EU Revises CLP Regulation on Substances and Mixtures

SafeGuardSAutomotive, Electrical & Electronics, Hardgoods, Personal and Protective Equipment, Softlines, Toys and Juvenile ProductsApril 04, 2023

SG 43/23

The EU has issued a revision to its Regulation on classification, labeling and packaging of substances and mixtures (CLP Regulation). The amendment will enter into force on April 20, 2023.

In March 2022, the European Union (EU) issued Commission Delegation Regulation (EU) 2023/707 to revise Regulation (EU) No. 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation, consolidated version to December 2022).

The latest amendment contains several important changes to the CLP Regulation. It:

Adds new requirements to Annex I ‘Classification and labeling requirements for hazardous substances and mixtures’ for the classification, assessment and labeling of substances and mixtures that are:

Endocrine disruptors (ED)
Persistent, bioaccumulative and toxic (PBT) or very persistent or very bioaccumulative (vPvB)
Persistent, mobile and toxic (PMT) and very persistent, very mobile (vPvM)

Revises Annex II ‘Special rules for labeling and packaging of certain substances and mixtures’ in relation to the concentration of a substance classified as an ED for human health category 2 or environmental category 2
Amends hazard statements falling under Annex III ‘List of hazard statements, supplemental hazard information and supplementary label elements’
Inserts new hazard codes and category codes for ED, PBT, vPvB, PMT and vPvM to Annex VI ‘Harmonized classification and labeling for certain hazardous substances’

Highlights of the aforementioned new requirements for Annex I to the CLP Regulation are summarized in Table 1.

