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FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

SUBSIDIARY LEGISLATION 449.25

FISH PACKING AND PROCESSING

ESTABLISHMENTS REGULATIONS

1st January, 2002

LEGAL NOTICE 255 of 2000.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

The title of these regulations is the Fish Packing and

Processing Establishments Regulations.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

Hygiene monitoring

Inspections/

Laboratory

Limits of

Frequency

examination

method

tolerance

Packing/Processing General level of

Every harvest

establishments and hygiene as listed in

(Packing

personnel

these regulations

Establishment)

/

/

and handling of the

Monthly

product

(Processing

Establishment)

Total bacterial

Colony counts on

< 2 x 10cfu/ml at

Monthly

count

plate count agar

37ºC

< 2 x 10 2 cfu/ml at

22ºC

Total coliforms;

Multiple tube

Monthly

Ice and water

Faecal coliforms

fermentation and

samples from each

MPN count

outlet

Organoleptic and

According to

According to

Yearly, if supply of

physicochemical

regulations as

regulations as

water is private

examination

issued under the

issued under the

Food, Drugs and

Food, Drugs and

Drinking Water Act Drinking Water Act

* colony-forming units

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

In these regulation unless the context otherwise requires

"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;

"appr oved p ro cessing es tablish ment" means a pro cessin g

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

prepared, including vacuum-packed products, which have not

undergone any treatment to ensure preservation other than chilling;

" f r o ze n p r o d u c t s " m e an s a n y f i s h e r y p r o d u c t w h i c h h a s

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;

" p ac k i n g " m e a n s t h e p r o c e d u r e o f p r o t e c t i n g f i s h e r y o r

aquaculture products by wrapping material, a container or similar

object;

"prepared products" means any fishery or aquaculture product

wh ich has u nd erg on e an o per atio n aff ectin g its anato m ical

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

s u ch a s s m o k i n g , s a l t i n g , h e a t i n g , m a r i n a t i n g a n d s i m i l ar

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

Quality control: microbiological

Type of analysis

Laboratory

Limits of

Tests

Frequency

method

tolerance

1 x 10 7 cfu/g

Total bacterial count

Colony counts on

Monthly

plate count agar

Bacteriological

Faecal coliforms

Multiple tube

100 E. coli/g

Monthly

fermentation at

44ºC and MPN

count

Salmonella;

Innoculation on

Monthly

S.fecalis;

selective and

< 100 S.fecalis/g

S.aureus;

confirmatory media

< 10 S.aureus/g

V.parahaemolyticus

Parasitological

Parasite check

Visual inspection

No visible parasites

Daily

(Processing Est.)

Each harvest

(Packing Est.)

Organoleptic

Inspection for

Visual inspection,

Freshly harvested

Every harvest

freshness

aided where

fish should be free

necessary by

from pressure

Torrymeter

marks, blemishes,

readings

injuries or

discoloration

FISH PACKING AND PROCESSING ESTABLISHMENTS

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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.

(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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

Quality Control: Chemical residues

Chemical group of

Laboratory

Level of

Number of

substances (Aquaculture

Compounds

Frequency

method

action

samples

products only)

Volatile Nitrogenous Bases

TVB-N

Reference

To be determined for

In case of

method

aquaculture animals

adverse

according to

organoleptic

95/149/EC

Stilbenes

DES;

1ppb

yearly

Hexestrol;

HPTLC

Dienestrol

Steroids

Oestradiol

HPTLC

2.5ppb

yearly

Antibacterial substances

Nitrofurans

HPTLC

5ppb

yearly

Tetracyclines

10ppb

Sulphonamides

four-plate

100ppb

6-8

monthly

Quinolones

Test

10ppb

Antihelminthics

Ivermectin

HPTLC

15ppb

yearly

Carbamates

Aldicarb

10ppb

Bufencarb

500ppb

Carbaryl

200ppb

HPTLC

yearly

Carbofuran

100ppb

Methiocarb

50ppb

Methomyl

20ppb

Pyrethroids

Cypermethrin

0.2ppm

Deltamethrin

0.5ppm

Flumethrin

GC-MS

yearly

Permethrin

0.5ppm

Tetramethrin

Organochlorie compounds

DDT

1.0ppm

BHC

0.1ppm

GC-MS

yearly

Lindane

0.1ppm

Dieldrin

0.1ppm

Organophosphorus

Melathion

compounds

Chlorphenvin-

phos

GC-MS

10ppm

yearly

Dichlorvos

Coumaphos

Chemical elements

Pb

500ppb

Hg

500ppb

GF-AAS

yearly

As

1000ppb

Cd

50ppb

Dyes

Malachite

Method still under development

HPLC

green

FISH PACKING AND PROCESSING ESTABLISHMENTS

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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,

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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)

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

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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.

(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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

A pest control programme must be set up for rodents,

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(1) Staff must wear clean, light-coloured working clothes

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

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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

c o n se r v at io n t em p e r at u r e b ef o r e p a ck i n g . T h e ap p r o p r ia te

conditions for storage must be clearly marked on the package.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(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 consu med as th ey are m ust, in additio n, 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

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(1) The packaging material for the dispatch of fresh or

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

pr otect the f ish and have ad equate d rainage 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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(1) Identification of the aquaculture product, in the form

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,

m u s t h a v e t h e a p p r o v a l n u m b e r, n a m e a n d a d d r e s s o f t h e

processing establishment, species of fish, ingredients, and storage

requirements in a clearly legible, indelible manner affixed onto

each container.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

(1) Transport vehicles for fresh or processed fish must

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.

Laws of Malta — Subsidiary Legislation 449.25 — FISH PACKING AND PROCESSING ESTABLISHMENTS REGULATIONS

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

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

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