SVHC Testing Service

SVHC

1. Introduction to SVHC

SVHC stands for Substance of Very High Concern, which refers to a category of hazardous substances defined under the EU REACH regulation.

SVHCs often possess one or more of the following hazardous properties (as per Article 57 of the REACH regulation):

（1）CMR  Carcinogenic, mutagenic, or toxic to reproduction substances of category 1 or 2;

（2）PBT  Persistent, bioaccumulative, and toxic substances;

（3）vPvB  Very persistent and very bioaccumulative substances;

（4）Other substances with evidence of equivalent concern, such as endocrine disruptors.

2. Candidate List of Substances

Candidate List of Substances = SVHC List

The REACH regulation designates SVHCs as candidate substances for authorization (REACH Annex XIV).

3. Responsibilities and Obligations

The REACH regulation categorizes products into the following three types: substances, mixtures, and articles. Enterprises producing SVHCs or manufacturing products containing SVHCs have different responsibilities and obligations.

Substances: When SVHCs are sold as substances, a Safety Data Sheet (SDS) must be provided to downstream users.

Mixtures: When an SVHC is a component of a mixture and its concentration is >0.1%, an SDS must be provided to downstream users.

Articles: When articles contain SVHCs, the main responsibilities and obligations are notification and information transmission.

4. Notification Conditions:

(1) The concentration of the substance in the article is greater than 0.1% (weight/weight);

(2) The total quantity of the substance manufactured or imported annually by each manufacturer or importer exceeds 1 ton;

(3) The substance has not been registered for this specific use.

lNotification Exemptions:

Enterprises may be exempt from notification if any of the following conditions are met:

（1）If the manufacturer or importer can demonstrate that, under normal or reasonably foreseeable conditions of use (including disposal), measures are in place to ensure that the SVHC substance is not released to humans or the environment, the notification obligation is waived. However, appropriate instructions must be provided to the recipient of the article.

（2）If another manufacturer or importer has already completed registration for the same use of the substance.

lInformation Transmission:

According to Article 31 and Annex II of the REACH regulation, when a mixture contains an SVHC from the Candidate List at a concentration exceeding 0.1% (by weight) in non-gaseous mixtures or 0.2% (by volume) in gaseous mixtures, an SDS must be provided.

According to Article 33 of the REACH regulation, when an article contains an SVHC from the Candidate List at a concentration exceeding 0.1% (by weight), sufficient information to ensure safe use must be provided within 45 days upon request by the recipient.

5. SVHC List

The SVHC List is typically updated twice a year. The current SVHC List consists of 29 batches, totaling 235 substances.

SVHC List Update History:

The first batch of the SVHC List (15 substances) was officially announced and came into effect on October 28, 2008.

The second batch of the SVHC List (13 substances) was officially announced and came into effect on January 13, 2010, and March 30, 2010.

The third batch of the SVHC List (8 substances) was officially announced and came into effect on June 18, 2010.

The fourth batch of the SVHC List (8 substances) was officially announced and came into effect on December 15, 2010.

The fifth batch of the SVHC List (7 substances) was officially announced and came into effect on June 20, 2011.

The sixth batch of the SVHC List (20 substances) was officially announced and came into effect on December 19, 2011.

The seventh batch of the SVHC List (13 substances) was officially announced and came into effect on June 18, 2012.

The eighth batch of the SVHC List (54 substances) was officially announced and came into effect on December 19, 2012.

The ninth batch of the SVHC List (6 substances) was officially announced and came into effect on June 20, 2013.

The tenth batch of the SVHC List (7 substances) was officially announced and came into effect on December 16, 2013.

The eleventh batch of the SVHC List (4 substances) was officially announced and came into effect on June 16, 2014.

The twelfth batch of the SVHC List (6 substances) was officially announced and came into effect on December 17, 2014.

The thirteenth batch of the SVHC List (2 substances) was officially announced and came into effect on June 15, 2015.

The fourteenth batch of the SVHC List (5 substances) was officially announced and came into effect on December 17, 2015.

