Compilation of legal and SPS requirements of fishery products of potential importing countries

Compilation of Legal and SPS requirements of fishery products of potential importing countries Vietnam, China, Hong Kong, Japan, Korea, Canada, Norway and European Union

UNITED NATIONS INDUSTRIAL DEVELOPMENT ORGANIZATION July 2015

DISCLAIMER: The views expressed in this report are based on the actual information and data collected during the study period and through review of currently available literatures. The views expressed in this report do not necessarily reflect those of the UNIDO or any participating organizations.

CEDEP II-Marine Fishery Legal and SPS requirements of fishery products of potential importing countries

List of Contents

List of Abbreviations……………………………………………………………………………….

3

Introduction ……………………………………………………………………………………......

5

Vietnam Section……………………………………………………………………………………

7

China Section ……………………………………………………………………………………..

15

Hong Kong Section………………………………………………………………………………..

33

South Korea Section………………………………………………………………………………

37

Japan Section ……………………………………………………………………………………..

50

Canada Section……………………………………………………………………………………

67

Norway Section……………………………………………………………………………………

79

European Union Section………………………………………………………………………….

80

Other Countries …………………………………………………………………………………...

119

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List of Abbreviations

ACIA

: Agence Canadienne d'Inspection des Aliments

AFR

: Advance Filing Rules

AQSIQ (China)

: General Administration of Quality Supervision, Inspection and Quarantine

BHCs

: Beta-Hexachlorocyclohexane

BL

: Bill of Loading

BSE

: Bovine Spongiform Encephalopathy

CA

: Competent Authority

CEDEP

: Cambodia Export Diversification and Expansion Program

CFIA

: Canadian Food Inspection Agency

CNCA

: Certification and Accreditation Administration of the People’s Republic of China

DDT

: Dichlorodiphenyltrichloroethane

EEA

: European Economic Area

EU

: European Union

FAO

: Food and Agriculture Organization

FBOs

: Food Business Operators

FFP

: Fish and Fishery Products

FHS

: Fish Health and Sanitary ( Controls )

FTA

: Free Trade Agreement

HACCP

: Hazard Analysis and Critical Control Point

HC

: Health Certificate

HCB

: Hexachlorobenzene

HPLC

: High-Performance Liquid Chromatography

HS Code

: International Harmonized System Code

ICMSF

: International Commission on Microbiological Specifications for Foods

IPCS

: International Programme on Chemical Safety

IUU

: Illegal, Unreported and Unregulated (Fisheries)

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KFDA

: Korean Food and Drug Administration

KRW

: Korean Won

LFA

: Lobster Fishing Area

MARD

: Ministry of Agriculture and Rural Development (Vietnam)

MIL

: Mandatory Inspection List

MOU

: Memorandum of Understanding

MRAs

: Mutual Recognition Agreements

MRL

: Maximum Residue Limit

NAFIQAD

: National Agro-Forestry-Fisheries Quality Assurance Department (Vietnam)

NFIS

: National Fisheries Products Quality Inspection Service (Korea)

PAH

: Polycyclic Aromatic Hydrocarbons

PCBs

: Polychlorinated Biphenyls

PCDDs

: Polychlorinated Dibenzo-para-dioxins

POL

: Port of Loading

PSP

: Paralytic Shellfish Poisoning

ROK

: Republic of Korea

SPS

: Sanitary and Phytosanitary (Measures)

TEFs

: Toxic Equivalency Factors

UNIDO

: United Nations Industrial Development Organization

WHO

: World Health Organization

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CEDEP II-Marine Fishery Legal and SPS requirements of fishery products of potential importing countries

Introduction The present compilation of legal and SPS requirements of fishery products of potential importing countries has been prepared under the Project “Standards Assessment” for the Marine Fishery Component of the Export Diversification and Expansion Program (CEDEP II), implemented by UNIDO. The project was carried out between 14 June to 3 July, 2015.

The content of such compilation has the objective to support and provide guidance for the target two main outcomes of the Marine Fisheries Product component: 

#1 - The needs of the marine fisheries product export sector are better understood, the sector is better structured, the policy dialogue with the Government is enhanced, and the enabling business environment is improved;



#2 - A group of marine fisheries processors have become export-ready and are increasing their export business including to new markets;

This compilation is however limited to the existing information made available by each Official source of the selected importing countries, identified in each section of the document. In complement it was also used the information made available from the Canadian Food Inspection Agency by each exporting jurisdiction. Other exporting country conditions may be found at CFIA at: http://www.inspection.gc.ca/food/fish-and-seafood/exports/byjurisdiction/eng/1304197334656/1304197442121 The consultant also cross-checked the available information with the practical experience of one of the main world seafood exporters (Indonesia), using non-confidential information made available from the Bilateral Agreements signed between Indonesia and the importing countries.

The present document has been prepared into 7 country sections and 1 regional market access area (the European Union). Each section provides direct information for the potential exporters to reach the required compliance for being eligible for exporting to the desired country of export destination.

Additionally, the contents also identify the necessary requirements which need to be fulfilled and observe compliance by the Competent Authorities in Cambodia in reference to the internal controls to be undertaken over the exporters, as required by most, if not all importing countries. Most of the importing countries Authorities will now require to check and audit incountry sanitary controls over the compliance of exporter operators. The fact is that internal sanitary measures are a must and will give a good feedback of the potential exporter’s level of fulfillment and performance of the hygiene requirements.

This document was prepared acknowledging that the Kingdom of Cambodia does not have any Import/Export Bilateral Agreement on Fish Products with any other country and has not been recognized/authorized for exporting to European Market and therefore is not listed in the EU country list for authorized establishments to export to the European Market. In addition from the contacts undertaken to the several institutions in the country (FiA; ISC; Camcontrol; MIH) seems that none has any clear documentation about the import requirements to each importing country except those related with the EU.

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Both UNIDO and the authors cannot assume any liability for the accuracy of this information, although it may be assumed as correct, due to the fact it fully depends on the information made available by the different sources and the actual application of the import/export criteria and procedures by the different country Authorities. In this respect the authors give as much as possible, all the links and sources of the information given, as it may also change or be updated in the meantime.

The document is therefore a guide for comprehensive understanding of the legal and SPS requirements of fishery products necessary for exporting to the set of countries here by identified.

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UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries VIETNAM section

VIETNAM Competent Authority: National Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD) http://www.nafiqad.gov.vn/?set_language=en&cl=en

1. Bilateral dispositions and Summary of import requirements A formal Bilateral Agreement signed between the exporting country and Vietnam is advisable for ease of the exports. Most exporting countries to Vietnam have signed a Bilateral Agreement covering this purpose, facilitating the food safety controls and guarantees of the exported products. Nevertheless the following requirements are applied: a) Establishment need to be registered and approved in terms of having implemented HACCP System (usually it is considered acceptable a lower level of HACCP compliance in comparison with EU approved establishments, when establishments are graded in terms of compliance performance) b) Processors must be on the Approved List of Cambodian FFP FBOs for Export to Vietnam as maintained on the website of Vietnam's National Agro-ForestryFisheries Quality Assurance Department (NAFIQAD). c) Products are exported with specific Health Certificate; Scope: the entire marine animals for human consumption, except amphibians and reptiles sea.

Summary of Vietnamese applicable Legislation: •

Circular No. 25/2010 / TT-BNNPTNT (8 April 2010) Guidelines on food hygiene and safety on the import of foodstuffs of animal origin.

• Circular No. 51/2010 / TT-BNNPTNT (8 September 2010) Changes / amendments to Circular No. 25/2010 / TT-BNNPTNT and Circular 06/2010 / TT-BNNPTNT. These are available at: http://www.nafiqad.gov.vn/b-legal-documents

2. Procedure for the Food Hygiene and Safety Inspection to Exporting Countries a) The National Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD) is the contact point in Vietnam for the export of fishery products into Vietnam. http://www.nafiqad.gov.vn/?set_language=en&cl=en It is in particular the contact point: - to receive Registration documents from Competent Authorities of exporting countries relating FHS conditions of FBOs registering to export to Vietnam; - communicate to adopt annual inspection plan with Competent Authorities of exporting countries and submit the Minister for establishment of inspection mission to exporting countries; - to publish lists of FBOs approved to export products of animal origin to Vietnam; to suspend FBOs to export to Vietnam; - communicate notifications on noncompliance cases, request to investigate non-compliance causes and establish corrective actions to Competent Authorities of exporting countries;

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-

to build up Pre-mission questionnaires for Competent Authorities of exporting countries; to set up and carry out inspection plans and programs to exporting countries to access their FHS control system and FBOs of products of animal origin.

b) Submission of application for exporting to Vietnam.

Competent authorities of exporting countries provide the National Agro-Forestry Fisheries Quality Assurance Department of Vietnam with the required registration documents, including: - List of food business operators registering to export products to Vietnam - Information on FHS control system and competencies of FHS Competent Authorities of exporting countries - Summary on FHS conditions of the food business operator For all requested documents, forms are available in the appendixes of Circular No. 25/2010, downloadable at: http://www.nafiqad.gov.vn/b-legal-documents c) Within 30 working days of receipt of completed registration document, the National Agro-Forestry-Fisheries Quality Assurance Department, together with the Department of Animal Health verify registration document, inform Competent Authorities of the exporting country of the verification result and inspection plan to the exporting country if necessary. d) Inspection items: 1. Legal system on food hygiene and safety control; 2. Competencies of FHS Competent Authorities of exporting countries; 3. FHS conditions of FBOs registering to export to Vietnam. e) Type of inspection: 1. Initial inspection to assess exporting countries’ FHS control system and their FBOs’ hygiene conditions for approval.

2. Follow-up inspection to check the on-going performance of FHS control system by exporting countries and of FHS conditions by approved FBOs. f)

Inspection reports and communication on list of FBOs approved for export to Vietnam: 1. When on-site inspection to the exporting country is considered unnecessary, the National Agro-Forestry-Fisheries Quality Assurance Department publishes the result of registration document checks, together with its list of FBO approved for export to Vietnam.

2. When on-site inspection to the exporting countries is considered necessary, within 30 working days after the inspection, the National Agro-ForestryFisheries Quality Assurance Department publishes the on-site inspection report, its list of FBOs approved for export to Vietnam.

When inspection result is not satisfactory, the National Agro-ForestryFisheries Quality Assurance Department informs Competent Authorities of exporting countries of the non-compliance.

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3. In case of request for additional FBOs approved to export to Vietnam, the Competent Authority of the exporting country submits additional registration document.

As the result of document check and/or on-site inspection to the exporting country, additional FBOs shall be approved to export to Vietnam or not. g) Inspection of products at the border. Products will be subject to inspection and random sampling for testing. Criteria are set out in the National Legislation. h) Actions in case of Non-compliance.

1. Non-compliant Products.

Depending on the seriousness of non-compliance, appropriate actions shall be applied to products: being re-dispatched or destroyed.

Competent Authority of the exporting country shall be required to investigate cause of non-compliance and apply corrective actions.

2. Non-compliant FBOs. Import suspension from non-compliant FBOs shall be applied to the FBOs where the result of follow-up inspection shows that the FBO’s food hygiene conditions have not fully met Vietnamese regulations.

The import suspension shall be lifted providing that the result of later followup inspection reflects the FBO’s compliance with Vietnamese regulations on food hygiene and safety.

3. Non-compliant Exporting Country.

Import suspension shall be applied to an exporting country when the result of follow-up inspection shows that the FHS control system of the country has not fully met Vietnamese regulations.

The import suspension shall be lifted providing that the result of later followup inspection reflects that the FHS control system of the exporting country has fully met Vietnamese regulations. i)

Charges for inspections to exporting countries.

Inspections to exporting countries are covered by the State Budget.

Inspection and supervision to imported products placed on the market is covered by the State Budget.

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Annex 1 This annex consists of “Appendix 3” of Circular No. 25/2010/TT-BNNPTNT issued by Vietnam's Ministry of Agriculture and Rural Development (MARD) - For Establishment Approval Fish processing establishments interested in being placed on the list of approved FBOs to export to Vietnam, must complete, date, and sign “Appendix 3” for submission to their national Competent Authority which will subsequently forward this information to NAFIQAD for review and approval. As NAFIQAD has up to 30 working days to complete its review, exporters should submit the completed Appendix 3 well in advance of the anticipated date of shipping products.

“Appendix 3” Summary on food hygiene and safety conditions of the food business operator 1. Business name: 2. Address: 3. Products: 4. Production conditions (production chain and export)    

4.1 Farming and processing areas: 4.2 Farming, harvesting, preparation and processing methods: 4.3 Feed handling and control measures applied in farming process: 4.4 Packing (labeling), transport and distribution methods:

5. Quality management systems applied: Date: Name of establishment representative: Signature of establishment representative:

Explanatory notes to assist with completing this Appendix are outlined below: 1. Business name: Full legal name and registration number of federally registered establishment 2. Address: Provide mailing address 3. Products: Name/description of products that establishment processes for export to Vietnam; At minimum "fish and seafood products" 4. Production conditions (production chain and export) 4.1 Farming and processing areas: In case of prepared/processed foodstuffs, provide information describing the processing establishment 4.2 Farming, harvesting, preparation and processing methods: In case of processed foodstuffs, provide information on preparing/processing, packing and storage methods

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4.3 Feed handling and control measures applied in farming process: Not applicable to fish processing establishments 4.4 Packing (labeling), transport and distribution methods: Provide details about packaging and labelling procedures, transportation procedures (containers, destination and temperature controls) and distribution methods.

5. Quality management systems applied: Provide information regarding Quality Management Program Plan which is based on HACCP principles

2. Certificates Each shipment of fish and seafood products for human consumption intended for export to Vietnam must be accompanied at least by a Certificate of Origin and Hygiene of Cambodia along with one of the following certificates depending on the type of products being exported: For non-live fish for human consumption: Sanitary Certificate covering for fish and fishery Products; For live aquatic animals for human consumption: Aquatic Animal Health Certificate

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ANNEX 2 – Testing Criteria to be applied at border inspection

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UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries CHINA section

China Last information update: August 28, 2014 Competent Authorities:

 

General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) http://english.aqsiq.gov.cn/ Certification and Accreditation Administration of the People's Republic of China (CNCA).

1. Bilateral dispositions and summary of import requirements

A formal Bilateral Agreement signed between the exporting country and China is advisable for ease of the exports. Most exporting countries to China have signed a Bilateral Agreement covering this purpose, facilitating the food safety controls and guarantees of the exported products. Nevertheless the following requirements are applied. a. Establishment must be registered (has a registration number), not necessary based on product specifications b. Establishment unit has HACCP implemented (usually it is considered acceptable a lower level of HACCP compliance in comparison with EU approved establishments, when establishments are graded in terms of compliance performance). c. Products are exported with specific Health Certificate; (Imposition of appropriate regulatory models includes new HC - 135 June 25, 2012). d. Products conform with

2. Establishment Registration and Listing Except in the case of establishments that ship live product only, the fish processing establishment's name must appear on the list of establishments of the exporting country for exports to the People`s Republic of China. To be included on this list: processing establishments and cold storage warehouses.

For any exports to the People’s Republic of China two separate registration processes must be carried out in advance of exporting any fishery products to this destination.

This involves separate registrations with two Chinese authorities as follows, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the Certification and Accreditation Administration of the People's Republic of China (CNCA).

Registration with the AQSIQ must be carried out by the exporter / agent themselves while registration with the CNCA can be carried out through the exporting country Competent Authority.

Since the 1st of October 2012 China’s AQSIQ has introduced a system requiring the registration with its Inspection and Quarantine Bureau of exporters of food products to China. This registration process can be carried out online by the relevant exporter/agent through their website: http://ire.eciq.cn In case of registration through the exporting country Authority, information required as part of this process includes exporter / agent’s name, address details, contact details, relevant food category, Chinese trade partner details etc. p. 16 / 119

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A separate registration process is required for fish and fishery products processed at processing establishments or stored at cold storage warehouses to be eligible for export to the People's Republic of China, as of the 1st of May 2013.

These establishments and warehouses must be registered with the CNCA, and subsequently appear on the List of the exporting country establishments approved for export to the People's Republic of China as maintained by the CNCA.

3. Certificate issuance For fresh and frozen products including bivalve molluscan shellfish, the certificate should include:    

Under Section II. Origin of the fishery products, "Production place" should be completed by identifying the appropriate Regional Area if applicable.

For all wild caught fish, the name and registration number of one of the fishing vessels used to harvest the fish as well as the FAO fishing area must be provided on the certificate.

For all aquaculture fish, the name and address of one of the fish farms where the fish were raised must be provided on the certificate.

Under Section II. Origin of the fishery products, "Name(s), registration number(s) and address(es) of producing and processing enterprise(s), factory vessel(s), cold store(s) or freezer vessel(s) registered by the Cambodian Competent Authority for export to the People's Republic of China," identifying all which are applicable (i.e. the processor and the cold storage).

For live product, including live bivalve molluscan shellfish: Origin and Hygiene Certificate for live fish intended for export for human consumption from Canada to the People's Republic of China (CFIA/ACIA 5584). 



For all live bivalve molluscs, under Section II. Origin of the fishery products, the FAO fishing area and the harvest area must be provided in the space under the heading "Fishing Region". For Cambodian harvest areas, the harvest areas must be indicated as they appear on the List to be done for designating the Cambodian bivalve harvest areas.

Under Section II. Origin of the fishery products, "Name(s), registration number(s) and address(es) of producing and processing enterprise(s), factory vessel(s), cold store(s) or freezer vessel(s) registered by the CA for export to the People's Republic of China," identify all which are applicable.

4. Chemical Contaminants Tolerances and Guidelines Maximum level of contaminants in fish products: 

Lead: 0.5 ppm



Mercury: 1.0 ppm (for carnivores)



Mercury: 0.5 ppm (other fish)



Inorganic arsenic: 0.1 ppm for finfish / 0.5 ppm for all other fish



Cadmium: 0.1 ppm (finfish only) p. 17 / 119

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

Total PCB: 2.0 ppm (sum of PCB congeners #28, 52, 101, 118, 138, 153 and 180)



PCB 138: 0.5 ppm



PCB 153: 0.5 ppm

List of Tolerances and Guidelines for Therapeutants and Antibiotics Item

Products

Standard

Chloramphenicol

Aquaculture and wild caught fresh water fish

None Detected

Crystal Violet (and Leucocrystal violet)

Aquaculture and wild caught fresh water fish

None Detected

Furazolidone

Not specified

None detected

Malachite Green (and Leucomalachite green)

Aquaculture and wild caught fresh water fish

None detected

Nitrofurans

Aquaculture and wild caught fresh water fish

None Detected

Quinolones

Aquaculture and wild caught fresh water fish

= 0.1 mg/kg

Stilbestrol

Not specified

None detected

Sulfonamide

Aquaculture and wild caught fresh water fish

= 0.1 mg/kg

Terramycin

Not specified

= 0.1mg/kg muscle

Uritrate (Oxolinic Acid)

Eels

= 0.3 mg/kg muscle and skin

(1 mg/kg = 1 ppm)

5. Microbiological Criteria Non official information available. However from the practice within other exporting countries to China the following has been considered: -

Application of Codex Standards;

-

Absence / negative testing of: E.coli (0157); Salmonella; Listeria monocytogenes, Vibrio parahaemolyticus; Vibrio Cholerae.

6. Other Information

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Further information on import requirements can be obtained from the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. (http://english.aqsiq.gov.cn/) Exporters should carefully discuss regulations and their application with Chinese importers to ensure that their interpretation of the regulations is accurate.

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Annex 1. General Background Food Hygiene Law of the People's Republic of China 2007-09-05

http://english.aqsiq.gov.cn/LawsandRegulations/allenglish/200709/t20070905_3 8073.htm see full document below Emphasize for background understanding of imported foods: Article 30 Imported foods, food additives and containers, packagings, utensils and equipment used for food must comply with the national hygiene standards and the hygiene control regulations.

The above-mentioned imports shall be subject to hygiene supervision and inspection by the frontier agencies for hygiene supervision and inspection of imported food. Only those proved to be up to the standards through inspection shall be allowed to enter the territory. The Customs authorities shall grant clearance of goods on the strength of the inspection certificate.

When declaring such products for inspection, the importer shall submit the relevant data and inspection reports on the pesticides, additives, fumigants and other such substances used by the exporting country (region).

The imports mentioned in the first paragraph shall be subject to inspection in accordance with the national hygiene standards. In the absence of the national hygiene standards for such imports, the importer must provide the hygiene evaluation data prepared by the health authorities or organization of the exporting country (region) to the frontier agencies for hygiene supervision and inspection of imported food for examination and inspection and such data shall also be reported to the administrative department of public health under the State Council for approval.

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Food Hygiene Law of the People's Republic of China

2007-09-05

(Adopted at the 16th Meeting of the Standing Committee of the Eighth National People's Congress on October 30, 1995, promulgated by Order No. 59 of the President of the People's Republic of China on October 30, 1995, and effective as of the date of promulgation) Contents Chapter I General Provisions Chapter II Food Hygiene Chapter III Hygiene of Food Additives Chapter IV Hygiene of Containers, Packagings, Utensils and Equipment Used for Food Hygiene Control Chapter V Formulation of Food Hygiene Standards and Measures for Food Hygiene Control Chapter VI Food Hygiene Control Chapter VII Food Hygiene Supervision Chapter VIII Legal Responsibility Chapter IX Supplementary Provisions Chapter I General Provisions Article 1 This Law is enacted for the purpose of ensuring food hygiene, preventing food contamination and harmful substances from injuring human health, safeguarding the health of the people and improving their physical fitness.

Article 2 The State institutes a system of food hygiene supervision.

Article 3 The administrative department of public health under the State Council shall be in charge of supervision and control of food hygiene throughout the country.

Other relevant departments under the State Council shall, within the scope of their respective functions and duties, be responsible for control of food hygiene.

Article 4 Whoever engages in food production or marketing within the territory of the People's Republic of China must observe this Law. This Law applies to all foods and food additives as well as containers, packagings, utensils and equipment used for food, detergents and disinfectants; it also applies to the premises, facilities and environment associated with food production or marketing. p. 21 / 119

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Article 5 The State encourages and protects the social supervision exercised by public organizations and individuals over food hygiene.

