Summary of notifications received in 2009 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council
Date: 2010-11-11
Institutions: European Commission
Subjects: disclosure of information, food safety, foodstuff, foodstuffs legislation, marketing








C_2010305EN.01000701.xml










11.11.2010   


EN


Official Journal of the European Union


C 305/7





Summary of notifications received in 2009 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council
2010/C 305/06
Between 1 January 2009 and 31 December 2009 the Commission had received 32 notifications of placing on the market novel foods or novel food ingredients pursuant to Article 5 of Regulation (EC) No 258/97 (1).










 


Applicant


Description of Food or Food Ingredient


Scientific Evidence


Notification


Transmission to Member States




31







Cognis Deutschland GmbH & Co. KG




Postfach 13 01 64




40551 Düsseldorf




DEUTSCHLAND









Henkelstrasse 67




40589 Düsseldorf




DEUTSCHLAND






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







Lesieur




29 quai Aulagnier




92665 Asnières-sur-Seine Cedex




FRANCE






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







Varvello Pharma Nutrition srl




Piazza Castello 2




20121 Milano MI




ITALIA






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







Lesaffre Austria AG




Industriezentrum




NÖ-Süd Straße 7




2355 Wien




ÖSTERREICH






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 Link




3120 Great Western Court




Hunts Ground Road




Stoke Gifford




Bristol




BS34 8HP




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;










 


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






The phytosterols are provided by Cognis


21 September 2009


1 October 2009




41







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 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







Lanitis Bros. Ltd




66, Kyriakos Matsis Ave.




2409 Engomi




PO Box 2200




1515 Nicosia




CYPRUS






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







Vitae-Caps SA




Polígono Industrial Torrehierro




C/ Gutemberg, 356




45600 Talavera de la Reine Toledo




ESPAÑA






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 (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






 


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 (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






 


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 esters are provided by VitaeCaps


2 May 2009


8 June 2009




57g







Senna Nahrungsmittel GmbH




Stockhammergasse 19




1144 Wien




ÖSTERREICH






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







Pomurske Milkane




Industrijska ulica 10




p.p. 230




SI-9000 Murska




SLOVENIJA






Products based on milk 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 VitaeCaps


29 April 2009


19 January 2010




117







Diar Argan




Am Altwasser 44




85459 Berglern




DEUTSCHLAND






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







SARL Argamis




711 bis Lotissement




Allah Route de Guelin




Tiznit




MAROC






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







SARL SOUSS TERROIR




Lotissement Yasmina 2 C5




AIT Mlloul 80150




MAROC






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







Lindemann GmbH & Co. KG




Postfach 2249




32255 Bünde




DEUTSCHLAND






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







Laboratoires Expanscience




Rue de 4 Filles




28231 Épernon Cedex




FRANCE






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







Cauvin




2350 Route de St. Gilles




30000 Nimes




FRANCE






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







Bionatur




18 chemin de Roquerose




83690 Sillans la Cascade




FRANCE






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







Arganhaus




Geditschstr. 77




10823 Berlin




DEUTSCHLAND






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







Bioresco




Bundesstrasse 29




4064 Basel




SWITZERLAND




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







I.R.B. s.r.l.




Istituto di Ricerche Biotecnologiche




Via Piave 24/B




36077 Altavilla Vic. NA VI




ITALIA






Extracts from Echinacea angustifolia



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


5 August 2009


13 August 2009




130







ABGUR GmbH




Burkheimerstr. 9




79111 Freiburg




DEUTSCHLAND






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







Codefa




718 M.i.n. des Arnavaux




13323 Marseille Cedex 14




FRANCE






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







Souk du Maroc




Mainzer Str. 45




53179 Bonn




DEUTSCHLAND






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







Smart food inno kft.




Hősök útja 1–3.




4027 Debrecen




MAGYARORSZÁG/HUNGARY






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 Fruit Company S.a.r.l.




Via A. Mondadori 15




46025 Poggio Rusco MN




ITALIA






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 export company




Rue de Ramillies 2a




1367 Ramillies




BELGIQUE/BELGIË






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







JFM SUNILE AS




Holtbrekka 7




Postboks 109




5202 Os




NORWAY






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







Zenith-Group




Siedlungsstr. 7




75203 Königsbach-Stein




DEUTSCHLAND






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







Bioriginal Europa/Asia bv




Bosland 40




3258 AC den Bommel




NEDERLAND






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







Original Chia Aps.




Stranvej 1 D




6400 Sønderborg




DANMARK






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







Aker BioMarine Antarctic AS




Fjordalléen 16




PO Box 1423 Vika




0115 Oslo




NORWAY






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







Fruchtquell Getränkeindustrie GmbH & Co. KG




Kogelerstr. 16




19243 Dodow




DEUTSCHLAND






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







Pacifique Sud Cosmetique




ZI Napollon




530 Avenue des Templiers Bat. 7




13400 Aubagne




FRANCE






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






(1)  OJ L 43, 14.2.1997, p. 1.

(2)  FSA Food Standards Agency (UK).

(3)  NFB Novel Food Board (FIN).

(4)  FSAI Food Safety Authority of Ireland (IRL).

(5)  AESA Agencia española de seguridad alimentaría (E).

(6)  DGCCRF Direction Générale de la Concurrence, de la consommation et de la Répression des Fraudes (F).

(7)  AFSSA Agence française de sécurité sanitaire des alimentes (F).

(8)  FSP-HFCSE Federal public Service — Health, Food Chain Safety and Environment (B).

(9)  CSS Conseil Supérieur de la Santé (B).

(10)  DSPVNSA Ministero della Salute — Dipartimento per la Sanità Pubblica veterinaria, la Nutrizione e la Sicurezza degli Alimenti (I).

(11)  OETI National Institue for Food and Nutrition Science (HU).

(12)  CUDN Commissione Unica Dietetica e Nutrizione (I).

(13)  MfFLoF Ministeriet for Fødevarer, Landbrug og Fiskeri (DK).

(14)  NFU Novel Foods Unit (NL).

(15)  BVL Bundesamt für Lebensmittelsicherheit und Verbraucherschutz (D).