加拿大化妆品登记法规问题集

加拿大主要城市公司设立登记,商标登记，进出口证，特许行业申请等。公司设立后云端系统支援的会计薪资服务。 加拿大多伦多与臺湾同事携手协同爲您服务。为地球暖化尽一份心力，减少空中旅行。
Email：yto4ww@evershinecpa.com
或
加拿大永辉BPO有限公司
Canada time zone:
Manager Ian Lin 说中文和英文
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

各国化妆品登记法规问答集

时间：2023/07/28 drafted by Yvonne Chen

HLF-TW-10
请问加拿大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 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，化妆品的监管由加拿大卫生部(HC)负责，化妆品是製造、销售或代表用于清洁、改善或改变肤色、皮肤、头发或牙齿的任何物质或物质混合物，包括除臭剂和香水。例如：肥皂、人造指甲、保湿剂、有色保湿霜（遮瑕膏）、纹身墨水、化妆产品、牙齿美白剂、清洁湿巾等。

如果产品分类不明确，加拿大卫生部将根据具体情况对产品进行分类，将依据以下条件进行判断：
1.描述：该产品是否被描述为具有美容功能，例如：清洁、保湿、润滑、添香或改变人类的头发、皮肤或牙齿。
2.产品的成分：虽然产品的成分本身并不一定决定其分类，但某种成分的存在或其浓度可能会使该产品不适合分类为化妆品。
3.作用程度: 化妆品通常涂抹在身体的表部，而不是被皮肤吸收以达到美容效果。

注意
1.化妆品可以涂在眼睛周围的皮肤上，但直接涂在眼睛上的产品不是化妆品。
2.除纹身墨水外，通过摄入、吸入或注射（例如肌内、皮下或静脉注射）施用的产品不属于化妆品。

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.

【参考连结】
https://www.canada.ca/en.html
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics.html

HLF-TW-20
外国公司要到加拿大销售化妆品，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 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：
无需营业特许证。
如果在加拿大製造、进口或销售产品，必须向加拿大卫生部报告涉及消费品的健康或安全事件。製造商、进口商有责任提供有关该事件的更多详细信息以及对受影响的消费品採取的任何纠正措施。
报告包含：

1. 产品讯息
   ．产品品牌和名称
   ．产品描述
   ．管道：商店或其他
   ．产品包装上的年龄建议
   ．产品编号
   ．製造或进口日期
   ． 产品购买日期
   ．产品製造或进口的地址
2. 事故信息
   ．伤患
   ．受伤类型
   ．事件发生日期
   ．事件描述
   ．医疗护理

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

【参考连结】
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
假如需要办理，请问加拿大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：
无需营业特许证。

HLF-TW-30
外国公司要到加拿大销售化妆品，可以指派加拿大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 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：
非居民进口商可以申请商业登记，註册商业登记时须留存一组当地(美国/加拿大)的实际地址。

非居民企业号码和帐户註册
1.网页：https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/gst-hst-businesses/digital-economy-gsthst/terms-conditions.html

2.需要资料
·GST/HST
·申请者身分、基本资料、联繫方式
·负责人基本资料、联繫方式
·企业名称、所有权类型(独资/合伙等)、行业类别、是否为註册公司(登记日期)
·联繫语言(英语/法语)
·公司电子邮件
·美洲实际联繫地址(美国/加拿大)
·商业活动内容(产品内容)
·是否已有加拿大税务局 (CRA) 的商业号码

产品责任
化妆品在加拿大销售，进口商有责任向加拿大卫生部报告涉及消费品的健康或安全事件，提供有关该事件的更多详细信息以及对受影响的消费品採取的任何纠正措施。
报告包含：

1. 产品讯息
   ．产品品牌和名称
   ．产品描述
   ．管道：商店或其他
   ．产品包装上的年龄建议
   ．产品编号
   ．製造或进口日期
   ． 产品购买日期
   ．产品製造或进口的地址
2. 事故信息
   ．伤患
   ．受伤类型
   ．事件发生日期
   ．事件描述
   ．医疗护理

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

【参考连结】
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
外国公司销售到加拿大化妆品本身，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 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，每个製造商和进口商应在製造商或进口商首次销售化妆品最迟 10 天向加拿大卫生部通报化妆品通知表格（CNF），可以线上通报或者缴交纸本。
1.网页：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妆品通知表格（CNF）内容：
．化妆品标籤上的製造商名称和地址
．名称
．功能
．成分列表(每种成分的准确浓度或包括该成分浓度的浓度范围)
．形式
．製造商、进口商或经销商在加拿大的名称和地址
．如果化妆品不是由标籤上姓名出现的人製造的，则需填上製造或配製该化妆品的人的姓名和地址
．申请人的姓名和职务
．文件和图片

