Pursuant to the Federal Law of the Russian Federation dated March 30, 1999 No.52-FZ “On Sanitary & Epidemiological Welfare of the Population”, perfumery and cosmetic products shall be subject to sanitary & epidemiological surveillance that can be performed in the form of state registration, certification and declaration of conformity.
It is generally accepted to attribute “a substance or a mix of substances meant for applying directly on the outer parts of a human being (skin, hair, nails, lips, genital organs) or teeth and oral mucosa with the only and main purpose of their cleaning, changing their outward appearance, attaching a pleasant smell and/or correction of a body odor and/or preservation in good condition and/or care” to perfumery and cosmetic products.
According to the Unified list of commodities subject to sanitary & epidemiological surveillance (control) at the customs border and customs territory of the Customs Union EurAsEC (Russian Federation, Republic of Belarus, Republic of Kazakhstan) the following cosmetic products, oral hygiene means and articles are subject to mandatory state registration:
- Perfumery & cosmetic products for artificial tanning;
- Perfumery & cosmetic products for skin whitening (lightening);
- Cosmetics for tattoo;
- Intimate cosmetics;
- Perfumery & cosmetic products of individual skin protection against harmful production factors;
- Childcare cosmetics;
- Perfumery & cosmetic products for hair chemical dyeing, lightening and highlighting;
- Perfumery & cosmetic products for hair perming and detangling;
- Perfumery & cosmetic products produced with the use of nanomaterials;
- Perfumery & cosmetic products for depilation;
- Fluorous oral hygiene means, where mass fraction of fluorides exceeds 0.15% (for liquid oral hygiene means – 0,05%);
- Means for whitening teeth containing hydrogen peroxide and other components educing hydrogen peroxide, including urea peroxide and zinc peroxide with the hydrogen peroxide concentration (as an ingredient or educed) 0.1%-6.0%
Based upon documents verifying conformity of perfumery & cosmetic products to the requirements of the Technical regulation of the Customs union TR CU 009/2011 “On safety of perfumery & cosmetic products” the Federal Service for Consumer Rights and Human Welfare Protection (Rospotrebnadzor) shall issue a certificate on state registration.
Such documents include as follows:
- Regulatory and/or technical documents (technical specifications, process instructions, recipes etc.) for the products;
- Sanitary & epidemiological inspection report for conformity of the manufacturing conditions to the requirements of state sanitary & epidemiological rules and standards;
- Document on complete ingredient composition;
- Product conformity certificates – analysis certificate, quality & safety passport, certificate of origin or a similar document (with preferred attachment of product quality assessment methods);
- Instructions on application, package insert, annotation etc. (in the event that all necessary information cannot be placed on the label);
- Consumer (or package) label and its draft;
- Sampling act (for specimen) of the set form;
- In case of availability of a certificate of trademark, patent – a copy of documents certified in the manner established by the legislation of the Russian Federation;
The verification of safety and consumer properties of the products shall be performed by conducting the respective organoleptic, physical & chemical, microbiological, toxicological and clinical research in the accredited laboratories.
The organization of research, collection and preparation of all necessary documents is a long-term and labor-intensive process. The company “Medcertificate” offers services in the following lines:
- Preliminary analysis of ingredient composition for verification of an option for registering products;
- Organization of product tests (organoleptic, physical & chemical, microbiological, toxicological and clinical) with the authorized organizations;
- Preparation of a package of documents according to the applicable requirements;
- Submission of documents with the expert opinion to Rospotrebnadzor;
- Receipt of a certificate on state registration.