Home · Blog · Cosmetics

Cosmetics: when a declaration is enough and when state registration is required

Two products that look alike can need different documents: a hand cream needs a declaration, but a baby cream needs state registration. You must find out which one applies before you order a batch.

Cosmetics is a category where two products that look alike need completely different documents. A hand cream needs only a declaration. A baby cream needs state registration, and preparing it takes many times longer. You need to know which group your product belongs to before you order a batch from a contract manufacturer.

Scope of the regulation

TR CU 009/2011 applies to perfumery and cosmetic products. These are substances and mixtures that are applied to the skin, hair, nails, lips, teeth and the mucous membrane of the mouth to clean them, change their appearance, give them a scent, protect them or keep them in good condition.

The key words are “surface action”. When a product claims a medical effect, it leaves the cosmetic regulation and falls under the rules for medicines or medical devices, which are very different. The wording on the package has legal meaning here: “relieves inflammation” and “soothes the skin” give the product a different legal status.

Where the line is Cosmetics improve appearance and keep the body in a normal condition. A claim of treatment, of restoring tissue structure or of acting on processes in the body is a sign of a medicine. If the wording is unclear, the supervisory authority looks at the labelling and the advertising, not at the manufacturer’s intention.

Two forms of conformity assessment

The regulation divides all cosmetics into two groups. This is the main division, and you need to understand it from the start.

DeclarationState registration
What is issuedDeclaration of conformityState registration certificate (SGR)
Who makes the decisionThe applicant, under its own responsibilityRospotrebnadzor
Validity periodUp to 5 years for serial productionUnlimited, as long as the product does not change
Typical time to obtainWeeksA month or more
What it confirmsCompliance with the requirements of the regulationCompliance with the uniform sanitary requirements

Most ordinary cosmetics follow the declaration route: creams, shampoos, shower gels, decorative cosmetics and perfumes. State registration is required for products with a higher risk of harm.

Which cosmetics need an SGR

The regulation sets the list of categories. The products that need state registration include, in particular:

If a product falls into at least one of these categories, a declaration does not cover it. The opposite is also true: a product with an SGR does not need a declaration in addition, because the certificate is sufficient.

An expensive mistake for sellers A batch of baby cream is ordered from the manufacturer, a declaration is issued and the goods are shipped to the marketplace warehouse. The marketplace asks for documents, finds that state registration is required and blocks the product card. While the SGR is being issued, the batch stays in paid storage. You must check the form of conformity assessment before you place the production order.

Declaration schemes

Schemes 3d, 4d and 6d are used for cosmetics.

SchemeObjectWhat is needed
3dSerial productionTesting of a type sample in an accredited laboratory
4dBatchTesting of samples from the batch; the declaration covers only that batch
6dSerial productionTesting plus a certified quality management system

For a product line there is an important practical point: one declaration can cover a group of similar products if they have the same purpose and a similar composition. But you cannot combine a shampoo and a face cream in one declaration, because they are different kinds of products with different sets of indicators.

Which tests are carried out

The set of tests depends on the type of product and on where it is applied, but the basic set is as follows.

GroupWhat is determined
OrganolepticAppearance, colour, smell, consistency
Physico-chemicalpH value, colloidal stability, thermal stability, mass fraction of moisture
MicrobiologicalTotal count of mesophilic microorganisms, yeasts and moulds, pathogenic microflora
ToxicologicalIrritating effect on the skin and mucous membranes, sensitizing effect
Content of toxic elementsLead, arsenic, mercury
ClinicalFor products with claimed consumer properties and for some categories

A separate block is preservatives, colourants and ultraviolet filters. The regulation contains lists of permitted substances with maximum concentrations and lists of prohibited substances. Check the formulation against these annexes before testing. Finding a prohibited component in the test report is the most expensive way to learn about it.

For products with a claimed sun protection, the claimed protection factor is confirmed separately. You cannot write on the package a value that a study has not confirmed.

Labelling: where most time is lost

The labelling requirements for cosmetics are more detailed than in many other regulations, and they are checked first. The following must be stated:

The list of ingredients is given in order of decreasing mass fraction. You may use the international nomenclature of cosmetic ingredients in Latin letters. This is standard practice, and you do not need to translate the names into Russian. Perfume compositions are shown in a general way.

