Programme Funded

by the European Union


Programme Implemented by Secretariat of ACP

Group of States


Manual/Handbook for sanitary inspection at fish landing sites and aquaculture facilities


May 2010



Strengthening Fishery Products Health Conditions in ACP/OCT Countries


Manual/Handbook for Sanitary Inspection at fish landing sites and aquaculture facilities


 rue Abbe cuypers 3, etterbeek, B-1040, Bruxelles, Belgique

Tel: +32 (0)2 741 6837, Fax: +32 (0)2 734 79 10

 Email ero@sfp-acp.eu












Module I

Strengthening National Health Control Capacity for Fishery Products

Email: contact@sfpmodule1.be

Strengthening Fishery Products Health Conditions in ACP/OCT Countries 8ACPTPS137


1          Introduction.. 1

1.1      Background.. 1

1.2      Organisation of the manual. 1

2          Approach adopted by the manual.. 2

3          Glossary.. 3


4          Hazards and hazard controls.. 6

4.1      Biological hazards. 6

4.2      Chemical hazards. 7

4.3      Physical hazards. 9

4.4      Sources of information on fishery product hazards. 9

5          Requirements for fish hygiene controls.. 10

5.1      EU Regulatory Framework.. 10

5.2      EU Regulatory framework for Food Safety.. 11

5.3      EU Fish hygiene controls. 15

6          Health standards for fishery products.. 20

6.1      Prohibited species. 20

6.2      Fish toxins harmful to health.. 20

6.3      Organoleptic properties. 22

6.4      Histamine. 24

6.5      Requirements concerning parasites. 26

6.6      Benzopyrene in smoked fish.. 26

6.7      Residues of veterinary medicines. 27

7          Water supply.. 29

7.1      General requirements. 29

7.2      Definition of potable water and clean water.. 30

7.3      Council Directive 98/83/EC on water quality.. 30

7.4      Commission technical note on water quality.. 30

7.5      Checks on water chlorination.. 30

8          Traceability.. 32

8.1      Need for traceability.. 32

8.2      Traceability techniques. 32

8.3      Batch codes. 33

8.4      Tracefish standard.. 34

8.5      Traceability in the exported consignments. 34


9          Organisation of the Competent Authority.. 37

9.1      Inspection functions. 37

9.2      Inspection staff training and competences. 37

9.3      Equipment for inspectors. 38

9.4      Anti corruption measures. 39

10         Implementation of inspection, approval and surveillance system... 40

10.1     Official controls. 40

10.2     National legal basis for fish hygiene. 41

10.3     Annual inspection plan.. 42

10.4     Risk – based approach to inspection.. 43

10.5     Non-compliance procedures. 43

10.6     Sanctions for non-compliance. 44

10.7     Suspension or withdrawal of approval. 44

10.8     Annual reports. 45

11         Monitoring programmes for fishery products.. 45

11.1     Objectives of monitoring.. 45

11.2     Monitoring plans. 46

11.3     Monitoring requirements for fishery products. 46

11.4     Residue monitoring requirements for aquaculture products. 47

11.5     Actions in case of non-compliance. 50


12         guidelines for inspection techniques.. 53

12.1     The inspector.. 53

12.2     The Inspection sequence. 53

12.3     Use of checklists for inspection.. 53

12.4     Reporting the results. 54


13         Competent Authority Model Record Forms.. 56

13.1     Overview... 56

13.2     Form G1: Inspection at artisanal landing sites and authorization for fish landing.. 57

13.3     Form G4: Certificate of Origin.. 58

13.4     Form G7: Notification of fish product seizure. 60

13.5     Form G9: Report of Sensory Evaluation.. 61

14         Model Inspection Check Lists.. 63

14.1     Overview... 63

14.2     Classification of non- compliance. 63

14.3     Cover Page for Inspection Forms. 65

14.4     Checklist F06 for inspection of aquaculture production facilities. 67

14.5     Checklist F07 for inspection of ice production facilities. 70

14.6     Checklist F09 for inspection of landing sites and harbours. 73

14.7     Checklist F11 for inspection of fishing and freezer vessels. 75

14.8     Checklist F12 for inspection of small-scale fishing vessels. 79

14.9     Checklist F13 for inspection of road transport vehicles. 81

14.10   Checklist F14 for assessment of traceability conditions. 83

Annexes.. 85

Annex 1: Fishery products Requirements Regulation EC 853/2004/EC.. 86

Annex 2: Check of Water – Fishery Establishments. 87






Table 1: Some examples of biological hazards in fishery products. 6

Table 2: Examples of Chemical Hazards. 8

Table 3: Definition of fishery products in terms of harmonised system Tariff codes. 17

Table 4: Examples of fish associated with ciguatera toxin. 21

Table 5: Some Quality Aspects of Fish and Fish Products. 23

Table 6: Sensory score sheet for cooked cod. 23

Table 7: Histamine limits for fishery products. 25

Table 8: Maximum limits for benzo(a)pyrene in in fishery products. 27

Table 9: Permitted list of veterinary medicines for application to fishery products. 28

Table 10: Risk categorisation of establishments. 43

Table 11: Group A and B substances considered in residue monitoring programmes for farmed fish. 48

Table 12: Typical monitoring parameters for farmed fish. 49

Table 13: Example of overall rating of fish landing site. 64

1           Introduction

1.1        Background

Of 4.7 million tonnes of fish produced in ACP countries in 1997, about 700.000 tonnes (14%) entered international trade bringing export revenues of over €1.3 billion. The majority of this revenue (76%) was derived from trade with the European Union; since 1995, sixty ACP states have supplied this market.

Many ACP countries depend on the export of fishery products, to provide both foreign exchange revenues and employment in coastal or rural regions. Even where there is substantial reliance on foreign industrial fishing as a source of exports (such as West Africa) an estimated 10% of exports are derived from small-scale fisheries and foreign fishing may frequently provide benefits in terms of jobs for onshore processing and distribution of by-catch. Maintaining access to export markets for fishery products is therefore of strategic importance to many ACP countries. The major export market for most ACP exporters of fishery products is the European Union.

In 1991, the European Council introduced harmonised health controls for fishery products for human consumption, which included strengthened controls of products from third countries. These requirements are presently expressed in several Council Regulations concerning food safety in the European Union, described in detail later in this manual. Not only must industry in these third countries meet the hygiene and HACCP[1] conditions, but in each country a Competent Authority must establish health controls over the sector which are at least equivalent to those defined in EU legislation.

The potential loss of access to international markets for fishery products through a lack of capacity to respond to the requirements for strengthened health conditions is a problem faced by many less developed countries with only limited resources for implementing the legal, institutional and technical steps for applying effective food safety controls to the fishery sector.  A key requirement is for appropriate and timely information regarding the legal and technical requirements. This manual, which is produced by the EDF Funded project “Strengthening fishery product health conditions in ACP/OCT Countries”,  is therefore intended to support the relevant competent authorities and their staff in the practical implementation of inspection, control and certification systems in compliance with the EU requirements.

The objective of the manual is to provide a standard updatable reference document for daily use by fish inspectors, as well as a training resource. To this end the document will contribute to the strengthening the capacity for sustainable export health controls and improving production conditions in all beneficiary countries.

