Summary of notifications received in 2005 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council
Date: 2006-08-05
Institutions: European Commission
Subjects: foodstuff, foodstuffs legislation, market approval, marketing

Summary of notifications received in 2005 by the Commission pursuant to Article 5 of Regu-
lation (EC) No 258/97 of the European Parliament and of the Council

(2006/C 183/02)

Between 1 January 2005 and 31 December 2005 the Commission had received 31 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

27a

Dr. L. Nyberg
Skånemejerier
S-205 03 Malmö

31

Dr Horst Messinger
Cognis Deutschland GmbH & Co. KG
Postfach 13 01 64
D-40551 Düsseldorf
Henkelstrasse 6
D-40589 Düsseldorf

Yoghurt type products with added phytosterols

The phytosterols are provided by Teriaka (Diminicol) 26 August 2005

8 September 2005

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/phytosta-
nols;

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

NFB (1) (FIN) Opinion on the substantial equivalence
of foods enriched with plant sterols and phytosterol
esters (Cognis Deutschland GmbH & Co)

20 April 2005

29 June 2005

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 Comis-
sion Decision 2004/334/EC and milk based fruit
drinks
by Commission Decision
2004/336/EC.

specified

as

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/phytosta-
nols;

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

spicy sauces will be packed as single portions.

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Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member
States

31d

Dr. R. Keller
MIFA AG Frenkendorf
Rheinstraβe 99
CH–4402 Frenkendorf

Yellow fat spreads 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

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

30 May 2005

29 June 2005

31e

Mr. F. Meindl
Nöm AG
Vöslauer Straße 109
A–2500 Baden

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/phytosta-
nols;

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

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

2 September 2005

9 September 2005

31f

Mr. M._A. García Baquero
LÁCTEAS GARCIA BAQUERO S.A.
Polígno industrial
E-13600 Alcázar de San Juan

‘Alces’ 22-23

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

22 July 2005

8 September 2005

39

40

Mr David Backstrom
Resort Health Products
Noni Maui Nutrition & Cosmetics
211, Napoko Place
Kulu Maui 96790 Hawai
USA

Mr Gerhard Stemmler
Herbex Ltd.
P.O.Box 516
17 Vesi Crescent Waiyavi
Lautoka
Fidji Islands

Noni juice (juice of the fruits of Morinda citrifolia)

Opinion of the AFSSA (F) (2) on assessment of the
substantial equivalence of a Hawaiian noni
juice
with another noni juice authorised by the Decision
of 5 June 2003 of the European Commission's Scien-
tific Committee on Food

28 January 2005

22 February 2005

Noni juice (juice of the fruits of Morinda citrifolia)

ACNFP (3) (UK) Opinion on substantial equivalence
Juice produced on a number of Pacific
of Noni
Islands considered under Article 5 of
the Novel
Foods Regulation

11 January 2005

11 February 2005

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Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member
States

40a

40b

40c

40d

41

Mr W. G. Brull
Royal Noni (Fiji) Limited
P.O.Box 5842
Lautoka
Fiji Islands

Mr. Alexander Litterst
Blütenweg 17
d-78351 Bodmann-Ludwigshafen
on behalf of
Tauro Tukaroa
Sunline Noni Ltd.
Rarotonga
P.O. Box 295
Cook Islands

Mr Ken Newton
C.C.K. Trading Ltd.
P.O. Box 3043
Apia
Samoa

Mr. Bradley J. Stafford
Cook Islands Noni Marketing Ltd.
P.O.Box 184
Rarotonga
Cook Islands

Dr David Stewart
Forbes Medi-Tech Inc.
750 West Pender Street
Vancouver B.C. V6C 2T8
Canada

Noni juice (juice of the fruits of Morinda citrifolia)

ACNFP (3) (UK) Opinion on substantial equivalence
Juice produced on a number of Pacific
of Noni
Islands considered under Article 5 of
the Novel
Foods Regulation

15 April 2005

25 April 2005

Noni juice (juice of the fruits of Morinda citrifolia)

ACNFP (3) (UK) Opinion on substantial equivalence
Juice produced on a number of Pacific
of Noni
Islands considered under Article 5 of
the Novel
Foods Regulation

2 June 2005

29 June 2005

Noni juice (juice of the fruits of Morinda citrifolia)

ACNFP (3) (UK) Opinion on substantial equivalence
Juice produced on a number of Pacific
of Noni
Islands considered under Article 5 of
the Novel
Foods Regulation

25 May 2005

29 June 2005

Noni juice (juice of the fruits of Morinda citrifolia)

ACNFP (3) (UK) Opinion on substantial equivalence
Juice produced on a number of Pacific
of Noni
Islands considered under Article 5 of
the Novel
Foods Regulation

29 September 2005

20 October 2005

Foods listed in Article 1 of Commission Decision
2000/500/EC and in annex 1 of Commission Deci-
sions 2004/333/EC, 2004/334/EC, 2004/335/EC
and 2004/336/EC (yellow fat spreads, salad dres-
sings,
fermented milk type products, soya drinks,
cheese type products, yoghurt type products, spicy
sauces, milk based fruit drinks) with added phytos-
terols/ phytostanols (ReducolTM)

