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◉ Introduction to SVHC
SVHC is the abbreviation of Substance of Very High Concern (Very High Concern), which is a class of hazardous substances stipulated by the EU REACH regulations.
SVHC often has one or more of the following hazardous properties (Article 57 REACH properties):
(1) CMR has class 1 or class 2 carcinogens, teratogenic substances and reproductive toxic substances;
(2) PBT persistent, bioaccumulative and toxic substances;
(3) vPvB substances with high persistence and high bioaccumulation;
(4) Others There is evidence that there are substances with the same hazard level, such as endocrine disrupting substances.
◉ Candidate Substance List
Candidate Substance List = SVHC List
REACH regulations designate SVHC as candidate substances for Authorization Substances (REACH Annex XIV).
◉ Responsibilities and Obligations
The REACH regulation divides products into the following three categories: substances, preparations, and articles. Companies that produce SVHC and companies that manufacture products containing SVHC have different responsibilities.
Substances: When SVHC is sold as a substance, SDS is required to be provided to downstream users.
Preparations: When SVHC is a constituent substance in preparations and the content is >0.1%, SDS needs to be provided to downstream users.
Articles: When the articles contain SVHC, there are two main responsibilities: notification and information transmission.
◉ Notification Conditions:
(1) The concentration of the substance in the article is greater than 0.1% (weight ratio W/W);
(2) The total amount of the substance in the articles manufactured or imported by each manufacturer or importer per year exceeds 1 ton;
(3) The substance has not been registered for this use.
• Notification of exemptions:
Businesses are exempt from notification when any of the following conditions are met:
(1) If the manufacturer or importer can provide measures to ensure that the contained SVHC substances are not exposed to humans or the environment under normal or reasonably predictable conditions of use (including disposal, etc.) of the article, the notification obligation is not required, However, appropriate instructions should be provided to the recipient of the item.
(2) Other manufacturers or importers have completed registration for the use of the substance.
• Information transfer:
According to Article 31 and Annex II of REACH regulation, when the mixture contains SVHC in the candidate list, the content in non-gas mixture exceeds 0.1% (mass fraction) or the content in non-gas mixture exceeds 0.2% (volume fraction) , the SDS must be provided.
According to Article 33 of the REACH regulation, when the content of SVHC in the candidate list exceeds 0.1% (mass fraction), if the recipient requests, sufficient information to ensure safe use shall be provided within 45 days.
◉ SVHC List
The SVHC list is generally updated twice a year. There are 35 batches of SVHC list, a total of 251 substances.
SVHC list update process:
The first batch of SVHC list (15 items) was officially announced on October 28, 2008.
The second batch of SVHC list (13 items) was officially announced on January 13, 2010 and March 30, 2010.
The third batch of SVHC list (8 items) was officially announced on June 18, 2010.
The fourth batch of SVHC list (8 items) was officially announced on December 15, 2010.
The fifth batch of SVHC list (7 items) was officially announced on June 20, 2011.
The sixth batch of SVHC list (20 items) was officially announced on December 19, 2011.
The seventh batch of SVHC list (13 items) was officially announced on June 18, 2012.
The eighth batch of SVHC list (54 items) was officially announced on December 19, 2012.
The ninth batch of SVHC list (6 items) was officially announced on June 20, 2013.
The tenth batch of SVHC list (7 items) was officially announced on December 16, 2013.
The eleventh batch of SVHC list (4 items) was officially announced on June 16, 2014.
The 12th batch of SVHC list (6 items) was officially announced on December 17, 2014.
The 13th batch of SVHC list (2 items) was officially announced on June 15, 2015
The 14th batch of SVHC list (5 items) was officially announced on December 17, 2015.
The 15th batch of SVHC list (1 item) was officially announced on June 20, 2016.