1.2        Organisation of the manual

This manual is presented in four parts.

Part A deals with the technical standards and requirements of food safety conditions for fishery products, based mainly on the EU regulatory requirements.

Part B deals with the organisational aspects of the Competent Authority, including elements based on the regulatory requirements set out in the EU legislation, and drawing on the experiences in its implementation.

Part C sets out the technical steps which inspectors need to address in the organisation of their work, to ensure an effective, efficient and thorough coverage of the technical requirements when they are making inspections.


Part D includes a series of inspection and record keeping forms which can be adapted and applied as required by inspectors operating in the field. They provide a set of useful checklists and scoring systems to help inspectors ensure that they cover all of the key elements required for regulatory compliance and certification,

2           Approach adopted by the manual

The focus of the manual is very closely aligned to the objectives of the inspection and control process. This is exclusively focused on the production and placing on the market of fishery products which are safe for human consumption. The role of the inspector is to assess the food safety conditions of the production, assess them against the legal requirements, and to take action to prevent injury or death when conditions evidently do not meet the required standards.

The role of the fish inspector is not to:

  • promote the local industry
  • assist exports
  • ensure that the quality is appropriate to the commercial requirements of the market.


Therefore fish inspectors should be only concerned with those matters which affect the safety of the product. Inspectors should accept that the sale of low quality fishery products is acceptable, and even desirable, in terms of resource utilisation, providing that the consumer is not misled and that the product is safe to eat.

This manual therefore focuses only on food safety aspects in the official control of fishery products. It concentrates exclusively on the hazards to human health which may arise in fishery products, and the organisation of a system of official controls (consisting of legislation, and an inspection and enforcement system) which can be used to minimise the probability of injury to health.

The manual is focused on responding to the EU regulatory framework for food safety conditions for fishery products. This is because of all of the major importing nations, the EU regulations express specific demands on the organisation of the inspection system. Although several importing countries require production under the HACCP conditions, only the EU expressly requires the Governments in the supplying countries to undertake specified steps to ensure that the conditions are in place. In this respect, the EU requirements are generally the most difficult to respond to, not only by the exporting enterprises, but also requiring actions by the state apparatus of the exporting country.

It should be noted that food can never be 100% safe. It is a biological material and (in the case of most fishery products) it is hunted from a wild environment which is not subject to human controls. Sources of supply, processing technology and distribution systems are in a constant state of dynamic flux. Inspection and control is a costly activity, and it is neither possible nor desirable to control everything all of the time.

The task of the inspector is therefore one of risk management to ensure that the limited resources available are applied in an efficient and effective manner so that that the risk of a food safety hazard causing harm to the consumer is minimised.

Therefore the core knowledge required by any inspector is of fishery product hazards, how they arise and how they can be controlled.

There are many types of health hazards associated with fishery products. Humans harvest and consume several thousands of different species of fishery products principally from several of the major phyla of animals;


  • mollusca (including bivalve, gastropod and cephalopod molluscs),
  • arthropoda (including crustacea and chelicerata)
  • invertebrate chordata such as the tunicates and echinoderms (such as sea urchins)
  • vertebrate chordata including teleostomi (the true fishes) and chondricthyes (cartilagenous fishes).

Each species has its own specific biochemistry and environment. The fish inspector should have a good scientific understanding of how these factors, along with post-harvest variables in handling and processing, can affect food safety.

3                    Glossary

EU approved establishments:

A freezer-factory vessel, onshore plant, building or premise where fish are processed or stored for export to the European market and that is registered and included in the list of establishment authorized and officially communicated to the Commission.

Competent Authority: 

The central authority of a Member State (within the EU) or central national authority in any country, competent to carry out veterinary or health checks or any authority to which it has delegated that competence. The national authority designated and empowered by the law to perform inspections, assess facilities an production and control systems, to register and approve and provide certificates of agreement to the establishments and other facilities and to issue health certificates to permit the putting in the market of fishery products.

Corrective action:

The procedure that is to be followed whenever a deviation from a critical limit in a HACCP plan occurs or whenever the results of monitoring procedures in respect of a prerequisite program plan, or a food safety program for the importing or exporting of fish or fishery products show that there is non-compliance with the regulation.


Hazard analysis critical control point system; a product safety management system which identifies critical process variables affecting the level of and presence of hazards to human health in the final product, and which defines critical monitoring indicators and methods to ensure that process variables remain within defined safe limits.


General food safety conditions, and includes contaminants and other food safety hazards which may be found in fish and fishery products.


An official agent authorized by the Competent Authority to perform the duties of inspection in order to ensure food safety.


The official examination of establishments, of animals and food, and the processing thereof, of food businesses, and their management and production systems, including documents, finished product testing and feeding practices, and of the origin and destination of production inputs and outputs, in order to verify compliance with the legal requirements in all cases;


A shipment or part of a shipment of fish or fishery products, that is of the same species, is produced in the same manner by the same producer, at the same date or short period, is packaged in the same size of container and bears the same name.


A planned observation, or measurement of a parameter, at a specified point or time, which is then compared to a target (i.e. a standard, an operational limit, a critical limit).


A deviation from a processing establishment's HACCP, GMP, or SSOPs that results in the establishment not following its HACCP, GMP, SSOP plan or not complying with the regulation.

Official control:

Means any form of control that the competent authority performs for the verification of compliance with food law, including animal health and animal welfare rules;



































4           Hazards and hazard controls

Hazards in fishery products are typically classified according to their nature; chemical, biological and physical. Some of the hazards, particularly hazards originating from the source of production, are highly specific to the species of fishery products (species related hazards). Others are more generic in their nature (for example in relation to post-harvest contamination) and may be encountered in other foodstuffs (process related hazards). Examples of potential biological, chemical and physical hazards are given in the accompanying boxes (Tables 2 and 3)[2].

4.1        Biological hazards

Food borne biological hazards include microbiological organisms such as bacteria, viruses, fungi and parasites. These organisms are commonly associated with humans and with raw products entering the food establishment. Many of these microorganisms occur naturally in the environment where foods are grown. Most are killed or inactivated by cooking and numbers can be minimized by adequate control of handling and storage practices (hygiene, temperature and time).

Table 1: Some examples of biological hazards in fishery products

Bacteria (spore-forming)

Clostridium botulinum

Bacteria (non-spore-forming)

Pathogenic Escherichia coli (eg. E. coli 0157)
Listeria monocytogenes
Salmonella spp. (S. typhimurium, S. enteriditis)
Shigella (S. dysenteriae)
Staphylococcus aureus
Streptococcus pyogenes
Vibrio cholerae
Vibrio parahaemolyitcus
Vibrio vulnificus
Yersinia enterocolitica


Hepatitis A and E
virus group

Protozoa and parasites

Diphyllobothrium latum
Entamoeba histolytica
Giardia lamblia
Clonorchis sinensis


The majority of reported food borne disease outbreaks and cases are caused by pathogenic bacteria. A certain level of these microorganisms can be expected with some raw foods. Improper storage or handling of these foods can contribute to a significant increase in the level of these microorganisms.

Cooked foods often provide fertile media for rapid growth of microorganisms if they are not properly handled and stored. They are regarded as high risk since there is no further heat treatment before consumption which would otherwise kill the microorganism.

