澳洲化妆品登记法规问题集

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各国化妆品登记法规问答集

时间：2023/08/24 drafted by Yvonne Chen

HLF-TW-10
请问澳洲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 Australia? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
在澳洲，美容产品根据用途分为两类：化妆品和治疗用品。
1.化妆品：与人体表层(表皮、头发和毛细血管、指甲、嘴唇和外生殖器)，或牙齿和口腔黏膜接触的任何物质或混合物。以清洁、发出香味、改善外观、改善身体气味或保护身体使之保持良好状态为主要目的的物质和製剂。包括肥皂、洗发水和护发素、保湿霜、泡澡球、染发剂、香水、口红、睫毛膏、指甲油、除臭剂和许多其他产品，化妆品的成分可能是工业化学品。
2.治疗用品：预防、诊断或治疗疾病，或者影响人体结构/功能的产品，包括大多数美白乳液、防晒霜、消毒剂、脱敏牙膏、补充药物和血液製品等。

化妆品的监管由三个政府监管机构负责管理：
1.治疗用品管理局(TGA)：监管治疗商品的营销和供应，即营销为具有治疗效果的药品和产品
2.澳洲工业化学品引进计划 (AICIS)：隶属于澳洲政府卫生部，负责监管工业用途进口或製造的化学品。化妆品中的成分即使是天然也作为工业化学品进行监管，但是AICIS 不监管治疗商品。
3.澳洲竞争和消费者委员会(ACCC)：负责监管化妆品标籤、产品安全。

In Australia, beauty products are divided into two categories according to their use: cosmetics and therapeutic products.

1. Cosmetics: any substance or mixture that comes into contact with the surface of the human body (epidermal, hair and capillaries, nails, lips and external genitalia), or teeth and oral mucosa. Substances and preparations whose primary purpose is to cleanse, to scent, to improve appearance, to improve body odor or to keep the body in good condition. Including soaps, shampoos and conditioners, moisturizers, bath bombs, hair dyes, perfumes, lipsticks, mascaras, nail polishes, deodorants, and many other products, the ingredients in cosmetics can be industrial chemicals.
2. Therapeutic products: products that prevent, diagnose or treat diseases, or affect the structure/function of the human body, including most whitening lotions, sunscreens, disinfectants, desensitizing toothpastes, supplementary medicines and blood products, etc.

The regulation of cosmetics is administered by three government regulatory agencies:

1. Therapeutic Goods Administration (TGA): Regulates the marketing and supply of therapeutic goods, that is, drugs and products marketed as having a therapeutic effect
2. Australian Industrial Chemicals Introduction Scheme (AICIS): It belongs to the Australian Government Department of Health and is responsible for the supervision of chemicals imported or manufactured for industrial purposes. Ingredients in cosmetics are regulated as industrial chemicals even if they are natural, but AICIS does not regulate therapeutic commodities.
3. Australian Competition and Consumer Commission (ACCC): responsible for supervising cosmetic labeling and product safety.

【参考连结】
https://www.industrialchemicals.gov.au/glossary/cosmetics
https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic

HLF-TW-20
外国公司要到澳洲销售化妆品，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 Australia, 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：
欲在澳洲销售从海外购买的化妆品，无论销售多少，都必须在进口到澳洲之前先向AICIS完成商业註册。
商业註册
1.期限：自註册日起每年 8 月 31 日到期。
2.网页：
https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
3.外国公司：外国(非澳洲)企业，需要先取得澳洲註册机构号码 (ARBN)。
4.流程：
．註册帐户
．阅读免责声明
．输入企业代码(澳洲企业ABN；外国企业ARBN)
．密码重置并登入系统
．输入上一年度(7/1-6/30)期间进口的工业化学品的价值(澳元)。并确认资料无误。如果是首次註册，并且上一财政年度没有引入工业化学品，请输入 0 澳元。
．付款、确认註册后取得企业名称和註册号。
5.註册费：註册费用取决于上一年度(7/1-6/30)进口的工业化学品价值。
6.工业化学品的价值=海关价值+保险和运费+关税+劳动力和材料成本+工厂成本。

澳洲註册机构号码 (ARBN)
1.网址：
https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/registrable-australian-bodies/#registeredbody
2.流程
第 1 步-确保名称可用：https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/company-name-availability/
第 2 步-缴交 401 表格
．公司/组织
．联繫人姓名/职位描述
．ASIC 註册代理号码(如果适用)
．电话号码、地址
．法人团体名称
．公司成立/註册的州或地区
．该机构成立或成立所依据的立法
．是否已缴交姓名保留以保留机构的名称？ 如果是，请提供姓名；如果不是，提议的名称是否与在澳洲註册的企业名称相同？如果是，请提供企业名称註册详细资讯
．声明书
．註册办事处的单位、级别、街道号码、街道名称、郊区/城市、州/地区、邮政编码、工作时间、公司是否佔用场地？
．董事或负责人的详细资讯：担任职务、任命日期、名字或公司名称、居住地址、街道号码和街道名称、郊区/城市、州/地区、邮政编码、国家(如果不是澳洲)、出生地(城镇/城市)(州/国家)
．申请人声明：名称、身份、签名、签署日期
第 3 步-附上证明文件
．公司註册/註册证书的核证副本。
．经认证的机构章程副本(例如组织章程大纲和章程细则)。
．董事/高级职员以书面形式发表声明。
第 4 步-缴交表格并缴交费用
．申请表必须由董事或授权人员签署。
．邮寄至：澳洲证券和投资委员会。

