Quyết định 117/2008/QD-BNN

DECISION

PROMULGATING THE REGULATION ON INSPECTING AND CERTIFYING FOOD HYGIENE AND SAFETY CONDITIONS OF FISHERY TRADERS AND PRODUCERS

MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Decree No.01/2008/ND-CP dated January 03, 2008 of Government defining the functions, tasks, powers and organizational structure of The Ministry Of Agriculture and Rural Development;
Pursuant to the Fisheries Law of November 26, 2003;
Pursuant to the Ordinance on Food Hygiene and Safety and Decree No.163/2004/ND-CP dated September 07, 2004 of the Government detailing the implementation of some Articles of the Ordinance on Food Hygiene and Safety;
Pursuant to Decree No.59/2005/ND-CP dated May 04, 2005 of the Government on conditions for trading a number of aquatic resource production and business lines;
Pursuant to the Decree No.79/2008/ND-CP dated July 18, 2008 of the Government stipulating the system of organization and management, inspection and testing of food hygiene and safety;
Pursuant to the Joint Circular No.24/2005/TTLT-BYT-BTS dated December 08, 2005 of the Ministry of Health and the Ministry of Fisheries (now the Ministry of Agriculture and Rural Development), guiding the centralization, coordination in the state management on fishery-food hygiene and safety;
At the Proposal of the Director of National Agro-Forestry-Fisheries Quality Assurance Department,

DECIDES:

Article 1. Issuing together with this Decision the "Regulation on inspecting and certifying food hygiene and safety conditions of fishery traders and producers ", replaces the "Regulation on inspection and recognition of getting food hygiene and safety standards of fishery traders and producers" issued together with Decision No.649/2000/QD-BTS dated 04/8/2000 by the Minister of Fisheries;

Article 2. This Decision takes effect 15 days after its publication on Official Gazette

Article 3. Head of Ministry's Office, Director of National Agro-Forestry-Fisheries Quality Assurance Department, Heads of the agencies under the Ministry, the Directors of Agriculture and Rural Development Departments of the provinces and cities under central authority shall implement this Decision./.

REGULATION

ON INSPECTING AND CERTIFYING FOOD HYGIENE AND SAFETY CONDITIONS OF FISHERY TRADERS AND PRODUCERS
 (Promulgated in closure with Decision No. 117/2008/QĐ-BNN dated December 11 2008 of Minister of Agriculture and Rural Development)

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation

The regulation lays down procedures on inspecting and certifying food hygiene and safety (hereinafter abbreviated to FHS) of fishery traders and producers (hereinafter called establishments for short); obligations and rights imposed on stakeholders.

Article 2. Subjects of Regulation

1. The following subjects governed by the Regulation:

a) Fishing vessels with main engine of at least 50 CV (including factory vessels which process fishery products for domestic consumption); landing sites; auction markets; separate establishments which produce ice-water for fishery preservation and processing; midlemen, preparing establishments; establishments which store and package fishery products for domestic consumption; establishments which process fishery products for domestic consumption;

b) Factory verssels which process fishery products for export; bivalve molluskc purifying establishments and midlemen; separate cold storage for fishey preservation; establishments which store and package fishery products for export; establishments which process fishery products for export.

2. The following subjects not governed by the Regulation:

a) Small-size producers (households and individuals) for individual consumption.

b) Retailers and restaurants

c) Retail markets;

d) Establishments manufacturing products of aquatic animal origin not destined for human consumption

Article 3. Interpretation

For the purposes of the Regulation, the following definitions shall apply:

1. Fishery product means all aquatic animals, plants and amphibians, or parts thereof, including their roes used for producing food or component products.

2. Preparation means any operation that affects the initial wholeness of raw materials (i.e. heading, gutting, skinning, filleting, slicing, boning, mincing, grinding, cutting, pruning, purifying, peeling, flattening, chilling or freezing for preservation) but not alter their anatomical nature.

3. Processing means any operation that substantially alters anatomical nature of raw materials (i.e. heating, smoking, curing, maturing, drying, salting, extraction and extrusion).

4. Ready-to-eat fishery product means any fishery product which does not require handling before consumption.

5. High risk fishery product means any ready-to-eat fishery product or fishery product of aquatic animal origin which have serious risks.

6. Similar fishery products means fishery products which have similar risk level if consumpted, similar processing procedures and originated from same establishment.

7. Middleman means any point where collection, purification, classification, preservation of raw fishery materials are carried out to provide for markets or processing establishments

8. Preparing establishment means any premise where one or some operations on preparing are carried out to provide raw materials for other processing establishments.

