Overview

European Union REACH Regulation (EC) No 1907/2006, full name "Registration, Evaluation, Authorisation and Restriction of Chemicals""Chemical Registration, Evaluation, Authorisation and Restriction (REACH)", a regulation of the European Union concerning the registration, evaluation, authorisation, and restriction of chemicals, came into force on June 1, 2007, and was implemented on June 1, 2008.

Applicable Product Range

REACH regulation has replaced EU regulations or directives such as (EEC) No 793/93, (EC) No 1488/94, and 76/769/EEC, becoming a comprehensive regulation for the unified preventive management of all chemicals entering the EU market. The implementation of this regulation has significantly impacted exports to the EU, including those from China, particularly in industries such as chemicals, machinery and electronics, textiles, dyeing and printing, rubber, plastics, toys, and furniture.

Main content of REACH regulation

1. Registration: All chemicals with an annual production or import volume exceeding 1 ton must be registered. Chemical safety reports must also be submitted for substances with an annual production or import volume of 10 tons or more.
2. Evaluation(Valuation): Includes document assessment and material assessment. Document assessment is to verify the completeness and consistency of the registered documents submitted by the company; material assessment is to confirm the risk of chemical substances to human health and the environment.
3. Authorization: Authorization for the production and import of chemicals with certain hazardous characteristics that attract high public concern, including CMR, PBT, vPvB, etc.
Regulation (EC) No 1907/2006, Annex XIV lists substances requiring authorization, and companies must obtain authorization to use substances included in this Annex. Currently, Annex XIV includes 43 substances. Substances requiring authorization are evaluated and selected from the list of authorization candidates. The candidate list for substances requiring authorization is known as the Substances of Very High Concern (SVHC) list, which is not included in the REACH Annex. The SVHC list currently contains 209 substances.
4. Restriction: If it is deemed that the manufacture, marketing, or use of a substance, product, or item poses an unacceptably high risk to human health or the environment, its production or importation within the EU will be restricted.
REACH Regulation Annex XVII lists restrictions on the manufacture, placement on the market, and use of certain hazardous substances, mixtures, and articles, known as the Restriction of Substances List (RoHS), which includes 74 substances.

Responsibilities and obligations under the REACH Regulation

1. Materials/Finished Products
Except as otherwise specified under REACH, any manufacturer or importer of a substance in the EU, whether on its own or in a mixture containing one or more substances, in quantities of 1 ton or more per year, must submit a registration to ECHA.
2. Item
If the product contains a substance that is intentionally released and its annual export volume exceeds 1 ton, registration is required.
(2) If the product does not contain any intended release substances, it must be judged according to the following conditions:
If the product contains substances of very high concern (SVHC) and the content is less than 0.1%, there is no need for notification and proactive information disclosure. However, the supplier is obligated to provide relevant information upon request by the importer or consumer.
If the product contains SVHCs at a concentration exceeding 0.1%, and the annual export volume is less than 1 ton, it is mandatory to inform the downstream importer and provide relevant information, along with proof documents. The information transmission usually includes SDS (Safety Data Sheets) and the like.
If the product contains SVHCs and the content exceeds 0.1%, and the annual export volume is greater than 1 ton, it is mandatory to notify ECHA.
In response to consumer requests, all suppliers of the item should provide consumers with adequate information obtainable within 45 days of the request, to ensure the safe use of the item. This information should at least include the name of the substance.
(3) Material restrictions, i.e., the restrictions on certain hazardous substances, mixtures, and articles as outlined in Annex XVII of the REACH Regulation, are a significant aspect of work concerning the manufacture, placing on the market, and use of articles, in addition to SVHCs.

How businesses can comply with the REACH regulations.

1. Ensure chemicals with an export volume exceeding 1t/y are registered. After the company successfully submits the chemical registration dossier to the European Chemicals Agency (ECHA), they will receive an 18-digit registration number.
2. Conduct screenings for SVHC and Annex XVII restricted substances in items, notify when SVHC levels exceed limits in products, ensure proper supply chain information transfer, and guarantee that harmful substances in the products do not exceed regulatory requirements. Performing SVHC tests or Annex XVII restricted substance tests and obtaining test reports is a universally applicable method.

Routine inspection items