印度化妝品登記法規問題集
Email：del4ww@evershinecpa.com
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印度永輝BPO有限公司
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The Engaging Manager Punit Negi, Indian citizenship
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聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
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Skype: daleccchen
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linkedin address:Dale Chen Linkedin
HLF-TW-10
請問印度對於化妝品的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
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，化妝品由中央藥品標準控制機構-衛生與家庭福利部負責監管(CDSCO)。化妝品的生產受各州政府指定的國家許可機構檢查、許可制度監管，而化妝品的進口則受制於中央指定的中央許可機關登記制。
化妝品被定義為任何旨在用作化妝品成分的物品，以摩擦、傾倒、噴灑、引入或以其他方式應用於人體或其任何部位，用以清潔、美化、提升吸引力或改變外觀。
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.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-20
外國公司要到印度銷售化妝品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
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：
無須申請營業許可證。
No business license is required.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-25
假如需要辦理，請問印度有專業服務公司可以協助辦理化妝品公司營業許可證？
Evershine RD：
無須申請營業許可證。
HLF-TW-30
外國公司要到印度銷售化妝品，可以指派印度公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
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。須由印度當地的公司申請化妝品產品許可證，可以是製造商/製造商的授權代理/製造商的子公司/進口商或由第三方擔任產品持有人。
註冊方式：
1. 先通過網站向 CDSCO註冊：http://cdscoonline.gov.in
2. 註冊並創建登錄憑證。
3. 使用有效的電子郵件 ID 和手機號碼提交所有詳細信息並完成註冊過程。(用戶必須上傳必要的文件，如身份證明詳細信息、授權書、公司地址等信息應在註冊過程之前將這些文件準備好 PDF 格式。)
4. 註冊成功後登錄門戶。
5. 在表單提交部分，選擇部門並選擇表單類型：新申請、代理。
6. 上傳相關文件。
7. 付款。
8. 提交審查。
產品許可證持有公司須負責化妝品的安全、品質，及不良事件之處理，並向主管機關回報。
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.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-35
HLF-TW-40
外國公司銷售到印度化妝品本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
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。須由印度當地的公司申請化妝品產品許可，可以是製造商/製造商的授權代理/製造商的子公司/進口商或由第三方擔任產品持有人。
註冊方式
1. 先通過網站向 CDSCO註冊：http://cdscoonline.gov.in
2. 註冊並創建登錄憑證。
3. 使用有效的電子郵件 ID 和手機號碼提交所有詳細信息並完成註冊過程。(用戶必須上傳必要的文件，如身份證明詳細信息、授權書、公司地址等信息應在註冊過程之前將這些文件準備好 PDF 格式。)
4. 註冊成功後登錄門戶。
5. 在表單提交部分，選擇部門並選擇表單類型：新申請、代理。
6. 上傳相關文件。
7. 付款。
8. 提交審查。
具備文件
1. 申請書