Viruses can be food borne/water-borne or transmitted to food by human, animal or other contact. Unlike bacteria, viruses are unable to reproduce outside a living cell. They cannot therefore replicate in food, and can only be carried by it. They are a particular risk in filter feeding bivalve molluscs.

Parasites are most often animal host-specific and can include humans in their life cycles. Parasitic infections are commonly associated with undercooked fishery products or contaminated ready-to-eat food. Some parasites in products that are intended to be eaten raw, marinated or partially cooked can be killed by effective freezing techniques.

Fungi include moulds and yeasts. Fungi can be beneficial, as they can be used in the production of certain foods (e.g. cheese). However, some fungi produce toxic substances (mycotoxins) which are toxic for humans and animals, and can enter the food chain via animal feeds.

4.2        Chemical hazards

Chemical contaminants in food may be naturally occurring or may be added during the processing of food. Harmful chemicals at high levels have been associated with acute cases of food borne illnesses and can be responsible for chronic illness at lower levels.

Table 2: Examples of Chemical Hazards

Naturally occurring chemicals

Mycotoxins                            (e.g. aflatoxin)
Scombrotoxin (histamine)

Shellfish toxins:

- Paralytic shellfish poisoning (PSP)
- Diarrhoeic shellfish poisoning (DSP)
- Neurotoxic shellfish poisoning (NSP)
- Amnesic shellfish poisoning (ASP)
- Pyrrolizidine alkaloids
-              Phytohaemagglutinin


Contaminants, additives and residues

Environmental contaminants:

Polychlorinated biphenyls (PCBs)
Agricultural chemicals
- Pesticides
- Fertilizers
- Antibiotics
- Growth hormones

Toxic heavy metals:

- Lead
- Zinc
- Cadmium
- Mercury

Food additives
Vitamins and minerals

- Lubricants
- Cleaners
- Sanitizers
- Coatings
- Paints
- Refrigerants
- Water or steam treatment chemicals
Pest control chemicals

From packaging materials

Vinyl chloride
Printing/coding inks


4.3        Physical hazards

Illness and injury can result from hard foreign objects in food. These physical hazards can result from contamination and/or poor practices at many points in the food chain from harvest to consumer, including those within the food establishment. Examples are metal and glass inclusions.

4.4        Sources of information on fishery product hazards

The best readily available source of global level information regarding specific hazards in fishery products and their controls is provided in the:

U.S. Food & Drug Administration
for Food Safety & Applied Nutrition
Third Edition June 2001

The contents page is shown below. This is available on line at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm

 This document sets out to describe all of the common hazards associated with the production, processing and distribution of fishery products. It also provides detailed guidance on the design and implementation of HACCP plans to ensure control of the hazards.

Inspectors should have an intimate knowledge of the information contained in this document insofar as it applies to fishery products which fall within their jurisdiction. Without this knowledge and the ability to apply it in the fish production and distribution chain, inspectors will not be able to address their basic duties. It should however be noted that the guide does not provide an exhaustive treatment of all hazards, and that it is the inspectors primary duty to be aware of the risks associated with the production and distribution of fishery products falling within his or her jurisdiction.

Chapter 1:


Chapter 2:

Steps in Developing Your HACCP Plan

Chapter 3:

Potential Species -Related & Process-Related Hazards

Chapter 4:

Pathogens From the Harvest Area

Chapter 5:


Chapter 6:

Natural Toxins

Chapter 7:

Scombrotoxin (Histamine) Formation

Chapter 8:

Other Decomposition-Related Hazards

Chapter 9:

Environmental Chemical Contaminants & Pesticides

Chapter 10:

Methyl Mercury

Chapter 11:

Aquaculture Drugs

Chapter 12:

Pathogen Growth & Toxin Formation (Other than Clostridium botulinum) as a Result of Time/Temperature Abuse

Chapter 13:

Clostridium botulinum Toxin Formation

Chapter 14:

Pathogen Growth & Toxin Formation as a Result of Inadequate Drying

Chapter 15:

Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes

Chapter 16:

Pathogen Survival Through Cooking

Chapter 17:

Pathogen Survival Through Pasteurization

Chapter 18:

Introduction of Pathogens After Pasteurization and Specialized Cooking Processes

Chapter 19:

Allergens/Food Intolerance Substances and Prohibited Food and Color Additives

Chapter 20:

Metal Inclusion

Chapter 21:

Glass Inclusion (Draft)

Appendix 1:


Appendix 2:

Sample Product Flow Diagrams

Appendix 3:

CCP Decision Tree

Appendix 4:

Bacterial Pathogen Growth and Inactivation

Appendix 5:

FDA & EPA Safety Levels in Regulations and Guidance

Appendix 6:

Food Allergens

Appendix 7:


Appendix 8:

Seafood HACCP Regulation


Additional sources of information on HACCP can be found at:

http://www.fao.org/docrep/003/t1768e/T1768E00.htm#TOC (Hazards understanding and control measures)

5           Requirements for fish hygiene controls

5.1        EU Regulatory Framework

The legal basis in the EU for food safety conditions is found in Article 29 of the EU Treaty, which requires free movement of goods in intra-community trade without quantitative restriction, and prohibits any measures which may have a similar effect.

EU legislation comprises Directives (which require Member States to enact legislation with the effect described in the Directive) or Regulations (which apply directly as if they were the law of the Member State). Power to specify some administrative and legal measures is delegated to the European Commission (Commission Decisions, Commission Regulations or Commission Directives). Inspectors should be aware of the different legal effect of the different legal instruments, since it affects how they should be interpreted.

5.2        EU Regulatory framework for Food Safety

5.2.1        General concept

In the case of food safety, the food safety conditions are described for food produced and marketed within the EU. Much food consumed in the EU is imported from outside the Community, that is from third (non-EU) countries. The general approach adopted by European law is to apply the equivalent conditions to food imported from third countries as it does to food produced within the EU. The general requirement is that conditions applied to third county supplies should be “at least equivalent” to the conditions defined in the legislation.

This is an important consideration. It does not require that conditions are the same, but that they have an equivalent effect, thus providing a degree of flexibility for the development of control systems within the context of the third country situation. The interpretation and transposition of EU legislation for third country suppliers must therefore take this into account.

5.2.2        List of main legal instruments

The main legal instruments which determine the requirements for food safety conditions for fishery products are listed below. All are available online[3] at  


These regulations define the general food safety and hygiene conditions applied to foods in general, and foods of animal origin in particular, including fishery products. They also set out the system of official controls – the activities of government undertaken to ensure that the regulatory conditions are complied with.

REGULATION (EC)No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

REGULATION (EC)No 882/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

REGULATION (EC)No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the hygiene of foodstuffs

REGULATION (EC)No 853/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 laying down specific hygiene rules for food of animal origin.

REGULATION (EC)No 854/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption.


In addition to the above, there are a number of general legal requirements applied to food (and therefore fishery products) with regard to:

  • authorisation and Maximum Residue Levels (MRLs) of veterinary medicines in farmed products of animal origin (including fish)
  • environmental contaminants (heavy metals, organochlorine and organophosphate compounds, dioxins and dioxin like PCBs)
  • residue monitoring of farmed products of animal origin
  • additives
  • water for human consumption


These requirements are described in the appropriate sections of this document. The main regulations are also supported by a large number of Commission Decisions which provide greater detail on the technical and administrative requirements (detailed procedural rules, certificates and forms, technical standards to be complied with etc). These are also introduced in the relevant parts of the manual.

