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

1 AgrEvo UK Limited Chesterford Park Saffron Walden Essex CB10 1XL United Kingdom Processed oil from genetically modified canola seed, transformation event TOPAS 19/2 and all conventional crossed ‘Report on oil from a genetically modified (GM) glufosinate ammonium tolerant oilseed rape’ (ACNFP) (1) (UK) 9 June 1997 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 24 June 1997

2a Plant Genetic Systems N.V. Jozef Plateaustraat 22 B-9000 Gent Processed oil from genetically modified oilseed rape seed derived from: (i) male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses; (ii) fertility restorer RF2Bn (B94-2) oilseed rape line and all conventional crosses; (iii) hybrid combination MS1XRF2 ‘Report on oil from a fertility restorer line for use in a hybrid breeding programme for genetically modified (GM) oilseed rape’ (ACNFP) (1) (UK) 10 June 1997 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 24 June 1997 again 28 July 1998

2b Plant Genetic Systems N.V. Jozef Plateaustraat 22 B-9000 Gent Processed oil from genetically modified oilseed rape seed derived from: (i) male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses; (ii) fertility restorer RF1Bn (B93-101) oilseed rape line and all conventional crosses; (iii) hybrid combination MS1XRF1 ‘Report on oil from a fertility restorer line for use in a hybrid breeding programme for genetically modified (GM) oilseed rape’ (ACNFP) (1); and ‘Report on oil from genetically modified oilseed rape’ (ACNFP) (1) (UK) 10 June 1997 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 24 June 1997 again 28 July 1998

3 Monsanto Services International S.A Avenue de Tervuren 270-272 B-1150 Brussels Refined oil from glyphosate tolerant oilseed rape line GT73 ‘Report on oil from genetically modified (GM) glyphosate tolerant oilseed rape’ (ACNFP) (1) (UK) 10 November 1997 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 21 November 1997

4 Monsanto Services International S.A Avenue de Tervuren 270-272 B-1150 Brussels Food and food ingredients produced from maize flour, maize gluten, maize semolina, maize starch, maize glucose and maize oil derived from the progeny of maize line MON 810 ‘Report on processed products from genetically modified (GM) insect protected maize’ (ACNFP) (1) (UK) 10 December 1997 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 6 February 1998

5 AgrEvo France S.A. Les Algorithmes Bâtiment Thalès Saint Aubin F-91197 Gif-sur-Yvette Cedex (i) Starch and all its derivatives; (ii) crude and refined oil; (iii) all heat-processed or fermented products obtained from hominys, grits and flour (dry milled fragments) obtained from the genetically modified maize, tolerant to glufosinate ammonium, transformation event T25 and all the varieties derived from ‘Report on processed products from genetically modified (GM) glufosinate ammonium tolerant maize’ (ACNFP) (1) (UK) 12 January 1998 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 6 February 1998

6 Novartis Seeds AG Schwarzwaldallee 215 CH-4058 Basel Food and food ingredient products derived from the original transformant Bt11 crossed with the Northrup King Company inbred line #2044 (maize), as well as from any inbred and hybrid lines derived from it and containing the introduced genes ACNFP (1) (UK) Report on grain from maize genetically modified for insect resistance 30 January 1998 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 6 February 1998

7 Pioneer Overseas Corporation Avenue Tedesco, 7 B-1160 Brussels Novel foods and novel food ingredients produced from genetically modified maize line MON 809 ACNFP (1) (UK) Report on genetically modified (GM) insect protected maize Pioneer Hi-bred International — line MON 809 14 October 1998 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 23 October 1998

8 Hoechst Schering, AgrEvo GmbH Industriepark Hoechst AgrEvo-Haus K 607 D-65926 Frankfurt am Main Processed oil from genetically modified oilseed rape derived from Falcon GS 40/90 BgVV (2) Statement on the substantial equivalence of refined edible oil extracted out of the transgenic glufosinate-tolerant oil seed rape variety Falcon GS/40/90 21 October 1999 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 8/9 November 1999

