I. Introduction to Certification

REACH, short for "Registration, Evaluation, Authorization and Restriction of Chemicals," is a European Union regulation for the preventive management of all chemicals entering its market. Implemented on June 1, 2007, it serves as a chemical regulatory system that covers the safety of chemical production, trade, and usage. This regulation aims to protect human health and environmental safety, maintain and enhance the competitiveness of the European chemical industry, foster innovation in the development of non-toxic and harmless compounds, increase transparency in chemical usage, and pursue sustainable social development. The REACH directive requires all chemicals imported or produced in Europe to undergo a comprehensive process of registration, evaluation, authorization, and restriction to better and more simply identify chemical components, thereby ensuring environmental and human safety.

II. Applicable Regions

27 member states of the European Union: United Kingdom (withdrew from the EU in 2016), France, Germany, Italy, the Netherlands, Belgium, Luxembourg, Denmark, Ireland, Greece, Spain, Portugal, Austria, Sweden, Finland, Cyprus, Hungary, Czech Republic, Estonia, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, Bulgaria, and Romania.

III. Product Scope

The scope of the REACH regulation is extensive, covering almost all commercial products excluding food, feed, and medicinal products. Consumer products such as clothing and footwear, jewelry, electronic and electrical products, toys, furniture, and health and beauty products are all within the scope of the REACH regulation.

IV. Certification Requirements

1. Registration

All chemical substances with an annual production or import volume exceeding 1 ton require registration. Additionally, chemical substances with an annual production or import volume of over 10 tons must submit a chemical safety report.

2. Evaluation

This includes dossier evaluation and substance evaluation. Dossier evaluation involves verifying the completeness and consistency of the registration dossiers submitted by enterprises. Substance evaluation refers to confirming the risks posed by chemical substances to human health and the environment.

3. Authorization

Production and import of chemical substances with certain hazardous properties that cause significant concern, including CMR, PBT, vPvB, etc., require authorization.

4. Restriction

If it is deemed that the manufacture, placing on the market, or use of a substance, its preparations, or articles thereof poses risks to human health and the environment that cannot be adequately controlled, its production or import within the European Union will be restricted.