Approval will be required by large food business establishments proposing to manufacture and handle “products of animal origin”.
Under Regulation (EC) No.853/2004, food business establishments may require approval if they intend to handle “products of animal origin”, for example, fresh meat, raw minced meat, raw milk, eggs, shellfish and fish, to produce any of the following:
- Minced meat
- Meat preparations
- Mechanically separated meat
- Meat products
- Live Bi Valve Molluscs
- Fishery products
- Raw milk (other than raw cows’ milk)
- Dairy products
- Eggs (not primary production)
- Egg products
- Frogs legs and snails
- Rendered animal fats and greaves
- Treated stomachs, bladders and intestines
- Gelatine and collagen
- Certain cold stores
- Certain wholesale markets.
If your food business requires approval there are a number of requirements that need to be followed. You cannot operate until your food establishment has received a full or conditional approval from us.
There are a number of exemptions from the requirement for approval:
‘Composite’ products exemption
- You produce food containing both products of plant origin (for example, herbs and spices) and pre-processed products of animal origin.
General retail exemption
- You retail the products of animal origin you produce direct to the final consumer only (for example the public).
Marginal, localised and restricted exemption
If you are a retailer or have a genuine retail element to your business (for example farm gate sales) and intend to supply other retailers or caterers, you could be exempt from approval if the supply of the food of animal origin is “marginal and localised and restricted”.
- “Marginal” is interpreted as a small part of the establishment’s business as meaning up to a quarter of the business in terms of food or less than 2 tonnes in terms of meat.
- “Localised” is interpreted as meaning: sales within the supplying establishment’s own county plus the greater of either the neighbouring county or counties or 30 miles from the boundary of the supplying establishments county.
- “Restricted” is interpreted as concerning only certain types of products being made or establishments being supplied.
Hazard Analysis and Critical Control Points (HACCP) principles and pre-requisites
The approval process requires that you put in place procedures to manage food safety and that these procedures be based upon the Hazard Analysis and Critical Control Points (HACCP) principles.
The Hazard Analysis and Critical Control Points principles are:
- To identify any hazards that must be prevented, eliminated or reduced to acceptable levels.
- To identify the Critical Control Points (CCP’s) at the step(s) at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels.
- Establish a critical limit at those Critical Control Points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards.
- Establish and implement effective monitoring procedures at the Critical Control Points.
- Establish corrective actions when monitoring indicates a Critical Control Point is not under control.
- Establish procedures to verify that the above measures are working effectively.
- Establish documents and records commensurate with the nature and size of the food business to ensure that the above measures are effective.
Your food safety management system based on the Hazard Analysis and Critical Control Points principles can be tailored to fit your business and should be appropriate to the scale and type of production you intend to carry out.
Prior to implementing your documented food safety management system, a pre-requisite programme should be developed and set in place to provide a sound foundation for your Hazard Analysis and Critical Control Points. Examples of pre-requisites to consider would be:
- Cleaning and sanitation
- Personal hygiene
- Training in food safety and hygiene matters for yourself and employees
- Pest control
- Supplier quality assurance
- Management of waste
- Preventative maintenance programme
- Food incident or recall management systems.
Once you have put these pre-requisites in place it is recommended a process workflow for each of your products is developed. This requires you to think about:
- where the raw materials are going to be stored and managed,
- stock control and rotation
- how to avoid the raw materials coming into contact with the processed product and
- where the finished product will be stored after production.
An effective workflow diagram will also identify the process steps and help you with your Hazard Analysis and Critical Control Points programme.
Once an establishment has been approved, it is a legal requirement for the business operator to inform us of changes to any detail previously supplied. For example, a change of food business operator, a change to the activities carried out in relation to food or the closure of an establishment.
How to apply for an Approved Food Premise licence
If you think your food business proposal may need approval, contact us in the first instance to arrange a site meeting or advisory visit from an officer.
The officer may suggest a planned programme of works in order to achieve approval. If this is the case, they will guide you through each of the steps required.
Apply for an Approved Food Premises License
Or complete our Approved Food Premises paper application form.
For help with your application, view our Approved Food Premises guidance notes.
We can only issue approval when all infrastructure and document requirements have been satisfactorily met.
Once your establishment is approved, you will be issued with a unique approval number. This number will need to be applied to all products handled in the establishment that are subject to the approval.
To ensure that you are complying with the labelling requirements, you will need to contact Trading Standards.
Information provided on the approval form will form part of our Public Register, as required by the Food Law Code of Practice (England) April 2015.
My application has been refused, suspended, withdrawn or cancelled
In this situation, we advise that you contact us first.
You may appeal to the local magistrates court 1 month from the date of refusal.
The Food Standards Agency has a dedicated business appeals section which explains:
- what businesses should expect from local authority inspections
- how to determine if food safety officer actions or requirements are reasonable (and if there are grounds for an appeal)
- how to challenge local authority decisions or actions through a panel called the Independent Business Appeals Panel and more.