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The EU "Regulations on Registration, Evaluation, Authorization, and Restriction of Chemicals" (REACH Regulation) passed the final vote of the European Union Council on December 18, 2006 and has been formally promulgated. It will begin on June 1, 2007. Full implementation. Its purpose is to protect human health and the environment, to maintain and improve the competitiveness of the EU chemical industry; to increase the transparency of chemical information; to reduce vertebrate animal testing; consistent with the EU's international obligations under the WTO framework; in the substantive sense, REACH A unified chemicals management system will be created within the EU so that companies can follow the unification principle 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 REACH came into effect. As of June 20, 2013, ECHA (European Chemicals Agency) has officially released 9 batches of SVHC checklists. From then on, there are 144 SVHCs in the list of REACH regulated substances of very high concern.
"Registration, Evaluation, Authorization and Restriction of Chemicals, Chemical Registration, Evaluation, Licensing and Restrictions" is the European Union's regulations for the preventive management of all chemicals entering its market. It was formally implemented on June 1, 2007.
The main content of REACH
Registration All chemical substances with an annual production or import volume exceeding 1 ton need to be registered, and chemical substances with an annual production or import volume over 10 tons must also submit a chemical safety report.
Evaluation includes file evaluation and material evaluation. The file evaluation is to check the completeness and consistency of the registration documents submitted by the company. Physical assessment refers to the identification of chemical substances that pose a risk to human health and the environment.
Authorization Authorizes the production and import of chemical substances that have certain hazardous characteristics and cause people's high regard, including CMR, PBT, vPvB, etc.
Restriction If it is considered that the hazards to human health and the environment caused by the manufacture, placing on the market, or use of certain substances or their configuration products or products cannot be adequately controlled, they will be restricted from producing or importing in the EU.
REACH control object:
Substance The chemical elements and their compounds obtained in the natural state (existing) or through the production process.
Mixture A mixture or solution of two or more substances.
Article An object consisting of one or more substances and/or one or more formulations. Have a specific shape, appearance or design.
REACH total 17 attachments
Annex I Chemical Safety Assessment
Annex II Guidelines for preparation/preparation of safety data sheets
Annex III Registration Standards for Substances 1 to 10 Tonnage
Annex IV Requirements for exemption from registration
Annex V Exemption Registration Details
Annex VI Notification Requirements in Chapter X
Annex VII Requirements for more than one ton of substances
Annex 8 Substance requirements for more than 10 tons
Annex 9 Substance requirements for more than 100 tons
Annex 10 Substance requirements above 1000 tons
Annex 11 Deviations from standard tests of Annexes 10 to 10
Annex XII General guidelines for downstream users
Annex 13. Identification of PBT and vPvB substances
Annex XIV Registration/Indexing of SVHC
Annex 15 file
Annex XVI Social Economic Analysis
Annex XVII Limitations of Certain Hazardous Substances
SVHC SVHC
Source of law
Substances of Very High Concern substance of great concern, abbreviated as SVHC. According to the provisions of Articles 57 and 59 of the REACH Regulation, substances that meet the following criteria may be included in the SVHC candidate list:
According to the EU CLP regulations, it belongs to 1A and 1B carcinogens;
In accordance with EU CLP regulations, it belongs to Class 1A and Class 1B teratogens;
In accordance with EU CLP regulations, they belong to category 1A and 1B reproductive toxicity substances;
Persistent, Bioaccumulative and Toxic Substances (PBT) according to Annex XIII of the REACH Regulation;
In accordance with Annex XIII of the REACH Regulation, strong persistent and strong bioaccumulative substances (vPvB);
According to REACH Article 59 other hazardous substances identified.
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 list of SVHC candidates has continued to be updated. In general, ECHA will update the inventory material at least every two years, and since 2010, it will basically update the SVHC candidate list twice a year. The latest SVHC candidate list is available at: http://echa.europa.eu/web/guest/candidate-list-table.
SVHC related liability obligations
Article 3 of the REACH Regulation classifies products into three types of substances, mixtures and articles. Requirements for products containing SVHC mainly include notification and information transfer, as described below.
Notification conditions: According to the provisions of Article 7.2 of the REACH Regulation, if the articles contain substances that have been included in the SVHC candidate list, any SVHC content > 0.1% (w/w), and the total export volume of the SVHC in the articles exceeds 1 Ton/year/manufacturer or importer, the manufacturer or importer of this article must notify ECHA.
Notification time: Substances listed on the SVHC candidate list before December 1, 2010 shall be notified before June 1, 2011. Substances listed on the list after December 1, 2010 should be notified within six months of their inclusion in the list.
Content of the notification: According to the provisions of Article 7.4 of the REACH Regulation, the information to be provided at the time of notification includes company information, registration number (if any), substance information, substance classification, brief description of the use of the substance in the article, and brief description of the use of the article. Material tonnage range.
Information transfer: According to the provisions of Article 31 and 33 of the REACH Regulation, if any substance in the SVHC Candidate List exceeds 0.1% (w/w) in the substance/mixture type product, 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), perform the obligation to provide sufficient information to the recipient/consumer, including allowing safe use, with at least substance The name of the relevant information to be provided free of charge within 45 days.
REACH Regulation Enforcement: According to Article 126 of the REACH Regulation, EU member states should establish their own punitive measures to make them applicable to violations of the regulations, and take all necessary measures to ensure the implementation of these punitive measures. That is, ECHA does not directly participate in REACH law enforcement, and specific measures for law enforcement are completed by the law enforcement authorities of each member country.
German law enforcement: The German Environmental Protection Agency (UBA) issued a new penalty for violating the REACH regulations. Since May 1, 2013, when the company violated the SVHC disclosure requirements, it will face a fine of 50,000 euros.