EU REACH Testing and Certification Services

EU REACH

1. Introduction to REACH

The full name of the EU REACH Regulation is "Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals." It officially came into effect on June 1, 2007, and began implementation on June 1, 2008. Almost all products placed on the EU market fall under the scope of the REACH Regulation.

The REACH Regulation is a management system for the production, trade, and use of chemicals, consisting of 15 volumes and 17 annexes. It primarily covers four aspects: registration, evaluation, authorization, and restriction. The content is comprehensive, systematic, and rigorous, incorporating both legal provisions and technical standards. It is information-intensive and highly specialized, covering approximately 30,000 chemical products on the EU market and their downstream products such as textiles, light industrial goods, and pharmaceuticals.

2. Main Content

(1) Registration: All chemical substances produced or imported in quantities exceeding 1 ton per year must be registered. Substances produced or imported in quantities of 10 tons or more per year must also submit a Chemical Safety Report (CSR). Non-EU manufacturers must submit registrations to the EU through an Only Representative (OR).

After successfully submitting the registration dossier for a chemical substance to the European Chemicals Agency (ECHA), companies receive an 18-digit registration number. Substances that fail to obtain a registration number cannot continue to be placed on the EU market.

(2) Evaluation: Includes dossier evaluation and substance evaluation. Dossier evaluation checks the completeness and consistency of the registration dossier submitted by companies; substance evaluation confirms the risks of chemical substances to human health and the environment.

(3) Authorization: Authorization is required for the production and import of chemical substances with certain hazardous properties that attract significant concern. For substances listed in the Authorization List (Annex XIV of the REACH Regulation), producers, importers, or downstream users in the supply chain must submit an authorization application to ECHA 18 months before the sunset date to obtain the right to use or place the substance on the EU market.

(4) Restriction: If the manufacture, placing on the market, or use of a substance, mixture, or article is deemed to pose risks to human health and the environment that cannot be adequately controlled, its production or import within 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, mixtures, and articles, known as the Restricted Substances List.]

3. Supply Chain Obligations

REACH covers almost all products exported to the EU (excluding food, pharmaceuticals, and pesticides). To comply with the REACH Regulation, all links in the supply chain must fulfill corresponding obligations:

(1) Chemical suppliers: Transmit chemical information and provide Safety Data Sheets (SDS).

(2) Raw material suppliers: Collect chemical information, transmit chemical information, and check for the presence of Substances of Very High Concern (SVHC).

(3) Non-EU article manufacturers: Collect chemical information, transmit chemical information, pre-register as required, and notify the presence of SVHC.

(4) Brand owners: Pre-register as required, collect/notify the presence of SVHC, collect SDS for preparation, perform notification calculations, and demonstrate due diligence.

(5) Retailers: Pre-register as required, collect/notify the presence of SVHC, collect SDS for preparation, perform notification calculations, and demonstrate due diligence.

4. Scope of Control

The scope of the REACH Regulation is extensive, covering the production and use of chemical substances in almost all industries. It includes not only industrial chemicals but also products made using chemical substances in daily life, such as detergents, paints, clothing, furniture, and electronic and electrical products. Therefore, it will have a significant impact on various industries worldwide, including the electronics and electrical industry.

5. Examples of Projects Involving Electronic and Electrical Products

6. EU REACH Annex XIV—Authorization List

EU REACH Annex XIV, the Authorization List, specifies that once a substance is listed, it may not be placed on the market or used after its specified "sunset date," unless authorization has been granted for a specific use or an application was submitted before the "latest application date." Unauthorized substances are prohibited from all EU market activities after the sunset date. This requirement applies regardless of the tonnage of the substance placed on the market or used. The authorization requirements under the EU REACH Regulation primarily target the placing on the market and use of substances within the EU. For imported products, authorization requirements apply only to substances and mixtures. Authorization requirements do not apply to articles imported into the EU containing authorized substances added outside the EU. According to the REACH Regulation, the Authorization List is updated at least every two years.

The REACH Regulation designates SVHC as candidate substances for the Authorization List (Annex XIV of REACH).

7. EU REACH Annex XVII—Restrictions on the Manufacture, Placing on the Market, and Use of Certain Hazardous Substances, Mixtures, and Articles

REACH Annex XVII (Restrictions) is a tool for the EU to protect public health and the environment from unacceptable risks posed by chemicals. According to Article 67.1 of the REACH Regulation, when a chemical substance is included in EU REACH Annex XVII (Restrictions) for restricted control, products involving that substance must comply with the specified restrictions to be manufactured, used, or placed on the market within the EU. The EU's restrictions on chemicals are an ongoing process. Annex XVII has been updated and revised dozens of times since the REACH Regulation came into effect, and authorities continue to evaluate and add more restrictions. It is important to note that REACH Annex XVII differs significantly from SVHC controls in the following two aspects:

(1) Scope of Control: SVHC control requirements apply to products manufactured within the EU or exported to the EU. REACH Annex XVII specifies the applicable product scope for each restriction clause.

(2) Control Requirements: When the SVHC content in a product exceeds the threshold, the product can still enter the EU market as long as the relevant companies fulfill their obligations to notify authorities or transmit information along the supply chain. For products involving substances restricted under REACH Annex XVII, they must comply with the specified restrictions (such as concentration limits) to be manufactured, used, or placed on the market within the EU.