In this article, the Standards and Quality team provides step-by-step instructions: from determining the need for a contract to obtaining it and keeping it up to date.
For which goods is a conclusion mandatory?
The list of products requiring sanitary and epidemiological certification is defined by resolutions of the Ministry of Health of Ukraine and relevant regulatory acts. Main categories:
Food products and raw materials. New types of food products, dietary supplements, baby food, products with specific declared properties. For most standard food products, it is sufficient to undergo the food product certification procedure without a separate conclusion, but for new or specialized categories, the SEV remains mandatory.
Detergents and disinfectants. All household and industrial chemicals that come into contact with human skin or are used to treat surfaces that come into contact with food. Certification of detergents is not possible without first obtaining a SEV, which is one of the basic documents on which all further conformity assessment is based.
Children’s products. Toys, clothing for children under three years of age, baby food, hygiene products for children. Safety requirements for children’s products are the most stringent, and the conclusion confirms the absence of harmful substances in the materials.
Building materials. Finishing materials for rooms, thermal insulation, paints and varnishes, adhesives and sealants — anything that can release harmful substances into the air inside rooms.
Products that come into contact with drinking water. Pipes, fittings, filters, water storage containers. For these categories, the conclusion confirms that the materials do not release hazardous substances into the water in concentrations exceeding the permissible limits.
For which goods is a conclusion not required?
Не все товары требуют СЭВ. Если продукция подпадает под действие технического регламента, который предусматривает собственную процедуру оценки соответствия, отдельное санитарное заключение обычно не требуется. Это касается, например, электротехнической продукции, машин и механизмов, средств индивидуальной защиты, подъемного оборудования. Для таких товаров достаточно пройти процедуру сертификации продукции по соответствующему техническому регламенту и оформить декларацию соответствия.
Not all goods require SEV. If the product is subject to technical regulations that provide for their own conformity assessment procedure, a separate sanitary certificate is usually not required. This applies, for example, to electrical products, machinery and mechanisms, personal protective equipment, and lifting equipment. For such goods, it is sufficient to undergo the product certification procedure in accordance with the relevant technical regulations and issue a declaration of conformity.
However, there are situations when a product falls under both technical regulations and requires a CE mark, for example, household appliances that come into contact with food (meat grinders, blenders with plastic bowls). In such cases, both documents are required.
Package of documents for submitting an application
To obtain a sanitary and epidemiological conclusion, you must prepare a set of documents. Its composition depends on the product category, but the basic list includes:
- A standard application form with the applicant’s full details.
- Technical specifications or standards according to which products are manufactured. If the product is new and technical specifications do not yet exist, technical specifications must first be developed.
- Protocols of laboratory tests of product samples for sanitary-chemical, microbiological, and toxicological indicators.
- Technical description of the product: composition, purpose, method of application, storage conditions.
- Label or label layout with complete information for the consumer.
- Copy of the certificate of state registration of the enterprise.
- For imported products, additionally: safety documents from the country of manufacture, invoice, contract, certificate of origin.
A critical point is laboratory testing. Protocols must be issued by an accredited laboratory and cover precisely those indicators that are required for a specific product category. Testing based on an incomplete list of indicators is one of the most common reasons for documents being returned for revision.
Procedure for submission and review deadlines
Documents are submitted to the territorial body of the State Service for Food Safety and Consumer Protection at the applicant’s place of registration or through the electronic administrative services system. The review procedure consists of several stages.
After registering the application, the authority checks the completeness of the package of documents within three working days. If the package is incomplete, the application is returned with a list of missing documents. If everything is in order, the examination of the submitted materials begins.
The examination includes analysis of research protocols, verification of product composition compliance with declared characteristics, and evaluation of labeling and instructions. If necessary, the expert may request additional research or explanations from the applicant.
The total review period is up to 30 business days from the date of receipt of the complete set of documents. In practice, for uncomplicated product categories, the conclusion is issued within two to three weeks. For new types of products with atypical composition or imported goods entering the Ukrainian market for the first time, the review period may take up to 30 days.
Validity period and renewal conditions
Sanitary and epidemiological certificates are issued for an unlimited period for domestic products manufactured in accordance with unchanged technical specifications, and for a fixed period (usually five years) for imported products and certain categories of goods. However, “unlimited period” does not mean that the document is valid forever.
The conclusion must be reissued if the name or legal form of the enterprise changes, the composition or recipe of the product changes, the technical specifications change, the production site or raw material supplier changes (for imported goods). In fact, any significant change in the production process or product characteristics requires a new conclusion to be obtained.
Common reasons for failure and how to avoid them
The experience of supporting clients by Standards and Quality allows us to identify several typical reasons why applicants are rejected or delayed.
The first reason is that research protocols do not cover all the necessary indicators. Each product category has its own list of mandatory tests, and laboratories do not always perform all of them by default. Before submitting samples, check the full list of indicators required for your specific type of product.
The second reason is inconsistency between documents. The product name in the technical specifications, on the label, and in the protocols must match word for word. Any discrepancies—even an abbreviation instead of the full name—can be grounds for returning the product for revision.
The third reason is that the labeling does not meet requirements. This is particularly critical for detergents and household chemicals: the label must contain the full composition, warnings, instructions for use, and first aid information in case of contact with eyes or skin.
Relationship between the SEV and other regulatory documents
A sanitary and epidemiological conclusion is not an isolated document. It is part of a general package of documentation required for the legal circulation of products. For food products, the SEC supplements the declaration of conformity and HACCP documentation. For detergents, it is a mandatory requirement for product certification. For building materials, it is included in the package of documents together with test reports in accordance with technical regulations.
Therefore, the best approach is to plan for obtaining the SEV at the same time as preparing other documents, rather than as a separate process. This avoids duplication of laboratory tests and reduces the overall processing time.
Компания «Стандарты и качество» сопровождает предприятия на всех этапах — от определения необходимости санитарно-эпидемиологического заключения для конкретного товара до формирования полного пакета документов и подачи заявления. Мы помогаем правильно составить перечень исследований, выбрать аккредитованную лабораторию и подготовить документацию, включая разработку технических условий, если они отсутствуют. Обратитесь за консультацией — и сэкономьте время на процедуре, которая при правильном подходе занимает недели, а не месяцы.
Standards and Quality supports companies at all stages—from determining the need for a sanitary and epidemiological conclusion for a specific product to compiling a complete set of documents and submitting an application. We help you correctly compile a list of tests, select an accredited laboratory, and prepare documentation, including the development of technical specifications if they are not available. Contact us for a consultation and save time on a procedure that, with the right approach, takes weeks rather than months.
