A1186 Soy Leghemoglobin (Impossible Foods)

Submission to the FSANZ

Application A1186 Soy Leghemoglobin

February 13, 2020

FSANZ Supporting documents can be found here

A successful approval of A1186 Soy Leghemoglobin by FSANZ will result in the release of Impossible Foods burgers and associated products onto the New Zealand market for consumption by the product. Much of this product would be sold through take-away outlets and restaurants and in this form, would remain unlabelled.

Soil and Health consider that the application for A1186 Soy Leghemoglobin which is a mixture referred to as ‘LegH Prep’ is inadequate to ensure a high standard of public health protection. Much of the documentation and marketing of Impossible Foods products infer that these products are substantially equivalent to unprocessed meat, and represent a safe and healthy vegetarian protein option.

We consider that regulatory activities which fail to consider the implications of release of an ultra-processed, high salt, genetically modified soy protein product on the market – and regulatory treatment of this product as substantially equivalent to healthy, grass raised beef or lamb, or home-made vegetarian burgers made from non-genetically modified vegetable proteins, may be misleading.

Therefore the Soil & Health Association of New Zealand consider that the current application and approval process does not contain sufficient information to ensure activities relevant to the approval will fulfill the Objectives of the Food Standards Australia New Zealand Act 1991. We note:

1.1. The report ignores the health impact of the final product. The LegH Prep has been specifically developed to be an ingredient in an ultra-processed convenience food product.

1.2. Nutrition is cherry-picked despite the product being positioned as a meat substitute. Equivalent iron is not substantially equivalent as other nutritional parameters are ignored in the application.

1.3. The contaminant profile 2 from herbicides contained in the retail product, which unprocessed meat does not contain has been ignored.

1.4. Differing health effects relating to the potential for endocrine disruption at different life stages has been ignored.

1.5. There are no long-term dietary studies – a 28-day study restricts consideration on health effect and the longer dietary studies are reasonable to scientifically risk assess long term (chronic) effects.

1.6. The chronic toxicological parameters relating to immunotoxicity, carcinogenicity, oxidative stress, as well as endocrinological effects are not clearly published.

1.7. 90-days dietary study must be supplied, including endocrinological test results, for the risk assessment to be scientifically appropriate to assess health risk:

– OECD Test Guideline (TG) 408 – repeated dose 90-day oral toxicity study –       (Updated in 2018)

1.8. Due to the scientific knowledge gaps and the deficiencies, and with particularly consideration of the commercial outcome of the approval of LegH Prep – the potential for a commercial product that the applicant intends to be considered a staple dietary product in the New Zealand and Australian diet – the Soil and Health Association of New Zealand propose that the LegH Prep (A1186) application should be declined.


In addition, the attached PDF which formed the content of our submission to the FSANZ discussed the following issues:

2.0 Precautionary Principle.

3.0 Soil and Health note that section 18

4.0 Food Standards Australia New Zealand Act Section 18.

5.0 Endocrine gaps and gender specific health effects.

6.0 Ultra-processed convenience food.

7.0 90-day dietary studies should study the formulated retail product.

8.0 Contaminants from dietary exposure.

9.0 Misleading cost-benefit analysis.

10.0 Misleading: Substantial Equivalence.

11.0 Misleading: Greater toxicity of the formulation

12.0 Misleading: Scientific knowledge gaps

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