Table of Contents

Page

European Union Import Requirements

on Fish & Fishery Products Along
The Supply Chain

- Fishing Vessels 3
- Landing Sites 6
- Aquaculture Farms 9
- Processing Establishments 16

Enquiry Points 34

1
Preface
This booklet provides guideline to businesses intending to
export fishery products to the European Union (EU). This
guideline applies to the whole fishery products supply chain
namely fishing vessels, landing sites, aquaculture farms
and processing establishments. Exporters shall comply to
all the EU legislation and requirements before exporting
their products to the European Union.

To ensure that exports can take place smoothly and

efficiently, interested businesses should understand the
fundamental principles and philosophy of the European
Food Law, which form the basis for their import rules. EU
requirements are based on a systems approach and to
meet these expectations, the food law of the European
Union prescribes the principles of quality management and
process-oriented controls throughout the food supply
chain - from the fishing vessel or aquaculture farm to the
consumer's table.
Fishing Vessels

A. Structure and Equipment of Fishing Vessels

Elements to be Checked Objective to the Legislation References

1. Structure and Equipment - To minimize the chances of - Reg. 853/2004
All Vessels cross contamination of the Section VIII,
• Bilge water, fuel, smoke, oil, product. Chapter I Part IA
grease, etc. cannot contaminate - Reg. 852/2004,
products. Annex I
• Surfaces in contact with fish
are smooth, easy to clean and
non-corrosive.
• Surface coatings must be
durable and non-toxic.
• Equipment for working with
fish is smooth, easy to clean
and non-corrosive.
• Water intake is located so as
to avoid contaminated water
to be taken into the vessel.
2. Supplementary Structure and To avoid cross contamination - Reg. 853/2004,
Equipment - Vessels to preserve of the products and to Section VIII,
fish more than 24 hours minimize spoilage by Chapter I Part B
• Holds, tanks or containers are temperature abuse.
separated from engine
compartment and crew quarters.
• Holds, tanks and containers are
adequate to store products at
temperature approaching that
of melting ice.
• Containers for storage of
products with ice allow melted
water to drain out.
• CSW and RSW systems allow
for uniform temperature to be
maintained throughout the tank.
• Temperature of products in
CSW and RSW systems can
be monitored.
3. Supplementary Structure and To minimize spoilage by - Reg. 853/2004,
Equipment - Freezer Vessels temperature abuse. Section VIII,
• Freezing equipment with Chapter I Part C
capacity to lower the product
core temperature to that of not
more than -18°C (-9°C in brine)
is available.
• Storage holds equipped with a
temperature recording device
in a location where it can be
easily read.
• The temperature sensor is
situated in the area where the
temperature is likely to be the
highest (usually the main
opening).

3
 Elements to be Checked Objective to the Legislation References
4. Supplementary Structure and To avoid cross contamination - Reg. 853/2004,
Equipment - Factory Vessels of the products and to Section VIII,
• Receiving area designed to minimize spoilage by Chapter I Part D
allow each successive catch to temperature abuse.
be separated.
• A hygienic system for conveying
fishery products from the
receiving area to the work area is
available.
• Work areas are large enough for
hygienic preparation and
processing (easy to clean,
disinfect and prevent cross-
contamination).
• Storage areas for the finished
products that are large enough
and designed so that they are
easy to clean.
• If a waste processing unit
operates on board (fishmeal,
etc.), a separate hold must be
designated for its storage.
• A designated area for storing
packaging materials that is
separated from the product
preparation and processing
areas.
• An area for the hygienic
disposal and/or management
of waste/products is available.
• Water intake situated in a
position that avoids contamination
of the water supply.
• Hand washing equipment for
use by the workers with non-
hand operated taps to prevent
the cross-contamination.

B. Hygienic Practices on Fishing Vessels

Elements to be Checked Objective to the Legislation References

5. General Hygiene To minimize the chances of - Reg. 852/2004,
• Facilities for storage and cross contaminating the Annex 1, Part A II
handling of products are kept product. 4a, 4b
clean and in good repair. - Reg. 853/2004
• Containers kept clean, are in Section VIII,
good repair and maintained in Chapter I Part I,
good condition. Point 1
• No contamination with fuel or
bilge water.

4
 Elements to be Checked Objective to the Legislation References

6. Products To avoid cross contamination - Reg. 852/2004,

• Protected from contamination of the products and to Annex 1, Part A II,
and effect of sun & other minimize spoilage by 4d
sources of heat. temperature abuse. - Reg. 853/2004
• Clean water is used for Section VIII,
washing. Chapter I Part II,
• Handling do not cause 2, 3, 4
bruising of flesh of products.
• Chilling starts as soon as
possible after loading to vessel
OR
• Landing takes place as soon as
possible after loading to vessel.
• On CSW and RSW the mix of
fish and clean seawater reaches
3°C after six hours and 0°C after
16 hours from the time of
loading.
• Temperature approaching that
of melting ice is maintained
throughout all parts of the
container in ice cooled system.

7. Ice To minimize the chances of - Reg. 853/2004,

• Made of potable water or cross contaminating the Section VIII,
clean water. product. Chapter I, Part II,
• Handled and stored under Point 5
hygienic conditions.

8. Handling on Board To minimize the chances of - Reg. 853/2004,

• Heading and gutting carried cross contaminating the Section VIII,
out hygienically. product. Chapter I, Part II,
• Clean water used for washing Point 6
the product.
• By products intended for
human consumption chilled
immediately.
• By products not intended for
human consumption kept
separated from the product.

9. Crew To minimize the chances of - Reg. 852/2004,

• Procedure to ensure good cross contaminating the Annex 1,
health is in place and effective. product. Part A II 4e
• Medical examination of crew is
carried out according to
guideline given by the Ministry
of Health.
• Procedures for staff reporting of
diseases and afflictions are
planned, implemented and
effective.
• Crew is appropriately trained.

5
 Landing Sites

A. Sanitary Requirements in Relation with Hygiene and Good Handling Practices

Elements to be Checked Objective to the Legislation References

1. Unloading and Landing To prevent the contamination - Reg. 853/2004
Operations of the products and ensure Section VIII,
• Equipment easy to clean and they are not handled in a way Chapter II Part II,
disinfect. that could alter their quality 1a, 1b
• Equipment in good repair, and safety.
clean and in good condition.
• Operations carried out rapidly.
• Operations do not damage
fishery products.
• Products immediately placed
in protected environment.
• Products maintained at
temperature approaching that
of melting ice.

2. Practices and Operations Good handling practices to - Reg. 852/2004

avoid cross contamination of Annex 2,
• Fresh products not chilled on
products and prevent Chapter II, 3
board are iced or otherwise
deterioration of products due Annex 1,
chilled immediately after landing.
to temperature abuse. Part A II,
• Containers used for storage of
3a and 4g
fishery products under ice
- Reg. 852/2004
allow drainage of melt water.
Annex 2,
• Handling and storage of waste
Section VIII,
preclude risk of cross-
Chapter III, A4
contamination of products.
and A5, A2
• Operations such as gutting,
cleaning, sorting and repacking
are carried our hygienically.
• Adequate procedures for
washing and disinfection of
facilities, equipment, containers,
vehicles etc. are in place and
effective.
• Adequate procedures for
control of pests and animals are
in place.

