Scientific Opinion on the substantiation of health claims related to polyphenols in olive and protection of LDL particles from oxidative damage (ID 1333, 1638, 1639, 1696, 2865), maintenance of normal blood HDL cholesterol concentrations (ID 1639), maintenance of normal blood pressure (ID 3781), “anti-inflammatory properties” (ID 1882), “contributes to the upper respiratory tract health” (ID 3468), “can help to maintain a normal function of gastrointestinal tract” (3779), and “contributes to body defences against external agents” (ID 3467) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2011;9(4):2033 [25 pp.].
doi
10.2903/j.efsa.2011.2033
Panel members at the time of adoption
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
Acknowledgements

The Panel wishes to thank for the preparatory work on this scientific opinion: 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. The members of the Claims Sub-Working Group on Cardiovascular Health/Oxidative Stress: Antti Aro, Marianne Geleijnse, Marina Heinonen, Ambroise Martin, Wilhelm Stahl and Henk van den Berg.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2008-2070
EFSA-Q-2008-2374
EFSA-Q-2008-2375
EFSA-Q-2008-2432
EFSA-Q-2008-2615
EFSA-Q-2008-3598
EFSA-Q-2008-4195
EFSA-Q-2008-4196
EFSA-Q-2008-4498
EFSA-Q-2008-4500
Adopted
12 November 2010
Published
8 April 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

No abstract available

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to polyphenols in olive and protection of LDL particles from oxidative damage, maintenance of normal blood HDL-cholesterol concentrations, maintenance of normal blood pressure, “anti-inflammatory properties”, “contributes to the upper respiratory tract health”, “can help to maintain a normal function of gastrointestinal tract”, and “contributes to body defences against external agents”. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.

The food constituent, which is the subject of the health claims, is polyphenols (e.g. hydroxytyrosol and oleuropein complex) in olive (olive fruit, olive mill waste waters or olive oil, Olea europaea L. extract and leaf).

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 in relation to the claimed effects.

Protection of LDL particles from oxidative damage

The claimed effects are “reduces oxidative stress”, “antioxidant properties”, “lipid metabolism”, “antioxidant activity, they protect body cells and LDL from oxidative damages”, and “antioxidant properties”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the protection of low density lipoproteins (LDL) particles from oxidative damage. The Panel considers that protection of LDL particles from oxidative damage may be a beneficial physiological effect.

In weighing the evidence, the Panel took into account that a well conducted and powered study, and two smaller-scale studies, showed a dose-dependent and significant effect of olive oil polyphenol consumption (for three weeks) on appropriate markers of LDL peroxidation (oxLDL), that these results were supported by one short-term and one acute study, and by supportive markers of LDL peroxidation (conjugated dienes, ex vivo resistance of LDL to oxidation) going in the same direction, and that evidence for a biologically plausible mechanism by which olive oil polyphenols could exert the claimed effect has been provided.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of olive oil polyphenols (standardised by the content of hydroxytyrosol and its derivatives) and protection of LDL particles from oxidative damage.

The Panel considers that in order to bear the claim, 5 mg of hydroxytyrosol and its derivatives (e.g. oleuropein complex and tyrosol) in olive oil should be consumed daily. These amounts, if provided by moderate amounts of olive oil, can be easily consumed in the context of a balanced diet. The concentrations in some olive oils may be too low to allow the consumption of this amount of polyphenols in the context of a balanced diet. The target population is the general population.

Maintenance of normal blood HDL-cholesterol concentrations

The claimed effect is “lipid metabolism”. The target population is assumed to be the general population. In the context of the proposed wording, the Panel assumes that the claimed effect refers to the maintenance of normal blood HDL-cholesterol concentrations. The Panel considers that maintenance of normal blood HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) is a beneficial physiological effect.

In weighing the evidence, the Panel took into account that the results from the studies provided are inconsistent, and that no evidence for a biologically plausible mechanism by which olive oil polyphenols could exert the claimed effect has been provided.

On the basis of the data presented, the Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption olive oil polyphenols (standardised by the content of hydroxytyrosol and its derivatives) and maintenance of normal blood HDL cholesterol concentrations.

Maintenance of normal blood pressure

The claimed effect is “contributes to the maintenance of a normal blood pressure”. The target population is assumed to be the general population. The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect.

No human studies were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of polyphenols in olive (olive fruit, olive mill waste waters or olive oil, Olea europaea L. extract and leaf) standardised by the content of hydroxytyrosol and its derivatives (e.g. oleuropein complex) and maintenance of normal blood pressure.

“Anti-inflammatory properties”

The claimed effect is “a potent source of olive biophenols with anti-inflammatory properties”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel considers that the claim refers to diseases such as osteoarthritis or rheumatoid arthritis, in which a reduction of inflammation would be a therapeutic target for the treatment of the disease.

The Panel considers that the reduction of inflammation in the context of diseases such as osteoarthritis or rheumatoid arthritis is a therapeutic target for the treatment of the disease, and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

“Contributes to the upper respiratory tract health”

The claimed effect is “contributes to the upper respiratory tract health”. The target population is assumed to be the general population.

The claimed effect is not sufficiently defined and no clarification has been provided by Member States. The Panel notes that different health outcomes were mentioned in the information provided, and that it was not possible to establish which specific effect is the target for the claim.

The Panel concludes that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

“Can help to maintain a normal function of gastrointestinal tract”

The claimed effect is “can help to maintain a normal function of gastrointestinal tract”. The target population is assumed to be the general population.

The claimed effect is not sufficiently defined and no clarification has been provided by Member States. The Panel notes that different health outcomes were mentioned in the information provided, and that it was not possible to establish which specific effect is the target for the claim.

The Panel concludes that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

“Contributes to body defences against external agents”

The claimed effect is “contributes to body defences against external agents”. The target population is assumed to be the general population.

The claimed effect is not sufficiently defined and no clarification has been provided by Member States. The Panel notes that different health outcomes were mentioned in the information provided, and that it was not possible to establish which specific effect is the target for the claim.

The Panel concludes that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

Keywords
Olive, polyphenols, LDL, HDL, cholesterol, oxidative damage, blood pressure, inflammation, upper respiratory tract, gastrointestinal tract, body defences, external agents, health claims
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Number of Pages
25