Substances of Very High Concern
A Substance of Very High Concern identified under Article 57 of REACH. It meets CMR 1A/1B, PBT, vPvB criteria or is a substance of equivalent concern. Listed in ECHA’s Candidate List.
Context
An SVHC substance (Substance of Very High Concern) is a substance identified under Article 57 of REACH as of Very High Concern. It meets one or more criteria: CMR category 1A or 1B, PBT, vPvB or substance of equivalent concern.
Regulatory origin
Regulation (EC) 1907/2006 (REACH) Article 57. A public list managed by ECHA in the Candidate List. It is typically updated twice a year (June and December).
SVHC criteria (Article 57)
Carcinogenic, mutagenic or toxic for reproduction (category 1A confirmed or 1B presumed).
Persistent, bioaccumulative, toxic.
Very persistent, very bioaccumulative.
Substance of equivalent concern for human health or the environment.
Timeline
REACH enters into force
The SVHC mechanism is operational from the start of the Regulation.
First Candidate List
ECHA publishes the first identified SVHC.
Six-monthly update
ECHA updates the list in June and December each year.
Over 250 SVHC
The current Candidate List contains over 250 substances.
Applied case
A textile brand that imports zips from Asia checks whether they contain SVHC above 0.1 per cent weight/weight.
Receives the supplier’s SDS with the full composition of the zip (aluminium body, nickel coating, zamak pull).
Cross-checks components against the current SVHC Candidate List · detects lead (0.1 per cent threshold) in some batches.
Applies Article 33: communicates to B2B customers in free format + responds to the consumer within 45 days.
Notifies SCIP to ECHA in structured XML format with a reference to the article, concentration and location of the SVHC.
Common mistakes
SVHC does not mean "prohibited".
Being on the Candidate List generates information obligations. The operational prohibition arrives via inclusion in Annex XIV (authorisation) or Annex XVII (restrictions). They are different lists.
SVHC does not apply only to chemical substances sold as such.
It also applies to substances contained in articles. A dyed fabric is an article. If it contains SVHC >0.1% by weight, there is an obligation.
It is not the same as the Annex XVII restrictions.
Annex XVII restricts specific uses. SVHC is a list of candidates for future restrictions that ALREADY generate information obligations.
The 0.1% threshold is calculated on the article, not on the whole product.
A metal buckle with 0.1% SVHC integrated into a belt meets the threshold even if the mass of the buckle is small vs the product. ECHA clarifies this in its guidance on complex articles.
Frequently asked questions
What is an SVHC substance?
A Substance of Very High Concern under the REACH Regulation. In accordance with Article 57: a substance that meets one or more of the following criteria — CMR category 1A or 1B (carcinogenic, mutagenic, toxic for reproduction), PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative), or substances of equivalent concern.
Who must verify whether their articles contain SVHC?
Any brand or importer that places articles on the EU market. If an article contains SVHC at a concentration >0.1 per cent weight/weight it must (i) communicate the information to the B2B customer (Art. 33.1) or consumer within 45 days (Art. 33.2), and (ii) notify ECHA’s SCIP database.
How is a substance identified as SVHC?
Through the Article 59 REACH procedure: the Commission or a Member State prepares a dossier in accordance with Annex XV; ECHA publishes a notice inviting comments; within 60 days Member States and ECHA may submit comments; if there are no comments, ECHA includes the substance in the Candidate List automatically.
What is the difference between SVHC and a restricted substance under Annex XVII?
SVHC is a category of substance (it meets the Article 57 criteria). Annex XVII is the list of substances with restrictions that are IN FORCE and binding (direct prohibition of use under conditions). A substance can be SVHC without being in Annex XVII (only in the Candidate List + possibly Annex XIV). The two lists are not interchangeable.
How many SVHC substances are there currently?
In 2026 the ECHA Candidate List contains >250 identified SVHC substances. It is typically updated twice a year (June and December). Substances relevant to textiles: short-chain chlorinated paraffins SCCP, certain phthalates (DEHP, BBP, DBP), formaldehyde, certain PFAS. Current list at echa.europa.eu/candidate-list-table.
Fuentes oficiales
- European Chemicals AgencyActualización semestralRegulatory list
- European Chemicals Agency2024Technical guidance
- European Parliament and Council · OJEU2006 (vigente)Regulation in force
