SVHC is a substance of very high concern, which comes from the EU REACH regulations. According to Article 57 of the REACH Regulation, SVHC is determined in accordance with the following standards. Substances that are very high concern substances have serious consequences. Substances that meet the conditions can be placed in a list. The SVHC of this list was first published on October 28, 2008 and last updated on June 20, 2013. This list is called the Candidate List for all substances added by the European Chemicals Agency (ECHA). SVHC may have very serious, or in some cases, irreversible effects on people and the environment, and therefore the reason for its authorization.
     a) According to the EU Directive 67/548/EEC, it is classified as carcinogens, teratogenic substances and reproductive toxic substances. The directive will be replaced by the European Union 1272/2008/EC ("Classification, Labeling and Packaging of Chemical Substances and Mixtures", that is, the CLP Regulation) in the near future, and will be classified as 1a and 1b of the above-mentioned hazardous substances in the new regulations.
     b) Persistent, bioaccumulative, toxic substances (PBT) and strong persistent and strong bioaccumulative substances (vPvB) determined in accordance with Annex XIII of REACH.
     c) Other substances ([1] such as endocrine disruptors) that have actual cases that have serious harmful effects on humans and the environment.

 

Candidate list:
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Determine the procedure
According to Article 58 of the REACH Regulation, SVHC will be confirmed by the law enforcement agencies of the member states and the European Chemicals Agency (on behalf of the European Commission) in accordance with the aforementioned SVHC criteria. These institutions need to submit proposals in accordance with REACH regulations, and then the proposals will be publicly reviewed. After the public review is over, the European Commission of Member States will refer to the review results to determine which substances will ultimately be recognized as SVHC after research and discussion. It is up to ECHA to decide whether to include these substances in the so-called "candidate list". The substances in the candidate list may be further included in the authorization list (ie REACH Regulation Annex XIV).

Candidate list update:

□ On October 28, 2008, the first batch of SVHC list (15 items), a total of 15 items;

□ On January 13, 2010, the second batch of SVHC list (14 items), a total of 29 items;

□On March 30, 2010, acrylamide was included in the SVHC list (the second batch of lists), and the second batch of SVHC lists a total of 30 items;

□ On June 18, 2010, the third batch of SVHC list (8 items), a total of 38 items

□ On December 15, 2010, the fourth batch of SVHC list (8 items), a total of 46 items

□ On June 20, 2011, the fifth batch of SVHC list (7 items), a total of 53 items

□ On December 19, 2011, the sixth batch of SVHC list (20 items), a total of 73 items

□ On June 18, 2012, the seventh batch of SVHC list (13 items), a total of 84 items

□ On June 18, 2012, the second batch of aluminum silicate refractory ceramic fiber (A1-RCF) and zirconia aluminum silicate refractory ceramic fiber (ZrA1-RCF) were integrated into the sixth batch of SVHC list. The list of the second batch of lists was reduced to 13 items, and the list totaled 84 items

□ On December 19, 2012, the eighth batch of SVHC list (54 items), a total of 138 items

□ On June 20, 2013, the ninth batch of SVHC list (6 items), a total of 144 items

□ On December 16, 2013, the tenth batch of SVHC list (7 items), a total of 151 items

□ On June 16, 2014, the eleventh batch of SVHC list (4 items), a total of 155 items

□ On December 17, 2014, the twelfth batch of SVHC list (6 items), a total of 161 items

□ On June 15, 2015, the 13th batch of SVHC list (2 items), a total of 163 items

□ On December 17, 2015, the 14th batch of SVHC list (5 items), a total of 168 items

□ On June 20, 2016, the 15th batch of SVHC list (1 item), a total of 169 items

□ On January 12, 2017, the sixteenth batch of SVHC list (4 items), a total of 173 items

□ On July 10, 2017, the 17th batch of SVHC list (1 item), a total of 174 items, at the same time, the five substances in the list, bisphenol A, BBP, DEHP, DBP, and DIBP, increased the impact on the human body. Endocrine disrupting properties

□ On January 15, 2018, the eighteenth batch of SVHC list (7 items), a total of 181 items, and at the same time updated the bisphenol A in the list

□ On June 27, 2018, the 19th batch of SVHC list (10 items), a total of 191 items

□ On January 15, 2019, the 20th batch of SVHC list (6 items), a total of 197 items

□ On July 16, 2019, the twenty-first batch of SVHC list (4 items), a total of 201 items

□ On September 3, 2019, the twenty-second batch of SVHC list (4 items), a total of 205 items

□ On June 25, 2020, the 23rd batch of SVHC list (4 items), a total of 209 items

 

related requirements
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Introduction
According to the provisions of the REACH regulations, if an article contains a substance on the SVHC Candidate List, and the mass score and/or export volume of the substance meets certain requirements, the company will trigger related responsibilities.
 

SVHC notification
According to Article 7.2 of the REACH Regulation, when an article contains a substance in the SVHC Candidate List with a mass fraction of more than 0.1%, and the substance enters the EU more than 1 ton/year/company each year, the manufacturer or importer of the article must The European Chemicals Agency made a notification.
 

Notification can be exempted under certain specific circumstances:
1) According to Article 7.3 of the regulations, if the manufacturer or importer can provide measures to ensure that the contained SVHC substances will not be exposed to humans or the environment if the products are used under normal or reasonably foreseeable conditions (including disposal, etc.), they will not Need to fulfill the responsibilities of Article 7.2 of the EU REACH Regulation, but should provide the recipient of the article with appropriate instructions.
2) The substance has been registered for this purpose. For substances included in the SVHC Candidate List before December 1, 2010, notification must be completed before June 1, 2011; for substances included in the Candidate List after December 1, 2010, they must be included in the list of 6 Complete the notification within months.
 

Notification conditions
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(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 each year exceeds 1 ton;
(3) The substance has not been registered for this purpose.
 

However, under normal, reasonable and foreseeable use and disposal conditions, if the manufacturer or importer can exclude the possibility of exposure of the substance to the human body or the environment, then there is no need to notify. As stipulated in Article 7(7) of REACH, the notification of a substance of very high concern (SVHC) shall not be later than after the substance is included in the list of candidate substances that require permission to be used 6 Submit within months, and the clause will be implemented from June 1, 2011. The relevant information about the substance contained in the candidate substance list should be directly submitted by the supplier of the article to the recipient of the article after the substance is included in the candidate list (Article 33 of the REACH Regulation). When a substance is determined to meet the criteria of Article 57’, the list of candidate substances will be continuously updated.
 

Information transfer
According to Article 31 of the REACH Regulation and Annex II, when the mixture contains SVHC in the candidate list, the content in the non-gas mixture exceeds 0.1% (mass fraction) or the content in the non-gas mixture exceeds 0.2% (volume fraction) When, 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 score), if the recipient requests it, sufficient information to ensure safe use should be provided within 45 days.