FDA Status
GRAS
Lecithin (Soy/Sunflower) (E322), CAS 8002-43-5, is a emulsifier additive holding a composite safety score of 5 out of 5 (Generally Safe). The U.S. Food and Drug Administration currently classifies it as GRAS, while the European Union lists it as Approved. It is most commonly used as Chocolate, baked goods, margarine, cooking spray.
No U.S. state has enacted specific legislation targeting Lecithin (Soy/Sunflower) to date, keeping federal FDA classification as the operative standard. State-level food safety legislation remains active nationally, and that picture may shift as new bills advance.
Peer-reviewed research has flagged 1 distinct area of health concern for Lecithin (Soy/Sunflower), which factors directly into the assigned safety score. All figures above draw on FDA SAFFA inventory records, EU food additive regulation (EC) No 1333/2008, EFSA scientific opinions where published, and legislative records from individual U.S. states.
Regulatory Snapshot
| Property | Value | Source |
|---|---|---|
| FDA Status | GRAS | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | E322 | EU additive register |
| CAS Number | 8002-43-5 | CAS Registry |
| Category | Emulsifier | FDA functional class |
| Composite Safety Score | 5 / 5 (Generally Safe) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | Not yet tracked | Open Food Facts (US) |
Values reflect official agency classifications as published by the U.S. Food and Drug Administration and the European Union's regulatory framework. See our methodology for scoring details.
5.0 / 5
Composite Safety Generally Safe
Safety Score: 5 out of 5
Safety Rating 100.0%
EU Status
Approved
E322
U.S. State Regulations
0 states
None enacted
Safety Assessment
Lecithin (Soy/Sunflower) receives a safety score of 5/5 (Generally Safe) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA classifies Lecithin (Soy/Sunflower) as "Generally Recognized As Safe" (GRAS), meaning qualified experts consider it safe under intended conditions of use.
Research has identified 1 area of health concern associated with Lecithin (Soy/Sunflower). Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Lecithin (Soy/Sunflower)?
Natural emulsifier from soybeans or sunflower.
Health Concerns
- Safe. Soy lecithin may concern soy allergy sufferers.
Common Uses
Chocolate, baked goods, margarine, cooking spray
Frequently Asked Questions
Is Lecithin (Soy/Sunflower) safe to consume?
Lecithin (Soy/Sunflower) has a safety score of 5/5 (Generally Safe). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Lecithin (Soy/Sunflower) used for in food?
Lecithin (Soy/Sunflower) is commonly used as: Chocolate, baked goods, margarine, cooking spray. It belongs to the Emulsifier category of food additives.
Is Lecithin (Soy/Sunflower) banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Lecithin (Soy/Sunflower). However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Lecithin (Soy/Sunflower)?
The FDA classifies Lecithin (Soy/Sunflower) as "GRAS", while the EU status is "Approved" (E322). The FDA and EU use separate evaluation frameworks — the EU often applies the precautionary principle, sometimes banning additives that remain approved in the US. Always check both jurisdictions when evaluating food additive safety.
What health concerns are associated with Lecithin (Soy/Sunflower)?
Research has identified the following health concerns for Lecithin (Soy/Sunflower): Safe. Soy lecithin may concern soy allergy sufferers.. These findings inform its safety score of 5/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Lecithin (Soy/Sunflower) calculated?
The safety score of 5/5 for Lecithin (Soy/Sunflower) is a composite assessment based on FDA regulatory status, EU approval status, published scientific research on health effects, and state-level legislative actions. A score of 1 means "Banned / Avoid" and 5 means "Generally Safe." The score is updated as new regulatory actions or scientific evidence emerge.
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Related Data Sources
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Related Resources
Read our methodology — how this data is sourced, computed, and verified.
Related
Data sourced from official EWG, FDA GRAS, and ingredient toxicology databases. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial