# C_2005208EN.01000201.xml

| 25.8.2005 | EN | Official Journal of the European Union | C 208/2 |
| --- | --- | --- | --- |

25.8.2005

EN

Official Journal of the European Union

C 208/2

---

Summary of notifications received by the Commission until 31 December 2004 pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council

(2005/C 208/02)

Between the entry into force of Regulation (EC) No 258/97 on 15 May 1997 and 31 December 2004 the Commission received 46 notifications of placing on the market novel foods or novel food ingredients pursuant to Article 5 of Regulation (EC) No 258/97.

| | 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 |

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)

1

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 |

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; |
| --- | --- |

(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; |
| --- | --- |

(ii)

fertility restorer RF2Bn (B94-2) oilseed rape line and all conventional crosses;

| (iii) | hybrid combination MS1XRF2 |
| --- | --- |

(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)

1

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 |

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; |
| --- | --- |

(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; |
| --- | --- |

(ii)

fertility restorer RF1Bn (B93-101) oilseed rape line and all conventional crosses;

| (iii) | hybrid combination MS1XRF1 |
| --- | --- |

(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

1

‘Report on oil from genetically modified oilseed rape’ (ACNFP) (1) (UK)

1

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 |

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)

1

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 |

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)

1

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 |

AgrEvo France S.A.

Les Algorithmes

Bâtiment Thalès

Saint Aubin

F-91197 Gif-sur-Yvette Cedex

| (i) | Starch and all its derivatives; |
| --- | --- |

(i)

Starch and all its derivatives;

| (ii) | crude and refined oil; |
| --- | --- |

(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 |
| --- | --- |

(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)

1

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 |

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

1

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 |

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

1

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 |

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

2

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 |

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

2

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 |

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

2

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 |

F. Hoffman — La Roche Ltd.

Vitamins & Fine Chemicals

Regulatory Affairs

Bldg 241/283

CH-4070 Basel

Riboflavin from Bacillus subtilis as nutrient

Bacillus subtilis

ACNFP (1) (UK) Report on Riboflavin from fermentation using genetically modified (GM) Bacillus subtilis

1

Bacillus subtilis

20 March 2000

26 April 2000

12

| Mr. Jean-Pierre Clavié |
| --- |
| ‘Vidalou’ |
| F-47300 Pujols |

Mr. Jean-Pierre Clavié

‘Vidalou’

F-47300 Pujols

‘prune kernel oil’

AFSSA (3) (F) Opinion on placing on the market of ‘prune kernel oil’

3

24 July 2000

4 August 2000

13

| Ms Catherine Drevet |
| --- |
| CD & A sarl |
| 14 avenue de l'opera |
| F-75001 Paris |

Ms Catherine Drevet

CD & A sarl

14 avenue de l'opera

F-75001 Paris

Argan oil

(Argania spinosa L.)

Argania spinosa

AFSSA (3) (F) Opinion concerning the substantial equivalence of argan oil (Argania spinosa L.) with other food oils

3

Argania spinosa

23 July 2002

26 August 2002

14

| Dr. Bruno Tinland |
| --- |
| Monsanto Services International |
| Avenue de Tervuren 270-272 |
| B-1150 Brussels |

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

1

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 |

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

1

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 |

M Jean-Paul Braud

Innovalg S.A.R.L.

Centre d'Algoculture

Polder du Dain

F-85230 Bouin

Microalga Odontella aurita

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

3

Odontella aurita

9 December 2002

19 December 2002

17

| Herr Matthias Werner |
| --- |
| NCT Nord Trading GmbH |
| Albert-Schweitzer-Str. 20 |
| D-85375 Neufahrn b. Freising |

Herr Matthias Werner

NCT Nord Trading GmbH

Albert-Schweitzer-Str. 20

D-85375 Neufahrn b. Freising

Juice of the fruits of Morinda citrifolia

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

4

Morinda citrifolia

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 |

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

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 |

Poul A Svane

Svane Trading ApS

Rypevang 4

DK-3450 Allerød

Juice of the fruits of Morinda citrifolia

Morinda citrifolia

See 17

Confirmed by BVL (4) (D) for MfFLoF (7) (DK)

4

7

6 July 2004

16 July 2004

17c

| Kerstin Wiegärtner |
| --- |
| Xerion Overseas |
| Hauptstrasse 36-38 |
| D-91278 Pottenstein |

Kerstin Wiegärtner

Xerion Overseas

Hauptstrasse 36-38

D-91278 Pottenstein

Juice of the fruits of Morinda citrifolia

Morinda citrifolia

See 17

Confirmed by BVL (4) (D)

