Technical Regulations TR CU 009/2011

TECHNICAL REGULATION
OF THE CUSTOMS UNION

TR CU 009/2011
On the Safety of Perfumery and Cosmetic Products Contents

Article 1. Scope of Application

1. This Technical Regulation applies to:

finished perfumery and cosmetic products (including those on carriers) placed on the market in the territories of the Member States of the Eurasian Economic Union (hereinafter, respectively, the Member States and the Union);

perfumery and cosmetic products applied to light industry articles placed on the market in the territories of the Member States, which are not classified as perfumery and cosmetic products on carriers;

perfumery and cosmetic products applied to articles (other than light industry articles) placed on the market in the territories of the Member States, which are not classified as perfumery and cosmetic products on carriers.

2. Perfumery and cosmetic products that are applied to articles placed on the market in the territories of the Member States and are not classified as perfumery and cosmetic products on carriers are subject only to the requirements of paragraphs 2 – 6, 9.1, 9.3 and 10, as well as paragraph 9.2 (with regard to information on special precautions (if necessary) and information on the methods of use of the perfumery and cosmetic products, the absence of which may lead to improper use of the perfumery and cosmetic products by the consumer (if necessary)), of Article 5 of this Technical Regulation.

3. This Technical Regulation does not apply to the following products:

1) products intended for ingestion, inhalation, injection or implantation into the human body;

2) products for permanent make-up (tattooing) applied with disruption of the skin integrity;

3) products used for diagnostics (ultrasound gel, etc.) and treatment, including those registered as a medicinal product, a medical device or a traditional medicine remedy;

4) products intended for pain relief, resolution of bruises, relief of leg swelling, treatment of bruises and wounds, removal of benign neoplasms (warts, papillomas, etc.), acting on veins and joints;

5) products intended for the ear canal, the nasal mucosa or the mucous membrane of the eyes;

6) disinfectants and antiseptics, repellents;

7) products intended for the detection of dental plaque;

8) lubricants, intimate lubricating gels;

9) fluoride dental varnishes;

10) moist toilet paper;

11) products intended for the mucous membrane of the genitals and anus;

12) adhesive for attaching eyelashes, rhinestones, nail tips.

4. This Technical Regulation establishes requirements for products and for the related production processes in order to protect human life and health and property, protect the environment, and prevent actions that mislead consumers regarding the intended use and safety of the products.

Article 2. Rules for Identification of Perfumery and Cosmetic Products

1. For the purposes of applying this Technical Regulation, identification is carried out on the basis of the features characterizing perfumery and cosmetic products and established in this Technical Regulation.

2. The features characterizing perfumery and cosmetic products are:

- method of use of the product - perfumery and cosmetic products are intended exclusively for external application to specific parts of the human body;

- site of application of the product - perfumery and cosmetic products are applied to the skin, hair, nails, lips, teeth, oral mucosa and external genitalia;

- purposes of use of the product (individually or in any combination) - cleansing and/or changing the appearance of the skin, hair, nails, lips, teeth, oral mucosa and external genitalia without disrupting their integrity, imparting a pleasant odor to them and/or odor correction, and maintaining them in a normal functional condition.

3. Identification of perfumery and cosmetic products for the purposes of applying this Technical Regulation is carried out on the basis of documentation. Technical documents, and/or supply contracts, and/or specifications, and/or labels, and/or product leaflets and other documents characterizing the products may be used as documentation.

Article 3. Terms and Definitions

For the purposes of applying this Technical Regulation, the concepts established by the Protocol on Technical Regulation within the Eurasian Economic Union (Annex No. 9 to the Treaty on the Eurasian Economic Union of 29 May 2014) and by the standard conformity assessment schemes approved by Decision of the Council of the Eurasian Economic Commission No. 44 of 18 April 2018 are used, as well as the following concepts, which mean the following:

"safety of perfume and cosmetic products" means the combination of properties and characteristics of perfume and cosmetic products that ensure the absence of any harmful effect of perfume and cosmetic products on the consumer when they are used in accordance with their intended purpose and method of application during their shelf life;

"secondary packaging" means packaging into which perfume and cosmetic products in primary packaging are placed, but which is not transport packaging;

"finished products" means perfume and cosmetic products that have passed through all stages of production, filling (packing) and labelling;

"demineralising action" means the ability of perfume and cosmetic products or their ingredients to remove mineral substances from the enamel and bone structures of teeth without loss of their integrity;

"ingredient of perfume and cosmetic products (ingredient)" means a substance or mixture of substances of synthetic or natural origin used for the production of perfume and cosmetic products. Ingredients do not include impurities in ingredients, or materials used in the manufacturing process of perfume and cosmetic products that are not present in the finished products;

"toxicity index" means a value reflecting the degree of toxicity of perfume and cosmetic products;

"preservatives" means chemical substances of natural and (or) synthetic origin that ensure the resistance of perfume and cosmetic products to microbial contamination during their shelf life;

"decorative cosmetics" means perfume and cosmetic products for make-up of the face, eyes, lips, eyebrows and body, and for colouring hair and nails;

"children's cosmetics" means perfume and cosmetic products intended for children under 14 years of age;

"cosmetics for tattooing" means perfume and cosmetic products intended for applying a design to the skin without injection (face and body paints, including those applied by airbrush, temporary tattoos, skin transfers, henna for tattooing, etc.);

"intimate cosmetics" means perfume and cosmetic products for the care of the external genital organs and the areas of the body around them;

"professional cosmetics" means perfume and cosmetic products intended for use by legal entities and individual entrepreneurs when providing hairdressing and (or) cosmetic services;

"family cosmetics" means perfume and cosmetic products intended for the whole family;

"margin of safety MoS (The Margin of Safety)" means the value obtained by dividing the highest dose or exposure level at which no adverse effects are observed by the systemic exposure dose of an ingredient of perfume and cosmetic products;

"colorants" means chemical substances of natural or synthetic origin intended to impart colour to perfume and cosmetic products, or contained in perfume and cosmetic products intended for colouring the skin, hair and nails;

"readily fermentable carbohydrates" means carbohydrates that are broken down in the oral cavity to form acids that cause destruction of the tooth enamel surface. Readily fermentable carbohydrates include glucose, fructose, galactose, sucrose, lactose, cellobiose and other mono- and oligosaccharides, as well as the polysaccharides processed starch, inulin and glycogen. Readily fermentable carbohydrates are contained in sugar, honey, maple syrup, etc. Readily fermentable carbohydrates do not include pectins, dietary fibre (cellulose), hemicelluloses or sucralose;

"labelling of perfume and cosmetic products (labelling)" means information for the consumer in the form of inscriptions and numerical, colour and graphic symbols applied to the consumer packaging, label or tag;

"name of perfume and cosmetic products" means the verbal and (or) numerical designation of an item assigned to it by the manufacturer;

"intended purpose of perfume and cosmetic products" means a functional property of perfume and cosmetic products that specifies their area of application;

"product type designation of perfume and cosmetic products" means the designation of a type of homogeneous perfume and cosmetic products (toothpaste, lotion, perfume, cream, etc.);

"nanomaterial" means an insoluble or biopersistent and intentionally manufactured material with at least one external dimension or internal structure in the range from 1 to 100 nm;

"circulation of products on the market" means the movement on the market of the Member States of perfume and cosmetic products dispatched from the warehouse of the manufacturer, the person authorised by the manufacturer, or the importer (seller), or shipped without warehousing, for sale or other transfer to consumers in the territories of the Member States;

"general toxic action" means the adverse effect of harmful substances on the organism;

"homogeneous perfume and cosmetic products" means products of the same product type designation that are similar in ingredient composition and meet the same requirements;

"perfume and cosmetic products (PCP)" means a substance or mixtures of substances intended for application directly to the external surfaces of the human body (skin, hair, nails, lips and external genital organs) or to the teeth and the mucous membrane of the oral cavity with the sole or main purpose of cleaning them, changing their appearance, imparting a pleasant odour, and (or) correcting body odour, and (or) protecting them, and (or) keeping them in good condition, and (or) caring for them;

"perfume and cosmetic products for personal protection of the skin against harmful occupational factors" means perfume and cosmetic products intended for application to human skin to protect it, or used to clean the skin in order to reduce exposure to harmful and hazardous factors in industrial production conditions, which are not objects of technical regulation of the Technical Regulation of the Customs Union "On the Safety of Personal Protective Equipment" (TR CU 019/2011);

