Introduction

Bringing chemical products into the EU market requires strict compliance with multiple regulations — including REACH, CLP, PCN, SCIP, and SVHC requirements.

Our one-stop solution for exporting chemical products to the EU helps enterprises streamline complex procedures, ensure product safety, and maintain continuous access to the European market.

EU REACH Regulation Registration Obligations

According to the EU REACH Regulation, enterprises manufacturing or importing chemical substances into the EU in quantities of 1 tonne or more per year (whether as a substance on its own, in a mixture, or intentionally released from an article) must submit a registration to the European Chemicals Agency (ECHA). Enterprises that fail to register will be prohibited from manufacturing, importing, or placing the substance on the EU market. Furthermore, some substances are also subject to ongoing obligations related to evaluation, authorisation, and restriction. 

EU CLP Regulation: SDS Preparation and Update Requirements

On January 20, 2009, the EU enacted the Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation), building upon the UN GHS framework and aligning with the implementation of the REACH Regulation. This regulation has been effective for substances since December 1, 2010, and was extended to mixtures on June 1, 2015, fully enforcing all relevant classification, labelling, and packaging requirements.

On June 29, 2020, the European Commission amended Annex II of the EU REACH Regulation (EC) No 1907/2006 by publishing COMMISSION REGULATION (EU) 2020/878. This regulation mandates that all Safety Data Sheets (SDSs) prepared from January 1, 2021, must comply with the updated requirements, with a grace period provided until December 31, 2022. Consequently, as of January 1, 2023, SDSs for products supplied to the EU market must be updated to meet the new requirements of (EU) 2020/878, otherwise, such products cannot be placed on the EU market.

Note that if products placed on the EU market are subject to Poison Centre Notification (PCN) requirements, the SDS and label for the respective product must be updated to include the Unique Formula Identifier (UFI).  

EU C&L Notification

According to Article 40 of the CLP Regulation, EU manufacturers and importers who place hazardous substances on the market (on their own), or hazardous components in a mixture above the concentration limits that trigger a GHS classification for the mixture, must notify the classification and labelling of the substance(s) to ECHA. This is known as a C&L notification. 

EU Poison Centre Notification (PCN) and UFI Application Requirements

EU Poison Centre Notification (PCN)

As required by Article 45 of the CLP Regulation, for all mixtures placed on the EU market that are classified for physical or health hazards, enterprises must submit a Poison Centre Notification to the appointed bodies in the relevant Member States and include the Unique Formula Identifier (UFI) on the product label.

Unique Formula Identifier (UFI)

The UFI is a 16-character alphanumeric code generated by the ECHA UFI generator tool, based on the company's VAT number and an internal formulation number. Each UFI corresponds to a single, specific mixture formulation. As long as the formulation is unchanged, the same UFI can be used in the supply chain. The UFI also helps protect confidential business information, as only known ingredient information is required for the notification.  

EU SCIP Notification Requirements

Under the revised EU Waste Framework Directive (WFD, Directive 2008/98/EC), as of January 5, 2021, any supplier of an article containing a Substance of Very High Concern (SVHC) in a concentration above 0.1% (w/w) on the EU market must submit a SCIP notification to ECHA. ECHA collects this information to establish and maintain the SCIP database to ensure transparency on SVHCs in articles. 

SVHC Notification Requirements

According to the REACH Regulation, if an article contains an SVHC in a concentration above 0.1% (w/w) and the total annual quantity of that substance imported in those articles exceeds 1 tonne, the EU producer, importer, or Only Representative must submit an SVHC notification to ECHA. For newly added SVHCs, this notification must be completed within 6 months of the substance's inclusion in the Candidate List.

A Reminder for Exporters

To ensure smooth market entry and maintain continuous compliance in the EU, enterprises should effectively mitigate the risks of enforcement actions—such as fines, product confiscation, or even criminal liability—thereby securing uninterrupted trade with Europe. It is therefore imperative that enterprises:

• Fully Assess Compliance Obligations: Immediately determine if products are subject to REACH registration, SCIP, or SVHC notification obligations, and initiate the compliance process promptly.

• Update Technical Documentation: Strictly adhere to CLP Regulation and PCN requirements by updating Safety Data Sheets (SDS) and product labels, ensuring the UFI is accurately and fully included.

• Establish Internal Compliance Mechanisms: Implement a management system for product formulations and substance information to ensure the uniqueness and traceability of the UFI.

• Proactively Track Regulatory Updates: Closely monitor changes to the SVHC Candidate List and related transition periods, preparing notification dossiers in advance to prevent penalties for non-compliance.

Leveraging our extensive practical experience in these regulations and our international team, we provide comprehensive, multilingual compliance support throughout the entire process of trading with the EU. Please feel free to contact us if you require assistance.