Commission Delegated Regulation (EU) 2023/707 of December 19, 2022, amending Regulation (EC) No. 1272/2008 as regards hazard classes and criteria for the classification, labeling and packaging of substances and mixtures, March 31, 2023, Official Journal of the EU
Section to Regulation (EC) 1272/2008	Highlights
Annex I Part 3 Section 3.11 ‘Endocrine disruption for human health’
Section 3.11.1.1 ‘Definitions’ New definitions, including one for ‘endocrine disruption’ – a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulation
Section 3.11.2 ‘Classification criteria for substances’ Table 3.11.1 details the hazard categories of ED for human health Date of applicability for substances May 1, 2025, for classification of substances in accordance with sections 3.11.2.1 to 3.11.2.3 (substances which were placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)
Section 3.11.3 ‘Classification criteria for mixtures’ Table 3.11.2 details the generic concentration limits for components of a mixture classified as ED for human health that trigger classification of the mixture Date of applicability for mixtures: May 1, 2026, for mixtures to be classified in accordance with sections 3.11.3.1., 3.11.3.2 and 3.11.3.3 (mixtures that were placed on the market before this date are not required to be classified in accordance with these sections until May 1, 2028)
Section 3.11.4 ‘Hazard communication’ Table 3.11.3 details the label elements of ED for human health Date of applicability for substances May 1, 2025, for substances to be labeled in accordance with section 3.11.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026) Date of applicability for mixtures: May 1, 2026, for mixtures in accordance with section 3.11.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)
Annex I Part 3 Section 4.2 ‘Endocrine disruption for the environment’	Section 4.2.2 ‘Classification criteria for substances’ Table 4.2.1 details the hazard categories of ED for the environment Date of applicability for substances: May 1, 2025, for substances to be classified in accordance with sections 4.2.2.1 to 4.2.2.3 (substances that were placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)
Section 4.2.3 ‘Classification criteria for mixtures’ Table 4.2.2 details the generic concentration limits for components of a mixture classified as ED for the environment that trigger classification of the mixture (a safety data sheet (SDS) must be available for the mixture upon request if the concentration of a category 2 ED for the environment is ≥ 0.1% in the mixture) Date of applicability for mixtures: May 1, 2026, for mixtures to be classified in accordance with sections 4.2.3.1 to 4.2.3.3 (mixtures that were placed on the market before this date are not required to be classified in accordance with these sections until May 1, 2028)
Section 4.2.4 ‘Hazard communication’ Table 4.2.3 details the label elements of ED for the environment Date of applicability for substances May 1, 2025, for substances to be labeled in accordance with sections 4.2.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026) Date of applicability for mixtures: May 1, 2026, for mixtures to be labeled in accordance with sections 4.2.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)
Annex I Part 3 Section 4.3 ‘Persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) properties’	Section 4.3.2 ‘Classification criteria for substances’ Details the classification and assessment criteria for PBT and vPvB substances Date of applicability for substances: May 1, 2025, for substances to be classified in accordance with sections 4.3.2.1 to 4.3.2.4 (substances placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)
Section 4.3.3 ‘Classification criteria for mixtures’ A mixture is classified as PBT or vPvB when at least one component in the mixture has been classified as PBT or vPvB and its concentration is ≥ 0.1% Date of applicability for mixtures: May 1, 2026, for mixtures to be classified in accordance with section 4.3.3.1 (mixtures that were placed on the market before this date are not required to be classified in accordance with this section until May 1, 2028)
Section 4.3.4 ‘Hazard communication’ Table 4.3.1 details the label elements for PBT and vPvB properties in substances and mixtures Date of applicability for substances May 1, 2025, for substances to be labeled in accordance with section 4.3.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026) Date of applicability for mixtures May 1, 2026, for mixtures to be labeled in accordance with section 4.3.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)
Annex I Part 3 Section 4.4 ‘Persistent, mobile and toxic (PMT) or very persistent, very mobile properties (vPvM)’	Section 4.4.2 ‘Classification criteria for substances’ Details the classification and assessment criteria for PMT and vPvM Date of applicability for substances May 1, 2025, for substances to be classified in accordance with sections 4.4.2.1 to 4.4.2.4 (substances that were placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)
Section 4.4.3 ‘Classification criteria for mixtures’ A mixture is to be classified as a PMT or vPvM when at least one of its components has been classified as a PMT or vPvM and its concentration is ≥ 0.1% Date of applicability for mixtures May 1, 2026, for mixtures to be classified in accordance with section 4.4.3.1 (mixtures that were placed on the market before this date are not required to be classified in accordance with this section until May 1, 2028)
Section 4.4.4 ‘Hazard communication’ Table 4.4.1 details the label elements for substances or mixtures meeting PMT and vPvM properties Date of applicability for substances May 1, 2025, for substances to be labeled in accordance with sections 4.4.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026) Date of applicability for mixtures May 1, 2026, for mixtures to be labeled in accordance with section 4.4.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)

Commission Delegated Regulation (EU) 2023/707 of December 19, 2022, amending Regulation (EC) No. 1272/2008 as regards hazard classes and criteria for the classification, labeling and packaging of substances and mixtures, March 31, 2023, Official Journal of the EU

Section to Regulation (EC) 1272/2008

Highlights

Annex I Part 3 Section 3.11 ‘Endocrine disruption for human health’

Section 3.11.1.1 ‘Definitions’

New definitions, including one for ‘endocrine disruption’ – a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulation

Section 3.11.2 ‘Classification criteria for substances’

Table 3.11.1 details the hazard categories of ED for human health

Date of applicability for substances

May 1, 2025, for classification of substances in accordance with sections 3.11.2.1 to 3.11.2.3 (substances which were placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)

Section 3.11.3 ‘Classification criteria for mixtures’

Table 3.11.2 details the generic concentration limits for components of a mixture classified as ED for human health that trigger classification of the mixture

Date of applicability for mixtures:

May 1, 2026, for mixtures to be classified in accordance with sections 3.11.3.1., 3.11.3.2 and 3.11.3.3 (mixtures that were placed on the market before this date are not required to be classified in accordance with these sections until May 1, 2028)

Section 3.11.4 ‘Hazard communication’

Table 3.11.3 details the label elements of ED for human health

Date of applicability for substances

May 1, 2025, for substances to be labeled in accordance with section 3.11.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026)

