Date: 2025-06-20Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2025/1222 of 2 April 2025 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
Here's a policy analysis report based on the provided text, structured as an amendment to an existing policy.
**Policy Analysis Report: Amendment to Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures**
**1. Executive Summary:**
This report analyzes Commission Delegated Regulation (EU) 2025/1222 of 2 April 2025, an amendment to Regulation (EC) No 1272/2008 (the CLP Regulation) regarding the harmonized classification and labelling of certain hazardous substances. The core purpose of this amendment is to update Annex VI, Table 3 of the CLP Regulation, which lists the harmonized classifications and labels for hazardous substances. This report details the key changes introduced by this amendment, focusing on the substances affected, the new hazard classifications, and the implications for suppliers. The amendment reflects scientific opinions from the European Chemicals Agency (ECHA) and aims to improve the protection of human health and the environment.
**2. Introduction:**
This report provides an informative overview of Commission Delegated Regulation (EU) 2025/1222, based solely on the provided text. The purpose is to inform affected industry stakeholders about the key changes introduced by this amendment to the CLP Regulation.
**3. Policy Overview:**
* This regulation amends Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
* **Core Objective:** To update the harmonized classification and labelling of certain hazardous substances listed in Annex VI, Table 3 of Regulation (EC) No 1272/2008, based on scientific risk assessments. The over-arching aim is to ensure a high level of protection for human health and the environment.
**4. Background and Rationale:**
The amendment addresses the need to incorporate new scientific information and risk assessments regarding the hazards posed by certain substances. Proposals for introducing or updating harmonized classifications were submitted to ECHA, which then issued opinions via its Committee for Risk Assessment (RAC). The European Commission has assessed these opinions, and based on those assessments, determined that updates to the harmonized classifications and labelling are necessary. This amendment aims to ensure that the CLP Regulation reflects the most current scientific understanding of the risks associated with these substances. The text mentions stakeholders contested the scientific assessment regarding dinitrogen oxide, indicating the need for careful consideration and justification for the changes.
**5. Key Provisions / Changes:**
This amendment focuses specifically on updating Annex VI, Table 3 of the CLP Regulation. The following key changes are introduced:
* **Insertion of New Entries:** The amendment inserts new entries into Table 3, adding harmonized classifications and labelling for substances not previously listed. Examples include:
* 2-ethylhexanoic acid, monoester with propane-1,2-diol
* N1-naphthylaniline; N-phenylnaphthalen-1-amine
* Tetrairon trispyrophosphate; ferric pyrophosphate
* Ozone
* Dinitrogen oxide
* Barium chromate
* Chrysanthemum cinerariaefolium extracts (obtained with supercritical CO2 and hydrocarbon solvents)
* 2-bromo-2-bromomethylpentanedinitrile; DBDCB
* Bixlozone ISO; 2,4-dichlorobenzyl-4,4-dimethyl-1,2-oxazolidin-3-one
* Tetrahydrofurfuryl methacrylate
* 2,3-epoxypropyl isopropyl ether
* Trimethyl phosphate
* Fluoroethylene
* 2-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride
* 2,3-epoxypropyl o-tolyl ether
* Methyl oct-2-ynoate
* Dinotefuran ISO; RS-1-methyl-2-nitro-3-tetrahydro-3-furylmethylguanidine
* **Replacement of Existing Entries:** The amendment replaces existing entries in Table 3, updating the harmonized classifications and labelling for substances already listed. Examples include:
* 2-phenylpropene; methylstyrene
* Tetraphosphorus trisulphide; phosphorus sesquisulphide
* 1,1-dichloroethylene; vinylidene chloride
* Pethoxamid ISO; 2-chloro-N-2-ethoxyethyl-N-2-methyl-1-phenylprop-1-enylacetamide
* 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone diisocyanate
* Folpet ISO; N-trichloromethylthiophthalimide
* Captan ISO; 1,2,3,6-tetrahydro-N-trichloromethylthio phthalimide
* Clopyralid ISO; 3,6-dichloropyridine-2-carboxylic acid
* Proquinazid ISO; 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one
* 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate
For each substance, the changes involve updates to:
* Hazard Class and Category
* Hazard Pictogram
* Signal Word
* Hazard Statement Codes
* Specific Concentration Limits, M-factors, and Notes (where applicable)
* Acute Toxicity Estimates (ATEs) (where applicable)
For instance, the entry for 2-phenylpropene; methylstyrene has been updated to include a Carc. 2 H351 classification. The entry for 1,1-dichloroethylene; vinylidene chloride has been updated to include a Carc. 1B H350 classification.
