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  4. New hazard classes 2023

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 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 2025Mixtures placed on themarket before 1 May 2026Mixtures placed on themarket after 1 May 2026

Nested Applications

New hazard classes 2023

 

For new substances on the market, companies need to comply with the new rules from 1 May 2025, whereas substances that have already been on the EU market, companies have until 1 November 2026 to comply.

Separate transition times apply for mixtures. New hazard classes apply from 1 May 2026 to new mixtures, whereas companies have until 1 May 2028 to update the classification and labelling for existing mixtures.

 

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.

 

 

Available guidance

In cooperation with EFSA, ECHA is preparing an update of the Guidance on the Application of the CLP criteria to include guidance on the new hazard classes. Following consultations with stakeholders, the updated guidance is planned to be published in mid 2024.

Until then, the following guidance can be used:

For endocrine disruptors: EFSA/ECHA Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and EC No 1107/2009 https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5311

This guidance describes how to perform hazard identification for endocrine disrupting properties by following scientific criteria outlined in Commission Delegated Regulation (EU) 2017/2100 and Commission Regulation (EU) 2018/605 for biocidal products and plant protection products, respectively.

It is used to assess whether a substance meets the criteria for endocrine disruptors under the biocidal or plant protection product regulations. In addition, for the SVHC (substances of very high concern) identification process under the REACH Regulation, principles from this guidance have been used.

The criteria in the biocidal and plant protection product regulations are very similar to the new CLP criteria for Category 1. Therefore, the ECHA/EFSA guidance may be applied as such for assessing whether the substance meets the criteria for classification Category 1 (for human health and for the environment). When the evidence available for adversity or endocrine activity or both does not allow a robust conclusion to place a substance in Category 1, for example, due to inconsistencies in results or issues with study design, then Category 2 may be more appropriate.

For persistence and bioaccumulation: Guidance on Information Requirements and Chemical Safety Assessment, Part C: PBT/vPvB assessment (R11), Version 3.0, June 2017
https://echa.europa.eu/documents/10162/17235/information_requirements_part_c_en.pdf/e56a6015-807e-46eb-b808-e5a7dc9fd572?t=1498463948441

Please note that this guidance is also under revision.
https://echa.europa.eu/support/guidance/consultation-procedure/ongoing-reach

The CLP criteria for persistence (P), bioaccumulation (B) and toxicity (T) are almost identical to the ones currently in Annex XIII of the REACH Regulation. Accordingly, the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11, currently being updated, will provide the first point of reference when evaluating these properties also under CLP.

This R.11 Guidance will be translated into CLP terminology in the Guidance on the Application of the CLP criteria to explain how to compare evidence with the CLP criteria.

Regarding mobility (M), new guidance is under development, including the weight-of-evidence determination for assessing all reliable and relevant information on mobility as a whole.

Chapters for endocrine disruptors, persistence, bioaccumulation, toxicity and mobility will be available by mid 2024.

 

Templates