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EU REACH: Updates on SVHCs, Registration, and CLH Proposals

from CIRS by

ECHA Proposes Adding Six SVHCs to Candidate List

On August 30, 2024, the European Chemicals Agency (ECHA) proposed adding six chemicals to the REACH Candidate List of Substances of Very High Concern (SVHC). These are:

  • 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (CAS: 2156592-54-8);
  • O,O,O-triphenyl phosphorothioate (CAS: 597-82-0);
  • Octamethyltrisiloxane (CAS: 107-51-7);
  • Perfluamine (CAS: 338-83-0);
  • Reaction mass of triphenylthiophosphate and tertiary butylated phenyl derivatives (CAS: 192268-65-8); and
  • Tris(4-nonylphenyl, branched) phosphite.

ECHA is holding a public consultation on these nominations until October 14, 2024. Stakeholders are invited to submit feedback, which will inform the final decision on their SVHC status. Further details are provided in the table below.

Name CAS Num. EC Num. Reason for proposing Common Uses
6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid 701-118-1 2156592-54-8 Toxic for reproduction (Article 57c) Synthesis intermediate for pharmaceuticals and pesticides.
O,O,O-triphenyl phosphorothioate 209-909-9 597-82-0 PBT (Article 57d) Flame retardant and stabilizer for plastics and rubber.
Octamethyltrisiloxane 203-497-4 107-51-7 vPvB (Article 57e) Drug carrier in pharmaceuticals.
Perfluamine 206-420-2 338-83-0 vPvB (Article 57e) Additive for high-performance coatings and lubricants.
Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives 421-820-9 192268-65-8 PBT (Article 57d) Stabilizer in pesticide production and plastic manufacturing.
Tris(4-nonylphenyl, branched) phosphite - - Endocrine disrupting properties (Article 57(f) – environment) Antioxidant in plastics and rubber to enhance durability.
Further Information

SVHC

Upcoming Approval for REACH Registration Testing Proposals for 22 Substances

On August 22, 2024, the European Chemicals Agency (ECHA) released testing proposals for 22 substances, inviting public comments by specified deadlines.

This public consultation process is integral to assessing whether additional tests are needed for registered chemicals under REACH regulations. Before moving forward with tests required under Annexes IX and X (for registration volumes of 100-1000 tonnes/year and over 1000 tonnes/year), registrants must submit a testing proposal. Following the public feedback period, ECHA will finalize the testing requirements based on stakeholder input and substance properties. This feedback helps refine safety assessments and adjust testing protocols accordingly. Registrants are then obligated to conduct these tests and update their safety data, ensuring chemical safety and promoting sustainable industry practices.

For detailed information on the 22 substances, please visithttps://echa.europa.eu/information-on-chemicals/testing-proposals/current

ECHA Holding a Public Consultation on CLH Proposals for Two Chemical Substances

On August 19, 2024, the European Chemicals Agency (ECHA) launched 60-day public consultations for the harmonized classification and labeling of two chemicals.

The CLH process aims to standardize hazard information across Europe, involving hazard evaluations, proposed classifications, public feedback, and final assessments by ECHA's Risk Assessment Committee (RAC).

Name EC Num. CAS Num. Hazard classes open for comment Start of consultation Deadline for comment
4-hydroxy-4-methylpentan-2-one; diacetone alcohol 204-626-7 123-42-2 Reproductive toxicity 19/08/2024 18/10/2024
8-methyldecan-2-yl propionate; 8-methyldecan-2-yl propanoate - 81931-28-4 Explosives
Flammable liquids
Self-reactive substances
Pyrophoric liquids
Self-heating substances
Substances which in contact with water emit flammable gases
Oxidising liquids
Corrosive to metals
Acute toxicity - inhalation
Acute toxicity - oral
Acute toxicity - dermal
Respiratory sensitisation
Skin corrosion/irritation
Serious eye damage/eye irritation
Skin sensitisation
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity – single exposure
Specific target organ toxicity – repeated exposure
Aspiration hazard
Hazardous to the aquatic environment
19/08/2024 18/10/2024
Further Information

CLH

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