* **Effect of Changes:** The updates to classifications and labelling will directly impact the way these substances are handled, packaged, and labelled by suppliers. This includes updating safety data sheets (SDS), labels, and ensuring that risk management measures are appropriate for the newly classified hazards.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders are:
* Manufacturers, importers, and suppliers of the listed substances, either as individual substances or in mixtures.
* Downstream users who handle these substances in their industrial processes.
* Companies involved in the packaging and labelling of chemical products.
* Any business placing these substances or mixtures containing them on the EU market.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The European Commission is responsible for adopting the regulation. The European Chemicals Agency (ECHA) plays a key role in providing scientific opinions through its Committee for Risk Assessment (RAC). Member States are responsible for enforcing the regulation within their jurisdictions.
* **Timelines:** The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union. It applies from 1 February 2027. However, suppliers may voluntarily comply with the updated classifications and labelling from the date of entry into force.
* **Implementation Aspects Related to Changes:**
* Suppliers will need to review their current classifications, labels, and safety data sheets for the substances affected by this amendment.
* They will need to update their labels and packaging to comply with the new harmonized classifications before 1 February 2027 (or earlier if they choose to comply voluntarily).
* Suppliers will need to communicate the changes to their downstream users, providing updated safety data sheets and information on safe handling practices.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of these specific changes is to:
* Improve the accuracy and consistency of hazard communication for the listed substances.
* Enhance the protection of workers, consumers, and the environment by ensuring that the risks associated with these substances are properly identified and managed.
* Facilitate the safe use of these substances by providing clear and consistent labelling and safety information.
* Ensure compliance with the latest scientific understanding of the hazards posed by these substances.
**9. Conclusion:**
Commission Delegated Regulation (EU) 2025/1222 represents a significant update to the harmonized classification and labelling of certain hazardous substances under the CLP Regulation. The amendments reflect updated scientific assessments and aim to improve the protection of human health and the environment. Suppliers of the listed substances must take appropriate steps to comply with the new requirements, including updating their classifications, labels, safety data sheets, and communication practices. The amendment's significance lies in its commitment to aligning chemical regulations with the most current scientific knowledge, ensuring a safer and more sustainable approach to the management of hazardous substances within the European Union.
Key Entities Referenced
European Union: Political and economic union of member states located primarily in Europe.
Regulation EC No 1272/2008: Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (CLP Regulation).
European Parliament: Legislative branch of the European Union.
Council of the European Union: A body composed of government ministers from each EU member state.
Directives 67/548/EEC: A previous European Economic Community directive on the classification, packaging and labelling of dangerous substances.
Directive 1999/45/EC: A previous European Economic Community directive concerning the classification, packaging and labelling of dangerous preparations.
Regulation EC No 1907/2006: Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
European Chemicals Agency: Agency of the European Union that implements EU chemicals legislation.
Committee for Risk Assessment RAC: A committee within the European Chemicals Agency (ECHA) responsible for forming opinions on risk assessments.
2-ethylhexanoic acid, monoester with propane-1,2-diol: A chemical substance under evaluation for harmonized classification and labeling.
Aqueous extract from the germinated seeds of sweet Lupinus albus: A chemical substance under evaluation for harmonized classification and labeling.
N-1-naphthylaniline; N-phenylnaphthalen-1-amine: A chemical substance under evaluation for harmonized classification and labeling.
propyl 4-hydroxybenzoate: A chemical substance under evaluation for harmonized classification and labeling.
,propylenedinitrilodiocresol: A chemical substance under evaluation for harmonized classification and labeling.
ozone: A chemical substance under evaluation for harmonized classification and labeling.
dinitrogen oxide: A chemical substance under evaluation for harmonized classification and labeling.
tetrairon trispyrophosphate; ferric pyrophosphate: A chemical substance under evaluation for harmonized classification and labeling.
2-phenylpropene; methylstyrene: A chemical substance under evaluation for harmonized classification and labeling.
tetraphosphorus trisulphide; phosphorus sesquisulphide: A chemical substance under evaluation for harmonized classification and labeling.
pethoxamid ISO; 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl)acetamide: A chemical substance under evaluation for harmonized classification and labeling.
