FDA Status
GRAS
Maltitol (E965), CAS 585-88-6, is a sweetener additive holding a composite safety score of 4 out of 5 (Low Risk). The U.S. Food and Drug Administration currently classifies it as GRAS, while the European Union lists it as Approved. This ingredient appears in approximately 308 tracked food products across our database. It is most commonly used as Sugar-free chocolate, baked goods.
No U.S. state has enacted specific legislation targeting Maltitol 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 Maltitol, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2006-05-18. 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 | E965 | EU additive register |
| CAS Number | 585-88-6 | CAS Registry |
| Category | Sweetener | FDA functional class |
| Composite Safety Score | 4 / 5 (Low Risk) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | 308 | 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.
4.0 / 5
Composite Safety Low Risk
Safety Score: 4 out of 5
Safety Rating 80.0%
EU Status
Approved
E965
U.S. State Regulations
0 states
None enacted
Safety Assessment
Maltitol receives a safety score of 4/5 (Low Risk) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA classifies Maltitol 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 Maltitol. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Maltitol?
Sugar alcohol with 75-90% sweetness.
Health Concerns
- Safe. Higher glycemic index than other sugar alcohols.
Common Uses
Sugar-free chocolate, baked goods
Frequently Asked Questions
Is Maltitol safe to consume?
Maltitol has a safety score of 4/5 (Low Risk). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Maltitol used for in food?
Maltitol is commonly used as: Sugar-free chocolate, baked goods. It belongs to the Sweetener category of food additives.
Is Maltitol banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Maltitol. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Maltitol?
The FDA classifies Maltitol as "GRAS", while the EU status is "Approved" (E965). 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 Maltitol?
Research has identified the following health concerns for Maltitol: Safe. Higher glycemic index than other sugar alcohols.. These findings inform its safety score of 4/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Maltitol calculated?
The safety score of 4/5 for Maltitol 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
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