Approved Establishments Scottish National Protocol

General requirements 

12.1. FBOs are required to notify the relevant CA of any significant changes in activities in existing establishments under Regulation (EC) 852/2004, Article 6.2. FBOs should be reminded of this during all programmed interventions. The CA should also include this in approval documentation and/or correspondence with FBOs so that the FBOs’ obligations are clear. There is a Notification of Change(s) template form on the FSS website.

12.2. Where the FBO notifies the CA of such changes, officers need to consider whether a visit should be made to inspect the alterations and whether an amended HACCP based food safety management system is required. This will depend on the extent of the changes, such as: 

• Proposed additional activities and changes to activities;
• Change to approved curtilage/re-structuring;
• Change of FBO;
• Change of name;
• Closure of an approved establishment;
• Surrender of approval. 

Additional activities 

12.3. If a FBO, of an approved establishment wishes to undertake additional approvable activities, the FBO must apply to the relevant CA for approval before commencing the operation of that additional activity. 

12.4. The establishment’s ability to undertake additional activities should be assessed following the same procedures as a new establishment. 

12.5. Depending upon the circumstances, it may be necessary to issue conditional approval in relation to additional activities. This will be the case where new risks not adequately controlled by the existing food safety management procedures are introduced. 

12.6. Where an additional activity requires conditional approval, the conditional approval relates specifically to this activity. The existing full approval continues to apply to the other activities. In effect, the establishment has two concurrent approvals, albeit with one approval number. 

12.7. A revised approval document will need to be issued to reflect changes in the approval. Once the additional activity is assessed as being appropriate for full approval, a single revised approval document should be issued for all the relevant activities at the establishment. 

12.8. For LA approvals, once a determination has been made to alter an approval in relation to additional activities has been made by the CA, information regarding this should be communicated to the FSS Enforcement Delivery Branch LAapprovals@fss.scot.

12.9. When considering the approval of an additional activity, the CA should give consideration to wider compliance issues within the establishment and the compliance history of the establishment. This does not preclude additional activities being approved, where non-compliance is minor or is of limited relevance to the additional activity. 

12.10. For FSS approved establishments, if the most recent audit has the outcome ‘Improvement 

Necessary’ or ‘Urgent Improvement Necessary’ FSS will not consider any applications for further activities or species until such time as the FBO has demonstrated sufficient improvement to exit the Improvement Necessary or Urgent Improvement Necessary status during a subsequent audit. 

Change to approved curtilage / restructuring 

12.11. A notification to the CA of significant curtilage changes and/or restructuring to the approved establishment will require the FBO to provide revised plans indicating those changes. An assessment should be made to ascertain if the changes are appropriate. As part of this assessment professional judgement should be used to determine whether an on-site visit is also required. 

12.12. Once acknowledged by the CA, curtilage changes or restructuring should not require further or additional approval. It is the FBO’s responsibility to ensure that all such changes meet the respective requirements of the Regulations. 

Change of food business operator 

12.13. A food business establishment is defined as a unit of a food business. In this regard, it is distinctly different to a premises – which relates to the physical structure. In relation to approval, it should be considered to consist of a combination of the food business operator, the premises and the activity being conducted. Therefore, an approved establishment cannot change hands, as the new owner operating at the premises creates a new establishment and the previous establishment ceases to exist. 

12.14. If a premises used for an approved establishment changes FBO, the new establishment will have to be assessed and granted a new approval under the prospective FBO.

12.15. The approval assessment should be undertaken as soon as possible and in all cases within 20 working days of receiving an approval application (including all relevant supporting information) from the prospective FBO. Therefore, upon receipt of a new application made ahead of the date of change of FBO, the CA should endeavour to conduct a new approval assessment in the immediate run up to the effective date of change. Conditional approval may be granted to the new FBO, once the change has been implemented, if the premise establishment meets the infrastructure and equipment requirements of Regulation (EC) 852/2004 and Regulation (EC) 853/2004, including a valid food safety management system. The prospective FBO should therefore ensure the CA is provided sufficient notice (at least 20 working days) of the change of FBO.

12.16. The CA may, on request by the FBO, carry out a pre change of FBO advisory visit, (see 7.8). However, any views given at such a visit will in no way provide a guarantee as to the future approval status of the business. 

