News Brief
The Ministry of Environmental Protection and Natural Resources of Ukraine (MEPR) has recently unveiled the Draft Rules for Joint Submission of Information When Registering the Same Chemical Substance (hereinafter referred to as the "Draft Rules") for public consultation. This Draft Rules is a cornerstone in the implementation of the Ukrainian REACH Regulation, aiming to streamline the collaborative registration process for identical chemical substances among multiple enterprises. The Draft Rules emphasize mandatory data sharing, reducing redundant testing and costs, and minimizing vertebrate animal testing, aligning closely with the principles of the EU REACH Regulation.
Key Mechanisms: Data Sharing Consortium (Substance Information Exchange Forum) and Lead Registrant
The Draft Rules focus on establishing the "Data Sharing Consortium" system, commonly known as the "Substance Information Exchange Forum (SIEF)," and introducing the "Lead Registrant" mechanism.
Establishing the Substance Information Exchange Forum (SIEF)
The Draft Rules propose the formation of a Substance Information Exchange Forum (SIEF) for enterprises registering the same chemical substance. The SIEF's main responsibilities include: Coordinating Joint Submission of Registration Information: Ensuring all members collaborate on registration submissions. Standardizing Hazard Data: Maintaining consistency in hazard evaluations across registrants. Reducing Redundant Testing: Mandating data sharing to alleviate compliance burdens and enhance animal welfare by avoiding unnecessary vertebrate testing.
Selection of the Lead Registrant
SIEF members must appoint a Lead Registrant, who will play a pivotal role in the registration process: Submitting the Joint Notification: Within 10 working days of the SIEF's establishment, the Lead Registrant must submit a "Joint Notification" to the MEPR via Ukraine's National Unified Electronic Portal. This notification should include: Contact details of the Lead Registrant and all SIEF members. The chemical substance's name and unique identifier (e.g., CAS Number). Documentation confirming the SIEF's establishment. Representing SIEF Members: Acting on behalf of all members to submit the lead registration dossier. Coordinating Registration Processes: Ensuring data accuracy and completeness throughout the process.
Documentation Requirements for Joint Notification
The Lead Registrant must compile and submit a comprehensive technical dossier, including:
Hazard classification data.
Summaries of study results.
Chemical Safety Report (CSR) or exposure scenarios (if applicable).
Justifications for new testing proposals (if additional data is required).
Industry Concerns and Challenges
The Draft Rules signify a significant step forward in Ukraine's chemical management system, aligning with EU standards. However, several aspects of the draft raise questions within the industry:
Applicability of Simplified Registration Procedures
For enterprises that have completed EU REACH registration and are pursuing simplified registration under Articles 26-27 of the Ukrainian REACH Regulation, it remains unclear whether participation in the SIEF is mandatory or if alternative procedures are available. Further clarification from MEPR is needed.
Detailed Requirements for Joint Notification
The Draft Rules requires extensive information, such as hazard classification data and study summaries, to be included in the Joint Notification. This diverges from EU REACH practices, where such details are typically submitted during the dossier preparation stage. The Draft Rules appear to conflate the distinct stages of "notification of nomination" and "dossier submission" (or perhaps the terminology itself has resulted in such confusion). MEPR should clarify the distinction between "notification of nomination" and "dossier submission" to avoid confusion.
Update Requirements and Liability Mechanism
The Draft Rules mandates that any changes to submitted information must be reported to the MEPR within 10 working days. Additionally, the Lead Registrant bears legal responsibility for the authenticity and accuracy of all submitted data on behalf of SIEF members.
Conclusion
The Draft Rules represent a critical milestone in the implementation of the Ukrainian REACH Regulation. By introducing mandatory data sharing and joint submission mechanisms, the rules aim to reduce compliance costs, improve registration efficiency, and protect animal welfare. However, ambiguities in key areas, such as Joint Notification requirements and simplified registration procedures, need to be addressed to ensure clarity and operability. REACH24H will continue to monitor developments in Ukrainian REACH regulations and provide timely updates. If you have any questions in this regard, please feel free to contact us at customer@reach24h.com.
