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Definitions and differences of SVHC, authorized substances (Annex 14), and restricted substances (Annex 17) under REACH

Definitions and differences of SVHC, authorized substances (Annex 14), and restricted substances (Annex 17) under REACH

Regulation Standard
2021/07/13 13:34
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Often companies are asked by customers to test REACH 191 items, and are asked whether the product contains SVHC and whether it complies with REACH Annex 17 (RSL list). However, companies are often not particularly clear about where these terms come from and what the specific requirements are. In fact, the terms SVCH, REACH Annex 17, REACH Authorized Substances all come from the EU REACH regulations. They are all the control requirements set forth by REACH regulations specifically for the use of chemicals in downstream articles.
SVHC definition
SVCH stands for Substance of Very High Concern. Generally speaking, REACH 163 items and REACH 191 items refer to SVCH. SVCH is generally updated twice a year, in June and December respectively. As of 2018.09.07, SVHC has 19 batches with a total of 191 substances.
SVHC range
SVHC generally has one or more of the following dangerous characteristics (the characteristics of Article 57 of the REACH Regulation):
According to CLP regulations, substances with class 1 or class 2 carcinogenicity, mutagenicity or reproductive toxicity, namely CMR 1A/1B substances; persistent, bioaccumulative and toxic substances, namely PBT substances; high persistence, high Bioaccumulative substances, namely vPvB substances; there is evidence that there are equally harmful substances, such as endocrine disrupting substances.
Regulatory requirements for SVHC
The regulations have the following requirements for SVHC:
1. Notification: If the content is >0.1% and at the same time meets the export volume of >1 ton/year, it needs to be notified to ECHA;
2. Information transmission: If the content is >0.1%, information about the substance needs to be transmitted in the supply chain.
Authorized substance definition
Authorized substances refer to those substances that can only be put on the market and used after being authorized by the government.
Authorized substance scope
Authorized substances are selected from SVHC, that is, SVHC is a candidate for authorized substances. Therefore, the official SVHC list is also called the Candidate List (Candidate List).
List of authorized substances
Authorized substances officially announced are required to be included in REACH Annex XIV. There are currently 43 authorized substances.
Regulatory requirements for authorized substances
According to the REACH regulations, the use and placing on the market for use of substances listed in Annex XIV, whether it is the substance itself, as a component of a mixture or used in an article, from a certain date (the regulations call this date the "sunset day" ), are prohibited unless the use has been authorized or is an exempt application. The substances in this Annex XIV are authorized substances. In layman's terms, an authorized substance cannot be freely exported to the EU after its sunset day, and it needs to obtain relevant authorization from the EU before it can be exported.
It should be noted that the placing on the market and use of articles containing authorized substances do not require authorization. That is, the authorization is for the requirements of the substance, not for the article. In addition, according to regulatory requirements, when the sunset day of the authorized substance is reached, ECHA needs to consider whether the substance has a risk of insufficient control over human health or the environment. If it exists, ECHA needs to prepare a corresponding file to propose the substance. At this time, the authorized substance may become a restricted substance.
Definition of restricted substances
Restricted substances are substances whose dosages are restricted in certain products.
List of restricted substances
Restricted substances are mainly those that pose unacceptable risks to human health or the environment. Annex XVII of the REACH Regulation is the complete list of restricted substances. There are currently 71 restricted substances.
Regulatory requirements for restricted substances
The use of restricted substances shall comply with the requirements in the second column of Annex XVII of REACH. For example, item 5 of Annex XVII requires that benzene cannot be used in toys or toy parts, and the mass fraction of free benzene in toys or toy parts shall not exceed 5 mg/kg (0.0005%). Then, toy companies need to pay close attention to this restriction to ensure that toys or toy parts cannot contain more than 5 mg/kg of free benzene. Other companies, such as textile companies, if their products contain textile parts that will be used in toys, they need to pay attention to whether their textile parts contain more than 5 mg/kg of free benzene to avoid violations.

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