．製造商和製造場所的詳細信息：名稱、地址以及要註冊的製造場所電話號碼、傳真號碼和電子郵件地址、合夥人/董事的姓名和地址。
．印度授權進口商/分銷商/代理的名稱和地址，負責製造商的業務，包括其合作夥伴/董事的名稱和地址。
．簡要介紹製造商在國內和全球市場的業務活動。
．化妝品名稱及其品牌名稱、類別、包裝尺寸和變體，以供註冊並用於進口到印度並在印度使用。
2. 製造商授權（正式認證）
3. 化妝品的化學信息
．標準參考命名中的成分名稱，以及化妝品中所含的百分比。
．化妝品測試規範和測試方法。
．產品的標籤
．包裝說明書、插頁（如果有）。
4. 承諾聲明
．聲明遵守 2020 年化妝品規則規定的化妝品進口註冊證書上的所有條件。
．聲明進口到印度的每種化妝品均符合印度標準局製定的標準。
．非動物試驗聲明。
．聲明如果註冊產品或其規格的標籤、成分，或測試發生任何變化，應通知許可當局，並承諾產品符合印度標準局製定的標準。
．聲明將不時報告因不良反應而採取的任何行政行動，化妝品銷售或分銷的任何國家/地區的任何監管機構與註冊證書有關的任何化妝品的市場退出/監管限制，或取消授權和/或質量報告不合格時，化妝品的發貨和銷售應停止並立即通知當局。
．聲明將遵守印度政府根據該法案和規則制定的進一步要求。
．如果許可當局認為有必要，將允許當局或其他授權的任何人抽取化妝品樣品進行測試。
．重金屬和六氯酚含量聲明，檢測報告包括鉛、砷、汞、其他重金屬和微生物檢測結果（如適用）或製造商的承諾，聲明所使用的所有原材料/顏料、重金屬（有規定的限制）和應用產品中的六氯酚含量均符合規定的標準。
．聲明上述提交之文件皆為真實的。
5. 在原產國製造化妝品的製造許可證/產品許可/營銷授權/自由銷售證明（如果有）的詳細信息以及由該國監管機構或任何其他主管當局/協會簽發的副本。
6. 產品規格和測試協議
7. 該化妝品已獲得上市許可或進口許可的國家名單。
8. 品牌、產品和製造商的信息影本
9. 其他文件（如有）如為外文，申請人應提供由合格翻譯人員提供的任何其他外語文件的英文翻譯版本。
10. 費用：支付費用的原始電子收據
11. 如果沒有在原產國製造化妝品的許可證，進口商應將在宣誓書上提供一份聲明。
12. 散裝進口到印度進行重新包裝以 100% 出口到其他國家的化妝品不需要註冊證書，但是進口商必須從 CDSCO 總部獲得必要的許可。進口商必須書面承諾這些產品不會在國內銷售。
13. 用於研發目的的化妝品進口，如包裝試驗、消費者研究、保質期研究和運輸研究，不需要註冊證書，但是進口商必須從 CDSCO 總部獲得必要的許可。進口商必須書面保證這些產品不會在國內銷售
14.許可證的有效期為 3 年。
標籤
1. 化妝品名稱。
2. 製造商名稱、製造商場所的完整地址。
．如果產品不是在製造商擁有的工廠製造的，則應該在標籤上標示實際製造商名稱、地址或實際製造的國家、地區。
．如果化妝品裝在一個非常小的容器中，化妝品是固態或半固態30 克以下，液態 60 毫升以下，不能給出製造商的地址，則製造商的名稱、主要製造地應一起標示。
3. 到期日。
4. 獨特的批號
5. 生產許可證編號，編號前加字母M或 L. No或Mfg.，
．對於進口產品，如果該規定在原產國不是強制性的，則可以允許此類化妝品不提供生產許可證號，但須符合其他進口法規。
6. 容量以固體重量、液體計量或半固體重量的淨含量表示，如果內容被細分，則結合數字計數。如果包裝淨含量不超過 60 毫升的香水、花露水等或任何淨含量不超過 30 克的固體或半固體化妝品，則不需要標示。
7. 如果是化妝品；在存在危險的情況下，每個內部標籤都應清楚地標明安全使用的充分說明，消費者需要遵守的任何警告、注意或特殊說明，以及說明危險或有毒成分的名稱和數量的聲明。
8. 在印度銷售的進口化妝品，應在單位包裝標籤上註明進口註冊證號，以字母RC/RC No/Reg.證書，以及進口商的名稱和地址標示。
9. 如果化妝品包裝只有一個標籤，則該標籤應包含本規則規定的內標籤和外標籤上要求顯示的所有信息。
10.濃度超過 1% 的成分列表應按添加時重量或體積的降序排列，然後是濃度小於或等於1%的成分，並在前面加上成分字樣。對於小於或等於 60 毫升液體和 30 克固體和半固體的包裝，不需要出現此聲明。
11.進口化妝品標籤上應標明該產品的註冊證號和該產品在印度銷售的註冊證持有人的名稱和地址。如果進口化妝品需要印度特定標籤，則應允許在保稅倉庫的單位包裝上貼上相同的標籤。
12.在印度生產/進口並銷售的所有化妝品標籤上的規格必須用英文、 或印度地區語言註明。
注意
1. 任何人不得更改、塗抹或污損製造商在任何化妝品容器、標籤或包裝上製作或記錄的任何銘文或標記。
2. 任何化妝品不得聲稱、聲稱或傳達任何虛假或誤導預期用戶的想法。
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.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-45
HLF-TW-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？
