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Health claims subject to individual authorisation procedure

  • Claims based on new scientific evidence and/or including a request for the protection of proprietary data - Article 13(5)
  • Claims referring to the reduction of a risk factor in the development of a disease - Article 14(1)(a)
  • Claims referring to children's development and health - Article 14(1)(b)

The Commission makes publicly available comments it has received from applicants and the public (according to Article 16(6) of the Regulation) until it makes a decision on the relevant health claim.

Processing of personal data is handled according to Regulation (EC) No 45/2001 and a specific Privacy Statement (PDF document) privacy statement

You can see health claims for which a decision has been taken on the EU Register

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Applicant EFSA opinion reference EFSA opinion receipt date EFSA reference year Comments Claim ID Response from EFSA
Vivatech
8, rue Christophe Colomb,75008
Paris
FRANCE
Q-2013-00650 31/10/2013 2013 pdf
Comments from university professors in the field of pharmacognosy and phytotherapy (FRANCE)
pdf
Comments from Vivatech
2890 pdf
EFSA TECHNICAL REPORT
Italsur s.r.l.
C. da Pianura Vomano,,64024
Notaresco, Teramo
ITALY
Q-2013-00574 31/10/2013 2013

2891
Italsur s.r.l.
C. da Pianura Vomano,,64024
Notaresco, Teramo
ITALY
Q-2013-00576 31/10/2013 2013

2892
Italsur s.r.l.
C. da Pianura Vomano,,64024
Notaresco, Teramo
ITALY
Q-2013-00575 31/10/2013 2013

2893
Italsur s.r.l.
C. da Pianura Vomano,,64024
Notaresco, Teramo
ITALY
Q-2013-00579 31/10/2013 2013

2894
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-147 10/01/2014 2008

2895
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-176 10/01/2014 2008

2896
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-144 10/01/2014 2008

2897
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-145 10/01/2014 2008

2898
Institute of Cellular Pharmacology Ltd
Unit F24/F25,MOSTA
Technopark
MALTA
Q-2013-00249* 10/01/2014 2013

2899
Raisio Nutrition Ltd.
P.O. Box 101
(Rasionkaari 55),21201
Raisio
FINLAND
Q-2011-00851 16/05/2012 2011 pdf
Comments from RAISIO
32 pdf
EFSA response to comments on EFSA-Q-2011-00851
Sylvan Bio Europe BV
Venrayseweg 132/a,5961 NT
Horst
NETHERLANDS
Q-2012-00736 13/02/2013 2012 pdf
Comments from NUTRAVERIS SARL
2869 pdf
EFSA response to comments
UNILEVER PLC/NV
Unilever PLC - Port Sunlight
Wirral - Merseyside, CH62 4ZD - UK
Unilever NV: Weena 455,3013 AL
Rotterdam
Q-2011-01241 16/05/2012 2011 pdf
Comments from RAISIO
34 pdf
EFSA response to comments
Health Concern B.V.
Randhoeve 225a,Houten
3995 GA
NETHERLANDS
Q-2009-00237,
Q-2011-01114
17/07/2012 2009

2839
IDACE
rue de l'Association 50,1000
Brussels
BELGIUM
Q-2008-183 22/07/2010 2008 pdf
Comments from IDACE
69
Beneo-Orafti SA,
Rue L. Maréchal 1, B-4360 Oreye, Belgium
Sensus BV, Borchwerf 3, 4704 RG Roosendaal, The Netherlands
Cosucra-Groupe Warcoing SA, 1, Rue de la Sucrerie,,B-7740
Warcoing
BELGIUM
Q-2013-00615 10/01/2014 2013

