Since October 1, 2023, sanitary and epidemiological conclusions, or SES conclusions, have been canceled and are no longer issued. This change stems from the implementation of the Ukrainian Law "On the Public Health System," which annulled the existing law "On Ensuring Sanitary and Epidemiological Well-being of the Population," where the conduct of state sanitary and epidemiological expertise of products was stipulated.
We have emphasized the legal collision where established methods of proving safety are abolished without introducing new operational mechanisms. What should manufacturers, importers, or authorized persons do next? How can the safety of products be substantiated?
As of today, the principles of introducing non-food products into circulation in Ukraine and ensuring their safety are defined by the laws of Ukraine, namely the "On the Public Health System", "On the General Safety of Non-food Products" and "On State Market Surveillance and Control of Non-food Products."
First and foremost, safe non-food products refer to any products that, under ordinary or reasonably foreseeable conditions of use (including service life and the need for installation and maintenance), do not pose any risk or pose only minimal risks deemed acceptable and do not create threats to public interests.
One of the key requirements of the law "On the General Safety of Non-food Products" is Article 4, "General Requirement for Product Safety," which states that manufacturers (importers, authorized representatives) are obligated to introduce only safe products into circulation.
Article 5 of the law "Proving the Safety of Products" states that:
A product is considered safe if it meets the requirements for ensuring product safety established by legislation.
In the absence of requirements for ensuring product safety specified in the first part of this article, the relevant product is considered safe if the state market surveillance authority does not prove that such product is unsafe.
The safety of the product is evidenced by its compliance with national standards harmonized with the relevant European standards. The list of such harmonized national standards is formed by the central executive authority implementing state policy in the field of standardization. This list is published annually by January 1 through its publication in the printed media of the central executive authority implementing state policy in the field of standardization (in the absence thereof, in the printed media determined by this authority) and by placing it on the official website of the central executive authority implementing state policy in the field of standardization.
In the absence of requirements for ensuring product safety specified in the first part of this article or the absence or non-application of national standards specified in the third part of this article, the state market surveillance authority, when proving that the product is unsafe, may take into account, in this sequence:
national standards of other states for ensuring product safety harmonized with the relevant European and international standards;
regional standards for ensuring product safety in accordance with international treaties of Ukraine;
standards of Ukraine for ensuring product safety, except those specified in the third part of this article;
codes of established practice for ensuring product safety in relevant industries;
achievements of science and technology in the field of product safety;
expectations of consumers (users) regarding the product's safety under ordinary or reasonably foreseeable conditions of its use (including the service life and, if necessary, the introduction into operation requirements for installation and maintenance).
5. The product cannot be considered unsafe solely because there are opportunities to achieve a higher level of product safety or because other products are offered on the market.
Let's break it down! Point 1: If there is no technical regulation or industry standards for a specific type of product, it is considered that there are no requirements for ensuring the safety of the product in Ukrainian legislation. Point 2: In the absence of such requirements, the product is considered safe, and the state market surveillance authority must prove the opposite if it sees grounds to do so. Point 3: Currently, there is a list of national standards approved by the Ministry of Economic Development as of February 22, 2018 (Order No. 241) and January 22, 2021 (Order No. 119 with amendments, supplemented by Order No. 2862 of May 2, 2023). Suppose there is a standard for your product. In that case, you should acquire the corresponding Ukrainian standard (DSTU) from the State Enterprise "Ukrainian Scientific Research and Educational Center for Standardization, Certification, and Quality" (SE "UkrNDNC") and adhere to its requirements. Point 4:
Other countries' standards: Importers may frequently apply this point, requiring foreign manufacturers to provide test reports, certificates, declarations, quality passports, etc., complying with the requirements of the countries where the product was manufactured.
Regional standards according to international treaties: For those well-versed in their industry.
Ukrainian standards, excluding harmonized ones: This may include technical regulations and other requirements depending on the industry.
Codes of established practice: Could involve quality management system requirements for product safety.
Achievements of science and technology: Staying updated with the latest advancements in product safety.
Consumer expectations: The cherry on top, as incorporating consumer expectations is uncertain.
Point 5: The most positive aspect, is that it maintains the presumption of innocence for the manufacturer even if there are higher safety standards on the market. As anticipated, manufacturers and importers who obtained SES conclusions have a temporal buffer to address all legal issues in the relevant areas. Others need to act at their own risk, considering the potential ambiguity in interpreting the law on safety. The letters of explanation from government institutions suggest that more specific answers won't be provided to entrepreneurs, as this is a time for solutions rather than detailed guidance. The positive example of regulating legislation in the detergent industry is the adoption of the Cabinet of Ministers' resolution dated August 19, 2023, No. 872, amending the Technical Regulation on detergents. It excludes the conclusion of state sanitary and epidemiological expertise from the list of technical documentation submitted by businesses to prove compliance with detergent requirements.
With faith in Ukraine and the strong entrepreneurial spirit of Ukrainians, we hope for a speedy resolution of the safety-proofing issues in each industry!
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