FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 1
SUBSIDIARY LEGISLATION 231.43
FISH PACKING AND PROCESSING 
ESTABLISHMENTS REGULATIONS
1st January, 2002
LEGAL NOTICE 255 of 2000.
Title .
Processing Establishments Regulations.
lnterpretation.
"approved packing establishment" means a packing
establishment where aquaculture and coastal fish products are
packed, chilled or stored, insofar as the establishment complies
with these regulations and has been inspected and approved by the
Director;
"approved processing establishment" means a processing
establishment where chilled or frozen fishery products undergo a
chemical or physical process such as heating, smoking, salting,
dehydration or marinating, or any other process insofar as the
establishment complies with these regulations and has been
inspected and approved by the Director;
"aquaculture products" means all fishery products born and
raised in controlled conditions until placed on the market as
foodstuff. Fish caught in their natural environment when juvenile
and kept in fattening units until they reach the desired commercial
size for human consumption, are also considered aquaculture
products. However, they are not considered so if the fish are merely
kept alive to be sold at a later date without any attempt being made
to increase their size or weight;
"batch" means the quantity of fishery products obtained under
practically identical conditions;
"chilling" means the process of cooling fishery products to a
temperature approaching that of melting ice;
"clean seawater" means seawater which is free from
microbiological contamination, harmful substances or toxic marine
plankton in such quantities as may affect the health quality of
aquaculture products;
"critical point" means any site, procedure, or part of a procedure
at which a potential food safety hazard can be prevented or reduced
to acceptable levels by appropriate control measures;
"drinking water" means water of such quality as to be fit for
human consumption;
"fishery products" means all seawater or freshwater animals, or
parts thereof, including their roes but excluding aquatic mammals
and amphibians;
"fresh products" means any fishery product, whether whole or
2 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
prepared, including vacuum-packed products, which have not
undergone any treatment to ensure preservation other than chilling;
"frozen products" means any fishery product which has
undergone a freezing process to reach a core temperature of -18C
or lower after temperature stabilisation;
"licensee" means a person who is licensed in terms of regulation
3 to keep an aquaculture packing establishment;
"Minister" means the Minister responsible for fishing and
aquaculture;
"packing" means the procedure of protecting fishery or
aquaculture products by wrapping material, a container or similar
object;
"prepared products" means any fishery or aquaculture product
which has undergone an operation affecting its anatomical
wholeness, such as gutting, filleting, slicing, heading, and similar
operations;
"processed products" means any fishery or aquaculture product,
whether chilled or frozen, whether associated or not with other
foodstuffs, which has undergone a chemical or physical process
such as smoking, salting, heating, marinating and similar
processes;
"Superintendent" means the Superintendent of Public Health;
"visible parasite" means a parasite or a group of parasites which
has dimension, colour or texture which is clearly distinguishable
from fish tissues and which can be seen without optical means of
magnifying and under good illumination for human vision;
"visual inspection" means a non-destructive examination of fish
or fishery products without optical means of magnifying and under
good light conditions for human vision, including, if necessary,
candling.
Licence to keep a 
fish packing or 
processing 
establishment.
3. (1) No person shall keep a fish packing or processing
establishment unless he holds a licence issued for that purpose by
the Minister.
(2) No premises shall be used as a fish packing or processing
establishment unless such premises are licensed by the Minister for
such use.
(3) The Minister may only grant a licence for the keeping of a
fish, packing or processing establishment after considering an
application thereof, and after he has ascertained that all the
requirements listed in these regulations and any further
requirements he may have requested the applicant to perform, have
been satisfied.
(4) The Minister may, in granting or renewing any licence,
impose any such condition as he may deem fit.
(5) Licences shall be valid for one calendar year and may be
renewed from year to year by the Minister after inspection by an
authorised officer.
FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 3
(6) An authorised officer shall have the power of entry to
inspect the establishment whenever the Superintendent deems it
necessary.
(7) No extensions or alterations in any fish packing or
processing establishment may be carried out unless previously
authorised by the Superintendent.