Note also that EU food safety law is not static. Within the framework established by the main regulations, there is a continuous review of safe levels of contaminants such as heavy metals, dioxins and biotoxins (for example as a result of the risk assessment work of the European Food Safety Authority). At the time of writing, a major revision and harmonisation of European food additive legislation is also underway. Inspectors should ensure that they refer to the latest amendments, or the consolidated version of any regulation consulted.

Furthermore, additional certification requirements were introduced by the EU from 1st January 2010 in respect of illegal, unreported and unregulated (IUU) fishing (under the terms of Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing). In some countries fish inspectors responsible for food safety, may be allocated the additional responsibility for IUU certification of fishery products  More information is available from the European Commission at:


5.2.3        Approval of establishments and certain vessels

Approval of establishments (and vessels) is the principal means of control used by the EU for official control of food safety conditions for all products of animal origin.

Regulation 853/2004 states that: “establishments handling those products of animal origin for which Annex to this regulation lays down requirements shall not operate unless the Competent Authority has approved them….

Certain establishments supplying products of animal origin do not require approval. These are set out in Annex V of Regulation 854/2002 and in relation to fishery products include “establishments carrying out only the storage of products of animal origin not requiring temperature controlled storage”. This would include for example the storage of canned fishery products.

Otherwise, national legislation of the third country must therefore provide the legal basis for the approval of establishments, which should include provision for:

  • Provisional approval for new establishments
  • Technical conditions for approval
  • Circumstances for suspension and withdrawal of approval
  • Routine monitoring and supervision

The technical conditions for approval will therefore correspond to Annex III of Regulation 853/2004, Section VII (for bivalve molluscs) and Sections VIII (Fishery products). These are described in more detail in Part B of this manual.

The specific conditions and procedures must be laid down in national legislation, and this provides the fundamental legal basis for the work of the inspectors. For third countries supplying the European Community, this legislation (and its implementation) must be “at least equivalent” to the conditions set out in Regulation 853/2004.

The Competent Authority must maintain a list of approved establishments and factory vessels which are considered to meet the conditions set out in the legislation. The list is submitted and held by the European Commission, and is circulated to all Border Inspection Posts (BIP) in the EU. Only products certified as originating from approved establishments and factory vessels and which are formally approved and listed will be allowed entry at the EU BIP. New lists of establishments are periodically submitted by the Competent Authority of the third country to keep the system up to date.

Exports to other regions, with different requirements, may be treated differently. However, experience has shown that it is often convenient to apply the approval system (which includes a HACCP requirement) to all establishments supplying export markets which require production of fishery products to be subject to HACCP controls[4].

5.2.4        EU Approval of third countries

Whilst the general requirement for health conditions for foods of animal origin imported from third countries is set by the EU Regulations, specific import conditions may be established by the European Commission. Usually, these will follow an inspection of the health conditions in the third country by the Food Veterinary Office (FVO) of DG Health and Consumer Protection of the European Commission.

The assessment of the health conditions will take into account (Article 11 of Regulation 854/2004):

  • the legislation of the third country  (including powers and sanctions)
  • the organisation of the third countries competent authorities
  • the training of staff in the performance of official controls, including in-service training and skills updating:
  • the resources, including diagnosis facilities available to competent authorities;
  • the existence and operation of documented control procedures
  • the extent and operation of official controls on imports of animals and products of animal origin;
  • the assurances which the third country can give regarding equivalence to Community requirements;
  • the hygiene conditions of production, manufacture, handling, storage and dispatch
  • the performance of the traceability system
  • experience of marketing of the product from the third country and the results of any import controls carried out;
  • results of Community controls carried out in the third country
  • existence, implementation and communication of an approved residue control programme.


Before such an assessment is undertaken, the FVO of DG Health and Consumer Protection (DG SANCO) may request that the Competent Authority completes a “Pre-mission Questionnaire”, to ensure the communication of factual information. Note that under certain circumstances (e.g. low perceived risk) Article 11 of Regulation 854/2004 allows for a third country to be placed on a list without an inspection by the Commission.

The specific import conditions are set out in Article 48 of Regulation 882/2004 and will generally set out:

  • the list of approved establishments
  • the format and content of model certificates,
  • any special import conditions or limitations set by the Commission.  This may be used for example to limit exports to certain categories of fishery products considered to be lower risk and subject to adequate health controls, or to limit the territorial origin of certain products.


5.2.5        Controls regarding raw materials originating in other third countries

In maritime law, the origin of a fishery product from capture fisheries is determined by the flag of the vessel from which it was caught, not by the country in whose waters it is caught or in which it is first landed. The origin of aquaculture products is derived from the country in which the juveniles are produced.

Inspectors should be aware of the specific provisions of EU law relating to the controls to be placed on fishery products which do not originate in their own country. This can occur in two main circumstances, when:

  • Freezer and factory vessels from other third countries land fishery products in the third country, for processing and onward trade
  • Processing establishments import raw material product from another third country for further processing and re-export


In all circumstances EU law is quite clear. Fishery products must always originate from a country which is allowed to export to the EU (i.e. listed in Annex I or II of Commission Decision 2006/766/EC of 6 November 2006). It must originate from an approved establishment or an approved factory vessel, or from a freezer vessel registered with and under the control of the Competent Authority. The originating establishment or vessel must therefore be subject to inspection and control by the Competent Authority of the originating third country.

Article 15 of Regulation 854/2004 provides two derogations to this requirement. Firstly, when a third country vessel lands fish directly into the European Community, there are separate Community inspection and certification procedures which may be invoked. Secondly, products may be derived from a third country vessel landing in another third country, providing that:

  • Both countries are authorised for supply of fishery products to the Community
  • The Competent Authority of the first country has authorised the Competent Authority of the second to inspect vessels on its behalf
  • The vessel is listed by the Competent Authority of the flag state and has been inspected and approved by the second Competent Authority

Inspectors required to issue certificates in such circumstances are strongly advised to refer to Article 15 of Regulation of 854/2004.

Inspectors should be aware that importing and re-processing fishery products from other third countries and vessels flagged in other third countries is a normal and lawful part of the international fish business.

However it is well known that some traders do attempt to circumvent the health and hygiene controls by exporting under the name of an approved establishment in another country. This typically occurs in cases where:

  • A country is not listed  Commission Decision 2006/766/EC of 6 November 2006
  • An establishment or vessel is not approved
  • A temporary ban is put in pace on certain products originating from certain countries

In all cases therefore inspectors should pay particular attention to the international trade patterns in fishery products in their country, including imports, both formal imports and landings from foreign flagged vessels. Monitoring of imported fishery products is a big part of the control system.

The traceability systems of enterprises receiving imported fishery products for re-processing (discussed in Section 9) should clearly distinguish the country of origin of fishery products where this is not the country from which they are exported. In such enterprises inspectors should be especially vigilant and aware of the potential for fraud, and ensure that certification criteria fully take into account the origin of the fishery products being exported.