3. Supply of Water, CSW and Ice To ensure only potable or clean - Reg. 852/2004,
water come into contact with Annex II,
Water
fishery products. Chapter VII 14
• Water available at all times in
- EC Directive
sufficient amounts.
98/83 Annex II
• Quality of water regularly
Table A and B
monitored.
• Water quality complies with the
standard of clean water and
potable water (drinking water).

6
 Elements to be Checked Objective to the Legislation References

Ice
• Produced using potable water
in facilities that meet EU
requirements (the source is
controlled).
• Stored under hygienic conditions.
• Transported under hygienic
conditions.
• Handled under hygienic conditions.
• Quality regularly monitored.
• Ice quality complies with the
standard of clean water and
potable water (drinking water).
4. Personal Hygiene Minimize the risk of - Reg. 852/2004,
• All workers wear suitable contamination of seafood by Annex II,
protective clean clothing. pathogenic microorganisms Chapter VIII 12
• Workers maintain a high and other hazards which may
degree of personal hygiene. be carried by workers.
• Procedure to ensure good
health is in place and effective.
• Medical examination of crew is
carried out according to
guideline given by the Ministry
of Health.
• Procedures for workers to
report diseases and afflictions
are planned, implemented and
effective.
• All workers are trained in food
hygiene and safety elements
relevant to their nature of work.
5. Control of Specific Hygiene Products placed on the market - Reg. 853/2004,
Parameters and Food Safety shall meet minimum freshness Annex III,
Hazards criteria and not be obviously Section XIII,
• Organoleptic examinations are contaminated with parasites. Chapter V-A
carried out to ensure that Fish known to be poisonous or - Reg. 853/2004,
products comply with freshness toxic to humans shall not be Annex III,
criteria before being placed on placed on the market. Section XIII,
the market. Chapter V-D
• Fishery products with visible - Reg. 852/2004,
parasites are not placed on the Annex II,
market or treated as per Reg. Chapter IX 12
853/2004, Annex III, sec XIII, Ch. D. - Reg. 2074/2005,
• Products are rejected if known Annex 2, Section I,
or reasonable suspected to be Chapter I and II
contaminated. - Reg. 2406/1996,
The following species of fish Article 3 and
are not placed on the market: Annex I
- Species of Tetraodontidae,
Molidae, Diodontidae,
Canthigastridae or other
known toxic species.
- Species of family Gempylidae
(Oil fish Ruvettus pretiosus
and Escolar Lepidocybium
flavobrunneum) if not in
wrapped packed form.

7
 B. Sanitary Requirements in Relation to Structures and Equipment

Elements to be Checked Objective to the Legislation References

6. Facilities and Infrastructures Facilities and equipment are - Reg. 852/2004

• Provide adequate protection constructed so as to prevent Annex 1,
against contamination. contamination of products. Part A II, 2 and
• Structures are of smooth, easy 3a, 4e, 4g
to clean and made of - Reg. 852/2004
impervious material. Annex 2,
• Structures maintained in good Chapter II, 2
condition. - Reg. 852/2004,
• Precautions against Annex II,
contamination by exhaust Chapter I-3, 4,
fumes of engine are in place. 6, 9
• Precautions against other
hazardous substances are in
place and effective.
• Protection against rodents and
other pests are in place and
effective.
• Lighting is adequate for the
operations.
• Site is used for handling and
storage of fishery products only.
• Lavatories and hand washing
facilities for staff are adequate
and located away from fish
handling areas.
• If possible, there should be
separate facilities for storage
of detained fishery products.

8
Aquaculture Farms

A. Surroundings, Location and Construction

Elements to be Checked Objective to the Legislation References

1. Location Protect raw materials from - Reg. 852/2004,
• Location is in environmentally contamination from Annex I,
suitable area where risks to food surroundings. Chapter II.2
safety from chemical, biological
and physical hazards through air,
soil and water are minimized.
2. Water To reduce the risk of - Reg. 852/2004,
• Farm water input is far from contamination from water. Annex II,
polluted areas, sufficient and Chapter I-5
suitable at all times.
3. Layout and Design To ensure that the adequate - Reg. 852/2004,
• Farm is used for aquaculture conditions are in place for Annex I,
purposes only (no livestock implementation of good Chapter II.3a,
production). practices in regard to 3b, 4f
• Farm design and lay out contamination through daily
prevents cross contamination. operation.
• Septic tanks, toilet facilities and
bathrooms/showers are
constructed and located such
that they do not pose a risk for
contamination of farm facilities.
• Equipment such as cages and
nets are designed and
constructed to ensure minimal
physical damage to fish during
growing & harvesting and to allow
for adequate cleaning and
disinfection.
• Equipment such as containers
and vehicles for feed, fry and
harvested fish/crustaceans are
designed and constructed to allow
for adequate cleaning and
disinfection.
4. Pest Control - Reg. 183/2005,
• Structures in combination with a pest Annex III.1
control system ensure that the risk - Reg. 852/2004,
for contamination of feed, equipment Annex 1 Chapter
and farming system by pests is 4f
minimized.
5. Facilities - Reg. 852/2004,
• Feed, drug and disinfection Annex I,
deposits are available and suitable. Chapter II.4g
• Medicated and non-medicated - Reg. 183/2005,
feed are stored to minimize the Annex III
risk for feeding to non-target animals. - Reg. 88/2006
• Facilities for disposal of solid and Art 34
liquid waste is available in suitable - Reg. 852/2004,
area (allow for hygienic disposal). Annex I,
Chapter II.3a, 4g

9
 B. General Practices

Elements to be Checked Objective to the Legislation References

6. Facility and Equipment To ensure that the design of - Reg. 852/2004,

Cleanliness facilities shall permit good Annex I,
• Farm and surroundings practices including protection Chapter II.4a, 4b,
maintained in clean and hygienic against contamination from 4f, 4d
condition. domestic animals and pests. - Reg. 183/2005,
• Measures taken to prevent Annex III.
animals and pests from
causing contamination.
• Fuel, chemical substances
(disinfectant, fertilizer, reagents),
feed and veterinary drugs stored
in separate and safe conditions.
• Containers, equipment and
farm facilities are maintained in
sound condition so they are
easy to clean and disinfect.
• Adequate procedures for
cleaning and disinfection of
containers, equipment and farm
facilities are in place and
implemented.

7. Pond Preparation for Stocking Effective pond preparation shall - Reg. 852/2004,
• Pond preparation practices minimize the outbreak and Annex I,
minimize risk for cross spread of diseases, hence use Chapter II.3
contamination. of veterinary drugs. - EC Directive
• Pond preparation practices do 2006/88, Art. 9
not include prohibited chemical - Reg. 183/2005,
or biological substances. Annex III.2
• Fertilizers, probiotics, chemicals
etc. are use according to
instruction for proper use.

8. Water Management The entrance and growth of - Reg. 852/2004,

human and fish pathogenic Annex I,
• Water is properly
organisms such as parasites, Chapter II.3
screened/settled/aerated and
bacteria and virus shall be - EC Directive
quality is maintained as
minimized. 2006/88, Art. 9
suitable for cultured stock.
• Water quality verified through
testing as adequate to ensure
safety.