Any person shall have the right to inform the authorities and lodge a complaint about any violation of this Law. Chapter II Food Hygiene Article 6 Food shall be nontoxic and harmless, conform to proper nutritive requirements and have appropriate sensory properties such as colour, fragrance and taste.

Article 7 Principal and supplementary foods intended specially for infants and preschool children shall conform to the nutritive and hygienic standards promulgated by the administrative department of public health under the State Council.

Article 8 In the process of food production or marketing, the requirements for hygiene stated below shall be conformed to: (1) The environment inside and outside any food production or marketing establishment shall be kept clean and tidy; measures shall be taken to eliminate flies, rodents, cockroaches and other harmful insects and to remove conditions for their propagation; and a prescribed distance shall be kept from any toxic or harmful site; (2) An enterprise engaged in food production or marketing shall have workshops or other premises for the preparation of raw materials and for processing, packing and storage that are commensurate with the varieties and quantities of the products handled; (3) Appropriate facilities shall be made available for disinfectants, changing clothes, toilet, natural and artificial light, ventilation, prevention of spoilage, protection against dust, elimination of flies and rodents, washing of equipment, sewage discharge and the containment of garbage and other wastes; (4) The layout of installations and the application of technological processes shall be rational in order to prevent contamination between foods to be processed and ready-to-eat foods, and between raw materials and finished products; food must not be placed in contact with any toxic substance or filth; (5) Tableware, kitchenware and containers for ready-to-eat foods must be cleaned and disinfected prior to use; cooking utensils and other utensils must be washed after use and kept clean; (6) Any containers, packagings, utensils and equipment used for the storage, transportation, loading and unloading of food as well as the conditions under which these operations are carried out must be safe, harmless and kept clean in order to prevent food contamination; (7) Ready-to-eat foods shall be kept in small packets or in nontoxic, clean packaging materials; p. 22 / 119

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(8) All persons involved in food production or marketing shall maintain a constant standard of personal hygiene, taking care to wash their hands thoroughly and wear clean work clothes and headgear while preparing or selling food; also, proper utensils must be used when selling ready-to-eat foods; (9) Any water used must conform to the national hygiene standards for drinkingwater in urban and rural areas; (10) The detergents and disinfectants used shall be safe and harmless to human health.

The hygienic requirements for food production or marketing undertaken by food vendors and persons engaged in the food business in urban and rural markets shall be formulated specifically according to this Law by the standing committees of the people's congresses in the provinces, autonomous regions, or municipalities directly under the Central Government.

Article 9 The production and marketing of foods in the following categories shall be prohibited: (1) foods that can be injurious to human health because they are putrid or deteriorated, spoiled by rancid oil or fat, moulded, infested with insects or worms, contaminated, contain foreign matter or manifest other abnormalities in sensory properties; (2) foods that contain or are contaminated by toxic or deleterious substances and can thus be injurious to human health; (3) foods that contain pathogenic parasites, microorganisms or an amount of microbial toxin exceeding the tolerance prescribed by the State; (4) meat and meat products that have not been inspected by the veterinary health service or have failed to pass such inspection; (5) poultry, livestock, game and aquatic animals that have died from disease, poisoning or some unknown cause, as well as products made from them; (6) foods contaminated by use of filthy or seriously damaged containers or packages, or filthy means of conveyance; (7) foods that impair nutrition or health because they are adulterated or misbranded; (8) foods processed with non-food raw materials; foods mixed with non-food chemical substances, or non-food stuffs used as food; (9) foods that has expired the date for guaranteed quality; (10) foods of which the sale has been specifically prohibited, for the prevention of diseases or other special reasons, by the administrative department of public health under the State Council or by the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government; (11) foods that contain additives not approved for use by the administrative department of public health under the State Council or residues of pesticides exceeding the tolerance prescribed by the State; and

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(12) other foods that do not conform to the standards and requirements for food hygiene.

Article 10 Food must not contain medicinal substances, with the exception of those materials that have traditionally served as both food and medicaments and are used as raw materials, condiments or nutrition fortifiers.

Chapter III Hygiene of Food Additives Article 11 The production, marketing and use of food additives must conform to the hygiene standards for use of food additives and the hygiene control regulations; the food additives that do not conform to the hygiene standards and the hygiene control regulations may not be marketed and used.

Chapter IV Hygiene of Containers, Packagings, Utensils and Equipment Used for Food Article 12 Containers, packagings, utensils and equipment used for food must conform to the hygiene standards and the hygiene control regulations.

Article 13 The raw materials for making containers, packagings, utensils and equipment used for food must meet hygiene requirements. The finished products should be easy to clean and disinfect.

Chapter V Formulation of Food Hygiene Standards and Regulations for Food Hygiene Control Article 14 The administrative department of public health under the State Council shall formulate or approve and promulgate the national hygiene standards, hygiene control regulations and inspection procedures for food, food additives, the containers, packagings, utensils and equipment used for food, the detergents and disinfectants used for washing food or utensils and equipment used for food, and the tolerances for contaminants and radioactive substances in food.

Article 15 If the State has not formulated hygiene standards for a certain food, the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government may establish local hygiene standards for that food and report them to the administrative department of public health under the State Council and the competent standardization administration department under the State Council for the record.

Article 16 Norms of significance to the science of health to be included in the national quality standards for food additives must be examined and approved by the administrative department of public health under the State Council. p. 24 / 119

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Appraisals on the safety for use of agricultural chemicals, such as pesticides and chemical fertilizers, shall be examined and approved by the administrative department of public health under the State Council.

Veterinary hygiene inspection procedures for slaughtered livestock and poultry shall be formulated jointly by the relevant administrative departments under the State Council and the administrative department of public health under the State Council.

Chapter VI Food Hygiene Control Article 17 The departments in charge of control of food production or marketing of the people's governments at various levels shall strengthen control of food hygiene and oversee the implementation of this Law. The people's governments at various levels shall encourage and support efforts to improve food processing technology so as to promote the improvement of hygienic quality of food.

Article 18 Enterprises engaged in food production or marketing shall improve their own system for food hygiene control, appoint full-time or part-time workers to control food hygiene and strengthen inspection of the foods they produce or market.

Article 19 The selection of sites and the designs for construction, extension or renovation projects of enterprises engaged in food production or marketing shall meet hygiene requirements, and the administrative department of public health must participate in the examination of those designs and in the inspection and acceptance of finished projects.

Article 20 Before starting production of new varieties of food or food additives with new resources, the enterprises engaged in their production or marketing must submit the data required for evaluation of the hygiene and nutrition of such products; before starting production of new varieties of containers, packagings, utensils or equipment used for foods, with new raw or processed materials, the enterprises engaged in their production or marketing must submit the data required for evaluation of the hygiene of such products. Before the new varieties mentioned above are put into production, it shall also be necessary to provide samples of the varieties and the matter shall be reported for examination and approval in accordance with the specified procedures for examining and approving food hygiene standards.

Article 21 Any standardized packaged food or food additive must, according to the requirements for different products, have the name of the product, the place of manufacture, the name of the factory, the date of manufacture, the batch number (or code number), the specifications, the formula or principal ingredients, the date of expiration for guaranteed quality, the method of consumption or use, and other such p. 25 / 119

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information indicated in the label of the package or the product description. The product description for any food or food additive shall not contain exaggerated or false advertising.

The label of the food package must be clearly printed and easy to read. Foods sold on domestic markets must have labels in the Chinese language.

Article 22 With regard to the food indicated to have specific health functions, the products and its description must be submitted to the administrative department of public health under the State Council for examination and approval; its hygiene standards and the measures for control of its production and marketing shall be formulated by the administrative department of public health under the State Council.

Article 23 The food indicated to have specific health functions may not be harmful for human health; the content of the product description shall be true, and the functions and ingredients of the product shall be identical with the information given in the product description andthere shall be no false information.

Article 24 Food, food additives and containers, packagings and other utensils used specially for food may be dispatched from factory or sold only after their producers have carried out inspection and found them to be up to the standards according to the hygiene standards and the hygiene control regulations.

Article 25 Whenever producers or marketers of food procure supplies, they shall, in accordance with the relevant State regulations, request inspection certificates or laboratory test reports and the supplier must provide these. The scopes and types of food that requires certificates shall be specified by the administrative department of public health of the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government.

Article 26 All persons engaged in food production or marketing must undergo an annual medical examination; persons newly employed or serving temporarily in this field must also undergo a medical examination and may not start work until they have obtained health certificates.

No persons suffering from dysentery, typhoid, viral hepatitis or other infectious diseases of the digestive tract (including pathogen carriers), active tuberculosis, suppurative or exudative dermatosis or any other disease incompatible with food hygiene, may be engaged in any work involving contact with ready-to-eat foods.

Article 27 Enterprises engaged in food production or marketing as well as food vendors must obtain a hygiene license issued by the administrative department of public health before they shall be permitted to apply for registration with the administrative departments of industry and commerce. No person who has not obtained a hygiene license may engage in food production or marketing. p. 26 / 119

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Food producers or marketers may not forge, alter or lend the hygiene license.

The measures for the issuance and control of hygiene licenses shall be worked out by the administrative departments of public health of the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government.

Article 28 Persons who run a food market of any type shall be responsible for the food hygiene control of the market, set up necessary public sanitary facilities in the market and maintain a good sanitary environment.

Article 29 The administrative departments of industry and commerce shall be responsible for the control of food hygiene on urban and rural markets; the administrative departments of public health shall be responsible for the supervision and inspection of food hygiene.

Article 30 Imported foods, food additives and containers, packagings, utensils and equipment used for food must comply with the national hygiene standards and the hygiene control regulations.

The above-mentioned imports shall be subject to hygiene supervision and inspection by the frontier agencies for hygiene supervision and inspection of imported food. Only those proved to be up to the standards through inspection shall be allowed to enter the territory. The Customs authorities shall grant clearance of goods on the strength of the inspection certificate.

When declaring such products for inspection, the importer shall submit the relevant data and inspection reports on the pesticides, additives, fumigants and other such substances used by the exporting country (region).

The imports mentioned in the first paragraph shall be subject to inspection in accordance with the national hygiene standards. In the absence of the national hygiene standards for such imports, the importer must provide the hygiene evaluation data prepared by the health authorities or organization of the exporting country (region) to the frontier agencies for hygiene supervision and inspection of imported food for examination and inspection and such data shall also be reported to the administrative department of public health under the State Council for approval.

Article 31 Foods for export shall be subject to hygiene supervision and inspection by the national inspection agency for import and export commodities.

The Customs authorities shall grant clearance of export commodities on the basis of the certificates issued by the national inspection agency for import and export commodities.

Chapter VII Food Hygiene Supervision

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Article 32 The administrative departments of public health of the local people's governments at or above the county level shall exercise their functions and duties for food hygiene supervision within the scope of their jurisdiction.

The agencies for food hygiene supervision set up by the administrative departments of railways and communications shall exercise their functions and duties for food hygiene supervision jointly prescribed by the administrative departments of public health under the State Council and other relevant departments under the State Council.

Article 33 The duties for food hygiene supervision shall be as follows: (1) to provide monitoring, inspection and technical guidance for food hygiene; (2) to contribute to the training of personnel for food production and marketing and to supervise the medical examination of such personnel; (3) to disseminate knowledge of food hygiene and nutrition, provide appraisals of food hygiene and publicize the existing situation in food hygiene; (4) to conduct hygiene inspection of sites selected or designs made for construction, extension or renovation projects of enterprises engaged in food production or marketing and participate in the inspection and acceptance of finished projects; (5) to undertake investigation of accidents involving food poisoning or food contamination and take measures of control; (6) to make supervision and inspection rounds to see whether any act is committed against this Law; (7) to pursue investigation of the responsibility of persons who violate this Law and impose administrative punishment on them according to law; and (8) to take charge of other matters that concern food hygiene supervision.

Article 34 The administrative departments of public health of the people's governments at or above the county level shall be manned with food hygiene supervisors. Such supervisors shall be qualified professionals and issued with such certificates by the administrative departments of public health at the corresponding levels.

The food hygiene supervisors appointed by departments in charge of railways and communications agencies shall be issued with the certificates by the competent authorities at a higher level.

Article 35 Food hygiene supervisors shall carry out the tasks assigned to them by the administrative department of public health.

Food hygiene supervisors shall enforce laws impartially, be loyal to their duties and may not seek personal gain by taking advantage of their office.

While carrying out their tasks, food hygiene supervisors may obtain information from the food producers or marketers, request necessary data, enter production or marketing premises to inspect them, and get free samples in accordance with p. 28 / 119

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regulations. The producers or marketers may not turn down such requests or hold back any information.

Food hygiene supervisors shall be obliged to keep confidential any technical data provided by the producers or marketers.

Article 36 The administrative department of public health under the State Council and those of the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government may, if the need arises, assign qualified units as units for food hygiene inspection; these units shall undertake food hygiene inspection and provide inspection reports.

Article 37 The administrative department of public health of the local people's governments at or above the county level may adopt the following temporary measures of control over the food producer or marketer when a food poisoning accident has occurred or when there is evidence of a potential food poisoning accident: (1) to seal up the food and its raw materials that have caused food poisoning or that are likely to cause food poisoning; (2) to seal up the contaminated utensils used for food and order the food producer or marketer to have them cleaned and disinfected.

The food that is found to be contaminated after inspection shall be destroyed, while the food that is found not contaminated shall be unsealed.

Article 38 The units where food poisoning accidents have occurred and the units that have admitted the victims for medical treatment shall, in addition to taking rescue measures, submit prompt reports to the local administrative departments of public health in accordance with relevant State regulations.

The administrative department of public health of a local people's government at or above the county level shall, upon receipt of such report, conduct prompt investigation and handle the matter and adopt control measures.

Chapter VIII Legal Responsibility Article 39 Whoever, in violation of this Law, produces or markets food which is not up to the hygiene standards, thus causing an accident of food poisoning or resulting in a disease caused by food-borne bacteria, shall be ordered to stop such production or marketing; the food causing such food poisoning or disease shall be destroyed; the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 1,000 yuan and not more than 50,000 yuan shall be imposed.

Whoever, in violation of this Law, produces or markets food which is not up to the hygiene standards, thus causing a serious accident of food poisoning or resulting in a p. 29 / 119

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disease caused by food-borne bacteria, and seriously harming human health, or adulterates food he produces or markets with toxic or harmful non-food raw materials, shall be investigated for criminal responsibility according to law.

If a person commits any of the acts mentioned in this Article, his hygiene license shall be revoked.

Article 40 If anyone, in violation of this Law, engages in food production or marketing without obtaining a hygiene license or with a forged hygiene license, such production or marketing shall be banned; the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal income shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 500 yuan and not more than 30,000 yuan shall be imposed. If anyone alters or lends his hygiene license, his hygiene license and the illegal gains shall be confiscated; and a penalty of not less than one time and not more than three times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 500 yuan and not more than 10,000 yuan shall be imposed.

Article 41 If, in violation of this Law, any food producer or marketer does not comply with the hygiene requirements, he shall be ordered to set it right and given a disciplinary warning, and a penalty of not more than 5,000 yuan may be imposed; if he refuses to set it right or other serious circumstances are involved, his hygiene license shall be revoked.

Article 42 If anyone, in violation of this Law, produces or markets food the production and marketing of which is prohibited, he shall be ordered to stop producing or marketing such food, a public announcement shall be made immediately to recall the sold food and the food shall be destroyed; the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 1,000 yuan and not more than 50,000 yuan shall be imposed; if the offence is serious, the offender's hygiene license shall be revoked.

Article 43 If anyone, in violation of this Law, produces or markets the principal and supplementary foods intended specially for infants and preschool children which do not conform to the nutritive and hygiene standards, he shall be ordered to stop producing and marketing such foods, a public announcement shall be made immediately to recall the sold foods and the foods shall be destroyed; the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 1,000 yuan and not more than 50,000 yuan shall be imposed; if the offence is serious, the offender's hygiene license shall be revoked.

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Article 44 If anyone, in violation of this Law, produces, markets or uses the food additives, food containers, packagings, utensils and equipment used for food as well as the detergents and disinfectants which do not conform to the hygiene standards and the hygiene control regulations, he shall be ordered to stop producing and using them; the illegal gains shall be confiscated and a penalty of not less than one time and not more than three times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not more than 5,000 yuan shall be imposed.

Article 45 If anyone, in violation of this Law, produces or markets the food indicated to have specific health functions without examination and approval by the administrative department of public health under the State Council, or if the product description of such food provides false information, he shall be ordered to stop producing or marketing such food, the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 1,000 yuan and not more than 50,000 yuan shall be imposed; if the offence is serious, the offender's hygiene license shall be revoked.

Article 46 If anyone, in violation of this Law, does not indicate or falsely indicates specified matters such as the date of manufacture and the date of expiration for guaranteed quality in the labels of packages of the standardized packaged food or food additives or in the product descriptions, or in violation of the regulations, does not have labels in the Chinese language, he shall be ordered to set it right and a penalty of not less than 500 yuan and not more than 10,000 yuan may concurrently be imposed.

Article 47 If a food producer or marketer, in violation of this Law, engages in food production or marketing without obtaining a health certificate, or if the producers or marketers who suffer from diseases and may not contact with ready-to-eat foods are not transferred to other posts according to relevant regulations, they shall be ordered to set it right and a penalty of not more than 5,000 yuan may be imposed.

Article 48 If anyone, in violation of this Law, causes an accident of food poisoning or a disease engendered by food-borne bacteria or causes harm to another person by other acts against this Law, he shall bear the civil liability for compensation according to law.

Article 49 The administrative punishment provided in this Law shall be decided by the administrative department of public health of a local people's government at or above the county level. Other authorities exercising the power of food hygiene supervision as provided by this Law shall, within the stipulated scope of functions and duties, make decisions on administrative punishment in accordance with the provisions of this Law. p. 31 / 119

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Article 50 If a party is not satisfied with the decision on administrative punishment, he may, within 15 days from receipt of the notice of punishment, apply for reconsideration to the organ at the next higher level over the one that has made the decision. The party may also directly bring a suit in a People's Court within 15 days from receipt of the said notice.

The reconsideration organ shall, within 15 days from receipt of the application for reconsideration, make a reconsideration decision. If the party concerned is not satisfied with the reconsideration decision, he may, within 15 days from receipt of the reconsideration decision, bring a suit in a People's Court.

If a party neither applies for reconsideration, nor brings a suit in a People's Court within the time limit, nor execute the decision on administrative punishment, the organ that has made the decision may apply to a People's Court for compulsory execution.

Article 51 If an administrative department of public health, in violation of this Law, issues hygiene licenses to producers or marketers not meeting the requirements, the persons who are directly responsible for the offence shall be given administrative sanctions; those who accept bribes, if the case constitutes a crime, shall be investigated for criminal responsibility in accordance with law.

Article 52 Food hygiene supervisors and administrators who by abusing their power, neglecting their duties or engaging in malpractice for personal gain, cause a major accident, which constitutes a crime, shall be investigated for criminal responsibility in accordance with law; if the offence does not constitute a crime, the offender shall be given administrative sanctions according to law.

Article 53 Whoever prevents, by force or intimidation, food hygiene supervisors or administrators from performing their duties according to law shall be investigated for criminal responsibility in accordance with law; whoever prevents or obstructs, without resorting to force or intimidation, food hygiene supervisors or administrators from performing their duties according to law shall be punished by the public security organs in accordance with the Regulations on Administrative Penalties for Public Security.

Chapter IX Supplementary Provisions Article 54 For the purpose of this Law, the definitions of the following terms are: "Food" means any finished product or raw materials provided for people to eat or drink, as well as any product that has traditionally served as both food and medicament, with the exception of products used solely for medical purposes. "Food additive" means any synthetic compound or natural substance put into food to improve its quality, color, fragrance or taste, or for the sake of preservation or processing.

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"Food fortifier" means any natural or artificial food additive belonging to the category of natural nutrients that is put into food to increase its nutritive value.

"Containers and packagings use for food" means products of various materials including paper, bamboo, wood, metal, enamelware, ceramics, plastics, rubber, natural fibres, synthetic fibres and glass that are used to wrap or contain food, as well as paints or coatings that come in direct contact with food.

"Utensils and equipment used for food" means apparatus including machinery, piping, conveyor belts, containers, utensils and tableware that come in direct contact with food in the course of food production or marketing.

"Food production or marketing" means all operations in the production of food (other than planting and breeding) and activities such as the gathering, purchase, processing, storage, transport, display, supply and sale of food.

"Producers or marketers of food" means all units or individuals involved in food production or marketing, including workers' dining halls and food vendors.

Article 55 Measures for the administration of food for export shall be formulated separately by the national import and export commodities inspection department in conjunction with the administrative department of public health and other relevant administrative departments under the State Council.

Article 56 Hygiene control measures for food specially used or supplied for its own use by the Army shall be formulated by the Central Military Commission in accordance with this Law. Article 57 This Law shall come into force as of the date of promulgation. The Food Hygiene Law of the People's Republic of China (for trial implementation) shall be annulled on the same date.

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UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries HONG KONG section

Hong Kong Last information update: 2014-09-24

Competent Authority: Food and Environmental Hygiene Department http://www.fehd.gov.hk/

1. Certification Requirements Products Cooked Prior to Consumption: Certification of air-freighted shipments using a Certificate of Origin and Hygiene will expedite customs clearance.

Products Destined for Raw Consumption (e.g., molluscan shellfish): Certificate of Origin and Hygiene.

Live Crustacea (i.e., lobster and crabs): Shipments of live lobster must be accompanied by a Statement of Inspection (for non-registered plants) or a Certificate of Origin and Hygiene.