1,1-dichloroethylene; vinylidene chloride: A chemical substance under evaluation for harmonized classification and labeling.
bixlozone ISO; 2-(2,4-dichlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one: A chemical substance under evaluation for harmonized classification and labeling.
9-octadecenoic acid (Z)-, sulfonated, potassium salts: A chemical substance under evaluation for harmonized classification and labeling.
barium bis(2-chloro-5-(2-hydroxy-1-naphthylazo)toluene-4-sulphonate); C.I. Pigment Red 53:1: A chemical substance under evaluation for harmonized classification and labeling.
barium chromate: A chemical substance under evaluation for harmonized classification and labeling.
Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents: A chemical substance under evaluation for harmonized classification and labeling.
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2: A chemical substance under evaluation for harmonized classification and labeling.
fluoroethylene: A chemical substance under evaluation for harmonized classification and labeling.
tetrahydrofurfuryl methacrylate: A chemical substance under evaluation for harmonized classification and labeling.
2,3-epoxypropyl isopropyl ether: A chemical substance under evaluation for harmonized classification and labeling.
trimethyl phosphate: A chemical substance under evaluation for harmonized classification and labeling.
3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone diisocyanate: A chemical substance under evaluation for harmonized classification and labeling.
2-bromo-2-(bromomethyl)pentanedinitrile; DBDCB: A chemical substance under evaluation for harmonized classification and labeling.
folpet ISO; N-(trichloromethylthio)phthalimide: A chemical substance under evaluation for harmonized classification and labeling.
2-bromo-3,3,3-trifluoroprop-1-ene: A chemical substance under evaluation for harmonized classification and labeling.
clopyralid ISO; 3,6-dichloropyridine-2-carboxylic acid: A chemical substance under evaluation for harmonized classification and labeling.
3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate: A chemical substance under evaluation for harmonized classification and labeling.
captan ISO; 1,2,3,6-tetrahydro-N-(trichloromethylthio)phthalimide: A chemical substance under evaluation for harmonized classification and labeling.
dinotefuran ISO; RS-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine: A chemical substance under evaluation for harmonized classification and labeling.
methyl oct-2-ynoate: A chemical substance under evaluation for harmonized classification and labeling.
proquinazid ISO; 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one: A chemical substance under evaluation for harmonized classification and labeling.
2,3-epoxypropyl o-tolyl ether: A chemical substance under evaluation for harmonized classification and labeling.
2-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride: A chemical substance under evaluation for harmonized classification and labeling.
Brussels: The location where the Commission adopted the regulation.
Commission: The European Commission.
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2025/1222 20.6.2025
COMMISSION DELEGATED REGULATION(EU) 2025/1222
of 2 April 2025
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards
the harmonised classification and labelling of certain substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
and 1999/45/EC, and amending Regulation (EC) No 1907/2006(1), and in particular Article 37(5) thereof,
Whereas:
(1) Part 3, Table 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and
labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.
(2) Proposals to introduce harmonised classification and labelling of certain substances and to update the harmonised
classification and labelling of certain other substances have been submitted to the European Chemicals Agency (‘the
Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment (RAC) of
the Agency adopted, after having taken account of the comments received from the parties concerned, the following
opinions(2)on those proposals:
— Opinion of 16 March 2023 concerning 2-ethylhexanoic acid, monoester with propane-1,2-diol;
— Opinion of 16 March 2023 concerning Aqueous extract from the germinated seeds of sweet Lupinus albus;
— Opinion of 16 March 2023 concerning N-1-naphthylaniline; N-phenylnaphthalen-1-amine;
— Opinion of 16 March 2023 concerning propyl 4-hydroxybenzoate;
— Opinion of 16 March 2023 concerning α,α’-propylenedinitrilodi-o-cresol;
— Opinion of 16 March 2023 concerning ozone;
— Opinion of 16 March 2023 concerning dinitrogen oxide;
— Opinion of 16 March 2023 concerning tetrairon tris(pyrophosphate); ferric pyrophosphate;
— Opinion of 16 March 2023 concerning 2-phenylpropene; α-methylstyrene;
— Opinion of 16 March 2023 concerning tetraphosphorus trisulphide; phosphorus sesquisulphide;
(1) OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj.
