UK Cosmetics Regulations QA

WFOE Registration, Work Permit, Special Industry Permit application according to London Regulations, we need to do KYC (Know your client) before engagement with your assignment.

E-mail: lon4ww@evershinecpa.com
Ms. Anny Lin, speak both English and Chinese.
WeChat: annylin8008
Skype: annylin8008

2023/09/08  drafted by Yvonne Chen

HLF-TW-10
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：

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.

【Reference link】
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
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：
No business license.
【Reference link】
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
If needed, are there professional service companies in the UK that can assist with obtaining a business license for a cosmetics company?
Evershine RD：
No business license.

HLF-TW-30
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：

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.

1. 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.
2. 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

1. 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.
2. Serious Adverse Events (SUE) must be reported immediately to the UK Competent Authorities by the person in charge and/or the distributor.
3. URL
   https://www.gov.uk/guidance/sue-and-safeguarding-notifications-for-cosmetics
4. 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

【Reference link】
https://www.ctpa.org.uk/uk-cosmetic-regulations-amendments
https://submit.cosmetic-product-notifications.service.gov.uk/

HLF-TW-35

HLF-TW-40
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：

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.)

1. 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/
2. 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.

【Reference link】
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
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：

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.)

1. 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/
2. 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.

【Reference link】
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
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：

Cosmetics that have completed the product notification can be imported to the UK for sale. The import process:

1. 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.
2. 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
3. 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
4. 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.

【Reference link】
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：

1. 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
2. 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
3. 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.
4. 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.

【Reference link】
https://www.gov.uk/government/publications/cosmetic-products-enforcement-regulations-2013/regulation-20091223-and-the-cosmetic-products-enforcement-regulations-2013-great-britain

HLF-TW-75

HLF-TW-77

HLF-TW-80
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：

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

1. 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.
2. Serious Adverse Events (SUE) must be reported immediately to the UK Competent Authorities by the person in charge and/or the distributor.
3. URL
   https://www.gov.uk/guidance/sue-and-safeguarding-notifications-for-cosmetics
4. 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

【Reference link】
https://www.ctpa.org.uk/uk-cosmetic-regulations-amendments
https://submit.cosmetic-product-notifications.service.gov.uk/

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London Evershine BPO Service Limited Corp.
E-mail: lon4ww@evershinecpa.com
Ms. Anny Lin, speak both English and Chinese.
WeChat: annylin8008
Skype: annylin8008

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Email address: dalechen@evershinecpa.com
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