2. Hong Kong Acts and Regulations Food Hygiene Code: Food and Environmental Hygiene Department, Safe Food and Public Health http://www.fehd.gov.hk/english/publications/code/code_index.htm

3. Tolerances or Guidelines

Environmental Contaminants - Maximum level permitted in applicable fish products Metal

Applicable Fish Products

Maximum level permitted (in ppm)

Antimony

All fish products excluding molluscs and crustaceans other than crab, oyster, prawn and shrimp

1

Arsenic

All fish products (excluding molluscs and crustaceans) in solid form

6

Arsenic

All fish products in liquid form

0.14

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Arsenic

All shellfish products (molluscs and crustaceans) in solid form

10

Arsenic

Marine mammals (seals)

1.4

Cadmium

All fish products excluding molluscs and crustaceans other than crab, oyster, prawn and shrimp

Cadmium

Marine mammals (seals)

Chromium

All fish products excluding molluscs and crustaceans other than crab, oyster, prawn and shrimp

1

Lead

All fish products in liquid form

1

Lead

All fish products in solid form

6

Mercury

All fish products

0.5

Tin

All fish products

230

2

0.2

The following hormones are prohibited for use in all fish products: dienoestrol, diethylstilboestrol, hexoestrol and oestradiol.

Fish products exported to Hong Kong cannot contain preservatives or antioxidants unless specified in the following table.

Preservatives which are permitted in the following Fishery Products only

Fishery Product

Fish ball, fish cake, and dried shredded fish

Preservative

 

Sorbic acid / Sodium sorbate / Potassium sorbate / Calcium sorbate Benzoic acid / Sodium benzoate / Potassium Benzoate / Calcium benzoate

Maximum level permitted

1000 ppm

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   Fish sauce

Fish sauce

Methyl para-hydroxybenzoate Ethyl para-hydroxybenzoate Propyl para-hydroxybenzoate

Sulphur dioxide / Sulphurous acid / Sodium sulphite / Sodium hydrogen sulphite / Sodium metabisulphite / Potassium sulphite / Potassium metabisulphite / Calcium sulphite / Calcium hydrogensulphite 

350 ppm

Benzoic acid / Sodium benzoate / Potassium Benzoate / Calcium benzoate Methyl para-hydroxybenzoate Ethyl para-hydroxybenzoate Propyl para-hydroxybenzoate

800 ppm

Gelatin

Sulphur dioxide / Sulphurous acid/ Sodium sulphite/ Sodium hydrogen sulphite/ Sodium metabisulphite / Potassium sulphite/ Potassium metabisulphite/ Calcium sulphite/ Calcium hydrogensulphite

1000 ppm

Gelatin capsules

Sorbic acid / Sodium sorbate / Potassium sorbate / Calcium sorbate

3000 ppm

  

Oyster sauce

    

Prawn, shrimp and scampi

Shrimp paste

Benzoic acid / Sodium benzoate / Potassium Benzoate / Calcium benzoate Methyl para-hydroxybenzoate Ethyl para-hydroxybenzoate Propyl para-hydroxybenzoate Sorbic acid / Sodium sorbate / Potassium sorbate / Calcium sorbate

Sulphur dioxide / Sulphurous acid / Sodium sulphite / Sodium hydrogen sulphite / Sodium metabisulphite / Potassium sulphite / Potassium metabisulphite / Calcium sulphite / Calcium hydrogensulphite    

Benzoic acid / Sodium benzoate / Potassium Benzoate / Calcium benzoate Methyl para-hydroxybenzoate Ethyl para-hydroxybenzoate Propyl para-hydroxybenzoate

1000 ppm

200 ppm (in the edible part)

1000 ppm

4. Other Information For further information please contact the importer/client in Hong Kong.

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Further details on the restrictions concerning the sale of food containing preservatives or antioxidants are available from the Hong Kong Food and Environmental Hygiene Department (http://www.gov.hk/en/residents/health/hosp/#/en/residents/health/foodsafe/ )

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UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries KOREA section

Korea (South) Competent Authority KFDA (Korea Food and Drug Administration) - Imported Agricultural Products, Processed Foods, Food Additives, Utensils, Containers & Packages or Health Functional Foods: (http://www.mfds.go.kr/eng/index.do NFIS (National Fisheries Products Quality Inspection Service) - Imported Marine products (Fresh, chilled, frozen, salted, dehydrated, eviscerated marine produce which can be recognized its characteristics)

1. Bilateral dispositions and summary of import requirements A formal Bilateral Agreement signed between the exporting country and Korea is advisable for ease of the exports. Most exporting countries to Korea have signed a Bilateral Agreement covering this purpose, facilitating the food safety controls and guarantees of the exported products. Nevertheless the following requirements are applied. a. Establishment must be registered (has a registration number), not necessary based on product specifications; b. Schedule for registration number within the following registration period: the second week of March, June, October and December; c. Establishment unit has HACCP implemented (usually it is considered acceptable a lower level of HACCP compliance in comparison with EU approved establishments, when establishments are graded in terms of compliance performance). d. Products are exported with specific Health Certificate; e. Establishments are annually inspected by CA of Korea; f. HACCP and sanitary program consistently implemented and in accordance with the requirements laid down in Codex Code of Practice for Fish and Fishery Products (CAC/RCP 52-2003).

See detailed description of import system into Korea in annex.

2. Tolerances or Guidelines (Last information update: April 22, 2013) Contaminant

Levels by product type

Cadmium:

  

Copper Zinc

2.0 ppm - for molluscs 1.0 ppm - for crustaceans, except swimming blue crab (Portunus trituberculata) with intestines 5.0 ppm - swimming blue crab (Portunus trituberculata) with intestines 

60.0 ppm



40.0 ppm

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

Lead



1.0 ppm - for crustaceans, except swimming blue crab (Portunus trituberculata) with intestines 2.0 ppm - swimming blue crab (Portunus trituberculata) with intestines 0.3 ppm - all other products



0.5 ppm - except for shark, tuna and grouper



Mercury

Antibiotics are prohibited.

Food Additives Approved  

Redfish: Sustane Emulsion T Antioxidant composed of Butylated hydroxytoluene.

Frequency of sampling and testing South Korea's new government regulations “Special Inspections on Imported Fishery Products in 2014” imposes mandatory specific frequencies of sampling and testing of fish products according to the substance / contaminant and the country of provenience of the imported products, namely:  Nitrofuran  Chloramphenicol  Carbonmonoxide  Sulphurdioxide  Benzopyrene (smoked fish products)

Further information can be obtained from the Korean Food and Drug Administration (http://www.mfds.go.kr/eng/index.do) See also annex: for the description of the import system.

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Annex 1. Detailed description of Import System into Korea Source: http://www.mfds.go.kr/eng/index.do?nMenuCode=67 Information Update: unavailable 1. Imported Food Safety According to the Food Import and Export Statistics (Korea Agro-Fisheries & Food Trade Corporation, 2009), South Korea's dependence on imported food is 65% compared to the total calories and more than 80% of processed food ingredients are imported from abroad.

In addition, as the FTA including South Korea-United States, South Korea-EU etc. proportion of food imports is expected to increase gradually and importance of food import control has embossed increasingly.

Therefore, Korean Food and Drug Administration has been trying to ensure the safety of imported foods including to strengthen safety control for local manufacturing plants in the exporting countries and conduct customs clearance inspection of imported food through real-time information collection and analysis etc.

Responsibility for imported foods inspection is performed by the Regional Food and Drug Administration (Seoul, Incheon, Busan, Daegu, Daejeon, Kwangju). The respective Regional Food and Drug Administration is checking and testing to determine whether conform to relevant criteria and standards with regard to standards for raw materials and food additives, foods labelling standards and MRLs for hazardous substances such as pesticides, veterinary drugs etc. for declared imported food (foods, foods additive, apparatus, containers and packages).

Guidelines for Import Procedure provides an overview of the national regulatory and policy requirements for the commercial importation of food into Korea.

On the other hand, KFDA has operating "Overseas Manufacturing Facility Registration System" that checks and registers hygiene status through field survey for food manufacturing and processing companies which is imported to South Korea and passes rapidly customs clearance by omitting inspection in whole or in part.

2. Onsite Inspection of Exporters' Facilities System Purpose For exporters with a track record of exporting below standard food, or those that have been found to contain hazardous materials, onsite inspections will be conducted at the manufacturers' facilities.

To identify causes of any food safety contingencies, recommend necessary measures, and ensure that they are implemented.

To enhance the safety of food imports in advance, by educating and promoting the ROK's food import system and food criteria & standards.

Background

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Problems that have arisen during the ROK based customs stage of inspections have prompted the implementation of onsite inspections during the manufacturing and processing stages to ensure the safety of food imports (Foreign Inspection Division was created on Apr. 30, 2009).

Parliamentary reviews in September 2005 raised serious issues with the Chinese kimchi incident where some shipments of kimchi originating from China were found contaminated with parasite eggs, ultimately leading to the implementation of onsite inspections of exporters' facilities beginning in 2006.

Legal Basis In the process of preparing relevant clauses within the Food Sanitation Act Outline Identifying of sanitation in manufacturing facilities Identification of causes of any inadequate elements or hazards in food products and taking necessary measures to prevent future problems Briefing session on food import management system (optional) Providing education and promotion (briefing session on food safety) to exporters on the Republic of Korea's food import system, food criteria & standards Discussions with relevant officials (optional) Exchange of information with exporting countries and their food safety management representatives, promotion of understanding on each other's food export import systems (discussions with government officials in relevant divisions) Criteria to select countries and businesses subject to onsite inspection Businesses targeted for inspection should first belong to those countries with a track record of exporting a significant volume of products in question and demonstrating frequent inadequate or hazardous materials contaminations. Plus, they need to fall into the following categories Businesses that have provided products repeatedly violating prescribed import criteria & standards, or containing hazardous materials Businesses manufacturing import- prohibited food or reported to have food safety problems Other businesses for which onsite inspections are deemed necessary

3. English Certificate of Food Export Purpose To assist food exporters selling domestically produced food, food additives, utensils or containers and packages at the request of importers Types of issued English Certificates

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Certificate of Health Certificate of Free Sale Certificate of Analysis Certificate of Manufacture Issuing Authority The KFDA and its six local offices Certified Contents: Certificate of Health verifies that a product is produced, manufactured, managed, and distributed meeting the requirements prescribed in the Food Sanitation Act Certificate of Free Sale verifies that a product is sold in domestic markets and manufactured to be exported without any restrictions Certificate of Analysis verifies that a product is manufactured meeting the criteria and standards prescribed in the Food Sanitation Act Certificate of Manufacture verifies that a product is manufactured, of which the raw materials and manufacturing methods are the same as specified in the product manufacturing report Methods used to verify authenticity and originality First enter (http://eng.kfda.go.kr) and fill in the Document Number followed by the Serial Number, you will then verify the authenticity of the Certificate The bar-code in the lower center also allows the document's authenticity verified when passed through a bar-code reader Certificate in foreign languages other than English Certificate is issued when an applicant fills in the required items and translate them into the language of the importing country and notarize and submit them

4. MOUs in Food Safety Area Purpose To enhance food safety capacities through cooperative efforts; by arranging for MOUs to be signed for the exchange of food safety information, expeditious investigation and identification of causes of food safety problems, implementation of measures to prevent future incidents, etc.

Contents Information exchange of laws and technologies regarding food safety and quality standards Prompt investigation of any food safety contingencies and implementation and publicization of necessary follow-up measures Cooperation to expedite onsite inspection of exporters' facilities p. 42 / 119

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Active provision of information of the other party's relevant systems; such as overseas certified public inspection agencies and registration for Prior Inspection Completion Current Status Invitation letters for MOUs have been sent to 6 countries: (Thailand, Vietnam, Philippines, Malaysia, Indonesia and Australia), as of June 10, 2008 MOU signed with China (General Administration of Quality Supervision, Inspection and Quarantine of P.R.C, China), Oct. 31, 2003 and revised on Nov. 26, 2007 MOU signed with Chile (Ministry of Public Health, Chile) Jun. 20, 2006 MOU signed with Vietnam (Ministry of Public Health, Vietnam) May. 29, 2009 MOU signed with China and Japan (Ministry of Public Health and Welfare (Korea), Ministry of Health (China), Ministry of Health, Labor and Welfare (Japan) ), Nov. 23, 2009 MOU signed with Australia and New Zealand (Food Standards Australia New Zealand), Jul.11,2011 Contact information If you are interested in signing MOUs with the KFDA, please contact the Foreign Inspection Division on Tel +43-719-2230

5. Good Importer Practice Purpose To ensure that safety guarantee outcomes are achieved by designating importers as a "good importer" and entrusting them with the first line of responsibility for the safety of food imports Purpose Article 20 of the Food Sanitation Act promulgated on August 7, 2009 Article 16 or Article 18 of the Enforcement Rule of the Food Sanitation Act promulgated on Aug. 12, 2009 The KFDA Notification 2009-152 (publicly announced on Aug. 9, 2009) Outline An importer that inspects sanitation procedures in exporters' facilities in advance shall be permitted to register as a good importe Application Procedure Inspect sanitation procedures in the exporter's facilities > apply to register > onsite sanitation inspection by the KFDA > register as a good importer 

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o

o

o

o o 

o

o o o o o o

Inspection Items Raw materials and their storage, facilities, process management, quality control of finished products and their storage, consumer information, and staff training for conducting sanitation inspections in accordance with the「Sanitation Inspection Items for Registering as a Excellent Import Business」 Incentives Exemption from random sampling inspections p. 44 / 119

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Fast-track administrative procedure Designated on KFDA homepages as a "good importer"

6. Registration for Prior Inspection Completion System Purpose To secure safety of food imports by preemptively identifying any food safety hazards in manufacturing and processing facilities either by; conducting onsite inspections or, requiring the exporting country government to administer inspections and report the results Legal Basis Article 19 of the Food Sanitation Act and Article 15 of its Enforcement Rule Article 8 of「The Health Function Food Act」and Article 11 of its Enforcement Rule Outline Qualification Food, food additives, utensils, containers, and packages to be exported to Korea ( agricultural and forestry food products and other food products made though simple processing are excluded) Health function food Application procedures Applying for registration for Prior Inspection Completion (required documents must be attached) > evaluation of documents > onsite inspection > final evaluation and determination > registration, notification Required documents Supporting documents with details of food products (product name, mixing ratio of ingredients, manufacturing process) Original test reports or test certificates issued by certified public test agencies based in the Republic of Korea or foreign countries Documents of addresses of manufacturing and processing facilities, building arrangement map (machinery, equipment layout included), factory floor plan, etc.

Inspection Items whether or not the products should be included in the sales prohibition list with safety hazards whether or not the product's criteria and standards are adequate whether or not the facilities meet prescribed minimum standards whether or not there are any false or misleading labels

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whether or not the product satisfies HACCP (Hazard Analysis Critical Control Point) standards Incentives Expedited customs clearance without close inspection and random sampling inspection Costs Application charge of KRW 28,000 Travel expenses for onsite inspectors (air fares, daily expenditure, lodging and meals in accordance with the ROK Public Officials' Travel Expense Guideline)

7. Analysis Certificate Laboratory Analysis Certificate  o

KFDA commissioner approves overseas laboratories after on-site inspection Certificate of analysis issued by overseas laboratories can be substituted for inspection at the border ☞ For Information of Approved Overseas Laboratories (www.kfda.go.kr) ☞ ENGLISH (an enhanced button at the top of the page) ※ Please check an operating country and scope of analysis for each laboratory

Details on Inspection of Imported Foods Same Product o   

Factors determining the same product from the same company Processed foods, food additives : importer·country of origin· manufacturer·product name·processing flow and every ingredients are identical Agricultural products : importer·country of origin·manufacturer· category of produce·exporter and packer are identical Utensils, containers & packages : importer·country of origin· manufacturer·food-contact material and color are identical

Type of Inspection 





Document Review (2 days) - Once the product conforms with standard as a result of laboratory test, the next consignment of the same product goes to document review - Ingredients for processing - Flavour(food grade) and utensils·containers made with woods or stones Sensory Test (3 days) - Once agricultural produce conforms with standard as a result of lab analysis, the next consignment of the same produce goes to sensory test - Any product which is required for checking characteristics(flavor, taste, color), storage, labelling and/or package Laboratory Test (10 days, 14 days for canned or retort foods) - The first import of a product p. 46 / 119

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

- The product with rejection record or risk information from various sources - In case that standards or specification has been changed<>/ Random Sampling Test (5 days) - Products are chosen by KFDA system according to annual random sampling plan

Please be reminded of when you report: Category of Foods     

Agricultural Products : fresh, chilled, dehydrated, frozen or minimally processed products Processed Foods Food Additives Utensils, Containers & Packages : in contact with foods or food additives Health Functional Foods

Purpose of Import  

For sale : registered importer can import foods for sale For processing : registered food manufacturer can import foods for processing

Address of Manufacturer / Processor  

It is required to state address of place where the product is actually manufactured or processed It is not admitted to state address of headquarter or distribution office

Ingredients, Components, Materials  o o

Foods : Name of every ingredients or components has to be stated.

Quantity of food additives has to be stated when the food additives have limitation in use in Korea Food Additive Code.

Utensils, Containers & Packages : Every food-contact materials has to be stated

Processing flow 

Processing flow and solvent / enzyme used have to be stated

Inspection Procedure for Imported Foods Foods or Health functional foods imported for commercial purposes

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



   o o o

Document Review(2days)

1. To review food import report, processing flow, ingredients 2. Labelling 3. To review attachment documents 

 o o o o

Sensory Test (3 days) Sensory test Check consignment information Whether labelling misleads consumer Storage temperature and condition 

 o o

Sensory Test

Laboratory Test

Laboratory Test (10days) Random Sampling Test(5days) Result p. 48 / 119

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Conform Reject Market release Return or discard

How to report Foods or Health functional foods imported for commercial purposes   o

You can access to UNI-PASS (http://portal.customs.go.kr) User Registration Business registration > Application for ID > Registration of certificate of authentication > Approval request ※ Anyone who requested for approval is expected to visit Customs Service.

Guide to import report for each category of foods You can access to (www.foodnara.go.kr/importfood)

Scope required for Food Import Report Foods or Health functional foods imported for commercial purposes Food Sanitation Act

Agricultural Products

Processed Foods

Food Additives

Utensils, Containers & Packages

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Food Sanitation Act

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UNIDO â&#x20AC;&#x201C; CEDEP II Legal and SPS requirements of fishery products of potential importing countries JAPAN section

Japan Last update: June 18, 2013 Competent Authority: Ministry of Health, Labour and Welfare

http://www.mhlw.go.jp/english/

A) Introduction Exports to Japan rely specifically on the import procedures to be taken in Japan by the importer. Food-related business operators including a person who intends to import foods that have been manufactured, processed, etc., in another country are required to recognize that they themselves bear primary responsibility for ensuring food safety, and to appropriately take necessary measures to ensure food safety at each stage of the food supply process. Moreover, under Article 3 paragraph 1 of the Food Sanitation Law (Law No. 233 of 1947;), they are also required to take responsibility for obtaining necessary knowledge and techniques, ensuring the safety of raw materials, practicing self-imposed examination and taking any other measures to ensure the safety of imported foods, etc.

The Imported Foods Monitoring and Guidance Plan sets out basic matters for guidance to importers based on these responsibilities, and promotes the practice of hygiene control. However, owing to recent cases of chemical food poisoning, etc., it has now become necessary to ensure and confirm the safety of imported processed foods in the exporting country to a level equivalent to that within Japan, at all stages of the food supply process including raw materials, manufacturing and processing, storage and transportation.

B) Summary of Requirements imposed to the Japanese importer These requirements are important to understand in the sense they will therefore identify what will be indirectly imposed also to the exporter.

1. Food is manufactured and processed in compliance with the laws and regulations of the exporting country. In particular, when there is a system of registration of manufactory, a system of permission for product exports, or other such system in the exporting country, that these are properly observed.

2. That the standard of establishments, facilities and equipment of the manufactory is at least equal to the standards concerning establishments, facilities and equipment stipulated in related Japanese laws and ordinances, etc.

3. That the standard of hygiene control in manufactory is at least equal to the following standards concerning hygiene control stipulated in related Japanese laws and ordinances, etc. It should be noted that using methods of hygiene control based on HACCP system is also effective, and the active introduction of these is recommended. a. Hygiene control in the harvesting of fishery products b. Hygiene control in food handling establishments, etc.

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c.

Hygiene control by food handlers and others in food handling establishments, etc.

d. Training for food handlers and others in food handling establishments, etc.

Specific References: - Guidelines on Management and Operation Standards to be Observed by Food-Related Business Operators (Annex to Notice Shoku-an No. 0227012 of February 27th, 2004; hereinafter “Guidelines on Management and Operation Standards”) (PDF:33KB) - Procedure for Implementation of the Total Hygiene Controlled Manufacturing Process Approval System (Annex to Notice Sei-ei No. 1634 of November 6th, 2000) (Under translation) - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 4-2003)(PDF:115KB) - Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application (Annex to CAC/RCP 1-1969, Rev. 4-2003)(PDF:73KB) 4. Importers should confirm the following matters with manufacturers at the stage of accepting raw materials.

4.1 That quality criteria including Specification and Standards based on Japanese Law have been established for each raw material, and that it has been confirmed that each delivery lot complies with these. Specifically, importers should aim to procure raw materials for which the use of agricultural chemicals, veterinary drugs and other production materials, etc., is clear from contracts or other documentation shared with specific producers or vendors. Meanwhile, basic matters for confirmation in accordance with the characteristics of raw materials are mainly those shown below. a) Foods in general (universal matters) 



    

That, when harvesting agricultural, livestock and fishery products to be used as raw materials, measures are taken to prevent contamination by dirt or wastewater, as well as measures to prevent contamination by agricultural chemicals, veterinary drugs, feedstuffs, fertilizers, faecal and others, by appropriately managing poisonous substances, wastes, etc.

That, when harvesting, storing and transporting agricultural, livestock and fishery products to be used as raw materials, measures are taken to prevent contamination by rodents, insects, chemicals, foreign matter, micro-organisms, etc.

That additives for which there is no designation based on Japanese Law have not been used.

That additives that do not comply with Specification and Utilization Standards based on Japanese Law have not been used, and that the appropriate amount have been used.