(8) The Superintendent shall keep a fish packing or processing
establishment register in which there shall be kept the following
information:
( a ) service approval number issued by the Superintendent;
( b ) name, address and telephone number of the manager;
( c ) name, address and telephone number of the licensee;
( d ) address and telephone number of establishment;
( e ) site plan, elevation plan, building layout plan and
equipment layout plan of the establishment.
(9) The licensee shall be responsible for any premises used in
the packing or processing establishment, and such premises shall be
either constructed or removed as specified in these regulations.
(10) Persons responsible for the packing or processing
establishment shall take all necessary measures so that, at all stages
of production, the conditions listed below are met with.
(11) Packing establishments may only be used for their
designated purpose of packing fresh fish and no other product may
be prepared therein.
(12) Processing establishments shall provide a detailed
description of the fish product, and the processing procedures
particular to that establishment. This must include all parameters
that are being monitored and controlled throughout the process.
Records must be available for the Government veterinarian, and
must be kept for at least the duration of the shelf-life of the
product.
(13) Only scientifically valid treatments may be used in
processing establishments to prevent the development of
pathogenic micro-organisms or otherwise preserve the product.
Packing and 
processing 
establishment 
structure.
4. (1) The fish packing or processing establishment shall be
sited at least two hundred metres away from inhabited areas,
livestock farms and any other industrial or other structures that may
emit fumes or other materials that may contaminate the fish and
aquaculture products.
(2) Each packing establishment shall be divided into a
"contaminated" area where harvested fish are brought in,
slaughtered, and first sorted, and a "clean" area where the fish are
graded and placed in containers. Work and workers must always
proceed from clean to contaminated area, and never the other way
round. Both areas are to be of sufficient size to allow for good
hygienic conditions.
(3) Each processing establishment shall be divided into a
"contaminated" area where fresh or frozen fish are first brought in,
4 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
thawed, cleaned, headed or gutted, and a "clean" area where the
fish are filleted, sliced or otherwise processed and placed in
containers. Work and workers must always proceed from clean to
contaminated area, and never the other way round. Both areas are
to be of sufficient size to allow for good hygienic conditions.
(4) The following building requirements shall be complied
with within any fish packing or processing establishment:
( a ) floors and walls must be smooth, durable, easy to
clean and disinfect, as well as waterproof. A light-
coloured, washable coating or paint at a height of at
least two metres, with rounded edges and corners must
cover the walls. Excess water must drain easily from
the flooring;
( b ) doors and windows must be easy to clean. These
apertures must be constructed in such a way as to
prevent entry of animals, birds, flies, and insects.
Wood is not to be used if possible, and flush-fitting
apertures are preferred. Ceilings and roof-lining must
be easy to clean;
( c ) adequate illumination either natural or artificial over
the work areas is necessary;
( d ) equipment, instruments, utensils and working surfaces
must be kept clean and disinfected, and must be
corrosion-resistant. Working tables and other working
surfaces must not be made of wood;
( e ) the temperature in the packing areas must be <12ºC,
and in cold storage 0ºC. Adequate ventilation must be
set up, if necessary, to ensure temperature
maintenance.
Cleaning and 
disinfection.
5. (1) There must be an adequate number of facilities for the
cleaning of hands, instruments and tools, with hot and cold running
water, cleaning and disinfecting products, and single-use hand
towels. These must be as near as possible to the work stations, and
the taps must not be hand-operable.
(2) There must be an adequate number of facilities for the
cleaning and disinfection of the establishment itself as well as its
equipment, instruments, and working surfaces.
(3) Disinfectants or detergents used on equipment or
instruments which come in contact with the fish must be approved
for use in food preparation.
(4) There must be an adequate number of changing rooms and
shower rooms with flush lavatories and wash hand basins, foot- or
elbow- operated. These rooms must not open directly onto the
working area. The wash hand basins shall be near the lavatories and
shall have hot and cold running water, materials for cleansing and
disinfecting the hands, and disposable hand towels.
Waste removal. 6. (1) A watertight, corrosion-resistant container for waste
fish must be available at all times during the packing or processing
of fish, and its contents removed from the work area frequently.
These must be cleansed and disinfected each time they are emptied.
FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 5
(2) Waste fish must be immediately and hygienically disposed
of in appropriate premises outside the establishment at the end of
each harvest and, or processing cycle. If waste fish is not removed
every day from the establishment, lt must be stored in a lockable,
temperature-controlled room separate from the work area.
(3) If the destruction of waste fish or the technical treatment of
waste fish intended for industrial purposes is carried out on the
premises of the establishment, it must take place in lockable rooms
separate from the work areas.
(4) Waste water must be collected in an adequate container
reservoir or sedimentation tank and disposed of in such a way as to
prevent environmental contamination.
Pest control.
insects and other pests. Rodenticides, other pesticides and any
potentially harmful substances must be stored in a lockable
cupboard and used with extreme care to prevent the contamination
of any product.
Freshwater and 
seawater supply.
8. (1) An adequate supply of clean seawater or potable water
shall be used for all purposes except for cooling systems. The
relevant pipes must be adequately marked to distinguish them from
those carrying drinking water or clean seawater. A diagram of the
water distribution system and its outlets must be available for
inspection by the Government veterinarian.
(2) If a chlorination system is used, the chlorine shall be
injected prior to intermediate storage in tanks or reservoirs to allow
a contact time of at least twenty minutes between the water and the
chlorine within the tank. Hyperchlorinated water must not come
into contact with the aquaculture or fishery products, so the
chlorine level must be equivalent to that of potable water for direct
human consumption.
(3) For the production and storage of ice, there must be a room
of sufficient size, easy to clean and disinfect, and equipped with a
refrigeration system of adequate power and a temperature-reading
device. Ice may, however, be produced in licensed cold stores
outside the packing or processing establishment, and transported in
hygienic containers to the establishment when needed.
(4) Ice must be made from clean sea or drinking water and
stored in clean receptacles in the cold room.
Personnel.
with plastic apron, gloves, and head gear to enclose the hair. Hands
must be washed every time work is resumed, and any cuts or skin
abrasions covered in a waterproof dressing. No smoking or eating
is allowed in the working areas.
(2) Medical certificates must be issued certifying and enabling
each member of staff to handle food. These certificates must be
renewed annually or whenever requested by the Government
veterinarian to whom such certificates will always be available.
Persons who may contaminate the food product shall be prohibited
from handling it.
(3) The licensee shall ensure that all employees in his
6 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
establishment shall be educated on the importance of personal
hygiene and basic food safety principles. The licensee shall also be
responsible for maintaining amongst his employees an awareness
of any medical condition that may develop that might effect their
employment.
(4) A room for the exclusive use of the Government
veterinarian must be available when the volume of work entails his
permanent presence.
Self-check system. 10. (1) A self-check system, based on Hazard Analysis
Critical Control Point, must be set up by the licensee to identify
critical points and monitor them.
(2) Records of results and procedures are to be kept on the
premises and be available for inspection.
(3) Critical points are specific to each establishment and must
thus be identified for each packing or processing establishment
according to its structures, equipment, and work process.
(4) The self-check system must be aimed at monitoring such
critical points to ensure that the aquaculture and fishery products
satisfy the requirements of these regulations.
(5) This self-check system must include the following:
( a ) description of aquaculture or fishery product;
( b ) identification of critical points all along the packing or
processing line;
( c ) identification of the food safety hazards at each critical
point;
( d ) control measures to be taken at each critical point to
avoid risk;
( e ) personnel especially trained in the field of food safety,
hygiene and related subjects, who will undertake the
setting up of the self-check system and its running, and
keep written records of results obtained for at least two
years;
( f ) monitoring procedures and critical limits for the
parameters concerned;
( g ) corrective measures to be taken in case of deviation
from specified critical limits;
( h ) a sampling programme to be carried out by an
approved laboratory in conjunction with the
specialised personnel in order to verify and reconfirm
the efficacy of the self-check system itself, and
revalidate it in case of any change in the work
procedures.
Harvest and 
slaughter in 
packing 
establishments.
11. (1) All equipment necessary for the unloading, harvesting,
and landing of fish from the sea cages into the packing
establishment must be kept clean and in a good state of repair.
(2) Handling of fish during harvest, landing and slaughter
must be as rapid as possible and the fish transferred to a protected
chilled environment as soon as possible. If not packaged
FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 7
immediately, fish must be kept chilled.
