海关联盟化妆品EAC认证 Customs Union Cosmetics EAC Certification

EAC Сертификация косметической продукции

化妆品是否需要认证？

Are cosmetics subject to certification?

在欧亚经济联盟境内合法销售化妆品需要确认产品符合2012年7月1日海关联盟技术法规 "TR CU 009/2011"《香水和化妆品安全》的要求。 该技术法规在整个欧亚经济联盟（以下简称EAEU）境内具有法律效力，根据该技术法规颁发EAC证书或声明（CU-TR符合性声明）也具有法律效力。

Legal sale of cosmetic products in the territory of the Eurasian Economic Union requires confirmation of conformity of products to the requirements of the Technical Regulations of the Customs Union "TR CU 009/2011" dated 1 July 2012 "On the safety of perfumery and cosmetic products" The Technical Regulations are legally valid throughout the territory of the Eurasian Economic Union (hereinafter EAEU), as well as permits issued in accordance with it.

目前，欧亚经济联盟成员国包括俄罗斯、白俄罗斯、哈萨克斯坦、亚美尼亚和吉尔吉斯斯坦。

Today the EAEU member states are Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.

香水和化妆品可包括以下产品：

人工鞣制产品；

皮肤漂白（美白）产品；

化妆产品；

永久化妆产品；

私处卫生产品；

儿童香水和化妆品；

脱毛产品；

脱皮产品；

染发、烫发和直发产品；

口腔卫生产品和牙齿美白产品；

用于保护个人皮肤免受有害生产因素伤害的香水和化妆品；

使用以下成分生产的香水和化妆品。

TR CU 009/2011不适用于用于摄入、吸入、注射或植入人体的产品，用于侵犯皮肤的纹身产品，以及用于诊断和治疗疾病的产品。

TR CU 009/2011 does not apply to products intended for ingestion, inhalation, injection or implantation in the human body, products for tattooing applied with violation of the skin, as well as products used for diagnosis and treatment of diseases.

化妆品合格评定涉及一系列程序，旨在确认产品对消费者和环境的安全性。化妆品与人体皮肤和粘膜接触，因此其生产和销售受到欧亚经济联盟（以下简称欧亚联盟）技术法规的严格要求。

Conformity assessment of cosmetics involves a series of procedures that aim to confirm the safety of products for consumers and the environment. Cosmetic products come into contact with human skin and mucous membranes, so their production and sale are regulated by the strict requirements of the technical regulations of the Eurasian Economic Union (hereinafter EAEU).

化妆品的合格证明文件是什么？

What document of conformity is issued for cosmetics?

根据第009/2011号海关联盟技术条例（以下简称TR CU）"关于香水和化妆品产品的安全"，这些产品必须经过以下形式的强制性合格确认程序：香水和化妆品产品的合格声明；香水和化妆品产品的国家注册：

According to the Technical Regulations of the Customs Union (hereinafter TR CU) 009/2011 "On the safety of perfumery and cosmetic products", these products are subject to the procedure of mandatory confirmation of conformity in the form of:

1、香水和化妆品产品符合性声明：declaration of conformity of perfume and cosmetic products; 

2、香水和化妆品产品国家注册 ：state registration of perfume and cosmetic products.

EAC符合性声明和EAC合格证书--有什么区别？

EAC Declaration and EAC certificate - what is the difference?

海关联盟技术法规符合性声明（DOC TR CU）是确认产品符合海关联盟标准的官方文件。

A Declaration of Conformity to Customs Union Technical Regulations (DC TR CU) is an official document that confirms compliance with the standards set by the Customs Union.

要确定您的产品是否需要强制性EAC符合性声明，请参考海关联盟的技术法规。每份技术法规都有一个附件，规定您是否需要出具EAC合格证书或EAC符合性声明。

To determine whether your products are subject to mandatory declaration, refer to the technical regulations of the Customs Union. Each regulation has an annex that specifies whether you need to issue a certificate of conformity or a declaration.

TR CU 009/2011《香水和化妆品安全技术法规》旨在确保在关税同盟境内流通的香水和化妆品的安全。根据TR CU 009/2011，化妆品产品符合该法规要求的EAC符合性声明由TR CU确认（根据附件12列入清单的产品除外）。

Technical Regulation CU 009/2011 "On the safety of perfumes and cosmetics" was developed to ensure the safety of perfumes and cosmetics in circulation in the territory of the Customs Union. According to TR CU 009/2011, the compliance of cosmetic products with the requirements of the regulation is confirmed by a declaration of conformity to TR CU (except for products included in the list according to Annex 12)

EAC认证和EAC声明的最大区别在于责任的分配。当符合性声明被注册时，EAC声明的持有人对文件的可靠性承担全部责任，无论他是否是产品的制造商。

The most significant difference between certification and declaration lies in the distribution of responsibility. When a declaration of conformity is registered, the holder of the declaration bears full responsibility for the reliability of the document, regardless of whether he is the manufacturer of the product.

