Small and low throughput establishments: examples of EU hygiene regulations flexibilities

The hygiene regulations provide food business operators (FBOs) with flexibilities for meeting the requirements of the legislation through the use of words such as 'adequate', ‘sufficient’ and ‘equivalent’. Practical examples of the flexibilities are available.

The tables below, which are sector specific, list practical examples of those flexibilities in use by small and low throughput establishments across the UK, and provide a point of reference for FBOs and official controllers. The flexibilities apply to the general hygiene requirements and, for some examples, detailed legislative references have been provided.

If you have any queries about the tables, please email James Ridsdale at: james.ridsdale@foodstandards.gsi.gov.uk

Red and white meat slaughterhouses

AreaExamples of specific flexibilities (structural/operational)Legislation and notes
OV facilities Where the premises are small and next door to a slaughterhouse with access throughout working hours, a room in the slaughterhouse may be sufficient, but a separate room may not need to be provided in small premises where a single official is normally working for only a few hours a week. Regulation (EC) No 853/2004 Annex III Slaughterhouses: Section I Chapter II point 9 and Section II Chapter II:
7. They must have an adequately equipped lockable facility or, where needed, room, for the exclusive use of the veterinary service.
Cleaning and disinfecting of livestock vehicles Derogation under UK national measure for pre-2006 low throughput licensed slaughterhouses. Regulation (EC) No 853/2004 Annex III, Section I, Chapter. II:
6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority so permits and official authorised places and facilities exist nearby.
Intake A separate area/pen is not required where a single animal is held for slaughter. It may be used for temporary storage (e.g. bedding) as long as this can be and is removed immediately if the facility is needed for livestock. Regulation (EC) No 853/2004 Annex III, Section I, Chapter II:
1(b) They must also have separate lockable facilities or, climate permitting, pens for sick or suspect animals with separate draining and sited in such a way as to avoid contamination of other animals, unless the competent authority considers that such facilities are unnecessary.
Processing Slaughter of sick and suspect animals – where separate facilities, reserved for the slaughter of animals found or suspected to be suffering from disease, are not available in red meat slaughterhouses, those animals will have to be slaughtered at the end of the normal slaughter period. Note: for welfare reasons (e.g. because of injury) it may become necessary to slaughter an animal immediately. Regulation (EC) No 853/2004 Annex III, Section I, Chapter II:
7. They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period.
  Suitable animal restraint facilities (e.g. a crush) are recommended to allow detailed examination of individual animals. Where this is not the case, appropriate procedures and/or assistance will need to be provided. Regulation (EC) No 853/2004 Annex III, Section I, Chapter II:
7. They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period.
  Cradle dressing is permitted for red meat production. General hygiene requirements apply.
  A scald tank for pigs may not be necessary if an alternative hygienic skinning method is carried out. General hygiene requirements apply.
  An alternative method to the sterilisation of tools in water at 82ºC in red meat slaughterhouses has been approved. Regulation (EC) No 853/2004 Annex III, Section I, Chapter II:
3. Have facilities for disinfecting tools with hot water supplied at not less than 82ºC, or an alternative system having an equivalent effect.
Gut room Time separation for emptying and cleaning green offal may be authorised at the premises, providing the OV agrees the operator’s written procedure on how this operation will be carried out. Regulation (EC) No 853/2004 Annex III, Section I, Chapter II:
2(b) To avoid contaminating meat, they must: (b) have a separate room for the emptying and cleaning of stomachs and intestines, unless the CA authorises the separation in time of these operations within a specific slaughterhouse on a case-by-case basis
Storage Detained meat – a lockable refrigerated facility for storing detained meat is required, but a dedicated room or a cage, (made of corrosion-resistant, cleanable material with provision to contain drip), placed within a chiller may be used, or, as long as hygiene cannot be compromised, an arrangement such as a lockable rail within a chiller. Derogation under UK national measure for pre-2006 low throughput licensed slaughterhouses allows use of chillers in e.g. the retail shop.
Unfit meat – separate, lockable and clearly marked place for storing meat declared unfit for human consumption, prior to disposal as an animal by-product, is required but may, for example, be a dedicated room or lockable container(s) held in a secure area.
Regulation (EC) No 853/2004 Annex III, Section I, Chapter. II:
5. Lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.
Despatch Prevent contamination of meat from, e.g. diesel fumes, dust, flies, birds, leaves, poor weather conditions, during loading and unloading between premises and vehicles. This is best achieved by using a vehicle docking system or, where this is not possible (e.g. for planning reasons), a canopy or awning may be sufficient. In limited situations (e.g. because vehicles have to be loaded/unloaded on the street) it will be necessary for the operator to set out satisfactory procedures for protecting exposed meat from contamination. Regulation (EC) No 852/2004 Annex II, Chapter IX Foodstuffs:
3. At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state.
Meat transport Red meat may be sent for further processing while still above 7ºC if certain provisions are met but vehicles must leave the slaughterhouse or co-located cutting room as soon as practicable after loading and transport is to specified establishments no more than two hours away. Regulation (EC) No 853/2004 Annex III, Section I, Chapter VII:
3. Meat must attain the temperature specified in point 1 before transport, … However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that: (a) such transport takes place in accordance with the requirements that the competent authority specifies in respect of transport from one given establishment to another.
OV attendance The OV may not need to be present throughout post-mortem if meat with non-routine abnormalities is detained for veterinary inspection. Regulation (EC) No 1244/2007 Discontinuous Slaughter Annex VIb:
2(a) The competent authority may decide that the official veterinarian need not be present at all times during post-mortem inspection, provided that the following conditions are complied with:
  • the establishment concerned is an establishment carrying out discontinuous slaughter or game handling activities and has sufficient facilities to store meat with abnormalities until a final post-mortem inspection by the official veterinarian can take place
Meat Inspection Subject to approval, inspection of certain fattening pigs and young bovine, ovine and caprine animals may be reduced to a visual inspection with limited palpation. Regulation (EC) No 854/2004 Annex I, Section IV, Chapter IV B as amended by Regulation (EC) No 1244/2007:
2. The competent authority may decide, on the basis of epidemiological or other data from the holding, that fattening pigs housed under controlled housing conditions in integrated production systems since weaning need, in some or all of the cases referred to in paragraph 1, only undergo visual inspection.
See also Regulation (EC) No 1244/2007 3(b)(v)
Sampling Not currently used. Regulation (EC) No 854/2004 Annex I, Section III, Chapter III B
Slaughterhouse staff who have received specific training, ... may, under the responsibility and the supervision of the OV carry out specific sampling and testing tasks in respect of animals of all species.
Cold Inspection It may be possible to conduct cold inspection as long as carcases and offal can be appropriately stored and correlated. Read the guidance on cold inspection

