加拿大化妝品登記法規問題集

加拿大主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。 加拿大多倫多與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。
Email：yto4ww@evershinecpa.com
或
加拿大永輝BPO有限公司
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Manager Ian Lin 說中文和英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
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Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

各國化妝品登記法規問答集

時間：2023/07/28 drafted by Yvonne Chen

HLF-TW-10
請問加拿大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 Canada? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
在加拿大，化妝品的監管由加拿大衛生部(HC)負責，化妝品是製造、銷售或代表用於清潔、改善或改變膚色、皮膚、頭髮或牙齒的任何物質或物質混合物，包括除臭劑和香水。例如：肥皂、人造指甲、保濕劑、有色保濕霜（遮瑕膏）、紋身墨水、化妝產品、牙齒美白劑、清潔濕巾等。

如果產品分類不明確，加拿大衛生部將根據具體情況對產品進行分類，將依據以下條件進行判斷：
1.描述：該產品是否被描述為具有美容功能，例如：清潔、保濕、潤滑、添香或改變人類的頭髮、皮膚或牙齒。
2.產品的成分：雖然產品的成分本身並不一定決定其分類，但某種成分的存在或其濃度可能會使該產品不適合分類為化妝品。
3.作用程度: 化妝品通常塗抹在身體的表部，而不是被皮膚吸收以達到美容效果。

注意
1.化妝品可以塗在眼睛周圍的皮膚上，但直接塗在眼睛上的產品不是化妝品。
2.除紋身墨水外，通過攝入、吸入或注射（例如肌內、皮下或靜脈注射）施用的產品不屬於化妝品。

In Canada, cosmetics are regulated by Health Canada (HC), and cosmetic means any substance or mixture of substances, including deodorants, manufactured, marketed or represented for cleansing, improving or altering the complexion, skin, hair or teeth and perfume. Examples: soaps, artificial nails, moisturizers, tinted moisturizers (concealers), tattoo inks, makeup products, teeth whiteners, cleaning wipes, etc.

If the classification of the product is not clear, Health Canada will classify the product on a case-by-case basis and will be judged based on the following conditions:

1. Description: Whether the product is described as having a cosmetic function such as: cleansing, moisturizing, lubricating, perfuming or altering human hair, skin or teeth.
2. Composition of a product: While the composition of a product itself does not necessarily determine its classification, the presence or concentration of an ingredient may render the product unsuitable for classification as a cosmetic product.
3. Degree of action: Cosmetics are usually applied on the outside of the body, rather than being absorbed by the skin to achieve cosmetic effects.

Note

1. Cosmetics can be applied to the skin around the eyes, but the products applied directly to the eyes are not cosmetics.
2. Except tattoo inks, products applied by ingestion, inhalation or injection (e.g. intramuscular, subcutaneous or intravenous) are not cosmetic products.

【參考連結】
https://www.canada.ca/en.html
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics.html

HLF-TW-20
外國公司要到加拿大銷售化妝品，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 Canada, 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：
無需營業特許證。
如果在加拿大製造、進口或銷售產品，必須向加拿大衛生部報告涉及消費品的健康或安全事件。製造商、進口商有責任提供有關該事件的更多詳細信息以及對受影響的消費品採取的任何糾正措施。
報告包含：

1. 產品訊息
   ．產品品牌和名稱
   ．產品描述
   ．管道：商店或其他
   ．產品包裝上的年齡建議
   ．產品編號
   ．製造或進口日期
   ． 產品購買日期
   ．產品製造或進口的地址
2. 事故信息
   ．傷患
   ．受傷類型
   ．事件發生日期
   ．事件描述
   ．醫療護理

No business license is required.
Health or safety incidents involving consumer products must be reported to Health Canada if the product is manufactured, imported or sold in Canada. It is the manufacturer, importer’s responsibility to provide further details on the incident and any corrective actions taken on the affected consumer product.
The report contains:

