Rwanda FDA Food Premises Guidelines

What is the name of the regulatory body established by Law N° 003/2018 of 09/02/2018?

What is the main function of RWANDA FDA?

Food premises are categorized into two major categories namely facilities for food manufacturers and food outlets.

What are the two main types of facilities for food manufacturers as categorized by RWANDA FDA?

What are the criteria used by RWANDA FDA to classify food manufacturing facilities?

What criteria are used to classify food outlets by Rwanda FDA?

What are the main types of food products regulated by RWANDA FDA?

What is the definition of processed food?

Any organization or company intending to manufacture/process store, distribute and retail any food falling into these categories or any food product which will be defined by Rwanda FDA shall request authorization.

What are the four types of applications for premise registration classified by Rwanda FDA?

What are the required documents for a new application for premise registration?

What are the required documents for a new application for premise licensing of a food manufacturing premises?

What are the required documents for a new application for premise licensing of a wholesale of food products?

What are the required documents for a new application for premise licensing of a retail of food products?

What are the required documents for a new application for premise licensing of a restaurant and related food businesses?

What are the required documents for a new application for premise licensing of a wholesale or retail of food supplements and/or infant formula shop?

The minimum space required for a retail of food supplements premise in Kigali is 40m² which can be separated into a minimum sales area of 30m² and 10m² for storage.

A premise license grants the authorization to manufacture food products and to sell the products on market.

The processing time for applications for manufacturing facilities and food outlets should not exceed 30 working days from the application date.

For renewal of a premise license, an application must be made at least one month prior to the expiry of the existing registration.

A change of responsible technician is considered as a variation of registered premise license.

The Authority may consider prosecution for non-adherance to the guidelines only if the situation poses a risk of food safety to consumers.

What are the three classes of non-compliance used by RWANDA FDA to define the appropriate regulatory action?

For minor non-compliance, the Authority will recommend a corrective action within a given time frame and request for compliance reports.

For major non-compliance, the Authority will recommend a corrective action within a given time frame, and request for a comprehensive compliance report.

For critical non-compliance, the Authority may implement temporary closure of the establishment, permanent withdrawal/revocation of operational license, and not grant the operational license.

The food premises must be a permanent structure and must be located away from any sites or activities that emit obnoxious material like fumes, dust smoke, offensive trade or breeding sites for vermin.

The food premise should have sufficient space for the carrying out and supervision of the necessary operations.

The physical address of the premise should be clearly indicated in the application form.

The food premise should be located within a residential area.

The food premises should be designed for the intended purpose and should not have any direct link with any business or occupation that may lead to contamination of food.

The food premises should be of suitable layout, constructed to facilitate easy maintenance, sanitation and good flow of operations.

The food premises and facilities installed shall have adequate space for placement and storage of materials which are necessary for sanitary operations.

The food premises and facilities installed shall have adequate space for each activity that may cause contamination of food.

The walls and ceiling of food premises shall be adequately seamless, cleanable and maintained in a clean and good state of repair.

The fixtures, ducts and pipes may be suspended over areas where drips or condensate may contaminate food and raw materials or food contact surfaces

Aisles or working spaces between equipment and walls shall be unobstructed and of sufficient width to allow employees to perform their duties without contaminating the food or food contact surface with their clothing or personal contact.

Every utensil and equipment used in food premises shall be suitable for their intended use and food grade; well designed and adequately cleanable and proper maintenance of cold chain for frozen products.

Every food contact surface shall be smooth and impervious, free from pits, crevices and loose scale, non-toxic, and capable of withstanding repeated cleaning disinfection and sanitization.

Every food premise should present the Managing Director the responsible technician and a trained personnel from a recognized institution.

Persons suffering from communicable diseases shall be involved in handling of food or food contact surfaces.

Thorough medical examination for food handlers shall be carried out prior to employment.

Medical examination records for each worker shall be kept properly and accessible for inspection.

Any responsible technician wishing to resign from his/her responsibilities shall inform the authority with a resignation letter signed by both the employer and the employee.

Storage facilities should be provided to protect products from deterioration and shall be maintained accordingly.

Storage conditions should be monitored and maintained accordingly.

Controlled storage environments should be made available and monitored using suitable temperature recording devices.

All food products shall be stored on the floor in well-fitted shelves or pallets.

Storage facilities for grains should be monitored for humidity, temperature and pests and records should be kept properly

All food premises shall be provided with adequate and easily accessible sanitary conveniences to cater separately for both genders, for employees and/or customers

Food premises should be provided with an adequate supply of potable water.

There should be a proper waste disposal system.

Food handlers shall be clean in person and shall avoid unhygienic practices.

Food premises should be provided with adequate hand washing facilities with hot & cold running water, nail brushes and disinfectant liquid soap.

Doors may be designed to open by pushing from all sides or self-operating doors to avoid contaminating the food handler's hands.

Food premises need to ensure regular water supply of an appropriate quality.

Water for injections should be produced, stored and distributed in a manner which prevents microbial growth, for example by constant circulation at a temperature above 70°C.

All processing containers, vessels and utensils shall be cleaned and labeled as such before they are stored and shall be rechecked for cleanliness before being issued out to the manufacturing areas.

All product labels, printed packaging and descriptive materials shall: be stored in a secure manner, accessed by only authorized personnel, and records should be kept for the labels, printed packaging and descriptive materials issued, to avoid any mix-up.

The premises shall have sufficient fire-fighting equipment which shall, at all times, be in good condition and readily accessible.

The equipment used for weighing, measuring, testing and recording shall be subjected to recorded checks for accuracy in accordance with a regular set schedule.

Quality Control laboratories shall be designed to suit the operations to be carried out in them. Sufficient space shall be given to avoid mix-ups and cross- contamination. There shall be adequate suitable storage space for samples and records.

The applicant shall show a capacity to prompt and effective system of traceability and recall from the market of products known or suspected to be defective or hazardous.

In case of recall of a product, the applicant shall notify the Authority of the reason for the recall.

Recall operations shall be capable of being initiated promptly, at least down to the level of retailers.

The distribution records shall contain sufficient information related to the product.

The disposal of recalled, rejected, or withdrawn products from the market shall be effected within one month after completion of exercise.

The Authority shall take regulatory actions based on Minor, Major, and Critical category of non-compliances.

For minor non-compliances, the Authority will implement a warning letter, recommend corrective action within a given time frame, recommend temporary withdrawal or suspension of an operational license, request for a comprehensive compliance report.

For major non-compliances, the Authority will implement temporarily closure of the establishment, permanent withdrawal/revocation of operational license, and not grant the operational license.

For critical non-compliances, the Authority will implement a warning letter, recommend corrective action within a given time frame, and request for a comprehensive compliance report.

The authority shall cancel, suspend, or withdraw the license to operate a food processing premise/ food outlet if the circumstances under which it was licensed no longer exist.

The authority shall cancel, suspend, or withdraw the license to operate a food processing premise/ food outlet if the grounds on which it was licensed are later found to be false, or any provision under which it was licensed has been contravened.

The authority may suspend, or revoke the authorization if the applicant is not complying with any of the requirements or conditions in the guideline, or has ceased to be fit to carry on the business.

The authority may consider prosecution for non- adherence to the guidelines if the situation poses a risk of food safety to consumers.

Administrative fines are provided in the Regulations related to regulatory service tariff/fees and fines available on Rwanda FDA website.