For products with a shelf life of more than thirty months, you may state the period after opening instead of the shelf life. This is the familiar open-jar symbol with a number of months.

Relabelling imports Imported cosmetics almost always arrive with labelling in the language of the producing country. A Russian label must be applied so that it does not cover the mandatory information of the original, and it must be applied before the product is put into circulation. That means before sale, not after a request from the marketplace.

Contract manufacturing: who is responsible

Most new cosmetic brands work under a contract: the factory owns the formulation and the production, and the customer owns the brand. In this case you must clearly record who the applicant is and in whose name the documents are issued.

The worst case is when nobody checked this question, and a product appears on the marketplace with a declaration that names another brand and another manufacturer.

What to do when the formulation changes

Cosmetic formulations change often: the raw material became more expensive, the supplier replaced a component, or the technologist improved the texture. Under the regulation, any change in composition is potentially a different product.

If you continue production under the old declaration after the formulation has changed, the document formally remains valid but in fact describes a product that is not the one on the shelf.

Stability and shelf life

The shelf life of a cosmetic product is not set by decision. It is confirmed by stability studies. The product is stored under the specified conditions, and at control points the laboratory checks that it has not separated, has not changed colour or smell, has not lost its pH value and has not lost its microbiological purity.

The effectiveness of the preservative system is checked separately. In this test the product is deliberately contaminated with test cultures, and the laboratory observes whether the preservative can cope. This matters for cosmetics that the consumer takes from a jar with the fingers, because an opened package is contaminated at each use.

Claims on the package: what you can write

Marketing wording is the area where cosmetic brands lose the most. The rule is simple: every claimed consumer property must be confirmed. If the package says “moisturizes for 24 hours”, this is a statement about properties, and it needs a study.

WordingWhat stands behind it
“Moisturizes”, “nourishes”, “softens”Ordinary cosmetic properties; confirmed by a study
“Moisturizes for 24 hours”, “reduces wrinkles by 30%”A quantitative claim; needs clinical confirmation
“Hypoallergenic”Needs confirmation by the relevant tests
“Treats”, “restores cells”, “relieves inflammation”Signs of a medicine; not allowed for cosmetics
“Paraben-free”Allowed if it is true and does not mislead about the safety of other components
“Organic”, “natural”Needs confirmation by a suitable standard; otherwise it is misleading

Wording such as “0% chemistry” is a separate case. It is misleading by definition, because every substance is a chemical. Such claims regularly become the subject of complaints from supervisory authorities and competitors.

Advertising and packaging are checked together If the package is worded carefully, but the product card on the marketplace promises to treat acne, a claim will come for the whole of it. Check the texts of product cards in the same way as the label.

How to check supplier documents

Sellers most often work with finished products made by another company, so the question is different: how to make sure that the documents you received are genuine and apply to your delivery.

Pay special attention to batch documents: they are valid strictly for one specific batch, and you cannot attach the document from the previous delivery to a new one. How the register works and what to look at in it is explained in the article on electronic documents. To check the laboratory that issued the test report, see the article on the Rosaccreditation register.

Samples, sets and gift kits

This is a practical question that every cosmetic brand has before the gift season. Samples and miniatures are cosmetic products in the same way, and the same requirements apply to them, including labelling. A smaller format does not remove the mandatory information, although you may place part of the information on an insert or on the group package.

A gift set of several products is not a new product if it contains items that are already certified, in their own consumer packages. The documents for each product remain valid, and the set additionally carries labelling with the contents of the kit. The situation is different if the product is poured into another container for the set: this is a different package, and stability in it must be confirmed again. We explained the topic of assembled deliveries in more detail in the article on sets and kits.

What to do when a marketplace raises a claim

A typical scenario: the product card is blocked and the marketplace demands the “right document”. This order of actions saves time:

What exactly the marketplaces ask for and in what form is collected in a separate article on documents for marketplaces.

Action plan

You can read more about state registration, its terms and the set of documents in a separate article on the SGR. If your product is sold on marketplaces, it is useful to look in advance at which documents the marketplaces ask for.

Check your product Describe the cosmetic product in ordinary words. The system will determine whether a declaration or state registration is needed and will show the set of documents. Start the check.
Related reading

More on documents