Compliance of the Icelandic and Vietnamese Fisheries Sectors with the New Eu Legislation on Food Hygiene and Official Control

Background and rationale for this study

Vietnam's fisheries sector plays a crucial role in the national economy, positioning the country as one of the world's leading fish exporters In 2004, the export value of fishery products reached 2.4 billion USD, making it the third-largest contributor to the economy after textiles and crude oil (GSO 2005).

The EU is an important market for Vietnamese fishery products, making up 10% of the total fishery export value in 2004, especially for shrimp, only after Japan (32%) and the

US (25%) (FICEN 2005) However in 2002 the export value was under 4% of the total fishery exports mainly due to antibiotic residues in shrimp, although in 2004 it had increased to 10% (FICEN 2005)

To enhance its position in the global market and secure WTO membership in 2006, Vietnam must adhere to the various general and specific requirements established by different markets, with the EU playing a significant role in this process.

In January 2000, the European Commission presented a complete overhaul of the legislation on food hygiene and official control, including four proposals on the following subjects:

- Specific hygiene rules for food of animal origin;

- Official controls on products of animal origin intended for human consumption;

- Animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption

In January 2006, the European Union implemented significant reforms, introducing four regulations and one directive focused on official food controls and food hygiene These updates modernized existing EU standards, mandating that all food products, whether produced domestically or imported/exported, must adhere to the new legislation as outlined in Regulation (EC) No 852/2004 (Huss et al 2005).

The Vietnamese fisheries sector currently faces significant challenges due to weaknesses in its quality management system, particularly in food hygiene knowledge and official control skills Additionally, the existing legislation on quality management does not adequately address external requirements, and there is a lack of awareness among businesses, middlemen, farmers, and fishermen regarding new regulations These factors hinder the overall effectiveness of the sector and its ability to meet international standards.

Scope of research

This study examines food hygiene and official controls within Vietnam's fishery production chain, drawing comparisons with the Icelandic fisheries sector's experiences and advancements The aim is to identify strategies for enhancing quality management in Vietnam to comply with new legislative requirements.

Purpose of this study

Aims

This study aimed to analyze the operational practices within the Vietnamese fisheries sector, focusing on the entire process from harvest to export, commonly referred to as "field to fork." It evaluated these practices in the context of new EU legislation regarding food hygiene and official food control, compared them with those in Iceland, and identified essential changes needed throughout the production chain.

This study analyzed Vietnam's current legislation and practices in relation to the new EU regulations, while also assessing Iceland's compliance experience, results, and shortcomings The findings led to recommendations for essential changes needed in Vietnam's fishing industry and regulatory authorities.

Tasks

In order to achieve the aim, the following tasks were conducted:

- An evaluation of the quality management system of the Icelandic fisheries sector in compliance with the new legislation to gain implementation experience and learn lessons from Iceland

- An evaluation of the weaknesses and shortcomings in the quality management system of Vietnam and the ability of the Vietnamese fisheries sector to comply with the new legislation

- A preparation of recommendations and guidelines for the Vietnamese fishing industry and authorities on food hygiene and official control matters to meet the new EU legislation requirements.

Potential benefits to the industry from this study

Long term

The new legislation is set to enhance the quality of Vietnamese fish products, thereby boosting export opportunities to the EU and other markets This improvement will also strengthen the brand reputation and competitiveness of Vietnamese fish producers, as both foreign and domestic customers gain greater confidence in the quality of these products.

Short term

The project's outcomes will serve as a catalyst for future initiatives in Vietnam, facilitating the dissemination of new legislation and the implementation of essential reforms within the Vietnamese fisheries sector.

The findings will contribute to a seminar focused on the application of SSOP in Vietnam, featuring participation from industry representatives, VASEP, and officials from the Ministry of Fisheries of Vietnam The project's recommendations will be reviewed for potential enhancements and improvements.

The seminar will focus on discussing the results to refine the recommendations Following this, a comprehensive guideline for the industry will be created and made available on the VASEP website Additionally, it will be published as a booklet for distribution to Vietnamese fish production businesses and individuals during meetings and annual fishery exhibitions organized by VASEP.

The Human and Technological Development Unit of VASEP will develop training materials focused on the new EU legislation and essential industry changes, following the seminar's outcomes, to enhance fishery quality management.

Legislation study

The recent EU legislation package on food hygiene and official control has been thoroughly analyzed, outlining the fundamental requirements for fish production This summary categorizes the information into specific field groups related to hygiene and official control.

Case studies: production, processing and marketing of shrimp intended for the

A comparative analysis was conducted on the legislation and practices of the Icelandic fisheries sector regarding coldwater wild shrimp production, alongside a similar examination of the Vietnamese fisheries sector focused on warm water cultured shrimp production This study evaluated these practices in relation to the new EU legislation.

- For wild shrimp: compare the new legislation with the current situation of the

The Icelandic fisheries sector is undergoing an analysis of new legislation to align with EU regulations, focusing on the practices of shrimp production businesses, including fishing, auctioning, processing, cold storage, and transportation This evaluation aims to identify experiences, outcomes, and challenges in adhering to the updated legislation Additionally, the current state of Vietnamese wild shrimp production is assessed to uncover weaknesses in quality management systems and to explore Vietnam's potential to implement lessons learned from Iceland's practices.

The study analyzes the new legislation in relation to the existing conditions of Vietnam's fisheries sector, focusing on identifying the weaknesses and shortcomings in the country's quality management systems for cultured shrimp.

The study examined the journey of shrimp from farms or catching vessels to export ports, as illustrated in Figures 1 and 2 Key locations in Iceland, including shrimp catching boats, auctions, processing factories, and export ports, were visited for thorough observation and investigation.

Figure 1: Production chain of wild shrimp products to export (Case study No 1)

Figure 2: Production chain of cultured shrimp products to export (Case study No 2)

Recommendations

Insights from Iceland's case studies indicate that enhancing quality management systems in the Vietnamese fisheries sector is essential to align with new EU regulations This includes implementing solutions that benefit both regulatory authorities and the fishing industry.

Step sequence of the study is illustrated in Figure 3:

Auction/ Wholesale market Fishing vessel

Figure 3: Study process flow chart

1 Compare new legislation with current situation of Icelandic fishery sector

Gaps of Vietnamese fishery sector

Compare new legislation with current situation of Vietnamese fishery sector

Analysis and summarise new EU legislation by field

Case 1: wild shrimp in Iceland

Case 2: cultured shrimp in Vietnam

2 Evaluation of application ability of Vietnamese fishery sector

With this study method in mind, the report is organised as follows:

Statistics of seafood borne diseases and seafood consigmment rejections in

- Importance of hygiene and official controls for food safety assurance

- Introduction of the new EU legislation on food hygiene and official control

- Overviews of the fisheries sectors and quality management systems in Iceland and Vietnam

- Assessment of compliance with the new EU legislation in the production of shrimp products intended for the EU market in Iceland and Vietnam

- Proposals for changes in hygiene management and official control systems in Vietnam

3 THE IMPORTANCE OF HYGIENE AND OFFICIAL CONTROL IN

FISHERY SAFETY AND QUALITY ASSURANCE

Fishery products play a crucial role in global economies and serve as a primary source of animal protein for many populations However, seafood can also pose health risks as a potential carrier of diseases to humans, making food hygiene a significant factor in seafood import refusals in international trade These issues are detailed in section 3.1.

3.1 Statistics of seafood borne diseases and seafood consigmment rejections in international trade

Statistics indicate that seafood is responsible for 10-25% of foodborne outbreaks in developed countries, with 10% of the 1,425 outbreaks reported in the UK from 1992 to 1999 linked to seafood The primary contributors to these outbreaks were Scombrotoxin (32%), viruses (18%), and Salmonella (10%) Poor hygiene conditions and procedures are identified as significant factors leading to the presence of viruses and Salmonella in seafood.

Food hygiene encompasses the essential conditions and measures required to guarantee the safety and quality of food throughout the entire food chain Good Hygiene Practices (GHP) serve as the foundational element for food safety management systems in the fishery production sector These practices establish general guidelines that focus on maintaining appropriate environmental conditions for food processing, alongside hygienic procedures and controlled working environments GHP is a crucial component of the Hazard Analysis and Critical Control Points (HACCP) system, which is a mandatory requirement in many countries involved in fish import and export.