(2) The opinions are accessible via the following website: https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/name/-/
ecNumber/-/casNumber/-/dte_receiptFrom/-/dte_receiptTo/-/prc_public_status/Opinion+Adopted/dte_withdrawnFrom/-/
dte_withdrawnTo/-/sbm_expected_submissionFrom/-/sbm_expected_submissionTo/-/dte_finalise_deadlineFrom/-/dte_finalise_deadli
neTo/-/haz_addional_hazard/-/lec_submitter/-/dte_assessmentFrom/-/dte_assessmentTo/-/prc_regulatory_programme/-/.
ELI: http://data.europa.eu/eli/reg_del/2025/1222/oj 1/11EN
OJ L, 20.6.2025
— Opinion of 16 March 2023 concerning pethoxamid (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-
1-phenylprop-1-enyl)acetamide;
— Opinion of 8 June 2023 concerning 1,1-dichloroethylene; vinylidene chloride;
— Opinion of 8 June 2023 concerning bixlozone (ISO); 2-(2,4-dichlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-
3-one;
— Opinion of 8 June 2023 concerning 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)-sulphoocta
decanoic acid, potassium salt [3];
— Opinion of 8 June 2023 concerning barium bis[2-chloro-5-[(2-hydroxy-1- naphthyl)azo]toluene-
4-sulphonate]; C.I. Pigment Red 53:1;
— Opinion of 8 June 2023 concerning barium chromate;
— Opinion of 8 June 2023 concerning Chrysanthemum cinerariaefolium, extract from open and mature flowers of
Tanacetum cinerariifoliumobtained with hydrocarbon solvents;
— Opinion of 8 June 2023 concerning Chrysanthemum cinerariaefoliumextract from open and mature flowers of
Tanacetum cinerariifoliumobtained with supercritical CO ;
2
— Opinion of 8 June 2023 concerning fluoroethylene;
— Opinion of 8 June 2023 concerning tetrahydrofurfuryl methacrylate;
— Opinion of 8 June 2023 concerning 2,3-epoxypropyl isopropyl ether;
— Opinion of 8 June 2023 concerning trimethyl phosphate;
— Opinion of 8 June 2023 concerning 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone
di-isocyanate;
— Opinion of 8 June 2023 concerning 2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB];
— Opinion of 8 June 2023 concerning folpet (ISO); N-(trichloromethylthio)phthalimide;
— Opinion of 14 September 2023 concerning 2-bromo-3,3,3-trifluoroprop-1-ene;
— Opinion of 14 September 2023 concerning clopyralid (ISO); 3,6-dichloropyridine-2- carboxylic acid;
— Opinion of 14 September 2023 concerning 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl
butylcarbamate;
— Opinion of 14 September 2023 concerning captan (ISO); 1,2,3,6-tetrahydro-N- (trichloromethylthio)
phthalimide;
— Opinion of 14 September 2023 concerning dinotefuran (ISO); (RS)-1-methyl-2-nitro-3-(tetrahydro-
3-furylmethyl)guanidine;
— Opinion of 14 September 2023 concerning methyl oct-2-ynoate;
— Opinion of 14 September 2023 concerning proquinazid (ISO); 6-iodo-2-propoxy-3- propylquinazolin-
4(3H)-one;
— Opinion of 14 September 2023 concerning 2,3-epoxypropyl o-tolyl ether;
— Opinion of 14 September 2023 concerning 2-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihy
dro-1,2-thiazol-3-one hydrochloride.
2/11 ELI: http://data.europa.eu/eli/reg_del/2025/1222/ojEN
OJ L, 20.6.2025
(3) The Commission has received additional information from stakeholders contesting the scientific assessment set out in
the RAC opinion of 16 March 2023 concerning dinitrogen oxide. The additional information has been assessed by
the Commission and has not been found sufficient to cast doubts on the scientific analysis contained in the RAC
opinions.
(4) In light of the RAC opinions, it is appropriate to introduce or update the harmonised classification and labelling of
the substances concerned on the basis of the assessment made in those opinions and following the further
assessment by the Commission.
(5) Regulation (EC) No 1272/2008 should therefore be amended accordingly.
(6) Compliance with the new or updated harmonised classifications should not be required immediately as a certain
period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the
new or updated classifications and to sell existing stocks subject to the pre-existing regulatory requirements. That
period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing
compliance with other legal requirements following the changes made under this Regulation. Suppliers should,
however, have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and
packaging accordingly, on a voluntary basis before the date of application of this Regulation, to ensure a high level
of protection of human health and of the environment and to provide sufficient flexibility to suppliers,
HAS ADOPTED THIS REGULATION:
Article 1
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
It shall apply from 1 February 2027.