1. Product information
   ． Product brand and name
   ． Product Description
   ． Pipeline: store or other
   ． Age advice on product packaging
   ． Product number
   ． Date of manufacture or import
   ． Product purchase date
   ． The address where the product was manufactured or imported
2. Accident information
   ． Injured person’s name
   ． Type of injury
   ． Event date
   ． Event description
   ． Health care

【參考連結】
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#4
https://www.canada.ca/en/health-canada/services/consumer-product-safety.html

HLF-TW-25
假如需要辦理，請問加拿大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：
無需營業特許證。

HLF-TW-30
外國公司要到加拿大銷售化妝品，可以指派加拿大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 Canada, can it assign a Canada 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：
非居民進口商可以申請商業登記，註冊商業登記時須留存一組當地(美國/加拿大)的實際地址。

非居民企業號碼和帳戶註冊
1.網頁：https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/gst-hst-businesses/digital-economy-gsthst/terms-conditions.html

2.需要資料
·GST/HST
·申請者身分、基本資料、聯繫方式
·負責人基本資料、聯繫方式
·企業名稱、所有權類型(獨資/合夥等)、行業類別、是否為註冊公司(登記日期)
·聯繫語言(英語/法語)
·公司電子郵件
·美洲實際聯繫地址(美國/加拿大)
·商業活動內容(產品內容)
·是否已有加拿大稅務局 (CRA) 的商業號碼

產品責任
化妝品在加拿大銷售，進口商有責任向加拿大衛生部報告涉及消費品的健康或安全事件，提供有關該事件的更多詳細信息以及對受影響的消費品採取的任何糾正措施。
報告包含：

1. 產品訊息
   ．產品品牌和名稱
   ．產品描述
   ．管道：商店或其他
   ．產品包裝上的年齡建議
   ．產品編號
   ．製造或進口日期
   ． 產品購買日期
   ．產品製造或進口的地址
2. 事故信息
   ．傷患
   ．受傷類型
   ．事件發生日期
   ．事件描述
   ．醫療護理

Non-resident importers can apply for business registration. When registering for business registration, a set of local (US/Canada) physical addresses must be kept.

Non-resident business number and account registration

1. URL: https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/gst-hst-businesses/digital-economy-gsthst/terms-conditions.html
2. Required information
   ·GST/HST
   ·Applicant identity, basic information, contact information
   ·Basic information and contact information of the person in charge
   ·Company name, ownership type (sole proprietorship/partnership, etc.), industry category, whether it is a registered company (registration date)
   ·Contact language (English/French)
   ·Company email
   ·America actual contact address (USA/Canada)
   ·Business activity content (product content)
   ·Already have a Canada Revenue Agency (CRA) business number

Product liability
When cosmetics are sold in Canada, it is the importer’s responsibility to report a health or safety incident involving a consumer product to Health Canada, providing further details about the incident and any corrective actions taken with respect to the affected consumer product.
The report contains:

1. Product information
   ． Product brand and name
   ． Product Description
   ． Pipeline: store or other
   ． Age advice on product packaging
   ． Product number
   ． Date of manufacture or import
   ． Product purchase date
   ． The address where the product was manufactured or imported
2. Accident Information
   ． Injured
   ． Type of injury
   ． Date of event
   ． Event description
   ． Medical care

【參考連結】
https://www.canada.ca/en/health-canada/services/consumer-product-safety.html
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#4

HLF-TW-35

HLF-TW-40
外國公司銷售到加拿大化妝品本身，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 Canada? 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，每個製造商和進口商應在製造商或進口商首次銷售化妝品最遲 10 天向加拿大衛生部通報化妝品通知表格（CNF），可以線上通報或者繳交紙本。
1.網頁：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妝品通知表格（CNF）內容：
．化妝品標籤上的製造商名稱和地址
．名稱
．功能
．成分列表(每種成分的準確濃度或包括該成分濃度的濃度範圍)
．形式
．製造商、進口商或經銷商在加拿大的名稱和地址
．如果化妝品不是由標籤上姓名出現的人製造的，則需填上製造或配製該化妝品的人的姓名和地址
．申請人的姓名和職務
．文件和圖片

