Certificate of state registration: who needs it and how to get it

A certificate of state registration (SGR) is a document that can be replaced neither by a certificate nor by a declaration. If a product is on the list of products subject to state registration, no other form of confirmation will make it lawful. At the same time, an SGR takes longer to obtain than other documents and requires preparation that cannot be speeded up with money.

What an SGR is and how it differs from a declaration

State registration is a sanitary-epidemiological procedure, not technical regulation in the pure sense. It confirms that a product conforms to the uniform sanitary-epidemiological and hygienic requirements in force in the territory of the Union. The decision is taken by an authorised state body — in Russia this is Rospotrebnadzor — and it also enters the record in the unified register.

The unlimited validity of an SGR is not an advantage of the “issue it and forget it” kind. The certificate is valid as long as the product remains the same. If the recipe, the site or the name has changed, the certificate no longer relates to what you produce.

What is subject to state registration

The list of products subject to state registration was established by a decision of the Customs Union Commission. The main groups:

• Specialised food products. Baby food, food for pregnant and breastfeeding women, food for athletes, dietary therapeutic and preventive nutrition.
• Dietary supplements. In full, regardless of the form of release.
• Food products of a new type. Products using GMOs, as well as raw materials not previously used.
• Mineral water of certain categories, as well as drinking water packaged in containers for baby food.
• Certain categories of cosmetics. Children’s cosmetics, hair dyeing and bleaching products, sun protection products, intimate hygiene products and others from the list in TR CU 009/2011.
• Disinfectants, insecticides and rodenticides.
• Household chemicals of certain types and household chemical goods that come into contact with the skin.
• Certain goods for children. Some of the products for young children, oral hygiene products for children.
• Materials in contact with food products, in certain cases.

The list must be checked for the specific item: within one product group some products are registered and some are declared. For example, an ordinary toothpaste for adults goes by declaration, while a children’s one goes by state registration.

How the procedure goes

The process consists of three consecutive stages, and each next one cannot be started before the previous one.

The registration action itself takes about a month, but this is only the last stage. The full cycle together with testing and expert review usually takes significantly longer, and it cannot be predicted exactly: the time of laboratory studies depends on the type of product. Microbiology requires time for culturing, and stability studies even more so.

The set of documents

The content of the package differs for domestic and imported products.

For products made in the Union:

• An application in the established form
• A regulatory document for the product: a company standard, technical specifications or a reference to a valid standard
• A recipe with the full quantitative composition
• Test reports of an accredited laboratory
• Label layouts or samples of the labelling
• A copy of the document on state registration of the legal entity
• Documents confirming the safety of raw materials and components

For imported products, additionally:

• A manufacturer’s document confirming that the product is permitted for free sale in the country of origin
• A document confirming the applicant’s authority to act on behalf of the manufacturer
• Information on the production site
• Translations of the documents into Russian

The free sale document is a frequent cause of delays. It is issued in the country of production, its form and name differ, and obtaining it takes weeks that the importer learns about at the last moment.

Who can be the applicant

The applicant is the manufacturer or a person authorised by the manufacturer and registered in the territory of the Union. For import this is, as a rule, the importer or an official representative.

There is a non-obvious consequence here for those who trade on marketplaces: if the SGR was issued to another company, you cannot simply attach it to your card. You need either documents confirming that you sell the products of this holder of the certificate, or your own certificate. The platforms check this point.

Why refusals happen

A refusal of state registration is not rare, and almost always the reason is procedural, not substantive.

The most frequent of them is a mismatch in the product name between documents. It sounds petty, but from the point of view of the registering body, a recipe for “Nourishing cream” and a test report for “Nourishing hand cream” describe different objects.

Dietary supplements: a separate difficulty

Dietary supplements are registered in full, and here the question of claimed properties is added to the usual requirements. The wording on the packaging and in accompanying materials must not create the impression of a therapeutic effect: a dietary supplement does not treat, it is an additional source of substances.

The composition is checked separately: the components must be on the lists permitted for use in dietary supplements, and the daily doses of active substances must not exceed the established upper levels. Plant raw materials are checked against the lists of permitted and prohibited plants. This is the part where a refusal comes quickly and without options for rework if the recipe contains a non-permitted component.

