The Department of Quality, Processing and Market Development (Ministry of Agriculture and Rural Development) has provided information on the necessary regulations that seafood exporting enterprises must comply with in order to meet European requirements.
Major seafood importing markets require oversight by the competent authority (CA) of the exporting country to ensure food safety. To meet these requirements, the competent authorities of exporting countries must undergo evaluation and recognition of their capacity and establish a list of export processing establishments that comply with the prescribed standards. Each export consignment must be inspected, sampled for testing, and issued a food safety certificate.
Compliance with the EU’s stringent food safety regulations for imported seafood poses significant challenges. Vietnamese seafood consignments are frequently warned by the EU competent authorities regarding antibiotic residues. In addition, Viet Nam has not yet resolved the “yellow card” under the Illegal, Unreported and Unregulated (IUU) Fishing Programme.
The EU’s requirements for the recognition of establishments within the supply chain are highly stringent. At present, only processing establishments and cold storage facilities are eligible to be listed. The food safety assurance conditions of many establishments have yet to fully comply with EU regulations.
Furthermore, strict requirements imposed on imported products (regarding certification and chain controls), particularly the requirement that tuna preserved in brine be used exclusively for the canning industry, create additional difficulties for exporting enterprises.
Specific Requirements
The EU has recognized Viet Nam’s seafood food safety control system and the Department of Quality, Processing and Market Development (NAFIQPM) as the competent authority of Viet Nam responsible for controlling seafood exports to the EU. Establishments within the seafood production and trading chain for export must be inspected and recognized as meeting food safety assurance conditions and complying with EU regulations. At the same time, these establishments must be included on the official list in order to be eligible to export to the EU. Each consignment exported to the EU is subject to appraisal, sampling for testing, and issuance of a food safety certificate in accordance with Circular No. 48/2013/TT-BNNPTNT of the Ministry of Agriculture and Rural Development (as amended and supplemented by Circular No. 32/2022/TT-BNNPTNT).
Farmed seafood: A National Residue Monitoring Programme for chemical and antibiotic residues in farmed seafood must be developed, implemented, and recognized by the EU.
Bivalve Mollusc Monitoring Programme for exports to the EU: A programme must be developed, implemented, and recognized by the EU to ensure hygiene and safety of harvesting areas.
Annually, the competent authority of the exporting country must report to the EU on the implementation results of the monitoring programme; periodically, the EU competent authority will conduct on-site inspections of the development and implementation of the programme. The EU competent authority requires the establishment of separate lists for facilities producing frog legs, snails, and gelatine/collagen derived from seafood raw materials.
There is also a requirement to establish lists covering all establishments participating in the supply chain, including collection facilities, preliminary processing facilities, cold storage facilities, processing establishments, freezer vessels, and factory vessels.
Regulations on Combating IUU Fishing.
General Regulations on Food Safety Assurance Conditions
Regulation (EC) No 178/2002 lays down the general principles and fundamental requirements of food law, as well as the obligations of food business operators within the EU. This Regulation includes precautionary measures, food safety principles, emergency measures, labeling requirements, transparency, recall and traceability obligations, as well as the responsibilities of Food Business Operators (FBOs) and the Rapid Alert System for Food and Feed (RASFF).
The Regulation emphasizes transparency, including public consultation on decisions related to food safety. Article 18 provides for traceability, requiring that each food product be traceable one step back and one step forward within the supply chain. If a problem is identified, the product must be withdrawn immediately. EU Member States are responsible for enforcing the legislation and monitoring compliance with these requirements, ensuring their full implementation.
Risk assessment under this Regulation must be based on available scientific evidence and carried out in an independent, objective, and transparent manner.
Regulation (EC) No 852/2004 on the hygiene of foodstuffs establishes requirements concerning equipment design, staff training, water quality, record-keeping, pest control, the use of chemicals, HACCP (Hazard Analysis and Critical Control Points), and waste management. This Regulation applies to all stages of the food and feed chain, from production to consumption.
Food business operators must comply with food hygiene obligations, including the implementation of good hygiene practice guidelines and the principles of HACCP. Food establishments must be registered and approved and must comply with the import control provisions set out in Regulation (EC) No 178/2002.
Regulation (EC) No 178/2002, also known as the EU General Food Law, lays down the general principles and requirements of food safety, including precautionary measures, emergency measures, labeling, transparency, recall and traceability, as well as the responsibilities of Food Business Operators (FBOs) and the Rapid Alert System for Food and Feed (RASFF). This Law establishes general principles and overarching obligations for food business operations and stipulates that the EU food safety authority shall ensure transparency through public consultation.
One of the key requirements of the Regulation is traceability, which obliges establishments to be able to identify the origin of food one step back and one step forward within the supply chain (Article 18). In the event of an incident, unsafe products must be withdrawn. EU Member States are responsible for enforcing the legislation and for supervising and verifying that these requirements are fully implemented.
Risk assessment is conducted on the basis of available scientific evidence and must be carried out in an independent, objective, and transparent manner.
Regulation (EC) No 852/2004 on the hygiene of foodstuffs sets out requirements concerning equipment design, staff training, water quality, record-keeping, pest control, the use of chemicals, HACCP, and waste management. This Regulation applies to all stages of the food and feed chain and emphasizes the obligations of food business operators in ensuring hygiene.
Food business operators must comply with good hygiene practice guidelines and the principles of HACCP. All establishments must be registered and approved. Import controls are carried out in accordance with Regulation (EC) No 178/2002. The Regulation also includes annexes containing specific hygiene rules for production. Regulation (EC) No 853/2004 establishes specific hygiene rules for food of animal origin, including provisions applicable to fishery products. This Regulation clearly defines “unprocessed” and “processed” products and requires establishment approval to ensure that only approved establishments are permitted to place products on the market.
