英国化妆品登记法规问题集
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Email:lon4ww@evershinecpa.com
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英国永辉BPO有限公司
Nady Wong, CA in ACCA说中文和英文
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电话:+886-2-2717-0515 分机:110
时间:2023/09/08 drafted by Yvonne Chen
HLF-TW-10
请问英国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 The United Kingdom? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD:
在英国,安全与标准办公室(OPSS)是英国化妆品的主管机构。
化妆品指的是与人体表层(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物质和製剂。
如果产品的成分不符合法规,无论是否提出声明,都不能作为化妆品销售。如果产品不是化妆品,则可能属于其他监管制度,例如食品、杀菌剂或一般产品安全的监管制度。
In the UK, the Office of Safety and Standards (OPSS) is the governing body for UK cosmetics.
Cosmetics refer to any substance or mixture that comes into contact with the surface layers 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.
If the composition of the product does not comply with the regulations, it cannot be marketed as a cosmetic product, whether a claim is made or not. If the product is not a cosmetic, it may fall under other regulatory regimes, such as those for food, biocides, or general product safety.
【参考连结】
https://www.gov.uk/government/publications/cosmetic-products-enforcement-regulations-2013/regulation-20091223-and-the-cosmetic-products-enforcement-regulations-2013-great-britain
https://www.gov.uk/government/organisations/office-for-product-safety-and-standards
HLF-TW-20
外国公司要到英国销售化妆品,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 The United Kingdom, 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:
无营业特许证。
No business license.
【参考连结】
https://www.gov.uk/government/publications/cosmetic-products-enforcement-regulations-2013/regulation-20091223-and-the-cosmetic-products-enforcement-regulations-2013-great-britain
HLF-TW-25
假如需要办理,请问英国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:
无营业特许证。
No business license.
HLF-TW-30
外国公司要到英国销售化妆品,可以指派英国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 The United Kingdom, can it assign a The United Kingdom 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,如果营业代理人为经销商的话,无特殊条件限制。如营业代理人同时为产品负责人(经授权),则需要是英国内的个人(自然人)或公司(法人)。
1.经销商
定义为供应链中除製造商或进口商之外的在英国市场上销售化妆品的任何自然人或法人。涵盖在英国市场上提供化妆品(有偿或免费)以供分销、消费或使用的任何公司或个人,例如:批发商、零售商、商店、美容或美发沙龙、电话销售、直销店和互联网销售。
2.产品负责人(RP)
RP必须是英国的个人(自然人)或公司(法人),须将投放英国市场的产品通知SCPN,参照HLF-TW-40。
产品责任
1.责任人和安全责任人有责任确保投放到英国市场的每种化妆品都是安全的并符合英国法规。
2.严重不良反应(SUE)必须由负责人和/或经销商立即向英国主管当局报告。
3.网页
https://www.gov.uk/guidance/sue-and-safeguarding-notifications-for-cosmetics
4.报告内容
.案例报告
.公司资料、负责人资料
.严重性标准
.主彙报
.最终使用者
.可疑产品
.产品用途
.严重不良影响的描述、位置、结果
.基础条件
.相关医疗资讯/病史
.案例管理
.补充调查
.负责人或分销商的摘要
Yes, if the business agent is a distributor, there are no special restrictions. If the business agent is also the person in charge of the product (authorized), it needs to be an individual (natural person) or company (legal person) in the UK.
- Dealer
Defined as any natural or legal person in the supply chain who sells cosmetics on the UK market other than the manufacturer or importer. Covers any company or person who offers cosmetic products (paid or free) for distribution, consumption or use on the UK market, for example: wholesalers, retailers, shops, beauty or hair salons, telesales, direct sales stores and internet sales. - Product Owner (RP)
The RP must be a British individual (natural person) or company (legal person), and must notify SCPN of the products put on the British market, referring to HLF-TW-40.
Product liability
- Responsible and Safety Responsible Persons are responsible for ensuring that every cosmetic product placed on the UK market is safe and in compliance with UK regulations.
- Serious Adverse Events (SUE) must be reported immediately to the UK Competent Authorities by the person in charge and/or the distributor.
