Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member States

31

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Extracts from Ajuga reptans

DSPVNSA (10)Subject: Substantial equivalence for Ajuga reptans extracts from plant tissue cultures

19 December 2008

19 January 2009

119

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

122

Noni juice (juice of the fruits of Morinda citrifolia)

IRPZ (11)Opinion on the substantial equivalence of ‘NONI SOK’ juice with ‘TAHITIAN NONI®’ juice as authorised by Commission Decision 2003/426/EC

26 November 2008

27 March 2009