海关联盟cutr认证|俄罗斯测试认证中心TEST CERT LTD
gost@gost.org.cn                  021-36411293

俄罗斯标准-测试认证中心 "Стандарт-Тест"

海关联盟授权代码:RA.RU.11AB24 

上海卡卢加机电设备检测中心


新闻中心

State registration,EAC Declaration,TR CU 009
来源: | 作者:pmt579fb4 | 发布时间: 2018-11-10 | 1462 次浏览 | 分享到:
According to the technical regulation TR CU 009/2011 there are 2 forms of conformity assessment: EAC Declaration and state registration.

perfumes and other beauty products subject to EAC Declaration. This means that all products for hair care such as shampoo, conditioner, hair spray or gel, decorative cosmetics such as lipstick, nail polish or mascara, body care like shower gel, bath additive or body lotions, facial care such as creams, masks or peels, deodorants and perfumes need a conformity assessment, before they can be imported into Russia or the EAEU. The products must demonstrate their conformity with the technical regulations of the Eurasian Economic Union. The technical regulation TR CU 009/2011 On safety of perfume and toiletrie productsconsists of special requirements for the cosmetics.

According to the technical regulation TR CU 009/2011 there are 2 forms of conformity assessment: EAC Declaration and state registration.

EAC Declaration

The EAC declaration is a manufacturer's declaration that the products meet the minimum requirements of the technical regulation of the Eurasian Economic Union. The declaration is carried out by the manufacturer himself. The EAC Declaration becomes legally binding after its registration by a notified body in the EAEU.

The registration of the EAC Declaration may only be carried out by a company established in the territory of the EAEU. Therefore an authorized representative within the EAEU is required. If you need an authorized representative, we will be pleased to offer you a suitable company that takes over this function.

State registration

The conformity assessment of the products listed in Annex 12 occurs in the form of state registration. The state registration acknowledges the conformity assessment of the products with the sanitary-hygienic regulations of the EAEU.

The notified bodies accredited by Rosstandart or Rospotrebnadzor are responsible for issuing certificates of state registration. The registration procedure includes both an analysis of the manufacturer's documents, as well as laboratory tests and, in some cases, an inspection of the production. All certificates of state registration are entered in a special register and kept there.

The products that are subject to state registration:

  • tanning creams

  • products for skin whitening

  • compounds for permanent make-up

  • perfumery and cosmetic products for intimate care

  • cosmetics for children

  • peeling

  • depilatory

  • hair lighteners

  • perfumery and cosmetic products for permanent waves     and hair straightening

  • perfumery and cosmetic products with nanoparticles

  • fluorinated oral hygiene products with a mass     fraction of fluorides exceeding 0.15%

  • teeth whitening agents containing hydrogen peroxide,     carbamide peroxide, zinc peroxide (hydrogen concentration not exceeding     0.1 to 6%)

Process of conformity assessment

Before you can register the EAC Declaration, the products must be tested by an approved laboratory in the EAEU.

The products are tested for the following criteria:

  • composition

  • physical and chemical parameters

  • microbiological parameters

  • content of toxic elements

  • toxic data

  • clinical (clinical-laboratory) measurements

  • processing

  • consumer packaging

  • marking of production

The corresponding requirements and permitted values are specified in the Annexes to the technical regulations 009/2011:

  • Annex 1 contains a list of prohibited substances

  • Annex 2 gives the maximum permissible values for the     ingredients in tabular form

  • Annex 3 contains the list of authorized dyes

  • Annex 4 lists the authorized preservatives

  • Annex 5 lists the approved UV filters

  • Annex 6 contains the permitted pH values

  • Annex 7 provides information on microbiological     product safety

  • Annex 8 contains requirements for the toxicological     indicators

After successful tests, the labs create test reportss. These test reports shall be submitted at the registration of the EAC Declaration in one of the certification authority.

Since January 25, 2017, perfumes and cosmetic products can be declared according to 3 schemes:

  • Scheme 3d is intended for series production

  • Scheme 4d applies to a delivery

  • Scheme 6d is used for serial production if the     manufacturer has implemented a GMP-compliant quality management system.

Period of validity of the EAC Declaration

Since January 25, 2017, new provisions have been applied to the validity period of the EAC Declaration.

  1. For series production (Scheme 3d) - 5 years.

  2. For Scheme 4d, the validity period of the EAC     declaration is limited to the shelf life of the product.

  3. The declaration according to the scheme 6d is issued     for a maximum of 7 years.

EAC marking

The products declared according to TR CU 009/2011 must be marked with the EAC conformity mark before launching in the market. The conformity mark shall be affixed to each unit of perfumery and cosmetic production and (or) shipping documents. The marking must be carried out in such a way that it is easily recognizable and legible throughout the entire shelf life of the product. Appropriate marking may only be made if the corresponding production meets the requirements of all relevant technical regulations.

Labeling

The label shall include the following information:

  • product name

  • product indication, e.g. child care products

  • manufacturer, his address

  • country of origin (if the address of the     manufacturer does not match the place of manufacture)

  • importer, his address

  • volume

  • color and (or) tone (for make-up)

  • fluorinated oral hygiene products with a mass     fraction of fluorides exceeding 0.15%

  • shelf life period and expiration date (month, year)     or "durable until: mm-jj" or "use before: mm-jj"

  • instructions for storage

  • information about special precautions

  • delivery number

  • list of ingredients

  • EAC conformity mark

Documents required for the EAC declaration:

  • list of all ingredients

  • copy of documents with details of organoleptic and     physico-chemical properties of products

  • test logs (if available)

  • sample of the labeling of the consumer package with     the package insert

  • certificate of GMP-compliant quality management     system

  • documents which prove the product features announced     on the label, e.g. antibacterial effect, light protection factor,     anti-wrinkle effect or anti-inflammatory effect of oral hygiene products

Documents required for state registration:

  • list of all ingredients with concentration and mass     proportions

  • a quality certificate or a written confirmation from     manufacturer that the products meet all quality requirements

  • copy of documents with details of organoleptic and     physico-chemical properties of products

  • in the case of the use of nanoparticles, the exact     particulars of the chemical composition of the particles and their size     must be made

  • a sample of the labeling of the consumer package     with the package insert

  • cover sheet with information on consumption     characteristics, special precautions for use and instructions for use

  • test reports

  • certificate of GMP-compliant quality management     system

  • documents which prove the product features announced     on the label, e.g. antibacterial effect, light protection factor,     anti-wrinkle effect or anti-inflammatory effect of oral hygiene products.

The supporting documents must be submitted in Russian or in the official language of the Member State of the Customs Union.

Our offer

Our export consultants have many years of experience in the import of cosmetics to Russia and its customs processing. We offer a comprehensive service package, which includes the preparation of all necessary documents, the corresponding customs handling, and the logistics. We will help you acquire necessary certificates and permits.

We offer:

  • counselling on all questions about the import of     cosmetics, perfumery and toiletry products

  • execution     of copies of conformity certificates

  • provision     of an authorized representative

  • execution     of all necessary documentation

  • translation     of documents into Russian(labels, product descriptions, etc.)

  • customs     clearance

  • communication     with end comsumers

  • execution of foreign trade contracts

  • delivery to any place in the     world




上海经合工业设备检查有限公司

021-36411223  021-36411293

邮件:gost@gost.org.cn    gost-r@163.com

skype:gostchina

微信:18621862553

www.gost.org.cn  

                         

  微信号 扫一扫联系我               公众号 扫一扫                企业微信