"perfume and cosmetic products for artificial tanning" means products that give the skin a tanning effect by means of a chemical reaction without exposing the skin to UV rays (self-tanner, self-bronzer, etc.);

"perfume and cosmetic products on carriers" means perfume and cosmetic products applied to textile, pulp-and-paper, polymer and similar materials (cosmetic wipes, masks on a woven or non-woven base, wax strips, peeling socks, cosmetic plasters, patches, etc.). Such products perform only a perfume and cosmetic function;

"perfumery and cosmetic product applied to an article" – a perfumery and cosmetic product applied to an article that is not a perfumery and cosmetic product and that performs functions other than the functions of a perfumery and cosmetic product (light industry articles with a perfumery and cosmetic product applied to and (or) incorporated into them that is released from them during use, toothpaste applied to a toothbrush, liquid soap applied to a sponge, etc.), which is not a perfumery and cosmetic product on carriers;

"perfumery and cosmetic product obtained from a kit" – a product obtained after mixing the components contained in a kit in accordance with the instructions enclosed with it (for example, a soap-making kit, a shampoo-making kit, a balm-making kit, a perfume-making kit, etc.);

"primary packaging" – packaging in direct contact with the perfumery and cosmetic product;

"peeling" – a perfumery and cosmetic product for removing surface cells of the epidermis by chemical action;

"consumer packaging of a perfumery and cosmetic product" – primary packaging or a combination of primary and secondary packaging of a perfumery and cosmetic product that reaches the consumer together with the perfumery and cosmetic product and does not perform the function of transport packaging;

"sample (tester)" – a sample of a perfumery and cosmetic product presented in a small pack size and (or) simplified packaging, intended for testing and trial;

"microbiologically low-risk product" – a product whose medium excludes physical and chemical conditions for the growth and (or) survival (preservation of viability) of microorganisms;

"irritant action" – a localized non-specific inflammatory reaction of the skin or mucous membrane upon contact exposure to a perfumery and cosmetic product;

"formulation" – the complete list, established by the manufacturer, of the ingredients contained in a perfumery and cosmetic product, indicating the mass fraction of the ingredients;

"sachet" – a perfumery and cosmetic product in single-use flexible consumer packaging;

"sensitizing action" – the ability of a substance, upon entering the body, to cause the development in it of specific hypersensitivity mediated by hyperergic immune mechanisms;

"trace amount of a substance" – an unintentionally present amount of a prohibited substance resulting from impurities of natural or synthetic ingredients, from the process of production, storage, or migration from packaging, which is technically unavoidable when the requirements for production conditions are complied with;

"oral hygiene products" – perfumery and cosmetic products with a hygienic and (or) preventive action, intended for direct application to the teeth, gums and oral mucosa with the sole and (or) main purpose of cleaning them, perfuming them, changing their appearance, protecting them, or keeping them in good condition;

"shelf life of a product (perfumery and cosmetic product, raw material)" – the period after the expiry of which the product is considered unfit for its intended use. The shelf life is established by the product manufacturer in the technical documents. During the shelf life of a perfumery and cosmetic product, the manufacturer is obliged to guarantee the conformity of the perfumery and cosmetic product with the safety requirements for the life and health of the consumer and the preservation of its consumer properties, provided that the storage conditions are complied with. During the shelf life of a raw material for which a shelf life has been established, the manufacturer of the raw material is obliged to guarantee the conformity of the properties and characteristics of the raw material specified by it in the technical documents, provided that the storage conditions are complied with;

"storage period of a product (raw material, packaging, labelling materials)" – the period during which the product, provided that the established storage conditions are complied with, retains the properties and characteristics established in the technical documents. The storage period is established in the technical documents. Expiry of the storage period does not mean that the product is unfit for its intended use;

"standard storage conditions for perfumery and cosmetic products" – storage temperature for liquid products – not lower than 5 °C and not higher than 25 °C, for solid toilet soap – not lower than minus 5 °C, for other perfumery and cosmetic products – not lower than 0 °C and not higher than 25 °C; absence of direct exposure to sunlight;

"sterile perfumery and cosmetic product" – a perfumery and cosmetic product packed in hermetically sealed packaging, intended for single use, for which sterility requirements have been established;

"technical documents" – documents in accordance with which perfumery and cosmetic products are manufactured, stored and transported (technical specifications, standards, process instructions, formulations, specifications and others);

"transport packaging" – packaging intended for the storage and transportation of products in order to protect them from damage during movement, and forming an independent transport unit;

"UV filter (ultraviolet filter)" – a substance intended to protect the skin from the penetration of ultraviolet radiation by absorption, reflection or scattering;

"label" – a means of information about a packaged perfumery and cosmetic product placed on the consumer packaging;

"tag" – an article of any shape, size and material intended for the application of labelling, attached to or enclosed with a unit of a perfumery and cosmetic product or inserted into the packaging.

Article 4. Rules for the Circulation of Perfumery and Cosmetic Products on the Union Market

1. Perfumery and cosmetic products shall be placed on the market in the territories of the Member States provided that they have undergone the necessary conformity assessment procedures established by this Technical Regulation and by other technical regulations of the Union (Customs Union) that apply to them.

2. Perfumery and cosmetic products that comply with the requirements of this Technical Regulation and with the requirements of other technical regulations of the Union (Customs Union) applicable to them, and that have undergone the conformity assessment procedure, shall bear the single mark of product circulation on the Union market.

Perfumery and cosmetic products whose conformity with the requirements of this Technical Regulation and with the requirements of other technical regulations of the Union (Customs Union) applicable to them has not been confirmed shall not be marked with the single mark of product circulation on the Union market and shall not be permitted to be placed on the Union market.

3. The circulation of perfumery and cosmetic products placed on the market in the customs territory of the Union during the period of validity of the declaration of conformity or the certificate of State Registration confirming the conformity of the perfumery and cosmetic products with the requirements of this Technical Regulation (the requirements of other technical regulations of the Union (Customs Union)) is permitted until the expiry of the shelf life of the products established by the manufacturer.

Article 5. Requirements for Perfumery and Cosmetic Products

1. The safety of perfumery and cosmetic products is ensured by a set of requirements:

1) for composition;

2) for physicochemical indicators;

3) for microbiological indicators;

4) for the content of toxic elements;

5) for toxicological indicators;

6) for clinical (clinical and laboratory) indicators;

7) for production;

8) for consumer packaging;

9) for product labelling.

2. Requirements for the composition of perfumery and cosmetic products

2.1. the use in perfumery and cosmetic products of the substances listed in Annex 1 is prohibited;

2.1¹. the use of sucrose and other readily fermentable carbohydrates as ingredients in oral hygiene products is prohibited;

2.2. the use in perfumery and cosmetic products of substances subject to the restrictions specified in Annex 2 is permitted;

2.3. the use in perfumery and cosmetic products of colorants in accordance with Annex 3 is permitted;

2.4. the use in perfumery and cosmetic products of preservatives in accordance with Annex 4 is permitted;

2.5. the use in perfumery and cosmetic products of ultraviolet filters in accordance with Annex 5 is permitted.

2.6. The lists of ingredients of perfumery and cosmetic products given in Annexes 1 - 5 are updated in accordance with the established procedure.

2.7. Family cosmetics intended, among others, for children under 14 years of age shall not contain ingredients that are not permitted for use in products for children under 14 years of age in accordance with Annexes 2 – 5 to this Technical Regulation.

3. Requirements for the physicochemical indicators of perfumery and cosmetic products

For the perfumery and cosmetic products specified in Annex 6, the pH value shall comply with the standard established in that Annex. Requirements for the pH value are not regulated for the following perfumery and cosmetic products:

depilatory waxes and wax strips;

anhydrous hair styling gels;

fat- and wax-based cosmetic products;

hair sprays;

solid toilet soap;

powdered and compact decorative products;

anhydrous cosmetic oils;

cosmetic products for nail modelling and polishing;

perfumery products (solid, dry, liquid);

anhydrous cosmetic nail care products based on organic solvents;

solid deodorants and solid antiperspirants;

solid bath products;

100-percent essential oils.