5.2.6        Controls on farmed products of animal origin

Under Council Directive 96/23/EC of 29 April 1996on measures to monitor certain substances and residues thereof in live animals and animal products” there is a requirement for Member States to prepare a Residue Monitoring Programme for products of animal origin. This should include monitoring of the substances set out under above Annexes. The requirement is also applied to third countries. The requirement applies to “aquaculture animals” but not other fishery products.

Thus third countries wishing to export aquaculture products to the EU must also implement a regulatory framework to ensure suitable controls of veterinary medicines in line with the Annexes to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 “laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council” and a residue monitoring programme in line with Directive 96/23/EC. This regime (legislation, organisation, monitoring plan, implementation measures and results) should be submitted to the European Commission for consideration for the making of specific decision regarding the import conditions. Then latest decision is published under Commission Decision of 29 April 2004 “on the approval of residue monitoring plans submitted by third countries in accordance with Council Directive 96/23/EC”.

Only countries which are listed in the Annex to this Decision are permitted to supply the listed farmed products of animal origin, for which residue monitoring programmes have been submitted and approved.

Specific details on the design and format of the residue monitoring programmes to meet the EU requirements are set out in Section 14. For more detailed information inspectors are referred to the SFP Publication “Guide to the Establishment of Environmental (EMP) and Residue (RMP) Monitoring Plans”[5].

5.3        EU Fish hygiene controls

5.3.1        Legal basis

General food safety conditions applying to all food business operators are set out in the Annex II to Regulation 852/2004 on the hygiene of foodstuffs. The additional health conditions for the production and placing on the market of fishery products for human consumption are set out in Regulation 853/2004 “laying down the specific rules for hygiene of  products of animal origin” 

Definitions are set out in Annex I.

Annex II sets out requirements for identification marks.

Annex III sets out the specific requirements for health conditions for products of animal origin. The requirements are supplementary to those set out in Regulation 852/2004.

Bivalve Molluscs are covered in Section VII

Fishery products are considered in Section VIII. A copy of this section is provided in Annex 1 of this manual.

Requirements for production of gelatine and collagen (including from fishery products) are set out in Section XIV.

5.3.2        Definitions

Definitions are set out in the Regulation 853/2004. Some of the key definitions, with which inspectors should be familiar, are given here.

Fishery products

Fishery products means:

all seawater or freshwater animals (except for live bivalve  molluscs, live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms ,parts and products of such animals”.

Fishery products are further defined by the list in Article 1 of Council Regulation (EC) No 104/2000. This refers to a number of composite and processed products and may be more helpful in determining the extent of jurisdiction of the Competent Authority. The key definitions are in Table 4 overleaf.

Table 3: Definition of fishery products in terms of harmonised system Tariff codes

CN code[6]

Description of goods



Live Fish


Fish, fresh or chilled, excluding fish fillets other fish meat of heading No 0304«


Fish, frozen excluding fish fillets and other fish meat of heading No 0304


Fish fillets and other fish meat (whether or not minced), fresh, chilled or frozen



Fish, dried, salted or in brine; smoked fish, whether or not cooked before or during the smoking process; flours, meals and pellets of fish, fit for human consumption





Crustaceans, whether in shell or not, live, fresh, chilled, frozen, dried, salted or in brine; crustaceans, in shell, cooked by steaming or by boiling in water, whether or not chilled, frozen, dried, salted or in brine; meals and pellets of fish, fit for human consumption


Molluscs, whether in shell or not, live, fresh, chilled, frozen, dried, salted or in brine; aquatic invertebrates other than crustaceans and molluscs, live, fresh, chilled, frozen, dried, salted or in brine; meals and pellets of aquatic invertebrates other than crustaceans, fit for human consumption



Prepared or preserved fish; caviar and caviar substitutes prepared from fish eggs



Crustaceans, molluscs and other aquatic invertebrates, prepared or preserved

Other definitions

Factory vessel

Any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing.

Freezer vessel

Any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging.

Note that shrimp vessels which freeze whole or head off shrimp will be classed as freezer vessels. If they process peeled shrimp they should be considered factory vessels.

Fresh fishery products

Unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling.

Prepared fishery products

Unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping.

Processed fishery products

Processed products resulting from the processing of fishery products or from the further processing of such processed products.

Products of animal origin

Generally excludes live animals, but it includes: live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption

5.3.3        Requirements for Vessels

All vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, must comply with the structural and equipment requirements laid down in the Annex to Regulation 853/2004. All operations carried out on board vessels should also take place in accordance with Section VIII of Annex III of the regulation.

The requirements set out the hygiene conditions with respect to design, layout, equipment and materials of construction, all with the objective of eliminating or minimizing contamination of fishery products. These apply to all vessels.

Where vessels are designed and equipped to preserve fresh fishery products for more than 24 hours, additional requirements are specified, in relation to arrangements for fish storage areas, including requirements for chilling. At a minimum this requires an insulated box, with drainage and impermeable and easily cleaned surfaces, which can be used to chill and store fish with ice.

Separate additional requirements are specified for freezer vessels and factory vessels. The former must have capacity to freeze fishery products to less than -18°C and to store them at that temperature. This is usually vertical or horizontal plate or blast freezing. Where freezing in brine of whole fish intended for canning is practised, a temperature of less than -9 °C must be achieved. 

Factory vessels must be in possession of additional features such as reception area, packaging stores, waste disposal system and hand washing equipment. The specific hygiene requirements are set out in the Regulation and will be expressed in the relevant national legislation of the third country.

5.3.4         Requirements during and after landing

Requirements are specified for the handling of fish during landing and first sale. These are designed to ensure the hygiene conditions at landing sites are adequate to prevent contamination of the product, and that the temperature of the product is maintained. These requirements should be transposed into the national legislation of the third country.

In general, fish landing sites should have a covered area to avoid exposure of the fish to direct sunlight. There should be adequate storage facilities for fish and ice, including lockable facilities for the refrigerated storage of fishery products detained or declared unfit for human consumption. A lockable facility for the inspectors should also be available. The landing site should be provided with an impermeable floor, and supply of potable water or clean sea or fresh water. There should be adequate sanitary and hand washing facilities for staff. Animals should be excluded (which generally will require the area to be fenced), and only authorised persons should be allowed access to the areas where fish is handled or displayed. Proper facilities for washing fish with potable or clean water must be provided. Inspectors should be vigilant to prevent the use of harbour water for washing fish, since it is invariably contaminated.

5.3.5        Requirements for handling fresh fish

Fish processing establishment operators must ensure compliance with the following general requirements. These requirements also apply to factory vessels. Specific points to note are:

  • heading and gutting must be carried out hygienically and where it is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed. The products must be washed thoroughly with potable water or ,clean sea or lake water immediately after these operations.
  • filleting and cutting must be carried out so as to avoid contamination or spoilage of fillets and slices. In the establishment the cutting or filleting operations should take place in a separate place to gutting. In some circumstances it will be acceptable to undertake them in the same place, but at different times, with a cleaning and sanitizing operation in between.
  • Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water does not remain in contact with the products. This means fish boxes should have adequate drainage channels, including those on board fishing vessels.