标籤
1.化妆品标籤必须以英语和法语标示，但 INCI 名称除外。
2.必须抱持在正常销售和使用条件下、化妆品的整个使用寿命内，或者在可再填充容器的情况的整个使用寿命内，都维持清晰并且容易阅读。
3.内标籤应标明：製造商名称、製造商主要营业地址、化妆品的通用名或其功能的特性(除非该特性是显而易见的)。
4.外标籤应标明成分清单
．每种成分仅以其 INCI 名称列出。
．对于以一系列色调出售的化妆品、指甲油和珐琅，如果前面带有符号+/–或±或短语，则可以列出该范围内使用的所有着色剂。
．植物药必须至少指定 INCI 名称的属和种部分来列出。
．明细表中包含的成分可以通过明细表第 1 栏列出的欧盟俗名或第 2 栏和第 3 栏列出的相应英文和法文等效名称来列出。
．没有 INCI 名称的成分必须按其化学名称列出。
．成分必须按照其重量浓度的降序排列。
．浓度为 1% 或更低的成分和所有着色剂，无论其浓度如何，可以随机顺序列在浓度超过 1% 的成分之后。
．对于香精和香精，可在成分列表末尾分别插入香精和芳香一词，表明此类成分已添加到化妆品中。
．如果化妆品的直接容器或外包装太小，以至于标籤无法符合要求，则成分列表可以出现在标籤上、胶带或卡片贴在容器或包装上。
．如果化妆品装在没有外包装的装饰性容器中，成分列表可能会出现在贴在容器上的标籤、胶带或卡片上。
．如果化妆品没有外包装，且其尺寸、形状或纹理或其直接容器的尺寸、形状或纹理使其无法在其上黏贴标籤、胶带或卡片，容器中，成分列表可能会出现在销售点必须随附化妆品的传单中。
5.特殊要求
．含有对苯二胺或其他煤焦油染料基料或煤焦油中间体的染发剂必须在内标籤和外标籤上均带有警告、副作用及效果说明。
．含有汞或者其盐类及其衍生物作为防腐剂的化妆品，其外标籤应标明防腐剂的名称及其在化妆品中的浓度。
．用于生殖器区域并在压力容器中销售的除臭剂应在其内部和外部标籤上载：使用说明、适用条件、注意事项、警告等。
．加压容器内外标籤应显示危险符号，并附有小心/注意的提醒词，以及危险声明
6.安全包装
．任何人不得出售供人类使用的漱口水，除非该漱口水包含在安全包装中。
．安全包装的内部标籤必须带有引起人们注意的声明或插图，并且，如果只是外包装的一部分，外标籤还必须带有声明或插图。
．含有 5 mL 或更多甲醇的化妆品的内外标籤必须显示危险符号、提醒词、声明。
．含有600毫克或以上溴酸钠或50毫克或以上溴酸钾应放置在儿童接触不到的地方，如果意外摄入，应立即联繫毒物中心或医生。

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.
   .
   【参考连结】
   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：
可以，条件是在提出产品许可时要求提供至少一家位于加拿大的製造商或进口商的联繫信息。

每个製造商和进口商应在製造商或进口商首次销售化妆品最迟 10 天向加拿大卫生部通报化妆品通知表格（CNF），可以线上通报或者缴交纸本。
1.网页：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妆品通知表格（CNF）内容：
．化妆品标籤上的製造商名称和地址
．名称
．功能
．成分列表(每种成分的准确浓度或包括该成分浓度的浓度范围)
．形式
．製造商、进口商或经销商在加拿大的名称和地址
．如果化妆品不是由标籤上姓名出现的人製造的，则需填上製造或配製该化妆品的人的姓名和地址
．申请人的姓名和职务
．文件和图片

