REACH with 250 SVHC

A list of 250 SVHC is under scrutiny. Indeed, as of March 2025, the European Chemicals Agency (ECHA) has initiated a public consultation to consider adding three substances to the REACH Substances of Very High Concern (SVHC) Candidate List.

What are the 3 Latest SVHC?

Substance Name	CAS #	Proposing Authority	Hazard & Concern	Application (Where they are used)	Ref.
1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxan	17928-28-8	Norway	Very Persistent and Very Bioaccumulative (vPvB) Concern: This substance does not easily break down in the environment and can accumulate in living organisms, leading to potential long-term ecological risks.	Used as a processing aid in industrial manufacturing. Functions as a silicone-based intermediate in the production of other chemicals. Used in coatings, sealants, and personal care products.	1
Decamethyltetrasiloxane	141-62-8	Norway	Very Persistent and Very Bioaccumulative (vPvB) Concern: This substance does not easily break down in the environment and can accumulate in living organisms, leading to potential long-term ecological risks.	Used as a processing aid in industrial manufacturing. Functions as a silicone-based intermediate in the production of other chemicals. Used in coatings, sealants, and personal care products.	2
Reactive Brown 51	EC #: 466-490-7)	Sweden	vPvB Concern: Similar to the first substance, this siloxane compound has high environmental persistence and bioaccumulation potential, raising concerns about long-term environmental exposure.	A textile dye used for coloring fabrics, particularly in cotton, wool, and other fibers. Used in the paper and leather industries for dyeing materials. May be present in inks and printing applications.	3

These substances come in additional to the current SVHC list.

Health and Environmental Concerns of Newly Proposed SVHC Substances Under EU REACH

Norway and Sweden have submitted to ECHA three substances for inclusion in the SVHC Candidate List under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation. As listed above, these substances, identified based on their hazardous properties, include:

1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane,
ecamethyltetrasiloxane, and
Reactive Brown 51.

The proposed classifications of these substances highlight significant human health and environmental risks, necessitating further regulatory scrutiny.

Environmental Concerns

1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane

This substance has been categorized as very persistent and very bioaccumulative (vPvB), raising serious environmental concerns. Persistence in the environment means that it does not readily degrade, leading to long-term contamination in ecosystems. Bioaccumulation implies that the substance accumulates in living organisms, potentially disrupting biological functions and affecting aquatic life. The continuous presence of vPvB substances in the environment can lead to toxic effects in the food chain, impacting both wildlife and human health.

Decamethyltetrasiloxane

Similar to 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane, decamethyltetrasiloxane is classified as a vPvB substance. This siloxane compound is widely used in personal care products, industrial coatings, and lubricants. Due to its high persistence, it remains in the environment for extended periods, accumulating in sediments, water bodies, and biota. The bioaccumulative nature of siloxanes has been associated with potential endocrine-disrupting effects and toxicity in aquatic species.

Health Concerns

Reactive Brown 51 – Toxic for Reproduction
Reactive Brown 51 is classified as toxic for reproduction (Repr. 1B) due to its potential to impair fertility and harm unborn children. Reproductive toxicants can lead to adverse effects such as reduced fertility, developmental abnormalities, and fetal toxicity. Long-term exposure to such dyes, especially in industrial settings, may pose occupational hazards for workers involved in textile and leather manufacturing (Kumar & Gupta, 2021). Additionally, residual traces in consumer products may increase human exposure risks.

Regulatory and Risk Management Implications of the 250 SVHC

The inclusion of these substances in the SVHC Candidate List could lead to strict regulatory measures, including mandatory safety assessments, use restrictions, and substitution with safer alternatives (European Commission, 2024). The potential classification of these chemicals under authorization or restriction processes under REACH would require industries to implement risk management measures to mitigate exposure to humans and the environment

Evaluation and Consideration of Proposed SVHC Substances Under EU REACH

The ECHA has initiated a public consultation process to evaluate three recently proposed substances for inclusion in the SVHC Candidate List under the REACH regulation. These substances—1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane, decamethyltetrasiloxane, and Reactive Brown 51—have been identified as potential threats due to their persistent, bioaccumulative, and toxic (PBT) properties or reproductive toxicity. This evaluation is crucial in determining the regulatory future of these chemicals, including potential restrictions or bans.

The Rationale for Consideration into the 250 SVHC List

The inclusion of a substance in the SVHC Candidate List is based on scientific assessments of its potential hazards, persistence in the environment, and risks to human health. The current evaluation focuses on the following concerns:

Persistence and Bioaccumulation
- 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane and decamethyltetrasiloxane have been classified as very persistent and very bioaccumulative (vPvB) substances. This means they do not degrade easily in the environment and accumulate in living organisms over time.
- Siloxanes, widely used in personal care products, industrial lubricants, and coatings, have been detected in aquatic environments and wildlife, raising concerns over their long-term ecological impact.
- Studies have shown that bioaccumulation of siloxanes can affect endocrine functions in aquatic species, leading to potential ecosystem disruptions.
Reproductive Toxicity
- Reactive Brown 51 has been identified as a reproductive toxicant (Repr. 1B) due to its potential effects on fertility and fetal development.
- Occupational exposure in textile, leather, and paper industries poses a health risk to workers, and residual contamination in consumer products raises broader human health concerns.
Regulatory Precedents and International Concerns

- The European Commission has previously restricted other siloxanes with similar vPvB properties due to their widespread environmental persistence.

Several international studies have highlighted the need for stricter regulations on persistent synthetic chemicals due to their long-term effects on both ecosystems and human health.

Decision-Making Process and Timeline for 250 SVHC

The evaluation of these substances follows the standard SVHC identification process under REACH, which includes:

1. Public Consultation (March-April 2025)

ECHA opened a public consultation period on March 26, 2025, inviting stakeholders, industry representatives, and scientific experts to submit data and opinions regarding the classification of these substances.
The consultation period is set to close on April 14, 2025.

2. Scientific Review and Committee Assessment (April-June 2025)

The Member State Committee (MSC) and ECHA’s Risk Assessment Committee will evaluate submitted data and determine whether these substances meet the criteria for SVHC
The review process involves a comprehensive risk analysis, considering alternative substances, socio-economic impacts, and environmental data.

3. Final Decision and Inclusion in 250 SVHC List

Once approved, substances are formally added to the SVHC Candidate List.
Once listed, companies must report their use of these chemicals in consumer products and may face authorization requirements before continued use.

Potential Implications of Inclusion to the 250 SVHC Candidate List

If these substances are added to the SVHC Candidate List, several regulatory and industrial changes may follow:

Increased regulatory scrutiny: Companies using these substances are required to provide detailed safety information and may need to phase out their use.
Possible authorization or restriction: If further risk assessments confirm their hazards, these substances may be subject to REACH authorization, requiring manufacturers to seek approval before continued use.
Industry shifts towards alternatives: The listing may encourage research into safer chemical substitutes, particularly in cosmetics, coatings, and textile dyeing industries.

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