The 16th batch of SVHC list (4 items) was officially announced on January 12, 2017
The seventeenth batch of SVHC list (1 item) was officially announced on July 7, 2017
The eighteenth batch of SVHC list (7 items) was officially announced on January 15, 2018
The 19th batch of SVHC list (10 items) was officially announced on June 27, 2018
The 20th batch of SVHC list (6 items) was officially announced on January 15, 2019
The 21st batch of SVHC list (4 items) was officially announced on July 16, 2019
The 22nd batch of SVHC list (4 items) was officially announced on January 16, 2020
The 23rd batch of SVHC list (4 items) was officially announced on June 25, 2020
The twenty-fourth batch of SVHC list (2 items) was officially announced on January 19, 2021
The twenty-fifth batch of SVHC list (8 items) was officially announced on July 8, 2021
The twenty-sixth batch of SVHC list (4 items) will be officially announced on January 17, 2022
The twenty-seventh batch of SVHC list (1 items) will be officially announced on June 10, 2022
The twenty-eighth batch of SVHC list (9 items) will be officially announced on January 17, 2023
The twenty-nineth batch of SVHC list (2 items) was officially announced on June 14, 2023
The 30th batch list of SVHC (5 items) was officially announced and came into effect on January 23, 2024
The 31st batch list of SVHC (1 item) was officially announced and came into effect on June 27, 2024
The 32nd batch of SVHC list (1 item) will be officially announced and come into effect on November 7, 2024
The 33rd batch of SVHC list (5 items) will be officially announced and come into effect on January 21, 2025
The 34th batch of SVHC list (3 items) will be officially announced and come into effect on June 25, 2025
The 35th batch of SVHC list (1 item) will be officially announced and come into effect on November 5, 2025
The 36th batch of SVHC list (2 items) will be officially announced and come into effect on February 4, 2026
◉ Solution
Now, the EU strictly implements REACH regulations on products circulating in the country, that is, products in the EU must fulfill the obligations of the REACH regulations before they can be legally produced or imported. SVHC is an important part of REACH regulations, and companies that do not provide SVHC information in products violate REACH regulations. Businesses that violate the regulations face product recalls, fines and even jail time.
(1) SVHC detection
SVHC detection refers to a method of analyzing the presence and content of SVCH in products by means of chemical analysis.
a. The operation is convenient and simple: the enterprise only needs to provide samples to the testing agency, and the subsequent testing agency will complete it.
b. Short cycle: The test generally takes 3-5 days to complete, and the enterprise can provide the importer with the relevant test report as soon as possible to prove that the product complies with the REACH regulations.
c. High testing costs and increased enterprise management costs: High costs need to be paid through testing methods, especially when SVHC substances continue to increase, which will increase huge testing costs.
d. Duplicate detection: Due to the lack of information transmission in the supply chain, the same detection is performed on the same material at different levels in the supply chain, resulting in duplicate detection.
(2) Survey on supply chain information management
Supply chain information investigation management is to collect, organize, store and transmit all relevant information on the supply chain (such as SDS, test reports, etc.).
a. Easy to manage material information: good supply chain information investigation and management can help companies fully understand the basic information of each component and raw material in the product;
b. Strong traceability: good supply chain information investigation and management can timely and effectively trace the source of purchased parts with hazardous substances;
c. Cost reduction: Through supply chain information management, it is possible to understand the material parts in the product that have been tested for SVHC, thereby reducing repeated testing and reducing unnecessary cost increases caused by repeated testing;
d. Weak enterprise concept: At this stage, most of the enterprises in my country do not have a clear concept of establishing supply chain management, and it is difficult to promote the establishment of supply chain information management;
e. High level of cooperation: At the same time, the collection of information requires the cooperation of upstream companies, and the capabilities and cooperation of upstream companies restrict the management of supply chain information.
(3) Self-declaration
A self-declaration is a self-assurance for the presence of SVHC in one's own products and for compliance with REACH regulations. Businesses are responsible for the declarations submitted and must not sign blindly or hastily.
a. Simple production: Enterprises only need to prepare a signed document statement.
b. Document preparation is complicated: Enterprises should implement effective risk control in the supply chain of hazardous substances in products, cooperate with appropriate testing, and prepare compliance documents to make the signed content effective and accurate.
◉ Compliance Services
As a professional third-party testing and certification service organization, Jiayu Testing has qualifications such as CMA, CNAS, CPSC, and has obtained laboratory accreditation from multiple authoritative certification agencies at home and abroad. The laboratory is strictly built and managed according to standards, equipped with advanced instruments and equipment, and has a skilled professional technical team with rich industry service experience and strong testing technology capabilities. It is proficient in various regulatory standards. Jiayu Testing has rich project experience in the field of SVHC hazardous substance control, providing customized raw material and whole machine restricted substance testing solutions for customers, assisting enterprises in actively responding to regulatory requirements, helping enterprises achieve hazardous substance risk control, and effectively improving product compliance. Welcome to contact us at 400-9269-886!
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