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1 February 2015

Technical regulations for export and Import of fishery products

Final Version 1.0

Executive Summary

TECHNICAL REGULATIONS FOR EXPORT AND IMPORT OF FISHERY PRODUCTS

Food and Agriculture Organization of the United NationsTCP/MYA/3401 (D)

February 2015

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Technical Regulations for export and import of fishery products have been prepared for the Republic of the Union of Myanmar with the technical and financial support of Food and Agricultural Organization (FAO) under the project TCP/MYA/3401- “Capacity Building to Improve Market Access for Fish and Fishery Products”. The major objective of this Technical Regulation is to improve the accessibility for Fish and Fishery Products of the Republic of the Union of Myanmar in the international market by establishing suitable food control systems throughout the food chain, starting from the primary production areas.

The legal basis of this technical regulation is the ‘Myanmar Marine Fisheries Law’ dated 25 th

April 1990, which empowers the Department of Fisheries (DoF) of the Republic of the Union of Myanmar to lay down orders, standards, regulations etc relating to fishery sector and to take suitable actions as and when required.

Even though this Technical Regulation has been formulated mainly based on the requirements of European Union, requirements of other major importing countries have also been taken into account while drafting the document. Moreover a ‘holistic food chain approach’ has been taken while preparing the document to ensure that all stake holders of the food chain are brought under the control system to ensure food safety.

Salient Features of the regulation:

There are two sections for the document, namely the export requirement and import requirements. The export requirements have been specified in three Chapters; Chapter 1 covers primary production, Chapter 2 specifies activities other than primary production and Chapter 3 covers the Official control activities. Import requirements have been specified in Chapter 4.

a) Chapter 1:- Control on the primary production and allied areas have been highlighted in this Chapter, including the specific requirements of hatcheries, farms, feed mills, vessels, landing sites and auction halls, etc, based on the requirement of Regulation (EC) No. 852/2004 dated 29.04.2004. Some of the requirements of Directive No.2006/88/EC, Directive No.2008/53/EC,OIE’s ‘Aquatic Animal Health Code’ and European Feed Manufacture’s Guide 2009 were also considered while framing the standard.

b) Chapter 2 & Chapter 3: In Chapter 2, the responsibilities of business operators and in Chapter 3, responsibilities of Competent Authority have been specified mainly as per the requirements of Regulation (EC) No. 853/2004 and 854/2004 dated 29.04.2004. However the requirements specified in ‘ASEAN Common Principles and Requirements’, ‘National Standard of China’ (GB/T 23871-2009), AVA’s ‘Sale of Food Act’ of July 2002, Technical Regulation of Customs Union (TR CU 021/2011) , Federal Food, Drug and Cosmetic Act (the Act) of 1938, as amended (21 USC.301-392), Fish & Fisheries Products Hazards and Control Guidance amongst others were also considered while framing the rules.

Further, in order to streamline the export of aquaculture products, minimum requirements have been specified in clause 1.4.3 of Chapter-2, mainly as per the requirements of Council Directives 96/23/EC, 2006/88/EC and 2008/53/EC. The export of live fishes has been specified in clause.1.6 of Chapter 2, taking into account of the requirements of Council Directives 2006/88/EC and 2008/53/EC, FAO’s “Asia Regional Technical Guidelines on Health Management for the Responsible Movement of Live Aquatic Animals” and others.

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The parameters for testing of water and ice for EU and non-EU countries have been specified separately in clause 1.5.3. Even though, it is mandatory that water andice of EU approved units are tested as per EC Directive 98/83/EC, different Non-EU countries have different standards for potable water. Therefore, for Non-EU countries, the requirement of ASEAN has been proposed.

The labelling requirements specified in clause1.5.11 are mainly based on Commission Directive No 2000/13, Directive No. 2000/104, ASEAN requirements for labelling and USFDA requirements.

Although (EC) Regulation No. 852/2004 does not specify the approval of primary production areas, in this Technical Regulation covers primary production and allied areas involved in the export of fishery products and specifies that these shall be approved and monitored by Fish Inspection and Quality Control Division (FIQCD), the National Competent Authority (NCA). Approval of establishments processing fishery products meant for export shall be approved by NCA in two stages as specified in 854/2004. In the first stage, conditional approval is given to the establishment based on the satisfactory assessment of infrastructural facilities and full approval is given only after the successful completion of HACCP audit. Exports are permitted only after full approval.

During surveillance visits to the approved facilities, the NCA will draw samples for testing. The method of sampling, frequency, size etc has been specified in Annexure-7 of the document. Further, the chemical and biological requirements of major importing countries have been given at Annexure 6 of the document.

Procedure for issuance for health certificate for export to Non-EU countries has been introduced as per the requirements of the importing countries. In case the importing country does not specify the health certificate format, the generic health certificate format given at Annexure 5 can be used.

Chapter 4: In this Chapter, import procedures have been highlighted which are similar to the import procedures of other ASEAN countries. Department of Fisheries is responsible for the import of fishery products into the Union of Myanmar. An importer intending to import fishery products to Myanmar from a third country needs to obtain a valid license from the Department of Fisheries (DOF).

A licensed importer can import fishery products processed by approved overseas processor having DOF registration. Only those overseas establishments, factory vessels or freezer vessels, which are approved and monitored by the Competent Authority of that country, are eligible for getting registration from DOF

In the case of import of live aquatic animals, the requirements specified in FAO’s “Asia Regional Technical Guidelines on Health Management for the Responsible Movement of Live Aquatic Animals” have also been considered. In this case the importer needs to submit a Health Certificate issued by the overseas Competent Authority as per the format given at Annexure 4, along with other specified documents. All the consignments of live aquatic animals will be subject to quarantine measures, where the animals are kept in isolation for physical and clinical examination by ICS officials. Only healthy and disease-free animals without injury or damage are allowed for importation.

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The standard specification of fishery products meant for import has not been specified separately in the draft regulation, since Directive 3/2009, the legal document, already specifies national standards.

Model Health certificates for import of fishery products for human consumption and import of live fishes have been proposed at Annexure 3 and 4.

Conclusion

Efforts have been made to make the regulation as comprehensive as possible by giving cross references to the existing national regulations, wherever applicable. This document will be highly useful for the Competent Authority to establish food safety controls across the food chain. It will also be beneficial to all the stake holders to understand the legal requirements and also to meet international requirements.

FOREWORDTechnical Regulations play a pivotal role in international trade in establishing food safety and also in demonstrating equivalency. As envisaged in the SPS agreement, member countries can

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establish their own standards and technical regulations for protecting the health and safety of their populations. However, these need to be within the framework of the Sanitary and Phytosanitary measures Agreement. An important aspect of this Agreement is harmonization with international standards/guidelines which also plays a critical role towards establishing equivalency. Accordingly, the document of Technical Regulations for export and import of Fishery products has been prepared for the Republic of the Union of Myanmar based on international requirements under the project TCP/MYA/3401- “Capacity Building to Improve Market Access for Fish and Fishery Products”.

Even though, the Department of Fisheries (DoF) have laid down procedures to establish proper control measures for the export of fishery products from the Union of Myanmar, a well defined Technical Regulation specifying the export and import requirements of fishery products was lacking. Therefore, Food and Agricultural Organisation (FAO) has extended support for the preparation of the Technical Regulation, which will be highly beneficial for not only to the Competent Authority but also to all the stakeholders handling fishery products meant for export and import. This manual will be of great use as a reference document to exporters of seafood industry and also to the importers. Based on these Technical Regulations, the Competent Authority can establish and implement regulatory food control systems. Furthermore, these Technical Regulations will automatically help Myanmar to have better accessibility for their fishery products in the international market. The new import policies specified in the Technical Regulation for live fishes will also help in preventing the introduction of exotic diseases in Myanmar waters.

These Technical Regulations have been prepared mainly based on the requirements of European Union, since the Republic of Union of Myanmar has already adopted all EU Regulations in their DoF Directive No 3/2009 dated 03.04.2009. However, requirements of other major importing countries including China, USA, Japan, ASEAN etc have also been taken into consideration while preparing the manual.

This manual address the requirements of all stake holders of the food chain of fishery sector starting from primary production, processing, storage and distribution, etc in separate Chapters. The responsibilities of the Competent Authority have also been addressed in a separate Chapter.

I hope that the Technical Regulations for export and import of Fishery products will be a useful document for the Republic of the Union of Myanmar towards implementing controls over export and import of fishery products thus leading to safe and quality products for both domestic and overseas consumers.

Bui Thi Lan FAO Representative in Myanmar

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Contents

Preface 8Objectives 9Terms & Definitions 9Abbreviations 12Chapter-I. Controls on Primary Production 15

1.1 General Requirements......................................................................................151.2 Specific Requirements..........................................................................................16

1.2.1. Hatchery............................................................................................................................16

1.2.2. Aquaculture Farms............................................................................................................17

1.2.3. Feeding Mills.....................................................................................................................18

1.2.4. Fishing Vessels...................................................................................................................20

1.2.5. Landing Sites/ Fishing Harbor............................................................................................21

1.2.6. Auction Hall.......................................................................................................................22

Chapter-II. Processing & Allied Activities 242. Responsibility of business operators....................................................................24

2.1. General................................................................................................................................24

2.2. Infrastructural Facilities......................................................................................................25

2.3. HACCP Based Control System........................................................................................29

2.4. Product Control...................................................................................................................30

2.5. Process Control..................................................................................................................33

2.5.1. Hygiene and sanitation......................................................................................................33

2.6. Special Requirements For Export Of Live Fish..............................................................38

2.7. Management Commitment................................................................................................38

2.8. Management Responsibility..............................................................................................39

Chapter-III. Official Control Activities 403.1 Approval...............................................................................................................................41

3.2. Surveillance Visits..............................................................................................................44

3.3. HACCP Audits.....................................................................................................................47

3.4. National Residue Monitoring Plan (NRMP).....................................................................47

3.5. Action In Case of Non- Compliance.................................................................................48

3.6. Procedure To Deal With Foreign Rejections..................................................................49

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3.7 Export Certification.............................................................................................................50

3.8. Training................................................................................................................................52

3.9. Transparency......................................................................................................................52

Chapter-IV. Import of Fish & Fishery Products 544.1. General Requirements......................................................................................544.2. Registration of Overseas Processors.................................................................544.3. Import Procedures.............................................................................................554.4. Additional requirements for import of fishery products meant for export purpose.......................................................................................................................564.5. Additional requirements for import of aquaculture products............................564.6. Additional requirements for import of live fishes..............................................56

Annexure-I 58Annexure-2 59Annexure-3 60Annexure-4 61Annexure-5 62Annexure-6 63Annexure- 7 74Annexure- 8 78Annexure- 9 87Annexure- 10 98Annexure- 11 107Annexure- 12 111Annexure- 13 116Annexure- 14 133Annexure- 15 139

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PrefaceGlobalization has, in fact, helped the consumers to have access to a vast variety of food products all over the world. This in turn has made them more conscious for demanding food products with better quality and safety. In order to cope up with the ever-increasing consumer demands and also to compete with the ever-changing international market requirements, countries are forced to develop suitable national regulations so as to ensure the quality and safety of food products as per the international requirements. Even though, such stringent national food safety regulations may be essential to protect the health and interest of the consumers of their country, it may naturally create trade barriers. In order to reduce trade barriers and to increase the international trade, SPS agreement has brought out the policy of ‘Equivalence’, which specifies that member countries shall recognize other countries SPS measures and regulations as equivalent to their own, if it is demonstrated that these measures can achieve the appropriate level of sanitary and phytosanitary protection. For this purpose, countries can harmonize their sanitary or phytosanitary measures as per the international standards/ guidelines or can develop their own SPS measures based on risk analysis. The principles of achieving harmonization of standards and equivalency in food control systems and the use of scientifically-based standards are the most important guidelines of WTO agreements. National food safety standards of any country, developed based on the international Codex standards, guidelines or recommendations, are deemed to be appropriate and not discriminatory.

The most important aspect in establishing the safety of fishery products is the holistic food chain approach, where the primary responsibility of maintaining the quality and safety of the fish is bestowed on the stakeholders such as producers, processors, transport/storage operators and distributers. However, the implementation of the ‘food chain approach’ requires well developed regulatory standards and a properly defined regulatory control system, without which the ‘farm to fork’ concept cannot be achieved.

In view of the above, the technical regulations of Myanmar have been developed based on the national and international requirements for the smooth trade of Fish and Fishery Products. This document is addressed to the entire stakeholders of the food chain starting from primary producers to the processors and distributors (including feed manufacturers, hatcheries, farms, fishing vessels, auction centres, ice manufacturers, cold storage and processors) as well as the Competent Authority by providing norms and instructions necessary for the export and import of fishery products based on the requirements of Union of Myanmar. These regulations covers all the major SPS requirements for hygienic handling of fish and fishery products meant for import and export purpose. Even though, these regulations are prepared based mainly on the requirements of European Union (EU), the requirements of other major importing countries like USA, China, Japan, Russia etc are also taken into account. Since Myanmar is a member country of ASEAN, the requirements of ASEAN Economic Community are well taken into consideration.

The legal basis of this technical regulation is the ‘Myanma Marine Fisheries Law’ dated 25 th

April 1990. In exercise of the powers conferred by Section 23 of ‘Myanma Marine Fisheries Law 1990’, the Director General of the Department of Fisheries is empowered to issue conditions, prohibitions, orders, and directives relating to fishery.

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As per Section 19 of the said law, the Department of Fisheries (DoF) is also empowered to grand approval/ registration to fish handling establishments, fishing vessels etc of Myanmar and as per Section 24, the Director General of the Department of Fisheries can suspend, revoke, terminate or cancel any license/ approval or to take any action as deemed fit.

Envisaging greater opportunities for the fish trade of Union of Myanmar in the international market, Food and Agricultural Organization of the United Nations has sponsored this project of developing the technical regulations based on the SPS requirements for the export and import of fishery products.

ObjectivesThe major objective of these technical regulations is to achieve smooth flow and development of trade of fish and fishery products of Union of Myanmar by;

1. Establishing proper control systems throughout the food chain, starting from the primary production areas such as hatcheries, farms, feed mills, fishing vessels, landing sites, auction halls etc.

2. Achieving the desired quality and safety of fish and fishery products at all stages of production, storage and distribution with an integrated farm-to-table concept thereby ensuring high level protection of consumer health

3. Entrusting responsibilities on producers, business operators and also on competent authority.

4. Establishing HACCP based control system by the industry as a tool to achieve food safety.

5. Enforcing legal and regulatory requirements by the competent authority through regular monitoring/surveillance visits

6. Carrying out risk analysis before laying down standards/control measures for controlling food safety hazards

7. Establishing transparency through public consultation and public information.

Terms & Definitions1. Additives : ‘Food additive’ shall mean any substance not normally consumed as a food

in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods;

2. Aquaculture : means the rearing or cultivation of aquatic organisms using techniques designed to increase the production of those organisms beyond the natural capacity of the environment and where the organisms remain the property of one or more natural or legal persons throughout the rearing or culture stages, up to and including harvesting

3. Business Operator: means the natural or legal person responsible for implementing the requirements specified by the Competent Authority within the food business under his control.

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4. Carry-over: means the level of transfer of any substance or product from one production batch to the immediate subsequent batch in a particular section of the plant.

5. Catch Certificate: means the certificate validated by a public authority of the flag state of the fishing vessel(s) to certify that the catches mentioned in the certificate have been made in accordance with applicable law, regulations and international conservation and management measures.

6. Control Measure: means any action or activity that can be used to prevent, eliminate or reduce a significant food safety hazard.

7. Critical Control Points (CCPs): means a step at which control can be applied and is essential to prevent or eliminate a food-safety hazard or to reduce it to acceptable level.

8. Exotic diseases: means diseases of aquatic animals which are not known in the country/zone and the pathogen is not reported in the country waters.

9. Factory vessel : means any vessel on board of which fishery products undergo processing such as filleting, slicing, skinning, shelling, shucking or mincing etc followed by packing/wrapping and chilling or freezing

10. Feed additives: means substances, microorganisms or preparations, other than feed materials and pre-mixtures, which are intentionally added to the feed or water in order to fulfil a specific need.

11. Freezer vessel : means any vessel on board of which freezing of fishery products is carried out, where appropriate, after processing and packing

12. Hazard: means a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

13. Hazard Analysis Critical Control Point (HACCP): is a food safety system wherein a systematic approach has been developed for the identification, evaluation and control of food safety hazards.

14. Hatchery: means a place where spawning and larval rearing of aquatic animals takes place generally for commercial purpose.

15. Illegal treatment: shall mean the use of unauthorized substances/ products or the use of authorized substances/products above the permissible limit.

16. Independent cold store : means a cold store constructed separately to store fishery products meant for export produced by approved establishments, factory vessels or freezer vessels

17. Independent ice plant: means an ice producing plant constructed separately to supply ice to establishments, factory vessels, freezer vessels, fishing vessels, landing sites and/or auction hall approved by competent authority.

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18. Ingredients: means a component part or a constituent of any combination or mixture, of a (commercial) feed/food.

19. Labelling : shall mean any words, particulars, trademarks, brand name, or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff

20. Medicated feeding stuffs : means any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product

21. National Competent Authority: means the government authority to ensure compliance with the requirements of this guidelines or any other authority to which the government authority has delegated that power.

22. Organoleptic evaluation : means the sensory evaluation to assess the quality parameters of fishery products such as their appearance, colour, smell, texture, weight, size etc

23. Pharmacologically active substances: means any chemical or substance that affects the physiology, the function of the body of a human or animal. These substances can be artificial or natural, i.e. those created by the body in response to stimulation or injury

24. Processing: means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes.

25. Pre-mixtures: means mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended to direct feeding to animals.

26. Prerequisite programs: - means procedures including Good Manufacturing Practices (GMPs) that address operational conditions providing the foundation for the HACCP system

27. Risk analysis : means a process consisting of three inter connected components: risk assessment, risk management and risk communication

28. Standard Operating Procedure (SOP): means procedures that describe as to how routine operations such as receiving, storing, processing, labelling, shipping etc are to be conducted in such a way to ensure the safety and wholesomeness of the product and food contact surfaces.

29. Sanitation Standard Operating Procedure (SSOP): means a set of procedures to establish a total sanitary environment in fish handling and processing areas, in order to control food safety hazards effectively.

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30. Traceability : means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution.

31. Validation: means the element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.

32.Withdrawal period : means period necessary between the last administration of the veterinary medicinal drugs to animals under normal conditions of use and the harvesting, in order to ensure that such foodstuffs do not contain residues in quantities in excess of the maximum permissible limits as specified in DOF Directive No 3/2009 dated03.04.2009

Abbreviations1. ALS: Analytical Laboratory Section

2. ASEAN : Association of Southeast Asian Nations

3. CAR : Corrective Action Request

4. DOF: Department of Fisheries

5. DG SANCO: acronym of ‘Directorate General for Health and Consumer Protection’

6. EC: European Commission

7. FAO: Food and Agricultural Organisation

8. FIQCD: Fish Inspection and Quality Control Division

9. FSVPS: Federal Service for Veterinary and Phytosanitary Surveillance

10.GMP: Good Manufacturing Practices

11.HACCP: Hazard Analysis and Critical Control Points

12. ICS: Inspection and Certification Section

13. NCA: National Competent Authority

14. NRMP: National Residue Monitoring Plan

15. OIE: Office of International Epizooties

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16. RMC: Residue Monitoring Committee

17. WHO: World Health organisation

18. WTO: World Trade Organisation

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EXPORT REQUIREMENTS

CHAPTER 1

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Chapter-I. Controls on Primary Production1.1General Requirements1.1.1. In order to ensure the quality and safety of fish and fishery products meant for export,

it is essential that controls shall be established from primary production and allied areas. The primary production and allied areas include fishing vessels, landing sites, auction halls, transporting vehicles, hatcheries, aquaculture farms, feed mills etc meant for the production/ handling of fishery products/feed involved for export purpose.

1.1.2. The primary production and allied areas operating in the food chain meant for export purpose shall be approved and monitored by the Fish Inspection and Quality Control Division (FIQCD) of the Department of Fisheries (DOF), Ministry of Livestock, Fisheries and Rural Development, the designated National Competent Authority (NCA) of Union of Myanmar. For this purpose all the primary production and allied areas shall maintain minimum required infrastructural/hygienic facilities as specified in this chapter.

1.1.3. Even though, the primary responsibility to ensure the quality and safety of fishery products lies with the business operator, the competent authority shall exercise official control activities to ascertain proper compliance of the regulatory requirements. Under Section 27 of the ‘Myanma Marine Fisheries Law’ dated 25 th April 1990, the Director General may delegate his powers to any officer of the Department or any Officer-in-charge of the Department. The inspector of the Department of Fisheries is empowered to inspect any licensed premises and take action and shall also carry out all activities as specified by the Director General from time to time as per Section 30 of the ‘Myanma Marine Fisheries Law’ dated 25th April 1990.

1.1.4. Approval and monitoring of primary producing and allied areas are done by the Fish Inspection and Quality Control Division (FIQCD) to ensure the safety and quality of fishery products. Business operators shall offer full co-operations and necessary assistance to the Competent Authority for carrying out the official control activities

1.1.5. Business operators shall maintain high level hygiene standards at all stages of production, harvest, storage and transportation so as to ensure the safety and quality of raw fishery products/ feed by avoiding contaminations from possible sources.

1.1.6. It is the primary responsibility of the producer to ensure that only approved chemicals and veterinary drugs are used at the allowable dosage during production ( Ref: DOF Directive No 3/2009 dated 03.04.2009).They shall test the fishery products and fish feed regularly to ensure that they are free from harmful chemicals and biological contaminants.



1.1.7. Business operator of the primary production area shall impart regular training to their employees for maintaining hygiene and sanitation

1.1.8. Producers and allied operators shall maintain records of production, harvest/landing, cleaning and sanitation, personal hygiene, chemicals used, treatment of diseases, traceability etc for verification by the competent authority during surveillance visits.

1.1.9. The procedure for approval and monitoring of the primary production and allied areas has been specified in the “Official Control System Manual for Inspection and Certification of Fish and Fishery Products” issued by FIQCD, Department of Fisheries (DOF).

1.2 Specific Requirements

1.2.1. Hatchery

1.2.1.1 Hatcheries shall be located in an area having good climatic condition and availability of clear, good quality sea water or fresh water throughout the year. Availability of fresh water, uninterrupted power supply, healthy spawners etc shall also be considered, while selecting the site for hatchery.

1.2.1.2 Basic components like, maturation tanks, spawning tanks, larval rearing tanks, live food culture tanks, water storage and filtration tank etc as applicable shall be provided in the hatchery. The tanks shall be of suitable size, shape, depth, and made up of materials which will not cause harm or injury to the animal reared. Newly constructed tanks shall be used only after conditioning and disinfecting it with suitable methods depending upon the material of the tank so that pH of water in the tank is stabilized before stocking. The tanks which are in operation must be cleaned regularly with clean fresh water, dried in sun and disinfected, preferably with 12% sodium hypochloride solution at 200 ppm level for 24 hrs.

1.2.1.3 Maximum care shall be taken while rearing the larvae at different stages of development. Optimum temperature, salinity, pH, dissolved oxygen etc shall be maintained as per the requirement of concerned species and stage of development. Density of stocking of larvae in each tank shall be pre-determined to avoid overcrowding. Biological filters may be used, wherever applicable. Aeration is essential during the entire larval raring stages to maintain sufficient dissolved oxygen and for uniform water temperature.

1.2.1.4 Water management system shall be adequate to control contamination. Continuous monitoring of physico-chemical parameters such as salinity, pH, nitrogenous compound concentration, temperature, dissolved oxygen level etc at regular intervals shall be ensured for optimal environmental conditions in the hatchery so as to achieve maximum growth and survival.

1.2.1.5 As far as possible, water temperature, salinity and pH shall be checked twice daily. The movements, eating habits and other health aspects of the larvae at different stages shall be closely monitored. Moreover, the number of larvae at each stage shall be calculated and recorded. All records of monitoring shall be maintained.



1.2.1.6 It shall be ensured that banned chemicals or pharmacologically active substances shall not be used at any stage during hatchery operation. Instructions contained in the EC Directive No 96/23/EC as highlighted in DOF Directive No 3/2009 dated 03.04.2009 shall be strictly followed. Only permissible chemicals shall be stored and used in hatcheries. An input and output register shall be maintained.

1.2.1.7 Care shall be taken while feeding the larvae with live or organic feeds to ensure optimum availability of the feed. Feed shall be checked for its quality and for contaminants at regular interval.

1.2.1.8 Good hygienic practices shall be followed at all stages of hatchery operation to avoid microbial contamination. Records of cleaning and sanitation shall be maintained. Proper training shall be imparted to the employees for cleaning and sanitation, hygienic handling, and also for good hatchery practices.

1.2.1.9 Suitable pest control measures shall be adopted as specified at Chapter -2, clause. no 2.5.4. Moreover, personal hygiene practices similar to those specified at Chapter -2, clause no. 2.5.2, as applicable, to be followed strictly to avoid cross contamination.

1.2.1.10 Hatchery operators shall have a documented procedure for cleaning and sanitation and maintain records such as input & output records including the movements of aquaculture animals, monitoring records, cleaning and sanitation records, personal hygiene records, training records, testing records etc.

1.2.2. Aquaculture Farms

1.2.2.1. While selecting the site for aquaculture farming it shall be ensured that construction of the farm shall not disturb the ecosystem and natural habitats of that locality and undesirable pollutants/ chemicals from nearby areas do not contaminate the farm. Prevent the entry of unwanted species into the ponds by screening inlet and outlet of water. The percolation rate / porosity of soil of the pond shall be law enough to hold the pond water satisfactorily. The ponds should be free from harmful chemical and natural pollutants.(eg :-pyrite). Quality and chemical composition of water shall be species specific.

1.2.2.2. Good Aquaculture Practices (GAP) shall be adopted at all stages of production to ensure the quality and safety of the aquaculture animals. Farms may adopt international code of practices like OIE’s ‘Aquatic Animal Health Code’ to minimize pathogen/other diseases.

1.2.2.3. In case of pond farming, maximum care shall be taken for pond preparation. Allow the pond to dry fully and disinfect every year. Depending upon the soil, use stone meals to control pH and apply probiotics as per requirement. Use only quality post larvae for stocking and do not overstock.

1.2.2.4. The farm shall receive inputs including larvae, feed, fertilizer, chemicals, equipments etc based on the legal requirements and maintain proper stock /utilization register of all inputs and out puts. The quality of inputs must be known.



1.2.2.5. Only products approved for use by the farm shall be stored & used. Always store and use chemicals according to the instructions given in the label. The storage area shall be clean and neat and maintained properly to avoid contamination. Responsible person for receiving, storage and utilisation of inputs shall be identified.

1.2.2.6. Post larvae, fingerlings etc shall be procured only from hatcheries approved by FIQCD with proper records, after ensuring that they are free from diseases, harmful chemicals and pharmacologically active substances. Proper traceability shall be maintained for all movements of aquaculture animals in and out of the farm. Feed shall be obtained only from approved feed mills after ensuring that the feed is free from banned chemicals/pharmacologically active substances.

