Applicant

Description of Food or Food Ingredient

Substantial equivalence

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

Phytosterols and phytosterol 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 Commission Decision 2004/334/EC and milk based fruit drinks as specified by Commission Decision 2004/336/EC.

and

UUS  (3)(FIN) Lausunto Cognis kasvisterolien ja niiden esterien sekä näillä täydennettyjen elintarvikkeiden oleellisesta vastaavuudesta (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.

UUS  (3)(FIN) Lausunto Cognis kasvisteroliaineksella täydennetyn ruisleivän oleellisesta vastaavuudesta (Cognis Deutschland GmbH & Co)

23 May 2006

9 June 2006

31g

Soya drinks 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

9 March 2006

31 March 2006

31i

Cheese 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

The phytosterol esters ingredient is the one that was notified by Cognis

13 July 2006

20 July 2006

31j

Rye bread with added phytosterols and/or 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

The phytosterol ingredient is the one that was notified by Cognis and/or Cargill

5 July 2006

20 July 2006

31k

Yellow fat spreadswith added phytosterols, but 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 phytosterol esters

The phytosterol ingredient is the one that was notified by Cognis

7 June 2006

3 August 2006

31l

Fermented milk (yoghurt) 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 phytosterol esters;

a container of beverages will not contain more than 3 g of added phytosterol esters

The phytosterol ingredient is the one that was notified by Cognis

26 July 2006

31 July 2006

31m

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 ingredient is the one that was notified by Cognis

26 October 2006

6 November 2006

31o

Rye bread with added phytosterols and/or 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 phytosterols are provided by Cognis

28 November 2006

8 February 2007

38

Foods with added phytosterols:

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

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;

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

UUS  (3)(FIN) lausunto elintarvikkeissa käytettäviksi tarkoitettujen kasvisterolien/kasvistanolien olennaisesta vastaavuudesta (Cargill Incorporation)

24 October 2004

13 December 2004

Rye bread 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.

UUS  (3)(FIN) Lausunto CorowiseTM kasvisteroliaineksella täydennetyn ruisleivän oleellisesta vastaavuudesta (Cargill)

4 September 2006

12 September 2006

38a

Soy 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 phytosterol ingredient is the one that was notified by Cargill

3 August 2006

7 September 2006

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 (ReducolTM)

UUS  (3)(FIN) Lausunto Forbes sterol esters kasvisteroliaineksen vastaavuudesta elintarvikkeissa käytettäväksi hyväksyttyjen kasvisterolien ja kasvisteroliestereiden kanssa (Forbes Medi-Tech Inc.) of 28 February 2005

22 April 2005

6 June 2005

Rye bread

UUS  (3)(FIN) Lausunto Reducol™ kasvisteroliaineksella täydennetyn ruisleivän oleellisesta vastaavuudesta

12 June 2006

3 August 2006

Cheese products (fat content < 12 g per 100g) with added phytosterols and/or phytosterol esters

Letter of 6 September 2006 by the FSAI  (4)(IRL) concerning the substantial equivalence

3 October 2006

6 November 2006

41e

Yellow fat spreads with added phytosterols 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 2004/845/EC

20 March 2006

31 March 2006

41h

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 the same as authorised by Commission Decision 2004/845/EC

24 April 2006

19 May 2006

41i

Yellow fat spreads with added phytosterols/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 phytosterols/phytostanols

The phytosterols/phytosterol esters are provided by Forbes MediTech

5 December 2006

26 December 2006

41j

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

23 May 2006

26 June 2006

54

Phytosterols to be used in milk type, yoghurt type products

ACNFP  (5)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

UUS  (3)Lausunto Triple Crown yrityksen valmistaman kasvisteroliaineksen ja sillä täydennettyjen elintarvikkeiden oleellisesta vastaavuudesta (Triple Crown AB)

16 October 2006

7 November 2006

54a

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 November 2006

20 December 2006

55

Cheese type products with added phytostereols

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

12 January 2006

21 February 2006

56

Yogurth 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

FSAI  (4)(IRL) has delivered an opinion that the foods are substantially equivalent to existing ones

7 February 2006

21 February 2006

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;

Milk type products; and

Yoghurt type products

AESA  (6)(E) Opinión sobre el proceso de equivalenca sustancial de acuerdo al articulo 3 (4) al articulo 5 del reglamento (CE) No 258/97 respecto a la solicitud presenta sobre el producto ‘Vitasterol S-80 non GMO’, por la empresa Vital Caps S.A.

