Registration of perfume and cosmetic products

Perfume and beauty products under the Federal Law of the Russian Federation of March 30, 1999 N 52-FZ “On the sanitary-epidemiological welfare of population” is subject to sanitary - epidemiological surveillance, which can be implemented in the form of state registration, certification or declaration of conformity.

"A substance or mixture of substances intended for application directly on the outer integument of a human (skin, hair, nails, lips and external genital organs) or on teeth and oral mucosa with the sole or main purpose of their cleansing, changing their appearance, giving a pleasant smell, and/or correcting body odors, and/or maintenance in good condition, and/or care for them” refer by convention to perfume and cosmetic products.

According to the Unified list of goods subject to sanitary-epidemiological supervision (control) at the customs border and customs territory of the Eurasian Economic Community Customs Union (Russian Federation, Republic of Belarus, Republic of Kazakhstan) cosmetic products, means and products of oral hygiene are subject to obligatory state registration, namely:

• Perfumes and cosmetics for artificial tanning;
• Perfumes and cosmetics for whitening (bleaching) of skin;
• Makeup for a tattoo;
• Intimate cosmetics;
• Perfumes and cosmetics for personal protection of skin from harmful production factors;
• Baby cosmetics;
• Perfumes and cosmetics for the chemical coloring, bleaching and hair highlighting;
• Perfumes and cosmetics for perming and hair straightening;
• Perfumes and cosmetics made with use of nanomaterials;
• Perfumes and cosmetics for hair removal;
• Peeling;
• Fluorine-containing oral hygiene products, which mass fraction of fluoride excess 0.15% (for liquid oral hygiene - 0.05%);
• Products for whitening teeth containing hydrogen peroxide or other components that produce hydrogen peroxide, including carbamide peroxide and zinc peroxide, with the concentration of hydrogen peroxide (as an ingredient or produced) 0.1% - 6.0%

Issuance of certificate of state registration is carried out by the Federal Service for Surveillance in sphere of Consumer Rights Protection and Human Welfare (Rospotrebnadzor) on the basis of documents confirming the conformity of perfume and cosmetic products to the requirements of the Technical Regulations of the Customs Union CU TR 009/2011 “On safety of perfume and cosmetic products”.

These documents include:

1. Normative and/or technical documents (specifications, technological instructions, recipes, etc.) for the products;
2. Sanitary-epidemiological certificate of compliance with the conditions of production to requirements of state sanitary and epidemiological rules and norms;
3. Document on full ingredient composition;
4. Certificates of conformity of the product - the certificate of analysis, certificate of quality and safety, certificate of origin or similar document (with the desired application of methods of assessing the quality of the product);
5. Instructions for use, leaflet, abstract, etc. (if all the necessary information can not be placed on the label);
6. Consumer (or tare) label or its draft;
7. The act of sampling (specimen) the prescribed form;
8. In the presence of a certificate of trademark, patent - a copy of documents certified in accordance with legislation of the Russian Federation;

Confirmation of safety and consumer properties of the product is conducted by appropriate organoleptic, physico-chemical, microbiological, toxicological and clinical research studies in accredited laboratories.

The organization of research studies, collection and preparation of all necessary documents is a long and laborious process. The company RusClinic CRO offers the following services:

• Preliminary analysis of ingredient composition for confirmation of the possibility of the products registration;
• Organization of conducting of the product trials (organoleptic, physico-chemical, microbiological, toxicological, and clinical) in the authorized organizations;
• Preparation of documents in accordance with the applicable requirements;
• Filing of documents with the conclusion of the experts to the Rospotrebnadzor;
• Obtaining the Certificate of state registration.