The fifteenth batch of the SVHC List (1 substance) was officially announced and came into effect on June 20, 2016.

The sixteenth batch of the SVHC List (4 substances) was officially announced and came into effect on January 12, 2017.

The seventeenth batch of the SVHC List (1 substance) was officially announced and came into effect on July 7, 2017.

The eighteenth batch of the SVHC List (7 substances) was officially announced and came into effect on January 15, 2018.

The nineteenth batch of the SVHC List (10 substances) was officially announced and came into effect on June 27, 2018.

The twentieth batch of the SVHC List (6 substances) was officially announced and came into effect on January 15, 2019.

The twenty-first batch of the SVHC List (4 substances) was officially announced and came into effective on July 16, 2019.

The twenty-second batch of the SVHC List (4 substances) was officially announced and came into effect on January 16, 2020.

The twenty-third batch of the SVHC List (4 substances) was officially announced and came into effect on June 25, 2020.

The twenty-fourth batch of the SVHC List (2 substances) was officially announced and came into effect on January 19, 2021.

The twenty-fifth batch of the SVHC List (8 substances) was officially announced and came into effect on July 8, 2021.

The twenty-sixth batch of the SVHC List (4 substances) was officially announced and came into effect on January 17, 2022.

The twenty-seventh batch of the SVHC List (1 substance) was officially announced and came into effect on June 10, 2022.

The twenty-eighth batch of the SVHC List (9 substances) was officially announced and came into effect on January 17, 2023.

The twenty-ninth batch of the SVHC List (2 substances) was officially announced and came into effect on June 14, 2023.

6. Response Methods

Currently, the EU strictly enforces the REACH regulation for products circulating within its territory. This means that products within the EU must comply with all obligations under the REACH regulation to be legally manufactured or imported. SVHC is a critical component of the REACH regulation, and failure to provide information on SVHCs in products constitutes a violation. Enterprises violating the regulation may face product recalls, fines, or even imprisonment.

（1）SVHC Testing

SVHC testing refers to a method of analyzing whether SVHCs are present in products and their concentrations through chemical analysis.

a. Simple and convenient operation: Enterprises only need to provide samples to testing institutions, which handle the subsequent steps.

b. Short cycle: Testing typically takes 3-5 days, allowing enterprises to quickly provide relevant test reports to importers to demonstrate compliance with the REACH regulation.

c. High testing costs, increasing management expenses: Testing incurs significant fees, especially as the number of SVHC substances continues to grow, leading to substantial testing costs.

d. Redundant testing: Due to a lack of information transmission within the supply chain, the same material may undergo identical testing at different levels of the supply chain, resulting in redundant testing.

（2）Supply Chain Information Management Survey

Supply chain information management involves collecting, organizing, storing, and transmitting all relevant information (such as SDS, test reports, etc.) across the supply chain.

a. Facilitates material information management: Effective supply chain information management helps enterprises fully understand the basic information of each component and raw material in their products.

b. Strong traceability: Effective supply chain information management enables timely and efficient tracing of purchased components containing hazardous substances.

c. Cost reduction: Through supply chain information management, enterprises can identify materials and components that have already undergone SVHC testing, thereby reducing redundant testing and unnecessary costs.

d. Lack of enterprise awareness: Currently, most enterprises in China have an unclear understanding of establishing supply chain management, making it challenging to promote and implement supply chain information management.

e. High level of cooperation required: Information collection depends on the cooperation of upstream enterprises, whose capabilities and willingness to cooperate constrain the management of supply chain information.

（3）Self-Declaration

Self-declaration is a self-assurance of the presence of SVHCs in one's products and compliance with the REACH regulation. Enterprises are responsible for the declarations they submit and must not sign them blindly or hastily.

a. Simple preparation: Enterprises only need to prepare and sign a declaration document.

b. Complex document preparation: Enterprises must implement effective risk control for hazardous substances in their products, conduct appropriate testing, and prepare compliance documentation to ensure the declaration is valid and accurate.