2900
Italsur s.r.l.
C. da Pianura Vomano,,64024
Notaresco, Teramo
ITALY
Q-2013-00578 10/01/2014 2013

2901
Omikron Italia S.r.l.
Viale Bruno Buozzi, 5,,00197
Roma
ITALY
Q-2013-00354 13/01/2014 2013

2902
Omikron Italia S.r.l.
Viale Bruno Buozzi, 5,,00197
Roma
ITALY
Q-2013-00353 13/01/2014 2013

2903
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-174 21/02/2014 2008

2904
SmithKline Beecham Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
UNITED KINGDOM
Q-2013-00399 21/02/2014 2013

2905
SANOFI-AVENTIS FRANCE
9 Boulevard Romain Rolland,75159 Cedex 14
Paris
FRANCE
Q-2013-00595 21/02/2014 2013

2906
Omikron Italia S.r.l.
Viale Bruno Buozzi, 5,,00197
Roma
ITALY
Q-2013-00757 21/02/2014 2013

2907
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-178 24/02/2014 2008

2908
Hassia Mineralquellen GmbH
Gießener Straße 30,61118
Bad Vilbel
GERMANY
Q-2013-00444 24/02/2014 2013

2909
Leiber GmbH,
Hafenstraße 24,,49565
Bramsche
GERMANY
Q-2012-00761 08/04/2013 2012 pdf
Comments from Analyze Realize ag
2871 pdf
EFSA response to comments
Minami Nutrition Health BVBA
Leugstraat 51,2630
Aartselaar
BELGIUM
Q-2012-00573 08/04/2013 2012

2872
McNeil Nutritionals, a division of Cilag GmbH International, 1 Landis & Gyr Strasse
6300 Zug, Switzerland and
Raisio Nutrition Ltd,
P.O. Box 101 ,Raisionkaari 55,21201
Raisio
FINLAND
Q-2012-00915** 08/04/2013 2012 pdf
Applicants comments
pdf
Comments from Intertek Cantox
2873 pdf
TECHNICAL REPORT OF EFSA
Vivatech
8, rue Christophe Colomb,75008
Paris
FRANCE
Q-2013-00087 14/06/2013 2013

2874
Fuko Pharma Ltd
Microkatu 1
PO Box 1188,70211
Kuopio
FINLAND
Q-2013-00015 18/06/2013 2013

2875
Clasado Limited
Regent House
Office 25
Bisazza Street,SLM 1641
Sliema
MALTA
Q-2012-01007 18/06/2013 2012

2876
Gelita AG
Uferstrasse 7,69412
Eberbach
GERMANY
Q-2012-00839 20/06/2013 2012

2877
Pharmatoka, S.A.S
118 avenue Paul Doumer,92563
Rueil Malmaison cedex
FRANCE
Q-2012-00700 26/07/2013 2012 tif
Comments from Pharmatoka
2878 pdf
EFSA response to comments
Laboratoire Lescuyer
ZAC de Belle Aire Nord
15 rue le Corbusier,17440
Aytré
FRANCE
Q-2012-00968 26/07/2013 2012

2879
Kraft Biscuits Europe
R&D
RD128,,91767
Palaiseau Cedex
FRANCE
Q-2008-666 30/04/2009 2008

42 pdf
EFSA response to comments on EFSA-Q-2009-548
Lactalis B&C
ZA Les Placis,35230
Bourgbarré
FRANCE
Q-2009-00458 25/05/2011 2009 pdf
Comments from Lactalis
pdf
Comments from RAISIO
pdf
Comments from Unilever
13
European Natural Soyfood Manufacturers Association (ENSA), Neo Building Box 7,
Rue Montoyer 51, 1000 Brussels, Belgium;
European Vegetable Protein Federation (EUVEPRO), c/o AGEP,
Boulevard Saint-Michel 77-79, B-1040 Brussels, Belgium;
Soya Protein Association (SPA), Food and Drink Federation,
Q-2011-00784 02/02/2012 2011 pdf
Comments from HARLANDHALL LTD (on behalf of the applicants)
pdf
Comments from Scientific Advisory Committee (SAC) of the European Natural Soyfoods Manufacturers Association (ENSA)
pdf
Comments from Penny M. Kris-Etherton, PhD, RD, FAHA, FNLA Distinguished Professor of Nutrition
pdf
Comments from David J.A. Jenkins, Arash Mirrahimi, Kristie Srichaikul, Laura Chiavaroli, Livia S.A. Augustin, John L. Sievenpiper, Russell J. de Souza, Cyril W.C. Kendall.
46 pdf
EFSA response to comments on EFSA-Q-2011-00784
GP International Holding B.V
Am Roda Ring 39,6460
HA Kerkrade
NETHERLANDS
Q-2009-412 29/10/2009 2009 pdf
Comments from Meyer Meisterernst
4
Dextro Energy GmbH & Co.
KG. Hafenstrasse 77,47809
Krefeld
GERMANY
Q-2012-00266 11/05/2012 2012 pdf
Comments from BSNA
48
Dextro Energy GmbH & Co.
KG. Hafenstrasse 77,47809
Krefeld
GERMANY
Q-2012-00267 11/05/2012 2012 pdf
BSNA comments
pdf
Dextro Energy GmbH & Co. comments
49 pdf
EFSA response to comments
HiPP GmbH & Co. Vertrieb KG
Georg-Hipp-Straße 7,85276
Pfaffenhofen
GERMANY
Q-2009-00197 08/04/2011 2009 pdf
Comments from BFLG
8
Dextro Energy GmbH & Co.
KG. Hafenstrasse 77,47809
Krefeld
GERMANY
Q-2012-00269 11/05/2012 2012 pdf
BSNA comments
51
Abtei Pharma Vertriebs GmbH
Abtei 1,37696
Marienmunster
GERMANY
Q-2008-721 07/08/2009 2008 pdf
Comments from Abtei Pharma Vertriebs GmbH
3
Rank Nutrition Ltd
Long Barn
Etchden Court
Bethersden
Kent
TN26 3DP
UNITED KINGDOM
Q-2013-00265 26/07/2013 2013

