As part of its ongoing commitment to chemical safety and regulation, the European Chemicals Agency (ECHA) has recently made significant strides in its REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) program. This blog post provides a comprehensive overview of the latest updates regarding the inclusion of new Substances of Very High Concern (SVHC) in the Candidate List, upcoming testing proposals, and public consultations on Harmonized Classification and Labelling (CLH) for various chemical substances.

New SVHC Proposals

On August 30, 2024, ECHA proposed the addition of six new chemicals to the REACH Candidate List of SVHCs. These substances have been identified based on their hazardous properties, which pose risks to human health and the environment. The proposed substances include:

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

ECHA is conducting a public consultation on these nominations until October 14, 2024, inviting stakeholders to submit their feedback. This consultation is crucial in determining the final SVHC status of these substances.

Upcoming REACH Registration Testing Proposals

On August 22, 2024, ECHA released testing proposals for 22 substances, inviting public comments before specified deadlines. This public consultation is a critical part of the REACH process, allowing for assessment on whether additional tests are needed for registered chemicals.

Registrants are required to submit a testing proposal prior to conducting tests needed under Annexes IX and X (for registration volumes of 100-1000 tonnes/year and over 1000 tonnes/year). Following the feedback period, ECHA will finalize testing requirements based on stakeholder input and the properties of the substances.

This collaborative approach aims to enhance safety assessments and improve testing protocols. Registrants will then be obligated to conduct these tests and update their safety data, ensuring compliance with chemical safety standards and promoting sustainable industry practices.

For detailed information on the 22 substances, please visit ECHA’s testing proposals page.

Public Consultation on CLH Proposals

On August 19, 2024, ECHA initiated a 60-day public consultation for the harmonized classification and labeling of two chemical substances. The CLH process aims to standardize hazard information across Europe, ensuring clear communication of risks associated with chemical substances.

The substances under consultation are:

1. 4-hydroxy-4-methylpentan-2-one (diacetone alcohol)
   • CAS Number: 123-42-2
   • Hazard classes open for commenting: Reproductive toxicity
   • Consultation period: August 19, 2024 – October 18, 2024
2. 8-methyldecan-2-yl propionate (8-methyldecan-2-yl propanoate)
   • CAS Number: 81931-28-4
   • Hazard classes open for commenting:
     • 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, oral, dermal)
     • Respiratory sensitisation
     • Skin corrosion/irritation
     • Serious eye damage/eye irritation
     • Skin sensitisation
     • Germ cell mutagenicity
     • Carcinogenicity
     • Reproductive toxicity
     • Specific target organ toxicity (single and repeated exposure)
     • Aspiration hazard
     • Hazardous to the aquatic environment
   • Consultation period: August 19, 2024 – October 18, 2024

This consultation is critical for gathering public input on the proposed classifications, which will then be assessed by ECHA’s Risk Assessment Committee (RAC).

The recent developments in EU REACH concerning SVHC registrations, testing proposals, and CLH consultations underscore the importance of stakeholder engagement in the regulatory process. Companies operating within the EU chemical market must stay informed about these changes to ensure compliance, mitigate risks, and capitalize on opportunities for innovation in chemical safety and sustainability.

Source 1

Source 2