(3) The slaughtering of aquaculture products must be carried
out hygienically, and the fish must not come into contact with
earth, dust or other contaminating substance.
Post-mortem 
examination during 
harvest in packing 
establishments.
12. A visual inspection on a representative number of samples
per batch, must take place during the packing of fresh fish, and any
visible parasites or parts of fish which are infested, shall be
removed and considered as waste fish, that is, fish unfit for human
consumption.
Fish used for 
processing in 
processing 
establishments.
13. Fish, whether fresh or frozen, which are to be used for
processing, must satisfy the following conditions:
( a ) if chilled fish are to be used for processing, they must
be hygienically stored in the cold room under ice made
from drinking water or clean seawater until processed;
( b ) if frozen fish products are used, they must be stored in
rooms equipped with a sufficiently powerful freezing
apparatus which enables a rapid lowering of the
temperature to ensure that a core temperature of -18ºC
or lower is reached and maintained. Thawing of these
products must be carried out hygienically, with good
drainage for melt water and a well controlled
temperature increase. After thawing, the products must
be processed as soon as possible.
Smoked fishery 
products in 
processing 
establishments.
14. (1) Heading and gutting must be carried out as
hygienically as possible in a different section from that of filleting
and slicing to avoid contamination.
(2) Guts and other offal must be frequently removed from such
section in leakproof containers which are easy to clean and
disinfect.
(3) The smoking process itself must be earned out in rooms
specially equipped to prevent smoke, heat and other products of
combustion to affect other parts of the building where fish is
prepared, processed or stored.
(4) Wood or other material used for the smoking process must
be stored and handled as much as possible, in the contaminated area
away from the clean part of the smoking process.
(5) Wood used for producing smoke must not be painted or
glued or treated chemically in any way.
(6) After smoking, the products must be rapidly cooled to their
conservation temperature before packing. The appropriate
conditions for storage must be clearly marked on the package.
Salting in 
processing 
establishments.
15. (1) Salting must take place in premises which are
separated from the rest of the processing plant. Such premises must
be kept in a good state of cleanliness and hygiene during and after
the salting process.
(2) Salt used for salting or brining must be clean and stored
hygienically. It may not be reused.
(3) Containers used for salting or brining must be clean, in
8 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
good state of repair, and must be constructed in such a way as to
prevent any contamination during the process.
Canning 
processing 
establishments.
16. In the case of fishery products which have been subjected
to sterilisation in hermetically sealed containers -
( a ) the water used for the preparation must be drinking
water;
( b ) the process used for the heat treatment must be
appropriate, having regard to such major criteria as
heating time, temperature, filling, size of containers,
and others, and a record of which must be kept. The
heat treatment must be capable of destroying or
inactivating pathogenic organisms and the spores of
pathogenic micro-organisms. The heating equipment
must be fitted with devices for verifying whether the
containers have in fact undergone appropriate heat
treatment. Drinking water must be used to cool
containers after heat treatment, without prejudice to
the presence of any chemical additives used in
accordance with good technological practice to
prevent corrosion of the equipment and containers;
( c ) further checks must be carried out at random by the
manufacturer to ensure that the processed products
have undergone appropriate heat treatment, that is -
- incubation tests: incubation must be carried out
at 37ºC for seven days or at 35ºC for ten days, or
at any other equivalent combination;
- microbiological examination of contents and
containers in the establishment’s laboratory or
in another approved laboratory;
( d ) samples must be taken of production each day at
predetermined intervals to ensure the efficacy of
sealing or of any other method of hermetic closure. For
that purpose, appropriate equipment must be available
for the examination of cross-sections of the can-seams;
( e ) checks are carried out in order to ensure that
containers are not damaged;
( f ) all containers which have undergone heat treatment
under practically identical conditions must be given a
batch identification mark.
Cooked 
crustaceans and 
molluscan shellfish 
products.
