1.1. Fruits and/or vegetables (ID 1212, 1213, 1214, 1217, 1218, 1219, 1301, 1425, 1426, 1427, 1428, 1429, 1430)

The foods that are the subject of the health claims are “fruits (fresh, frozen, canned, bottled, dried, juiced)”, “fruit-rich diet”, “vegetables (fresh, frozen, canned, bottled, dried, juiced)”, “vegetable-rich diet”, and “fruits and vegetables” related to the following claimed effects: cardiac function, weight management, and blood glucose control.
The macronutrient composition and energy density of different fruits and fruit products is widely variable. For example, fresh fruits generally have a low the energy density, have fructose as the
predominant sugar, and contain variable amounts of (generally soluble) dietary fibre, whereas the energy density of dried fruits is higher owing to dehydration; fruit juices can contain large amounts of added sugars, particularly glucose and sucrose, and the amount of dietary fibre is generally very low, unless it is added in the manufacturing process. The macronutrient composition and energy density of different vegetables and vegetable products is also widely variable. The energy density of fresh vegetables is generally low, and they contain variable amounts of dietary fibre, whereas processed vegetable products may contain considerable amounts of fat. Also the type and amount of vitamins, minerals, carotenoids and phenolic compounds contained in different types of fruits and vegetables is very variable.
The Panel notes that the type and amount of the specific fruits/vegetables and/or of the fruit/vegetable products required to obtain the claimed effects have not been indicated in the information provided, and that the significant differences in composition existing between such fruit/vegetable products may have an impact on the claimed effects. The Panel also notes that the health effects of “fruit-rich” and “vegetable-rich” diets may depend on the overall characteristics (e.g. energy, energy density, and macronutrient composition) of such diets as influenced by other foods.
The references submitted for the scientific substantiation of the health claims included narrative reviews and consensus opinions which addressed the association between dietary patterns and lifestyle factors (e.g. physical activity) on the risk of chronic disease, including coronary heart disease, obesity and type 2 diabetes (e.g. Lichtenstein et al., 2006; WHO/FAO, 2003). Dietary patterns which include a high consumption of fruits and vegetables have been associated with a decreased risk of chronic diseases (e.g. coronary heart disease, obesity and type 2 diabetes (WHO/FAO, 2003)) as compared to dietary patterns, amongst others, characterised by low consumption of fruits and vegetables (Lichtenstein et al., 2006; WHO/FAO, 2003). However, the food items which are included in the “fruit” and “vegetable” categories are generally not reported in these studies, and the evidence provided by these studies relates to overall dietary patterns rather than to an effect of “fruit” and “vegetable” consumption independent of other dietary modifications. Accordingly, dietary recommendations for the primary prevention of such diseases generally include consumption of a diet rich in fruits and vegetables, together with an appropriate intake of other foods to achieve dietary balance of fat/fatty acids, carbohydrates, adequate intake of dietary fibre and limited intake of sodium and alcohol.
The references submitted also included human observational studies and narrative reviews on the association between dietary patterns and consumption of vitamins, minerals, carotenoids and phenolic compounds on the risk of chronic disease and on markers of oxidative stress; human intervention studies on the effects of different fruits and vegetables, and fruit and vegetable products (e.g. red grape fruit, citrus fruit, purple grape juice, strawberries, cherries, tea, and coffee) on platelet aggregation, markers of inflammation and oxidative damage to molecules; and references on the effects of plant food processing on the content and bioavailability of phenolic compounds in the final products (e.g. green beans, sweet corn, and lettuce).
The Panel notes that most of the references provided have not characterised the intake of fruits/vegetables or of fruit/vegetable products by type and amount, or have not assessed the effects of fruit and vegetable consumption independent of other dietary modifications, but rather the effects of overall dietary patterns or the effects of specific food constituents (e.g. phenolic compounds and their classes, antioxidant vitamins, certain minerals, and dietary fibre) present in plant foods. The Panel also notes that the remaining references provided, which investigated the effects of a particular intervention on different health outcomes, referred to very specific food products, generally characterised by their antioxidant capacity in vitro or by their polyphenol content (and their classes), and that none of these studies addressed health outcomes related to normal cardiac function, body weight changes or blood glucose control.
The Panel considers that because of the high variety of the foods and food products that are the subject of the health claims, “fruits (fresh, frozen, canned, bottled, dried, juiced)”, “fruit-rich diet”, “vegetables (fresh, frozen, canned, bottled, dried, juiced)”, “vegetable-rich diet”, “fruits and vegetables”, these foods are not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of “fruits (fresh, frozen, canned, bottled, dried, juiced)”, “fruit-rich diet”, “vegetables (fresh, frozen, canned, bottled, dried, juiced)”, “vegetable-rich diet” or “fruits and vegetables” and the claimed effects considered in this section because of the insufficient characterisation of these food categories and diets.

1.2. “Mediterranean diet” (ID 1423)

The diet that is the subject of the health claim is the “Mediterranean diet” related to the following claimed effect: cardiac function.
The characterisation provided by Member States specifies such diet as “based on high consumption of fruits, vegetables, cereals, pulses, nuts and seeds; moderate consumption of dairy products, fish, poultry and eggs and little use of red meat; low to moderate amount of wine; olive oil is the main cooking and dressing oil”. However, the Panel notes that quantitative amounts and appropriate characterisation of the food items or food groups listed have not been provided, and no reference to the macronutrient composition (including dietary fibre) of the diet has been made. The Panel also notes that wine, which is listed as one of the components of the “Mediterranean diet”, contains more than 1.2 % alcohol by volume and therefore should not bear health claims in accordance with Regulation (EC) No 1924/2006.
Most of the references provided for the scientific substantiation of the claim reported on human observational studies which addressed the association between some dietary patterns defined as typical of the “Mediterranean diet”, or specific components of it, and different health outcomes, including blood lipids, blood pressure, obesity, incidence of coronary heart disease, and death from cardiovascular disease and from all causes. Human intervention studies on the effects on various health outcomes of different dietary interventions, collectively designated as the “Mediterranean diet”, have also been provided.
In these studies, the characterisation of the “Mediterranean diet” is very variable. Some studies only referred to the fatty acid composition of the diet, or only considered the addition of nuts or wine (reviewed in Serra-Majem et al., 2006); other studies used the “Mediterranean Adequacy Index” obtained by dividing the sum of total energy percentages from food groups “typical of the reference Mediterranean diet” (i.e. bread, cereals, legumes, potatoes, vegetables, fresh fruit, fish, wine, vegetable oils) by the sum of the total energy percentage from food groups (milk, cheese, eggs, animal fats and margarines, sweet beverages, cakes/pie/cookies, sugar) “less typical” of the “reference Mediterranean diet” (Fidanza et al., 2004); finally, some studies used different scales indicating the degree of adherence to the “traditional Mediterranean diet” with scores which were either calculated on the basis of the mean consumption of a series of “food groups” (e.g. vegetables, legumes, fruits and nuts, cereal, fish, meat, poultry, and diary products) within the same study population (Panagiotakos et al., 2005; 2006a; 2006b; Psaltopoulou et al., 2004; Trichopoulou et al., 2003; 2005) or on the basis of fixed thresholds of intake using similar “food groups” (Estruch et al., 2006; Martinez-Gonzalez et al., 2004).
The Panel notes that different dietary patterns exist in different Mediterranean countries (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010).
The Panel notes that different definitions of “Mediterranean diet” have been used in the references provided, and that therefore the diet which is the subject of the health claim is unclear.
The Panel considers that the diet, “Mediterranean diet”, which is the subject of the health claim, is not sufficiently characterised.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of a “Mediterranean diet” and the claimed effect considered in this section because of the insufficient characterisation of the term “Mediterranean diet”.