Products must bear identification marks and comply with specific hygiene requirements, including those applicable to live bivalve molluscs, fishery products, frog legs and snails, collagen and gelatine, as provided in the annexes to the Regulation.
These Regulations help ensure that food products imported into the EU meet high standards of food safety and hygiene, protect consumer health, and maintain the reputation of products in the international market.
Regulation (EC) No 2073/2004 lays down microbiological criteria for foodstuffs, and Regulation (EC) No 1441/2007 amends Regulation (EC) No 2073/2004. These Regulations establish specific microbiological standards that food products must comply with in order to ensure consumer safety.
Regulation (EC) No 1881/2006 establishes maximum levels for contaminants such as heavy metals, dioxins, and other substances. Regulation (EU) 2021/1323 amends Regulation (EC) No 1881/2006 with regard to maximum levels of cadmium in foodstuffs, and Regulation (EU) 2022/617 amends Regulation (EC) No 1881/2006 concerning maximum levels of mercury in fish. Accordingly, the mercury content in fish ranges from 0.3 to 1.0 mg/kg depending on the species, and the mercury content in salt is set at 0.10 mg/kg.
Regulation (EC) No 333/2007 lays down methods of sampling and analysis for the control of processing contaminants in food, specifically lead, cadmium, mercury, inorganic tin, 3-MCPD, and benzo(a)pyrene. Regulation (EU) 2017/644 establishes methods of sampling and analysis for dioxins and PCBs.
Regulation (EC) No 470/2009 establishes maximum residue limits (MRLs) for veterinary medicinal products in food of animal origin, and Regulation (EC) No 396/2005 sets MRLs for pesticides. Regulation (EU) No 37/2010 establishes a list of substances prohibited or permitted for use in food of animal origin.
Regulation (EC) No 1333/2008 governs the management and use of food additives and processing aids in food. This Regulation sets out specific standards for food additives such as colorants, thickeners, and flavorings.
Regulation (EU) No 1169/2011 lays down requirements regarding food information to consumers. Mandatory information to be indicated on the label includes: the name of the product (including both the commercial name and the scientific name), the list of ingredients, allergen information, genetically modified food status, origin, net weight, shelf life, the EU approval number, and lot identification.
Some New EU Regulations on Seafood Imports
The EU has modernized its official control system through the initiative “Smarter Rules for Safer Food and Plant Health,” aimed at enhancing effectiveness and safety in food and plant health controls. Three core Regulations have been adopted, namely the Official Controls Regulation (OCR): (EU) 2017/625; the Animal Health Regulation (AHR): (EU) 2016/429; and the Plant Health Regulation (PHR): (EU) 2016/2031.
As of 14 December 2019, most provisions of the OCR and PHR have entered into force. As of 21 April 2021, the AHR officially entered into force.
Regulation (EU) 2017/625 ensures the enforcement of food and feed law, expands the scope, and harmonizes provisions concerning products of animal origin, live animals, plants, and high-risk food not of animal origin. This Regulation replaces Regulation (EC) No 882/2004, Regulation (EC) No 854/2004, Directives 96/23/EC, 97/78/EC, and 91/496/EC. Pursuant to Article 127(3) of this Regulation, establishments wishing to export to the EU must be listed.
The Information Management System for Official Controls (IMSOC) has been established to manage information related to official controls.
Regulation (EU) 2019/625, as amended by Regulation (EU) 2022/2292, lays down import conditions for consignments of products of animal origin such as fishery products, live bivalve molluscs, and composite products, applicable from 21 April 2021.
Regulation (EU) 2019/627, as amended by Regulation (EU) 2022/2503, sets out requirements for the performance of controls on live bivalve molluscs (Articles 51–65) and control measures for fishery products (Articles 67–71).
In addition, requirements concerning composite products are specified in Regulation (EU) 2019/625 and Regulation (EU) 2020/692. Composite products are food products containing both products of plant origin and processed products of animal origin, as defined in Article 2 of Regulation (EU) 2019/625. The corresponding HS codes include: 1601, 1602, 1603, 1604, 1605, 1901, 1902, 1905, 2004, 2005, 2103, 2104, 2105, and 2106.
The classification of composite products is based on risks to public health and animal health, rather than on the percentage of components of animal origin as previously applied, as provided for in Articles 162 and 163 of Regulation (EU) 2020/692. It includes three main categories:
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Non-shelf-stable composite products: Products that are stored/transported under temperature-controlled conditions, in accordance with Article 12 of Regulation (EU) 2019/625.
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Shelf-stable composite products containing meat as an ingredient: Products that do not require temperature control during storage/transport..
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Shelf-stable composite products not containing meat as an ingredient.
Certain conditions for the export of composite products include the requirement that the manufacturing establishment must be included on the list recognized by the EU. If the product contains meat, dairy products, eggs, or products derived therefrom, it must be produced in a country and at an establishment authorized by the EU for export (including compliance with residue monitoring programmes, disease control measures, etc.), as listed in Regulations (EU) 2021/405 and (EU) 2022/2293.
Shelf-stable composite products not containing processed meat must contain processed products of animal origin other than processed meat and must be heat-treated in accordance with Regulation (EU) 2020/692.
The import control process comprises a series of steps to ensure food safety and compliance with applicable regulations. First, the documents accompanying the consignment are subject to thorough examination. Next, an identity check is carried out to ensure that the certificates or relevant documents correspond to the product. Finally, a physical inspection of the product is conducted, including checks of packaging, temperature, sampling, and testing. Upon completion of these steps, a conclusion on the inspection results is issued.
Source: Viet Nam SPS Office