For fluoride-containing oral hygiene products, the fluoride content (calculated on the molar mass of fluorine) shall comply with the requirements set out in Annex 2.

4. Requirements for microbiological indicators of perfumery and cosmetic products

4.1. Microbiological indicators of perfumery and cosmetic products shall comply with the requirements set out in Annex 7.

4.2. Microbiological indicators are not determined for perfumery and cosmetic products with a microbiologically low risk, including:

1) perfumery and cosmetic products containing ethyl alcohol and (or) organic solvents at a concentration of more than 20 % by volume, used without dilution;

2) nail varnishes, except water-based nail varnishes;

3) deodorants, deodorant-antiperspirants, antiperspirants;

4) oxidative hair dyes, lightening and highlighting products;

5) permanent waving products and hair straightening products based on thiol compounds;

6) depilatory products;

7) fat-based solid toilet soap;

8) dry pencils;

9) bath salts;

10) 100-percent essential oils;

11) tooth whitening products containing hydrogen peroxide or other components releasing hydrogen peroxide, including carbamide peroxide and zinc peroxide, with a hydrogen peroxide concentration (present as an ingredient or released) of 0,1 – 6,0 %;

12) shaving products (creams, gels, etc.) having a pH value of more than 10,0.

5. Requirements for the content of toxic elements

In perfumery and cosmetic products containing raw materials of natural plant or natural mineral origin in an amount of more than 1 %, the content of toxic elements shall not exceed: arsenic - 5,0 mg/kg; mercury - 1,0 mg/kg; lead - 5,0 mg/kg.

6. Requirements for toxicological and clinical (clinical-laboratory) indicators of perfumery and cosmetic products

6.1. Perfumery and cosmetic products, when used as intended, shall be safe for humans.

6.1.1. Where the assessment of toxicological indicators is carried out by determining the skin irritant effect, the irritant effect on mucous membranes and the general toxic effect, the toxicological indicators of perfumery and cosmetic products shall comply with the requirements according to Annex 8.

Where the assessment of toxicological indicators of perfumery and cosmetic products is carried out on the basis of an analysis of the toxicological characteristics of the ingredients, the perfumery and cosmetic product shall be considered toxicologically safe if it contains ingredients each of which has a margin of safety (MoS) greater than or equal to 100. An ingredient shall be recognised as safe without calculation of the MoS if it has no dermal absorption or if the level of such absorption is low.

6.1.2. Clinical (clinical-laboratory) indicators of perfumery and cosmetic products shall comply with the requirements set out in Annex 9.

6.1.3. Clinical indicators of oral hygiene products shall comply with the requirements set out in Annex 10.

For liquid oral hygiene products and liquid tooth whitening products not containing fluorine compounds, with a pH value of less than 5,5 and (or) containing substances that cause enamel demineralisation, the absence of a demineralising effect is determined by laboratory methods (in vitro).

6.1.4. Toxicological tests of decorative cosmetics, including nail varnishes, as well as hair colouring and tinting products of the same product type name and product name, manufactured according to a single technical document but differing in shade, are carried out in full on a sample of not less than 30 % of the shades submitted for examination. The samples examined shall contain the maximum amount of each specific colorant. For the remaining shades submitted for examination, only the sensitising effect is determined.

6.1.5. Toxicological and clinical (clinical-laboratory) indicators of perfumery and cosmetic products are determined in accredited testing laboratories (centres) after positive results of testing the products for physico-chemical and microbiological indicators have been obtained.

7. Requirements for the production of perfumery and cosmetic products

7.1. Requirements for production processes

To ensure the safety of perfumery and cosmetic products during production, it is necessary to:

- carry out their production in accordance with the requirements of clause 7.2 of this technical regulation;

- carry out the production of products in production premises that comply with the requirements of clause 7.3 of this technical regulation;

- use process equipment and implements that comply with the requirements of clause 7.4 of this technical regulation;

- admit to the production of products personnel who meet the requirements of clause 7.5 of this technical regulation;

7.2. Ensuring the safety of perfumery and cosmetic products during their production

The safety of products during their production and circulation shall be ensured by:

- selecting the production processes necessary to ensure product safety;

- selecting a sequence and flow of production processes that excludes contamination of raw materials, packaging materials, bulk products and finished products;

- defining, in production control programmes, the controlled stages of production processes and of the products at the stages of their production;

- carrying out control of raw materials, processing aids and auxiliary materials used in the production of products, as well as control of bulk and finished products, by means ensuring the necessary reliability and completeness of control;

- establishing requirements for raw materials, packaging, labelling materials, acceptance criteria, measures to be taken in the event of defects or minor deviations, and conditions of transportation and storage. Raw materials, packaging and labelling materials that do not meet the acceptance criteria shall be appropriately marked and placed so as to prevent their use in production. Raw materials, packaging and labelling materials for which a storage period has been established shall, after the storage period has expired, be checked for conformity with the properties and characteristics specified by the manufacturer of the raw materials, packaging and labelling materials in the technical documents, in order to determine their suitability for further use and to establish a new storage period. The use in production of raw materials whose shelf life has expired is prohibited;

- monitoring the operation of process and measuring equipment in a manner that ensures the production of products meeting the requirements of this Technical Regulation;

- ensuring the documentation of information on the controlled stages of technological processes and of the results of control of perfumery and cosmetic products at the stages of their production;

- recording and registering in detail all technological operations for each stage (specifying the raw materials added, temperatures, speeds, mixing times, sampling, cleaning, sanitary treatment of equipment, if necessary, and transfer of bulk products)

- observing the storage conditions of products;

- maintaining production premises, process equipment and implements used in the production of products in a condition that prevents contamination of the products;

- selecting methods by which workers comply with personal hygiene rules in order to ensure product safety;

- using methods that ensure the safety of bulk and finished products, and establishing the frequency of cleaning, washing, disinfection, disinsection and deratization of production premises, process equipment and implements used in the production of perfumery and cosmetic products;

- keeping and storing documentation, on paper and (or) electronic media, confirming the conformity of the manufactured products with the requirements established by this Technical Regulation;

- traceability of perfumery and cosmetic products at all stages of production;

- carrying out control of finished products, in accordance with established test methods, for conformity with acceptance criteria before placing them on the market.

- retaining archive samples from each batch of perfumery and cosmetic products.

7.3. Requirements for production premises in which perfumery and cosmetic products are produced

7.3.1. Production premises shall meet the following requirements:

- ventilation and/or air-conditioning systems installed in production premises shall ensure that the air supplied to the production premises cannot be a source of product contamination;

- lighting systems installed in production premises shall make it possible to contain all fragments and prevent them from entering the products, and shall also not be a source of product contamination;

- production premises shall not contain staff changing rooms for storing personnel's personal and work (special) clothing;

- production premises shall not contain toilets, and toilet doors shall not open directly into production premises;

- the layout of production premises shall make it possible to ensure the sequence and flow of technological processes that exclude counter-flows or cross-flows of raw materials, bulk and finished products, and contaminated and clean implements, where this is necessary to prevent product contamination;

- production premises shall be arranged so as to ensure protection against the entry of animals, including rodents and insects;

- production premises shall be arranged so as to exclude areas from which dirt, condensate, mould and other similar sources of product contamination cannot be removed;

- the floor construction shall prevent the accumulation of water in the production premises;

- floor, wall and door surfaces shall be made of waterproof, washable and non-toxic materials that can be subjected to sanitary treatment and disinfection;

- ceilings (where there are no ceilings, the inner surface of the roof) and structures located above production premises shall prevent any particles or condensate from entering the products;

- opening windows (transoms) shall be fitted with protective insect screens;

- sewerage equipment in production premises shall be designed and constructed so as to exclude the risk of product contamination.

7.3.2. The storage in production premises of any substances and materials not used in the production of perfumery and cosmetic products is not permitted, with the exception of detergents and disinfectants. Detergents and disinfectants may be stored in specially designated areas of the production premises.

7.4. Requirements for process equipment and implements used in the production of perfumery and cosmetic products

7.4.1. Process equipment and implements used in the production of perfumery and cosmetic products shall:

- allow them to be sanitized and disinfected;

- be made of materials that are not sources of product contamination.

7.4.2. Process equipment shall, where necessary to achieve the objectives of this Technical Regulation, be fitted with appropriate control instruments.

