Registration and technical regulation of cosmetics
The term defined by the Technical Regulations for cosmetic products:
A cosmetic product is any substance or a complex thereof intended for application to various external parts of the human body (epidermis, hair, nails, lips, external genital organs), teeth, oral mucosa exclusively or mainly for the purpose of purification, flavoring, changing their appearance, protecting, preserving them in a satisfactory condition or correcting body odor.
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.
The Technical regulations for cosmetics were developed on the basis of EU Regulations 1223/2009 of November 30, 2009.
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Since 2006 we provide professional services of certification of cosmetic products in Ukraine. We have deep knowledge of Ukrainian and European legislation, experience, and necessary resources. Our services:
Our team has an excellent knowledge of the legislation, fluently communicates in English, possesses 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
Until August 2, 2022, a sanitary-epidemiological (hygienic) certificate is required for the introduction of a cosmetic product into circulation in Ukraine.
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 September 10, 2020. The expert process is carried out by certifying authorities, the procedure includes an expert examination of documentation and laboratory testing of samples. Based on the positive results of the expert examination, a draft conclusion (certificate) is prepared, which is approved by the signature of the Head of the State Service of Ukraine on Food Safety and Consumer Protection and is entered into the electronic register. The conclusion (hygienic certificate) is issued for up to 5 years.
The placing of the cosmetic products on the market on the basis of hygiene certificates is allowed until the entry into force of the Technical Regulations for cosmetic products, that is, until August 3, 2022.
The transition period to the Technical Regulations
By Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021, the Technical Regulations for cosmetic products were adopted, with a transitional period of 18 months from the date of its publication.
This transitional period provides an opportunity for operators of the cosmetics market to prepare for the entry into force of the Technical Regulations. From August 3, 2022, the introduction of cosmetic products is allowed only if they comply with the requirements of the regulation.
Cosmetic products that were introduced into circulation before August 3, 2022 can be provided (sold) without bringing to conformity. In other words, cosmetic products manufactured or imported and introduced into circulation can be sold without any additional actions until the end of their expiration date.
Technical Regulations for cosmetic products
Cosmetic products introduced from August 3, 2022 must comply with the requirements of the Technical Regulations approved by Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021 and other applicable legislative acts in the scope of technical regulation.
Ukrainian Technical regulations for cosmetic products were developed on the basis of EU Regulations 1223/2009 of November 30, 2009.
However, since Ukraine is not an EU member state, manufacturers, before placing a product on the market, must ensure that all national requirements are met, including the designation of a responsible person in Ukraine, filling of the Products Information File (PIF) that should include Cosmetic Product Safety Report (CPSR), development of the national labeling in Ukrainian language, notification (registration) of the product and registration of the package graphical file.
Responsible person in Ukraine
The responsible person is a resident entity or a resident individual of Ukraine, responsible for compliance with the requirements of the Technical Regulations. A foreign manufacturer must designate a responsible person in Ukraine; the national manufacturer is himself a responsible person for his products, or he can appoint a third party.
The designation of the responsible person is carried out in writing, by issuing a power of attorney from the manufacturer and consent from the responsible person. Power of Attorney issued by a foreign manufacturer must be properly legalized.
The responsible person bears responsibility for compliance with the requirements, including product composition, information on the labeling, instructions and advertising materials, conformity of manufacture with GMP requirements, assessment and demonstration of safety, notification (registration) in the competent authority, storage of documentation (PIF) and the organization of post-marketing monitoring and reporting of the adverse events.
The address of the responsible person is indicated on the labelling of each cosmetic product.
| We offer the service of a responsible person in Ukraine. We are fluent in the Ukrainian legislation on cosmetic products, we have all the requisite knowledge and resources. |
GMP Conformity
According to clause 21 of the Technical Regulations, the manufacture of cosmetics must comply with the requirements for Good Manufacturing Practice (GMP).
Ukraine has adopted the state standard DSTU EN ISO 22716:2015 “Cosmetics. Good Manufacturing Practice (GMP). Guideline for Good Manufacturing Practice”, which is identical to the EN ISO 22716:2007 standard.
The EN ISO 22716 standard is an industry-specific standard developed for the cosmetics industry, offering organizational and practical guidelines for managing the human, technical and administrative factors that affect product quality at every stage of manufacturing.
Product Information File
A file with documentation about a cosmetic product is one of the mandatory requirements of the Technical Regulations, which must be fulfilled before the product is placed on the Ukrainian market. Each cosmetic product must have its own documentation containing a description of the product, a safety report in two parts, a description of the manufacturing process, a declaration of conformity of manufacturing process with GMP requirements, confirmation of claims, data on product testing on animals, primary and secondary labeling, etc.
