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The Ministry of Environmental Protection and Natural Resources of Ukraine has made a significant move by republishing the Ukraine REACH Resolution “On the Approval of the Technical Regulation on the Safety of Chemical Products,” on its website for public commentary as of March 22, 2024: ПОВІДОМЛЕННЯ про оприлюднення проєкту постанови Кабінету Міністрів України «Про затвердження Технічного регламенту щодо безпечності хімічної продукції» – Міністерство захисту довкілля та природних ресурсів України (mepr.gov.ua). The Ukraine REACH draft, identical to the one submitted to the World Trade Organization in 2023, is a comprehensive chemical legislative framework aimed at aligning Ukraine’s chemical safety regulations with the EU standards. Therefore, businesses placing chemicals (substances/mixtures) on the Ukrainian market as importers, manufacturers, or as foreign businesses represented by local Only Representatives, and downstream users of these chemical will be affected by Ukraine REACH.

Ukraine REACH and Annex XVIII

The draft encompasses 18 annexes, with Annex XVIII being of particular interest as it provides a comparative analysis between the EU REACH and Ukraine REACH. This annex is a valuable resource for stakeholders looking to understand the specifics of regulatory alignment and differences, aiding in compliance planning and implementation strategies.

Draft Decree and Registration Deadlines

Accompanying the Ukraine REACH draft is a draft decree detailing the implementation of the regulation, specifying substances’ registration deadlines:

• Over 1000 tons: By June 1, 2025
• 100-1000 tons: By June 1, 2026
• 1-100 tons: By June 1, 2027

These deadlines are notable for being part of the draft decree rather than the Ukraine REACH text itself, suggesting a potential flexibility in adjusting timelines if necessary. Looking at the pre-registration deadline, which must be completed within one year from the effective date, and considering the planned registration deadlines, it seems the effective date of Ukraine REACH could be June 1, 2024.  Acknowledging the detailed compliance processes that come into play once the regulation is enacted, the proposed timeline invites reflection on its practicability. The requirement for pre-registration within a year, alongside the deadline for substances over 1000 tons, presents a considerable challenge. Given that the chemical industry will also be addressing K-REACH and Turkey’s KKDIK deadlines around the same time, it’s crucial for the deadlines set by Ukraine REACH to be realistically achievable. Once the regulation is in place, revising these timelines could prove difficult, emphasizing the need for thoughtful consideration of effective and manageable deadlines from the outset.

Simplified Registration Process: Practical Challenges

The draft reiterates a simplified registration process for substances already registered under EU REACH, as outlined in Articles 26-27. However, this “simplified” approach still necessitates:

1. A technical dossier
2. A Chemical Safety Report (CSR), where required
3. Confirmation of EU registration through the REACH–IT system

The requirement to submit a technical dossier and a CSR for Ukraine REACH registration introduces significant procedural and legal challenges. These documents, originating from EU REACH, cannot be simply copied, or transferred for use in Ukraine REACH without appropriate permissions. A registrant must secure the right to use the data contained in these documents outside of the EU’s jurisdiction. Acquiring the necessary rights is a detailed, lengthy, and often expensive process, involving intricate negotiations and agreements to ensure lawful data usage and sharing. This requirement adds a complex layer to achieving compliance with Ukraine’s regulatory demands, highlighting the need for meticulous planning and resource allocation.

Drawing from the experience with Turkey’s KKDIK, it’s clear that establishing data sharing agreements and joint submissions is a complex and time-consuming endeavor.

Consequently, the proposed registration deadlines appear too ambitious, and the process for EU-registered substances, while intended to be streamlined, may not be as straightforward in practice.

Concerns Over Annex XIV Authorisation Deadlines

Further complicating matters is Annex XIV, which pertains to substance authorization. Of the 59 entries listed, 44 have been assigned a latest application date of January 1, 2025, and a sunset date of January 1, 2026. The remaining entries are yet to be assigned corresponding dates. These deadlines, especially for substances requiring authorization by the specified dates, present a significant challenge, appearing quite unrealistic for industry compliance within the proposed timeframe. The ambitious nature of these dates raises concerns over the practicability of meeting such deadlines and the potential impact on the industry’s ability to comply.

 Opportunity for Industry Input

Given the critical nature of these issues, REACHLaw will be submitting detailed comments on the draft resolution, including the specific concerns raised here regarding registration deadlines, data sharing, simplified registration and authorization deadlines.

We encourage industry stakeholders to also review these aspects and provide their feedback to ensure the regulation is both effective and achievable.

To share your comments, you can reach out to the Ministry of Environment by April 22^nd:

• Address: Vul. Mytropolyta Vasylia Lypkivskoho, 35, Kyiv, 03035
• Phone: (044) 206 31 26
• Email: info@mepr.gov.ua; laziuta.a@mepr.gov.ua

For further details or assistance, please do not hesitate to reach out to REACHLaw’s Global Accounts Lead and Legal Advisor, Olesia Vinterberg, at olesia.vinterberg@reachlaw.fi.