NFB (1) (FIN) Opinion on the substantial equivalence
foods enriched with ReducolTM phytosterols/
of
phytostanols (Forbes Medi-Tech Inc.) of 28 February
2005

22 April 2005

6 June 2005

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Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member
States

41a

Timo Keski-Kasari
Juustoportti Oy
Meijeritie 3
FIN-61600 Jalasjärvi

Yoghurt
phytostanols (ReducolTM)

type products with added phytosterols/

The yoghurt
type products shall be presented in
conformity with the provisions of Article 2 of
Commission
—
2004/336/EC

2004/334/EC

Decisions

NFB (1) (FIN) Opinion on the substantial equivalence
foods enriched with ReducolTM phytosterols/
of
phytostanols (Forbes Medi-Tech Inc.) of 28 February
2005

10 May 2005

30 June 2005

41b

Dr. Gilles Nassy
Novandie
19, rue de la République
F-76153 Maromme Cedex

Yoghurt
with added phytosterol esters (ReducolTM)

type products and other dairy products

The yoghurt type products and other diary products
shall be presented in conformity with the provisions
of Article 2 of Commission Decision 2004/845/EC.

The phytosterol esters ingredient is the one that was
authorised by Commission Decision 2004/845/EC.
In addition, the yoghurt type products and other
dairy products containing this phytosterol esters
ingredient were already notified by Forbes Medi
Tech (see No 41).

27 May 2005

29 June 2005

41c

Ms N. Carrolo
Pingo Doce Distribuição Alimentar S.A.
Rua Actor António Silva, 7
Aparto 52022
P-1649-033 Liboa

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/phytosta-
nols;

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

41d

41f

Mr D. Dobbins
Robert Wisemans & Sons Limited
159 Glasgow Road
East Kilbride
Glasgow G74 4PA
United Kingdom

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/phytosta-
nols;

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

Mr C Swire
Fayrefield Foods Ltd.
Englesa House
Barthomley Road
Crewe, Cheshire CW1 UF
United Kingdom

Yellow fat spreads with added phytosterols, exluding
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

17 June 2005

4 July 2005

The phytosterols are the same as authorised by
Commission Decision 2004/845/EC

27 June 2005

26 July 2005

The phytosterols are the same as authorised by
Commission Decision 2004/845/EC

13 July 2005

3 August 2005

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Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member
States

41g

Dr. Walter Link
Walter Rau Lebensmittelwerke GmbH &
Co. KG
Münsterstr. 9-11
D-49171 Hilter

Yellow fat spreads with added phytosterols, exluding
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 Forbes MediTech

15 November 2005

7 December 2005

42

43

Dr David Stewart
Forbes Medi-Tech Inc.
750 West Pender Street
Vancouver B.C. V6C 2T8
Canada

Dr David Stewart
Forbes Medi-Tech Inc.
750 West Pender Street
Vancouver B.C. V6C 2T8
Canada

Foods listed in Article 1 of Commission Decision
2000/500/EC and in annex 1 of Commission Deci-
sions 2004/333/EC, 2004/334/EC, 2004/335/EC
and 2004/336/EC (yellow fat spreads, salad dres-
sings, milk type products,
fermented milk type
products, soya drinks, cheese type products, yoghurt
type products, spicy sauces, milk based fruit drinks)
with added plant sterol esters

Foods listed in Article 1 of Commission Decision
2000/500/EC and in annex 1 of Commission Deci-
sions 2004/333/EC, 2004/334/EC, 2004/335/EC
and 2004/336/EC (yellow fat spreads, salad dres-
sings, milk type products,
fermented milk type
products, soya drinks, cheese type products, yoghurt
type products, spicy sauces, milk based fruit drinks)
with added phytosterols/phytostanols (Phyto-S-Ster-
olsTM)

NFB (1) (FIN) Opinion on the substantial equivalence
of Forbes plant sterol esters with authorised plant
sterol esters (Forbes Medi-Tech) of 28 February 2005

22 April 2005

6 June 2005

NFB (1) (FIN) Opinion on the substantial equivalence
of Phyto-S-SterolTM with authorised phytosterols/
phytostanols (Forbes Medi-Tech Inc.) of 4 November
2004

20 Mai 2005

6 June 2005

44

Reinhard Bursian
Trisana GmbH
Diemendorf 8
D-82327 Tutzing

Noni juice (juice of the fruits of Morinda citrifolia)

BVL (4) Opinion on the substantial equivalence,
in
accordance with Article 3(4) of Regulation (EC) No
258/97, of juice from the Morinda citrifolia L. fruit
produced by Trisana GmbH to the ‘Noni-Saft’ (juice
from the Morinda citrifolia L.
fruit) produced by
Morinda Inc., which is approved as a novel food
ingredient in accordance with Regulation (EC) No
258/97

Dated 14 September
2004
wrongly
but
addressed,
therefore
received only on 2
May 2005

29 June 2005

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Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member
States

45

Mr. L. Sita
Granarolo S.p.a.
Via Cadriano, 27/2
I-40127 Bologna

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 phytosterols/phytosta-
nols;