When the certificate stops working

An SGR has no time limit, but it is tied to the specific products of a specific manufacturer. A new registration is needed if:

• the composition or recipe of the product has changed
• the production site has changed
• the name of the product has changed
• the information on the holder of the certificate has changed so that it is already a different person
• the range is extended: a new flavour, a new form of release, a new dosage

A change of the holder’s name without a change of the legal entity itself is usually solved by reissuing. But a new flavour in a line of dietary supplements is, as a rule, a new registration, which for owners of product lines means planning the budget for each item separately.

What the certificate looks like and what to check in it

The certificate is issued in a single form valid in all states of the Union and contains a limited set of information. It is exactly this that must be compared when a supplier sends the document.

A mismatch in the name is the most frequent reason why a formally valid certificate does not fit a specific delivery. “Tonic non-alcoholic beverage” and “Tonic non-alcoholic carbonated beverage” describe different objects from the point of view of the inspector.

Disinfectants and household chemicals

A separate layer of products that people remember last. Disinfectants, insecticides and rodenticides are subject to state registration, and the requirements for them are stricter than for ordinary household chemicals.

• Confirmation of effectiveness. The claimed action against specific microorganisms is verified by tests, not claimed by analogy.
• Instructions for use — a mandatory part of the set, with treatment modes, concentrations and exposure time.
• Toxicological assessment. The hazard class determines whether use at home is permissible or only professional use.
• Scope of application. A product for medical organisations and a product for the home are different documents, even if the composition is similar.

For ordinary household chemicals — washing powders, dishwashing products, cleaning products — declaration is more often applied, but some items still fall on the registration list. The check must be made for the specific type of product, not for the product group as a whole.

Materials in contact with food products

Tableware, packaging, equipment, parts of food lines — everything that touches food is assessed by the migration of substances into model media. The model medium is chosen for the type of product: one for fatty food, another for acidic, a third for dry.

A practical conclusion for importers of tableware and packaging: a test report is tied to the conditions of use. A document for a container tested for cold products does not confirm suitability for hot filling or for use in a microwave oven. Microwave suitability can be claimed on the packaging only with confirmed tests in the corresponding mode.

Cost and what it consists of

It is impossible to give an exact figure — it depends on the product, but the structure of expenses is the same, and understanding it helps to assess a contractor’s offer.

• Laboratory tests — usually the main part of the budget, depends on the number of indicators
• Expert review of the documents and test results
• State fee for the registration action
• Development or rework of the regulatory document for the product
• Translations of the foreign manufacturer’s documents
• Obtaining the free sale document in the country of production
• Resubmission after rework — allowed for as a risk

Each item of the line is registered separately, and this is the key point for budget planning. Five flavours of one drink are, as a rule, five procedures, not one with an annex.

What to do if a refusal arrives

A refusal does not mean that the product cannot be brought to market. It means that the set of documents or the product itself does not meet the requirements, and it almost always states a specific reason.

• A procedural reason — an incomplete set, a mismatch of names, errors in the application. It is eliminated by reworking the documents and resubmitting.
• A substantive reason — indicators outside permissible values. It requires changing the recipe and repeat testing.
• An unremovable reason — a prohibited component or an impermissible product category. Registration is impossible without reworking the product.

An error that is expensive: resubmitting the same set in the hope of a different expert. The reason for refusal is recorded, and resubmission without eliminating the remarks leads to a repeated refusal and the loss of another cycle.

Planning for a product line

If you are launching not one product but a line, it is sensible to arrange the order so as not to pay twice.

• Start with one item and go through the whole cycle — this will reveal all the requirements in practice
• Form a single template of the regulatory document and labelling for the whole line
• Agree the names at once for all items, to avoid mismatches
• Group the tests by laboratory — some indicators can be tested as a package
• Allow for a period of several months before the product appears on sale
• Plan the launch of new flavours and forms as separate procedures with their own budget

How to plan the timing

State registration is the longest of the documents, and it should be planned from the date when the product must appear on sale, going backwards.

• Check against the list whether registration is really needed, and not a declaration
• Compare the recipe with the lists of permitted components before ordering a batch
• Request the free sale document from the foreign manufacturer in advance — this takes the longest
• Agree the name of the product and record it identically in all documents
• Prepare the labelling layout before submission, not after
• Allow time for possible rework and resubmission

If the product is a cosmetic, it is useful to determine the group first — the review of the regulation on perfumery and cosmetic products explains what goes by declaration and what by registration. For specialised food products the starting point is the article on TR CU 021/2011.