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REACH with 247 SVHC

On August 30th, 2024, the European Chemicals Agency (ECHA) proposed adding six substances to its list of Substances of Very High Concern (SVHCs) under REACH regulations, for a total of 247 SVHCs. On November 7th, 2024, triphenyl phosphate was added to the list. Then, on Januray 21st, 2025, the remaining 5 SVHCs completed the list. This step is part of efforts to improve chemical safety across industries.

UK REACH Registration

What Are These Six New Chemicals to 247 SVHC?

Authorities from different European countries proposed the following six substances to the EU REACH candidate list of SVHCs.

Substance Name

CAS #

Proposing Authority

Hazard

Application (Where used)

Ref.

6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (also known as Tetra-PSCA)

2156592-54-8

Austria

Reprotoxic

Used in lubricants, greases, release products, and metal working fluids. Its utilization extends to formulation of packaging (no consumer uses).

1

O,O,O-triphenyl phosphorothioate

597-82-0

Netherlands

Persistent, Bioaccumulative, and Toxic (PBT)

Used in lubricants, greases, hydraulic and metal working fluids. It can also be used as cooling liquids in refrigerators, oil-based electric heaters, lubricants in motor oil and break fluids, etc.

2

Octamethyltrisiloxane

107-51-7

Norway

Very Persistent and Very Bioaccumulative (vPvB)

Used in the formulation and production of cosmetics and personal care products, health care products, pharmaceuticals, non-metal surface treatment, automotive care products (e.g., polishes, wax blends, washing, and cleaning products), adhesives, sealants, coatings, inks, paints, plasters, etc.

3

Perfluamine

338-83-0

Belgium

vPvB

It is a PFAS used in the manufacturing of computers, electrical and electronic devices, and optical equipment as a heat transfer fluid and immersion cooling in semiconductors, and in semiconductors thermal testing. 

4

Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives

192268-65-8

Netherlands

PBT

Used in lubricants, greases, metal working fluids, and hydraulic fluids in industrial sites. It can also be used as cooling liquids in refrigerators, lubricants in motor oil, and oil-based electric heaters used by professional workers.

5

And a 6th substance added back in Nov 2024:


Tris(4-nonylphenyl, branched and linear) phosphite




-




France




Endocrine disruptor




Used in polymers, plastic products, rubber products, adhesives, sealants, and coatings. This substance was added to the SVHC list on November 7, 2024, before the other above.

6

Approval Process of the 247 SVHC

These substances have been under public consultation to potentially restrict or regulate their use due to environmental and health impacts. The consultation ended on October 14, 2024.

This move reflects ongoing EU efforts to reduce the use of hazardous chemicals in products and industrial processes.

What Are the Environmental and Health Concerns of These 247 SVHC?

Health Concerns

  1. Toxicity: Substances such as O,O,O-triphenyl phosphorothioate and Perfluamine can cause long-term damage to organs like the liver and nervous system. Moreover, some are linked to cancer, reproductive harm, or developmental issues in infants.
  2. Endocrine Disruption: Chemicals like Octamethyltrisiloxane and Tris(4-nonylphenyl) phosphite are suspected of disrupting hormonal systems, leading to reproductive and developmental problems.
  3. Irritation: Substances like 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid can cause skin and eye irritation and may be harmful with prolonged exposure.

Environmental Concerns

  1. Persistence: Chemicals such as Perfluamine (a PFAS) and Octamethyltrisiloxane are highly resistant to breaking down in the environment, leading to long-lasting pollution.
  2. Bioaccumulation: Substances, including Tris(4-nonylphenyl) phosphite, are prone to building up in living organisms, posing risks to wildlife and ecosystems.
  3. Aquatic Toxicity: Some chemicals can harm aquatic life, potentially causing long-term damage to ecosystems, especially for water-based organisms.

What Should Companies Do to Maintain Compliance with REACH 247 SVHC?

When a substance is added to the list of Substances of Very High Concern (SVHC) under EU REACH regulations, manufacturers, importers, and downstream users are required to take several steps to ensure compliance and manage risks:

  1. Communication Obligations: If a product contains more than 0.1% of any SVHC, suppliers must inform their customers and provide sufficient information on safe use. For consumers, this information must be provided upon request, typically within 45 days.
  2. Authorization Requirement: Once the substance is included in the Authorization List (Annex XIV of REACH), companies must apply for permission to continue using the substance. Without this authorization, the use of the substance is prohibited after a specific “sunset date.”
  3. Notification to ECHA: If the product contains an SVHC in quantities greater than 1 ton per year and above 0.1% concentration, manufacturers and importers must notify ECHA, unless the use of the substance has already been registered under REACH.
  4. Substitution Plans: In many cases, inclusion on the SVHC list prompts manufacturers to look for safer alternatives. Companies are encouraged to explore substitutes to reduce risks, especially if the substance poses significant health or environmental hazards.
  5. Safety Data Sheets: The presence of an SVHC requires an update to the Safety Data Sheets (SDSs), ensuring all downstream users are aware of the risks and necessary precautions.

 

By ensuring compliance, companies can minimize legal and financial risks, protect worker safety, and maintain market access within the EU.

If you have any questions regarding SVHCs and REACH compliance, contact Enviropass!