CU TR 009/2011 "Safety of cosmetic products" - certification and declaration of conformity

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 LaunchCertificate CU TR 009 2011 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 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 EACEurasian Conformity mark 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 :Declaration of conformity EAEU TR 009 2011 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