17. Crustaceans and molluscan shellfish must be cooked as
follows:
( a ) any cooking must be followed by rapid cooling. Water
used for this purpose must be drinking water or clean
seawater. If no other method of preservation is used,
cooling must continue until the temperature
approaching that of melting ice is reached;
( b ) shelling or shucking must be carried out under
hygienic conditions avoiding the contamination of the
product. Where such operations are done by hand,
workers must pay particular attention to the washing
FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 9
of their hands and all working surfaces must be
cleaned thoroughly. If machines are used, they must be
cleaned at frequent intervals and disinfected after each
working day. After shelling or shucking, cooked
products must immediately be frozen or kept chilled at
a temperature which will preclude the growth of
pathogens, and be stored in appropriate premises;
( c ) every manufacturer must carry out microbiological
checks, according to regulation 10, on his production
at regular intervals, both during the manufacturing
process and before the crustacean and molluscan
shellfish products are cooked in the processing plant,
in order to comply with the standards set out in the
Fourth Schedule;
( d ) sampling programmes must be established by the
managerial staff of the processing plant in relation to
the nature of the products (whole, shelled or shucked),
the temperature, the time of cooking and the risk
evaluation;
( e ) the programmes referred to in paragraphs ( c ) and ( d )
shall contain, in the event of failure to comply with the
standards laid down under headings 1 and 2 of the
Fourth Schedule, an undertaking -
- to notify the Superintendent of the findings
made and the action taken with regard to
unsatisfactory batches, as well as the measures
provided for in the second indent below,
- to review the methods of supervising and
checking the critical points so as to identify the
contamination source, and to carry out analyses
more frequently,
- not to market for human consumption batches
found to be unsatisfactory on account of the
discovery of pathogens or where the M value for
Staphylococcus  provided for under heading 2 of
the Fourth Schedule is exceeded.
The method of analysis used must be recorded with the
corresponding results.
Mechanically 
recovered fish 
flesh.
18. The mechanical recovery of fish flesh must be carried out
under the following conditions:
( a ) mechanical recovery of gutted fish must take place
without undue delay after filleting, using raw materials
free of guts. Where whole fish are used, they must be
gutted and washed beforehand;
( b ) the machinery must be cleaned at frequent intervals
and at least every two hours;
( c ) after recovery, mechanically recovered flesh must be
frozen as quickly as possible or incorporated in a
product intended for freezing or stabilizing treatment.
10 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
Conditions 
concerning 
parasites.
19. (1) During production and before they are released for
human consumption, fish and fish products must be subject to a
visual inspection as in the Third Schedule for the purpose of
detecting and removing any parasites that are visible. The scale and
frequency of the inspections, which must be carried out by a
qualified person, shall be determined according to the nature of the
fishery products, their geographical origin, and their use.
(2) During preparation of eviscerated fish the visual inspection
must be carried out on the abdominal cavity and livers and roes
intended for human consumption in the following manner:
( a ) in the case of manual evisceration, the visual
inspection must be earned out in a continuous manner
by the operative at the time of evisceration, and
( b ) in the case of mechanical evisceration, the visual
inspection must be carried out by sampling at least ten
fish per batch.
(3) The visual inspection of fish fillets or fish slices must be
carried out during trimming after filleting or slicing. Where an
individual examination is not possible, because of the size of the
fillets or filleting operations, a sampling plan will be drawn up by
the Government veterinarian. Where candling of fillets is possible
from a technical viewpoint, it will be included in the sampling plan.
(4) Fish or parts of fish which are obviously infested with
parasites, and which are removed, must not be placed on the market
for human consumption.
(5) The fish and fish products referred to in subregulation (6)
which are to be consumed as they are must, in addition, be
subjected to freezing at a temperature of not more than -20ºC in all
parts of the product for not less than twenty-four hours. Products
subjected to this freezing process must be either raw or finished.
(6) The fish and products subject to the conditions in
subregulation (5) are:
( a )  fish to be consumed raw or almost raw, such as raw
herring,  maatje ;
( b ) the following species, if they are to undergo a cold
smoking process at which the internal temperature of
the fish is less than 60ºC:
- herring,
- mackerel,
- sprat,
- (wild) Atlantic and Pacific salmon;
( c )  marinated and, or salted herring where this process is
insufficient to kill the larvae of nematodes.
This list may be amended, in the light of scientific data,
and criteria will be laid down to define the processes which are
deemed sufficient or insufficient to destroy nematodes.
