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化妆品,香水和美容产品EAC符合性声明(EAC declaration)
    发布时间: 2019-06-03 20:03    

化妆品,化妆品,香水和美容产品须遵守EAC符合性声明(EAC declaration)。护发产品,如洗发水,护发素,发胶或凝胶,装饰性化妆品,如口红,染发剂或睫毛膏,护发需要遵守EAEU。欧亚经济联盟条例。 CU 009/2011化妆品和化妆品的技术法规。

根据技术法规TR CU 009/2011,有2种形式的
EAC合格评定EAC declaration
国家注册证书(State Registration certificate/Свидетельство о государственной регистрацииCSR))

1
EAC符合性声明(EAC declaration
欧亚经济联盟的技术要求。声明由制造商自己进行。 EAEUEAC声明具有法律约束力。
欧亚经济联盟申请符合性声明(EAC declaration)需要有欧亚经济联盟内的授权代表。

2
、海关联盟国家注册证State Registration certificate/Свидетельство о государственной регистрации 国家注册证(CSR
册国家证书以符合欧亚经济联盟的卫生卫生法规。

有欧亚联盟各国成员国的卫生部门Rospotrebnadzor负责颁发国家注册证书。注册程序属于技术测试领域。所有国家注册证书都没有在那里注册。

受国家注册(State Registration certificate/Свидетельство о государственной регистрации 国家注册证(CSR))的产品清单:
防晒面霜/防晒剂
皮肤美白产品
用于永久性化妆的化合物的产品
香水和贴心护理产品
儿童化妆品
去死皮产品
脱毛产品
染发剂
香水产品
具有纳米颗粒的香水和化妆品
氟化物口腔卫生产品,氟化物质量分数超过0.15
含有过氧化脲,过氧化锌的牙齿浓度(氢浓度不超过0.1%至6%)

State Registration certificate/Свидетельство о государственной регистрации
国家注册证(CSR)合格评定程序,产品按以下标准进行测试项目:
主要组成成分
理化参数
微生物参数
有毒元素含量
有毒数据
临床(临床 - 实验室)测量
处理
消费品包装
生产标记


技术要求009/2011
附件1包含禁用物质清单
附件2给出了表格形式
附件3包含授权染料清单
附件4列出了授权的防腐剂
附件5列出了批准的紫外线过滤器
附件6包含允许的pH
附件7提供了有关微生物产品安全的信息
附件8包含毒理学指标的要求

2017125日起,香水和化妆品可根据3模式符合性声明(EAC declaration):

符合性声明(EAC declaration3d模式适用于批量生产
方案4d适用于单批交付
如果方案6d是符合GMP的质量管理系统,则方案6d用于批量生产。

EAC
声明的有效期
2017125日起,符合性声明(EAC declaration)已经实施。

用于批量生产(方案3d - 最长有效期5年。
对于方案4d,产品仅限于产品的使用寿命内。
根据6d的声明。

EAC标志

TR CU 009/2011关于香水和化妆品的安全性

获得TR CU 009/2011认证的产品必须标有EAC标志。它可以在产品的整个生命周期中轻松识别,确保产品合格。

如果没有添加或无证书假冒添加需要承担高额的罚款和罚没产品。

 

Cosmetics, make-up, 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

Your benefits

We rely on the German commercial tradition of management. Responsibility, competence and loyalty are not empty words for us, but the basis of our commercial philosophy. Our customers choose us because we prove every day that our services are the right choice for those who appreciate both your time and money. That is why we guarantee:

  • personal handling of each order
  • transparency
  • high quality of services
  • swift processing of your documents
  • free from defect of title