Table 1: Etiological agents of foodborne outbreaks in the UK associated with seafood

Total 1 Food- borne suspected confirmed

1: Total number of reported intestinal disease outbreaks

In response to seafood-borne diseases, authorities in developed countries have implemented stricter import regulations and controls for seafood Many seafood shipments face detention or rejection due to safety and quality issues, with approximately 10% of food products refused by the US FDA between 2001 and 2002 being seafood The primary reason for these refusals is "filth," indicating that the products may contain filthy, putrid, or decomposed substances While specific statistics for each rejected product are lacking, microbial spoilage is believed to be a significant factor contributing to this issue, with Salmonella also cited as a common cause of rejection.

Table 2: Seafood import refusals by the US FDA from July 2001 to June 2002 (Huss et al 2004)

No refused No of seafood import refusals according to reason

Total 1 Seafood Filthy Salmonella Listeria Histamine Poison Other

1: Total of food consignment refusals

2: Number of rejections where “filthy” is stated as a reason; note that some product rejections have several reasons

Between 1999 and 2001, the number of alerts for food imported into the EU from non-member countries increased steadily, with a significant spike in 2002 The primary reasons for these alerts were microbiological contaminants and chemical residues, accounting for 44.8% and 41.4% of cases, respectively This data indicates that the sanitary and food hygiene conditions in the handling and processing of fish in these third countries remain insufficient.

Table 3: Causes of rejection/detention of seafood imported into the EU during the period January 1999 - June 2002(Huss et al 2004).

No of rejections / detentions Average of rejections/year

From 1999 to June 2002, Asian seafood exporting countries were responsible for 70% of alert cases related to seafood safety, with Africa contributing 18%, the Americas 9%, Europe (non-EU) 3%, and Oceania 1% In 2000, Asia's export volume was only 15% of the total exports from third countries, trailing behind the Americas at 23% and Africa at 20% These statistics highlight the urgent need to enhance hygienic conditions across the entire fishery production chain and to strengthen official control systems in developing countries, particularly in Asia.

The importance of hygiene in fishery quality management

The rise of international food trade and globalization has led to significant social and economic benefits, while also facilitating the spread of foodborne illnesses worldwide Food safety, particularly in the fishery industry, has become a critical concern as consumer awareness and demand for safe food continue to grow In the context of global trade, ensuring food safety is essential not only for consumer protection but also for the effective functioning of the market (Huss et al 2004).

Food safety is essential for safeguarding consumer health and maintaining the reputation of producers, as well as protecting the interests of those involved in food processing and marketing A key component of food safety is food hygiene, with Good Hygiene Practices (GHP) serving as a fundamental element of food safety management systems in the fishery sector The Codex Alimentarius Commission emphasizes that effective hygiene control is crucial in preventing foodborne illnesses and their adverse effects on human health.

Official control: a govermental tool to assure fishery product safety and quality 15

As the volume of food-related information continues to grow, consumers are increasingly aware of food safety and quality issues While past concerns focused on visible factors like underweight contents and misleading labeling, today's consumers are more concerned about invisible threats, including micro-organisms, banned drug residues, and environmental contaminants such as pesticides and heavy metals Consequently, there is a rising demand for government action to enact legislation that reduces foodborne health risks and guarantees the quality of imported food products.

As consumer protection groups gain prominence globally, governments are increasingly pressured to safeguard communities against foodborne diseases and subpar food quality Foodborne outbreaks not only threaten public health but also harm trade and tourism, undermine the credibility of importers, elevate trade barriers in importing nations, and contribute to food waste due to spoilage.

In order to overcome the problem mentioned above, competent authorities all over the world have set up adequate “from farm to forks” control and monitoring measures The

The EU, US, and Japan are key players in the global fish market, collectively accounting for 75-80% of total fishery import value (FAO 2003) These regions have led the way in food safety management reforms, implementing numerous new regulations in recent years In the EU, recent health regulations have introduced stringent directives concerning the production, import, and marketing of food products, emphasizing technical requirements for HACCP systems, as well as delineating the responsibilities of manufacturers and the obligations of regulatory authorities, including official control measures.

4 THE NEW EU LEGISLATION ON FOOD HYGIENE AND OFFICIAL

CONTROL: INTRODUCTION AND BASIC REQUIREMENTS

Review of international legislation on food hygiene and official control

The WTO agreements

Harmonizing food standards and legislation is essential for facilitating international trade, enhancing the free movement of food, and minimizing trade barriers, all while ensuring consumer health protection The WTO agreements on multilateral trade negotiations, established in April 1994 through the Marrakesh Agreement of the Uruguay Round, promote international harmonization in food safety and standards (FAO and WHO, 2003 and 1999).

Two key WTO agreements concerning food safety and quality are the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement), both part of the Multilateral Agreements on Trade in Goods under the Marrakesh Agreement The SPS Agreement allows governments to implement necessary measures to safeguard human health while prohibiting discrimination by imposing different requirements on various countries Meanwhile, the TBT Agreement ensures that technical regulations and standards do not create unnecessary trade barriers.

All WTO members, including the EU and Iceland, are required to adopt and implement two essential agreements Vietnam, in its efforts to join the WTO in 2006, must also comply with these agreements promptly.

The Codex Alimentarius Commission (CAC) standards, codes of practices

Established in 1961 by the Eleventh Session of the FAO Conference and the Sixteenth World Health Assembly in 1963, the Codex Alimentarius Commission (CAC) aims to protect consumer health from foodborne hazards and promote fair practices in food trade The CAC has developed and issued numerous standards, codes of practice, and guidelines that cover various aspects of food production, including essential areas like food hygiene.

The Codex Alimentarius Commission (CAC) plays a crucial role in food safety through its General Principles governing the use of food additives, the addition of essential nutrients, and the inspection and certification of food imports and exports Among numerous Codex Standards, these documents define product characteristics, particularly for fishery products, and address critical food safety aspects, including Maximum Residue Limits (MRLs), contaminants, and food labeling Essential Codes of Practice, primarily focused on hygienic practices, guide safe food production, with the Codex General Principles of Food Hygiene emphasizing the implementation of Hazard Analysis and Critical Control Point (HACCP) systems across all food types Additionally, the CAC has developed various guidelines that outline key policy principles and interpretations of Codex general standards, further enhancing food safety and quality.

To ensure food safety and harmonize legislation, the SPS and TBT Agreements have designated specific standards, guidelines, and codes of practice as benchmarks for assessing national regulations among WTO members and resolving international disputes (FAO and WHO 1999) Consequently, Codex international documents have become essential within the WTO legal framework, playing a crucial role in food safety and official control practices.

The new EU legislation package on food hygiene and official control for the

Review of the new EU legislation package on food hygiene and official

In response to the rising awareness of seafood-borne diseases and consumer demands for food safety, food businesses are now mandated to enhance their hygiene practices Consequently, legislation governing hygiene in the fisheries sector has been progressively strengthened, particularly in significant global fish markets like the EU.

In recent years, the European Union has implemented numerous regulations aimed at ensuring food safety for imported and marketed products These laws have undergone a comprehensive recast to simplify the framework and address inconsistencies that emerged during their implementation.

In 2002, the pivotal Regulation (EC) No 178/2002 was adopted, establishing fundamental principles and requirements for food law and safety in the European Union This regulation also created the European Food Safety Authority and outlined essential procedures for ensuring food safety across the entire production chain of food and animal feed.

The 2005 legislation established the European Food Safety Authority (EFSA), which serves as a scientific reference for food safety control and evaluation This Regulation forms the legal framework for new measures concerning food and feed safety and the overall control of the food chain In 2004, four regulations and one directive were adopted, outlining specific requirements for official food controls and hygiene, set to be enforced starting January 1, 2006.

1 Regulation (EC) No 852/2004 on hygiene of foodstuffs, 29 April 2004 (called hereafter Regulation 852/2004)

2 Regulation (EC) No 853/2004 on specific hygiene rules for food of animal origin, 29 April 2004 (called hereafter Regulation 853/2004)

3 Regulation (EC) No 854/2004 on rules for the organisation of official controls on products of animal origin intended for human consumption, 29 April 2004 (called hereafter Regulation 854/2004)

4 Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, 29 April 2004 (called hereafter Regulation 882/2004)

5 Directive 2004/41/EC repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives

89/662/EEC and 92/118/EEC and Council Decision 95/408/EC, 21 April 2004 (called hereafter Directive 2004/41)

Directive 2002/99/EC, issued on December 16, 2002, establishes essential animal health rules for the production, processing, distribution, and introduction of animal-origin products for human consumption This directive is closely linked to seven other regulations and directives that collectively form a comprehensive framework for food hygiene and official control of food products within the EU The new legislative package aims to enhance food safety and ensure high standards for products marketed in the European Union.

