REACH SVHC Test for Substances of Very High Concern

The EU "Regulations on Registration, Evaluation, Licensing and Restriction of Chemicals" (REACH Regulations) passed the final vote of the European Council on December 18, 2006, and has been officially promulgated, and will start on June 1, 2007 Full implementation. Its purpose is to protect human health and the environment, maintain and improve the competitiveness of the EU chemical industry; increase the transparency of chemical information; reduce vertebrate testing; be consistent with the EU’s international obligations under the WTO framework; in a substantial sense, REACH A unified chemical management system will be created within the EU, enabling companies to follow unified principles to produce new chemicals and their products.
 As a major focus of REACH regulations, the Candidate List of Substances of Very High Concern (SVHC) has undergone several updates since the entry into force of REACH. As of June 20, 2013, ECHA (European Chemicals Agency) has officially released 9 batches of SVHC lists. Since then, the REACH list of substances of very high concern has a total of 144 SVHCs.

"Registration, Evaluation, Authorization and Restriction of Chemicals, chemical registration, evaluation, permit and restriction" is the EU's regulations on preventive management of all chemicals entering its market. It was officially implemented on June 1, 2007.

The main content of REACH

Registration (Registration) All chemical substances with an annual output or import volume of more than 1 ton need to be registered, and chemical substances with an annual output or import volume of more than 10 tons should also submit a chemical safety report.

Evaluation (Evaluation) includes file evaluation and material evaluation. File evaluation is to check the completeness and consistency of the registration files submitted by the company. Substance assessment refers to the confirmation of the risk of chemical substances harming human health and the environment.

Authorization (Authorization) Authorize the production and import of chemical substances that have certain hazardous characteristics and attract people's attention, including CMR, PBT, vPvB, etc.

Restriction If it is deemed that the manufacture, placing on the market or use of a certain substance or its configuration, product and the risk to human health and the environment cannot be fully controlled, its production or import in the EU will be restricted.

REACH control objects:

Substance (Substance) A chemical element and its compound obtained in the natural state (existing) or obtained through the production process.

Mixture is a mixture or solution composed of two or more substances.

Article (Article) An object composed of one or more substances and/or one or more preparations. Have a specific shape, appearance or design scheme.

REACH 17 attachments in total

Annex I Chemical Safety Assessment

Annex II Preparation/Preparation Guidelines for Safety Data Sheets

Annex III Registration Standards for Substances of 1 to 10 Tons

Annex IV Exemption from Registration Requirements

Annex 5 Detailed Explanation of Registration Exemption

Notification requirements in Chapter 10 of Annex VI

Annex VII Requirements for substances above one ton

Annex VIII Requirements for substances above 10 tons

Annex 9 Requirements for substances over 100 tons

Annex 10 Requirements for Substances Above 1,000 Tons

The deviation of the standard test from Annex 7 to Annex 10

Annex XII General Guidelines for Downstream Users

Annex 13 Identification of PBT and vPvB substances

Annex 14 Registration/Index of SVHC

Annex 15 files

Annex XVI Socio-economic Analysis

Annex XVII Restriction of Certain Hazardous Substances

SVHC Substances of Very High Concern

Source of Law

Substances of Very High Concern, referred to as SVHC. According to Articles 57 and 59 of the REACH Regulation, substances meeting the following criteria may be included in the SVHC Candidate List:

According to EU CLP regulations, it belongs to 1A and 1B carcinogens;

According to EU CLP regulations, it belongs to Class 1A and Class 1B teratogenic substances;

According to EU CLP regulations, it belongs to 1A and 1B reproductive toxic substances;

Persistent, bioaccumulative and toxic substances (PBT) in accordance with Annex XIII of REACH;

According to Annex XIII of REACH Regulations, strong persistent and strong bioaccumulative substances (vPvB);

Other hazardous substances determined in accordance with REACH Article 59.

SVHC Candidate List

Since the official release of the first batch of SVHC lists on October 28, 2008, more and more SVHCs have been included in the list, and the SVHC candidate list has been continuously updated. Generally, ECHA will update the list of substances at least once every two years. Since 2010, the SVHC candidate list has been updated basically twice a year. The latest SVHC candidate list can be found at:

SVHC related responsibilities

Article 3 of the REACH Regulation divides products into three types: substances, mixtures and articles. The requirements for products containing SVHC mainly include notification and information transmission, as described below.

Notification conditions: According to Article 7.2 of the REACH Regulation, if the article contains a substance included in the SVHC Candidate List, any SVHC content is >0.1% (w/w), and the total export volume of the SVHC in the article exceeds 1 Tons/year/manufacturer or importer, the manufacturer or importer of this item must notify ECHA.

Notification time: For substances included in the SVHC Candidate List before December 1, 2010, notification should be completed before June 1, 2011. Substances included in the list after December 1, 2010 should be notified within 6 months after being included in the list.

Notification content: According to the provisions of Article 7.4 of the REACH Regulation, the information that needs to be provided during notification includes company information, registration number (if any), substance information, substance classification, short description of the use of the substance in the article, and a brief description of the purpose of the article, and Range of material tonnage.

Information transmission: According to the provisions of Articles 31 and 33 of the REACH Regulation, if the concentration of any substance in the SVHC candidate list exceeds 0.1% (w/w) in the substance/mixture type product, an SDS must be submitted to the buyer. If the article contains substances that have been included in the SVHC candidate list and the content exceeds 0.1% (w/w), the obligation to provide sufficient information to the recipient\consumer must be fulfilled, including allowing safe use, and at least the substance The name and related information must be provided free of charge within 45 days.

Enforcement of REACH Regulations: According to Article 126 of REACH Regulations, EU member states should formulate their own penalties to apply to violations of the regulations, and take all necessary measures to ensure the implementation of these penalties. That is to say, ECHA does not directly participate in the enforcement of REACH, and the specific enforcement measures are completed by the enforcement authorities of each member state.

German law enforcement: The German Environmental Protection Agency (UBA) has issued new penalties for violating REACH regulations. Starting May 1, 2013, companies will face a fine of 50,000 euros when they violate SVHC information disclosure requirements.