9. Contingency Plans To dispose of aquatic animals - Reg. 852/2004,

and waste minimizing risk of Annex VII,
• Facilities for keeping of dead/ill
spread of disease and Chapter II.
animals until safe disposal is
environmental damage.
possible are available and
suitable.

10
C. Management of Feed

Elements to be Checked Objective to the Legislation References

10. Origin of Feed and Feed - Reg. 183/2005

Substances Art. 9
- Reg. 183/2005
• Fish/shrimp feed is from
Art. 10
company which is registered by
- Reg. 183/2005
national Competent Authority.
Art. 23
• Additives, premixes and
compound feeding stuffs are from
company approved by Competent
Authorities.
• Imported feed is from company
registered by national
Competent Authority to comply
with prevailing EU requirements.

11. Storage of Feed - Reg. 183/2005,

Annex III
• Stored in properly in cool and
dry place.

12. Feed Quality - Reg. 1831/2003

and Community
• Content of additives and veterinary
register on Feed
drugs comply with EU Regulations.
Additives Rev. 5.
• Packages are properly labeled
2005
with description of composition,
storage conditions, expiry date,
feeding rate and other necessary
guidance in adequate language.

13. Feeding - Reg. 183/2005

Art. 4. 2 and
• Feeding Practices shall
Annex III.2
minimize the risk for biological,
chemical and physical
contamination of feed and
animals.
• Feeding practices ensure the
maintenance of water and
sediment quality.

14. Feed Production on Farm - Reg. 183/2005,

Annex 1
• Ingredients, additives and
- Reg. 852/2004,
veterinary drugs shall include
Annex 1, Ch.II.4.j
only substances allowed for
aquaculture species.
• Good Hygiene Practices are
applied to minimize hazards
with potential to compromise
feed and food safety.

11
 D. Management of Veterinary Drugs and Chemicals

Elements to be Checked Objective to the Legislation References

15. Veterinary Drugs and Chemicals - EC Directives

Used 2001/82 and
• Veterinary drugs, medicated 2004/28 Art. 65,
feeds, chemical and biological 66, 67, 68
substances are obtained from - EC Directive
registered/authorized 2001/82 and
manufactures and suppliers only. 2004/28 Art. 5
• Veterinary drugs, medicated feeds, and Art. 6
chemical and biological substances - EC Directive
are permitted/registered according 2001/82 Art. 9
to EU/national regulations. - EC Directive
• Substances requiring 96/22
prescription are used under - Reg. 852/2004
adequate supervision by Annex I Chapter II
qualified expert. 4(j)
• Veterinary drugs, medicated - EC Directives
feeds, chemical and biological 2001/82 and
substances are, by adequate 2004/28 Art. 58,
language, labeled with clear 59, 60, 61
information at least about name,
active substance, target species
of animals, storage conditions,
dosage, route of administration,
expire date and withdrawal
period.

16. Storage and use of Veterinary - Reg. 852/2004,

Drugs and Chemicals Annex I,
• Veterinary drugs, medicated Chapter II.4g
feeds, chemical and biological - Reg. 852/2004,
substances are adequate Annex I,
stored according to instructions. Chapter II.4j
• Veterinary drugs, medicated - Reg. 2377/90
feeds, chemical and biological consolidated
substances are used according version 2007
to manufactures instruction and - EC Decision
as specified on label. 2003/181
• Withdrawal periods and - EC Decision
residues are verified by 2004/25
adequate testing. - EC Directives
2001/82 and
2004/28 Art. 11

12
E. Disease Risk Management

Elements to be Checked Objective to the Legislation References

17. Control Spread of Diseases All aquaculture businesses are - EC Directive

registered/authorized by 2006/88/EC
• Farm is registered/authorized
competent authority to facilitate Chapter II Article 4
by Competent Authority.
official control and traceability. - Reg. 853/2004
• Processing establishments
Art. 4
slaughtering aquaculture Introduction and spread of
- EC Directive
animals for diseases control diseases shall be controlled
2006/88/EC
purposes are authorized by through good practices in
Chapter II Art. 4
Competent Authority. whole chain of handling and
- EC Directive
• Traceability records for moving healthy and diseased
2006/88/EC
movement of animals in place. animals.
Chapter II Art. 8
• Good Hygienic Practices/Good Control of diseases of aquatic - EC Directive
Aquaculture Practices in place. animals through communication 2006/88/EC
• Risk-based animal health between farmers and Chapter II Art. 9
surveillance scheme in place. competent authority and - EC Directive
• Aquaculture animals intended implementation of appropriate 2006/88/EC
for farming and restocking are investigations. Chapter II Art. 10
clinically healthy.
- EC Directive
• Aquaculture animals and
2006/88/EC
products placed on the market
Chapter III, Art. 15
for further processing before
- EC Directive
human consumption are disease
2006/88/EC
free.
Chapter III, Art. 18
• Measures for the notification
- EC Directive
and control of diseases of
2006/88/EC,
aquatic animal origin are in
Chapter V Art. 26
place.
- EC Directive
• Surveillance programme in place
2006/88/EC,
for diseases of animal origin.
Chapter VI
• Disease free status of
(Art. 44-48)
aquaculture premises.
- EC Directive
2006/88/EC
Section II
Chapter VII
(Art. 49-53)

F. Post Harvest Management

Elements to be Checked Objective to the Legislation References

18. Ice and Water Supplies Good Practices imply that - Reg. 852/2004
system of supply and handling Annex I,II.4d and
• Potable or clean water available
of ice and water is planned to Annex II,
and used in sufficient amount
minimize risk for contamination. Chapter VII 14
for harvest, handling and
- EC Directive
cleaning operations.
98/83 Annex II
• Ice supplied from approved
Table A and B
establishment using potable or
- Reg. 853/2004
clean water (if applicable).
Annex 3,
• Ice received/arrived in good
Section VIII,
sanitary conditions.
Chapter I, Part II.5
• Ice handled and stored under
good sanitary conditions which
preclude risks for contamination.

13
 Elements to be Checked Objective to the Legislation References

19. Harvesting To prevent the contamination - Reg. 852/2004

of the products and ensure it is Annex 1, II. 4.b
• Harvesting equipment and
not handled in a way that - Reg. 852/2004
utensils easy to clean, disinfect
could alter its quality and Annex 1, II.2
and kept in clean condition.
safety; i.e. protected from and II.3a
• Harvesting planned in advance
contamination and kept in - Reg. 852/2004
and timed to avoid exposure
favorable preservation Annex 1, II.4.d
fish and shrimp to unduly high
conditions. - Reg. 853/2004
temperatures.
Annex 3,
• Practices ensure rapid killing of
Section VIII,
harvested fish/shrimp
Chapter VII.3
(if applicable).
- Reg. 853/2004
• Practices ensure that viability live
Annex 3,
fish/shrimps are not affected by
Section VIII,
extreme temperatures, physical
Chapter II, 1b
damage or undue stress
- Reg. 852/2004
(if applicable).
Annex 1, III.7, 8.
• Fish/shrimp quickly and
hygienically handled, using
practices which do not cause
physical damage to edible part of
product.
• Records on harvesting are
maintained for traceability.

