SVHC

Summary

According to Article 57 of the REACH regulation, SVHC (Substance of Very High Concern) is a substance that meets one or more of the following hazardous characteristics:

1. Substances in Class 1/2 that are carcinogenic, teratogenic, and have reproductive toxicity, namely CMR1/2 substances;

2. Persistent, bioaccumulative, and toxic substances, namely PBT substances;

3. Substances with high persistence and high bioaccumulation, namely vPvB substances;

4. Substances with endocrine disrupting properties, persistence, bioaccumulation and toxicity, or high persistence, high bioaccumulation but not meeting the criteria of 2 and 3, and with scientific evidence proving serious impacts on humans or the environment.

Substances that meet the requirements of Article 57 of REACH are generally considered as substances of high concern (SVHC). For substances of high concern (SVHC) that meet the following conditions, notification is required in accordance with Article 7 (2) of REACH:

(1) The substance has been included in the list of candidate substances that require permission for use (Annex XIV);

(2) The concentration of the substance in the item is greater than 0.1% (weight ratio W/W);

(3) Each manufacturer or importer produces or imports more than 1 ton of the substance annually;

(4) This substance has not been registered for this purpose.

SVHC Authorization Candidate List

The competent authorities or institutions of member states may propose to include substances in the SVHC candidate list by submitting substance files that meet the above characteristics. Stakeholders will be invited to comment on the substances in the dossier, and once discussed and approved, the substance will be identified as an SVHC substance, i.e. an authorized candidate substance.

Authorized substances are selected as priority substances from the list of authorized candidate substances, namely SVHC substances, and are listed in Annex XIV (Authorization List). Manufacturers, importers, or downstream users in the supply chain must submit authorization applications to ECHA 18 months before sunset in order to obtain the right to use or place in the EU market.

As of now, there are 233 substances on the SVHC list, and the list release process is as follows:

On October 28, 2008, the European Chemicals Agency (ECHA) announced the first batch of 15 substances on the SVHC list.

On January 13, 2010, the European Chemicals Agency (ECHA) announced the second batch of 14 substances on the SVHC list.

On March 30, 2010, the European Chemicals Agency (ECHA) announced the inclusion of acrylamide in its list.

On June 18, 2010, the European Chemicals Agency (ECHA) released the third batch of SVHC list consisting of 8 substances.

On December 15, 2010, the European Chemicals Agency (ECHA) announced the fourth batch of SVHC list consisting of 8 substances.

On June 20, 2011, the European Chemicals Agency (ECHA) released the fifth batch of SVHC list consisting of seven substances.

On December 19, 2011, the European Chemicals Agency (ECHA) announced the list of 20 substances in the sixth batch of SVHC.

On June 18, 2012, the European Chemicals Agency (ECHA) released the seventh batch list of 13 substances for SVHC.

On December 19, 2012, the European Chemicals Agency (ECHA) announced the eighth batch of 54 substances on the SVHC list.

On June 20, 2013, the European Chemicals Agency (ECHA) announced the sixth batch of substances on the SVHC list.

On December 16, 2013, the European Chemicals Agency (ECHA) released the tenth batch of SVHC list consisting of seven substances.

On June 16, 2014, the European Chemicals Agency (ECHA) released the eleventh batch of SVHC list consisting of four substances.

On December 17, 2014, the European Chemicals Agency (ECHA) announced the list of six substances in the twelfth batch of SVHC.

On June 15, 2015, the European Chemicals Agency (ECHA) announced two substances on the thirteenth batch of the SVHC list.

On December 17, 2015, the European Chemicals Agency (ECHA) released the 14th batch list of 5 substances in SVHC.

On June 20, 2016, the European Chemicals Agency (ECHA) announced one substance on the 15th batch list of SVHC.

On January 12, 2017, the European Chemicals Agency (ECHA) released the 16th batch of SVHC list consisting of four substances.

On July 7, 2017, the European Chemicals Agency (ECHA) announced one substance on the 17th batch of SVHC list.

On January 16, 2018, the European Chemicals Agency (ECHA) announced the 18th batch of SVHC list consisting of 7 substances.

On June 27, 2018, the European Chemicals Agency (ECHA) announced the list of 10 substances in the 19th batch of SVHC.

On January 15, 2019, the European Chemicals Agency (ECHA) announced the list of six substances in the 20th batch of SVHC.

On July 16, 2019, the European Chemicals Agency (ECHA) announced the list of four substances in the 21st batch of SVHC.

On January 16, 2020, the European Chemicals Agency (ECHA) released the 22nd batch of SVHC list consisting of four substances.

On June 25, 2020, the European Chemicals Agency (ECHA) released the 23rd batch of SVHC list consisting of four substances.

On January 19, 2021, the European Chemicals Agency (ECHA) announced two substances on the 24th batch of the SVHC list.

On March 16, 2021, the European Chemicals Agency (ECHA) announced the list of 8 substances in the 25th batch of SVHC.

On January 18, 2022, the European Chemicals Agency (ECHA) announced the 26th batch of SVHC list consisting of four substances.

On June 10, 2022, the European Chemicals Agency (ECHA) announced one substance on the 27th batch list of SVHC.

On January 17, 2023, the European Chemicals Agency (ECHA) announced the 28th batch of SVHC list consisting of 9 substances.

On June 14, 2023, the European Chemicals Agency (ECHA) announced two substances on the 29th batch of the SVHC list.

On January 23, 2024, the European Chemicals Agency (ECHA) announced the list of 5 substances in the 30th batch of SVHC.

On June 27, 2024, the European Chemicals Agency (ECHA) announced one substance on the 31st batch list of SVHC.

On November 7, 2024, the European Chemicals Agency (ECHA) announced one substance on the 32nd batch list of SVHC.

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