Feed Manual of Official Controls

The FDB is responsible for duties relating to the handling of applications for registration and approval and maintenance of the Feed Establishment Register.  Although the default position is that FSS shall carry out approval of businesses, officers from Agents may be authorised to undertake this work in exceptional circumstances and with written agreement from FSS. FSS will manage any timeframes for approval and liaise with the relevant Authorised Officer of the Agent to assign any agreed visits or inspections. The necessary requirements are laid out in this Chapter, should they be required. 

If an Authorised Officer becomes aware of an unregistered feed business establishment during a visit, and where time permits within the visit, the Authorised Officer should assist the FeBO to submit the on-line registration using the FSS Online Registration Platform. If time does not allow, they shall notify FDB by email at feed@fss.scot , providing the name and address of the FeBO, and advise the business to complete the form on the FSS Online Registration Platform (also provided as Annex 4.1 and 4.2 in this Manual).

If an Authorised Officer becomes aware of a feed business establishment that should be approved but is not, they shall notify FDB by emailing Annex 4.9 to feed@fss.scot, and advise the business to complete the form on the FSS Online Registration Platform (also provided as Annex 4.1 and 4.2 in this Manual). FSS shall consider reporting to the incidents team and/or appropriate enforcement action if necessary. 

Details of the approval and registration activity codes are available on the FSS Online Registration Platform with further details at Annex 4.2 in this Manual.

All feed businesses are required to register, unless they require to be approved by the competent authority. Business activities that require to be approved are detailed in Article 10(1)(a) and (b) and Annex II (point 10 Facilities and Equipment) of  Regulation (EC) 183/2005:

• manufacturing and/or placing on the market of feed additives covered by  Regulation (EC) 1831/2003 or products covered by Directive 82/471/EEC and referred to in Chapter 1 of Annex IV to Regulation (EC) 183/2005
• manufacturing and/or placing on the market of premixtures prepared using nutritional feed additives referred to in Chapter 2 of Annex IV to  Regulation (EC) 183/2005
• establishments carrying out one or more of the following activities to place on the market products for use in feed:
  • processing of crude vegetable oil except those under the scope of Regulation (EC) No 852/2004.
  • oleochemical manufacturing of fatty acids.
  • manufacturing of biodiesel.
  • fat blending

Responsibility for approval at an establishment relating to the activity of the manufacture of a premixture and feeding stuffs containing a medicinal substance or a specified feed additive e.g. coccidiostats, histomonostats and growth promoters as listed in Regulation (EC) 183/2005 Article 10(1) (b) and (c) falls to the Veterinary Medicines Directorate (VMD) in Great Britain. This is regardless of whether vitamin A or D, or the trace elements, copper or selenium have been incorporated in the feed or other activities are carried out at the establishment where FSS has responsibility for approval or official controls.

Applications for approval received from a FeBO are dealt with by the FDB. Applications for approval of establishments shall only be accepted from FeBO’s that intend to engage in activities for which approval is required, in accordance with  Regulation (EC) 183/2005 and on receipt of the relevant fee set out in Schedule 2 of The Feed (Hygiene and Enforcement) (Scotland) Regulations 2005. FSS requires the FeBO to supply all relevant information as listed in 5.3.8 before an application for approval is determined. Once all the relevant information has been received, the FDB shall pass this information to the Authorised Officer in order that they can undertake the inspection process.  If the FeBO has not been able to provide all the necessary documentation, the FDB shall consider whether the inspection is to go ahead. If the inspection does go ahead, the Authorised Officer will be asked to collect all outstanding documentation at this time.

In consultation with the Authorised Officer, the FDB will determine whether it is appropriate to undertake an advisory visit to an establishment that has applied for approval, prior to an approval visit. The aim of the advisory visit is to help FeBO’s identify any problems in the areas of structure and maintenance and feed safety management,  to avoid any potential difficulties when the establishment is formally assessed for approval. The Authorised Officer will contact the FeBO to arrange the visit and will make the FeBO aware of the differences between an advisory and an approval visit. This shall be re-iterated by the officer at the time of the inspection. 

