Registration of perfumes and cosmetics in the countries of the Customs Union
State registration is a procedure in which the quality and safety of products that are in direct contact with the human body (for example, cosmetics, medical devices, dietary supplements, etc.) is confirmed.
State registration is mandatory carried out prior to the importation of an imported product or serial production of the Domestic.
Registration of perfumery and cosmetic products in the Customs Union is regulated by law TR TS 009/2011 "On the safety of perfumery and cosmetic products." Key concepts, lists of documents and other important aspects relating to the circulation and registration of perfume and cosmetic products are given in technical regulations and other regulatory documents.
What types of perfumes and cosmetics should be registered?
In the technical regulations of the TR CU 009/2011 “On the safety of perfumery and cosmetic products” a complete list of products subject to state registration is indicated. It includes the following remedies and drugs:
• Perfumery and cosmetic products for artificial tanning;
• Perfumery and cosmetic products for skin whitening (lightening);
• Cosmetics for tattoo;
• Intimate cosmetics;
• Perfumes and cosmetics personal protection of the skin from the effects of harmful production factors;
• Children's cosmetics;
• Perfumery and cosmetic products for chemical coloring, lightening and highlighting of hair;
• Perfumery and cosmetic products for perm and straightening hair;
• Perfumery and cosmetic products manufactured using nanomaterials;
• Perfumery and cosmetic products for depilation;
• Fluorine-containing oral hygiene products, the mass fraction of fluorides in which exceeds 0.15% (for liquid oral hygiene products is 0.05%) (based on the molar mass of fluorine).
All other perfumery and cosmetic products are not subject to the state registration procedure at the CU TR with receipt of the state registration certificate, but are subject to mandatory declaration of conformity according to the Technical Regulations of the CU "On safety of perfumery and cosmetic products."
In case of successful registration, the CGR (state registration certificate) is issued for cosmetics, and in the case of declaration, a declaration of conformity, the product is entered in the register of cosmetic products that have passed state registration or declaration.
It should be noted that when passing through the procedure, a certificate is issued separately for each group or each product (according to the current TR).
The main body that oversees the registration and issuance of a certificate is the RSU of the Committee for Quality Control and Safety of Goods and Services of the Ministry of Health of the Republic of Kazakhstan.
The standard procedure includes several important steps:
1. Collection of documentation, execution of all necessary documents;
2. Preliminary analysis, evaluation of the assembled package and making adjustments;
3. Preparation of product samples, conclusion of a research contract;
4. Conducting laboratory studies, drawing up protocols and scientific reports;
5. Providing the assembled package of documents together with the application to the registration authority, or certification authority;
6. Making adjustments (if there are comments);
7. Obtaining a certificate / declaration and entry in the register.
The standard term for issuing a certificate is 3-4 months, but the final time and cost of the procedure will depend on the product features and other nuances.
The final cost and terms of registration can be calculated on your request.
According to the requirements of TR CU 009/2011 for state registration it is necessary to submit:
• samples of labels and packages;
• certified copies of technical documentation (enterprise standard and instruction);
• documents confirming the quality of the product and compliance with the declared characteristics;
• acts and reports of accredited laboratories and research centers;
• copies of documents on all important indicators of the product (organoleptic, physical, microbiological, chemical, etc.);
• annotations with all the information about the properties of the specified drug, methods of use, precautions;
• constituent documents of the manufacturer.
If the perfumery and cosmetic products contain nanomaterials, you will also need to make copies of documents with complete information about each of them (size of nanoparticles, properties and other features).
If products are imported from abroad, all documents in a foreign language must be translated into Russian. Translations must be certified in the prescribed manner.
What can we do for you?
Group of Companies "MEDEXPERT" provides services for the full support of the state registration of perfumes and cosmetics. We will help you to successfully complete all stages of the procedure and get a positive result.
What do we offer:
• making changes to the registration certificate;
• making changes to the registration dossier;
• preparation and collection of registration dossier;
• development and analysis of technical documentation;
• cooperation with testing centers;
• support in testing;
• interaction with registration authorities;
If you need to register perfumes and cosmetics and other care products, please contact us. Competent specialists with years of experience will answer all questions, gather the necessary documents and make corrections.
Minimize risks with MedExpert!