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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[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 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
Słowa kluczowe: HDL   Polyphenols   cholesterol   health claims   olive  
ID:    1639  
Produkty: Hydroksytyrozol, oleuropeina  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is 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).
Polyphenols comprise a very wide group (several thousands of compounds) of plant secondary metabolites including flavonoids, isoflavonoids, phenolic acids, proanthocyanidins and other tannins, and lignans with different biological activities. The major polyphenols in olive oil are phenolic alcohols (e.g. hydroxytyrosol and tyrosol), secoiridoids (e.g. oleuropein) and lignans (e.g. pinoresinol). Table olives typically contain hydroxytyrosol, tyrosol, caffeoylquinic acid, verbacoside, luteolin and rutin. Hydroxytyrosol, a major polyphenol typically present in olives, is also present in olive mill waste water. In nature, hydroxytyrosol is found in olives also in the form of a glucoside of its elenolic acid ester, oleuropein. These polyphenolic compounds can be measured in foods by established methods.
Total polyphenols are usually expressed as gallic acid equivalents, but other phenolic compounds such as catechin/epicatechin or caffeic acid have also been used for standardisation. This standardisation refers to the traditional spectrophotometric measurement of total polyphenols using the Folin-Ciocalteau method (Singleton and Rossi, 1965), which is based on reducing capacity. The method is not specific for polyphenols because other reducing compounds such as ascorbic acid, sugars and proteins will also be included in the quantification, thus leading to an overestimation of the actual polyphenol content. The total polyphenol content assessed with this method is not suitable for characterisation of polyphenols in foods.
The Panel considers that polyphenols (e.g. hydroxytyrosol and oleuropein complex) in olive (olive fruit, olive mill waste waters or olive oil, Olea europaea L. extract and leaf) can be characterised by their content of hydroxytyrosol and its derivatives (e.g. oleuropein complex).
The Panel considers that 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), which is the subject of the health claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

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.
High-density lipoproteins (HDL) act as cholesterol scavengers and are involved in the reverse transport of cholesterol in the body (from peripheral tissues back to the liver). Conversely, low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries.
The Panel considers that maintenance of normal HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi

In its earlier opinion (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011) the Panel took into account that the results from the two human intervention studies provided (Covas et al., 2006; Marrugat et al., 2004) were inconsistent, and that no evidence for a biologically plausible mechanism by which olive oil polyphenols could exert the claimed effect was provided.
In the framework of further assessment, nine human intervention and four animal studies were provided. In five of the human intervention studies (Estevez-Gonzalez et al., 2010; Haban et al., 2004; Perona et al., 2011; Ruano et al., 2007; Violante et al., 2009), as well as in one animal study (Mangas- Cruz et al., 2001), the content of hydroxytyrosol or its derivatives (e.g. oleuropein complex) in the olive oils administered in the studies was not reported. In one human intervention study (Susalit et al., 2011), designed to assess the effects of olive polyphenols on blood pressure, 23 % of subjects were withdrawn from the study due to stopping rules related to the primary outcome of the study, which might have led to selection bias through breaking randomisation with respect to blood lipid outcomes. Two human intervention studies described in one publication (Perrinjaquet-Moccetti et al., 2008) with 10 subjects per group each, which showed no effect on HDL-cholesterol concentrations, were likely to have been underpowered to detect a significant effect of polyphenols in olive on blood HDL-cholesterol concentrations. Another intervention study (Weinbrenner et al., 2004) was of a duration of four days, which does not allow conclusions to be drawn on a sustained effect of consumption of polyphenols in olive on changes in blood HDL-cholesterol concentrations, and in one cross-over study (Vissers et al., 2001) and a study in rabbits (Gonzalez-Santiago et al., 2006) no baseline measurements were taken. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
The remaining animal studies assessed the effect of hydroxytyrosol on blood lipid concentrations in male Wistar rats (Fki et al., 2007; Jemai et al., 2008). The Panel considers that results from rat studies cannot be extrapolated to humans because of differences in lipid metabolism between these two species, and considers that no conclusions can be drawn from these animal studies for the scientific substantiation of the claim.
The Panel notes that no evidence from which conclusions can 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.

Wnioski

On the basis of the data presented, the Panel concludes that:
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), which is the subject of the health claim, is sufficiently characterised.
The claimed effect eligible for further assessment relates to the maintenance of normal blood HDL-cholesterol concentrations. The target population is the general population. Maintenance of normal blood HDL-cholesterol concentrations (without increasing LDL cholesterol concentrations) is a beneficial physiological effect.
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.