5.3.6        Storage and transport of fishery products

Inspectors should check that fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, are maintained at a temperature approaching that of melting ice and that frozen fishery products must be kept at a temperature of not more than -18 °C in all parts of the product. The only exception is that whole frozen fish in brine intended for the manufacture of canned food may be kept at a temperature of not more than -9 °C.

Inspectors should always check means of transport. This should include vehicles transporting raw materials from landing sites to processing establishments and transporting the final product. Vehicles include road vehicles, transport vessels or even aircraft. Checks should take place at the landing site, at the factory, at the port from which the final export takes place (airport, road transport depot or harbour). Spot checks of some fish vehicles should also always be undertaken in transit. Powers of inspectors should include the power to stop and search vehicles which appear to be transporting fishery products for the purposes of ascertaining whether the legislation is being complied with.

 During transport, fishery products must be maintained at the required temperature. In particular fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, should be maintained at a temperature approaching that of melting ice.

Frozen fishery products must be kept at a temperature of not more than -18 °C in all parts of the product. However, during transport short upward fluctuations of not more than 3 °C may be tolerated.  Also when frozen fishery products are to be thawed at their destination they may be transported at the discretion of the inspector without registration.

6           Health standards for fishery products


Specific standards for fishery products are set out in the EU legislation, and should be transposed to an equivalent effect in the national legislation of the third country. This section sets out the specific standards for fishery products. Note that the requirements are not all expressed within a single regulation. The Competent Authority is advised to maintain a file of the relevant EU legislative instruments, and ensure that this is kept updated. The latest EU legislation is available at: http://eur-lex.europa.eu/

It should be noted that the EU regulations are specifically targeted at fishery products produced in the European Union and that it is not scientifically justifiable in all cases to apply the same standards to different species produced in different environments. In all cases therefore the following standards should be adapted by the Competent Authority to the local conditions.

The Codex Alimentarius Commission also provides international standards for fishery products, which may be adopted and applied by third countries, for example in cases which are not covered by EC legislation. The Codex Alimentarius codes of practice and standards are available at: http://www.codexalimentarius.net/web/standard_list.jsp

6.1        Prohibited species

Certain fish species are naturally toxic and they should not be marketed. The inspectors should be able to identify any such species or genera which are encountered in the fisheries which they control. National legislation should prohibit their sale or possession for sale for human consumption. The genera concerned (set out in the Annex to Council Regulation 854/2004) are Tetraodontidae, Molidae, Diodontidae and Canthigasteridae. In some tropical regions the blue ringed octopus Hapalochlaena lunulata is also a hazard.

Inspectors should be aware that a number of species of puffer fish of the order Tetraodontiformes are considered to be a Japanese delicacy (fugu fish). Generally, since such fish cannot be guaranteed to be safe, their marketing should be prohibited.

Commission Regulation No 1021/2008 of 17 October 2008 extended the marketing restrictions for toxic fish to the family Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum (known as oilfish or escolar) which may only be placed on the market in wrapped/packaged form and with appropriate labelling regarding the risk of adverse gastrointestinal effects.

The Competent Authority should prohibit the marketing of other known poisonous species.  Inspectors should undertake periodic information campaigns to ensure that fishermen are aware of the risks of consuming and marketing affected species. The Competent Authority should make sure that warnings are displayed at landing sites.

6.2        Fish toxins harmful to health

Some fish species in some regions or at some times may containing biotoxins. One frequently encountered example is ciguatoxin, which causes the toxic syndrome known as ciguatera. This is a neurotoxin found in the muscle of certain predatory fish species, typically reef dwellers in tropical waters. The toxin is of marine algal origin. Typical species associated with ciguatoxin are shown in Table 7.

Table 4: Examples of fish associated with ciguatera toxin



Lined surgeonfish (Acanthurus linearis)


Bonefish (Albula vulpes)

Worldwide in warm seas

Gray triggerfish (Balistes carolinensis)

Atlantic, Gulf of Mexico

Gaucereye porgy (Calamus calamus)

Western Atlantic

Horse-eye jack (Caranx latus)


Whitetip shark (Carcharinus longimanus)


Humphead wrasse (Cheilinus undulatus)


Heavybeak parrotfish (Chlorurs gibbus)


Red grouper (Epinephelus morio)


Giant moray (Gymnothorax javanicus)


Hogfish (Lachnolaimus maximus)

Western Atlantic

Northern red snapper (Lutjanus campechanus)

Western Atlantic, Gulf of Mexico

Tarpon (Megalops atlanticus)

Eastern Atlantic

Narrowhead gray mullet (Mugil capurri)

East Central Atlantic

Yellowtail snapper (Ocyurus chrysurus)

Western Atlantic

Spotted coralgrouper (Plectropomus maculatus)

Western Pacific

Blue parrotfish (Sparus coeruleus)

Western Atlantic

Spanish mackerel (Scomberomorus maculatus)

Western Atlantic

Lesser amberjack (Seriola fasciata)

Western Atlantic

Great barracuda (Sphyraena barracuda)

Indo-Pacific, Western Atlantic

Chinamanfish (Symphorus nematophorus)

Western Pacific


The precise mix of species, and seasonality of toxicity is highly location dependent, and the Fish Inspector should be aware of the patterns of toxicity in his or her locality. Fish of affected species or from affected regions should be banned from the market.

Fishermen are often a very good source of knowledge in this respect. Ciguatera toxin levels should be monitored in areas which are known to be subject to incidences of toxicity. This should collect data not only on the levels of toxin, but also species, size of fish and catch location (see section 14). Where fish of a particular species are frequently toxic, Commission Regulation No 1021/2008 of 17 October 2008 requires that their marketing is prohibited. In such cases the Competent Authority should consider adding them to the list of prohibited species.

Ciguateria maybe tested using mouse bioassay, HPLC with mass spectrophotometer or by a rapid ELISA-based method. There are a number of rapid methods useful for field test kits.

  • Ciguatect is an antibody-based assay that detects ciguatoxin based on its structure, and it may not detect all forms of the toxin.
  • Oceanit  from Test Systems Inc., Hawaii, USA, is currently marketing Cigua-Check, a ciguatoxin test kit, based on an immunoassay. Cigua-Check is most sensitive for the detection of ciguatoxin at the concentration that causes clinical symptoms in humans (equal or greater than 80 pg/g fish (0.08 mg/kg). Ciguatoxin is not detected by Cigua-Check at levels of less than 50 pg/g (or 0.05 mg/kg).

More information is available in FAO Food And Nutrition Paper 80, Marine Biotoxins

Food and Agriculture Organization of the United Nations Rome, 2004 ISBN 95-5-105129-1,
ISSN 0254-4725


6.3        Organoleptic properties

Sensory properties of fishery products are an important indicator of spoilage. In many cases spoilage per se does not directly present a risk to the consumer, although when advanced beyond a certain degree the product is considered to be unfit for human consumption.

In some fish species, spoilage is associated with chemical changes which present a risk to consumer health (for example histamine toxicity) in which case even slight spoilage may render the product unfit.  Inspectors use an assessment of the organoleptic properties to assess the level of spoilage, this therefore being one of the factors used to assess the fitness for human consumption.

Treatments which mask spoilage (for example by altering the colour of the flesh through treatment with carbon monoxide) are therefore not permitted under European legislation.