Before reaching a decision on an application for approval, the FDB will require the Authorised Officer to carry out an on-site visit made in accordance with Article 13 of  Regulation (EC) 183/2005, unless the exemption from an on-site visit, in accordance with Article 17 of  Regulation (EC) 183/2005, applies (see 5.3.5). The on-site visit should take the form of an inspection of the establishment. The inspection should be conducted in accordance with, and cover, all aspects of the relevant inspection form for the business concerned (Annex 5) and consider all issues required by Regulation (EC) 183/2005.

Clear concise records must be kept of the inspection and the completed inspection form uploaded onto FMIS. 

The Authorised Officer is responsible for making recommendations to the FDB on the granting of approval. This can be shared with the FeBO, but the officer must be clear that it is their recommendation and not provide it as a guarantee that approval shall be granted. The decision to grant approval is the responsibility of the FDB and shall be determined once all evidence has been considered. 

An exemption from an on-site approval visit applies to feed businesses that solely trade feed products and never hold the product on their premises (including modes of transport such as lorries or ships). To qualify for this exemption, feed businesses must make a declaration to the FDB in accordance with Article 17 of  Regulation (EC) 183/2005. A model declaration form is provided on the FSS Online Registration Platform.

Article 13(2) of  Regulation (EC) 183/2005 permits the granting of conditional approval following an on-site visit to an establishment which does not fully comply with the requirements of feed law, but only if the establishment meets all the infrastructure and equipment requirements. 

Full approval should not be recommended unless all relevant requirements of the legislation have been met and the FeBO demonstrates that the operational controls are in place, and they are fully compliant. For a new establishment, in all circumstances, conditional approval should be recommended prior to full approval being granted. This is because it will be impossible for the FeBO to demonstrate that the feed safety management system is valid and to verify its effectiveness until it is operational.

The Authorised Officer will make a recommendation to the FDB as to whether conditional approval may be granted to an establishment where they do not fully comply with the requirements. However, conditional approval should not be recommended if the non-compliance could lead to feed adversely affecting the health of animals, or to humans through the consumption of animal products. If conditional approval is granted by the FDB, a further visit must be carried out within three months of the conditional approval being granted in accordance with Article 13(2) of  Regulation (EC) 183/2005. 

In appropriate circumstances as set out in Article 13(2) of  Regulation (EC) 183/2005, conditional approval may be extended, but this is restricted to a maximum of six months from the date of the initial granting of conditional approval. The FDB, in discussion with the Authorised Officer, shall determine whether it would be appropriate to extend conditional approval.

An amended version of the inspection form in FMIS is to be used in connection with approval status determination. 

The FDB shall maintain a properly structured file, held electronically on FMIS/eRDM, containing all the relevant information submitted and produced for establishments which require formal approval. It provides a history of the establishment concerned and how it has developed and provides continuity for new officers. 

The following information shall be available from the FeBO and if not, it shall be requested at the time of inspection: 

• the application form
• declaration for exemption from on-site visit, where applicable
• a plan or plans of the establishment indicating:
  • the layout of the establishment
  • the location of equipment
  • workflows for each product line and
  • pest control - baiting and/or trapping points within the establishment and external areas.
• a synopsis of the establishment which briefly describes what type of establishment it is, products produced, volume of product, type of trade, number of employees, and, if already approved, approval number and what it is approved for. This synopsis should be no more than one side of an A4 sheet
• planned programme of works to achieve approval, where applicable
• approval notification document specifying:
  • details of activities to which the approval relates
  • approval number
  • any special direction(s) or conditions specified by FSS; and
  • labels and commercial documents bearing the identification mark.
• copy of company’s emergency withdrawal plan and traceability system including names, telephone numbers, etc., of key personnel within the company
• location of any off-site facilities
• copy of any other documents that have been provided by, or copied at, the approved premises, including:
  • HACCP documentation
  • product list
  • raw material, product sampling plans and test results
  • process records
  • management and key contact names and contact details
  • photographs and digital images and
  • product recall procedures.
• The following information shall be available from the officer and/or FDB:
• pre-approval visit report
• intervention reports on premises in chronological order
• correspondence with establishment in chronological order
• copies of notices or other formal action taken in chronological order
• results of all samples taken by the Authorised Officer.