標籤
1.化妝品標籤必須以英語和法語標示，但 INCI 名稱除外。
2.必須抱持在正常銷售和使用條件下、化妝品的整個使用壽命內，或者在可再填充容器的情況的整個使用壽命內，都維持清晰並且容易閱讀。
3.內標籤應標明：製造商名稱、製造商主要營業地址、化妝品的通用名或其功能的特性(除非該特性是顯而易見的)。
4.外標籤應標明成分清單
．每種成分僅以其 INCI 名稱列出。
．對於以一系列色調出售的化妝品、指甲油和琺瑯，如果前面帶有符號+/–或±或短語，則可以列出該範圍內使用的所有著色劑。
．植物藥必須至少指定 INCI 名稱的屬和種部分來列出。
．明細表中包含的成分可以通過明細表第 1 欄列出的歐盟俗名或第 2 欄和第 3 欄列出的相應英文和法文等效名稱來列出。
．沒有 INCI 名稱的成分必須按其化學名稱列出。
．成分必須按照其重量濃度的降序排列。
．濃度為 1% 或更低的成分和所有著色劑，無論其濃度如何，可以隨機順序列在濃度超過 1% 的成分之後。
．對於香精和香精，可在成分列表末尾分別插入香精和芳香一詞，表明此類成分已添加到化妝品中。
．如果化妝品的直接容器或外包裝太小，以至於標籤無法符合要求，則成分列表可以出現在標籤上、膠帶或卡片貼在容器或包裝上。
．如果化妝品裝在沒有外包裝的裝飾性容器中，成分列表可能會出現在貼在容器上的標籤、膠帶或卡片上。
．如果化妝品沒有外包裝，且其尺寸、形狀或紋理或其直接容器的尺寸、形狀或紋理使其無法在其上黏貼標籤、膠帶或卡片，容器中，成分列表可能會出現在銷售點必須隨附化妝品的傳單中。
5.特殊要求
．含有對苯二胺或其他煤焦油染料基料或煤焦油中間體的染髮劑必須在內標籤和外標籤上均帶有警告、副作用及效果說明。
．含有汞或者其鹽類及其衍生物作為防腐劑的化妝品，其外標籤應標明防腐劑的名稱及其在化妝品中的濃度。
．用於生殖器區域並在壓力容器中銷售的除臭劑應在其內部和外部標籤上載：使用說明、適用條件、注意事項、警告等。
．加壓容器內外標籤應顯示危險符號，並附有小心/注意的提醒詞，以及危險聲明
6.安全包裝
．任何人不得出售供人類使用的漱口水，除非該漱口水包含在安全包裝中。
．安全包裝的內部標籤必須帶有引起人們注意的聲明或插圖，並且，如果只是外包裝的一部分，外標籤還必須帶有聲明或插圖。
．含有 5 mL 或更多甲醇的化妝品的內外標籤必須顯示危險符號、提醒詞、聲明。
．含有600毫克或以上溴酸鈉或50毫克或以上溴酸鉀應放置在兒童接觸不到的地方，如果意外攝入，應立即聯繫毒物中心或醫生。

Each manufacturer and importer shall notify Health Canada, either online or in paper form, to Health Canada no later than 10 days after the first sale of the cosmetic by the manufacturer or importer.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

