印度化妆品登记法规问题集
Email：bom4ww@evershinecpa.com
或
印度永辉BPO有限公司
India time zone:
The Engaging Manager Punit Negi, Indian citizenship
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110
HLF-TW-10
请问印度对于化妆品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？
What are the categories of cosmetics in India? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
在印度，化妆品由中央药品标准控制机构-卫生与家庭福利部负责监管(CDSCO)。化妆品的生产受各州政府指定的国家许可机构检查、许可制度监管，而化妆品的进口则受制于中央指定的中央许可机关登记制。
化妆品被定义为任何旨在用作化妆品成分的物品，以摩擦、倾倒、喷洒、引入或以其他方式应用于人体或其任何部位，用以清洁、美化、提升吸引力或改变外观。
In India, cosmetics are regulated by the Headquarters of the Central Drug Standards Control Organization – Department of Health and Family Welfare (CDSCO). The production of cosmetics is subject to the inspection and licensing system of the state licensing agencies designated by the state governments, while the import of cosmetics is subject to the registration system of the central licensing agency designated by the central government.
Cosmetics is defined as any article intended to be used as a cosmetic ingredient, rubbed, poured, sprayed, introduced or otherwise applied to the human body or any part thereof, for the purpose of cleaning, beautifying, enhancing attractiveness or altering the appearance.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-20
外国公司要到印度销售化妆品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
If a foreign company wants to sell cosmetics in India, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无须申请营业许可证。
No business license is required.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-25
假如需要办理，请问印度有专业服务公司可以协助办理化妆品公司营业许可证？
Evershine RD：
无须申请营业许可证。
HLF-TW-30
外国公司要到印度销售化妆品，可以指派印度公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
If a foreign company wants to sell cosmetics in India, can it assign an India company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。须由印度当地的公司申请化妆品产品许可证，可以是製造商/製造商的授权代理/製造商的子公司/进口商或由第三方担任产品持有人。
註册方式：
1. 先通过网站向 CDSCO註册：http://cdscoonline.gov.in
2. 註册并创建登录凭证。
3. 使用有效的电子邮件 ID 和手机号码提交所有详细信息并完成註册过程。(用户必须上传必要的文件，如身份证明详细信息、授权书、公司地址等信息应在註册过程之前将这些文件准备好 PDF 格式。)
4. 註册成功后登录门户。
5. 在表单提交部分，选择部门并选择表单类型：新申请、代理。
6. 上传相关文件。
7. 付款。
8. 提交审查。
产品许可证持有公司须负责化妆品的安全、品质，及不良事件之处理，并向主管机关回报。
Yes. Cosmetic products need to be registered by a local company in India, which can be the manufacturer/authorized agent of the manufacturer/subsidiary/importer of the manufacturer or a third party as the product holder.
Registration:
1. First register with CDSCO through the website: http://cdscoonline.gov.in
2. Sign up and create your login credentials.
3. Submit all details and complete the registration process using a valid email ID and mobile number. (Users have to upload the necessary documents such as identification details, power of attorney, company address, etc. These documents should be prepared in PDF format before the registration process.)
4. After successful registration, log in to the portal.
5. In the Form Submission section, select the department and select the form type: New Application, Proxy.
6. Upload the relevant files.
7. Pay.
8. Submit for review.
The product license holder shall be responsible for the safety, quality of cosmetics, and handling of adverse events, and report to the competent authority.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-35
HLF-TW-40
外国公司销售到印度化妆品本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Do foreign companies need to apply for an approval before importing cosmetics sold to India? If yes, which authority is in charge?
