Recently, the European Union has issued Commission Delegated Regulation (EU) 2025/1222, which amends Regulation (EC) No 1272/2008 on the Classification, Labeling and Packaging of Substances and Mixtures. This amendment involves harmonized classification and labeling requirements for more than 30 substances.
The revision is based on a series of opinions previously issued by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA), covering various substances such as N-phenyl-1-naphthylamine, ozone, and nitrous oxide. This change will directly affect the production, import, sales, and other links of the relevant substances.
The update involves Table 3 of Annex VI to the CLP Regulation (EC) No 1272/2008 - "List of harmonised classification and labeling of hazardous substances", including the addition of 22 substances and the revision of 10 substances. The specific information is as follows:
List of Newly Added Substances
Index No | Chemical name | EC No | CAS No | Classification | Labelling | Specific Conc. Limits, M-factors and ATEs | Notes | |||
Hazard Class and Category Code(s) | Hazard statement Code(s) | Pictogram, Signal Word Code(s) | Hazard statement Code(s) | Suppl. Hazard statement Code(s) | ||||||
607-776-00-5 | 2-ethylhexanoic acid , monoester with propane-1,2-diol | 285-503-5 | 85114-0 0-7 | Repr . 1B | H360D | GHS08Dgr | H360D | |||
612-300-00-4 | N-1-naphthylaniline; N-phenylnaphthalen- 1-amine | 201-983-0 | 90-30-2 | Acute Tox. 4 STOT RE 2 Skin Sens. 1 | H302 H373 (blood system, liver) H317 | GHS07 GHS08 Wng | H302 H373 (blood system, liver) H317 | oral: ATE = 1200 mg/kg bw | ||
026-005-00-8 | tetrairon tris(pyrophosphate); ferric pyrophosphate | 233-190-0 | 10058-44-3 | Eye Irrit. 2 | H319 | GHS07 Wng | H319 | |||
604-103-00-7 | α,α’- propylenedinitrilodi-o- cresol | 202-374-2 | 94-91-7 | Repr. 1B | H360FD | GHS08 Dgr | H360FD | |||
008-004-00-4 |
ozone | 233-069-2 | 10028-15-6 | Ox. Gas 1 Carc. 2 Muta. 2 Acute Tox. 1 STOT SE 1 STOT RE 1 Aquatic Acute 1 Aquatic Chronic 1 | H270 H351 H341 H330 H370 (nervous system, respiratory system, cardiovascular system) H372 (nervous system, respiratory system) H400 H410 | GHS03 GHS08 GHS06 GHS09 Dgr | H270 H351 H341 H330 H370 (nervous system, respiratory system, cardiovascular system) H372 (nervous system, respiratory system) H410 | inhalation: ATE = 10 ppm V STOT SE 1; H370: C ≥ 0,002 % STOCKS SE 2; H371: 0.0005% ≤ C < 0.002 % STOCKS RE 1 ; H372: C ≥ 0.05% STOCKS RE 2 ; H373: 0,01 % ≤ C < 0,05 % M = 100 M = 1 | ||
007-031-00-9
| dinitrogen oxide | 233-032-0 | 10024-97-2 | Repr. 1B STOT SE 3 STOT RE 1 Ozone 1 | H360Df H336 H372 (nervous system) H420 | GHS08 GHS07 Dgr | H360Df H336 H372 (nervous system) H420 | |||
