Process
Introduction
The EU REACH Regulation ((EC) No 1907/2006) is called "Registration, Evaluation, Authorization and Restriction of Chemicals". It is an EU regulation on the registration, evaluation, authorization and restriction of chemicals, which was established on June 1, 2007 It came into effect on June 1, 2008 and was officially implemented on June 1, 2008.
Scope of Application
The REACH regulation has replaced (EEC) No793/93, (EC) No 1488/94, 76/769/EEC and other EU regulations or directives, becoming a complete regulation for unified preventive management of all chemicals entering the EU market. The implementation of this regulation has seriously affected the export of products to the EU including China, especially products in the chemical, mechanical and electrical, textile, printing and dyeing, rubber, plastic, toys, and furniture industries.
The Main Content of REACH Regulations
1. Registration (Registration): All chemical substances with an annual output or import volume of more than 1 ton need to be registered, and a chemical safety report should also be submitted for substances with an annual output or import volume of more than 10 tons.
2. Evaluation (Evaluation): including file evaluation and material evaluation. The file evaluation is to check the completeness and consistency of the registration files submitted by the company; the substance evaluation is to confirm the risk of chemical substances that harm human health and the environment.
3. Authorization (Authorization): Authorization of the production and import of chemical substances that have certain hazardous characteristics and attract people's attention, including CMR, PBT, vPvB, etc. Annex XIV of the REACH Regulation is a list of substances that need to be authorized. Enterprises need to apply for authorization for the substances listed in Annex XIV of the REACH Regulation to use them. Currently Annex XIV contains 43 substances, Authorized substances are evaluated and selected from the authorized candidate list. The candidate list of authorized substances is called the list of substances of very high concern (SVHC). The list is not listed in the annex to the REACH regulation. There are currently 209 SVHC lists substance.
4. Restriction: If it is deemed that the manufacture, placing on the market or use of a certain substance, configuration or article causes the risk to human health and the environment to be insufficiently controlled, its production or import in the EU will be restricted.
Annex XVII of the REACH Regulation lists restrictions on the manufacture, placing on the market and use of certain hazardous substances, preparations and articles, which is called the restricted substance list and contains 74 substances.
Responsibilities and Obligations of REACH Regulations
1. Substances/preparations
Except as otherwise provided by REACH, any manufacturer or importer shall submit a registration to ECHA regardless of whether it is a substance in the European Union whose quantity is greater than or equal to 1 ton/year in one or more preparations.
2. Items
(1) If the product contains an intentionally released substance, and the annual export volume of the substance is greater than 1 ton, registration is required.
(2) If the product does not contain intentionally released substances, it needs to be judged according to the following conditions:
a If the product contains substances of very high concern (ie SVHC) and the content is less than 0.1%, there is no need to notify and actively carry out information transmission, but if the importer or consumer requires it, it is obliged to provide relevant information;
b If the product contains SVHC and the content is greater than 0.1%, and the annual export volume is less than 1 ton, it must be notified to the downstream importer and related information transmission, and relevant certification documents shall be issued at the same time. The information transmission usually includes the SDS safety number table, etc.;
c If the product contains SVHC and the content is greater than 0.1%, and the annual export volume is greater than 1 ton, it must be notified to ECHA; d At the request of consumers, all suppliers of goods should provide consumers with sufficient information available to consumers within 45 days of receiving the request to make the goods safe to use. This information includes at least the name of the substance.
(3) Substance restrictions, that is, the restriction on the manufacture, placing on the market and use of certain hazardous substances, preparations and articles in Annex XVII of the REACH Regulation, is an important work content for articles other than SVHC.
How Companies Comply with REACH
1. Ensure that chemical substances with an export volume exceeding 1t/y are registered. After the company successfully submits the registration dossier of the chemical substance to the European Chemicals Agency (ECHA), a registration number consisting of 18 digits can be obtained.
2. Carry out SVHC and Annex XVII restricted substances screening on items, notify when the SVHC in the product exceeds the limit, and do a good job in supply chain information transmission, and ensure that the hazardous substances in the product do not exceed the regulatory requirements. Carrying out SVHC test or Annex XVII restricted substance test and obtaining test report is the most common method.
Except as otherwise provided by REACH, any manufacturer or importer shall submit a registration to ECHA regardless of whether it is a substance in the European Union whose quantity is greater than or equal to 1 ton/year in one or more preparations.