Label

1. Cosmetics labels must be in English and French, except for the INCI name.
2. Must remain legible and easy to read under normal conditions of sale and use, throughout the useful life of the cosmetic product, or in the case of a refillable container.
3. The inner label shall indicate: the name of the manufacturer, the main business address of the manufacturer, the general name of the cosmetic product or its functional characteristics (unless the characteristics are obvious).
4. The outer label should indicate the list of ingredients
   ．Each ingredient is listed by its INCI name only.
   ．For cosmetics, nail polishes and enamels sold in a range of shades, if preceded by the symbol +/– or ± or a phrase, you can list all the colorants used in that range.
   ．Botanicals must specify at least the genus and species portion of the INCI name to be listed.
   ．Ingredients included in the schedule may be listed by their EU common name listed in column 1 of the schedule or by their corresponding English and French equivalents in columns 2 and 3 of the schedule.
   ．Ingredients that do not have an INCI name must be listed by their chemical name.
   ．Ingredients must be listed in descending order of their concentration by weight.
   ．Ingredients at a concentration of 1% or less and all colorants, regardless of concentration, may be listed in random order after ingredients at a concentration of more than 1%.
   ．For fragrance and fragrance, the words fragrance and aroma can be inserted respectively at the end of the list of ingredients to indicate that such ingredients have been added to the cosmetic product.
   ．If the immediate container or outer packaging of the cosmetic product is too small for the label to meet the requirements, the ingredient list can appear on the label, tape or card attached to the container or packaging.
   ．If the cosmetic product is in a decorative container with no outer packaging, the ingredient list may appear on a label, tape, or card affixed to the container.
   ．If the cosmetic product has no outer packaging and its size, shape or texture, or the size, shape or texture of its immediate container, makes it impossible to affix a label, tape or card to it, the container, the ingredient list may appear at the point of sale and must accompany Cosmetics in the flyer.
   5.Special request
   ．Hair dyes containing p-phenylenediamine or other coal tar dye bases or coal tar intermediates must carry warnings, side effects, and effects on both the inner and outer labels.
   ．For cosmetics containing mercury or its salts and their derivatives as preservatives, the name of the preservative and its concentration in the cosmetic should be indicated on the outer label.
   ．Deodorants intended for the genital area and sold in pressurized containers should have on their inside and outside labels: directions for use, conditions of application, precautions, warnings, etc.
   ．The inside and outside labels of pressurized containers shall display the hazard symbol with a caution/note signal, and a hazard statement
5. Safe packing
   ．No person may sell mouthwash for human use unless it is contained in safe packaging.
   ．The inner label of the security package must carry a statement or illustration that draws attention to it and, if only part of the outer packaging, the outer label must also bear the statement or illustration.
   ．Cosmetic products containing 5 mL or more of methanol must display the hazard symbol, cautionary word, statement on the inner and outer labels.
   ．Contains 600 mg or more of sodium bromate or 50 mg or more of potassium bromate should be kept out of the reach of children and in case of accidental ingestion contact a poison center or doctor immediately.
   .
   【參考連結】
   https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/page-1.html#h-567428
   https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/

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：
可以，條件是在提出產品許可時要求提供至少一家位於加拿大的製造商或進口商的聯繫信息。

每個製造商和進口商應在製造商或進口商首次銷售化妝品最遲 10 天向加拿大衛生部通報化妝品通知表格（CNF），可以線上通報或者繳交紙本。
1.網頁：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妝品通知表格（CNF）內容：
．化妝品標籤上的製造商名稱和地址
．名稱
．功能
．成分列表(每種成分的準確濃度或包括該成分濃度的濃度範圍)
．形式
．製造商、進口商或經銷商在加拿大的名稱和地址
．如果化妝品不是由標籤上姓名出現的人製造的，則需填上製造或配製該化妝品的人的姓名和地址
．申請人的姓名和職務
．文件和圖片

