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
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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DOI：
10.2903/j.efsa.2011.2033
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发表时间：
2011-04-01
期刊：
影响因子：
3.3
通讯作者：
Verhagen, Hans
中科院分区：
文献类型：
--
作者：
Agostoni, Carlo;Bresson, Jean-Louis;Verhagen, Hans
根据欧盟委员会的要求，膳食产品、营养和过敏小组被要求根据法规（EC） No 1924/2006第13条就健康声明清单提供科学意见。本意见书阐述了橄榄中多酚和保护低密度脂蛋白颗粒免受氧化损伤、维持正常血液高密度脂蛋白胆固醇浓度、维持正常血压、“抗炎特性”、“有助于上呼吸道健康”、“有助于维持胃肠道正常功能”和“有助于身体抵御外部因素”等健康主张的科学依据。科学依据是基于成员国在第13条健康声明综合清单中提供的信息，以及EFSA从成员国或直接从利益相关者那里收到的参考资料。健康声明的主题食品成分是橄榄（橄榄果、橄榄厂废水或橄榄油、油橄榄提取物和叶子）中的多酚（例如羟基酪醇和橄榄苦苷复合物）。小组认为，橄榄（橄榄果、橄榄厂废水或橄榄油、油橄榄提取物和橄榄叶）中的多酚经其羟基酪醇及其衍生物（如橄榄苦苷复合物）的含量标准化后，就所声称的效果而言已得到充分表征。声称的效果是“减少氧化应激”、“抗氧化性能”、“脂质代谢”、“抗氧化活性，它们保护身体细胞和LDL免受氧化损伤”和“抗氧化性能”。假设目标人群是一般人群。在拟议措辞的背景下，委员会假设所声称的效果是指保护低密度脂蛋白（LDL）颗粒免受氧化损伤。专家小组认为，保护低密度脂蛋白颗粒免受氧化损伤可能是一种有益的生理作用。在权衡证据时，小组考虑到一项进行良好且有力的研究和两项较小规模的研究表明，橄榄油多酚摄入（三周）对低密度脂蛋白过氧化（oxLDL）的适当标记具有剂量依赖性和显着影响，这些结果得到一项短期研究和一项急性研究的支持，并且LDL过氧化的支持性标记（共轭二烯，LDL抗氧化的体外抗性）在同一方向上。橄榄油多酚能够发挥所谓效果的生物学机制的证据已经提供。根据所提供的数据，专家小组得出结论认为，橄榄油多酚（按羟基酪醇及其衍生物的含量进行标准化）的摄入与保护低密度脂蛋白颗粒免受氧化损伤之间存在因果关系。评估小组认为，为了实现这一说法，每天应食用橄榄油中的5毫克羟基酪醇及其衍生物（例如橄榄苦苷复合物和酪醇）。这些量，如果由适量的橄榄油提供，在均衡饮食的背景下很容易被消耗。在均衡饮食的情况下，一些橄榄油中的多酚浓度可能太低，无法摄入这么多的多酚。目标人群是一般人群。维持正常的血液高密度脂蛋白胆固醇浓度声称的效果是“脂质代谢”。假设目标人群是一般人群。在拟议措辞的背景下，小组假设所声称的效果是指维持正常的血液高密度脂蛋白胆固醇浓度。小组认为维持正常的血液高密度脂蛋白胆固醇浓度（不增加低密度脂蛋白胆固醇浓度）是一种有益的生理效应。在权衡证据时，小组考虑到所提供的研究结果不一致，并且没有证据表明橄榄油多酚可以发挥所声称的效果的生物学上合理的机制。根据所提供的数据，专家小组得出结论，所提供的证据不足以确定食用橄榄油多酚（按羟基酪醇及其衍生物的含量标准化）与维持正常血液高密度脂蛋白胆固醇浓度之间的因果关系。维持正常血压声称的效果是“有助于维持正常血压”。假设目标人群是一般人群。小组认为维持正常血压是一种有益的生理效应。没有提供任何人体研究，可以得出结论，以科学地证实所声称的效果。根据所提供的数据，评估小组得出结论认为，以羟基酪醇及其衍生物（如橄榄苦苷复合物）含量为标准的橄榄（橄榄果、橄榄厂废水或橄榄油、欧洲橄榄提取物和橄榄叶）中多酚的摄入与维持正常血压之间没有因果关系。“抗炎特性”声称的效果是“具有抗炎特性的橄榄生物酚的有效来源”。假设目标人群是一般人群。在拟议措辞方面，专员小组认为，索赔涉及骨关节炎或类风湿性关节炎等疾病，减少炎症将是治疗这些疾病的治疗目标。评估小组认为，减少骨关节炎或类风湿性关节炎等疾病的炎症是治疗该疾病的治疗目标，不符合法规（EC） No 1924/2006中规定的标准。“有助于上呼吸道健康”声称的效果是“有助于上呼吸道健康”。假设目标人群是一般人群。所声称的效果没有得到充分界定，会员国也没有作出澄清。小组注意到，所提供的资料中提到了不同的健康结果，无法确定哪一种具体影响是索赔的目标。委员会的结论是，所声称的效果是一般的和非特异性的，不涉及法规（EC） No 1924/2006所要求的任何特定健康声称。“可以帮助维持胃肠道的正常功能”所声称的效果是“可以帮助维持胃肠道的正常功能”。假设目标人群是一般人群。所声称的效果没有得到充分界定，会员国也没有作出澄清。小组注意到，所提供的资料中提到了不同的健康结果，无法确定哪一种具体影响是索赔的目标。委员会的结论是，所声称的效果是一般的和非特异性的，不涉及法规（EC） No 1924/2006所要求的任何特定健康声称。“有助于身体防御外部因素”声称的效果是“有助于身体防御外部因素”。假设目标人群是一般人群。所声称的效果没有得到充分界定，会员国也没有作出澄清。小组注意到，所提供的资料中提到了不同的健康结果，无法确定哪一种具体影响是索赔的目标。委员会的结论是，所声称的效果是一般的和非特异性的，不涉及法规（EC） No 1924/2006所要求的任何特定健康声称。
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 damageThe 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 concentrationsThe 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 pressureThe 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.