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

31z

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

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

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 based beverages with added phytosterols

The phytosterols are provided by Cognis

21 September 2009

1 October 2009

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 (4) concerning the substantial equivalence

3 October 2006

6 November 2006

41n

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

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;

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

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

The phytosterol esters are provided by VitaeCaps

2 May 2009

8 June 2009

57g

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

Products based on milk with added phytosterols

The phytosterols are provided by VitaeCaps

29 April 2009

19 January 2010

117

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

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

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

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

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

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

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

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

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

Extracts from Echinacea angustifolia

DSPVNSA (10) (I) Substantial equivalence for Echinacea angustifolia extract from plant tissue cultures

5 August 2009

13 August 2009

130

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

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

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

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 dried fruit pulp

CUDN (12) (I) Substantial equivalence of the Baobab (Adansonia digitata) dried fruit pulp

17 August 2009

17 September 2009

135

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

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

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

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

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

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

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

144

Dry extract from Noni juice (juice of the fruits of Morinda citrifolia) for use in food supplements

AFFSA (7) (F) Opinion of the French Food Safety Agency concerning the evaluation of the substantial equivalence of dried noni juice extract with Morinda citrifolia L. juice

23 November 2009

20 May 2010