What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要。须由印度当地的公司申请化妆品产品许可，可以是製造商/製造商的授权代理/製造商的子公司/进口商或由第三方担任产品持有人。
註册方式
1. 先通过网站向 CDSCO註册：http://cdscoonline.gov.in
2. 註册并创建登录凭证。
3. 使用有效的电子邮件 ID 和手机号码提交所有详细信息并完成註册过程。(用户必须上传必要的文件，如身份证明详细信息、授权书、公司地址等信息应在註册过程之前将这些文件准备好 PDF 格式。)
4. 註册成功后登录门户。
5. 在表单提交部分，选择部门并选择表单类型：新申请、代理。
6. 上传相关文件。
7. 付款。
8. 提交审查。
具备文件
1. 申请书
．製造商和製造场所的详细信息：名称、地址以及要註册的製造场所电话号码、传真号码和电子邮件地址、合伙人/董事的姓名和地址。
．印度授权进口商/分销商/代理的名称和地址，负责製造商的业务，包括其合作伙伴/董事的名称和地址。
．简要介绍製造商在国内和全球市场的业务活动。
．化妆品名称及其品牌名称、类别、包装尺寸和变体，以供註册并用于进口到印度并在印度使用。
2. 製造商授权（正式认证）
3. 化妆品的化学信息
．标准参考命名中的成分名称，以及化妆品中所含的百分比。
．化妆品测试规范和测试方法。
．产品的标籤
．包装说明书、插页（如果有）。
4. 承诺声明
．声明遵守 2020 年化妆品规则规定的化妆品进口註册证书上的所有条件。
．声明进口到印度的每种化妆品均符合印度标准局製定的标准。
．非动物试验声明。
．声明如果註册产品或其规格的标籤、成分，或测试发生任何变化，应通知许可当局，并承诺产品符合印度标准局製定的标准。
．声明将不时报告因不良反应而採取的任何行政行动，化妆品销售或分销的任何国家/地区的任何监管机构与註册证书有关的任何化妆品的市场退出/监管限制，或取消授权和/或质量报告不合格时，化妆品的发货和销售应停止并立即通知当局。
．声明将遵守印度政府根据该法案和规则制定的进一步要求。
．如果许可当局认为有必要，将允许当局或其他授权的任何人抽取化妆品样品进行测试。
．重金属和六氯酚含量声明，检测报告包括铅、砷、汞、其他重金属和微生物检测结果（如适用）或製造商的承诺，声明所使用的所有原材料/颜料、重金属（有规定的限制）和应用产品中的六氯酚含量均符合规定的标准。
．声明上述提交之文件皆为真实的。
5. 在原产国製造化妆品的製造许可证/产品许可/营销授权/自由销售证明（如果有）的详细信息以及由该国监管机构或任何其他主管当局/协会签发的副本。
6. 产品规格和测试协议
7. 该化妆品已获得上市许可或进口许可的国家名单。
8. 品牌、产品和製造商的信息影本
9. 其他文件（如有）如为外文，申请人应提供由合格翻译人员提供的任何其他外语文件的英文翻译版本。
10. 费用：支付费用的原始电子收据
11. 如果没有在原产国製造化妆品的许可证，进口商应将在宣誓书上提供一份声明。
12. 散装进口到印度进行重新包装以 100% 出口到其他国家的化妆品不需要註册证书，但是进口商必须从 CDSCO 总部获得必要的许可。进口商必须书面承诺这些产品不会在国内销售。
13. 用于研发目的的化妆品进口，如包装试验、消费者研究、保质期研究和运输研究，不需要註册证书，但是进口商必须从 CDSCO 总部获得必要的许可。进口商必须书面保证这些产品不会在国内销售
14.许可证的有效期为 3 年。
标籤
1. 化妆品名称。
2. 製造商名称、製造商场所的完整地址。
．如果产品不是在製造商拥有的工厂製造的，则应该在标籤上标示实际製造商名称、地址或实际製造的国家、地区。
．如果化妆品装在一个非常小的容器中，化妆品是固态或半固态30 克以下，液态 60 毫升以下，不能给出製造商的地址，则製造商的名称、主要製造地应一起标示。
3. 到期日。
4. 独特的批号
5. 生产许可证编号，编号前加字母M或 L. No或Mfg.，
．对于进口产品，如果该规定在原产国不是强制性的，则可以允许此类化妆品不提供生产许可证号，但须符合其他进口法规。
6. 容量以固体重量、液体计量或半固体重量的淨含量表示，如果内容被细分，则结合数字计数。如果包装淨含量不超过 60 毫升的香水、花露水等或任何淨含量不超过 30 克的固体或半固体化妆品，则不需要标示。
7. 如果是化妆品；在存在危险的情况下，每个内部标籤都应清楚地标明安全使用的充分说明，消费者需要遵守的任何警告、注意或特殊说明，以及说明危险或有毒成分的名称和数量的声明。
8. 在印度销售的进口化妆品，应在单位包装标籤上註明进口註册证号，以字母RC/RC No/Reg.证书，以及进口商的名称和地址标示。
9. 如果化妆品包装只有一个标籤，则该标籤应包含本规则规定的内标籤和外标籤上要求显示的所有信息。
10.浓度超过 1% 的成分列表应按添加时重量或体积的降序排列，然后是浓度小于或等于1%的成分，并在前面加上成分字样。对于小于或等于 60 毫升液体和 30 克固体和半固体的包装，不需要出现此声明。
11.进口化妆品标籤上应标明该产品的註册证号和该产品在印度销售的註册证持有人的名称和地址。如果进口化妆品需要印度特定标籤，则应允许在保税仓库的单位包装上贴上相同的标籤。
12.在印度生产/进口并销售的所有化妆品标籤上的规格必须用英文、 或印度地区语言註明。
注意
1. 任何人不得更改、涂抹或汙损製造商在任何化妆品容器、标籤或包装上製作或记录的任何铭文或标记。
2. 任何化妆品不得声称、声称或传达任何虚假或误导预期用户的想法。
Cosmetic products need to be registered by a local company in India, which can be the manufacturer/authorized agent of the manufacturer/subsidiary/importer of the manufacturer or a third party as the product holder.
