Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member States

1

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

Processed oil from genetically modified oilseed rape seed derived from:

‘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

Processed oil from genetically modified oilseed rape seed derived from:

‘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

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

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

‘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

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

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

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

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

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

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

‘prune kernel oil’

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

24 July 2000

4 August 2000

13

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

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

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

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

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

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

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

Juice of the fruits of Morinda citrifolia

See 17

Confirmed by BVL (4) (D)

10 August 2004

16 August 2004

18

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

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

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

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

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

Noni juice (juice of the fruits of Morinda citrifolia)

see 22

21 June 2004

29 June 2004

23

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

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

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

for

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

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

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

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

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

Phytosterol esters for the addition to

FSA (9) (UK) Request for an opinion on the substantial equivalence of phytosterols and their esters

23 July 2004

4 August 2004

31a

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

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

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

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

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

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

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

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

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

38

Foods 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.

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