- To modernise and consolidate the EU food hygiene and official control legislation and focus controls on aspects that are necessary for public health protection

Food businesses and competent authorities play crucial roles in ensuring food safety and animal health throughout the production and supply chain within the EU It is essential to clarify their responsibilities to maintain high standards and protect consumers effectively.

- To apply effective and proportionate controls throughout the food chain, from primary production to sale or supply to the final consumer (FSA 2005)

Regulation 852/2004 establishes comprehensive food hygiene standards for all stages of the production process, from primary production to sale to consumers To complement this, Regulation 853/2004 introduces specific hygiene requirements tailored to various sectors of animal origin, including bivalve molluscs and fishery products.

Regulation 854/2004 outlines the framework for official controls on animal-origin products intended for human consumption, detailing the responsibilities of competent authorities and food business operators It sets specific rules for various sectors, including bivalve molluscs and fishery products, and includes procedural requirements for importing these products from third countries Additionally, Regulation 882/2004 complements this by establishing general rules for conducting official controls to ensure compliance with EU regulations.

Scope of the new EU hygiene and official control package

Food businesses and operators within the EU, along with those importing animal-origin products from third countries for human consumption, must adhere to the new EU hygiene and official control legislation This regulation applies at every stage of production, processing, and distribution.

- “Food business” means any undertaking, whether for profit or not and whether public or private, carrying out any stage of production, processing and distribution of food.”

A "food business operator" refers to individuals or entities accountable for ensuring compliance with food law requirements within their food business, as defined in Article 3.2 and 3.3 of Regulation 178/2002.

However, there are some activities excluded from the scope of the EU legislation:

- Primary production for private domestic use (Article 1.2 - Regulation 852/2004, Article 1.2 - Regulation 853/2004 and Article 1.3 – Regulation 178/2002)

- The domestic preparation, handling or storage of food for private domestic consumption (Article 1.2 - Regulation 882/2004, Article 1.2 - Regulation 853/2004 and Article 1.3 – Regulation 178/2002)

Producers can directly supply small quantities of primary products to final consumers or local retail establishments, as outlined in Article 1.2 of Regulations 882/2004 and 853/2004 Despite this direct supply, these products fall under the scope of Regulation 178/2002, meaning they must still adhere to the safety requirements for food placement in the market as specified in Article 14 of Regulation 178/2002.

Basic requirements on fishery hygiene of the new package

Requirements related to the food hygiene of food production businesses are covered in Regulation 178/2002, Regulation 852/2004 and 853/2004

4.2.3.1 General hygiene requirements for primary producers

According to Article 3.17 of Regulation 178/2002, "primary production" encompasses the production, rearing, and harvesting of primary products, including activities like farming, milking, hunting, and fishing Under new EU legislation, primary production businesses face distinct hygiene requirements for registration, production, and record keeping compared to other food businesses Additionally, they must adhere to the same traceability and cooperation responsibilities with competent authorities as outlined in Article 18 of Regulation 178/2002, Annex II of Regulation 853/2004, and Article 6 of Regulation 852/2004.

Primary production businesses are required to register with the competent authority in accordance with Article 6.1 of Regulation 852/2004 It is essential for business operators to promptly notify the competent authority of any changes to previously submitted information, such as alterations in the food business operator or modifications to food operations, as stipulated in Article 6.2 of the same regulation.

Regulation 852/2004, specifically Annex I, Part A, outlines the essential hygiene requirements for primary production It mandates that primary food business operators take necessary measures to safeguard primary products from contamination.

2) and control of hazards that have implications for human health such as contamination arising from the environment and inputs/outputs of the culture/harvest progress, animal/plant health and welfare (Section II, item 3) In compliance with those requirements, primary animal production businesses have to set up programmes for the monitoring and control of zoonoses and zoonotic agents as well as take adequate measures (Section II, item 3 and 4) Key matters which the businesses must carry out are:

- keep clean and, where necessary after cleaning, disinfect, in an appropriate manner, any facilities, equipment, containers, crates, vehicles and vessels

- use potable water, or clean water, whenever necessary

- ensure that staff handling foodstuffs are in good health and undergo training on health risks

- prevent animals and pests from causing contamination

Properly store and manage waste and hazardous substances while adhering to relevant legislation, specifically using feed additives and veterinary medicinal products as directed This ensures compliance with regulatory standards and promotes safety in handling these materials.

- keep raw materials and all ingredients in appropriate conditions designed to prevent harmful deterioration and protect them from contamination (Annex II, Chapter IX, item 2)

Vessel designs, arrangements, and constructions must ensure that equipment and facilities do not contaminate products All food contact surfaces on vessels should be constructed from suitable corrosion-resistant materials that are smooth and easy to clean, with durable and non-toxic surface coatings, as outlined in Regulation 853/2004 (Annex II, Section VIII, Chapter I, items A and B) Additionally, proper record keeping is essential for compliance.

Primary production businesses must maintain records of hazard control measures for an appropriate duration, tailored to their size and nature, and provide this information to competent authorities upon request, as outlined in Regulation 852/2004 Specifically, operators in the animal culture sector are required to keep detailed records regarding their operations.

- the nature and origin of feed fed to the animals;

- veterinary medicinal products or other treatments administered to the animals, dates of administration and withdrawal periods;

- the occurrence of diseases that may affect the safety of products of animal origin;

- the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance for human health;

- any relevant reports on checks carried out on animals or products of animal origin (Annex I, item 8 - Regulation 852/2004):

4.2.3.2 General hygiene requirements for businesses after primary production

The new EU legislation on hygiene requirements closely aligns with previous directives, such as Directive 91/493/EEC and Directive 93/43/EEC, but offers clearer and more detailed guidelines for food businesses to ensure compliance Notably, the updated regulations impose stricter standards regarding traceability and the handling of raw materials in auctions and wholesale markets Additionally, the legislation emphasizes the importance of robust food safety management systems.

Food business operators, excluding primary production businesses, are mandated to ensure the safety of their products and processes as per Article 3 of Regulation 852/2004 They must develop, implement, and maintain food safety management procedures that adhere to HACCP principles, in accordance with Article 5.1 of the same regulation This requirement also extends to auctions and wholesale markets.

To comply with food law requirements, food and feed business operators must conduct internal verification activities throughout all stages of production, processing, and distribution (Article 17.1 - Regulation 178/2002) Additionally, the approval of establishments is essential to ensure adherence to these regulations.

All food businesses involved in the production chain, except for primary production, transport operations, and non-temperature-controlled storage, must obtain approval from the competent authority as per Article 4.2 of Regulation 853/2004 Unlike previous legislation, which exempted cold storage businesses from needing approval and an approval number, the new regulations now require all such establishments to comply with approval requirements unless they are part of a handling or processing facility.

Business operators are required to promptly notify the competent authority of any changes to previously submitted information, such as modifications in food business operators or alterations in food operations, as stipulated in Article 6.2 of Regulation 852/2004 Additionally, maintaining identification marks and ensuring traceability are crucial components of food safety compliance.

The new legislation, specifically Article 18 of Regulation 178/2002 and Article 5, item 1 of Regulation 853/2004, enhances the clarity and proximity of requirements regarding traceability and identification marks compared to previous regulations Food and feed businesses must implement traceability procedures across all production, processing, and distribution stages for food, feed, food-producing animals, and any substances intended for food or feed Additionally, operators are required to identify suppliers and recipients of their products, ensuring this information is accessible to competent authorities upon request Notably, all fishery products must bear an identification mark before being marketed, and the application of these marks must be verified in establishments approved by competent authorities as outlined in Regulation 854/2004.

The new legislation, in line with Directive 93/43/EEC, mandates that raw materials and ingredients in food businesses be stored under conditions that prevent deterioration and contamination (Annex II, Chapter IX, item 2 - Regulation 852/2004) However, it introduces additional requirements for the reception of raw materials, particularly in the aquaculture sector Food business operators are prohibited from accepting raw materials unless they possess essential information that correlates with data maintained by aquaculture businesses.

- culture conditions of the business

- the animal health status and the occurrence of diseases if any

- veterinary medicinal products or other treatments chemicals, their use dates and withdrawal periods

- the results of any analysis of samples taken from the animals, including samples taken in the framework of the monitoring and control of zoonoses and residues

- production data, when this might indicate the presence of disease

- the name and address of the private veterinarian normally attending the business (Annex II, Section III – Regulation 853/2004)

Under the new legislation, food businesses must promptly withdraw any non-compliant raw materials from the market and notify the relevant authorities if they suspect that their imported ingredients do not meet food safety standards, as outlined in Article 19 of Regulation 178/2002.