Registration:
1. First register with CDSCO through the website: http://cdscoonline.gov.in
2. Sign up and create your login credentials.
3. Submit all details and complete the registration process using a valid email ID and mobile number. (Users have to upload the necessary documents such as identification details, power of attorney, company address, etc. These documents should be prepared in PDF format before the registration process.)
4. After successful registration, log in to the portal.
5. In the Form Submission section, select the department and select the form type: New Application, Proxy.
6. Upload the relevant files.
7. Pay.
8. Submit for review.
Document
1. Application
． Manufacturer and manufacturing site details: name, address and phone number, fax number and e-mail address of the manufacturing site to be registered, name and address of the partner/director.
． The name and address of the authorised importer/distributor/agent in India who is responsible for the manufacturer’s business including the name and address of its partners/directors.
． A brief overview of the manufacturer’s business activities in the domestic and global markets.
． Cosmetics name and its brand name, category, pack size and variants for registration and for import into and use in India.
2. Manufacturer’s Authorization (Formal Certification)
3. Chemical information of cosmetic products
． The name of the ingredient in the standard reference nomenclature, and the percentage contained in the cosmetic.
． Cosmetic testing specifications and test methods.
． Product labeling
． Package leaflet, inserts (if any).
4. Statement of Commitment
． Declare compliance with all conditions on the Cosmetics Import Registration Certificate under the Cosmetics Rules 2020.
． Declare that every cosmetic product imported into India complies with the standards set by the Bureau of Indian Standards.
． Non-animal testing statement.
． A statement that the licensing authority shall be notified of any changes in the labelling, composition, or testing of the registered product or its specifications, and a commitment that the product complies with the standards set by the Bureau of Indian Standards.
． Statement to report from time to time any administrative action taken due to adverse reactions, market withdrawal/regulatory restrictions on any cosmetic product in relation to the registration certificate, or deauthorization and/or quality reporting by any regulatory authority in any country/region where the cosmetic product is sold or distributed In the event of non-compliance, the shipment and sale of cosmetic products shall be stopped and the authorities notified immediately.
． The statement will comply with further requirements made by the Government of India under the Act and Rules.
． If the licensing authority deems it necessary, the authority or anyone else authorised to take a cosmetic sample for testing will be allowed.
． Heavy metal and hexachlorophenol content declaration, test report including lead, arsenic, mercury, other heavy metal and microbiological test results (if applicable) or manufacturer’s commitment to declare all raw materials/pigments used, heavy metals (with specified limits) and The content of hexachlorophenol in the applied products meets the specified standards.
． Declare that the documents submitted above are true.
5. Details of the manufacturing license/product license/marketing authorization/certificate of free sale (if any) for the manufacture of cosmetic products in the country of origin and a copy issued by the country’s regulatory authority or any other competent authority/association.
6. Product Specifications and Testing Protocols
7. List of countries that have obtained marketing authorization or import authorization for the cosmetic product.
8. Copies of brand, product and manufacturer information
9. If other documents (if any) are in a foreign language, the applicant should provide English translations of any other foreign language documents provided by a qualified translator.
