Which products are subject to the state registration?
For certain cosmetic products manufacturers (persons authorized by manufacturers), sellers or importers must obtain a state registration certificate (instead of a conformity declaration). These products are listed in Annex 12 of Technical Regulation on the Safety of Perfumery and Cosmetic Products, TR CU 009/2011 or TR TS 009/2011, adopted by the Customs Union Commission Decision No. 799 of 23 September 2011.They include hair bleaching and lightening products, depilation products, peeling products, self-tanning mixtures, intimate cosmetics, tooth whitening products, etc.
Imported products must undergo the registration procedure before they enter the territory of Russia (the Customs Union).
Domestic products must undergo state registration at the commencement of their manufacturing process.
The state agency responsible for registering cosmetic products is the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor).
Documents required in order to register cosmetic or perfumery products
In order to apply for a registration certificate the manufacturer (a person authorized by the manufacturer), seller or importer (the Applicant) must submit to Rospotrebnadzor the following documents:
- The registration application;
- Copies of documents in accordance with which the products are being manufactured (i.e. technical documents and/or the list of ingredients specifying the concentrations of restricted substances listed in Annexes 2-5 to the TR on the Safety of Perfumery and Cosmetic Products), certified by the Applicant;
- Written notification from the manufacturer that the products comply with the requirements contained in the documents in accordance with which the products have been manufactured. A quality certificate signed by the manufacturer or a letter from the manufacturer will be accepted as such a notification;
- Copies of documents describing organoleptic and physical-chemical properties of the product, signed by the manufacturer ; If the manufacturer uses nano-materials in the product, then the information about these materials must be submitted, including the chemical names of such materials, particle sizes and physical and chemical properties of these materials;
- Product label sample. The label must comply with the requirements contained in clause 9 of Article 5 of the TR on the Safety of Perfumery and Cosmetic Products;
- Annotation describing the claimed consumer properties of the product (if the manufacturer claims these properties on the product label), special safety measures (if any) which are to be taken during use and the information on the methods of use of the product, the absence of which may lead to an incorrect use of the product by the end user;
- Testing protocols or hygienic expert assessment results or scientific reports or expert conclusions obtained at an accredited (certified) laboratory or center and reporting whether the product complies with physical, chemical, microbiological and other safety requirements imposed by clauses 3-6 of Article 5 of the TR on the Safety of Cosmetic and Perfumery Products;
- Document issued by the manufacturer and confirming that the manufacturing process complies with clause 7 of Article 5 of the TR on the Safety of Cosmetic and Perfumery Products OR a declaration from the manufacturer on compliance with the GMP principles or a quality management certificate OR a certificate confirming compliance with the GMP practices;
- Documents confirming the claimed consumer properties of the product stated on the product label (e.g. anti-microbe, anti-wrinkle, SPF-factor, anti-inflammatory, etc.) certified by the Applicant. Confirmation of consumer properties may be performed: by way of product testing on volunteers and/or by way of research performed on samples or models, with the use of instrumental methods and/or on the basis of scientific data for the product ingredients;
- An extract from the Common State Legal Persons Registry of from the Common Sole Traders Registry of Russia.
All documents translated from a foreign language into Russian must be certified by a notary or by the translator, provided the translator has attached a copy of his/her diploma confirming his or her qualification.
If the product is registered, it will be recorded into the Common Registry of State Registration Certificates.