Important updates in technical regulation for cosmetics TR CU 009/2011

Even before the new version of the TR CU 009/2011 "On the Safety of Perfume and Cosmetic Products" came into force, new amendments had already been adopted. Here is a summary.

On December 24, 2025, the amendments adopted by the decision of the Council of the Eurasian Economic Commission (EEC) No. 114 dated November 29, 2024 came into force.

The regulation was updated in the following areas:

• Terms and definitions,
• Scope of application, including clarification of what is not covered by the regulation,
• Individual safety requirements,
• Requirements for consumer packaging and labeling,
• Lists of prohibited substances,
• Substances allowed for use with restrictions,
• Approved colorants, preservatives, and UV filters.

The form of conformity confirmation itself does not change: it continues to be state registration or EAC declaration.

Changes in Product Groups

1. A new subgroup has been added – family cosmetics;
2. Four new items have been added:
   • Cosmetic wipes;
   • Cosmetic wipes, including those made with nanomaterials, for intimate hygiene, or intended for children;
   • Family cosmetics, including those intended for children under 14 years of age;
3. Cosmetics for tattoos (permanent makeup);

The draft proposes that HS codes be detailed up to 10 digits to simplify customs procedures.

Scope of Application

The scope of the regulation has been expanded. Added are:

• Perfume and cosmetic products applied to light industry products that are not considered cosmetic or perfume-cosmetic products.
• Products applied to products which do not belonge to light industry products and are also not considered cosmetic or perfume.

There are clarifications and new exclusions from the scope of the regulation. For example, the following products are excluded:

• Products intended for the ear canal, nasal mucosa, or eye mucosa;
• Lubricants and intimate gels;
• Wet wipes;
• Disinfectants and repellents.

Changes in TR CU 009/2011 Regarding Composition

Changes partially effective from October 28, 2026:

• 14 substances have been added to the list of prohibited substances in perfume and cosmetic products;
• Three substances, with specification of product types and application areas, have been added to the list of substances allowed with restrictions;
• A new UV filter has been introduced, both in conventional and nano form;
• Use of fluorides in liquid oral hygiene products for children under 6 years old is prohibited;
• From January 1, 2027, an additional point comes into force tightening requirements for the maximum theoretical formaldehyde concentration released from formaldehyde-donor preservatives, which must be indicated on the labeling.

Prohibited Substances

The first changes affect Annex 1 of TR CU 009/2011, namely the list of substances prohibited in perfume and cosmetic products. This list is expanded by 14 new items. For example, the following substances will be prohibited:

• Tetrafluoroethylene
• 3-Methylpyrazole
• 4-Methylpentan-2-one
• Isobutyl methyl ketone (MIBK)
• … and others

The list of substances allowed with restrictions (Annex 2 of TR CU 009/2011) has also been revised, and some items have been updated in the new version. The list of preservatives allowed for use in perfume and cosmetic products (Annex 4) has also been updated.

Changes Regarding Formaldehyde Content

These amendments also update the rules on formaldehyde—specifically the maximum theoretical concentration that can be released from the finished product. This information must be indicated on the product labeling.

Under current rules, the label “contains formaldehyde” is required if the theoretical concentration exceeds 0.05%. After the amendments come into force, this value must be indicated if it exceeds 0.001%.

The list of UV filters allowed for use in perfume and cosmetic products (Annex 5) has been revised for some items, and 2 new items have been added.

Clarifications Regarding Clinical and Toxicological Tests

From July 1, 2026, a toxicological assessment must be conducted either by:

1. Determining general toxic effects (toxicity index) and irritating effects on mucous membranes in vitro, or
2. Determining skin irritation and irritating effects on mucous membranes using in vivo or in vitro methods.

This increases the scope of toxicological testing.

Additionally, it will be possible to evaluate toxicological parameters using only an alternative calculation method, based on the Margin of Safety (MoS). Results calculated by this method must be obtained in an accredited testing laboratory.

Changes in State Registration

New schemes (1p, 2p) have been added for state registration:

• Scheme 1p is only for domestic manufacturers;
• Scheme 2p is for foreign manufacturers.

A very important change concerns the validity period of the state registration certificate: it is now a maximum of five years (for schemes 1p and 2p). Previously, the certificate was indefinite.

Changes in Labeling

1. It is not allowed to use a name for perfume and cosmetic products that is identical or confusingly similar to the trade name of a registered medicinal product or medical device—neither in meaning, sound, nor transliteration. However, the name may include information about ingredients, including biologically active substances.
2. For family and children’s cosmetics, it has been clarified that products must be clearly labeled as children’s or family cosmetics.
   • For family cosmetics, the minimum age of intended users must be indicated on the packaging.
   • For children’s cosmetics, the packaging must indicate the age of the children for whom the product is intended.
3. Changes also concern the indication of the authorized person for consumer complaints on the product labeling. If the manufacturer and the authorized person are different legal entities, labeling may include phrases such as:
   • “For questions/comments, contact”
   • “Customer service”
   • “Address in the Member State”
   • “Supplier”
   • and similar

   Name and location of the authorized person must be provided; optionally, a phone number and email address may also be included.

4. The indication of the expiration date on the bottom of the primary packaging, on the seam of a tube, etc., may be provided as follows:
   • “Manufacture date (produced): see/on the packaging”
   • “Best before (or use by): see/on the packaging”
   • “Manufacture date (produced) / Best before (or use by): see/on the packaging”

Transitional Provisions

1. Previously registered declarations of conformity do not need to be reissued—they remain valid until their specified expiration date.
2. Certificates of state registration remain valid for 5 years from the entry into force of the amendments, i.e., until December 23, 2030.

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