10. Fees: Original electronic receipt for payment of fees
11. If there is no licence to manufacture the cosmetic product in the country of origin, the importer shall provide a statement on the affidavit.
12. Cosmetics imported into India in bulk for repackaging for 100% export to other countries do not require a registration certificate, but importers must obtain the necessary licenses from CDSCO headquarters. Importers must undertake in writing that these products will not be sold domestically.
13. The import of cosmetic products for R&D purposes, such as packaging testing, consumer research, shelf life research and shipping research, does not require a registration certificate, but the importer must obtain the necessary licenses from CDSCO headquarters. Importers must guarantee in writing that these products will not be sold domestically
14. The validity period of the license is 3 years.
Label
1. Cosmetics name.
2. Manufacturer’s name, full address of manufacturer’s premises.
． If the product is not manufactured in a factory owned by the manufacturer, the actual manufacturer’s name, address or country of manufacture should be indicated on the label.
． If the cosmetic is packed in a very small container, the cosmetic is solid or semi-solid under 30 grams and liquid under 60 ml, and the manufacturer’s address cannot be given, the manufacturer’s name and the main place of manufacture should be marked together.
3. Expiration Date.
4. Unique Lot Number
5. The production license number, preceded by the letters M or L. No or Mfg.,
． For imported products, if this provision is not mandatory in the country of origin, such cosmetics may be permitted without a production license number, subject to other import regulations.
6. Volumes are expressed as net content by solid weight, liquid measure or semi-solid weight, combined with digital counts if the content is subdivided. No labelling is required if the packaging does not exceed 60ml net content of perfume, toilet water, etc. or any solid or semi-solid cosmetic product with a net content of not more than 30g.
7. In the case of cosmetics; in the event of a hazard, each internal label should clearly identify adequate instructions for safe use, any warnings, cautions or special instructions that consumers need to follow, and a description of the name and name of the hazardous or toxic ingredient. Quantity statement.
8. Imported cosmetics sold in India should be marked with the import registration certificate number on the unit package label, with the letters RC/RC No/Reg. certificate, and the name and address of the importer.
9. If the cosmetic packaging has only one label, the label shall contain all the information required to be displayed on the inner and outer labels as specified in this rule.
10. The list of ingredients with a concentration of more than 1% shall be listed in descending order of weight or volume at the time of addition, followed by the ingredients with a concentration of less than or equal to 1%, preceded by the word ingredient. This declaration is not required for packages of less than or equal to 60ml of liquid and 30g of solid and semi-solid.
11. The label of imported cosmetic products should indicate the registration number of the product and the name and address of the holder of the registration certificate for sale in India. If India specific labelling is required for imported cosmetic products, the same label should be allowed to be affixed to the unit package in bonded warehouse.
12. The specifications on the labels of all cosmetic products manufactured/imported and sold in India must be stated in English, or in Indian regional languages.
Notice
1. No person shall alter, apply or deface any inscription or marking made or recorded by the manufacturer on any cosmetic container, label or packaging.
