Identifiers
Functions
Hazards
Regulatory treatment varies by market and product category. In the EU, lavender extract (Lavandula angustifolia flower extract) is listed as an active cosmetic ingredient with functions including cleansing, deodorant, fragrance, refreshing, and tonic, and is subject to the EU ozone-depleting substances ban. In the US, the related substance linalyl acetate is FDA-recognized as generally recognized as safe (GRAS) for use as a synthetic flavoring substance in human food and animal drugs/feeds, and is an active TSCA commercial substance. In Australia, it appears on the industrial chemicals inventory, while in New Zealand it lacks individual approval but may be used under a group standard. California's Safe Cosmetics Program lists it as a reportable fragrance allergen.
4 regulations
1,6-Octadien-3-ol, 3,7-dimethyl-, 3-acetate is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of 1,6-Octadien-3-ol, 3,7-dimethyl-, 3-acetate 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)
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 182.60 | 21 CFR 182.60 | Food Additive | authorized | View |
Emergency treatment: Linalool; [HSDB] Included in list of established contact allergens in humans; [EC: Scientific Committee on Consumer Safety: Fragrance allergens in cosmetic products (2011)] Causes somnolence and ataxia and acts as a general anesthetic in lethal dose studies of rats; [RTECS] Safe when used as a flavoring agent in food; [JECFA] Hydrolyzed in the GI tract into linalool and acetic acid; Not a mutagen; Not likely to be a sensitizer; Linalool, a hydrolysis product, caused hepatocellular cytoplasmic vacuolisation in 28-day feeding studies of rats; [Reference #1] See Linalool.
Sources
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
2 regulations
Status: Active Update: 11-04-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/14484
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 337 | 2023/1545 | III | restricted |
Product applications
| Product Type | Limit |
|---|---|
| Rinse-off products | 0.01% |
| Leave-on products | 0.001% |
Conditions
The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:; —; 0,001 % in leave-on products; —; 0,01 % in rinse-off products.
Record details
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 115-95-7 | 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: 1,6-Octadien-3-ol, 3,7-dimethyl-, acetate
1 regulation
Linalyl acetate: Does not have an individual approval but may be used under an appropriate group standard
1 regulation
Hazard Traits - Fragrance Allergen
Key conditions include GHS hazard classifications that trigger labeling and safety data requirements: skin irritation (H315), allergic skin reaction (H317), serious eye irritation (H319), respiratory irritation (H335), drowsiness/dizziness (H336), and aquatic toxicity (H401). No specific concentration limits or use restrictions are provided for the cosmetic ingredient, and no exposure limits are available. The substance is combustible (H227), requiring appropriate handling. For food use, linalyl acetate is GRAS with no stated limits, but animal studies show high oral LD50 (14,550 mg/kg) and potential liver effects from a hydrolysis product. These classifications and toxicological data inform risk assessment and hazard communication.
Before launch, a compliance assessment should confirm the ingredient's regulatory status in each target market. For cosmetics, verify that the specific extract (e.g., Lavandula angustifolia flower extract, CAS 90063-37-9) is listed in the EU cosmetic ingredient database and check for any applicable restrictions or bans, such as the ozone-depleting substances ban. For US food or flavor use, ensure the substance is covered by the FDA GRAS listing for synthetic flavoring substances. For industrial uses, confirm TSCA active status and CDR reporting obligations. Also prepare GHS-compliant labeling and safety data sheets reflecting the hazard classifications (skin/eye irritation, sensitization, etc.).
The available regulatory position is insufficient to support a final launch decision because it lacks specific use conditions, concentration limits, and product-category restrictions for the cosmetic ingredient. While the EU database lists the extract as active with no restrictions, this does not confirm safety for all product types or exposure levels. The US GRAS listing applies to linalyl acetate as a flavoring substance, not to lavender extract as a whole or to cosmetic uses. GHS classifications are based on company notifications and may not reflect all hazards. Additionally, the New Zealand group standard and Australian inventory status do not provide use-specific approvals. Therefore, a full regulatory assessment requires additional market-specific and product-specific data.
A material regulatory change is the EU REACH registration status for linalyl acetate, which is active as of April 11, 2023, indicating ongoing compliance obligations for manufacturers and importers. Additionally, the EU cosmetic ingredient database lists Lavandula angustifolia flower extract as active and subject to the ban on ozone-depleting substances, which is a current regulatory requirement. No other recent changes or effective dates are provided in the evidence. Companies should monitor these registrations and any updates to the EU cosmetic regulation, as changes could affect market access.