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：
須由印度當地的公司申請化妝品產品許可，可以是製造商/製造商的授權代理/製造商的子公司/進口商或由第三方擔任產品持有人。
註冊方式
1. 先通過網站向 CDSCO註冊：http://cdscoonline.gov.in
2. 註冊並創建登錄憑證。
3. 使用有效的電子郵件 ID 和手機號碼提交所有詳細信息並完成註冊過程。(用戶必須上傳必要的文件，如身份證明詳細信息、授權書、公司地址等信息應在註冊過程之前將這些文件準備好 PDF 格式。)
4. 註冊成功後登錄門戶。
5. 在表單提交部分，選擇部門並選擇表單類型：新申請、代理。
6. 上傳相關文件。
7. 付款。
8. 提交審查。
具備文件
1. 申請書
．製造商和製造場所的詳細信息：名稱、地址以及要註冊的製造場所電話號碼、傳真號碼和電子郵件地址、合夥人/董事的姓名和地址。
．印度授權進口商/分銷商/代理的名稱和地址，負責製造商的業務，包括其合作夥伴/董事的名稱和地址。
．簡要介紹製造商在國內和全球市場的業務活動。
．化妝品名稱及其品牌名稱、類別、包裝尺寸和變體，以供註冊並用於進口到印度並在印度使用。
2. 製造商授權（正式認證）
3. 化妝品的化學信息
．標準參考命名中的成分名稱，以及化妝品中所含的百分比。
．化妝品測試規範和測試方法。
．產品的標籤
．包裝說明書、插頁（如果有）。
4. 承諾聲明
．聲明遵守 2020 年化妝品規則規定的化妝品進口註冊證書上的所有條件。
．聲明進口到印度的每種化妝品均符合印度標準局製定的標準。
．非動物試驗聲明。
．聲明如果註冊產品或其規格的標籤、成分，或測試發生任何變化，應通知許可當局，並承諾產品符合印度標準局製定的標準。
．聲明將不時報告因不良反應而採取的任何行政行動，化妝品銷售或分銷的任何國家/地區的任何監管機構與註冊證書有關的任何化妝品的市場退出/監管限制，或取消授權和/或質量報告不合格時，化妝品的發貨和銷售應停止並立即通知當局。
．聲明將遵守印度政府根據該法案和規則制定的進一步要求。
．如果許可當局認為有必要，將允許當局或其他授權的任何人抽取化妝品樣品進行測試。
．重金屬和六氯酚含量聲明，檢測報告包括鉛、砷、汞、其他重金屬和微生物檢測結果（如適用）或製造商的承諾，聲明所使用的所有原材料/顏料、重金屬（有規定的限制）和應用產品中的六氯酚含量均符合規定的標準。
．聲明上述提交之文件皆為真實的。
5. 在原產國製造化妝品的製造許可證/產品許可/營銷授權/自由銷售證明（如果有）的詳細信息以及由該國監管機構或任何其他主管當局/協會簽發的副本。
6. 產品規格和測試協議
7. 該化妝品已獲得上市許可或進口許可的國家名單。
8. 品牌、產品和製造商的信息影本
9. 其他文件（如有）如為外文，申請人應提供由合格翻譯人員提供的任何其他外語文件的英文翻譯版本。
10. 費用：支付費用的原始電子收據
11. 如果沒有在原產國製造化妝品的許可證，進口商應將在宣誓書上提供一份聲明。
12. 散裝進口到印度進行重新包裝以 100% 出口到其他國家的化妝品不需要註冊證書，但是進口商必須從 CDSCO 總部獲得必要的許可。進口商必須書面承諾這些產品不會在國內銷售。
13. 用於研發目的的化妝品進口，如包裝試驗、消費者研究、保質期研究和運輸研究，不需要註冊證書，但是進口商必須從 CDSCO 總部獲得必要的許可。進口商必須書面保證這些產品不會在國內銷售。
14.許可證的有效期為 3 年。
標籤
1. 化妝品名稱。
2. 製造商名稱、製造商場所的完整地址。
．如果產品不是在製造商擁有的工廠製造的，則應該在標籤上標示實際製造商名稱、地址或實際製造的國家、地區。
．如果化妝品裝在一個非常小的容器中，化妝品是固態或半固態30 克以下，液態 60 毫升以下，不能給出製造商的地址，則製造商的名稱、主要製造地應一起標示。
3. 到期日。
4. 獨特的批號
5. 生產許可證編號，編號前加字母M或 L. No或Mfg.，
．對於進口產品，如果該規定在原產國不是強制性的，則可以允許此類化妝品不提供生產許可證號，但須符合其他進口法規。
6. 容量以固體重量、液體計量或半固體重量的淨含量表示，如果內容被細分，則結合數字計數。如果包裝淨含量不超過 60 毫升的香水、花露水等或任何淨含量不超過 30 克的固體或半固體化妝品，則不需要標示。
7. 如果是化妝品；在存在危險的情況下，每個內部標籤都應清楚地標明安全使用的充分說明，消費者需要遵守的任何警告、注意或特殊說明，以及說明危險或有毒成分的名稱和數量的聲明。
8. 在印度銷售的進口化妝品，應在單位包裝標籤上註明進口註冊證號，以字母RC/RC No/Reg.證書，以及進口商的名稱和地址標示。
9. 如果化妝品包裝只有一個標籤，則該標籤應包含本規則規定的內標籤和外標籤上要求顯示的所有信息。
10.濃度超過 1% 的成分列表應按添加時重量或體積的降序排列，然後是濃度小於或等於1%的成分，並在前面加上成分字樣。對於小於或等於 60 毫升液體和 30 克固體和半固體的包裝，不需要出現此聲明。