2. No cosmetic product shall claim, purport to or communicate any idea that is false or misleading to the intended user.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-45
HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
须由印度当地的公司申请化妆品产品许可，可以是製造商/製造商的授权代理/製造商的子公司/进口商或由第三方担任产品持有人。
註册方式
1. 先通过网站向 CDSCO註册：http://cdscoonline.gov.in
2. 註册并创建登录凭证。
3. 使用有效的电子邮件 ID 和手机号码提交所有详细信息并完成註册过程。(用户必须上传必要的文件，如身份证明详细信息、授权书、公司地址等信息应在註册过程之前将这些文件准备好 PDF 格式。)
4. 註册成功后登录门户。
5. 在表单提交部分，选择部门并选择表单类型：新申请、代理。
6. 上传相关文件。
7. 付款。
8. 提交审查。
具备文件
1. 申请书
．製造商和製造场所的详细信息：名称、地址以及要註册的製造场所电话号码、传真号码和电子邮件地址、合伙人/董事的姓名和地址。
．印度授权进口商/分销商/代理的名称和地址，负责製造商的业务，包括其合作伙伴/董事的名称和地址。
．简要介绍製造商在国内和全球市场的业务活动。
．化妆品名称及其品牌名称、类别、包装尺寸和变体，以供註册并用于进口到印度并在印度使用。
2. 製造商授权（正式认证）
3. 化妆品的化学信息
．标准参考命名中的成分名称，以及化妆品中所含的百分比。
．化妆品测试规范和测试方法。
．产品的标籤
．包装说明书、插页（如果有）。
4. 承诺声明
．声明遵守 2020 年化妆品规则规定的化妆品进口註册证书上的所有条件。
．声明进口到印度的每种化妆品均符合印度标准局製定的标准。
．非动物试验声明。
．声明如果註册产品或其规格的标籤、成分，或测试发生任何变化，应通知许可当局，并承诺产品符合印度标准局製定的标准。
．声明将不时报告因不良反应而採取的任何行政行动，化妆品销售或分销的任何国家/地区的任何监管机构与註册证书有关的任何化妆品的市场退出/监管限制，或取消授权和/或质量报告不合格时，化妆品的发货和销售应停止并立即通知当局。
．声明将遵守印度政府根据该法案和规则制定的进一步要求。
．如果许可当局认为有必要，将允许当局或其他授权的任何人抽取化妆品样品进行测试。
．重金属和六氯酚含量声明，检测报告包括铅、砷、汞、其他重金属和微生物检测结果（如适用）或製造商的承诺，声明所使用的所有原材料/颜料、重金属（有规定的限制）和应用产品中的六氯酚含量均符合规定的标准。
．声明上述提交之文件皆为真实的。
5. 在原产国製造化妆品的製造许可证/产品许可/营销授权/自由销售证明（如果有）的详细信息以及由该国监管机构或任何其他主管当局/协会签发的副本。
6. 产品规格和测试协议
7. 该化妆品已获得上市许可或进口许可的国家名单。
8. 品牌、产品和製造商的信息影本
9. 其他文件（如有）如为外文，申请人应提供由合格翻译人员提供的任何其他外语文件的英文翻译版本。
10. 费用：支付费用的原始电子收据
11. 如果没有在原产国製造化妆品的许可证，进口商应将在宣誓书上提供一份声明。
12. 散装进口到印度进行重新包装以 100% 出口到其他国家的化妆品不需要註册证书，但是进口商必须从 CDSCO 总部获得必要的许可。进口商必须书面承诺这些产品不会在国内销售。
13. 用于研发目的的化妆品进口，如包装试验、消费者研究、保质期研究和运输研究，不需要註册证书，但是进口商必须从 CDSCO 总部获得必要的许可。进口商必须书面保证这些产品不会在国内销售。
14.许可证的有效期为 3 年。
标籤
1. 化妆品名称。
2. 製造商名称、製造商场所的完整地址。
．如果产品不是在製造商拥有的工厂製造的，则应该在标籤上标示实际製造商名称、地址或实际製造的国家、地区。
．如果化妆品装在一个非常小的容器中，化妆品是固态或半固态30 克以下，液态 60 毫升以下，不能给出製造商的地址，则製造商的名称、主要製造地应一起标示。
3. 到期日。
4. 独特的批号
5. 生产许可证编号，编号前加字母M或 L. No或Mfg.，
．对于进口产品，如果该规定在原产国不是强制性的，则可以允许此类化妆品不提供生产许可证号，但须符合其他进口法规。
6. 容量以固体重量、液体计量或半固体重量的淨含量表示，如果内容被细分，则结合数字计数。如果包装淨含量不超过 60 毫升的香水、花露水等或任何淨含量不超过 30 克的固体或半固体化妆品，则不需要标示。
7. 如果是化妆品；在存在危险的情况下，每个内部标籤都应清楚地标明安全使用的充分说明，消费者需要遵守的任何警告、注意或特殊说明，以及说明危险或有毒成分的名称和数量的声明。
8. 在印度销售的进口化妆品，应在单位包装标籤上註明进口註册证号，以字母RC/RC No/Reg.证书，以及进口商的名称和地址标示。
9. 如果化妆品包装只有一个标籤，则该标籤应包含本规则规定的内标籤和外标籤上要求显示的所有信息。
10.浓度超过 1% 的成分列表应按添加时重量或体积的降序排列，然后是浓度小于或等于1%的成分，并在前面加上成分字样。对于小于或等于 60 毫升液体和 30 克固体和半固体的包装，不需要出现此声明。
11.进口化妆品标籤上应标明该产品的註册证号和该产品在印度销售的註册证持有人的名称和地址。如果进口化妆品需要印度特定标籤，则应允许在保税仓库的单位包装上贴上相同的标籤。
12.在印度生产/进口并销售的所有化妆品标籤上的规格必须用英文、 或印度地区语言註明。
注意
1. 任何人不得更改、涂抹或汙损製造商在任何化妆品容器、标籤或包装上製作或记录的任何铭文或标记。
2. 任何化妆品不得声称、声称或传达任何虚假或误导预期用户的想法。
Cosmetic products need to be registered by a local company in India, which can be the manufacturer/authorized agent of the manufacturer/subsidiary/importer of the manufacturer or a third party as the product holder.