If you plan to sell any cosmetics purchased from overseas in Australia, no matter how much you sell, you must complete commercial registration with AICIS before importing into Australia.
business registration
1.Term: expires on August 31 every year from the date of registration.
2.URL:
https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
3.Foreign companies: Foreign (non-Australian) companies need to obtain an Australian Registered Body Number (ARBN).
4.Process:
．Register account
．Read the disclaimer
．Enter the business code (ABN for Australian companies; ARBN for foreign companies)
．Password reset and login system
．Enter the value (AUD) of industrial chemicals imported during the previous year (7/1-6/30). And confirm that the information is correct. If you are registering for the first time and no industrial chemicals were introduced in the previous financial year, please enter AUD 0.
．After payment and confirmation of registration, the company name and registration number are obtained.
5.Registration fee: The registration fee depends on the value of industrial chemicals imported in the previous year (7/1-6/30).
6.The value of industrial chemicals = customs value + insurance and freight + customs duties + labor and material costs + factory costs.

Australian Registered Body Number (ARBN)

1. URL:
   https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/registrable-australian-bodies/#registeredbody
2. Process
   Step 1 – Make sure the name is available:
   https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/company-name-availability/
   Step 2 – Submit Form 401
   ．Company/organization
   ．Contact Name/Job Description
   ．ASIC registered agent number (if applicable)
   ．Phone number, address
   ．Body corporate name
   ．State or territory of incorporation/incorporation
   ．The legislation under which the institution was established or established
   ．Has a name reservation been filed to reserve the institution’s name? If yes, please provide the name; if no, is the proposed name the same as the business name registered in Australia? If yes, please provide business name registration details
   ．Statement
   ．Unit, Class, Street Number, Street Name, Suburb/City, State/Region, Zip Code, Hours of Operation, Does the Company Occupy Space of Registered Office?
   ．Details of director or principal: position held, date of appointment, name or company name, residential address, street number and name, suburb/city, state/territory, postcode, country (if not Australia), place of birth (town) /city)(state/country)
   ．Applicant Statement: Name, Identity, Signature, Date Signed
   Step 3 – Attach supporting documents
   ． Certified copy of Certificate of Incorporation/Incorporation.
   ． Certified copy of the constitution of the institution (e.g. Memorandum and Articles of Association).
   ． Directors/Officers make a statement in writing.
   Step 4 – Submit the form and pay the fee
   ． The application form must be signed by a director or authorized officer.
   ． Mail to: Australian Securities and Investments Commission.

【参考连结】
https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-much-my-registration-fee
https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
https://www.industrialchemicals.gov.au/cosmetics-and-soap/personal-care-skincare-make-and-other-cosmetic-products

HLF-TW-25

HLF-TW-30
外国公司要到澳洲销售化妆品，可以指派澳洲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 Australia, can it assign a Australia 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，营业代理人须为澳洲企业，并已具备澳洲註册机构号码(ABN)必须在进口到澳洲之前先向AICIS完成商业註册。

商业註册
1.期限：自註册日起每年 8 月 31 日到期。
2.网页：https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
3.须为澳洲企业，并已具备澳洲註册机构号码(ABN)
4.流程：
．註册帐户
．阅读免责声明
．输入企业代码(ABN)。
．密码重置并登入系统
．输入上一年度(7/1-6/30)期间进口的工业化学品的价值(澳元)。并确认资料无误。如果是首次註册，并且您在上一财政年度没有引入工业化学品，请输入 0 澳元。
．付款、确认註册后取得企业名称和註册号。
5.註册费：註册费用取决于上一年度(7/1-6/30)进口的工业化学品价值。
6.工业化学品的价值=海关价值+保险和运费+关税+劳动力和材料成本+工厂成本。

产品责任
如果产品未达到公众普遍期望的安全水平，则该产品存在安全缺陷。虽然预期的安全水平因情况而异，但最终要由法院来确定产品是否存在安全缺陷。针对产品责任，为製造商的责任。

供应商有监察、报告之责任，当发现产品安全疑虑时，供应商(包含进口商、经销商必须尽所知在2天内完成报告，强制性报告是保密的，报告并不意味着承认责任，但如果应该缴交强制性报告而没有缴交，可能会被判犯有刑事罪或被罚款。

Yes, the business agent must be an Australian company, and has an Australian Registered Body Number (ABN) and must first complete the commercial registration with AICIS before importing into Australia.

Business registration

1. Term: expires on August 31 every year from the date of registration.
2. URL:
   https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
3. It must be an Australian company and have an Australian Registration Number (ABN)
4. Process:
   ．Register account
   ．Read the disclaimer
   ．Enter the Business Number (ABN).
   ．Password reset and login system
   ．Enter the value (AUD) of industrial chemicals imported during the previous year (7/1-6/30). And confirm that the information is correct. If you are registering for the first time and you have not introduced industrial chemicals in the last financial year, please enter $0.
   ．After payment and confirmation of registration, the company name and registration number are obtained.
5. Registration fee: The registration fee depends on the value of industrial chemicals imported in the previous year (7/1-6/30).
6. The value of industrial chemicals = customs value + insurance and freight + customs duties + labor and material costs + factory costs.

Product liability
A product has a safety defect if it does not meet the level of safety generally expected by the public. While the expected level of safety varies from case to case, ultimately it is up to the courts to determine whether a product has a safety defect. For product liability, it is the responsibility of the manufacturer.

Suppliers have the responsibility to monitor and report. When product safety concerns are discovered, suppliers (including importers and distributors must complete the report within 2 days to the best of their knowledge. Mandatory reports are confidential, and reporting does not mean admitting responsibility. However, failing to make the mandatory report may result in a criminal offense or a fine.