4

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 |

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)

TM

BfR (5) (D) Expert opinion concerning recognition of the substantial equivalence of DHA45 oil and the registered novel foodstuff Omega GoldTM oil

5

TM

10 November 2003

24 December 2003

19

| Dr. Ernst Karrer |
| --- |
| Paracelsus Haus GmbH |
| Freistädter Straße 236 |
| A-4040 Linz |

Dr. Ernst Karrer

Paracelsus Haus GmbH

Freistädter Straße 236

A-4040 Linz

Noni juice (juice of the fruits of Morinda citirfolia)

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

6

Morinda citrifolia

23 December 2003

14 January 2004

20

| Herr Michael Gracher |
| --- |
| GSE-Vertrieb |
| Biologische Nahrungsergänzungs- und Heilmittel GmbH |
| Saargemünder Str. 18 |
| D-66119 Saarbrücken |

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)

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

4

Morinda citrifolia

Morinda citrifolia

24 December 2003

26 January 2004

21

| Herr Franz Brenner |
| --- |
| Botanical Products International |
| F.M. Brenner GmbH |
| Hauptstrasse 10 |
| A-2392 Wienerwald/Grub |

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)

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)

6

Morinda citrifolia

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)

6

Morinda citrifolia

30 June 2004

5 August 2004

22

| Poul A Svane |
| --- |
| Svane Trading ApS |
| Rypevang 4 |
| DK-3450 Allerød |

Poul A Svane

Svane Trading ApS

Rypevang 4

DK-3450 Allerød

Noni juice (juice of the fruits of Morinda citrifolia)

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

7

Morinda citrifolia

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. |

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)

Morinda citrifolia

see 22

21 June 2004

29 June 2004

23

| Herr Franz Mitterbauer |
| --- |
| FM Network Marketing GmbH |
| Stadtplatz 13/1 |
| A-5280 Braunau |

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

Morinda citrifolia

and

Noni juice (juice of the fruits of Morinda citrifolia)

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)

6

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)

6

2 August 2004

5 August 2004

24

| Georg Jessner |
| --- |
| Planta Naturstoffe Vertriebsges.m.b.H. |
| Erlgasse 48 |
| A-1120 Wien |

Georg Jessner

Planta Naturstoffe Vertriebsges.m.b.H.

Erlgasse 48

A-1120 Wien

Noni juice (juice of the fruits of Morinda citrifolia)

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

6

29 March 2004

21 April 2004

25

| Els Deprez |
| --- |
| G.D.I. nv |
| Wolvenhovenstraat 12 |
| B-8870 Izegem |

Els Deprez

G.D.I. nv

Wolvenhovenstraat 12

B-8870 Izegem

Noni juice (juice of the fruits of Morinda citrifolia)

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 |

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 |

US Nutra

2751 Nutra Lane

USA — 32726 Eustis Fl

Capsules with Astaxanthin-rich Carotenoid Oleoresin extracted from Haematococcus Pluvialis (max 4 mg Astaxanthin/capsule)

Haematococcus Pluvialis

ACNFP (1)(UK) Request for an Article 5 Opinion on the Substantial Equivalence of Astaxanthin-rich Carotenoid Oleoresin extracted from Haematococcus pluvialis

1

Haematococcus pluvialis

28 June 2004

13 July 2004

27

| Ms Leena Morander |
| --- |
| Teriaka Ltd. |
| Siirakuja 3 |
| FIN-01490 Vantaa |

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.)

8

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.)

8

4 October 2004

16 November 2004

28

| Mr Javier Echevarria Gutierrez |
| --- |
| Corporaction Alimentaria PEÑASANTA S.A. |
| E-33199 Granda-Siero |

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 |

(i)

MEDICURA AG

Am Baumfeld 14

D-97616 Bad Neustadt

| (ii) | Littlefood GmbH |
| --- | --- |
| Schmiedweg 6 |
| A-6380 St. Johann |

(ii)

Littlefood GmbH

Schmiedweg 6

A-6380 St. Johann

| (iii) | Naturana GmbH |
| --- | --- |
| Eichthalstraße 12a |
| D-82377 Penzberg |

(iii)

Naturana GmbH

Eichthalstraße 12a

D-82377 Penzberg

Noni juice (juice of the fruits of Morinda citrifolia)

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.

