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Scientific Opinion on the substantiation of a health claim related to zinc and “the prevention of bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Journal 2011;9(6):2169[7 pp.]. doi:10.2903/j.efsa.2011.2169
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen Acknowledgment The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Competent Authority of Finland Question number: EFSA-Q-2010-01092 Adopted: 13 May 2011 Published: 01 June 2011 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following an application from EJP Pharmaceutical ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Denmark, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to zinc and “the prevention of bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity”. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The claimed effect is “prevents bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity”. The target population, as proposed by the applicant, is adults over the age of 18 who wish to improve their bad breath. The Panel considers that the proposed claim is related to breath odour rather than to a function of the body as required by Article 13 of Regulation (EC) No 1924/2006. The Panel considers that the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

© European Food Safety Authority,2011

Summary

Following an application from EJP Pharmaceutical ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Denmark, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to zinc and “the prevention of bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity”.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The claimed effect is “prevents bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity”. The target population, as proposed by the applicant, is adults over the age of 18 who wish to improve their bad breath.

The Panel notes that health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 are required to describe or refer to, among other roles, the role of a nutrient or other substance in the functions of the body. Thus, the applicant was requested to clarify how the proposed claim might comply with this requirement. The applicant replied by expressing the view that the production of volatile sulphur compounds and halitosis as part of the bacterial flora of the mouth and oral cavity is related to the function of the mouth and oral cavity, and thus to a function of the body. The Panel notes that the applicant did not provide any additional evidence that the chemical neutralisation of volatile sulphur compounds in the mouth in order to improve bad breath constitutes a physiological effect in relation to a function of the body.

The Panel considers that the claim “prevents bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity” is related to breath odour rather than to a function of the body as required by Article 13 of Regulation (EC) No 1924/2006.

The Panel considers that the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

Keywords

Zinc, bad breath, health claims