Regulations of Carnauba Wax

COPERNICIA CERIFERA CERA

Identifiers

FormulaC26H52O2·CAS506-46-7·EC208-040-2

Functions

SKIN Conditioning - EmollientFILM Forming +1 more

Hazards

Irritant

How does the regulatory treatment of carnauba wax differ by market or product category?

Regulatory treatment varies by market, with the EU listing aggregated GHS hazard notifications and Australia listing the related substance hexacosanoic acid on its industrial chemicals inventory. In New Zealand, hexacosanoic acid lacks individual approval but may be used under a group standard. For cosmetics, carnauba wax (Copernicia cerifera cera) is an active ingredient in the EU with no specific restrictions, conditions, or concentration limits, and it is not flagged as perfuming. No food or drug additive status is documented in the available evidence.

What regulations apply to Carnauba wax in Canada?

1 regulation

DSL / NDSL

Regulatory records

EntryRegulationTypeStatus
506-46-7SOR/94-311DSLauthorized
8015-86-9SOR/94-311DSLauthorized

Key dates

Published: 11 Feb 2004

Published: 04 May 1994

Effective: 11 Feb 2004

Effective: 04 May 1994

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

SOR/94-311

professional use only
No

What regulations apply to Carnauba wax in Australia?

1 regulation

The Australian Inventory of Industrial Chemicals

Chemical: Hexacosanoic acid

What regulations apply to Carnauba wax in New Zealand?

1 regulation

New Zealand EPA Inventory of Chemical Status

Hexacosanoic acid: Does not have an individual approval but may be used under an appropriate group standard

Which conditions, limits, and use contexts most affect a compliance assessment for carnauba wax?

The most decision-relevant conditions are the absence of cosmetic restrictions, concentration caps, or body-part limitations for Copernicia cerifera cera, combined with its active status in the EU cosmetics inventory. However, GHS notifications from EU companies indicate potential skin, eye, and respiratory irritation hazards, which would affect labeling and handling requirements. No exposure limits are documented. The lack of any specified maximum concentration means formulation flexibility is not constrained by the cosmetic regulation evidence, but hazard communication obligations may still apply.

What should be in place before a product containing carnauba wax is assessed for launch?

Before launch assessment, confirm the ingredient's identity as Copernicia cerifera cera with CAS 8015-86-9 and EC 232-399-4, and verify its active status in the relevant cosmetics inventory. Since no cosmetic restrictions or concentration limits are documented, the compliance file should focus on hazard communication: the GHS notifications for skin, eye, and respiratory irritation require appropriate labeling and safety data. For markets like New Zealand, confirm whether the related substance hexacosanoic acid falls under an applicable group standard, as it lacks individual approval.

Where does the available regulatory position stop short of supporting a decision on carnauba wax?

The evidence stops short of confirming market-specific approvals for food, drug, or pharmaceutical use, as no food additive or FDA drug listings were found. The EU GHS data reflects only aggregated company notifications, not an official harmonized classification, so hazard conclusions are provisional. For Australia and New Zealand, the inventory entries refer to hexacosanoic acid, a related substance, not carnauba wax itself, creating uncertainty about direct applicability. The absence of any cosmetic restrictions or concentration limits should not be read as a universal safety clearance.

Which recent regulatory changes or effective dates are material for carnauba wax?

No recent regulatory changes or effective dates are documented in the available evidence. The EU cosmetics entry for Copernicia cerifera cera is marked as active and published in the official journal, but no amendment dates or revision history are provided. The GHS notifications reflect current company submissions but do not indicate when they were filed or whether they represent new requirements. Without dated regulatory actions, no material changes can be identified for compliance planning.