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New hazard classes 2023

New hazard classes 2023

Nested Applications

New hazard classes 2023

The European Commission has published a Delegated Regulation amending CLP Regulation, which sets out new hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.

It applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in biocidal products and plant protection products, which are normally prioritised for harmonised classification in the EU.

This EU legislation is binding to manufacturers, importers, downstream users and distributors placing substances on the European Union market. Member States will also refer to the new hazard classes and criteria when making proposals for harmonised classification and labelling.

The new hazard classes are:

  • ED HH in Category 1 and Category 2 (Endocrine disruption for human health)
  • ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment)
  • PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative)
  • PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)

New EU hazard statements:

Hazard class and category code Hazard statement code Hazard statement
ED HH 1 EUH380 May cause endocrine disruption in humans
ED HH 2 EUH381 Suspected of causing endocrine disruption in humans
ED ENV 1 EUH430 May cause endocrine disruption in the environment
ED ENV 2 EUH431 Suspected of causing endocrine disruption in the environment
PBT EUH440 Accumulates in the environment and living organisms including in humans
vPvB EUH441 Strongly accumulates in the environment and living organisms including in humans
PMT EUH450 Can cause long-lasting and diffuse contamination of water resources
vPvM EUH451 Can cause very long-lasting and diffuse contamination of water resources

 

Application dates

The new rules are in force as of 20 April 2023. From this day on, the Member States can make proposals for harmonised classification and labelling (CLH) with the new hazard classes and manufacturers, importers, downstream users and distributors can self-classify their substances and mixtures accordingly.

There are transitional periods from the entry into force of the Delegated Regulation, during which manufacturers, importers, downstream users and distributors are not yet required to classify their substances or mixtures according to the new hazard classes. During these periods, the new hazard classes can be applied on a voluntary basis.

At the end of the transitional periods, all manufacturers, importers, downstream users and distributors must apply the new hazard classes.

New hazard classes 2023 - links

New hazard classes 2023 timeline

New classification and labelling is notrequired, but can be voluntarily appliedNew classification &labelling mandatoryNew classification andlabelling mandatoryNew classification and labelling is not required,but can be voluntarily appliedNew classification andlabelling mandatory20 April 20231 May 20251 November 202620 April 20231 May 20261 May 202824 months18 months36 months24 monthsNew classification &labelling mandatorySubstances placed on themarket before 1 May 2025Substances placed on themarket after 1 May 2025(1)Mixtures placed on themarket before 1 May 2026Mixtures placed on themarket after 1 May 2026(2)(1)This corresponds to substances placed on the market as of 1 May 2025, and tonew quantitiesof substancesalready on the market before 1 May 2025, when the new quantity is placed on the market as of 1 May 2025.(2)This corresponds to mixtures placed on the market as of 1 May 2026, and tonew quantitiesof mixturesalready on the market prior to 1 May 2026, when the new quantity is placed on the market as of 1 May 2026.

New hazard classes 2023 part2

Substances that are placed on the market for the first time on 1 May 2025 or later, including new quantities of substances that were already on the market before that cut-off date, must comply with the new rules. Substances that were placed on the market before 1 May 2025, and are already in the supply chain, do not need to be re-classified or re-labelled before 1 November 2026.  

Mixtures that are placed on the market for the first time on 1 May 2026 or later, including new quantities of mixtures that were already on the market before that cut-off date, must comply with the new rules. Mixtures that were placed on the market before 1 May 2026, and are already in the supply chain, do not need to be re-classified or re-labelled before 1 May 2028.

 

Examples

Substances 

  • For example, substance A is placed on the market for the first time on 2 May 2025. Substance A must be classified and labelled in accordance with the new hazard classes, as applicable.
  • Substance B has been on the market since 20 April 2018. A company manufactures new quantities of it and sells them as of 10 May 2025.
    The amounts of substance B that were already on the EU market from 20 April 2018 to 30 April 2025 do not have to be re-classified or re-labelled until 1 November 2026, unless the formulation of the substance is changed. The new quantities of substance B, supplied as of 10 May 2025 must be classified and labelled in accordance with the new hazard classes, as applicable.

Mixtures

  • For example, mixture X is placed on the market for the first time on 2 May 2026. Mixture X must be classified and labelled in accordance with the new hazard classes, as applicable.
  • Mixture Y has been on the market since 20 April 2018. A company manufactures new quantities of it and sells them as of 10 May 2026. The amounts of mixture Y that were already on the EU market from 20 April 2018 to 30 April 2026 do not have to be re-classified or re-labelled until 1 May 2028, unless the formulation of the mixture is changed. The new quantities of mixture Y, supplied as of 10 May 2026 must be classified and labelled in accordance with the new hazard classes, as applicable.

 

 

What this means

The CLP Regulation defines criteria for identifying a wide range of hazards that chemical substances and mixtures may have. ECHA’s Risk Assessment Committee (RAC) will assess any proposals for harmonised classification and labelling for the new hazard classes and include these in an opinion. This supports the principle of one substance, one assessment, which aims to bring more consistency to hazard identification across European legislation.

 

 

Updated CLH proposal template

ECHA has updated the harmonised classification and labelling (CLH) proposal template and the combined CLH/biocide template. The templates now include sections for the new hazard classes.

Member States are invited to use the revised template for preparing CLH proposals including the new hazard classes. A manufacturer, importer or downstream user may also prepare a CLH proposal and submit it to ECHA if there is no existing entry for that substance in the table of harmonised entries in Annex VI to CLP.

 

 

Submitting information to ECHA

The new hazard classes will be included in IUCLID during spring 2024. From then on, manufacturers, importers, downstream users and distributors will be able to include information related to the new hazard classes in their classification and labelling notifications, REACH registrations and dossiers for product and process orientated research and development (PPORD), as well as in their submissions under the Biocidal Products Regulation and poison centre notifications.

After the expiry of the transition period, it will be mandatory to indicate if the substance is classified in any of the new hazard classes.

 

New hazard classes 2023 - guidance

 

Available guidance

Guidance for Endocrine disruption for human health can be found in Part 3 of the Guidance on the Application of the CLP Criteria (section 3.11), Guidance on Endocrine Disruption in the Environment and PBT/vPvB and PMT/vPvM can be found in Part 4 (sections 4.2 and 4.3, respectively). 

 

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