【参考连结】
https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
https://www.productsafety.gov.au/product-safety-laws/legislation/mandatory-reporting

HLF-TW-35

HLF-TW-40
外国公司销售到澳洲化妆品本身，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 Australia? 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：
治疗用品需要完成TGA产品註册，而化妆品无产品许可。

化妆品无产品许可，但在进口和/或生产化妆品之前，企业必须检查产品的所有化妆品成分是否已列入AICS并符合使用条件。如果是，只要满足任何相关条件，该产品就可以进口或製造，无需通知 NICNAS。如果任何一种成分未列在清单中或使用条件与预期用途不同，则对澳洲来说，它是一种新的工业化学品，需要向 NICNAS 通报并评估其对环境和人类健康的风险。

治疗用品产品註册

1. 註册帐号 (Client ID)
   ．担保人：担保人必须是澳洲居民或澳洲的法人团体并有在澳洲开展业务，且公司代表居住在澳洲。
   ．详细地址：街道、郊区/州、邮政编码、邮寄地址、公司联繫方式、账单详细讯息、电子邮件、电话、帐单电子邮件。
   ．组织管理者：管理员全名(负责建立和维护组织的联繫)、电子邮件、电话。
   ．澳洲代表：必须保留至少一名澳洲代表，境外代理商请指定您所在组织的澳洲代表作为授权联繫人，需留存全名、电子邮件、电话。
   ．声明。
   2.缴交：电子邮件交至 TGA TBS 服务台：ebs@health.gov.au
   3.产品註册
   ．风险较高的药物必须在澳洲治疗产品登记册 (ARTG) 上註册，其中涉及对产品的品质、安全性和有效性进行单独评估。
   ．含有预先批准的低风险成分且声明有限的低风险药物可以在 (ARTG)上列出。
   4.产品註册资料：标籤(包括标籤清单)、广告、SPF 测试结果的再现性、稳定性测试、製造和品质控制、允许的成分、新成分。
   5.网页：https://www.tga.gov.au/

标籤
1.成分列表
．按体积或品质(颜色除外)降序列出浓度为 1% 或更高的成分。低于 1% 的成分以任意顺序列标示(颜色除外)。最后，颜色添加剂标示可能含有或+/-标题下以任意顺序列出。需要注意的是，如果在配料时可能添加产品中的颜色添加剂用于颜色匹配，或者将其用于一系列化妆品中的一种或多种，则可能会列出产品中不存在的颜色添加剂。该清单必须清晰易读并显着地显示在包装上。
．成分列表必须在产品本身上。如果容器空间/尺寸有限，则需要显示标籤讯息以告知消费者。
．成分名称可以写为英文名称或国际命名化妆品成分 (INCI) 名称。
．如果产品包含任何风味(即用于产生或掩盖特定风味的材料或组合)，则成分列表必须包括以下词语之一：风味、香气。
．如果产品包含任何香料，则成分列表必须包含以下词语之一：香料、香料、香水。
．化妆品中的所有成分都必须列在澳洲化学物质名录 (AICS)中，或通知 NICNAS 进行上市前评估，除非适用豁免条件(免费样品/测试仪，以及治疗用品)。所有未列入 AICS 并通知 NICNAS 的成分都将接受公共卫生、工作健康和安全以及环境风险评估。
2.声明
．化妆品标籤上的声明通常由所使用的成分决定，特别是浓度。声明必须确保它们仅与化妆品相关，并且不提供任何治疗措施。所有主张都必须得到适当证实。
．如有纠纷需申请索赔时，可以通过以下方式证实：临床测试、感官测试、市场调查、技术文献。

3.包装
预包装货物
．重量：重量的测量可以通过预包装货物的共同测量或恆定标称含量的两种方法来确定。
．统一贸易计量立法 (UTML)
．样品量的平均含量不能少于包装上註明的数量。预包装产品的重量不足不得超过规定重量的5%。
．对肥皂或包装后重量减轻的产品等物品进行补贴。
．平均数量系统 (AQS) 。
．查看预包装物品生产过程中样品的平均淨含量，测量的数量不能少于包装上列出的数量。
．少数文章可能超出可容忍的缺陷。
．样本中的任何物品的含量均不得超过规定的可容忍赤字的两倍。
位置
．重量或体积测量必须显示在包装的主要部分。向买家展示的部分必须是其中之一。
．圆柱形、球形、椭圆形或圆锥形包装应具有测量标记，该测量标记完全包含在垂直穿过主显示面板中心的线两侧的 60 度弧内。
．如果採用压印或压花代替印刷，则测量标记的尺寸必须至少是上述最小印刷字符尺寸的三倍。

4.姓名和地址
．包装者(或其所属人员)的姓名和街道地址必须在澳洲包装的产品上清晰可见。地址必须是澳洲境内的街道地址，不允许使用其他地址。
．未要求尺寸或位置，但必须清晰可辨。

5.成分
．产品上所列成分的讯息应在销售点向消费者提供。
．成分清单必须列在容器或外包装/纸箱上。
．如果容器的尺寸、形状或性质无法通过上述任何方法进行成分标记，则可以在销售点附上一份额外的传单显示，以便消费者了解。

6.其他
．开封后期限 (PAO)：时间段以月和/或年为单位，在符号内部或旁边表示。
．原产地、原产国声明。
．产品声明、製造声明。
网页：https://www.industrialchemicals.gov.au/

Therapeutic supplies need to complete TGA product registration, and cosmetics have no product license.

