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EU cosmetic ingredients, restrictions and safety
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Official EU label nameGlossary entry 29534

TROMETHAMINE HCl

This record confirms an official common ingredient name for EU cosmetic product labelling. It does not by itself confirm that the substance is permitted, unrestricted or safe.

Global evidence snapshot

The resolved identity has matching regulatory evidence in 0 of 13 indexed market datasets: 0 country records and 0 EU Annex records. Every result and evidence gap is listed below.

0 markets with evidence
Markets checked
13
Markets with evidence
0
Evidence gaps
13
Resolved identifiers
2

A missing local match is not permission, approval or proof of safety. It means no strong identity match was resolved in that indexed dataset.

Resolved substance identity

CAS:1185-53-1
EC:214-684-5
Ingredient index records:
TROMETHAMINE HCL
Cosmetic functions: ANTIMICROBIAL

Tromethamine HCl is the amine salt that conforms to the formula:

Open full local profile
1 matched or reported name
TROMETHAMINE HCL

Regulatory evidence in all 13 markets

Open each matched record for its scope, concentration, conditions, warnings and official source version.

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MarketResultRecordsDatasetMeaning / next action
European Union
EU
No local match0
Complete annex dataset
Regulation (EC) 1223/2009 consolidated to 1 May 2026
No annex match only means that these five annexes did not return a match; CosIng identity data and other EU obligations still need review.
Great Britain
GB
No local match0
Complete consolidated annex dataset
GB retained Regulation 1223/2009 schedules, effective 15 August 2026
No annex match is not approval and does not cover Northern Ireland, which follows the applicable EU framework.
Canada
CA
No local match0
Complete Hotlist snapshot
Health Canada Cosmetic Ingredient Hotlist, 13 August 2025
The Hotlist is an administrative compliance tool, not an exhaustive safety approval list.
New Zealand
NZ
No local match0
Complete schedules dataset
Cosmetic Products Group Standard schedules effective 1 January 2026
The searchable spreadsheet is an aid; the legal Group Standard and incorporated notices remain authoritative.
ASEAN
ASEAN
No local match0
Complete regional annex dataset
ASEAN Cosmetic Directive annexes 2026-1, 22 June 2026
Regional annex coverage does not replace member-state implementation dates, notifications or national deviations.
China
CN
No local match0
Complete prohibited catalogues plus official-source workflow
NMPA 2021 banned catalogues plus dynamic IECIC List I/List II system current since 2025
IECIC listing is not blanket approval; absence may require the new cosmetic ingredient route, and restrictions are checked separately.
Japan
JP
No local match0
Complete Standards appendices dataset
MHLW Standards for Cosmetics official English source and Japanese amendments checked for the imported snapshot
The Japanese text and subsequent notices are canonical; no local match is not a product-compliance conclusion.
South Korea
KR
No local match0
Complete current appendix dataset
MFDS Notice 2026-19, effective 18 March 2026
Korean source wording is canonical and other positive lists/notices may still apply to the formulation.
United States
US
No local match0
Complete enumerated federal ingredient rules
eCFR Title 21 issue date 27 August 2026
FDA has no general approved-cosmetic-ingredient catalogue; absence from these sections is not approval or proof of safety.
Australia
AU
No local match0
Complete cosmetic-relevant Poisons Standard subset plus official workflow
Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026
An AICIS Inventory match is not cosmetic approval; no Inventory match can indicate a new, exempted, reported or confidential introduction.
Brazil
BR
No local match0
Complete prohibited dataset plus current restricted-list workflow
ANVISA RDC 1.029/2026 and RDC 1.030/2026, published 15 June 2026
RDC 1.030/2026 amends rather than replaces the prohibited baseline, and the second restricted-list revision was still under consultation in July 2026.
India
IN
No local match0
Complete current Part 2 dataset plus official workflow for Parts 1, 3 and 4
Cosmetics Rules 2020 plus current BIS IS 4707 parts (1:2020, 2:2025, 3:2025, 4:2022)
The standards are separate controlled publications; absence from a locally indexed excerpt is not permission.
Saudi Arabia
SA
No local match0
Complete official list index
SFDA live prohibited/restricted lists, snapshot 30 August 2026
No list match is not permission; Gulf/SFDA product, claim, notification and technical requirements still apply.
No market rows match this filter.