Subject to the outcome of the approval inspection and review of the approval documentation, the Authorised Officer shall make a recommendation for approval or otherwise to FDB. The FDB shall make the final decision informing the FeBO and the officer that conducted the inspection. 

If the outcome of the inspection and review of documentation are satisfactory, the FDB shall notify the FeBO that approval has been granted and issue an approval number using Annex 4.4. The approval number shall be formatted in accordance with Article 19(5) of Regulation (EC) 183/2005.

An approval can be refused at any time in the approval assessment process. 

Approval can be refused if there are structural or equipment deficiencies at the initial approval visit or if the prospective FeBO has no proposed HACCP based feed safety management system, or it is deemed inappropriate to protect public and/or animal health, food or feed safety. 

Full approval after conditional approval can be refused if: 

• within the three months of conditional approval, insufficient progress has been made to meet the legal requirements in full, and, in the judgement of the officer, there is insufficient evidence to demonstrate that the necessary work will be completed if a further period of conditional approval is granted; and
• at the end of the six-month period there is insufficient compliance with structural, equipment and/or operational requirements and/or other relevant requirements of feed law, including the implementation of an effective feed safety management system based on HACCP principles. 

The approval process will be discontinued if, following conditional approval and before consideration can be given to recommend full approval or prolong conditional approval, the establishment ceases operations, or a visit cannot be undertaken because of the relevant activities not being in operation. In such cases, conditional approval will cease to have effect and the FDB shall notify the FeBO accordingly. 

If the premises are refused approval, the FeBO has a right to appeal to a Sheriff against the FSS decision. This is in accordance with Regulation 13 of The Feed (Hygiene and Enforcement) (Scotland) Regulation 2005. The time limit for lodging an appeal is one month from the date notice of the decision was served.

If the Authorised Officer considers that any activities undertaken in an establishment, pending the result of an appeal, may present a risk to public and/or animal health, food or feed safety, it should consider the use or recommendation of use of relevant enforcement powers, appropriate to the circumstances involved. The recommendation to use enforcement action must be referred to FSS by email, providing information of the FeBO, circumstances, recommended enforcement action and reasons for this course of action, taking the FSS Feed Delivery Enforcement Policy into consideration. The email should have the following text in the subject line: “Third party referral - enforcement action to FSS”.

The appropriate form (Annex 4.5 or 4.6) shall be used to confirm refusal of approval. 

Article 16 of Regulation (EC) 183/2005 requires the Competent Authority to amend details of the approval of an establishment, where the business has demonstrated its capacity to develop activities which are additional to those for which it was first approved, or which replace them. 

If a FeBO of an approved establishment wishes to undertake additional activities subject to approval, they must apply to FSS for approval before commencing the operation of that additional activity. The FeBE’s ability to undertake additional activities should be assessed following the same procedures as a new establishment. The FDB shall consider whether an inspection should be made to inspect the alterations and whether an amended HACCP based feed safety management system is required. This will depend on the extent of the changes. 

If an inspection is required, professional judgement should be used by the Authorised Officer, in the case of approving additional activities, to determine whether to recommend full approval in the first instance. This is only appropriate when the officer is satisfied with infrastructure, equipment and FeBO controls. The FDB shall issue a revised confirmation of approval document (Annex 4.4) to the FeBO to reflect the changes in the approval.

Article 9(b) of  Regulation (EC) 183/2005 requires FeBO’s to provide the Competent Authority with up-to-date information on any establishments under their control, including changes in ownership. 

An approved establishment cannot change ownership and retain the existing approval. If premises used for an approved establishment changes ownership, an inspection and re-approval is required. The FDB will instruct the Authorised Officer to do so as appropriate.

What would be regarded as a change of FeBO may vary in different business arrangements. For example, when a member of a partnership leaves, it does not necessarily trigger a new approval if the remaining members of the partnership continue the business. However, if the partners sold the business to a sole trader who was not in the partnership, then this would constitute a change of FeBO. 