12.17. Article 6(2) of Regulation (EC) 852/2004 requires the FBO to inform the CA when there is a change of FBO. This will be by means of an application form which includes the type of business entity, name of officers and relevant address of the FBO wishing to apply for approval. The FBO is then obliged to keep the CA informed about significant changes to those details (see 12.1)

12.18. Table 3 in Annex 1 outlines the different situations where a change in FBO, between different business entities, requires a new approval or where the approval can be retained. 

12.19. Once an application is received, the CA should assess the application in the same way as a new establishment and if approval is granted may be subject to a new approval number (see 10.1). In some cases, it may be possible to grant full approval immediately (i.e when the FSMS and its implementation in practice has not been affected by the change in FBO)

12.20. Information that requires to be submitted by LAs to FSS Enforcement Delivery Branch LAapprovals@fss.scot includes: 

• Details of the previously approved establishment that has expired;
• Details of the application;
• Decision to issue approval or conditional approval; or
• Refusal.

12.21. A copy of the relevant documentation provided to the FBO should be supplied to FSS at LAapprovals@fss.scot. 

12.22. The FBO will not be able to undertake activities that require approval until approval or conditional approval is granted. 

12.23. Where the CA becomes aware of a change of FBO that continues placing food on the market without seeking a new approval after the change of operator, the action regarding withdraw/recall of such food should be risk-based and proportionate. Advice should be sought from the FSS Scottish Food Crime and Incidents Unit incidents@fss.scot. However, food not yet placed on the market should be detained until the new FBO has been able to gain approval. 

12.24. In the case of wholesale markets the following principles may apply: 

• The overall approval for the market (common parts) will be treated in the same way as an individual premises ownership change. Therefore, the change in FBO would necessitate a re-approval and there might be a need for a new approval number to be granted for the wholesale market. The individual units within the market do not need to be individually re- approved, however if the markets approval number is changed, the units can be re- allocated a new corresponding number using the new market approval number (for common areas of the market). The impact on the individual units should be considered before changing their approval numbers.
• In the event that the common parts of a wholesale market are not granted approval, the individually approved units are not able to operate as the approval of the common parts facilities is a prerequisite to their approval. Where the units are able to become self- sufficient in their own right, separate approval as an individual establishment can be sought.
• If an individual unit of a wholesale market changes ownership, this will be treated in the same way as an individual premises ownership change. 

Change of trading name 

12.25. The Notification of Approval document includes the details for the establishment and the identity of the FBO. Where there is a change of name in either of these areas, the approval document needs to reflect this. A copy of the relevant documentation provided to the FBO should be supplied by LAs to FSS at LAapprovals@fss.scot.

12.26. For FSS approved establishments, any change to the trading name must be submitted by email to Approvals@fss.scot. This should be made by the owner of the business or at least by one director of the Company. 

NB. This is not to be confused with a change of ownership, which would warrant a re-assessment for approval. The change of name does not affect any existing matters arising in relation to the establishment, which may be the subject of separate inspection or enforcement activity. 

Closure of an approved establishment 

12.27. Where an establishment has a break in operation or closure, the FBO is obliged to keep the CA informed (Article 6 (2) of Regulation (EC) 852/2004). These breaks are categorised as follows: 

• Seasonal closure 

An establishment may operate to a seasonal pattern with routine breaks in operation. Notification of this pattern should be provided by the FBO as part of the application process by identifying the months when the FBO intends to operate the establishment. The FBO is then obliged to keep the CA informed about any significant changes to those details including any establishment moving to or from a seasonal pattern. When an FBO intends to re-commence operations the CA needs to be notified at least two weeks before operations are intended to re-commence. 

• Temporary closure 

When an FBO needs to temporarily halt operations due to renovation / development work at an establishment or due to a temporary downturn in trade the FBO is obliged to keep the CA informed regarding these significant changes to the operational pattern. In these cases the FBO must notify the CA at least two weeks before operations re-commence. 

• Long-term closure 

When an FBO stops operations with no immediate intention to recommence for at least 6 months or longer the closure is classed as long-term. The FBO is obliged to keep the CA informed about this significant change to the operational pattern and must notify the CA at least two weeks before operations re-commence [Regulation (EC) 852/2004 Article 6]. The CA may consider suspending the approval of the establishment during the closure.