- URL
https://www.gov.uk/guidance/sue-and-safeguarding-notifications-for-cosmetics - Report content
. Case report
. Company information, responsible person information
. Severity criteria
. Main report
. End user
. Suspicious product
. Product Usage
. Description, location, outcome of serious adverse effects
. Basic condition
. Relevant medical information/history
. Case management
. Supplementary survey
. Summary of Responsible Person or Distributor
【参考连结】
https://www.ctpa.org.uk/uk-cosmetic-regulations-amendments
https://submit.cosmetic-product-notifications.service.gov.uk/
HLF-TW-35
HLF-TW-40
外国公司销售到英国化妆品本身,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 The United Kingdom? 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,需委任当地的英国的个人(自然人)或公司(法人)担任产品的负责人,并缴交产品通知。
化妆品的负责人必须通过 SCPN 缴交在英国市场上投放或提供的产品的相关资讯。(化妆品包装上不需要标註 SCPN 编号。)
1.负责人(RP):
.投放到英国市场的每种化妆品都应标有RP)的姓名和地址。
.RP负责确保投放到英国市场的每种化妆品均符合英国法规的所有要求
.RP必须是英国的个人(自然人)或公司(法人)。
.RP可以是:製造商或品牌所有者、进口商、品牌所有者或进口商授权担任 RP的英国个人或公司(需有书面授权书)。
2.网页:https://submit.cosmetic-product-notifications.service.gov.uk/
3.缴交资料:
.化妆品的类别及名称
.英国 RP 的名称和地址
.是否存在奈米材料形式的物质
.化学名称(IUPAC)
.暴露条件
.原始标籤以及相应包装的照片(需要清晰可见)
.其他
标籤
1.所有化妆品(除非适用特定例外情况)在其容器和包装上清晰且不可磨灭地标记以下讯息:
.负责人的姓名、地址
.进口产品原产国
.标称含量
.最短保存期限或 开封后期限PAO (如果最短保存期限超过 30 个月)
.警告声明和预防资讯
.批号
.产品功能(当其包装/展示不明显时)
.成分清单,奈米材料成分后面必须带有nano
.在某些情况下,可能不需要标示使用日期、重量或体积,例如:样品包装等含量小于 5 克或 5 毫升的型态。
.如果包装上空间无法完整标示预防措施和成分,请将内容另外标示于单张中,并用符号指引消费者可以看到讯息。
.标籤需使用英文。
It is required. A local British individual (natural person) or company (legal person) must be appointed as the person in charge of the product and submit a product notification.
Responsible persons for cosmetic products must submit information about products placed or offered on the UK market through the SCPN. (The SCPN number does not need to be marked on the packaging of cosmetics.)
- Person in charge (RP):
.Every cosmetic product placed on the UK market should be marked with the name and address of RP).
.The RP is responsible for ensuring that every cosmetic product placed on the UK market complies with all requirements of the UK regulations
.The RP must be a UK individual (natural person) or company (legal person).
.The RP can be: the manufacturer or brand owner, the importer, a UK individual or company authorized by the brand owner or importer to act as the RP (with a written authorization).
2.URL: https://submit.cosmetic-product-notifications.service.gov.uk/ - Submit the information:
.Types and names of cosmetics
.Name and address of UK RP
.Is there matter in the form of nanomaterials?
.Chemical name (IUPAC)
.exposure conditions
.Original label and a photo of the corresponding packaging (needs to be clearly visible)
.Other
Label
1.All cosmetic products (unless specific exceptions apply) are clearly and indelibly marked on their containers and packaging with the following message:
.Name and address of person in charge
.Country of Origin of Imported Products
.Nominal content
.Minimum shelf life or PAO after opening (if minimum shelf life exceeds 30 months)
.Warning Statements and Precautionary Information
.Batch number
.Product functionality (when its packaging/display is not obvious)
.Ingredient list, nano material ingredients must be followed by nano
.In some cases, the use-by date, weight or volume may not be required, e.g. samples containing less than 5 grams or 5 milliliters.
.If there is insufficient space on the package to fully display the preventive measures and ingredients, please mark the content on the leaflet separately, and use symbols to guide consumers to see the information.
. Labels must be in English.