If, during an inspection or revisit, the Authorised Officer becomes aware of a change to an approved FeBO, they must advise the FDB by using the Notification of Changes to FeBO Details form (Approved Premises) at Annex 4.9. The FDB shall then contact the FeBO to request a new feed business approval form.

When the FDB or the Authorised Officer becomes aware of a change of FeBO for a FeBE that continues placing feed on the market without seeking a new approval after the change of operator, FDB shall initiate action to withdraw/recall feed if it is risk based and proportionate (see Chapter 7). However, feed not yet placed on the market should be detained until the new FeBO has been able to gain approval. 

Where an establishment has been re-assessed for approval, due to a change of ownership and approval is granted, generally a new approval number will be allocated by FSS. However, having regard to issues of risk, cost and proportionality, a business may be able to retain its approval number where, other than for the change of FeBO, the business is to continue to operate from the same premises and in essentially the same way i.e. the type of feed production by the business and the feed safety control arrangements of the business remain essentially the same. 

Unlike a change of ownership, which would warrant a re-assessment for approval, a change of name for either the establishment or the FeBO, the approval document needs to reflect this. The change of name alone does not affect any existing matters arising in relation to the establishment. If the Authorised Officer becomes aware of one or both changes, they must advise the FDB using Annex 4.9.

Where an approved establishment has a break in operation or closure, the FeBO is obliged to keep FSS informed. Such breaks in operation can be categorised as follows:

If the Authorised Officer becomes aware of the closure (seasonal, temporary or long-term) of an approved establishment, they must advise the FDB using Annex 4.9.

Following a period of closure of more than 4 months, the FeBO must not start operations until the FDB has been notified. The Authorised Officer may be asked to carry out a pre-opening visit. The purpose of the visit is to assess that the establishment meets all structural and equipment requirements and other relevant requirements of feed law, including the existence of a feed safety management system based on HACCP principles. 

The FeBO’s feed safety management system must be available at the pre-opening 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 FeBO’s feed safety management system will be assessed at the first scheduled visit after opening. 

The process of pre-opening assessments is described below: 

• where the pre-opening assessment results in the Authorised Officer being confident that the requirements of relevant feed law are met, the FeBO will be notified by the FDB that operations at the establishment can recommence
• where the pre-opening assessment identifies serious deficiencies in meeting the requirements of relevant feed law, the FeBO is required to provide the FDB with reassurance on how the deficiencies will be resolved on a permanent basis and within a reasonable time
• where the FeBO provides adequate guarantees that the deficiencies will be resolved on a permanent basis and within a reasonable time, the approval will remain and
• where the FeBO does not provide adequate guarantees or the timescale suggested for the deficiencies to be resolved is not reasonable, the establishment. The approval will be reviewed by the FDB, in collaboration with the Authorised Officer. The FeBO will be notified of the deficiencies by FSS who will take appropriate enforcement action until the deficiencies are resolved on a permanent basis, or a formal review of approval has been undertaken. 

Following the pre-opening assessment visit, and when the FDB and the Authorised Officer are content that the establishment meets all the relevant requirements of feed law, the FeBO will be notified that operations can re-commence by FSS.

FeBO’s should be reminded by the Authorised Officer of the requirement to notify FSS of any changes that could affect the scope of approval during all programmed inspections. 

An approval number is not generally transferrable. However, if a FeBO of an approved establishment moves from their existing premises to a new one, FSS may allow the FeBO to retain the same approval number which was provided to them for the establishment which they are vacating. Reallocation of an approval number would only be permissible when the establishment moves to a new location, where the FeBO of the business remains the same, and the activities remain substantially the same. 

To ensure that the approval numbers remain unique to a single establishment, the approval must first be surrendered by the FeBO to FSS and operations at the existing premises must cease. The same number may then be re-issued by FSS to the FeBO at the new premises, if approval at the new premises is deemed to be appropriate.