Basic requirements on official control of the newEU legislative package 24

Requirements related to the food hygiene of food production businesses are mostly covered in Regulation 178/2002, 854/2004, 882/2004 and 2002/99 a Requirements for third countries importing fishery products into the EU

The new EU legislation establishes essential criteria for third countries wishing to import food products into the EU market According to this legislation, all food intended for sale within the EU must adhere to specific compliance standards.

- the relevant requirements of the EU food law, or

The European Union acknowledges certain conditions that are considered at least equivalent to food produced within its borders or to the standards outlined in specific agreements with exporting countries.

This requirement of the Regulation 178/2002 is detailed in Regulation 854/2004, 882/2004 and 2002/99, thereof competent authorities of exporting countries must provide appropriate equivalence guarantees, including:

- the legislation of the third country

- the organisation of the third countries’ competent authorities, their powers, independence and effective enforcements

- the competent authority facilities for effectively verifying the implementation of their legislation in force

- the training of relevant staff in the performance of official controls

- the existence and operation of documented control procedures and control systems based on priorities, including procedures of animal health control and animal outbreak notification

(Article 46.1 - Regulation 882/2004, Article 11.2, 4 - 854/2004, Article 8.1 - Regulation 2002/99)

When approving a third country to import animal-origin food products into the EU, the following factors are also considered:

- the actual health conditions during the production, storage and dispatch of fishery products intended for the EU, including animal health and zoonoses control situation

- the extent and operation of official controls on imports of animals and their products

(Article 46.1 - Regulation 882/2004, Article 11.2, 4 - 854/2004, Article 8.1 - Regulation 2002/99)

- the assurances that the third country can give regarding compliance with standards of the EU (Article 46.1 - Regulation 882/2004), including:

Third country authorities must ensure that establishments authorized to export to the EU adhere to EC requirements They are responsible for maintaining an updated list of these establishments and communicating it to the Commission, as outlined in Article 12, paragraph 2 of Regulation (EC).

To meet certification requirements for importing animal origin products, each consignment must include an original certificate that is signed, stamped by the relevant authority, and issued prior to the consignment's departure from that authority's control, as outlined in Article 14 and Annex VI of Regulation 854/2004 Additionally, appropriate inspection and remedial actions must be taken in cases of non-compliance.

Competent authorities must implement a system of official controls to ensure that food and feed businesses comply with food law requirements throughout all stages of production, processing, and distribution (Article 17.2 - Regulation 178/2002) These official controls for fishery products include regular hygiene checks at landing sites and first sales, as well as inspections of vessels and land-based establishments such as fish auctions and wholesale markets, in addition to monitoring storage and transport conditions (Annex III, Chapter 1, item 1 – 854).

If the competent authority identifies non-compliances, it must take appropriate action to ensure that the operator remedies the situation (Article 54 - Regulation 882/2004 and Article 9 - Regulation 854/2004)

Competent authorities are required to establish rules regarding measures and penalties for violations of food and feed laws, as well as regulations concerning animal health and welfare Additionally, they must take all necessary actions to ensure the effective implementation of these rules, as outlined in Article 17.2 of Regulation 178/2002 and Article 55 of Regulation 882/2004.

In order to ensure that official controls carried out by the competent authority can be performed effectively, food businesses are required to offer necessary assistance to the authority, including:

- give the inspectors access to all buildings, premises, installations or other infrastructures

- make available any documentation and record required under the present regulation or considered necessary by the competent authority for judging the situation (Article 4.1 - Regulation 854/2004)

To comply with regulatory requirements, the competent authority must implement legal procedures that grant staff access to the premises and documentation of feed and food business operators, enabling them to effectively perform their duties (Article 8, item 2 - Regulation 882/2004) Additionally, the approval of establishments is essential for maintaining industry standards.

Each approved business receives a unique approval number that can be supplemented with codes to specify the types of animal origin products manufactured, as outlined in Article 3.3 of Regulation 854/2004 The competent authority is responsible for regularly reviewing these approval numbers during official controls, which may include actions such as withdrawing or suspending the establishment's approval (Article 3.4) Additionally, they must maintain updated lists of approved establishments, including their approval numbers and relevant information, and ensure this data is accessible to EU authorized representatives (Article 3.6) Training for official control staff is also essential to uphold these standards.

To meet the equivalence requirements set by importing countries, it is essential for the competent authority to provide comprehensive and up-to-date training for staff involved in official controls This training must equip personnel with the necessary knowledge and skills to perform their duties effectively and consistently, while also fostering a collaborative attitude for multidisciplinary cooperation, as outlined in Article 6 of Regulation 882/2004 Additionally, proper delegation of responsibilities to inspection bodies and official laboratories is crucial for maintaining these standards.

The new legislation allows that the competent authority may delegate specific tasks concerned with official controls to one or more control body (Article 5.1 - Regulation 882/2004)

However assigned control bodies must ensure following requirements:

- They have the expertise, equipment and infrastructure required to carry out the delegated tasks;

- They have a sufficient number of suitably qualified and experienced staff;

- They are impartial and free from any conflict of interest as regards the exercise of the tasks delegated to it;

Accredited in line with European Standard EN 45004, which outlines the general criteria for various inspection bodies, these organizations ensure compliance with delegated tasks This standard is fully aligned with ISO 17020, reinforcing the credibility and reliability of their inspection processes.

The control body regularly reports the results of its inspections to the competent authority and responds promptly to any requests for information In cases where the results reveal non-compliance or suggest a potential for non-compliance, the control body is required to notify the competent authority immediately.

- There is efficient and effective coordination between the delegating competent authority and the control body

In order to comply with the above requirements of control bodies, the delegating competent authorities shall organise audits or inspections of control bodies as necessary

If the designated bodies are found to be inadequately performing their responsibilities and failing to implement timely corrective measures, the competent authority has the right to promptly revoke the delegation (Article 5.3 - Regulation 882/2004).

The new legislation mandates that competent authorities designate official laboratories to conduct sample analyses during official controls, as outlined in Article 12.1 of Regulation 882/2004 These laboratories are required to operate, be assessed, and accredited in compliance with established European standards.

- EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories” (This standard was revised into the Standard ISO/IEC 17025:2005 in last year)

- EN 45002 on “General criteria for the assessment of testing laboratories”

- EN 45003 on “Calibration and testing laboratory accreditation system — General requirements for operation and recognition”

The accredited testing criteria have to relate to individual tests or groups of tests

(Article 12.2 and 12.3 - Regulation 882/2004) f Transparency and confidentiality

The new legislation mandates that competent authorities operate with enhanced transparency, requiring them to promptly make relevant information accessible to the public This initiative aims to ensure that citizens can easily access essential data and insights.

- information on the control activities of the competent authorities and their effectiveness

Understanding the health risks associated with contaminated food and feed is crucial for safeguarding both human and animal well-being This article identifies potential hazards that may arise from unsafe food and feed products and outlines the preventive measures that can be implemented to mitigate, reduce, or eliminate these risks effectively By prioritizing safety protocols and risk management strategies, we can ensure a healthier food supply and protect public health.

(Article 7.1 - Regulation 882/2004 and Article 10 - Regulation 178/2002)

5 AN OVERVIEW OF THE ICELANDIC FISHERIES SECTOR

Assessment of the Icelandic fisheries sectors’ compliance with the new EU

Caught shrimp production in Iceland, which constituted just 1.24% of the total fishery production in 2004, has seen significant growth in recent years The production of caught crustaceans, primarily shrimp, rose from 4,607 tonnes in 1970 to 32,678 tonnes in 2004, marking a sevenfold increase In contrast, the overall fishery production in Iceland grew only 1.4 times during the same period, from 1,198,304 tonnes to 1,727,785 tonnes.

In recent years, Iceland has implemented significant quality management practices in shrimp production to enhance safety and meet customer demands The country has transitioned from final product inspections to comprehensive control measures throughout all production and distribution stages, including fishing, auctioning, handling, processing, transportation, storage, and distribution This study evaluates the outcomes, strengths, and weaknesses of the Icelandic shrimp production sector in relation to the new EU legislation, which is crucial for its primary market.