1.2.2.7. Proper water management system shall be introduced to ensure the quality of water. Suitable water filtration system shall be established to avoid organic impurities. Water shall be tested for microbiological and chemical contaminants on a laid down frequency

1.2.2.8. Actively dispose the waste in a suitable manner to avoid cross contamination. Chemical wastes and non- biodegradable wastes shall be disposed of as per legal requirement. Dispose of waste as per the label instructions. Receive precise quantity of chemicals as per the need to avoid wastage.

1.2.2.9. Adequate cleaning & sanitation shall be done at all areas of the farm, including machineries/ equipments to avoid microbial contamination. Employee shall strictly adhere to the personnel hygiene practices specified at Chapter -2, clause no. 2.5.2, as applicable.

1.2.2.10. Banned chemicals/ pharmacologically active substance shall not be received or used. Only permitted chemicals and pharmacologically active substance shall be used under the advice of veterinary doctor for treatment of animals. Sufficient withdrawal period shall be given after treatment before harvest. Instructions contained in the EC Directive No 96/23/EC as highlighted in DOF Directive No 3/2009 dated 03.04.2009 shall be strictly followed.

1.2.2.11. Regular monitoring shall be done to ascertain the health status of aquatic animals, their movements, mortality rates and the spread of exotic and non-exotic diseases and records maintained. Information regarding the emerging diseases and action taken to prevent them shall be immediately communicated to FIQCD

1.2.2.12. Aquaculture animals which have reached commercial size and show no clinical sign of disease may be harvested under the supervision of the competent authority for human consumption, or further processing.

1.2.2.13. The farm shall have a documented procedure for Good Aquaculture Practices and shall maintain all records as required to establish traceability of animals reared, input & output records, monitoring records, test reports, cleaning records, training records, chemical treatment records etc for verification by the Competent Authority. The traceability record as given at Annexure.1 of this regulation shall be maintained by the farm for verification by the Competent Authority



1.2.3. Feeding Mills

1.2.3.1. Feed mills are one of the important links in primary production chain where proper control systems shall be in place to establish the safety of aquaculture products produced. Therefore, feed mills shall implement Good Manufacturing Practices (GMP), HACCP based control systems and also comply with the following basic requirements to produce safe and quality feeds consistently.

1.2.3.2. The premises shall be kept clean and shall have defined curtilage. The factory shall be housed in a building of permanent nature affording sufficient protection from the environment and shall be of sufficient size for the work to be carried out under hygienic conditions.

1.2.3.3. The design and layout shall be such as to preclude contamination. The layout of different sections shall be such as to facilitate smooth and orderly flow of work and to prevent possible cross contamination and backtracking.

1.2.3.4. Change room(s) with adequate facilities shall be provided for workers and suitable facilities for washing hands shall be provided for workers at entry points

1.2.3.5. A well documented effective cleaning and sanitation programme shall be developed and implemented as per the laid down frequency. Employees shall adopt proper hygiene practices and wear clean protective cloths. The requirements specified at Chapter -2, clause no. 2.5.2, may be implemented, as applicable.

1.2.3.6. Waste shall be collected promptly and, or stored in dedicated waste containers away from incoming raw material and finished product storage areas and shall be disposed of legally.

1.2.3.7. Utensils, machineries, conveyors, mills, aspirators, screeners, mixers and other feed contact surfaces shall be smooth, clean and maintained in good hygienic condition to avoid contamination of the feed. Sieves, screens, filters, separators and mixers shall be regularly checked for damages, cleanliness and their effective operation.

1.2.3.8. Separate storage facilities shall be provided for storing incoming materials, finished products and also packing materials hygienically. Storage areas shall be hygienically maintained and shall be free from moisture, dust, vermin and birds. Medicated feeding stuff, premix and feed additives shall be stored in suitable, separate and secured rooms or hermetic containers with proper labelling and traceability records on a first in - first out basis. Only authorised person shall have access to these stores. Proper records of storage, with details of incoming and outgoing materials shall be maintained by a responsible person.

1.2.3.9. Suitable pest control measures shall be taken to prevent the entry of flies, rodents, lizards etc into the premises as specified at Chapter -2, clause. No 2.5.4.

1.2.3.10. HACCP based control system shall be implemented. Critical Control Points shall be monitored on a laid down frequency and in case of deviation, corrective action shall be taken promptly. Traceability of incoming materials and finished products shall be established from the source. Recall procedures shall be developed to address



customer complaints. Control of carry-over shall be considered within the HACCP study. Carry-over must be measured with an appropriate method at least once in a year or after installation of facilities

1.2.3.11. Incoming materials, process materials & finished products shall be tested for microbiological and chemical parameters in the in-house laboratory or external labs on a laid down frequency. Effective quality control of all ingredients and final products shall be established to ensure the wholesomeness and safety of feed produced. Specifications of incoming materials, feed additives, pre-mixtures, finished products shall be developed and strictly implemented. Banned chemicals shall not be used.

1.2.3.12. A written procedure shall be developed to ensure regular cleaning of cooler. If air is used for conveying or cooling, it should be checked for microbial contamination. Pelleting conditions must be assessed to ensure stability of the feed additives

1.2.3.13. Internal audits shall be performed at least once in a year to establish that the HACCP is in place and all the control systems are effective to produce safe feed products.

1.2.3.14. Well documented internal standards, specifications, operating procedures etc shall be developed as a part of ‘Feed Safety Management System’. All records pertaining to hygiene and sanitation, personal hygiene, pest control, calibration, HACCP control ,traceability, testing, training, incoming and outgoing material, stock register, carry over etc shall be maintained for verification by the NCA

1.2.4. Fishing Vessels

1.2.4.1. Vessels must be designed and constructed so as to avoid contamination of fishery products with bilge water, sewage, smoke, fuel, oil, grease or other objectionable substances

1.2.4.2. Surfaces that come in contact with fishery products must be made of suitable corrosion-resistant material that is smooth, non toxic and easy to clean.

1.2.4.3. Vessels designed and equipped to preserve fresh fishery products for more than 24 hours shall be equipped with holds, tanks or containers for the storage of fishery products at a temperature approaching that of melting ice. These holds shall be separated from the machinery space and the crew quarters by partitions which are sufficient to prevent any contamination of the stored fishery products. Melt water should not come in contact with fishery products.

1.2.4.4. In vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices for achieving a uniform temperature throughout the tanks. Such devices must achieve a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 3C six hours after loading and not more than 0C after 16 hours

1.2.4.5. Utmost care shall be taken while catching/ storing/handling of fish to avoid injury to the animal. Fish should be handled hygienically to avoid contamination at all stages.

1.2.4.6. Equipments and material used for working fishery products shall be made of corrosion resistant material that is easy to clean and disinfect



1.2.4.7. The fishery products should not be dumped directly on the deck. Clean food grade polythene sheet or other suitable material may be used for receiving the fish. On receiving fishery products shall be protected from contamination, heat etc. Washing of fish shall be done only by potable water or clean sea water. Ice used for chilling shall be clean and made up of potable water.

1.2.4.8. Fish receiving deck shall be smooth, clean and free from engine oil, grease, etc

1.2.4.9. Where fish is beheaded and /or gutted on board, such operations must be carried out hygienically and the products must be washed immediately and thoroughly with potable water or clean seawater

1.2.4.10. Staff assigned for handling of fishery products shall be required to maintain a high standard of cleanliness for themselves and their clothes. Persons liable to contaminate fishery products shall not be permitted to handle the products. Periodic cleaning and sanitation of equipments, food contact surfaces shall be exercised to avoid contamination.

1.2.5. Landing Sites/ Fishing Harbor

1.2.5.1. The Landing Site /Fishing Harbour of fish and fishery products shall be located at a site ideal for the purpose and shall be free from undesirable smoke, dust, other pollutants and stagnant water. The premises shall be kept clean. The layout and design of landing site /fishing harbour shall be such as to preclude contamination. Adequate working space shall be provided for hygienic handling of fishery products

1.2.5.2. Suitable covering shall be given at the landing site/ fishing harbour to protect fishery products from environmental hazards such as sun light, rain, wind blown dust etc. Suitable provisions shall also be given to avoid the entry birds/pests into the landing sites.

1.2.5.3. Floor and walls shall be smooth and easy to clean and disinfect. The floor shall have sufficient slope for proper drainage and to avoid stagnation of water. Drainage lines of adequate size and slope shall be provided to remove waste water, the out let of which shall not open to the sea near the landing birth. Sufficient artificial lighting shall be provided and the lights shall be protected with suitable covering.

1.2.5.4. Provision of adequate quantity of potable water or clean sea water shall be available in the landing sites for cleaning and sanitation. There shall be provision for hygienic handling and storing of sufficient quantity of good quality ice for keeping the fish in chilled condition.

1.2.5.5. The utensils & equipments used to handle fish and fishery products shall be smooth and made of corrosion free material, which is easy to clean and disinfect and kept in a good state of repair and cleanliness

1.2.5.6. Landing sites/fishing harbours shall be maintained hygienically. Cleaning and sanitation shall be implemented at all areas of the landing site on a laid down frequency to avoid cross contamination. Proper waste management shall be adopted to remove solid and liquid wastes immediately after its formation so as to avoid cross contamination



1.2.5.7. Workers shall adopt personal hygiene practices to avoid contamination of fishery products. There shall be sanitary facilities at appropriate places for hand washing with sufficient number of washbasins, soap, disinfectants and single use hand towels. Appropriate number of flush lavatories shall also be provided outside the landing sites /auction centres.

1.2.6. Auction Hall

1.2.6.1. Auction halls used for the display and sale of fishery products shall be well protected from the entry of dust, pests/insects and other contaminants

1.2.6.2. Since, fishery products shall not be kept directly on floor, as far as possible, provision may be given for raised platforms for display of fishery products, which are smooth, easy to clean and disinfect. However, instead of raised platforms, any other suitable provision can be made so as to ensure that fishery products will not come in contact with the floor directly.

1.2.6.3. The premises and all the surfaces that come in contact with fishery products shall be cleaned before and after each sale. The crates/utensils shall also be cleaned and rinsed inside and outside with potable water or clean sea water and disinfected before use. Workers engaged in handling fishery products shall maintain highest degree of cleanliness. They shall wash hands properly before and after handling fishery products, ice and food contact surfaces.

1.2.6.4. Fish and fishery products shall be properly iced using good quality ice made up of potable water so as to maintain the core temperature of fishery products below 4ºC. Refrigerated room of adequate size for storing fishery products may be provided, if required.

1.2.6.5. Sign boards prohibiting smoking, spitting, eating, drinking etc inside the auction hall shall be exhibited at prominent positions. Unauthorized person(s) shall not be permitted to enter into the auction hall

1.2.6.6. Separate area may be earmarked for storage of fishery products which are unfit for human consumption. Cleaning and sanitation chemicals shall be stored in separate lockable cupboards with proper labelling for identification.

1.2.6.7. A responsible person of the landing site/ auction hall shall conduct random checking of fishery products meant for export for organoleptic factors, including the core temperature to ensure chilling of fishery products below 4ºC and records maintained

1.2.6.8. Sea water used for cleaning of fishery products/ food contact surfaces shall be tested for SPC, Coliforms in government labs on a laid down frequency. If fresh water is used for cleaning, same shall be tested. Similarly ice shall also be tested for SPC, Coliform on a laid down frequency. In order to ensure effectiveness of cleaning, swabs taken from food contact surfaces shall also be tested on a laid down frequency for SPC and Coliforms.



Chapter-II. Processing & Allied Activities

2. Responsibility of business operators

CHAPTER 2Processing & Allied

Activities



2.1. General

2.1.1. Processing and allied activities are operations other than primary production, which may include transportation, storage, handling, processing, heat/cold treatments etc of fishery products

2.1.2. Business operators shall obtain approval of their establishments from the National Competent Authority (NCA) for handling, transporting, processing and storing of fishery products, for which they shall maintain proper infrastructural facilities and hygienic standards of their establishments/ facilities as per the national and international requirements

2.1.3. In order to achieve safety and quality of fishery products, business operator shall implement HACCP based control system starting from the source of raw materials and also establish flow of information within the stake holders and also within the company. They shall be committed to high level protection of human health and consumer interest, for which a well documented recall procedure shall be implemented.

2.1.4. Establishments/factory vessels/freezer vessels shall maintain all the approved facilities of the unit in good repair. Prior approval has to be obtained from FIQCD, the National Competent Authority (NCA) for making any major alterations/ changes in the infrastructure of the approved facility.

2.1.5. Approved establishments/factory vessels/freezer vessels shall exercise proper controls at all stages of production starting from raw material procurement to the final dispatch of the cargo and maintain records thereof. Business operators shall comply with all the regulatory requirements of DOF as well as those specified by the importing country to ensure that the fishery product meant for export meets the requirement of that country.

2.1.6. Test reports pertaining to the quality and safety of the raw material and the additives/ preservatives used shall be maintained by the processor. If any new ingredient is to be used for treatment, prior approval/permission is to be obtained from FIQCD before its use.

2.1.7. Business operator shall not purchase /procure raw materials, semi-processed products from unapproved units. Water and ice shall not be brought from unauthorized centres

2.1.8. Traceability of the raw material, permitted chemicals etc shall be maintained right from the source of production.

2.1.9. Business operator shall validate the processing method used for cooking, retorting etc and calibrate all the recording devices at a laid down frequency so as to ensure proper temperature control

2.1.10. Business operators shall obtain Health Certificates from NCA, as per the requirement of importing country, on or before the departure day of the cargo.



2.2. Infrastructural Facilities

2.2.1 Establishments

a) Business operator intending to process fish and fishery products for export shall get their establishment(s), including those producing semi processed materials, approved by FIQCD, the National Competent Authority, for which establishments shall meet the minimum requirements specified in DOF Directive No 3/2009 dated 03.04.2009. However, if any additional requirement has been specified by the importing country, same shall also be complied with. Major infrastructure and hygiene requirements for approval are highlighted below;

b) The surroundings of the factory shall be free from objectionable odours, smokes, dust and other contaminants. It shall be maintained clean without stagnant water or garbage accumulation. The establishment shall be housed in a building of permanent nature affording sufficient protection from the environment and shall be of sufficient size for the work to be carried out under hygienic conditions. The design and layout shall be such as to preclude contamination. Immediate surroundings of the building shall be tarred/ concreted to avoid pest/windblown dust.

c) The layout of different sections shall be such as to facilitate smooth and orderly flow of work and to prevent possible cross contamination and backtracking. All the fish handling areas shall be separate from areas used for residential purpose. There shall be adequate lighting and ventilation and light fixtures shall be protected with proper covering. The layout shall ensure sufficient space in different sections for machinery, equipment, personnel etc. without congestion. The building shall provide sufficient protection against the entry and harbourage of rodent, insects, birds etc. Non –operative areas inside the establishment, if any, shall be properly cordoned off to avoid possible cross- contamination

d) The floor of fish handling areas shall be smooth, impermeable and easy to clean and disinfect. There shall be no water stagnation on the floor. The floor shall have sufficient slope opposite to the flow of work or sideways. The wall to floor and wall-to-wall junctions shall be rounded off to facilitate easy cleaning. The walls should be durable, smooth, light coloured and easy to clean and disinfect. The ceiling shall be free from cracks and open joints and shall be smooth and easy to clean.

e) There shall be adequate drainage facility and slope of the drainage shall be opposite to the flow of work/ material. The drains shall be of adequate size having sufficient slope for easy cleaning.

f) The doors shall be self closing and tight fitting to prevent the entry of flies. All doors and windows shall be durable and made of corrosion resistant material and windowsills, if any, shall be sloped inwards. The windows/ ventilators shall be constructed at least two meters above the floor with fly proofing nets to prevent the entry of flies. Mechanical ventilation/ exhaust fans shall be provided in areas of air stagnation.



g) All the entry points shall have suitable arrangements to prevent the entry of flies/dust. Suitable washing and sanitizing facilities for feet and hands shall be provided at the entry points. Hand washing facilities such as non-hand operated wash basin, liquid soap, nail brush, disinfectants, hand dryers etc shall be provided.

h) All utensils and equipments shall be made of non-corrodible material and shall be smooth without cracks and crevices and easy to clean and disinfect. Separate colour codes shall be given for utensils/crates/tubs using in the high risk areas to avoid cross contamination.

i) Adequate number of change rooms for workers of suitable size having smooth, washable walls and floors shall be provided depending upon the quantum of production and number of workers employed. Change room shall have all facilities for cleaning and changing the dress, including toilet facility. There shall be lockable cupboards and facility for keeping gumboots, shoes and uniforms inside the change room.

j) Chill rooms having adequate size with mechanical refrigeration system to maintain temperature at the required level (0c to 4c) or adequate number of insulated boxes may be provided for storing fishery products. Establishments processing frozen fishery products shall have cold storage having suitable refrigeration system to maintain the product temperature below -18C which may be attached to the establishment or may be detached.

k) Solid wastes shall be collected in separately identifiable containers/bags and shall be stored in waste rooms for disposal at the earliest.

l) A suitable water purification and disinfection system shall be implemented which shall include use of plumbing diagrams showing the entire reticulation of the water, identifying each tap with consecutive numbers. Taps shall be fitted with non-return valves to avoid back flow of water. Water storage tanks shall be protected from dust, pest by covering with lockable lids and the tanks shall be cleaned on a laid down frequency. If the ice plant is not integrated to main establishment, it shall be approved by the Competent Authority separately

m) There shall be separate stores for wet and dry items and the chemicals/ disinfectants should be properly labelled. Packing material store shall be of adequate size with proper fly and dust proofing system. Cartons shall be kept on cleanable pallets away from the walls and covered properly.

n) The establishment may have a well-equipped in house laboratory for testing microbiological and other chemical parameters or can test their products in government laboratories.

2.2.2 Freezer vessels/factory vessels



a) Freezer vessels/ Factory vessels shall have following infrastructure/ hygiene requirements in additions to those specified for fishing vessels at Chapter-1, Clause No 1.2.4 of this regulation, as applicable:

b) Vessels shall be equipped with freezing equipment(s) which can achieve core temperature of fish not more than -18ºC rapidly.

c) Shall also be equipped with a cold storage of sufficient capacity that can maintain a temperature of not more than -18ºC and the store shall be fitted with a temperature recording device. If EU approved vessel, the device shall comply with EN 12830, EN 13485 and EN 13486 standards. The sensor of the device shall be at the warmest area of the store.

d) When whole fishes intended for canning are frozen in brine, fish core temperature shall not be achieved more than -9ºC. The brine used shall be free from contamination.

e) Change rooms and hand washing facilities shall be provided at the convenient area

f) Separate area for processing fishery products shall be available, which is sufficiently large for hygienic operation and easy to clean and disinfect. All the utensils and equipments shall be made of non-corrodible material and shall be smooth without cracks and crevices and easy to clean and disinfect.

g) In case of factory vessel a separate raw material receiving area shall be identified on board to receive each fish catch separately, which shall be kept clean and well protected from environmental hazards and pests. Suitable hygienic system shall be in place to transfer the fish from receiving area to fish processing area

h) The processing and storage areas of factory vessel shall be sufficiently large for hygienic handling and storing fishery products. If a waste processing unit is operating on board, that should be well separated from processing areas to avoid cross contamination and the hold must be designed for the storage of such waste separately. Packing materials shall be stored separately in a clean area.

i) In case of factory vessels processing cooked products, processing of raw products or waste products is not permissible.

j) Sufficient quantity of ice made up of potable water or clean sea water shall be made available for chilling fishery products.

k) Proper hygiene and sanitation shall be maintained at all stages of production and the workers shall implement strict personal hygiene practices to avoid contamination.

2.2.3 Independent ice producers

a) Independent ice plants intend to supply ice to approved primary producers and processors of fishery products meant for export shall be approved and monitored by



FIQCD. For this purpose the ice plant shall implement following minimum infrastructure and hygiene requirements.

b) Many of the infrastructure and hygiene requirements specified for establishments at Chapter-2, Clause No 2.2.1 is also applicable for independent ice plants, since the objective is to produce good quality ice which is free from contamination. Utmost importance shall be given for cleaning and sanitation and personal hygiene. Business operator shall implement a written Sanitation Standard Operating Procedure (SSOP)

c) Proper water management system shall be implemented to ensure that the water used to produce ice shall comply with requirements specified at Clause .No 2.5.3 (a), (b) & (c) of Chapter-2 of this regulation, as applicable.

d) All records pertaining to cleaning and sanitation, personal hygiene, ice production, Ice supply details, training, testing etc shall be maintained for verification by NCA.

2.2.4 Independent Cold Storages

a) In order to store frozen and chilled fishery products meant for export, independent refrigerated stores shall obtain necessary approval from FIQCD, for which they shall comply with the following minimum requirements

b) The surroundings shall be reasonably free from objectionable odours, smoke, dust and other contaminants. The cold storages shall be housed in a building of permanent nature affording sufficient protection from the environment and shall be of sufficient size for the work to be carried out under hygienic conditions. The design and layout shall be such as to preclude contamination. Hygiene and sanitation shall be strictly implemented.

c) In the case of frozen store, ante-room with suitable size having smooth walls, floor and roof shall be provided, the door of which shall be made of non-absorbent material and fitted with air curtain / strip curtains. There shall be suitable mechanism to prevent condensation of water inside ante room and suitable provisions for loading and unloading the cargo hygienically without causing temperature fluctuation shall be provided.

d) Frozen Cold storage shall have powerful refrigeration system to maintain the core temperature of the product at -18°C or below. There shall be suitable defrosting system and suitable arrangement to remove melt water from the frost.

e) It shall be ensured that during defrosting, variation in temperature is minimal and the period is short so as to avoid temperature abuse.

f) The cold store shall have an automatic temperature recording device (thermograph), the temperature sensor of which shall be located at the warmest place in the cold storage. In case of EU approved cold store, the automatic recording device (data logger) installed to monitor air temperature of cold store shall comply with EN 12830, EN 13485 and EN 13486 standards



g) Chill rooms for storing chilled fishery products shall have a refrigeration system to maintain the product temperature at 4°C or below.

h) Records pertaining to cleaning and sanitation, details of loading, unloading and storage of products (frozen & chilled), core-temperatures of the product, store temperatures, calibration etc shall be maintained.

2.2.5 Additional requirements for European Union

a) In case of factory vessels/freezer vessels/ establishments, including those producing semi processed materials intend to export fishery products to European Union, they shall also comply with following requirements in addition those specified at Clause No 2.2.1 and 2.2.2 of Chapter-2. A number of Non-EU countries like Russian Federation, Norway, Iceland etc are following EU requirements

b) The frozen cold store and refrigerated transport vehicles shall have automatic temperature recording device (data logger) to monitor air temperature, which shall comply with EN 12830, EN 13485 and EN 13486 standards.

c) Water used for processing shall be of potable nature and shall meet the requirements of EC Directives No. 98/83/EC dated 03.11.1998. There shall be adequate quantity of ice made of potable water that meets the requirements of the Directive No. 98/83 EC dated 03.11.1998

2.3. HACCP Based Control Systema) Since the sole responsibility for maintaining the quality and safety of fishery products

processed in the approved establishment/factory vessels/freezer vessels lies with the business operators, they shall develop and implement HACCP based own check system.( Refer: A Regional Draft Guidance on Criteria for GMP/HACCP for Asian Countries)

b) All the pre-requisite programs shall be in place before implementing HACCP

c) All the seven principles of HACCP shall be properly implemented and records maintained. Any deviation in the process flow or, changes made in the CCP shall be brought to the notice of the competent authority immediately. Documented control measures and sampling procedures shall be established by the processor.

d) HACCP has to be reviewed by the business operator of approved establishment/factory vessel/freezer vessel at least once in a year or in case of any change in the product/process/ source of raw material or in case of foreign complaint. The review records shall be maintained for verification.

e) Implementation of HACCP shall be monitored at all stages so as to ensure the quality and safety of the product. There shall be properly documented SOPs, SSOPs, GMPs recall procedures etc developed by the establishment.

f) Approved processors shall conduct internal audits at least once in a year covering all areas of Sanitation Standard Operating Procedure (SSOP), Good Manufacturing Practices (GMP),



Standard Operating Procedure (SOP), HACCP etc and records maintained. Validation of critical limits/ HACCP Plan shall be conducted on a laid down frequency.

g) Business operator shall maintain all the HACCP records including CCP monitoring, corrective action records, verification records, production records, testing records, cleaning and sanitation records, validation records, calibration records, temperature records etc for verification by FIQCD

2.4. Product Control

2.4.1.Raw material control

Business operator shall take utmost care to ensure the quality and safety of raw material used for processing, for which following steps shall be taken:

a) Traceability of raw material from source of procurement shall be established by the processor. Selection of suppliers/source shall also be done to identify the right area of procurement of raw material. Supplier/source audits shall be conducted at regular intervals to ensure the quality and safety of raw materials.

b) Proper washing and chilling to 4 ºC using good quality water and ice shall be ensured immediately after procurement of raw material. Transportation of raw material is done in clean vehicles in properly covered condition.

c) Before accepting the raw material for further processing, it shall be subjected to organoleptic evaluation by a qualified/ experienced employee of the factory. Only good quality materials are to be accepted for further processing. The sample size shall be documented.

d) Raw fishery products procured by the unit as raw material may be tested (variety wise/ source wise) for microbiological factors like Standard Plate Count (SPC), Escherichia coli, Staphylococcus, Salmonella, V. cholerae, and V.parahaemolyticus in the in-house lab or in Government laboratory as per the laid down frequency.