There is no product license for cosmetics, but before importing and/or producing cosmetics, enterprises must check whether all cosmetic ingredients of the product are listed on AICS and meet the conditions for use. If yes, the product may be imported or manufactured without notification to NICNAS provided any relevant conditions are met. If any ingredient is not on the list or is used in conditions other than the intended use, it is a new industrial chemical to Australia and needs to be notified to NICNAS and assessed for risk to the environment and human health.

Therapeutic Goods Product Registration

1. Register account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Mailing Address, Business Contact, Billing Details, Email, Phone, Billing Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ．Statement.
2. Submit: Email to TGA TBS Service Desk: ebs@health.gov.au
3. Product registration
   ．Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves an individual assessment of the quality, safety and effectiveness of the product.
   ．Low-risk medicines that contain pre-approved low-risk ingredients with limited claims can be listed on (ARTG).
4. Product registration information: label (including label list), advertisement, reproducibility of SPF test results, stability test, manufacturing and quality control, allowed ingredients, new ingredients.
5. URL: https://www.tga.gov.au/

Label

1. List of ingredients
   ．List ingredients with a concentration of 1% or greater in descending order by volume or quality (except color). Ingredients below 1% are listed in random order (except color). Finally, color additive designations may contain or be listed under the +/- heading in any order. It should be noted that color additives that are not present in the product may be listed if they may be added to the product for color matching at the time of formulation, or if they are used in one or more of a range of cosmetic products. This list must be legible and prominently displayed on the packaging.
   ．The ingredient list must be on the product itself. If container space/size is limited, a label message needs to be displayed to inform consumers.
   ． Ingredient names can be written as English names or International Nominated Cosmetic Ingredients (INCI) names.
   ．If the product contains any flavors (i.e. materials or combinations used to create or mask a particular flavor), the ingredients list must include one of the following words: flavor, aroma.
   ．If the product contains any fragrances, the ingredients list must contain one of the following words: fragrance, fragrance, fragrance.
   ．All ingredients in cosmetic products must be listed on the Australian Inventory of Chemical Substances (AICS) or notified to NICNAS for pre-market assessment unless an exemption applies (free samples/testers, and therapeutic supplies). All ingredients not listed on AICS and notified to NICNAS will be subject to public health, work health and safety and environmental risk assessments.
2. Declaration
   ．Claims on cosmetic labels are often determined by the ingredients used, especially the concentration. Claims must ensure that they are cosmetic only and do not provide any therapeutic action. All claims must be properly substantiated.
   ．If there is a dispute and it is necessary to apply for a claim, it can be confirmed by the following methods: clinical testing, sensory testing, market research, technical literature.
3. Packaging
   prepackaged goods
   ．Weight: The measurement of weight can be determined by two methods of common measurement of prepackaged goods or constant nominal content.
   ．Uniform Trade Measurement Legislation (UTML)
   ．The average content of the sample size cannot be less than the amount indicated on the package. The underweight of pre-packaged products shall not exceed 5% of the specified weight.
   ．Subsidize items such as soap or products that reduce weight after packaging.
   ．Average Quantity System (AQS).
   ．Look at the average net content of samples during the production of the prepackaged item and measure no less than the amount listed on the packaging.
   ．A small number of articles may have more than tolerable defects.
   ．The amount of any item in the sample shall not exceed twice the stated tolerable deficit.
   Location
   ．Weight or volume measurements must be shown on the main part of the packaging. The part shown to buyers has to be one of these.
   ．Cylindrical, spherical, elliptical, or conical packages shall have measurement marks fully contained within a 60-degree arc on either side of a line perpendicular to the center of the primary display panel.
   ．If embossing or embossing is used instead of printing, the measurement marks must be at least three times the size of the minimum printed characters above.
4. Name and address
   ．The name and street address of the packer (or the person to whom it belongs) must be clearly visible on the product packed in Australia. The address must be a street address in Australia, other addresses are not allowed.
   ．Size or position is not required, but must be legible.
5. Ingredients
   ．Information on the ingredients listed on products should be provided to consumers at the point of sale.
   ．The ingredient list must be listed on the container or outer packaging/carton.
   ．If the size, shape or nature of the container does not permit ingredient labeling by any of the above methods, an additional leaflet display may be attached at the point of sale for consumers to know.
6. Other
   ．Post Open Period (PAO): Time period in months and/or years, indicated inside or next to the symbol.
   ．Declaration of origin, country of origin.
   ．Product declaration, manufacturing declaration.
   URL: https://www.industrialchemicals.gov.au/

【参考连结】
https://ascc.com.au/cosmetic-labelling-australia/
https://www.industrialchemicals.gov.au/cosmetics-and-soap/personal-care-skincare-make-and-other-cosmetic-products#what-are-my-obligations-as-an-importer-or-manufacturer-of-cosmetics

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
可以，治疗用品需要完成TGA产品註册，而化妆品无产品许可。

化妆品无产品许可，但在进口和/或生产化妆品之前，企业必须检查产品的所有化妆品成分是否已列入AICS并符合使用条件。如果是，只要满足任何相关条件，该产品就可以进口或製造，无需通知 NICNAS。如果任何一种成分未列在清单中或使用条件与预期用途不同，则对澳洲来说，它是一种新的工业化学品，需要向 NICNAS 通报并评估其对环境和人类健康的风险。