The operation at the new premises will be subject to new approval, including an application for approval, a site visit and an assessment of compliance with the requirements of the legislation. The FeBO must be granted approval prior to operations commencing in the new location. 

FSS is responsible for enforcement action and generally will take enforcement action based on advice and recommendations from Authorised Officers from Agents. However, there may be occasions when it is necessary and/or appropriate for enforcement action to be taken by Agents and in such cases, this shall be agreed in writing (by email) between FSS and the Agent.

Powers to revoke or suspend the registration or approval of an establishment in accordance with  Regulation (EC) 183/2005 are in The Feed (Hygiene & Enforcement) (Scotland) Regulations 2005. Decisions to revoke or suspend approval will be based on recommendations by the Authorised Officer to the FDB because of outcomes of official controls and enforcement activity. The recommendation to use enforcement action must be referred to FSS by email, providing information of the FeBO, circumstances, recommended enforcement action and reasons for this course of action, taking the FSS Feed Delivery Enforcement Policy into consideration. The email should have the following text in the subject line: “Third party referral - enforcement action to FSS”.

The immediate effect of the suspension or withdrawal of an establishment’s approval is such that the establishment may not be used for those relevant activities.  The Authorised Officer should, before recommending to the FDB, a suspension or revocation, explore other enforcement options to control the feed hazards presented by the establishment having regard to FSS Feed Delivery Enforcement Policy (see Chapter 7).

Non-compliance should not necessarily be considered sufficient to justify the immediate suspension or withdrawal of an establishment’s approval or conditional approval, and a reasonable opportunity to achieve compliance should be allowed, where this is appropriate.

The FDB will only initiate procedures to suspend an establishment’s registration or approval where in accordance with Article 14 of Regulation (EC) 183/2005, the establishment no longer fulfils the conditions applicable to the activities for which it is registered or approved.

The FDB shall notify the FeBO of suspension using Annex 4.7. 

The FDB will only initiate procedures to revoke an establishment’s registration or approval if other enforcement options have been considered and discussed with the Authorised Officer, including suspension of the registration or approval, and if circumstances exist, in accordance with Article 15 (b) or (c) of  Regulation (EC) 183/2005.

• it is shown that the establishment has not fulfilled the conditions applicable to its activities, for a period of one year; or
• it identifies ‘serious deficiencies’ or has had to stop production at an establishment repeatedly and the feed business operator is still not able to provide adequate assurance regarding future production.

Revocation will only be initiated where other enforcement options have been considered by the Authorised Officer in conjunction with the FDB.

The FeBO must provide the FDB with written assurance that it will resolve the deficiencies within a reasonable time (“reasonable” would be relative to the nature and magnitude of the deficiencies present although FSS considers ‘a reasonable time’ as being within 14 calendar days from the date of issue of notification of revocation (Annex 4.8) to the FeBO). The process for consideration of assurance is described below:

• where FSS, in consultation with the Authorised Officer, accepts that the FeBO’s assurance that serious deficiencies will be permanently resolved immediately and that there will be no foreseeable future stoppages of production, approval will continue
• where FSS accepts assurance that the serious deficiencies will be permanently resolved within a reasonable time and the situation will be such that, once the serious deficiencies have been resolved, there will be no foreseeable future deficiencies serious enough to warrant stoppages of production, the approval will be suspended. Where this is not the case, approval will be revoked
• where the FeBO’s assurance regarding future production is not accepted, the approval will be revoked and
• where the FeBO does not provide assurance, approval will be revoked.

Regulation 13(5) of The Feed (Hygiene and Enforcement) (Scotland) Regulations 2005 stipulates that following an appeal against a decision of a Competent Authority (FSS) to suspend or revoke an approval/registration, the feed business operator who, immediately before such suspension or revocation, had been using the establishment concerned, may continue to use it, pending the results of the appeal, subject to any conditions imposed by the Competent Authority for the protection of public health.

If the Authorised Officer considers that any activities undertaken in an establishment pending the result of an appeal may present a risk to animal or public health, it should notify the FDB which shall consider the use of other relevant enforcement powers appropriate to the circumstances involved (see Chapter 7).