EU Project: Significant Quality Issues with Extended Safety Data Sheets

As part of a European project, REACH-EN-FORCE 5, inspectors found significant quality issues when examining extended safety data sheets (eSDS) in 2017. They wanted to determine if information is transmitted correctly along the supply chain. In that context, they also examined how well downstream users implement the required risk management measures and develop their own safety assessments.

The goal of the inspection is to protect employees who must deal with hazardous substances at their workplace. In total, they inspected documents from 898 companies in 29 EU and European Economic Area (EEA) countries. The ECHA has published a press release on the project.

The inspectors uncovered 296 violations as part of their examinations. In most of the deficient cases, the companies had failed to translate the content of the eSDS into the language of the member states in which the substance was marketed. In their closing report, the authors also warn about poor-quality information and issues like missing updates on the harmonized classification of substances in the eSDS (see Chapter 1.2: Main Results and Conclusions in the closing report of the REACH-EN-FORCE 5 project). They also found missing or incomplete exposure scenarios, inadequately specified risk management measures, incorrectly applied exposure models, and questionable exposure estimates.

According to the authors, these issues affect the supply chain negatively because not only the information, but also the deficiencies and erroneous specifications are transmitted. That situation makes the use of such information questionable.

Overall, official agencies acted in 665 cases. Most of the actions involved verbal advice and written advice. Only 4% of the cases resulted in fines.

The authors appealed to companies to update registration dossiers, SDS, and extended SDS on a regular basis and, if needed, suggest risk management measures in the SDS. In turn, downstream users should work for better communication in the supply chain. Official agencies must also do their part to contribute to better information and, for example, explain the legal requirements to companies better within the context of national campaigns. The sponsors of the REACH-EN-FORCE 5 project provide additional recommendations in Chapter 3.2 of the closing report.

The creation of almost every country-specific version of safety data sheets has been one of our core competencies for many years. If you have any questions, please contact us at sds@kft.de.

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