治疗用品产品註册

1. 註册帐号 (Client ID)
   ．担保人：担保人必须是澳洲居民或澳洲的法人团体并有在澳洲开展业务，且公司代表居住在澳洲。
   ．详细地址：街道、郊区/州、邮政编码、邮寄地址、公司联繫方式、账单详细讯息、电子邮件、电话、帐单电子邮件。
   ．组织管理者：管理员全名(负责建立和维护组织的联繫)、电子邮件、电话。
   ．澳洲代表：必须保留至少一名澳洲代表，境外代理商请指定您所在组织的澳洲代表作为授权联繫人，需留存全名、电子邮件、电话。
   ．声明。
   2.缴交：电子邮件交至 TGA TBS 服务台：ebs@health.gov.au
   3.产品註册
   ．风险较高的药物必须在澳洲治疗产品登记册 (ARTG) 上註册，其中涉及对产品的品质、安全性和有效性进行单独评估。
   ．含有预先批准的低风险成分且声明有限的低风险药物可以在 (ARTG)上列出。
   4.产品註册资料：标籤(包括标籤清单)、广告、SPF 测试结果的再现性、稳定性测试、製造和品质控制、允许的成分、新成分。
   5.网页：https://www.tga.gov.au/

标籤
1.成分列表
．按体积或品质(颜色除外)降序列出浓度为 1% 或更高的成分。低于 1% 的成分以任意顺序列标示(颜色除外)。最后，颜色添加剂标示可能含有或+/-标题下以任意顺序列出。需要注意的是，如果在配料时可能添加产品中的颜色添加剂用于颜色匹配，或者将其用于一系列化妆品中的一种或多种，则可能会列出产品中不存在的颜色添加剂。该清单必须清晰易读并显着地显示在包装上。
．成分列表必须在产品本身上。如果容器空间/尺寸有限，则需要显示标籤讯息以告知消费者。
．成分名称可以写为英文名称或国际命名化妆品成分 (INCI) 名称。
．如果产品包含任何风味(即用于产生或掩盖特定风味的材料或组合)，则成分列表必须包括以下词语之一：风味、香气。
．如果产品包含任何香料，则成分列表必须包含以下词语之一：香料、香料、香水。
．化妆品中的所有成分都必须列在澳洲化学物质名录 (AICS)中，或通知 NICNAS 进行上市前评估，除非适用豁免条件(免费样品/测试仪，以及治疗用品)。所有未列入 AICS 并通知 NICNAS 的成分都将接受公共卫生、工作健康和安全以及环境风险评估。
2.声明
．化妆品标籤上的声明通常由所使用的成分决定，特别是浓度。声明必须确保它们仅与化妆品相关，并且不提供任何治疗措施。所有主张都必须得到适当证实。
．如有纠纷需申请索赔时，可以通过以下方式证实：临床测试、感官测试、市场调查、技术文献。

3.包装
预包装货物
．重量：重量的测量可以通过预包装货物的共同测量或恆定标称含量的两种方法来确定。
．统一贸易计量立法 (UTML)
．样品量的平均含量不能少于包装上註明的数量。预包装产品的重量不足不得超过规定重量的5%。
．对肥皂或包装后重量减轻的产品等物品进行补贴。
．平均数量系统 (AQS) 。
．查看预包装物品生产过程中样品的平均淨含量，测量的数量不能少于包装上列出的数量。
．少数文章可能超出可容忍的缺陷。
．样本中的任何物品的含量均不得超过规定的可容忍赤字的两倍。
位置
．重量或体积测量必须显示在包装的主要部分。向买家展示的部分必须是其中之一。
．圆柱形、球形、椭圆形或圆锥形包装应具有测量标记，该测量标记完全包含在垂直穿过主显示面板中心的线两侧的 60 度弧内。
．如果採用压印或压花代替印刷，则测量标记的尺寸必须至少是上述最小印刷字符尺寸的三倍。

4.姓名和地址
．包装者(或其所属人员)的姓名和街道地址必须在澳洲包装的产品上清晰可见。地址必须是澳洲境内的街道地址，不允许使用其他地址。
．未要求尺寸或位置，但必须清晰可辨。

5.成分
．产品上所列成分的讯息应在销售点向消费者提供。
．成分清单必须列在容器或外包装/纸箱上。
．如果容器的尺寸、形状或性质无法通过上述任何方法进行成分标记，则可以在销售点附上一份额外的传单显示，以便消费者了解。

6.其他
．开封后期限 (PAO)：时间段以月和/或年为单位，在符号内部或旁边表示。
．原产地、原产国声明。
．产品声明、製造声明。
网页：https://www.industrialchemicals.gov.au/

Yes, therapeutic supplies need to complete TGA product registration, and cosmetics have no product license.

There is no product license for cosmetics, but before importing and/or producing cosmetics, enterprises must check whether all cosmetic ingredients of the product are listed on AICS and meet the conditions for use. If yes, the product may be imported or manufactured without notification to NICNAS provided any relevant conditions are met. If any ingredient is not on the list or is used in conditions other than the intended use, it is a new industrial chemical to Australia and needs to be notified to NICNAS and assessed for risk to the environment and human health.

