4-16. Latest Revisions to the EU Chemical Regulation (REACH) and Precautions for Exporters

EU's REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation is one of the most comprehensive and strict chemical regulations in the world, making compliance an unavoidable challenge for exporting companies. The latest revisions, which will be implemented by 2025, focus on strengthening restrictions on hazardous chemicals and tightening registration requirements. Exporting companies, including those in Japan, must quickly adapt. Here are the key points of the revision and areas for companies to pay attention to.

1. Overview of the Latest Revisions

REACH mandates the registration of chemical substances manufactured or imported into the EU in quantities of one tonne or more per year, including existing substances. The latest revisions are particularly focused on adding more Substances of Very High Concern (SVHCs) to the list, with a strong trend toward including PFAS (per- and polyfluoroalkyl substances) and endocrine disruptors. Furthermore, companies are now required to refine registration data and strengthen the scientific basis for testing methods and toxicity assessments.

2. The Importance of Supply Chain Management

When Japanese companies export products to the EU, they are subject to these obligations even if they don't directly manufacture chemicals themselves, if the components or raw materials in their products contain SVHCs. Providing information to the SCIP (Substances of Concern in Products) database is now mandatory, making it essential to establish a system for collecting and sharing chemical information throughout the entire supply chain. It is also recommended to explicitly include chemical information disclosure clauses in contracts with business partners.

3. Challenges for Japanese Companies

• Lack of Information: Many small and medium-sized enterprises (SMEs) are often slow to respond due to a lack of awareness of overseas regulatory changes.

• Cost Burden: The high cost of registration and testing can be a significant burden, especially for companies handling multiple chemical substances.

• Lack of Human Resources: There is a limited number of personnel with specialized knowledge, and coordination between legal/quality assurance departments and the EHS department can be insufficient.

4. Practical Points for Action

• Establish a system for continuously monitoring regulatory changes and responding promptly to updates to the SVHC list.

• Reliably collect SDS (Safety Data Sheets) and component certificates from the supply chain to understand the chemical substances in your products.

• Use an "Only Representative (OR)" within the EU to streamline registration and communication with authorities.

• Integrate into your EHS management system and link with ISO 14001 and ISO 45001 to achieve continuous improvement.

5. Summary

The REACH revision is not just about legal compliance; it is a factor that influences competitiveness and credibility in the global market. Exporting companies are required to understand the latest revisions and establish an information management system that involves the entire supply chain. Positioning EHS compliance as a part of business strategy, in anticipation of future international chemical substance regulations, will be key to sustainable growth.