TR CU声明包含有关产品及其制造商、申请人、注册号和注册日期的信息。与合格证不同，EAC声明的可靠性由申请人负责。

The TR CU declaration contains information about the product and its manufacturer, applicant, registration number and date of registration. Unlike a certificate of conformity, the responsibility for the reliability of the declaration remains with the applicant.

签发什么：化妆品需要EAC声明还是SGR国家注册证？

What to issue: declaration or SGR for cosmetics?

在化妆品认证时，申请人必须在符合TR CU声明（DOC TR CU）和国家注册证书（SGR）之间做出选择；

When drawing up authorisation documentation for cosmetics, the applicant has to choose between a Declaration of Conformity to the TR CU (DC TR CU) and a State Registration Certificate (SGR).

首先，对产品进行鉴定。它根据三个特征进行：使用方式、使用地点和使用目的。

First of all, the identification of products is carried out. It is carried out on three characteristic features: the way of use, place of use and purpose of use.

TR CU 009/2011规定了香水和化妆品产品的特征标志：

TR CU 009/2011 establishes the signs that characterise perfume and cosmetic products:

使用方法：专用于人体某些部位的外用；

How to use: Exclusively for external application to certain parts of the human body;

使用部位：皮肤、毛发、指甲、嘴唇、牙齿、口腔粘膜和外生殖器；

Place of use: on the skin, hair, nails, lips, teeth, oral mucosa and external genitalia;

根据技术法规，EAC符合性声明是主要文件。除TR CU 009/2011附件12所列产品外，大多数货物都必须进行EAC符合性声明。

什么是SGR国家注册证？何时签发？

海关联盟产品国家注册证书（SGR）是确认产品符合海关联盟技术法规安全要求的官方文件。该文件确认产品的安全性。

某些化妆品需要国家注册证书（SGR）。TR CU 009/2011号法规附件12规定了此类商品的清单。

因此，香水和化妆品产品的SGR确认此类产品已办理国家注册手续，已在相关登记册中登记，并符合TR CU 009/2011的要求。

根据附件12，对以下产品颁发《香水和化妆品国家注册证书》：

用于人工鞣制的香水和化妆品；

用于皮肤漂白（美白）的香水和化妆品；

用于纹身的化妆品 贴身化妆品；

针对有害生产因素的个人皮肤保护香水和化妆品；

儿童化妆品（14岁以下儿童）；

用于化学染发、美白和熔化头发的香水和化妆品；

用于化学烫发和直发的香水和化妆品；

香水和化妆品、 使用纳米材料制造的香水和化妆品；

用于脱毛的香水和化妆品；

去皮；

含氟口腔卫生产品，其氟化物的质量分数超过0.15%（液体口腔卫生产品为0.05%）（以氟化物摩尔质量计）。

含有过氧化氢或其他过氧化氢释放成分的牙齿美白剂，包括过氧化卡巴酰胺和过氧化锌，过氧化氢浓度（作为成分或可释放）为0.1%-6.0%。

化妆品EAC符合性声明注册程序

化妆品EAC符合性声明的注册涉及质量评估的几个阶段。第一步是根据应用场所、目的和使用方法确定产品。其次，确定声明所依据的认证方案--EAC符合性声明的有效期取决于此。

EAC符合性声明所需文件

要签发化妆品EAC声明，您需要准备以下文件：

- 公司组织文件

- 技术文件（质量许可证等）；

- 产品标签；

- 产品描述（用途、成分、品牌）；

- 合同、发票和制造商详细信息（如果您不是制造商）。

如何获得测试报告？

为了获得化妆品EAC声明，有必要对产品进行抽样测试并获得测试报告。

测试是确认产品是否符合关税同盟技术法规要求的强制性认证程序阶段。

测试报告必须包括：

- 进行测试的理由；

- 申请人和制造商的详细信息

- 提交样品的描述

- 测试方法

- 试验规程编号和日期；

- 获得的结果。

试验报告还包括其他数据，如制造商确定的产品特性、参照规范性文件要求的安全指标、所用试验设备和测量仪器的信息。

试验报告应交给申请人。测试中心至少将协议副本保存3年。

测试报告只能在经认可的测试中心获得。您可以在欧亚经济委员会网站上的 "海关联盟认证机构和检测实验室（中心）统一登记册 "中了解认可实验室的名单，以及检查CI的认可范围。

