How to Apply to the REACH System

Sistem Patent Kalite explains how to apply to the REACH system: the REACH framework covers chemical substances produced in the EU and imported into the EU from non-EU countries. At this stage, the EU deals only with natural and legal persons established in the EU, and does not deal directly with non-EU manufacturers. Manufacturers or exporters based in Turkiye fall into the non-EU manufacturer class for REACH purposes. Companies in this class cannot apply directly to the EU. There are two alternatives for our companies to register with the REACH system and export to the EU.

On how to apply to the REACH system, the first alternative is for an EU-based importer to register the chemical substances imported from Turkiye in the REACH system themselves. In this case, the importer's role is equivalent to that of any EU manufacturer. The Turkiye-based firm must provide the importer with all the information needed to prepare the registration dossier on their behalf (regardless of confidentiality level). A significant drawback of this alternative is that the importer gains access to all the information about the chemical substance. Importers may also be reluctant to take on the registration responsibility (given the length of the registration and bureaucratic process).

The second alternative is for Turkiye-based manufacturers or exporters to appoint an Only Representative (OR). The OR can be a legal or natural person established in the EU. The OR is the sole counterparty for other EU organizations within the system. In the REACH process, EU firms will not accept Turkiye-based firms as direct counterparties. The Only Representative registers the substances to be exported on behalf of the relevant firm and becomes the sole responsible party under REACH. In this case, the importer becomes a downstream user, and can request from the OR the Chemical Safety Report (CSR), Chemical Safety Assessment (CSA), Safety Data Sheet (SDS), Exposure Scenario (ES), and other reports, documents, and information, rather than preparing them itself.