Iceland became a signatory of the European Economic Area (EEA) Agreement in 1992, which took effect on January 1, 1994, mandating compliance with EU legislation This Agreement facilitates the integration of new EU legislation into Icelandic law through decisions made by the EEA Joint Committee As a result, Iceland has adapted its legal framework to align with EU standards, particularly in the food sector Key legislation includes the Foodstuffs Act No 93/1995, which is crucial for ensuring food safety, quality, and accurate labeling, alongside other important acts related to hygiene, animal diseases, and environmental protection.

Icelandic Ministries issue regulations under various Acts that detail requirements for fishery products Directive 91/493/EEC, a key EU law governing health conditions for fishery product production and market placement, is incorporated into Icelandic law through Act No 55/1998, effective May 10, 1998, along with Regulation 233/1999, which took effect on March 30, 1999, and Regulation 558/1997 concerning self-check systems in fishery production.

Act No 55/1998 is a key piece of legislation in the Icelandic fisheries sector, established in alignment with EU Directives 91/493/EEC, 91/492/EEC, and 92/48/EEC This law serves as the foundation for various Icelandic regulations concerning fishery hygiene and official control, which are issued by the Ministry of Fisheries of Iceland.

- Regulation No 233/1999 which is mentioned above and amended by Regulation

- Regulation No 849/1999 on control of import of fishery products amended by Regulation No 387/2000

- Regulation No 450/1997 on surveillance framework and working methods of accredited inspection bodies in the fish industry

- Regulation No 238/2003 on farming of marine species amended by Regulation

Besides these, there are certain laws issued by other Ministries in Iceland which also relate closely with hygiene and official control activities of the Icelandic fisheries sector:

Regulation No 526/2003, issued by the Ministry of Agriculture and effective from July 16, 2003, outlines the animal health conditions for the marketing of aquaculture animals and their products This regulation aims to ensure the health and safety of aquaculture species and products in the marketplace.

- Regulation No 536/2001 on water intended for human consumption which was issued by the Ministry for the Environment and drafted based on Directive 98/83/EC

- Regulation No 665/2001 on action to be taken in the case of contagious diseases issued by the Ministry of Agriculture

Iceland's food hygiene and official control legislation is aligned with EU standards as mandated by the EEA Agreement, ensuring equivalence with EU regulations However, the latest EU legislation on food hygiene and official control, effective since January 1, 2006, has not yet been incorporated into Icelandic law Currently, FISKISTOFA is working on drafting these new regulations, with plans to release them in the third quarter of this year.

7.1.2 Structure and activities of the authorities

7.1.2.1 Structure, functions and powers of the competent authorities

Under the Icelandic Foodstuffs Act, the responsibility for ensuring food safety in seafood products, especially wild shrimp, is shared among the Ministry for the Environment, the Ministry of Agriculture, and the Ministry of Fisheries.

The Ministry oversees food legislation and the regulation of both domestic and imported retail food, implementing Icelandic laws regarding water for human consumption, including food processing water, while also monitoring contaminants in food The Environment and Food Agency (EFA), operating under the Ministry for the Environment, is responsible for monitoring ocean areas, including fishing and aquaculture zones, alongside the Ministry of Agriculture.

The Ministry is tasked with regulating the production and trade of live aquaculture animals, overseeing fish disease control, and issuing licenses for freshwater fish farming The Chief Veterinary Office (CVO), part of the Ministry of Agriculture, manages trade and monitoring of fish diseases and seed, including inspections of fish farms Currently, the CVO operates 15 District Veterinary Offices (DVOs) to carry out local activities Additionally, the Directorate for Freshwater Fisheries (DFF) under the Ministry of Agriculture is responsible for licensing the farming of freshwater and anadromous species.

The Ministry of Fisheries in Iceland is tasked with enacting legislation and overseeing the governance of marine product harvesting, processing, and distribution Established in 1993, FISKISTOFA serves as the competent authority for managing these activities, including the operation of Icelandic border inspection posts that regulate fishery product imports and issue marine species farming licenses Unlike other organizations, FISKISTOFA does not maintain local or regional offices It collaborates with Statistics Iceland to collect, process, and publish fisheries data and oversees inspections conducted by two private bodies to ensure hygiene and compliance in fishery processing and fishing vessels The organization's fishing management practices are informed by scientific research from the Marine Research Institute (MRI), which has provided marine resource and environmental advice since its establishment in 1965.

A chart of the governmental management system in the Icelandic fisheries sector is shown in Figure 5

In Iceland, the competent authorities responsible for food hygiene and official control have clearly defined roles and responsibilities While operating independently, these agencies maintain close cooperation to effectively execute their designated tasks.

Figure 5: Important governmental management institutions in the Icelandic fisheries sector

7.1.2.2 Production condition monitoring and control activities a Monitoring of ocean areas

Since 1989, EFA has conducted an annual monitoring program of Iceland's ocean areas, collecting water samples to assess heavy metals and organic pollutants The monitoring of organochlorine compounds began in 1991, focusing on designated water regions within the Icelandic sea.

Criteria concerning plankton and HAB in Icelandic seawaters are monitored by the MRI

In case the EEA or MRI detects that a test value of any criterion is over its Maximum

Residue Limit (MRL), the EEA or MRI will issue a notice of harvest area close to the relevant businesses b Inspection of vessels, auctions and processing factories

Since 1998, FISKISTOFA has authorized two private inspection bodies, Frumherji HF and Sýni skoðunarstofa EHF, to conduct routine inspections of fishing vessels, freezer vessels, factory vessels, auctions, and fishery processing factories These organizations are accredited by the Icelandic Metrology and Accreditation Service, ensuring compliance with industry standards.

Swedish Board for Accreditation and Conformity Assessment (SWEDAC) according to ÍST EN 45004:1995 on general criteria for the operation of various types of bodies performing inspections

Fishery processing factories and factory vessels undergo inspections a minimum of four times annually, whereas other types of vessels and auction sites are inspected at least once or twice each year.

Licencing for freshwater farming trade and monitoring/control of fish diseases and seed

Evaluation of the ability of the Vietnamese fisheries sector to apply lessons

learnt in Iceland in wild shrimp production

As mentioned, Vietnam has great potential for fishing activity with a total area of inland and territorial waters of 226,000 km 2 and an EEZ of over 1 million km 2 In addition,

Vietnam boasts over 4,000 islands that offer essential logistic services and transshipment facilities, providing safe havens for fishing vessels during stormy seasons Between 2001 and 2003, fishing accounted for 40-50% of the total fisheries value, with shrimp ranking second in value, contributing 17.3-18.6% of the overall caught fishery value during this period.

Between 2001 and 2003, the Ministry of Fisheries reported that freshwater fishermen in Vietnam primarily operated at the household level, yielding minimal daily catches ranging from a few to a hundred kilograms In contrast, marine fishing emerged as the predominant resource, with 87% of marine fishermen and fishery collectors also working at the household level This reliance on small-scale operations poses significant challenges for fishing management and official quality control in the country.

Table 4: Fishery output value of Vietnam from 2001 – 2003

Table 5: Output value of capture in Vietnam from 2001 – 2003

Fishing vessels in Vietnam typically lack specialization for shrimp catching due to their small scale and the limited catching seasons in various regions Consequently, raw material middlemen and collectors gather not only shrimp but also other fishery species This study, therefore, focuses on the broader category of fishery vessels and their middlemen or collectors.

7.2.1 Possibility of a change of the Vietnamese legislation system

In recent years, Vietnam has enacted numerous legislative measures to ensure the safety and quality of domestic products while meeting import market standards, similar to Iceland's approach The cornerstone of these regulations is the Ordinance on Goods Quality No 181999PL-UBTVQH10, established by the Government of Vietnam on December 24, 1999, and effective from July 1, 2000 This ordinance outlines the principles and policies for managing product quality in Vietnam, including the establishment and enforcement of quality standards, certification processes, and the accreditation of quality control systems for the examination and inspection of goods.

In accordance with Article 38 of the Ordinance, the Government issued Decree 179/2004/ND-CP on October 21, 2004, to provide detailed guidelines for the implementation of the Ordinance's principles regarding goods quality management Article 23 of the Ordinance outlines the specific management responsibilities of various ministries and emphasizes the importance of inter-ministerial cooperation Additionally, the fishery goods management responsibilities of the Ministry of Fisheries, along with its structure and authority, are further clarified in Government Decree 43/2003/ND-CP, dated May 2, 2003.

On July 26, 2003, the Government enacted the Decree on Food Hygiene and Safety, complementing the existing Decree on Goods Quality This legislation establishes essential principles to guarantee food hygiene and safety throughout all phases of food production, distribution, and transportation, while also outlining preventive and corrective measures for foodborne illnesses and poisonings.