Organoleptic evaluation takes into account the visual appearance, smell, and muscle texture. In cases of doubt, the inspectors should also be able to assess the flavour of the cooked fish muscle. Inspection facilities at fish markets and landing sites need to be designed to take into account the need to make organoleptic assessment of both whole raw fish and cooked fillets.

Fish inspectors need to be familiar with the spoilage characteristics of the species with which they deal. Generally, the inspector can make use of changes in the appearance of the eyes, gills, belly and skin, in the smell and the texture of the muscle. Some aspects of sensory quality are shown in Table 8.

It should be noted that different species exhibit widely different spoilage characteristics and that certain features which might indicate unfitness in some species (for example sunken eyes), are in other species only poor indicators. Whilst there are grading schemes developed for fish quality assessment in the EU legislation for a wide range of species, these are generally for those species found in the European waters.

Therefore inspectors should endeavour to develop national or regional grading schemes for all of the key commercial species with which they deal. An example is given below in Table 9, for the cod Gadus morhua, a north Atlantic species.  During training, inspectors should be trained in the organoleptic assessment of fish using these schemes.

Table 5: Some Quality Aspects of Fish and Fish Products


Aspect of quality


General appearance and condition, size, shape, physical blemishes, colour, gloss, identity


Freshness, off-odours and flavours, taints, oiliness, rancidity, smokiness


Freshness, off-tastes and flavours, taints, oiliness, rancidity, smokiness, astringency, the primary tastes of acidity, bitterness, saltiness, sweetness

Touch (by fingers & mouth)

General texture, hardness, softness, elasticity, brittleness, roughness, smoothness, grittiness, gumminess, fluidity, wetness, dryness, crispness, presence of bones


An alternative approach is set out in the Council Regulation (EC) No 2406/96 of 26 November 1996 laying down common marketing standards for certain fishery products. Here fish may be classified as Extra, A or B Grades, or as unfit (Grade E). However, most of the grading standards are designed for species found in European fisheries and they should be used with care when applied to fishery products from other regions, since they may have significantly different spoilage characteristics.

Table 6: Sensory score sheet for cooked cod




Texture, mouth feel and appearance


initially weak odour of sweet, boiled milk, starchy, followed by strengthening of these odours

watery, metallic, starchy; initially no sweetness but meaty flavours with slight sweetness may develop

dry, crumbly with short tough fibres


shellfish, seaweed, boiled meat, raw green plant

sweet, meaty, creamy, green plant, characteristic



loss of odour, neutral odour

Sweet and characteristic flavours but reduced in intensity

Succulent, fibrous; initially firm going softer with storage; appearance originally white and opaque going yellowish and waxy on storage.


wood shavings, woodsap, vanillin




condensed milk, caramel, toffee-like




milk jug odours, boiled potato, boiled clothes-like

slight sourness, trace of 'off' flavours



lactic acid, sour milk, 'byre-like'

slight bitterness, sour, 'off' flavours



lower fatty acids (eg acetic or butyric acids), composted grass, soapy, turnipy, tallowy

strong bitter, rubber, slight sulphide


NB. Scores of 10 and 3 relate, respectively, to the freshest fish and to fish stored for 20-25 days in ice. Further score points down to zero can be defined as spoilage continues, but, since the fish is by that stage totally inedible, these points are of little practical significance to inspectors.

More information can be obtained from the FAO Technical Paper on Quality Changes in fresh fish:



6.4        Histamine

Histamine is a chemical product of the action of a bacterial enzyme histidine decarboxylase on the free amino acid histidine, found in species of fish such as mackerel, tuna, bluefish and mahi mahi. Histamine toxicity occurs when the bacterial action typically associated with high temperature spoilage is allowed to produce the enzyme. Until it is deactivated by being denatured (for example with heat) the enzyme can then continue working on the substrate to produce toxicity, even if the fish is subsequently chilled or frozen.

For more information, consult the references indicated in Section 5.4.

It is important to note that the spoilage processes which give rise to histamine toxicity are not the same processes (in terms of bacterial species and substrates) which give rise to the decomposition products associate with spoiled fish. Therefore fish may present a histamine hazard when there are no other signs of spoilage.

The only sure method assessing histamine toxicity is by sampling and analyzing the product in a laboratory.

Histamine limits in fishery products are included in the microbiological criteria for foods as set out in Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs.. These are described in Section 7.7.

For compliance purposes the measurement of histamine should be undertaken by the reference method, which is by HPLC with UV detection. Some rapid ELISA (enzyme-linked immuno-sorbent assay) based test kits methods are available although they still require a limited laboratory and some expertise for their effective implementation.

With the exception of the Agrimeter II, all of the kits are based on a form of ELISA assay.  Extracted histamine competes with a histamine-conjugate for binding to antibodies coated on the walls of microtitre wells. The amount of histamine is determined by the development of a colour based on the bound conjugate. Histamine is determined as a function of the colour intensity using a Total volatile nitrogen (TVN)

Limits for TVN are specified for fishery products in Commission Regulation (EC) No 2074/2005 of 5 December 2005[7]. However, this only sets limits (in the range 25 to 35 milligrams of nitrogen/100 grams of flesh) for certain species which occur in EU waters. The Regulation also sets out the reference method to be used for the analysis.

Whilst the TVB-N is a useful indicator of fish quality, these limits cannot be applied universally. They are of little direct use for third country suppliers, especially those supplying fish from tropical waters.  If the inspector wishes to use a chemical indicator of quality, then this must be based on research. This should:

  • Identify suitable spoilage indicators (for example TVN, or trimethylamine in the case of marine fish, or hypoxanthine in the case of fresh water fish, or composite indicators such as k-value.
  • Characterise their change over time in the target species, under different conditions and correlate their values with sensory, microbiological and other parameters
  • Establish limits of acceptability
  • Develop and specify a reference test method validated and calibrated by comparison of analytical results from the different methods


The histamine limits for different species are shown in the following table.

Table 7: Histamine limits for fishery products

Food Category

Micro-organisms/their toxins, metabolites

Sampling plan(1)


Analytical reference method (3)

Stage where the criterion applies









1. 26. Fishery products from fish species associated with a high amount of histidine (16)







mg/ kg



mg/ kg


HPLC (18)

Products placed on the market

during their shelf- life


1. 27. Fishery products which have undergone

enzyme maturation treatment in brine,

manufactured from fish species associated

with a high amount of histidine (16)






mg/ kg



mg/ kg


HPLC (18)

Products placed on the market

during their shelf- life



(1) n = number of units comprising the sample; c = number of sample units giving values over m or between m and M.

(2) For points 1.25 and 1.26 m=M.

(3) The most recent edition of the standard shall be used.

(16) Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae.

(17) Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of Regulation (EC) No 178/ 2002, according to which the whole batch should be deemed unsafe, shall not apply.

(18) References: 1. Malle P., Valle M., Bouquelet S. Assay of biogenic amines involved in fish decomposition. J. AOAC Internat. 1996, 79, 43- 49.

2. Duflos G., Dervin C., Malle P., Bouquelet S. Relevance of matrix effect in determination of biogenic amines in plaice (Pleuronectes platessa ) and whiting ( Merlangus merlangus) . J. AOAC Internat. 1999, 82, 1097- 1101.