【参考连结】
https://www.gov.uk/guidance/making-cosmetic-products-available-to-consumers-in-great-britain#labelling-cosmetic-products
https://www.gov.uk/guidance/submit-a-cosmetic-product-notification
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:
不行,需委任当地的英国的个人(自然人)或公司(法人)担任产品的负责人,并缴交产品通知。
化妆品的负责人必须通过 SCPN 缴交在英国市场上投放或提供的产品的相关资讯。(化妆品包装上不需要标註 SCPN 编号。)
1.负责人(RP):
.投放到英国市场的每种化妆品都应标有RP)的姓名和地址。
.RP负责确保投放到英国市场的每种化妆品均符合英国法规的所有要求
.RP必须是英国的个人(自然人)或公司(法人)。
.RP可以是:製造商或品牌所有者、进口商、品牌所有者或进口商授权担任 RP的英国个人或公司(需有书面授权书)。
2.网页:https://submit.cosmetic-product-notifications.service.gov.uk/
3.缴交资料:
.化妆品的类别及名称
.英国 RP 的名称和地址
.是否存在奈米材料形式的物质
.化学名称(IUPAC)
.暴露条件
.原始标籤以及相应包装的照片(需要清晰可见)
.其他
标籤
1.所有化妆品(除非适用特定例外情况)在其容器和包装上清晰且不可磨灭地标记以下讯息:
.负责人的姓名、地址
.进口产品原产国
.标称含量
.最短保存期限或 开封后期限PAO (如果最短保存期限超过 30 个月)
.警告声明和预防资讯
.批号
.产品功能(当其包装/展示不明显时)
.成分清单,奈米材料成分后面必须带有nano
.在某些情况下,可能不需要标示使用日期、重量或体积,例如:样品包装等含量小于 5 克或 5 毫升的型态。
.如果包装上空间无法完整标示预防措施和成分,请将内容另外标示于单张中,并用符号指引消费者可以看到讯息。
.标籤需使用英文。
No, it is required to appoint a local British individual (natural person) or company (legal person) as the person in charge of the product and submit the product notification.
Responsible persons for cosmetic products must submit information about products placed or offered on the UK market through the SCPN. (The SCPN number does not need to be marked on the packaging of cosmetics.)
- Person in charge (RP):
.Every cosmetic product placed on the UK market should be marked with the name and address of RP).
.The RP is responsible for ensuring that every cosmetic product placed on the UK market complies with all requirements of the UK regulations
.The RP must be a UK individual (natural person) or company (legal person).
.The RP can be: the manufacturer or brand owner, the importer, a UK individual or company authorized by the brand owner or importer to act as the RP (with a written authorization).
2.URL: https://submit.cosmetic-product-notifications.service.gov.uk/ - Submit the information:
.Types and names of cosmetics
.Name and address of UK RP
.Is there matter in the form of nanomaterials?
.Chemical name (IUPAC)
.exposure conditions
.Original label and a photo of the corresponding packaging (needs to be clearly visible)
.Other
Label
1.All cosmetic products (unless specific exceptions apply) are clearly and indelibly marked on their containers and packaging with the following message:
.Name and address of person in charge
.Country of Origin of Imported Products
.Nominal content
.Minimum shelf life or PAO after opening (if minimum shelf life exceeds 30 months)
.Warning Statements and Precautionary Information
.Batch number
.Product functionality (when its packaging/display is not obvious)
.Ingredient list, nano material ingredients must be followed by nano
.In some cases, the use-by date, weight or volume may not be required, e.g. samples containing less than 5 grams or 5 milliliters.
.If there is insufficient space on the package to fully display the preventive measures and ingredients, please mark the content on the leaflet separately, and use symbols to guide consumers to see the information.
.Labels must be in English.
【参考连结】
https://www.gov.uk/guidance/making-cosmetic-products-available-to-consumers-in-great-britain#labelling-cosmetic-products
https://www.gov.uk/guidance/submit-a-cosmetic-product-notification
HLF-TW-55
HLF-TW-60
经过核准登记的化妆品,进口到英国要检附什麽文件?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 The United Kingdom? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD:
完成产品通知的化妆品可以进口至英国销售,进口流程:
- 经济运营商註册和识别号(EORI号):如果企业位于要将货物运入或运出的国家/地区,需要先取得EORI号码。
.企业通常需要在进口或出口的国家/地区拥有经营场所,的场所必须是以下之一:註册办事处、中央总部、永久营业机构。
.如果没有资格自行申请EORI号码,则需要指定某人代表处理海关事宜。 - 申请使用简化进口报关单
网页:https://www.gov.uk/topic/business-tax/import-export
.补充声明汇总
.使用简化声明
.使用声明人记录
.第三方代表申请授权 - 进口报关单(所有从英国境外进口的货物都必须向英国海关申报。)
.公司经济经营者註册和识别号 (EORI)
.公司增值税号
.进口原因
.商品描述
.关税号/商品代码
.货物价值
.任何可能适用的进口管制
4.具备资料
.商业发票或运输发票
.运输文件(例如提单、空运单等)
.装箱单
.保险凭证/保单
.商品编码
.关税估价
.採购订单/合约
.海关入境文件
.货运代理或承运人发票
.附加证书
无销售通知。
Cosmetics that have completed the product notification can be imported to the UK for sale. The import process:
- Economic Operator Registration and Identification Number (EORI Number): If the business is located in the country/region where the goods are to be shipped into or out of, it needs to obtain an EORI number first.
