Technical Regulation on the Safety of Perfumery and Cosmetic Products, TR CU 009/2011 or TR TS 009/2011, adopted by the Customs Union Commission Decision No. 799 of 23 September 2011
Entry into force: 1 July 2012
Which products does the TR on the Safety of Perfumery and Cosmetics apply to?
The TR applies to cosmetics and perfumery released on the Customs Union market in consumer packaging.
The TR does not apply to any products which are to be swallowed, inhaled, injected or implanted into a human body. It also does not apply to products used for tattooing, with the breach of the skin layer and to products used for diagnostics and treatment of illnesses.
What are perfumery and cosmetic products?
Perfumery and cosmetics are intended exclusively for external application on certain parts of human body.
Perfumery and cosmetic products are to be applied on: skin, hair, nails, lips, teeth, oral mucosa and external genital organs.
The purposes of use of perfumery and cosmetic products (separately or in any combination) are to clean or to change the external appearance of skin, hair, nails, lips, teeth, oral mucosa or external parts of genitalia, without breaching their integrity, to give these parts a pleasant smell or to correct their smell or to maintain them in a good condition.
Release on the market
Cosmetic and perfumery products may be released on the Russian (Customs Union) market only if they comply with the requirements set out in the TR on the Safety of Perfumery and Cosmetic Products and with other applicable Technical Regulations. No additional requirements may be imposed on perfumery and cosmetic products.
Requirements pertaining to perfumery and cosmetic products
Composition
The list of substances the use of which in cosmetic products and perfumery is prohibited (i.e. which must not form a part of the products’ composition) is provided in Annex 1 to the Technical Regulation. The List contains 1328 substances (whereas the EC Cosmetics Directive prohibits 1371 substances).
The list of substances the use of which in perfumery and cosmetic products is restricted and subject to certain conditions, is provided in Annex 2 to the Technical Regulation. This list includes 102 substances.
The list of colouring agents permitted to be used in perfumery and cosmetics and the conditions of their use in the mentioned products is provided in Annex 3 to the Technical Regulation.
The list of preservatives permitted to be used in perfumery and cosmetic products is provided in Annex 4 to the Technical Regulation.
The list of UV-filters permitted to be used in perfumery and cosmetic products is provided in Annex 5 to the Technical Regulation.
All lists are to be updated from time to time.
Physical and chemical criteria
The pH limits for perfumery and cosmetics are provided in Annex 6. For oral hygiene products the content of fluoride must comply with the limits set out in Annex 2.
Microbiological criteria
Microbiological criteria are set out in Annex 7 to the Technical Regulation. For the following products these requirements do not have to be complied with:
- perfumery and cosmetics containing ethylene alcohol and/or organic solvents in the concentration exceeding 25% of the non-diluted product volume;
- nail varnishes, except water-based nail varnishes;
- deodorants, deodorants-antiperspirants and antiperspirants;
- oxidising hair colours, products for hair bleaching and highlighting;
- hair waving and hair straightening products based on thiol compounds;
- depilation products based on thioglycollic acid;
- fat-based solid soap;
- dry pencils;
- bath salts;
- 100% essential oils;
- tooth whitening products containing hydrogen peroxide or substances emitting hydrogen peroxide, including carbamide peroxide and zinc peroxide, with the concentration of hydrogen peroxide (either emitted or as an ingredient) in the concentrations between 0,1% and 6%; and
- shaving products (creams, gels, etc.) with the pH exceeding 10,0.
Toxicity criteria
Perfumery and cosmetic products which include natural plant or mineral raw materials in the concentration exceeding 1%, the content of toxic substances must not exceed the following thresholds:
- arsenic – 5,0 mg/kg;
- mercury – 1,0 mg/kg; and
- lead – 5,0 mg/kg.
Toxicity parameters for perfumery and cosmetic products must comply with the requirements set out by Annex 8 to the Technical Regulation.
Clinical and laboratory parameters must comply with the requirements set out by Annex 9 to the Technical regulation.
Both toxicity, clinical and laboratory parameters must be assessed by accredited testing laboratories (centers) after the products have undergone physical, chemical and microbiological tests.
Requirements pertaining to the product manufacturing process
The Technical Regulation imposes a number of requirements applicable to the process of product manufacturing. For example, the manufacturer must install the ventilation system in the production premises in a way that the air supplied by the ventilation does not pollute the products in any way.
The manufacturer must explicitly prohibit their employees to consume food on the premises where the products are being manufactured.
Labelling requirements
Products must bear consumer labelling (marking) in a form of writings, digital, colour and symbolic images. The marking must be placed on consumer packages, labels and/or tags, taking into consideration the requirements set out in Annexes 2 – 5 to the Technical Regulation (e.g. “Not to be used for children under 3 years of age”). If the user information is provided in a tag attached to the product, then the product must be marked (labelled) with a sign depicting a hand placed on an open book.