標籤
1.化妝品標籤必須以英語和法語標示，但 INCI 名稱除外。
2.必須抱持在正常銷售和使用條件下、化妝品的整個使用壽命內，或者在可再填充容器的情況的整個使用壽命內，都維持清晰並且容易閱讀。
3.內標籤應標明：製造商名稱、製造商主要營業地址、化妝品的通用名或其功能的特性(除非該特性是顯而易見的)。
4.外標籤應標明成分清單
．每種成分僅以其 INCI 名稱列出。
．對於以一系列色調出售的化妝品、指甲油和琺瑯，如果前面帶有符號+/–或±或短語，則可以列出該範圍內使用的所有著色劑。
．植物藥必須至少指定 INCI 名稱的屬和種部分來列出。
．明細表中包含的成分可以通過明細表第 1 欄列出的歐盟俗名或第 2 欄和第 3 欄列出的相應英文和法文等效名稱來列出。
．沒有 INCI 名稱的成分必須按其化學名稱列出。
．成分必須按照其重量濃度的降序排列。
．濃度為 1% 或更低的成分和所有著色劑，無論其濃度如何，可以隨機順序列在濃度超過 1% 的成分之後。
．對於香精和香精，可在成分列表末尾分別插入香精和芳香一詞，表明此類成分已添加到化妝品中。
．如果化妝品的直接容器或外包裝太小，以至於標籤無法符合要求，則成分列表可以出現在標籤上、膠帶或卡片貼在容器或包裝上。
．如果化妝品裝在沒有外包裝的裝飾性容器中，成分列表可能會出現在貼在容器上的標籤、膠帶或卡片上。
．如果化妝品沒有外包裝，且其尺寸、形狀或紋理或其直接容器的尺寸、形狀或紋理使其無法在其上黏貼標籤、膠帶或卡片，容器中，成分列表可能會出現在銷售點必須隨附化妝品的傳單中。
5.特殊要求
．含有對苯二胺或其他煤焦油染料基料或煤焦油中間體的染髮劑必須在內標籤和外標籤上均帶有警告、副作用及效果說明。
．含有汞或者其鹽類及其衍生物作為防腐劑的化妝品，其外標籤應標明防腐劑的名稱及其在化妝品中的濃度。
．用於生殖器區域並在壓力容器中銷售的除臭劑應在其內部和外部標籤上載：使用說明、適用條件、注意事項、警告等。
．加壓容器內外標籤應顯示危險符號，並附有小心/注意的提醒詞，以及危險聲明
6.安全包裝
．任何人不得出售供人類使用的漱口水，除非該漱口水包含在安全包裝中。
．安全包裝的內部標籤必須帶有引起人們注意的聲明或插圖，並且，如果只是外包裝的一部分，外標籤還必須帶有聲明或插圖。
．含有 5 mL 或更多甲醇的化妝品的內外標籤必須顯示危險符號、提醒詞、聲明。
．含有600毫克或以上溴酸鈉或50毫克或以上溴酸鉀應放置在兒童接觸不到的地方，如果意外攝入，應立即聯繫毒物中心或醫生。

Yes, the contact information of at least one Canadian-based manufacturer or importer is required when submitting a product license request.

Each manufacturer and importer shall notify Health Canada, either online or in paper form, to Health Canada no later than 10 days after the first sale of the cosmetic by the manufacturer or importer.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

Label

1. Cosmetics labels must be in English and French, except for the INCI name.
2. Must remain legible and easy to read under normal conditions of sale and use, throughout the useful life of the cosmetic product, or in the case of a refillable container.
3. The inner label shall indicate: the name of the manufacturer, the main business address of the manufacturer, the general name of the cosmetic product or its functional characteristics (unless the characteristics are obvious).
4. The outer label should indicate the list of ingredients
   ．Each ingredient is listed by its INCI name only.
   ．For cosmetics, nail polishes and enamels sold in a range of shades, if preceded by the symbol +/– or ± or a phrase, you can list all the colorants used in that range.
   ．Botanicals must specify at least the genus and species portion of the INCI name to be listed.
   ．Ingredients included in the schedule may be listed by their EU common name listed in column 1 of the schedule or by their corresponding English and French equivalents in columns 2 and 3 of the schedule.
   ．Ingredients that do not have an INCI name must be listed by their chemical name.
   ．Ingredients must be listed in descending order of their concentration by weight.
   ．Ingredients at a concentration of 1% or less and all colorants, regardless of concentration, may be listed in random order after ingredients at a concentration of more than 1%.
   ．For fragrance and fragrance, the words fragrance and aroma can be inserted respectively at the end of the list of ingredients to indicate that such ingredients have been added to the cosmetic product.
   ．If the immediate container or outer packaging of the cosmetic product is too small for the label to meet the requirements, the ingredient list can appear on the label, tape or card attached to the container or packaging.
   ．If the cosmetic product is in a decorative container with no outer packaging, the ingredient list may appear on a label, tape, or card affixed to the container.
   ．If the cosmetic product has no outer packaging and its size, shape or texture, or the size, shape or texture of its immediate container, makes it impossible to affix a label, tape or card to it, the container, the ingredient list may appear at the point of sale and must accompany Cosmetics in the flyer.
   5.Special request
   ．Hair dyes containing p-phenylenediamine or other coal tar dye bases or coal tar intermediates must carry warnings, side effects, and effects on both the inner and outer labels.
   ．For cosmetics containing mercury or its salts and their derivatives as preservatives, the name of the preservative and its concentration in the cosmetic should be indicated on the outer label.
   ．Deodorants intended for the genital area and sold in pressurized containers should have on their inside and outside labels: directions for use, conditions of application, precautions, warnings, etc.
   ．The inside and outside labels of pressurized containers shall display the hazard symbol with a caution/note signal, and a hazard statement
5. Safe packing
   ．No person may sell mouthwash for human use unless it is contained in safe packaging.
   ．The inner label of the security package must carry a statement or illustration that draws attention to it and, if only part of the outer packaging, the outer label must also bear the statement or illustration.
   ．Cosmetic products containing 5 mL or more of methanol must display the hazard symbol, cautionary word, statement on the inner and outer labels.
   ．Contains 600 mg or more of sodium bromate or 50 mg or more of potassium bromate should be kept out of the reach of children and in case of accidental ingestion contact a poison center or doctor immediately.