7.5. Requirements for workers engaged in the production of perfumery and cosmetic products

7.5.1. Workers engaged in the production of perfumery and cosmetic products who come into direct contact with raw materials, bulk and finished products, and materials and implements in contact with the products (raw materials) shall observe personal hygiene and wear clean special work clothing and footwear to the extent necessary so as not to be a source of product contamination.

7.5.2. Workers engaged in the production of perfumery and cosmetic products are prohibited from bringing into production premises any items that are not used in the performance of their job duties and may become sources of product contamination, and from smoking and eating in these premises.

8. Requirements for the Consumer Packaging of Perfumery and Cosmetic Products

8.1. Perfumery and cosmetic products shall be placed in consumer packaging (primary packaging or a combination of primary and secondary packaging) and closures (if any) that ensure the safety of such products and the preservation of their consumer properties during circulation throughout the shelf life, and that comply with the requirements of this Technical Regulation and of the Technical Regulation of the Customs Union "On the Safety of Packaging" (TR CU 005/2011).

8.2. Oral hygiene products shall be packed in consumer packaging that guarantees first-opening control, or in consumer packaging protected against unauthorized opening until it is opened by the consumer. Other perfumery and cosmetic products may be packed in consumer packaging that guarantees first-opening control, or in consumer packaging protected against unauthorized opening until it is opened by the consumer.

8.3. It is not permitted to place on the market perfumery and cosmetic products in consumer packaging whose external design (the combination of graphic images and text information applied to the packaging) is identical to the external design of the packaging of food products, including alcoholic beverages, or of medicinal products, and misleads the consumer as to the purpose of the packaged product.

9. Requirements for the Labeling of Perfumery and Cosmetic Products

9.1. Perfumery and cosmetic products shall be labeled by applying information for the consumer in the form of inscriptions and numerical, color and graphic designations to the consumer packaging, label or tag, taking into account the labeling requirements specified in Annexes 2, 3, 4, 5. If information on the composition of the product and on precautions is placed on a tag attached to or accompanying each unit of the product and (or) inserted into the secondary packaging, a graphic symbol in the form of a hand on an open book (Annex 11) shall be applied to the consumer packaging. Instead of the graphic symbol, it is permitted to provide information indicating where this information is placed (for example: "Composition/Ingredients and precautions see on.

9.2. The labeling of perfumery and cosmetic products shall contain the following information:

- the generic name and the product name (if any) of the perfumery and cosmetic product. The product name assigned by the manufacturer to a perfumery and cosmetic product shall not be identical or confusingly similar to the trade name of a registered medicinal product or to the name of a medical device. The criterion of similarity is a semantic (meaning-based), phonetic (sound-based) or transliteration-based (relating to the use of another alphabet to render the name) feature determining the similarity of invented names. At the same time, the product name (generic name) of a perfumery and cosmetic product may include information on the ingredients contained in the product, including biologically active substances (hand cream with vitamin F, after-sun cream with d-panthenol, face cream with hyaluronic acid, etc.);

- the purpose of the perfumery and cosmetic product, if it does not follow from the generic name of the product;

- cosmetics intended for children (children's and family cosmetics) shall bear the corresponding information in the labeling (children's, for children, for newborns, family, for the whole family, or another inscription classifying the product as children's or family cosmetics) in the product name, and (or) the name of the series (line), and (or) in the purpose. Family cosmetics shall bear information on the minimum age of the users for whom they are intended. Children's cosmetics shall contain information on the age of the children for whom they are intended. The presence in the labeling of a perfumery and cosmetic product of conditions of use and warnings that must be communicated to the consumer in accordance with the requirements of Annexes 2 – 5 to this Technical Regulation (for example, "do not use for children under …", "children aged 6 years and under…", etc.) does not classify the product as children's cosmetics but constitutes warning information;

- the name of the manufacturer (producer) and its location (legal address, including the country);

- the Country of Origin of the perfumery and cosmetic product (if the country where the production of the product is located does not coincide with the legal address of the manufacturer);

- if the manufacturer does not accept claims in the territory of a Member State, the labeling of the perfumery and cosmetic product shall use phrases that directly or indirectly convey to the consumer information identifying the organization or individual entrepreneur authorized to accept claims from consumers (for example, "for questions/suggestions contact", "consumer service", "address in the Member State", "supplier" and similar), and shall also state its name and location; a telephone number and e-mail address may be stated. If the manufacturer itself accepts claims in the territory of the Member State, the phrase "authorized to accept claims" and phrases of similar meaning are not required in the labeling of the perfumery and cosmetic product;

- the nominal quantity of the product in the consumer packaging (volume, and (or) mass, and (or) number of pieces). For solid toilet soap, the nominal mass of the bar at the time of packing. For products with a nominal volume of less than 5 мл (ml) or a nominal mass of less than 5 г (g), as well as for product samples (testers), the nominal quantity need not be indicated;

- Color and/or Tone (for decorative cosmetics and coloring products);

- the mass fraction of fluoride calculated on the basis of the molar mass of fluorine (%, or mg/kg, or ppm) for oral hygiene products containing fluorine compounds;

- the shelf life shall be indicated in one of the following ways:

"Годен до…" (date);

"Использовать до…" (date);

"Дата изготовления…" (date) and "Срок годности…" (months, years);

"Дата изготовления…" and "Годен до…" (date);

"Дата изготовления…" and "Использовать до…" (date);

"Срок годности… from the date of manufacture indicated on the packaging" (months, years).

The words "Дата изготовления…" in the marking may be replaced by the word "Изготовлено…".

Where the shelf life is applied to the bottom of the primary packaging, the seam of a tube, etc., the information on where the shelf life of the product is applied may be given in the form of the following wording: "Date of manufacture (manufactured): indicated on/see the packaging", "Best before (or use by): indicated on/see the packaging" or "Date of manufacture (manufactured)/Best before (or use by): indicated on/see the packaging. For products whose consumer packaging is small in size or has a complex shape (lipstick, eyeliner, eye shadow, mascara, etc.), the shelf life may be indicated as follows: "До…" (date). The date includes the month and year (mm.yyyy or mm.yy) or the day, month and year (dd.mm.yyyy or dd.mm.yy). The shelf life may be indicated without a separator or with a separator. A hyphen "-", a full stop ".", a slash "/", etc. may be used as the separator. A word-and-number format of the date is permitted, in which case the month is written as a word. Where the shelf life of the product is indicated as "До…" (month, year), the shelf life expires on the last day of the preceding month; if "До…" (day, month, year), the shelf life expires before the specified day;

- a description of the storage conditions where these conditions differ from the standard ones;

- Special Precautions (where necessary) when using the product, including information on the warnings set out in Annexes 2-5 to this Technical Regulation;

- the batch number or a special code allowing the batch of perfumery and cosmetic products to be identified;

- information on the methods of use of the perfumery and cosmetic product, the absence of which may lead to misuse of the perfumery and cosmetic product by the consumer;

- the List of Ingredients in accordance with paragraph 9.3. of this Article.

For aerosol products with a propellant, warning inscriptions (warnings) shall be given regarding:

protection from direct sunlight and from heating of the container;

the rules for use by children;

flammability and the danger of spraying near an open flame and red-hot objects (where necessary);

the danger of contact with the eyes or with irritated skin (where necessary);

the impossibility of spraying the product in aerosol packaging with the head pointing down (for products in aerosol packaging containing carbon dioxide or compressed air as the propellant) (where necessary);

the prohibition on breaching the integrity of the aerosol packaging.

For perfumery and cosmetic products for the personal protection of the skin against harmful occupational factors, the product marking shall contain the relevant information on the intended purpose of such products.

The marking of a kit for making perfumery and cosmetic products shall contain information on its contents (the designation, the name (if any) and the quantity of components). Each component of the kit shall bear a designation and a name (if any). The List of Ingredients shall comply with paragraph 9.3 of this Article. The kit shall contain instructions for making the product.

9.3. The List of Ingredients shall be preceded by the heading "Ингредиенты" or "Состав".

If the information is given in accordance with the International Nomenclature of Cosmetic Ingredients (INCI) using letters of the Latin alphabet, the heading "Ингредиенты" or "Состав" may be given together with information indicating where the List of Ingredients is located (for example: "Состав/Ingredients смотри на…").

