State Registration Certificate is a document certifying the conformity of products, substances and food supplements (except for medicines) to the state sanitary and epidemiological rules and regulations. State registration of products is performed by the Federal Supervision Agency for Consumer Protection and Human Welfare (Rospotrebnadzor).
The validity period of the certificate is fixed for the whole period of industrial manufacture of the Russian products and imported products supplies.
State registration includes:
а) expert examination of the results of tests conducted, toxicological, hygienic and other kinds of assessment of the product quality (so called laboratory studies);
b) examination of documents submitted by the applicant and characterizing the product qualities and compliance with the requirements of state sanitary and epidemiological rules and regulations (pursuant to the list of documents, for each type of products it is peculiar);
c) if Rospotrebnadzor takes a positive decision concerning the state registration of your products, the data on your products shall be entered into the State Register of Products registered;
d) issuance of state registration certificate.
Following products are subject to the state registration: introduced into the production for the first time and not used before chemicals and biological materials, as well as manufactured on their base preparations that are potentially dangerous to human life and health (except for medicines), some kinds of products that are potentially dangerous to human life and health; new food products, materials and articles imported into the Russian Federation for the first time.
List of products that are subject to the state registration:
1. Baby food products:
- Breast milk substitutes and subsequent mixtures;
- Supplemental feeding products (on a grain, grain and milk, fruit and vegetable, meat, fish, meat and cereal and fish and cereal base)
- Food stuffs for kids from 1 up to 3 years;
- Milk drinks, including drinks on a milk base;
- Food stuffs for preschoolers and schoolchildren;
- Food stuffs for premature infants;
- Health food, including those enriched in probiotics;
- Herbal teas for children;
- Fruit and vegetable preserves, vegetable preserves and fruit preserves;
- Raw materials for the manufacture of baby food.
2. Mineral water (natural table water, therapeutic table water, therapeutic water), bottled pure water.
3. Dietary foods (therapeutic and preventive), special foods:
- Dietic and diabetic bread and bread and flour products;
- Dietic and diabetic confectionery products;
- Dietic soft drinks;
- Tallow and vegetable oils, margarine products for a healthy diet; dietic fruit and vegetable and fruit preserves;
- Fortified preserves;
- Mono- and multicomponent products for the weight control;
- Special food for sportsmen;
- Special food for enteral feeding;
- Special food for pregnant and nursing women;
- Special food for old people;
- Special food for persons with a high physical activity;
- Special food with ordered composition.
4. Dietary supplements on a base of:
- Proteins, aminoacids and their complexes;
- Lipids of animal and vegetable origin, produced by biotechnological methods; assimilable carbohydrates (including honey) and syrups with the supplement of bioactive agents;
- Dietary fibers (cellulose, gum, pectin, gums, microcrystalline cellulose, fructooligosaccharide, chitosan and other polysaccharides);
- Pure substances of macro- and micronutrients, bioactive agents or their concentrates with different additives, including dry beverages;
- Natural materials (zeolites and others), as well as Mumiyo;
- Food and medical plants, including pollen; processing or meat and milk raw materials, poultry, byproducts, arthropods, amphibians, hive products (royal jelly, propolis etc.);
- Fish, marine invertebrates, shellfish etc.;
- Marine plant bodies (seaweeds and others);
- Probiotic microorganisms; unicellular algae (spirulina, chlorella etc.);
- Yeasts and their lysates; prebiotics and their compositions; raw materials for manufacture of bioactive additions, including those of biotechnological origin.
5. Food supplements (particularly complex supplements), technological auxiliaries which enrich the supplements, flavouring agents and flavors, bioactive agents and starters:
- Preservation agents;
- antioxidants;
- substances for meal treatment (bread improvers);
- anticaking agents;
- emulsifiers;
- emulsifying salts; thickeners;
- gelling agents;
- stabilizers;
- densifiers;
- foaming agents;
- foam destroyers;
- water-holding agents;
- leaveners;
- fillers (dissolving fillers, carrying fillers);
- propellents;
- acidity regulators;
- acids; colors;
- color fixing agents and stabilizers;
- sweeteners;
- flavor intensifiers;
- glazing agents;
- food flavors (aromatic essences, bases);
- enzyme preparations;
- materials and solid binders for enzyme immobilization;
- nutrients (feeding) for yeasts;
- extractive and technologic solvents;
- clarifying agents;
- filtering agents;
- sorbents;
- flocculation agents;
- coagulating agents;
- ion-exchange resins, membranes and molecular sieves;
- detergents;
- washing and cleansing agents;
- catalysts;
- antiinfection agents;
- contact freezing and cooling agents;
- greasing, releasing and antisticking agents, substances for pan treatment;
- flavors and flavoring agents, aromatic and vegetable extracts;
- bioactive agents (coffein, carnitine, taurin, quinine, polyunsaturated fatty acids etc.);
- enriching ingredients (vitamins, macro- and microelements), among them complex enriching premixes;
- starter materials, starter cultures, biomasses of microorganisms and bacterial concentrates for the food industry.
