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

31z Lesieur 29 quai Aulagnier 92665 Asnières-sur-Seine Cedex FRANCE Salad dressings with added phytosterols The salad dressings will be packed as single portions 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 2009 15 June 2009

31.1a Varvello Pharma Nutrition srl Piazza Castello 2 20121 Milano MI ITALIA 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 phytosterols are provided by Cognis 26 May 2009 20 July 2009

31.1b Lesaffre Austria AG Industriezentrum NÖ-Süd Straße 7 2355 Wien ÖSTERREICH 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 phytosterols are provided by Cognis 18 September 2009 23 September 2009

31.1c Milk Link 3120 Great Western Court Hunts Ground Road Stoke Gifford Bristol BS34 8HP 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; a container of beverages will not contain more than 3 g of added phytosterols The phytosterols are provided by Cognis 21 September 2009 1 October 2009

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 (4) concerning the substantial equivalence 3 October 2006 6 November 2006

41n Lanitis Bros. Ltd 66, Kyriakos Matsis Ave. 2409 Engomi PO Box 2200 1515 Nicosia CYPRUS 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 provided by Forbes MediTech 2 April 2009 22 April 2009

57 Vitae-Caps SA Polígono Industrial Torrehierro C/ Gutemberg, 356 45600 Talavera de la Reine Toledo 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; Milk type products; and Yoghurt type products AESA (5) (E) opinion on the application submitted by the company VitaeCaps, SA to record its phytosterols and phytosterol esters under the substantial equivalence process of Regulation (EC) No 258/97 in accordance with the procedure provided in Article 5 of the same (27 September 2005) 30 January 2006 21 February 2006

Yellow fat spreads; milk type products; fermented milk type products; cheese type products, salad dressings; and soya drinks AESA (5) (E) Opinion on the application submitted by the company VitaeCaps, SA to record its phytosterols and phytosterol esters under the substancial equivalente process of Regulation (EC) No 258/97 in accordance with the procedure in Article 5 of the same (4 May 2006) 22 June 2006 27 September 2006

Spicy sauces; rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) ≤ 30 % wheat and with ≤ 4 % sugar but no fat added with added phytosterols AESA (5) (E) Opinion about the application presented by the company VitaeCaps, SA to register its phytosterols and phytosterolesters according to the process of substantial equivalence according to the procedure established in Aritle 5 of Regulation (EC) No 258/97 (27 July 2006) 26 October 2006 16 November 2006

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; salad dressing will be packed as single portions AESA (5) (E) Opinion on substancial equivalente for phytosterol from the company VitaeCaps SA on the basis of Article 5 of Regulation (EC) No 258/97 (26 of May of 2008) 25 June 2008 9 July 2008

57f Lactea Antequerana Poligono Industrial Yoghurt drinks 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; a container of beverages will not contain more than 3 g of added phytosterols/phytostanols The phytosterol esters are provided by VitaeCaps 2 May 2009 8 June 2009

57g Senna Nahrungsmittel GmbH Stockhammergasse 19 1144 Wien ÖSTERREICH 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 phytosterol esters are provided by VitaeCaps 7 July 2009 9 July 2009

57h Pomurske Milkane Industrijska ulica 10 p.p. 230 SI-9000 Murska SLOVENIJA Products based on milk 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 VitaeCaps 29 April 2009 19 January 2010

117 Diar Argan Am Altwasser 44 85459 Berglern DEUTSCHLAND Argan oil The DGCCRF (6) (F) confirmed that the previously issued opinion by AFSSA (8) (F) was also applicable to the Argan oil placed on the market by the company 12 January 2009 22 January 2009

120 SARL Argamis 711 bis Lotissement Allah Route de Guelin Tiznit MAROC Argan oil The FPS-HFCSE (8) (B) confirmed that the previously issued opinion by CSS (9) (B)was also applicable to the Argan oil placed on the market by SARL Argamis 20 March 2009 26 March 2009

121 SARL SOUSS TERROIR Lotissement Yasmina 2 C5 AIT Mlloul 80150 MAROC Argan oil The FPS-HFCSE (8) (B) confirmed that the previously issued opinion by CSS (9) (B) was also applicable to the Argan oil placed on the market by SARL SOUSS TERROIR 20 March 2009 26 March 2009

123 Lindemann GmbH & Co. KG Postfach 2249 32255 Bünde DEUTSCHLAND 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 phytosterols are the same as authorised by Commission Decision 2004/333/EC 17 April 2009 21 April 2009

124 Laboratoires Expanscience Rue de 4 Filles 28231 Épernon Cedex FRANCE Extract from Sunflower oil as an ingredient to food supplements AFSSA (7) (F) Opinion of the AFSSA on the evaluation of the substantial equivalence of an extract of sunflower oil to an extract of maize-germ oil 4 May 2009 5 May 2009

125 Cauvin 2350 Route de St. Gilles 30000 Nimes FRANCE Argan oil The DGCCRF (6) (F) confirmed that the previously issued opinion by AFSSA (7) (F) was also applicable to the Argan oil placed on the market by the company Cauvin 4 May 2009 2 June 2009

126 Bionatur 18 chemin de Roquerose 83690 Sillans la Cascade FRANCE Noni juice (juice of the fruits of Morinda citrifolia) AFSSA (7) (F) Opinion of AFSSA on the evaluation of substantial equivalence of a noni juice to the juice of Morinda citrifolia L. 2 June 2009 9 July 2009

