Approved Establishments Scottish National Protocol

6.1. Applications for approval must be sought for new build/start-up establishments and are also required in the following circumstances: 

• Registered establishments under Regulation (EC) 852/2004 applying to undertake activities that require approval;
• Establishments approved under Regulation (EC) 853/2004 applying to undertake additional activities or significant changes; and change of food business operator. 

6.2. In considering applications for approval, Competent Authorities should ensure that they fully consider any exemption that may be afforded to the applicant by Article 1 of Regulation (EC) 853/2004. 

6.3. Following an enquiry from a prospective FBO or a relevant establishment, the LA should ensure that the FBO is provided with an application form. Templates of Application for Approval forms. 

6.4. If the FBO requires FSS’s approval, the application can be found here or by contacting FSS at Approvals@fss.scot. 

6.5. The approval application will not be considered without all relevant supporting documentation. 

6.6. An FBO can only make an application for approval for an establishment under their control and only for processes and/or activities that they intend to carry out.

6.7 The applicant must complete the application form and provide details of: 

   a) The premises for which approval is requested; 

   b) activities for which approval is sought; and 

   c) The identity of the FBO including relevant contact details. The legislation allows for natural and legal persons to be FBOs therefore the applicant is required to identify themselves (including the name of officers, address and proof of status) as either a: 

• Sole trader or partnership (natural person/s) who is required to be compliant with food law.
• Incorporated and registered company (legal person) which is required to be compliant with food law.
• Other business types such as cooperatives, registered charities and other specialised types of organisation will have to establish the natural or legal person who will have control and responsibility for the operation of the food business. 

The CA may request further information/supporting evidence from the FBO to process the approval request.

6.8. Applications for approval of establishments can only be accepted from FBOs that intend to engage in activities for which approval would be required in accordance with Regulation (EC) No. 853/2004. However, where an establishment is exempt from approval through application of the ‘retail to retail’ exemption, consideration should be given to providing conditional approval to establishments that require approval in order to tender for contracts or commercial purpose. If approval is required to access international markets, but the activities undertaken are not considered to be approvable, the matter should be referred to FSS at LAapprovals@fss.scot for consideration.

6.9. An application for approval requires supporting documentation as well as the application form itself. A CA cannot make a determination to issue an approval or conditional approval until all relevant information has been received. 

6.10. In relation to LA approvals, once an application has been received, a copy of the application form should be sent  to the FSS Enforcement Delivery Branch LAapprovals@fss.scot. Information should include the name and contact details of the FBO, the address of the establishment and the nature of the approval sought. 

6.11. In relation to FSS approvals, all supporting documentation together with the application form itself, must be submitted to Approvals@fss.scot mailbox. 

6.12. Relevant documentation required to support the application includes, but is not limited to: 

• A detailed scale plan of the (proposed) establishment showing the location of rooms and other areas to be used for the storage and processing of raw materials, product and waste, and the layout of facilities and equipment;
• A description of the (proposed) food safety management system based on HACCP principles;
• A description of the (proposed) establishment and equipment maintenance arrangements;
• A description of the (proposed) establishment, equipment and transport cleaning and disinfection arrangements;
• A description of the (proposed) waste collection and disposal arrangements;
• A description of the (proposed) water supply;
• A description of the (proposed) water supply quality testing arrangements;
• A description of the (proposed) arrangements for product testing;
• A description of the (proposed) pest control arrangements;
• A description of the (proposed) monitoring arrangements for staff health;
• A description of the (proposed) arrangements for record keeping;
• A description of the (proposed) arrangements for applying the ID mark to product packaging or wrapping (where applicable);
• A description of the traceability arrangements for all ingredients, packaging and final products;
• A description of the products to be produced including, where appropriate, the physiological characteristics of the product. 

6.13. Where other documents are requested prior to the application being considered, e.g. specific details of any particular control e.g. in-line pasteurisation, or challenge testing results, these requests should be made at the earliest opportunity. 

6.14. The level of detail required will vary on a case by case basis, and officials are required to use their discretion on the documentation required. e.g. in some circumstances, a sketch plan of the pipework may be required and in others, formal plans of the water distribution network will be required. 

6.15. Initial assessment of an application will be conducted prior to all the necessary documentation being submitted at the discretion of the CA. However a determination cannot be made without all supporting documentation having been provided.