In the case of fresh vegetables, fish and shellfish, etc., that no colorants or other additives that may mislead consumers in the determination of quality or freshness are used.

That compositional standards, manufacturing and processing standards, and other Specification and Standards based on Japanese Law have been met.

That sterilization or other processes using irradiation not permitted in Specification and Standards based on Japanese Law have not been conducted. p. 52 / 119

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

That the formal names, composition, and other details of raw materials and additives used are clearly notified.

That drug substances specified in Pharmaceutical Affairs Law have not been included (Law No. 145 of 1960).

That the history of food use, etc. in the exporting country is available.

 

b) Fishery products and products processed from them 

That measures are taken to prevent contamination by Vibrio parahaemolyticus and other pathogenic micro-organisms.

That shellfish are caught in seas in which shellfish poisoning is appropriately monitored.

That species of blowfish are those whose import is permitted.

That measures are taken, through identification of fish species, to prevent contamination by other species of blowfish.

That measures are taken to confirm the sea area subject to catches and, through proper identification of fish species, to prevent contamination by poisonous fish.

That the use of veterinary drugs and feed additives has been confirmed.

That maximum residue limits for veterinary drugs and feed additives based on Japanese Law have been met.

     

That the matters listed in above have been confirmed by regular tests, inspections, etc c) No raw materials should be accepted if it is known to contain parasites, pathogenic micro-organisms, poisonous substances, decomposed matter, deteriorated matter or foreign matter which would not be eradicated or removed to an acceptable level by normal processing, cooking, etc.

4.2 When the monitoring results carried out by an administrative organ or other body in the exporting country are available, importers should confirm the results, but should also import samples and confirm said results by means of tests and inspections inside Japan whenever necessary.

4.3 That each raw material has been subjected to appropriate lot management 5. Importers should confirm the following matters with manufacturers at the stages of manufacturing and processing products.

5.1 That a system of control has been arranged to ensure that food can be manufactured and processed under a hygienic condition. As measures for preventing contamination by poisonous or harmful substances, in particular, that the following matters are thoroughly observed. a. Hygiene control of establishments, facilities and equipment, etc. b. Measures against rodents and insects c.

Handling of wastes and waste water

d. Handling of foods, etc. e. Management of water used, etc. f.

Hygiene control of food handlers

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5.2 That persons responsible for food hygiene have been appointed to each food handling establishments or each division.

5.3 That it has been confirmed, through regular tests and inspections, that final products comply with Specification and Standards based on the Japanese Law. Importers should also confirm this, whenever necessary, via tests and inspections by a official laboratory in the exporting country, or inside Japan.

6. Importers should confirm the following matters with manufacturers at the stages of storage, transportation and distribution of products.

6.1 That products are handled hygienically during storage, transportation and distribution, and that the following matters are thoroughly applied as measures to prevent contamination by poisonous or harmful substances. a. That measures are taken to prevent contamination of food through appropriate handling of insecticides, etc. b. That vehicles, haulage containers and others used for transporting foods are not those which could contaminate the foods, containers or packaging. Also, that their structure makes them easy to wash and disinfect, and that they are always kept in a clean condition. c.

That, when foods and loads other than foods are mixed, if necessary, the food is put in appropriate containers and separated from the other loads to prevent contamination.

d. That foods are controled during transportation in such a way as to avoide contamination by dirt, toxic gases. e. That, when vehicle or haulage container once used for transporting different commodities of food or loads other than foods is re-used, the vehicle or container is washed effectively and disinfected as needed. f.

That appropriate lot management has been carried out, and that any abnormalities in volume and packaging condition, etc., are confirmed as the situation demands.

6.2 Besides the matters listed in (6.1) above, that the following matters have been confirmed. a. That appropriate temperature control is carried out to prevent the occurrence of safety hazards owing to the reproduction of micro-organisms. b. That there is no decomposition or deterioration caused by accidents or inappropriate temperature control, etc. c.

That, when preservation standards based on the Japanese Law have been stipulated for foods, these have been observed.

d. That salt-cured and other foods, etc., have not been stored outdoors for long periods. e. That establishments are managed so that outsiders cannot access them without permission. p. 54 / 119

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The full Regulation providing Hygiene Control Conditions for imports of food is shown in annex.

C) Information on Tolerances and Guidelines    

(PSP) toxin in the Live Lobster hepatopancreas and Lobster Products, Oysters and other Bivalves meets Japan's standard of 80 µg/100 g.

Total mercury - 0.4 ppm (does not apply to tuna or sturgeon, fish oils, gelatin or other fish by-products) Methyl mercury - 0.3 ppm (does not apply to tuna or sturgeon, fish oils, gelatin or other fish by-products) PCB - 0.5 ppm (does not apply to fish oils, gelatin or other fish by-products)

Further information can be obtained from the Japan Authority: Ministry of Health, Labour and Welfare. http://www.mhlw.go.jp/english/

D) Specific PSP Product Control Measures for Lobster Intent - Exporters ship lobsters that will satisfy the importing country's requirements.

Requirements 1. The plan must provide a full description of the type of lobsters that are being exported : 





the primary method of preservation (eg., fresh/live, frozen, canned), the form (eg., live, whole, meat, tomalley) and any other secondary processing (cooked); the origin of lobsters that specifies as a minimum, the date of harvest and the Lobster Fishing Area (LFA) designated by the Department of Fisheries and Oceans; and the identity of the establishment(s) where the lobsters were stored, processed, and packaged with confirmation that the establishment(s) operated with a Quality Management Program Plan or equivalent in compliance with the Fish Inspection Regulations.

2. The plan must provide a full description of the controls for incoming live lobsters to ensure that they were harvested, handled and transported to the establishment under sanitary conditions (according to appropriate sanitary Schedules).

3. The plan must describe the process to control each lot before shipping to verify that it will meet the importing country´s standard for PSP.

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This control must include testing to check lobsters for the presence or absence of PSP. Testing may be performed by the exporter or by a third party. The testing procedures must clearly specify what is being tested, how it is being tested, at what frequency, and by whom. The frequency must be sufficient to control shipments to satisfy the importing country´s PSP standard.

The procedures to test lobsters should consider factors, such as, but not limited to:     

the size of the LFA and variations in the occurrence of PSP throughout the LFA; historical knowledge and other sources of information about the occurrence of PSP in lobsters from the LFA; migration patters; changing conditions that would indicate an increased probability in the occurrence of PSP in a LFA or portion of the LFA; and the capacity to segregate lobsters from different parts of the LFA.

Exporters may wish to consider arrangements with other parties to enhance their knowledge about PSP and lobsters as part of their efforts for continuous improvement of their testing procedures.

Exporters may supplement product testing with additional controls. Examples may include, but are not limited to, checking:  

documents regarding the origin of incoming lobsters to verify that they are complete and accurate; or quantities and description of incoming lobsters to verify that they correspond to accompanying documents.

The objective of this control is to provide exporters with the means to continuously gather and review information about the levels of PSP in lobsters in order to prevent the shipment of lobsters with unacceptable levels of PSP. E) Non-partner State Rules

JAPAN 24 HOURS ADVANCE FILING RULES (AFR) – NEW RULE JAPAN CUSTOM The Regulation "Japan 24 hours advance filling" has effect from March 1, 2014. It consists of the following requirements: •

The document should be sent to Japan Customs 24 hours before the ship departed from the Port of Loading (POL)

•

Description obligatory on the Bill of Loading (BL) which is in "Advance Filing Rule" is as follows: nomor telpon; kode pos pengirim dan penerima 1. name; complete address; telephone number; zip code sender and receiver 2. Product code - Minimal consists of 6-digit codes (HS6 codes) per cargo p. 56 / 119

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3. The type and number of packaging 4. size 5. number seal 6. For delivery of goods with a wide range of commodities, shall be specified by commodity 7. A maximum of 100 containers per BL 8. The exact description of the cargo - general information not allowed

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ANNEX 1: Regulation providing Hygiene Control Conditions for imports of food

Guidelines on Hygiene Control of Import Processed Foods (Annex to Notice Shoku-an No. 0605001 of June 5th, 2008) Section 1 Objectives Under Article 8 paragraph 1 of the Food Safety Basic Law (Law No. 48 of 2003), food-related business operators including a person who intends to import foods that have been manufactured, processed, etc., in another country (hereinafter “importers”) are required to recognize that they themselves bear primary responsibility for ensuring food safety, and to appropriately take necessary measures to ensure food safety at each stage of the food supply process. Moreover, under Article 3 paragraph 1 of the Food Sanitation Law (Law No. 233 of 1947; hereinafter “Japanese Law”), they are also required to take responsibility for obtaining necessary knowledge and techniques, ensuring the safety of raw materials, practicing self-imposed examination and taking any other measures to ensure the safety of imported foods, etc.

The Imported Foods Monitoring and Guidance Plan sets out basic matters for guidance to importers based on these responsibilities, and promotes the practice of hygiene control. However, owing to recent cases of chemical food poisoning, etc., it has now become necessary to ensure and confirm the safety of imported processed foods in the exporting country to a level equivalent to that within Japan, at all stages of the food supply process including raw materials, manufacturing and processing, storage and transportation.

The purpose of these Guidelines is not only to prevent contamination by poisonous or harmful substances, etc., but also to emphasize basic matters for guidance on processed foods required of importers under the Imported Foods Monitoring and Guidance Plan, to promote hygiene control of import processed foods, and to take steps to improve safety.

After the completion of import procedures, all stages including storage, transportation, manufacturing, processing and sale within Japan are governed by the Law, and attention is also drawn to other laws, ordinances and notices designed to prevent the contamination of distributed foods by poisonous or harmful substances.

(Reference) - Food Safety Basic Law, Article 8 (Responsibility of Food-Related Business Operators)(PDF:8KB) - Food Sanitation Law, Article 3 (Responsibility of Food-Related Business Operators)(PDF:8KB) - Special Measures Law Concerning the Prevention of Poisonous Substances from Contaminating Food in Distribution (Law No. 103 of 1987), Article 3 (Government Measures, etc.)(PDF:12KB)

Section 2 Scope These Guidelines are designed for importers who manufacture and import products to be exported to Japan under direct contract with overseas manufacturers, as well as p. 58 / 119

UNIDO â&#x20AC;&#x201C; CEDEP II Legal and SPS requirements of fishery products of potential importing countries JAPAN section

importers of processed food in general. Moreover, even importers who are not in a direct contractual relationship with an overseas manufacturer should also, through the agency of an exporter or other such concern in the exporting country, strive to confirm the matters stated in these Guidelines with said manufacturer.

Section 3 Confirmation System To confirm the matters stated in these Guidelines, importers should appoint responsible staff and contact personnel who have the necessary knowledge and skills.

Section 4 Matters to be Confirmed Importers should confirm the matters set forth below, in writing, with the manufacturers of processed food that they intend to import. They should do so when signing contracts, upon the manufacture of products to be exported to Japan (including examination and certification), upon the renewal of contracts and whenever any problems arise, taking into account the establishment and enforcement of regulations on food hygiene in the exporting country, the level of hygiene control practiced by the manufacturer, and other factors. In addition, importers should also make necessary confirmation by conducting field surveys, posting local representatives, testing and inspecting products, etc. When confirming these matters, they should make use of manufacturersâ&#x20AC;&#x2122; records concerning raw materials, records of manufacturing controls, records related to products, records related to Hazard Analysis and Critical Control Point (HACCP) system, and so on.

1

Supervision by the Government of the Exporting Country, Etc. Importers should confirm with manufacturers the following matters concerning supervision by the government of the exporting country, the standard of establishments, facilities and equipment of the manufactory, and hygiene control in the manufactory.

(1) That the food is manufactured and processed in compliance with the laws and regulations of the exporting country. In particular, when there is a system of registration of manufactory, a system of permission for product exports, or other such system in the exporting country, that these are properly observed.

(Reference) - Response Related to Imports (material used at the Emergency Inter-Sector Joint Conference on Safety Assurance of Imports, July 20th, 2007)(Under translation) (2) That the standard of establishments, facilities and equipment of the manufactory is at least equal to the standards concerning establishments, facilities and equipment stipulated in related Japanese laws and ordinances, etc.

(Reference) - Abattoir Law Enforcement Order (Cabinet Order No. 216 of 1953), Article 1 (Standards for Structure and Facilities of Ordinary Abattoirs)(Under translation) p. 59 / 119

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- Enforcement Regulations of the Law Concerning Rules for Poultry Processing Business and Poultry Inspection (Ministry of Health & Welfare Ordinance No. 40 of 1990), Article 2 (Standards for Structure and Facilities)(Under translation) - Rules for Food Business Establishment Standards Based on the Food Sanitation Law (Annex to Notice Ei-kan No. 43 of September 9th, 1957) (Under translation) (3) That the standard of hygiene control in manufactory is at least equal to the following standards concerning hygiene control stipulated in related Japanese laws and ordinances, etc. It should be noted that using methods of hygiene control based on HACCP system is also effective, and the active introduction of these is recommended. (a) Hygiene control in the harvesting of agricultural, forestry and fishery products (b) Hygiene control in food handling establishments, etc. (c) Hygiene control by food handlers and others in food handling establishments, etc. (d) Training for food handlers and others in food handling establishments, etc.

(Reference) - Guidelines on Management and Operation Standards to be Observed by FoodRelated Business Operators (Annex to Notice Shoku-an No. 0227012 of February 27th, 2004; hereinafter “Guidelines on Management and Operation Standards”) (PDF:33KB) - Procedure for Implementation of the Total Hygiene Controlled Manufacturing Process Approval System (Annex to Notice Sei-ei No. 1634 of November 6th, 2000) (Under translation) - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 4-2003)(PDF:115KB) - Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application (Annex to CAC/RCP 1-1969, Rev. 4-2003)(PDF:73KB)

2

Raw Material Acceptance Stages Importers should confirm the following matters with manufacturers at the stage of accepting raw materials.

(1) That quality criteria including Specification and Standards based on Japanese Law have been established for each raw material, and that it has been confirmed that each delivery lot complies with these. Specifically, importers should aim to procure raw materials for which the use of agricultural chemicals, veterinary drugs and other production materials, etc., is clear from contracts or other documentation shared with specific producers or vendors. Meanwhile, basic matters for confirmation in accordance with the characteristics of raw materials are mainly those shown below. (a) Foods in general (universal matters) 

That, when harvesting agricultural, livestock and fishery products to be used as raw materials, measures are taken to prevent contamination by dirt or wastewater, as well as measures to prevent contamination by agricultural chemicals, veterinary drugs, feedstuffs, fertilizers, faecal and others, by appropriately managing poisonous substances, wastes, etc. p. 60 / 119

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

 



    

That, when harvesting, storing and transporting agricultural, livestock and fishery products to be used as raw materials, measures are taken to prevent contamination by rodents, insects, chemicals, foreign matter, micro-organisms, etc.

That additives for which there is no designation based on Japanese Law have not been used.

That additives that do not comply with Specification and Utilization Standards based on Japanese Law have not been used, and that the appropriate amount have been used.

In the case of fresh vegetables, fish and shellfish, etc., that no colorants or other additives that may mislead consumers in the determination of quality or freshness are used.

That compositional standards, manufacturing and processing standards, and other Specification and Standards based on Japanese Law have been met.

That sterilization or other processes using irradiation not permitted in Specification and Standards based on Japanese Law have not been conducted.

That the formal names, composition, and other details of raw materials and additives used are clearly notified.

That drug substances specified in Pharmaceutical Affairs Law have not been included (Law No. 145 of 1960).

That the history of food use, etc. in the exporting country is available.

(b) Agricultural products and products processed from them      

That, when products contain natural toxins, measures are taken to remove them by manufacturing, processing, etc.

That the harvesting area is not polluted by radioactivity.

That the use of agricultural chemicals and fertilizers has been confirmed.

That maximum residue limits for agricultural chemicals based on Japanese Law have been met.

That measures are taken to prevent contamination by genetically modified food that has not undergone safety assessment based on Japanese Law. That measures are taken to prevent the occurrence of mold when harvesting as well as during transportation and storage.

(c) Livestock products and products processed from them 

  

That measures are taken to prevent contamination by Enterohemorrhagic Escherichia coli O157, Listeria monocytogenes and other pathogenic microorganisms.

That the breeding area is not polluted by radioactivity.

That the breeding area is not a country or region from which import is prohibited in connection with bovine spongiform encephalopathy (BSE).

That the products contain no specified risk material connected with BSE.

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

 

That the products do not use (and are not contaminated by) beef, etc., derived from countries or regions from which imports are prohibited in connection with BSE. That the use of veterinary drugs and feed additives has been confirmed.

That maximum residue limits for agricultural chemicals, veterinary drugs and feed additives based on Japanese Law have been met.

(d) Fishery products and products processed from them       

That measures are taken to prevent contamination by Vibrio parahaemolyticus and other pathogenic micro-organisms.

That shellfish are caught in seas in which shellfish poisoning is appropriately monitored.

That species of blowfish are those whose import is permitted.

That measures are taken, through identification of fish species, to prevent contamination by other species of blowfish.

That measures are taken to confirm the sea area subject to catches and, through proper identification of fish species, to prevent contamination by poisonous fish.

That the use of veterinary drugs and feed additives has been confirmed.

That maximum residue limits for veterinary drugs and feed additives based on Japanese Law have been met.

(2) That the matters listed in (1) above have been confirmed by regular tests, inspections, etc. Tests for residual agricultural chemicals, etc., should take into account the type of chemicals used for the agricultural products in question, records of their application, and other details on the state of use, as well as the results of soil and water quality surveys, etc.

(3) No raw materials should be accepted if it is known to contain parasites, pathogenic micro-organisms, poisonous substances, decomposed matter, deteriorated matter or foreign matter which would not be eradicated or removed to an acceptable level by normal processing, cooking, etc.

(4) When the monitoring results carried out by an administrative organ or other body in the exporting country are available, importers should confirm the results, but should also import samples and confirm said results by means of tests and inspections inside Japan whenever necessary.

(5) That each raw material has been subjected to appropriate lot management.

(Reference) - Guidelines on Management and Operation Standards(PDF:33KB) - Basic Matters for Guidance to Importers (Annex Table 2, Notice Shoku-an No. 0331001 of March 31st, 2008) (PDF:44KB)

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3

Product Manufacturing and Processing Stages Importers should confirm the following matters with manufacturers at the stages of manufacturing and processing products.

(1) That a system of control has been arranged to ensure that food can be manufactured and processed under a hygienic condition. As measures for preventing contamination by poisonous or harmful substances, in particular, that the following matters are thoroughly observed. (a) Hygiene control of establishments, facilities and equipment, etc. 









That windows and entrances are not left open. If they have to be left open of necessity, that measures are taken to prevent dirt, rodents, insects, etc., from entering establishments.

That equipment, utensils and dismantled parts of them are properly cleaned, sterilized and disinfected to prevent the food from contaminating by metal fragments, foreign matter, chemical substances, etc., and that they are stored hygienically in appropriate places by means of preventing contamination.

That chopping boards, kitchen knives, protective clothing and others that come into direct contact with food are fully cleaned and disinfected each time they are contaminated or after the end of the work.

That containers for detergents, sterilizers, disinfectants and other chemicals are clearly identified, and that measures are taken to prevent them from contaminating food (for example, by preparing utilization management records and storage facility).

That establishments are managed so that outsiders cannot access them without permission.

(b) Measures against rodents and insects 

 

That establishments and surrounding areas are appropriately managed and maintained, breeding sites of rodents and insects are eliminated, and measures are taken to prevent rodents and insects from entering establishments (for example, by installing wire mesh screens, traps, etc.).

That, when rodenticides or insecticides are used, these are handled appropriately to prevent them from contaminating food.

That raw materials, products, packaging materials, etc., are placed in containers, and stored away from floors or walls.

(c) Handling of wastes and waste water   



That procedures are specified for the methods of storing and disposing wastes.

That waste containers are clearly distinguished from other containers and are kept clean to prevent leakage of waste fluids or foul odors.

That areas for storing wastes are separated from food handling and storage areas (including areas adjacent to these) and are appropriately managed so that they can have no adverse impact on the surrounding environment.

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(d) Handling of foods, etc. 



  

That pathogenic micro-organisms, etc., and their toxins are eradicated or removed to a safe level in the processes of manufacturing, processing or cooking food.

That measures are taken to prevent contamination of raw materials and products by metals, glass, dirt, detergents, machine oil and other foreign matter, and that inspections are carried out whenever necessary.

That cut or sliced meat, etc., is checked for foreign matter, and that, if any foreign matter is found, the part suspected of contamination should be removed.

That containers and packaging are hygienic and protect products from contamination or damage, and that they can be appropriately labeled.

That packaging materials and sealant gas are non-poisonous, and that they cannot impact the safety or quality of food during storage or under specific conditions of use.

(e) Management of water used, etc. 



 

 

That water used in processes that have a direct impact on food manufacturing and processing (hereinafter “water used”) should be potable water. Also, that steps are taken to prevent water used from being contaminated by other water used inside establishments for purposes not directly related to food manufacturing, or water used in processes such as cooling that do not have a direct impact on food safety.

That the quality of water used is regularly tested. Also, when there is a risk that water sources have been contaminated as a result of an unforeseen disaster, etc., that they are not used until their safety has been confirmed.

That, when water tanks are used, said tanks are regularly cleaned and are kept clean.

That, when well water, an independent water supply, or other water is used, it is regularly confirmed and recorded that sterilizing or water purifying devices are working properly.

That ice is made from potable water supplied by appropriately managed water supply equipment.

That, when water is re-used, it is appropriately treated as necessary to prevent an adverse impact on food safety.

(f) Hygiene control of food handlers 



That food handlers are provided with a hygienic uniform, cap, mask and shoes for exclusive use, etc., that they are prohibited from bringing foreign matter inside food handling establishments, and that access to and from establishments is controlled.

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appropriate location and to observe hygiene control provisions in the establishments.

(2) That persons responsible for food hygiene have been appointed to each food handling establishments or each division.

