Regulations

TR CU 009/2011 on perfumery and cosmetics

Learn how TR CU 009/2011 classification affects the declaration route, state registration, labels and evidence for cosmetics.

TR CU 009/2011 is the technical regulation for covered perfumery and cosmetic products. For each product, the formula, claims, user group and application determine the compliance route. The practical decision is whether the product follows a declaration route or belongs to a category in Annex 12 that is subject to state registration.

This page explains how an overseas supplier can structure that decision without assuming that an EAC certificate is the ordinary document for cosmetics. The product classification comes first. Labels and supporting evidence follow that classification.

What TR CU 009/2011 covers

TR CU 009/2011 applies to the covered product being assessed. The regulation is therefore relevant when a supplier is preparing a cosmetic product for the market covered by the regulation. The product itself is the central object, while its formula, claims, user group and application are the classification inputs.

The product formula affects its classification. The product claims affect its classification. The intended user group affects its classification. The application affects its classification. These inputs should be reviewed together rather than treated as separate wording exercises.

How to choose the compliance route

The route depends on the product classification. A covered cosmetic follows the declaration route when the classification places it on that route. A covered cosmetic follows state registration when its category appears in Annex 12 as subject to state registration.

  1. Identify the product. Record the formula, the claims, the intended user group and the application.
  2. Check Annex 12. Compare the product category with the categories subject to state registration.
  3. Determine the route. Use the classification to decide whether the product requires a declaration route or state registration.
  4. Prepare the matching information. Align the label and evidence with the route selected for that product.
  5. Check the final product presentation. Confirm that the product description, claims, user group and application remain consistent across the available information.

The decision path is classification first, route second and documentation third. Starting with a preferred document can produce the wrong route because the formula or claims may place the product in a different category.

Declaration route

The declaration route is one possible route for covered cosmetics under TR CU 009/2011. Whether it applies depends on the product classification. The product does not qualify for this route merely because it is described as a cosmetic.

The supplier should link the declaration route to the product record. That record should identify the formula, claims, user group and application used for the classification decision. Evidence should support the same product description and the same route.

A change to the product can change the assessment. A revised claim can affect classification. A different user group can affect classification. A different application can affect classification. The route should therefore be checked again when these inputs change.

Annex 12 and state registration

Annex 12 contains categories subject to state registration. The relevant question is whether the product falls within one of those categories. The answer must be based on the product’s classification, not on the general label “cosmetics”.

State registration is a distinct route from the declaration route. A product in a category subject to state registration should not be handled as though a declaration alone settled the classification. The supplier must first compare the product with Annex 12.

The available reference is the TR CU 009/2011 page on the Eurasian Economic Commission website. Use the applicable text of Annex 12 when checking the category. Do not rely on a copied category description whose edition or wording has not been verified.

Why the formula matters

The formula is a classification input under TR CU 009/2011. It helps identify the product that is being assessed and separates the product from a marketing description. Two products with similar claims may require different assessment if their formulas lead to different classifications.

The formula should therefore be connected to the product name, the intended user group and the application. If those elements describe different products, the compliance record is not internally consistent. The classification should be reconsidered before the route is selected.

Why claims matter

Claims are classification inputs under TR CU 009/2011. A claim can describe what the product is intended to do, so the claim must be reviewed with the formula and application. A cosmetic description that changes the product’s stated purpose can change the route assessment.

Claims should be checked before the label and evidence are finalised. The label should reflect the product assessed. Evidence should support the claims used in that assessment. Unsupported or inconsistent claims create a classification question rather than resolving one.

User group and application

The intended user group is a classification input. The application is also a classification input. These details explain how the product is used and by whom, so they should be recorded in the product assessment.

The user group and application should remain stable across the product file, label and evidence. If the intended user group changes, the product classification may need a new review. If the application changes, the selected route may also need a new review.

Labels and evidence

Labels and evidence depend on the product classification. A label prepared before the route is known can describe the wrong product or support the wrong assessment. The supplier should first determine the route, then align the label and evidence with that route.

  • The formula should match the product assessed.
  • The claims should match the product presentation.
  • The user group should match the intended product.
  • The application should match the use described.
  • The evidence should support the selected route.

These checks do not create a separate route. They make the product record consistent with the route already determined from the classification. A mismatch should be resolved before the product information is treated as complete.

Practical review sequence

Begin with the product formula. Record the claims, user group and application. Compare the resulting classification with Annex 12. Select the declaration route or state registration route as applicable. Then review the label and evidence against that decision.

InputQuestionEffect on the review
FormulaWhat product is being assessed?The formula contributes to classification.
ClaimsWhat does the product claim to do?The claims contribute to classification and must match the label.
User groupWho is the product intended for?The user group contributes to classification.
ApplicationHow is the product intended to be used?The application contributes to classification.
Annex 12Does the product fall within a listed category?The result identifies whether state registration must be considered.

Frequently asked questions

Does TR CU 009/2011 mean that every cosmetic needs an EAC certificate?

No. The route depends on classification. For covered cosmetics, check the declaration route and check whether the product falls within a category in Annex 12 that is subject to state registration.

What determines the route for a cosmetic product?

The formula, claims, intended user group and application determine the classification. That classification determines whether the declaration route or state registration route is relevant.

What is the role of Annex 12?

Annex 12 identifies categories subject to state registration. The supplier must compare the product’s classification with those categories before treating the declaration route as sufficient.

For TR CU 009/2011, classify the product first, verify Annex 12, and then align the route, label and evidence.

Compare the claims with Annex 12 before filing

Article 6 provides for state registration for Annex 12 categories and a declaration for other covered cosmetics. Annex 12 includes children’s cosmetics and products intended for artificial tanning. The manufacturer supplies the formula, packaging and intended use. For the declaration route, check who can act as the applicant under Article 6 and make sure the test evidence identifies the same product.

What changes if we add a children’s variant?

Check the new intended user group, formula and label against Annex 12 before reusing evidence from the adult version.

Compare the certificate and declaration routes and check what evidence applies to your product.

Related requirements and services

Sources

  1. TR CU 009/2011 on the EEC website
  2. Consolidated text of TR CU 009/2011

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