However, suppliers may classify, label and package substances and mixtures in accordance with Regulation (EC)
No 1272/2008 as amended by this Regulation from the date of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 April 2025.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_del/2025/1222/oj 3/11ANNEX
Part 3, Table 3, of Annex VI to Regulation (EC) No 1272/2008 is amended as follows:
(1) the following entries are inserted following the consecutive order of the index numbers corresponding to each entry:
Classification Labelling
Suppl. Specific Conc.
Index No Chemical Name EC No CAS No Hazard Class Hazard Pictogram, Hazard statement Hazard Limits, M-factors Notes
and Category statement Signal Word Code(s) statement and ATEs
Code(s) Code(s) Code(s)
Code(s)
‘607-776-00-5 2-ethylhexanoic acid, 285-503-5 85114-0 Repr. 1B H360D GHS08 H360D’
monoester with 0-7 Dgr
propane-1,2-diol
‘612-300-00-4 N-1-naphthylaniline; 201-983-0 90-30-2 Acute Tox. 4 H302 GHS07 H302 oral: ATE =
N-phenylnaphthalen- STOT RE 2 H373 GHS08 H373 (blood 1 200 mg/kg
1-amine Skin Sens. 1 (blood Wng system, liver) bw’
system, H317
liver)
H317
‘026-005-00-8 tetrairon 233-190-0 10058-4 Eye Irrit. 2 H319 GHS07 H319’
tris(pyrophosphate); 4-3 Wng
ferric pyrophosphate
‘604-103-00-7 α,α’- 202-374-2 94-91-7 Repr. 1B H360FD GHS08 H360FD’
propylenedinitrilodi-o- Dgr
cresol
‘008-004-00-4 ozone 233-069-2 10028-1 Ox. Gas 1 H270 GHS03 H270 inhalation:
5-6 Carc. 2 H351 GHS08 H351 ATE = 10
Muta. 2 H341 GHS06 H341 ppmV
Acute Tox. 1 H330 GHS09 H330 STOT SE 1;
STOT SE 1 H370 Dgr H370 (nervous H370: C
(nervous system, ≥ 0,002 %
system,
4/11
ELI:
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EN
OJ
L,
20.6.2025Classification Labelling
Suppl. Specific Conc. Index No Chemical Name EC No CAS No Hazard Class Hazard Pictogram, Hazard statement Hazard Limits, M-factors Notes
and Category statement Signal Word Code(s) statement and ATEs
Code(s) Code(s) Code(s)
Code(s)
STOT RE 1 respiratory respiratory STOT SE 2;
Aquatic system, system, H371:
Acute 1 cardiovas cardiovascular 0,0005 % ≤ C
Aquatic cular system) < 0,002 %
Chronic 1 system) H372 (nervous STOT RE 1;
H372 system, H372: C
(nervous respiratory ≥ 0,05 %
system, system) STOT RE 2;
respiratory H410 H373: 0,01 % ≤
system) C < 0,05 %
H400 M = 100
H410 M = 1’
‘007-031-00-9 dinitrogen oxide 233-032-0 10024-9 Repr. 1B H360Df GHS08 H360Df
7-2 STOT SE 3 H336 GHS07 H336
STOT RE 1 H372 Dgr H372 (nervous
Ozone 1 (nervous system)
system) H420’
H420
‘056-006-00-9 barium chromate 233-660-5 10294-4 Carc. 1B H350 GHS08 H350’
0-3 Dgr
‘650-060-00-2 Chrysanthemum 289-699-3 89997-6 Acute Tox. 4 H332 GHS07 H332 inhalation:
cinerariaefolium, extract 3-7 Acute Tox. 4 H302 GHS08 H302 ATE = 2,6 mg/L
from open and mature STOT SE 1 H370 Dgr H370 (nervous (dusts or mists)
flowers of Tanacetum STOT RE 2 (nervous system) oral: ATE =
cinerariifoliumobtained Skin Sens. 1 system) H373 730 mg/kg bw
with supercritical CO Aquatic H373 (respiratory tract, M = 1 000
2
Acute 1 (respira inhalation) M = 100’
Aquatic tory tract, H317
Chronic 1 inhalation) H410
H317
H400
H410
ELI:
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20.6.2025
ENClassification Labelling
Suppl. Specific Conc.