Date of applicability for mixtures:

May 1, 2026, for mixtures in accordance with section 3.11.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)

Annex I Part 3 Section 4.2 ‘Endocrine disruption for the environment’

Section 4.2.2 ‘Classification criteria for substances’

Table 4.2.1 details the hazard categories of ED for the environment

Date of applicability for substances:

May 1, 2025, for substances to be classified in accordance with sections 4.2.2.1 to 4.2.2.3 (substances that were placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)

Section 4.2.3 ‘Classification criteria for mixtures’

Table 4.2.2 details the generic concentration limits for components of a mixture classified as ED for the environment that trigger classification of the mixture (a safety data sheet (SDS) must be available for the mixture upon request if the concentration of a category 2 ED for the environment is ≥ 0.1% in the mixture)

Date of applicability for mixtures:

May 1, 2026, for mixtures to be classified in accordance with sections 4.2.3.1 to 4.2.3.3 (mixtures that were placed on the market before this date are not required to be classified in accordance with these sections until May 1, 2028)

Section 4.2.4 ‘Hazard communication’

Table 4.2.3 details the label elements of ED for the environment

Date of applicability for substances

May 1, 2025, for substances to be labeled in accordance with sections 4.2.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026)

Date of applicability for mixtures:

May 1, 2026, for mixtures to be labeled in accordance with sections 4.2.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)

Annex I Part 3 Section 4.3 ‘Persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) properties’

Section 4.3.2 ‘Classification criteria for substances’

Details the classification and assessment criteria for PBT and vPvB substances

Date of applicability for substances:

May 1, 2025, for substances to be classified in accordance with sections 4.3.2.1 to 4.3.2.4 (substances placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)

Section 4.3.3 ‘Classification criteria for mixtures’

A mixture is classified as PBT or vPvB when at least one component in the mixture has been classified as PBT or vPvB and its concentration is ≥ 0.1%

Date of applicability for mixtures:

May 1, 2026, for mixtures to be classified in accordance with section 4.3.3.1 (mixtures that were placed on the market before this date are not required to be classified in accordance with this section until May 1, 2028)

Section 4.3.4 ‘Hazard communication’

Table 4.3.1 details the label elements for PBT and vPvB properties in substances and mixtures

Date of applicability for substances

May 1, 2025, for substances to be labeled in accordance with section 4.3.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026)

Date of applicability for mixtures

May 1, 2026, for mixtures to be labeled in accordance with section 4.3.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)

Annex I Part 3 Section 4.4 ‘Persistent, mobile and toxic (PMT) or very persistent, very mobile properties (vPvM)’

Section 4.4.2 ‘Classification criteria for substances’

Details the classification and assessment criteria for PMT and vPvM

Date of applicability for substances

May 1, 2025, for substances to be classified in accordance with sections 4.4.2.1 to 4.4.2.4 (substances that were placed on the market before this date are not required to be classified in accordance with these sections until November 1, 2026)

Section 4.4.3 ‘Classification criteria for mixtures’

A mixture is to be classified as a PMT or vPvM when at least one of its components has been classified as a PMT or vPvM and its concentration is ≥ 0.1%

Date of applicability for mixtures

May 1, 2026, for mixtures to be classified in accordance with section 4.4.3.1 (mixtures that were placed on the market before this date are not required to be classified in accordance with this section until May 1, 2028)

Section 4.4.4 ‘Hazard communication’

Table 4.4.1 details the label elements for substances or mixtures meeting PMT and vPvM properties

Date of applicability for substances

May 1, 2025, for substances to be labeled in accordance with sections 4.4.4.1 (substances that were placed on the market before this date are not required to be labeled in accordance with this section until November 1, 2026)

Date of applicability for mixtures

May 1, 2026, for mixtures to be labeled in accordance with section 4.4.4.1 (mixtures that were placed on the market before this date are not required to be labeled in accordance with this section until May 1, 2028)

Table 1

The amendment will enter into force on April 20, 2023.

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