标籤
1.化妆品标籤必须以英语和法语标示，但 INCI 名称除外。
2.必须抱持在正常销售和使用条件下、化妆品的整个使用寿命内，或者在可再填充容器的情况的整个使用寿命内，都维持清晰并且容易阅读。
3.内标籤应标明：製造商名称、製造商主要营业地址、化妆品的通用名或其功能的特性(除非该特性是显而易见的)。
4.外标籤应标明成分清单
．每种成分仅以其 INCI 名称列出。
．对于以一系列色调出售的化妆品、指甲油和珐琅，如果前面带有符号+/–或±或短语，则可以列出该范围内使用的所有着色剂。
．植物药必须至少指定 INCI 名称的属和种部分来列出。
．明细表中包含的成分可以通过明细表第 1 栏列出的欧盟俗名或第 2 栏和第 3 栏列出的相应英文和法文等效名称来列出。
．没有 INCI 名称的成分必须按其化学名称列出。
．成分必须按照其重量浓度的降序排列。
．浓度为 1% 或更低的成分和所有着色剂，无论其浓度如何，可以随机顺序列在浓度超过 1% 的成分之后。
．对于香精和香精，可在成分列表末尾分别插入香精和芳香一词，表明此类成分已添加到化妆品中。
．如果化妆品的直接容器或外包装太小，以至于标籤无法符合要求，则成分列表可以出现在标籤上、胶带或卡片贴在容器或包装上。
．如果化妆品装在没有外包装的装饰性容器中，成分列表可能会出现在贴在容器上的标籤、胶带或卡片上。
．如果化妆品没有外包装，且其尺寸、形状或纹理或其直接容器的尺寸、形状或纹理使其无法在其上黏贴标籤、胶带或卡片，容器中，成分列表可能会出现在销售点必须随附化妆品的传单中。
5.特殊要求
．含有对苯二胺或其他煤焦油染料基料或煤焦油中间体的染发剂必须在内标籤和外标籤上均带有警告、副作用及效果说明。
．含有汞或者其盐类及其衍生物作为防腐剂的化妆品，其外标籤应标明防腐剂的名称及其在化妆品中的浓度。
．用于生殖器区域并在压力容器中销售的除臭剂应在其内部和外部标籤上载：使用说明、适用条件、注意事项、警告等。
．加压容器内外标籤应显示危险符号，并附有小心/注意的提醒词，以及危险声明
6.安全包装
．任何人不得出售供人类使用的漱口水，除非该漱口水包含在安全包装中。
．安全包装的内部标籤必须带有引起人们注意的声明或插图，并且，如果只是外包装的一部分，外标籤还必须带有声明或插图。
．含有 5 mL 或更多甲醇的化妆品的内外标籤必须显示危险符号、提醒词、声明。
．含有600毫克或以上溴酸钠或50毫克或以上溴酸钾应放置在儿童接触不到的地方，如果意外摄入，应立即联繫毒物中心或医生。

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.

【参考连结】
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
经过核准登记的化妆品，进口到加拿大要检附什麽文件？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 Canada? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
进口化妆品需完成进口预先通知；销售至少10天前须完成通报。

进口商每次进口前必须向加拿大卫生部提前申请，受监管方可以在一张表格上填写 3 个月内多次进口的计画。
进口预先通知表为新办理的试点计划，进口商需要：
1.确保产品符合加拿大法律
2.与检查局索取表格，须提供：公司详细信息、运输详细信息和产品详细信息，并概述将要进行的更正/修改。
3.发货前通过电子邮件将表格提交给所在地区的加拿大卫生部办公室。
4.确保产品在进口后 3 个月内重新贴标或修改。

海关进口流程
1.登记註册商业号码(BN)或增加进/出口帐户识别码至现有的 BN
网页：
https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/registering-your-business/register.html
2.申请进口许可证：需表明化妆品符合加拿大化妆品市场的所有要求，如包装、标籤、配料表等。
3.提交进口申报书和商检申报：需与加拿大海关联繫并向其备案所要进口的化妆品类别、品项、品牌及数量等信息。同时提供化妆品的包装、标籤、配料表等必要信息。
4.商检、海关查验：海关会在一系列检查中检验包装、标籤和配料表是否符合标准，同时也会检查货物是否有破损或受到危险物质汙染。
5.所需文件：
．货运提单
．海关发票或商业发票，标明买家、卖家、原产地、价格及货物的详细说明，以及数量、单价。
．进口许可证
．装箱单
．装运前检验证书
．其他文件：保险证书、符合优惠关税的提单等。

需要，每个製造商和进口商应在製造商或进口商首次销售化妆品最迟 10 天向加拿大卫生部通报化妆品通知表格（CNF），可以线上通报或者缴交纸本。
1.网页：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妆品通知表格（CNF）内容：
．化妆品标籤上的製造商名称和地址
．名称
．功能
．成分列表(每种成分的准确浓度或包括该成分浓度的浓度范围)
．形式
．製造商、进口商或经销商在加拿大的名称和地址
．如果化妆品不是由标籤上姓名出现的人製造的，则需填上製造或配製该化妆品的人的姓名和地址
．申请人的姓名和职务
．文件和图片

