ECHA updates on New Hazard Classes for Substances and Mixtures

ECHA updates on New Hazard Classes for Substances and Mixtures

The European Chemicals Agency (ECHA) has recently updated its guidelines on the classification, labelling, and packaging of substances and mixtures, introducing new hazard classes to provide more accurate and detailed information on potential risks. This update specifically aims to address endocrine disruptors and persistent, bioaccumulative and mobile substances.

The introduction of these new hazard classes is a significant step forward in providing more accurate and detailed information on the potential risks associated with the use of chemicals. This development is crucial for ensuring the safety of human health and the environment. ECHA has provided guidance on the application of these new hazard classes, including the effective dates for compliance with the new requirements. It is essential for companies to take these changes seriously and to take appropriate measures to ensure compliance with the new rules.

One of the new hazard classes is the endocrine disruption for human health (ED HH) categories 1 and 2. ED HH category 1 will be indicated with the code EUH380 and the hazard statement: “May cause endocrine disruption in humans.” Meanwhile, ED HH category 2 will have the code EUH381 and will be stated as “Suspected of causing endocrine disruption in humans.”

Endocrine disruptors in the environment will have a similar classification with categories 1 and 2. ED ENV 1 will be announced with the code EUH 430, and its hazard statement is “may cause endocrine disruption in the environment”. ED ENV 2 will have the code EHU 431 and will be stated as “suspected of causing endocrine disruption in the environment”.

Persistent substances also have four new categories, namely persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), and very persistent very mobile (vPvM). These categories are indicated with the hazard statements EUH440: Accumulates in the environment and living organisms including in humans, EUH441: Strongly accumulates in the environment and living organisms including in humans, EUH450: Can cause long-lasting and diffuse contamination of water resources, and EUH441: Can cause very long-lasting and diffuse contamination of water resources, respectively.

The new rules came into force on 20 April 2023, and member states can make proposals using these new hazard classes for harmonized classification and labelling. Manufacturers, importers, downstream users, and distributors can already use them in their substances and mixtures. For new substances on the market, companies need to comply with the new rules from 1 May 2025. Substances that have already been on the EU market will have a transitional period from 1 May 2025 to 1 November 2026 where compliance becomes mandatory.

Different transition times apply to mixtures. New hazard classes apply from 1 May 2026 to new mixtures, and companies have a transitional period from 1 May 2026 until 1 May 2028, where updating the classification and labelling for existing mixtures becomes mandatory.

If you need support with CLP classification of substances/mixtures please contact the regulatory team at Kerona Scientific at info@kerona.ie or call the office at +353 1 8495284