Conformity assessment of perfumes and cosmetics According to the requirements of the TR CU 009/2011
Perfumes and cosmetics for children and adults are subject to the Technical Regulation of the Customs Union 009/2011 “On safety of perfumes and cosmetics” (hereafter — the Regulation).
Import and sale of perfumes and cosmetics in the territory of EAEU is possible only upon availability of documents on conformity assessment to TR CU 009/2011, either a Declaration of conformity or a State registration certificate.
What requirements are established by TR CU 009/2011?
The Regulation establishes a quite long list of requirements to safety of perfumes and cosmetics:
|Requirements of TR CU 009/2011||Description|
|to the composition||Substances, coloring agents, preserving agents and UV filters are specified in appendices 2-5 to the Regulation.|
|to physical and chemical indicators||Standard hydrogen index values (pH) are specified in appendix 6 to the Regulation.|
|to microbiological indicators||Standards of microbiological indicators (the content of microorganisms such as «Candida», «Escherichia coli», «Staphylococcus» etc.) are specified in appendix 7 to the Regulation.|
|to the content of toxic elements||The content of toxic elements must not exceed:
|to toxicological indicators||Indicators of skin irritating effect, effect on mucosae and general toxic effect are specified in appendix 8 to the Regulation.|
|to clinical (clinical-laboratory) indicators||Clinical indicators are indicators of irritating and sensitizing effect (specified in appendix 9 to the Regulation).|
|to production||Requirements to production processes, to production facilities, to technological equipment etc. (requirements to production are specified in article 6, paragraph 7 of the Regulation).|
|to consumer packaging||Consumer packaging must provide for safe-keeping and integrity of the products during the entire shelf life of the products.|
|to product labeling||Label should contains the data according to paragraph 9, article 5 of the Regulation (name of the products, composition, shelf life etc.)|
Testing for conformity to the TR CU 009/2011
Compliance with the requirements of the Regulation is confirmed by laboratory testing of the products. In accordance with article 6, paragraph 5 of the Regulation, this testing can be carried out only in accredited testing laboratories.
For Declaration, the scope and methods of testing are determined by the applicant, depending on which requirements are applied to the products. Compliance with some requirements, such as requirements to composition and physical and chemical indicators, can be confirmed by the manufacturer’s documents.
If several names of products are specified under one general name in the declaration of conformity, it is necessary to carry out testing for each name of the products.
According to the legislation, the applicant shall independently determine the list and the scope of necessary testing, form evidentiary materials and bear responsibility for violation of requirements of the Regulation.
In respect of non-typical or multi-component products, it can be quite difficult to determine the requirements applied. IFCG Specialists will help you determine the scope of testing and find laboratories in the territory of EAEU, capable of conducting such tests.
Documents on conformity assessment
Declaration of conformity
Declaration of conformity is issued for all finished perfumes and cosmetics, except for the products included in the list from appendix 12 to the Regulation.
During procedure of preparing the Declaration, testing takes most of the time. Testing is carried out on average during 14 – 20 working days after the samples are delivered to the testing laboratory.
Declaration of perfumes and cosmetics is carried out according to one of the following declaring schemes:
- 3d – for series production;
- 4d – for single batch of product;
- 6d – for series-produced products (if the manufacturer has a certified Quality Management System / GMP certificate)
Starting from Jan 01, 2021 Declaration of conformity must be registered by the applicant via the personal account in System of Federal Service for Accreditation (herein after — register of FSA) in accordance with the order established by Government Decree № 936 dated June 19, 2021.
IFCG specialists will:
- help to prepare all the necessary documents,
- help to enter the data in the register of FSA according to the legislation,
- consult on registration of declaration in the FSA service,
- prepare the final version of the document.
If necessary, our company renders representative services. We can act as the applicant during execution of Declaration of conformity for your products.
State registration certificate
Potentially hazardous to human health products specified in the list of appendix 12 to the Regulation are subject to state registration:
- Perfumes and cosmetics for artificial tanning (products for self-tanning and fake tanning);
- Intimate cosmetics (soap, foams and gels for intimate hygiene, etc.);
- Baby cosmetics (baby soap, baby skincare cosmetics, etc.);
- Perfumes and cosmetics for chemical dyeing, bleaching and highlighting of hair (hair dye, special products for hair dyeing);
In Russia, state registration of perfumes and cosmetics is carried out by the Russian Federal State Agency for Health and Consumer Rights (Rospotrebnadzor).
The applicant for state registration can be the manufacturer (person authorized by the manufacturer) or the importer (seller).
For execution of a State registration certificate, first of all it is necessary to carry out testing and to obtain an Expert opinion in accredited laboratory. This procedure takes an average of 5-6 weeks.
Then, it is necessary to provide the authorized body with the documents according to article 6, paragraph 4 of the Regulation:
- certificate of quality or manufacturer’s letter on product conformity to the requirements in accordance whereto it is manufactured;
- copies of documents containing organoleptic and physical and chemical indicators of the product;
- a sample of labeling of consumer packaging;
- summary specifying the claimed consumer properties;
The term of documents review is 2 weeks on average.
State registration certificate is issued during 8 – 12 weeks on average and is valid until introduction of changes in the name or composition of the product.
Peculiarities of conformity assessment of perfumes and cosmetics
- Labeling of perfumes and cosmetics should comply with the requirements of paragraph 9, article 5 of the Regulation, which includes the requirements to the information contained on the label of the products, requirements to specification of the composition of the products, information about the manufacturer, storage requirements, etc.
- Toilet water and perfume must be labeled with “Chestny Znak”.
- Translation of manufacturer’s documents (written notifications, test reports, GMP certificates etc.), which will be provided during issuing of Declaration of conformity or state registration, from foreign language into Russian must be notarized or certified by translator’s signature, with attached copy of the diploma confirming their qualification (article 6, paragraph 4 of the Regulation).
The Regulation determines rather extensive requirements to labeling of the products. Thus, the products must be labeled preliminarily (before import to the EAEU territory and provision to the laboratory for testing).
We are ready to assist you with development of the model of labeling of your products in accordance with the requirements of TR CU 009/2011. For this purpose, please send our specialists the information about your products.
We are ready to assist you with conformity assessment of perfumes and cosmetics in any situation and at any stage:
Inform us about the type of product, its composition, available labelingWe will analyze the information and determine:
1) whether your products are subject to TR CU 009/2011;
2) what type of document it is necessary to execute;
3) what other authorization documents will be needed for import and sale of products.
If you do not have labeling in Russian language, we will assist with development of label model in accordance with the requirements of TR CU 009/2011
We will help you to import the samples of products for testingWe will receive all necessary documents and carry out customs formalities.
We will select the most suitable laboratories and organize testingOur experts will help you determine what requirements are specified to your products, and which testing is required. We will select necessary laboratories, organize testing and ensure the completeness of results.
IFCG is very thorough in selection of the laboratories, taking into account not only their technical facilities and accreditation, but also the possibility to carry out the testing of all parameters in one place, using the minimum quantity of samples, which will save you money and time.
We will help you register the Declaration of conformity / organize the process of state registration of products in Federal State Agency for Health and Consumer Rights (Rospotrebnadzor)Our specialists will help you:
1) enter the data in the register of RusAccreditation (Federal Service for Accreditation);
2) prepare the final document in accordance with legislation.