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

【参考连结】
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：
化妆品良好生产规范 (GMP)
1.加拿大卫生部鼓励所有化妆品製造商遵守良好生产规范 (GMP)，认可使用国际标准组织(ISO) 化妆品良好生产规范指南（ISO 标准 22716）。
2.GMP 是用于确保产品质量控制和风险管理的有效方法的生产指南。规定了产品製造、测试、储存、处理和分销的标准，以确保製造的每个步骤对于产品的质量和安全都是可接受的。
3.GMP 没有提供产品生产方式的具体细节，是概述了流程的预期结果。每个製造商可能有实现这些成果的独特方法。

製造化妆品时的一些重要注意事项，以确保其不受汙染

1. 建筑及设施
   ．建筑足以生产和储存化妆品
   ．牆壁、地板、固定装置、管道、管道、照明、通风、供水、排水、卫生间设施适合工作且维护良好
   ．建筑物有足够的空气供应质量
   ．建筑物有足够的害虫防治计划，以防止吸引或藏匿害虫
   2.设备
   ．加工过程中使用的设备充足、维护良好且无汙染
   3.人员
   ．人员有足够的教育、培训、经验和个人清洁度
   4.原料
   ．储存和处理原材料以防止汙染或变质
   ．材料经过测试或检查以确保质量
2. 生产
   ．建立製造和控製程序并维护程序的书面说明
   6.实验室控制
   ．对原材料、样品和成品进行测试或检查，以确保其符合规定的标准
   ．供水不受汙染
3. 记录
   ．保存原材料、製造、成品和分销的记录
4. 标籤
   ．成品上的标籤包含所需信息
5. 投诉
   ．企业保留消费者投诉档案
6. 其他
   ．产品符合所有监管要求
   ．产品不含违禁成分或物质

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

【参考连结】
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
外国子公司进口化妆品后，如果委託加拿大的经销商销售，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 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：
无需营业许可证，但製造/进口商首次销售化妆品最迟 10 天向加拿大卫生部通报化妆品通知表格（CNF），可以线上通报或者缴交纸本。
1.网页：https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2.化妆品通知表格（CNF）内容：
．化妆品标籤上的製造商名称和地址
．名称
．功能
．成分列表(每种成分的准确浓度或包括该成分浓度的浓度范围)
．形式
．製造商、进口商或经销商在加拿大的名称和地址
．如果化妆品不是由标籤上姓名出现的人製造的，则需填上製造或配製该化妆品的人的姓名和地址
．申请人的姓名和职务
．文件和图片

产品责任
化妆品在加拿大销售，进口商有责任向加拿大卫生部报告涉及消费品的健康或安全事件，提供有关该事件的更多详细信息以及对受影响的消费品採取的任何纠正措施。
报告包含：

1. 产品讯息
   ．产品品牌和名称
   ．产品描述
   ．管道：商店或其他
   ．产品包装上的年龄建议
   ．产品编号
   ．製造或进口日期
   ． 产品购买日期
   ．产品製造或进口的地址
2. 事故信息
   ．伤患
   ．受伤类型
   ．事件发生日期
   ．事件描述
   ．医疗护理

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

【参考连结】
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

各国化妆品登记法规问答集

Email：yto4ww@evershinecpa.com
或
加拿大永辉BPO有限公司
接洽人:
Vincent Wang 加拿大籍来自台湾
或
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
全球永辉服务据点参考资料:
永辉100%关係企业
永辉总部、台北永辉、厦门永辉、北京永辉、上海那灵、深圳常新、纽约永辉、加州永辉、德州永辉、凤凰城永辉、东京永辉、首尔永辉、河内永辉、越南胡志明、曼谷永辉、新加坡永辉、吉隆玻永辉、雅加达永辉、马尼拉永辉、墨尔本永辉、澳洲雪梨、孟加拉永辉、新德里永辉、印度孟买、杜拜永辉、法兰克福永辉、巴黎永辉、伦敦永辉、荷兰永辉、西班牙永辉、义大利永辉、罗马尼亚永辉、多伦多永辉、墨西哥永辉、捷克永辉。
其他已提供中文化服务城市：
迈阿密、亚特兰大、俄克拉荷马、密歇根、西雅图、特拉华；
柏林; 斯图加特;布拉格；布加勒斯特；班加罗尔；泗水；
高雄、香港、深圳、东关、广州、清远、永康、杭州、苏州、崑山、南京、重庆、许昌、青岛、天津。
永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

更多城市更多服务 请点击 网站导览