20. Post Harvest Handling To ensure products are chilled - Reg. 852/2004
and/or kept under chilled and Annex 1, II.4.a
• Utensils and equipment for
hygienic conditions when they - Reg. 853/2004
handling and holding is
are in the facilities of the Annex 3,
maintained in easy to clean and
establishment. Section VIII,
clean condition.
Chapter II.1a
• Live fish/shrimp is handled and
- Reg. 853/2004
kept under physical conditions
Annex 3,
which do not affect adversely
Section VIII,
their viability.
Chapter VII.3
• Killed fishes/shrimp is cooled
- Reg. 853/2004 S
down quickly and maintained at
Annex 3,
temperature approaching that of
Section VIII, Ch. II,
melting ice in all parts of each unit.
1.b and
• Operations such as sorting,
Chapter VII.1
weighing, washing, drainage
- Reg. 853/2004
etc. is carried out quickly,
Annex 3,
hygienically and without damage
Section VIII,
to the edible part of product.
Chapter II, 1b
• Food additives and chemicals
- EC Directive
are used in contact with
1995/2 and
products only in compliance
2006/52
with prevailing legal
- Reg. 852/2004
requirements.
Annex 1, II.3.a
• Harvesting wastes are collected
- Reg. 853/2004
in designated equipments and
Art. 3
disposed to preclude risk of
- Reg. 852/2004
cross contamination.
Annex 1, II.3a, 4g

14
 Elements to be Checked Objective to the Legislation References
21. Transport (If applicable) To ensure products are chilled - Reg. 853/2004
and/or kept under chilled and Annex 3,
• Transport is carried out in easy hygienic conditions when they Section VIII,
to clean and clean facilities are in the facilities of the Chapter VIII, 4
(boxes, containers etc.). establishment. - Reg. 853/2004
• Transport conditions arranged to Annex 3,
avoid contamination from Section VIII,
surroundings e.g. air, soil, water, Chapter III A4
oil, chemicals etc. and A5 and
• Live fish/shrimp transported Chapter VIII.1a
under physical conditions which - Reg. 853/2004
do not affect adversely their viability. Annex 3,
• Dead fish/shrimp is transported Section VIII,
in containers with ice or with ice Chapter VIII.3
and water, in sufficient amount - Reg. 852/2004
to ensure temperature around Annex 1, III.7, 8.
0ºC (approaching that of melting
ice) in all products and during
the whole period of transport.
• Containers for ice and product
allow melt water to drain away
from product.
• Based on the prevailing
requirement, prohibited additives
and chemicals are not used in
contact with products/live animals.
• Records for transport of fish and
shrimp maintained to ensure
product traceability.

G. Record Keeping
Elements to be Checked Objective to the Legislation References
22. Adequate records shall be kept on: Use of conditions or - Reg. 852/2004
substances which may Annex 1,
• Type, origin and use of feed and compromise food safety shall Part III.7, 8
feed ingredients. be controlled and traceable. - EC Directives
• Veterinary drugs or other 2001/82 and
treatments administered. 2004/88, Art. 69
• Occurrences of diseases which
may affect food safety.
• Pond management activities
(e.g. preparations and water
quality controls).
• Origin and type of seed used.
• Buyers of final products.

H. Staff Training
Elements to be Checked Objective to the Legislation References
23. Training - Reg. 852/2004
Annex 1,
• Staff is trained and has knowledge Chapter II.4e
on food safety issues related to - Reg. 183/2005
handling of feed, veterinary Annex III.2
medicines, chemicals, live animals Dec. 2003/858
and harvested products, adequate Annex IV
to the nature of duty. - EC Directives
• Staff is adequately trained to 2006/88 Annex IV,
recognize clinical manifestations Part II
of exotic and non-exotic
diseases listed in EU.

15
 Processing Establishments

A. Surroundings and Construction

Elements to be Checked Objective to the Legislation References

1. Surroundings, Constructions To ensure that design, - Reg. 852/2004,

and Layout construction, location and size Annex II,
of the food premises allow for Chapter I 1,
• External environment hygienic
adequate control of food 2a-2d.
and kept clean.
hygiene and safety. - Refer also to item
• Surroundings maintained to
23, 26 and
prevent harbourage of pest. Maintenance of sanitation and 47 below
• Establishments designed to hygiene during handling and
prevent access to pests (e.g. no processing of products.
gaps at entrances.
• Establishments shall not have
accumulated dirt, condensate,
mould or other undesirable
particles.
• Conditions in areas for handling
and processing of products are
sanitary and hygienic.
• Conditions are suitable to allow
storage, handling and
processing at appropriate
temperatures.
• Layout and appropriate product flow
to preclude cross contamination
from less clean to clean areas.

2. Ventilation To reduce the risk of - Reg. 852/2004,

contamination of the products. Annex II,
• Sufficient and suitable for the
Chapter I-5
operation.
• Mechanical airflow ensures flow
from clean to less clean area.

3. Staff Facilities To ensure personal hygiene of - Reg. 852/2004,

workers. Annex II,
• The number of lavatories is
Chapter I-3, 4,
adequate.
6, 9
• Lavatory facilities that do not open
directly into processing areas.
• Number of hand washing basins
is adequate.
• Hand washing basins are suitably
located.
• Hand washing basins are suitable
designed (non-hand operated).
• Hand washing basins have
adequate facilities for effective
hand washing (running water,
liquid soap and paper towels.
• Lavatory facilities have adequate
ventilation.
• Changing facilities are adequate
for the workers.

16
 Elements to be Checked Objective to the Legislation References

4. Light To ensure sufficient lighting in - Reg. 852/2004,

working areas and to prevent Annex II,
• Premises have adequate light
contamination of products. Chapter I-7
for operations.
• Lights are covered to prevent
broken parts from
contaminating products.

5. Drainage System To make sure that the drainage - Reg. 852/2004,

system is not a source of Annex II,
• Constructed to avoid risk of
contamination of the Chapter I-8
contamination with flow of
establishment.
waste water from less clean to
clean areas.
• Adequate capacity for the
operation.

6. Storage of Chemicals To ensure that cleaning and - Reg. 852/2004,

disinfecting chemicals do not Annex II,
• Adequate storage facilities allow
contaminate food. Chapter I-10
for safe storage of cleaning and
- Refer also to item
disinfection agents in areas
22 below.
where food is not handled.

B. Construction Requirements in Areas Where Food is Handled

Elements to be Checked Objective to the Legislation References

7. Floors To ensure that the design of - Reg. 852/2004,

facilities permits good hygiene Annex II,
• Made of impervious, non-
practices including protection Chapter II, 1a-1f
absorbent, washable and non-
against contamination during
toxic materials.
processing.
• Surfaces maintained in sound
condition so they are easy to
clean and disinfect.
• Surfaces allow adequate
drainage of water.

8. Walls
• Made of impervious, non-
absorbent, washable and non-
toxic materials.
• Surfaces maintained in sound
condition so that they are easy
to clean and disinfect.

9. Ceilings and Light Fittings

• Constructed and finished to
prevent accumulation of dirt,
growth of moulds, shedding of
particles and minimize
condensation.

17
 Elements to be Checked Objective to the Legislation References

10. Windows and Other Openings

• Constructed so to prevent
accumulation of dirt.
• Fitted with insect proof screens
if to be opened to the outside.
• Insect screens in windows and
other openings are easy to
remove for cleaning.

