Scientific Opinion on the substantiation of a health claim related to Prolibra® and “helps to reduce body fat while preserving lean muscle” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2012;10(11):2949 [8 pp.].
doi
10.2903/j.efsa.2012.2949
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Acknowledgements

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
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of Ireland following an application by Glanbia Nutritionals plc
Question Number
EFSA-Q-2012-00001
Adopted
30 October 2012
Published
8 November 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Glanbia Nutritionals plc, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Prolibra® and “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss. Prolibra® was described by the applicant as a partially hydrolysed whey protein isolate containing whey protein, peptides and milk minerals. The applicant denoted the peptides contained in Prolibra® as “weight loss peptides” and claims that these particular peptides contribute to the specificity of Prolibra® in relation to the claimed effect. The Panel notes that, while a specific fraction (i.e. the peptide fraction) of Prolibra®, is claimed to play a role on the claimed effect (i.e. “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss), the information provided by the applicant was insufficient to characterise these peptides and thus the food constituent (i.e. Prolibra®) for which the claim is made. The Panel considers that the food, Prolibra®, which is the subject of the health claim, is not sufficiently characterised in relation to the claimed effect. The Panel concludes that a cause and effect relationship cannot be established between the consumption of Prolibra® and “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss.

Summary

Following an application from Glanbia Nutritionals plc, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Prolibra® and “helps to reduce body fat while preserving lean muscle”.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data.

The food constituent that is the subject of the health claim is Prolibra® in relation to “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss.

Prolibra® was described by the applicant as a partially hydrolysed whey protein isolate containing whey protein, peptides and milk minerals. The applicant denotes the peptides contained in Prolibra® as “weight loss peptides” and claims that these particular peptides contribute to the specificity of Prolibra® in relation to the claimed effect. However, no information was provided on the process of hydrolysis or on the characterisation of the peptides resulting from that process.

The applicant was requested to provide information inter alia on the process of hydrolysis, the degree of hydrolysis of the whey protein, and the full characterisation of the peptides. In reply, the applicant provided a general overview of the steps involved in the manufacturing of Prolibra® and some information on the hydrolysed protein component of the product. However, the full manufacturing process was not described, no information was provided on the enzyme used for hydrolysis or on the specific conditions applied, the amount of the hydrolysed whey protein component that is present in the final product was not specified, and no further information was available on the characterisation of the peptides.

The Panel notes that no information on the characterisation of Prolibra® in relation to the peptides claimed by the applicant to have a central role on the claimed effect has been provided in the two published human intervention studies (including the study reports and protocols for these two studies), the unpublished bioavailability study, or the unpublished animal study, which were provided for the scientific substantiation of the claim.

The Panel notes that, while a specific fraction, i.e. the peptide fraction, of Prolibra®, is claimed to play a role on the claimed effect (i.e. “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss), the information provided by the applicant was insufficient to characterise these peptides and thus the food constituent (i.e. Prolibra®) for which the claim is made.

The Panel considers that the food, Prolibra®, which is the subject of the health claim, is not sufficiently characterised in relation to the claimed effect.

The Panel concludes that a cause and effect relationship cannot be established between the consumption of Prolibra® and “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss.

Keywords
Prolibra®, whey protein, milk minerals, weight loss, health claims
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Number of Pages
8