While EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) recognised reduced LDL cholesterol as a viable biomarker for reduced risk of heart disease, it said the 40-study strong dossier failed to demonstrate causality.
The NDA took issue with most of the 32 randomised controlled trials and eight observational studies submitted in the article 14 disease reduction dossier because it said they did not specifically test for soy protein but rather soy protein isolate or soyfoods that contained other constituents.
In the assessment process this issue was communicated to the applicants – the Soya Protein Association (SPA), the European Vegetable Protein Federation (EUVEPRO), and the European Natural Soyfood Manufacturers Association (ENSA) – who then resubmitted a meta-analysis that included four “high quality”, soy protein-specific, intervention trials.
But the NDA, while recognising that soy isoflavones had a statistically significant effect on cholesterol levels in at least one of these four studies, reaffirmed its initial observation that the evidence did not back the effects of the protein constituents of soy.
“The Panel considers that results from these four intervention studies identified by the applicant as being controlled for the macronutrient composition of the test products do not support an effect of the protein component of soy on LDL-cholesterol concentrations,” it wrote.
The panel said other constituents that could have had a bearing on any statistically significant effects included fat and fatty acids, including polyunsaturated fatty acids, soy fibre, and soy isoflavones.
The proposed claim stated: “Soy protein has been shown to lower/reduce blood cholesterol; blood cholesterol lowering may reduce the risk of (coronary) heart disease.”
The applicants stated positive benefits could be attained if adults consumed between 12-25 grams per day of soy protein or 3.75g per standard serving. They also noted authorities that had approved similar claims such as in Malaysia, the UK Joint Health Claims Initiative (JHCI), the US Food and Drug Administration (FDA), the Ministry of Health, Labour and Welfare in Japan.
It is estimated coronary heart disease (CHD) accounts for about two million deaths in the European Union and more than 4.35 million deaths in Europe each year.
The opinion can be found here.