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Overview of Ethylenediamine (EDA) under REACH

Updated: 2 days ago

Understanding the regulatory and industrial challenges associated with this substance subject to authorisation


Introduction

Ethylenediamine (EDA, CAS 107-15-3) is a chemical compound widely used as an intermediate in many industrial processes, such as chemical synthesis, resin manufacturing, chelating agents, and additives for lubricating oils.


However, due to its hazardous properties, in particular its classification as a respiratory and skin sensitiser, EDA has been identified as a Substance of Very High Concern (SVHC). At this stage, it is included in the 11th Recommendation List for a possible inclusion in Annex XIV of the REACH Regulation.


As a reminder, intermediate uses are exempt from REACH authorisation. A future inclusion in Annex XIV would therefore apply only to non-intermediate uses.


This overview aims to explain why EDA is concerned by the REACH authorisation process, which stakeholders could be impacted, and how CEHTRA supports its clients throughout this strategic process.


Why is Ethylenediamine subject to authorisation?

EDA presents several critical hazards, in particular:

  • Respiratory sensitisation (Skin Sens. 1, Resp. Sens. 1), with a high risk of severe allergic reactions, even at low exposure levels.


These properties led to its identification as a Substance of Very High Concern (SVHC).

When a substance is included in Annex XIV of REACH, its use becomes prohibited after a sunset date, unless an authorisation is granted for a specific use.


The objectives of REACH authorisation applied to EDA are to:

  • control health risks linked to exposure, particularly in occupational settings,

  • encourage companies to identify safer alternatives,

  • allow only those uses for which no technically or economically viable alternative is available.


Who is concerned?

The following stakeholders would be directly concerned by authorisation:

  • Industrial users of EDA for non-intermediate uses, in particular:

    • formulation of resins, adhesives, coatings or inks,

    • manufacture of finished products containing EDA,

    • certain applications in lubricants, additives or treatment products,

  • Importers placing this substance on the market for a specific use.

  • Companies along the value chain when they rely on a product containing EDA.


As for any Annex XIV substance, authorisation is linked to the use, not to the substance itself. A company may be authorised for one use, but not for another.


When should an authorisation be requested?

To date, Ethylenediamine (EDA) has not yet been formally included in Annex XIV of REACH. It is currently listed in the 11th Recommendation List, meaning that a future inclusion is being considered, potentially by 2026.


As a result, the key regulatory dates, namely the Latest Application Date (LAD) and the Sunset Date, are not yet defined. They will only be set once a potential inclusion in Annex XIV is confirmed.


Once these dates are published, the application must be submitted before the Latest Application Date (LAD).


Submitting the application before the LAD would then allow:

  • continued use of EDA after the Sunset Date, while the ECHA and the European Commission finalise their assessment,

  • maintenance of industrial continuity without interruption.


Once granted, the authorisation allows the use to continue under strictly controlled conditions.


As a reminder, the full REACH authorisation procedure is described in detail in our dedicated article.


For any questions or to assess your situation regarding Ethylenediamine, our experts are at your disposal.



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