Cosmetics Registration in Russia
Regulatory Authority:
Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor)
Link for RA:
https://www.rospotrebnadzor.ru/en/
Local regulation:
Technical Regulation on the Safety of Cosmetic Products (CU TR 009/2011)
Who can register :
- Manufacturers of cosmetics
- Customs Union based Authorized representative
Data to be communicated :
- An application
- Formulation (including CAS)
- The layout of electronic labels (front and back)
- Certificates from ISO and GMP
- Documents of registration for the product (OGRN, TIN, extract from the Unified State Register of Legal Entities of Russia)
- Contract for supply (agreement)
Process:
Cosmetics registration/declaration is a multi-step process that culminates in the issuance of a Marketing Authorization:
- The State Registration Certificate issued by the Federal Service for Consumer Rights Protection and Human Welfare (Rospotrebnadzor)
- The Declaration of Conformity to TR TS 009/2011.
- Preliminary examination:
- examination of the manufacturer’s technical and administrative files, particularly the investigation of product compliance, manufacturing conditions, and health standards;
- based on the type of product, conducting suitable tests (toxicological, clinical, and others);
- Compiling a sanitary expert report on product compliance based on test results and document analysis;
- entry of product and manufacturer data into the customs union’s unique sanitary database;
- issuance of product registration certificate
- Preparation of dossier
- Import of samples
- Quality and safety testing in accredited Laboratories
- Obligatory Declaration of cosmetics by an accredited institution
- Evidence of Sanitary Control (Sanitary expert report and Registration Certificate) is valid while controlled products are circulating in the territory of the Customs Union.
Timeframe and fees:
The state fee for obtaining the certificate is 5,000 rubles ($79.20)