EU REACH certification
SVHC high concern substance detection:
SVHC, Substances of high concern, sourced from the EU REACH regulation. According to Article 57 of the REACH regulation, SVHC is determined based on the following criteria. Substances of very high concern 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 referred to as the candidate list for all substances added by the European Chemicals Agency (ECHA). SVHC may have very serious, or in some cases, irreversible impacts on people and the environment, hence the reason for its authorization.
a)、 According to EU Directive 67/548/EEC, it is classified as a carcinogen, teratogen, and reproductive toxic substance in Class 1 and Class 2. This directive will soon be replaced by the EU 1272/2008/EC (Classification, Labelling and Packaging of Chemicals and Mixtures, also known as CLP Regulation), which classifies the above-mentioned hazardous substances as 1a and 1b in the new regulation.
b)、 Persistent, Bioaccumulation, Toxic Substances (PBT) and Strong Persistent and Strong Bioaccumulation Substances (vPvB) determined in accordance with Annex XIII of the REACH Regulation.
c)、 Other substances with proven cases of serious harm to humans and the environment, such as endocrine disruptors.
Candidate List: According to Article 58 of the REACH regulation, SVHC will be confirmed by the enforcement agencies of member states and the European Chemicals Agency (on behalf of the European Commission) based on the SVHC determination criteria mentioned above. These institutions are required to submit proposals in accordance with REACH regulations, which will then undergo public evaluation. After the public evaluation is completed, the European Commission will refer to the evaluation results and determine which substances will be confirmed as SVHC through 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 (i.e. Annex XIV of REACH Regulation).
Related requirements:
Introduction: According to the provisions of the REACH regulation, if an article contains substances on the SVHC candidate list and the mass fraction and/or export volume of the substance meet certain requirements, it will trigger relevant responsibilities for the enterprise.
SVHC Notification: According to Article 7.2 of the REACH regulation, if an article contains a substance on the SVHC candidate list with a mass fraction exceeding 0.1%, and the substance enters the EU more than 1 ton/year/company annually, the producer or importer of the article must notify the European Chemicals Agency.
Exemption from notification may be granted in certain specific circumstances:
1) According to Article 7.3 of the regulation, if the manufacturer or importer can provide measures to ensure that the SVHC substances contained in the goods are not exposed to humans or the environment under normal or reasonably foreseeable use (including waste disposal, etc.), they do not need to fulfill the responsibility of Article 7.2 of the EU REACH regulation, but should provide appropriate guidance to the recipient of the goods.
2) The substance has been registered for its intended use.
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, notification must be completed within 6 months of their inclusion in the list.
Notification conditions:
(1) The concentration of the substance in the item is greater than 0.1% (weight ratio W/W);
(2) Each manufacturer or importer produces or imports more than 1 ton of the substance annually;
(3) The substance has not been registered for this purpose.
However, under normal, reasonable, and foreseeable conditions of use and disposal, if the manufacturer or importer can exclude the possibility of exposure to humans or the environment from the substance, then no notification is required. As stipulated in Article 7 (7) of REACH, notifications regarding substances of high concern (SVHC) must be submitted no later than 6 months after the substance is included in the list of candidate substances that require permission for use. This provision came into effect on June 1, 2011. The relevant information regarding substances included in the candidate list of items should be submitted directly by the supplier of the item to the recipient of the item 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 transmission:
According to Article 31 and Annex II of the REACH regulation, SDS must be provided when the mixture contains SVHC from the candidate list, with a content exceeding 0.1% (mass fraction) in non gas mixtures or 0.2% (volume fraction) in non gas mixtures.
According to Article 33 of the REACH regulation, when an article contains SVHC content exceeding 0.1% (mass fraction) from the candidate list, if requested by the recipient, sufficient information to ensure safe use should be provided within 45 days.
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Training and consulting to assist enterprises in easily responding to regulatory requirements.