.Businesses usually need to have a place of business in the country from which they are importing or exporting. The place of business must be one of the following: registered office, central headquarters, permanent establishment.
.If you are not eligible to apply for an EORI number yourself, you will need to appoint someone to represent you in customs matters. - Apply for the simplified import declaration form
URL: https://www.gov.uk/topic/business-tax/import-export
.Summary of Supplementary Statements
.Use simplified declarations
.Use the declarant record
.Application for Authorization by a Third-Party Representative - Import declaration form (All goods imported from outside the UK must be declared to UK customs.)
.Economic Operator Registration and Identification Number (EORI)
.Company VAT number
.Import reason
.Product description
.Tariff Number/Commodity Code
.Value of goods
.Any import controls that may apply - Have information
.Commercial invoice or shipping invoice
.Shipping documents (e.g. bill of lading, air waybill, etc.)
.Packing List
.Insurance certificate/policy
.Commodity code
.Tariff Valuation
.Purchase Order/Contract
.Customs Entry Documents
.Freight Forwarder or Carrier Invoice
.Additional certificate
No sale notification.
【参考连结】
https://www.gov.uk/topic/business-tax/import-export
https://www.gov.uk/government/publications/cosmetic-products-enforcement-regulations-2013/regulation-20091223-and-the-cosmetic-products-enforcement-regulations-2013-great-britain#chapter-vii–market-surveillance
HLF-TW-70
英国化妆品审核机构,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:
1.良好生产规范(GMP)
GMP 的目的是透过提高化妆品整个供应链(从原材料生产商到化妆品成品製造商:设计、配方、製造、包装、储存和销售)的安全和品质来保护消费者。确定每个环节都是安全、卫生和负责的。
ISO 22716是化妆品製造行业良好生产规范 (GMP) 的新指导原则,重点包括:
.管理阶层及从业人员
.厂房及设施
.设备
.原料及包装材料
.生产
.成品
.品质管制实验室
.不符合规格产品之处理
.废弃物
.委託与受託作业
.偏差处理
.申诉及回收
.变更管制
.内部稽核
.文件化
2.化妆品安全资讯
.定量和定性成分
.物理/化学特性和稳定性
.微生物
.杂质、痕迹和包装材料
.正常且合理的使用方式
.产品暴露
.物质暴露
.物质的毒理学特徵
.不良反应和严重不良反应
.产品的其他相关资讯
3.化妆品安全评估
.化妆品:说明该产品是否可以安全使用或在有限制的情况下安全使用。
.强制性标籤:安全评估员的责任是确定产品的警告或使用说明是否清楚,以确保产品的安全使用。
.安全评估详细内容:使用适当的证据权重方法来审查所有现有的数据。
.安全评估员的姓名、地址和资格证明;应由安全评估员签名并註明日期。
.安全评估应定期审查和修订
.负责安全评估的人员称为安全评估员,安全评估员应拥有在完成大学药学、毒理学、医学或类似学科的理论及实践学习课程或国家认可的同等课程后授予的文凭或其他正式资格证明。
4.产品资讯文件(PIF) :应包含的资讯和数据的详细资讯
.化妆品的描述
.化妆品安全报告
.生产方法和 GMP
.产品的性质和效果证明
.动物测验
.PIF 必须自最后一批化妆品投放市场之日起保存十年。
.产品负责人必须根据规定,使主管当局能够取得产品的PIF。
.PIF 应根据需要进行更新。
- Good Manufacturing Practice (GMP)
The purpose of GMP is to protect consumers by improving the safety and quality of the entire supply chain of cosmetics, from raw material producers to manufacturers of finished cosmetic products: design, formulation, manufacturing, packaging, storage and sales. Make sure every link is safe, hygienic and responsible.
