The EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation has been officially implemented for more than ten years. Compared with various other regulatory directives implemented by the EU in recent years, REACH has a broader scope of influence and is the EU's regulation for the preventive management of all chemicals entering its market.

Recently, when our company helped to solve enterprises' questions about EU REACH regulation, we found that many enterprises confused the concept of REACH registration and REACH testing. Today we will briefly talk about these two pieces of content.

▌ REACH registration

REACH registration means that unless exempted, when the production or import of chemical substances in the EU is ≥1 ton/year, the registration dossier of the substance needs to be submitted to ECHA to obtain the registration number of the substance before it can enter the circulation of the EU market.The chemical substances regulated under REACH include the substance itself, the substance in the mixture and the intentional release of the substance in the article, as long as the standard of 1 ton/year is reached, all The obligation to register is required.

图片源自网络 侵删

For intentional release of substances from articles, i.e., substances that are intentionally released from articles to provide some auxiliary functions for the purpose of promoting sales and providing a good customer experience, etc. If no one has currently registered for that use, it is necessary to submit the corresponding registration.

▌ #Case Intentional release of substances

The scented substance in the rubber must be volatilized in order to be smelled, and this scented substance is an intentionally released substance.

▌REACH testing

EU officials believe that only the registration and assessment of substances still cannot solve the risk problem of all chemicals, for substances with high hazard risk, they need to be included in the corresponding list of controlled substances, and need to fulfill the corresponding supply chain information transfer, notification, authorization and restriction obligations.

According to REACH Article 57, substances with hazard classification (CMR 1A/1B, PBT, vPvB, substances of serious health hazard or environmental high concern such as endocrine disruptors) will be gradually included in the list of substances of very high concern (SVHC). SVHC substances have certain hazard classification, and these substances will be selected to be included in the list of authorized substances, so SVHC list is also called the authorized candidate list.

Another category of controlled substances is included in Annex XVII of REACH, a list that sets out the restriction obligations for substances, mixtures and/or articles. Each entry shows a substance or a group of substances or mixtures in a substance or article, as well as the corresponding restrictions. "REACH testing is mainly said to be SVHC testing, which is a test for the presence of substances of very high concern (SVHC) and their content in articles, and the corresponding report. In addition at the request of the official or the importer, it may also refer to the inclusion of REACH Annex XVII restricted list of relevant products to carry out the corresponding test and issue a compliance report."

Enterprises need to note that if they import SVHC substances, mixtures containing SVHC substances or articles containing SVHC substances, they need to fulfill the corresponding obligations before they can be produced, imported or used in the EU.

Up to now, the official list of SVHC substances officially announced by the EU is 224 items.

Scan the QR code to view the library of High Concern Authorized Substance List

▌SVHC List Substance Compliance Requirements

Supply chain information transmission

◆ Substances and mixtures containing more than 0.1% of SVHC must transmit to the downstream the SDS in compliance with EU REACH regulations.

◆ Substances containing more than 0.1% of SVHC must transmit to the downstream recipient instructions for safe use, which include at least the name of the substance of the SVHC. Consumers may also make similar requests, and suppliers should provide relevant information free of charge within 45 days. If necessary, suppliers are also required to provide a REACH compliance statement that includes the SVHC test results.

SVHC Notification

If the article contains >0.1% SVHC substance and also meets the total amount of SVHC substance >1 ton/year, the official notification must be completed to ECHA. Unless the SVHC substance has been registered for that use or is not exposed to the environment in the article.

▌Summary

Through the interpretation of REACH regulations, we can find that REACH registration applies to the chemical substance itself, and when its total amount reaches 1 ton/year, the enterprise has to fulfill the obligation of REACH registration for the chemical substance; while REACH testing is mainly for the articles (finished products), the articles themselves are exempt from REACH registration, but when REACH testing is conducted and the articles are found to contain When SVHC substances are found to be contained in the products, enterprises need to fulfill the corresponding supply chain information transfer (including test report, declaration of conformity, SDS, etc.) and SVHC notification and other compliance obligations according to the product testing and total export volume.

We would like to remind you that if you violate the REACH regulation, you may face product recall, fines or even imprisonment, so be sure to actively check the compliance situation before exporting your products and reduce the trade risks in advance.