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  (6)(E) Opinión sobre la solicitud presentada por la empresa VitaeCaps S.A. para registrar sus fitosteroles y sus ésteres de fitosterol según el proceso de equivalencia sustancial del Reglamento (CE) No 258/97, de acuerdo con el procedimiento establecido en el Articulo 5 del mismo (4 Mayo 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

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;

salad dressing will be packed as single portions

AESA  (6)(E) Opinión sobre la solicitud presentada por la empresa VitaeCaps S.A. para registrar sus fitosteroles y sus ésteres de fitosterol según el proceso de equivalencia sustancial del Reglamento (CE) No 258/97, de acuerdo con el procedimiento establecido en el Articulo 5 del mismo (27 julio 2006)

26 October 2006

16 November 2006

57a

Milk type products with addedd 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 phytosterols/phytostanols;

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

The phytostereol esters are the same as notified by VitaeCaps

7 September 2006

19 September 2006

57b

Milk type products, yoghurt type products, spicy sauces and salad dressings 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;

spicy sauces and salad dressings will be packed as single portions; a container of beverages will not contain more than 3g g of added phytosterols/phytostanols

The phytosterols are the same as notified by VitaeCaps

8 September 2006

29 September 2006

58

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 and 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 3g g of added phytosterols/phytostanols

ACNFP  (2)(UK) Opinion on substantial equivalence of phytosterols considered under Article 5 the Novel Foods Regulation

16 January 2006

21 February 2006

58a

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 and 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 3g g of added phytosterols/phytostanols

The phytosterols are provided by PrimaPharm

13 March 2006

27 April 2006

58b

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 and 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 3g g of added phytosterols/phytostanols

The phytosterols are provided by PrimaPharm

3 May 2006

24 May 2006

59

Noni juice (juice of the fruits of Morinda citrifolia)

AFSSA  (7)(F) Avis de l'Agence française de sécurité sanitaire des aliments relatif à une demande d'évaluation de l'équivalence en substance d'un jus de noni tahitien au stade de ‘produit en vrac ’avec un autre jus de noni autorisé par décision du 5 juin 2003 du Comité Scientifique de l'Alimentation Humaine de la Commission européenne

28 February 2006

31 March 2006

60

Noni juice (juice of the fruits of Morinda citrifolia)

IRPZ  (8)(POL) Opinia o istotnej równowartości soku ‘Noni Vita — 100 % Noni soku z owoców noni ’z autoryzowanym decyzja KE no 2003/426/EC sokiem ‘Tahitian Noni’

6 February 2006

19 April 2006

61

Noni juice (juice of the fruits of Morinda citrifolia)

DSPVNSA  (9)(I) Parere sulla sostanziale equivalenza del prodotto TABARI NONI

18 January 2006

11 April 2006

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

UUS  (3)(FIN) Lausunto Arboris® sterol AS-2TM kasvisterolaineksen sekä sillä täydennettyjen elintarvikkeiden olelllisesta vastaavuudesta (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 3g g of added phytosterols/phytostanols;

salad dressings and spicy sauces will be packed as single portions.

7 December 2006

19 February 2007

63

Argan Oil (Oil from Argania spinosa)

The DGCCRF  (10)(F) confirmed that a previously issued opinion by AFSSA  (4)was also applicable to this Argan Oil

4 April 2006

27 April 2006

64

Astaxanthin in food supplements

LIV  (11)(Sweden) Substantial equivalence application for the approval ot the astaxanthin-rich supercritical carbon dioxide extract, AstaREAL-L10, derived from Haematococcus pluvialis, for use in dietary supplements

17 May 2006

22 May 2006

65

Noni juice (juice of the fruits of Morinda citrifolia)

UUS  (3)(FIN) Lausunto nonimehun oleellisesta vastaavuudesta (Ecoway Oy)

22 May 2006

9 June 2006

66

Noni juice (juice of the fruits of Morinda citrifolia)