ISO 22716 is a new guideline for Good Manufacturing Practice (GMP) for the cosmetics manufacturing industry, focusing on:
.Management and employees
.Plant and facilities
.Equipment
.Raw materials and packaging materials
.Production
.Finished product
.Quality Control Laboratory
.Handling of non-compliant products
.Waste
.Commissioned and entrusted work
.Deviation handling
.Complaint and recovery
.Change control
.Internal audit
.Documented - Cosmetics Safety Information
.Quantitative and Qualitative Components
.Physical/Chemical Properties and Stability
.Microorganism
.Foreign matter, traces and packaging materials
.Normal and reasonable usage
.Product exposure
.Substance exposure
.Toxicological profile of the substance
.Adverse reactions and serious adverse reactions
.Other related information about the product - Cosmetic safety assessment
.Cosmetic: State whether the product is safe to use or is safe to use with limitations.
.Mandatory Labeling: It is the safety assessor’s responsibility to determine whether a product’s warnings or directions for use are clear enough to ensure the product is safe to use.
.Safety Assessment Details: Review all available data using an appropriate weight-of-evidence approach.
.Safety Assessor’s name, address and proof of qualifications; should be signed and dated by the Safety Assessor.
.Security assessments should be reviewed and revised periodically
.The person responsible for the safety assessment is called the Safety Assessor, and the Safety Assessor shall have a diploma or other formal qualification awarded upon completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a nationally recognized equivalent. - Product Information File (PIF): Details of information and data to be included
.Description of cosmetics
.Cosmetic Safety Report
.Manufacturing methods and GMP
.Proof of the nature and effect of the product
.Animal quiz
.The PIF must be kept for ten years from the date on which the last cosmetic product was placed on the market.
.The product owner has to make the PIF of the product available to the competent authorities according to the regulations.
.PIF should be updated as needed.
HLF-TW-75
HLF-TW-77
HLF-TW-80
外国子公司进口化妆品后,如果委託英国的经销商销售,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 The United Kingdom 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:
不需要。
经销商定义为供应链中除製造商或进口商之外的在英国市场上销售化妆品的任何自然人或法人。涵盖在英国市场上提供化妆品(有偿或免费)以供分销、消费或使用的任何公司或个人,例如:批发商、零售商、商店、美容或美发沙龙、电话销售、直销店和互联网销售。
产品责任
1.责任人和安全责任人有责任确保投放到英国市场的每种化妆品都是安全的并符合英国法规。
2.严重不良反应(SUE)必须由负责人和/或经销商立即向英国主管当局报告。
3.网页
https://www.gov.uk/guidance/sue-and-safeguarding-notifications-for-cosmetics
4.报告内容
.案例报告
.公司资料、负责人资料
.严重性标准
.主彙报
.最终使用者
.可疑产品
.产品用途
.严重不良影响的描述、位置、结果
.基础条件
.相关医疗资讯/病史
.案例管理
.补充调查
.负责人或分销商的摘要
It is not required.
Dealer: Defined as any natural or legal person in the supply chain who sells cosmetics on the UK market other than the manufacturer or importer. Covers any company or person who offers cosmetic products (paid or free) for distribution, consumption or use on the UK market, for example: wholesalers, retailers, shops, beauty or hair salons, telesales, direct sales stores and internet sales.
Product liability
- Responsible and Safety Responsible Persons are responsible for ensuring that every cosmetic product placed on the UK market is safe and in compliance with UK regulations.
- Serious Adverse Events (SUE) must be reported immediately to the UK Competent Authorities by the person in charge and/or the distributor.
- URL
https://www.gov.uk/guidance/sue-and-safeguarding-notifications-for-cosmetics - Report content
. Case report
. Company information, responsible person information
. Severity criteria
. Main report
. End user
. Suspicious product
. Product Usage
. Description, location, outcome of serious adverse effects
. Basic condition
. Relevant medical information/history
. Case management
. Supplementary survey
. Summary of Responsible Person or Distributor
【参考连结】
https://www.ctpa.org.uk/uk-cosmetic-regulations-amendments
https://submit.cosmetic-product-notifications.service.gov.uk/
HLF-TW-85
Email:lon4ww@evershinecpa.com
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