Hygienic certification (until August 3, 2022)
The technical regulation of cosmetic products in Ukraine is in the process of active harmonization with the EU legislation.
The Technical Regulations for cosmetic products, approved by Resolution of the CMU No. 65 dated 20/01/2021 (with the transitional period of 18 months), divided regulatory requirements into two periods:
- until August 2, 2022 – import and placing on the market of cosmetic products is regulated by the Law of Ukraine “On ensuring the sanitary and epidemiological well-being of the population”, a sanitary-epidemiological certificate (hygienic certificate) is required;
- from August 3, 2022 – cosmetic products placed on the market of Ukraine must meet the requirements of the Technical Regulations.
In this section of our website, we describe the certification requirements necessary for the import and placing of cosmetic products on the market of Ukraine before the Technical Regulations on cosmetic products will come into force, that is, until August 3, 2022.
Since 2006 we have been professionally performing work on certification of cosmetic products in Ukraine, we have extensive knowledge of Ukrainian and European legislation, practical knowledge of their application. We have certified more than 200 foreign and national manufacturers.
Our team has an excellent knowledge of the legislation, fluently communicates in English, possesses the broad experience, and will be able to answer all questions. Cooperation with us will grant you high-quality professional service and fast results.
Sanitary-Epidemiological (Hygienic) Certification
According to the requirements of the Law of Ukraine “On ensuring the sanitary and epidemiological well-being of the population”, a sanitary-epidemiological certificate (hygienic certificate) is required for the introduction of a cosmetic product.
A sanitary-epidemiological (hygienic) is a one-time document issued by the bodies of the state sanitary-epidemiological service, confirming the safety for human health and life of certain types of consumer’s goods (cosmetics, production of children’s assortment, household products, etc.) based on the results of sanitary-chemical, toxicological, physical-chemical, radiological, microbiological and other studies.
The procedure for conducting sanitary-hygienic expert examination and issuing certificates was approved by Order of the MoH of Ukraine No. 247 dated October 9, 2010.
An application for a sanitary-hygienic expert examination contains information about the manufacturer, the Applicant (owner of the conclusion), the code of international business activity, the name and scope of application and sales of products. The application may include an extensive list of similar products.
Together with the Application, it is necessary to submit documentation for products and samples. No manufacture visitation is carried out, GMP conformity is not required.
The expert examination is carried out and the results of its conclusion are issued by the State Service of Ukraine on Food Safety and Consumer Protection. The expert examination includes laboratory studies of product samples, expert examination of the submitted documents, scientific substantiation of safety criteria and conditions for the use of products.
Based on the results of the expert examination, a conclusion (certificate) is issued, approved by the Head of the State Service of Ukraine on Food Safety and Consumer Protection, and is entered into the electronic register.
The duration of the conclusion (hygienic certificate) for imported products is 5 years. After the date of expiry of the conclusion, you must go through the procedure again.
The labeling of a cosmetic product introduced on a hygienic conclusion must comply with the Laws of Ukraine “On the Protection of Consumer Rights”, “On the General Safety of Non-food Products”, DSTU ISO 22715:2019 “Cosmetic Products. Packaging and Labelling” and other legislative acts.
The labeling should include:
- product name, trade name;
- the name and address of the person responsible for providing the product on the market;
- name and address of the manufacturer;
- list of ingredients;
- purpose of the product;
- storage conditions;
- nominal quantity;
- batch number, manufacturing date or other data for product identification;
- expiration date;
- instructions for use;
- information on the content of harmful substances and warnings for use;
- a note on the presence of genetically modified organisms;
- information about the necessary actions after the expiration date and the possible consequences in case of failure to perform these actions;
- if applicable: if a cosmetic product may be hazardous to the health or property of the consumer, or to the environment, then information on such properties and possible consequences.
Information is provided in the state (Ukrainian) language.
Labeling with a sticker is not prohibited. Package artworks for cosmetic products introduced on a hygienic conclusion do not require registration.
Cratia provides full regulatory support and accompanies at all stages of placing a cosmetic product on the Ukrainian market:
- assessment the composition of cosmetic products;
- obtaining a sanitary-epidemiological certificate;
- development of labeling and package graphics file;
- assessment of conformity of a cosmetic product with the requirements of the Technical Regulations;
- legal and consulting support of the manufacturer, Responsible person or distributor (importer).
We possess deep knowledge and experience, speak and write fluent English. We will take over the organization of the process, assist in filling of the set of documents and perform the required procedures in a short time.