Index No Chemical Name EC No CAS No Hazard Class Hazard Pictogram, Hazard statement Hazard Limits, M-factors Notes
and Category statement Signal Word Code(s) statement and ATEs
Code(s) Code(s) Code(s)
Code(s)
‘650-059-00-7 Chrysanthemum 289-699-3 89997-6 Acute Tox. 4 H332 GHS07 H332 inhalation:
cinerariaefolium, extract 3-7 Acute Tox. 4 H302 GHS08 H302 ATE = 2,6 mg/L
from open and mature STOT SE 1 H370 Dgr H370 (nervous (dusts or mists)
flowers of Tanacetum STOT RE 2 (nervous system) oral: ATE =
cinerariifoliumobtained Skin Sens. 1 system) H373 730 mg/kg bw
with hydrocarbon Aquatic H373 (respiratory tract, M = 1 000
solvents Acute 1 (respira inhalation) M = 100’
Aquatic tory tract, H317
Chronic 1 inhalation) H410
H317
H400
H410
‘607-777-00-0 barium bis[2-chloro- 225-935-3 5160-02 Carc. 2 H351 GHS08 H351’
5-[(2-hydroxy- -1 Wng
1-naphthyl)azo]toluene-
4-sulphonate]; C.I.
Pigment Red 53:1
‘608-070-00-X 2-bromo- 252-681-0 35691-6 Acute Tox. 2 H330 GHS06 H330 inhalation:
2-(bromomethyl) 5-7 Acute Tox. 4 H302 GHS08 H302 ATE = 0,27 mg/
pentanedinitrile; STOT RE 2 H373 GHS05 H373 (thyroid, L (dusts or
[DBDCB] Eye Dam. 1 (thyroid, GHS09 central nervous mists)
Skin Sens. central Dgr system) oral: ATE =
1A nervous H318 500 mg/kg bw
Aquatic system) H317 Skin Sens. 1A;
Chronic 2 H318 H411 H317: C
H317 ≥ 0,001 %’
H411
‘607-779-00-1 9-octadecenoic acid (Z)-, 271-843-1 68609-9 Repr. 1B H360D GHS08 H360D’
sulfonated, potassium [1]; 3-8 [1]; Dgr
salts [1]; Reaction - [2]; - [2];
products of fatty acids, 267-966-5 67968-6
C18 (unsaturated) alkyl [3] 3-2 [3]
with sulfur trioxide,
potassium salts [2]; 9(or
10)-sulphooctadecanoic
acid, potassium salt [3]
6/11
ELI:
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EN
OJ
L,
20.6.2025Classification Labelling
Suppl. Specific Conc. Index No Chemical Name EC No CAS No Hazard Class Hazard Pictogram, Hazard statement Hazard Limits, M-factors Notes
and Category statement Signal Word Code(s) statement and ATEs
Code(s) Code(s) Code(s)
Code(s)
‘613-352-00-0 bixlozone (ISO); — 81777-9 Aquatic H400 GHS09 H410 M = 1
2-(2,4-dichlorobenzyl)- 5-9 Acute 1 H410 Wng M = 10’
4,4-dimethyl-1,2-oxazo Aquatic
lidin-3-one Chronic 1
‘603-248-00-3 2,3-epoxypropyl 223-672-9 4016-14 Repr. 1B H360F GHS08 H360F’
isopropyl ether -2 Dgr
‘607-778-00-6 tetrahydrofurfuryl 219-529-5 2455-24 Repr. 1B H360Df GHS08 H360Df
methacrylate -5 Skin Sens. H317 GHS07 H317’
1A Dgr
‘015-209-00-2 trimethyl phosphate 208-144-8 512-56-1 Carc. 1B H350 GHS08 H350 oral: ATE =
Muta. 1B H340 GHS07 H340 1 300 mg/kg
Repr. 1B H360FD Dgr H360FD bw’
Acute Tox. 4 H302 H302
STOT RE 2 H373 H373 (nervous
(nervous system)
system)
‘602-111-00-5 fluoroethylene 200-832-6 75-02-5 Carc. 1A H350 GHS08 H350 D’
Muta. 2 H341 Dgr H341
‘602-112-00-0 2-bromo-3,3,3-trifluoro — 1514-82 Repr. 1B H360FD GHS08 H360FD
prop-1-ene -5 STOT SE 3 H335 GHS07 H335
STOT SE 3 H336 Dgr H336’
‘613-353-00-6 2-methyl-2H-isothiazol- 247-499-3 26172-5 Acute Tox. 2 H330 GHS06 H330 EUH071 inhalation:
3-one hydrochloride; 4-3 Acute Tox. 3 H311 GHS05 H311 ATE = 0,15 mg/
2-methyl-2,3-dihy Acute Tox. 3 H301 GHS09 H301 L (dusts or
dro-1,2-thiazol-3-one Skin Corr. 1 H314 Dgr H314 mists)
hydrochloride Eye Dam. 1 H318 H317 dermal: ATE =
Skin Sens. H317 H410 320 mg/kg bw
1A H400 oral: ATE =
Acute H410 180 mg/kg bw
Aquatic 1 Skin. Sens 1A;
Acute H317: C
Chronic 1 ≥ 0,0015 %
M = 10
M = 1’
ELI:
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7/11
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20.6.2025
ENClassification Labelling
Suppl. Specific Conc.
