10)Subject: Substantial equivalence for Ajuga reptans extracts from plant tissue cultures 19 December 2008 19 January 2009

119 Arganpur KlönneStr. 94 44143 Dortmund DEUTSCHLAND Argan oil The DGCCRF (7)(F) confirmed that the previously issued opinion by AFSSA (4)(see No 13) was also applicable to the Argan oil placed on the market by the company Arganpur 25 June 2008 17 July 2008