The legal framework for fishery quality, hygiene, and veterinary activities is supported by several key decrees and laws Notably, the Fishery Law, enacted on August 7, 2003, establishes essential requirements for the fisheries sector, focusing on food safety and quality assurance Additionally, the Veterinary Decree, issued on April 29, 2004, along with the Decree on Breeds of Animals from April 5, 2004, outlines the necessary standards for official controls related to veterinary practices and animal diseases in the cultivation and production of animal breeds intended for import and export.

Like Iceland, the regulations and standards set forth by the Ministry of Fisheries outline specific requirements in this area, with the most significant documents being the following.

On January 26, 2000, the Ministry of Science and Technology and Environment issued Decision No 117/2000/QD-BKHCNMT, establishing the 2000 list of export and import goods that require State Quality Inspection This decision outlines the specific products that must undergo quality inspections in collaboration with various related ministries.

- Decision of the Ministry of Fisheries, 649/2000/QD-BTS, 4 August 2000, to issue a Regulation on inspection and certification for health conditions in fishery processing establishments

- Decision of the Ministry of Fisheries, 650/2000/QD-BTS, 4 August 2000, on a Regulation on governmental inspection and certification for the quality of fishery products

- Decision of the Ministry of Fisheries, 15/2002/QD-BST, 17 May 2002, promulgating the Regulation on a monitoring programme for chemical contaminants and residues hereof in aquaculture animals and aquaculture products

- Decision of the Ministry of Fisheries, 07/2005/QD-BST, 24 February 2002, promulgating a list of veterinary drugs permitted, restricted and banned for use in fishery production, distribution and trading

All fishery businesses must adhere to mandatory sectorial standards to ensure safety, with key regulations including 28 TCN 129:1998, which outlines a HACCP-based program for food quality and safety assurance, and 28 TCN 130:1998, which specifies general conditions for food safety in fish processing establishments.

The Vietnamese fish hygiene and official control legislation has been assessed by EU experts and found to be largely aligned with EU standards However, there are notable deficiencies, particularly in the completeness and timeliness of guidelines and sub-legal documents Additionally, similar to Iceland, there are no legal documents in place that adhere to the latest EU food hygiene regulations Furthermore, authorities have yet to communicate the new EU legislation and its changes to the public and industry stakeholders.

7.2.2 Possibility of change in Vietnam of the structure and activities of the authorities

7.2.2.1 Structure, functions and powers of the competent authorities

As stipulated in the Decree 179/2004/ND-CP, there are three ministries with responsibilities related to fishery hygiene and official control in Vietnam: a Ministry of Science and Technology

The Ministry is responsible for:

- Instructing and establishing universal policies on good quality, including fishery products

- Developing and publishing national standards

- Publishing a list of commodities imported, exported and domestically produced subject to quality control, in cooperation with related ministries

- Publishing list of commodities subject to a Vietnamese standard (as minimum), in cooperation with related ministries b Ministry of Health

The Ministry is responsible for:

- Monitoring hygiene and safety of food for domestic consumption, including seafood as well as inspecting the health conditions of fishery retailers, wholesalers and restaurants

- Managing and inspecting the production and import of food additives, chemical food ingredients, disinfecting agents etc for use in the food industry c Ministry of Fisheries

The Ministry oversees the management of fisheries in the country, encompassing fish farming, catching, processing, and the protection and development of both inland and offshore fishery resources The National Fisheries Quality Assurance and Veterinary Directorate (NAFIQAVED) operates under the Ministry, ensuring professional state management of quality, food safety, and veterinary practices throughout the entire fishery production chain, from primary production to processing, storage, and transportation NAFIQAVED has six regional centers in key fishery production cities or provinces, responsible for implementing official controls in various fishery businesses, including fishing vessels and aquaculture farms, while also monitoring chemical residues and bivalve mollusc harvest areas This Directorate was reorganized in 2003 from the National Fisheries Inspection and Quality Assurance Center (NAFIQACEN) in accordance with Government Decree 43/2003/ND-CP and Decision 07/2003/QD-BTS.

2003 of the Ministry of Fisheries

In cities or provinces, there are Provincial Fishery Resource Protection Sub-departments

Provincial Departments of Fisheries (DOFI) oversee Provincial Fisheries Resource Protection Services (PFRPS), working alongside NAFIQAVED regional centers to regulate fishing vessels, landing sites, and wholesale markets NAFIQAVED provides essential technical guidance and training for PFRPS personnel while supervising their professional activities To enhance collaborative effectiveness, the Ministry plans to establish a new division focused on Quality Assurance, Seafood Safety, and veterinary control in partnership with NAFIQAVED Additionally, the authority to issue and revoke business operation licenses, including those for fisheries, is also under the purview of these departments.

Provincial Department of Planning and Investment A chart of the governmental management system in the Vietnamese fisheries sector is shown in Figure 6

NAFIQAVED's equipment, facilities, and staff possess the necessary professional skills and knowledge, adhering to EU requirements as per the FVO 2005 standards Despite meeting these standards, the organization currently lacks the authority to revoke or suspend operational licenses of fishery businesses, a power that resides with the Provincial authorities.

Departments of Planning and Investment

Figure 6 : Important governmental management institutions in the Vietnamese fisheries sector

Universal policies on quality and national standards

Departments of Planning and Investment

Provincial Fishery Resource Protection Sub-departments

Markets, Retailers, Restaurants, Food Services

Chemicals and additives used for food industry

7.2.2.2 Monitoring production conditions and control activities a Monitoring of ocean areas

Vietnam has yet to establish a comprehensive monitoring program for its ocean areas, resulting in no fishing zones being closed due to pollution, contamination, or harmful algal blooms (HAB) To enhance seafood safety, Vietnam can draw on the monitoring experiences and models from Iceland A significant step in this direction is the Ministry of Fisheries' Decision No 17/2004/QĐ-BTS, issued on June 14, 2004, which led to the creation of the National Center of Sea Environment Monitoring and Warning This center is tasked with developing a sea environment monitoring program and deploying monitoring post nets across Vietnamese waters, providing timely information for aquaculture and fishery resource protection This initiative lays the groundwork for the future monitoring of fishing areas in Vietnam.

Assessment of the Vietnamese fisheries sectors’ compliance with the new EU

This study focuses on the initial stages of the production chain, specifically evaluating the culture stage to the receiving phase at fishery processing factories It is important to note that the assessment from processing plants to export ports remains consistent for wild shrimp products.

Vietnam boasts extensive freshwater resources, including lakes, reservoirs, and rivers, making aquaculture a vital component of its fisheries sector Cultured shrimp is the most valuable aquaculture product, accounting for over 70% of the sector's total value According to a survey by the FAO and the Ministry of Fisheries, a significant majority of fishery farmers (94%) and collectors (87%) operate at the household level, with many being newcomers; 35% have less than three years of experience, while only 15% possess over a decade of experience This prevalence of small-scale aquaculture enterprises and limited experience has led to similar management challenges in aquaculture as those faced in fishing and fishery collection.

Table 6: Output value of aquaculture in Vietnam from 2001 – 2003

7.3.1 Legislation system, structure and activities of the authorities

In recent years, several key laws have been enacted in Vietnam to address veterinary aspects of aquaculture, including the Fishery Decree (August 7, 2003), the Veterinary Decree (April 29, 2004), and the Decree on Breeds of Animals (April 5, 2004) However, challenges persist in the legislative framework governing the catching of products, as the existing sub-laws and guidelines for veterinary practices and HACCP principles remain incomplete and inconsistent with EU regulations and the realities of production This situation underscores the urgent need for a comprehensive analysis of Icelandic legislation to enhance and refine Vietnam's legal framework in this sector.

NAFIQAVED is the authority responsible for overseeing aquaculture and fishery collection control, a function transferred from the Fishery Resource Protection Departments (FRPD) following the NAFIQACEN reorganization in 2003, as per Decision 07/2003/QD-BTS by the Ministry of Fisheries Currently, provincial and city-level control is managed by PFRPSs, centralizing oversight within NAFIQAVED after a period of division between NAFIQACEN and FRPD Additionally, Decision 649/2000/QD-BTS established new requirements for registration, approval, and inspection for aquaculture and fishery collection businesses, which were not mandated under previous regulations This shift is beneficial for the fisheries sector in aligning with EU legislation on aquaculture and fishery collection.