(7) Manufacturers must ensure that fish and fish products
listed in subregulation (3) or the raw materials for use in their
FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 11
manufacture are subjected to the treatment described in
subregulation (2) prior to their release for consumption.
(8) The fishery products listed in subregulation (3) must, when
they are placed on the market, be accompanied by a document from
the manufacturer stating the type of process they have undergone.
Packaging.
processed fish must not alter their organoleptic characteristics or
contaminate fish with chemicals or substances harmful to human
health.
(2) They must be impervious and designed to preserve and
protect the fish and have adequate drainage for melt water.
Preferably they must not be reusable, unless strong and easy to
clean and disinfect.
(3) Unused packaging material is to be stored in a protected,
clean environment.
Identification.
of labels, must have the approval number, name and address of
farm and packing establishment, and species of fish in a clearly
legible, indelible manner affixed onto each container.
(2) Identification of the fishery product, in the form of labels,
must have the approval number, name and address of the
processing establishment, species of fish, ingredients, and storage
requirements in a clearly legible, indelible manner affixed onto
each container.
Transport.
transport no other product that might contaminate or otherwise alter
the organoleptic characteristics of the fish.
(2) Such vehicles must be equipped to maintain the
temperature at 0ºC for fresh fish (or according to the type of
product in the case of processed fish) throughout transportation and
have a temperature charting device.
(3) Such vehicles must also be easy to clean and disinfect at
appropriate facilities provided by the farm itself or by other
establishments.
(4) A container for melt water must form part of the vehicle.
Monitoring 
programme for 
packing or 
processing 
establishments.
23. Packing or processing establishments are to be monitored
by the Superintendent according to this programme, which is
subdivided into three sections:
( a ) Fish health monitoring:
Random samples of all batches of fish from fish farms
are to be taken by the Government Veterinarian for a
complete parasitological, bacteriological and anatomo-
pathological examination, to determine the state of
health, and any emergent diseases at various stages of
the life cycle.
Action will be taken in case of any outbreak of the
diseases listed as notifiable.
( b ) Hygiene monitoring:
12 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
Each packing and processing establishment must be
inspected regularly by a Government veterinarian to
ensure compliance with the above conditions, and
swabs, samples of ice, water and fish shall be taken
once a month, for bacteriological examination to
ensure that the level of hygiene is satisfactory. The
tests indicated in the First Schedule must be carried
out.
( c ) Quality control and residue analysis:
Samples of harvested and processed fish must be taken
by an authorised officer to be analysed
microbiologically for the presence of bacterial
pathogens, organoleptically for freshness and
suitability for human consumption in terms of the
Second Schedule, and chemically for the presence of
various residues as indicated in the Third Schedule.
FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 13
FIRST SCHEDULE
Hygiene monitoring
SECOND SCHEDULE
Quality control: microbiological
Inspections/
examination
Laboratory 
method
Limits of 
tolerance Frequency
Packing/Processing 
establishments and 
personnel
General level of 
hygiene as listed in 
these regulations 
and handling of the 
product
/ /
Every harvest 
(Packing 
Establishment) 
Monthly 
(Processing 
Establishment)
Ice and water 
samples from each 
outlet
Total bacterial 
count
Colony counts on 
plate count agar
< 2 x 10cfu/ml at 
37ºC
< 2 x 10 2 cfu/ml at 
22ºC
Monthly
Total coliforms;
Faecal coliforms
Multiple tube 
fermentation and 
MPN count
0 Monthly
Organoleptic and 
physicochemical 
examination
According to 
regulations as 
issued under the 
Food, Drugs and 
Drinking Water Act
According to 
regulations as 
issued under the 
Food, Drugs and 
Drinking Water Act
Yearly, if supply of 
water is private
* colony-forming units
Type of analysis Tests Laboratory 
method
Limits of 
tolerance Frequency
Total bacterial count Colony counts on 
plate count agar
1 x 10 7  cfu/g Monthly
Bacteriological Faecal coliforms Multiple tube 
fermentation at 
44ºC and MPN 
count
100  E. coli/g Monthly
Salmonella ;
S.fecalis ;
S.aureus ;
V.parahaemolyticus
Innoculation on 
selective and 
confirmatory media
0
< 100  S.fecalis/g
< 10  S.aureus/g
0
Monthly
Parasitological Parasite check Visual inspection No visible parasites Daily
(Processing Est.) 
