Summary of notifications received in 2008 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council
Date: 2009-10-24
Institutions: European Commission
Subjects: disclosure of information, food safety, foodstuff, foodstuffs legislation, marketing








C_2009255EN.01000801.xml










24.10.2009   


EN


Official Journal of the European Union


C 255/8





Summary of notifications received in 2008 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council
2009/C 255/05
Between 1 January 2008 and 31 December 2008 the Commission had received 29 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




31v







Gebr. Woerle GmbH




Postfach 18




Enzing 26




5302 Henndorf bei Salzburg




ÖSTERREICH






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







Mills of Crete SA




Eth. Veniselou 40




73 200 Souda




Crete




GREECE






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







Valio Ltd




PO Box 10




Meieritje 6, Pitäjanmaki




FI-00039 Valio Helsinki




SUOMI/FINLAND






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







Viotros SA




Block 31




DA 13 Phase B




574 00 Industrial Area of Sindos (Echedoros — Thessaloniki)




GREECE






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







R & L Holdings Ltd.




P.O. Box 977




Vaitele




Apia




SAMOA






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







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 (5)concerning the substantial equivalence


3 October 2006


6 November 2006




41l







Caseifcio Pinzolo Fiavè Rovereto S.c.r.l.




Via A. Degasperi 12/A




38075 Favé (Trento) TN




ITALIA






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







Rupp Käseexport GmbH




Krüzastraße 8




6912 Hörbranz




ÖSTERREICH






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







Triple Crown AB




Stenslingan 10




SE-182 38 Stockholm




SVERIGE






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









Stenslingan 10




SE-182 38 Danderyd




SVERIGE






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







Koninklijke ERU Kaasfabrik BV




Postbus 7




3440 AA Woerden




NEDERLAND









Middelandse Zee 7




3446 CG Woerden




NEDERLAND






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







Vitae-Caps S.A.




Polígono Industrial Torrehierro




C/ Gutemberg, 356




45600 Talavera de la Reine (Toledo)




ESPAÑA






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







Oy Foodfiles Ltd




Niementie 2 L 6




FI-70210 Kuopio




SUOMI/FINLAND




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







Dale Farm Ltd




Shap Road




Kendal




Cumbria




LA9 6NS




UNITED KINGDOM






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







Lipofoods




Calle Issac Peral, 17




08850 Gavà (Barcelona)




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; 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







Nöm AG




Vöslauer Strasse




2500 Baden




ÖSTERREICH






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







SanoVia




Im Kühstiefel 19




56653 Wehr




DEUTSCHLAND






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







ARGANA d.o.o.




Rentje 50




SI-4294 Križe




SLOVENIJA









Arganoil Company




213, Lot Habiba El Oulfa




Casablanca




MAROC






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







BPF Bioactive Products Faktory




ul. Sloneczna 4




95-020 Justynów




POLSKA/POLAND






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







Hygieiea Global




Building #54,5F




1089 N, Quinzhou Rd




Shanghai




CHINA









Hygieia Europe




Postfach 1601




40641 Meerbusch




DEUTSCHLAND






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







Alga Technologies Ltd.




Kibbbutz Ketura D.N.




Hevel Eliot 88840




ISRAEL






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







KitoZyme sa




Rue Haute Claire 4




Parc Industriel Huats Sarts, Zone 2




4040 Herrstal




BELGIQUE/BELGIË






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







Thiele Lifestyle




Baymex Außenhandelsges. mbH




Am Bahnhof 12




94538 Fürstenstein




DEUTSCHLAND






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







EZA Natürlich Fair




Wenger Straße 5




5203 Köstendorf




ÖSTERREICH






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







Hygieiea Global




Building #54,5F




1089 N, Quinzhou Rd




Shanghai




CHINA









Hygieia Europe




Postfach 1601




40641 Meerbusch




DEUTSCHLAND






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







EFIT Srl




Via Bramante 41




05100 Terni TR




ITALIA






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







Korzonek




Gottfried Kellerstr. 61a




94315 Straubing




DEUTSCHLAND






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







EUROFROID




Rue Denis Papin




Zone industrielle




24100 Bergerac




FRANCE






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







ArganEden SARL




BP 60331




33164 La Teste Cedex




FRANCE






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







Copram




Société de commercialisation des produits alimentaires du Maroc




17 rue Copenhague




B.P. 80168




13745 Vitrolles Cedex




FRANCE






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







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




Istituto di Ricerche Biotecnologiche




Via Piave 24/B




36077 Altavilla Vic. NA VI




ITALIA






Extracts from Ajuga reptans



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


19 December 2008


19 January 2009




119







Arganpur




KlönneStr. 94




44143 Dortmund




DEUTSCHLAND






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







FORMOR Polska




Ul. Objazdowa 1




05-119 Legonovo




POLSKA/POLAND






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






(1)  OJ L 43, 14.2.1997, p. 1.

(2)  







FSA


:


Food Standards Agency (UK).





(3)  







NFB


:


Novel Food Board (FIN).





(4)  







ACNFP


:


Advisory Committee on Novel Foods and Processes (UK).





(5)  







FSAI


:


Food Safety Authority of Ireland (IRL).





(6)  







AESA


:


Agencia española de seguridad alimentaría (E).





(7)  







DGCCRF


:


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





(8)  







IZIZ


:


Instytut Żywności I Żywienia (PL).





(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)  







IRPZ


:


Instytut Roślin i Przetworów Zielarskich (PL).