【參考連結】
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/page-1.html#h-567428
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#4
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/

HLF-TW-55

HLF-TW-60
經過核准登記的化妝品，進口到加拿大要檢附什麼文件？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 Canada? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
進口化妝品需完成進口預先通知；銷售至少10天前須完成通報。

進口商每次進口前必須向加拿大衛生部提前申請，受監管方可以在一張表格上填寫 3 個月內多次進口的計畫。
進口預先通知表為新辦理的試點計劃，進口商需要：
1.確保產品符合加拿大法律
2.與檢查局索取表格，須提供：公司詳細信息、運輸詳細信息和產品詳細信息，並概述將要進行的更正/修改。
3.發貨前通過電子郵件將表格提交給所在地區的加拿大衛生部辦公室。
4.確保產品在進口後 3 個月內重新貼標或修改。

海關進口流程
1.登記註冊商業號碼(BN)或增加進/出口帳戶識別碼至現有的 BN
網頁：
https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/registering-your-business/register.html
2.申請進口許可證：需表明化妝品符合加拿大化妝品市場的所有要求，如包裝、標籤、配料表等。
3.提交進口申報書和商檢申報：需與加拿大海關聯繫並向其備案所要進口的化妝品類別、品項、品牌及數量等信息。同時提供化妝品的包裝、標籤、配料表等必要信息。
4.商檢、海關查驗：海關會在一系列檢查中檢驗包裝、標籤和配料表是否符合標準，同時也會檢查貨物是否有破損或受到危險物質污染。
5.所需文件：
．貨運提單
．海關發票或商業發票，標明買家、賣家、原產地、價格及貨物的詳細說明，以及數量、單價。
．進口許可證
．裝箱單
．裝運前檢驗證書
．其他文件：保險證書、符合優惠關稅的提單等。

需要，每個製造商和進口商應在製造商或進口商首次銷售化妝品最遲 10 天向加拿大衛生部通報化妝品通知表格（CNF），可以線上通報或者繳交紙本。
1.網頁：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妝品通知表格（CNF）內容：
．化妝品標籤上的製造商名稱和地址
．名稱
．功能
．成分列表(每種成分的準確濃度或包括該成分濃度的濃度範圍)
．形式
．製造商、進口商或經銷商在加拿大的名稱和地址
．如果化妝品不是由標籤上姓名出現的人製造的，則需填上製造或配製該化妝品的人的姓名和地址
．申請人的姓名和職務
．文件和圖片

Imported cosmetics need to complete the import pre-notification; at least 10 days before the sale must complete the notification.

