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Conclusion of the state sanitary and epidemiological examination: legal support

Conclusion of the state sanitary and epidemiological examination: legal support

The conclusion of the state sanitary and epidemiological examination is an official document confirming the safety of products for human health and allowing legal conduct of economic activity in Ukraine. Its issuance is regulated by the Law of Ukraine “On Ensuring the Sanitary and Epidemiological Well-being of the Population”.

The absence of a conclusion can lead to serious problems for businesses, including fines, a ban on the sale of products, and reputational damage.

We will help you obtain a SES opinion if:

  • You are planning to import products to Ukraine
  • You are launching the production of new products
  • You need to update or extend a previously obtained opinion
  • You have a non-standard situation that requires expert assessment
  • You have encountered a refusal to issue an opinion

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For which goods is a SES conclusion required?

The conclusion of the state sanitary and epidemiological examination is required for a wide range of goods and services. Let’s consider in detail each category and its features:

Food products and food supplements

This category includes not only ready-made food products, but also food additives, flavors, colors and other components used in the food industry. Special attention is paid to new types of products and innovative production technologies.

Cosmetics and hygiene products

This group includes all types of cosmetic products, body care products, decorative cosmetics, perfumes. An important aspect is the assessment of the safety of components and possible allergic reactions.

Children’s goods and toys

This category requires particularly careful inspection, as it concerns the most vulnerable group of consumers. Not only the safety of materials, but also the physical characteristics of the products are checked.

Household chemicals and detergents

Includes all types of cleaning, laundry, dishwashing products, etc. The main focus is on the chemical composition and potential impact on human health upon contact with skin and mucous membranes.

Building materials and finishing products

This group covers a wide range of materials from paints to insulation. Important factors are the release of harmful substances, radiation safety, and fire safety.

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Features of obtaining a CEE conclusion for different categories

дозвіл сес

Imported products

The procedure for obtaining a certificate for imported goods has its own specifics and requires special attention to detail.

A package of documents from the manufacturer. A complete package of documentation must be provided, including:

  • Product Specifications
  • Quality Certificates
  • Test Reports
  • Production Specifications

All documents must be translated into Ukrainian and duly certified. It is often difficult to obtain a complete set of documentation from foreign manufacturers who are not familiar with Ukrainian requirements.

Laboratory tests. You should also be prepared for additional laboratory tests in Ukraine, despite the presence of international certificates. This is due to the difference in research methods, the special requirements of Ukrainian standards and the need to verify compliance with the declared characteristics.

Product labeling. Special attention is paid to the correctness of the labeling, which must contain:

  • Information in Ukrainian
  • All necessary warnings and precautions
  • Rules of use and storage
  • Contact details of the importer

Domestic products

For Ukrainian products, the process of obtaining a conclusion has its own characteristics.

Technical documentation. You must provide:

  • Technical conditions of production
  • Technological regulations
  • Recipes and specifications
  • Production process description

Compliance with standards. Compliance must be confirmed:

  • State Standards of Ukraine
  • Sanitary Norms and Rules
  • Hygienic Standards
It will also be useful: Assistance in obtaining a license

Consult about the SEE permit

How to obtain a conclusion from the state sanitary and epidemiological examination?

Preparatory stage

At this stage, it is critically important to correctly determine:

  • Product category and relevant requirements
  • Required list of documents
  • Scope of required research
  • Potential risks and ways to minimize them

Our specialists conduct a preliminary audit of products and documentation, which allows us to identify possible problems even before submitting an application.

Laboratory studies

The choice of laboratory and research methods is an important stage that affects:

  • Time to obtain results
  • Recognition of results by expert institutions
  • Cost of research
  • Reliability of results

We cooperate with leading accredited laboratories in Ukraine, which guarantees the quality and reliability of research results.

Terms and cost of obtaining a SES opinion

The standard time for receiving a conclusion is up to 30 business days, but the actual time depends on many factors:

  • Product complexity
  • Need for additional research
  • Completeness of the documentation provided
  • Expert institutions’ workload

How much does it cost to obtain a state sanitary and epidemiological examination report?

дозвіл СЕЕ

The price depends on a large number of factors – product category, complexity of the examination, complexity of the laboratory research methodology, etc. Therefore, it is difficult to name the average price. However, here are its components:

  • Cost of documentation examination
  • Cost of laboratory tests
  • Cost of additional examinations (if necessary)
  • Cost of translation and certification of documents
  • Payment for legal services (if necessary)

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Typical reasons for refusal to issue a SES opinion

1. Incomplete set of documents

Найчастіша причина відмов. Важливо провести ретельну перевірку документації перед поданням:

  • Check for all required documents
  • Ensure translations are correct
  • Check validity of documents
  • Ensure copies are properly certified

2. Non-compliance of products with safety requirements

To avoid this problem, you must:

  • Conduct a preliminary product audit
  • Perform trial tests
  • Make necessary changes to the composition or technology
  • Prepare a safety case

Recent changes in legislation regarding sanitary and epidemiological expert opinions

A number of important changes have been introduced since 2023:

Electronic document management

  • Ability to submit documents online
  • Electronic queue for examination
  • Digital copies of conclusions

Harmonization with the EU

  • Recognition of European test protocols
  • Simplification of the procedure for CE marked products
  • Adaptation of Ukrainian norms to European standards

Simplification of procedures

  • Reduction of the list of documents for certain categories
  • Reduction of review periods for certain types of products
  • Optimization of the examination process

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Legal assistance in obtaining a SES opinion

Obtaining a state sanitary and epidemiological examination report can be difficult and tiring. That’s why we’re here to help. During the preparatory phase, our team will provide:

  • Product and documentation audit
  • Determination of the optimal strategy for obtaining a conclusion
  • Calculation of budget and deadlines

During the procedure, we will provide:

  • Preparation of documentation
  • We organize laboratory tests
  • We will interact with expert institutions

Additionally, we can advise on other permits, assist with the development of labeling, preparation of technical documentation, etc.

If you need to obtain a state sanitary and epidemiological examination report or any other permits, fill out the form below to discuss your situation with a lawyer as soon as possible.

Calculate the cost of services

1 question

Do you already have all the technical documentation for the product?

Yes
No

2 question

Has this product been previously laboratory tested?

Yes
No

3 question

Do you plan to export products to EU countries?

Yes
No

Is a subscriber form of service possible to quickly resolve issues as they arise?

Yes, of course, we take companies for permanent support.

The subscription form of service allows you to receive a full range of legal services on an ongoing basis for a fixed monthly fee.

Our lawyers will accompany all economic legal relations of your company: from drawing up contracts and solving corporate issues to representing interests during inspections by regulatory bodies and in court disputes.

We have very flexible pricing, so contact us and we will discuss your specific case.

Do you work only in Kyiv?

Fortunately, modern technologies allow us to effectively solve almost any legal issue online regardless of your location. In cases where personal presence is necessary, our lawyers are ready to travel to any point in Ukraine. Moreover, thanks to our network of reliable partners abroad, we can provide legal support even in international cases. Our goal is to provide you with quality legal assistance wherever you are.

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