Product label must contain the following information:
- product name;
- product purpose, if this is not self-evident from the product name;
- if a cosmetic product is intended for children, this must be specified on the label;
- name of the manufacturer and its location (including the country);
- country of the product’s origin (if the place of manufacture is not located at the manufacturer’s registered address);
- name and address (registered address) of the organisation authorised by the manufacturer to deal with consumers’ complaints (i.e. the authorised representative or importer), if the manufacturer does not accept complaints itself on the territory of the Customs Union member state;
- quantity (volume of weight) of the product in consumer packaging (for solid toilet soap – the weight of the bar at the time of packaging), except for perfumery or cosmetics with the weight less than 5 grams or volume less than 5 ml or sample products;
- colour or tone (for decorative cosmetics and colouring products);
- the content of fluorine (% or mg/kg or ppm) for oral hygiene products containing fluorine compounds;
- product life period:
- date of manufacture (month and year) and consumption period (months, years) or the writing “use by” (month, year) or “to be used until” (month, year);
- storage conditions, if these conditions are different from the usual ones;
- special precaution measures (if necessary) during the use of the product, including warnings contained in Annexes 2-5 to the Technical Regulation;
- batch number or a special code identifying the batch;
- information on the ways the product is to be used, the absence of which may lead to incorrect use of the product by the consumer;
- the list of the ingredients (see below).
The list of ingredients must be headed by the heading “Ingredients” or “Composition”
The ingredients must be listed in the descending order of their share in the product. Aromatic ingredient is to be specified as a single ingredient without disclosing its composition.
If the product’s composition includes ingredients No. 67 – 92 from Annex 2 to the Technical Regulation (e.g. 2-benzylideneheptanal, benzyl alcohol, cinnamyl alcohol, etc.) and their concentration exceeds 0,01% (for products which are to be rinsed off) or 0,001% for products which are not supposed to be rinsed off, then they must be specified in the list of ingredients.
Ingredients which are present in the form of nanomaterials, must be clearly mentioned in the list of ingredients and marked with the word “nano” in brackets.
Ingredients which are present in the concentration which is less than 1%, may be listed in any order after the ingredients the concentration of which exceeds 1%.
Colouring agents may be listed in any order after the other ingredients, according to the colour index or adopted symbols or codes.
The list of ingredients may be comprised in either the official/the state language(s) of the Customs Union members states where the products are to be placed on the market or in accordance with the INCI abbreviation with the use of Latin letters.
On decorative cosmetic products issued as a series of different tones, all colouring agents may be listed, with the use of the words “may contain” or the sign (+/-).
The marking must be clear, visible and indelible if the product is used in accordance with its purpose.
The language of the marking must be the official language (or languages) of the Customs Union member state where the product is to be distributed.
The name of the manufacturer, its location and the product name may be written with the use of Latin characters. The country of product origin must be written in the official (state) language(s) of the Customs Union member state where the product is to be distributed.
Conformity assessment of cosmetic products and perfumery
The product manufacturer or supplier (importer) which is registered as a legal person or a sole trader in the relevant Customs Union member state must organise conformity assessment of the products they manufacture or supply.
There are two forms of conformity assessment:
- conformity declaration; or
- state registration.
Conformity declaration for cosmetic products and perfumery
A conformity declaration must be obtained for all cosmetic products and perfumery except those listed in Annex 12 to the TR (see below). Conformity assessment for products listed in Annex 12 must be performed in the form of state registration.
The manufacturer or supplier must issue a conformity declaration on the basis of the supporting information obtained as a result of tests performed by accredited laboratories of the Customs Union member state and based on the manufacturer’s/supplier’s own information.
The declaration is valid until the product name or composition has been changed and such changes affect the product’s safety. The declaration may be issued for one or several product names belonging to the same type.
The manufacturer or supplier must submit the declaration to the accredited certification body of the relevant Customs Union member state. The accredited certification body will register the declaration in the special registry.
State registration of perfumery and cosmetic products
1. List of products subject to the state registration procedure
The following products are subject to the state registration procedure:
- self-tanning products;
- skin lightening/bleaching products;
- tatoo cosmetics;
- intimate cosmetics;
- cosmetic products for children;
- products for hair bleaching, lightening and highlighting;
- hair perm and permanent hair straightening products;
- products made with the use of nano-materials;
- products used for depilation;
- peeling products;
- mouth hygiene products containing fluorine with the mass fraction of fluorides (fluorine compounds) exceeding 0,15% (0,05% for liquid oral hygiene products);
- tooth whitening products containing hydrogen peroxide or other components emitting hydrogen peroxide, including carbamide peroxide and zinc peroxide, with the concentration of hydrogen peroxide (either as an ingredient or an emitted substance) – 0,1% – 6,0%.
2. Which state agency performs the state registration procedure of cosmetic products in the Customs Union?
In Russia the agency which performs state registration of cosmetics and perfumery is the Federal Consumer Protection and Public Welfare Service (Rospotrebnadzor). As a result of the registration a state registration certificate is issued to the product manufacturer or supplier.
3. Registration procedure
Products manufactured in the Customs Union must be registered at the stage of the commencement of their manufacturing process. Imported products must be registered before they may enter the customs territory of the Customs Union.
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