[Regulation]Regulation update: ECHA Adds Two New SVHCs

11 Feb 2026


On February 4, 2026, ECHA1) designated two new chemicals as SVHCs2) and added them to the Candidate List3). Consequently, the total number of entries in the list has increased from 251 to 253.

1) ECHA: European Chemicals Agency
2) SVHC: Substances of Very High Concern
3) Candidate List: The list of substances of very high concern for Authorisation


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1) Regulatory Overview


REACH (EC 1907/2006) is an integrated regulation for the Registration, Evaluation, Authorization, and Restriction of Chemicals. Pursuant to Articles 57 & 59 of the regulation, substances primarily exhibiting the following characteristics are identified as SVHCs and officially included in the Candidate List.

  • CMR: Carcinogenic, Mutagenic & Toxic for Reproduction

  • PBT: Persistent, Bioaccumulative & Toxic

  • vPvB: very Persistent & very Bioaccumulative

  • Substances giving rise to an equivalent level of concern to human health or the environment (e.g., endocrine disrupting properties) in accordance with Article 57(f).



2) Key Changes


Two new chemical entries have been added. Please refer to the table below for detailed information on each entry.


Entry
CAS No.
Reason for Inclusion
Examples of uses

n-hexane

110-54-3

Specific target organ toxicity after repeated exposure
(Article 57(f) - human health)

Formulation, polymer processing, coatings and cleaning agent

4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and its salts

-

Toxic for reproduction (Article 57c)

Process regulator and cross-linking agent



3) Business Impact


Companies manufacturing, importing, or distributing parts or products containing SVHCs in a concentration above 0.1% (w/w) are subject to the following obligations:

  • Duty to Communicate Information (Article 33): Provide customers and consumers with the name of the SVHC and sufficient information for safe use.

  • Duty to Notify ECHA (Article 7(2)): Notify ECHA if the total quantity of the substance exceeds 1 tonne per year and exposure cannot be excluded.

  • SCIP1) Registration: Submit information regarding the SVHC and the product to the database operated by ECHA.

1) SCIP (Substances of Concern In Products): ECHA database for registering information on products containing SVHCs.


Substances on the Candidate List undergo continuous evaluation and may eventually be added to the Authorisation List. Once listed there, their use is banned in principle unless specific authorization is granted. Therefore, preemptive measures—such as reviewing alternative substances, strengthening supply chain communication, and establishing long-term response strategies—are required starting from the Candidate List stage.



4) IMDS Impact


Updates regarding SVHCs are reflected in the substance information within the IMDS system. In accordance with Release 15.1 implementation, if a substance designated as an SVHC is currently set as a confidential substance, it will be immediately revealed. Consequently, once the immediate disclosure process is complete, a pop-up regarding GADSL/SVHC update will appear upon accessing IMDS. Users must complete the confirmation process to log in.


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[Fig. 1 Pop-up window displayed upon login after applying the GADSL/SVHC update]


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