The candidate list of substances of high concern (SVHC) under the EU REACH regulation is continuously updated to strengthen the supervision of potentially hazardous chemicals. According to the latest developments, the list has expanded from the initial few items to the current 253 items, covering various categories of substances that pose a threat to human health or the environment.

New categories of substances and criteria for determination

The newly added SVHC are mainly identified based on the following hazardous characteristics:

 

Reproductive Toxicity

Bisphenol AF (BPAF) and its salts are listed due to their clear harm to the human reproductive system. This type of substance is commonly found in industrial materials such as plastic plasticizers and epoxy resins.

 

Neurotoxicity

N-hexane has become the first substance to be included in SVHC due to neurotoxicity at the equivalent level of concern (ELOC), marking an expansion of REACH assessment criteria beyond the traditional carcinogenic, mutagenic, and reproductive toxicity (CMR) framework.

 

Very persistent and highly bioaccumulative (vPvB)

Siloxanes such as decamethyltetrasiloxane (D5) and 1,1,1,3,5,5,5,5-heptamethyl-3- [(trimethylsilyl) oxy] trisiloxane are strictly controlled due to their difficulty in degradation in the environment and their ability to accumulate in living organisms.

 

Azo dyes and allergenic components

Reactive Brown 51, which may release carcinogenic aromatic amines under specific conditions, is classified as a dye with sensitization risk.

 

Corporate compliance obligations

Once a substance is included in the SVHC candidate list, the relevant companies must immediately fulfill the following legal obligations:

Information transmission: If the SVHC content in the product exceeds 0.1% (by weight), the supplier must provide safety usage information to downstream customers and consumers.

SCIP Notification: According to the Waste Framework Directive (WFD), items containing SVHC are required to submit detailed information to ECHA's SCIP database to ensure traceability during the waste disposal phase.

SVHC Notification: If the annual export volume exceeds 1 ton and the SVHC content exceeds 0.1%, the manufacturer or importer must complete the formal notification to ECHA within six months.

Authorization preparation: Some SVHCs may be included in the authorization list in the future (Attachment XIV), and companies will need to apply for permission before they can continue to use them.