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No Regulatory Action Needed for Inorganic Carboxylates

REACH
24
February 2025
•
450
Dr Steven Brennan
ECHA's latest assessment confirms no regulatory risk management actions are needed for inorganic carboxylates. Learn how this impacts manufacturers, suppliers, and industry stakeholders.
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Summarise this article

ECHA’s latest assessment confirms no EU-wide regulatory risk management actions for inorganic carboxylates, ensuring stability for manufacturers, suppliers, and downstream users. While zinc-based substances require company-level risk management, the broader group remains safe for continued use. This decision removes uncertainty for businesses relying on these chemicals.

Will ECHA revisit the regulatory status of inorganic carboxylates?

ECHA’s assessment is based on the latest data but may be updated if new hazard evidence emerges. Companies should stay informed on regulatory developments and maintain compliance with existing safety standards.

Do manufacturers need to change their safety measures for inorganic carboxylates?

For most substances, no additional measures are required. However, companies handling zinc-based carboxylates should implement risk management for aquatic toxicity. Always check Safety Data Sheets (SDS) and regulatory classifications for updates.

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The European Chemicals Agency (ECHA) has completed its Assessment of Regulatory Needs for inorganic carboxylates, concluding that no further regulatory risk management (RRM) measures are required at the EU level. Published on 6 February 2025, the report evaluates 76 substances, including acetic acid, citric acid, and propionic acid. Manufacturers and value chain partners can expect continued use of these widely applied chemicals without additional compliance burdens.

Key Findings: Low Hazard Profile and High Biodegradability

ECHA’s assessment found no evidence of carcinogenic, mutagenic, reprotoxic (CMR), endocrine-disrupting (ED), persistent, bioaccumulative, and toxic (PBT), or persistent, mobile, and toxic (PMT) properties in these substances. Most inorganic carboxylates are readily biodegradable and do not bioaccumulate, minimising environmental concerns.

However, four zinc-based salts—including zinc di(acetate) (CAS 557-34-6) and trizinc dicitrate (CAS 546-46-3)—were self-classified for aquatic toxicity. These substances require risk management measures (RMM) at the company level rather than additional EU-wide regulations.

Widespread Industrial and Consumer Use

Key Applications Across Sectors

Inorganic carboxylates are essential across multiple industries, including:

  • Cleaning products (e.g., acetic acid in disinfectants)
  • Cosmetics and personal care (e.g., citric acid as a pH regulator)
  • Food and feed additives (e.g., propionic acid as a preservative)
  • Pharmaceuticals (e.g., tartaric acid as an excipient)
  • Water treatment (e.g., formic acid in descaling agents)

ECHA noted that 56 out of 63 fully registered substances are used by both professionals and consumers, posing potential exposure risks. However, due to their favourable hazard profiles, no additional risk management actions are required beyond existing classifications.

What This Means for Manufacturers and Suppliers

The absence of new restrictions offers regulatory stability for manufacturers, suppliers, and downstream users. Companies can continue current production and formulation processes without disruption. However, businesses dealing with zinc-based inorganic carboxylates should ensure compliance with self-imposed environmental safety measures.

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