EU REACH CANDIDATE LIST REACH OF SVHC

On July 8th, 2021, eight new EU REACH substances of very high concern (SVHCs) were added to the REACH Candidate List. These 8 chemicals are:

Substance Name	CAS # (Chemical Abstracts Service)	Where used (examples)
Medium-chain chlorinated paraffins (MCCP) [UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17]	–	Flame retardants and secondary plasticizing additives in plastics (PVC, cables, paints, coatings, etc.), adhesives (‘potting agents’ in electronic equipment, printed circuit boards (PCBs), etc.), sealants (polysulphide, polyurethane, acrylic, and butyl sealants, etc.), rubber (butyl rubber, etc.), and textiles. Coolants and lubricants (working fluids) in machinery and manufacture for metal products (cutting, grinding). Source: https://echa.europa.eu/documents/10162/d76192af-d18b-5a4e-2fc5-0219d09053a6
Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)	–	In the preparation of lubricant additives and fuel cleaners (in petrol- and diesel-powered engines). Chemical intermediate, transformed during the synthesis of chemicals (oil production), rubbers (tires), resins, paints, inks, and polymers plastic products. Source: https://echa.europa.eu/documents/10162/12b8138f-c562-8cd6-3da9-9492468d0ea8
Glutaral (Glutaraldehyde; GA)	111-30-8	Biocide in many industries (paper, paint, food, wood, cosmetics, medical devices, etc.), leather tanning, x-ray film processing, with possible other applications. Source: https://echa.europa.eu/documents/10162/ea9882b6-43f4-bf01-b54e-8ad9e4d047bf
4,4′-(1-methylpropylidene)bisphenol; (bisphenol B; BPB)	77-40-7	It may be used in the manufacture of phenolic and polycarbonate resins. Source: https://echa.europa.eu/documents/10162/526bbb99-fc0e-2959-eff4-bac584db1f24
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers	–	An intermediate or chemical compound in mixtures (e.g. cleaning agents, personal care products, paints, inks, and toners). Source: https://echa.europa.eu/documents/10162/eeb75545-127f-a33d-a6e3-3929fa0335e2
2,2-bis(bromomethyl)propane1,3-diol (BMP) 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA) 2,3-dibromo-1-propanol (2,3-DBPA)	1522-92-5, 3296-90-0, 36483-57-5, 96-13-9	Flame retardants, monomer intermediates in the manufacture of polymer resins or chemicals. Source: https://echa.europa.eu/documents/10162/264b955f-492b-ab69-951d-82bc1db1ca1a
1,4-dioxane	123-91-1	Mainly a solvent in the synthesis of chemicals. Found as a by-product, a constituent, or an impurity in mixtures. Source: https://echa.europa.eu/documents/10162/435f5245-3bad-5ff5-65f3-0b279c9b6847
Orthoboric acid, sodium salt	13840-56-7	Possible use as a solvent and a corrosion inhibitor. Source: https://echa.europa.eu/documents/10162/d603744a-2792-4092-7fa0-0c34319a516a

As a result, the SVHC list may include 219 SVHCs as of July 2021. If your articles sold into the EU market have components that contain SVHCs above the threshold of 0.1%, then they must be declared on the SCIP database.

Let’s Dive Deeper into 1,4-Dioxane:

What Is 1,4-Dioxane?

1,4-Dioxane (EC No. 204-661-8; CAS No. 123-91-1) is a synthetic, volatile, and flammable industrial chemical. It emits a faintly sweet odor and dissolves easily in water. Historically, manufacturers used it as a solvent, reaction medium, and stabilizer for chlorinated solvents.

Although its direct use in product formulations has significantly decreased, 1,4-dioxane remains an issue today. It commonly forms unintentionally during the ethoxylation process, a chemical reaction used to produce ethoxylated surfactants. These surfactants are prevalent in:

Cleaning agents
Personal care products
Also, detergents

Consequently, even when manufacturers do not deliberately add 1,4-dioxane, trace levels can still appear in a wide range of consumer products. As a result, regulatory attention has intensified to better understand its occurrence and potential health effects.

Why Is 1,4-Dioxane Being Considered an SVHC?

ECHA’s justification for proposing 1,4-dioxane as an SVHC lies in its classification as a Category 1B carcinogen under the CLP Regulation (Regulation (EC) No. 1272/2008). This means that, this classification means that the substance is presumed to cause cancer in humans.

In addition to its carcinogenicity, ECHA highlights other key concerns:

First, inhalation exposure risk: Workers may inhale 1,4-dioxane during manufacturing or processing, especially in confined environments.
Second, contaminant presence: The substance may appear unintentionally in formulations, complicating supply chain monitoring.
Finally, persistence in the environment: While not formally classified as a persistent, bioaccumulative, or toxic (PBT) substance, 1,4-dioxane is resistant to environmental degradation and has been detected in groundwater.

Given these factors, ECHA determined that 1,4-dioxane meets the criteria of Article 57(a) of the REACH Regulation, which addresses substances with carcinogenic properties.

Where Is 1,4-Dioxane Found?

Although 1,4-dioxane is not often added intentionally, it may appear in a wide range of products as a residual contaminant. These include:

Shampoos, soaps, and body washes
Industrial cleaning solutions
Laundry detergents and dishwashing liquids
Paints, inks, and varnishes
Textile and leather treatments
Pharmaceutical intermediates
Adhesives and sealants
Also, plastic and packaging materials

Moreover, 1,4-dioxane’s presence in municipal wastewater and groundwater has raised environmental concerns. As a result, in several countries, it has been detected in drinking water sources, which prompted additional scrutiny from environmental authorities.

Need assistance for the SVHC assessment in your products, REACH declarations, and the SCIP notification?

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