The importer must apply to Health Canada in advance before each import, and the regulated party can fill in a plan for multiple imports within 3 months on a single form.
The Import Advance Notification Form is a new pilot program, and importers need:

1. Make sure the product is in compliance with Canadian law
2. Request a form with the Inspectorate, provide: company details, shipping details and product details, and outline the corrections/amendments to be made.
3. Submit the form by email to the Health Canada office in your region prior to shipment.
4. Make sure the product is relabeled or modified within 3 months of import.

Customs Import Process
1.Register a business number (BN) or add an import/export account identification number to an existing BN
URL:
https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/registering-your-business/register.html
2.Apply for an import license: It is necessary to show that the cosmetics meet all the requirements of the Canadian cosmetics market, such as packaging, labels, ingredient lists, etc.
3.Submit the import declaration and commodity inspection declaration: You need to contact the Canadian Customs and file with it the category, item, brand and quantity of cosmetics to be imported. At the same time, it provides necessary information such as packaging, labels, and ingredient lists of cosmetics.
4.Commodity inspection and customs inspection: The customs will check whether the packaging, labels and ingredient lists meet the standards in a series of inspections, and will also check whether the goods are damaged or contaminated by dangerous substances.

5. Required documents:
   ．Bill of lading
   ．Customs invoice or commercial invoice, indicating the buyer, seller, place of origin, price and detailed description of the goods, as well as quantity and unit price.
   ．Import permit
   ．Packing List
   ．Certificate of pre-shipment inspection
   ．Other documents: Certificate of Insurance, Bill of Lading in compliance with preferential tariffs, etc.

Each manufacturer and importer shall notify Health Canada, either online or in paper form, to Health Canada no later than 10 days after the first sale of the cosmetic by the manufacturer or importer.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

【參考連結】
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/advance-notice-importation-process-cosmetics-drugs.html
https://www.canada.ca/en/health-canada/services/consumer-product-safety/legislation-guidelines/guidelines-policies/importing-exporting-commercial/document.html

HLF-TW-70
加拿大化妝品審核機構，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：
化妝品良好生產規範 (GMP)
1.加拿大衛生部鼓勵所有化妝品製造商遵守良好生產規範 (GMP)，認可使用國際標準組織(ISO) 化妝品良好生產規範指南（ISO 標準 22716）。
2.GMP 是用於確保產品質量控制和風險管理的有效方法的生產指南。規定了產品製造、測試、儲存、處理和分銷的標準，以確保製造的每個步驟對於產品的質量和安全都是可接受的。
3.GMP 沒有提供產品生產方式的具體細節，是概述了流程的預期結果。每個製造商可能有實現這些成果的獨特方法。

製造化妝品時的一些重要注意事項，以確保其不受污染

1. 建築及設施
   ．建築足以生產和儲存化妝品
   ．牆壁、地板、固定裝置、管道、管道、照明、通風、供水、排水、衛生間設施適合工作且維護良好
   ．建築物有足夠的空氣供應質量
   ．建築物有足夠的害蟲防治計劃，以防止吸引或藏匿害蟲
   2.設備
   ．加工過程中使用的設備充足、維護良好且無污染
   3.人員
   ．人員有足夠的教育、培訓、經驗和個人清潔度
   4.原料
   ．儲存和處理原材料以防止污染或變質
   ．材料經過測試或檢查以確保質量
2. 生產
   ．建立製造和控製程序並維護程序的書面說明
   6.實驗室控制
   ．對原材料、樣品和成品進行測試或檢查，以確保其符合規定的標準
   ．供水不受污染
3. 記錄
   ．保存原材料、製造、成品和分銷的記錄
4. 標籤
   ．成品上的標籤包含所需信息
5. 投訴
   ．企業保留消費者投訴檔案
6. 其他
   ．產品符合所有監管要求
   ．產品不含違禁成分或物質

Cosmetic Good Manufacturing Practice (GMP)

1. Health Canada encourages all cosmetics manufacturers to comply with Good Manufacturing Practices (GMP) and endorses the use of the International Standards Organization (ISO) Guide to Good Manufacturing Practices for Cosmetics (ISO Standard 22716).
2. GMP is a production guideline for ensuring effective methods of product quality control and risk management. Standards are specified for the manufacture, testing, storage, handling and distribution of products to ensure that each step of manufacture is acceptable for the quality and safety of the product.
3. GMP does not provide specific details of how a product is produced, but outlines the expected outcome of the process. Each manufacturer may have a unique approach to achieving these results.