(3) That it has been confirmed, through regular tests and inspections, that final products comply with Specification and Standards based on the Japanese Law. Importers should also confirm this, whenever necessary, via tests and inspections by a official laboratory in the exporting country, or inside Japan. Basic matters for confirmation in accordance with the characteristics of products shall be as shown in 2 (1).

(4) That each product has been subjected to appropriate lot management.

(Reference) - Guidelines on Management and Operation Standards(PDF:33KB) - Basic Matters for Guidance to Importers(PDF:44KB)

4

Product Storage, Transportation and Distribution Stages Importers should confirm the following matters with manufacturers at the stages of storage, transportation and distribution of products.

(1) That products are handled hygienically during storage, transportation and distribution, and that the following matters are thoroughly applied as measures to prevent contamination by poisonous or harmful substances. (a) That measures are taken to prevent contamination of food through appropriate handling of insecticides, etc. (b) That vehicles, haulage containers and others used for transporting foods are not those which could contaminate the foods, containers or packaging. Also, that their structure makes them easy to wash and disinfect, and that they are always kept in a clean condition. (c) That, when foods and loads other than foods are mixed, if necessary, the food is put in appropriate containers and separated from the other loads to prevent contamination. (d) That foods are controled during transportation in such a way as to avoide contamination by dirt, toxic gases. (e) That, when vehicle or haulage container once used for transporting different commodities of food or loads other than foods is re-used, the vehicle or container is washed effectively and disinfected as needed. (f) That appropriate lot management has been carried out, and that any abnormalities in volume and packaging condition, etc., are confirmed as the situation demands.

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(b) That there is no decomposition or deterioration caused by accidents or inappropriate temperature control, etc. (c) That, when preservation standards based on the Japanese Law have been stipulated for foods, these have been observed. (d) That salt-cured and other foods, etc., have not been stored outdoors for long periods. (e) That establishments are managed so that outsiders cannot access them without permission.

(Reference) - Guidelines on Management and Operation Standards(PDF:33KB) - Basic Matters for Guidance to Importers(PDF:44KB) - Ensuring Food Safety and Proper Control of Poisonous and Deleterious Substances Pertaining to Case No. 114 (Notice Ei-shoku No. 102, Yaku No. 999 of December 20th, 1984)(PDF:11KB)

Section 5 Recall and Disposal 1

Establishment of Recall Procedures If a food hygiene problem caused by food imported occurs, with a view to preventing health hazards to consumers in advance, importers should establish a system of responsibility for recall, specific measures of recall, and procedures of reporting to the relevant administrative organs, which allow importers to recall the products in question promptly and appropriately.

2

Product Disposition Measures Importers should accurately and promptly take measures such as disposing recalled products. Moreover, recalled products should be stored in clear distinction from normal products, and product disposition and other measures should be implemented appropriately under instructions from the relevant administrative organ.

(Reference) - Guidelines on Management and Operation Standards(PDF:33KB) 3 Public Notification Whenever necessary when recalling products, etc., importers should consider making public notification of information related to said recall, etc., with a view to creating cautionary awareness among consumers, etc.

Section 6 Other Matters 1

Education, Etc., on Japanese Food Hygiene Regulations

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Importers should give education and guidance on Japanese food hygiene regulations to manufacturers that intend to export food to Japan, as well as occasionally providing information whenever there are violations, etc., in food both in Japan and abroad, and taking steps for improvement whenever necessary.

Importers should also dispatch technicians or other personnel to local establishments whenever necessary to give guidance on food hygiene, etc., and should take steps to harmonize levels of technology, knowledge and awareness.

2

Proper Labeling Importers should ensure that the labeling of food imported by themselves complies with standards under related laws and ordinances in Japan, while also confirming these whenever necessary, for example by advance consulting the relevant administrative organ.

3

Preparing and Keepng Records Importers should make efforts to properly prepare and file records at the time of import, sale, and other processes in the supply of food imported by themselves, to ensure that the state of distribution of said food can be confirmed at all times.

(Reference) - Guidelines on the Creation and Filing of Records by Food-Related Business Operators under the Provisions of Article 1-3 Paragraph 2 of the Food Sanitation Law (Annex to Notice Shoku-an No. 0829001 of August 29th, 2003)(Under translation)

4

Tests and Inspections When implementing tests and inspections, and handling the results thereof, importers should confirm that reliability is assured in terms of their accuracy and precision, etc.

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Canada Competent Authority: Canadian Food Inspection Agency (CFIA) http://www.inspection.gc.ca/eng/1297964599443/1297965645317

A) Bilateral dispositions and summary of import requirements Fish and fish products imported into Canada are inspected to prevent the marketing of unsafe or unwholesome or mislabelled products. Inspection effort is directed at foreign processors which have demonstrated a history of poor compliance with Canadian standards. On the other hand, inspection effort is reduced through the establishment of Memoranda of Understanding (MOUs) or Mutual Recognition Agreements (MRAs) with other countries having reliable inspection systems.

A formal Bilateral Agreement signed between the exporting country and Canada is therefore advisable for ease of the exports. Most exporting countries to Canada have signed a Bilateral Agreement covering this purpose, facilitating the food safety controls and guarantees of the exported products. The following requirements are applied to the exporting country: •

Exporting Establisment is required to have HACCP implemented programme (usually it is considered acceptable a lower level of HACCP compliance in comparison with EU approved establishments, when establishments are graded in terms of compliance performance).

•

Exported Products are required to have issuance of Health Certificate for Exports to Canada

•

Establishments will be subject to a certain testing plan to be implemented by the Competent Authority of the exporting Country and/or by Canadian Authority. The sampling frequency will vary depending on the establishment has undergone prior registration for exporting to Canada and been approved. Example: For Indonesia it is applied a 5% testing plam, while for non-registered establishments it is applied 15% testing.

B) Overview of Canadian Fish Import Program Policy

1. Purpose The purpose of the fish import program policy is to define the intent and objectives of the Fish Inspection Act and Regulations and the approach taken by the Canadian Food Inspection Agency (CFIA) to enforce the applicable regulations as they relate to the importation of fish and seafood products into Canada.

2. Authority This regulatory policy is issued under the authorities of the Fish Inspection Act and the Fish Inspection Regulations.

The Canadian Food Inspection Agency is responsible for enforcing the food safety policies and standards that Health Canada sets.

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3. Scope This policy applies to all individuals or corporations importing fish and seafood products into Canada for commercial purposes as food for human consumption. This policy applies to the CFIA and its authorized representatives or agents, who are involved in the administration and enforcement of the Fish Inspection Act and the Fish Inspection Regulations.

4. Policy Statement The objective of the Fish Inspection Act and Regulations is to provide reasonable assurances that fish and seafood products imported into Canada for commercial purposes as food for human consumption are safe and meet regulatory requirements.

To achieve this, the CFIA is committed to a fair, open, transparent and consistent regulatory approach in the development, implementation and continuous improvements of a Canadian Fish Import Program.

5. Policy Requirements 5.1 Licensed importers are responsible for ensuring that they import fish and seafood products that meet all applicable regulatory requirements, including the regulations made under the authority of the Fish Inspection Act, the Food and Drugs Act, the Consumer Packaging and Labelling Act and the Canadian Food Inspection Agency Act. 5.2 The CFIA verifies compliance to Canadian regulatory requirements and works with the competent authorities of Canada's major trading partners to provide reasonable assurances that imported products are safe and meet regulatory requirements.

5.3 The Canadian Fish Import Program incorporates a risk-based approach and provides importers with flexibility to demonstrate product compliance.

C) Product Inspection Product inspections are conducted in accordance to the procedures set out in the Fish Products Inspection Manual, Chapter 2 (http://www.inspection.gc.ca/food/fish-andseafood/manuals/fish-products-inspectionmanual/eng/1352139208050/1352145864299 ). Products subject to inspection undergo an initial inspection for the test(s) which have been identified. The lot is sampled for testing in accordance to the procedures which apply for the tests being conducted. Test results are assessed against Canadian standards and guidelines. If the test result(s) do not meet Canadian standards, the lot is rejected and cannot be sold or distributed in Canada. The lot can undergo a re-inspection for the tests which failed provided that the product does not have in or upon it any poisonous or harmful substance.

In Annex 1 it is shown the full procedure and identification of the standards as well as the links to have access to each.

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D) Annual Sampling Plan and basic testing parameters Available at: http://www.inspection.gc.ca/food/fish-and-seafood/imports/productinspection/eng/1360343085758/1360343335938?chap=4#s1c4 The CFIA develops a risk based annual product sampling plan for assessing the compliance of fish products considered to be "good order" product. The sampling plan sets out the type and number of tests to be conducted on an annual basis for the assessment of imported lots which are not listed on the MIL. The following schematic provides an overview of the process for the development and adjustment of the annual product sampling plan.

Description for Schematic - Annual Sampling Plan

The annual sampling plan targets are based on an overall sampling target of 5% of the estimated annual lots imported by Basic importers and is developed based on an annual review of following information:     

imported fish product risk profiles; product inspection coverage; product inspection results; information acquired through environmental scanning activities; and program priorities

Based on the results of the annual review assessment, the target sampling frequencies for the specific species and product risk groups are developed for the upcoming fiscal year.

The CFIA conducts semi-annual reviews of the product inspection results and makes adjustments to the annual sampling plan as necessary.

Mandatory Inspection List (MIL) The MIL, which is maintained by the CFIA, is a list of imported fish products which have failed inspection. Subsequent imports of the same risk group from the same producer, as identified on the MIL, are required to undergo testing for the specific test/analysis indicated on the MIL. Addition of Product to the Mandatory Inspection List When a lot of imported fish product is inspected and the results of a test indicates that the product does not meet Canadian standards, the fish product and the producer are added to the Mandatory Inspection List for each test that does not meet regulatory standard.

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Description for Schematic - Import Product Inspection Process

The MIL commonly listed tests The tests performed are either linked to species risk or to product processing risk. The following table provides examples of the common tests and test group names that are linked to the MIL. Tests Related to Species Risk Environmental Contaminants

Polychlorinated biphenyls (PCBs), Dioxin-like PCBs, Dioxins, Furans, Pesticides, Mercury, other heavy metals

Marine Toxins

PSP, DSP, ASP, Ciguatoxin

Drug Residues/ Therapeutants

Amphenicols, Tetracyclines, Sulfonamides, Quinolones, Fluoroquinolones, Nitrofurans, Triphenylmethane dyes, Avermectins, Macrolides

Spoilage indicator

Histamine

Other Species Test

n/a

Tests Related to Product / Processing Risk Safety Parameters

salt content, pH, water activity (aw), moisture content

Food Additives

Borates, Sulphites, Phosphates etc.

Food Pathogens

E. coli, Listeria monocytogenes, Staphylococcus aureus, Salmonella spp., Vibrio spp.

Other Product Tests

Sensory, net content determination, label1 electrophoresis species identification

Package Tests

Container integrity; package integrity; can coding, sterility

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Footnote 1 Label infractions which pose a Health and Safety risk are posted on the MIL. All subsequent imports from the same product risk group and producer with the same Brand Name will be inspected until there is acceptable label correction made which applies to all subsequent imports. Label infractions of a technical nature are dealt with at the importer level. The CFIA captures all label infractions under an importer's record of compliance as a failure to meet fish import licence requirements.

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ANNEX 1. Sampling of a Lot for Inspection Available at: http://www.inspection.gc.ca/food/fish-and-seafood/imports/productinspection/eng/1360343085758/1360343335938?chap=5#s5c5

A lot is sampled for inspection in accordance to the procedures set out in the Standards and Methods Manual, Sampling.

Sample units may be used for more than one test provided that the unit size permits it, the sample units remain representative of the lot and that there is no impact on any of the test results.

5.2.1 Sample size The number of units to be sampled in a lot is based on the tests to be conducted and whether the inspection is an initial inspection or a re-inspection as described in the Standards and Methods Manual, Sampling.

Sample Size Determination Test

Sample Size - Sampling plan Standard

Microbiological Tests Food Pathogens

Adopted from the International Commission on Microbiological Specifications for Foods (ICMSF)

    

Sampling Policy and Procedures E. coli Salmonella Listeria monocytogenes Staphylococcus aureus Vibrio parahaemolyticus

Chemical Tests

      

Marine toxins (PSP, ASP, DSP, ciguatoxin) Environmental contaminants (mercury) Heavy metals Food additives Safety parameters Electrophoresis (species identification) Therapeutants

Histamine Sensory Evaluation

Adopted from the International Commission on Microbiological Specifications for Foods (ICMSF) Sampling Policy and Procedures

Adopted from the Codex AQL 6.5 sampling plan of the Food and Agriculture Organization of the United Nations (FAO) / World Health Organization (WHO) Codex Alimentarius Sampling Plans for Prepackaged Foods (CAC/RM 42-1969).

Net Content Determination Sampling Policy and Procedures Package Integrity

Container Integrity

Visual Inspection Protocol (VIP)

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Sample Size Determination Test

Sample Size - Sampling plan Standard Bulletin on the Container Integrity Evaluation Sampling and Tolerance Plan For Canned Fish and Canned Fish Product

5.3 Product Tests, Test Procedures and Canadian Standards Species Related Testing Production Source

Tests

Processing Type

Product form

Standards / Guidelines

Species subject to Environmental Contaminants

Wild caught

Mercury

All

Meat oil Roe Organ

Canadian Guidelines for Chemical Contaminants and Toxins in Fish and Fish Products

Species subject to Environmental Contaminants

Wild caught

Pesticides DDT, HCB, BHCs, heptachlor, chlordane, dieldrin, endrin, aldrin, mirex

All

Organ Oil Roe

Canadian Guidelines for Chemical Contaminants and Toxins in Fish and Fish Products

Species subject to Environmental Contaminants

Farmed

Drugs/Therapeutants

All

Meat Organ, Roe

Appendix 1 (A) - CFIAAquaculture Therapeutant Residue Monitoring List

Species subject to Histamine production

Wild caught, Farmed

Histamine

All

Meat Extracts Juice

Canadian Guidelines for Chemical Contaminants and Toxins in Fish and Fish Products

Species subject to Histamine production

Farmed

Drugs/Therapeutants

All

Meat Organ, Roe

Appendix 1 (A) - CFIAAquaculture Therapeutant Residue Monitoring List

Salmonids

Wild caught

Pesticides DDT, HCB, BHCs, heptachlor, chlordane, dieldrin, endrin, aldrin, mirex

All

Organ Oil Roe

Canadian Guidelines for Chemical Contaminants and Toxins in Fish and Fish Products

Species

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Species Related Testing

Species

Production Source

Tests

Processing Type

Product form

Standards / Guidelines

Salmonids

Farmed

Drugs/Therapeutants

All

Meat Organ, Roe

Appendix 1 (A) - CFIAAquaculture Therapeutant Residue Monitoring List

Crustaceans

Farmed

Drugs/Therapeutants

All

Meat Organ, Roe

Appendix 1 (A) - CFIAAquaculture Therapeutant Residue Monitoring List

Molluscan Shellfish Species subject to Marine Toxins 1

Wild caught Farmed

Marine Toxins Saxitoxins (PSP), Domoic Acid (ASP), DTX-1 and Okadaic Acid (DSP), Pectenotoxins PTX1, PTX-2, PTX3, PTX-4, PTX-6 and PTX-11

All

Meat Juice Extracts Dried

Canadian Guidelines for Chemical Contaminants and Toxins in Fish and Fish Products

Molluscan Shellfish Species subject to Marine Toxins (Bivalve molluscs only)

Wild caught Farmed

E. coli

All non RTE;RTE without safety parameters without heat treatment

Meat

Bacteriological Guidelines for Fish and Fish Products

Oysters

Wild caught Farmed

Vibrio parahaemolytic us

Live

Meat

Bacteriological Guidelines for Fish and Fish Products

Fish (other than salmonids, Molluscan shellfish and crustaceans)

Farmed

Drugs/Therapeutants

All

Meat Organ, Roe

Appendix 1 (A) - CFIAAquaculture Therapeutant Residue Monitoring List

1

Scallop products consisting of only the adductor muscle/meat free of viscera or roe do not require testing for marine toxins.

Note: Products which are a mixture of fish and other food components from which the fish component cannot be easily separated are not subject to testing for contaminants and therapeutants. The non-fish components are not part of the scope for these test methods and can interfere with the methods and accuracy of the test results. Examples of such products include but are not limited to shrimp wonton soup or dumplings.

Electrophoresis - When there is doubt regarding the species declared for a product, electrophoresis is conducted to verify whether the species used is the one which was declared.

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Processing Related Testing

Processing Type

Tests

Species

Product form

ALL (Canned, RTEcooked,RTE-pasteurized in container, RTE-Safety parameters, RTE-no heat or safety parameters, Non-RTE)

Sensory Evaluation

All

All

Fish Products Standards and Methods Manual

Fish Products Standards and Methods Manual

ALL (Canned, RTEcooked,RTE-pasteurized in container, RTE-Safety parameters, RTE-no heat or safety parameters, Non-RTE)

Net Content

All

All

Net Content Determination Procedures

Net Content Determination Procedures

ALL (Canned, RTEcooked,RTE-pasteurized in container, RTE-Safety parameters, RTE-no heat or safety parameters, Non-RTE)

Label Assessment

All

All

--

Fish and Fish Products Labeling directives

Procedures

Standards / Requirements

Product specific labelling requirements / standards of identity CFIA Fish List

ALL (Canned, RTEcooked,RTE-pasteurized in container, RTE-Safety parameters, RTE-no heat or safety parameters, Non-RTE)

Food Additives

Canned

Container Integrity

All

All

--

Guide to Additives Permitted in Fish and Fish Products Background Levels for NonPermitted Additives

All

All

Visual Inspection Protocol Metal Can Defects Manual

Metal Can Defects Manual Flexible Retort Pouch Manual

Flexible Retort Pouch Manual

RTE-Cooked (frozen or refrigerated with a short shelf-life)

Food Pathogens - Listeria monocytogenes - E. coli - Staphylococcus

All

Meat Organ

--

Bacteriological Guidelines for Fish and Fish Products

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Processing Related Testing

Processing Type

Tests

Species

Product form

Procedures

Standards / Requirements

aureus - Salmonella

RTE-cooked (refrigerated with a long shelf-life)

Food Pathogens - Listeria monocytogenes - E. coli - Staphylococcus aureus - Salmonella

All

Meat Organ

--

Bacteriological Guidelines for Fish and Fish Products

RTE-cooked (refrigerated with a long shelf-life)

Package Integrity

All

Meat Organ

Package Integrity Guideline

Package Integrity Guideline

RTE-cooked (refrigerated with a long shelf-life)

Food Safety Parameters (as applicable) - pH - Water activity - Water phase salt

All

Meat Organ

--

Guide - Process Control Technical Information

RTE - Pasteurized in container (frozen)

Package Integrity

All

All

Package Integrity of Pasteurized Products (to be issued at a later date)

Package Integrity of Pasteurized Products (to be issued at a later date)

RTE - Pasteurized in container (refrigerated with a long shelf-life or shelf-stable)

Package Integrity

All

All

Package Integrity of Pasteurized Products (to be issued at a later date)

Package Integrity of Pasteurized Products (to be issued at a later date)

RTE - Pasteurized in container (refrigerated with a long shelf-life or shelf-stable)

Food Safety Parameters (as applicable) - pH - Water activity - Water phase salt

All

Meat Roe Organ Extracts

--

Guide - Process Control Technical Information

RTE- Safety parameters

Food Safety Parameters (as applicable) - pH - Water activity - Water phase salt

All

Meat Roe Organ Extracts/C oncentrat e, Oil

--

Guide - Process Control Technical Information

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Processing Related Testing

Product form

Procedures

Standards / Requirements

Processing Type

Tests

Species

RTE- Safety parameters

Food Pathogens - Listeria monocytogenes - E. coli - Staphylococcus aureus - Salmonella

All

Meat Roe Organ Extracts/C oncentrat e, Oil

--

Bacteriological Guidelines for Fish and Fish Products

RTE- Safety parameters

Package Integrity

All

All

Package Integrity Guideline

Package Integrity Guideline

RTE- no safety parameters or heat

Food Pathogens - Listeria monocytogenes - E. coli - Staphylococcus aureus - Salmonella

All

Meat Roe Organ Juice

--

Bacteriological Guidelines for Fish and Fish Products

Non-RTE mixed food commodities (pre-cooked rice or pasta)

Food Pathogens - Staphylococcus aureus

All

Meat

--

Bacteriological Guidelines for Fish and Fish Products

Non RTE - Battered fish

Food Pathogens - Staphylococcus aureus

All

Meat

--

Bacteriological Guidelines for Fish and Fish Products

Non RTE - Battered fish

Percent Fish Determination for breaded/battered fish

All

Meat

Determination of percent fish in breaded and battered fish

Product Specific Requirements Smoked Fish  

Storage/Packaging requirements Labelling and weight determination of sliced smoked fish

Salted Anchovies 

Salted anchovy products must be kept refrigerated and labeled "keep refrigerated"

Scallops 

Moisture content

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5.4 Decision on product acceptability Based on an assessment of all the test results, the CFIA will make a decision on the acceptability of the product for sale and distribution in Canada: 1. If the product meets Canadian standards, the product is released by the CFIA from detention; 2. If the product does not meet Canadian standards, the product remains under detention until a plan for product disposition has been accepted by CFIA. The CFIA will monitor the delivery of the disposition plan by the importer.

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Norway A) Bilateral dispositions and summary of import requirements A formal Bilateral Agreement signed between the exporting country and Norway is advisable for ease of the exports. Most exporting countries to Norway have signed a Bilateral Agreement covering this purpose, facilitating the food safety controls and guarantees of the exported products. Nevertheless the following requirements are applied. (a) Establishment unit has HACCP implemented (it is expected a high level of HACCP compliance, equal to the level required for EU establishments) (b) Export Establishments, are required to have an EU Approval Number and to be listed in EU list of approved establishments. https://webgate.ec.europa.eu/sanco/traces/output/non_eu_listsPerCountry_en. htm (c) Products when exported require a Health Certificate (EU format). Only EU Approved Establishments are eligible for exporting their products into EU market. Every export consignment from individual establishments requires a HC.

