In accordance with Article 58 of the REACH Regulation, the SVHC will be confirmed by the law enforcement agencies of the Member States and the European Chemicals Agency (on behalf of the European Commission) on the basis of the above-mentioned SVHC criteria. These bodies are required to submit proposals in accordance with the REACH regulation, which will then be subject to public comment. At the end of the public comment, the EU Member States Committee will consider the results of the review and determine which substances will be identified as SVHCs. It is up to the ECHA to decide whether or not to include these substances in the so-called "Candidate List". Substances on the Candidate List may be further included in the Authorised List (i.e. Annex XIV of the REACH Regulation).
Candidate list update
Since October 28, 2008, the European Union Chemicals Agency first published the first batch of SVHC candidate lists, and as of December 30, 2014, SVHC candidate list substances have been updated 13 times. As of June 15, 2015, the official candidate list contains 163 SVHC substances, including a variety of inorganic and organic substances, and is used in various industries.
The first batch of SVHC lists (15 items) was officially published and entered into force in October 2008.
The second batch of SVHC lists (13 items) was officially published in January 2010, and on June 18, 2012, ECHA released the second batch of SVHC list of aluminum silicate refractory ceramic fibers with index number 650-017-00-8.
AL-RCF) and Zirconia Aluminum Silicate Refractory Ceramic Fibres (ZRAL-RCF) were integrated under the broader Al-RCF and ZRAL-RCF entries in the sixth batch of SVHC lists, and thus the second batch of SVHC lists were created.
The number of entries decreased from 15 to 13.
Conditions of notification
1) the concentration of the substance present in articles is greater than 0 1% (weight ratio w w); (2) the total amount of the substance in articles manufactured or imported by each manufacturer or importer exceeds 1 tonne per year;
3) The substance has not been registered for this use.
However, under normal and foreseeable conditions of use and disposal, no notification is required if the manufacturer or importer can rule out the possibility of exposure to the substance to humans or the environment. As stipulated in Article 7(7) of REACH, notifications for substances of very high concern (SVHC) should be submitted no later than six months after the substance has been included in the list of candidate substances subject to authorization for use, which came into force on 1 June 2011. Information about the presence of a substance on the Candidate List should be submitted directly to the recipient of the article by the supplier of the article after the substance has been included in the Candidate List (Article 33 of the REACH Regulation). The list of candidate substances will be updated on an ongoing basis when a substance is determined to meet the criteria of Article 57'.
Transfer of information
According to Article 31 and Annex of the REACH Regulation, when the mixture contains SVHC from the Candidate List, the content in the non-gaseous mixture exceeds 01% (mass fraction) or more than 0 in non-gaseous mixturesAt 2% (volume fraction), SDS must be provided.
According to Article 33 of the REACH Regulation, when an article contains SVHC in the Candidate List with a content of more than 01% (mass score), if requested by the recipient, should provide sufficient information to ensure safe use within 45 days.
On 10 September 2015, the European Court of Justice (ECJ) ruled on the determination of the content of substances of very high concern (SVHC) under the REACH Regulation, stipulating that the calculation of the content of substances of very high concern (SVHC) should be based on the component and not on the entire productBased on this, the unit of conformity has become smaller, and the original "composite item" (a product composed of multiple parts) has become the current "single item" (component), and the original overall test and evaluation scheme has become meaningless, and has been replaced by a component-based test and evaluation scheme.
The judgment has the following two conclusions:
1.According to Article 7(2) of the REACH Regulation, the manufacturer of an article must not produce an article containing a concentration of more than 01% of any SVHC in the Candidate List; and the importer of a product consisting of multiple articles, who is required to carry out SVHC control on all articles that make up the product, and none of the articles that make up the product must contain a concentration of more than 01% of any SVHC in the Candidate List;
2.According to Article 33 of the REACH Regulation, a product consisting of one or more articles is provided by a trader if any one of the articles contains a concentration of more than 0Any SHVC in the 1% candidate list needs to fulfill the responsibility of the information transmission of the ** chain.
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