Soybean | whatsinit

About

What it is and where it shows up.

Soybean (Glycine max) is a legume of East Asian origin used both as a whole food and as the raw material for a wide range of food ingredients including soy protein isolates and concentrates, soy flour, soybean oil, tofu, tempeh, miso, natto, and soy sauce. It is prized in food manufacturing for its high-quality complete protein, favourable fatty-acid profile, and functional properties such as emulsification and water-binding.

Safety summary

The regulatory and scientific consensus.

Soybean is broadly safe and nutritious for most people and carries no established acceptable daily intake because it is a whole food rather than a functional additive. However, it is consistently ranked among the world's most prevalent food allergens—listed as a mandatory-declaration allergen in the US, EU, and India—capable of causing reactions ranging from mild urticaria to life-threatening anaphylaxis in sensitised individuals. The phytoestrogens (isoflavones: genistein, daidzein) and goitrogenic compounds present in soy raise additional precautionary concerns for specific populations such as infants fed soy-based formula, individuals with thyroid disorders, and those on thyroid hormone therapy.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Soybeans are listed in Annex II of Regulation (EU) No 1169/2011 on food information to consumers as one of 14 major allergens requiring mandatory labelling whenever used as an ingredient or processing aid. Certain highly refined derivatives are granted labelling exemptions: fully refined soybean oil and fat, natural tocopherols (E306), natural D-alpha tocopherol and its acetate/succinate from soy, phytosterols/phytosterol esters from soy, and plant stanol esters from soy sterols.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Soybean and soy protein products are regulated under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. FSSAI issued draft amendments in 2017 to update compositional standards for whole soybeans and soy protein products, and in 2019 for non-fermented soybean products. Soybean oil standards are covered under regulations for vegetable oils (revised 2024 based on analytical data of domestic varieties).source
FDA (Food and Drug Administration) (United States)	Approved	Soy is designated a major food allergen under the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 (effective 1 Jan 2006), requiring mandatory declaration on food labels. Soybean-derived products such as soybean oil and soy protein are recognised as GRAS or are approved food ingredients under 21 CFR Parts 182 and 184. The FASTER Act (2023) added sesame as the 9th major allergen; soy remains on the list.source

Who should approach with care

Whose guidance would steer them away.

Other — Individuals with a confirmed soy allergy must strictly avoid soybean and all its derivatives, as reactions range from urticaria and gastrointestinal distress to life-threatening anaphylaxis; soy is a mandatory-declaration major allergen under FDA FALCPA, EU Regulation 1169/2011, and FSSAI regulations.

Infants — Soy-based infant formula delivers high concentrations of phytoestrogens (isoflavones) relative to body weight; medical guidance should be sought before using soy formula, especially for preterm infants, those with congenital hypothyroidism, or infants already sensitised to cow's milk protein.

Thyroid Disease — Soybean isoflavones (genistein, daidzein) exhibit goitrogenic activity and may impair thyroid hormone synthesis and reduce absorption of levothyroxine, warranting caution and appropriate dosing intervals in individuals with hypothyroidism or those on thyroid hormone replacement therapy.

Children — Soy is among the most common food allergens in childhood; introduction should be monitored carefully in young children, particularly those with a family history of food allergy, existing cow's milk allergy, or other legume sensitivities, as cross-reactivity is documented.

Research citations

The sources behind this verdict.

1FDA. Soy Allergy — Major Food Allergens (FDA). fda.gov
2PubMed. Assessment of genetically modified soybean GMB151 for food and feed uses, under Regulation (EC) No 1829/2003 (EFSA-GMO-NL-2018-153), 2021. pubmed.ncbi.nlm.nih.gov
3FSSAI. Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulation 2017 — Standards for Soybean and Soy Protein Products, 2017. archive.fssai.gov.in
4other. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers — Annex II, 2011. eur-lex.europa.eu
5EFSA. Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes — EFSA NDA Panel, 2004. efsa.europa.eu

Independently researched5 citations