EU food safety panel disputes health claims

The opinions published assessed the health relationship that an applicant claimed existed between a food/food ingredient and either disease risk reduction or children's health. The Authority notably disputed two dairy claims.

22/08/08 The European Food Safety Authority (EFSA) has disputed a number of health benefit claims submitted by manufacturers in its first opinion on eight of the 228 new product claims submitted. The Authority notably disputed that dairy products promote good teeth and healthy body weight in children. The opinions published assessed the health relationship that an applicant claimed existed between a food/food ingredient and either disease risk reduction or children's health.

EFSA spokesperson Lucia de Luca told FoodIngredientsFirst that the next step of the process will be to send the opinions back to the European Commission, where the risk managers of the member states will authorize the opinions or not. "Our scientific opinions are robust and deal in clear terms with the pros and cons and risk assessments for risk managers," she said. The Panel has a monthly meeting with further opinions on other health claims being passed each time.

The claimed effect ‘promote dental health’ in dairy relates to reduction of dental caries development. Dental caries is a disease with a high prevalence in the EU, particularly in children. Dietary factors may influence the development of dental caries. The target population is children. EFSA noted that four observational, cross-sectional studies report either lower caries frequency in children with milk consumption compared to those who do not drink milk or significantly lower milk consumption in children with caries symptoms as compared to children without caries. No association between caries status and milk consumption has been found in two prospective cohort studies. No intervention studies were provided on the effect of milk on dental caries development in children. Studies in rodents indicate that cow’s milk is noncariogenic and that milk may have a mild protective effect against the cariogenic effect of sucrose. The Panel considers that the evidence provided is insufficient to establish a cause-effect relationship between consumption of milk and reduction of dental caries development in children.

Following an application from National Dairy Council submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to dairy and healthy body weight. The scope of the application was proposed to fall under a health claim referring to children’s development and health. The food/constituent subject of the health claim is dairy foods, which for this application are defined as including milk, cheese and yogurt. Three portions of dairy foods per day are claimed to promote a healthy body weight in children and adolescents, a portion being specified as 200 ml milk, 28 g cheese or 125 ml yogurt. However, the Panel considers that these foods are not sufficiently characterised, e.g. data on the nutritional composition and its variability between products were not provided. In the context of this claim, body mass index (BMI) and occasionally body fat estimates are used as proxy measures for a healthy body weight. Of the 5 cross-sectional plus the 7 prospective observations presented, only 4 studies (two cross-sectional and two prospective studies) support an association between the consumption of dairy foods and BMI or body fat estimates in children and adolescents. The Panel noted that cross-sectional studies only provide an association and do not provide sufficient evidence of a cause and effect relationship. The two prospective studies included only a small sample size (53 and 92 subjects) and covered a limited age range (2 to 13 years). However, there are no intervention studies to specifically examine any causal relationship, and there are insufficient data to establish a specific level or frequency of consumption of dairy foods associated with any specific effect on body weight. On the basis of the data presented, the Panel concludes that a cause and effect relationship is not established between the daily consumption of dairy foods (milk, cheese and yogurt) and a healthy body weight in children and adolescents.

The panel found insufficient evidence to back the claim that a-linolenic acid and linoleic acid promote children's normal growth and development. In response to a Unilever submission, the company said that the evidence presented to support that LA and ALA are essential to growth and development of children are mainly case reports documenting clinical signs and symptoms of essential fatty acid (EFA) deficiency (largely as LA deficiency) in infants and children, one randomised intervention trial on the effects of LA deficiency in infants and two case reports documenting specific ALA deficiency in children 6-7 years of age. The Panel considers that a cause and effect relationship is established between the intake of ALA and LA and normal growth and development of children.

The applicant cites reports on LA and ALA intake in children in some EU countries being low or below the recommended (adequate) intakes which were based on observed median intakes in the US. Reported intakes of LA and ALA for children in the EU exceed the amounts of LA and ALA below which adverse effects on growth and development due to EFA deficiency have been observed. The Panel considers that the evidence provided does not establish that intakes of ALA and LA are inadequate for normal growth and development of children in the EU population. The wording “essential fatty acids are needed for normal growth and development of children” reflects the scientific evidence. The Panel considers that the evidence provided does not establish a benefit for normal growth and development of children of LA intakes greater than about 1% of total energy and of ALA greater than about 0.2% of total energy. These quantities are reported to be consumed by children as part of the recommended balanced diet.

The Agency was more positive about another Unilever submission. With respect to the association of LDL-cholesterol lowering with reduction in the risk of coronary heart disease the Panel considers that there is evidence that the risk of CHD can be reduced by cholesterol-lowering therapy including dietary intervention strategies. However, there are no studies demonstrating that plant sterols have an impact on population-based CHD morbidity and mortality rates. The Panel however, considers that products to which phytosterols are added should be consumed only by people who need and want to lower their blood cholesterol and that patients on cholesterol- lowering medication should only consume the product under medical supervision. The Panel discussed the wording proposed by the applicant and considers that the following wording reflects the available scientific evidence: “Plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease".

The agency  found "no significant effect" of "NeOpuntia" from BioSerae on blood lipid parameters (fatty acid or oil absorption). The Agency said that the proposed claim for NeOpuntia is based on one single study in 68 women with the metabolic syndrome and a body mass index between 25 and 40, who were randomly allocated to receive either 1.6 g of NeOpuntia capsules or placebo capsules 3 times a day for 6 weeks. The study did not reveal an effect of NeOpuntia on serum LDL-cholesterol levels. Serum HDL-cholesterol levels were slightly but not statistically significantly increased in the group consuming NeOpuntia (4,8 g/d). No control for any post-randomisation confounders such as dietary fat intakes or physical activity was undertaken and the study is focused only on one specific subgroup of the intended target population. On the basis of the data presented, the Panel concludes that no significant effect of NeOpuntia on blood lipid parameters has been demonstrated. Therefore, a cause and effect relationship could not be established between the consumption of NeOpuntia and the claimed effect.

The Agency also said there was no direct effect of "Femarelle" on post-menopausal women's bone density. The drug "Elancyl Global Silhouette" was also found to have "no demonstrable effect on body weight, body shape or body fat or water in humans". 

These 228 new claims submissions are however only the tip of the iceberg in terms of what the Agency will be looking at over the next few years. Some 2,800-3,000 existing claims will be assessed.