Therapeutic Goods Product Registration

1. Register account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Mailing Address, Business Contact, Billing Details, Email, Phone, Billing Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ．Statement.
2. Submit: Email to TGA TBS Service Desk: ebs@health.gov.au
3. Product registration
   ．Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves an individual assessment of the quality, safety and effectiveness of the product.
   ．Low-risk medicines that contain pre-approved low-risk ingredients with limited claims can be listed on (ARTG).
4. Product registration information: label (including label list), advertisement, reproducibility of SPF test results, stability test, manufacturing and quality control, allowed ingredients, new ingredients.
5. URL: https://www.tga.gov.au/

Label

1. List of ingredients
   ．List ingredients with a concentration of 1% or greater in descending order by volume or quality (except color). Ingredients below 1% are listed in random order (except color). Finally, color additive designations may contain or be listed under the +/- heading in any order. It should be noted that color additives that are not present in the product may be listed if they may be added to the product for color matching at the time of formulation, or if they are used in one or more of a range of cosmetic products. This list must be legible and prominently displayed on the packaging.
   ．The ingredient list must be on the product itself. If container space/size is limited, a label message needs to be displayed to inform consumers.
   ． Ingredient names can be written as English names or International Nominated Cosmetic Ingredients (INCI) names.
   ．If the product contains any flavors (i.e. materials or combinations used to create or mask a particular flavor), the ingredients list must include one of the following words: flavor, aroma.
   ．If the product contains any fragrances, the ingredients list must contain one of the following words: fragrance, fragrance, fragrance.
   ．All ingredients in cosmetic products must be listed on the Australian Inventory of Chemical Substances (AICS) or notified to NICNAS for pre-market assessment unless an exemption applies (free samples/testers, and therapeutic supplies). All ingredients not listed on AICS and notified to NICNAS will be subject to public health, work health and safety and environmental risk assessments.
2. Declaration
   ．Claims on cosmetic labels are often determined by the ingredients used, especially the concentration. Claims must ensure that they are cosmetic only and do not provide any therapeutic action. All claims must be properly substantiated.
   ．If there is a dispute and it is necessary to apply for a claim, it can be confirmed by the following methods: clinical testing, sensory testing, market research, technical literature.
3. Packaging
   prepackaged goods
   ．Weight: The measurement of weight can be determined by two methods of common measurement of prepackaged goods or constant nominal content.
   ．Uniform Trade Measurement Legislation (UTML)
   ．The average content of the sample size cannot be less than the amount indicated on the package. The underweight of pre-packaged products shall not exceed 5% of the specified weight.
   ．Subsidize items such as soap or products that reduce weight after packaging.
   ．Average Quantity System (AQS).
   ．Look at the average net content of samples during the production of the prepackaged item and measure no less than the amount listed on the packaging.
   ．A small number of articles may have more than tolerable defects.
   ．The amount of any item in the sample shall not exceed twice the stated tolerable deficit.
   Location
   ．Weight or volume measurements must be shown on the main part of the packaging. The part shown to buyers has to be one of these.
   ．Cylindrical, spherical, elliptical, or conical packages shall have measurement marks fully contained within a 60-degree arc on either side of a line perpendicular to the center of the primary display panel.
   ．If embossing or embossing is used instead of printing, the measurement marks must be at least three times the size of the minimum printed characters above.
4. Name and address
   ．The name and street address of the packer (or the person to whom it belongs) must be clearly visible on the product packed in Australia. The address must be a street address in Australia, other addresses are not allowed.
   ．Size or position is not required, but must be legible.
5. Ingredients
   ．Information on the ingredients listed on products should be provided to consumers at the point of sale.
   ．The ingredient list must be listed on the container or outer packaging/carton.
   ．If the size, shape or nature of the container does not permit ingredient labeling by any of the above methods, an additional leaflet display may be attached at the point of sale for consumers to know.
6. Other
   ．Post Open Period (PAO): Time period in months and/or years, indicated inside or next to the symbol.
   ．Declaration of origin, country of origin.
   ．Product declaration, manufacturing declaration.
   URL: https://www.industrialchemicals.gov.au/

【参考连结】
https://ascc.com.au/cosmetic-labelling-australia/
https://www.industrialchemicals.gov.au/cosmetics-and-soap/personal-care-skincare-make-and-other-cosmetic-products#what-are-my-obligations-as-an-importer-or-manufacturer-of-cosmetics

HLF-TW-55

HLF-TW-60
经过核准登记的化妆品，进口到澳洲要检附什麽文件？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 Australia? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
进口流程

1. 执照和许可证：治疗用品需完成产品註册、商业註册；化妆品需完成产商业註册，并确认商品安全、品质。
2. 登记：澳洲农药和兽药管理局 (APVMA)註册登记
3. 估价：所有进入澳洲的进口商品都需要准确估价，以计算相关关税、关税、费用和税费。交易价格以进口货物的实际支付(或应付)价格为基础，并作一定调整。海关在计算交易价值时使用货物出口当天(而不是货物到达澳洲当天)的汇率。
4. 税费、关税和收费
5. 具备澳洲商业号码(ARBN/ ABN)
6. 标籤和说明：标籤需要符合规范，以英文标示并且容易阅读。如果商品不符合标籤要求，可能会被扣押。
7. 进口报关(报关单分为三种)：价值超过1000 澳元的物品的进口报关单、通过空运或海运到达且价值低于 1000 澳元的物品的自评清关 (SAC) 声明、价值超过1000 澳元的清关前入库物品的仓库申报单(N20)。
   8.进口需要的资料
   ．贸易合约
   ．装箱单
   ．商业发票
   ．提单
   ．原产地证明文件
   ．成分分析表等。
   网页：
   https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/requirements