‘056-006-00-9 | barium chromate | 233-660-5 | 10294-40-3 | Carc. 1B | H350 | GHS08 Dgr | H350 | |||
650-060-00-2 | Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2 | 289-699-3 | 89997-63-7 | Acute Tox. 4 Acute Tox. 4 STOT SE 1 STOT RE 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 | H332 H302 H370 (nervous system) H373 (respira tory tract, inhalation) H317 H400 H410 | GHS07 GHS08 Dgr | H332 H302 H370 (nervous system) H373 (respiratory tract, inhalation) H317 H410 | inhalation: ATE = 2,6 mg/L (dusts or mists) oral: ATE = 730 mg/kg bw M = 1 000 M = 100 | ||
650-059-00-7 | Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents | 289-699-3 | 89997-63-7 | Acute Tox. 4 Acute Tox. 4 STOT SE 1 STOT RE 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 | H332 H302 H370 (nervous system) H373 (respiratory tract, inhalation) H317 H400 H410 | GHS07 GHS08 Dgr | H332 H302 H370 (nervous system) H373 (respiratory tract, inhalation) H317 H410 | inhalation: ATE = 2,6 mg/L (dusts or mists) oral: ATE = 730 mg/kg bw M = 1 000 M = 100 | ||
607-777-00-0 | barium bis[2-chloro- 5-[(2-hydroxy- 1-naphthyl)azo]toluene- 4-sulphonate]; C.I. Pigment Red 53:1 | 225-935-3 | 5160-02-1 | Carc. 2 | H351 | GHS08 Wng | H351 | |||
608-070-00-X | 2-bromo- 2-(bromomethyl) pentanedinitrile; [DBDCB] | 252-681-0 | 35691-65-7 | Acute Tox. 2 Acute Tox. 4 STOT RE 2 Eye Dam. 1 Skin Sens. 1A Aquatic Chronic 2 | H330 H302 H373 (thyroid, central nervous system) H318 H317 H411 | GHS06 GHS08 GHS05 GHS09 Dgr | H330 H302 H373 (thyroid, central nervous system) H318 H317 H411 | inhalation: ATE = 0,27 mg/ L (dusts or mists) oral: ATE = 500 mg/kg bw Skin Sens. 1A; H317: C ≥ 0,001 % | ||
607-779-00-1 | 9-octadecenoic acid (Z)-, sulfonated, potassium salts [1]; Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts [2]; 9(or 10)-sulphooctadecanoic acid, potassium salt [3] | 271-843-1 [1]; - [2]; 267-966-5 [3] | 68609-93-8 [1]; - [2]; 67968-63-2 [3] | Repr. 1B | H360D | GHS08 Dgr | H360D | |||
613-352-00-0 | bixlozone (ISO); 2-(2,4-dichlorobenzyl)- 4,4-dimethyl-1,2-oxazolidin-3-one | - | 81777-95-9 | Aquatic Acute 1 Aquatic Chronic 1 | H400 H410 | GHS09 Wng | H410 | M = 1 M = 10 | ||
603-248-00-3 | 2,3-epoxypropyl isopropyl ether | 223-672-9 | 4016-14-2 | Repr. 1B | H360F | GHS08 Dgr | H360F | |||
607-778-00-6 | tetrahydrofurfuryl methacrylate | 219-529-5 | 2455-24-5 | Repr. 1B Skin Sens. 1A | H360Df H317 | GHS08 GHS07 Dgr | H360Df H317 | |||
015-209-00-2 | trimethyl phosphate | 208-144-8 | 512-56-1 | Carc. 1B Muta. 1B Repr. 1B Acute Tox. 4 STOT RE 2
| H350 H340 H360FD H302 H373 (nervous system) | GHS08 GHS07 Dgr | H350 H340 H360FD H302 H373 (nervous system) | oral: ATE = 1300 mg/kg bw | ||
602-111-00-5 | fluoroethylene | 200-832-6 | 75-02-5 | Carc. 1A Muta. 2 | H350 H341 | GHS08 Dgr | H350 H341 | D | ||