Some important considerations when manufacturing cosmetics to ensure they are free from contamination

1. Buildings and Facilities
   ．Buildings are sufficient to produce and store cosmetics
   ．Walls, floors, fixtures, pipes, plumbing, lighting, ventilation, water supply, drainage, toilet facilities are fit for purpose and in good repair
   ．The building has sufficient air supply quality
   ．The building has an adequate pest control program to prevent attracting or harboring pests
2. Equipment
   ．The equipment used in the process is adequate, well maintained and non-polluting
3. Personnel
   ．Personnel have adequate education, training, experience and personal cleanliness
4. Raw materials
   ．Storing and handling raw materials to prevent contamination or deterioration
   ．Materials are tested or inspected for quality
5. Production
   ．Written instructions for establishing manufacturing and control procedures and maintaining procedures
6. Laboratory Control
   ．Testing or inspecting raw materials, samples and finished products to ensure they comply with specified standards
   ．Water supply is not polluted
7. Record
   ．Keeping records of raw materials, manufacturing, finished products and distribution
8. Labels
   ．Labels on finished products contain required information
9. Complaints
   ．Businesses keep consumer complaint files
10. Other
    ．The product complies with all regulatory requirements
    ．The product does not contain prohibited ingredients or substances

【參考連結】
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information/good-manufacturing-practices.html

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口化妝品後，如果委託加拿大的經銷商銷售，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 Canada 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：
無需營業許可證，但製造/進口商首次銷售化妝品最遲 10 天向加拿大衛生部通報化妝品通知表格（CNF），可以線上通報或者繳交紙本。
1.網頁：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妝品通知表格（CNF）內容：
．化妝品標籤上的製造商名稱和地址
．名稱
．功能
．成分列表(每種成分的準確濃度或包括該成分濃度的濃度範圍)
．形式
．製造商、進口商或經銷商在加拿大的名稱和地址
．如果化妝品不是由標籤上姓名出現的人製造的，則需填上製造或配製該化妝品的人的姓名和地址
．申請人的姓名和職務
．文件和圖片

產品責任
化妝品在加拿大銷售，進口商有責任向加拿大衛生部報告涉及消費品的健康或安全事件，提供有關該事件的更多詳細信息以及對受影響的消費品採取的任何糾正措施。
報告包含：

1. 產品訊息
   ．產品品牌和名稱
   ．產品描述
   ．管道：商店或其他
   ．產品包裝上的年齡建議
   ．產品編號
   ．製造或進口日期
   ． 產品購買日期
   ．產品製造或進口的地址
2. 事故信息
   ．傷患
   ．受傷類型
   ．事件發生日期
   ．事件描述
   ．醫療護理

No business license is required, but the manufacturer/importer first sells cosmetics to notify Health Canada of the Cosmetics Notification Form (CNF) within 10 days at the latest, which can be reported online or submitted in paper.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

Product liability
When cosmetics are sold in Canada, it is the importer’s responsibility to report a health or safety incident involving a consumer product to Health Canada, providing further details about the incident and any corrective actions taken with respect to the affected consumer product.
The report contains:

1. Product information
   ． Product brand and name
   ． Product Description
   ． Pipeline: store or other
   ． Age advice on product packaging
   ． Product number
   ． Date of manufacture or import
   ． Product purchase date
   ． The address where the product was manufactured or imported
2. Accident Information
   ． Injured
   ． Type of injury
   ． Date of event
   ． Event description
   ． Medical care

【參考連結】
https://www.canada.ca/en/health-canada/services/consumer-product-safety.html
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/

HLF-TW-85

各國化妝品登記法規問答集

Email：yto4ww@evershinecpa.com
或
加拿大永輝BPO有限公司
接洽人:
Vincent Wang 加拿大籍来自台灣
或
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin
全球永輝服務據點參考資料:
永輝100%關係企業
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

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