Ingredients are listed in descending order of their mass fraction in the formulation, and the perfume (fragrance) composition is listed as a single ingredient without disclosing its composition. If the composition contains ingredients (No. 67-92) listed in Annex 2 and their content exceeds a concentration of 0,01% for rinse-off products, 0,001% for leave-on products, they shall be indicated in the list of contents.

For products in aerosol packaging with a propellant, the composition of the propellant is indicated. The composition of the propellant may be indicated either in the List of Ingredients or separately.

Ingredients present in the form of nanomaterials shall be clearly indicated in the List of Ingredients, with the word "нано" or "nano" given in brackets after their name where the ingredients are indicated in accordance with the International Nomenclature of Cosmetic Products (INCI).

Ingredients at a concentration of less than 1 % may be listed in any order after those ingredients whose concentration is more than 1 %.

Colourants may be listed in any order after the other ingredients, in accordance with the colour index or accepted designations.

The list of ingredients may be given either in the state or official language(s) of the Member States in which the perfumery and cosmetic products are sold, or in accordance with the International Nomenclature of Cosmetic Ingredients (INCI) using letters of the Latin alphabet.

On decorative cosmetic products released as a series of different tones, all colorants used in the series may be listed, using the term "может содержать" or the sign (+/-).

Samples intended to be given to consumers shall be labelled in accordance with paragraph 9.2 of this Article.

Samples intended to demonstrate the properties of the product and not intended to be given to consumers shall bear labelling containing the following information:

the generic name, the product name (if any) and the intended use (where necessary) of the product, as specified in the manufacturer's technical documents;

the name of the manufacturer (abbreviated, sufficient to identify the manufacturer) and (or) the trademark;

color and (or) tone (for decorative cosmetics);

shelf life (in accordance with paragraph 9.2 of this Article);

the batch number or a special code allowing the batch of perfumery and cosmetic products to be identified.

This information may be indicated on the consumer packaging or on an information medium located in the immediate vicinity of the sample (tag, leaflet, brochure, etc.). In this case, the graphic symbol in the form of a hand on an open book (Annex 11) does not have to be applied to the consumer packaging.

9.4. The information provided for in paragraph 9.2 of this Article shall be indelible and legible. The labelling shall remain on the consumer packaging during storage, transportation, sale and use of the product throughout its shelf life.

9.5. The information on perfumery and cosmetic products provided for in paragraph 9.2 of this Article shall be given in Russian and, where the legislation of the Member States so requires, in the state language (state languages) of the Member State in whose territory such products are sold.

The name of the manufacturer, the location of the manufacturer and the product name, the name of the color and (or) tone (for decorative cosmetics and coloring products) expressed in words, the name of the line (series), and the units of volume (ml, L) or mass (g, kg) may be written using letters of the Latin alphabet. The country of origin of perfumery and cosmetic products shall be stated in Russian and, where the legislation of the Member States so requires, in the state language (state languages) of the Member State in whose territory such products are sold.

10. Requirements for perfumery and cosmetic products applied onto articles, which do not fall under perfumery and cosmetic products on carriers, placed on the market in the territories of the Member States.

Reports of studies (tests) and measurements (hereinafter, respectively, the test report and tests) and the report (if any) on the results of the assessment of toxicological indicators of perfumery and cosmetic products based on an analysis of the toxicological characteristics of the ingredients, confirming the conformity of perfumery and cosmetic products applied onto articles (other than light industry articles) that fall within the scope of other technical regulations of the Union (Customs Union) and are placed on the market in the territories of the Member States with the requirements of paragraphs 3 – 6 of Article 5 of this technical regulation, are included in the set of evidentiary materials compiled during the conformity assessment of such articles.

Test reports on toxicological and clinical (clinical-laboratory) indicators, except for the indicator "irritant effect on mucous membranes", or the report (if any) on the results of the assessment of toxicological indicators of perfumery and cosmetic products based on an analysis of the toxicological characteristics of the ingredients, confirming the conformity of perfumery and cosmetic products applied onto light industry articles that fall within the scope of other technical regulations of the Union (Customs Union) and are placed on the market in the territories of the Member States with the requirements of paragraph 6 of Article 5 of this technical regulation, shall be included in the set of evidentiary materials compiled during the conformity assessment of such articles.

Article 5¹. Ensuring the conformity of perfumery and cosmetic products with the requirements of the technical regulation

1. The conformity of products with this technical regulation is ensured by direct fulfilment of its safety requirements.

2. Research (test) methods are established in the standards included in the list of standards containing rules and methods of research (testing) and measurement, including sampling rules, necessary for the application and fulfilment of the requirements of this technical regulation and for the conformity assessment of objects of technical regulation.

Article 6. Conformity Assessment

1. Before being placed on the market in the customs territory of the Union, perfumery and cosmetic products shall undergo assessment of conformity with the requirements of this technical regulation in the following forms:

- proof of conformity in the form of declaration of conformity;

- state registration.

Conformity assessment of perfumery and cosmetic products against the requirements of this technical regulation is carried out in accordance with the standard conformity assessment schemes, taking into account the specifics established by this technical regulation.

2. Perfumery and cosmetic products included in the list according to Annex 12 are subject to state registration.

Perfumery and cosmetic products not included in the list according to Annex 12 to this technical regulation are subject to declaration of conformity.

3. State registration of perfumery and cosmetic products manufactured in the customs territory of the Union shall be carried out at the stage of putting them into production, and of perfumery and cosmetic products imported into the customs territory of the Union, prior to their importation into the customs territory of the Union.

In state registration, the applicants may be a legal entity or a natural person registered as an individual entrepreneur, registered in the territory of a Member State in accordance with its legislation, that is the manufacturer or the importer (seller), or a person authorized by the manufacturer.

State registration of perfumery and cosmetic products shall be carried out by the body (organization, institution) of a Member State authorized to perform such work in accordance with the legislation of that State (hereinafter, the authorized body).

4. State registration of perfumery and cosmetic products includes the following procedures:

a) identification and sampling (specimens) of perfumery and cosmetic products, carried out by the manufacturer, or the applicant, or, on the instruction (application) of the applicant and in the applicant's presence, by an accredited testing laboratory (centre), in accordance with the rules established in the documents included in the list of standards containing the rules and methods of research (testing) and measurement, including sampling rules, necessary for the application and fulfilment of the requirements of this Technical Regulation and for the conformity assessment of objects of technical regulation. Identification and sampling (specimens) may be carried out at the manufacturer's warehouse, or at the applicant's warehouse, or at a temporary storage warehouse, or a customs warehouse.

Sampling (specimens) of perfumery and cosmetic products may be carried out by an accredited inspection body of a Member State included in the unified register of conformity assessment bodies of the Union;

b) testing and, where necessary, assessment of the toxicological indicators of perfumery and cosmetic products on the basis of an analysis of the toxicological characteristics of the ingredients, of the selected samples (specimens) of perfumery and cosmetic products for compliance with the requirements of items 3 – 6 of Article 5 of this Technical Regulation in an accredited testing laboratory (centre);

c) submission by the applicant to the authorized body of the application for state registration and of the documents and information attached to it, as specified in item 5 of this Article;

d) registration of the application for state registration
and of the documents attached to it;

e) examination of the documents submitted by the applicant, including examination of the results of the tests performed on the perfumery and cosmetic products;

f) decision to issue a certificate or to refuse
state registration of the perfumery and cosmetic products;

g) entry of information on the state registration of the products into the national part of the unified register of certificates of state registration of products;

h) issue of the Certificate of State Registration.