Red and white meat cutting plants, minced meat, meat preparation, meat production, mechanically separated meat premises and game handling establishments

AreaExamples of specific flexibilities (structural/operational)Legislation and notes
Outside See the list of examples for general flexibilities. General hygiene requirements apply.
Intake See the list of examples for general flexibilities. General hygiene requirements apply.
Processing area Raw meat processors do not always have a temperature controlled room in which to process meat so it is permissible to allow a short period of time at ambient temperature for processing, which if done quickly shouldn’t allow the meat to rise outside of temperature control (4°C–7°C). Regulation (EC) No 853/2004, Annex III, Section I, Chapter III:
2. Have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat.
&nbsp An alternative system of hot water and cleaning chemicals can be used, e.g. UV and chemical disinfection. Regulation (EC) No 853 Annex III, Section V, Chapter I (5):
5. Have facilities for disinfecting tools with hot water supplied at not less than 82ºC, or an alternative system having an equivalent effect
&nbsp Raw materials, ingredients, intermediate products and finished products are in some cases allowed to be for limited period outside temperature control is permitted to accommodate the practicalities of handling, provided it does not result in a risk to public health. Regulation (EC) No 852, Annex II, Chapter IX, part 5, (Provision applicable to foodstuffs): Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health.
The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient separate refrigerated storage..
Despatch See the list of examples for general flexibilities. General hygiene requirements apply.
Other Storage of animal by-products Category 2 material in a chest freezer. Category 3 material is allowed to be stored in meat chillers provided they are not a risk to food (only applies to bones and trimmings). General hygiene requirements apply.
Official controllers attendance Frequency of attendance and audit is risk based. General hygiene requirements apply.
Sampling Less than two tonnes minced meat meat preparations excluded from microbiological sampling – national based on a risk assessment. General hygiene requirements apply.