NB. Long-term closures should not be confused with seasonal closures. Seasonal closures are pre-notified routine breaks in operation to a seasonal pattern. 

12.28. During non-operational periods official controls undertaken by the CA should be partially suspended, with the exception of ad hoc controls. 

12.29. Following a period of closure the FBO must not start operations until the CA has been notified and undertaken a pre-opening visit. This visit is to assess that the establishment meets all structural and equipment requirements and other relevant requirements of food law, including the existence of a food safety management system based on HACCP principles. 

12.30. The FBOs food safety management system must be available at the visit but as the establishment will not be operational, it will not be possible to assess how effectively this works in practice. The effectiveness of the FBO’s food safety management system will therefore be assessed at the first scheduled visit undertaken by the CA. 

12.31. The process of pre-opening assessments is described below: 

• Where the pre-opening assessment results in the CA being confident that the requirements of food law are met, the FBO will be notified that operations at the establishment can re- commence.
• Where the pre-opening assessment identifies serious deficiencies in meeting the requirements of food law, the FBO may provide the CA with guarantees on how the deficiencies will be resolved on a permanent basis and within a reasonable time.
• Where the FBO provides adequate guarantees that the deficiencies will be resolved on a permanent basis and within a reasonable time the approval will remain but operations cannot re-commence until the deficiencies have been resolved.
• Where the FBO does not provide adequate guarantees or the timescale suggested for the deficiencies to be resolved is not reasonable the establishment cannot re-commence operations and the approval will be referred for formal review. (See 13.1) 

12.32. For consistency of approach, the working definition for the term ‘serious deficiency’ used when assessing closed premises in advance of re-opening will be the same as that used in a formal review of approvals. Following the pre-opening assessment visit and when the CA is content that the establishment meets all of the relevant requirements of food law, the FBO will be notified that operations can re-commence. 

12.33. In the event that the CA is not content for operations to re-commence, the FBO will be notified of the deficiencies and appropriate enforcement action will be taken until the deficiencies are resolved on a permanent basis or a formal review of approval has been undertaken. 

12.34. Where the CA becomes aware of an establishment that has re-commenced operations without first notifying them and a pre-opening visit assessment has not been undertaken, the following measures will be taken: 

• Appropriate enforcement action will be taken to prevent FBO operating the establishment until a formal assessment of compliance has been undertaken or where deficiencies are identified such deficiencies have been rectified;
• If food has been placed on the market prior to a formal assessment the CA’s action regarding withdraw/recall of food will be risk-based and proportionate. Advice should be sought from the FSS Scottish Food Crime and Incidents Unit incidents@fss.scot. However, food not yet placed on the market can be detained under Regulation 9 of the Food Hygiene (Scotland) Regulations 2006 until the FBO has been notified that operations can recommence. 

If on further investigation and examination, the CA deems the food has not been produced in accordance with the Hygiene Regulations, they can certify the food as such using Regulation 27 of the Food Hygiene (Scotland) Regulations 2006. 

 Surrender of approval 

12.35. Where the FBO of an establishment under their control, holding an approval granted by the CA wishes to surrender that approval, the FBO is required to provide formal notice under Article 6(2) of Regulation (EC) 852/2004. 

12.36. Once acknowledged by the CA, the approval will cease to exist and the use of the approval number will also come to an end.

12.37. For LA approved establishments, the CA should notify the FSS Enforcement Delivery Branch accordingly (LAapprovals@fss.scot). Upon notification by the CA of the surrender, the establishment will be removed from the official list of approved establishments maintained by the FSS. 

12.38. For FSS approved establishments, the surrender of approval is formally acknowledged via approvals@fss.scot. In cases of slaughterhouse approvals, arrangements will be made to secure official health mark stamps accordingly. The establishment will be removed from the official list of approved establishments published by FSS. 

12.39. It would be an offence to resume activities subject to Regulation (EC) 852/2004 or Regulation (EC) 853/2004 at the establishment, before the FBO is granted approval or conditional approval or registered as appropriate by the relevant CA. 