5. For state registration of perfumery and cosmetic products, the applicant shall submit the following documents and information to the authorized body:

- application for state registration of the products (may be submitted as an electronic document);

- copies of the manufacturer's documents (formulations, product specifications, other documents), certified by the applicant, containing a list of the ingredients included in the perfumery and cosmetic products, indicating their functions, as well as the mass fraction of the ingredients provided for in Annexes 2 – 5 to this Technical Regulation, for each name of perfumery and cosmetic product;

- copies of documents containing information on the presence of trace amounts of substances in the perfumery and cosmetic products (if trace amounts are present);

- copies, certified by the applicant, of the documents in accordance with which the products were manufactured (technical conditions, specifications, etc.);

- report on the sampling (specimens) of the products;

- copies of documents, certified by the applicant, containing the organoleptic and physicochemical indicators for each product name;

- copies of documents, certified by the applicant, containing information on the nanomaterial (if it is present in the perfumery and cosmetic products): chemical name, particle size, and the physical and chemical properties provided for in Annexes 2 – 5 to this Technical Regulation;

- a labelling sample of the consumer packaging of the perfumery and cosmetic products, certified by the applicant (for example, a copy of the label (packaging), a photo, a layout approved for printing, an annotation containing the claimed consumer properties (if they are claimed in the product labelling), special precautions (if necessary) for use of the products and information on the methods of use of the perfumery and cosmetic products, the absence of which may lead to incorrect use of the perfumery and cosmetic products by the consumer (if any)), confirming compliance with the requirements of items 9.1 – 9.5 of Article 5 of this Technical Regulation;

- test reports on the conformity of the perfumery and cosmetic products with the requirements of paragraphs 3 – 6 of Article 5 of this Technical Regulation and a report (if any) on the results of the assessment of the toxicological indicators of the perfumery and cosmetic products based on an analysis of the toxicological characteristics of the ingredients for conformity with the requirements of paragraph 6 of Article 5 of this Technical Regulation, obtained from an accredited testing laboratory (centre). Test reports on the conformity of the perfumery and cosmetic products with the requirements of paragraphs 3 – 6 of Article 5 of this Technical Regulation, covering tests performed for the purpose of their State Registration, and reports (if any) on the results of the assessment of the toxicological indicators of the perfumery and cosmetic products based on an analysis of the toxicological characteristics of the ingredients for conformity with the requirements of paragraph 6 of Article 5 of this Technical Regulation, issued for the purpose of their State Registration, must have been obtained no earlier than one year before the date on which the authorized body registers the application for State Registration. Where the toxicological indicators of the perfumery and cosmetic products are assessed based on an analysis of the toxicological characteristics of the ingredients, the set of documents shall include the corresponding reports instead of test reports on the conformity of the perfumery and cosmetic products with the requirements of paragraph 6 of Article 5 of this Technical Regulation;

- copies of the manufacturer's documents on the conformity of production with the requirements of paragraphs 7 – 7.5.2 of Article 5 of this Technical Regulation (a written notification from the manufacturer on the conformity of production with the requirements of this Technical Regulation, or a declaration (statement or written notification) from the manufacturer on compliance with the principles of Good Manufacturing Practice (GMP), or a copy of the certificate of conformity of the quality management system, or a copy of the certificate of conformity of the production of perfumery and cosmetic products with the principles of Good Manufacturing Practice (GMP)), certified by the applicant;

- copies of documents confirming the consumer properties of the perfumery and cosmetic products claimed in the labelling of the consumer packaging (antimicrobial action, anti-wrinkle, SPF factor, anti-caries and anti-inflammatory action of oral hygiene products, etc.), certified by the applicant. Claims regarding the consumer properties of perfumery and cosmetic products must be substantiated taking into account the common criteria set out in Annex 13;

- information on the registration or record (individual, identification) number of the applicant assigned upon the state registration of a legal entity or of a natural person registered as an individual entrepreneur in accordance with the legislation of the Member States;

- a copy of the agreement with the manufacturer, including a foreign manufacturer, under which the person authorized by the manufacturer acts on behalf of that manufacturer in conformity assessment and in placing the perfumery and cosmetic products on the market in the customs territory of the Union, and bears liability for any non-conformity of the perfumery and cosmetic products with the requirements of the technical regulations of the Union (Customs Union), certified by the applicant (for a person authorized by the manufacturer);

- copies of documents confirming the importation of samples of the perfumery and cosmetic products into the customs territory of the Union, certified in accordance with the legislation of the Member State in which the State Registration of the perfumery and cosmetic products is carried out (scheme 2р).

Translations of the manufacturer's documents from a foreign language into Russian and (or), where the legislation of the Member State so requires, into the state language of the Member State in which the State Registration of the perfumery and cosmetic products is carried out, shall be certified in accordance with the legislation of that Member State, or by a translator holding a document confirming their qualification, or by the applicant.

The applicant shall be liable for the accuracy of the documents and information submitted to the authorized body for the purpose of issuing the Certificate of State Registration of the perfumery and cosmetic products.

6. State Registration of perfumery and cosmetic products shall be carried out according to one of the following schemes:

- scheme 1р applies to products manufactured in the customs territory of the Union;

- scheme 2р applies to products manufactured outside the customs territory of the Union.

6.1. Scheme 1р for the State Registration of perfumery and cosmetic products.

In the State Registration of perfumery and cosmetic products under scheme 1р, the applicant is the manufacturer (the person authorized by the manufacturer).

The manufacturer shall take all necessary measures to ensure the stability of the production process and the conformity of the perfumery and cosmetic products manufactured with the requirements of this Technical Regulation, and shall carry out production control.

For the purpose of testing in the State Registration of perfumery and cosmetic products, the applicant, or an accredited testing laboratory (centre) on the instruction (application) of the applicant and in the applicant's presence, shall carry out identification and sampling of the perfumery and cosmetic products at the manufacturer's warehouse or at the applicant's warehouse.

Sampling of perfumery and cosmetic products may be carried out by an accredited inspection body of a Member State included in the unified register of conformity assessment bodies of the Union.

The results of the identification and sampling of perfumery and cosmetic products shall be documented in the relevant report (reports).

Testing in the State Registration of perfumery and cosmetic products and the assessment of toxicological indicators based on an analysis of the toxicological characteristics of the ingredients of the selected samples of perfumery and cosmetic products for the purpose of State Registration shall be carried out by an accredited testing laboratory (centre).

The applicant shall compile the set of documents and information provided for in paragraph 5 of this Article and submit it to the authorized body.

6.2. Scheme 2р for the State Registration of perfumery and cosmetic products.

In the State Registration of perfumery and cosmetic products under scheme 2р, the applicants are the person authorized by the manufacturer and the importer (seller).

For the purpose of testing during State Registration of perfumery and cosmetic products, the manufacturer, the applicant or, on the instruction (application) of the applicant and in the applicant's presence, an accredited testing laboratory (centre) shall carry out identification and sampling of the products at the warehouse of the manufacturer or of the applicant, or at a temporary storage warehouse, or at a customs warehouse.

Sampling during State Registration of perfumery and cosmetic products may be carried out by an accredited inspection body of a Member State included in the unified register of conformity assessment bodies of the Union.

The results of identification and sampling of perfumery and cosmetic products shall be documented in an appropriate report (reports).

Testing of perfumery and cosmetic products and assessment of the toxicological indicators of perfumery and cosmetic products on the basis of an analysis of the toxicological characteristics of the ingredients of the selected samples of perfumery and cosmetic products for the purposes of State Registration shall be carried out by an accredited testing laboratory (centre).

The applicant shall compile the set of documents and information provided for in paragraph 5 of this Article and submit it to the authorized body.

The applicant shall take all necessary measures to ensure that the products it supplies comply with the requirements of this Technical Regulation.

7. The authorized body shall review the application for State Registration of perfumery and cosmetic products and the attached documents and information provided for in paragraph 5 of this Article, and shall register the application for State Registration of perfumery and cosmetic products.

Examination of the documents and information submitted by the applicant, including examination of the results of testing of perfumery and cosmetic products, shall be carried out by the authorized body.

If both the examination of the documents and information submitted by the applicant and the product tests performed yield positive results, the authorized body shall decide to issue a Certificate of State Registration of perfumery and cosmetic products.

If non-compliance of the products with the requirements of this Technical Regulation is established, the authorized body shall decide to refuse to issue a Certificate of State Registration of perfumery and cosmetic products. The decision refusing to issue a Certificate of State Registration of perfumery and cosmetic products shall be handed to the applicant or sent by registered mail with a list of enclosures and acknowledgement of receipt, in writing or as an electronic document (stating the reasons for refusal), within 3 working days from the date of such decision.

The authorized body shall issue the Certificate of State Registration of perfumery and cosmetic products to the applicant and enter information about it in the national part of the unified register of Certificates of State Registration of products.

8. The Certificate of State Registration of perfumery and cosmetic products shall be drawn up in accordance with the uniform form and rules approved by Decision of the Board of the Eurasian Economic Commission No. 80 of 30 June 2017.