way to register
1. First register with CDSCO through the website: http://cdscoonline.gov.in
2. Sign up and create your login credentials.
3. Submit all details and complete the registration process using a valid email ID and mobile number. (Users have to upload the necessary documents such as identification details, power of attorney, company address, etc. These documents should be prepared in PDF format before the registration process.)
4. After successful registration, log in to the portal.
5. In the Form Submission section, select the department and select the form type: New Application, Proxy.
6. Upload the relevant files.
7. Pay.
8. Submit for review.
Document
1. Application
． Manufacturer and manufacturing site details: name, address and phone number, fax number and e-mail address of the manufacturing site to be registered, name and address of the partner/director.
． The name and address of the authorised importer/distributor/agent in India who is responsible for the manufacturer’s business including the name and address of its partners/directors.
． A brief overview of the manufacturer’s business activities in the domestic and global markets.
． Cosmetics name and its brand name, category, pack size and variants for registration and for import into and use in India.
2. Manufacturer’s Authorization (Formal Certification)
3. Chemical information of cosmetic products
． The name of the ingredient in the standard reference nomenclature, and the percentage contained in the cosmetic.
． Cosmetic testing specifications and test methods.
． Product labeling
． Package leaflet, inserts (if any).
4. Statement of Commitment
． Declare compliance with all conditions on the Cosmetics Import Registration Certificate under the Cosmetics Rules 2020.
． Declare that every cosmetic product imported into India complies with the standards set by the Bureau of Indian Standards.
． Non-animal testing statement.
． A statement that the licensing authority shall be notified of any changes in the labelling, composition, or testing of the registered product or its specifications, and a commitment that the product complies with the standards set by the Bureau of Indian Standards.
． Statement to report from time to time any administrative action taken due to adverse reactions, market withdrawal/regulatory restrictions on any cosmetic product in relation to the registration certificate, or deauthorization and/or quality reporting by any regulatory authority in any country/region where the cosmetic product is sold or distributed In the event of non-compliance, the shipment and sale of cosmetic products shall be stopped and the authorities notified immediately.
． The statement will comply with further requirements made by the Government of India under the Act and Rules.
． If the licensing authority deems it necessary, the authority or anyone else authorised to take a cosmetic sample for testing will be allowed.
． Heavy metal and hexachlorophenol content declaration, test report including lead, arsenic, mercury, other heavy metal and microbiological test results (if applicable) or manufacturer’s commitment to declare all raw materials/pigments used, heavy metals (with specified limits) and The content of hexachlorophenol in the applied products meets the specified standards.
． Declare that the documents submitted above are true.
5. Details of the manufacturing license/product license/marketing authorization/certificate of free sale (if any) for the manufacture of cosmetic products in the country of origin and a copy issued by the country’s regulatory authority or any other competent authority/association.
6. Product Specifications and Testing Protocols
7. List of countries that have obtained marketing authorization or import authorization for the cosmetic product.
8. Copies of brand, product and manufacturer information
9. If other documents (if any) are in a foreign language, the applicant should provide English translations of any other foreign language documents provided by a qualified translator.
10. Fees: Original electronic receipt for payment of fees
11. If there is no licence to manufacture the cosmetic product in the country of origin, the importer shall provide a statement on the affidavit.
12. Cosmetics imported into India in bulk for repackaging for 100% export to other countries do not require a registration certificate, but importers must obtain the necessary licenses from CDSCO headquarters. Importers must undertake in writing that these products will not be sold domestically.