B) Specific requirements for exports of fishery products into Norway As a country which has signed the European Economic Area (EEA) agreement, Norway has adopted the certification and import requirements in place for the European Union.

Consult the European Union import requirements Section for more detailed information.

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European Union (EU) Directorate General for Health and Food Safety – European Commission Food and Veterinary Office http://ec.europa.eu/dgs/health_food-safety/index_en.htm 1. Summary of Requirements 1.1. Sanitary Requirements Three Basic Sanitary Requirements are necessary to be fulfilled: 1st Official Control, undertaken by formally established Competent Authority of exporting country, should be equivalent to EU and recognition shall be acquired by the EU through a Council Decision laying down: “Special Conditions Governing Imports of Fishery and Aquaculture Products Originating in …..” following an audit visit to the country by EU-DG Sanco.

2nd Industry Operators – Export Establishments, need to have an EU Approval Number and be listed in EU list of approved establishments. Approval is annually given in reference to their compliance (accomplishment and performance of EU hygiene requirements) in particular in the implementation of the HACCP System (and in practice fulfilling high level performance). https://webgate.ec.europa.eu/sanco/traces/output/non_eu_listsPerCountry_en. htm 3rd Products when exported require a Health Certificate (EU format). Only EU Approved Establishments are eligible for exporting their products into EU market. Every export consignment from individual establishments requires a HC. Requires: A. Officially designated Competent Authority with appropriate legal powers and capacity (resources, staff, equipment, organization) to fulfill effectively the task of Official Control.

B. Existence of appropriate Legislation in the country to be equivalent to the European Legislation, covering the hygiene matters of fishery products and the organizational scheme for official controls.

C. Control procedures in place and effectively performed for establishment approval, surveillance and monitoring.

D. Export Health Certification issuance organized in connection with outcomes of the control system applied to operators.

E. Accredited laboratory testing capacity available and able to support the surveillance and monitoring activities.

1.2. Non-Sanitary Requirements Additionally, it is also essential to fulfill 2 requirements not related with hygiene requirements: 

Catch Certificate - related with protection of fish resources; Products when exported require also a catch certification in reference to the measures for p. 81 / 119

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preventing, deterring and eliminating illegal, unreported and unregulated (IUU) fisheries. ď&#x201A;ˇ

Aquatic Animals Health guarantees, when applicable

2. Summary of applicable EU Legislation: Legislation Reference Regulation (EC) No 178/2002

Regulation (EC) No 852/2004 Regulation (EC) No.853/2004

Regulation (EC) No 854/2004

Regulation (EC) No 882/2004

Regulation (EC) No 2406/96 Directive 98/83/EC Regulation (EC) No. 2073/2005 Regulation (EC) No.1881/2006 Regulation EC No. 1664/2006 amending Regulation EC No. 2074/2005 Directive 2000/13/EC Directive 98/72/EC Regulation (EC) No.37/2010

Directive 96/23/EC; Decision 97/747 Regulation (EC) No.1005/2008

Main Contents Principles and General requirements of food law, (includes the provisions for Food Safety, Risk and Traceability) and establishing the European Food Safety Authority.

General Hygiene requirements for foodstuffs; HACCP. Specific hygiene requirements for foods derived of animals; includes Fish and Fishery Products and Live Bivalve Molluscs.

Specific rules and criteria for official controls (to be applied for inspection, surveillance, and certification of products of animal origin for human consumption).

Setting Surveillance System to verify compliance (suitability + fulfillment) with food law and animal health regulations and organizing Official Controls and Competent Authority. (How to setup Official Controls; How to setup the Competent Authority) Common marketing standards for fishery products (Sensory criteria) Quality of water for human consumption Microbiological criteria on foodstuffs Maximum levels for certain contaminants on foodstuffs regards implementing measures for certain products of animal origin intended for human consumption and repealing certain implementing measures.

Product Labelling Food additives (authorized and maximum levels).

Pharmacologically active substances and their classification, regarding maximum residue limits in products (defining authorised and non authorised substances and respective MRLs) Sampling in aquaculture for testing contaminants To prevent, deter and eliminate illegal, unreported and unregulated (IUU) fishing.

3. Notes

The following information have been subject to information last update on March 13, 2015.

Please note that the text information provided does not constitute an official version of the EU legislation.

The requirements identified in the present document for fish and fishery products does not cover the provisions for live bivalve molluscs, echinoderms, tunicates and marine gastropods.

Further, it has been expressed by several exporters that member states may adopt additional country specific requirements, in particular related with microbiological p. 82 / 119

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testing, that are not addressed by EU legislation. Therefore all exporters should confirm these product requirements before commencing full scale production for export.

4. Importing Countries covered The following countries are member states of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France (including Guyana, Martinique, Guadeloupe and RĂŠunion), Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain (including Andorra and Canary Islands), Sweden, and the United Kingdom.

While Norway and Iceland are not official EU Member States, they have adopted EU requirements and fish exported to those countries are subject to the same requirements. Products landed in either Norway or Iceland may proceed to EU Member States without any additional import controls.

5. Labelling Requirements The following applies to Labelling and Packaging Requirements for Fish and Seafood Products, excluding live bivalve molluscs.

Inner packages and containers for all fishery products exported to the EU must be labelled to indicate: 1. Establishment Approval Number; 2. Exporting Country name This information must be in close proximity, easy to understand and marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible.

The information must be placed so that it is not confused with the product coding information. The approved Exporting Countries establishment number and the Countries designation must be printed on all packaging materials for all products exported to the EU, including wrappers, liners, or any other material used to contain and protect products.

6. Export Certification Requirements Each shipment must be accompanied by a single, original, fully completed EU Health certificate. Certificates must be signed and stamped in ink that is a different colour than the remaining text on the certificate. EU Health certificates may only be issued for product processed or stored in establishments that are listed on the relevant EU Approval List for the product being exported. The name and number of the establishment where the fishery products were processed for export to the EU must be recorded on the EU Health Certificate.

The information on the List of the Exporting Establishments Approved to Export Fishery Products to the European Union must match the information about the exporting establishment that is listed on the certificate and the product labels.

In annex 2 it is shown the Health Certificate full contents and description of the information to be inserted.

Exporters should ensure that their products are accompanied by the proper EU documentation prior to being exported from the dispatch country if transhipped via another country.

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The certificate must provide an accurate description of the identity of the approved processor of the goods, the type of fish being shipped, the quantity of product being shipped, and the final destination of the goods. The details of the product description must indicate whether the product originated from an aquaculture operation or is classified as a fishery product. The certificate must be completed in an official language for the country where the shipment will be subject to import controls.

The EU requires certification of any samples of fish and fish products destined for human consumption.

The details of the product description must indicate whether the product originated from an aquaculture operation or is classified as a fishery product. The fish health attestations must be completed if fish originated from an aquaculture operation.

The certificate for fish and fishery products is different from the certificate for live bivalve molluscs, echinoderms, tunicates and marine gastropods. The process to complete these certificates is similar with a few exceptions.

7. Tolerances/Guidelines These are fully presented in Annex 1.

8. Fish Health and Aquaculture Fish The EU has set certification requirements affecting the marketing of fishery products harvested from aquaculture operations to prevent the introduction and spread of diseases within its territories.

8.1. Fish and Fish Products intended for Human Consumption Fish health requirements apply only if the fish are: - of aquaculture origin; - whole, uneviscerated fish; - not packaged for retail.

If the fish in the consignment meet all three criteria, see annex 2 which shows the Instructions for Part II.2 of Health Certificate for Imports of Fishery Products Intended for Human Consumption related to fish health.

8.2. Fish and Fish Products not intended for Human Consumption Live aquaculture and wild fish not intended for human consumption will require Fish Health certificates. Requirements for these certificates are not included in this document.

For more See Annex 2 - Part II of Certification

9. EU Traceability Requirements The EU has established a system to prevent, deter and eliminate illegal, unreported and unregulated (IUU) fishing. It is formally known as Regulation (EC) No. 1005/2008. View the complete regulation at EU IUU regulation . http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:286:0001:0032:EN:PDF

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The EU IUU regulation will require exporting countries to provide the EU with a Government-validated Catch Certificate attesting that fish and fish products originate from non-IUU (legal) fisheries. Compliance with the EU regulation is mandatory for anyone in the fishing industry who exports their products to the EU. This means that it will be mandatory the existence of a Fisheries Certificate System in the country.

The regulation will apply to catch landed after January 1, 2010 (i.e. not inventory in holding that was caught prior to this date). It generally includes all marine fishery products including live, fresh, chilled, frozen, prepared and preserved product forms.

All freshwater fisheries and aquaculture products are exempt from this regulation, as well as some forms of mollusks such as scallops, mussels, oysters and snails. Annex I of the Regulation (EC) No. 1005/2008 has the list of fishery products excluded from the scope of implementation of the catch certificate.

In case of Fish Processed from Imported Raw Materials for Export to the EU it will be applied a Foreign Catch Export Certificate to meet the Annex IV requirements of the European Union's Illegal, Unreported and Unregulated (IUU) catch regulation.

10. Guidance documents Guidance document on the implementation of certain provisions of Regulation (EC) No 852/2004 on the hygiene of foodstuffs: http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_8522004_en.pdf Guidance document on the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin: http://ec.europa.eu/food/food/biosafety/hygienelegislation/docs/guidance_doc_8532004_en.pdf Guidance document on the implementation of procedures based on the HACCP principles, and on the facilitation of the implementation of the HACCP principles in certain food businesses: http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.pdf Guidance document on sanitary export requirements: http://ec.europa.eu/food/safety/international_affairs/trade/docs/im_cond_fish_en.pdf Guidance document on IUU catch certification requirements: http://ec.europa.eu/fisheries/cfp/illegal_fishing/info/technical_note_en.pdf http://www.seafish.org/media/Publications/SeafishInfoNote_Guidefor3rdCountryExporte rs_201002.pdf

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ANNEX 1 – Tolerances and Guidelines

1. Environmental Contaminants Regulation (EC) No 1881/2006 – last update 1.5.2015 (Last checked: 24.6.2015)

Heavy Metals (Mercury, Lead, Cadmium), Dioxins and PCBs, Tin, PAH Table 1: Maximum Limits for Mercury The following fish species (edible part): anglerfish (Lophius species) atlantic catfish (Anarhichas lupus) bonito (Sarda sarda) eel (Anguilla species) emperor, orange roughy, rosy soldierfish (Hoplostethus species) grenadier (Coryphaenoides rupestris) kinglip (Genypterus capensis) halibut (Hippoglossus hippoglossus) marlin (Makaira species) megrim (Lepidorhombus species) mullet (Mullus species) pink cusk eel (Genypterus blacodes) pike (Esox lucius) plain bonito (Orcynopsis unicolor) poor cod (Tricopterus minutes) portuguese dogfish (Centroscymnus coelolepis) rays (Raja species) redfish (Sebastes marinus, S. mentella, S. viviparus) sail fish (Istiophorus platypterus) scabbard fish (Lepidopus caudatus, Aphanopus carbo) seabream, pandora (Pagellus species) shark (all species) snake mackerel or butterfish (Lepidocybium flavobrunneum, Ruvettus pretiosus, Gempylus serpens) sturgeon (Acipenser species) swordfish (Xiphias gladius) tuna (Thunnus species, Euthynnus species, Katsuwonus pelamis) for other species not referred above1

Limit (maximum) 1,0 mg/kg

0,5 mg/kg

Table 2: Maximum Limits for Lead Following species (edible part): fish Bivalves Cephalopodes Crustaceans1

Limit (max.)

0,3mg/Kg 1,5mg/kg 1,0 mg/kg 0,5mg/Kg

Table 3: Maximum Limits for Cadmium Following species (muscle meat): Fish except the species mentioned below Bivalves and Cephalopodes Crustaceans1 mackerel (Scomber species), tuna (Thunnus species, Katsuwonus pelamis, Euthynnus species), bichique (Sicyopterus lagocephalus) bullet tuna (Auxis species) anchovy (Engraulis species), swordfish (Xiphias gladius), sardine (Sardina pilchardus)

Limit (max.)

0,05 mg/kg 1,0 mg/kg 0,5 mg/kg 0,1 mg/kg 0,15 mg/kg 0,25 mg/kg

1

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Table 4: Maximum Limits for Inorganic tin 200 mg/kg

canned products

Table 5: Maximum Limits for Polycyclic Aromatic Hydrocarbons (PAH) Species

Benzo(a)pyrene

Sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene

2,0

12,0

5,0

30,0

6,0

35,0

Muscle meat of smoked fish and smoked fishery products, excluding fishery products listed below.

Smoked crustaceans1 Smoked sprats and canned smoked sprats (sprattus sprattus); Bivalve molluscs (fresh, chilled or frozen); Bivalve molluscs (smoked)

Table 6: Maximum Limits for Dioxins and PCBs Species

Sum of dioxins (WHO-PCDD/F-TEQ)

Sum of dioxins and dioxinlike PCBS (WHO-PCDD/F-PCB-TEQ)

Sum of PCB28, PCB52, PCB101, PCB138, PCB153 and PCB180 (ICES – 6)

3,5 pg/g wet weight

6,5 pg/g wet weight

75 ng/g wet weight

3,5 pg/g wet weight

6,5 pg/g wet weight

125 ng/g wet weight

3,5 pg/g wet weight

6,5 pg/g wet weight

200 ng/g wet weight

3,5 pg/g wet weight

10,0 pg/g wet weight

300 ng/g wet weight

Fish liver and derived products thereof with the exception of marine oils referred to below

—

20,0 pg/g wet weight (38)

200 ng/g wet weight

Marine oils (fish body oil, fish liver oil and oils of other marine organisms intended for human consumption)

1,75 pg/g fat

6,0 pg/g fat

200 ng/g fat

Muscle meat of fish and fishery products and products thereof, with the exemption of: - wild caught eel - wild caught spiny dogfish (Squalus acanthias) - wild caught fresh water fish, with the exception of diadromous fish species caught in fresh water - fish liver and derived products - marine oils Muscle meat of wild caught fresh water fish, with the exception of diadromous fish species caught in fresh water, and products thereof Muscle meat of wild caught spiny dogfish (Squalus acanthias) and products thereof Muscle meat of wild caught eel (Anguilla anguilla) and products thereof

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Dioxins and PCBs considered Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent using the WHO-toxic equivalency factors (WHO- TEFs)) and sum of dioxins and dioxin-like PCBs (sum of PCDDs, PCDFs and polychlorinated biphenyls (PCBs), expressed as WHO toxic equivalent using the WHO-TEFs). WHO-TEFs for human risk assessment based on the conclusions of the World Health Organization (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006)

Congener

TEF Value

Dibenzeno-p-dioxins (PCDDs)

Congener

TEF Value

‘Dioxin-like’ PCBs Non-ortho PCBs + Mono-ortho PCBs Non-ortho PCBs

2,3,7,8-TCDD

1

PCB 77

0,0001

1,2,3,7,8-PeCDD

1

PCB 81

0,0003

1,2,3,4,7,8,-HxCDD

0,1

PCB 126

0,1

1,2,3,6,7,8-HxCDD

0,1

PCB 169

0,03

1,2,3,7,8,9-HxCDD

0,1

1,2,3,4,6,7,8-HpCDD

0,01

OCDD

0,0003

Dibenzofurans (PCDFs)

Mono-ortho PCBs PCB 105

0,00003

PCB 114

0,00003

2,3,7,8-TCDF

0,1

PCB 118

0,00003

1,2,3,7,8-PeCDF

0,03

PCB 123

0,00003

2,3,4,7,8-PeCDF

0,3

PCB 156

0,00003

1,2,3,4,7,8-HxCDF

0,1

PCB 157

0,00003

1,2,3,6,7,8-HxCDF

0,1

PCB 167

0,00003

1,2,3,7,8,9-HxCDF

0,1

PCB 189

0,00003

2,3,4,6,7,8-HxCDF

0,1

1,2,3,4,6,7,8-HpCDF

0,01

1,2,3,4,7,8,9-HpCDF

0,01

OCDF

0,0003

«T»=tetra, «Pe» =penta, «Hx»= hexa, «Hp»= hepta, «O»= octa, «CDD» = chlorodibenzodioxin; «CDF»= chlorodibenzofuran «CB» = chlorobiphenyl

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2. Sampling Division of lots into sublots Large lots shall be divided into sublots on condition that the sublot may be separated physically. For products traded in bulk consignments (e.g. cereals) Table 1 shall apply.

For other products Table 2 shall apply. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %.

Number of incremental samples The aggregate sample shall be at least 1 kg except where it is not possible, e.g. when the sample consists of 1 package or unit. The minimum number of incremental samples to be taken from the lot or sublot shall be as given in Table 9.

The incremental samples shall be of similar weight/volume. The weight/volume of an incremental sample shall be at least 100 grams, resulting in an aggregate sample of at least about 1 kg. Departure from this method shall be recorded in the record provided for under point 1.8.

Table 7: Subdivision of lots into sublots for products traded in bulk consignments

Lot weight (ton)

Weight or number of sublots

≥ 1 500

500 tonnes

> 300 and < 1 500

3 sublots

≥ 100 and ≤ 300

100 tonnes

< 100

—

Table 8: Subdivision of lots into sublots for other products

Lot weight (ton)

Weight or number of sublots

≥ 15

15-30 tonnes

<15

—

Analysis is undertaken from homogenized sample. Based on Table 9: Minimum number of incremental samples to be taken from the lot/ sublot Weight or volume of lot/sub lot (in kg)

Minimum number of incremental samples to be taken from the lot or sub lot If individual fish than it refers to No. of individual fish which will comprise the sample

<50

3

50 to 500

5

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>500

10

If the lot or sublot consists of individual packages or units, then the number of packages or units which shall be taken to form the aggregate sample is given in Table 10.

Table 10: Number of packages or units (incremental samples) which shall be taken to form the aggregate sample if the lot or sublot consists of individual packages or units Number of packages or units in the lot/sublot â&#x2030;¤ 25

Number of packages or units to be taken At least 1 package or unit

26-100

About 5%, at least 2 packages or units

>100

About 5%, at maximum 10 packages or units

The maximum levels for inorganic tin apply to the contents of each can, but for practical reasons it is necessary to use an aggregate sampling approach. If the result of the test for an aggregate sample of cans is less than but close to the maximum level of inorganic tin and if it is suspected that individual cans might exceed the maximum level, then it might be necessary to conduct further investigations.

Where it is not possible to carry out the method of sampling set out in this chapter because of the unacceptable commercial consequences (e.g. because of packaging forms, damage to the lot, etc.) or where it is practically impossible to apply the abovementioned method of sampling, an alternative method of sampling may be applied provided that it is sufficiently representative for the sampled lot or sublot and is fully documented.

Specific sampling for large fish arriving in large lots In case the lot or sublot to be sampled contains large fishes (individual fishes weighing more than about 1 kg) and the lot or sublot weighs more than 500 kg, the incremental sample shall consist of the middle part of the fish. Each incremental sample shall weigh at least 100 g.

3. Histamine Tolerance Regulation (EC) No. 2073/2005 â&#x20AC;&#x201C; last update 8.03.2014 Applies to histamine producing species (ex. the families: Scombridae, Clupeidae, Engraulidae and Coryphaenidae) Table 11: Histamine Criteria (testing method: HPLC) Products

Sampling methodology

Limits:

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Fishery products from fish species associated with a high amount of histidine

9 samples/lot

Mean value must not exceed 100 ppm,

(if fish, each sample from 1 individual fish)

2 samples may exceed 100 ppm

Fishery products, except those below, which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine

9 samples/lot

Mean value must not exceed 100 ppm,

(if fish, each sample from 1 individual fish)

2 samples may exceed 200 ppm

Fish sauce produced by fermentation of fishery products

1

0 samples to exceed 200 ppm.

0 samples to exceed 400 ppm.

400 m

4. Microbiological Criteria Regulation (EC) No. 2073/2005 â&#x20AC;&#x201C; last update 8.03.2014 Table 12: Microbiological criteria Product

Microbiological criteria

Cooked crustaceans and molluscan shellfish

Salmonella

Shelled and shucked products of

E. coli (after processing):

cooked crustaceans and molluscan shellfish

n=5; c=0 Limits: absent in 25g

n=5; c=2; m=1/g; M=10/g

Method: EN/ISO 6579

Regulation Products placed on the market during their shelf-life

Method: ISOTS16649-3

Coagulase-positive staphylococci (after processing): n=5; c=2; m=100cfu/g; M=1000cfu/g

Method: EN/ISO 6888-1/2

Salmonella n=5; c=0 Limits: absent in 25g Live bivalve molluscs and live echinoderms, tunicates and gastropods

Method: EN/ISO 6579

Salmonella n=5; c=0 (absent in 25g)

Method: EN/ISO 6579

Method: ISOTS 16649-3

E. coli

n=1; (one sample should contain minimum of 10 animals) c=0 Ready to eat products

Limits: 230MPN/100g flesh and intravalvar liquid

Listeria monocytogenes n=5; c=0, m=M=100 cfu/g

Method: EN/ISO 11290-2

n=5; c=0, Absence in 25 g

Method: EN/ISO 11290-1

Before the food has left the immediate control of the food business operator, who has produced it

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5. Drug Residues Regulation (EC) No. 37/2010 – updated last 18.3.2015

a) Prohibited substances Prohibited substances for which monitoring / testing should be undertaken and an MRL cannot be established: Pharmacologically active substance Aristolochia spp. and preparations thereof Chloramphenicol Chloroform Chlorpromazine Colchicine Dapsone Dimetridazole Metronidazole Nitrofurans (including furazolidone) Ronidazole

Malachite Green

b) Substances for which MRLs have been defined (Reg. 37-2010) – last update 18.3.15

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Table 14: Veterinary Substances authorised with or without required Maximum Residue Limits Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

Absinthium extract

NA

All

No MRL

-

-

Acetyl cysteine

NA

All

No MRL

-

-

Acetylmethionine

NA

All

No MRL

-

-

Acetylsalicylic acid

NA

All, except finfish

No MRL -

-

All, except finfish

No MRL -

-

All

No MRL -

-

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per ten only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Acetylsalicylic acid DLlysine

NA

Adenosine and its 5’mono-, 5’- di-and 5’ triphosphates

NA

Adonis vernalis

NA

Aesculus hippocastanum

Agnus castus

Ailanthus altissima

NA

NA

NA

All

All

All

All

No MRL

No MRL

No MRL

No MRL

Alanine

NA

All

No MRL

-

-

Allantoin

NA

All

No MRL

-

For topical use only.