11. Doors
• Made of appropriate materials
(smooth and non-absorbent).
• Easy to clean and disinfect.

12. Surfaces in Contact with Food

• Made of appropriate materials
(smooth, washable, non-
corrosive, non-toxic).
• Maintained in sound conditions
which allow for easy cleaning
and disinfection.

13. Cleaning of Working Utensils To ensure that working utensils - Reg. 852/2004,
and equipment are clean. Annex II,
• Facilities for cleaning,
Chapter II-2
disinfecting and storage of
working utensils and equipment
are adequate.
• Facilities for cleaning, disinfecting
and storage of working utensils
constructed of materials which
are easy to clean and maintain.
• Facilities for cleaning, disinfection
of working utensils shall have
adequate supply water.

14. Facilities for Washing Food To avoid contamination of - Reg. 852/2004,

products. Annex II,
• Designed for the purpose.
Chapter I-4
• Provided with potable water.
- Reg. 852/2004,
• Kept clean.
Annex II,
Chapter II-3

18
 Elements to be Checked Objective to the Legislation References

15. Articles, Fittings and Equipment Articles, fittings and equipment - Reg. 852/2004,
in contact with food shall be Annex II,
• Appropriately installed to allow
constructed and maintained in Chapter V 1-3
adequate cleaning of both
good order to avoid any risk of
equipment and surrounding area.
contamination.
• Constructed of materials which do
not pose risk of contamination
of products.
• Constructed of suitable materials
and maintained to enable easy
cleaning.
• Effectively cleaned and disinfected
at sufficient frequency to avoid risk
of contamination.
• Additives for corrosion protection
used in accordance with good
practices.
• Equipment shall be fitted with
appropriate control devices (e.g.
thermometers).

C. Implementation of Pre-Requisite Programmes

Elements to be Checked Objective to the Legislation References

16. Raw Materials, Ingredients, Control at receiving and good - Reg. 852/2004,
Packaging and Other Input handling practices at storage Annex II,
Materials and at all processing steps Chap. IX, 1-8
shall ensure that the final - Reg. 852/2004,
• Are controlled at receiving.
products are fit for human Annex I,
• Are rejected if known or
consumption and are not Part A III-7, 8
reasonably expected to be
injurious to human health. - HACCP Guidance
contaminated with food safety
document
hazards which cannot be
Annex II
eliminated through normal sorting,
Chapter 5
preparation or processing.
• Are stored to prevent deterioration.
• Are stored to protect from
contamination.
• Ensure that EU compliant raw
materials are stored in the
designated area in the cold
room separated from non
compliant raw materials.
• Quality and safety criteria
defined and adequate to ensure
food is safe and fit for
consumption.
• Traceability criteria adequately
defined.
• Monitoring, corrective actions
and internal verification
adequately planned according
to defined criteria.

19
 Elements to be Checked Objective to the Legislation References

• Monitoring, corrective actions

and internal verification
implemented as planned.
• Monitoring and internal
verification effective to control
food hazards and to ensure
food is fit for consumption.
• Documents on raw material
supply system adequate and
updated (e.g. Supplier approval
program, system of traceability).

17. Wrapping and Packaging Wrapping and packaging - Reg. 852/2004,

Material materials shall not present any Annex II,
risk of contamination of the Chapter X 1-4
• Materials are not a source of
food. - Refer also to item
contamination.
35 below
• Materials are stored so they are
not exposed to contaminants
(e.g. shrink wrapped).
• Wrapping and packaging
operations designed to avoid
contamination of products.
• Integrity of container's construction
and cleanliness ensured where
relevant (e.g. sterilized cans and
glass jars products).
• Reused packaging materials are
easy to clean and disinfect.

18. Water To ensure that only potable or - Reg. 852/2004,

clean water is used in contact Annex II,
• Adequate supply of potable water
with fishery products. Chapter VII 16
in all areas where necessary.
- EC Directive
• Supply of clean seawater
98/83 Annex II
adequate in all areas where
Table A and B
allowed (if applicable only).
(Note: clean water
• Non-potable water circulated in
ice can only be
separate pipe system, designed
used for chilling
to prevent backflow to potable
whole fishery
water system.
products)
• Pipe system for non-potable
water is clearly identified.
• Recycled water is of adequate
quality for the purpose used
(if applicable only).

19. Ice
• Ice in contact with fishery
products made from potable
water or clean water.
• Protected from contamination
during production, transportation,
handling and storage.

20
 Elements to be Checked Objective to the Legislation References

20. Steam
• Steam used in contact with food
is clean and does not present
any hazards to fishery product.
• Quality criteria adequately defined.
• Process criteria adequately defined
(chlorine, UV treatment etc.).
• Monitoring, corrective actions and
internal verification are adequately
planned against defined criteria.
• Monitoring, corrective actions and
internal verification implemented
as planned.
• Documents on water supply
system adequate and updated
(map of supply system, monitoring
plan, results of analysis).

21. Food Waste and Other Refuse Food waste and other refuse - Reg. 852/2004,
shall be kept away from Annex II,
• Removed quickly from rooms
products and hygienically Chapter VI 1-4
where food is present (not
handled and stored in order to
allowed to accumulate).
minimize risk of cross
• Dispose in enclosed containers
contamination to products.
or other appropriate waste
disposal systems.
• Waste containers constructed of
materials that allow easy
cleaning and disinfecting.
• Facilities for waste disposal are
appropriately constructed,
maintained and easy to clean.
• Facilities for waste storage and
disposal designed and managed
to allow cleaning and prevent
from entrance of pests.
• Waste disposal is hygienic and
environment friendly.

22. Hazardous or Inedible To control chemical hazards. - Reg. 852/2004,

Substances (Feed, Disinfectants, Annex II,
Cleaning Agents, etc.) Chapter IX , 8
- Refer also to Item
• Adequately labelled.
6 above
• Stored in separate and secure
containers.

23. Pest Control To control (prevent and - Reg. 852/2004,

eliminate) pests from Annex II,
• Procedures for controlling pests
contaminating product. Chapter IX 4
such as insects, mice, rats, and
- Ref. also to
domestic animals, etc. in
Item 1 above
establishment and surroundings
are planned and implemented.
• Effectiveness of pest control
programme is evaluated at
regular intervals.

21
 Elements to be Checked Objective to the Legislation References

24. Personal Hygiene To minimize the risk of - Reg. 852/2004,

transmission of pathogenic Annex II,
• All workers wear suitable
microorganisms, and other Chapter VIII 1
protective clothing.
hazards which may be carried
• Protective clothing are clean and
by workers who handle food.
maintained in a clean condition.
• All workers maintain a high
degree of personal cleanliness.
• Protective clothing are laundered
by the establishment or
contracted laundry (shall not be
brought home by workers).
• Laundry facilities and procedures
for cleaning protective clothing
are adequate.
• Procedures for changing of dirty
protective clothes are adequate
and efficient.
• Facilities and procedures for hand
washing adequately designed,
implemented and monitored.
• Use and control of foot baths
adequately designed,
implemented and monitored.