127 Arganhaus Geditschstr. 77 10823 Berlin DEUTSCHLAND Argan oil The DGCCRF (6) (F) confirmed that the previously issued opinion by AFSSA (7) (F) was also applicable to the Argan oil placed on the market by the company Arganhaus 15 June 2009 14 July 2009

128 Bioresco Bundesstrasse 29 4064 Basel SWITZERLAND For DSM Nutritional Products Ltd. Purified extract from tea (Camellia sinensis) FSAI (4) (IRL): Substantial equivalence opinion of purified green tea extract — TEAVIGO 4 May 2009 6 August 2009

129 I.R.B. s.r.l. Istituto di Ricerche Biotecnologiche Via Piave 24/B 36077 Altavilla Vic. NA VI ITALIA Extracts from Echinacea angustifolia DSPVNSA (10) (I) Substantial equivalence for Echinacea angustifolia extract from plant tissue cultures 5 August 2009 13 August 2009

130 ABGUR GmbH Burkheimerstr. 9 79111 Freiburg DEUTSCHLAND Argan oil The DGCCRF (6) (F) confirmed that the previously issued opinion by AFSSA (7) was also applicable to the Argan oil placed on the market by the company ABGUR GmbH 28 July 2009 14 August 2009

131 Codefa 718 M.i.n. des Arnavaux 13323 Marseille Cedex 14 FRANCE Argan oil The DGCCRF (6) (F) confirmed that the previously issued opinion by AFSSA (7) was also applicable to the Argan oil placed on the market by the company Codefa 3 August 2009 17 August 2009

132 Souk du Maroc Mainzer Str. 45 53179 Bonn DEUTSCHLAND Argan oil The DGCCRF (6) (F) confirmed that the previously issued opinion by AFSSA (7) was also applicable to the Argan oil placed on the market by the company Souk du Maroc 10 August 2009 21 August 2009

133 Smart food inno kft. Hősök útja 1–3. 4027 Debrecen MAGYARORSZÁG/HUNGARY 2 Phytosterolcompositions for use in rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) ≤ 30 % wheat and with ≤ 4 % sugar but no fat added 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 OETI (11) (HU) Opinion on the Substantial Equivalence of Plant Sterol Compositions 20 August 2009 20 August 2009

134 Baobab Fruit Company S.a.r.l. Via A. Mondadori 15 46025 Poggio Rusco MN ITALIA Baobab dried fruit pulp CUDN (12) (I) Substantial equivalence of the Baobab (Adansonia digitata) dried fruit pulp 17 August 2009 17 September 2009

135 Argan export company Rue de Ramillies 2a 1367 Ramillies BELGIQUE/BELGIË Argan oil The FSP-HFCSE (8) (B) confirmed that the previously issued opinion by the CSS (9) (B) was also applicable to the Argan oil placed on the market by Argan export company 17 September 2009 23 September 2009

136 JFM SUNILE AS Holtbrekka 7 Postboks 109 5202 Os NORWAY Lipid extract from the crustaceae Anarctic krill (Euphausia superba) MfFLoF (13) (DK) Concerning a request for assessment of substantial equivalence between ColdSea krill oil (lipid extract from Antarctic Krill Euphausia superba) and krill oil from Neptune Technologies 29 October 2009 16 November 2009

137 Zenith-Group Siedlungsstr. 7 75203 Königsbach-Stein DEUTSCHLAND Argan oil The DGCCRF (5) (F) confirmed that the previously issued opinion by AFSSA (7) (F) was also applicable to the Argan oil placed on the market by the company Zenith-Group 27 October 2009 23 November 2009

138 Bioriginal Europa/Asia bv Bosland 40 3258 AC den Bommel NEDERLAND Refined Echium oil NFU (14) (NL) Refined echium oil — Assessment of substantial equivalence for a notification, in accordance with Regulation (EC) No 258/97 concerning novel foos and novel food ingredients 9 November 2009 27 November 2009

139 Original Chia Aps. Stranvej 1 D 6400 Sønderborg DANMARK Chia seed as ingredient to bread products (maximu 5 %) MfFLoF (13) (DK) Concerning a request for assessment of substantial equivalence of Chia (Salvia hispanica) seed from Origian Chia Aps to Chia seed from Columbus Paradigm Institute 3 December 2009 7 December 2009

140 Aker BioMarine Antarctic AS Fjordalléen 16 PO Box 1423 Vika 0115 Oslo NORWAY Lipid extract from the crustaceae Anarctic krill (Euphausia superba) NFB (3) (FIN) Opinion on the substantial equivalence of Superba™ krill oil (Aker Biomarine Antarctic AS) 11 December 2009 22 December 2009

141 GIE Targanine Rue de Marrakech, Bloc 3, No 33 Quartier Industriel 80000 Agadier MAROC Argan oil The FSP-HFCSE (8) (B) confirmed that the previously issued opinion by the CSS (9) (B) was also applicable to the Argan oil placed on the market by GIE Targanine 16 December 2009 15 January 2010

143 Fruchtquell Getränkeindustrie GmbH & Co. KG Kogelerstr. 16 19243 Dodow DEUTSCHLAND Noni juice BVL (15) (D) Opinion on the question of the substantial equivalence in accordance with Article 3 (4) of Regulation (EC) No 258/97 of Noni juice (juice from the fruit of the species Morinda citrifolia L.) from the company Fruchtquell Getränkeindustrie GmbH & Co. KG, D-19243 Dodow, to other noni juices already notified in accordance with Article 5 of Regulation (EC) No 258/97 7 May 2009 19 April 2010