9 Hoechst Schering, AgrEvo GmbH Industriepark Hoechst AgrEvo-Haus K 607 D-65926 Frankfurt am Main Processed oil from genetically modified oilseed rape derived from Liberator L62 BgVV (2)(D) Statement on the substantial equivalence of refined edible oil extracted out of the transgenic glufosinate-tolerant oil seed rape variety Liberator pHoe6/Ac 21 October 1999 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 8/9 November 1999

10 Plant Genetic Systems N.V. Jozef Plateaustraat 22 B-9000 Gent Processed oil from genetically modified oilseed rape derived from: the male sterile MS8 (DBN 230-0028) oilseed rape line and all conventional crosses; the fertility restorer RF (DBN212-0005) oilseed rape line and all conventional crosses; the hybrid combination MS8 x RF3 BgVV (2)(D) Statement on the substantial equivalence of refined edible oil extracted out of the transgenic glufosinate-tolerant oil seed rape variety MS8/RF3 21 October 1999 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 8/9 November 1999

11 F. Hoffman — La Roche Ltd. Vitamins & Fine Chemicals Regulatory Affairs Bldg 241/283 CH-4070 Basel Riboflavin from Bacillus subtilis as nutrient ACNFP (1) (UK) Report on Riboflavin from fermentation using genetically modified (GM) Bacillus subtilis 20 March 2000 26 April 2000

12 Mr. Jean-Pierre Clavié ‘Vidalou’ F-47300 Pujols ‘prune kernel oil’ AFSSA (3) (F) Opinion on placing on the market of ‘prune kernel oil’ 24 July 2000 4 August 2000

13 Ms Catherine Drevet CD & A sarl 14 avenue de l'opera F-75001 Paris Argan oil (Argania spinosa L.) AFSSA (3) (F) Opinion concerning the substantial equivalence of argan oil (Argania spinosa L.) with other food oils 23 July 2002 26 August 2002

14 Dr. Bruno Tinland Monsanto Services International Avenue de Tervuren 270-272 B-1150 Brussels Cottonseed oil from genetically modified cotton line 1445 (herbicide resistant) ACNFP (1) (UK) Request for an Article 5 opinion on the substantial equivalence of cotton seed oil and food ingredients derived from Roundup® Ready cotton 24 July 2002 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 19 December 2002

15 Dr. Bruno Tinland Monsanto Services International Avenue de Tervuren 270-272 B-1150 Brussels Cottonseed oil from genetically modified cotton line 531 (insect protected) ACNFP (1) (UK) Request for an Article 5 opinion on the substantial equivalence of cottonseed oil and food ingredients derived from insect protected cottonseed 24 July 2002 As from 18 April 2005 see register pursuant to Article 28 of Regulation (EC) No 1829/2003 19 December 2002

16 M Jean-Paul Braud Innovalg S.A.R.L. Centre d'Algoculture Polder du Dain F-85230 Bouin Microalga Odontella aurita AFSSA (3) (F) Opinion concerning a request for the evaluation of the demonstration of substantial equivalence of the micro-alga Odontella aurita to authorised algae 9 December 2002 19 December 2002

17 Herr Matthias Werner NCT Nord Trading GmbH Albert-Schweitzer-Str. 20 D-85375 Neufahrn b. Freising Juice of the fruits of Morinda citrifolia BVL (4) (D) Opinion on the determination of substantial equivalence of the juice of the fruits of the species Morinda citrifolia L. from the company NCT Trading Ltd and the ‘Noni Juice’ authorised as a novel food ingredient 10 November 2003 5 December 2003

17a Drs. René van Lohuizen Will & Co. B.V. Postbus 46 1170 AA Badhoevedorp Nederland Dellaertlaan 24 1171 HG Badhoevedorp Nederland Juice of the fruits of Morinda citrifolia See 17 Confirmed by Ministerie van Volksgezondheid, Welzijn en Sport (NL) 22 June 2004 6 July 2004

17b Poul A Svane Svane Trading ApS Rypevang 4 DK-3450 Allerød Juice of the fruits of Morinda citrifolia See 17 Confirmed by BVL (4) (D) for MfFLoF (7) (DK) 6 July 2004 16 July 2004

