State registration certificate (SGR)

Conformity assessment asks whether a product meets a technical regulation, and the answer is a certificate or a declaration with a validity period on it. State registration asks a narrower question — is this substance safe to eat, drink, absorb or handle — and the answer is an entry in a register. That entry has no end date. It stays valid until the product, its composition, its name or its manufacturing site changes, and any of those is a new registration rather than an amendment.

The practical consequence is that the two are often confused in a quotation. An SGR is not a cheaper EAC certificate and it does not stand in for one. A protein supplement needs an SGR under TR CU 021/2011 and a declaration for the packaging it ships in; a hair dye needs an SGR under TR CU 009/2011 and a declaration for the cosmetic itself. Budgeting for one of the two is the most common way a first estimate comes in short.

The legacy name is still in circulation. Until 2010 the document was a sanitary-epidemiological conclusion, a СЭЗ, and buyers and freight forwarders still ask for a "hygienic certificate". What they mean is almost always the SGR. A sanitary-epidemiological conclusion still exists as a separate instrument, but it now attaches to activities, premises and design documentation rather than to a product for sale.

The list is finite and it is worth checking rather than assuming, because the categories that need an SGR sit inside categories that mostly do not. Cosmetics are the clearest case. TR CU 009/2011 puts the great majority of the sector on a declaration of conformity, and reserves state registration for a named set: children’s cosmetics, intimate hygiene products, sun protection and artificial tanning products, hair dyes and bleaches, chemical depilatories, peels and skin-whitening products, and products for teeth whitening. A shampoo is declared; a children’s shampoo is registered.

Food follows the same shape under TR CU 021/2011. Ordinary foodstuffs are declared. Specialised food is registered — infant and baby food, dietary supplements, sports and clinical nutrition, food for pregnant and nursing women, food with novel ingredients, and food additives and flavourings under TR CU 029/2012. Bottled and packaged drinking water has its own regulation in TR EAEU 044/2017 and is registered under it.

Beyond food and cosmetics the same mechanism reaches chemical products under TR EAEU 041/2017, disinfectants and pest-control products, and materials intended for contact with food or with drinking water. Where a product falls in more than one of those, it takes one registration, not several.

This is the constraint that decides the shape of the project, and it is the same one that governs EAC certification. The health authority will not register a product to a foreign manufacturer directly. The applicant on the certificate must be a legal entity or individual entrepreneur registered in a member state, and that entity is the holder of the registration and the party the authority deals with.

Naming your importer as the applicant works and is the cheapest route on day one. It also ties the registration to that commercial relationship: the holder is the only party who can amend or rely on it, and a change of distributor means a new registration for a product that has not changed. Where the intention is to sell through several importers, or to keep the option of changing one, the applicant is better placed with a representative that is not also a competitor for the territory.

The evidence is laboratory work plus a description of what the product is and how it is made. Testing has to be done by a laboratory accredited in the union and listed in the EAEU unified register — a report from a well-regarded laboratory outside that register is not usable, however good the testing was, and this is the single most expensive thing to get wrong because the samples have to be shipped and tested again.

Alongside the reports the file carries the full quantitative composition, the manufacturing normative document, the label artwork in Russian, evidence that the product is sold freely in the country of origin, and information on the production site. For food and cosmetics a GMP statement or a manufacturer’s quality declaration is normally required with it.

Two things stall files repeatedly. The first is composition: a formulation given as trade names rather than INCI or CAS numbers with percentages has to go back to the manufacturer, and that round trip is measured in weeks. The second is the label. Russian-language labelling is assessed as part of the registration, so a claim the artwork makes that the dossier does not support — a health claim, an age claim, a "hypoallergenic" — is a finding on the registration itself and not a separate labelling problem to solve later.

The boundary is drawn by product category and not by industry, so one brand can sit on both sides of it — a shampoo declared and the children’s version of the same shampoo registered. Confirm the category before pricing the project, not after the samples ship.