UK Health Food 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 health food in The United Kingdom? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：

In the UK, health foods are called food supplements and are regulated by the Department of Health (DH). Definition: Any food intended to supplement the normal diet, composed of concentrated sources of vitamins or minerals or other substances with nutritional/physiological effects, combined individually or in combination, and sold in dosage form.

Food supplements may contain a variety of nutrients and other ingredients, which can include: vitamins, minerals, amino acids, essential fatty acids, fiber, and various plant and herbal extracts.

Food supplements are intended to supplement nutritional deficiencies, maintain adequate intake of certain nutrients, or support specific physiological functions. They are not pharmaceuticals and therefore cannot exert pharmacological, immunological or metabolic effects. The use of food supplements is not intended to treat or prevent human disease or to modify physiological functions. Therefore, in the UK, food supplements are regulated as food and are subject to the provisions of the General Food Act.

【Reference link】
https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs
https://www.gov.uk/government/organisations/department-of-health-and-social-care

HLF-TW-20
If a foreign company wants to sell health food 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：

Registration as a food business operator (FBO) is required.

To sell food supplements in the UK, you must register as a food business operator (FBO) with the local council 28 days before operating. The committee inspects business premises to ensure compliance with food safety and hygiene regulations.

Process:

1. Submit the food business registration form and mail it to the local council.
   URL: https://register.food.gov.uk/new
   ．Food business trade name, facility address (or location of removable facility), postal code, phone number, email
   ．Food business operator’s full name/company name, head office/registered office address, postal code, telephone number, email
   ．Food business operator’s full name, home address, postal code
   ．Food event type
   ．Opening date
   ．Signature and seal of food operator/company director
2. Food safety inspection: After opening, the committee arranges food safety inspections and completes risk assessment and rating.
   ．Assess potential hazards: types of food and methods of handling, methods of processing and handling food, types and numbers of consumers at risk, compliance of food operations, physical environment
   ．Determine compliance with regulations
   ．Validate management and control systems
   ．Assess the importance of risk

【Reference link】
https://register.food.gov.uk/new
https://www.camden.gov.uk/food-business-registration

HLF-TW-25

HLF-TW-30
If a foreign company wants to sell health food 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, the business agent needs to be registered as a food business operator (FBO).

To sell food supplements in the UK, you must register as a food business operator (FBO) with the local council 28 days before operating. The committee inspects business premises to ensure compliance with food safety and hygiene regulations.

Process:

1. Submit the food business registration form and mail it to the local council.
   URL: https://register.food.gov.uk/new
   ．Food business trade name, facility address (or location of removable facility), postal code, phone number, email
   ．Food business operator’s full name/company name, head office/registered office address, postal code, telephone number, email
   ．Food business operator’s full name, home address, postal code
   ．Food event type
   ．Opening date
   ．Signature and seal of food operator/company director
2. Food safety inspection: After opening, the committee arranges food safety inspections and completes risk assessment and rating.
   ．Assess potential hazards: types of food and methods of handling, methods of processing and handling food, types and numbers of consumers at risk, compliance of food operations, physical environment
   ．Determine compliance with regulations
   ．Validate management and control systems
   ．Assess the importance of risk

Product liability
The Food Standards Agency uses post-market controls to check that food supplements sold are for compliance with respect to ingredients, labeling and safety.

1. Business agent: The FBO has the responsibility to ensure the safety of food before placing it on the UK market.
2. Importer: The importer is responsible for legal responsibility, including the composition, safety and labeling of the product.

【Reference link】
https://register.food.gov.uk/new
https://www.camden.gov.uk/food-business-registration
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-35

HLF-TW-40
Do foreign companies need to apply for an approval before importing health food sold to The United Kingdom? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：

The license is not required.
Since Brexit, food supplements no longer require pre-market authorization. Labeling does not require pre-market approval, but compliance with regulations and post-market control checks are required.

Label

1. Must be labeled as a food supplement, not a dietary supplement.
2. Product labels must include:
   ．Company name, address (on product label or product packaging): sales company or import company
   ．Ingredient List: Common Allergens Must Be Emphasized
   ．Conditions of use: information on the recommended daily dosage and warnings not to exceed this dosage
   ．Storage Instructions: A statement that the product should be stored out of the reach of young children
   ．Best before date: indicate use before this date or best before this date and date
   ．Te content of any vitamin or mineral or other substance having a nutritional or physiological effect
   ．Statement that food supplements should not be a substitute for a varied diet
   ．Country of origin
3. Location
   ．Package
   ．labels affixed to packaging
   ．Labels clearly visible through packaging
   4.Attention
   ．Food supplements sold in Northern Ireland must include the Northern Ireland or EU address of the food business. If the food business is not located in Northern Ireland or the EU, a minimum font size must be included for mandatory information.
   ．The font size is determined by the letter x and whether the height is greater than or equal to 1.2mm; if the maximum surface area of the package is less than 80 square centimeters, a minimum x-height of 0.9mm can be used. The address of the importer in Northern Ireland or the EU.
   ．Mandatory food information must be legible and difficult to remove. It may not in any other way conceal, obscure, obscure or interfere with any other written or pictorial content.
   ．Language is indicated in English.