Interpretation of the test

The limits given refer to each sample unit tested.


Histamine in fishery products from fish species associated with a high amount of histidine:

— satisfactory, if the following requirements are fulfilled:

1. the mean value observed is < m

2. a maximum of c/n values observed are between m and M

3. no values observed exceed the limit of M,

— unsatisfactory, if the mean value observed exceeds m or more than c/n values are between m and M or one or more of the values observed are >M.


6.5        Requirements concerning parasites

The EU regulations are highly specific regarding the conditions to be applied to the handling and processing of certain fish species known to present a health risk associated with fish borne parasitic infections of humans.  Fishery products susceptible to parasitic infection which may be eaten raw (including cold smoked) should not be marketed unless they are frozen for a period known to render them safe.

Within the EU there are three classes of fish borne parasites of public health significance[8]. The EU health conditions for parasites (for example freezing for 24 hours) are specific to the characteristics of these species and there is no scientific basis to apply them to the different parasite hazards which are associated with third country waters, which have different aquatic fauna and environmental conditions.

The epidemiology of fish borne platyhelminth (i.e. nematode, trematode and cestode) parasites in many regions of the world is not well known. In others, especially in SE Asia for example, the liver fluke Clonorchis sinensis and the lung flukes (Paragonimus spp) are known to cause significant morbidity, and present a major public health problem associated with the consumption of raw or contaminated freshwater fish and crustacean respectively. The incidence of associated species in other tropical and sub-tropical regions (especially Africa and S. America) is little understood. EU legislation on food safety conditions of fishery products does not specifically address the trematode hazard.

Fish inspectors should be alert to the possibility that marine and freshwater fish in their region may be infected. Inspectors should therefore endeavour to collate information and mobilize local parasitology resources to improve understanding of the hazards in their region.

The requirements for visual inspection of fishery products for parasites are also laid down in Commission Regulation (EC) No 2074/2005 of 5 December 2005. This regulation requires visual inspection of a representative number of samples. Inspection should include the abdominal cavity, livers, roes and fillets of fishery products which may be subject to the parasite hazard. There should be a written sampling plan, adequate facilities (such as candling tables) and adequately trained staff.

For the most part, the export of frozen marine fishery products which are to be subject to cooking before consumption does not present a parasite hazard. Most fish parasites of known public health significance originating from tropical countries are from fresh water rather than marine fish and crustacea. The increasing trend to the trade of fresh fish increases the risk that infected fish may be presented for export. The export of chilled fishery products from fresh water species appears to present the greatest risk, and special attention therefore needs to be paid to species such as nile perch, tilapia and pangasius..

Detection methods for trematodes are based on the separation and microscopic identification of larval stages of the parasites in the fish flesh or viscera. The hazard cannot be detected by a visual inspection alone. If fish borne parasites are considered to present a public health problem, then the Competent Authority should ensure that there is a suitable laboratory testing capacity, and that appropriate control mechanisms are developed.

6.6        Benzopyrene in smoked fish

The smoking of food preserves through drying and the antibacterial effect of the vapours and particulates derived from the partial combustion of wood. Many of the organic compounds involved are carcinogenic. Smoke flavours derived from steam distillation of wood may also contain such compounds. One of them, benzo(a)pyrene, is used as a marker for the occurrence and effect of carcinogenic polycyclic aromatic hydrocarbons. To reduce the exposure of European consumers to these materials the EU has established limits to the amount which is permitted in different foods, including fishery products. These measures are set out in Commission Regulation (EC) No 1881/2006 of 19 December 2006 “setting maximum levels for certain contaminants in foodstuffs” as amended (summarised in Table 21).

Table 8: Maximum limits for benzo(a)pyrene in in fishery products



Limit (μg/kg net weight)


Muscle meat of smoked fish and smoked fishery products, exlcusing bivalve molluscs. The maximum level applies to crustaceans excluding the brown meat of crab and excluding the head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae)



Muscle meat of fish, other than smoked fish



Crustaceans, cephalopods other than smoked. The maximum level applies to crustaceans excluding the brown meat of crab and excluding the head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae)



Bivalve molluscs



Sampling methods, sample treatment and preparation and performance criteria for analytical methods for the testing for benzo(a)pyrene are set out in Commission Regulation (EC) No 333/2007 of 28 March 2007 “laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs”.

6.7        Residues of veterinary medicines

6.7.1        Residue Control System

If there is an aquaculture production system which is to supply fishery products for human consumption, a control system for veterinary medicines should be established. The control system is designed to ensure that:

·        Unauthorised or prohibited substances are not applied to food animals

·        Authorised substances are used in such a way to ensure that their residue levels in foods of animal origin do not exceed the permitted maxima.

A full description of the control systems which must be developed are beyond the scope of this manual. However the control system should ensure a number of key features are expressed in the regulatory framework of veterinary medicines, as follows:

·        Procedures for approval and classification of veterinary medicines according to positive list (approved) and negative list (banned). (see below)

·        Controls on import, production and distribution of controlled compounds

·        Controls on prescription and application of certain compounds to animals (for example under veterinary supervision)

·        Storage and stock controls on farm

·        Record keeping of medicinal applications on farm

·        Separation of treated and non-treated animals

·        Holding of treated animals for withdrawal period prior to slaughter

·        Information and communication requirements in respect of animals sold before the end of the withdrawal period.

Note that the above steps constitute an outline of a residue control system for veterinary medicines. Residue monitoring (described in Section 14) is used to help the Competent Authority assess whether the control system is working to prevent contaminated products from the market. Sampling and testing for residues is not a means for controlling those residues.

The Commission provides specific guidance for third countries exporting farmed animal products to the European Union. This is available at:


6.7.2        Permitted and non-permitted compounds

The EU requirements specifiying permitted and non-permittedd veterinary medicines and conditions for their use in food animals was revised at the end of 2009. The Annexes to Council Regulation 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin were repealed and replaced with Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.

The Annex to the Regulation, which is regularly amended, sets out the permitted substances in terms of the different veterinary medicinal products in products of animal origin, and the maximum residue limits permitted in the edible parts of the resulting products of animal origin. The Regulation applies to fishery products insofar as certain fish grown in aquaculture production systems may be subject to prophylactic and therapeutic veterinary interventions.

The regulation defines two categories of pharmacologically active substances, and lists them in the Annex to the Regulation and sets (where appropriate) the MRL in different substrates of animal origin.

Table I List of Allowed Substances. This represents the permitted list for veterinary medicines to be applied to food animals. Those which are typically used in aquaculture production are shown in Table 25.

Table 9: Permitted list of veterinary medicines for application to fishery products
















100 μg/kg

Oxy tetracycline

100 μg/kg


100 μg/kg


1000 μg/kg


500 μg/kg

Oxolinic acid




NB. All MRLs for fish in skin and muscle in commercial proportions

Table II List of pharmacologically active substances for which no maximum limits can be fixed.  These represent a negative list of prohibited substances which may not be applied to food animals (but they may be applied to other animals). The compounds are:

·           Aristolochia spp. and preparations thereof

·           Chloramphenicol and derivatives eg . thiamphenicol, (TAF)

·           Chloroform

·           Chlorpromazine

·           Colchicine

·           Dapsone

·           Dimetridazole