Identifiers
The only market-specific regulatory treatment evidenced for Starch is in the United States, where it is subject to EPA reporting under the Toxic Substances Control Act (TSCA) via the Chemical Data Reporting (CDR) rule. No other country-specific regulations, food additive approvals, or product-category classifications are available in the supplied evidence. This means a compliance assessment cannot currently differentiate Starch's regulatory status across markets or product categories beyond the U.S. EPA framework. For non-U.S. markets or food, drug, or cosmetic categories, no regulatory conclusions can be drawn from the evidence provided.
3 regulations
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 178.1010 | 21 CFR 178.1010 | Food Additive | authorized | View |
| 182.90 | 21 CFR 182.90 | Food Additive | authorized | View |
| 137.105 | 21 CFR 137.105 | Labeling Standards | authorized | View |
| 155.130 | 21 CFR 155.130 | Labeling Standards | authorized | View |
| 169.150 | 21 CFR 169.150 | Labeling Standards | authorized | View |
| 169.179 | 21 CFR 169.179 | Labeling Standards | authorized | View |
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 175.105 | 21 CFR 175.105 | Food Additive | authorized | View |
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: ANTICAKING AGENT OR FREE-FLOW AGENT | authorized |
| FDA Technical Effect: DRYING AGENT | authorized |
| FDA Technical Effect: FORMULATION AID | authorized |
| FDA Technical Effect: HUMECTANT | authorized |
| FDA Technical Effect: LEAVENING AGENT | authorized |
| FDA Technical Effect: LUBRICANT OR RELEASE AGENT | authorized |
| FDA Technical Effect: STABILIZER OR THICKENER | authorized |
| FDA Technical Effect: TEXTURIZER | authorized |
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 9005-25-8 | SOR/94-311 | DSL | authorized |
Conditions
This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.
Record details
The only condition affecting a compliance assessment for Starch is the U.S. EPA CDR reporting obligation under TSCA, which applies to manufacturers and importers based on their production volume and use. No exposure limits, GHS hazard classifications, or food additive conditions are provided in the evidence. Therefore, the primary compliance trigger is whether an entity qualifies as a manufacturer or importer under 40 eCFR Part 711. Without quantitative thresholds or use-specific limits, a compliance assessment cannot determine applicability beyond confirming the reporting obligation exists for listed entities.
Before launching a product containing Starch, an entity should confirm whether it qualifies as a manufacturer or importer under the U.S. EPA CDR rule, as Starch is listed on the CDR system and subject to TSCA reporting. This requires establishing production or import volumes and use details to determine if reporting is triggered. No other pre-launch documentation, such as food additive petitions, drug approvals, or safety data sheets, is evidenced. The absence of exposure limits or hazard classifications means additional safety or regulatory documentation may be needed but cannot be specified from the current evidence.
The available regulatory position for Starch is limited to a single U.S. EPA CDR listing, which does not address food, drug, cosmetic, or international regulatory status. This stops short of supporting a launch decision because there is no evidence of exposure limits, GHS classifications, or food additive approvals that would inform safety or category-specific compliance. Consequently, a decision based solely on this evidence would overlook potential regulatory requirements in other jurisdictions or product categories. The evidence gap is material: without additional data, the regulatory landscape for Starch remains largely undefined.