TECHNICAL APPENDIX
SPLEATS Ingredient Standards Framework
This appendix explains the regulatory and scientific rationale behind SPLEATS’ ingredient standards. It is intended for investors, regulatory partners, and commercial collaborators seeking transparency on how we evaluate ingredients and processing practices.
Regulatory context
Food safety governance differs across jurisdictions. The European Union applies the precautionary principle under Regulation (EC) No 178/2002, while the United States operates under the Federal Food, Drug, and Cosmetic Act (FFDCA), with ingredients approved through food additive authorizations or GRAS determinations. SPLEATS does not claim regulatory authority beyond either system. We apply a comparative review approach when differences exist. Primary bodies referenced include EFSA, FDA, IARC, and JECFA.
Ingredients excluded based on regulatory divergence
Potassium bromate
Potassium bromate is not authorized for food use in the European Union.¹ It remains permitted in limited applications in the United States, although usage has declined. The International Agency for Research on Cancer (IARC) classifies potassium bromate as Group 2B (possibly carcinogenic to humans).² Given this classification and the availability of functional alternatives in bakery systems, SPLEATS excludes its use.
Azodicarbonamide (ADA)
Azodicarbonamide is not authorized for food use in the European Union.³ It remains permitted in the United States as a flour treatment agent within regulated limits.⁴ Because it primarily functions as an industrial dough conditioning accelerator and is not required in traditional, high-quality bread processes, SPLEATS excludes its use.
Titanium dioxide (E171)
EFSA concluded in 2021 that titanium dioxide can no longer be considered safe as a food additive due to concerns that genotoxicity cannot be ruled out.⁵ The European Commission subsequently suspended its use in foods.⁶ Titanium dioxide remains permitted in the United States within specified limits.⁷ SPLEATS excludes titanium dioxide based on EFSA’s scientific conclusion.
Artificial color additives
Certain synthetic dyes permitted in the United States require mandatory warning labels in the EU due to potential behavioral effects in children.⁸ Although these colors are not universally banned, SPLEATS excludes synthetic dyes due to limited functional necessity and the availability of alternatives aligned with clean-label, premium positioning.
Hydrogenated oils
In 2015 the FDA determined that partially hydrogenated oils are no longer GRAS, based on evidence supporting their role as the primary dietary source of industrial trans fats.⁹ While phase-out is largely complete, SPLEATS excludes partially hydrogenated oils and avoids chemically restructured fats to maintain alignment with long-term lipid safety standards.
Production practice considerations
Recombinant bovine somatotropin (rBST / rBGH)
The European Union prohibits the use of recombinant bovine somatotropin in dairy production.¹⁰ The practice remains permitted in the United States. SPLEATS prioritizes dairy sourced from producers not using synthetic growth hormones.
Emulsifiers under scientific review
Peer-reviewed research has examined potential microbiome impacts associated with certain emulsifiers such as carboxymethylcellulose and polysorbate 80.¹¹ ¹² While regulatory evaluation continues, SPLEATS applies a precautionary review approach when credible evidence suggests potential adverse microbiome effects.
Processing methods
SPLEATS considers not only ingredient lists but also processing practices, including chemical flour bleaching, bromate-treated dough systems, and antimicrobial chlorine washes in poultry processing. The latter is prohibited in the European Union.¹³ Where viable alternatives exist that maintain safety while reducing chemical intervention, SPLEATS favors minimally interventionist methods.
Our scientific prudence framework
SPLEATS excludes ingredients when a credible regulatory authority has suspended or prohibited use based on safety concerns, when recognized scientific bodies identify carcinogenic, genotoxic, or endocrine-related concerns, or when an ingredient serves primarily cosmetic or industrial process functions rather than nutritional or safety necessity.
SPLEATS does not assert that all ingredients permitted in the United States are unsafe. This policy reflects voluntary adherence to a higher precautionary threshold where regulatory divergence exists, supported by regulatory review and peer-reviewed evidence.
REFERENCES
European Parliament and Council. Regulation (EC) No 1333/2008 on food additives. Official Journal of the European Union, 2008.
International Agency for Research on Cancer (IARC). Some Chemicals that Cause Tumours of the Kidney or Urinary Bladder in Rodents and Some Other Substances. IARC Monographs, Vol. 73, 1999.
European Commission. EU Food Additives Database. Azodicarbonamide not authorized for food use.
U.S. Food and Drug Administration. 21 CFR §172.806 – Azodicarbonamide.
EFSA Panel on Food Additives and Flavourings (FAF). Safety assessment of titanium dioxide (E171) as a food additive. EFSA Journal. 2021;19(5):6585.
European Commission Regulation (EU) 2022/63 amending Annex II to Regulation (EC) No 1333/2008 as regards titanium dioxide (E171).
U.S. Food and Drug Administration. 21 CFR §73.575 – Titanium dioxide.
European Parliament and Council. Regulation (EC) No 1333/2008, Annex V – Additional labeling requirements for certain colours.
U.S. Food and Drug Administration. Final Determination Regarding Partially Hydrogenated Oils. Federal Register, 2015.
European Commission Decision 1999/879/EC concerning the prohibition of bovine somatotropin in dairy production.
Chassaing, B. et al. Dietary emulsifiers impact the mouse gut microbiota promoting colitis and metabolic syndrome. Nature. 2015;519:92–96.
Viennois, E. et al. Dietary emulsifier-induced low-grade inflammation promotes colon carcinogenesis. Cancer Research. 2017;77(1):27–40.
European Commission Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin.