Practical Aspects and Recommendations in the Process of Harmonization of Technical Regulation with European Union Law

Practical Aspects and Recommendations in the Process of Harmonization of Technical Regulation with European Union Law

On April 7, 2026, the Verkhovna Rada of Ukraine took a further step toward European integration by adopting Draft Law No. 12221 in its second reading and in its entirety. This refers to the Law “On Amendments to Certain Laws of Ukraine Regarding the Harmonization of the Sphere of Accreditation of Conformity Assessment Bodies and the Technical Regulation System with European Union Requirements.”

This document is not merely a technical update of legislation; it establishes the foundation for deeper integration of the Ukrainian economy into the Internal Market of the European Union. Its primary objective is to align the national technical regulation system with European standards and practices.

One of the key innovations of the aforementioned Law is the implementation of mechanisms for the mutual recognition of accreditation results between Ukraine and European Union Member States. This implies that the results of conformity assessments conducted in Ukraine may be recognized in the European Union without the need for redundant procedures. Concurrently, the product conformity assessment procedures themselves are being refined to align closely with European models.

In practical terms, the implementation of the Law’s provisions paves the way for the conclusion of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA), commonly known as “industrial visa-free.” This specific instrument is poised to support Ukrainian businesses by significantly simplifying access for domestic industrial products to the European Union market.

The Law does not merely expand opportunities; it substantially raises the standards of liability. Oversight regarding the accuracy of product information is being strengthened, and approaches to interacting with European institutions in the fields of accreditation and technical regulation are evolving. Effectively, businesses are transitioning into a new regulatory reality where requirements are more stringent, yet simultaneously more predictable and unified with European standards.

As a result of these changes, Ukrainian manufacturers gain the opportunity to enter the EU market significantly faster and with lower costs, as the necessity for repeated certification in EU countries is eliminated. This will also facilitate a reduction in the administrative burden and enhance product competitiveness, as adaptation to European technical regulations inherently signifies improved quality and increased trust from foreign partners.

Despite the evident advantages, the new regulation entails a series of risks that Ukrainian enterprises should consider immediately:

1. Harmonization with EU law entails not only market access but also the obligation of full compliance with European standards. For most enterprises, this will require investment in production modernization, technological process changes, and the implementation of quality control systems.

2. Increased liability for the accuracy of product information creates additional legal risks. Errors in labeling, technical documentation, or declarations of conformity may result not only in fines but also in the restriction of product access to the EU market.

3. The mutual recognition of conformity assessment results will not take effect automatically. Until the actual conclusion of the ACAA, Ukrainian companies may still face the need to undergo additional procedures in the EU, creating a transitional period of legal uncertainty.

4. We anticipate that taxpayers will have to adapt to new procedures for interacting with accreditation bodies, which will become more formalized and demanding. This will increase the burden on corporate compliance functions and necessitate the involvement of specialized consultants.

In light of the above, we recommend that companies do not limit themselves to formal compliance but rather adopt a strategic approach to adaptation:

1. Evaluate products and production processes for compliance with European technical regulations to identify potential discrepancies early on.

2. Revise internal quality control procedures and the preparation of technical documentation, as these aspects are becoming critical from a liability perspective.

3. Ukrainian enterprises should invest in building an effective compliance system and staff training, particularly in technical regulation and interaction with accreditation bodies.

4. Stay informed regarding the progress of the ACAA conclusion to be prepared to leverage new opportunities immediately.

In conclusion, in the current environment, the competitive advantage will lie solely with those companies that proactively adapt to the new rules of operation.

Author: Dmytro Dovzhyk, Attorney at Law and Partner at ArtesLex

09.05.2026

Dmytro

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