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

The phytosterols are provide by the company Triple
Crown and the FSA (5) has delivered an opinion that
the
equivalent
‘Opinion on the substantial equivalence of a free
phytosterol ingredient’

substantially

phytosterols

are

5 August 2005

16 August 2005

2 Notifications concerning Argan oil
Argania spinosa L.)

(oil

from

AFSSA (2) (F) Opinion concerning the evaluation of
the substantial equivalence of argan oil
(Argania
spinosa L.) with other edible oils

23 May 2005
and
5 July 2005

26 July 2005

Noni juice (juice of the fruits of Morinda citrifolia

ACNFP (3) Opinion on substantial equivalence of
Noni juice considered under Article 5 of the Novel
Foods Regulation

28 June 2005

25 July 2005

46

47

Ms M. Weinzierl
Princesse de Mogador
Kellerstr. 11
D-81667 München

Mr G. Martin
Mi GmbH
Postfach 2535
CH-6342 Baar
Mi EU ltd.
c/o EAC Business Sevices Ltd.
Cariocca Business Park
2 Sawley Road
Manchester M40 8BB
United Kingdom

48

Ms N. Hanlon
Kerry Foods
Tralee Road, Listowel
Co. Kerry
Ireland

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

(IRL) provided an opinion that

the
The FSAI (6)
foods are substantially equivalent to those authorised
by Commission Decisions 2004/333/EC, 2004/334
EC and 2004/336.

15 June 2005

4 July 2005

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Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member
States

49

Mr M. Gebauer
Homann Feinkost GmbH & Co
Bahnhofstrasse 4
D-49197 Dissen

Salad dressings and mayonnaises with added phytos-
terols

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

5 July 2005

3 August 2005

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/phytosta-
nols;

the foods will be packed as single portions.

50

Mr M Werner
NCT Nord Trading GmbH
Albert-Schweitzer-Str. 20
D-85375 Neufahrn b.Freising

Noni juice (juice of the fruits of Morinda citrifolia)

51

Mr Bruce Burwick
Dynamic Health Labortories Inc.
110 Bridge Street
USA-Brooklyn
New York 11201

Noni juice (juice of the fruits of Morinda citrifolia)

19 May 2005

19 September 2005

27 September 2005

10 October 2005

BVL (4) Opinion concerning the substantial equiva-
lence, in accordance with Article 3(4) of Regulation
(EC) No. 258/97, of juice of the fruit of the species
Morinda citrifolia L. of NCT Nord Trading GmbH and
Dynamic Health Laboratories Inc. with the ‘Noni
juice’ (juice of the fruit of the species Morinda citri-
folia L.) of the company Morinda Inc, which has
been approved as a novel food ingredient in accord-
ance with Regulation (EC) No. 258/97

BVL (4) Opinion concerning the substantial equiva-
lence, in accordance with Article 3(4) of Regulation
(EC) No. 258/97, of juice of the fruit of the species
Morinda citrifolia L. of NCT Nord Trading GmbH and
Dynamic Health Laboratories Inc. with the ‘Noni
juice’ (juice of the fruit of the species Morinda citri-
folia L.) of the company Morinda Inc, which has
been approved as a novel food ingredient in accord-
ance with Regulation (EC) No. 258/97

52

Dr. Dirk Cremer
Degussa Food Ingredients GmbH
Lisa-Meitner-Strasse 34
D-85345 Freising

Foods listed in annex 1 of Commission Decisions
2004/333/EC, 2004/334/EC, 2004/335/EC and
2004/336/EC (yellow fat spreads, salad dressings,
milk type products, fermented milk type products,
soya drinks, cheese type products, yoghurt
type
products, spicy sauces, milk based fruit drinks) with
added plant sterol esters

NFB (1) (FIN) Opinion on Substantial equivalence in
the case of Cholestatin™ IP phytosterol/phytostanol
ingredient (Degussa Food Ingredients GmbH)

27 September 2005

13 October 2005

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Applicant

Description of Food or Food Ingredient

Scientific Evidence

Notification

Transmission to Member
States

Argan Oil (Oil from Argania spinosa)

AFSSA (2) (F) Opinion concerning the evaluation of
the substantial equivalence of argan oil
(Argania
spinosa L.) with other edible oils

17 October 2005

24 November 2005

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Phytosterols to be used in milk type and yoghurt
type products

ACNFP (3) Opinion on substantial Equivalence of
free phytosterols considered under Article 5 of the
Novel Foods Regulation

11 November 2005

8 December 2005

E
N

53

54

Mr Boujima Boujia
ARGANINE
Argan-Öl e.K.
D-86938 Schondorf

Mr Kjell Sjöberg
Triple Crown AB
Stenslingen 10
S-1238 Stockholm

(1) NFB: Novel Food Board (FIN)
(2) AFFSA: Agence française de sécurité sanitaire des aliments
(3) ACNFP: Advisory Committee on Novel Foods and Processes (UK)
(4) BVL: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (D)
(5) FSA: Food Standards Agency (FSA)
(6) FSAI: Food Safety Authority of Ireland (IRL)

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