Raw milk and dairy products

AreaExamples of specific flexibilities (structural/operational)Legislation and notes
Intake Transportation of milk – good practice would be for the milk to be piped straight from bulk tanks to the pasteuriser;. However, some premises carry it in a churn. This is a one-man operation and there are strict controls between clean and dirty areas to minimise the risk of cross-contamination, on this basis. General hygiene requirements apply.
Processing Dairies that obtain clean bottles from central units will not normally require mechanical bottle washing facilities, providing the clean bottles are not exposed to any risk of contamination during storage and before being filled at the dairy. Bottle washing and storage can take place in the same room where products are handled, but at different times or in a separate area- providing hygiene is not compromised. Separation in time between cheese production and cutting and packaging, i.e. the same room can be used for both if proper cleaning and disinfecting is conducted between processes. Regulation (EC) No 853/2004, Annex III, Section IX, Chapter I Section II, A:
3. Surfaces of equipment that are intended to come into contact with milk … must be easy to clean and, where necessary, to disinfect and be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials.
Storage Wood is generally not acceptable as a food contact surface as it is difficult to clean and disinfect and may shed splinters, but it may be acceptable for the storage and maturation of hard cheeses only on this surface, as long as the surface is well maintained. General hygiene requirements apply.
Maintenance of equipment There is no legal requirement to calibrate equipment such as thermometers (mercury thermometers are not permitted for use). Equipment should be clean, well maintained and 'fit for purpose'. General hygiene requirements apply.
Maintenance of equipment There is no legal requirement to calibrate equipment such as thermometers (mercury thermometers are not permitted for use). Equipment should be clean, well maintained and 'fit for purpose'. General hygiene requirements apply.
  Inspections can take place when a farmer’s private veterinary surgeon is present for other purposes. Food business operators are responsible for ensuring that the requirements of Regulation 853/2004, Annex III, Section IX, Chapter I, are met through private veterinary inspections at regular intervals.
HACCP Scope for small operations to use simplified HACCP procedures and documentation. General hygiene requirements apply.

Fish, shellfish and eggs

AreaExamples of specific flexibilities (structural/operational)Legislation and notes
Processing area Fish: There should be separate workstations for molluscs and wet fish but would shared use of equipment such as weighing scales is permitted subject to suitable time and cleaning separations. General hygiene requirements apply.
Processing area Eggs: It is possible for a small egg packer to work from a Regulation (EC) No 853 designated room within an existing Regulation (EC) No 852 designated food warehouse. General hygiene requirements apply.

General examples applicable to all premises

Flexibilities: structural, equipment, layout, operational and official controlsGeneral flexibilities (examples taken from Meat Industry Guide, comments from Official Controllers and industry practices) Legislation
HACCP Where food is prepared, manufactured or processed, operators can develop their own food safety management procedures by following a traditional HACCP process, or by following Guides to Good Practice, including generic HACCP guides.

Documentation is an important part of the HACCP process, providing evidence of the operator’s thinking and decisions that can be audited. However, flexibility includes the possibility of ‘exception reporting’ of visual monitoring checks. That means making a record only when there is such a problem or something unusual happens and recording the corrective action taken as a result.