25. Staff Health To ensure that food handlers - Reg. 852/2004,

are not a source of Annex II,
• Workers who may carry diseases
contamination. Chapter VIII 1
that can potentially be transmitted
through food or have afflictions
such as infected wounds, skin
infections, sores or diarrhoea are
not allowed to handle food.
• Procedures for staff reporting of
diseases and afflictions are
planned, implemented and
effective.
• Procedures for monitoring staff
health are planned, implemented
and effective.
• Health examination is carried
out according to guidelines given
by the Ministry of Health.

26. Sanitation (cleaning and To ensure that processing - Reg. 852/2004

disinfection) facilities and equipment in Annex II
contact with the product is not - Ref. also to Items
• Procedures for cleaning and
a source of contamination. 1 and 15 above
disinfection of processing
facilities and equipment before,
after and during processing are
adequately described and
implemented effectively.
• Procedures for cleaning and
disinfection of staff facilities are
adequately described and
implemented effectively.

22
 Elements to be Checked Objective to the Legislation References

• Sanitation chemicals' technical

specifications are available and
known by responsible staff.
• Criteria for sanitation are
adequately defined.
• Effectiveness of sanitation is
monitored.
• Objective evidence is available
to show that sanitation
procedures are effective.

27. Traceability, Withdrawal and To prevent risk to food safety - Reg. 178/2002,
Recall Procedures and collaborate with Art. 3, 15 and
competent authorities in risk Art. 18
• Procedures for recall adequately
management. - Reg. 178/2002,
described and communicated
Art.19
to recall team.
- Reg. 853/2004
• Identification marks correctly
Art. 5, 6 and
applied on products before
Annex II
leaving the establishment.
- Reg. 852/2004
• Raw materials from aquaculture
Annex I,
are traceable to identify primary
Part A III-7,8
producer unit.
- Reg. 853/2004
• Suppliers of raw materials from
Annex II,
aquaculture comply with
VII Chapter 1
specific criteria to record
- Refer also to Item
keeping and labelling.
16 above and
specific Diagnosis
Grids on Bivalves
and Aquaculture.

D. Specific Process Design Criteria and Control

Elements to be Checked Objective to the Legislation References

28. Procedures designed to protect To minimize the risk of product - Reg. 852/2004,
food at all stages of production, contamination from pathogenic Annex II, Chapter
processing and distribution microorganisms, chemical and IX 3, 5, 6, 7.
physical hazards and to - Ref. also to item
• Food protected against
minimize the risk for growth of 29, 31, 33 below.
contamination that may render
pathogenic microorganisms.
the product unfit for human
consumption.
• Raw materials, intermediary food
materials and finished products
(not frozen) are kept at
temperatures approaching that
of melting ice throughout the cold
chain (except when practicalities
of handling require otherwise).
• Ready to eat products are cooled
down immediately to temperatures
approaching that of melting ice
after final processing stage (e.g.
cooked and smoked products).

23
 Elements to be Checked Objective to the Legislation References

• Thawing processes are designed

to minimize the risk of
pathogenic microorganisms
growth or the formation of toxins.
• Thawed products treated like raw
materials (kept at temperatures
approaching that of melting ice).
• Run off water from thawing is
properly drained to prevent
cross-contamination.
• Containers have drainage holes
to adequately drain runoff water.

29. Fresh Products - Raw Materials To avoid contamination of food - Reg. 853/2004,
Handling and growth of pathogens. Annex III,
Section VIII,
• Stored under ice if not immediately
Chapter III A1,
distributed or processed.
A4, A5
• Melt water can drain away from
- Reg. 853/2004,
the product/container.
Annex III,
• Facilities for storage are appropriate
Section VIII,
to help maintain temperatures
Chapter. VII-1, 3
approaching that of melting ice.
• Raw materials received from
vessels or aquaculture are stored
in cooled water or in ice at arrival.
• Headed and gutted raw
materials are cleaned, especially
in the belly area.
• Heading and gutting (preprocessing)
in the factory carried out under
hygienic conditions.
• Live fish are kept at
temperatures that do not
adversely affect their viability or
food safety.

30. Fresh Products: Filleting and To avoid contamination of food - Reg. 853/2004,
Cutting of Fresh Products and growth of pathogens. Annex III,
Section VIII,
• Carried out hygienically.
Chapter III A2, A3
• Tools used are clean (procedure
described and implemented).
• Products removed from the
worktables without delay.
• Products appropriately chilled
without delay.

24
 Elements to be Checked Objective to the Legislation References

31. Frozen Products To ensure frozen products are - Reg. 853/2004,

• Capacity of freezing equipment is stored at the required
Annex III,
temperature. Section VIII,
sufficient to rapidly achieve core
Chapter III B
temperature of not more than -18ºC.
(ref: section VIII,
• Capacity in cold stores are
Chapter 1 Part1,
sufficient to maintain product
C1, C2)
temperature at least -18ºC.
- Reg. 853/2004,
• Cold store equipped with easy to
Annex III,
read temperature recording device
Section VIII,
which is capable of continuously
Chapter. VII2
monitoring the temperature.
- Refer also to Item
• Sensors for temperature
15.6 above
recording in cold stores are
placed in the area with highest
temperature.
• Fish stored in brine at least -9ºC are
used for canned products only.
• Evidence of temperature control
is available.
• Corrective actions in case of
non compliance with
requirements are adequate.

32. Mechanically Separated Fishery To ensure safety of - Reg. 853/2004,

Products mechanically separated fishery Annex III,
products. Section VIII,
• Raw materials for mechanical
Chapter III C1,
separation include whole fish
C2.
and bones after filleting, and
must exclude all gut material.
• Separation process carried out
immediately after filleting or
cutting (if applicable).
• Further processing takes place
immediately (freezing or
otherwise processed).

33. Cooked Products To ensure safety of cooked - Reg. 853/2004,

products. Annex III,
• Cooled immediately and rapidly
Section VIII,
in potable water or clean
Chapter IV-1,2,3.
seawater after cooking.
• Cooled down to temperatures
approaching that of melting ice
or frozen immediately to at least
-18ºC after cooling.
• Shucking or shelling procedures
are carried out hygienically.

25
 Elements to be Checked Objective to the Legislation References

34. Heat Sterilized Products To ensure safety of heat - Reg. 852/2004,

• Does the process conform to sterilized products. Annex II,
international recognized Chapter XI 13
standard? - Reg. 852/2004
• Does the process ensure that Art. 5
time-temperature parameters - Reg. 852/2004,
are specified and complied with? Annex II,
• Are relevant process parameters Chapter VII, 6
monitored by the use of - Codex Alimentarius:
automatic device? Low and
• Does the process prevent Acidified Low
contamination of the product? Acid Canned
• Sealing operation is appropriately Foods
controlled. CAC/RCP
• Are thermometers and other 23-1979,
measuring devices calibrated? Rev. 2 (1993).
• Are heat distribution tests made?
• Are heat penetration tests made
for each product?
• Are organoleptic examinations
carried out for each product?
• Are adequate placing of cans,
trays and racks monitored?
• Are proper functioning of the
equipment checked during
heating process?
• Are time-temperature parameters
checked in the (autoclave) retort
recorder?
• Are microbiological sampling and
testing carried out for each
finished product?
• Are cans integrity adequately
controlled?
• Is cooling water for heat treated
containers a possible source of
contamination?
35. Wrapping and Packaging To ensure safety of raw - Reg. 853/2004,
(of raw materials) materials. Annex III,
Section VIII,
• Handling containers for fresh fish
Ch. VI-1, 2, 3
and ice are water resistant.
- Refer also to Item
• Handling containers for fresh fish
17 above.
and ice and ensures that melt
water does not remain in contact
with product (efficient drainage).
• Block frozen raw materials are
adequately packed.
• Packaging materials for block
frozen raw materials are not a
source of contamination.