602-112-00-0 | 2-bromo-3,3,3-trifluoroprop-1-ene | - | 1514-82-5 | Repr. 1B STOT SE 3 STOT SE 3 | H360FD H335 H336 | GHS08 GHS07 Dgr | H360FD H335 H336 | |||
613-353-00-6 | 2-methyl-2H-isothiazol- 3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride | 247-499-3 | 26172-54-3 | Acute Tox. 2 Acute Tox. 3 Acute Tox. 3 Skin Corr. 1 Eye Dam. 1 Skin Sens. 1A Aquatic Acute 1 Aquatic Chronic 1 | H330 H311 H301 H314 H318 H317 H400 H410 | GHS06 GHS05 GHS09 Dgr | H330 H311 H301 H314 H317 H410 | EUH071 | inhalation: ATE = 0,15 mg/ L (dusts or mists) dermal: ATE = 320 mg/kg bw oral: ATE = 180 mg/kg bw Skin. Sens 1A; H317: C ≥ 0,0015 % M = 10 M = 1 | |
603-249-00-9 | 2,3-epoxypropyl o-tolyl ether | 218-645-3 | 2210-79-9 | Skin Irrit. 2 Skin Sens. 1A Muta. 2 Aquatic Chronic 2 | H315 H317 H341 H411 | GHS07 GHS08 GHS09 Wng | H315 H317 H341 H411 | C | ||
607-780-00-7 | methyl oct-2-ynoate | 203-836-6 | 111-12-6 | Skin Sens. 1A | H317 | GHS07 Wng | H317 | |||
612-301-00-X | dinotefuran (ISO); (RS)- 1-methyl-2-nitro- 3-(tetrahydro- 3-furylmethyl)guanidine | - | 165252-70-0 | Acute Tox. 4 Aquatic Acute 1 Aquatic Chronic 1 | H302 H400 H410 | GHS07 GHS09 Wng | H302 H410 | oral: ATE = 2000 mg/kg bw M = 10 M = 10 | ||
List of Revised Substances
Index No | Chemical name | EC No | CAS No | Classification | Labelling | Specific Conc. Limits, M-factors and ATEs | Notes | |||
Hazard Class and Category Code(s) | Hazard statement Code(s) | Pictogram, Signal Word Code(s) | Hazard statement Code(s) | Suppl. Hazard statement Code(s) | ||||||
601-027-00-6 | 2-phenylproPene ; α-methylstyrene | 202-705-0 | 98-83-9 | Flam. Liq. 3 Carc. 2 STOT SE 3 Eye Irrit. 2 Skin Sens. 1B Aquatic Chronic 2 | H226 H351 H335 H319 H317 H411 | GHS02 GHS08 GHS07 GHS09 Wng | H226 H351 H335 H319 H317 H411 | STOT SE 3; H335: C ≥ 25 % | D | |
616-145-00-3 | pethoxamid (ISO); 2-chlor- o-N-(2-ethoxyethyl)- N-(2-methyl- 1-phenylprop-1-enyl) acetamide |
- | 106700-29-2 | Acute Tox. 4 Skin Sens. 1A Aquatic Acute 1 Aquatic Chronic 1 |
H302 H317 H400 H410 |
GHS07 GHS09 Wng |
H302 H317 H410 | oral: ATE = 980 mg/kg bw M = 100 M = 10 | ||
015-012-00-1 | tetraphosphorus trisulphide; phosphorus sesquisulphid | 215-245-0 | 1314-85-8 | Flam. Sol. 1 Self-heat. 1 Acute Tox. 4* |
H228 H251 H302 |
GHS02 GHS07 Dgr |
H228 H251 H302 |
T | ||
602-025-00-8 | 1,1-dichloroethylene; vinylidene chloride | 200-864-0 | 75-35-4 | Flam. Liq. 1 Carc. 1B Muta. 2 Acute Tox. 1 Acute Tox. 3 STOT RE 1 Aquatic Chronic 3 |
H224 H350 H341 H330 H301 H372 (respiratory tract, kidney, liver) H412 |
GHS02 GHS08 GHS06 Dgr |
H224 H350 H341 H330 H301 H372 (respiratory tract, kidney, liver) H412 | inhalation: ATE = 0,5 mg/L (vapours) oral: ATE = 300 mg/kg bw |
D | |