HACCP Training: 'in house' training on HACCP is permissible as long as it is commensurate with the type and nature of production.
Regulation (EC) No 853/2004 Article 5:
4. FBOs shall: (a) provide the competent authority with evidence of their compliance with paragraph 1 in the manner that the competent authority requires, taking account of the nature and size of the food business; (b) ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times; (c) retain any other documents and records for an appropriate period.
Read the Commission Notice July 2016
Toilets Toilets should be in the same or a connected building as the food operation but exceptionally, where staff numbers are very small and the premises are next door to a house with access throughout working hours, the house toilet may be sufficient. These facilities can be used by any members of staff within the FBO (family and non-family members). Regulation (EC) No 852/2004 Annex II, Chapter I Food Premises:
3. An adequate number of flush lavatories are to be available and connected to an effective drainage system. Lavatories are not to open directly into rooms in which food is handled
Changing facilities Changing area should be in the same or a connected building as the food operation, but exceptionally, where staff numbers are very small and the premise is next to a house with access throughout working hours, a room in the house may be sufficient. These facilities can be used by any members of staff within the food business operator (family and non-family members). In some circumstances, a locker in a hallway may also be acceptable. Regulation (EC) No 852/2004 Annex II, Chapter I Food Premises:
9. Where necessary, adequate changing facilities for personnel are to be provided.
Cleaning materials Cleaning chemicals and utensils should be kept in a separate room but, exceptionally in small premises, in a cupboard that can be locked and is used only for this purpose. Regulation (EC) No 852/2004 Annex II, Chapter I Food Premises:
10. Cleaning agents and disinfectants are not to be stored in areas where food is handled.
Surfaces Door surfaces: wooden door frames are allowed as long as they are painted and can be cleaned and disinfected. Regulation (EC) No 852/2004 Annex II, Chapter II Rooms:
1(a) Floor surfaces 1(b) Wall surfaces 1(e) Doors are to be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials unless FBOs can satisfy the competent authority that other materials used are appropriate.
Working surfaces Wood is generally not acceptable as a food contact surface as it is difficult to clean and disinfect and may shed splinters.
  • May be acceptable for cutting blocks and the maturation of traditional cheese as long as the surface is well maintained.
  • Smooth open bare wood (shelving is also acceptable for maturing cheeses).
Regulation (EC) No 852/2004 Annex II, Chapter II Rooms:
1(f) Surfaces (including surfaces of equipment) in areas where foods are handled and in particular those in contact with food are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable corrosion-resistant and non-toxic materials, unless FBOs can satisfy the competent authority that other materials used are appropriate.
Food Waste Storage Food waste can be kept in lockable containers. Regulation (EC) No 852/2004 Annex II, Chapter VI Food waste:
2. Food waste, non-edible by-products and other refuse are to be deposited in closable containers, unless food business operators can demonstrate to the competent authority that other types of containers or evacuation systems used are appropriate. These containers are to be of an appropriate construction, kept in sound condition, be easy to clean and, where necessary, to disinfect.
Refrigerated Storage Free-standing chilled storage – if used to store chilled product, free-standing ‘reefers’ must provide an acceptable level of protection and temperature control that meets legal requirements. Particular attention must be paid to the:
  • nature, condition and cleanliness of interior surfaces
  • maintenance of temperatures
  • temperature monitoring and recording
  • protection from contamination during loading and unloading.
Such facilities are rarely appropriate for chilling of product.

Wrapped and unwrapped products can be stored in the same chiller room as long as suitable steps are taken to prevent contamination, e.g. covering with polythene sheeting to effect a separation.
Regulation (EC) No 852/2004 Annex II, Chapter IX Foodstuffs:
5 …Food businesses manufacturing, handling and wrapping processed foodstuffs are to have… sufficient separate refrigerated storage.
Separation This normally means ensuring that ‘clean’ and ‘dirty’ operations are carried out in separate rooms, or separate areas if adequate arrangements are made to avoid contamination. In premises where throughput is low, separation of operations in time rather than space may be possible with interim cleaning and disinfection.

To minimise the risk of contamination store unwrapped product, packaging and packaged product in separate rooms, or in the same room at a different time or at the same time with either a permanent barrier between them that can be cleaned and disinfected or by using an appropriately placed polythene covering to prevent air-borne cross-contamination.

Shared facilities may be allowed to be used with Regulation (EC) No 852/853, for example a cheese maker that only uses his cheese room once a week shares that room with his wife for her catering business on odd days. However, full separation and clean downs etc would be required.
Regulation (EC) No 852/2004 Annex II, Chapter. IX Foodstuffs:
3. At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state.

5. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms; large enough for the separate storage of raw materials from processed material.

Regulation (EC) No 853/2004 Annex III, Section I, Chapter II: 2. Ensure separation in space or time.
Documentation for approval The approval criteria apply to many small and micro businesses. The supplementary information required to be submitted with the application form in order to process the application can be onerous and inappropriate for some businesses. For example, many premises use mains water and the requirement to test water quality under these circumstances is onerous and places additional expense on the business. Hand drawn plans may be suitable for some businesses. In practice some micro businesses with very simple operations do not have formal equipment maintenance arrangements. Regulation (EC) No 852/2004, Annex II, Chapter VII, Water supply
Delivery of products of animal origin Provision of suitable canopies to cover products in the dispatch area. Regulation (EC) No 852/2004 Annex II, Chapter I Food Premises
Storage structures Separating areas by means of plastic curtains that are kept clean and do not contaminate foodstuffs. Regulation (EC) No 852/2004 Annex II, Chapter I Food Premises
Shared intake and dispatch facilities Some small premises may, for a variety of reasons (e.g. listed frontage), have only one entry/exit bay. If suitable time separation procedures are in place to control contamination, with appropriate cleaning, disinfecting and handling, then it is acceptable to use that single point of access for both intake and dispatch. Regulation (EC) 852/2004 Annex II, Chapter I Food Premises
Regulation (EC) 853/2004 Annex III, Section I, Chapter II:
2. Ensure separation in space or time.