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Recently, Ukraine's Ministry of Environmental Protection and Natural Resources (MEPR) released a draft rule for joint submission of information in applications for state registration of an identical chemical substance.
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.
The joint notification should contain the contact details of all applicants. In addition, the lead applicant should, acting with the consent and on behalf of other applicants, submit the following accompanying document for joint notification:
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 as a result 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.
The lead applicant should submit joint notification within 10 working days from the date of creation of the information exchange consortium. The joint notification can be sent in paper or electronic form via the Unified State Web Portal of Electronic Services.
The lead applicant is responsible for data accuracy and update the data in case of changes within 10 days.
Underlying issues
The release of the draft signifies Ukraine’s progress in establishing a functional chemicals management system and reaffirms its commitment to aligning regulatory practices with the EU. Despite the similarities of Ukraine SIEF mode in relation to EU's ambiguities in certain critical areas have raised concerns within the industry, necessitating clarification before finalization:
1. Eligibility for Simplified Registration: The draft fails to clarify whether existing EU REACH registrants that apply for simplified registration under Article 26–27 of Ukraine REACH must join a Substance Information Exchange Forum (SIEF) or if alternative procedures exist.
2. Overly Strict Requirements for Joint Notification: The draft mandates that joint notification include detailed content such as hazard classification data, study summaries, and Chemical Safety Reports (CSRs), diverging from standard EU REACH practices (e.g., the SIEF model). Under the EU REACH framework, such detailed submissions are typically required during dossier preparation after a lead registrant is designated—not during the initial nomination phase of SIEF formation. The draft appears to conflate the "nomination notification" and "dossier submission" stages (possibly due to terminological confusion).
The MEPR must address these phase-specific ambiguities to ensure the final regulation strikes a balance between regulatory rigor and operational clarity, particularly in alignment with EU standards.
The draft rule can be accessed here.
