Conformity assessment to the Technical Regulations
This section of the website applies to requirements of the Technical regulations on cosmetic products that will become effective from August 3, 2022. For earlier requirements please refer to the following page.
The technical regulations for cosmetic products were approved by Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021 and are based on EU Regulations No. 1223/2009 dated November 30, 2009. The technical regulations enter into the mandatory application after 18 months, that is, from August 3, 2022.
To comply with the requirements of the Technical Regulations for cosmetic products it is required:
- to make sure that the form of presentation, the intended use and the composition of the product meet the requirements;
- for a foreign manufacturer – to appoint a Responsible person in Ukraine;
- to prepare a product information file (PIF) including a safety report signed by a suitably qualified expert;
- to make sure that the manufacture meets GMP requirements;
- to develop labeling and graphics file for the package according to national requirements;
- to register (notify) the product with the competent authority;
- to register the graphics file of the package;
- to establish and maintain a system for collecting information on adverse events;
- to store the product information file in a way accessible to the market surveillance body.
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:
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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 allows 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 have been placed on the market 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.
Requirements for the composition of a cosmetic product
The technical regulations establish the exact requirements for the composition of the cosmetic product:
- banned substances are listed in Appendix 2;
- substances permitted under certain conditions are listed in Appendix 3;
- permitted coloring materials and restrictions on their use are indicated in Appendix 4;
- permitted preservatives and restrictions on their use are indicated in Appendix 5;
- permitted UV filters and restrictions on their use are indicated in Appendix 6;
- the use of CMR substances of categories 1A, 1B and 2 is prohibited.
Cosmetic products containing nanomaterials must be notified to the competent authority 6 months before the date of their introduction.
The Responsible Person (RP) is a resident entity or a resident individual of Ukraine, responsible for compliance with the requirements of the Technical Regulations. A foreign manufacturer is obliged to 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 responsible person is obliged to 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.
The address of the responsible person is indicated on the labeling 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.
Product Information File
Prior to notification (registration), the Qualified Person is obliged to prepare a cosmetic product information file. The file should contain the following information:
- Description of product and data for its identification.
- Cosmetic Product Safety Report (CPSR), drawn up by an expert that matches qualification requirements:
- Part A: Information on the safety of cosmetic products;
- Part B: Safety assessment of cosmetic products.
- Description of manufacturing methods and declaration of conformity with GMP requirements (EN ISO 22716).
- If necessary, confirmation of the declared effectiveness claims.
- Details of any animal studies.
Also, the documentation should contain information for package labeling and a graphical file.
The documentation must be kept by the Responsible Person accessible to competent authorities for at least 10 years from the date of the last cosmetic product being introduced into circulation.
Conformity of manufacture with GMP requirements
The technical regulations specify that the manufacture of cosmetic agents must comply with the requirements for Good Manufacturing Practice. By notifying (registering) a cosmetic product, the responsible person assumes responsibility for the conformity of manufacture with GMP requirements.
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.
At the same time, obtaining a GMP certificate is voluntary, however, it testifies the fulfillment of the requirements of the standard.
Each individual cosmetic product must be labeled with information that meets the requirements of the Technical Regulations and other legislative acts. The language of the labeling is Ukrainian; other additional languages are allowed.
Information should be visible, readable and durable. It can be affixed by a sticker, on a tab (leaflet), tag or card.
The responsible person (national manufacturer or representative of a foreign manufacturer) is responsible for compliance with product labeling requirements. Also, every operator in the supply chain must ensure that the required labeling information is available.
The labeling includes but is not limited to the following information:
- name and address of the responsible person;
- country of origin for imported products;
- units of mass or volume, or quantity of units if mass or volume does not matter;
- the minimum expiration date and the symbol or phrase “use before”;
- storage conditions and/or conditions under which the specified expiration date is guaranteed;
- if necessary, a period of time after opening during which the product is safe and can be used without harm to the consumer (indicated by the symbol);
- features of products intended for professional use;
- manufacturing lot number (batch) or data for identification;
- the purpose of cosmetic products, if it is not obvious;
- list of ingredients (“ingredients” or “composition”) in decreasing order of their mass fraction, including nanomaterials and coloring materials, using the generally accepted International Nomenclature of Cosmetic Ingredients (INCI);
- name and address of the manufacturer;
- date of manufacture;
- if a product may be hazardous to the health or property, or to the environment, then information on such properties and possible consequences.
Package artworks (graphical file and/or photo) are subject to registration with the competent authority.
Registration (notification) of a cosmetic product
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.
Safety monitoring (cosmetovigilance)
Cosmetic products that meet the requirements of the Technical Regulations are subject to safety vigilance. The responsible person (national manufacturer or representative of a foreign manufacturer), distributor, healthcare professionals, and consumers shall provide the competent authority with information:
- on any serious side effects (adverse events) that they are aware of or that can be reasonably expected;
- name of cosmetic products and data for its identification;
- on any corrective actions taken.
The competent authority responsible for organizing state safety surveillance of a cosmetic product is the State Service of Ukraine on Medicines and Drugs Control.
Cosmetic products that meet the requirements of the Technical Regulations are subject to state market surveillance, which is regulated by the Law of Ukraine “On State Market Supervision and Control of Non-Food Products” and other legislative acts.
The competent authority for state market surveillance is the State Service of Ukraine on Medicines and Drugs Control (SMDC).
Market surveillance is carried out at all stages of product commercialization: during custom clearance formalities, in trade and warehouse rooms, at the venue of a fair or exhibition. The market surveillance body 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.
The market surveillance body checks the conformity of products with the requirements of technical regulations, including the availability and relevance of notified information about the cosmetic product, labeling requirements and conformity with graphic layouts. In case of violations, decisions may be made to restrict or prohibit the sale, withdraw from commercialization or recall the products, and penalty charges may be imposed on the distributor, importer, manufacturer or his responsible person.
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.