Each harvest 
(Packing Est.)
Organoleptic Inspection for 
freshness
Visual inspection, 
aided where 
necessary by 
Torrymeter 
readings
Freshly harvested 
fish should be free 
from pressure 
marks, blemishes, 
injuries or 
discoloration
Every harvest
14 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
THIRD SCHEDULE
Quality Control: Chemical residues
Chemical group of 
substances (Aquaculture 
products only)
Compounds Laboratory  method Level of  action Number of  samples Frequency
Volatile Nitrogenous Bases TVB-N Reference 
method 
according to 
95/149/EC
To be determined for 
aquaculture animals
In case of 
adverse 
organoleptic
Stilbenes DES;
Hexestrol;
Dienestrol
HPTLC
1ppb 6 yearly
Steroids Oestradiol HPTLC 2.5ppb 6 yearly
Antibacterial substances Nitrofurans
Tetracyclines
Sulphonamides
Quinolones
HPTLC
four-plate
Test
5ppb
10ppb
100ppb
10ppb
12
6-8
yearly
monthly
Antihelminthics Ivermectin HPTLC 15ppb 20 yearly
Carbamates Aldicarb
Bufencarb
Carbaryl
Carbofuran
Methiocarb
Methomyl
HPTLC
10ppb
500ppb
200ppb
100ppb
50ppb
20ppb
10 yearly
Pyrethroids Cypermethrin
Deltamethrin
Flumethrin
Permethrin
Tetramethrin
GC-MS
0.2ppm
0.5ppm
0.5ppm
10 yearly
Organochlorie compounds DDT
BHC
Lindane
Dieldrin
GC-MS
1.0ppm
0.1ppm
0.1ppm
0.1ppm
10 yearly
Organophosphorus 
compounds
Melathion
Chlorphenvin-
phos
Dichlorvos
Coumaphos
GC-MS 10ppm 10 yearly
Chemical elements Pb
Hg
As
Cd
GF-AAS
500ppb
500ppb
1000ppb
50ppb
30 yearly
Dyes Malachite 
green HPLC
Method still under development
FISH PACKING AND PROCESSING ESTABLISHMENTS [ S.L.231.43 15
FOURTH SCHEDULE
Standards for cooked crustacean and molluscan shellfish products
1. Pathogens
Salmonella spp.  Absent in 25g
n = 5
c = 0
In addition, pathogens and toxins thereof which are to be sought according to the
risk evaluation, must not be present in quantities such as to affect the health of
consumers.
2. Organisms indicating poor hygiene (shelled or shucked products)
Staphylococcus aureus
m = 100
M = 1 000
n = 5
c = 2
either: Thermotolerant coliform (44ºC on solid medium)
m = 10
M = 100
n = 5
c = 2
or:  Escherichia coli  (on solid medium)
m = 10
M = 100
n = 5
c = 2
Where parameters n, m, M and c are defines as follows:
n = number of units comprising the sample,
m = limit below which all results are considered satisfactory,
M = acceptability limit beyond which the results are considered unsatisfactory,
c = number of sampling units giving bacterial counts of between m and M.
The quality of a batch is considered to be:
( a ) satisfactory where all the values observed are 3m or less;
( b ) acceptable where the values observed are between 3m and 10m (= M) and
where c/n is 2/5 or less.
The quality of a batch is considered to be unsatisfactory:
- in all cases where the values are above M,
- where c/n is greater than 2/5.
3. Indicator organisms (Guidelines)
16 [ S.L.231.43 FISH PACKING AND PROCESSING ESTABLISHMENTS
Mesophilic aerobic bacteria (30ºC)
( a ) Whole products
m = 10 000
M = 100 000
n = 5
c = 2
( b ) Shelled or shucked products with the exception of crabmeat
m = 50 000
M = 500 000
n = 5
c = 2
( c ) Crabmeat
m = 100 000
M = 1 000 000
n = 5
c =2