【Reference link】
https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-45
請問在英國有哪些專業服務機構，可以協助辦理保健食品產品許可證？
Evershine RD：
無須產品許可證。

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 health food packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：

The license is not required..
Since Brexit, food supplements no longer require pre-market authorization. Labeling does not require pre-market approval, but compliance with regulations and post-market control checks are required.

Label

1. Must be labeled as a food supplement, not a dietary supplement.
2. Product labels must include:
   ．Company name, address (on product label or product packaging): sales company or import company
   ．Ingredient List: Common Allergens Must Be Emphasized
   ．Conditions of use: information on the recommended daily dosage and warnings not to exceed this dosage
   ．Storage Instructions: A statement that the product should be stored out of the reach of young children
   ．Best before date: indicate use before this date or best before this date and date
   ．Te content of any vitamin or mineral or other substance having a nutritional or physiological effect
   ．Statement that food supplements should not be a substitute for a varied diet
   ．Country of origin
3. Location
   ．Package
   ．labels affixed to packaging
   ．Labels clearly visible through packaging
   4.Attention
   ．Food supplements sold in Northern Ireland must include the Northern Ireland or EU address of the food business. If the food business is not located in Northern Ireland or the EU, a minimum font size must be included for mandatory information.
   ．The font size is determined by the letter x and whether the height is greater than or equal to 1.2mm; if the maximum surface area of the package is less than 80 square centimeters, a minimum x-height of 0.9mm can be used. The address of the importer in Northern Ireland or the EU.
   ．Mandatory food information must be legible and difficult to remove. It may not in any other way conceal, obscure, obscure or interfere with any other written or pictorial content.
   ．Language is indicated in English.

【Reference link】
https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-55
請問在英國有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？
Evershine RD：
無須產品許可證。

HLF-TW-60
What documents are required when importing approved health food 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：

Without a product license, products can be imported if they comply with regulations.

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 additional statements
   ．Use simplified declarations
   ．Use the declarant record
   ．Application for Authorization by a Third-Party Representative
   ． Food Supplements Commodity Code: 2106
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

HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
Health food does not require review, but must comply with food laws and food safety laws.

Hazard Analysis and Critical Control Points (HACCP)
1.HACCP principle:
．Examine what might go wrong and what are the risks to food safety
．Identify critical control points that the business needs to focus on to ensure that risks are eliminated or brought down to a safe level
．Decide what action needs to be taken when a problem occurs
．Ensure procedures are followed and effective
．Keep records
．Develop appropriate food safety management procedures

2.Food safety hazards are mainly divided into three categories:
．Microbiology: Involves harmful bacteria
．Chemistry: involves chemical pollution
．Physics: Involves objects getting into food

【Reference link】
https://www.gov.uk/government/publications/nutrition-legislation-information-sources/nutrition-legislation-information-sheet–2#food-supplements

HLF-TW-75

HLF-TW-77

HLF-TW-80
After a foreign subsidiary imports health food and entrusts a distributor in The United Kingdom to sell it, does the distributor need a health food 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：

Registration as a food business operator (FBO) is required.

To sell food supplements in the UK, you must register as a food business operator (FBO) with the local council 28 days before operating. The committee inspects business premises to ensure compliance with food safety and hygiene regulations.

Process:

1. Submit the food business registration form and mail it to the local council.
   URL: https://register.food.gov.uk/new
   ．Food business trade name, facility address (or location of removable facility), postal code, phone number, email
   ．Food business operator’s full name/company name, head office/registered office address, postal code, telephone number, email
   ．Food business operator’s full name, home address, postal code
   ．Food event type
   ．Opening date
   ．Signature and seal of food operator/company director
2. Food safety inspection: After opening, the committee arranges food safety inspections and completes risk assessment and rating.
   ．Assess potential hazards: types of food and methods of handling, methods of processing and handling food, types and numbers of consumers at risk, compliance of food operations, physical environment
   ．Determine compliance with regulations
   ．Validate management and control systems
   ．Assess the importance of risk

Product liability
The Food Standards Agency uses post-market controls to check that food supplements sold are for compliance with respect to ingredients, labeling and safety.

1. Business agent: The FBO has the responsibility to ensure the safety of food before placing it on the UK market.
2. Importer: The importer is responsible for legal responsibility, including the composition, safety and labeling of the product.

【Reference link】
https://register.food.gov.uk/new
https://www.camden.gov.uk/food-business-registration
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-85

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

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