Chemical identity and properties

PubChem 2D chemical structure for CAS 1185-53-1
CAS 1185-53-1PubChem CID 93573

Tromethamine hydrochloride

IUPAC name
2-amino-2-(hydroxymethyl)propane-1,3-diol;hydrochloride
Molecular formula
C4H12ClNO3
Molecular weight
157.59 g/mol
Exact mass
157.0505709 Da
Topological polar surface area
86.7 Ų
Hydrogen-bond donors
5
Hydrogen-bond acceptors
4
Covalent units
2
Defined stereocentres
0

Also known as

Tris hydrochlorideTris(hydroxymethyl)aminomethane hydrochloride2-Amino-2-(hydroxymethyl)propane-1,3-diol hydrochlorideTRIS HClTris-HClTrometamol hydrochlorideTrizma hydrochlorideTromethamine HCl
16 more reported names
1,3-Propanediol, 2-amino-2-(hydroxymethyl)-, hydrochlorideTris chlorideTris hydrochloride bufferUNII-383V75M34EEINECS 214-684-5383V75M34E2-Amino-2-hydroxymethyl-1,3-propanediol hydrochlorideTROMETAMOL HYDROCHLORIDE [WHO-DD]1,3-Propanediol, 2-amino-2-(hydroxymethyl)-, hydrochloride (1:1)RefChem:1922472Amino2hydroxymethyl1,3propanediol hydrochloride2Amino2(hydroxymethyl)propane1,3diol hydrochloride1,3Propanediol, 2amino2(hydroxymethyl), hydrochloride2-Amino-2-(hydroxymethyl)-1,3-propanediol HydrochlorideTrometamol (hydrochloride)C4H12ClNO3
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match93573

Attributed physical-property, hazard, environmental and use annotations.

  • Note: This chemical does not meet GHS hazard criteria for 57.2% (103 of 180) of all reports. Source: European Chemicals Agency (ECHA)
  • Signal: Warning Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H315 (42.2%): Causes skin irritation [Warning Skin corrosion/irritation]; H319 (42.2%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]; H335 (40.6%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposure; Respiratory tract irritation] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P261, P264, P264+P265, P271, P280, P302+P352, P304+P340, P305+P351+P338, P319, P321, P332+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 180 reports by companies from 16 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Reported as not meeting GHS hazard criteria per 103 of 180 reports by companies.; There are 14 notifications provided by 77 of 180 reports by companies with hazard statement code(s).; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)

Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record

Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.

Additional source coverage and match status
SourceResultChecked
NIH PubChem PUG-ViewExact match2026-08-31

A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Additional authoritative substance research

These source-specific lookups can add hazard, toxicology, identity and assessment context. A link is a research route, not a claim that the source contains an exact record.

Cosmetic Ingredient Review safety assessments

Expert Panel conclusions, assessed ingredient groups, use conditions, dates and report documents

Independent expert review considered by FDA; not a government approval or binding market rule

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FDA Global Substance Registration System

UNII identifiers, preferred names, substance types, codes and public substance relationships

Identity registry only; UNII availability does not imply FDA review or approval

Research this identity

ILO/WHO International Chemical Safety Cards

Hazards, symptoms, first aid, storage, incompatibilities and physical properties for covered chemicals

International occupational chemical-safety reference; not cosmetic-use approval

Research this identity

Japan NITE-CHRIP

Chemical identity, Japanese and foreign legal lists, GHS hazards and exposure-related information

Chemical-management evidence; cosmetic status remains governed by the applicable MHLW standard and market rules

Research this identity

NIOSH Pocket Guide to Chemical Hazards

REL, PEL, IDLH, properties, exposure routes, symptoms, target organs, first aid and measurement methods for covered workplace chemicals

US occupational-health guidance and limits; not a cosmetic ingredient decision

Research this identity

OECD eChemPortal

Gateway to authority-owned physical-property, fate, ecotoxicity, toxicity, exposure and GHS records

Discovery gateway; each linked authority remains responsible for its data

Research this identity

US EPA CompTox CTX APIs

DTXSID identity, experimental and predicted properties, toxicity, bioactivity, exposure and environmental data

Scientific and computational evidence; predictions must remain labelled and do not determine cosmetic legality

Research this identity

Continue the compliance check

1. Confirm identity

Match the supplier specification, CAS/EC identifiers and composition to this official label name. Similar wording is not proof of chemical equivalence.

2. Review restrictions

Check every exact Annex record shown above, plus CMR, nanomaterial, SCCS and later-amendment requirements that may apply.

3. Verify the formula

Evaluate concentration, product type, purity, warnings, claims and each target market before making a compliance decision.

Screen in a formulaOpen standalone comparison

Official source and scope

Imported from Commission Implementing Decision (EU) 2025/1175 (dataset version EU 2025/1175). The glossary supplies common ingredient names for the ingredient list required by Article 19(1)(g); it is not an approval or safety list.

Open official Decision