26
 Elements to be Checked Objective to the Legislation References

36. Transport Conditions for Fishery To ensure safety of products - Reg. 853/2004,
Products during transport. Annex III,
Section VIII,
• Transported fresh fishery products,
Ch. VIII-1, 2, 3, 4
thawed unprocessed products
and cooked chilled products are
maintained at temperature
approaching that of melting ice.
• Melt water drains away
efficiently from products.
• Frozen fishery products kept at
temperatures of at least -18ºC
in all parts, with upward
fluctuations limited to a
maximum of 3ºC.
• Live fish kept at temperature
which do not affect adversely
their viability or food safety.
37. Training To ensure workers are - Reg. 852/2004,
knowledgeable on food safety. Annex II,
• All staff trained to properly carry out
Chapter XII 13
their responsibilities and activities.
- Ref. also to Item
• Training complies with national
57 below
laws concerning training of staff
in the food or fishery sectors.

E. Health Standards for Fishery Products

Elements to be Checked Objective to the Legislation References

38. Organoleptic Examination Products placed on the market - Reg. 853/2004,

shall meet minimum freshness Annex III, Section
• Carried against specified
criteria in order to be deemed VIII, Ch. VA
freshness criteria.
fit for human consumption. - Reg. 2406/1996,
Article 3 and
Annex I.
39. Freshness and Histamine To ensure freshness of fishery - Reg. 2073/2005
products. and 852/2004
• Levels of histamine complies with
Art. 4, 3a and 3e
requirements in all products of the
- Reg. 853/2004,
species: Scrombridae, Clupeidae,
Annex III,
Engraulidae, Coryfenidae,
Section VIII,
Pomatomidae, Scrombresosidae.
Ch. V-B
• Sampling plan includes 9 samples
- Reg. 2073/2005,
per lot (if sampling is applied).
Annex I,
• Histamine content does not
Chapter 1, 1.25
exceed 200 ppm in any of 9
- Reg. 853/2004,
samples per lot and is below
Annex III,
100 ppm in at least 7 of the
Section VIII,
same 9 samples and average
Chapter V-C
of 9 samples is below 100 ppm.
- Reg. 2074/2005
• Products are tested for TVB-N or
Annex 2,
TMA-N if organoleptic assessment
Section II,
indicates problems with freshness.
Chapter I and II
• Fishery products with TVB-N > 30
are not placed on the market.

27
 Elements to be Checked Objective to the Legislation References

40. Parasites Fishery products obviously - Reg. 853/2004,

contaminated with parasites Annex III,
• Are fishery products visually
shall not be placed on the Section XIII,
examined for visible parasites?
market. Chapter V-D
• Fishery products with visible
- Reg. 2074/2005,
parasites are not placed on the
Annex 2, Section I,
market.
Chapter I and II

41. Toxic Species Fish species poisonous to - Reg. 853/2004,

humans shall not be placed on Annex III,
• Species of Tetraodontidae,
the market. Section XIII,
Molidae, Diodontidae and
Chapter V-E.
Canthigastridae or other known
Fish species with mildly - Reg. 2074/2005
toxic species are not placed on
adverse effects such as family Annex VII, 2c
the market.
Gempylidae are appropriately
• Species of family Gempylidae
packaged and labelled.
(Ruvetus petriosis and
Lepidocybium flavobrunneum)
are placed on the market only in
wrapped packed form.
• Species of family Gempylidae
(Ruvetus petriosis and
Lepidocybium flavobrunneum)
are appropriately labelled with
scientific name and information
about specific related risks.

42. Microbiological Criteria To ensure microbiological - Reg. 2073/2005

safety of cooked products. and 852/2004
• Shelled and shucked products of
Art. 4, 3a and 3e
cooked crustaceans shall comply
- Reg. 2073/2005,
with microbiological criteria for
Annex I,
salmonella, E. coli and Coagulase
Chapter 2.4.1
positive staphylococci.

F. Assessment of HACCP Plans

Elements to be Checked Objective to the Legislation References

43. Management Commitment and Procedures based on HACCP - Reg. 852/2004,

Preliminary Steps principles shall be documented, Art. 5, Pt. 1, 3, 4
implemented and maintained.
• All pre-requisite programmes
and HACCP Plan documents
are up-to-date and approved by
management.
• Are modifications to
documentation/implementation
communicated to relevant staff
members.
• Membership of HACCP team
and responsibilities is up-to-
date.

28
 Elements to be Checked Objective to the Legislation References

44. HACCP Team HACCP Team Members shall - HACCP

• Made up of multidisciplinary and be trained and have the Guid.Doc.
multidivisional members. required knowledge. Annex 1, Ch. 1.1
• Scope of HACCP Plan is - Reg. 852/2004,
adequately defined. Annex II, Ch.
• All team members have skills XII, 2
and knowledge about hazards,
process, hygiene, product and
raw materials characteristics,
appropriate to the product.
• Team members have received
adequate training in application
of HACCP principles.

45. Product Description Complete product information - HACCP

Includes adequate information on: shall be available. Guid.Doc.
• Description of products; Annex 1
• Characteristics of raw materials Chapter 1.2
and end products;
• Composition (raw materials,
ingredients, additives etc.);
• Processing technologies used;
• Packaging method and materials;
• Storage and distribution conditions;
• Shelf life of products;
• Instructions for use: Applicable
microbiological and chemical
criteria.
• Are product descriptions up-to-
date, accurate and in compliance
with requirements.

46. Identification of Intended Use - HACCP

• Normal or expected use by Guid.Doc.
intended customers or consumer Annex 1
target groups are defined. Chapter 1.3
• Suitability for particular vulnerable
groups/consumers has been
considered.

47. Flow Diagram Procedures based on HACCP - Reg. 852/2004,

• Cover all steps in the process principles shall be documented, Art. 5, Pt. 1, 2
operation including delays implemented and maintained to - HACCP
during or between steps. ensure safety of food placed on Guid.Doc.
• Consider raw materials prior to the market Annex 1
receiving and product following Chapter 1.4
processing at the plant
(if company is in charge).
• Flow diagram is backed up by
adequate technical data on
planning and conducting the
operations (eg. in Lay Outs/
Blue prints, GMP and SSOP
documents).
• Flow diagram is up-to-date,
accurate and in compliance
with requirements.

29
 Elements to be Checked Objective to the Legislation References

48. Confirmation of Flow Diagram Procedures based on HACCP - Reg. 852/2004,

principles shall be documented, Art. 5, Pt. 1, 2
• HACCP team has conducted
implemented and maintained to - HACCP
onsite confirmation that each
ensure safety of food placed on Guid.Doc.
processing step in the plant is
the market. Annex 1
accurately included in the flow
Chapter 1.5
diagram.