13. The import of cosmetic products for R&D purposes, such as packaging testing, consumer research, shelf life research and shipping research, does not require a registration certificate, but the importer must obtain the necessary licenses from CDSCO headquarters. Importers must guarantee in writing that these products will not be sold domestically
14. The validity period of the license is 3 years.
Label
1. Cosmetics name.
2. Manufacturer’s name, full address of manufacturer’s premises.
． If the product is not manufactured in a factory owned by the manufacturer, the actual manufacturer’s name, address or country of manufacture should be indicated on the label.
． If the cosmetic is packed in a very small container, the cosmetic is solid or semi-solid under 30 grams and liquid under 60 ml, and the manufacturer’s address cannot be given, the manufacturer’s name and the main place of manufacture should be marked together.
3. Expiration Date.
4. Unique Lot Number
5. The production license number, preceded by the letters M or L. No or Mfg.,
． For imported products, if this provision is not mandatory in the country of origin, such cosmetics may be permitted without a production license number, subject to other import regulations.
6. Volumes are expressed as net content by solid weight, liquid measure or semi-solid weight, combined with digital counts if the content is subdivided. No labelling is required if the packaging does not exceed 60ml net content of perfume, toilet water, etc. or any solid or semi-solid cosmetic product with a net content of not more than 30g.
7. In the case of cosmetics; in the event of a hazard, each internal label should clearly identify adequate instructions for safe use, any warnings, cautions or special instructions that consumers need to follow, and a description of the name and name of the hazardous or toxic ingredient. Quantity statement.
8. Imported cosmetics sold in India should be marked with the import registration certificate number on the unit package label, with the letters RC/RC No/Reg. certificate, and the name and address of the importer.
9. If the cosmetic packaging has only one label, the label shall contain all the information required to be displayed on the inner and outer labels as specified in this rule.
10. The list of ingredients with a concentration of more than 1% shall be listed in descending order of weight or volume at the time of addition, followed by the ingredients with a concentration of less than or equal to 1%, preceded by the word ingredient. This declaration is not required for packages of less than or equal to 60ml of liquid and 30g of solid and semi-solid.
11. The label of imported cosmetic products should indicate the registration number of the product and the name and address of the holder of the registration certificate for sale in India. If India specific labelling is required for imported cosmetic products, the same label should be allowed to be affixed to the unit package in bonded warehouse.
12. The specifications on the labels of all cosmetic products manufactured/imported and sold in India must be stated in English, or in Indian regional languages.
Notice
1. No person shall alter, apply or deface any inscription or marking made or recorded by the manufacturer on any cosmetic container, label or packaging.
2. No cosmetic product shall claim, purport to or communicate any idea that is false or misleading to the intended user.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-55
HLF-TW-60
经过核准登记的化妆品，进口到印度要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
What documents are required when importing approved cosmetics into India? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
需完成海关申报。
进出口代码 (IEC)
进度进口化妆品的先决条件，需具备进出口代码 (IEC)才得以在印度进行商业的进口、出口。IEC 编号是对外贸易总干事颁发给印度公司的10位数代码。每个从事进出口业务的个人或实体都必须获得 IEC。 它具有终身有效期，大约需要 15 天才能签发。
1.网页註册：https://www.dgft.gov.in/CP/
．获得 IEC 的公司的性质可以是以下任何一种：独资企业、合伙企业、有限责任合伙企业、有限公司、信託、HU”。引入 GST 后，IEC 编号与公司的 PAN 相同。IEC 将由 DGFT 单独发布。
2.签署声明。
3.支付IEC费用。
4.签发IEC代码。
海关流程
1.于印度海关电子网关 (ICEGATE)註册会员
印度海关电子网关 (ICEGATE) 是印度海关中央间接税和海关委员会 (CBIC) 的国家门户，以电子方式向贸易、货运承运人和其他贸易伙伴提供电子申报服务。网页：https://www.icegate.gov.in/index.html
．申请人
．公司名称
．地址
．城市
．密码
．电话、传真号码、电子信箱
．类别：进口商/出口商等
．清关位置
2. 进口申报
．内容、发货地、收货地
．货物的详情、货物登记
．商业发票
．合约
．提单
．成分分析报告(需提供翻译文件)
．标籤样本(需提供翻译文件)
．木质包装薰蒸证(有木质包装需要提供)
．灌装日期
．化妆品产品许可证
．收方公司IEC Code
．收货人个人证件影本(PAN：永久帐户号/TAN：收税及减税帐号/身份证/护照)
3.通过电子现金分类账支付和电子税收信用分类。
Customs declarations are required.