615-008-00-5 | 3-isocyanatomethyl-3,5,5- trimethylcyclohexyl isocyanate; isophorone di-isocyanate | 223-861-6 | 4098-71-9 | Acute Tox. 1 Skin Corr. 1 Eye Dam. 1 Resp. Sens. 1 Skin Sens. 1A Aquatic Chronic 2 |
H330 H314 H334 H317 H411 |
GHS06 GHS05 GHS08 GHS09 Dgr |
H330 H314 H318 H334 H317 H411 |
EUH071 | inhalation: ATE = 0,03 mg/L (dusts or mists) Resp. Sens. 1; H334: C ≥ 0,5 % Skin Sens. 1A; H317: C ≥ 0,001 % | 2 |
613-045-00-1 | folpet (ISO); N-(trichloromethylthio) phthalimide | 205-088-6 | 133-07-3 | Carc. 2 Acute Tox. 2 STOT RE 1 Eye Dam. 1 Skin Sens. 1A Aquatic Acute 1 Aquatic Chronic 1 | H351 H330 H372 (respiratory tract) H318 H317 H400 H410 | GHS08 GHS06 GHS05 GHS09 Dgr | H351 H330 H372 (respiratory tract) H318 H317 H410 | EU- H066 | inhalation: ATE = 0,30 mg/L (dusts or mists) STOT RE 1: C ≥ 5 % STOT RE 2: 0,5 % ≤ C < 5 % Skin Sens. 1A; H317: C ≥ 0,001 % M = 10 M = 10 | |
613-044-00-6 | captan (ISO); 1,2,3,6- tetrahydro- N-(trichloromethylthio) phthalimide | 205-087-0 | 133-06-2 | Carc. 2 Repr. 2 Acute Tox. 2 STOT RE 1 Eye Dam. 1 Skin Sens. 1A Aquatic Acute 1 Aquatic Chronic 1 | H351 H361f H330 H372 H318 H317 H400 H410 | GHS08 GHS06 GHS05 GHS09 Dgr | H351 H361f H330 H372 H318 H317 H410 | inhalation: ATE = 0,22 mg/L (dusts or mists) Skin Sens. 1A; H317: C≥ 0,001 % M = 10 M = 10 | ||
607-231-00-1 | clopyralid (ISO); 3,6-dichloropyridine- 2-carboxylic acid | 216-935-4 | 1702-17-6 | Eye Dam. 1 Aquatic Chronic 1 | H318 H410 | GHS05 GHS09 Dgr | H318 H410 | EUH066 | M = 10 | |
616-211-00-1 | proquinazid (ISO); 6-iodo- 2-propoxy- 3-propylquinazolin-4(3H)- one | - | 189278-12-4 | Carc. 2 STOT RE 1 Aquatic Acute 1 Aquatic Chronic 1 | H351 H372 (thyroid, liver) H400 H410 | GHS08 GHS09 Dgr | H351 H372 (thyroid, liver) H410 | M = 1 M = 10 | ||
616-212-00-7 | 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate | 259-627-5 | 55406-53-6 | Acute Tox. 2 Acute Tox. 4 STOT RE 1 Eye Dam. 1 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 | H330 H302 H372 (larynx) H318 H317 H400 H410 | GHS06 GHS08 GHS05 GHS09 Dgr | H330 H302 H372 (larynx) H318 H317 H410 | inhalation: ATE = 0,17 mg/L (dusts or mists) M = 10 M = 10 | ||
This Regulation shall apply from 1 February 2027. However, from the date of entry into force of this Regulation (10 July 2025), substances and mixtures may be classified, labeled, and packaged in accordance with the content amended by this Regulation.
Enterprises shall conduct self-inspections against the above-mentioned substance information, adopt substance classification in advance, update safety data sheets and labels in a timely manner, ensure the accuracy of classification and labeling information, and make preparations for compliance.
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