2880
Roquettes Frères
.,62136
Lestrem
FRANCE
Q-2013-00040 26/07/2013 2013

2881
Institute of Cellular Pharmacology [ICP] Ltd
Unit F24/F25,Technopark
MOSTA
MALTA
Q-2013-00021 26/07/2013 2013

2882
IDACE - Association of the Food Industries for Particular Nutritional Uses of the European Union
194, rue de Rivoli,75001
Paris
FRANCE
Q-2008-150 26/07/2013 2008

2883
IDACE - Association of the Food Industries for Particular Nutritional Uses of the European Union
194, rue de Rivoli,75001
Paris
FRANCE
Q-2008-160 26/07/2013 2008

2884
IDACE - Association of the Food Industries for Particular Nutritional Uses of the European Union
194, rue de Rivoli,75001
Paris
FRANCE
Q-2008-199 26/07/2013 2008

2885
Dextro Energy GmbH & Co.
KG. Hafenstrasse 77,47809
Krefeld
GERMANY
Q-2012-00268 11/05/2012 2012 pdf
BSNA comments
50
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-184 25/10/2013 2008

2887
Specialised Nutrition Europe
9-31 Avenue des Nerviens,1040
Brussels
BELGIUM
Q-2008-186 25/10/2013 2008

2888
Aptonia
4, boulevard de Mons,59665
Villeneuve d'Ascq
FRANCE
Q-2013-00234 25/10/2013 2013 pdf
Comments from Oxylane, Aptonia
pdf
Comments from Naturalpha
2889 pdf
EFSA response to comments
DSM Nutritional Products Europe AG
Peter Merian Haus
Peter Merian-Strasse 80,4052
Basel
SWITZERLAND
Q-2010-01233 30/09/2011 2010 pdf
Comments from DSM
23
Dextro Energy GmbH & Co.
KG. Hafenstrasse 77,47809
Krefeld
GERMANY
Q-2012-00270 11/05/2012 2012 pdf
BSNA comments
pdf
Dextro Energy GmbH & Co. comments
63 pdf
EFSA response to comments
EJP Pharmaceutical ApS,
Ulvshalevej 70,4780
Stege
DENMARK
Q-2010-01092 01/06/2011 2010

14
HiPP GmbH & Co. Vertrieb KG
Georg-Hipp-Straße 7,85276
Pfaffenhofen
GERMANY
Q-2009-00455 11/02/2010 2009 pdf
Comments from ERNA
pdf
Comments from IDACE
59
Applicant EFSA opinion reference EFSA opinion receipt date EFSA reference year Comments Claim ID Response from EFSA

(*) The publication of the comments received and/or of the reply from EFSA to the concerned comments, is under evaluation from the Commission regarding the processing of personal and/or confidential data.

(**) Part of the comments received are under evaluation from the Commission regarding the processing of the personal and/or confidential data.