Allium cepa

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

For topical use only.

Aloe vera gel and whole leaf extract of Aloe vera

NA

All

No MRL

p. 93 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

All

MRL

Target Tissues

Therapeutic Classification & Use

-

-

Aloes, Barbados and Capae, their standardised dry extract and preparations thereof

NA

No MRL

Aluminium distearate

NA

All

No MRL

-

-

Aluminium hydroxide

NA

All

No MRL

-

-

Aluminium hydroxide acetate

NA

All

No MRL

-

-

Aluminium monostearate

NA

All

No MRL

-

-

Aluminium phosphate

NA

All

No MRL

-

-

Aluminium salicylate, basic

NA

All, except finfish

No MRL

Aluminium tristearate

NA

All

No MRL

-

-

2-Aminoethanol

NA

All

No MRL

-

-

2-Aminoethanol glucuronate

NA

All

No MRL

-

-

2-Aminoethyl dihydrogenphosphate

NA

All

No MRL

-

-

Ammonium chloride

NA

All

No MRL

-

-

Ammonium lauryl sulphate

NA

All

No MRL

-

-

Ammonium sulfate

NA

All

No MRL

-

-

Amoxicillin

Amoxicillin

All

50 μg/kg

fin fish

Ampicillin

Ampicillin

All

50 μg/kg

NA

All

No MRL

NA

All

No MRL

Anisi stellati fructus, standardised extracts and preparations thereof

NA

All

No MRL

Apocynum cannabinum

NA

Anisi aetheroleum

Aqua levici

NA

All

All

Muscle muscle and skin in natural proportions’

fin fish

Angelicae radix aetheroleum

-

muscle and skin in natural proportions’

-

-

-

-

-

-

-

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only. For oral use only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias only.

-

-

-

For topical use only.

No MRL

NA

All

No MRL

Arnica montana (arnicae flos and arnicae planta tota)

NA

All

No MRL

Anti-infectious agents/Antibiotics

Muscle

No MRL

Arginine

Topical use only

p. 94 / 119

UNIDO â&#x20AC;&#x201C; CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance Arnicae radix

Artemisia abrotanum

Marker residue NA

NA

Species

All

All

MRL

Target Tissues

No MRL

Therapeutic Classification & Use

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

No MRL

Asparagine

NA

All

No MRL

-

-

Aspartic acid

NA

All

No MRL

-

-

Atropa belladonna

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.

-

-

Atropine

NA

All

No MRL

Azagly-nafarelin

NA

All

No MRL

Azamethiphos

NA

Fin fish

No MRL

NA

Antiparasitic agents/ Agents against ectoparasites

Balsamum peruvianum

NA

All

No MRL

-

For topical use only.

Barium selenate

NA

All

No MRL

Bellis perennis

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Benzalkonium chloride

NA

All

No MRL

-

For use as an excipient at concentrations up to 0,05 % only.

Benzocaine

NA

All

No MRL

-

For use as local anaesthetic only.

Benzyl alcohol

NA

All

No MRL

-

For use as excipient.

Benzyl benzoate

NA

All

No MRL

-

-

Benzyl phydroxybenzoate

NA

All

No MRL

-

-

-

-

Alimentary tract and metabolism/mineral supplementsâ&#x20AC;&#x2122;

p. 95 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance Benzylpenicillin

Marker residue Benzylpenicillin

Species

All

MRL 50 μg/kg

fin fish

Target Tissues

Muscle muscle and skin in natural proportions’

Therapeutic Classification & Use Anti-infectious agents/Antibiotics

Betaine

NA

All

No MRL

-

-

Betaine glucuronate

NA

All

No MRL

-

-

Biotin

NA

All

No MRL

-

-

Bismuth subcarbonate

NA

All

No MRL

-

Oral use only

Bismuth subgallate

NA

All

No MRL

-

Oral use only

Bismuth subnitrate

NA

All

No MRL

-

Oral use only

Bismuth subsalicylate

NA

All

No MRL

-

Oral use only

Boldo folium

NA

All

No MRL

-

-

Boric acid and borates

NA

All

No MRL

-

-

Bromide, potassium salt

NA

All

No MRL

-

-

Bronopol

NA

Fin fish

No MRL

-

-

Buserelin

NA

All

No MRL

-

-

n-Butane

NA

All

No MRL

-

-

n-Butanol

NA

All

No MRL

-

Butyl 4-hydroxybenzoate

NA

All

No MRL

-

-

Butylscopolaminium bromide

NA

All

No MRL

-

-

Caffeine

NA

All

No MRL

-

-

Calcium acetate

NA

All

No MRL

-

-

Calcium aspartate

NA

All

No MRL

-

-

Calcium benzoate

NA

All

No MRL

-

-

Calcium borogluconate

NA

All

No MRL

-

-

Calcium carbonate

NA

All

No MRL

-

-

Calcium chloride

NA

All

No MRL

-

-

Calcium citrate

NA

All

No MRL

-

-

Calcium glucoheptonate

NA

All

No MRL

-

-

Calcium gluconate

NA

All

No MRL

-

-

Calcium glucono glucoheptonate

NA

All

No MRL

-

-

Calcium gluconolactate

NA

All

No MRL

-

-

Calcium glutamate

NA

All

No MRL

-

-

Calcium glycerophosphate

NA

All

No MRL

-

-

Calcium hydroxide

NA

All

No MRL

-

-

Calcium hypophosphite

NA

All

No MRL

-

-

Calcium malate

NA

All

No MRL

-

-

Calcium oxide

NA

All

No MRL

-

-

Calcium pantothenate

NA

All

No MRL

-

-

Calcium phosphate

NA

All

No MRL

-

-

For use as excipient.

p. 96 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

Calcium polyphosphates

NA

All

No MRL

-

-

Calcium propionate

NA

All

No MRL

-

-

Calcium silicate

NA

All

No MRL

-

-

Calcium stearate

NA

All

No MRL

-

-

Calcium sulphate

NA

All

No MRL

-

-

Calendula officinalis

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only.

Calendulae flos

NA

All

No MRL

-

For topical use only.

Camphor

NA

All

No MRL

-

External use only.

Camphora

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per hundred only.

-

-

-

-

-

-

Capsici fructus acer

NA

All

No MRL

Carbasalate calcium

NA

All, except finfish

No MRL

Cardamon extract

NA

All

No MRL

Cardiospermum halicacabum

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Carlinae radix

NA

All

No MRL

-

For topical use only.

Carnitine

NA

All

No MRL

-

-

Carvi aetheroleum

NA

All

No MRL

-

-

Centellae asiaticae extractum

NA

All

No MRL

-

For topical use only.

Cetostearyl alcohol

NA

All

No MRL

-

-

Cetrimide

NA

All

No MRL

-

-

Chlorhexidine

NA

All

No MRL

-

For topical use only.

Chlorocresol

NA

All

No MRL

-

-

Chlortetracycline

(sum of parent drug and its 4epimer)

All

100 μg/kg

Muscle

fin fish

Anti-infectious agents/Antibiotics

NA

All

No MRL

Choline

muscle and skin in natural proportions’ -

-

p. 97 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

MRL

Chrysanthemi cinerariifolii flos

NA

All

No MRL

Chymotrypsin

NA

All

No MRL

Cimicifugae racemosae rhizoma

NA

All

No MRL

Cinchonae cortex, standardised extracts and preparations thereof

NA

All

No MRL

Cinnamomi cassiae aetheroleum

NA

All

No MRL

Cinnamomi cassiae cortex, standardised extracts and preparations thereof

NA

All

No MRL

Cinnamomi ceylanici aetheroleum

NA

All

No MRL

Cinnamomi ceylanici cortex, standardised extracts and preparations thereof

NA

All

No MRL

Citronellae aetheroleum

NA

All

Citrulline

NA

All

Cloxacillin

Cloxacillin

All fin fish

300 μg/kg

Target Tissues

-

Therapeutic Classification & Use

For topical use only.

-

-

-

-

-

-

-

-

-

-

-

-

-

-

No MRL

-

-

No MRL

-

-

Muscle muscle and skin in natural proportions’

Anti-infectious agents/Antibiotics

Cobalt carbonate

NA

All

No MRL

-

-

Cobalt dichloride

NA

All

No MRL

-

-

Cobalt gluconate

NA

All

No MRL

-

-

Cobalt oxide

NA

All

No MRL

-

-

Cobalt sulphate

NA

All

No MRL

-

-

Cobalt trioxide

NA

All

No MRL

-

-

Coco alkyl dimethyl betaines

NA

All

No MRL -

For use as excipient.

Muscle

Anti-infectious agents/Antibiotics

Colistin

Condurango cortex, standardised extracts and preparations thereof Convallaria majalis

Copper chloride

Colistin

NA

NA

NA

All fin fish

150 μg/kg

All

No MRL

All

All

muscle and skin in natural proportions’

-

-

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.

-

-

No MRL

No MRL

p. 98 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

Copper gluconate

NA

All

No MRL

-

-

Copper heptanoate

NA

All

No MRL

-

-

Copper methionate

NA

All

No MRL

-

-

Copper oxide

NA

All

No MRL

-

-

Copper sulphate

NA

All

No MRL

-

-

Coriandri aetheroleum

NA

All

No MRL

-

-

Corticotropin

NA

All

No MRL

-

-

Crataegus

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Cupressi aetheroleum

NA

All

No MRL

Cysteine

NA

All

No MRL

Cytidine and its 5’-mono-, 5’-di- and 5’-triphosphates

NA

All

No MRL

Danofloxacin

Danofloxacin

All

100 μg/kg

Muscle

fin fish

-

For topical use only.

-

-

-

-

muscle and skin in natural proportions’

Anti-infectious agents/Antibiotics

Deltamethrin

Deltamethrin

Fin fish

10 μg/kg

muscle and skin in natural proportions’

Antiparasitic agents/ Agents against ectoparasites

Dexpanthenol

NA

All

No MRL

-

-

Diclazuril

NA

All

No MRL

-

For oral use only.

Difloxacin

Difloxacin

All

300 μg/kg

Muscle

fin fish

Anti-infectious agents/Antibiotics

muscle and skin in natural proportions’

Dimanganese trioxide

NA

All

No MRL

-

For oral use only.

Dimethicone

NA

All

No MRL

-

-

Dimethyl acetamide

NA

All

No MRL

-

-

Dimethyl phthalate

NA

All

No MRL

-

-

Dimethyl sulphoxide

NA

All

No MRL

-

-

Dinoprost

NA

All

No MRL

-

-

Dinoprost tromethamine

NA

All

No MRL

-

-

Dinoprostone

NA

All

No MRL

-

-

Diprophylline

NA

All

No MRL

-

-

D-Phenylalanine (6) – luteinising- hormone releasing hormone

NA

All

No MRL

-

-

Doxycycline

Doxycycline

Fin fish

100 μg/kg

“muscle and skin in natural proportions”.

Anti-infectious agents/Antibiotics’

p. 99 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance Echinacea

Marker residue NA

Species

All

MRL

Target Tissues

No MRL

Therapeutic Classification & Use

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

For topical use only.

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only.

-

For topical use only.

Echinacea purpurea

NA

All

No MRL

Emamectin

Emamectin B1a

Fin fish

100 μg/kg

muscle and skin in natural proportions’

Antiparasitic agents/ Agents acting against endo- and ectoparasites

Enrofloxacin

(sum of enrofloxacin and ciprofloxacin)

All

100 μg/kg

Muscle

fin fish

Anti-infectious agents/Antibiotics

Epinephrine

NA

All

No MRL

Erythromycin

Erythromycin A

All fin fish

200 μg/kg

muscle and skin in natural proportions’ -

-

Muscle

Anti-infectious agents/Antibiotics

muscle and skin in natural proportions’

Etamiphylline camsylate

NA

All

No MRL

-

-

Etamsylate

NA

All

No MRL

-

-

Ethanol

NA

All

No MRL

-

For use as excipient.

Ethyl lactate

NA

All

No MRL

-

-

Ethyl oleate

NA

All

No MRL

-

-

Ethylenediaminetetraacetic acid and salts

NA

All

No MRL

-

-

Eucalypti aetheroleum

NA

All

No MRL

-

-

Eucalyptol

NA

All

No MRL

-

-

Eucalyptus globulus

NA

All

No MRL

Euphrasia officinalis

NA

All

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

No MRL

p. 100 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance Florfenicol

Flumequine

Marker residue

Species

Sum of florfenicol and its metabolites measured as florfenicolamine

All

Flumequine

All

fin fish

MRL

100 μg/kg 1000 μg/kg

fin fish

200 μg/kg

Target Tissues

Muscle muscle and skin in natural proportions’

Muscle

600 μg/kg

muscle and skin in natural proportions’

Therapeutic Classification & Use Anti-infectious agents/Antibiotics

Anti-infectious agents/Antibiotics

Foeniculi aetheroleum

NA

All

No MRL

-

-

Folic acid

NA

All

No MRL

-

-

Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)

NA

All

No MRL -

-

Food additives (substances with a valid E number approved as additives in foodstuffs for human consumption)

NA

-

-

Formaldehyde

NA

All

No MRL

-

-

Formic acid

NA

All

No MRL

-

-

Frangulae cortex, standardised extracts and preparations thereof

NA

All

No MRL -

-

Gentianae radix, standardised extracts and preparations thereof

NA

-

-

Ginkgo biloba

NA

Ginseng

NA

All

All

All

All

All

No MRL

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

-

No MRL

No MRL

Ginseng, standardised extracts and preparations thereof

NA

No MRL

Glutamic acid

NA

All

No MRL

-

-

Glutamine

NA

All

No MRL

-

-

Glutaraldehyde

NA

All

No MRL

-

-

Glycerol formal

NA

All

No MRL

-

-

Glycine

NA

All

No MRL

-

-

Gonadotrophin releasing hormone

NA

All

No MRL

-

-

p. 101 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

-

-

-

-

Guaiacol

NA

All

No MRL

Guanosine and its 5’mono-, 5’- di- and 5’triphosphates

NA

All

No MRL

Hamamelis virginiana

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per ten only.

For topical use only.

Harpagophytum procumbens

Harunga madagascariensis

NA

NA

All

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only

No MRL

Heparin and its salts

NA

All

No MRL

-

-

Heptaminol

NA

All

No MRL

-

-

Hippocastani semen

NA

All

No MRL

-

For topical use only.

Histidine

NA

All

No MRL

-

-

Human chorion gonadotrophin

NA

All

No MRL

Human chorionic gonadotropin (natural HCG and its synthetic analogues)

NA

All

No MRL

Humic acids and their sodium salts

NA

All

No MRL

Hyaluronic acid

NA

All

No MRL

-

-

Hydrochloric acid

NA

All

No MRL

-

For use as excipient.

Hydrocortisone

NA

All

No MRL

-

For topical use only.

Hydrogen peroxide

NA

All

No MRL

-

-

Hydroxyethylsalicylate

NA

All, except fin fish

No MRL

All

No MRL

Hyperici oleum

-

-

-

NA

-

For oral use only.

For topical use -

For topical use only.

p. 102 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance Hypericum perforatum

Marker residue NA

Species

All

MRL

Target Tissues

No MRL

-

Inosine and its 5’-mono-, 5’-di- and 5’-triphosphates

NA

All

No MRL

Inositol

NA

All

No MRL

iodine inorganic compounds including: — Sodium and potassiumiodide — Sodium and potassium- iodate — Iodophors including polyvinylpyrrolidoneiodine

NA

All

No MRL

Iodine organic compounds — Iodoform

NA

All

No MRL

Iron ammonium citrate

NA

All

Iron dextran

NA

Iron dichloride

Therapeutic Classification & Use For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

-

-

-

-

-

-

-

No MRL

-

-

All

No MRL

-

-

NA

All

No MRL

-

-

Iron fumarate

NA

All

No MRL

-

-

Iron glucoheptonate

NA

All

No MRL

-

-

Iron sulphate

NA

All

No MRL

-

-

Isobutane

NA

All

No MRL

-

-

Isoeugenol

Isoeugenol

Fin fish

6000 μg/kg

muscle and skin in natural proportions’

Agents acting on the nervous system/ Agents acting on the central nervous system

Isoleucine

NA

All

No MRL

-

-

Isopropanol

NA

All

No MRL

-

-

Jecoris oleum

NA

All

No MRL

-

For topical use only.

Juniperi fructus

NA

All

No MRL

-

-

Kanamycin

Kanamycin

All, except fin fish

100 μg/kg

Muscle

Anti-infectious agents/Antibiotics

Ketamine

NA

All

No MRL

-

-

Lachnanthes tinctoria

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.

Lactic acid

NA

All

No MRL

-

-

Lanolin

NA

All

No MRL

-

-

Lauri folii aetheroleum

NA

All

No MRL

-

-

Lauri fructus

NA

All

No MRL

-

-

Lavandulae aetheroleum

NA

All

No MRL

-

For topical use only.

p. 103 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

Lespedeza capitata

NA

All

No MRL

-

-

Leucine

NA

All

No MRL

-

-

Lincomycin

Lincomycin

All fin fish

100 μg/kg

All

No MRL

Lini oleum

NA

Muscle muscle and skin in natural proportions’ -

Lobaria pulmonaria

-

Lobeline

NA

All

No MRL

Lufenuron

Lufenuron

Fin fish

(RS-isomers)

(RS-isomers)

1 350 μg/kg

Luteinising hormone (natural LH from all species and their synthetic analogues)

NA

All

No MRL

Lysine

NA

All

Magnesium

NA

Magnesium acetate

Anti-infectious agents/Antibiotics

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

-

Muscle and skin in natural proportions

Antiparasitic agents/Agents (acting) against ectoparasites’

-

-

No MRL

-

-

All

No MRL

-

-

NA

All

No MRL

-

-

Magnesium aluminium silicate

NA

All

No MRL

-

-

Magnesium aspartate

NA

All

No MRL

-

-

Magnesium carbonate

NA

All

No MRL

-

-

Magnesium chloride

NA

All

No MRL

-

-

Magnesium citrate

NA

All

No MRL

-

-

Magnesium gluconate

NA

All

No MRL

-

-

Magnesium glutamate

NA

All

No MRL

-

-

Magnesium glycerophosphate

NA

All

No MRL

-

-

Magnesium hydroxide

NA

All

No MRL

-

-

Magnesium hypophosphite

NA

All

No MRL

-

-

Magnesium orotate

NA

All

No MRL

-

-

Magnesium oxide

NA

All

No MRL

-

-

Magnesium phosphate

NA

All

No MRL

-

-

Magnesium stearate

NA

All

No MRL

-

-

Magnesium sulphate

NA

All

No MRL

-

-

Magnesium trisilicate

NA

All

No MRL

-

-

Majoranae herba

NA

All

No MRL

-

-

Malic acid

NA

All

No MRL

-

For use as excipient

Manganese carbonate

NA

All

No MRL -

Alimentary tract and metabolism/mineral supplements’

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Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

Manganese chloride

NA

All

No MRL

-

For oral use only.

Manganese gluconate

NA

All

No MRL

-

For oral use only.

Manganese glycerophosphate

NA

All

No MRL

Manganese oxide

NA

All

No MRL

-

For oral use only.

Manganese pidolate

NA

All

No MRL

-

For oral use only.

Manganese ribonucleate

NA

All

No MRL

-

For oral use only.

Manganese sulphate

NA

All

No MRL

-

For oral use only.

Mannitol

NA

All

No MRL

-

For oral use only.

Matricaria recutita and preparations thereof

NA

All

No MRL

Matricariae flos

NA

All

No MRL

-

-

Medicago sativa extractum

NA

All

No MRL

-

For topical use only.

Melissae aetheroleum

NA

All

No MRL

-

-

Melissae folium

NA

All

No MRL

-

-

Menadione

NA

All

No MRL

-

-

Menthae arvensis aetheroleum

NA

All

No MRL

Menthae piperitae aetheroleum

NA

All

No MRL

Menthol

NA

All

No MRL

-

-

Methionine

NA

All

No MRL

-

-

Methyl salicylate

Not aplicable

All , except fin fish

No MRL

-

-

-

For oral use only.

-

-

For topical use -

Methylbenzoate

NA

All

No MRL

-

-

1-Methyl-2- pyrrolidone

NA

All

No MRL

-

-

Millefolii herba

NA

All

No MRL

-

-

Mineral hydrocarbons, low to high viscosity including micorcristalline waxes, approximately C10- C60, aliphatic, branched aliphatic and alicyclic compounds

NA

All

No MRL

-

-

Excludes aromatic and unsaturated compounds.

Monothioglycerol

NA

All

No MRL

-

-

Montanide

NA

All

No MRL

-

-

Myglyol

NA

All

No MRL

-

-

Myristicae aetheroleum

NA

All

No MRL

-

-

Neomycin (including framycetin)

Neomycin B

All fin fish

500 μg/kg

Neostigmine

NA

All

No MRL

-

-

Nickel gluconate

NA

All

No MRL

-

-

Nickel sulphate

NA

All

No MRL

-

-

Muscle muscle and skin in natural proportions’

Anti-infectious agents/Antibiotics

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Pharmacologically active Substance Okoubaka aubrevillei

Marker residue NA

Species

All

MRL

Target Tissues

No MRL

Therapeutic Classification & Use

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Oleyloleate

NA

All

No MRL

-

For topical use only

Orgotein

NA

All

No MRL

-

-

Ornithine

NA

All

No MRL

-

-

Orotic acid

NA

All

No MRL

-

-

Oxacillin

Oxacillin

All

300 μg/kg

Muscle

Anti-infectious agents/Antibiotics

fin fish Oxolinic Acid

Oxolinic Acid

All fin fish

Oxytetracycline

100 μg/kg

(sum of parent drug and its 4epimer)

All fin fish

100 μg/kg

Papain

NA

All

No MRL

Paromomycin

Paromomycin

All fin fish

500 μg/kg

muscle and skin in natural proportions’ Muscle

Anti-infectious agents/Antibiotics

muscle and skin in natural proportions’ Muscle

Anti-infectious agents/Antibiotics

muscle and skin in natural proportions’ -

-

Muscle

Anti-infectious agents/Antibiotics

muscle and skin in natural proportions’

Pepsin

NA

All

No MRL

-

-

Peracetic acid

NA

All

No MRL

-

-

Phenol

NA

All

No MRL

-

-

Phenylalanine

NA

All

No MRL

-

-

Phloroglucinol

NA

All

No MRL

-

-

Phytolacca americana

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.