12.40. Following the surrender, the FBO should be advised that it would be an offence to apply the ID Mark on any food or to resume activities for which approval is required without being reassessed for and granted a new approval.

Establishments no longer engaged in Approvable Activity 

12.41. Only establishments engaged in (or with the intent to engage in) the supply of relevant POAO to other food business establishments can be approved. Where the nature of a food business changes so that approval is no longer relevant, the FBO should be requested to surrender the approval (see 12.35 - 12.43). Where the FBO fails to do so and the CA cannot verify the implementation of the FSMS in relation to the approvable activity, the CA should consider appropriate action and seek legal advice if required.

LAs should notify LAapprovals@fss.scot when a business has ceased trading or is no longer undertaking activities that require approval.

12.42. Where an approved establishment’s operations have been reduced in scope, or due to changes in approvals policy, are within scope of the retail to retail exemptions from approval. 

The establishment can be considered exempt from approval. In such circumstances the CA will consider on a case by case basis. 

12.43. FBOs are required to inform the CA of any changes to operational activity.  Where operations on an approved activity become inactive and the FBO wishes to retain approval they will be required to maintain a validated HACCP–based FSMS on the activity at all times during any non-operational period and it will be subject to Ad hoc Official Controls. This would apply for a period of up to 12 months. 

12.44. Exceeding the 12 months period, where operations do not commence and the FBO still wishes to retain the approval for the activity, the FBO should notify the CA to “suspend approval for the activity”. The FBO will also be required to inform the CA of intentions to commence to allow the activity to be re-assessed or re-approved to confirm suitable controls are in place. 

Transfer of official controls from FSS to LA 

12.45. Where the FBO holding an approval granted by FSS wishes to surrender the slaughterhouse, cutting plant and/or game handling establishment element of their approval but wishes to retain stand-alone approved activities, the establishment will be transferred to the LA. In these circumstances FSS will notify the relevant LA accordingly. As FSS had already approved the standalone activity, the LA may not have to undertake a separate re-approval. If appropriate, the CAs may suggest a discussion and joint visit if considered necessary.

12.46. LAs may allow FBOs to retain an approval code that had been allocated by FSS, where an establishment is passed from FSS to the LA and vice versa. This would avoid the need for businesses to change their packaging, labelling etc., thereby avoiding any potential cost implications.  However, the competent authorities are advised to consider phasing these out over a period of six months, by which time such businesses should have used up all existing stocks of pre-printed labelling materials. This is provided that it is satisfied that the establishment can continue to meet all the requirements of the Regulations, and that the establishment’s food safety management system is adequate to cover the stand alone activity or activities subject to approval. 

12.47. There may also be instances where FBOs approved by FSS will cease activities requiring approval or move within exemption limits which mean they need to be registered with the LA. In the case of FBOs: 

• deciding to limit their activities to meet the exemption criteria and surrendering the approval granted by FSS; or
• losing their right to operate through withdrawal or suspension or refusal of approval but deciding to limit their activities to meet the exemption criteria.

12.48. The establishment will remain subject to the requirements of Regulation (EC) 852/2004 and must therefore register with the LA as a Food Business prior to surrendering their approval. On surrender of the approval the establishment will be removed from the official list of FSS approved establishments. 

Transfer of official controls from LA to FSS 

12.49. There may be occasions where an FBO under LA jurisdiction wishes to carry out an activity which is subject to approval by FSS. Examples of this are: 

• A registered FBO operating within the limits of an exemption, who wishes to expand e.g. a retail butcher wishing to supply over 2 tonnes per week to other retail/catering establishments;
• An approved establishment under LA jurisdiction (e.g. meat preparations), who also wishes to cut and sell fresh meat, where this product is not a consequential activity, to other establishments. 

12.50. In both scenarios, the LA should contact FSS approvals team to arrange a joint visit. If the FBO is already operating in a way that requires FSS approval, any enforcement action remains the responsibility of the LA, until approval has been granted. In the second scenario, transfer of responsibility for enforcement of all approved activity co-located with cutting and/or slaughter to FSS will normally be transferred to FSS, but may, with agreement of both parties, be considered on a case-by case basis. All such cases should be referred to FSS for consideration to Approvals@fss.scot