Identifiers
Functions
Hazards
Regulatory treatment of castor oil varies by market and product category. In the EU, castor oil (Ricinus communis seed oil) is an active cosmetic ingredient with functions as a fragrance, skin conditioning, and perfuming agent, with no listed restrictions or maximum concentration limits. In the US, the primary component ricinoleic acid is an active TSCA-listed chemical subject to EPA Chemical Data Reporting for manufacturers and importers. In Australia, it is listed on the industrial chemicals inventory, while in New Zealand it lacks individual approval but may be used under a group standard. These differences mean compliance obligations depend on jurisdiction and whether the product is cosmetic, industrial, or otherwise regulated.
1 regulation
9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)- is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of 9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)- are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 141-22-0 | SOR/94-311 | DSL | authorized |
| 8001-79-4 | 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
1 regulation
Chemical: 9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)-
1 regulation
Ricinoleic acid: Does not have an individual approval but may be used under an appropriate group standard
The most decision-relevant conditions are the absence of cosmetic restrictions or concentration limits for castor oil in the EU, and the US TSCA reporting obligation for ricinoleic acid, which applies to manufacturers and importers under 40 eCFR Part 711. GHS hazard classifications—skin irritation (H315), serious eye irritation (H319), and respiratory irritation (H335)—are notified by a subset of companies, indicating potential labeling and safety data requirements. No exposure limits were provided. These factors affect formulation, labeling, and supply-chain documentation, but the lack of quantitative limits means compliance hinges on general chemical safety obligations rather than specific thresholds.
Before launch, a company should confirm its regulatory status in each target market: in the US, verify whether the product triggers TSCA Chemical Data Reporting for ricinoleic acid; in the EU, ensure cosmetic labeling and safety assessments reflect the active status and functions (fragrance, skin conditioning, perfuming) with no restrictions; in Australia, confirm inventory listing; and in New Zealand, identify the applicable group standard. Additionally, GHS classification data should be incorporated into safety data sheets and labels, particularly for skin, eye, and respiratory irritation hazards. Documentation should include production/import volumes, intended use, and hazard communication materials.
The available regulatory position is insufficient to support a final launch decision because it lacks specific use restrictions, concentration limits, or exposure thresholds for castor oil in any market. While the EU cosmetic listing shows active status without restrictions, this does not confirm safety for all product categories or concentrations. The US TSCA listing indicates reporting obligations but not product-specific approvals. New Zealand's group standard reference is vague, and Australia's inventory listing does not imply use authorization. Therefore, a company cannot conclude full compliance without additional jurisdiction- and category-specific regulatory review.
No recent regulatory changes or effective dates were identified in the provided evidence. The available data reflect current listings and statuses, such as the EU cosmetic active status and US TSCA active commercial activity, but do not indicate any upcoming amendments, new restrictions, or deadlines. Therefore, no time-sensitive regulatory action is evident from this evidence. Companies should monitor official sources for future changes, but based on current information, there is no immediate compliance deadline to plan for.