无销售通知。

Import process

1. Licenses and permits: Therapeutic supplies need to complete product registration and business registration; cosmetics need to complete production and business registration, and confirm product safety and quality.
2. Registration: Registered with the Australian Pesticides and Veterinary Medicines Administration (APVMA)
3. Valuation: All imported goods into Australia require an accurate valuation in order to calculate relevant duties, duties, fees and taxes. The transaction price is based on the actual payment (or payable) price of the imported goods, with certain adjustments. Customs uses the exchange rate on the day the goods are exported (not the day the goods arrive in Australia) when calculating the transaction value.
4. Taxes, duties and charges
5. Have an Australian business number (ARBN/ ABN)
6. Labeling and Instructions: Labeling needs to be compliant, in English and easy to read. Items may be seized if they do not meet labeling requirements.
7. Import customs declaration (customs declarations are divided into three types): import customs declaration for items worth more than AUD 1,000, self-assessment clearance (SAC) statement for items arriving by air or sea with a value of less than AUD 1,000, and declarations for items worth more than AUD 1,000 Warehouse declaration form (N20) for goods in storage before customs clearance.
8. Information required for import
   ．Trade contract
   ．Packing List
   ．Commercial invoice
   ．Bill of lading
   ．Certificate of Origin
   ．Component analysis table, etc.
   URL:
   https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/requirements

No sale notification.

【参考连结】
https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/requirements
https://www.agriculture.gov.au/agriculture-land/farm-food-drought/ag-vet-chemicals/regulation

HLF-TW-70
澳洲化妆品审核机构，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：
毒物标准 (SUSMP)

1. 标籤
2. 初级包装和直接容器
   3.警告声明、批准的名称和数量、比例或强度。
3. 使用说明、安全说明。
4. 急救处理方式。
5. 製造商或经销商的名称和地址。
6. 数量、比例或强度的陈述。
7. 运输容器和包装材料。
8. 禁止事项。
9. 批准的集装箱。
10. 儿童安全闭合装置。
11. 储存要求等。
    注意：自 2020 年 7 月 1 日起，禁止使用动物测试数据来支持化妆品成分资料。

Toxic Substances Standards (SUSMP)

1. Label
2. Primary packaging and immediate container
3. Warning statement, approved name and amount, proportion or strength.
4. Instructions for use, safety instructions.
5. First aid treatment.
6. Name and address of manufacturer or distributor.
7. Statements of quantity, proportion or intensity.
8. Shipping containers and packing materials.
9. Prohibition.
10. Approved container.
11. Child safety closures.
12. Storage requirements, etc.

NOTE: Effective July 1, 2020, the use of animal testing data to support cosmetic ingredient profiles is prohibited.

【参考连结】
https://www.industrialchemicals.gov.au/cosmetics-and-soap/personal-care-skincare-make-and-other-cosmetic-products
https://www.tga.gov.au/how-we-regulate/ingredients-and-scheduling-medicines-and-chemicals/poisons-standard-and-scheduling-medicines-and-chemicals

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口化妆品后，如果委託澳洲的经销商销售，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 Australia 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：
需要，经销商需要先向AICIS完成商业註册。
商业註册
1.期限：自註册日起每年 8 月 31 日到期。
2.网页：https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
3.外国公司：外国(非澳洲)企业，需要先取得澳洲註册机构号码 (ARBN)。
4.流程：
．註册帐户
．阅读免责声明
．输入企业代码。(澳洲企业ABN；外国企业ARBN)
．密码重置并登入系统
．输入上一年度(7/1-6/30)期间进口的工业化学品的价值(澳元)。并确认资料无误。如果是首次註册，并且上一财政年度没有引入工业化学品，请输入 0 澳元。
．付款、确认註册后取得企业名称和註册号。
5.註册费：註册费用取决于上一年度(7/1-6/30)进口的工业化学品价值。
6.工业化学品的价值=海关价值+保险和运费+关税+劳动力和材料成本+工厂成本。

澳洲註册机构号码 (ARBN)
1.网址：
https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/registrable-australian-bodies/#registeredbody
2.流程
第 1 步-确保名称可用：https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/company-name-availability/
第 2 步-缴交 401 表格
．公司/组织
．联繫人姓名/职位描述
．ASIC 註册代理号码(如果适用)
．电话号码、地址
．法人团体名称
．公司成立/註册的州或地区
．该机构成立或成立所依据的立法
．是否已缴交姓名保留以保留机构的名称？ 如果是，请提供姓名；如果不是，提议的名称是否与在澳洲註册的企业名称相同？如果是，请提供企业名称註册详细资讯
．声明书
．註册办事处的单位、级别、街道号码、街道名称、郊区/城市、州/地区、邮政编码、工作时间、公司是否佔用场地？
．董事或负责人的详细资讯：担任职务、任命日期、名字或公司名称、居住地址、街道号码和街道名称、郊区/城市、州/地区、邮政编码、国家(如果不是澳洲)、出生地(城镇/城市)(州/国家)
．申请人声明：名称、身份、签名、签署日期
第 3 步-附上证明文件
．公司註册/註册证书的核证副本。
．经认证的机构章程副本(例如组织章程大纲和章程细则)。
．董事/高级职员以书面形式发表声明。
第 4 步-缴交表格并缴交费用
．申请表必须由董事或授权人员签署。
．邮寄至：澳洲证券和投资委员会。

产品责任
如果产品未达到公众普遍期望的安全水平，则该产品存在安全缺陷。虽然预期的安全水平因情况而异，但最终要由法院来确定产品是否存在安全缺陷。针对产品责任，为製造商的责任。

供应商有监察、报告之责任，当发现产品安全疑虑时，供应商(包含进口商、经销商必须尽所知在2天内完成报告，强制性报告是保密的，报告并不意味着承认责任，但如果应该缴交强制性报告而没有缴交，可能会被判犯有刑事罪或被罚款。

Yes, dealers need to complete business registration with AICIS first.
business registration

1. Term: expires on August 31 every year from the date of registration.
2. URL: https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
3. Foreign companies: Foreign (non-Australian) companies need to obtain an Australian Registered Body Number (ARBN).
4. Process:
   ．Register account
   ．Read the disclaimer
   ．Enter the business code. (Australian company ABN; foreign company ARBN)
   ．Password reset and login system
   ．Enter the value (AUD) of industrial chemicals imported during the previous year (7/1-6/30). And confirm that the information is correct. If you are registering for the first time and no industrial chemicals were introduced in the previous financial year, please enter AUD 0.
   ．After payment and confirmation of registration, the company name and registration number are obtained.
5. Registration fee: The registration fee depends on the value of industrial chemicals imported in the previous year (7/1-6/30).
6. The value of industrial chemicals = customs value + insurance and freight + customs duties + labor and material costs + factory costs.