实验室测试确定产品是否符合安全要求

根据TR CU 009/2011，产品的以下参数和性能需要进行检测：

产品成分--检查是否含有违禁物质，以及染料、防腐剂、紫外线过滤剂和其他未列入欧亚经济联盟允许使用清单的成分；

毒理学特性--确定产品对皮肤和粘膜的刺激作用，检查对整个身体的影响；

微生物特性--检查是否含有违禁物质，以及染料、防腐剂、紫外线过滤剂和其他未列入欧亚经济联盟允许使用清单的成分；

物理化学特性--检查是否含有违禁物质，以及染料、防腐剂、紫外线过滤剂和其他未列入欧亚经济联盟允许使用清单的成分；

生物化学特性--检查是否含有违禁物质，以及染料、防腐剂、紫外线过滤剂和其他未列入欧亚经济联盟允许使用清单的成分；

生物化学特性--检查是否含有违禁物质，以及染料、防腐剂、紫外线过滤剂和其他未列入欧亚经济联盟允许使用清单的成分。

重要的是要记住！制造商（供应商）有义务为化妆品选择正确的消费包装。包装必须确保产品在标签上标明的保质期内的安全性。

It is important to remember! The manufacturer (supplier) is obliged to choose the correct consumer packaging for the cosmetic product. The packaging must ensure the safety of the product throughout the shelf life indicated on the label.

如果根据测试结果，产品未被确认符合技术法规的要求，则应签发测试结果为不合格报告。

If according to the results of tests the products have not received confirmation of conformity with the requirements of the Technical Regulations, a protocol with negative test results shall be issued.

新的EAC符合性声明注册登记规则

New rules for the registration of declarations

根据俄罗斯经济发展部2020年7月31日第478号命令批准的符合性声明登记程序，从新的一年开始，申请人通过俄罗斯合格评定FGIS独立登记符合性声明。

According to the procedure for registration of declarations of conformity approved by Order of the Ministry of Economic Development of Russia No. 478 of 31 July 2020, from the new year applicants register declarations of conformity independently through the FGIS of Rosakkreditation.

注册EAC声明时，申请人必须获得电子数字签名（EDS），然后在FGIS服务中正确注册声明，并根据技术规定附上所有必要的产品随附文件。

To register declarations, the applicant must obtain an electronic digital signature (EDS), and then correctly register the declaration in the FGIS service, attaching all the necessary accompanying documents for products in accordance with the technical regulations.

根据技术法规给化妆品贴标签

Labelling of cosmetic products according to the Technical Regulations

在获得合法销售香水和化妆品的认证后，其标签必须符合技术法规的要求。

After obtaining a permit document for perfume and cosmetic products for legal sale, it is necessary for its labelling to comply with the requirements of technical regulations.

根据技术法规，商品标签上应标有EAC标志和其他强制性信息。标签上必须标明的信息包括：

According to the technical regulations, the label of the goods is labelled with the EAC sign and other mandatory information. The list of information that must be indicated on the label includes:

产品名称；香水和化妆品的用途（如果与产品名称不符）；化妆品是为儿童设计的信息（如果是）；制造商名称及其法定地址（包括国家）；原产国（如果产品生产所在国与制造商的法定地址不一致）；制造商授权接受消费者索赔的组织的名称和法定地址

name of the product; purpose of the perfume and cosmetic product, if it does not follow from the name of the product; information that the cosmetic is intended for children (if so); name of the manufacturer and its legal address (including country); country of origin (if the country where the production of the product is located does not coincide with the legal address of the manufacturer); name and legal address of the organisation authorised by the manufacturer to accept claims

消费者索赔的组织的名称和法定地址（如果制造商本人不在欧盟成员国境内接受索赔）；消费者包装中产品的标称数量（体积和（或）重量和（或）件数）；颜色和（或）色调（用于装饰性化妆品和着色剂）；含氟化合物的口腔卫生产品的氟化物质量分数（以氟化物摩尔质量表示）（%，或mg/kg，或ppm）； 特别注意事项；有效期和贮存条件；批号或识别产品批次的特殊代码；产品使用方法的信息，缺少这些信息可能导致误用；成分清单；

from the consumer, if the manufacturer does not accept claims himself on the territory of the CU Member State; nominal quantity of the product in the consumer packaging (volume, and (or) weight, and (or) pieces); colour and/or tone (for decorative cosmetics and colouring agents); mass fraction of fluoride in terms of molar mass of fluoride (%, or mg/kg, or ppm) for oral hygiene products containing fluorine compounds; special precautions; expiry date and storage conditions; batch number or special code to identify the lot of the product; information on the methods of use of the product, the absence of which may lead to misuse; list of ingredients;

产品成分--检查是否含有禁用物质、着色剂、防腐剂、紫外线过滤剂和其他未列入欧洲经济区允许使用清单的成分；

Product composition - the absence of prohibited substances, as well as colouring agents, preservatives, UV filters and other components that are not included in the list of allowed for use in the EAEU is checked;