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History and main definitions
The Technical Regulation on the safety of cosmetic products CU TR 009/2011 adopted on 23 September 2011 by the Commission of the Customs Union (Russia, Belarus and Kazakhstan ) (Decree No. 799) entered into force on the July 1, 2012.Scope and relevant products
Moreover, while for the majority of products a declaration of conformity is enough, the Technical Regulation CU TR 009/2011 also lists a number of products for which registration is still needed:
- Self-tanners,
- Skin bleaching products,
- Products for tattoo,
- Hygiene products,
- Cosmetics for children,
- Hair dyes and professional products for hair perms and hair straightening,
- Hair removal products,
- Peels,
- Oral care products,
- Teeth whiteners.
For these products, the registration is a prerequisite for the placing on the market. For imported products, it must be completed prior to clearance the Union’s customs.
Market Launch
The declaration of conformity TR must be registered within an authorized agency in the TR system according to the conformity evidence given by the applicant. Obtaining the Declaration of Conformity is allowed only to legal entities registered in the Russian territory (distributors, importers or official representatives of foreign manufacturers). Furthermore, each applicant must have his own Declaration of conformity issued on his name.
Declaration of Conformity TR
Depending on the frequency of consignment and a number of other exporter’s criteria, the manufacturer can obtain:
- the declaration of conformity TR for shipment of a consignment
- the declaration of conformity TR for mass production with validity period up to 5 years.
Sanitary expert report about products compliance with health requirements of the Customs Union is issued by authorized centers in member states. Several products of the same family can be grouped into one sanitary expert report.
As for registration, the criteria which allow grouping several multiple products are more restricted.
The registration procedure includes following steps:
- evaluation of technical and administrative file provided by the manufacturer, especially the analysis of product compliance, manufacturing conditions, health standards;
- carrying out appropriate tests: toxicological, clinical and others, depending on the type of product;
- compilation of sanitary expert report about products compliance based ontest results and documents analysis;
- recording of data related to the product as well as its manufacturer in the unique sanitary database of the customs union;
- issue of product registration certificate.
Evidence of Sanitary Control (Sanitary expert report and Registration Certificate) is valid while controlled products are circulating in the territory of the Customs Union.
Applicable procedures
The registration procedure includes following steps:
- evaluation of technical and administrative file provided by the manufacturer, especially the analysis of product compliance, manufacturing conditions, health standards;
- carrying out appropriate tests: toxicological, clinical and others, depending on the type of product;
- compilation of sanitary expert report about products compliance based ontest results and documents analysis;
- recording of data related to the product as well as its manufacturer in the unique sanitary database of the customs union;
- issue of product registration certificate.
Evidenceof Sanitary Control (Sanitary expert report and Registration Certificate) is valid while controlled products are circulating in the territory of the Customs Union.
The duration and receipt of the documents:
Type of certificate
|
Validity
|
Time of receipt
|
Time of working out certification file
|
|
By exporter (standard procedure)
|
By us (accelerated procedure)
|
|||
Sanitary expert report
|
Valid while the test protocol is valid (about 1 year)
|
25 business days*
|
1 months
|
10 business days
|
Regstration certificate
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Valid for life
|
50 business days*
|
1-2 months
|
10 business days
|
TR Declaration of conformity
|
Valid for one entry : a single shipment of a product or a batch of products
|
5 business days*
|
1-2 months
|
10 business days
|
TR Declaration of conformity
|
Valid for 5 years : for mass production
|
25 business days*
|
1-2 months
|
10 business days
|
Conformity Marking EAC
The conformity marking "EAC" consists of an acronym. It means that the products certified to be compliant with the essential health and safety requirements of the Technical Regulation on the safety of cosmetic products CU TR 009/2011. It provides access to the free displacement of the machine on the whole territory of the Custom Union
TR conformity marking shall also be affixed visibly on the products and/or the accompanying documents
TR logo is presented on the right.
Our solutions :
- receipt of certificates / declarations TR
- advice on working out the conformity assessment file
- specification compliance
- assistance during audit of manufacturing site
- assistance during regulatory tests
- monitoring of certified sites
Statutore reference:
The text in English and/or French of the Technical Regulation of the Customs Union CU TR 009/2011 on safety of cosmetic products with comments of CCIS-EXPERTISE experts is available in our e-shop.