11.進口化妝品標籤上應標明該產品的註冊證號和該產品在印度銷售的註冊證持有人的名稱和地址。如果進口化妝品需要印度特定標籤，則應允許在保稅倉庫的單位包裝上貼上相同的標籤。
12.在印度生產/進口並銷售的所有化妝品標籤上的規格必須用英文、 或印度地區語言註明。
注意
1. 任何人不得更改、塗抹或污損製造商在任何化妝品容器、標籤或包裝上製作或記錄的任何銘文或標記。
2. 任何化妝品不得聲稱、聲稱或傳達任何虛假或誤導預期用戶的想法。
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.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-55
HLF-TW-60
經過核准登記的化妝品，進口到印度要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
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：
需完成海關申報。
進出口代碼 (IEC)
進度進口化妝品的先決條件，需具備進出口代碼 (IEC)才得以在印度進行商業的進口、出口。IEC 編號是對外貿易總幹事頒發給印度公司的10位數代碼。每個從事進出口業務的個人或實體都必須獲得 IEC。 它具有終身有效期，大約需要 15 天才能簽發。
1.網頁註冊：https://www.dgft.gov.in/CP/
．獲得 IEC 的公司的性質可以是以下任何一種：獨資企業、合夥企業、有限責任合夥企業、有限公司、信託、HU”。引入 GST 後，IEC 編號與公司的 PAN 相同。IEC 將由 DGFT 單獨發布。
2.簽署聲明。
3.支付IEC費用。
4.簽發IEC代碼。
海關流程
1.於印度海關電子網關 (ICEGATE)註冊會員
印度海關電子網關 (ICEGATE) 是印度海關中央間接稅和海關委員會 (CBIC) 的國家門戶，以電子方式向貿易、貨運承運人和其他貿易夥伴提供電子申報服務。網頁：https://www.icegate.gov.in/index.html
．申請人
．公司名稱
．地址
．城市
．密碼
．電話、傳真號碼、電子信箱
．類別：進口商/出口商等
．清關位置
2. 進口申報
．內容、發貨地、收貨地
．貨物的詳情、貨物登記
．商業發票
．合約
．提單
．成分分析報告(需提供翻譯文件)
．標籤樣本(需提供翻譯文件)
．木質包裝薰蒸證(有木質包裝需要提供)
．灌裝日期
．化妝品產品許可證
．收方公司IEC Code
．收貨人個人證件影本(PAN：永久帳戶號/TAN：收稅及減稅帳號/身份證/護照)
3.通過電子現金分類賬支付和電子稅收信用分類。
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.
【參考連結】
https://www.icegate.gov.in/index.html
HLF-TW-70
印度化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
印度標準局 (BIS)規範化妝品需要進行實驗室檢驗，符合進口化妝品註冊的標準，包含：
1.原料和有效成分的化學分析
2.評估化妝品、禁用色素和化學品中重金屬含量的安全測試
3.微生物質量檢查，以確保沒有微生物計數和病原體
4.活性成分的定性和定量估計
5.物理測試，包括粘度、鋪展能力、划痕測試、放線測試等參數
6.估計防曬係數
7.皮膚刺激和敏感性研究
8.穩定性測試、保質期測定等
9. 細菌需氧菌落數、真菌好氧平板計數
10. 防腐劑測試
11. 非動物安全/毒性測試
12. 定制測試等
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.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-75
HLF-TW-77
HLF-TW-80
外國子公司進口化妝品後，如果委託印度的經銷商銷售，經銷商需要化妝品營業許可證嗎？假如化妝品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
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：
無須申請營業許可證。
產品許可證持有公司須負責化妝品的安全、品質，及不良事件之處理，並向主管機關回報。
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.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-85
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Email：del4ww@evershinecpa.com
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或
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