Although Ukraine’s SIEF is like the EU in many aspects, there are still some unanswered problems regarding its implementation, such as whether simplified registration is applicable and whether joint notification dossier requirements are stringent. A draft rule for the joint submission of information in applications for state registration of similar chemical substances was published by Ukraine’s Ministry of Environmental Protection and Natural Resources (MEPR).
This rule determines the procedures for joint notification, which includes the following essential steps:
· Create an information exchange consortium (also known as substance information exchange forum, SIEF under EU REACH context) or join an existing information exchange consortium.
· Select the lead applicant.
· Send an official notification of the creation of an information exchange consortium.
· Send joint notification.
All candidates’ contact information should be included in the combined notification. Additionally, the lead applicant should submit the following supporting documentation for joint notification on behalf of the other applicants and with their consent:
· Data on the hazard classification of the chemical substance.
· A summary of studies on the hazardous properties of a chemical substance.
· A chemical safety report because of a chemical safety assessment or information on the levels of exposure to human health and/or the environment of the chemical.
· Proposals for conducting new tests.
Within ten working days of the information exchange consortium’s formation, the lead applicant must submit a joint notification. Through the Unified State Web Portal of Electronic Services, the joint notification may be sent electronically or on paper.
The lead applicant is responsible for data accuracy and update the data in case of changes within 10 days.
Underlying issues
The draft’s publication demonstrates Ukraine’s advancement in putting in place a workable chemicals management system and confirms its resolve to harmonize regulatory procedures with those of the European Union. Notwithstanding the parallels between the EU and Ukraine’s SIEF method, the
sector has expressed concerns about some crucial areas, which call for explanation before finalization:
1. Eligibility for Simplified Registration: The draft does not specify whether there are further processes or if current EU REACH registrants who seek for streamlined registration under Articles 26–27 of Ukraine REACH are required to join a Substance Information Exchange Forum (SIEF).
2. Overly Strict Requirements for Joint Notification: The draft deviates from typical EU REACH processes (e.g., the SIEF model) by requiring joint notice to contain detailed content such hazard categorization data, research summaries, and Chemical Safety Reports (CSRs). Such thorough submissions are normally needed during dossier preparation following the designation of a lead registrant, not during the initial nomination stage of SIEF formation, in accordance with the EU REACH framework. The “nomination notification” and “dossier submission” phases seem to be confused in the draft (maybe because of a terminological misunderstanding).
To guarantee that the final regulation achieves a balance between operational clarity and regulatory rigor, especially in accordance with EU standards, the MEPR must resolve these phase-specific issues.
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