Identifiers
Functions
Regulatory treatment of Polydeoxyribonucleotide varies by market and product category. In Australia, it appears on the AICIS industrial chemicals inventory as deoxyribonucleic acids. In New Zealand, it lacks individual approval but may be used under an appropriate group standard. In the EU cosmetics context, sodium DNA is an active skin-conditioning ingredient with no specific restrictions or concentration limits listed. No US FDA drug or food additive listings were found. This means compliance pathways differ: industrial chemical registration may apply in AU/NZ, while EU cosmetic use appears permissible without category-specific constraints.
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 9007-49-2 | 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
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 383 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Record details
1 regulation
Chemical: Deoxyribonucleic acids
1 regulation
Deoxyribonucleic acids: Does not have an individual approval but may be used under an appropriate group standard
The most decision-relevant conditions are the absence of individual approvals and the presence of group standards. In New Zealand, deoxyribonucleic acids have no individual approval but can be used under an appropriate group standard, which implies formulators must verify which group standard applies. In the EU, sodium DNA has no cosmetic restrictions, maximum concentration, or body-part limitations, so no specific use limits are imposed. However, the ingredient is subject to general bans on ozone-depleting substances. For compliance, the key is confirming the applicable group standard in NZ and ensuring no ozone-depleting properties are introduced.
Before launch assessment, documentation should confirm the ingredient's identity and inventory status. For Australia, evidence of listing on the AICIS inventory as deoxyribonucleic acids is needed. For New Zealand, documentation must identify the specific group standard under which the substance is used, since no individual approval exists. For EU cosmetics, the active status of sodium DNA as a skin-conditioning agent with no restrictions should be verified, along with confirmation that the product does not deplete the ozone layer. No FDA drug or food additive approvals exist, so any pharmaceutical or ingestible claim would lack regulatory support.
The available regulatory position stops short of confirming marketability in several respects. The New Zealand entry explicitly states no individual approval, leaving the applicable group standard unidentified. The Australian listing confirms inventory presence but does not indicate conditions of use or approval status. The EU cosmetic entry shows active status without restrictions, but this does not address safety assessments, efficacy claims, or other regulatory frameworks. Critically, no US FDA drug or food additive data exists, so any therapeutic or ingestible positioning is unsupported. These gaps mean a compliance decision cannot be finalized without additional jurisdiction-specific approvals or standards.
No recent regulatory changes or effective dates were identified in the available evidence. The regulatory entries reflect current inventory statuses and cosmetic listings without temporal markers. The New Zealand group standard approach and Australian AICIS listing appear as static statuses, not recent amendments. The EU sodium DNA entry shows active status with official journal publication, but no effective dates or transitional provisions are provided. For launch planning, this means there is no evidence of imminent regulatory shifts, but the absence of dated information limits the ability to assess whether any changes are pending or recently implemented.