Inspections of aquaculture farms and fishery collectors are emerging areas for both central and local authorities, but their implementation is hindered by a lack of guidelines Most fishery farmers and collectors operate on a small scale, particularly in rural areas, and often lack timely access to information regarding new aquaculture techniques, food safety legislation, and disease control measures The majority of these farmers have limited experience, with a 2003 survey revealing that only 15% had over 10 years of experience, while 35% had less than three years in the field (Lem et al 2004).

The National Fisheries Extension Centre (NAFEC) and Provincial Fisheries Extension Sub-department (PFES) staff play a crucial role in educating farmers about aquaculture techniques and the proper use of drugs and chemicals However, their effectiveness is hindered by constrained government salary budgets.

NAFIQAVED has been implementing an approved residue control programme for aquaculture areas since 1999 as required in Article 11 of Regulation 854/2004 During

Since 2004, the program has effectively monitored all intensive aquaculture areas, covering 137 locations across 35 cities and provinces, marking a 110% increase from 2003 Monthly monitoring results and closure notices are promptly communicated to PFRPDs and EU-approved factories However, the database is also made available on the FICEN website for other factories, relevant organizations, and consumers, albeit with significant delays and shortcomings As of February 17, 2006, the website indicated that the most recent monthly monitoring results were from December 2005.

7.3.2 Potential of the industry to upgrade production conditions and improve quality management systems

The aquaculture shrimp industry faces significant challenges due to the use of banned chemicals like chloramphenicol and nitrofurans To mitigate these risks, the Ministry has implemented regulations and enhanced public awareness through national and local media This initiative aims to educate farmers about legal compliance, advanced aquaculture techniques, and effective shrimp disease management, while also informing middlemen about the detrimental effects of using prohibited chemicals in shrimp cultivation and storage.

Unlike businesses in aquaculture and collection sectors, factories possess a strong understanding of the implications of banned chemicals in fisheries Currently, antibiotic hazards are identified as critical risks in the receiving phase of HACCP plans for shrimp processing, prompting factories to meticulously review documentation accompanying raw material batches and implement testing for antibiotic residues However, some factories, facing a shortage of raw shrimp, resort to purchasing products from unverified sources or those treated with chemicals, despite a collective commitment among VASEP members to reject such products To effectively prevent the intentional use of antibiotics in aquaculture and adhere to the informational requirements outlined in Regulation 852/2004, factories must honor their commitments.

Shrimp export factories approved by the EU have successfully implemented the HACCP system, but fishery collectors have yet to adopt these essential quality management practices as mandated by new EU regulations Many shrimp farmers and middlemen lack the necessary experience and knowledge regarding proper culture and storage methods, contributing to the increased use of banned antibiotics like chloramphenicol and nitrofurans in cultured shrimp Most aquaculture businesses operate based on experience rather than established quality management systems To address these issues, it is crucial for collectors to enhance their production conditions and establish HACCP-based quality systems, with support from organizations such as the Vietnam Fisheries Association (VINAFA), VASEP, and local government bodies like PFESs and PFRPDs.

To comply with Regulation 852/2004, shrimp culture businesses must implement quality management programs such as GAP, BAP, or HACCP The Ministry and local governments should support farming communities in developing shelf management programs based on the FAO's Code of Conduct for Responsible Fisheries to enhance public support and farmer awareness of responsible aquaculture Additionally, the establishment of certification bodies for GAP, BAP, HACCP, and CoC in aquaculture is encouraged by the Government and the Ministry of Fisheries These initiatives aim to minimize disease in aquaculture

Assesment of different aspects of food hygiene and official control in Iceland

The Icelandic fisheries sector possesses extensive expertise in managing food hygiene throughout the fishery production chain, which could be beneficial for implementation in Vietnam A comparative assessment of the fisheries sectors in both countries highlights key differences and similarities, as detailed in Table 7.

Table 7: Comparison of aspects on food hygiene and official control in the fisheries sectors of Iceland and Vietnam

No Item Icelandic fisheries sector Vietnamese fisheries sector

- Iceland has a good legal framework set up systematically in harmonisation with international requirements and standards

Vietnam boasts a strong legal framework for food hygiene and official control that meets the approval of EU inspectors However, the system lacks completeness and timeliness in its guidelines and sub-law documents.

- Vietnamese legislation does not require registration of small scale primary production businesses

- Iceland has not yet transmitted the new EU legislation into Icelandic legislation

- Vietnam has not yet issued any legal documents to comply with the new EU legislation

II Structure and activities of the authorities

1 Structure, functions and powers of the competent authorities

- Iceland has advanced private businesses in some official control activities under close supervision by the competent authority

- All official control works are in charge of governmental staff

- FIKISTOFA has the power to suspend operations of factories not meeting official requirements

- NAFIQAVED does not have any real power to suspend the operations of factories not meeting requirements

2 Monitoring of ocean areas - Iceland has implemented a monitoring programme of fishing seawaters

- Vietnam has not yet implemented a monitoring programme of fishing seawaters

3 Inspection of vessel, auction and processing factory

- Iceland carries out systematically food hygiene and HACCP principles in the whole production chain “from farm to folk”, not only in processing factories

Food hygiene and HACCP principles are essential for ensuring safety throughout the entire production chain, from farm to fork However, there remains a lack of comprehensive control over the quality of raw materials during primary production, collection, and import processes.

- Iceland has implemented risk analysis in fishery production

- Vietnam has not yet carried out risk analysis and risk assessment for emerging food safety hazards in fishery production

- Guidelines on HACCP application are disseminated widely

- HACCP guidelines for processing factories are disseminated widely but authorities has not issued guidelines on HACCP application to wholesale markets and middlemen/collectors

4 Import control of fishery products

- Iceland closely controls import fishery products - Fishery products for human consumption at present are not on the list of goods under mandatory import control

5 Official laboratory - Icelandic laboratories are accredited against ISO 17025 - NAFIQAVED laboratories are accredited against ISO 17025 but are overloaded with work

6 Training for official control staff

- Iceland often conducts training courses for governmental and inspection body staff

NAFIQAVED frequently offers training courses aimed at enhancing the skills of national and local staff However, local authority personnel often lack the necessary skills and experience for inspecting primary production and collectors, as this area is relatively new in Vietnam.

- Iceland makes use of broadcast mediums and the Internet for popularising and informing the industry and public on time

- The authorities have not yet informed the industry or public of the new legislation or other necessary information

III Implementation of the industry

1 Requirements on food safety management system

- All of kinds of fishery businesses have implemented quality management systems based on HACCP

- Handling businesses, wholesale markets and raw material collectors in the fisheries sector still have not applied quality management systems based on HACCP

- Factories have not completely carried out internal verification

- Factories have not completely carried out internal verification

2 Traceability - Traceability generally is well implemented in all links of the fishery production chain

- Traceability generally has not yet fully carried out, especially in primary production, fishery collection and handling

- Raw material quality is closely monitored by HACCP systems of factories

- Sense of community to comply with the legislation is good

- Some middlemen soak raw material in banned chemical or inject foreign matter/substances because of economic benefits

- Some factories still purchase raw material from unknown origins that may be soaked in chemical or injected foreign matter/substances

- All of kinds of businesses generally have good hygiene conditions

- Businesses and the public have high awareness of food safety

Many businesses involved in fishing and raw material collection are struggling to meet hygiene standards set by authorities Their limited knowledge and skills in maintaining proper hygiene conditions hinder compliance with these essential requirements.

8 PROPOSAL FOR CHANGES IN FISHERY HYGIENE MANAGEMENT

AND OFFICIAL CONTROL SYSTEMS IN VIETNAM

8.1 Summary of gaps in the Vietnamese fisheries sector to comply with the new

The assessment of two case studies on the shrimp production chain reveals significant gaps in food hygiene and control within the Vietnamese fisheries sector, particularly for fishery products, excluding bivalve molluscs due to their unique characteristics To achieve compliance with the new EU legislation package, it is essential to address these identified deficiencies.