The Certificate of State Registration of perfumery and cosmetic products may be drawn up as an electronic document.

The Certificate of State Registration of perfumery and cosmetic products shall be drawn up for one or more names of perfumery and cosmetic products of the same designation and shall remain valid until the product name is changed and (or) changes are made to the formulation (composition) that result in changes to the safety indicators of the perfumery and cosmetic products. The Validity Period of a Certificate of State Registration of perfumery and cosmetic products issued under scheme 1р and scheme 2р is 5 years.

After completion of the State Registration procedure for perfumery and cosmetic products, the original Certificate of State Registration of perfumery and cosmetic products and the set of documents and information provided for in paragraph 5 of this Article shall be kept by the applicant, including after production of the perfumery and cosmetic products has ceased or the last batch of the perfumery and cosmetic products has been supplied, for the duration of their shelf life.

The Certificate of State Registration of perfumery and cosmetic products and (or) its annex may be replaced without additional or repeated testing in the following cases:

- detection of errors (misprints) in the certificate and (or) its annex;

- change in the legal form or location (legal entity address) of the manufacturer;

- change in the legal form or location (legal entity address), as well as in the address (addresses) of the place(s) of business of the applicant (if the addresses differ).

Where the Certificate of State Registration of perfumery and cosmetic products and (or) its annex is replaced, circulation of the products in the customs territory of the Union shall not be suspended.

The Certificate of State Registration of perfumery and cosmetic products and (or) its annex may be replaced without submitting additional test reports or expert opinions on the perfumery and cosmetic products to the authorized body where the certificate and (or) its annex needs to be supplemented with information not relating to the safety indicators of the products, information on indications (contraindications) for the use of certain types of products by particular population groups, and information of no hygienic significance (for example, indication of additional product forms and volumes, types of consumer packaging, trademarks, etc.).

9. Proof of Conformity of perfumery and cosmetic products shall be carried out in the form of a declaration of conformity under one of the following schemes:

- scheme 3д – for serially produced perfumery and cosmetic products;

- scheme 4д – for a batch of perfumery and cosmetic products;

- scheme 6д – for serially produced perfumery and cosmetic products where the manufacturer has a certified quality management system or a certificate of conformity of production with the principles of good manufacturing practice (GMP).

The declaration of conformity of perfumery and cosmetic products with the requirements of this Technical Regulation is drawn up in respect of one or more names of perfumery and cosmetic products of one designation.

10. For the declaration of conformity of perfumery and cosmetic products with the requirements of this Technical Regulation, the applicant shall be a legal entity or a natural person acting as an individual entrepreneur, registered in the territory of a Member State in accordance with its legislation, that is:

- for schemes 3д and 6д – the manufacturer, a person authorized by the manufacturer;

- for scheme 4д – the manufacturer, a person authorized by the manufacturer, an importer (seller).

11. Depending on the declaration of conformity scheme applied by the applicant, a set of documents and information is drawn up for each name of perfumery and cosmetic products, which includes:

- copies of the manufacturer's documents containing the list of ingredients included in the composition of the perfumery and cosmetic products, indicating their functions and the mass fraction of the ingredients provided for in Annexes 2 – 5 to this Technical Regulation, certified by the applicant (schemes 3д, 4д, 6д);

- copies of documents containing information on the presence of trace amounts of substances in the perfumery and cosmetic products (if trace amounts are present), certified by the applicant (schemes 3д, 4д, 6д);

- copies of documents containing the organoleptic and physico-chemical parameters of the products, certified by the applicant (schemes 3д, 4д, 6д);

- test reports of perfumery and cosmetic products for conformity with the requirements of paragraphs 3 – 6 of Article 5 of this Technical Regulation (if any), a report (if any) on the results of the assessment of toxicological parameters of perfumery and cosmetic products based on an analysis of the toxicological characteristics of the ingredients for conformity with the requirements of paragraph 6 of Article 5 of this Technical Regulation, issued by an accredited testing laboratory (centre) (schemes 3д, 4д, 6д);

- a copy of the contract (supply agreement) and the shipping documents identifying the product batch, including its size (scheme 4д);

- a sample of the labelling of the consumer packaging of the perfumery and cosmetic products (for example, a copy of the label (packaging), a photo, a layout approved for printing, an annotation (if any)), confirming conformity with the requirements of paragraphs 9 – 9.5 of Article 5 of this Technical Regulation, certified by the applicant (schemes 3д, 4д, 6д);

- a copy of the manufacturer's document on the conformity of production with the requirements of paragraphs 7 – 7.5.2 of Article 5 of this Technical Regulation (a written notification by the manufacturer of the conformity of production with the requirements of this Technical Regulation or a declaration (statement or written notification) by the manufacturer of compliance with the principles of good manufacturing practice (GMP)), certified by the applicant (scheme 3д);

- a copy of the certificate of conformity of the quality management system and (or) a copy of the certificate of conformity of the production of perfumery and cosmetic products with the principles of good manufacturing practice (GMP), certified by the applicant (scheme 6д);

- a copy of the manufacturer's document on the conformity of production with the requirements of paragraphs 7 – 7.5.2 of Article 5 of this Technical Regulation (a written notification by the manufacturer of the conformity of production with the requirements of this Technical Regulation or a declaration (statement or written notification) by the manufacturer of compliance with the principles of good manufacturing practice (GMP)) or a copy of the certificate of conformity of the quality management system and (or) a copy of the certificate of conformity of the production of perfumery and cosmetic products with the principles of good manufacturing practice (GMP), certified by the applicant (scheme 4д);

- copies of documents confirming the consumer properties of the perfumery and cosmetic products declared in the labelling of the consumer packaging (antimicrobial action, anti-wrinkle, SPF factor, anti-caries, anti-inflammatory action of oral hygiene products, etc.), certified by the applicant. Claims regarding the consumer properties of perfumery and cosmetic products shall be substantiated taking into account the common criteria in accordance with Annex 13 to this Technical Regulation (schemes 3д, 4д, 6д);

- a copy of the agreement with the manufacturer, including a foreign manufacturer, on the basis of which the person authorized by the manufacturer acts on behalf of that manufacturer in conformity assessment and in placing perfumery and cosmetic products on the market in the customs territory of the Union, and also bears liability for non-conformity of the perfumery and cosmetic products with the requirements of the technical regulations of the Union (Customs Union), certified by the applicant (for a person authorized by the manufacturer) (schemes 3д and 6д);

- information on the registration or record (individual, identification) number of the applicant assigned upon state registration of a legal entity or a natural person as an individual entrepreneur in accordance with the legislation of the Member States (schemes 3д, 4д, 6д).

A person authorized by the manufacturer or an importer (seller) may use test reports of perfumery and cosmetic products for tests carried out on behalf of the manufacturer or of the person authorized by the manufacturer, on the basis of their written consent.

The set of documents and information provided for by this paragraph is compiled on paper or electronic media.

Translations of the manufacturer's documents from a foreign language into Russian and (or), where the legislation of a Member State contains a corresponding requirement, into the state language of the Member State in which the declaration of conformity is registered, are certified in accordance with the legislation of that Member State, or by a translator holding a document confirming their qualifications, or by the applicant.

12. The manufacturer, depending on the declaration of conformity scheme applied:

- carries out production control and takes all necessary measures to ensure that the production process of perfumery and cosmetic products is stable and ensures the conformity of the manufactured perfumery and cosmetic products with the requirements of this Technical Regulation (scheme 3д);

- carries out production control and takes all necessary measures to ensure the stable functioning of the implemented and certified management system and of the production conditions for manufacturing perfumery and cosmetic products that comply with the requirements of this Technical Regulation (scheme 6д).