49. Hazard Analysis Procedures based on HACCP - Reg. 852/2004,

principles shall be documented, Art. 5, Pt. 1, 2
• Conducted for each step in the
implemented and maintained to - HACCP
verified flow diagram.
ensure safety of food placed on Guid.Doc.
• Hazards were identified.
the market. Annex I
• Likely occurrence of hazards
Chapter 1.6
considered.
• Severity and likelihood is
considered.
• Significance evaluated.
• Effective control measures for each
significant hazards were identified.

50. CCP Determination Procedures based on HACCP - Reg. 852/2004

principles shall be documented, Art. 5
• Based on the Decision Tree or
implemented and maintained to - HACCP
a similar systematic approach.
ensure safety of food placed on Guid.Doc.
• Assessment conducted for each
the market. Annex I Chapter 2
step where a significant hazard
was identified.
• CCPs were appropriate and
correctly identified.

51. Critical Limits (CL) Procedures based on HACCP - Reg. 852/2004,

principles shall be documented, Art. 5, Pt. 1, 2
• Established for each identified CCP.
implemented and maintained to - HACCP
• Parameters and criteria scientifically
ensure safety of food placed on Guid.Doc.
validated (i.e. research, literature,
the market. Annex I Chapter 3
monitoring data etc. justify that
effective control is achieved).
• Applicable for real-time
observable or measurable
parameters by an operator.
• Correspond to extreme values
acceptable to product safety
that separate acceptability from
unacceptability.
• Target levels (i.e. more narrow
operational limits) were identified
where relevant.

30
 Elements to be Checked Objective to the Legislation References

52. Monitoring Procedures Procedures based on HACCP - Reg. 852/2004,

principles shall be documented, Art. 5, Pt. 1, 2
Requirements:
implemented and maintained to - HACCP
• Procedure established for each
ensure safety of food placed on Guid.Doc.
CCP/CL.
the market. Annex I Chapter 4
• Procedures are accurate,
implemented and able to detect
loss of control for timely corrective
action to be taken without delay.
• Location for monitoring is
appropriate.
• Frequencies, schedule, sampling
plan are adequate.
• Responsible operator is
appropriately trained and
competent.
• Monitoring records are available
for each CCP.
• Monitoring records are signed by
operator and verified by identified
official(s) of the establishment.
Implementation:
• Monitoring at each CCP are
carried out as planned.
• Corrective actions in case of
deviations from specified limits
are carried out as planned
without delay.
• Corrective actions in case of
deviations from specified limits are
effective to control food safety.

53. Corrective Actions (CA) Procedures based on HACCP - Reg. 852/2004,

principles shall be documented, Art. 5, Pt. 1, 2
Requirements:
implemented and maintained to - HACCP
• Established and defined
ensure safety of food placed on Guid.Doc.
specifically for each CCP/CL.
the market. Annex I Chapter 5
• Responsible operator is identified.
• Responsible operator is
appropriately trained and
competent.
• Isolation and treatment of
nonconforming product
specifically defined.
• Written records of CA measures
available.
Implementation:
• Corrective actions are
implemented as planned.
• Corrective actions are adequate
to control food safety.

31
 Elements to be Checked Objective to the Legislation References

54. Verification Procedures Procedures based on HACCP - Reg. 852/2004

principles shall be documented, Art. 5
Requirements: CCP verification
implemented and maintained to - HACCP
• Adequate methods and procedures
ensure safety of food placed on Guid.Doc.
are described and implemented for
the market. Annex I Chapter 6
each CCP/CL, e.g.
- record reviews (records for
monitoring, corrective action,
calibration, sampling and
analysis, etc.)
- operators who monitor CCPs
are supervised
- calibration of instruments
- sampling and analysis
• Responsible operator is
identified for each specific
verification activity who is
appropriately trained and
competent.
• Results of verification activities
are verified.
• Corrective actions in case of
noncompliance is identified for
each verification activity.
Requirements: System verification
• System audits are planned and
implemented at appropriate
intervals.
• System audits includes pre-
requisite programmes and
HACCP plan.
• Scope of system audits relates to
assessment of the effectiveness
of applied parameters, criteria,
procedures and method to
control food safety.
• Review of the whole system or
relevant parts are carried out at
appropriate intervals or when
there are changes in product,
process conditions, packaging
or intended consumers takes
place or when new information
about hazards is available.
• Responsible operators for
planning and conducting system
audits are appropriately trained
and competent.
Requirements: Validation
• Validation activities planned at
appropriate intervals to assess
the effectiveness of all elements
of the HACCP plan.
• Validation activities include at
least confirmation of established
critical limits and other scientific
and technical parameters as
appropriate to ensure food safety.

32
 Elements to be Checked Objective to the Legislation References

• Validation activities reviewed when

changes occurred (e.g. to raw
materials, processing equipment,
new information on hazards, etc).
• Responsible operator for planning
and conducting validation activities
are appropriately trained and
competent.
Implementation of Verification:
• Carried out as planned, including:
- Validation of critical limits (and
other scientific and technical
parameters as appropriate to
ensure food safety)
- Calibrations of measuring
equipments
- Product sampling and testing
- Records review
- Internal audits
- Reviews when there are relevant
changes
- System reviews (in addition to
internal audits) conducted at
appropriate intervals
• Corrective actions in case of
deviation from requirements are
effectively to control food safety.

55. Training To ensure that staff shall be - Reg. 852/2004

trained in HACCP according to Art. 5
• HACCP team members trained
their responsibilities and - Reg. 852/2004,
specifically in the application of
activities. Annex II,
HACCP principles.
Chapter XII 13
• Training needs identified for
- HACCP
operators monitoring CCPs.
Guid.Doc.
• Training conducted as planned
Annex I Chapter 8
and documented.

33
 Enquiry Points

For more information on Processing Establishments:

1. Export Section
Food Safety and Quality Division
Ministry of Health Malaysia
Level 3, Block E7, Complex E
Federal Government Administration Centre
62590, Putrajaya
Tel No : 03 8883 3505/3511
Fax No : 03 8889 3815/8889 3341
Email : weebeewah@moh.gov.my
thayalan@moh.gov.my
Website : http://fsq.moh.gov.my

For more information on Fishing Vessels and Aquaculture Farms:

2. Fisheries Biosecurity Division

Department of Fisheries
Ministry of Agricultural and Agro-Based Industry
Wisma Tani, Level 1-7, Tower 4G2, Presint 4
Federal Government Administration Centre
62628, Putrajaya
Tel No : 03 8870 4705/4707/4671/4723
Fax No : 03 8890 3794
Email : ziziawaameen@yahoo.com
piyan@dof.gov.my
ghazalimanap@dof.gov.my
nazriishak@dof.gov.my
Website : http://mutiara.dof.gov.my

For more information on Landing Sites:

3. Fish Landing Control and Monitoring Division

Fisheries Development Authority of Malaysia (LKIM)
Level 4, Olympia Tower
Jalan Raja Chulan, P.O. Box 12630
50200, Kuala Lumpur
Tel No : 03 2617 7000/2617 7156/2617 7286
Fax No : 03-2070 9323
Email : lin@lkim.gov.my
rahayu@lkim.gov.my
Website : www.lkim.gov.my

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