-

-

Phytomenadione

NA

All

No MRL

Piceae turiones recentes extractum

NA

All

No MRL

Policresulen

NA

All

No MRL

-

For topical use only

Poloxalene

NA

All

No MRL

-

-

Poloxamer

NA

All

No MRL

-

-

Polyethylene glycol 15 hydroxystearate

NA

All

No MRL

-

-

For oral use only.

For use as excipient.

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Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

Polyethylene glycol 7 glyceryl cocoate

NA

All

No MRL

Polyethylene glycol stearates with 8-40 oxyethylene units

NA

All

No MRL

Polyethylene glycols (molecular weight ranging from 200 to 10 000)

NA

Polyoxyethylene sorbitan monooleate and trioleate

NA

All

No MRL

Polyoxyl castor oil with 30 to 40 oxyethylene units

NA

All

No MRL

Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units

NA

All

No MRL

Polysorbate 80

NA

All

No MRL

-

-

Potassium DL- aspartate

NA

All

No MRL

-

-

Potassium glucuronate

NA

All

No MRL

-

-

Potassium glycerophosphate

NA

All

No MRL

Potassium nitrate

NA

All

No MRL

-

-

Potassium selenate

NA

All

No MRL

-

-

Pregnant mare serum gonadotrophin

NA

All

No MRL

Procaine

NA

All

No MRL

-

-

Proline

NA

All

No MRL

-

-

Propane

NA

All

No MRL

-

-

Propylene glycol

NA

All

No MRL

-

-

Prunus laurocerasus

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.

-

For topical use only.

-

At parenteral doses up to 40 mg/kg bw.

-

For use as preservative only at concentrations of up to 0,5 %.

-

For topical use only.

For use as excipient.

All

No MRL

-

-

For use as excipient.

For use as excipient.

-

Pyrethrum extract

NA

All

No MRL

2-Pyrrolidone

NA

All

No MRL

Quatresin

NA

All

No MRL

-

-

-

-

Quercus cortex

NA

All

No MRL

-

-

Quillaia saponins

NA

All

No MRL

-

-

Rhei radix, standardised extracts and preparations thereof

NA

All

No MRL

Ricini oleum

NA

All

No MRL

-

For use as excipient.

Rosmarini aetheroleum

NA

All

No MRL

-

-

-

p. 107 / 119

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Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

Rosmarini folium

NA

All

No MRL

-

-

Ruscus aculeatus

NA

All

No MRL

-

For topical use only.

Ruta graveolens

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.

-

For topical use

Salicylic acid

NA

All

No MRL

Except fin fish Salviae folium

NA

All

No MRL

-

-

Sambuci flos

NA

All

No MRL

-

-

Selenicereus grandiflorus

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Serenoa repens

NA

All

No MRL

Serine

NA

All

No MRL

-

-

Serotonin

NA

All

No MRL

-

-

Silybum marianum

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

-

-

-

-

-

Sinapis nigrae semen

NA

All

No MRL

Sodium acetylsalicylate

NA

All

No MRL

Except fin fish Sodium benzyl 4hydroxybenzoate

NA

All

No MRL

p. 108 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

MRL

Target Tissues

Therapeutic Classification & Use

-

-

-

-

-

For topical use only.

Sodium boroformiate

NA

All

No MRL

Sodium butyl 4hydroxybenzoate

NA

All

No MRL

Sodium cetostearyl sulphate

NA

All

No MRL

Sodium chloride

NA

All

No MRL

-

-

Sodium cromoglycate

NA

All

No MRL

-

-

Sodium dioctylsulphosuccinate

NA

All

No MRL

-

-

Sodium formaldehydesulphoxylate

NA

All

No MRL

-

-

Sodium glycerophosphate

NA

All

No MRL

-

-

Sodium hypophosphite

NA

All

No MRL

-

-

Sodium lauryl sulphate

NA

All

No MRL

-

-

Sodium propionate

NA

All

No MRL

-

-

Sodium pyrosulphite

NA

All

No MRL

-

-

Sodium salicylate

NA

All

No MRL -

For topical use only.

Except fin fish Sodium selenate

NA

All

No MRL

-

-

Sodium selenite

NA

All

No MRL

-

-

Sodium stearate

NA

All

No MRL

-

-

Sodium thiosulphate

NA

All

No MRL

-

-

Solidago virgaurea

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Sorbitan sesquioleate

NA

All

No MRL

-

-

Sorbitan trioleate

NA

All

No MRL

-

-

Spectinomycin

Spectinomycin

All

300 μg/kg

Muscle

fin fish

Anti-infectious agents/Antibiotics

All

No MRL

Substances used in homeopathic veterinary medicines

NA

Sulfogaiacol

NA

All

No MRL

Sulfonamides (all

Parent drug

All

100 μg/kg

substances belonging to the sulfonamide group) combined total residues of all substances within the sulfonamide group

fin fish

muscle and skin in natural proportions’

-

All substances used in homeopathic veterinary medicinal products provided that their concentration in the product does not exceed one part per ten thousand.

-

-

Muscle muscle and skin in natural proportions’

-

p. 109 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance

Marker residue

Species

MRL

Sulphur

NA

All

No MRL

Symphyti radix

NA

All

No MRL

Syzygium cumini

NA

All

No MRL

Target Tissues

Therapeutic Classification & Use

-

-

-

For topical use on intact skin only.

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

Tanninum

NA

All

No MRL

L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium

NA

All

No MRL

Terebinthinae aetheroleum rectificatum

NA

All

No MRL

Terebinthinae laricina

NA

All

No MRL

Tetracaine

NA

All

No MRL

Tetracycline

Sum of parent drug and its 4epimer

All fin fish

100 μg/kg

Theobromine

NA

All

No MRL

-

-

Theophylline

NA

All

No MRL

-

-

Thiamphenicol

Thiamphenicol

All

-

50 μg/kg

For use as excipient.

-

fin fish NA

All

No MRL

Thiomersal

NA

All

No MRL

NA

All

-

For topical use only.

-

For use as anaesthetic only.

Muscle muscle and skin in natural proportions’

Muscle

All

No MRL

Thuja occidentalis

NA

All

No MRL

Anti-infectious agents/Antibiotics

-

-

For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %.

-

NA

Anti-infectious agents/Antibiotics

-

No MRL

Threonine

For topical use only.

-

muscle and skin in natural proportions’

Thioctic acid

Thiopental sodium

-

For intravenous administration only.

-

-

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.

Thymi aetheroleum

NA

All

No MRL

-

-

Thymidine

NA

All

No MRL

-

-

Thymol

NA

All

No MRL

-

-

Tiliae flos

NA

All

No MRL

-

-

p. 110 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Pharmacologically active Substance Tilmicosin

Marker residue Tilmicosin

Species

All

MRL 50 μg/kg

fin fish Timerfonate

NA

All

Target Tissues

Muscle muscle and skin in natural proportions’

No MRL -

Toldimfos

NA

All

No MRL

-

Tosylchloramide sodium

NA

finfish

No MRL

-

Tragacanth

Therapeutic Classification & Use Anti-infectious agents/Antibiotics

For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %.

For water-borne use

-

Tricaine mesilate

NA

finfish

No MRL

Trimethoprim

Trimethoprim

All

50 μg/kg

fin fish

Muscle muscle and skin in natural proportions’ -

For water-borne use Anti-infectious agents/ Chemotheurapeutics

Trimethylphloroglucinol

NA

All

No MRL

-

Triptorelin acetate

NA

All

No MRL

Trypsin

NA

All

No MRL

-

-

Tryptophan

NA

All

No MRL

-

-

Turnera diffusa

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at

Agents acting on the reproductive system’

concentrations corresponding to the mother tincture and dilutions thereof only.

Tylosin

Tylosin A

All fin fish

100 μg/kg

Muscle muscle and skin in natural proportions’

Anti-infectious agents/Antibiotics

Tyrosine

NA

All

No MRL

-

-

Urea

NA

All

No MRL

-

-

Urginea maritima

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.

For oral use only.

-

-

Uridine and its 5’-mono-5’di- and 5’-triphosphates

NA

All

No MRL

Urticae herba

NA

All

No MRL

-

-

Valine

NA

All

No MRL

-

-

Virola sebifera

NA

All

No MRL

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.

p. 111 / 119

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Pharmacologically active Substance Viscum album

Marker residue NA

Species

All

MRL

Target Tissues

No MRL

Therapeutic Classification & Use

-

For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.

-

-

Vitamins A, B1, B2, B3, B5, B6, B12, D, E

NA

All

No MRL

Wool alcohols

NA

All

No MRL

-

Zinc acetate

NA

All

No MRL

-

-

Zinc aspartate

NA

All

No MRL

-

-

Zinc chloride

NA

All

No MRL

-

-

Zinc gluconate

NA

All

No MRL

-

-

Zinc oleate

NA

All

No MRL

-

-

Zinc oxide

NA

All

No MRL

-

-

Zinc stearate

NA

All

No MRL

-

-

Zinc sulphate

NA

All

No MRL

-

-

For topical use only.

6. Additives (Excluding Colouring agents and Sweeteners) EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No 95/2/EC

List of permitted additives and products with permitted usage and limits: Additive

Benzoic or Sorbic Acid 1

Sulphites 2

Product

Limit (ppm)

Semi-preserved fish products including fish roe

2000

Cooked Shrimp

2000

Salted, dried fish

200

Dried, salted fish of Gadidae species

200

Fresh and frozen cephalopods

150

Crustaceans of the families Penaeidae, Soleneridae and Aristedae  up to 80 units

150

Crustaceans of the families Penaeidae, Soleneridae and Aristedae  between 80 and 120 units

200

Crustaceans of the families Penaeidae, Soleneridae and Aristedae  over 120 units

300

Crustaceans of the families Penaeidae, Soleneridae andAristedae

50

p. 112 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

Additive

Product



Phosphates 3

Limit (ppm) cooked

Fresh and frozen crustaceans not included above

150

Surimi

1000

Frozen Fillets of unprocessed4 fish

5000

Frozen molluscan shellfish (excluding scallop meats)

5000

Frozen Crustaceans

5000

Fish and Crustacean pastes

5000

Calcium disodium EDTA

Canned and bottled fish, frozen crustaceans and molluscs

75

Boric Acid

Caviar (sturgeon's eggs)

4

Citrates

Unprocessed4 fish, crustaceans and molluscs

GMP

Nitrates

Pickled Herring and sprat

200

4-Hexylresorcinol

Fresh, frozen and deep-frozen crustaceans

Sorbitol, Mannitol, Isomalt, Maltitol, Lactitol, Xylitol

Frozen unprocessed4 fish, crustaceans, molluscs and cephalopods (for purposes other than sweetening).

2

GMP

1

Benzoic or Sorbic Acid may be used singly or in combination. If used in combination, total of both additives may not exceed the limit shown.

2 Sulphites expressed as sulphur dioxide (SO2) 3 Phosphates expressed as P2O5 4 Unprocessed fish refers to fish in its raw state, excluding products such as smoked or marinated fish.

5 GMP – in line with good manufacturing practices.

7. Guidelines on Parasites Parts of fish which contain visible live or dead nematodes are to be removed and must not be marketed. Processors should make every effort to achieve this through a nondestructive examination of the fish and fish products during processing by qualified personnel.

The procedure must be performed under good light conditions, including, if necessary, candling. When processing conditions do not allow for the examination of each individual fish (e.g., mechanical evisceration and/or filleting operations), the processor must develop a sampling plan for each batch of processed fish. The sampling plan for mechanically eviscerated fish must include a representative number of samples of not less than 10 fish per batch.

The following fish products must be subjected to freezing at a temperature of not more than -20°C in all parts of the product for not less than 24 hours: 1. fish to be consumed raw or almost raw; 2. the following species, if they are to undergo a cold-smoking process at which the internal temperature of the fish is less than 60°C: o herring; o mackerel; o sprat; o (wild) Atlantic and Pacific salmon; and p. 113 / 119

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3. marinated and/or salted herring where this process is insufficient to destroy the larvae of nematodes.

It is recommended that for salted fish, the ratio of minimum salt content in the fish tissue and the minimum storage time comply with the following: Ratio of salt content in fish tissue with minimum storage time Salt Content

Storage Time

20%

21 days

15%

28 days

12% (with sugars)

35 days

The required storage time does not include transportation time.

It is recommended that for marinated fish, the salt content, vinegar content, and duration of marination must comply with the following: the water contained in the tissue of the fish must contain at least 2.4% vinegar (as acetic acid) and 6% salt (sodium chloride), and the pH must not exceed 4.2. The fish must have been marinated for at least 35 days prior to further processing.

The manufacturer may have to supply documentation indicating the type of process that the above fishery products have undergone.

p. 114 / 119

UNIDO – CEDEP II Legal and SPS requirements of fishery products of potential importing countries EUROPEAN UNION section

ANNEX 2 – The EU Health Certificate: Information required to complete the EU Health

Certificate for Imports of Fishery Products Intended for Human Consumption General:  Please complete the certificate in capitals.  To positively indicate any option, please tick or insert an X.  Where mentioned, the ISO codes use the two-letter country code in compliance with the international standard ISO3166 alpha-2.

Part I – Information on the consignment shipped Country: Please indicate the third country issuing the certificate Box I.1: Consignor: Please give the name and address (street, town and region/province/state, as applicable) of the physical or legal person who sends the consignment. The consignor must be located outside of the European Community. It is recommended that telephone and fax numbers or the email address be given.

Box I.2: Certificate Reference Number: The certificate reference number is the number that the CFIA assigns in accordance with its own classification.

Box I.2a: Reserved for the EU's TRACES notification. The TRACES number of the certificate is a unique reference number assigned by the TRACES system.

Box I.3: Competent Central Authority: The name of the Central Authority of the country of dispatch which is responsible for certification.

Box I.5: Consignee: Please give the name and address (street, town and post code) of the physical or legal person to whom the consignment is shipped in the Member State of destination.

Box I.7: Country of origin: Please give the name and ISO Code of the third country in which the finished products were produced, manufactured or packaged (i.e., Cambodia – KH).

Box I.8: Region of origin: Only applicable for live, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods, excluding the adductor muscle of Pectinidae. Indicate the production area as defined by the country.

Box I.9: Country of destination: Please give the name ISO Code of the Member State of destination of the animals or products. (i.e., Portugal – PT).

Box I.11: Place of origin: place from which the products come. Only the establishment shipping the products or by-products is to be named, including cold storage warehouses if product is dispatched to the EU from storage, and the country of dispatch if different from the country of origin. Please give the name, address (street, town and region/province/state, as applicable) and the approval or registration number of these structures.

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Place of loading: For products, please indicate the place of loading.

Box I.14: Date of departure Box I.15: Means of transport: Registration number (railway wagons or container and Lorries), flight number (aircraft) or name (ship). Separate information is to be provided in the event of unloading and reloading.

Box I.16: BIP of entry into the EU: Please enter the name (column 1) and the number (column 2) of the BIP. To locate the correctbvBIP information, please consult the most recent document under the Consolidated Versions heading on the Commission Decision 2009/821/EC website that is available on the world wide web. [Note: this is a link to the Eur-lex bibliographic notice page.

Consolidated decisions and annexes are available from this page. The exporter should contact their importer in the European Union for any information on updated Border Inspection Posts (i.e., annexes to decision).]

This information can be changed until the Common Veterinary Entry Document is completed.

Box I.18: Description of goods: Give a description of the goods or use the titles as they appear in the World Customs Organisation's Harmonised System. This customs description shall be supplemented, if necessary, by any information required to classify the goods (species, processing, etc.).

Box I.19: Identify product according to HS code: Use the appropriate 4 digit HS codes under chapter 03, chapter 05, chapter 15 or chapter 16 as required.

Box I.20: Quantity: Must include both gross and net weight (in Kilograms).

Box I.21: Temperature of the product: please tick the appropriate temperature for transport/storage of the product.

Box I.22: Number of packages: Please indicate the total number of packages for products.

Box I.23: Identification of container/Seal Number: If shipping containers are used to transport the fish, please indicate the identification number(s) of the container(s), and the seal(s) used to secure the container(s).

Box I.24: Type of packaging: only for products.

Box I.25: Goods certified for the purposes of Human consumption.

Box I.27: Final import Box I.28:

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Identification of goods: Identification of the commodities: specify if aquaculture or wild origin.

Treatment type: live, chilled, frozen, processed. Manufacturing plant: includes factory vessel, freezer vessel, processing plant.

Part II – Certification Box II.a.: Certificate Reference number: cf. Box I.2.

Box II.b.: TRACES reference number: cf. Box I.2a.

Part II.2 under the health attestation section (page 2 of 3 of the certificate) is stricken for all exports except commodities that meet all of the following:    

are of aquaculture origin; are whole, uneviscerated fish; are not packaged for retail; are one of the following species:

Part II of the Notes should be left intact and must not be stricken out as they are part of the health certificate.

Scientific Name

Common Name

Oncorhynchus spp.

All Pacific salmon (chum, coho, masou, sockeye, pink, chinook)

Salmo salar

Atlantic salmon

Oncorhynchus mykiss

Rainbow trout

Salmo trutta

Brown trout / Sea trout

Clupea spp.

Herring

Gadus aeglefinus

Haddock

Gadus macrocephalus

Pacific cod

Gadus morhua

Atlantic cod

Perca fluviatilis

Redfin perch

Coregonus sp.

Whitefish

Esox lucius

Pike

Onos mustelus

Rockling

Scophthalmus maximus

Turbot

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Sprattus sprattus

Sprat

Thymallus thymallus

Grayling

Cyprinus carpio

Common carp / Koi carp

Decapoda

All decapod crustaceans

Catla

catla

Channa

Snakehead

Labeo

Labeo / carp

Mastacembelus

Spiny eel

Mugil

Mullet

Puntius

Barb

Trichogaster

Gourami

If the shipment meets the above-listed conditions, then they can be subject to the Aquatic Health Export conditions.

Aquaculture (as defined by Council Directive 2006/88/EC), means the rearing or cultivation of aquatic organisms using techniques designed to increase the production of those organisms beyond the natural capacity of the environment and where the organisms remain the property of one or more natural or legal persons throughout the rearing or culture stages, up to and including harvesting.

Animal Health Attestation for Fishery Products of Aquaculture Origin Instructions for Part II.2 of Health Certificate for Imports of Fishery Products Intended for Human Consumption (EU)related to fish health.

Please note that each deletion instructed below must be signed and stamped by the official inspector, in addition to the stamp at the bottom of the page.

Not relevant for wild-caught fish. - Delete all attestations under section II.2 Not relevant for products in packages that are intended for direct human consumption. – Delete all attestations under section II.2.

All other products of aquaculture origin must be eviscerated. - Delete appropriate conditions from section II.2 to indicate that the fish have been slaughtered and eviscerated.

1. Part II.2 is not relevant for consignments intended for retail, provided they comply with the rules applying to packaging and labelling laid down in Regulation (EC) No. 853/2004.

2. Aquacultured finfish must be eviscerated.

3. If fish susceptible to EHN and/or ISA (see list of known susceptible species) strike out the statement:  originate from a source considered free from ISA and/or EHN in accordance with the relevant EU legislation or OIE Standard.

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4. If fish susceptible to VHS and/or IHN (see list of known susceptible species) strike out the statement: ď&#x201A;§ originate from a source considered free from VHS/ IHN in accordance with the relevant EU legislation orOIE Standard.

5. If fish is not included in the list of species known to be susceptible to EHN, ISA, VHS, and/or IHN, strike out all applicable statements except for the general health attestation regarding clinical health and transportation.

List of known susceptible species Table of fish diseases and host species Disease

Susceptible host species

EHN

Redfin perch (Perca fluviatilis), rainbow trout (Oncorhyynchus mykiss)

ISA

Atlantic salmon (Salmo salar), rainbow trout (Oncorhyynchus mykiss), brown trout (Salmo trutta)

VHS

Atlantic cod (Gadus morhua), Atlantic herring (Clupea harengus), brown trout (Salmo trutta), Chinook salmon (Oncorhyynchus tshawytscha), coho salmon (O. kisutch), grayling (Tymallus thymallus), haddock (Melanogrammus aeglefinus), Pacific cod (Gadus macrocephalus), Pacific herring (Clupea harengus pallasi), pike (Esox lucius), rainbow trout (Oncorhyynchus mykiss), rockling (Rhinonemus cimbrius), sprat (Sprattus sprattus), turbot (Scopthalmus maximus), whitefish (Coregonus spp.)

IHN

Rainbow or steelhead trout (Oncorhyynchus mykiss), the pacific salmon species (Chinook salmon (Oncorhyynchus tshawytscha), sockeye salmon (O. nerka), chum salmon (O. keta), masou salmon (O. masou), pink salmon (O. rhodurus), and coho salmon (O. kisutch) and Atlantic salmon (Salmo salar)

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Other Countries

For introducing other exporting country conditions and requirements it is suggested as starting point to check the available information at the Canadian Food Inspection Agency website in reference to the conditions by country: http://www.inspection.gc.ca/food/fish-and-seafood/exports/byjurisdiction/eng/1304197334656/1304197442121

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