AFSSA  (7)(F) Avis de l'Agence française de sécurité sanitaire des aliments relative à une demande d'évaluation de l'équivalence en substance d'un jus de noni de République Dominicaine avec un autre jus de noni autorisé par décision du 5 juin 2003 du Comité Scientifique de l'Alimentation Humaine de la Commission européenne

23 February 2006

9 June 2006

67

Noni juice (juice of the fruits of Morinda citrifolia)

BVN  (12)(NL) Nonisap (4) Beoordeling van wezenlijke gelikwaardigheid bij een kennisgeving (notificatie) volgens de Europese verordening 258/97 betreffende nieuwe voedingsmiddelen en nieuwe voedselingrediënten

11 January 2006

21 February 2006

68

Milk type products, fermented milk type products, soya drinks, salad dressings, spicy sauces 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;

a container of beverages will not contain more than 3 g of added phytosterols;

salad dressing and spicy sauces will be packed as single portions

ACNFP  (2)(UK) Opinion on substantial equivalence of phytosterols considered under Article 5 of the Novel Foods Regulation

13 July 2006

28 July 2006

69

Milk type products, fermentd milk type products, yoghurt type products, 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;

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

DPSVNSA (9)(I) Parere sulla sostanziale equivalenza di nuovi ingredienti e prodotti alimentari addizionati di fitosteroli e/o steroli vegetali

26 June 2006

24 July 2006

69a

Yoghurt based 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;

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

The phytosterol ingredient is the one that was notified by Inpharma

1 August 2006

6 September 2006

69b

Fermented milk type products and yoghurt 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;

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

The phytosterol ingredient is the one that was notified by Inpharma

30 August 2006

15 September 2006

70

Noni juice (juice of the fruits of Morinda citrifolia)

AGES  (13)(AT) Feststellung der wesentlichen Gleichwertigkeit von Saft aus der Frucht der Spezies Morinda citrifolia L. (Noni-Saft) der Firma KaHuna GmbH Deutschland zur Verwendung und In-Verkehrbringen als neuartiges Lebensmittel und neuartige Lebensmittelzutat in pasteurisierten Fruchtsaftgetränken

2 August 2006

12 September 2006

71

Milk 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/phytostanols

The phytosterols are the same as authorised by Commission Decision 2004/333/EC

6 September 2006

15 September 2006

72

Yellow fat spreads as defined by Council Regulation (EC) No. 2991/94, excluding cooking and frying fats and spreads base don butter or other animal fat; milk based fruit drinks, yoghurt type products and cheese type products (fat content ≤ 12 g per 100g) where the milk fat and or protein has been fully or partly replaced by vegetable fat or protein 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

FSA  (2)Opinion on the equivalence of phytosterols produced by DRT

12 October 2006

6 November 2006

72a

Yellow fat spreads as defined by Council Regulation (EC) No 2991, 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 provided by Les Derives Resiniques et Terpeniques

27 December 2006

26 January 2007

73

Noni juice (juice of the fruits of Morinda citrifolia)

BVL  (14)(D) Steelungnahme über die Frage der wesentlichen Gleichwertigkeit gemäß Art. 3 Absatz 4 der Verordnung (EG) Nr. 258/97 von Saft aus der Frucht der Spezies Morinda citrifolia L. des Herrn Sebastian Held, 90409 Nürnberg, mit dem as neuartige Lebensmittelzutat gemäß der Verordnung (EG) Nr. 258/97 zugelassenen ‘Noni-Saft ’(Saft aus der Frucht der Spezies Morinda citrifolia L.) der Firma Morinda Inc.

10 October 2006

17 November 2006

74

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 products such as skimmed and semi skimmed milk type products, 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 100g) 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; 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

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

UUS  (3)(FIN) Lausunto CholevelTM kasvisterolaineksen sekä sillä täydennettyjen elintarvikkeiden oleellisesta vastaavuudesta (Fenchem Enterprises Ltd.)

1 November 2006

16 November 2006

75

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 products such as skimmed and semi skimmed milk type products, 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 100g) 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; 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 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 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

UUS  (3)(FIN) Lausunto COROWISE™ kasvisteroliesterien ja niillä täydennettyjen elintarvikkeiden oleellisesta vastaavuudesta (Cargill)

26 October 2006

23 November 2006