EPA TSCA Regulatory Flag
Section 8(a) of TSCA requires manufacturers of this chemical substance to report preliminary assessment information concerned with production, use, and exposure to EPA as cited in the preamble of 51 FR 41329.
Sources
Regulations of Ormocer
CtrlK
Identifiers
FormulaC10H20O5Si·CAS2530-85-0·EC219-785-8
Hazards
How does the regulatory treatment of Ormocer differ by market or product category?
Regulatory treatment of Ormocer varies by market. In the EU, the substance is an active REACH registration and subject to ECHA C&L notifications, with GHS classifications for skin, eye, and respiratory irritation. In the US, it is an active TSCA commercial substance with CDR reporting obligations and OSHA PPE requirements. In Australia, it is listed on AICIS. In New Zealand, it lacks individual approval but may be used under a group standard. Product category matters: dental and adhesive uses are documented, but no category-specific approvals are evidenced.
Which United States federal regulations apply to Ormocer?
1 regulation
What EU regulatory requirements apply to Ormocer?
3 regulations
REACH Registered Substance
Status: Active Update: 16-02-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/15277
EFSA Legal Basis
Regulation (EC) No 1935/2004 (amended)
Status Regulation (EC)
Regulation (EC) No 1935/2004 (amended)
What regulations apply to Ormocer in Canada?
1 regulation
DSL / NDSL
- Published
- 04 May 1994
- Effective
- 04 May 1994
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 2530-85-0 | 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 Ormocer in Australia?
1 regulation
The Australian Inventory of Industrial Chemicals
Chemical: 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester
What regulations apply to Ormocer in New Zealand?
1 regulation
New Zealand EPA Inventory of Chemical Status
3-(Trimethoxysilyl)propyl methacrylate: 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 Ormocer?
Key conditions include GHS hazard classifications (H315, H319, H335) that trigger labeling and safety data requirements. US OSHA mandates PPE for eyes, skin, and respiratory protection under specific conditions. EPA requires wastewater containment and evaluation against discharge criteria, with disposal per 40 CFR Part 261 if not manageable. TSCA CDR reporting applies to manufacturers/importers. No numeric exposure limits are provided. Use context—such as dental primer at 4% concentration—affects risk assessment but does not alter these obligations.
What should be in place before a product containing Ormocer is assessed for launch?
Before launch, confirm the substance's regulatory status in each target market: active REACH registration in the EU, TSCA active status and CDR compliance in the US, AICIS listing in Australia, and New Zealand group standard eligibility. Ensure GHS classification and labeling align with ECHA notifications. Implement OSHA-compliant PPE and respiratory protection programs. For US environmental compliance, establish wastewater containment and disposal procedures. Verify that any dental or adhesive use matches documented applications, but note that no product-specific approvals are evidenced.
Where does the available regulatory position stop short of supporting a decision on Ormocer?
The available regulatory position does not confirm whether Ormocer itself—as opposed to its constituent monomer—is the regulated entity. The evidence refers to 2-propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester, which may be a component, not the final Ormocer polymer. No specific use restrictions, concentration limits, or approval conditions for Ormocer as a finished material are provided. The absence of exposure limits and category-specific rules means a compliance decision cannot be fully supported without additional data.
Which recent regulatory changes or effective dates are material for Ormocer?
The only dated regulatory event is the EU REACH registration update on 16 February 2023, indicating active status. No other recent changes or effective dates are provided. This update confirms ongoing EU compliance but does not signal new restrictions. For other markets, no recent regulatory changes are evidenced. Businesses should monitor for future updates, but current evidence does not indicate any imminent regulatory shifts affecting Ormocer.