Index No Chemical Name EC No CAS No Hazard Class Hazard Pictogram, Hazard statement Hazard Limits, M-factors Notes
and Category statement Signal Word Code(s) statement and ATEs
Code(s) Code(s) Code(s)
Code(s)
‘603-249-00-9 2,3-epoxypropyl o-tolyl 218-645-3 2210-79 Skin Irrit. 2 H315 GHS07 H315 C’
ether -9 Skin Sens. H317 GHS08 H317
1A H341 GHS09 H341
Muta. 2 H411 Wng H411
Aquatic
Chronic 2
‘607-780-00-7 methyl oct-2-ynoate 203-836-6 111-12-6 Skin Sens. H317 GHS07 H317’
1A Wng
‘612-301-00-X dinotefuran (ISO); (RS)- - 165252- Acute Tox. 4 H302 GHS07 H302 oral: ATE =
1-methyl-2-nitro- 70-0 Aquatic H400 GHS09 H410 2 000 mg/kg
3-(tetrahydro- Acute 1 H410 Wng bw
3-furylmethyl)guanidine Aquatic M = 10
Chronic 1 M = 10’
(2) the entries corresponding to index numbers 015-012-00-1, 601-027-00-6, 602-025-00-8, 607-231-00-1, 613-044-00-6, 613-045-00-1, 615-008-00-5, 616-145-00-3,
616-211-00-1, 616-212-00-7 are replaced by the following entries respectively:
Pictogram, Suppl.
Hazard Class Hazard Hazard Specific Conc.
Signal Hazard
Index No Chemical Name EC No CAS No and Category statement statement Limits, M-factors Notes
Word statement
Code(s) Code(s) Code(s) and ATEs
Code(s) Code(s)
‘601-027-00-6 2-phenylpropene; 202-705-0 98-83-9 Flam. Liq. 3 H226 GHS02 H226 STOT SE 3; D’
α-methylstyrene Carc. 2 H351 GHS08 H351 H335: C ≥ 25 %
STOT SE 3 H335 GHS07 H335
Eye Irrit. 2 H319 GHS09 H319
Skin Sens. 1B H317 Wng H317
Aquatic H411 H411
Chronic 2
8/11
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OJ
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20.6.2025Pictogram, Suppl.
Hazard Class Hazard Hazard Specific Conc. Signal Hazard Index No Chemical Name EC No CAS No and Category statement statement Limits, M-factors Notes Word statement
Code(s) Code(s) Code(s) and ATEs
Code(s) Code(s)
‘616-145-00-3 pethoxamid (ISO); - 106700-29-2 Acute Tox. 4 H302 GHS07 H302 oral: ATE =
2-chlor Skin Sens. 1A H317 GHS09 H317 980 mg/kg bw
o-N-(2-ethoxyethyl)- Aquatic H400 Wng H410 M = 100
N-(2-methyl- Acute 1 H410 M = 10’
1-phenylprop-1-enyl) Aquatic
acetamide Chronic 1
‘015-012-00-1 tetraphosphorus 215-245-0 1314-85-8 Flam. Sol. 1 H228 GHS02 H228 T’
trisulphide; phosphorus Self-heat. 1 H251 GHS07 H251
sesquisulphid Acute Tox. 4* H302 Dgr H302
‘602-025-00-8 1,1-dichloroethylene; 200-864-0 75-35-4 Flam. Liq. 1 H224 GHS02 H224 inhalation: D’
vinylidene chloride Carc. 1B H350 GHS08 H350 ATE = 0,5 mg/L
Muta. 2 H341 GHS06 H341 (vapours)
Acute Tox. 1 H330 Dgr H330 oral: ATE =
Acute Tox. 3 H301 H301 300 mg/kg bw
STOT RE 1 H372 H372
Aquatic (respira (respiratory
Chronic 3 tory tract, tract, kidney,
kidney, liver)
liver) H412
H412
‘615-008-00-5 3-isocyanatomethyl-3,5,5- 223-861-6 4098-71-9 Acute Tox. 1 H330 GHS06 H330 EU inhalation: 2’
trimethylcyclohexyl Skin Corr. 1 H314 GHS05 H314 H071 ATE = 0,03 mg/L
isocyanate; isophorone Eye Dam. 1 H334 GHS08 H318 (dusts or mists)
di-isocyanate Resp. Sens. 1 H317 GHS09 H334 Resp. Sens. 1;
Skin Sens. 1A H411 Dgr H317 H334: C ≥ 0,5 %
Aquatic H411 Skin Sens. 1A;
Chronic 2 H317: C
≥ 0,001 %
ELI:
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ENPictogram, Suppl.
