In formerly submitted comments to the European Commission the three groups criticised EFSA for its narrow soy protein definition which they state is virtually impossible to find in the commercial world.
“Should the totality of the evidence relating to soy protein with naturally occurring isoflavones have been taken into account, we consider this would markedly affect the draft decision reached by the EFSA,” they wrote.
“This interpretation of 'soy protein' no longer reflects the 'soy protein' found in soy foods and ingredients, which would carry the claim. A constituent that comprises solely of the protein from soy does not exist as food and does not reflect the constituent's characterisation provided by the Applicant.”
The three groups – the European Vegetable Protein Federation (EUVEPRO), the European Natural Soyfoods Manufacturers Association (ENSA), the UK Soy Protein Association (SPA) – said this definition led to 18 studies being dismissed and additional information it submitted at the request of EFSA also being discounted.
The EFSA article 14 opinion can be found here.
“This interpretation of 'soy protein' no longer reflects the 'soy protein' found in soy foods and ingredients, which would carry the claim,” they added. “A constituent that comprises solely of the protein from soy does not exist as food and does not reflect the constituent's characterisation provided by the Applicant.”
EUVEPRO, ENSA and SPA said the interpretation of soy protein adopted by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) meant, “only soy protein isolate virtually depleted of isoflavones by alcohol-washing” were considered, thereby excluding, “food sources of soy protein with its naturally occurring isoflavones.”
They said this approach was “inappropriate” and suggested a potential solution in a reworded claim that may propose, “soy protein containing naturally occurring isoflavones”rather than soy protein alone.
If such a claim had the effect of reigniting the NDA’s interest in the dismissed studies, they noted the baseline shift in LDL cholesterol reduction was 5.5 per cent on average in that body of work.
They concluded that the NDA had not examined the totality of evidence.
Parties have a 30-day window to comment on proprietary and emerging science article 13.5 and article 14 children’s development and disease reduction claims. These comments are submitted to the European Commission after which the NDA then responds to the feedback that has come in and has the option to amend its opinions if it sees fit.
It is expected the comments may have a bearing on two generic, article 13.1 soy-cholesterol lowering dossiers that are yet to be assessed by the NDA.
Soy-cholesterol lowering claims are approved in Japan, the US, the UK, South Africa, the Philippines, Brazil, Indonesia, Korea, Malaysia and Turkey.