17c Kerstin Wiegärtner Xerion Overseas Hauptstrasse 36-38 D-91278 Pottenstein Juice of the fruits of Morinda citrifolia See 17 Confirmed by BVL (4) (D) 10 August 2004 16 August 2004

18 Professor Dr. G.-W. von Rymon Lipinski Head Regulatory Services & Management Nutrinova Industriepark Höchst D-65926 Frankfurt am Main DHA (docohexanoic-acid)-rich microalgal oil (DHActiveTM) BfR (5) (D) Expert opinion concerning recognition of the substantial equivalence of DHA45 oil and the registered novel foodstuff Omega GoldTM oil 10 November 2003 24 December 2003

19 Dr. Ernst Karrer Paracelsus Haus GmbH Freistädter Straße 236 A-4040 Linz Noni juice (juice of the fruits of Morinda citirfolia) AGES (6) (A) Application for recognition of substantial equivalence pursuant to Article 3(4) of Regulation (EC) No 258/97 for ‘Bula Noni® Juice -100% juice from the fruit of the species Morinda citrifolia L.’ produced by the company ‘Paracelsus Haus Handels- und Dienstleistungs GmbH’ as a novel food ingredient 23 December 2003 14 January 2004

20 Herr Michael Gracher GSE-Vertrieb Biologische Nahrungsergänzungs- und Heilmittel GmbH Saargemünder Str. 18 D-66119 Saarbrücken Noni juice (juice of the fruits of Morinda ctrifolia) BVL (4) (D) Opinion on the determination of substantial equivalence of juice from the fruit of the species Morinda citrifolia L. from the company GSE-Vertrieb and ‘noni juice’ (juice from the fruit of the species Morinda citrifolia L.) from Morinda Inc. authorised as a novel food ingredient 24 December 2003 26 January 2004

21 Herr Franz Brenner Botanical Products International F.M. Brenner GmbH Hauptstrasse 10 A-2392 Wienerwald/Grub Noni juice (juice of the fruits of Morinda citrifolia) AGES (6)(A) Application for determination of substantial equivalence under Article 3(4) of Regulation (EC) No 258/97 for a noni juice concentrate from the company ‘Botanical Products International (BPI) — F.M. Brenner GmbH’ made from fruit of the species Morinda citrifolia L. as a novel food ingredient (10 December 2003) 9 January 2004 14 January 2004

AGES (6) (A) Application for an evaluation of substantial equivalence pursuant to Article 3(4) of Regulation (EC) No 258/97 for a ‘noni juice’ from ‘Botanical Products International- F.M. Brenner GmbH’ produced from fruit of the species Morinda citrifolia L. as a novel food ingredient (28 June 2004) 30 June 2004 5 August 2004

22 Poul A Svane Svane Trading ApS Rypevang 4 DK-3450 Allerød Noni juice (juice of the fruits of Morinda citrifolia) MfFLoF (7), Fødevaredirektoratet (DK) — Opinion concerning the substantial equivalence of the noni juice product from Pouls Svane Trading to the product approved by Commission Decision 2003/426/EC of 5 June 2003 authorising the placing on the market of noni juice (juice of the fruit Morinda citrifolia L.) as a novel food ingredient 16 January 2004 6 February 2004

22a Tahiti Naturel EURL PO Box 14968 Arue — Tahiti French Polynesia c/o Mme Marysa Benjamin Tahiti Naturel 1 Square Xavier Monteny F-93220 Gagny. Noni juice (juice of the fruits of Morinda citrifolia) see 22 21 June 2004 29 June 2004

23 Herr Franz Mitterbauer FM Network Marketing GmbH Stadtplatz 13/1 A-5280 Braunau Noni juice (juice of the fruits of Morinda citrifolia) with 10% grape juice concentrate and Noni juice (juice of the fruits of Morinda citrifolia) AGES (6) (A) Application for evaluation of substantial equivalence pursuant to Article 3(4) of Regulation (EC) No 258/97 for ‘Indian Noni Indian Mulberry, Morinda juice with 10% grape juice concentrate’ from ‘FM Marketing Network GmbH’ as a novel food ingredient (27 February 2004) 1 March 2004 16 March 2004