Table 8: General gaps related to food hygiene and control aspects of the Vietnamese fisheries sector to comply with the new EU legislation package

No Item Gaps in the Vietnamese fisheries sector Reference to the new EU legislation

I Gaps in the legislation system - Vietnam has not yet issued any legal documents to comply with the new

- System of guidelines and sub-law documents (on veterinary issues, inspection and quality management systems of primary production and middlemen) are not complete or on time

- Authorities have also not yet issued regulations on registration for small scale primary production businesses

II Gaps in the structure and activities of the authorities and the industry

1 Structure, functions and powers of the competent authorities

- NAFIQAVED still does not have real power to enforce the PFRPSs Article 11 – Regulation

2 Monitoring of ocean areas - Vietnam has not yet implemented a monitoring programme of seawaters to close fishing areas which do not meet hygiene and safety requirements

3 Inspection of vessels, auctions and processing factories

- Inspection of primary production and fishery collectors have not been implemented as required of Vietnamese and EU legislation

Vietnam has not conducted risk analysis or assessment for emerging food safety hazards, which is crucial for establishing effective food legislation This lack of analysis hinders factories from selecting appropriate control measures, ultimately impacting the successful implementation of HACCP (Hazard Analysis and Critical Control Points).

- Authorities have not issued guidelines on HACCP application to wholesale markets and middlemen/collectors

4 Approval of establishments - Authorities in the fisheries sector have no mandate to suspend operations of businesses if they do not meet the food safety requirements

5 Importation control of fishery products

- Imported products are not required and inspected to be handled or produced under an equivalent regime of management of food safety

- Raw material products are not on the list of imported goods under mandatory official control in Vietnam

6 Official laboratories - There is overload of testing work in NAFIQAVED laboratories Article 12 - Regulation 882/2004

7 Training for official control staff - Some local inspectors do not have enough professional knowledge, skills or experience in the inspection of primary production

Article 11 – Regulation 854/2004, Article 6 and 46 – Regulation 882/2004

8 Transparency and confidentiality - The authorities have not yet informed the industry or the public of the new legislation

- There is much necessary information that is not available to the public, including:

Results of substance residue monitoring programmes in aquaculture areas and closing areas

The lists of approved of businesses (processors approved by Ministry of Fisheries and markets, middlemen, fishing vessels, aquaculuturers)

III Gap on the industry implementation

1 Requirements in food safety management systems

- Handling businesses, wholesale markets and raw material collectors in the fisheries sector still have not applied quality management systems based on HACCP

- Factories have not completely carried out internal verification

Article 3 – Regulation 852/2004; Article 5- Regulation 852/2004; Article 17- Regulation 178/200

2 Traceability - Traceability generally has not been fully carried out, especially in primary production, fishery collection and handling

Article 18 – Regulation 178/2002; Article 5 and Annex

3 Raw material management - Some middlemen soak raw material in banned chemicals or inject foreign matter/substances because of economic benefits

- Some factories still purchase raw material from unknown origins or soaked in chemicals or injected with foreign matter/substances

- Some farmers, middlemen do not have enough knowledge of culture methods, storage methods or legislation

Article 19 - Regulation 178/2002; Annex II, Chapter IX, item 2 - Regulation 852/2004; Annex II, Section III – 853

Businesses involved in fishing and raw material collection must improve their hygiene conditions, as current practices do not meet regulatory standards Additionally, there is a significant gap in knowledge and skills related to hygiene among these operators, highlighting the need for better training and compliance measures.

Annex I, II - Regulation 852/2004, Annex II, Section VIII - Regulation 853/2004

Solutions for the Vietnamese fisheries sector

To meet the new EU requirements for fishery products, Vietnam must implement comprehensive measures to enhance food safety and official control systems Iceland, a leading fishery export country with the EU as its primary market, has successfully developed robust food safety assurance systems in recent years By learning from Iceland's experiences and successes, Vietnam's fisheries sector can effectively improve its food safety practices and align with international standards.

8.2.1 Lessons learnt from the Icelandic fisheries sector a Systemisation and harmonisation of the legal framework

The fisheries sector must establish a robust legal framework that aligns with international standards, serving as a foundation for all sector activities To ensure compliance with global norms, it is essential to invest in the development of national standards, as well as effective monitoring and compliance mechanisms.

Food quality regulations and guidelines should be established based on a clear and thorough risk analysis and assessment conducted by authorities Additionally, a systematic and process-based approach to food quality assurance is essential for ensuring safety and compliance.

- The fisheries sector should carry out systematically food hygiene and HACCP principles in the whole production chain “from farm to folk”, not only in processing factories

The establishment and execution of regulatory systems, along with standards, guidelines, training, communication, and public awareness, are essential for enhancing competitiveness and fostering sustainable growth and development Additionally, promoting the involvement of the private sector in official oversight is vital for achieving these objectives.

The government can enhance operational efficiency by leveraging private businesses for certain official control activities, while ensuring strict oversight by competent authorities This strategy not only alleviates the workload of government staff, allowing them to concentrate on other critical management tasks, but also leads to significant savings in the government’s investment budget and labor resources Additionally, utilizing broadcast mediums and the Internet can further optimize these efforts.

The fisheries sector must enhance public communication channels, including broadcast media and the Internet, to timely disseminate essential information to the industry This will not only improve the knowledge of businesses and the public but also strengthen community ties within the sector.

To ensure compliance with food safety assurance legislation, it is crucial to raise public awareness about food safety and foster effective internal communication The government and the Ministry must implement measures to enhance public understanding and promote better communication practices within the food industry.

8.2.2 Recommendations for Vietnamese fishery authorities

8.2.2.1 Legal document framework a To the Government

- The Government should delegate power to NAFIQAVED to suspend operations of businesses if they do not meet food safety requirements

- The Government should add fishery products in raw material types to the import goods list under mandatory official control b To the authorities of the Vietnamese fisheries sector

- The Ministry of Fisheries should develop and promulgate legal documents to comply with the new EU legislation on food hygiene and official control this year

The Ministry of Fisheries requires a detailed strategy to establish legislation focused on food quality assurance This plan should systematically enhance guidelines and subordinate legal documents, particularly in the areas of veterinary control, inspection, and quality management systems for both primary production and intermediaries.

The Ministry of Fisheries should update Decision 649/2000/QD-BTS to mandate the registration of small-scale primary production businesses and the adoption of a quality management system grounded in HACCP principles for fishery collectors, middlemen, and wholesale markets Furthermore, it is essential to incorporate traceability requirements throughout the entire fishery production chain, along with setting appropriate deadlines for various types of production businesses.

The Ministry of Fisheries, known as NAFIQAVED, should translate all European Union legislation, particularly the new regulations effective from January 1, 2006, into Vietnamese and make them accessible online for both industry stakeholders and the general public.

8.2.2.2 Structure and activities of authorities in fishery quality management a To the authorities of the Vietnamese fisheries sector

Structure and functions of the authorities

The Ministry of Fisheries should initiate the establishment of a dedicated quality assurance and veterinary control division within each Department of Fisheries (DOFI) to enhance collaboration between DOFIs, Provincial Fisheries Resources Departments (PFRDs), and the National Fisheries Quality Assurance and Veterinary Directorate (NAFIQAVED) To facilitate this process, the Ministry must organize meetings with provincial People’s Committees to discuss the implementation of these divisions.

The Department of Science and Technology, in collaboration with the Ministry of Fisheries and NAFIQAVED, should partner with relevant research institutes and universities to conduct risk assessments on emerging food safety hazards and associated species This initiative aims to establish a legislative framework for food safety while assisting businesses in developing effective food quality management systems.

The Ministry of Fisheries should explore policies that allow private businesses to conduct official inspection activities, with stringent oversight from NAFIQAVED This approach would enable NAFIQAVED to concentrate on other critical control and management functions.

Monitoring, inspection and quality management systems

- The Ministry of Fisheries should sep up a monitoring programme for seawaters to provide clear statements on prohibited catching areas because of pollution, contamination and HAB

- NAFIQAVED and PFRDs should carry out inspections of primary production businesses and fishery collectors/wholesale markets as requirements of Decision 649/2000/QD-BTS

The Ministry of Fisheries must enforce stringent regulations and penalties against the soaking or injection of foreign substances into raw materials This enforcement should extend to all parties involved, including injection sites, middlemen, transporters, and factories that acquire these contaminated materials.

- NAFIQAVED should issue guidelines on HACCP application to wholesale markets and middlemen/collectors and, at the same time, NAFIQAVED should assign professional staff for directly guiding businesses

- The Ministry of Fisheries should continue the organisation of a HACCP contest every two years to encourage factories in HACCP implementation

The Ministry of Fisheries should establish preferential policies and incentives to motivate aquaculture enterprises to adopt Good Aquaculture Practices (GAP), Best Management Practices (BMP), and Hazard Analysis and Critical Control Points (HACCP) Additionally, implementing pilot models for fishery communication based on Chain of Custody (CoC) principles for both fish farming and fishing activities is essential.