2.4.2.Final product control

In order to ensure the wholesomeness of processed products, business operators shall implement proper Standard Operating Procedures and verification procedures. Business operators shall develop their own sampling and testing plan based on the risk analysis to ensure the safety of fishery products. They shall also test the products as per the requirement of the importing country. (Refer: Product standards of major importing countries given at Annexure-6)

a) Organoleptic evaluation of finished products is to be done to ascertain the freshness of the product before export. If organoleptic evaluation of raw material/ finished products reveals any doubt as to the freshness of fishery products, the same shall be tested for total volatile basic nitrogen (TVB-N) or trimethylamine nitrogen (TMA-N) as specified in DOF Directive No 3/2009 dated 03.04.2009.



b) Parasite Check: Business operators shall ensure that fishery products have been subjected to visual examination for the purpose of detecting visible parasites before or during processing, as envisaged in DOF Directive No 3/2009 dated 03.04.2009.

c) Processors should make every effort to achieve parasite check through a non-destructive examination of fish and fishery products during processing by qualified personnel. The checking shall be performed under good light conditions, if necessary, by using candling.

d) When processing conditions do not allow for the examination of each individual fish, the processor must develop a sampling plan for each batch of processed fish. The sampling plan for mechanically eviscerated fish must include a representative number of samples of not less than 10 fish per batch.

e) Microbiological checks: As a part of verification procedure, frozen fishery products meant for export shall be tested on a laid down frequency for different microbiological parameters such as Standard Plate Count (SPC), Escherichia coli, Staphylococcus, Salmonella, Vibrio cholerae, etc to ensure that the control measures are in order. Similarly, pasteurized (vacuum packed) fishery products shall be subjected to sterility tests and acidified fishery products for yeast and mould etc on a laid down frequency.

f) However, processors shall test the fishery products meant for export for microbiological parameters based on the requirement of the importing country.

g) Consignments of frozen cooked crustaceans meant for export to EU shall be tested for Standard Plate Count (SPC), E.coli, Staphylococcus, Salmonella, prior to shipment by the establishment. For this purpose 5 samples of 150 gm each shall be drawn aseptically covering maximum grades possible.

h) Consignments of frozen fishery products meant for export to Saudi Arabia shall be tested for Vibrio cholerae, for which 5 samples of 25 gm each shall be drawn touching all production codes and grades. In case of fresh/chilled fishery products meant for export to Saudi Arabia, one separate sample shall be tested for Vibrio cholerae on post facto basis and results submitted to the NCA

2.4.3.Special requirements for export of aquaculture products

a) Establishments intending to process aquaculture products meant for export shall have a unique approval number given by the National Competent Authority based on their Good Hygienic Practices (GHP) and Animal Health Surveillance Scheme.

b) Approved establishments shall process aquaculture products procured only from farms approved and monitored by National Competent Authority, as specified in the Official Control System Manual for Inspection and Certification of Fish and Fishery Products issued by FIQCD, Department of Fisheries (DOF).

c) Establishments shall accept raw materials only after ensuring that the animals have not undergone illegal treatments and sufficient withdrawal time is given after treatment before harvest. Copy of the traceability record specified at Annexure-1 pertaining to each lot of raw material shall be maintained by the establishment.



d) Raw aquaculture products shall be tested by the approved establishments for antibiotic residue and pesticides as per the frequency specified in HACCP manual.

e) Business operators of approved establishments shall maintain all records pertaining to the procurement, processing and testing of aquaculture products for verification by the NCA

f) Business operators of approved establishments shall conduct regular audits of the farms from where they procure aquaculture products to ensure that the farms are following Good Aquaculture Practices (GAP) and are not doing any illegal treatments as specified in DOF Directive 3/2009 and EC Directive 96/23/EC. They shall maintain audit reports for verification by the NCA

g) Business operators of approved establishments shall ensure that the approval number of the aquaculture pond/farm allotted by the competent authority shall be marked on all export packages of aqua cultured products meant for EU to establish traceability

2.4.4. Residue Monitoring Plan

a) Business operators of approved establishments shall develop a residue monitoring plan based on risk analysis and also based on the national and International requirements to ensure that fishery products are free from residual contamination.( Ref: DOF Directive No 3/2009 and DOF Directive No 2/2014)

b) As a part of source selection procedure, business operator may test raw materials of aquaculture origin for banned chemical, including pharmacologically active substances, heavy metals, dyes etc on a laid down frequency.

c) Farm audits shall be conducted by the processing establishments on a laid down frequency to ensure that the farms and hatcheries are following Good Aquaculture Practices and are not using banned chemicals.

d) Establishments shall test finished products for residual parameters based on the requirement of the importing country and on risk-basis (see a above).

2.4.5. Additives/ ingredients

a) Business operator shall use only permissible additive as per the recommended dosage as specified in DOF Directive No 3/2009 dated 03.04.2009. In case the exporter wants to use new additives or ingredients prior sanction shall be obtained from the National Competent Authority.

b) If salt is used during processing, it shall be ensured by the processor that all the batches of salt purchased shall be free from Staphylococcus and Sulphite reducing Clostridium.

c) Crustaceans shall be tested by the processor to ensure that residue of additives such as sulphites, phosphates etc., are within the permissible limit.

2.4.6.Histamine & Biotoxins



a) Histamine forming fishes meant for export to EU shall be tested by the establishment/factory vessel/freezer vessel to ensure that the limits of histamine are not exceeded. For this purpose, 9 samples of 100 gm each shall be taken from each batch

b) For the export of bivalve molluscs, business operator shall ensure that biotoxins are within the permissible limit.

2.4.7.Toxic Fishes

Fishery products derived from poisonous fishes belonging to the families like Tetraodontidae, Molidae, Diodontidae, and Canthigasteridae may be processed in the approved establishment/factory vessel/freezer vessel only under the supervision of qualified persons, for which special sanction shall be obtained from the NCA. However, poisonous fishes belonging to the above mentioned families shall not be permitted for export to European Union.

2.5. Process Control

2.5.1. Hygiene and sanitation

a) Business operators of approved establishment/factory vessel/freezer vessel shall ensure proper hygiene and sanitation throughout the handling, transportation and storage of fish and fishery products to avoid introduction and multiplication of microbial contaminants.

b) For this purpose business operator shall develop a written cleaning and sanitation procedure for strict compliance on a laid down frequency, which may cover all areas of the establishment/factory vessel/freezer vessel including utensils and equipments.

c) Effectiveness of cleaning and sanitation shall be ensured by visual inspection and also by testing the swab samples taken from food contact surfaces and from workers hands for microbiological parameters on a laid down frequency.

d) Records of cleaning and sanitation and also the test results of swab samples shall be maintained for verification by the NCA

2.5.2. Personal hygiene

a) Since employees are the major source of contamination, business operators shall develop proper control measures to ensure their personal hygiene, appropriate movements and behaviour.

b) Sufficient number of facilities shall be provided at appropriate places to enable the workers to clean and sanitize their hands and feet and to wear clean dress before each entry to the fish handling areas.

c) Utmost care shall be taken by the workers to maintain hygiene and sanitation while handling cooked products to avoid microbial contamination and toxin formation



d) Workers shall not eat, talk, cough, sneeze, spit etc inside fish handling areas. They shall trim their nails and remove their ornaments before entering the processing areas. They shall wear clean uniforms.

e) The movements of employees, utensils and equipments shall be restricted to prevent cross contaminations.

f) Works suffering from injury or disease shall not be permitted to work inside the fish handling area. Each employee working in the processing areas shall have a health certificate issued by an authorized medical practitioner stating that he/she is fit to work in a fish processing establishment and the certificate shall be renewed every year. Employees shall conduct medical examination before joining for duty after taking leave on medical ground.

g) Proper training shall be given to the workers for strictly following personal hygiene and behavioural activities. Records of training shall be maintained for verification.

2.5.3. Quality of water and ice

a) Business operator shall exercise proper control to ensure the quality and safety of water and ice used in their factory. They shall check the microbiological parameters such as coliform and E.coli of water and ice in their in-house lab/ government lab at least once in a month.

b) Moreover, establishment/factory vessel/freezer vessel approved for export to EU /Russian Federation shall test water used for processing and ice production for all parameters as per EC Directive No.98/83/EC in government lab at least once in three years or whenever the source of water is changed. The parameters applicable as per table A (1) of annexure II of the same EC Directive shall be tested once in a year.

c) However establishment/factory vessel/freezer vessel approved for export to countries other than EU and Russia shall test water used for processing and ice production as per the International Standards for Drinking water, WHO once in three years.

2.5.4. Pest control

a) Business operators shall take suitable measures to ensure a pest free environment inside the factory including the premises.

b) Methods for exclusion and eradication of pests shall be introduced wherever applicable. Elimination of shelters and attractants of pest shall be done to ensure pest free environment. Air curtains, fly catchers, rodent traps, nets, rodent grills etc may be provided, wherever applicable. Records of pest control activities shall be maintained for verification.

2.5.5. Time Temperature Control

a) As a major tool to control microbial contamination and toxin formation, approved establishment/factory vessel/freezer vessel shall implement time- temperature control starting from the procurement of raw material till shipment of the consignment.



b) Reduction/elimination of pathogens/parasites is achieved through freezing, blanching, cooking, pasteurization, smoking etc

c) Immediately after procurement, fish shall be chilled to 4 ºC or bellow to maintain the freshness of the product and to avoid histamine formation. The core temperature of the product shall be recorded at all stages of handling to ensure that the cumulative temperature does not exceed the desirable limits.

d) Special precaution shall be taken while procuring, transporting and processing histamine forming fishes to avoid temperature abuse. During procurement, it shall be ensured that the fish is caught without causing struggle, stress or injury to the animal. Bigger fishes, like tuna above 10 kg, shall be eviscerated before on-board chilling to 4ºC or below. Moreover, ice should be filled inside the eviscerated portion to maintain

uniform core temperature. Core temperature of the fish shall be maintained at 4ºC or below at all stages of processing of histamine forming fishes till it is exported. Damaged or spoiled pieces shall not be processed for export

e) All temperature recording devices shall be calibrated on a laid down frequency. Cooking devices shall be properly validated to ensure that the desired core temperature is achieved uniformly.

2.5.6. Control on Cross Contamination

a) Business operators shall establish proper control measures to prevent cross contamination of biological or chemical contaminants from unsanitary objects to food and /or food contact surfaces, which may include proper cleaning and sanitation, employees hygiene, employee movement and behaviour, pest control, waste management, time and space separation etc

b) Proper waste management system for the speedy collection and disposal of solid and liquid waste shall be in place to avoid cross contamination

c) Establishments/ factory vessels/freezer vessels shall adopt GMP for storage/ handling of printed materials and marking materials/articles in order to ensure that printed surfaces or marking ink applied to non food contact surfaces will not come in contact with food or food contact surfaces. Regular training shall be imparted to the workers in this regard

2.5.7. Traceability

Business operators shall develop proper methods to trace the source of raw materials, ingredients, packing materials, and other materials used for making food contact surfaces from its origin through all stages of production, processing and distribution. Lot identification is essential in product recall and in stock rotation.

2.5.8. Storage

a) Fresh fishery products, thawed/ unprocessed fishery products, and cooked and chilled products must be stored at a temperature approaching that of melting ice. If fishery products are kept under ice, melt water must not remain in constant contact with the



products, for which the containers used for storing fishery products shall have proper drainage facility.

b) Frozen fishery products during storage shall be kept at a temperature of not more than -18C in all parts of the products; however, whole frozen fish in brine intended for the manufacture of canned food may be kept at a temperature of not more than -9C.

c) Storage of cleaning and sanitation chemicals, ingredients etc shall be done separately under lockable condition with proper labels. Only food grade lubricants shall be used inside the factory, which shall be stored separately with label in locked condition under the supervision of a responsible person.

2.5.9. Transportation

a) Vehicles used for transporting fish and fishery products and ice shall have clean, smooth storage areas made up of non-corrosive material that will not contaminate the product. Cleaning and sanitation of vehicles shall be done before and after the use and the records of cleaning shall be maintained.

b) Frozen fishery products, with the exception of whole fish initially frozen in brine for the manufacture of canned food, must be maintained during transport at an even temperature of not more than -18C in all parts of the product, possibly with short upward fluctuation of not more than 3C

c) Vehicles used for the transportation of fishery products and ice meant for export purpose shall be approved and monitored by the National Competent Authority.

d) Refrigerated vehicles approved for transporting fishery products meant for export to EU shall have temperature recording device which shall comply with EN 12830, EN 13485 and EN 13486 standards.

2.5.10. Packaging

Fish and fishery products meant for export shall be packed in export worthy containers/packets that will not impart contamination or undesirable changes in the product but will give sufficient protection to the product till it reaches the customer.

2.5.11. Labelling

Proper information about the product shall be given to the consumer through labelling, invoice, or other commercial documents accompanying the goods. However, in no circumstances, false, misleading or illusory information shall be given in the label as regards to the nature, identity, properties composition, quantity, durability, origin, production or processing methods of the product.

A. General requirements



The outer packages of fishery products meant for export that has to undergo further processing at the destination shall have the following minimum information printed/stencilled/ pasted in English or in the language of the importing country or both. Additional requirements of importing country, if any, shall also be complied with.

a) Approval No of the establishment b) Name of the country of origin c) Production date

(In case of aquaculture products for EU approval number of the pond/farm and in case of export to China, the registration number allotted by China to be marked on carton)

B. Specific requirements

i. In case of food stuff to be sold directly to the consumer, following information shall be given in the label

a) Name under which the product is soldb) List of ingredients in descending order of proportionc) Quantity of certain ingredients or categories of ingredients expressed as

percentaged) Net weight/drained weighte) Date of minimum durability or best beforef) Storage conditions or condition of useg) Name/business name of the manufacturer or packer

Any ingredient known to cause hypersensitivity should always be declared. (Eg: Crustaceans) Any ingredient which has been treated with ionizing radiation should also be declared.

ii. In case of fishery products to be sold directly to the consumer, the following additional labelling requirements shall also be complied with.

a) Commercial and Scientific name of the productb) Production method (Wild catch or Aquaculture)c) Catchment area (FAO area code for sea catch, country name for aquaculture

and fresh water catch.)

2.6. Special Requirements For Export Of Live Fish

a) Only establishments approved and monitored by FIQCD shall be permitted for export of live aquatic animals, for which the establishments shall comply with the infrastructural/hygienic requirements and other food safety requirements, as applicable, specified in this Chapter elsewhere. Health certificate for the export of live fish, if required, shall be obtained from FIQCD. The business operator shall follow the



requirements specified in the draft “Standard Operating Procedures for the Responsible Movement of Live Aquatic Animals for ASEAN”, as applicable.

b) Special care shall be taken during procurement and transportation of live aquatic animals to ensure that the animals are healthy and free from injuries or diseases. If required, the animals may be hibernated in chilled water during transportation to the factory to avoid stress.

c) Aquatic animals may be kept for observation in suitable tanks with mechanical, biological or chemical filtration system to clean water by removing toxic nitrogen compounds, depending upon the variety of animal. Wherever necessary, suitable aeration facilities shall be provided

d) Only healthy and disease free animals shall be exported and where applicable, the animals may be hibernated at 15 ºC to 18 ºC in order to reduce their metabolic activities and avoid stress.

e) Proper hygiene and sanitation and personal hygiene shall be maintained at all stages of handling of live fish. HACCP based control system shall be implemented.(Refer: A regional Draft Guidance on Criteria for GMP/HACCP for Asian countries)

f) Ornamental fishes shall be packed in suitable plastic bags with two or more layers to avoid leakage. The bags are usually filled with 1/3 rd water and 2/3rd Oxygen, however, larger fishes shall be kept fully immersed in water to avoid mortality. Quality of water used for filling and quality of packing materials should be ensured before packing

g) Live prawns having eggs (gravid females) which had attained length of more than 178 mm (7 inches) will not be permitted for export. In general, Spawners, breeders and fingerlings are not permitted for export. Crabs meant for export shall attain a length from 6.15 to 8.15 cm

h) Exporters of live aquatic animals shall ensure that the requirements of CITES are complied with.

2.7. Management Commitment

a) The commitment of the food business management is the most important aspect of the food safety system. They shall be committed to the development, maintenance, operation and improvement of the food safety management system and to provide necessary resources.

b) The management shall demonstrate that food safety is one of the business objectives of the organisation.

c) They shall be committed in meeting the national and international food safety requirements and also the customer satisfaction.



d) They shall also be committed to conduct management reviews regularly to ensure that the management system is effective to establish food safety and quality.

2.8. Management Responsibility.

a) Top management of the organisation shall ensure that the responsibilities and authorities are well defined within the organisation to establish effective operation and control of the food safety management system.

b) Work instructions shall be clearly laid down to fix the responsibility in case of failure. All personnel in the organisations shall have the responsibility to report immediately to the management in case of any food safety issue.



CHAPTER -3Official Control Activities

CH CHAOPTER 22CHAPTER

Chapter-III. Official Control ActivitiesChapter –III. Official Control Activities

3. Responsibilities of the Competent Authority

3.1 Approval

CHAPTER 3Official Control Activities



3.1.1. Approval of Primary production and allied areas

3.1.1.1. One of the major responsibilities of NCA is the approval of entities of the export chain as empowered in Section 19 of ‘Myanma Marine Fisheries Law 1990’. Therefore, primary production and allied areas meant for export are to be approved and monitored by the Fish Inspection and Quality Control Division (FIQCD) of the Department of Fisheries (DOF), Ministry of Livestock, Fisheries and Rural Development, the designated National Competent Authority of Union of Myanmar.

3.1.1.2. In order to obtain necessary approval from FIQCD, the primary producers and allied operators dealing with hatcheries, aquaculture farms, feed mills, fishing vessels, landing sites, auction halls, vehicles etc shall submit the application for approval along with supporting documents to the NCA. Approval is granted based on satisfactory investigation by NCA to ensure their compliance with national and international requirements on primary production including those specified at Chapter- 1 of this regulation.

3.1.1.3. Procedure for approval of primary producers has been specified at Cl. No 4 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD. After approval, unique approval number is given to each approved facility and their names will be entered in the National List and Central Registry of NCA.

3.1.1.4. Special care shall be taken while approving hatcheries, aquaculture farms and feed mills, as applicable, to ensure that

a) the area is reasonably free from possible biological and chemical contamination

b) exotic or non-exotic diseases are not reported in that area.

c) producers have adopted GAP and monitoring system to ensure the health status of aquatic animals including their mortality rates, movements, feeding habits, disease occurrence etc.

d) development of disease control and preventive system.

e) implementation of high level hygiene standards and traceability system by adopting international code of practices.

f) proper control on the usage of authorized substances and non usage of unauthorized substances.

g) proper control measures are adopted by the feed mill to ensure that the feed produced by the mill is free from banned chemicals and other contaminants.

3.1.2. Approval of Factory Vessels/ Freezer Vessels/ Establishments including those producing semi processed materials.

3.1.2.1 Factory vessels/ freezer vessels/ establishments, including those producing semi processed materials intend to export fish and fishery products, shall be approved and monitored by FIQCD, for which the business operators shall implement the requirements specified at Chapter-2 ,Clause-2 of this regulation, as applicable and also those specified by DOF and importing countries from time to time.



3.1.2.2 Factory vessels/freezer vessels/ establishments including those producing semi processed materials intend to export fish and fishery products shall submit application for approval to FIQDC with all necessary documents including HACCP as specified at Cl. No 4.4 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD.

3.1.2.3 After successful completion of the scrutiny of application and supporting documents and also the desk audit of HACCP manual, the applicant’s facility will be inspected in detail by the Inspection and Certification Section (ICS) officials of FIQCD. The assessment of factory vessels, freezer vessels and establishments (including those producing semi- processed materials) shall be done in two stages as specified below:

a) In the first stage, the assessment is done to ascertain that the infrastructure/equipment facilities, hygiene and sanitation and other pre-requisite programmes are in place and the business operator has implemented all the regulatory requirements of DOF and also those specified by importing countries. On satisfactory completion of the assessment, “Conditional Approval” is granted to the establishment by the Director, FIQCD.

b) In the second stage, the facility is once again visited during the conditional approval period by ICS officials to conduct HACCP audit. After satisfying that the applicant’s facility has implemented HACCP based food safety system properly and is capable of producing safe and quality fishery products as per the national and international requirements, “Final Approval” is granted to the facility by the Director, FIQCD.

3.1.2.4. The conditional approval shall initially be given for a period of 3 months from the date of the approval, which may be extended up to a maximum period of 6 months. However, the conditional approval of freezer vessels and factory vessels can be extended to a maximum period of 12 months, if required. During conditional approval period, establishments/factory vessels/freezer vessels can start processing fishery products and also start the implementation of HACCP. Once HACCP is implemented properly, the processor may request FIQCD to carry out the HACCP audit to grant the ‘final approval’. Each approved facility will be allotted with a unique approval number with codes which indicates the type of product of animal origin approved for processing.

3.1.2.5. Once the final approval is granted, same will be intimated to the concerned facility and their names and approval numbers will be entered in the National List and Central Registry of NCA.

3.1.2.6. In the case the establishment, factory vessel or freezer vessel is approved for export to European Union; FIQCD will forward their name with all details of approval status to the DG SANCO for publication in their web site.

3.1.2.7. If the establishment/factory vessel/freezer vessel is approved to export to Russian Federation, then their names and other details shall be forwarded to FSVPS as per the formats given at Annexure-2 for notifying the names



3.1.2.8. If the establishment/factory vessel/freezer vessel is approved to export to China, Vietnam or Brazil, then after the final approval their names and approval details shall be send to the Competent Authorities of that country for registration. Moreover, any other country requires the list of approved establishments for registration; same will be forwarded to the concerned Competent Authority of that country by FIQCD. In case of China, the registration granted has to be renewed every four years, for which renewal application has to be submitted one year before the expiry of registration.

3.1.2.9. Export of fishery products to EU, Russia, China, Vietnam, Brazil etc will be permitted only after the name of the approved establishment/factory vessel/freezer vessel is notified by concerned overseas Competent Authority. However, after the final approval export of fishery products to other Non-EU countries where registration formalities are not required will be permitted.

3.1.2.10. In case Non-EU approved facilities intend to export fishery products to EU, they may upgrade their facilities as per the EU requirements after getting prior permission from the NCA and submit application for approval to FIQCD. In such situation, the assessment can be completed in the first stage itself and ICS officials of FIQCD can carry out assessment of infrastructure/equipment faculties and HACCP implementation in the first visit itself. No conditional approval is required in this case.

3.1.2.11. If any change in the approved processing activity, facility or in the name of approved establishments/factory vessels/freezer vessels is required, same shall be approved by NCA as specified at Cl. No 4.4 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD. In case of establishments approved for EU, Russia, China, Vietnam and Brazil, the details of change of name, approval of additional processing activity etc shall be intimated to the concerned competent authority for incorporation in their list.

3.1.2.12. Establishments intend to process aquaculture products for export shall mention this requirement in the application for approval and also in their HACCP manual. Approval to process and export aquaculture products is given by FIQCD based on the satisfactory compliance of the establishment with those requirements specified at Chapter-2, Cl. No. 2.4.3 and 2.4.4 of this regulation.

3.1.2.13. Establishments intend to handle live fishes for export shall be approved by FIQCD, for which the establishments shall also implement the requirements specified at Chapter-2, Clause No.2.6. Competent Authority shall implement the requirements specified in the draft “Standard Operating Procedures for the Responsible Movement of Live Aquatic Animals for ASEAN”, as applicable.

3.1.3. Approval of independent ice plant, independent refrigerated stores

3.1.3.1. Independent ice plants intended to supply ice to approved establishments /factory vessels/freezer vessels processing fishery products for export and independent frozen cold stores/chill rooms intended to store fishery products of approved establishments /factory vessels/freezer vessels meant for export, shall be approved by FIQCD, for which they shall comply with the minimum requirements specified at Chapter -2 , Cl. No 2.2.3 and 2.2.4 of this regulation.



3.1.3.2. The assessment for approval of ice plant and cold store can be completed in the first stage itself, as there is no requirement for conditional approval in this case.

3.1.3.3. Procedure for approval of independent ice plant and independent cold stores has been specified at Cl. No 4 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD.

3.1.3.4. After approval, unique approval number is given to each approved facility and their names will be entered in the National List and Central Registry of NCA. If the independent cold store is approved for storing fishery products meant for export to EU, the name of the approved cold store will be sent to European Commission for publication in their website.

3.2. Surveillance Visits

a) Another important official control activity of FIQCD is the monitoring of approved facilities as empowered in Section 30 of ‘Myanma Marine Fisheries Law 1990’. Procedure for official surveillance visits to the approved primary production areas and processing & allied areas has been specified at Cl. No 5 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD.

b) The visits shall be conducted unforeseen and unexpected, without giving prior information of the visits to the business operator. However, prior information needs to be given to the business operator for performing HACCP audits to ensure that the unit is processing of fishery products at the time of visit.

c) Major objective of the surveillance visits is to ensure that the business operators are maintaining the approved facilities properly and are complying with the national and international requirements and also to ensure that the products produced/ processed conform to the specification.

3.2.1. Surveillance Visits to Primary Production and Allied Areas

3.2.1.1. Primary production and allied areas including hatcheries, aquaculture farms, feed mills, fishing vessels, landing sites, auction hall, transporting vehicles etc are monitored by ICS officials of FIQCD on a laid down frequency, which is fixed based the performance of the primary producers during monitoring( Checklists specified at Annexure-8 to Annexure-12, as applicable, may be used for assessment.)

3.2.1.2. During surveillance visits, ICS officials shall ascertain that only the materials supplied/ handled by approved producers are being used for export purpose. While conducting surveillance visits to fishing vessels/landing sites, attention shall also be given to find out I.U.U activities, if any.

3.2.1.3. Infrastructure facilities, hygiene practices, personal hygiene, pest control, food /feed safety controls etc are verified during the visit to ensure that all the approved facilities are maintained properly. Records pertaining to input and output, hygiene & sanitation, personal hygiene, pest control, traceability, calibration, chemical treatments, test reports etc shall also be verified at the time of visit ,as applicable.



3.2.1.4. During surveillance visits, official samples shall be drawn by ICS officials for organoleptic evaluation and for testing following parameters on a laid down frequency: (Parameters to be tested and the frequency of testing are decided based on risk analysis. Samples for testing antibiotics are drawn as a part of NRMP monitoring)

a) Chloramphenicol, and metabolites of Nitrofurans- from product, water and feed samples from hatcheries , farms and feed mills

b) SPC and Coliforms- from water and ice from fishing vessels, landing sites and auction halls

c) SPC, E.coli, Salmonella- Product samples from fishing vessels, landing sites and auction halls

d) Organoleptic evaluation and for testing TVB-N & TMA-N in case of doubt of freshness of the sample drawn from auction hall/ landing site

3.2.1.5. Special care shall be taken during the surveillance visits to hatcheries and farms to ensure the health and welfare of aquatic animals. Implementation of proper traceability of animal movements in and out of the farms/hatcheries, Good Hygienic Practices and Animal Health Surveillance System etc shall be monitored. Spreading of exotic and non-exotic diseases, mortality rates, medical treatments, withdrawal periods, feeding habits, animal health status, non-usage of banned chemicals etc shall be closely monitored during the visit. Usage of unauthorized substances is also monitored under NRMP as per the “Official Control System Manual for the Inspection and Certification of Fish and Fishery Products” of FIQCD.

3.2.1.6. In case of detection of exotic or non-exotic diseases, illegal treatment, storage and use of unauthorized substances as specified in DOF Directive No 3/2009 and DOF Directive No 2/2014.; FIQCD officials shall prevent the harvest and/or movements of animals from the farm/hatcheries, until a detailed investigation is done to assess the health conditions of the animals and severity of the situation. After investigation, suitable decision may be taken by FIQCD depending upon the seriousness of the situation, which may include suspension of production or even withdrawal of approval.

3.2.1.7. ICS officials during surveillance visits shall ensure that the primary producers and allied operators are complying with the minimum requirements specified in the Chapter-1 of this regulation, as applicable.

3.2.2. Surveillance visits to establishments/ factory vessels/ freezer vessels, independent ice plant, independent cold store

3.2.2.1. Periodic official visits to the establishments/factory vessels/freezer vessels are performed by FIQDC to ensure that all the approved infrastructure/hygiene requirements are being maintained properly, all the regulatory requirements and those specified by the importing countries are being complied with, HACCP is in place and the products processed in the establishment conform to specification.( Checklist specified at Annexure-13 may be used for assessment)



3.2.2.2. The procedure of official visits, grading of establishments, fixing the frequency of visits, issuing Corrective Action Requests (CAR), closing of CAR, punitive action in case of failure etc have been specified at Cl. No 5 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD.

