The EU's Registration, Evaluation, Licensing and Restriction of Chemicals (REACH) has been officially implemented for many years. Compared with other directives implemented by the European Union in recent years, REACH regulation has a wider scope of impact and is a preventive management regulation for all chemicals entering its market by the EU.

Recently, we have found that many companies have confused the concepts of REACH registration and REACH testing when helping to address their concerns about the EU REACH regulation. Let's briefly introduce some differences between these two businesses through this article.

1. REACH registration

REACH registration refers to the requirement, unless exempted, to submit a registration file to ECHA for a chemical substance produced or imported in the EU with a capacity of ≥ 1 ton/year, and obtain a registration number for the substance before it can enter the market for circulation. The chemical substances regulated by REACH include the substance itself, monomers in polymers, certain substances in mixtures, or intentionally released substances in articles. As long as they meet the standard of 1 ton/year, they need to fulfill the registration obligation.

2. REACH testing

The REACH regulation sets a strict authorization system for the use of certain chemicals in Annex XIV, as the authorities believe that registering and evaluating substances alone cannot solve the risk issues of all chemicals. These substances included in the authorization list are called Substances of Very High Concern (SVHC).

REACH testing actually refers to SVHC testing, which tests whether an item contains substances of high concern (SVHC) and their content, and issues a corresponding report.

Enterprises need to be aware that as long as the items contain SVHC substances, even if the annual production or import volume of these substances does not exceed 1 ton, they must be officially authorized before they can be produced, imported or used within the European Union.

As of now, the official list of SVHC substances released by the European Union includes a total of 234 items (including 224 candidate substances, 1 substance awaiting resolution, and 9 substances under review).

3. SVHC substance compliance requirements

(1) Information transmission

If the SVHC content in substances or preparations exceeds 0.1%, SDS that complies with the EU REACH regulation must be transmitted downstream;

If the SVHC content in the item exceeds 0.1%, safety instructions must be conveyed to downstream recipients, including at least the name of the SVHC. Consumers can also make similar requests, and suppliers should provide relevant information free of charge within 45 days.

(2) Notification

If the content of SVHC substances in the item is greater than 0.1% and the total amount of SVHC substances is greater than 1 ton/year, it must be reported to the ECHA official.

4. Summary

Through the interpretation of the relevant provisions of the REACH regulation, we can find that the target of REACH registration is the chemical substance itself, and when its total amount reaches 1 ton/year, the enterprise must fulfill the obligation of REACH registration for the chemical substance; REACH testing is aimed at goods (finished products), which are exempt from REACH registration. However, when SVHC substances are found in the goods during REACH testing, companies need to fulfill corresponding compliance obligations such as obtaining authorization, information transmission, or notification based on product testing and export volume.

Finally, Zhongbang Consulting reminds all business friends exporting to the European Union that if they violate the REACH regulation, they may face product recalls, fines, or even imprisonment. Therefore, it is necessary to actively self check the compliance situation before exporting products and prepare in advance to reduce trade risks.