13. The applicant, depending on the conformity declaration scheme applied:

- compiles and analyses the set of documents and information provided for in paragraph 11 of this Article;

- ensures that identification and sampling (taking of specimens) of perfumery and cosmetic products are carried out. Identification and sampling (taking of specimens) of perfumery and cosmetic products may be carried out by the manufacturer, by the applicant or, on the applicant's instruction, by a product certification body or an accredited testing laboratory (centre). The applicant submits to the certification body or to the accredited testing laboratory (centre) the documents and information necessary for the identification and sampling (taking of specimens) of perfumery and cosmetic products. Sampling (taking of specimens) of perfumery and cosmetic products is carried out: for serially produced perfumery and cosmetic products – at the warehouse of the manufacturer (of the person authorized by the manufacturer), or at a temporary storage warehouse, or at a customs warehouse, or on the finished-product production line; for a batch of products – at the location of the batch (at the finished-product warehouse of the manufacturer (of the person authorized by the manufacturer), or at a customs warehouse, or at a temporary storage warehouse, or at the consignee's warehouse under safekeeping, or on the finished-product production line);

- ensures that the selected samples (specimens) of perfumery and cosmetic products are tested for compliance with the requirements of this Technical Regulation by an accredited testing laboratory (centre). For perfumery and cosmetic products at the stage of being put into production, samples (specimens) of perfumery and cosmetic products taken from a batch manufactured in the manufacturer's laboratory in accordance with technical documents approved in the established manner (technical specifications, formulation, specification, standard) and the manufacturing technology may be used for testing. The perfumery and cosmetic products must be filled into primary packaging made of a material identical to that of the packaging used in their production and labelled in accordance with the requirements of paragraphs 9 – 9.5 of Article 5 of this regulation. The labelling may be applied to the consumer packaging and (or) to a tag attached to it;

- adopts the declaration of conformity in accordance with the uniform form and rules approved by Decision of the Board of the Eurasian Economic Commission No. 293 of 25 December 2012;

- compiles and keeps a set of evidentiary materials confirming the conformity of the perfumery and cosmetic products with the requirements of this Technical Regulation, which includes:

the documents and information provided for in paragraph 11 of this Article;

Test Reports on the perfumery and cosmetic products for compliance with the requirements of paragraphs 3 – 6 of Article 5 of this Technical Regulation, and a report (if any) on the results of the assessment of toxicological indicators of the perfumery and cosmetic products based on an analysis of the toxicological characteristics of the ingredients for compliance with the requirements of paragraph 6 of Article 5 of this Technical Regulation, issued by an accredited testing laboratory (centre);

the registered declaration of conformity.

For the application of schemes 3д and 6д, the Test Report on samples (specimens) of perfumery and cosmetic products must have been issued no earlier than 1 year before the date of registration of the declaration.

For the application of scheme 4д, the results of tests on samples (specimens) of perfumery and cosmetic products may be used for subsequent batches of similar perfumery and cosmetic products for which a declaration of conformity was previously adopted and registered. In this case, the applicant identifies the batch of perfumery and cosmetic products in order to establish its similarity to the perfumery and cosmetic products for which a declaration of conformity was previously adopted and registered. If the applicant has established such similarity, sampling (taking of specimens) and testing of the perfumery and cosmetic products are not carried out. The validity period of the Test Report on the perfumery and cosmetic products used shall not exceed 2 years from the date of its approval, provided that the tests were carried out using the test methods in force at the time of adoption of the declaration of conformity and established by standards included in the list of standards containing rules and methods of research (testing) and measurement, including sampling rules, necessary for the application and implementation of the requirements of this Technical Regulation and for the conformity assessment of objects of technical regulation, provided for in paragraph 2 of Article 5¹ of this Technical Regulation, and that no changes have been made to the formulation (composition) of the perfumery and cosmetic products.

14. To register the declaration of conformity, the applicant submits the documents and information provided for by the Procedure for the Registration, Suspension, Resumption and Termination of Declarations of Conformity of Products with the Requirements of the Technical Regulations of the Eurasian Economic Union, approved by Decision of the Board of the Eurasian Economic Commission No. 41 of 20 March 2018, including copies of the documents and the information provided for in paragraph 13 of this Article, except for documents confirming the consumer properties of the perfumery and cosmetic products.

All copies of documents submitted shall be certified by the applicant.

15. The declaration of conformity of perfumery and cosmetic products with the requirements of this Technical Regulation remains valid until the name of the product is changed and (or) changes are made to the formulation (composition) that result in changes to the safety indicators of the perfumery and cosmetic products, but for not more than 5 years for conformity declared under scheme 3д, not more than 7 years for conformity declared under scheme 6д, and, for conformity declared under scheme 4д, taking into account the shelf life of the products included in the given batch of perfumery and cosmetic products.

If a registered declaration of conformity for serially produced perfumery and cosmetic products covers perfumery and cosmetic products manufactured from the date of manufacture of the selected samples (specimens) of the products that have undergone testing, this information and the details of the date of manufacture of the selected samples (specimens) of the products that have undergone testing shall be indicated in field 8 "Additional information" of the uniform form of the declaration of conformity with the requirements of the technical regulation of the Eurasian Economic Union, approved by Decision of the Board of the Eurasian Economic Commission No. 293 of 25 December 2012.

When registering a new declaration of conformity, the applicant shall decide to terminate the declaration of conformity that is to be replaced.

16. The original of the declaration of conformity and the set of documents and information provided for in paragraph 13 of this Article (in electronic form or on paper) shall be retained by the applicant after the discontinuation of production of the perfumery and cosmetic products or the delivery of the last batch of the perfumery and cosmetic products for the duration of their shelf life.

The set of evidentiary materials confirming the conformity of the perfumery and cosmetic products with the requirements of this Technical Regulation shall be retained by the body (organization) of the Member State authorized to register declarations of conformity, including an accredited certification body of the Member State, for 5 years after the expiry of the declaration of conformity.

Copies of the registered declaration of conformity and of the set of evidentiary materials may be stored in electronic form in accordance with the legislation of the Member States.

17. If a change is made to the formulation (composition) of perfumery and cosmetic products that does not lead to changes in the safety indicators of the perfumery and cosmetic products established by this Technical Regulation, and the product name is not changed, the perfumery and cosmetic products manufactured according to the new formulation shall be tested; in this case, adoption of a new declaration of conformity is not required.

The set of documents and information to be retained by the applicant shall be supplemented with the following documents:

- copies of the manufacturer's documents containing the list of ingredients included in the composition of the perfumery and cosmetic products, indicating their functions and the mass fraction of the ingredients provided for in Annexes 2 – 5 to this Technical Regulation, after the change to the formulation (composition), certified by the applicant;

- copies of documents containing information on the presence of trace amounts of substances in the perfumery and cosmetic products (if trace amounts are present);

- copies of documents containing the organoleptic and physicochemical indicators of the products after the change to the formulation (composition), certified by the applicant;

- test reports on the conformity of the perfumery and cosmetic products manufactured according to the new formulation with the requirements of paragraphs 3 – 6 of Article 5 of this Technical Regulation, and the report (if any) on the results of the assessment of the toxicological indicators of the perfumery and cosmetic products manufactured according to the new formulation, based on an analysis of the toxicological characteristics of the ingredients, for conformity with the requirements of paragraph 6 of Article 5 of this Technical Regulation, issued by an accredited testing laboratory (centre);

- a sample of the labelling, if it has been changed, certified by the applicant;

- a copy of the manufacturer's document (notification) on the release of products according to the new formulation, certified by the applicant.

Article 7. Marking with the Single Mark of Product Circulation on the Union Market

1. Perfumery and cosmetic products that comply with the requirements of this Technical Regulation and have undergone the conformity assessment procedure for this Technical Regulation in accordance with Article 6 shall be marked with the single mark of product circulation on the Union market.

2. Marking with the single mark of product circulation on the Union market shall be carried out before the products are placed on the market.

3. The single mark of product circulation on the Union market shall be applied to each unit of the products (consumer packaging, tag, label) and/or to the shipping documentation.

The single mark of product circulation on the Union market may be applied by any method that ensures a clear and distinct image throughout the entire shelf life of the perfumery and cosmetic products.

Article 8. Safeguard Clause

Article 9. State Control (Supervision)

ANNEX 1
to the Technical Regulation
of the Customs Union
"On the Safety of Perfumery and
Cosmetic Products"
(TR CU 009/2011)

LIST
of substances prohibited for use in perfumery and cosmetic products

Footnote. Annex 1 as revised by Decision of the Council of the Eurasian Economic Commission No. 32 of 29.03.2019 (enters into force upon expiry of 12 months from the date of its official publication); as amended by Decision of the Council of the Eurasian Economic Commission No. 64 of 15.04.2022 (enters into force upon expiry of 12 months from the date of its official publication).