6

23 July 2004

2 August 2004

30

| Ms Geraldine Perez |
| --- |
| Danone |
| 126, rue Jules-Guesde |
| F-92302 Levallois-Perret |

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)

8

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 |

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 |
| --- | --- |

(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 |
| --- | --- |

(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

9

23 July 2004

4 August 2004

31a

| Mr Gilles Nassy |
| --- |
| Novandie |
| 19, rue de la République |
| F-76153 Maromme Cedex |

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 |

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 |

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

8

8

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 |

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 |

Brent Rogers

Cargill Acidulants

Cargill Drive

Eddyville

IA 52553

USA

Glucosamine Hydryochloride from the fungus Aspergillus niger

Aspergillus niger

ACNFP (1) (UK) Opinion on Substantial equivalence of glucosamine HCl (Aspergillus niger) considered under Article 5 of the Novel Foods Regulation

1

Aspergillus niger

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 |

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)

Morinda citrifolia

AESA  (10) (E) Declaration of substantial equivalence for the product ‘Somanoni’ from the company Tico Catalana S.A.

10

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 |

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)

Morinda citrifolia

Gezondheidsraad (NL) Noni Juice (3) Assessment of substantial equivalence of a fruit juice from Morinda citrifolia

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 |

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)

Morinda citrifolia

Gezondheidsraad (NL) Noni Juice (2) Assessment of substantial equivalence of a fruit juice from Morinda citrifolia

Morinda citrifolia

14 October 2004

16 November 2004

37

| Mr Pascal Erdmann |
| --- |
| Natures Products |
| 15 Brailsford Court, Howick |
| Auckland |
| New Zealand |

Mr Pascal Erdmann

Natures Products

15 Brailsford Court, Howick

Auckland

New Zealand

Noni juice (juice of the fruits of Morinda citrifolia)

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

38

| Dr. F. Shinnick |
| --- |
| Cargill |
| 15407 McGinty Road |
| MS 110 |
| Wyazata, MN 55391 |
| USA |

Dr. F. Shinnick

Cargill

15407 McGinty Road

MS 110

Wyazata, MN 55391

USA

Foods with added phytosterols:

| | Yellow fat spreads excluding cooking or frying fats and spreads based on butter or other animal fat; |
| --- | --- |

Yellow fat spreads excluding cooking or frying fats and spreads based on butter or other animal fat;

| | Salad dressings, mayonnaise and spicy sauces; |
| --- | --- |

Salad dressings, mayonnaise and spicy sauces;

| | Milk-type drinks with fruit and/or cereals, milk-based fruit drinks, fermented milk type products, where the milk fat and/or protein has been partly or fully replaced by vegetable fat or protein and soy drinks; |
| --- | --- |

Milk-type drinks with fruit and/or cereals, milk-based fruit drinks, fermented milk type products, where the milk fat and/or protein has been partly or fully replaced by vegetable fat or protein and soy drinks;

| | Cheese type products (fat content ≤12g per 100g), where the milk fat and/or protein has been partly or fully replaced by vegetable fat or protein |
| --- | --- |

Cheese type products (fat content ≤12g per 100g), 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/phytostanols;

a container of beverages will not contain more than 3 g of added phytosterols/phytostanols.

Novel Food Board (FIN) Opinion on substantial equivalence in the case of plant sterol/plant stanol ingredient intended to be used in foods (Cargill Incorporation)

24 October 2004

13 December 2004

---

(1)

1

| ACNFP | Advisory Committee on Novel Foods and Processes (UK) |
| --- | --- |

ACNFP

Advisory Committee on Novel Foods and Processes (UK)

(2)

2

| BgVV | Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (D) |
| --- | --- |

BgVV

Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (D)

(3)

3

| AFFSA | Agence française de sécurite sanitaire des alimentes (F) |
| --- | --- |

AFFSA

Agence française de sécurite sanitaire des alimentes (F)

(4)

4

| BVL | Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (D) |
| --- | --- |

BVL

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (D)

(5)

5

| BfR | Bundesinstitut für Risikobewertung (D) |
| --- | --- |

BfR

Bundesinstitut für Risikobewertung (D)

(6)

6

| AGES | Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (A) |
| --- | --- |

AGES

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (A)

(7)

7

| MfFLoF | Ministeriet for Fødevarer, Landbrug og Fiskeri (DK) |
| --- | --- |

MfFLoF

Ministeriet for Fødevarer, Landbrug og Fiskeri (DK)

(8)

8

| NFB | Novel Food Board (FIN) |
| --- | --- |

NFB

Novel Food Board (FIN)

(9)

9

| FSA | Food Standards Agency (UK) |
| --- | --- |

FSA

Food Standards Agency (UK)

(10)

10

| AESA | Agencia espaniola de seguridad alimentaria (E) |
| --- | --- |

AESA

Agencia espaniola de seguridad alimentaria (E)

---