3.2.2.3. Official samples are drawn on a laid down frequency during the surveillance visits for testing different parameters as mentioned bellow, depending upon the availability of the product at the time of visit. The frequency of testing and parameters to be tested are decided based on risk analysis. ( Procedure and frequency of official sampling are given at Annexure-7 )

Parameters ProductsOrganoleptic evaluation and for testing TVB-N & TMA-N in case of doubt of freshness of the sample

Raw materials & finished product

SPC, E.coli, Coagulase +ve Staphylococcus, Salmonella, V. cholerae

Raw processed product

SPC, E.coli, Coagulase +ve Staphylococcus, Salmonella

Cooked shrimp products

SPC, Coliforms Water , ice & Swabs from food contact surfaces

Chloramphenicol, Metabolites of Nitrofurans, ,tetracycline,Oxy-tetracycline, Chlortetracycline

Aquaculture products (tested as a part of NRMP monitoring)

Cadmium, Lead, Mercury Processed product (tested as a part of NRMP monitoring)

Pesticides Aquaculture products (tested as a part of NRMP monitoring)

Histamine Histamine forming fishesSulphite & added Phosphates Processed shrimp productsParalytic Shellfish Poison (PSP) and Diarrhetic Shellfish Poison (DSP)

Shellfish belonging to Gastropoda and Bivalvia

Coagulase +ve Staphylococcus & sulphite reducing clostridium

Salt

3.2.2.4. Official inspection also include parasite checks in raw material and process samples, temperature checks on products/ equipments, checks of chlorination of water/ ice,/foot dip/hand dip etc

3.2.2.5. Traceability of raw materials, additives, ingredients etc shall be monitored closely to ensure the safety of the product. In the case of aquaculture products special care shall be taken to verify the pond/farm details and the traceability record of the farm/pond as specified at Annexure-1.

3.2.2.6. During the surveillance visits to ice plants, the quality and safety of ice shall be ensured by verifying the control measures adopted by the factory and also by testing the ice for the specified parameters on a laid down frequency. Infrastructure facilities, hygiene and sanitation, personal hygiene, pest control, records etc shall also be verified. Records pertaining to cleaning and sanitation, personal hygiene



practices, health cards, pest control, maintenance, test reports etc shall be verified during the visit.(Checklist specified at Annexure-15 may be used for assessment)

3.2.2.7. In case independent refrigerated stores, the store temperature, product temperature, data logger, calibration records, storage and dispatch records, hygiene records, personal hygiene, pest control etc are verified to ascertain that there is no temperature abuse and the product is maintained in good quality.(Checklist specified at Annexure-14 may be used for assessment)

3.3. HACCP Audits

3.3.1. FIQCD shall carry out periodic HACCP audits of establishments, factory vessel; freezer vessels approved for export of fishery products to ensure that the approved facilities are implementing food hygiene practices and HACCP based food safety system effectively. Audits may also be carried out for HACCP certification.

3.3.2. The procedure for HACCP audit specified in the ‘draft Guidelines for ASEAN Audit and Certification of Food Hygiene and HACCP’ may be followed for conducting hygiene and food safety audits.

3.3.3. Detailed audits shall be carried out in consultation with the establishment covering all areas of SSOP, GMP, SOP, HACCP etc. Validation of HACCP plan and validation of Critical limits shall also be carried out during audit. It shall be ensured that the unit is having production at the time of visit.

3.4. National Residue Monitoring Plan (NRMP)

3.4.1. DOF as the designated Central Competent Authority (CCA), is responsible for implementation of the National Residue Monitoring Plan (NRMP) for the aquaculture products meant for export. The procedure of the implementation of NRMP has been specified in the Official Control System Manual of DOF.

3.4.2. Residue Monitoring Committee (RMC) is responsible for carrying out the overall supervision to ensure effective implementation of NRMP. Inspection and Certification Section (ICS) officials are responsible for the collection of samples as per sampling schedule prepared by DOF each year for NRMP and Analytical Laboratory Section (ALS) is responsible for the analysis of samples as per the requirements specified by DOF

3.4.3. The major objectives of NRMP are ;

a) to develop a system to monitor aquaculture drugs, veterinary medicinal products and environmental contaminants in aquatic animals, larvae, animal feeds etc by analyzing samples drawn from aquaculture farms, hatcheries, feed mills and processing establishments and

b) to adopt necessary control measures to prevent the entry of contaminated products into food chain.



3.4.4. Area of monitoring under NRMP covers approved farms, hatcheries, feed mills and establishments which are involved in food chain meant for export.

3.4.5. FIQDC shall follow the sampling method, sampling frequency and sampling plan as specified in Official Control System Manual of DOF.

3.4.6. If the sample found positive on analysis, DOF shall immediately take necessary steps to prevent the contaminated product from entering the food chain. Moreover, a detailed investigation shall be carried out to find out the cause of contamination.

3.4.7. Residue Monitoring Committee (RMC) is responsible for conducting investigation and to suggest remedial measures. In case of detection of illegal treatment, the farm, hatchery and/or feed mill involved in the illegal activity shall be suspended from production, till such time DOF is satisfied that they will not repeat such activities again.

3.5. Action In Case of Non- Compliance

3.5.1. In case of non-compliance of regulatory requirements, the National Competent Authority is empowered to take suitable action against the approved facilities under Section 24 and Section 45 of Myanma Marine Fisheries Law 1990, which may include levying fee, withholding health certificates, imposing suspension or even withdrawing the approval granted for export.

3.5.2. During surveillance visits to the establishments, factory vessels, freezer vessels, Non-Conformance Ratings are given, based on which action is taken against the approved facilities as specified at Clause No 5.4 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD

3.5.3. In case of the failure of samples drawn during surveillance visits or under National Residue Monitoring Plan (NRMP), suitable steps shall be taken to prevent the contaminated product from entering the food chain and appropriate action shall be taken against the business operator based on the detailed investigation conducted to find out the cause of contamination.

3.5.4. In case of detection of diseases, illegal treatment, storage and use of unauthorized substances etc action as specified at Clause No 3.2.1.6 of Chapter -3 of this regulation shall be taken against the farms and/or hatcheries.

3.6. Procedure To Deal With Foreign Rejections

3.6.1. When a consignment of fish and fishery products is rejected or specific control measures are imposed by the importing country on food safety or quality grounds, FIQCD shall immediately communicate the matter in writing to the concerned business operator of the establishment/ factory vessel/ freezer vessel

3.6.2. Establishment/factory vessel/freezer vessel shall carry out an internal investigation/partial audit to determine the cause of rejection/ RASFF Notification and to take suitable corrective action as deemed fit.



3.6.3. Review of HACCP shall be carried out by the HACCP team in the light of the rejection and necessary amendments shall be made, if required. Details of investigation and corrective action taken by the unit shall be communicated to FIQCD

3.6.4. Meanwhile, the Incident Management Team (IMT) constituted by NCA shall also carry out a detailed investigation so as to find out the cause of rejection and also to suggest remedial measures to prevent its recurrence.

3.6.5. The constitution and the function of IMT have been specified at Clause No 7 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD. During the visit, IMT may draw samples for testing the reported contaminant from possible source(s) of contamination as decided by the team.

3.6.6. Based upon the investigation reports of the Incident Management Team (IMT) and that of the establishment/factory vessel/ freezer vessel, FIQCD shall take suitable action against the concerned unit, which may include increasing the surveillance visits, suspension of processing activities till such time the unit has done all the corrective actions satisfactorily, or even withdrawal of approval granted to the unit.

3.6.7. The business operator shall take necessary steps as per the laid down ‘recall procedure’ to withdraw the rejected product from the market at the earliest. As the Competent Authority, FIQCD shall offer necessary help to the business operator to bring back the rejected consignment from the importing country

3.6.8. The brought back consignment shall be tested for the contaminant(s) in question and based on the test report, suitable action will be taken by FIQCD. However, the returned consignment shall not be permitted for export to the country or to the group of countries where it had been rejected earlier.

3.6.9. The stock in hand products of the same production code shall be analyzed in detail and shall not be permitted for export depending upon the analytical report.

3.6.10. In case of repeated rejections due to same reason from one establishment/factory vessel/freezer vessel, the concerned unit will be suspended from producing fishery products till such time; the unit rectifies all defects suggested by IMT and demonstrates that they are capable of producing safe fishery products.

3.7 Export Certification

3.7.1. Health certificate for export to European Union

3.7.1.1. All consignment of fishery products exported to the European Union shall be accompanied by an original health certificate with unique number issued by FIQCD, the National Competent Authority duly completed, signed and dated.

3.7.1.2. The original of the health certificate is required for customs clearance at the destination and shall be made available to the customs authorities at the destination before the arrival of the consignment. The consignments cannot be cleared on the basis of a copy of the original or on the basis of a fax copy of the original. Health



Certificate meant for EU should be issued before or on the day of shipment and cannot be issued retrospectively.

3.7.1.3. As the National Competent Authority (NCA), FIQCD is responsible for the issuance of health certificate for export of fishery products meant for human consumption to EU as per the requirement of the Commission Regulation (EC) No 1250/2008/EC

3.7.1.4. Health certificates are issued only to those consignments originating from establishments/freezer vessels/factory vessels which are approved and monitored by the FIQCD as per the requirements of Regulation (EC) No.178/2002/EC, 852/2004/EC 853/2004/EC and 854/2004/EC

3.7.1.5. Procedure for the issuance of health certificate meant for export to EU has been specified at Clause No 6 of the “Official Control System Manual for the Inspection and Certification of Fish And Fishery Products” of FIQCD. Business operator shall submit the application for health certificate to FIQCD well in advance so that the certificate can be issued in time.

3.7.1.6. Each health certificate shall bear the name, designation and signature of the certifying official and the official stamp of FIQCD in a colour different from that of other endorsements. While issuing health certificate, the issuing officer must ensure that the colour of the signature is different from the colour of the ink used for printing the certificate. If the certificate is printed in black, the signature must not be in black colour. The copies of the certificate shall have the carbon impression of all entries and the signature.

3.7.1.7. Certifying official shall verify all records and connected documents including surveillance visit reports, test reports, HACCP audit reports etc to ensure the wholesomeness of fishery products certified for export and also to ensure that the unit meets all requirements of EU.

3.7.1.8. In case of aquaculture products, traceability records, NRMP test reports etc shall also be verified.

3.7.2. Health Certificate for export to Non-EU countries

3.7.2.1. Based on the request of the processor, FIQCD shall also issue the Health Certificate for consignments of fish and fishery products meant for export to Non-EU countries as per the format specified by the importing country. However, in case the importing country does not specify their own health certificate format, the generic format given at Annexure-5 may be used.

3.7.2.2. Health certificates for export to Non-EU countries can also be issued in EU format based on the request of the processor, provided if the unit meets all EU requirements and is already approved for export to EU. Some of the Non-EU countries may insist for issuance of health certificate in EU format.

3.7.2.3. While issuing health certificate for Non-EU countries, the issuing officer shall verify all documents and connected papers pertaining to the processor including surveillance reports, test reports, HACCP audit reports etc to ensure the compliance of all the



requirements of the concerned importing country. In case of export to Russia, China, Vietnam, Brazil etc, it shall be ensured that the name unit is already registered with the concerned overseas Competent Authority.

3.7.2.4. Before issuing the health certificate for Russian Federation, the certifying official shall ensure that all cartons of the consignment are sealed with quality label of FIQCD and the label of the establishment in such a manner that the opening of cartons will not be possible without damaging the seals.

3.7.3. Prevention of IUU activities and Issuance of Catch Certificate

3.7.3.1. Myanma Marine Fisheries Law 1990 dated 25.04.1990 has empowered Department of Fisheries (DOF), Union of Myanmar to take suitable action to control Illegal, Unreported and Unregulated fishing activities (IUU activities). As per the law, it is mandatory that all fishing vessels operating in Myanma Marine Fisheries Waters shall be registered with DOF and shall abide the rules and regulations issued by DOF. The officials of DOF have the power to inspect the fishing vessel at any time and can suspend or cancel the license or even confiscate the vessel, if required.

3.7.3.2. Myanmar Navy; Myanmar Coast Guard; DOF; Myanmar Customs Department; and Myanmar Police Force are involved in controlling the fishing activities and enforcing the law in Myanma Marine Fisheries Waters.

3.7.3.3. DOF has restricted fishing in various fishing grounds to maintain the sustainability of fish stock. Since waters within the 5 n.mi. mark are nursery grounds for juveniles of fish and shrimp, commercial fishing vessels, such as trawlers and fish purse seiners, are prohibited from fishing less than 5 n.mi. from the shore. Identified nursery areas have been protected and managed to ensure survival of the juveniles of commercially important fish species

3.7.3.4. FIQCD has already developed a laid down procedure for monitoring the fishing vessels and landing sites approved for handling fishery products meant for export. During surveillance visits, FIQCD officials shall monitor the illegal fishing activities

3.7.3.5. FIQCD has introduced catch certification system for fishery products of marine origin meant for export. The objectives of the catch certification is to prevent, deter and eliminate the activities of Illegal, Unreported and Unregulated fishing (IUU fishing) with a view to conserve and sustain the fish stocks and also to protect the environment.

3.7.3.6. It is mandatory that all the consignments of fish and fishery products of marine origin exported to EU shall be accompanied by a Catch Certificate issued by FIQCD.

3.7.3.7. However, fresh water and aquaculture fish and fishery products and also certain species of shell fishes are excluded from catch certification.

3.7.3.8. Business operator intends to export fishery products of marine origin to European Union shall obtain the Catch Certificate from FIQCD, the procedure of which is elaborated in the ‘EU Catch Certificate Guidelines- Myanmar, issued in September 2013.



3.8. Training

3.8.1. Conducting regular training program for their inspection and certification officials is a part of official control activity of the competent authority. As specified at Clause 3.3 of ‘the “Official Control System Manual for the Inspection and Certification of Fish and Fishery Products”, FIQCD is imparting regular training to the official inspectors of ICS to update them with the latest national and international food safety standards and requirements. They have been trained in organoleptic evaluation, sampling and analysis of fishery products, monitoring procedures, HACCP and food safety audits etc.

3.8.2. Business operators are also been given training on national and international food safety requirements, hygiene and sanitation, HACCP requirements etc in order to properly guide them for producing and exporting safe fishery products as per the international requirements.

3.9. Transparency

3.9.1. Transparency is the most important aspect of the official control activity. Development of food safety standards and official control systems shall be done in a transparent manner and all the stakeholders of the food chain shall have equal opportunity to give their contributions. Co-operation of all stakeholders is essential for the success of any food safety system.

3.9.2. Public information and public consultation are the major tools in achieving the transparency. Therefore, NCA shall have regular meetings with all the stakeholders to collect their suggestions before finalizing the standards and also to update them with the latest national and international requirements. Information may also be communicated through social media, official letters, websites etc.



3.9.3.

Chapter-IV. Import of Fish & Fishery Products4.1. General Requirements

4.1.1. Even though the importer is responsible for the quality and safety of fish and fishery products imported to the Union of Myanmar, Department of Fisheries (DOF) shall also ensure that the quality and safety parameters of the imported fishery products conforms to the requirements specified in DOF Directive No 3/2009 dated 03.04.2009.

IMPORT REQUIREMENTS

Import of Fish & Fishery ProductsCHAPTER 4



4.1.2. Fish and fishery products included in the negative list by the Department of Fisheries (DOF), Ministry of Livestock, Fisheries and Rural Development will not be permitted for import to the Union of Myanmar.

4.1.3. An importer intended to import fishery products to Myanmar from a third country shall obtain a valid license from the Department of Fisheries (DOF), Ministry of Livestock, Fisheries and Rural Development. Licensed importer can import fishery products processed by approved overseas processor having DOF registration.

4.2. Registration of Overseas Processors

4.2.1. Only those overseas establishments, factory vessels or freezer vessels, which are approved and monitored by the Competent Authority of that country, are eligible for getting registration from DOF

4.2.2. For the purpose of registration, the overseas processor shall approach the Competent Authority of that country to forward their request letter to DOF for registration along with the recommendation and a brief description of regulatory control system of the Competent Authority and also the approval details of the processor.

4.2.3. The approval details of the processor shall include;

a) name and address of the approved processor and/or exporter

b) approval number of the processing unit

c) scope of approval

d) name of countries/group of countries to where export is permitted

e) list of products approved for export

f) flow diagram and HACCP plan of each product intend to import

4.2.4. DOF shall consider the recommendation of the overseas Competent Authority after verifying the request letter and related documents. If satisfied, registration shall be granted to the concerned processor/exporter for importing fishery products to Union of Myanmar through licensed importer.

4.2.5. The details of registration shall be informed to the overseas Competent Authority with a request that any change in approval status of the overseas registered processor shall be intimated to DOF for necessary corrections. The list of overseas registered processors/exporters shall be published by DOF for information of the importers and other stakeholders.

4.2.6. If necessary, DOF may take necessary steps with the help of overseas Competent Authority to audit the registered processors of that country so as to ensure their compliance with the requirements of Union of Myanmar. Assessment of registered processors may be done by DOF officials directly or through qualified third party auditor(s).



4.3. Import Procedures

4.3.1. Licensed importers intending to import fish and fishery products meant for human consumption or for other purpose to Myanmar shall obtain prior permission from DOF by submitting details such as 1) name, address and approval number of registered overseas processor, 2) type, quantity, packages and value of fishery products meant for import, 3) details of Health Certificate issued by overseas Competent Authority as per the format given at Anneaure-3 etc

4.3.2. All the packages of the imported cargo shall be properly labelled giving details as specified at Chapter-2, Clause No.2.5.11, as applicable.

4.3.3. All documents connected to the imported cargo shall be scrutinized by DOF to ensure that the product is originating from an area/zone where epidemic diseases are not reported recently and also the product is processed in an establishment which is approved and monitored by the overseas Competent Authority.

4.3.4. 20% of the imported consignments of raw fishery products of each processor imported to Myanmar meant for human consumption shall be subjected to physical evaluation by ICS officials to assess quality and safety. However, in case of cooked products and shell fish products, 40% of imported consignments meant for human consumption will be subjected for physical evaluation. For this purpose samples are drawn for organoleptic evaluation and for testing different microbiological and chemical parameters, depending upon the type of product imported. Testing charges shall be borne by the importer.

4.3.5. Products which do not conform to the requirements of DOF Directive No 3/2009 dated 03.04.2009 shall not be given permission for entry into Myanmar. In such cases, importer shall take necessary steps to send back the rejected consignment to the country of origin.

4.3.6. Moreover, DOF shall intimate the concerned overseas Competent Authority details of the rejected consignment and the course of action taken. DOF shall also place the registered overseas processor “on alert” and test all the imported consignments of the concerned processor, till such time three consecutive consignments of the said processor got cleared on testing. Cost of testing shall be borne by the importer.

4.4. Additional requirements for import of fishery products meant for export purpose

4.4.1. Approved establishments of Myanmar willing to import fishery products for further processing and export shall also obtain necessary consent from DOF. Moreover; they shall address the processing of imported cargo in their HACCP.

4.4.2. While permitting the processing of imported cargo for export, DOF shall ensure that only those fishery products imported from an overseas EU approved processor will be permitted for export to European Union.



4.5. Additional requirements for import of aquaculture products

4.5.1. In case of aquaculture products meant for human consumption, a test report stating that the consignment is free from Chloramphenicol, Tetracycline, and metabolites of Nitrofurans shall be submitted by the importer along with the Health Certificate of the imported cargo.

4.6. Additional requirements for import of live fishes

4.6.1. Licensed importers shall follow the basic requirements of FAO’s “Asia Regional Technical Guidelines on Health Management for the Responsible Movement of Live Aquatic Animals” for the importation of live aquatic animals to avoid the introduction of new and emerging pathogens which may pose risks to the animal, plant and human health status of Union of Myanmar. The requirements specified in the draft “Standard Operating Procedures for the Responsible Movement of Live Aquatic Animals for ASEAN”, as applicable, shall also be followed

4.6.2. They shall submit Health Certificate issued by overseas Competent Authority as per the format given at Annexure-4, along with other specified documents for the import of live fishes for human consumption or for culture /ornamental purpose.

4.6.3. All the consignments of live aquatic animals will be subject to quarantine measures, where the animals are kept in isolation for physical and clinical examination by ICS officials. Only healthy and disease free animals without injury or damage are allowed for importation.

4.6.4. In case of any doubt regarding health condition of the aquatic animals, they will be further quarantined for sufficient period of time, for testing and/or treatment, the cost of which shall be borne by the importer. In such cases, Import Risk Analysis (IRA) shall also be done by ICS officials to identify the hazard(s) associated with the introduction of the particular fish variety so as to take suitable action by DOF. The results of these analyses are communicated to the overseas Competent Authority.

4.6.5. More care shall be taken while examining live aquatic animals meant for culture or for aquarium purpose, since the introduction of new pathogen may harm the entire ecosystem of the country. Likewise, more attention shall also be given while examining animals belonging to Molluscan and crustacean families, since they are more susceptible to diseases.

4.6.6. Special permission of DOF is required for importing exotic fishes that have not been introduced into Myanmar waters so far. The introduction of a new species will require special health management considerations, since scientific evidence has to be gathered regarding the risk of introducing pathogens to new areas.

4.6.7. Import of African cat fish (Clarias gariepinus) is prohibited into Myanmar territory

4.6.8. In case of import of marine ornamental fishes, the overseas competent authority needs to certify that the fishes are caught from wild from an area, which is more than 5 kilometres away from the existing aquaculture farms, and are not contaminated from aquaculture pollutants.



Annexure-ITraceability Record (pond wise)

1 General informationName of the aquaculture farm & locationApproval Number Pond Number Pond areaProduction capacity of pond2. Post Larvae/ fry/fingerlings stocked in the pondHatchery name & approval numberStocking date & quantityType of stockingPre-harvest Test Report from hatchery, if any3.Details of feed used in the pond Name of Feed Mill & approval numberType, quantity & lot no of feed utilized Test report of banned chemicals from Mill4. Therapeutic drugs useda) Drug - 1 Details of drug Disease treated Date of application with quantity Withdrawal period appliedb) Drug - 2 Details of drug Disease treated Date of application with quantity Withdrawal period applied5. Pesticide used in the ponda) Compound - 1 Details of compound Condition treated Date of application with quantity Application periodb) Compound - 2 Details of compound Condition treated Date of application with quantity Application period6. Details of Harvest from the pondDate of Harvest Quantity harvestedSodium metabisulphate treated or norDetails of Pre-harvest Test if any7. Details of supply materials harvested from the pondName and approval no of establishment(s)Quantity supplied to each establishmentMode of transportation

Place:Date: (signature with name)



Annexure-2

Format-A

Sl.No Name, No, type of enterprise(ship)

Type of Bio-resource

Volume of annual production(ton)

Volume of export to Russian Federation (ton)

Format -B

Sl.No Name, No.type of enterprise(ship)

Type ofBio-resource

Volume ofAnnualproduction(ton)

Volume of exportto RussianFederation (ton)

Name of the company- importerin the RussianFederation



Annexure-3 MODAL HEALTH CERTIFICATE FOR IMPORT OF FISHERY PRODUCTS INDENDED FOR HUMAN CONSUMPTION1.1. Name and address of consignor &

contact number:1.2 Certificate No1.3. Name ,address and contact number of the

Competent Authority issuing the Certificate

1.4. Name, address & contact number of Consignee:

1.5. Name ,address and contact number of processing establishment/ factory vessel/freezer vessel

1.6. Country of Origin !.7. Approval Number1.8 Place of loading 1.9 Date of Departure2.Product identification2.1 Product description with HS code

2.2 Nature of preservation

2.3 Date(s) of production 2.4 Net weight in Kg2.5 Total number of package2.6 Type and nature of pack2.7 Storage and transport temperature.5. HEALTH ATTESTATION The official inspector certify that the fishery/aquaculture products specified above: 3.1 were caught and handled on board vessels in accordance with the health rules specified

by Union of Myanmar as per DOF Directive No 3/2009 dated 03.04.2009 3.2 were landed, handled, processed, prepared, frozen, packed and/or stored in accordance

with the health rules specified by Union of Myanmar as per DOF Directive No 3/2009 dated 03.04.2009

3.3 have undergone health controls in accordance with the health rules specified in the “Official Control System Manual for the Inspection and Certification of Fish and Fishery Products” of FIQCD

3.4 are packed, marked ,stored and transported in accordance with the health rules specified by Union of Myanmar as per DOF Directive No 3/2009 dated 03.04.2009

3.5 have satisfactorily undergone organoleptic, parasitological, chemical and microbiological checks as per DOF Directive No 3/2009 dated 03.04.2009

3.6 are free from banned chemicals, additives, ingredients specified in DOF Directive No 3/2009 and are fit for human consumption.

3.7 come from an establishment/factory vessel/freezer vessel which is approved and monitored by the Competent Authority and had implemented HACCP.

3.8 come from aquaculture farms which are approved/registered and monitored by the Competent Authority and are free from exotic or non-exotic diseases notified by OIE

Place:Date: (signature of certifying official, with name,

designation and qualification)

(Seal of Competent Authority)

(Strike whichever not applicable)



Annexure-4MODAL HEALTH CERTIFICATE FOR IMPORT OF LIVE FISHES

1.1. Name and address of consignor & contact number:

1.2 Certificate No1.3. Name ,address and contact number of the

Competent Authority issuing the Certificate

1.4. Name, address & contact number of Consignee:

1.5. Name ,address and contact number of live fish handling establishment:

1.6. Country of Origin !.7. Approval Number1.8 Place of dispatch 1.9 Date of Departure1.10 Mode of transportation 1.11. Place of arrival2.Product identification2.1 Description of animal with Species name:2.2 Nature & type of packing:2.3. Net weight in Kg:2.4.Total number of package:2.5.Whether for human consumption/ for culture/ ornamental purpose:

3. HEALTH ATTESTATION The official inspector certify that the live aquatic animals specified above: 3.1

are caught, handled and/or packed hygienically in an establishment approved and monitored by the Competent Authority.

3.2

are examined within seven days before loading and found to be healthy and free from any clinical signs of disease

3.3

originate from an area or a zone or an aquaculture farm that has been subject to an official fish health surveillance system equivalent to the relevant OIE standard and is officially recognized as being free from Spring viraemia of carp (SVC), Koi herpesvirus disease (KHV), Epizootic ulcerative syndrome (EUS), Epizootic haematopoietic necrosis (EHN) and White spot disease (WSD).

3.4

are wild caught from an area, which is more than 5 kilometres away from the existing aquaculture farms, and is not contaminated from aquaculture pollutants.

