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

www.food.gov.uk/foodindustry/guidancenotes/hygguid/euhygieneregulationsflexibilities

examples of the flexibilities are

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 Keira Benefer at: [email protected]

Red
and white meat slaughterhouses


Area Examples 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


Area Examples 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.

  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

  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:


Area Examples 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


Area Examples 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
controls
General
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 CAcompetent 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 guidance 16/11/05 Annex II point 6.1, 7.3,
7.14, 8.4

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
  • Pprotection 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, ChapterIX 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
facilties
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.