AGES (6) (A) Application for evaluation of substantial equivalence pursuant to Article 3 (4) of Regulation (EC) No 258/97 for ‘Indian Noni Indian Mulberry, Morinda juice’ from ‘FM Marketing Network GmbH’ as a novel food ingredient (27 July 2004) 2 August 2004 5 August 2004

24 Georg Jessner Planta Naturstoffe Vertriebsges.m.b.H. Erlgasse 48 A-1120 Wien Noni juice (juice of the fruits of Morinda citrifolia) AGES (6)(A) Application for an evaluation of substantial equivalence pursuant to Article 3(4) of Regulation (EC) No 258/97 for ‘Nonivera Saft (trade name), Bio Noni Saft’ of the company ‘Planta Naturstoffe Vertriebsges.m.b.H.’ as a novel food ingredient 29 March 2004 21 April 2004

25 Els Deprez G.D.I. nv Wolvenhovenstraat 12 B-8870 Izegem Noni juice (juice of the fruits of Morinda citrifolia) Gezondheidsraad (B) Opinion of the Public Health Board concerning the request for recognition of the substantial equivalence of a Noni juice submitted by the GDI company under Article 3(4) of Regulation (EC) No 258/97 24 May 2004 6 July 2004

26 Dr. John Wilkinson Herbal Sciences International Ltd. The Seed Bed Centre, Langston Road Loughton Essex IG10 3TQ United Kingdom for US Nutra 2751 Nutra Lane USA — 32726 Eustis Fl Capsules with Astaxanthin-rich Carotenoid Oleoresin extracted from Haematococcus Pluvialis (max 4 mg Astaxanthin/capsule) ACNFP (1)(UK) Request for an Article 5 Opinion on the Substantial Equivalence of Astaxanthin-rich Carotenoid Oleoresin extracted from Haematococcus pluvialis 28 June 2004 13 July 2004

27 Ms Leena Morander Teriaka Ltd. Siirakuja 3 FIN-01490 Vantaa Milk type products and soya drinks with added phytosterols/phytostanols And Fermented milk products with added phytosterols/phytostanols 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. NFB (8) (FIN) Opinion of the Novel Food Board on substantial equivalence in the case of a milk and soya drink with added Diminicol® ingredient (Teriaka Ltd.) 1 July 200 16 July 2004

NFB (8) (FIN) Opinion on substantial equivalence in the case of fermented milk products with added Diminicol® ingredient (Teriaka Ltd.) 4 October 2004 16 November 2004

28 Mr Javier Echevarria Gutierrez Corporaction Alimentaria PEÑASANTA S.A. E-33199 Granda-Siero Milk type and fermented milk type products with added phytosterols/phytostanols 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/phytostanols are those that were authorised by Commission Decision 2004/333/EC 7 June 2004 4 August 2004

29 Friedrich Reuss for (i) MEDICURA AG Am Baumfeld 14 D-97616 Bad Neustadt (ii) Littlefood GmbH Schmiedweg 6 A-6380 St. Johann (iii) Naturana GmbH Eichthalstraße 12a D-82377 Penzberg Noni juice (juice of the fruits of Morinda citrifolia) AGES (6) (A) Application for recognition of substantial equivalence, under Article 3(4) of Regulation (EC) No 258/97, for a product known as ‘Noni-Fruchtsaft von den Cook-Inseln’ (Noni Fruit Juice from the Cook Islands) to be marketed by the firms ‘Littlefood’, ‘Naturana GmbH’ und ‘Medicura AG’ as a novel food ingredient. 23 July 2004 2 August 2004

30 Ms Geraldine Perez Danone 126, rue Jules-Guesde F-92302 Levallois-Perret Yoghurt with added phytosterols/phytostanols 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. NFB (8) (FIN) Opinion of the Novel Food Board on substantial equivalence in the case of a yoghurt type product with added DANACOL® ingredient (DANONE France) 29 July 2004 12 August 2004

