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Scientific Opinion on the substantiation of a health claim related to polyphenols in olive and maintenance of normal blood HDL cholesterol concentrations (ID 1639, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

EFSA Journal 2012;10(8):2848[14 pp.]. doi:10.2903/j.efsa.2012.2848
  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 for the preparatory work on this scientific opinion: 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. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2012-00164 Adopted: 28 June 2012 Published: 07 August 2012 Last updated: 07 September 2012. This version replaces the previous one/s. Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on a health claim pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment related to polyphenols in olive and maintenance of normal blood HDL-cholesterol concentrations. The food constituent, polyphenols in olive (olive fruit, olive mill waste waters or olive oil, Olea europaea L. extract and leaf) standardised by their content of hydroxytyrosol and its derivatives (e.g. oleuropein complex), that is the subject of the health claim is sufficiently characterised. The claimed effect, maintenance of normal blood HDL-cholesterol concentrations, which is eligible for further assessment, is a beneficial physiological effect. The proposed target population is the general population. No evidence from which conclusions could be drawn for the scientific substantiation of the claim, in addition to the Panel’s earlier opinion, was provided. The Panel considers that no data were submitted which would require a reconsideration of the conclusions expressed in its previous opinion, in which it concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of olive oil polyphenols (standardised by the content of hydroxytyrosol and its derivatives) and maintenance of normal blood HDL cholesterol concentrations.

© European Food Safety Authority,2012

Summary

This scientific output, published on 7 September 2012, replaces the earlier version published on 7 August 2012.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. The Commission has agreed with EU Member States that a certain number of Article 13 health claims would be eligible for further assessment by EFSA in order to be able to take a final decision on whether or not to include these claims in the list of permitted health claims. This opinion addresses the scientific substantiation of a health claim in relation to polyphenols in olive and maintenance of normal blood HDL-cholesterol concentrations. The assessment is based on the information provided by the Member States in the consolidated list of Article 13 health claims, references that EFSA has received from Member States or directly from stakeholders and the additional information provided by the competent Authority of Germany for further assessment of this claim.

The food constituent that is the subject of the health claim is polyphenols in olive. The Panel considers that polyphenols in olive (olive fruit, olive mill waste waters or olive oil, Olea europaea L. extract and leaf) standardised by their content of hydroxytyrosol and its derivatives (e.g. oleuropein complex) are sufficiently characterised.
The claimed effect, which is eligible for further assessment, relates to the maintenance of normal blood HDL-cholesterol concentrations. The proposed target population is the general population. The Panel considers that maintenance of normal blood HDL-cholesterol concentrations (without increasing LDL‑cholesterol concentrations) is a beneficial physiological effect.

In the framework of further assessment nine human intervention and four animal studies were provided. The Panel notes that none of these studies allowed conclusions to be drawn for the scientific substantiation of the claim owing to the fact that the content of hydroxytyrosol or its derivatives (e.g. oleuropein complex) in the olive oils administered in the studies was not reported, that studies showed major methodological limitations, and that results from rat studies could not be extrapolated to humans because of differences in lipid metabolism between these two species.

The Panel notes that no evidence from which conclusions could be drawn for the scientific substantiation of the claim, in addition to the Panel’s earlier opinion, was provided.

The Panel considers that no data were submitted which would require a reconsideration of the conclusions expressed in its previous opinion, in which it concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of olive oil polyphenols (standardised by the content of hydroxytyrosol and its derivatives) and maintenance of normal blood HDL-cholesterol concentrations.

Keywords

Polyphenols, olive, cholesterol, HDL, health claims