EPA TSCA Regulatory Flag
Cyclohexanol, 3-[(2E)-2-[(1R,3aS,7aR)-1-[(1R)-1,5-dimethylhexyl]octahydro-7a-methyl-4H-inden-4-ylidene]ethylidene]-4-methylene-, (1S,3Z)-: ACTIVE
Regulations of Cholecalciferol
CtrlK
Identifiers
FormulaC27H44O·CAS67-97-0·EC200-673-2
Functions
ORAL CARESKIN Conditioning - Miscellaneous
Hazards
How does the regulatory treatment of Cholecalciferol differ by market or product category?
Regulatory treatment of cholecalciferol varies by market and product category. In the US, it is an FDA-approved prescription drug, a food additive permitted for direct addition to food, affirmed as GRAS, and an active ingredient in registered rodenticide products. In the EU, it is listed under ECHA C&L notifications and regulated under EFSA legal basis Regulation (EC) No 178/2002 and status regulation 2004/129/EC. In Australia, it appears on the AICIS industrial chemicals inventory. In New Zealand, it has HSNO approval with controls. In cosmetics, it is listed in the EU with restriction II/335, indicating a regulatory constraint.
Which United States federal regulations apply to Cholecalciferol?
5 regulations
FDA Direct Food Additives
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 184.1950 | 21 CFR 184.1950 | Food Additive | authorized | View |
FDA 21 CFR Indirect Food Additives
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 172.380 | 21 CFR 172.380 | Food Additive | authorized | View |
FDA GRAS Notices
Substance added directly to human food affirmed as generally recognized as safe (GRAS).
Sources
FDA Technical Effects
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: NUTRIENT SUPPLEMENT | authorized |
What EU regulatory requirements apply to Cholecalciferol?
3 regulations
EFSA Legal Basis
Regulation (EC) No 178/2002 (amended)
Status Regulation (EC)
2004/129/EC
COSING Annex II Prohibited Substances (Reg 1223/2009)
- Published
- 22 Dec 2009
- Effective
- 11 Jan 2010
- Transition
- 11 Jul 2013
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 335 | EU 1223/2009 | II | prohibited |
Record details
EU 1223/2009
- professional use only
- No
What regulations apply to Cholecalciferol in Canada?
1 regulation
DSL / NDSL
- Published
- 04 May 1994
- Effective
- 04 May 1994
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 67-97-0 | 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
SOR/94-311
- professional use only
- No
What regulations apply to Cholecalciferol in Australia?
1 regulation
The Australian Inventory of Industrial Chemicals
Chemical: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, (3.beta.,5Z,7E)-
What regulations apply to Cholecalciferol in New Zealand?
1 regulation
New Zealand EPA Inventory of Chemical Status
Cholecalciferol: HSNO Approval: HSR002778 Approved with controls
Which conditions, limits, and use contexts most affect a compliance assessment for Cholecalciferol?
Key conditions affecting compliance include the intended product category and use context. For food use, the quantity added must not exceed the amount reasonably required to achieve its intended effect, and the substance must be of appropriate food grade. For drugs, FDA approval under the FD&C Act is required for prescription products. For OTC wound healing products, there is inadequate data to establish safety and effectiveness. GHS classifications indicate acute toxicity (fatal if swallowed, in contact with skin, or inhaled) and target organ toxicity, which may trigger labeling and handling requirements. In cosmetics, restriction II/335 applies, but specific concentration limits are not provided.
What should be in place before a product containing Cholecalciferol is assessed for launch?
Before launch, a product containing cholecalciferol should have documentation confirming its regulatory status for the specific market and category. For US food use, evidence of GRAS affirmation or food additive compliance is needed. For drug products, FDA approval or appropriate OTC monograph compliance is required. For pesticide products, EPA registration is necessary. In the EU, compliance with EFSA regulations and cosmetic restrictions (II/335) must be verified. GHS classification data should be incorporated into safety data sheets and labeling. Additionally, for rodenticide uses, current EPA-approved uses must be confirmed as they may change.
Where does the available regulatory position stop short of supporting a decision on Cholecalciferol?
The available regulatory position is insufficient to support a final launch decision because it lacks specific concentration limits, detailed conditions, and documentation requirements for most categories. For cosmetics, the restriction II/335 is noted but its exact meaning is not explained. For food additives, the permitted levels are not quantified. For OTC drugs, the inadequate data statement for wound healing products indicates a potential barrier. Additionally, GHS classifications are aggregated from company notifications and may not reflect a definitive regulatory classification. Therefore, further regulatory research is needed before proceeding.
Which recent regulatory changes or effective dates are material for Cholecalciferol?
No recent regulatory changes or effective dates are provided in the evidence. The available information includes current statuses such as FDA approval, GRAS affirmation, and EPA registration, but no upcoming or recent amendments are mentioned. For the EU, the legal basis references Regulation (EC) No 178/2002 (amended) and status regulation 2004/129/EC, but the amendment details and effective dates are not specified. Therefore, it is not possible to identify any material regulatory changes affecting cholecalciferol from the supplied evidence.