31 Dr Horst Messinger Cognis Deutschland GmbH & Co. KG Postfach 13 01 64 D-40551 Düsseldorf Henkelstrasse 67 D-40589 Düsseldorf 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 FSA (9) (UK) Request for an opinion on the substantial equivalence of phytosterols and their esters 23 July 2004 4 August 2004

31a Mr Gilles Nassy Novandie 19, rue de la République F-76153 Maromme Cedex Yogurth type products 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 phytosterol esters; a container of beverages will not contain more than 3 g of added phytosterol esters The phytosterol esters ingredient is the one that was notified by Cognis 22 July 2004 9 September 2004

31b Ms Maria Donzília de Jesus Cantarinho LACTOGAL Produtos Alimentares S.A. Rua do Campo Alegre 830 5° P-4150-171 Porto Milk and yogurth type products 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 phytosterol esters; a container of beverages will not contain more than 3 g of added phytosterol esters The phytosterol esters ingredient is the one that was notified by Cognis 30 September 2004 21 October 2004

31c Mr Eric Grande Danone Vitapole Route Départementale 128 F-91767 Palaiseau Cedex for Compagnie Gervais Danone Fermented milk type products 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 phytosterol esters; a container of beverages will not contain more than 3 g of added phytosterol esters NFB (8) (FIN) Opinion on substantial equivalence of a phytosterol ingredient and yoghurt type products added with that ingredient (Compagnie Gervais Danone) (4 November 2004) and the opinion of the NFB (8) (FIN) issued in connection with the notification No 30 The phytosterol esters ingredient may also be the same that was notified by Cognis. 23 November 2004 13 December 2004

32 Michael O'Shea QA Consumer Food Manager Dairygold Clonmel Road Mitchelstown Co.Cork Ireland Yellow fat spreads excluding cooking and frying fats and spreads based on butter or other animal fat 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 phytosterol esters. Food Safety Authority of Ireland By letter of 11 August expressed their opinion that these yellow fat spread was substantial equivalent to a similar product on the EU market. 30 August 2004 20 September 2004

33 Brent Rogers Cargill Acidulants Cargill Drive Eddyville IA 52553 USA Glucosamine Hydryochloride from the fungus Aspergillus niger ACNFP (1) (UK) Opinion on Substantial equivalence of glucosamine HCl (Aspergillus niger) considered under Article 5 of the Novel Foods Regulation 6 August 2004 13 October 2004

34 Mr Salvador Martí Gómez-Lechón SomaNoni TICO CATALANA S.A. Sucursal en España Camino de Aldaya 18 E-46940 Manises, Valencia Noni juice (juice of the fruits of Morinda citrifolia) AESA (10) (E) Declaration of substantial equivalence for the product ‘Somanoni’ from the company Tico Catalana S.A. 16 August 2004 7 October 2004

35 Mr Daniel Deneke COSMOS-AN Europe B.V. Postbus 2699 6401 DD Heerlen Nederland Economiestraat 13 6433 KC Hoensbroek Nederland Noni juice (juice of the fruits of Morinda citrifolia) Gezondheidsraad (NL) Noni Juice (3) Assessment of substantial equivalence of a fruit juice from Morinda citrifolia 13 October 2004 16 November 2004

36 Mr Gerry Reints NONI Hawaii BV Postbus 1342 9701 BH Groningen Nederland Aweg 43 9718 CX Groningen Nederland Noni juice (juice of the fruits of Morinda citrifolia) Gezondheidsraad (NL) Noni Juice (2) Assessment of substantial equivalence of a fruit juice from Morinda citrifolia 14 October 2004 16 November 2004

37 Mr Pascal Erdmann Natures Products 15 Brailsford Court, Howick Auckland New Zealand Noni juice (juice of the fruits of Morinda citrifolia) Food Standards Agency (UK) Opinion on the equivalence of Cook Island Noni juice by Natures Products Ltd. 2 November 2004 15 November 2004