At “Standards and Quality,” we are already seeing these changes in practice: consultations regarding the new requirements have become perhaps the most popular topic since the beginning of the year. So, I’ll explain exactly what has changed and what to do about it.
The essence of the changes: from mere declarations to actual oversight
In short, the law has finally been given “teeth.” Previously, it was a framework law: it established the general principle that products must be safe, but the mechanisms for oversight and accountability were vague. Now there are specific obligations, specific procedures, and specific fines.
The key change concerns the approach to liability. Whereas previously the focus was mainly on products subject to technical regulations (electrical equipment, toys, building materials), the law now clearly regulates products for which there are no specific regulations. In other words, if you manufacture or import goods that are not covered by any specific regulation—this still applies to you.
New obligations for manufacturers
The list of a manufacturer’s responsibilities has been expanded and clarified. Here are the new requirements.
Internal traceability. The manufacturer is required to maintain records that allow for the identification of each product batch, the determination of the raw material supplier, and the distribution chain. If a product needs to be recalled, you must do so quickly and know exactly where each batch has gone. In practice, for small manufacturers, this means implementing at least a basic batch tracking system.
Risk assessment even without technical regulations. Previously, manufacturers of products not subject to technical regulations often operated without any safety assessment at all. Now, the law requires a risk assessment for any non-food product—and the results must be retained. This does not necessarily have to be a full-scale laboratory study, but a document showing that the manufacturer has considered the risks and taken measures must exist.
Reporting on hazardous products. If a manufacturer or importer learns that a product poses a risk to consumers, they are required to immediately notify the State Service of Ukraine for Food Safety and Consumer Protection. Not “when convenient,” not “if there are complaints,” but immediately. And take corrective action: warn consumers, recall the product, and repair or replace it. Response deadlines are now specified—and there is separate liability for violating them.
A special note for importers: You are now required to verify that the manufacturer has conducted the necessary conformity assessment before placing the product on the market. You cannot simply “assume” that they have done so; you must have documentary evidence. You must have the declaration of conformity or test reports in your possession before the goods cross the border.
The powers of the State Service for Food Safety and Consumer Protection have been significantly expanded. Previously, an inspector could simply visit a facility, conduct an inspection, and issue a corrective order. Now, they have far greater capabilities.
First, a “mystery shopping” mechanism has been introduced. An inspector can purchase products from a retail chain or online and send them for laboratory testing. Without warning, without notice. If the results show non-compliance—the full program follows: recalls, fines, public announcements.
Second, powers regarding online commerce have been significantly expanded. Now, the market surveillance authority can require marketplaces and online stores to remove listings for dangerous products. For those selling through Rozetka, Prom, or OLX, this means that improperly issued product certification or missing documentation can lead to your product being blocked on the platform—even without an inspection of the warehouse or production facility.
Third, a public registry of hazardous products has been launched—an equivalent to the European Safety Gate (formerly RAPEX). If your product ends up there, it will be a public stain on your reputation that partners, consumers, and competitors will all see.
Fines: finally, substantial amounts
Here’s what “hurts” the most. Penalties have been increased, and now they’re no longer symbolic amounts but figures that can have a real impact on a business.
For putting dangerous products on the market—a fine of up to 10% of the company’s annual turnover. For failure to comply with a market surveillance authority’s recall order—an additional fine and mandatory seizure. For failure to report dangerous products in a timely manner—separate liability. And this applies not only to manufacturers: importers and distributors bear joint and several liability.
In practice, we see that small businesses are at the greatest risk precisely because of a lack of knowledge. A manufacturer of children’s toys may not even realize that their products are subject to specific regulations and require specialized testing. An importer of household appliances may sincerely believe that a certificate from a Chinese supplier is sufficient for the Ukrainian market. And electrical products are a special case where even experienced importers sometimes get confused about which regulations apply.
Unregulated products: the biggest gray area
I’d like to focus specifically on a category that few people talk about: products for which there are no specific technical regulations. Furniture for adults, tableware, gardening tools, office supplies, gift items, and sports equipment—most of these products are not subject to specific regulations, but the law requires that they be safe.
What does this mean in practice? The manufacturer or importer must conduct a risk assessment, ensure compliance with general safety requirements, and document this. In many cases, it is advisable to obtain a declaration of conformity or a sanitary-epidemiological opinion for products that come into contact with the skin or food. If the products are not manufactured in accordance with DSTU standards, the manufacturer must also have its own specifications—without them, the manufacturer’s evidence base appears weak.
The problem is that manufacturers of “unregulated” goods have operated for decades without any assessment whatsoever. “We don’t make toys or electrical appliances—why do we need certificates?” Now the “why” has become clear: because a fine of up to 10% of turnover is a compelling argument.
How to prepare: a practical plan
At “Standards and Quality,” we offer our clients a simple step-by-step guide to preparing for the new requirements.
Step 1. Determine which regulation applies to your products. If a specific one applies, make sure your declaration of conformity or product certificate is up to date and properly issued. If there is no specific regulation—don’t get too excited, because general safety requirements still apply, and fines apply to everyone.
Step 2. Check traceability. Can you determine within an hour which batch of raw materials was used for a specific series of finished products? Do you know which customers each batch was shipped to? If not—this is the first thing you need to fix.
Step 3. Conduct a documented risk assessment. For products not subject to regulations, this can be a relatively simple document, but it must exist. For regulated products, the technical file must be complete and up to date.
Step 4. Check the labeling and ensure a sanitary-epidemiological certificate is available for products that come into contact with the skin or food. New labeling requirements mandate the inclusion of contact information for reporting hazards. Review your labels—do they contain all the necessary details?
Step 5. Develop a recall procedure. Even if you never need it (we hope not)—it must be in place. Who is responsible, how information is communicated, which communication channels are used, and the timeframes—all of this is now not “recommended” but “mandatory.”
The “Standards and Quality” team helps companies bring their documentation into compliance with the updated requirements: from reviewing existing certificates and declarations to developing recall procedures and conducting risk assessments. If you’re not sure whether the changes apply to your specific products—reach out, and we’ll figure it out in a single consultation. It’s better to spend an hour now than months fixing the consequences later.