3.5

are free from microbial, chemical or parasitic contamination and are fit for human consumption

Place:

Date: (signature of certifying official, with name, designation and qualification)





Annexure-5

GENERIC HEALTH CERTIFICATE FOR EXPORT OF FISHERY PRODUCTSINDENDED FOR HUMAN CONSUMPTION

1. Name, address and contact number of the Competent Authority issuing the Certificate

1.1. Certificate No

2. Provenance of the fishery products2.1.Name ,address and contact number of processing establishment/ factory vessel/freezer vessel & Approval Number2.2. Country of Origin & ISO code2.3. Country of transit2.4. Date of Departure 2.5. Means of Transport.2.6. Name and address of consignor & contact

Number. 3. Destination of the fishery products3.1 .Name, address & contact number of Consignee3.2. Country & Place of Destination4. Product Identification4.1 Product description with HS code4.2 Nature of preservation4.3 Date(s) of production 4.4 Net weight in Kg4.5 Number of package & Type and nature of pack4.6 Storage and transport temperature.4.7 Container identification / Seal no.

5. Health AttestationThe official inspector certify that the fishery/aquaculture products specified above: 5.1

have been handled, prepared or processed, identified,labeled, stored and transported under a competent HACCP and sanitary programme consistently implemented and in accordance with the requirements laid down in Codex Code of Practice for Fish and Fishery Products (CAC/RCP 52-2003)

5.2

come from an establishment/factory vessel/freezer vessel which is approved and monitored by the Competent Authority.

5. 3

have undergone health controls in accordance with the laid down health rules and the product is fit for human consumption.

5.4

come from aquaculture farms which are approved/registered and monitored by the Competent Authority and are free from exotic or non-exotic diseases notified by OIE

Place:

Date: (signature of certifying official, with name, designation and qualification)



\



Annexure-6PRODUCT STANDARS OF MAJOR IMPORTING COUNTRIES

I. REQUIREMENTS OF EUROPEAN UNION

Chemical Requirements for Fish & Fishery Products

List of Analysis Fish & Fishery Products Maximum LevelAntibiotic, Drug and Chemical Residue

Chloramphenicol 1. Aquaculture Fish, Aquaculture Shrimp, Crab

MRPL = 0.3 ppb

2. Dried fish (except dried anchovy and dried tuna) and Dried shrimp3. Fermented fish

MRPL = 0.1 ppb

Malachite Green and Leuco- Malachite Green

1. Aquaculture Fish and Aquaculture Shrimp

MRPL = 1 ppb

2. Dried fish (except dried anchovy and dried tuna)3. Fermented fish

MRPL = 0.8 ppb

Nitrofuran metabolities

1. Aquaculture Shrimp, Aquaculture Fish, Crab

MRPLAOZ, AMOZ, AHD,

SEM= 1 ppb

2. Dried fish (except dried anchovy and dried tuna) and Dried shrimp3. Fermented fish

MRPL AOZ, AMOZ, AHD,

SEM= 0.5 ppb

Oxolinic acid Aquaculture Fish (Muscle and skin in natural proportions)

0.1 ppm

Fluroquinolone Aquaculture Fish,Aquaculture Shrimp

Difloxacin = 300 ppbSum of Enrofloxacin and Ciprofloxacin =

100 ppbFlumequine = 600

ppbSarafloxacin = 30

ppbDanofloxacin = 100

ppbHeavy Metal Cadmium 1. Muscle meat of Fish

(except those in 2) and Surimi Based

0.05 ppm

2. Muscle meat of 2.1 Anchovy(Engraulis species)2.2 Bonito (Sarda sarda)2.3 Common two-bandedSeabream (Diplodus vulgaris)

0.1 ppm



Heavy Metal

(continued)

Cadmium 2.4 Eel (Anguilla Anguilla)2.5 Grey Mullet(Mugil labrosus labrosus2.6 Horse Mackerel or Scad(Trachurus species)2.7 Louvar or luvar2.8 Sardine (Sardina pilchardus)2.9 Sardinops (Sardinops species)2.10 Tuna (Thunnus Species, Euthynnus species, Katsuwonus pelamis)2.11 Wedge sole(Dicologoglossa cuneata)

0.1 ppm

0.1 ppm

3. Swordfish (Xiphias gladius) 0.3 ppm4. Crustaceans: muscle meat from appendages and abdomen (excluding crab and crab-like)

0.5 ppm

5. Crabs and crab-like crustaceans (brachyuran and Anomura): muscle meat from appendages

0.5 ppm

6. Bivalve Molluscs, Cephalopods (without viscera), Seafood mix and Surimi Based mix with Seafood7. Dried Cephalopod

1.0 ppm

Heavy Metal

Lead 1. Muscle meat of Fish 0.3 ppm2. Crustaceans: muscle meat fromappendages and abdomen (excluding crab and crab-like) 3. Crabs and crab-like crustaceans (brachyuran and Anomura): muscle meat from appendages

0.5 ppm

4. Bivalve Molluscs 1.5 ppm5. Cephalopods (without viscera) 1.0 ppm

Mercury 1. Fishery products (except those in 2)2. Dried Anchovy, Dried Fish3. Salted mackerel4. Fish4.1 Angler Fish (Lophius spp.)4.2 Atlantic Catfish (Anarhicha lupus)4.3 Bonito (Sarda sarda)4.4 Eel (Anguilla species)4.5 Emperor, Orange roughy, Rosy soldierfish (Hoplostehus species)4.6 Grenadier (Coryphaenoides ruperstris)4.7 Halibut (Hippoglossus hippoglossus)4.8 Marlin (IMakaira species)4.9 Megrim (Lepidorhombus species)

0.5 ppm

1.0 ppm

Mercury 4.10 Mullet (Mullus species)4.11 Pike (Esox lucius)4.12 Plain bonito (Orcynopsis unicolor)4.13 Poor Cod (Tricopterus minutes)4.14 Portuguese dogfish (Centroscymnus coelolepis)4.15 Rays (Raja species)4.16 Red fish (Sebastes marinus, S.mentella, S. viviparous)4.17 Sail fish (Istiophorus platypterus)

1.0 ppm



4.18 Scabbard fish (Lepidopus Caudatus, Aphanopus carbo)4.19 Seabream, Pandora(Pagellus species)4.20 Shark (all species)4.21 Snake mackerel or Butter fish (Lepidocybium flavobrunneum, Ruvettus pretiosus, Gempylus serpens)4.22 Sturgeon (Acipenser species)4.23 Sword fish (Xiphias gladius)4.24 Tuna (Thunnus species, Euthynnus species, Katsuwonus pelanis )5. Crustaceans : muscle meat from appendages and abdomen(excluding crab and crab-like)6. Crabs and crab-like crustaceans (Brachyuran and Anomura): muscle meat from appendages7. Dried anchovy and dried tuna8. Dried fish (except dried anchovy and dried tuna)9. Salted mackerel

0.5 ppm

Food Additive

Benzoic and Sorbic acid

Cooked Shrimps 2,000 ppm

EDTA Canned Crustaceans, Molluscs and Cephalopos 75 ppmPhosphate Frozen Fish fillets, Molluscs, Crustaceans, Fish paste,

Crustean paste and Sueimi Based0.5 %

Surimi and Canned Crustances 0.1%Sulferdioxide Frozen Crustaceans 150 ppm

Canned / CookedShrimps and Crabs

50 ppm

Quality Index

Histamine 1. Histamine poisoning fish: Tuna, Mackerel, Sardine, Saba, etc.2. Dried Anchovy & Dried Tuna3. Fish Sauce4. Salted Mackerel

n = 9, c = 2

m = 100 ppm

M = 200 ppm

Biotoxin

(Analyzed from Raw Material)

ASP Bivalve Molluscs 20 ppm

AZA Bivalve Molluscs 0.16 ppm

DSP & PTX Bivalve Molluscs 0.16 ppm

PSP Bivalve Molluscs 0.8 ppm

YTX Bivalve Molluscs 1 ppm

Note :

MRPL = Minimum Required Performance Limit follow by EU Directive Histamine analysis| n = number of units comprising the sample | c = number of sample units giving values over m or between m and M

II. Microbiological requirements for Fish & Fishery Products- EU

Product TPC E. coli S. aureus V. V. Salmonell L.



CFU/g CFU/g cholerae/25g

parahaemolyticusMPN/g

a spp./25g

monocytogens/25g

Raw fish:(Cooked before consumption)

n = 5, c = 2m = 5x106

M = 5x107

n = 5, c = 2 m = 11M = 500

MPN/g

n = 5, c = 2 m = 103 M = 104

n = 5, c = 0m = 0

NT n = 5, c = 0m = 0

NT

Raw crustaceans:(Cooked before consumption)

n = 5, c = 2m = 5x106

M = 5x107

n = 5, c = 2 m = 11M = 500

MPN/g

n = 5, c = 2 m = 103 M = 104

n = 5, c = 0m = 0

NT n = 5, c = 0m = 0

NT

Cooked fish:(Ready to eat: consumption without further cooking)

n = 5, c = 2m = 1x105

M = 1x106

n = 5, c = 2 m = 1M = 10

CFU/g

n = 5, c = 2 m = 102 M = 103

n=5, c=0m= 0

n=5 c=0 m= <3

n = 5, c = 0m = 0

n = 5, c = 0

m = 0

Cooked crustaceans:(Ready to eat: consumption without further cooking)

n = 5, c = 2m = 1x105

M = 1x106

n = 5, c = 2 m = 1M = 10

CFU/g

n = 5, c = 2 m = 102 M = 103

n=5, c=0m= 0

n=5 c=0 m= <3

n = 5, c = 0m = 0

n = 5, c = 0

m = 0

*Note: NT = Not tested, n = number of sample units, m = minimum amount of bacteria for good quality product, M = maximum recommended bacteria for products of marginal quality, c = Number of sample units giving values between m and M.

III. REQUIREMENTS OF PEOPLE’S REPUBLIC OF CHINA


List of Analysis Fish & Fishery Products Maximum



LevelBiotoxin

(Analyzed from Raw Materials)

DSP Bivalve Molluscs 0.6 ppm

PSP Bivalve Molluscs 0.8 ppmAntibiotic and Drug Residue

Oxolinic acid 0.1 ppm

Oxytetracycline 0.2 ppm

Food Additive Benzonic acid and Sorbic acid

2,000 ppm

Heavy Metal Cadmium Fishery Products (Excluding canned fish) 0.1 ppm

Canned Fish 0.2 ppm

Frozen/Canned Crustaceans 0.5 ppm

Frozen/Canned Molluscs & Cephalopods 2.0 ppm

Lead Fishery and Crustaceans 0.5 ppm

Frozen/Canned Molluscs, Cephalopods, Other fish products

1.0 ppm

Mercury Fishery Products (excluding predatory fish) 0.5 ppm

Predatory Fish; Tunny, Shark and others 1.0 ppm

Quality Index Histamine Histamine Poisoning Fish: Tuna, Mackerel, Sardine, Saba, etc.

100 ppm

TVB-N Frozen Uncooked Marine Fish, Marine Crustaceans, and Marine Cephalopods

30 mg %

Frozen Uncooked Freshwater Fish and Freshwater Crustaceans

20 mg %

Frozen Uncooked Crab 25 mg %

Microbiological requirements for Fish & Fishery Products

Microbiological requirements for Fish & Fishery Products- ChinaProduct TPC

CFU/g

Coliforms

MPN/100g

E. coliMPN/100g

S. aureusMPN/g

V. cholerae

/25g

Salmonella spp./25g

L. mono-*/25g

V. para**MPN/g

All Fishery Products: (Cooked before consumption

1x106 NT < 30 NT n = 5, c = 0

m = 0

n = 5, c = 0

m = 0

n = 5, c = 0

m = 0

Negative

Ready to cook:(Prepared fishery products for cooking)

5x104 NT < 30 Negative

n = 5, c = 0

m = 0

n = 5, c = 0

m = 0

n = 5, c = 0

m = 0

Negative

Ready to eat:(Cooked fishery products for consumption)

3x103 NT < 30 Negative

n = 5, c = 0

m = 0

n = 5, c = 0

m = 0

n = 5, c = 0

m = 0

Negative



Note: L. mono-* = L. monocytogens, V. para** = Vibrio parahaemolyticus

IV. REQUIREMENTS OF JAPAN


List of Analysis Fish & Fishery Products Maximum LevelBiotoxin (Analyzed from Raw Materials)

DSP Bivalve Molluscs 0.05 MU/g

PSP Bivalve Molluscs 4 MU/g

Antibiotic, Drug and Chemical Residue

Oxytetracycline Aquaculture Fish, Aquaculture Shrimp and Raw consumption Oysters

0.2 ppm

Chloramphenicol a Aquaculture Fish,

Aquaculture Shrimp

0.5 ppb

Nitrofuran metabolites a Aquaculture Fish,

Aquaculture Shrimp

1.0 ppb

Oxolinic acid Aquaculture Crustaceans 0.03 ppm

Aquaculture Fish 0.05 ppm

Salmon and Trout 0.1 ppm

Malachite Green and b

Leuco-malachite green

Aquaculture Fish, Aquaculture

Shrimp and Snapping turtle

2.0 ppb

Fluoroquinolone a Aquaculture Fish, Aquaculture

Shrimp

Difloxacin 300 ppb

Enrofloxacin 100 ppb

Flumequine 500 ppb

Sarafloxacin 30 ppb

Danofloxacin 100 ppb

Heavy Metal

Mercury Fishery Products 0.4 ppm

Food Additive

EDTA Canned Fishery Products (Excluding Canned Fish)

250 ppm

Sorbic acid Fish past products (excluding surimi)

2,000 ppm

Sulferdioxide Crustaceans 100 ppm

Note: In case of seafood mix and surimi based mix with seafood analyse only in aquaculture shrimp/fish parts.

If products contain Malachite Green and/or Leuco-Malachite Green > 0.5 ppb to ≤ 1.00 ppb, gathering of information will be required to determine deliberate use in Canada.



V. Microbiological requirements for Fish & Fishery Products- Japan

Product TPCCFU/

g

Coliforms

MPN/g

E. coliMPN/g

S. aureusMPN/g

V. cholerae

/25g

Salmonella spp.

/25g

L. monocyt

ogens/25g

Raw fish:(Cooked before consumption

<1.0 x 107

NT 500 1.0 x 103 n = 5,c = 0 m = 00

n = 5,c = 0 , m =

0

NT

Raw crustaceans:(Cooked before consumption

<1.0 x 107

NT 500 1.0 x 103 n = 5,c = 0 m = 0

n = 5,c = 0 m = 0

NT

Raw seafood mix:(Cooked before consumption

< 1.0 x 105

NT 500 1.0 x 103 n = 5, c = 0 m =

0

n = 5, c = 0

m = 0

NT

Ready to cook:(Prepared fish and fishery products for further cooking)

< 1.0 x 105

Negative

NT Negative n = 5, c = 0

m= 0

n = 5, c = 0

m = 0

NT

Ready to eat:(Cooked fish and fishery products)

< 5.0 x 104

Negative

NT Negative n = 5, c = 0

m= 0

n = 5, c = 0

m= 0

n = 5, c = 0

m= 0

Note: NT = Not tested, n = number of sample units, m = minimum amount of bacteria for good quality product, M = maximum recommended bacteria for products of marginal quality, c = Number of sample units giving values between m and M.

VI. REQUIREMENTS OF UNITED STATES OF AMERICA


List of Analysis Fish & Fishery Products Maximum Level



Biotoxin DSP Shell Fish 0.2 ppm okadaic

acid plus 35-methy

okadaic acid

PSP All Fish 0.8 ppmNSP Shell Fish 0.8 ppmASP All Fish 20 ppm domoic

acid Ciguatera All Fish 0.01 ppb CTX

equivalent Antibiotic and Drug Residue

Sulfadimethoxine/ ormetoprim combination

Salmonids and Cat fish 0.1 ppm for each

Oxytetracycline Finfish & lobster 2.0 ppm

Florfenicol Salmonids and Cat fish 1.0 ppm

Chloramphenicol; Dimetridazole, Nitroimidazoles; Furazolidone, Nitrofurazone, and other nitrofurans;

All Fish No residue

permitted

Heavy Metal Cadmium Crustacean 3.0 ppm

Lead Crustaceans 1.5 ppm

Methyl Mercury All Fishes 1.0 ppm

Chromium Crustacean 12 ppm

Nickel Crustacean 70 ppm

Quality Index Histamine Histamine forming fishes 50 ppmPesticide residues

Aldrin/ Dieldrin All Fishes 0.3ppmBenzene hexachloride

Frog legs 0.3ppm

Chlordane All Fishes 0.3ppmChlordecone All Fishes 0.3ppmDDT, TDE, DDE All Fishes 5.0 ppmFluridone Finfish & Crayfish 0.5ppm

Microbiological requirements for Fish & Fishery Products

Contaminants Levels Food commodity ReferenceSalmonella Absence /25 g All fishes Compliance Policy Guide

(555.300)Staphylococcus aureus

104/ 1g (MPN) All fishes Compliance programme 7303.842

Clostridium Absence of viable spore & All fishes Compliance programme



botulinum toxin 7303.842E.Coli 1x 103/ 1g Ready to eat fishery

products-do-

Listeria moncytogenes

Absent -do- -do-

Vibrio cholera Absent -do- -do-

Vibrio parahaemolyticus

1x 104/ 1g -do- -do-

VII. REQUIREMENTS OF OTHER COUNTRIES


List of Analysis Fish & Fishery Products Maximum LevelAntibiotic, Drug and Chemical Residue

Chloramphenicol Aquaculture Fish,Aquaculture Shrimps, Crab

Not Detected

Nitrofuran metabolities

Aquaculture Fish,Aquaculture Shrimps, Crab

Not Detected

Malachite Green and Leuco- Malachite Green

Aquaculture Fish and Aquaculture Shrimps

0.5 ppb

Oxolinic acid Aquaculture Fish and Shrimps Not DetectedOxytetracycline Aquaculture Fish and

Aquaculture Shrimps0.1 ppm

Food Additive

EDTA Canned Crustaceans, Molluscs and Cephalopods

250 ppm

Sulfurdioxide Frozen Uncooked Crustaceans 150 ppmFrozen Cooked/Canned Crustaceans

50 ppm

Heavy Metal

Cadmium Molluscs, Cephalopods, Seafood mix and Surimi Based mix with Seafood

1.0 ppm

Fish, Crustaceans and Surimi Based

0.2 ppm

Lead Fish, Crustaceans, Molluscs, Cephalopods, Seafood mix and Surimi Based mix with Seafood

2.0 ppm

Mercury Fish, Crusteans, Molluscs, Cephalopods, Seafood mix and Surimi Based mix with Seafood

0.5 ppm

Quality Index

Histamine Histamine poisoning fish; Tuna, Mackerel, Sardine, Saba, ect.

100 ppm

I. Microbiological requirements for Fish & Fishery Products



Product TPCCFU/g

E. coliMPN/

g

S. aureusMPN/g

V. chlorae

/25g

V. para*MPN/g

Salmonella spp./25g

L. mono-**

/25g

Shigella***

/25gRaw Fish:(Cooked before consumption)

NT 10 100 NT NT n = 5, c = 0m = 0

NT n = 5, c = 0

m = 0Raw Crustaceans:(Cooked before consumption)

NT 10 100 NT NT n = 5, c = 0m = 0

NT n = 5, c = 0

m = 0

Ready to cook:(Prepared fish and fishery products)

5x105 10 100 NT NT n = 5, c = 0m = 0

NT n = 5, c = 0

m = 0

Ready to eat:(Cooked fish and fishery products)

5x104 <3 <100 n = 5, c = 0

m = 0

<100 n = 5, c = 0m = 0

n = 5, c = 0

m = 0

n = 5, c = 0

m = 0

Note: V. para*** = Vibrio parahaemolyticus L. mono-** = L. monocytogens Shigella*** only for GCC.

II Microbiological Requirement of Traditional Fishery Products for all Countries

Product TPCCFU/g

Yeast & MouldCFU/g

S. aureusMPN/g

V. cholerae/25g

C. Perfringen/0.1g

Salmonellaspp./25g

Fermented shrimp paste

NT <1,000 <3 n = 5 c = 0m = 0

10 n = 5 c = 0m = 0

Dried cephalopods

NT <1,000 <100 NT ND n = 5 c = 0m = 0

Dried fish NT <1,000 <100 NT ND n = 5 c = 0m = 0

Dried other fisheries product

NT <1,000 <100 NT NT n = 5 c = 0m = 0

Dried other fisheries product (Ready to eat)

<50,000 <200 <100 n = 5 c = 0m = 0

NT n = 5 c = 0m = 0

Fermented fish(Ready to eat)

<50,000 <200 <100 n = 5 c = 0m = 0

ND n = 5 c = 0m = 0



Salted fish (Fresh)

NT <1,000 <100 NT ND n = 5 c = 0m = 0

Traditional other fisheries product (Ready to eat)

<50,000 <200 <100 n = 5 c = 0m= 0

ND n = 5 c = 0m= 0

III Reference documents

1. AQSIQ, 2010. Safety qualification for agriculture product-safety requirement for non-environment pollution aquatic products, GB 18406,4:p,66-71

2. COMMISSION RECULATION (EC) No 1441/2007. Amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs. & Regulation (EC) 466/2001, 2377/90

http://www.fsai.ie/uploadedFiles/Consol_Reg2073_2005.pdf

3. Fishery Products and Prepared Products: A-40, Element Standards of marine Products (abstract) under the Food Sanitation Law.

https://www.jetro.go.jp/en/reports/regulations/pdf/foodext201112e.pdf

4. Recommended microbiological limits for fish and fishery products (ICMSF,1986).

http://seafood.ucdavis.edu/haccp/compendium

5. Department of Fisheries, 2004. Quality Reference Criteria, Fish Inspection and Quality Control Division, Department of Fisheries,Thailand. August 2004, revision 2

6. USFDA- “Fish and Fishery Products Hazards and Controls Guidance”

Annexure- 7SAMPLING TECHNIQUES

1. PROCEDURE FOR OFFICIAL SAMPLING OF FISHERY PRODUCTS

a) For microbiological analysis

1) Arrange sampling tools such as sampling records, isolation box, medical gloves, spirit lamp, cotton, scooper/scissors/knifes; sterile dishes and 70% alcohol containing spray bottles, ice, marker, labels etc

2) During the surveillance visit, Inspectors shall change the uniforms which are provided by the factory before entering the cold storage for taking official samples.

http://seafood.ucdavis.edu/haccp/compendium

https://www.jetro.go.jp/en/reports/regulations/pdf/foodext201112e.pdf

http://www.fsai.ie/uploadedFiles/Consol_Reg2073_2005.pdf



3) Inspectors have to check the previous sampling records and also the monthly sampling schedule to ascertain the number of samples and type of products to be sampled during the visit for microbiological analysis.

4) Inspectors shall inform the factory regarding the type of product and the quantity to be sampled. 5) Inspectors shall select the cartons from the cold storage for sampling on random basis. They

shall select five master cartons of each type of product. Since a minimum of five samples are required for microbiological analysis for each type of product (n = 5), select one packet/ inner carton from each master carton for microbiological testing after sanitizing the hands.

6) The sample size for microbiological factors is 500 grams. Therefore, if the quantity of the packet so selected for sampling from the master carton is less than 500 gms, inspector shall take 2 such packets from each master carton so as to ensure the sample size.

7) In case, the quantity of the unit selected for sampling from the master carton is more than 1 Kg (Ex:- IQF pack), inspector shall open the packet and collect 500 g of the products into sterile dish(s) aseptically, wearing medical gloves and sanitizing hands using 70% alcohol. In case of non-availability of medical gloves, the inner side of plastic bags used for packing fishery products may be used to cover the hand. In case of block frozen products, the frozen block is scooped/sized using sterilized scooper/knife/scissor and 500 gm of material is collected in sterilized dish(s).

8) The samples so collected shall be properly labeled to identify the sampled lot, place & date of sampling, sampled person etc. Frozen samples are placed in the insulated box/ isolation box with sufficient quantity of ice to maintain temperature below 4°C. Samples of dry, sterilized products are kept in separate isolation box without ice. Seal the box with official seal/ paper seal and send to the Laboratory for analysis. While sealing the box the signatures of the inspector and the food business operator shall be affixed on the seal.

9) On arrival at the lab, laboratory staff shall ensure that the seal is intact and record the details and conditions of all samples received. In case of any delay in analysis, keep frozen samples in freezer at -18˚C and samples of dried and canned products at room temperature in lockable condition.

b) For chemical analysis

1) Arrange sampling tools such as sampling records, insulated box, gloves, knife/ scissor/scooper, cotton, clean plastic bags, cutting board, ice, marker pen, labels etc

2) Inspectors have to check the previous sampling records and also the monthly sampling schedule to ascertain the number of samples and type of products to be sampled during the visit for chemical analysis and the same shall be informed to FBO.

3) Quantity of samples to be collected:

Product Parameters to be tested Sample size

Whole fish(fresh water / sea water ) lead, cadmium and mercury 1 Kg

Fish meat and shrimp choramphenical, nitrofuram and malachite green

500 gm

Fish meat and shrimp Antibacterial substance such astetracycline,oxytetracycline.

500 gm

Fish meat(histamine forming fishes) Histamine 500 gm x 9

Whole fish and shrimp Pesticide like DDT, Aldrin, Dieldrin etc

1 Kg

Shrimp/prawn Sulphurdioide 100 gm



4) Select cartons as per the sampling scale from the lot at random. Collect required quantity of the product in the clean plastic bag. Label the bag properly to identify the sampled lot, place & date of sampling, sampled person etc.

5) Frozen samples are placed in the insulated box with sufficient quantity of ice to maintained temperature below 4°C. Samples of dry, sterilized products are kept in separate box without ice. Seal the box with official seal/ paper seal and send to the Laboratory for analysis. While sealing the box the signatures of the inspector and the food business operator shall be affixed on the seal.

6) On arrival at the lab, laboratory staff shall ensure that the seal is intact and record the details and conditions of all samples received. In case of any delay in analysis, keep frozen samples in freezer at -18˚C and samples of dried and canned products at room temperature in lockable condition

7) Sampling for chemical and microbiological analysis may be done simultaneously.

2. PROCEDURE FOR SAMPLING OF WATER

1. Arrange the sampling tools such as 500ml sterile bottles, 70% alcohol spray bottle, spirit lamp, cotton, sampling records, ice, label, marker and insulated box

2. Inspectors shall wear uniform while entering the factory and sanitize their hands prior to the collection of water samples.

3. Inspector shall record the details such as source of water, place of collection of water, serial number of the tap etc. before the collection of water.

4. Inspector shall flame the tip of the tap for sterilization and open the tap to let the water run out for 15 seconds before the collecting water in the bottle.

5. Remove lid of the sterilized bottle with one hand and while holding lid with one hand, fill bottle with other hand. The opening and closing of the sterile bottle must be done with meticulous care to avoid any contamination. (Eg: Do not adjust water line or water flow rate before taking sample. Do not rinse bottle prior to sampling. Be careful not to touch sides or inside lid of bottle)

6. Do not overfill the bottle. Make sure that there is approximately 1 inch of air space at top of container to allow for adequate shaking prior to analysis. After collecting sufficient quantity of water, immediately replace lid tightly.

7. If sample is to be taken from chlorinated water supply, it is important that any trace of chlorine should be neutralized immediately after collection. For this purpose, a crystal of sodium thiosuphate (Na2SO3) or 0.1ml.of 2% solution of thiosuphate introduced into the sampling bottle prior to sterilization serves neutralization of chlorine.

