| Project Overview

REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) refers to the registration, evaluation, authorization, and restriction of chemicals. It is a regulation that ensures the safe entry and use of chemicals in the EU market. The REACH regulation was legislated and passed in December 2006, officially came into force on June 1, 2007, and started to be implemented on June 1, 2008. According to the EU REACH regulation, as of June 1, 2018, unregistered chemicals with an annual import volume of more than 1 ton are not allowed to be placed on the EU market.

| Main Contents of REACH

Registration: All chemical substances with an annual production or import volume of more than 1 ton need to be registered. For chemical substances with an annual production or import volume of more than 10 tons, a Chemical Safety Report (CSR) should also be submitted.

Evaluation: It includes dossier evaluation and substance evaluation. Dossier evaluation is to verify the completeness and consistency of the registration dossiers submitted by enterprises; substance evaluation refers to confirming the risks of chemical substances to human health and the environment and checking whether enterprises need to provide further information on such substances.

Authorization: Authorize the production and import of chemical substances that are of a certain degree of danger and draw high-level attention. Enterprises need to obtain authorization for substances listed in Annex XIV.

Restriction: Prohibit or only allow the production, import, sale, and use of particularly dangerous substances under restricted conditions, mainly based on the list of restricted substances in Annex XVII of the REACH regulation.

| Product Scope Controlled by REACH

The REACH Regulation has a very wide scope of control, covering almost all products composed of chemical substances sold in the EU market, such as electronic and electrical products, chemical products, automobiles and other various products.

| Requirements of REACH for Hazardous Chemical Substances

The requirements of the REACH Regulation regarding hazardous substances mainly involve two groups of substances: the candidate substances of SVHC (Substances of Very High Concern) and the restricted substances in Annex XVII of the REACH Regulation. Products exported to the EU must take both of these requirements into account.

The control requirements for SVHC apply to products manufactured within the EU or exported to the EU. Annex XVII of the REACH Regulation has specific provisions on the scope of applicable products for different clauses.

| Candidate List of Substances of Very High Concern (SVHC)

SVHC is simply a list of substances of very high concern before REACH registration. According to the REACH certification regulation, substances with one of the following characteristics can be regarded as Substances of Very High Concern (SVHC):

(1) CMR Category: Substances with carcinogenicity, mutagenicity, and reprotoxicity, such as phthalates, polycyclic aromatic hydrocarbons, etc.;

(2) PBT Category: Substances with persistence, bioaccumulation, and toxicity, such as mercury, polychlorinated biphenyls, etc.;

(3) vPvB Category: Substances with very persistence and very bioaccumulation, such as lead, nickel, etc.;

(4) Substances with equivalent hazards, such as endocrine disruptors.

On November 7, 2024, the European Chemicals Agency (ECHA) officially announced the inclusion of triphenyl phosphate (TPP) in the Candidate List of Substances of Very High Concern (SVHC). To date, the number of substances on the SVHC Candidate List has increased to 242.

Triphenyl phosphate is a colorless or white needle-like crystal or crystalline powder, odorless or with a slight aromatic odor and tasteless; its relative density is 1.185 (25°C), melting point is 47°C-53°C, boiling point is 370°C, and flash point is 223°C; it is insoluble in water, soluble in benzene, chloroform, ether, and acetone, and easily soluble in ethanol.

| Obligations of Enterprises

The REACH Regulation stipulates that if a product contains SVHC substances with a content of more than 0.1% and the annual export volume is less than 1 ton, the downstream importer needs to be informed, and relevant information needs to be transmitted; if a product contains SVHC substances with a content of more than 0.1% and the annual export volume is more than 1 ton, a notification to ECHA is required.

According to the EU Waste Framework Directive (WFD), since January 5, 2021, all articles placed on the market in the EU containing Substances of Very High Concern (SVHC) above 0.1% (w/w) need to be notified to the European Chemicals Agency (ECHA).

| MTT Suggestions

With the continuous update of the SVHC Candidate List, enterprises are facing more and more regulatory requirements. In the EU, law-enforcement inspections of Annex XVII of REACH have gradually become normalized. Enterprises in violation will face penalties such as product recall, product delisting, and fines. In case of serious violations, the enterprise's responsible persons may also face fines and imprisonment at the same time. Enterprises within the scope of regulation need to respond actively. It is recommended that enterprises conduct investigations on their supply chains as early as possible to cope with regulatory changes calmly.

MTT has a professional technical team and rich experience in product testing. It can help you easily understand whether your products are safe and compliant. It can provide you with a complete REACH testing solution to help you efficiently respond to regulatory updates.