Import/Export Code (IEC)
A prerequisite for importing cosmetic products, an Import and Export Code (IEC) is required to be able to import and export commercially in India. The IEC number is a 10-digit code issued to Indian companies by the Director General of Foreign Trade. Every person or entity engaged in importing or exporting business must obtain IEC. It has a lifetime validity and takes about 15 days to issue.
1. Web registration: https://www.dgft.gov.in/CP/
．The nature of the company that obtains the IEC can be any of the following: Sole Proprietorship, Partnership, LLP, Limited Company, Trust, HU”. With the introduction of GST, the IEC number will be the same as the company’s PAN. The IEC will be issued separately by the DGFT.
2. Sign the statement.
3. Pay the IEC fee.
4. Issue the IEC code.
Customs procedure
1. Register as a member in India Customs Electronic Gateway (ICEGATE)The Indian Customs Electronic Gateway (ICEGATE) is the national gateway to the Central Indirect Tax and Customs Board (CBIC) of Customs of India, providing electronic declaration services to trades, freight carriers and other trading partners electronically.
URL: https://www.icegate.gov.in/index.html
． Applicant
． Company Name
． Address
． City
． Password
． Telephone, fax number, e-mail
． Category: Importer/Exporter etc.
． Customs clearance location
2. Import declaration
． Contents, place of origin, place of receipt
． Details of cargo, cargo registration
． Commercial invoice
． Contract
． B/L
． Component analysis report (translation document required)
． Label sample (translation file required)
． Wood packaging fumigation certificate (wooden packaging needs to be provided)
． Filling date
． Cosmetic Product License
． Receiving company IEC Code
． Photocopy of the consignee’s personal certificate (PAN: Permanent Account Number/TAN: Tax and Tax Reduction Account Number/ID Card/Passport)
3. Payment via electronic cash ledger and electronic tax credit sorting.
【参考连结】
https://www.icegate.gov.in/index.html
HLF-TW-70
印度化妆品审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
印度标准局 (BIS)规范化妆品需要进行实验室检验，符合进口化妆品註册的标准，包含：
1.原料和有效成分的化学分析
2.评估化妆品、禁用色素和化学品中重金属含量的安全测试
3.微生物质量检查，以确保没有微生物计数和病原体
4.活性成分的定性和定量估计
5.物理测试，包括粘度、铺展能力、划痕测试、放线测试等参数
6.估计防晒係数
7.皮肤刺激和敏感性研究
8.稳定性测试、保质期测定等
9. 细菌需氧菌落数、真菌好氧平板计数
10. 防腐剂测试
11. 非动物安全/毒性测试
12. 定制测试等
The Bureau of Indian Standards (BIS) regulates that cosmetics need to undergo laboratory testing and meet the standards for imported cosmetics registration, including:
1. Chemical analysis of raw materials and active components
2. Safety testing to evaluate heavy metal content in cosmetics, banned pigments and chemicals
3. Microbiological quality inspection to ensure no microbial counts and pathogens
4. Qualitative and quantitative estimation of active ingredients
5. Physical test, including parameters such as viscosity, spreading ability, scratch test, and pay-off test
6. Estimate SPF
7. Skin irritation and sensitivity studies
8. Stability test, shelf life determination, etc.
9. Bacterial aerobic counts, fungal aerobic plate counts
10. Preservative testing
11. Non-animal safety/toxicity testing
12. Customized tests, etc.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-75
HLF-TW-77
HLF-TW-80
外国子公司进口化妆品后，如果委託印度的经销商销售，经销商需要化妆品营业许可证吗？假如化妆品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？
After a foreign subsidiary imports cosmetics and entrusts a distributor in India to sell it, does the distributor need a cosmetics business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
无须申请营业许可证。
产品许可证持有公司须负责化妆品的安全、品质，及不良事件之处理，并向主管机关回报。
No business license is required. The product license holder shall be responsible for the safety, quality of cosmetics, and handling of adverse events, and report to the competent authority.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-85
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Email：bom4ww@evershinecpa.com
或
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或
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