EPA TSCA Regulatory Flag
Phenol, 4,4'-(1,1-dioxido-3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-: ACTIVE
Regulations of Ph Indicator Dyes
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Identifiers
FormulaC27H28Br2O5S·CAS76-59-5·EC200-971-2
Functions
Colorant
Hazards
How does the regulatory treatment of Ph Indicator Dyes differ by market or product category?
Regulatory treatment varies by jurisdiction and inventory status. In the US, the substance is listed as ACTIVE under EPA TSCA, indicating commercial activity is recognized. In Australia, it appears on the AICIS industrial chemicals inventory. In the EU, only aggregated GHS notifications exist, with no individual approval noted. In New Zealand, it lacks individual approval but may be used under an appropriate group standard. These differences mean market entry requirements differ: US and Australian listings support industrial use, while EU and NZ require checking group standards or notification status. Product category matters—food and drug uses have no evidence of specific approvals.
Which United States federal regulations apply to Ph indicator dyes?
1 regulation
What EU regulatory requirements apply to Ph indicator dyes?
1 regulation
COSING Annex IV Colorants (Reg 1223/2009)
- Published
- 22 Dec 2009
- Effective
- 11 Jan 2010
- Transition
- 11 Jul 2013
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 151 | EU 1223/2009 | IV | authorized |
Record details
EU 1223/2009
- professional use only
- No
What regulations apply to Ph indicator dyes in Canada?
1 regulation
DSL / NDSL
- Published
- 04 May 1994
- Effective
- 04 May 1994
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 76-59-5 | 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 Ph indicator dyes in China?
2 regulations
STSC Permitted Colorants (Table 6)
- Published
- 28 May 2021
- Effective
- 28 May 2021
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 152 | Safety and Technical Standards for Cosmetics (STSC 2015) | Table 6 | authorized |
Record details
Safety and Technical Standards for Cosmetics (STSC 2015)
- professional use only
- No
IECIC Listed Ingredients (List I)
- Published
- 24 Jun 2025
- Effective
- 24 Jun 2025
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 8888 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Conditions
Use in accordance with the Safety and Technical Standards for Cosmetics (STSC)
Record details
Inventory of Existing Cosmetic Ingredients in China (IECIC) I
- professional use only
- No
What regulations apply to Ph indicator dyes in Australia?
1 regulation
The Australian Inventory of Industrial Chemicals
Chemical: Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxide
What regulations apply to Ph indicator dyes in New Zealand?
1 regulation
New Zealand EPA Inventory of Chemical Status
Bromothymol blue: 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 Ph Indicator Dyes?
The most material conditions are GHS hazard classifications and inventory status. The substance is classified with warnings for acute oral toxicity (H302), skin irritation (H315), and serious eye irritation (H319), based on 11.1% notification ratios. These classifications trigger labeling and safety data sheet requirements across product categories. No exposure limits are provided, so occupational exposure controls cannot be specified. The absence of food additive or FDA drug data means no conditions for those categories are established. For compliance, the key limits are the GHS warning thresholds and the need to verify group standards in NZ or EU notification status.
What should be in place before a product containing Ph Indicator Dyes is assessed for launch?
Before launch, a company should have documentation of the substance's inventory status in each target market: TSCA ACTIVE status in the US, AICIS listing in Australia, and confirmation of NZ group standard applicability. For the EU, GHS classification data from ECHA notifications should be compiled, including the H302, H315, and H319 hazard statements. Safety data sheets must reflect these classifications. No evidence supports food or drug use, so if the product is in those categories, additional regulatory assessment is needed beyond the available data. The absence of exposure limits means occupational exposure assessments cannot rely on established values.
Where does the available regulatory position stop short of supporting a decision on Ph Indicator Dyes?
The regulatory position is insufficient for decisions involving food, drug, or cosmetic applications because no food additive or FDA drug approvals are documented. The EU data only reflects aggregated GHS notifications, not a harmonized classification, so hazard communication may vary by supplier. The NZ status indicates no individual approval, but the specific group standard is not identified. TSCA ACTIVE status confirms commercial activity but does not imply safety for all uses. These gaps mean a compliance assessment cannot conclude on product-category-specific approvals or exposure limits without additional jurisdiction-specific research.
Which recent regulatory changes or effective dates are material for Ph Indicator Dyes?
No recent regulatory changes or effective dates are provided in the evidence. The available data reflects current inventory statuses and GHS notifications without indicating any upcoming amendments. This absence means a compliance assessment cannot rely on any known timeline for regulatory shifts. Companies should monitor for updates to TSCA, AICIS, and ECHA notifications, but no specific changes are documented. The lack of effective dates does not alter the current compliance requirements, but it introduces uncertainty for long-term planning.