REACH regulations
The full name of reach Certification Regulation (EC) no 1907 / 2006 is "registration, evaluation, authorization and restriction of chemicals", that is, the registration, evaluation, authorization and restriction of chemicals. It is the EU regulation on the preventive management of all chemicals entering its market. The regulation came into force on June 1, 2007 and came into force on June 1, 2008.
Reach regulation replaces EU regulations or directives such as (EEC) no 793 / 93, (EC) no 1488 / 94 and 76 / 769 / EEC. The implementation of this regulation has seriously affected the export of products to EU, including China, especially products in chemical, electromechanical, textile, printing and dyeing, rubber, plastics, toys, furniture and other industries.
Reach certification
According to the EU REACH regulation, the enterprise shall submit registration to the European Chemicals Administration (ECHA) for the chemical substances (substances themselves, substances in mixtures or substances intentionally released in articles) with an annual output or import volume of more than 1 ton in the EU, otherwise the enterprise will not continue to manufacture, import or sell the chemical within the EU. In addition, for some registered substances, the regulations also stipulate the obligations of continuous evaluation, notification / authorization and restriction.
1. Registration: all chemical substances with an annual output or import of more than 1 ton shall be registered, and the substances with an annual output or import of more than 10 tons shall also submit a chemical safety report.
2. Evaluation: including file evaluation and material evaluation. The purpose of archives evaluation is to verify the integrity and consistency of the registration files submitted by enterprises; Substance assessment is to confirm the risk of chemical substances endangering human health and the environment.
3. Authorization: authorizing the production and import of chemical substances with certain hazardous characteristics and attracting great attention, including CMR, PBT, vpvb, etc【 Annex XIV of reach regulation is the list of substances to be authorized. Enterprises need to apply for authorization for substances listed in Annex XIV of reach regulation before they can use them. The substances to be authorized are evaluated and selected from the list of authorized candidate substances. The list of candidate substances to be authorized is called the list of substances of high concern (SVHC), which is not listed in the annex to reach regulation. At present, there are 209 substances in the SVHC list.]
4. Restriction: if it is considered that the manufacturing, putting on the market or use of a substance, configuration or article can not fully control the risk to human health and the environment, it will restrict its production or import in the EU【 Annex XVII of reach regulation lists the restrictions on the manufacture, placing on the market and use of certain hazardous substances, mixtures and articles, which is called the list of restricted substances]
Responsibilities and obligations of reach certification enterprises
Under reach certification regulations, chemicals are divided into three categories: substances, mixtures and articles.
Substance: refers to chemical elements and their compounds obtained in natural state (existing) or through production process, including additives necessary to maintain its stability and impurities generated during processing, but excluding separable solvents that will not affect the stability of substances or change their components.
Mixture: refers to a mixture or solution composed of two or more substances. The mixture is artificially mixed by the producer according to a certain proportion, such as color masterbatch, auxiliary masterbatch, etc.
Article: refers to an object with a specific shape, appearance or design obtained in the manufacturing process. The chemical composition of these shapes, appearance and design can better determine its function.
For substances in substances or mixtures:
Under the reach regulation, all enterprises producing or importing more than 1 ton / year of chemical substances into the EU are required to register the chemical substances produced or imported with the EU chemicals management agency.
Substances in articles:
Since the articles may contain substances of high concern (SVHC) given by REACH regulations, they shall undertake the obligation of conformity assessment, that is, articles within the EU or imported into the EU market need to be tested for SVHC to determine whether the articles contain SVHC substances, and the subsequent response steps shall be determined according to the test results.
If the article contains SVHC substance and the content exceeds 0.1% of the whole product, and the annual export volume of the substance exceeds 1 ton (the two conditions shall be met at the same time), the product meets the notification requirements, the enterprise must notify ECHA.
If the articles contain intentional release substances (such as air fresheners and erasers) and the amount in the articles is greater than 1 ton / year, these substances shall also bear the obligation of (pre) registration.