8. Proper labelling shall be done to identify the source of water, place & date of sampling, name of inspector etc. The water bottle is placed inside the insulated box with ice and the box is sealed properly.

9. On arrival at the lab, laboratory staff shall ensure that the seal is intact and record the details and conditions of the sample received.Immediately before testing, the water sample should be mixed thoroughly by inverting the bottle several times. Thereafter, some of the contents are poured off, the stopper is replaced and the bottle is shaken once again vigorously.

3.PROCEDURE FOR SAMPLING OF ICE

1. Arrange the sampling tools such as 1000 ml capacity sterile container, 70% alcohol spray bottle, spirit lab, cotton, sampling records and insulated box/ transportation box, scooper, medical gloves etc

2. Inspectors shall wear uniform while entering the factory and sanitize their hands prior to the collection of ice samples

3. Inspector shall record the details such as source of ice, type of ice etc. before the collection of ice.



4. Collect approximately 500 gms of ice in sterile container aseptically. In case of block ice, the ices is scooped/ broken to desired sizes using sterile scooper or other tools and collect the required quantity of ice. Care shall be taken to avoid cross contamination.

5. Label the sample properly to identify the source of ice, place & date of sampling, name of inspector etc. Place the sample in the insulated box and the box is sealed before sending to lab

6. On arrival at the lab, laboratory staff shall ensure that the seal is intact and record the details and conditions of the sample received

.

4. PROCEDURE FOR COLLECTING SWAB SAMPLES

1. Arrange sampling tools such as steel template 25cm2 (square 5x5 cm), bottles containing sterilized 10 ml buffer solution, sterilized cotton sticks (1g of cotton), spirit lamb, forceps, transportation box, ice, medical gloves and 70% alcohol spray bottles.

2. Inspectors shall wear uniform while entering the factory and sanitize their hands prior to the collection of swab samples.

3. Swab samples from food contact surfaces are taken after the routine cleaning of the contact surfaces. Sterilize the template by alcohol flaming. Place the sterile template on the food contact surface from where swab sample is to be taken. Dip the sterile cotton stick in the 10 ml buffer solution and wipe the food contact surface inside the template from one side to other side slowly and repeat the wiping to ensure that all areas inside the template is covered. Place the swab immediately in the buffer bottle, close the lid and pull stick to release the swab into the buffer solution.

4. For analysis of V.cholerae from worker’s hand separate swab shall be collected. Swab from the worker’s hand shall be drawn from different parts of hand aseptically and immediately transferred into a flask containing 100 ml. of sterile alkaline peptone water at pH 8.6.

5. Label the sample properly to identify the food contact surface, place & date of sampling, name of inspector etc. Place the sample in the insulated box with ice and the box is sealed before sending to lab

6. On arrival at the lab, laboratory staff shall ensure that the seal is intact and record the details and conditions of the sample received

5. SAMPLING FREQUENCY AND RESPONSIBILITY

a) Sampling frequency for microbial tests of official control samples

Matrix Status of Processing Plant Frequency (for each factory)

Responsibility

Water & Ice

All EU & Non-EU processing plants

Quarterly ICS Inspector & Lab personnel

Products 1.EU and Non-EU active Processing Plants2. Others Processing Plants

Monthly

Quarterly

ICS Inspector

Swabs All EU and Non-EU Processing Plants

Quarterly ICS Inspector & Lab personnel

NOTE: The Fisheries Inspector of ICS is responsible for planning and conducting the sampling at the processing factories.

b) Sampling frequency for chemical tests of official control samples

Test Parameter Product FrequencyVeterinary Drugs- Nitrofurans- Chloramphenicol

1.Aquaculture

2. Wild catch

1.quarterly

2.once in a year



- Malachite Greenand Leuco Malachite GreenHeavy Metals- Mercury - Cadmium- Lead

1.Aquaculture & Wild catch (Frozen product)

2.Cephalopods

1.Two times a year

2.Everyshipment(EU)

Histamine Only scombroid (high histamine)Fishes (Frozen product)(Tuna, Mackerel, Platu, Anchovy, Sardine)

Every shipment

Pesticide-DDT-Aldrin-Dieldrin

Aquaculture & Wild catch (Frozen product)

Quarterly (As per area based survey system)

Sulfide Freshwater Prawn & Marine water shrimp (Frozen product)

Quarterly

NOTE : (1)Factory Side :- The Fisheries Inspector of ICS and Laboratory personal are responsible for planning and to conduct the sampling at the processing factories.

(2)Farm level of Official Control for Aquaculture products under NRMP:- The Aquaculture Department Surveillance and Monitoring Team (AQ.MST) is responsible for planning and conducting the sampling at farm level and the ICS Inspector is responsible for planning and conducting sampling at the processing factories according to annual National Residues Monitoring Programme.

Based on the Annual Sampling Plan, AQMST and ICS officials shall ensure that the sampling is done as per the schedule unforeseen and unexpected. Ensure that all samples are collected from farms, hatcheries, feed mills, factories etc as per monthly schedule and same is tested for different parameters specified in the National Plan.

They shall also collect data from Township Fisheries Officers about production cycles of the farms involved and species cultivated in each farm with quantity produced.

Annexure- 8Inspection Checklist for Fish and Fishery Products

Hatchery

1. Company & Inspection Details

Company Name: Approval No.



Location Address:

Business Activity:

Contact Person:Phone:Email:

2. Activity of the Hatchery

Nature of Hatchery

Size of hatchery

Targeted Species:

Production capacity

Name(s) of approved farm(s) to where seed is supplied

3. Inspection Details

Inspection Date/Ref No.:

Lead Inspector:

Other Inspectors:

Scope of Inspection:

Targeted Elements:

Results of previous inspection

NCs closed/open

H 01: Surroundings, Location and ConstructionElements to be checked OK? MI SE CR Observations /

Comments

1. Location (To protect Aquatic animals from contamination from surroundings)

1.1. Location is environmentally suitable area and no disease reported in rear by areas



Elements to be checked OK? MI SE CR Observations / Comments

Reg. 852/2004, Annex I, chapter II.2

2. Water (To protect Aquatic animals from contamination)

2.1. Availability of unpolluted, good quality of sea water and fresh water.

Reg 852/2004, Annex II, chapter I-5

3. Layout and design (To ensure that adequate conditions are in place for implementation of good hatchery practices)

3.1. Hatchery is used for seed production only

3.2. Hatchery design and layout prevents cross contamination

3.3. Septic tanks, toilet facilities and bathrooms/showers are constructed and placed so drainage do not poses a risk for contamination of hatchery facilities

3.4. Equipment such as rearing tanks, filters, aerators etc are designed and constructed to ensure minimal physical damage to fish and to allow for adequate cleaning and disinfection

Reg 852/2004, Annex I, chapter II.3a, 3b, 4f

4. Facilities

4.1. The tanks are of suitable size, shape, depth, and made up of materials which do not cause harm or injury to the animal reared.

4.2. Tanks/ponds are designed for easy drainage & cleaning

4.3. Ponds have adequate depth to maintain seasonal water quality parameters and thermal stability

Reg 852/2004, Annex I chapter II.4gReg. 183/2005, Annex IIIReg 88/2006 Art 34Reg. 852/2004 Annex I, Chapter II.3a, 4g

FM 02: Good Hatchery Management Practices



Elements to be checked OK?

MI SE CR Observations / Comments

5. Cleaning and sanitation (To ensure good hygiene practices)

5.1 Hatchery surroundings maintained in clean and hygienic condition

5.2 Measures taken to prevent animals and pests from causing contamination

5.3 Newly constructed tanks are used only after conditioning and disinfecting it with suitable methods depending upon the material of the tank so that pH of water in the tank is stabilized before stocking.

5.4 Tanks, equipment and facilities are maintained in sound condition for easy cleaning and sanitation.

5.5 Personal hygiene practices, employee’s movement and behavior are strictly followed to avoid cross contamination.Reg. 852/2004, Annex I, ch II.4a, 4b, 4f, 4dReg. 183/2005 Annex III.

6. Pond/tank Management (Effective pond/tank preparation shall minimize microbial contamination).

6.1 Pond/tank drying & disinfection done properly

6.2 Only technical grade fertilizers are used to enhance algae growth

6.3 Stocking of animals done at optimum level.Reg. 852/2004, Annex I, ch. II.3Directive 2006/88 Art. 9Reg. 183/2005, Annex III.2

7. Water Management (To prevent the contamination of water & aquatic animals).

7.1 Water is properly screened/settled/aerated and water quality parameters such as temperature, nitrogenous compound, salinity, pH, dissolved oxygen etc are maintained at optimum level.

7.2 Continuous monitoring of physico-chemical parameters of water is done at regular intervals (supported by test reports).Reg 852/2004, Annex I, ch. II.3Directive 2006/88 Art. 9

8. Pest Control Management

8.1 Constructions in combination with a pest control system ensure that the risk for





contamination of seed, feed, equipment and hatchery system is minimizedReg. 183/2005, Annex III.1Reg.852/2004, Annex 1 Chapter 4f

9. Waste Management (to prevent cross contamination)

9.1 Chemical wastes and non- biodegradable wastes are disposed of as per legal requirement and also as per the label instructions

9.2 Empty containers containing toxic residues or, waste with a potential toxicity are disposed of in the presence of competent authority or a specialist permitted by CA

9.3 Only required quantity of chemicals and feed etc are purchased to avoid wastage.Directive 2006/88 Annex VII Chapter 11

10. Broodstock & Spawning Management ( to prevent disease)

10.1 Only fully matured healthy broods without damage or disease are procured. Procurement method & source of broodstock are recorded.

10.2 Maximum care is taken during handling and transportation of broodstock to avoid injury or, stress

10.3 Broodstocks are subjected to screening tests to ensure that they are free from diseases.

10.4 Stocking density of brood stock is appropriate with the size of maturation tank.

10.5 Induced maturation is done hygienically to avoid contamination or stress

10.6 After spawning, the fertilized eggs are properly cleaned to avoid contamination.

10.7 Special care is taken while rearing the larvae at different stages of growth to avoid contamination. Larvae are also screened for disease detection

11. Input and output management11.1 Maintenance of records of all inputs

and outputs, including feed, chemicals, utensils, aquatic animals etc





11.2 Record of quality / condition of the input is maintained in the stock register while receiving the input.

11.3 Responsible person to handle inputs identified.

H 03: Management of FeedElements to be checked OK? MI SE CR Observations /

Comments

12. Origin of feed and feed substances

12.1 Feed is procured from the feed mill approved by DOF

12.2 Additives, premixes and compound feeding stuffs are from suppliers approved by DOF

Reg. 183/2005 Art. 9Reg. 183/2005 Art. 10Reg. 183/2005 Art. 23

13. Storage of Feed

13.1 Stored properly in cool, dry and protected place

Reg. 183/2005, Annex III

14. Feed Quality

14.1 Traceability & purity of chemical feeds/ supplements are ensured during procurement. Organic feeds are also free from contamination. (supported by test reports)

14.2 Packages are properly labelled with description of composition, storage conditions, expiry date, feeding rate and other necessary guidance

Reg. 1831/2003 and Community register on Feed Additives Rev. 5. 2005

15. Feeding

15.1 Quantity, timing, method of feeding etc are predetermined depending upon species and stages of development.

15.2 Only optimum quantity of feeding done and feeding practices ensure the maintenance of water and sediment quality




Reg. 183/2005 Art. 4. 2 and Annex III.2

16. Live/ organic Feed Production

16.1 Live and organic feed supplied to larvae are produced in the hatchery and the quality is suitable

16.2 Good Hygiene Practices are applied to minimize hazards with potential to compromise feed and food safety.

Reg. 183/2005 Annex 1Reg. 852/2004, Annex 1, ch.II.4.j

H 04: Management of Veterinary Drugs and ChemicalsElements to be checked OK? MI SE CR Observations /

Comments

17. Veterinary drugs and chemicals used

17.1 Veterinary drugs, medicated feeds, chemical and biological substances are obtained from registered / authorized manufactures and suppliers only.

17.2 Only approved chemicals as specified at DOF Directive 3/2009 are stored and used as per labeling instructions with records

17.3 Substances requiring prescription are used under adequate supervision by qualified expert

17.4 Only minimum use of chemicals practiced

17.5 Proper withdrawal periods are given before harvest and residues are verified by adequate testing & records maintained.Directives 2001/82 and 2004/28 Art. 65, 66, 67, 68Directive 2001/82 and 2004/28 Art. 5 and Art 6Directive 2001/82 Art. 9Directive 96/22Reg. 852/2004 Annex I Chapter II 4(j)Directives 2001/82 and 2004/28 Art. 58, 59, 60, 61

18. Storage and use of Veterinary Drugs and Chemicals




18.1 Storage of chemicals as per labeling instructions in cool, neat & dry place under the custody of responsible person.

18.2 Veterinary drugs, medicated feeds, chemical and biological substances are used according to manufactures instruction and as specified on label.

18.3 Traceability & purity of chemicals ensuredReg. 852/2004, Annex I, chapter II.4gReg. 852/2004, Annex I, chapter II.4jReg. 2377/90 consolidated version 2007Decision 2003/181Decision 2004/25Directives 2001/82 and 2004/28 Art. 11

H 05: Disease Risk ManagementElements to be checked OK? MI SE CR Observations /

Comments

19. Animal Health Surveillance System (Objective: To ensure that the animal is free from disease)

19.1 Qualified, trained person employed for monitoring of animal health status

19.2 Regular monitoring of animal movements, feeding habits, mortality rates, spreading of exotic and non-exotic diseases etc are done and records maintained

19.3 Information regarding the emerging diseases and action taken to prevent them are immediately communicated to DOF

19.4 Good Hygienic Practices / Good Hatchery Practices in placeDir 2006/88/EC Chapter II Art. 9

19.5 Risk-based animal health surveillance scheme in placeDir 2006/88/EC Chapter II Art. 10

H 06: Post Harvest Management




20. Harvesting and Transportation of Larvae (Objective: To ensure the larvae/fingerlings are harvested & transported hygienically to avoid contamination and stress to the animal).

20.1 Healthy larvae/ fingerlings which have reached suitable size and show no clinical sign of disease are harvested and transported to approved farms for further growth.

20.2 Utensils, polythene bags etc used for collection and transportation of larvae are clean and are free from contamination

20.3 The polythene bags are filled with sufficient quantities of good quality water and oxygen before transportation of larvae

20.4 Harvesting and transportation are done hygienically to avoid contamination and damage of the larvae/fingerlings.

20.5 Larvae/fingerlings are supplied to farms approved by DOF

20.6 Records on harvesting and transportation is maintained for traceability

20.7 In order to avoid stress, the larvae is hibernated by chilling during transportation

20.8 Transportation is done in clean vehicles as fast as possible to avoid mortalityReg. 852/2004 Annex 1, II. 4.b / Annex 1, II.2 and II.3a / Annex 1, II.4.dReg. 853/2004 Annex 3, Section VIII, Ch.VII.3Reg. 853/2004 Annex 3, Section VIII, Ch.II, 1bReg. 852/2004 Annex 1, III.7, 8.

H 07: Record Keeping


21. Record Management: (Objective: For effective management control and traceability)




21.1 Type, origin, quality and use of feed and feed ingredients

21.2 Veterinary drugs or other treatments administered

21.3 Occurrences of diseases which may affect food safety

21.4 Pond/tank management activities (e.g. tank preparations and water quality controls)

21.5 Brood stock & larval management

21.6 Harvest and transportation of larvae

21.7 Cleaning & sanitation,

21.8 Input & output records

21.9 Pest control records

21.10 Personal hygiene

21.11 Monitoring records & test reports

Reg. 852/2004 Annex 1, part III.7, 8 Directives 2001/82 and 2004/88, Art.

69

H 08: Staff Training


22. Training

22.1 Staff is trained and has knowledge on food safety issues related to handling of feed, veterinary medicines, chemicals, broodstock management, larval rearing adequate to the nature of duty.

22.2 Staff has adequate knowledge of the exotic and non-exotic diseases.Reg. 852/2004 Annex 1, chapter II.4eReg. 183/2005 Annex III.2Dec. 2003/858 Annex IVDir. 2006/88 Annex IV, part II

Over all Findings:-



Place:

Date: Signature

(Auditor/ inspector)


Aquaculture Farm(including leasable fishery)



Location Address:

Business Activity:


2. Activity of the Farm

Nature of farming

Area of farming, number and size of ponds

Species reared:

Production capacity

Name(s) of hatchery from where seed is obtained. Is it approved?

Name(s) of feed mills from where feed is procured



Lead Inspector:

Other Inspectors:




Targeted Elements:


NCs given earlier are closed/open

AF 01: Surroundings, Location and ConstructionElements to be checked OK? MI SE CR Observations /

Comments

1. Location (To protect raw materials from contamination from surroundings)

1.1. Location is in environmentally suitable area where risks to food safety from chemical, biological and physical hazards from air, soil and water are minimized.


2. Water (To reduce the risk of contamination from water).

2.1 Farm input water is far from pollution source and sufficient and suitable throughout the yearReg 852/2004, Annex II, chapter I-5

3. Layout and design (To ensure that the adequate conditions are in place for implementation of good practices in regard to contamination trough daily operation)

3.1 Farm is used for aquaculture purposes only (no livestock production)

3.2 Farm design and layout prevents cross contamination

3.3 Septic tanks, toilet facilities and bathrooms/showers are constructed and placed so drainage do not posses a risk for contamination of farm facilities

3.4 Equipment such as cages, nets, are designed and constructed to ensure minimal physical damage to fish during growing and harvesting and to allow for adequate cleaning and disinfection

3.5 Equipment such as containers and vehicles for feed, seed and harvested fish/crustaceans are designed and constructed to allow for adequate cleaning and disinfection.




Reg 852/2004, Annex I, chapter II.3a, 3b, 4f

4. Pest Control

4.1 Constructions in combination with a pest control system ensure that the risk for contamination of feed, equipment and farming system is minimizedReg. 183/2005, Annex III.1Reg.852/2004, Annex 1 Chapter 4f

5. Facilities

5.1 Feed, drug and disinfection deposits are available and suitable.

5.2 Medicated and non-medicated feed are stored to minimize the risk for feeding to non-target animals

5.3 Facilities for disposal of solid and liquid waste is available in suitable area (allow for hygienic disposal)Reg 852/2004, Annex I chapter II.4gReg. 183/2005, Annex IIIReg 88/2006 Art 34Reg. 852/2004 Annex I, Chapter II.3a, 4g

AF 02: General PracticesElements to be checked OK

?MI SE CR Observations /

Comments

6. Facility and Equipment cleanliness (To ensure that the design of facilities shall permit good practices including protection against contamination from domestic animals and pests)

6.1 Farm and surroundings maintained in clean and hygienic condition

6.2 Measures taken to prevent animals and pests from causing contamination

6.3 Fuel, chemical substances (disinfectant, fertilizer, reagents) feed and veterinary drugs stored in separate and safe conditions

6.4 Containers, equipment and farm facilities are maintained in sound condition so they are easy to clean and disinfect





6.5 Adequate procedures for cleaning and disinfection of containers, equipment and farm facilities are in place and implemented.

Reg. 852/2004, Annex I, ch II.4a, 4b, 4f, 4dReg. 183/2005 Annex III.

7. Pond preparation for stocking (Effective pond preparation shall minimize the outbreak and spread of diseases, hence use of veterinary drugs).

7.1 Pond preparation practices minimize risk for cross contamination and

7.2 Pond preparation practices do not include prohibited chemical or biological substances

7.3 Fertilizers, probiotics, chemicals etc. are used according to instructions for proper use.

7.4 Source of larvae/fingerlings used for stockingReg. 852/2004, Annex I, ch. II.3Directive 2006/88 Art. 9Reg. 183/2005, Annex III.2

8. Water Management (The entrance and growth of human and fish pathogenic organisms such as parasites, bacteria and virus shall be minimized).

8.1 Water is properly screened/settled/aerated and quality is maintained as suitable for cultured stock

8.2 Water quality verified trough testing as adequate to ensure safety.

Reg 852/2004, Annex I, ch. II.3Directive 2006/88 Art. 99 Contingency Plans (To dispose of

aquatic animals and waste minimizing risk of spread of disease and environmental damage)

9.1 Facilities for keeping of dead / sick animals until safe disposal is possible are available and suitableDirective 2006/88 Annex VII Chapter 11

AF 03: Management of Feed




10 Origin of feed and feed substances

10.1 Fish / Shrimp feed is from company that is registered/ approved with DOF

10.2 Additives, premixes and compound feeding stuffs are from suppliers approved by DOF

10.3 Imported feed is from suppliers registered by DOF to comply with prevailing EU requirements

Reg. 183/2005 Art. 9Reg. 183/2005 Art. 10Reg. 183/2005 Art. 23

11 Storage of Feed

11.1 Stored properly in cool, dry and protected place

Reg. 183/2005, Annex III

12 Feed Quality

12.1 Content of additives and veterinary drugs comply with EU regulations

12.2 Packages are properly labelled with description of composition, storage conditions, expiry date, feeding rate and other necessary guidance

Reg. 1831/2003 and Community register on Feed Additives Rev. 5. 200513 Feeding

13.1 Feeding Practices shall minimize the risk for biological, chemical and physical contamination of feed and animals

13.2 Feeding practices ensure the maintenance of water and sediment quality

Reg. 183/2005 Art. 4. 2 and Annex III.2

14 Feed Production on Farm

14.1 Ingredients, additives and veterinary drugs shall include only substances allowed for aquaculture species




14.2 Good Hygiene Practices are applied to minimize hazards with potential to compromise feed and food safety.

Reg. 183/2005 Annex 1Reg. 852/2004, Annex 1, ch.II.4.j

AF 04: Management of Veterinary Drugs and ChemicalsElements to be checked OK? MI SE CR Observations /

Comments

15 Veterinary drugs and chemicals used15.1 Veterinary drugs, medicated

feeds, chemical and biological substances are obtained from registered / authorized manufactures and suppliers only.

15.2 Veterinary drugs, medicated feeds, chemical and biological substances are permitted / registered according to EU / national regulations

15.3 Veterinary drugs, medicated feeds, chemical and biological substances are, by adequate language, labelled with clear information at least about name, active substance, target species of animals, storage conditions, dosage, route of administration, expire date and withdrawal period.

15.4 Substances requiring prescription are used under adequate supervision by qualified expert

Directives 2001/82 and 2004/28 Art. 65, 66, 67, 68Directive 2001/82 and 2004/28 Art. 5 and Art 6Directive 2001/82 Art. 9Directive 96/22Reg. 852/2004 Annex I Chapter II 4(j)Directives 2001/82 and 2004/28 Art. 58, 59, 60, 61

16 Storage and use of Veterinary Drugs and Chemicals16.1 Veterinary drugs, medicated

feeds, chemical and biological substances are adequate stored according to instructions




16.2 Veterinary drugs, medicated feeds, chemical and biological substances are used according to manufactures instruction and as specified on label.

16.3 Withdrawal periods and residues are verified by adequate testing

Reg. 852/2004, Annex I, chapter II.4gReg. 852/2004, Annex I, chapter II.4jReg. 2377/90 consolidated version 2007Decision 2003/181Decision 2004/25Directives 2001/82 and 2004/28 Art. 11

AF 05: Disease Risk Management


17 Control spread of diseases (Objective: All aquaculture businesses are registered / authorised by DOF to facilitate official control and traceability)

17.1 Farm is registered / authorized by DOF Dir 2006/88/EC Chapter II Article 4Reg. 853/2004 Art. 4

17.2 Processing establishments slaughtering aquaculture animals for diseases control purposes are authorized by DOF (Objective: Introduction and spread of diseases shall be controlled trough good practices in whole chain of handling and moving healthy and diseased animals)

Dir 2006/88/EC Chapter II Art. 417.3 Traceability records for movement

of animals in placeDir 2006/88/EC Chapter II Art. 8

17.4 Good Hygienic Practices / Good Aquaculture Practices in place

Dir 2006/88/EC Chapter II Art. 917.5 Risk-based animal health

surveillance scheme in placeDir 2006/88/EC Chapter II Art. 10

17.6 Aquaculture animals intended for farming and restocking are clinically healthy

Dir 2006/88/EC Chapter III, Art. 15




17.7 Aquaculture animals and products placed on the market for further processing before human consumption are disease free

Dir 2006/88/EC Chapter III, Art. 1817.8 Measures for the notification and

control of diseases of aquatic animal origin are in place (Objective: Control of diseases of aquatic animals through communication between farmers and CA and implementation of appropriate investigations)

Dir 2006/88/EC, Chapter V Art. 2617.9 Surveillance programme in place

for diseases of animal origin.Dir 2006/88/EC, Chapter VI (Art. 44-48)

17.10 Disease free status of aquaculture premises

Dir 2006/88/EC Section II Chapter VII (Art. 49-53)

AF 06: Post Harvest ManagementElements to be checked OK? MI SE CR Observations /

Comments

18 Ice and Water Supplies (Objective: Good Practices imply that system of supply and handling of ice and water is planned to minimize risk for contamination).18.1 Potable or clean water available

and used in sufficient amount for harvesting, handling and cleaning operations

18.2 Ice supplied from approved establishment using potable or clean water

18.3 Ice received / arrived in good sanitary conditions

18.4 Ice handled / stored under sanitary conditions that precludes risk of contamination

Reg. 852/2004 Annex I,II.4d and Annex II, chapter VII 1-4EC Directive 98/83 Annex II table A and B853/2004 Annex 3, Section VIII, Ch.I, part II.519 Harvesting (Objective: To




prevent the contamination of the products and ensure it is not handled in a way that could alter its quality and safety; i.e. protected from contamination and kept in favourable preservation conditions).

19.1 Harvesting equipment and utensils easy to clean, disinfect and kept in clean condition

19.2 Harvesting planned in advance and timed to avoid that fish and shrimp are exposed to unduly high temperatures

19.3 Practices ensure rapid killing of harvested fish/ shrimp (if applicable).

19.4 Practices ensure that live fish/shrimp are not affected on their viability due to extreme temperatures, physical damage or undue stress

19.5 Fish/shrimp quickly and hygienically handled, using practices which do not cause physical damage to edible part of product

19.6 Records on harvesting is maintained for traceability

Reg. 852/2004 Annex 1, II. 4.b / Annex 1, II.2 and II.3a / Annex 1, II.4.dReg. 853/2004 Annex 3, Section VIII, Ch.VII.3Reg. 853/2004 Annex 3, Section VIII, Ch.II, 1bReg. 852/2004 Annex 1, III.7, 8.

20 Post Harvest Handling (Objectives: Good handling practices to avoid contamination and deterioration imply that products are chilled and/or kept under chilled and hygienic conditions when they are in the facilities of the establishment)

20.1 Utensils and equipment for handling and holding is maintained in easy to clean and clean condition

20.2 Live fish/shrimp is handled and kept under physical conditions that do not affect adversely their viability.




20.3 Killed fishes/shrimp is cooled down quickly and maintained at temperature approaching that of melting ice in all parts of each unit.