Australian Registered Body Number (ARBN)

1. URL:
   https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/registrable-australian-bodies/#registeredbody
2. Process
   Step 1 – Make sure the name is available:
   https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/company-name-availability/
   Step 2 – Submit Form 401
   ．Company/organization
   ．Contact Name/Job Description
   ．ASIC registered agent number (if applicable)
   ．Phone number, address
   ．Body corporate name
   ．State or territory of incorporation/incorporation
   ．The legislation under which the institution was established or established
   ．Has a name reservation been filed to reserve the institution’s name? If yes, please provide the name; if no, is the proposed name the same as the business name registered in Australia? If yes, please provide business name registration details
   ．Statement
   ．Unit, Class, Street Number, Street Name, Suburb/City, State/Region, Zip Code, Hours of Operation, Does the Company Occupy Space of Registered Office?
   ．Details of director or principal: position held, date of appointment, name or company name, residential address, street number and name, suburb/city, state/territory, postcode, country (if not Australia), place of birth (town) /city)(state/country)
   ．Applicant Statement: Name, Identity, Signature, Date Signed
   Step 3 – Attach supporting documents
   ．Certified copy of Certificate of Incorporation/Incorporation.
   ．Certified copy of the constitution of the institution (e.g. Memorandum and Articles of Association).
   ．Directors/Officers make a statement in writing.
   Step 4 – Submit the form and pay the fee
   ．The application form must be signed by a director or authorized officer.
   ．Mail to: Australian Securities and Investments Commission.

Yes, dealers need to complete business registration with AICIS first.

1. Term: expires on August 31 every year from the date of registration.
2. URL: https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
3. Foreign companies: Foreign (non-Australian) companies need to obtain an Australian Registered Body Number (ARBN).
4. Process:
   ．Sign up to create an account
   ．Read the disclaimer
   ．Enter the business code. (Australian company ABN; Foreign companies ARBN)
   ．Password reset and login system
   ．Enter the value in Australian dollars of industrial chemicals imported during the previous year (7/1-6/30). And confirm that the information is correct. If you are registering for the first time and you have not introduced industrial chemicals in the last financial year, please enter $0.
   ．After payment and confirmation of registration, the company name and registration number are obtained.
5. Registration fee: The registration fee depends on the value of industrial chemicals imported in the previous year (7/1-6/30).
6. The value of industrial chemicals = customs value + insurance and freight + customs duties + labor and material costs + factory costs.

Australian Registered Body Number (ARBN)

1. URL:
   https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/registrable-australian-bodies/#registeredbody
2. Process
   Step 1 – Make sure the name is available:
   https://asic.gov.au/for-business/registering-a-company/steps-to-register-a-company/company-name-availability/
   Step 2 – Submit Form 401
   ．Company/organization
   ．Contact Name/Job Description
   ．ASIC registered agent number (if applicable)
   ．Phone number, address
   ．Body corporate name
   ．State or territory of incorporation/incorporation
   ．The legislation under which the institution was established or established
   ．Has a name reservation been filed to reserve the institution’s name? If yes, please provide the name; if no, is the proposed name the same as the business name registered in Australia? If yes, please provide business name registration details
   ．Statement
   ．Unit, Class, Street Number, Street Name, Suburb/City, State/Region, Zip Code, Hours of Operation of Registered Office Does the company occupy premises?
   ．Details of director or principal: position held, date of appointment, name or company name, residential address, street number and name, suburb/city, state/territory, postcode, country (if not Australia), place of birth (town) /city) (state/country)
   ．Applicant Statement: Name, Identity, Signature, Date Signed
   Step 3 – Attach supporting documents
   ．Certified copy of Certificate of Incorporation/Incorporation.
   ．A certified copy of the constitution of the institution (such as the Memorandum and Articles of Association).
   ． Directors/Officers make a statement in writing.
   Step 4 – Submit the form and pay the fee
   ． The application form must be signed by a director or authorized officer.
   ． Mail: Australian Securities and Investments Commission.

Product liability
A product has a safety defect if it does not meet the level of safety generally expected by the public. While the expected level of safety varies from case to case, ultimately it is up to the courts to determine whether a product has a safety defect. For product liability, it is the responsibility of the manufacturer.

Suppliers have the responsibility to monitor and report. When product safety concerns are discovered, suppliers (including importers and distributors must complete the report within 2 days to the best of their knowledge. Mandatory reports are confidential, and reporting does not mean admitting responsibility. However, failing to make the mandatory report may result in a criminal offense or a fine.

【参考连结】
https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-much-my-registration-fee
https://www.industrialchemicals.gov.au/business/register-your-business-and-renew-your-registration/how-register
https://www.industrialchemicals.gov.au/cosmetics-and-soap/personal-care-skincare-make-and-other-cosmetic-products

HLF-TW-85

各国化妆品登记法规问答集

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