Hazard Class Hazard Hazard Specific Conc.
Signal Hazard
Index No Chemical Name EC No CAS No and Category statement statement Limits, M-factors Notes
Word statement
Code(s) Code(s) Code(s) and ATEs
Code(s) Code(s)
‘613-045-00-1 folpet (ISO); 205-088-6 133-07-3 Carc. 2 H351 GHS08 H351 EU inhalation:
N-(trichloromethylthio) Acute Tox. 2 H330 GHS06 H330 H066 ATE = 0,30 mg/L
phthalimide STOT RE 1 H372 GHS05 H372 (dusts or mists)
Eye Dam. 1 (respira GHS09 (respiratory STOT RE 1: C
Skin Sens. 1A tory tract) Dgr tract) ≥ 5 %
Aquatic Acute H318 H318 STOT RE 2:
1 H317 H317 0,5 % ≤ C < 5 %
Aquatic H400 H410 Skin Sens. 1A;
Chronic 1 H410 H317: C
≥ 0,001 %
M = 10
M = 10’
‘613-044-00-6 captan (ISO); 1,2,3,6- 205-087-0 133-06-2 Carc. 2 H351 GHS08 H351 inhalation: ATE
tetrahydro- Repr. 2 H361f GHS06 H361f = 0,22 mg/L
N-(trichloromethylthio) Acute Tox. 2 H330 GHS05 H330 (dusts or
phthalimide STOT RE 1 H372 GHS09 H372 mists)
Eye Dam. 1 H318 Dgr H318 Skin Sens. 1A;
Skin Sens. 1A H317 H317 H317:
Aquatic Acute H400 H410 C≥ 0,001 %
1 H410 M = 10
Aquatic M = 10’
Chronic 1
‘607-231-00-1 clopyralid (ISO); 216-935-4 1702-17-6 Eye Dam. 1 H318 GHS05 H318 EU M = 10’
3,6-dichloropyridine- Aquatic H410 GHS09 H410 H066
2-carboxylic acid Chronic 1 Dgr
‘616-211-00-1 proquinazid (ISO); 6-iodo- — 189278-12-4 Carc. 2 H351 GHS08 H351 M = 1
2-propoxy- STOT RE 1 H372 GHS09 H372 M = 10’
3-propylquinazolin-4(3H)- Aquatic Acute (thyroid, Dgr (thyroid,
one 1 liver) liver)
Aquatic H400 H410
Chronic 1 H410
10/11
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EN
OJ
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20.6.2025Pictogram, Suppl.
Hazard Class Hazard Hazard Specific Conc. Signal Hazard Index No Chemical Name EC No CAS No and Category statement statement Limits, M-factors Notes Word statement
Code(s) Code(s) Code(s) and ATEs
Code(s) Code(s)
‘616-212-00-7 3-iodo-2-propynyl 259-627-5 55406-53-6 Acute Tox. 2 H330 GHS06 H330 inhalation: ATE
butylcarbamate; Acute Tox. 4 H302 GHS08 H302 = 0,17 mg/L
3-iodoprop-2-yn-1-yl STOT RE 1 H372 GHS05 H372 (dusts or mists)
butylcarbamate Eye Dam. 1 (larynx) GHS09 (larynx) M = 10
Skin Sens. 1 H318 Dgr H318 M = 10’
Aquatic Acute H317 H317
1 H400 H410
Aquatic H410
Chronic 1
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