20.4 Operations such as sorting, weighing, washing, drainage etc. is carried out quickly, hygienically and without damage to the edible part of product

20.5 Food additives and chemicals are used in contact with products only in compliance with prevailing legal requirements

20.6 Harvesting wastes are collected in designated equipments and disposed to precludes risk of cross contamination

Reg. 852/2004 Annex 1, II.4.aReg. 853/2004 Annex 3, Section VIII, Ch.II.1aReg. 853/2004 Annex 3, Section VIII, Ch. VII.3Reg. 853/2004 S Annex 3, Section VIII, Ch. II, 1.b and Ch. VII.1Reg. 853/2004 Annex 3, Section VIII, Ch.II, 1bDir. 1995/2 and Dir. 2006/52Reg. 852/2004 Annex 1, II.3.aReg. 853/2004 Art. 3Reg. 852/2004 Annex 1, II.3a, 4g

21 Transport (Objectives: Good practices to avoid contamination and deterioration imply that products are chilled and/or kept under chilled and hygienic conditions when they are in the facilities of the establishment21.1 Transport is carried out in easy to

clean and clean facilities (boxes, containers etc.)

21.2 Transport conditions arranged to avoid contamination from surroundings e.g. air, soil, water, oil, chemicals etc

21.3 Transport conditions arranged to avoid contamination from surroundings e.g. air, soil, water, oil, chemicals etc

21.4 Live fish/shrimp transported under physical conditions which do not affect adversely their viability

21.5 Dead fish/shrimp is transported in containers with ice or with ice + water, in sufficient amount to ensure temperature around 0C




(approaching that of melting ice) in all products and during the whole period of transport.

21.6 Containers for ice + product allow melt water to drain away from product.

21.7 Based on the prevailing requirement, prohibited additives and chemicals are not used in contact with products/live animals

21.8 Records for transport of fish and shrimp maintained to ensure product traceability

853/2004 Annex 3, Section VIII, Ch.VIII, 4853/2004 Annex 3, Section VIII, Ch.VIII,4Reg. 853/2004 S Annex 3, Section VIII, Ch.VIII, 4Reg. 853/2004 Annex 3, Section VIII, Ch.III A4 and A5 and Ch. VIII.1aReg. 853/2004 Annex 3, Section VIII, Ch. VIII.3Reg. 852/2004 Annex 1, III.7, 8.

F 07: Record KeepingElements to be checked OK? MI SE CR Observations /

Comments

22 Adequate records shall be kept on: (Objective: Use of conditions or substances which may compromise food safety shall be controlled and traceable)

22.1 Type, origin and use of feed and feed ingredients

22.2 Veterinary drugs or other treatments administered

22.3 Occurrences of diseases which may affect food safety

22.4 Pond management activities (e.g. preparations and water quality controls)

22.5 Origin and type of seed used

22.6 Buyers of final products

Reg. 852/2004 Annex 1, part III.7, 8Directives 2001/82 and 2004/88, Art. 69

AF 08: Staff Training




23 Training

23.1 Staff is trained and has knowledge on food safety issues related to handling of feed, veterinary medicines, chemicals, live animals and harvested products, adequate to the nature of duty.

23.2 Staff is adequately trained to recognize clinical manifestations of exotic and non-exotic diseases listed in EU regulations

Reg. 852/2004 Annex 1, chapter II.4eReg. 183/2005 Annex III.2Dec. 2003/858 Annex IVDir. 2006/88 Annex IV, part II

Over all Findings:-

Place:

Date: Signature

(Auditor/ inspector)Annexure- 10

Inspection Checklist for Fish and Fishery Products

Feed Mill



Location Address:

Business Activity:


2. Activity of the Feed Mill

UNION OF MYANMARSPONSORED BY FOOD AND AGRICULTUTRAL ORGANISATION

OF UNITED NATION



Products approved for processing

Year of starting the factory

Production capacity

Whether the feed mill approved for medicated feeding stuff?

Name(s) of approved farm(s) /hatcheries to where feed is supplied



Lead Inspector:

Other Inspectors:


Targeted Elements:



FM 01: Surroundings, Location and Construction


1. Location (To protect feed from contamination from surroundings)

1.1 Location is environmentally suitable area


2. Water (To protect Aquatic animals from contamination)

2.1 Availability of sufficient quantity of potable water


3. Layout and design (To ensure the production of good quality feed without contamination)

3.1 Factory is used for feed production only

100

February 2015 Final Version 1.0



3.2 The design and layout is such as to preclude contamination. The premises is kept clean and have defined curtilage

3.3 Factory is housed in a building of permanent nature affording sufficient protection from the environment and has sufficient area for the work to be carried out under hygienic conditions.

3.4 The layout of different sections is such as to facilitate smooth and orderly flow of work and to prevent possible cross contamination and backtracking.

3.5 Separate storage facilities are provided for storing incoming materials, finished products and also packing materials hygienically

3.6 Change rooms and cleaning and sanitation facilities are provided at appropriate places.

Reg 852/2004, Annex I, chapter II.3a, 3b, 4fReg. 183/2005, Annex III4. Facilities

4.1 All facilities, machineries and equipments are designed and operated in such a way to minimize the risk of error, permit effective cleaning and maintenance, avoid contamination and carry-over, minimize condensation etc

Reg 852/2004, Annex I chapter II.4gReg. 183/2005, Annex III

H 02: FEED SAFETY MAMAGEMENT SYSTEM



5. Implementation of HACCP (To ensure the safety of the feed produced)

5.1 HACCP is in place and documented properly

5.2 All seven principles of HACCP implemented

101





5.3 CCP monitoring is done properly and corrective action is taken in case of deviation.

5.4 Internal audits and HACCP review are done at least once in a year

5.5 Traceability & recall procedures are in place

Reg. 183/2005 Annex III.6. Input and output Management

(To ensure the wholesomeness of inputs & safety of outputs)

6.1 Maintenance of records of all inputs and outputs, including, ingredients, additives, feed, other chemicals, utensils, etc

6.2 Record of quality / condition of the input is maintained in the stock register while receiving the input

6.3 Responsible person to handle inputs identified

6.4 Only those incoming materials that meets the company specification are accepted

Reg. 852/2004, Annex I, ch. II.3Reg. 183/2005, Annex III.27. Feed Manufacturing Procedures

(To ensure feed safety).7.1 A trained employee is designated

as in-charge of production.7.2 Feed Production at different stages

is carried out according to pre-established written procedures

7.3 Maximum care is taken to avoid carry-over, bacteriological contamination, and human errors and to maintain the hygiene and safety standards.

7.4 Production schedule is established to minimize the risk for public health in relation to carry-over

7.5 Equipments are cleaned and/or flushed so as to avoid contamination between batches and flushing is collected into clearly identified containers to deal in accordance with written procedures

7.6 All equipments used for measuring, inspection and testing are calibrated

102





7.7 Additives are incorporated in animal feed in accordance with the legal requirements, ensuring that only exact quantity is incorporated.

7.8 Temperatures of the product and environment are controlled and monitored and records maintained.

7.9 Only those final products that comply the company specification are accepted

7.10 Magnets and metal detects are used to avoid metal contamination

7.11 Records are kept for each batch of manufactured products with details like 1) Nature of feed 2) Batch No. 3) Date/time of production.4) Details of ingredients with percentage etc

Reg 852/2004, Annex I, ch. II.3Reg 183/2005, Annex IIIReg 178/20028. Storage of final products

8.1 Accepted finished feed products are kept in good hygienic storage places in packed condition with proper labelling under the control of a responsible person & records maintained

8.2 The storage area is dry, clean and free from pest.

8.3 Storage is done in an orderly manner to enable ‘first in- first out’ policy. Materials stored are clearly identifiable for effective stock rotation

Reg. 183/2005, Annex III.1Reg.852/2004, Annex 1 Chapter 4f9. Inspection and testing (To verify

the effectiveness of control measures)

9.1 Inspection, sampling and testing of incoming material, intermediate materials and final products are done based on a written procedure by competent staff.

9.2 Incoming material and final products are tested to ensure that they are free from banned chemicals and microbial contamination in the in-hose lab or outside lab permitted by C.A.

103





9.3 Sampling of all incoming and finished feed is done with adequate techniques.

9.4 A portion of sample of incoming and finished feed is retained in sealed and labeled containers for a period appropriate to the use for which the feed is placed on the market.

Reg 882/2004Reg 852/200410. Good Hygiene Practices ( to

prevent cross contamination)10.1 Utmost care is taken for cleaning

and sanitation of all areas of the factory as per the documented cleaning procedure and records maintained.

10.2 Utensils, machineries, conveyors, mills, aspirators, screeners, mixers and other feed contact surfaces are smooth, clean and maintained in good hygienic condition to avoid contamination of the feed.

10.3 Cleaning and sanitation of feed contact surfaces are monitored physically and by taking swab samples for testing microbiological factors.

10.4 A written procedure is developed to ensure regular cleaning of cooler so as to avoid bacterial contamination.

10.5 Precautions are taken to avoid dust accumulation and other residual materials in the processing and storage areas.

10.6 Personal hygiene practices, employee’s movement and behavior are strictly done to avoid cross contamination. Health cards are issued to all employees working in the factory.

11. Control of contamination and carry-over

11.1 Control of contaminants at all stages of production, storage and distribution is carried out based on risk assessment.

11.2 Carry-over is measured with an appropriate method at least once in a year.

104





11.3 The air used for conveying/ cooling, is checked for microbial contamination

11.4 The process flow within the manufacturing facility is designed to minimize the potential for contamination and carry-over.

12. Waste management (to prevent cross contamination)

12.1 Proper waste management is in place to avoid cross contamination

12.2 Waste is collected or stored in identifiable, dedicated waste containers and stored away from incoming and finished feed storage or production areas and disposed of legally.

12.3 A documented procedure for the dealing with non-complying feed with proper identification, storage, disposal and recording is in place. The cause of non-compliance is evaluated and affected batches are segregated.

13 Pest Control management13.1 Suitable methods evolved to

prevent and/or eradicate the pest entering the hatchery

13.2 Care is taken while using chemicals or sprays to avoid coming in contact with feed, water, or production equipment.

13.3 Pest control measures cover incoming and finished product storage area also.

FM 03: Management incoming Drugs and ChemicalsElements to be checked OK? MI SE CR Observations /

Comments

14. Veterinary drugs and chemicals used

14.1 Only approved chemicals as specified at DOF Directive 3/2009 are stored and used and record maintained.

105




14.2 Permissible drugs, chemicals and biological substances etc are obtained from registered/authorized manufactures only with purity certificate.

14.3 Those incoming drugs/chemicals meeting the factory specification are accepted

14.4 Traceability & purity of chemicals, additives, pre-mixtures etc are ensured. ( test reports)

Directives 96/25/EECDirective 90/167/EECReg. 852/2004 Annex I Chapter II 4(j)Reg No 1831/2003 15 Storage and use of Veterinary Drugs and Chemicals

15.1 Storage of Drugs & chemicals as per labeling instructions in cool, neat & dry place under the custody of responsible person.

15.2 Storage is done in an orderly manner to enable ‘first in- first out’ policy.

Reg. 852/2004, Annex I, chapter II.4gReg. No 767/2009Reg No 1831/2003Decision 2004/217/ECDirectives 90/167/EEC

FM 04: Post Manufacturing ManagementElements to be checked OK? MI SE CR Observations /

Comments

16 Dispatch of finished products (Objective: To ensure that feed is handled properly to avoid contamination till reaches the customer.).16.1 Records are kept regarding the

customer to whom the final product was sold to: with details like 1) Nature of feed 2) Batch No. 3) Name and address of customer.4) Date/time of delivery. 5) Delivery order. 6) Details of vehicle.

16.2 The transport of incoming material as well as finished feed is made by using only hygienic vehicles. (vehicle cleaning records)

16.3 Only covered vehicles are used for transportation to protect the feed

106




from environmental hazards and contaminants.

17 Traceability and Recall Procedures

17.1 Traceability of the feed, ingredients, additives etc are maintained at all stages of production, till it reaches the consumer.

17.2 Recall procedures are in place to ensure that the materials dispatched to the customer can be recalled if found defective.

Reg. 852/2004 Reg. 853/2004 Reg. 178/2002

FM 05: Record Keeping


18 Record Management: (Objective: For effective management control and traceability)18.1 Type, origin, quality and use of

feed and feed ingredients18.2 HACCP records

18.3 Production and storage records

18.4 Monitoring records & test reports

18.5 Traceability and dispatch records

18.6 Cleaning & sanitation, Personal hygiene

18.7 Input & output records

18.8 Pest control, Waste management

18.9 Training Records

Reg. 852/2004 Annex 1, part III.7, 8Reg 183/2005

FM 06: Staff Training


19 Training

19.1 Staff is trained and has knowledge on feed safety issues related to handling of feed,

107




veterinary medicines, chemicals, preparation of feed etc

19.2 Staff has adequate knowledge of implementation of HACCP, internal audits etc

Reg. 852/2004 Annex 1, chapter II.4eReg. 183/2005 Annex III.2Dec. 2003/858 Annex IVDir. 2006/88 Annex IV, part II

Over all Findings:-

Place:

Date: Signature



Fishing Vessels


108




Location Address:

Business Activity:


2. Activity of the Vessel

Size/type of the vessel/power of engine.

Nature of fishing/fishing gears used

Vessel designed for less than or more than 24 hrs fishing

Quantity & type of materials procured.

Name(s) of approved landing site & unit(s) material catered to



Lead Inspector:

Other Inspectors:


Targeted Elements:



FV01 – Sanitary Requirements for Structures and Equipment

Elements to be checked OK? Observations / Comments

1. Structure and Equipment – All vessels (Objective: To minimize the chances of cross-contaminating the product).

109




1.1. Bilge water, fuel, smoke, oil, grease, etc. cannot contaminate products

1.2. Surfaces in contact with fish are smooth, easy to clean and non-corrosive. Surface coatings must be durable and non-toxic.

1.3. Equipment for working with fish is smooth, easy to clean and non-corrosive

1.4. Water intake is placed so to avoid contaminated water to be taken in the vessel

Reg. 853/2004 Section VIII, CH I Part IAReg. 852/2004 Annex I2. Supplementary Structure and

Equipment – Vessels to preserve fish more than 24h (Objective: To maintain the sanitary quality of the product, avoid cross - contamination and to minimize spoilage by temperature abuse)

2.1. Holds, tanks or containers are separated from engine compartments and crew quarters

2.2. Holds, tanks and containers are adequate to store products at temperature approaching that of melting ice

2.3. Containers for storage with ice allow melted water to drain away from products

2.4. CSW and RSW systems allow for uniform temperature throughout the tank

2.5. Temperature in CSW and RSW systems can be monitored

Reg. 853/2004 Section VIII, CH I Part B

3. Supplementary Structure and Equipment – Freezer Vessels (Objective: To maintain the sanitary quality of the product, avoid cross - contamination and to minimize spoilage by temperature abuse)

3.1. Have freezing equipment with capacity to lower product to a core temperature of not more than -18 °C (-9 °C in brine)

3.2. Storage holds must be equipped with a temperature-recording device in a place where it can be easily read.

FV02 – Sanitary requirements in relation with hygiene on board fishing vessels

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4. General hygiene (Objective: To minimize the chances of cross-contaminating the product).4.1. Vessel facilities for storage and

handling of products are kept clean and in good repair

4.2. Containers kept clean and in good repair and condition

4.3. No contamination with fuel or bilge water

Reg. 852/2004 Annex 1, Part A II 4a, 4bReg. 853/2004 Section VIII, CH I Part II, point 15. Products (Objective: To maintain the

sanitary quality of the product, avoid cross -contamination and to minimize spoilage by temperature abuse)5.1. Protected from contamination and

effect of sun and other sources of heat

5.2. Clean water is used for washing

5.3. Handling do not cause bruising of flesh of products

5.4. Chilling starts as soon as possible after loading to boat

OR

5.5. Landing takes place as soon as possible after loading to boat

5.6. On CSW and RSW the mix of fish and clean seawater reaches 3 °C six hours after loading and 0 °C after 16 hours

5.7. On CSW and RSW the mix of fish and clean seawater reaches 3 °C six hours after loading and 0 °C after 16 hours

5.8. In ice cooling systems temperature approaching that of melting ice is complied with in all parts of the containers

Reg. 852/2004 Annex 1, Part A II, 4dReg. 853/2004 Section VIII, CH I Part II, 2, 3, 4

6. Ice (Objective: To minimize the chances of cross-contaminating the product).

6.1. Made of potable water or clean water

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6.2. Handled and stored under hygienic conditions

Reg. 853/2004, section VIII, Chap. I, part II, point 57. Handling on board (Objective: To

minimize the chances of cross-contaminating the product.

7.1. Heading and gutting carried out hygienically

7.2. Clean water used for washing the product

7.3. By-products intended for human consumption chilled immediately

7.4. By-products not intended for human consumption kept separated from the product

Reg. 853/2004 Section VIII, Chap. I, Part II, point 68. Crew (Objective: To minimize the

chances of cross-contaminating the product).

8.1. Procedure to ensure good health are in place and efficient

8.2. Crew is appropriately trained

Reg. 852/2004 Annex 1, Part A II 4e

9. Pests

9.1. Evidence of any pests on board

9.2. Evidence of pest control treatment

Over all Findings:

Place:

Date: Signature



Landing Site & Auction hall

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Location Address:

Business Activity:


2. Activity of the Landing site/auction hall

Type/ size of the harbour

Year of starting the harbour

Number of boats landed during peak season

Major types of fishery product landings and average quantity of landing per day

Number of fishing days



Lead Inspector:

Other Inspectors:


Targeted Elements:



LS 01: Landing Sites - Sanitary requirements in relation to hygiene and good handling practices

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Elements to be checked OK MI SE CR Observations / Comments

1. Unloading and landing operations (Objective: To prevent the contamination of the products and ensure it is not handled in a way that could alter its quality and safety; i.e. protected from contamination and kept in favourable preservation conditions)1.1 Equipment easy to clean and disinfected

1.2 Equipment in good repair and cleanliness stage

1.3 Operation carried out rapidly

1.4 Operations do not damage fishery products

1.5 Products immediately placed in protected environment

1.6 Products maintained at temperature approaching that of melting ice

Reg. 853/2004 Section VIII, Chap II Part II, 1a, 1b

Water and IcePest Control

LS 02: Auction Facilities and Wholesale Markets - Sanitary requirements in relation to structures and equipment


2. Facilities and Infrastructures (Objective: Facilities and equipment are constructed so to prevent contamination from surroundings, surfaces and other external sources).2.1 Provide adequate protection against

contamination from air, soil and water

2.2 Constructions are of smooth, easy to clean, impervious material

2.3 Constructions maintained in good condition

2.4 Precautions against engine exhaust gases in place

2.5 Precautions against other hazardous substances in place and efficient

2.6 Protection against rodents and other pests in place and efficient

2.7 Light is adequate for the operations

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2.8 Premises are used for display or storage of fishery products only

2.9 Lavatories and hand washing facilities for staff are adequate located and designed

2.10 If available, there should be separated facilities for storage of detained fishery products

Reference: Reg 852/2004 Annex 1, Part A II, 2 and 3a, 4e, 4gReg 852/2004 Annex 2, chapter II, 2Reg 852/2004, Annex II, chapter I-3, 4, 6, 9

LS 03: Auction Facilities and Wholesale Markets - Sanitary requirements in relation to hygienic practices


3. Practices and operations (Objective: Good handling practices to avoid contamination and deterioration imply that products are chilled and/or kept under chilled and hygienic conditions when they are in the facilities of the establishment)

3.1 Fresh material not chilled on board are iced or otherwise chilled immediately after landing

3.2 Containers used for storage under ice allow drainage of melt water

3.3 Handling and storage of waste preclude risk for contamination of raw materials

3.4 Operations such as gutting, cleaning, sorting, repacking are carried our hygienically

3.5 Adequate procedures for washing and disinfection of facilities, equipment, containers, vehicles etc. are in place and efficient

3.6 Adequate procedures for control of harmful animals pests are in place

Reg 852/2004 Annex 2, chapter II, 3Annex 1, Part A II, 3a and 4g852/2004 Annex 2, Section VIII, chapter III, A4 and A5, A24. Supply of water, CSW and ice (Objective:

Water supply system shall ensure that only potable or clean water can be used in contact with fishery products)

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4.1 Water available at any time in sufficient amounts

22.1. Quality of water regular monitored

4.2 Water quality comply with requirements to clean water and potable water (drinking water)

4.3 Produced of potable water in adequate facilities (origin controlled)

4.4 Stored under hygienic conditions

4.5 Transported under hygienic conditions

4.6 Handled under hygienic conditions

4.7 Quality regular monitored

4.8 Ice quality comply with requirements to clean water and potable water (drinking water)

Reg. 852/2004, Annex II, chapter VII 1-4EC Directive 98/83 Annex II table A and B5. Personal Hygiene (Objective: Minimization of

the risk of contamination of seafood by human pathogenic microorganisms, and other hazards which may be carried by staff )5.1 All staff members wear suitable protective

clean clothing

5.2 Personnel with access to the facilities maintain a high degree of personal cleanliness

5.3 Internal regulations ensure that staff who may carry diseases are not allowed to handle food

5.4 All staff members are trained in food hygiene and safety issues adequate to the nature of duty

Reference: Reg. 852/2004, Annex II, chapter VIII 1-2

6. Control of specific hygiene parameters and food safety hazards (Objective: Products placed on the market shall meet minimum freshness criteria and not be obviously contaminated with parasites. Fish know to be poisonous or toxic humans shall not be placed on the market)6.1 Organoleptic assessment to b carried out

to assure that product comply with any freshens before placing on the market

6.2 Fishery products with visible parasites are not placed on the market or treated as per

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Reg. 853/2004, Annex III, sec XIII, ch. D 6.3 Materials are rejected if known or

reasonable expected to be contaminated with food safety hazards.

7. Prohibitions of market placement (if applicable)

- Species of Tetraodontidae, Molidae, Diodontidae, Canthigastridae or other known toxic species.

- Species of family Gempylidae (Oilfish-Ruvettus pretiosus and Escolar-Lepidocybium flavobrunneum) if not in wrapped packed form

Reg. 2074/2005, Annex 2, section I, chapter I and IIReg. 2406/1996, Article 3 and Annex I.Reg. 853/2004, Annex III, section XIII, ch. V-AReg. 853/2004, Annex III, section XIII, ch. V-DReg. 852/2004, Annex II, chap. IX 1-2

Over all Findings:-

Place:

Date: Signature



Processing Establishments (PE) – On-site Visit


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Location Address:

Business Activity:


2. Activity of the Establishment

Type of processing activities

Type of species handled

Production capacity / day

Source of raw materials

Name(s) & app no. of farm(s), if applicable

Products exported to



Lead Inspector:

Other Inspectors:


Targeted Elements:



PE 01: Surroundings and Construction


1. Surroundings, Constructions and Layout (Objective: To ensure that design, construction, location and size of the food premises allow for

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adequate control of food hygiene and safety)

1.1. Surroundings maintained to prevent access and harbourage of pest

1.2. Conditions suitable to allow storage, handling and processing at adequate temperatures and under sanitary and hygienic conditions.

Reg 852/2004, Annex II, chapter I-1, 2a-2d. Ref. also to Item 16, 19 and 41 below

2. Ventilation (Objective: To reduce the risk of product contamination)

2.1. Sufficient and suitable for the operation

2.2 Mechanical airflow ensure flow from clean to less clean areaReg 852/2004, Annex II, chapter I-5

3. Staff Facilities (Objectives: To ensure that adequate conditions are in place to ensure implementation of personal hygiene rules)

3.1. The number of flushable lavatories is adequate

3.2 Lavatory facilities that do not open directly into processing areas

3.3 Number of suitable designed (non-hand operated) hand washing basins is adequate and suitably located

3.4 Hand washing basins have adequate facilities for efficient hand washing (hot and cold running water, soap and hygienic drying facilities

3.5 Changing facilities are adequate for the operation.

Reg 852/2004, Annex II, chapter I-3, 4, 6, 9Reg 852/2004, Annex II, chapter I-7

4 Drainage system (Objective: To make sure that the drainage system is not a source of contamination)

4.1 Constructed to avoid risk of contamination with flow of waste water from less clean to clean areas system is minimized

4.2 Adequate for the operation

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5 Storage of Chemicals (Objectives: To ensure that dangerous cleaning and disinfecting chemicals cannot contaminate food)

5.1 Adequate storage facilities allow for safe storage of cleaning and disinfection agents in areas where food is not handled

5.2 Hazardous and/or inedible substances ( sanitise agents, cleaning agents, etc.) Adequately labelled and Stored in separate and secure containers

Reg 852/2004, Annex II, chapter I-10Ref. also to point 15 below

PE 02: Construction Requirements in Areas Where Food is Handled



6 Specific Plant Infrastructures (Objectives: To ensure that the design of facilities shall permit good hygiene practices including protection against contamination between and during processing operations)

6.1 Floors/walls Made of impervious, non-absorbent,

washable and non-toxic materials Surfaces maintained in sound condition

that are easy to clean and sanitise Floor Surfaces allow adequate surface

drainage6.2 Ceiling and light fittings Constructed and finished to prevent

accumulation of dirt, growth of moulds, shedding of particles and minimize condensation.

Premises have adequate light for operations

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6.3 Windows and other openings Constructed to prevent accumulation of

dirt Fitted with insect proof screens if opened

to the outside Insect screens in windows and other

openings are easy to remove for cleaning

6.4 Surfaces in contact with food Made of appropriate materials (smooth,

washable, non-corroding, non-toxic) Maintained in sound conditions for easy

cleaning and sanitising

Reg. 852/2004, Annex II, chapter II-1a-1f

7 Articles, fittings and equipment (Objective: Articles, fittings and equipment in contact with food shall be constructed and maintained in good order to avoid any risk of contamination

7.1 Constructed of materials and maintained to minimize risk of contamination.

7.2 Constructed of materials and maintained to enable effective cleaning and sanitising

7.3 Effectively cleaned and sanitised at sufficient frequency to avoid risk of contamination Reg. 852/2004, Annex II, chapter V 1-3

PE 03: Implementation of Pre-requisite Programmes


8 Ingredients, packaging and other input materials (Objective: Control at receiving, good handling practices at storage and at all processing steps to ensure that the final products are fit for human consumption and are not injurious to human health).

8.1 Are stored to prevent deterioration and protect from contamination.

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8.2 Quality and safety criteria defined and adequate to ensure food is safe and fit for consumption

8.3 Traceability criteria adequately defined and implemented.

Reg. 852/2004, Annex II, Ch IX 1-2Reg. 852/2004, Annex I, part A III-7,8HACCP Guidance Document, Annex II, Ch59 Wrapping and packaging material

(Objective: Wrapping and packaging materials shall not present any risk for contamination of the food).

9.1 Materials selected not to be a source of contamination

9.2 Materials stored so they are not exposed to contaminants

9.3 Re-used packaging materials are easy to clean and sanitise

Reg/852/2004, Annex II, Ch X 1-4Refer also item 28 below

10 Water, Ice and Steam (Objective: Water supply system shall ensure that only potable or clean water can be used in contact with fishery products).