6. Food raw material made of genetically modified sources on the base of genetically modified plant and animal bodies as well as genetically modified microorganisms.
7. Food products, including food staples manufactured by using new technologies and/or from the not used before raw materials and other components (among them drink concentrates on a herbal base, herbal teas, energy (tonic) drinks).
8. Materials touching with food products:
- raw polymer materials for the production of goods touching with the food products;
- steels, metals and alloys;
- supplements (antioxidants, stabilizers, plasticizers, colors, fillers) being put into the raw materials;
- lacquers, colors and other materials used for coating of goods that touch with the food products;
- sealants and plastisols;
- rubs and rubber articles.
9. Oral hygiene preparations:
- fluorine-containing oral hygiene preparations where the weight ratio of fluorides exceeds 0,15 % (for liquid oral hygiene preparations - 0,05 %);
- teeth whitening preparations containing more than 0,1 % of hydrogen dioxide;
- special-purpose medicated dentifrices with рН 4,5-5,5;
- colouring tablets for the dental calculus detection;
- chewing-gum (medical and preventive).
10. Perfumery and cosmetic products:
- special-purpose cosmetics (creams, masks, peelings, hair balsams) meant for professional use in beauty and hair salons;
- special-purpose cosmetic products (sun care range, self-tanning products, skin bleachers, products used for tattoos without injections), intime hygiene preparations;
- individual skin protection cosmetics (ointments, creams, pastes etc.) distributed to employees;
- perfumery and cosmetic products for kids; dyeing hair-care products (except for coloring shampoos);
- hair perming preparations.
11. Tobacco goods, including raw materials:
- tobacco raw materials;
- cigars;
- cigarettes;
- cigarillos;
- Russian cigarettes;
- Other tobacco products and substitutes, including industrially manufactured tobacco and industrial tobacco substitutes as well as smoking and chewing tobacco.
12. Household products:
- Cleaners and polishers (sprays);
- Spray removers;
- Spray cleaners;
- Spray polishers;
- Chamois- and leather-care products (sprays);
- Dyes for the coloration of textiles, soft and knitted goods;
- Toners, fragrances and deodorants (air fresheners, odor absorbers, aerosol perfumes for shoes and dress).
13. Potentially dangerous chemical and biological substances:
- Chemical elements; inorganic acids and oxygen nonmetal inorganic compounds;
- Halogen or sulphur nonmetal compounds;
- Inorganic bases, oxides, hydroxides and metal peroxides;
- Salts, mineral and metal peroxysalts;
- Other inorganic compounds; hydrocarbons and their halogenated, sulfonated, nitrated and nitrosificated derivatives;
- Alcohols and their halogenated, sulfonated, nitrated and nitrosificated derivatives;
- Phenols, phenolic alcohols and their halogenated, sulfonated, nitrated and nitrosificated derivatives;
- Ethers and alcohol, ether and ketone peroxides, three-ring epoxides, acetals and semiacetals and their halogenated, sulfonated, nitrated and nitrosificated derivatives;
- Aldehyde functional compounds and their derivatives;
- Ketone and kinone functional compounds and their derivatives; carboxylic acids and their anhydrides, acid halides, peroxides, peroxyacids and their halogenated, sulfonated, nitrated and nitrosificated derivatives;
- Esters, their salts and their halogenated, sulfonated, nitrated and nitrosificated derivatives;
- Nitrogen functional compounds and their derivatives;
- Organic-inorganic compounds, heterocyclic compounds, nucleic acids and their salts, sulfonamides and their derivatives;
- Active ingredients of vitamin and hormone preparations;
- Glycosides and alkaloids of plant origin, natural or synthesized, their salts, ethers and esters and other derivatives;
- Organophosphorus and other organic compounds;
- Chemicals that are the component of fertilizers;
- Coloring materials, pigments and their intermediates;
- Surfactants;
- Polymeric and copolymer compounds, their mixtures and mixtures’ modifications;
- Mineral compounds (minerals, limestone, cements etc., ores and slags);
- Oil and petroleum refinery products;
- Natural resins;
- Volatile oils;
- Fats an oils of animal and vegetable origin;
- Albumins, enzymes, starches and their modifications;
- Industrial microorganisms.
14. Sanitizers, deinfestation and exterminating products for the household use and use in prevention and treatment facilities and other objects in order to insure human safety and health (except for those used by veterinaries).
15. Materials, equipment and other water treatment facilities intended for use in potable water supply systems.