The responsible person must prepare the Product Information File (PIF) in accordance with the requirements of the Technical Regulations and keep it accessible to competent authorities for at least 10 years from the date of the last cosmetic product being introduced into circulation.
Notification (registration)
The responsible person, prior to the introduction of a cosmetic product into circulation, must inform (notify) the product data to the competent authority. The competent authority is the Ministry of Health of Ukraine.
The responsible person prior to placing on the market must notify the cosmetic product to the competent authority. The following information is submitted (notified):
- product category, its name or identification data;
- name and address of the Responsible Person;
- country of origin;
- contact details of an individual who can be contacted if necessary;
- data on the availability of nanomaterials and methods of their identification;
- name and identifiers of substances (CAS) or EU CRM numbers of substances;
- a formulation frame that is taken into account in the provision of emergency medical services.
In case of any changes in the previously notified data, the Responsible Person must immediately submit a notification to the competent authority.
Also, when a cosmetic product is introduced, the Responsible Person submits to the competent authority a graphical file of the labeling and, if necessary, a photo of the package.
Labeling requirements
Package of cosmetic products must contain the necessary information that meets the requirements of the Technical Regulations and other legislative acts before placing on the market. Each individual cosmetic product is subject to labeling.
Language of the labeling in Ukrainian, other additional languages are allowed. The use of abbreviations or symbols is also permitted.
The technical regulation establishes graphic symbols, the use of which makes it possible not to duplicate information in different languages:
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| See information in accompanying materials | The period after opening the package | Minimum expiration date |
The labeling must correspond to the documentation for the cosmetic product.
A graphic file of the package labeling, and, if necessary, a photo of the package, must be submitted to the competent authority when the cosmetic product is introduced into circulation in Ukraine.
Market surveillance
Cosmetic products are subject to state market surveillance, which is carried out at all stages of product commercialization: during customs clearance, in trade and warehouse rooms, at the venue of a fair or exhibition. The qualified person is obliged to keep the documentation for the cosmetic product for presentation at the request of the market surveillance body.
The body for state market surveillance is the State Service of Ukraine on Medicines and Drugs Control (SMDC). The State Service of Ukraine on Medicines and Drugs Control conducts scheduled inspections in accordance with the approved sectoral plan, as well as unscheduled inspections upon requests from consumers, executive authorities, law enforcement agencies, etc.
In the event of inconsistencies, the market surveillance body may decide to restrict or prohibit the sale, withdraw from commercialization or recall the products, and penalty charges may be imposed on the distributor, importer or qualified person.
Adverse events (cosmevigilance)
If serious side effects of cosmetic products are detected in Ukraine, the responsible person, distributor, consumer or healthcare professional immediately provides the state market surveillance body with information about all serious adverse events (side effects), names of cosmetic products or data for its identification, taken corrective actions.
Advertising
Advertising materials for a cosmetic product, including product information, and its name should not give reason to believe that such products have characteristics or functions that they do not meet.
In advertisements of cosmetic products, it is prohibited to refer to the fact that they have medicinal properties.
Legislation
The main legislative acts on the technical regulation of cosmetic products are:
For products placed on the market before August 3, 2020:
- Law of Ukraine “On ensuring the sanitary and epidemiological well-being of the population”;
- Order of the MoH of Ukraine No. 247 dated 09/10/2000 “On approval of the temporary procedure for conducting state sanitary-hygienic expert examination”;
For products placed on the market from August 3, 2020:
- Technical regulations for cosmetic products approved by the Resolution of the CMU No. 65 dated January 20, 2021;
- Law of Ukraine “On technical regulations and conformity assessment”;
- Law of Ukraine “On State Market Supervision and Control of Non-Food Products”.
On the page of our website, we have presented the list of the main legislative acts that we use on a daily basis in our work.
We also pay great attention to EU legislation and professional recommendation documents. If in a disputable situation the national legislation does not have an answer, then a reference to the relevant European document will be a weighty argument.
Our services
Cratia provides comprehensive regulatory support and accompanies at all stages of regulatory compliance of cosmetic products in Ukraine:
- outsourcing of a Responsible Person (RP) in Ukraine;
- assessment of the composition of the product;
- filling of the Product Information File;
- Cosmetic Product Safety Report (CPSR);
- verification/development of labeling, instructions, and advertising materials;
- product notification;
- development and implementation of Good Manufacturing Practice in accordance with ISO 22716 (GMP);
- 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.
We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.