10.1 Adequate supply of potable water in all areas where necessary

10.2 Non-potable water circulated in separate pipe system, designed to prevent backflow to potable water system and duly identified

10.3 Recycled water potable or of adequate quality for the purpose used (if applicable only)

10.4 Ice in contact with fishery products made from potable water or clean water

10.5 Ice protected from contamination during production, handling and storage

10.6 Monitoring, corrective actions and internal verification implemented as planned

Reg. 852/2004, Annex II, Ch VII 1-6Dir 98/83 , Annex II Table A and B11 Food waste and other refuse

(Objective: Food waste and other refuse shall be kept away from products and hygienically handled and stored in order to minimize risk for cross-contamination to products)

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11.1 Removed quickly from rooms where food is present (not allowed to accumulate)

11.2 Containers constructed of materials that allow easy cleaning and sanitising

11.3 Facilities for waste deposit are appropriate constructed, maintained and easy to clean

Reg. 852/2004, Annex II, Ch VI 1-4Reg 852/2004, Annex II, Ch IX, 8Refer also item 6 above12 Pest Control (Objective: To control

(prevent and eliminate) pests from contaminating product as per Reg. 852/2004, Annex II, chapter IX 4)

12.1 Establishments designed to prevent admission of pests.

12.2 Procedures for controlling pests such as insects, mice, rats etc. in processing areas are planned , implemented and monitored.

Reg. 852/2004, Annex II, Ch IX 4Refer also item 1 above13 Personal Hygiene (Objective: The

risk for transmission of human pathogenic microorganisms, and other hazards which may be carried by staff who handle food shall be minimized).

13.1 All staff members wear suitable protective clothing

13.2 Protective clothing are clean and maintained in a clean condition

13.3 All staff members maintain a high degree of personal cleanliness

13.4 Use and control of boot baths adequately designed, implemented and monitored

13.5 Staff who may carry diseases 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

13.6 Procedures for monitoring staff health are planned, implemented and effective

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Reg. 852/2004, Annex II, chapter VIII 1

14 Sanitation (cleaning and sanitation) (Objective: To ensure that processing facilities and equipment in contact with the product is not a source of contamination as per Regulation)

14.1 Facilities for cleaning, sanitising and storage of working utensils and equipment adequate and easy to clean and maintain

14.2 Criteria for sanitation are adequately defined

14.3 Effectiveness of sanitation is monitored

14.4 Designed for the specific purpose of food washing

Reg. 852/2004 Annex IIRef. also to Items 1 and 10 above

15 Traceability, Withdrawal and Recall Procedures (Objective: To prevent risks to the final consumer and collaborate with competent authorities in risk management)

15.1 Identification Marks correct applied on products before leaving the establishment

15.2 Raw materials from aquaculture and bivalve molluscs are traceable to identified primary producer unitReg. 178/2002, Art. 3, 15 and Art. 18Reg. 178/2002, Art.19Reg. 853/2004 Art. 5, 6 and Annex IIReg. 852/2004 Annex I, Part A III-7,8Reg. 853/2004 Annex II, VII ch. 1Ref. also to Item 11 above and specific checklist on Aquaculture

PE 04: Specific Process Design Criteria and Control

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16 Procedures designed to protect food at all stages of production, processing and distribution (Objective: To minimize the risk of product contamination from pathogenic micro-organisms, chemical and physical hazards and to minimize the risk for growth of pathogenic micro-organisms).

16.1 Food protected against contamination that may render the product unfit for human consumption or injurious to health

16.2 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).

16.3 Thawing processes are designed to minimize the risk of pathogenic microorganisms growth or the formation of toxins

16.4 Runoff water from thawing is properly drained to prevent cross-contamination

16.5 Designed for the specific purpose of food washing and Kept clean

Reg. 852/2004, Annex II, chapter IX 3, 5,6,7Ref also to point 22, 24, 26 below Reg. 853/2004, Annex III, section VIII, chapter III A1, A4, A5 Reg. 853/2004, Annex III, section VIII, chapter. VII-1, 3

17 Raw Material handling and preparation of products

17.1 Carried out hygienically

Reg. 853/2004, Annex III, chapter III.A2, A318 Frozen Products (Objective: Good handling and manufacturing practices imply that products shall be frozen rapidly to -18oC or less in the core and kept at -18C or lower. Storage temperatures shall be monitored and documented).

18.1 Capacity of freezing equipment is sufficient to rapidly achieve core temperature lower than -18oC.

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18.2 Capacity in cold stores are sufficient to maintain product temperature at least –18oC

18.3 Cold store equipped with easy to read automated temperature recording device

Reg. 853/2004, Annex III, section VIII, chapter III B (ref: section VIII, ch. 1 part 1, C1, C2)Reg. 853/2004, Annex III, section VIII, chapter. VII-2

Ref. also to Item 10.6 aboveReg. 853/2004, Annex III, section VIII, ch. III C1, C2.

19 Cooked Products (Objective: Good handling and manufacturing practices imply that cooked crustaceans and molluscs shall be hygienically handled, rapidly cooled in potable water down to temperatures approaching that of melting ice or immediately frozen)

19.1 Cooled immediately and rapidly in potable water or clean seawater after cooking

19.2 Cooled down to temperatures approaching that of melting ice or frozen immediately to at least -18 C after cooling

Reg. 853/2004, Annex III, section VIII, ch. IV-1,2,3.

20 Training (Objective: To ensure that staff shall be instructed and trained in food hygiene, appropriate to properly carry out their responsibilities and activities as food handlers).

20.1 All staff trained to properly carry out their responsibilities and activitie

20.2 Training complies with national laws concerning training of staff in the food or fishery sectors.

Reg. 852/2004, Annex II, chapter XII 1-3 Ref. also to Item 50 below

PE 05: Health Standards for Fishery Products

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21 Organoleptic examination (Objective: Products placed on the market shall meet minimum freshness criteria in order to be deemed fit for human consumption)21.1 Carried against specified freshness

criteriaReg. 853/2004 Annex IIIReg 2406/1996 Article 3 & Annex I22 Freshness and histamine (Objective:

Monitoring and Internal verification of Prerequisite and HACCP programmes shall include sampling and testing for compliance with certain process and product standards)

22.1 Levels of histamine complies with requirements in all products of the specie families of: Scrombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scrombresosidae

22.2 Sampling plan includes 9 samples per lot (if sampling is applied)

Reg 2073/2005 & 852/2004Reg 853/2004, Annex III, Cha V-BReg 2073/2005, Annex-I, Ch 1,22.3 Parasites (Objective: Fishery Products obviously contaminated with parasites shall not be placed on the market).

22.4 Are fishery products visually examined for visible parasites

Reg. 853/2004, Annex III, section XIII, ch. V-DReg. 2074/2005, Annex 2, section I, chapter I and II

PE 06: Assessment of HACCP Plans



23. Management Commitment and Preliminary Steps (Objective: Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market)

23.1 All prerequisite programmes and HACCP Plan documents are up-to-date and approved by management

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23.2 Are modifications to documentation / implementation communicated to relevant staff members

23.3 HACCP team up-to-date in regard to members and responsibilities

Reg. 852/2004 Art 5, Pt 1,3,4

24 HACCP Team

24.1 Made up of multi-disciplinary and multi-divisional members

24.2 Team leader is appointed

24.3 Scope of HACCP Plan is adequately defined

24.4 All team members have skills and knowledge about hazards, process, hygiene, product and raw materials characteristics, appropriate to the product.

24.5 Team members have received adequate training in application of HACCP principles

Reg. 852/2004 Annex, II. Ch XII,2HACCP guide Doc Annex I Ch 1.1025 Product Description

25.1 Description of products

25.2 Characteristics of raw materials and end products.

25.3 Composition (raw materials, ingredients, additives etc.)

25.4 Processing technologies used

25.5 Packaging method and materials

25.6 Storage and distribution conditions

25.7 Required shelf life

25.8 Instructions for use

25.9 Applicable microbiological and chemical criteria

25.10 Are product descriptions up-to-date, accurate and in compliance with requirements

HACCP guide Doc Annex I

26 Identification of intended use

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26.1 Normal or expected use by intended customers or consumer target groups are defined

26.2 Suitability for particular vulnerable groups /consumers has been considered (YOPI

HACCP Guide Doc Annex I, Ch 1.3

27.Flow diagram (Objective: Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market)

27.1 Cover all steps in the process operation including delays during or between steps

27.2 Consider raw materials prior to receiving and product following processing at the plant (if company is in charge)

27.3 Flow diagram is backed up by adequate technical data on planning and conducting the operations (e.g. in Lay Outs/Blue prints, GMP and SSOP documents)

27.4 Flow diagram is up- to- date, accurate and in compliance with requirements.Reg. 852/2004, Art. 5, pt. 1, 2HACCP Guid.Doc. Annex 1 ch. 1.4

28 Verification of Flow Diagram (Objective: Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market )

28.1 HACCP team has conducted on-site confirmation that each processing step in the plant is accurately included in the flow diagram during operation hours.Reg. 852/2004, Art. 5, pt. 1, 2HACCP Guid.Doc. Annex 1 ch. 1.5

29 Hazard Analysis (Objective: Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market)

29.1 Conducted for each step in the verified flow diagram

29.2 Identification of hazards are specific

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29.3 Likely occurrence hazards considered

29.4 Severity identified and considered

29.5 Risk considered

29.6 Significance evaluated

29.7 Effective control measures for each significant hazards are identified

Reg. 852/2004, Art. 5, pt. 1, 2HACCP Guid.Doc. Annex I ch. 1.6

30 CCP Determination (Objective: Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market)

30.1 Based on the Decision Tree or a similar systematic approach

30.2 Assessment conducted for each step where a significant hazard was identified

30.3 CCPs are appropriate and correctly identified

Reg. 852/2004 Art. 5HACCP Guid.Doc. Annex I ch. 231 Critical Limits (CL) (Objective:

Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market)

31.1 Established for each identified CCP

31.2 Parameters and criteria scientifically validated (i.e. research, literature, monitoring data etc. justify that effective control is achieved)

31.3 Applicable for real-time observable or measurable parameters by an operator

31.4 Correspond to extreme values acceptable to product safety that separate acceptability from unacceptability

31.5 Target levels (i.e. more narrow operational limits) are identified where relevant.Reg. 852/2004, Art. 5, pt. 1, 2HACCP Guid.Doc. Annex I ch. 3

32 Monitoring Procedures (Objective: Procedures based on HACCP principles shall be documented, implemented and

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maintained to ensure safety of food placed on the market)

32.1 Procedure established for each CCP/CL

32.2 Procedures are accurate, implemented and able to detect loss of control for timely corrective action to be taken without delay

32.3 Location for monitoring is appropriate

32.4 Frequencies, schedule, sampling plan are adequate

32.5 Responsible operator is appropriately trained and competent

32.6 Monitoring Records are associated with each CCP

32.7 Monitoring Records are signed by operator and verified by identified official(s) of the company.

32.8 Monitoring at each CCP are carried out as planned

32.9 Corrective actions in case of deviations from specified limits are carried out as planned without delay.

32.10 Corrective actions in case of deviations from specified limits are effective to control food safetyReg. 852/2004, Art. 5, pt. 1, 2HACCP Guid.Doc. Annex I ch. 4

33 Corrective Actions (CA) (Objective: Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market)

33.1 Established and defined specifically for each CCP/CL

33.2 Responsible operator is identified

33.3 Responsible operator is appropriately trained and competent

33.4 Isolation and treatment of non-conforming product specifically defined

33.5 Written records of CA measures available.

33.6 Corrective actions are implemented as planned

33.7 Corrective actions are adequate to control food safety

Reg. 852/2004, Art. 5, pt. 1, 2HACCP Guid.Doc. Annex I ch. 5

34 Verification Procedures (Objective: Procedures based on HACCP principles shall be documented, implemented and

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maintained to ensure safety of food placed on the market)

34.1 Adequate methods and procedures are described and implemented for each CCP/CL, e.g.

• record reviews (records for monitoring, corrective action, calibration, sampling and analysis, etc.)

• staff monitoring• calibration of instruments• sampling and analysis

34.2 Responsible operator is identified for each specific verification activity who is appropriately trained and competent

34.3 Results of verification activities are themselves verified

34.4 Corrective actions in case of non-compliance is identified for each verification activity

34.5 System audits are planned and implemented at appropriate frequencies

34.6 System audits includes Pre-requisite programmes and HACCP plan

34.7 Scope of system audits links to assessment of the efficiency of applied parameters, criteria, procedures and method to control food safety

34.8 Review of whole system or relevant parts are carried out at appropriate intervals or when changes in product, process conditions, packaging or intended consumers takes place or when new information about hazards reveals

34.9 Responsible operator for planning and conducting system audits are appropriately trained and competentReg. 852/2004 Art. 5HACCP Guid.Doc. Annex I ch. 6

35 Validation Requirements (Objective: Validation Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of food placed on the market)

35.1 Validation activities planned at appropriate frequencies to efficacy of all elements of the HACCP plan

35.2 Validation activities include at least confirmation of established Critical Limits parameter and other scientific and technical parameters as appropriate to ensure food safety

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35.3 Validation activities reviewed when changes occur (e.g. to raw materials, processing equipment, new information on hazards, etc).

35.4 Responsible operator for planning and conducting validation activities are appropriately trained and competent.

35.5 Carried out as planned, including:• Validation of critical limits (and other

scientific and technical parameters as appropriate to ensure food safety)

• calibrations of equipment• product sampling and testing• records review• Internal audits• Reviews when there are relevant

changes• System reviews (in addition to

internal audits) conducted at appropriate frequencies

35.6 Corrective actions in case of deviation from requirements are efficient to control food safetyReg. 852/2004 Art. 5HACCP Guid.Doc. Annex I ch. 6

36 Training (Objective: To ensure that staff shall be instructed and trained in food hygiene as relevant to their responsibility and activity with food).

36.1 HACCP team members trained specifically in the application of HACCP principles

36.2 Training needs identified for all staff working at CCPs

36.3 Training conducted and documented

Reg. 852/2004 Art. 5Reg. 852/2004, Annex II, chapter XII 1-3HACCP Guid.Doc. Annex I ch

37 Record Keeping

37.1 Records pertaining to HACCP, production, purchase, shipment, inspection, testing, calibration, hygiene sanitation, personal, pest control, maintenance etc are maintained properly.

Reg. 852/2004 Art. 5HACCP Guid.Doc. Annex I ch. 6

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Total number of: CR: SE: MI:

Rating of Facility PASS FAIL

Signature of Lead Inspector: Date:

Notes:

Inspections that result in one or more Critical Non-conformance (CR) or five or more Serious Non-conformances (SE) not noted by the establishment or the corrective action for the non-conformance is unacceptable, shall be considered as a (CR) and corrected immediately. Establishments must pass inspection to continue exporting.

Critical Non-conformance (CR) is a situation where the establishment has not complied with the EU Fish and Fishery Products requirements in such a manner that results in the production of food that is unsafe or is a health hazard. Examples could include, severe breakdown in sanitation procedures, waste contaminating foods, use of non-potable water (including ice or steam) or serious pest infestation. A CR shall cause the establishment to stop processing, until FIQCD is satisfied that the cause of the CR no longer exists.

Serious Non-conformance (SE) is a situation where the establishment has not complied with the EU Fish and Fishery Products requirements in such a manner that results in the production of food that is unsafe but is not a Critical non-conformance. Examples could include, ineffective pest control, inadequate cleaning program, inaccurate calibration, and failure to label chemicals, inadequate trained staff or premises not in good repair. The SE shall be corrected by the operator quickly within an agreed short time frame.

Minor Non-conformance (MI) is a situation where the establishment has not complied with the EU Fish and Fishery Products requirements but a CR or SE has not resulted. Examples could include, equipment not meeting correct standard, temperature of water, minor sanitation or construction deficiencies. The non-conformance shall be corrected at a date agreed to by FIQCD Inspectors and the processing establishment operator.

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Independent Cold Stores (ICS) – On-site Visit



Location Address:

Business Activity:


2. Activity of the Cold store

Size of cold store

Storage capacity & number of cartons stored at the time of visit

Products approved for storage

Name(s) & app no. of freezer vessels/ establishments utilising the storage facility.



Lead Inspector:

Other Inspectors:


Targeted Elements:



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ICS 01: Surroundings and Facilities



1. Surroundings, Constructions and Layout (Objective: To ensure that design, construction, location and size of the cold store allow adequate control of food hygiene and safety)

1.1 Surroundings maintained to prevent access and harbourage of pest

1.2 Premises are clean and reasonably free from objectionable odours, smoke, dust and other contaminants.

Reg 852/2004, Annex II, chapter I-1, 2a-2d. Ref. also to Item 16, 19 and 41 below

2. Alternate Power backup system (Objective: To reduce the risk due to power failure)

1.1. Alternate power supply system of adequate capacity is provided


3.1 Sufficient numbers of flushable lavatories that do not pollute the environment are provided.

3.2 Lavatory facilities that do not open directly into storage areas

3.3 Sufficient number of wash basins with non- hand operated taps are provided at suitable locations for hand washing.

3.4 Hand washing facilities such as liquid soap, nail brush, hygienic hand drying facilities are adequate and suitable.

3.5 Changing facilities such as lockable cupboards, gum boots; protective cloths etc are adequate for the operation.

Reg 852/2004, Annex II, chapter I-3, 4, 6, 9Reg 852/2004, Annex II, chapter I-7

4. Storage of Chemicals (Objectives: To ensure that dangerous cleaning and disinfecting chemicals cannot contaminate food)

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4.1 Adequate storage facilities allow for safe storage of cleaning and disinfection agents in areas where food is not handled. Chemicals are properly labelled.


ICS 02: Construction Requirements in Areas Where Food is Stored



5. Ante room

5.1 Ante room of suitable size is provided.5.2 Door, walls, floor & roof are smooth, clean

and properly insulated to avoid temperature loss.

5.3 Suitable methods are adopted to avoid condensation of water on the roof and walls.

5.4 Lighting of ante room is adequate and light fitting are protected

5.5 Suitable provisions for loading and unloading of fishery products into the ante room is provided

5.6 The door at loading point is fitted with air curtains/ suitable devices to avoid temperature fluctuation during loading/unloading activities and to prevent entry of flies


6. Cold Store

6.1 Door, walls, floor & roof are smooth, clean and properly insulated to maintain uniform temperature.

6.2 Air curtain or suitable device is provided at the entry point of cold store to prevent temperature fluctuation when the door is open.

6.3 Prevention of frost formation on the door, walls , roof and floor are suitably addressed

6.4 Light fittings are adequate and well protected

6.5 Suitable facilities are provided on the floor and walls of the store to facilitate proper air circulation

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6.6 Alarm bell is provided in case of emergency.

6.7 Sufficiently powerful refrigeration system is provided to maintain a uniform temperature of -180C or below at all parts of the cold store.

6.8 Defrosting system and arrangements to remove melt water are adequate and suitable.

6.9 Temperature abuse during defrosting is avoided by minimising the temperature fluctuation and the period of defrosting.

6.10 An automatic temperature recording device (thermograph) is provided, the temperature sensor of which is located at the warmest place in the cold storage.

6.11 The recording device is calibrated on a laid down frequency.

6.12 For storing frozen fishery products meant for EU, the automatic temperature recording device (data logger) is calibrated against EN 12830, EN 13485 and EN 13486 standards.

6.13 The frozen products are stored in such a way to facilitate free flow of chilled air at all areas of the store and also to provide easy movement for workers and competent authority.

6.14 The cold store temperature and core temperature of the products are effectively monitored to ensure product safety. Reg. 852/2004, Annex II, chapter V 1-3

ICS 03: Implementation of HACCP and Pre-requisite Programmes


7. Sanitation (cleaning and sanitation) (Objective: To ensure hygienic environment for the safety of the product)

7.1 Adopted a laid down procedure to clean and sanitize all storage facilities at regular intervals.

7.2 Criteria for sanitation is adequately defined

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7.3 Effectiveness of sanitation is monitored.

Reg. 852/2004, Annex II,

8. Personal Hygiene (Objective: The risk for transmission of human pathogenic microorganisms, and other hazards which may be carried by staff who handle food shall be minimized).

5.1. All staff members wear suitable, clean protective clothings, gum boots etc

5.2. All staff members maintain a high degree of personal cleanliness

5.3. Staff who may carry diseases 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

5.4. Procedures for monitoring staff health are planned, implemented and effective ( health cards)

Reg /852/2004, Annex II, Ch vii 1

9. Pest Control (Objective: To control (prevent and eliminate) pests from contaminating the product)

9.1. Cold store designed to prevent admission of pests.

9.2. Procedures for controlling pests such as insects, mice, rats etc. in storing areas are planned, implemented and monitored.

Reg. 852/2004, Annex II, Ch IX 4

10. Record Keeping

10.1 Records pertaining to HACCP, loading/unloading and storage of materials, cleaning and sanitation, pest control, personal hygiene, temperature monitoring, calibration etc are maintained

139




11 Management Commitment and implementation of HACCP (Objective: Procedures based on HACCP principles shall be documented, implemented and maintained to ensure safety of fishery products)

11.1 All prerequisite programmes and HACCP Plan documents are up-to-date and approved by management

11.2 Are modifications to documentation / implementation communicated to relevant staff members and the CA

11.3 HACCP is properly implemented and documented.

11.4 Internal audits and review of HACCP are done on a laid down frequency.

Reg. 852/2004 Art 5, Pt 1,3,4

Over all Findings:-

Place:

Date: Signature


140




Independent Ice Plants (IIP) – On-site Visit



Location Address:

Business Activity:


2. Activity of the Ice Plant

Type of Ice produced (block ice/flake ice/tube ice etc)

Production capacity/day

Name(s) & app no. of freezer vessels/ establishments/ fishing vessels/ landing sites etc utilising the ice produced by the plant.



Lead Inspector:

Other Inspectors:


Targeted Elements:


NCs given earlier are

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closed/open

IIP 01: Surroundings and Facilities



1. Surroundings, Constructions and Layout (Objective: To ensure that design, construction, location and size of the ice plant allow adequate control for producing safe & quality ice )

1.1 Surroundings maintained to prevent access and harbourage of pest

1.2 Premises are clean and reasonably free from objectionable odours, smoke, dust and other contaminants. Reg 852/2004, Annex II, chapter I-1, 2a-2d. Ref. also to Item 16, 19 and 41 below

2. Ice Crusher (In case of block ice)

2.1 Ice crusher provided is clean, smooth, easy to clean and disinfect and made up of non-corrosive materials.


3.1 Sufficient numbers of flushable lavatories that do not pollute the environment are provided.

3.2 Lavatory facilities that do not open directly into storage areas

A Sufficient number of wash basins with non- hand operated taps are provided at suitable locations for hand washing.B. Hand washing facilities such as liquid soap, nail brush, hygienic hand drying facilities are adequate and suitable.C. Changing facilities such as lockable cupboards, gum boots; protective cloths etc are adequate for the

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operation.Reg 852/2004, Annex II, chapter I-3, 4, 6, 9Reg 852/2004, Annex II, chapter I-7

4. Storage of Chemicals (Objectives: To ensure that dangerous cleaning and disinfecting chemicals cannot contaminate food)

4.1 Edible chemicals (salt) and non edible chemicals (cleaning/sanitizing agents) are stored separately away from ice production areas and are properly labelled.


IIP 02: Construction Requirements in Areas Where Ice is Produced



5. Bock Ice Production Facilities (as applicable)

5.1 Adequate protection is given to the block ice production area to prevent the entry of pests, rodent, vermin and unauthorized person.

5.2 Self-closing door is provided at the entry point.

5.3 Walls, floor & roof of the ice production area are smooth, clean and easy to clean and disinfect.

5.4 Lighting of ice production area is adequate and light fitting are protected

5.5 Roof & walls are free from condensation of water

5.6 Windows/ ventilators are protected with fly-proofing nets

5.7 Refrigeration unit is installed away from the ice production area

5.8 Chilling media storage tank(s) is made of non-corrosive materials

5.9 Only food grade quality salt is used after testing it for chemical and microbial contaminants.

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5.10 Ice cans made of non-corrosive materials are used, which are easy to clean & disinfect. The cans are provided with non- corrosive, smooth lids

5.11 Precautions are taken to ensure that the chilling media do not come in contact with the ice.

5.12 Precautions are taken while defrosting and handling ice cans to avoid contamination of ice from lubricants, defrosting water and also from contact surfaces.

5.13 Ice dispatch area is properly protected to avoid entry of pest & dust


6. Flake ice/ Tube ice/ Cube ice etc Production Facilities (as applicable)

6.1 The ice producing machine is smooth, clean and made up of non-corrosive material that do not contaminate the ice.

6.2 Walls, floor and roof of the ice making area are smooth, easy to clean and disinfect.

6.3 Ice is collected and stored in clean, smooth containers made up of stainless steel material.

6.4 Light fittings are adequate and well protected

6.5 Shovels/utensils used to handle ice are smooth clean, without edges/ welding and made up of non-corrosive material.

6.6 Ice is handled hygienically to avoid cross- contamination

6.7 Necessary arrangements are made to avoid condensation of water on roof & walls.

Reg. 852/2004, Annex II, chapter V 1-3

IIP 03: Implementation of Pre-requisite Programmes

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7. Sanitation (cleaning and sanitation) (Objective: To ensure hygienic environment for the safety of the ice)

7.1 Adopted a laid down procedure to clean and sanitize all ice producing/handling areas at regular intervals.

7.2 Criteria for sanitation is adequately defined

7.3 Effectiveness of sanitation is monitored.

Reg. 852/2004, Annex II,

8. Personal Hygiene (Objective: The risk for transmission of human pathogenic microorganisms, and other hazards which may be carried by staff who handle ice shall be minimized).

8.1 All staff members wear suitable, clean uniforms, gum boots etc

8.2 All staff members maintain a high degree of personal cleanliness

8.3 Staff who may carry diseases 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

8.4 Procedures for monitoring staff health are planned, implemented and effective ( health cards)

Reg /852/2004, Annex II, Ch vii 1

9. Pest Control (Objective: To control (prevent and eliminate) pests from contaminating the product)

9.1 Ice plant designed to prevent admission of pests.

9.2 Procedures for controlling pests such as insects, mice, rats etc. in storing areas are planned, implemented and monitored.

Reg. 852/2004, Annex II, Ch IX 4

10. Record Keeping

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10.1 Records pertaining to the production and dispatch of ice, cleaning and sanitation, pest control, personal hygiene, pest control etc are maintained

11. Water & Ice Management (Objective: Water supply system shall ensure that only potable or clean water can be used for ice production).

11.1 Adequate supply of potable water is readily available for ice production.

11.2 Suitable purification system is established to ensure that the water used for ice production meets the required National and International standards. (International Standards for Drinking water, WHO / Regulation 98/83/EC)

11.3 Care is taken to avoid cross contamination from non-potable water supply system.

11.4 Water storage tanks are properly cleaned on a laid down frequency and records maintained.

11.5 Physical quality of ice of each batch is checked before dispatch and ice is also tested for microbiological parameters regularly

Reg. 852/2004 Annex II, Ch VII 1-6Dir 98/83/EC, Annex II, Table A & B

Over all Findings:-

Place:

Date: Signature

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