9. Fishery processing establishment means any premise where one or some operations on preparing or processing are carried out and its products are packaged to place on the market.

10. Separate fishery processing establishment means any premise which is established in compliance with existing regulations and granted own seal; separated from other premises; with sufficient factories, equipments and facilities for carrying out all production stages from raw material receipt to final products.

11. Fishing vessel means any ship or boat used to catch, collect, transport, prepare and preserve fishes.

12. Factory vessel means any vessel which is equipped to carry out one or some operations on preparing or all production stages including package, and chilling or freezing if any.

13. Landing site means any area (including coast and port) where fishing vessels land. Landing site consist of wharf, freight yard, premises, areas reserved for administration, service and commerce (export, import).

14. Auction market means any point where wholesale or auction and collection , preparation (if any) are carried out.

Article 4. Bases for inspection, certification

1. Inspection and certification for FHS conditions shall be carried out in compliance with Vietnamese FHS regulations and standards applicable to fisheries.

2. In addition, inspecting and certifying establishments which have fishery products for export shall be carried out incompliance with not only the Item 1 of this Article but also the international protocols, the bilateral arrangements, requirements of importing countries

Article 5. Inspecting, certifying bodies (ICBs)

1. Local ICB assigned by Provincial Departments of Agriculture and Rural Development shall be responsible for inspecting and certifying establishments regulated by the Point a, the Item 1, the Article 2 of the Regulation.

2. The National Agro-Forestry-Fisheries Quality Assurance Department shall be responsible for inspecting and certifying establishments mentioned at the Point b, the Item 1, the Article 2 of the Regulation

3. The National Agro-Forestry-Fisheries Quality Assurance Department, Provincial Departments of Agriculture and Rural Development shall decentralize responsibility for implementation, pursuant to scope and subjects regulated by the Article 1 and 2 of the Regulation.

Article 6. Forms of inspection and audit

1. Inspection for certification:

a) Shall inspect all FHS conditions including premises, equipments, hygiene management program, procedures on traceability

b) Shall apply for any establishment which is not certified yet; any establishment which is already certified but repaired and upgraded that makes risk possibility change other than the initial inspection; any establishment which has new products not similar with the approved products; any establishment which has completed corrective actions after being suspended; any establishment which register for approval of exportation to the countries under bilateral arrangements;

2. Routine inspection: shall apply for any establishment which has valid certificate so as to supervise FHS conditions maintained by such establishment; hygiene management program and traceability procedures implemented by such establishment.

3. Unforeseen inspection: shall apply for any establishment which has violations of FHS conditions and be randomly implemented by ICBs.

4. Audit: shall be implemented by ICBs if any establishment disagree with results given by inpsection team.

Article 7. Issuance, management and use of approval codes

1. Every separate fishery processing establishment which is approved for FHS conditions shall be granted approval code and certificate. System on approval codes shall be applied in compliance with the enclosed Annex of the Regulation. If any establishment which has many factories but they are not separate as required, such establishment shall be granted only one approval code.

2. If any establishment which has many factories that are not separate but have been granted approval codes before the effective date of the Regulation, such factories could use the existing approval codes but shall be subject to the same management and control taken by ICB, particularly in case of that one of factories commits FHS regulations.

Chapter II

PROCEDURES ON INSPECTION AND CERTIFICATION

Article 8. Planning and Information

1. ICB shall make annual inspection plan and inform establishments which are not certified yet, together with guidance for application in writing to establishments to be inspected under control.

2. If any establishment does not register for inspection as laid down in the Item 1 of the Article, ICB shall still inspect such establishment as planned.

3. If any establishment registers for inspection:

a) Shall comply regulations on registration for inspection as laid down in the Article 9;

b) ICB shall, within 5 (five) working days, review applications and request such establishment to supplement documents (if any).

c) In case of satisfaction, ICB shall, within 7 (seven) working days, inform such establishment the timing for inspection activities but no later than 15 (fifteen) days since reception of satisfactory documents.

4. For any fishing vessel which is not certified yet, ICB shall make consensus with owner to define the appropriate timing and place for on-site inspection activities.

Article 9. Registration for Inspection

1. Establishments, which are not certified yet, shall complete and submit their registration documents to ICB as regulated in the Article 5 of the Regulation.

2. Documents are required as follows:

a) Registration form according to the Annex 2 of the Regulation (the Annex 2a: apply for fishery processing establishments, the Annex 2b: apply for other establishments).

Hygiene management program as regulated in the Table 3, the Annex 1 of the Regulation

c) Procedures on traceability

3. Registration documents may be sent to ICB by personal submission, fax, e-mail, electronic system (the original shall be sent later), post.

Article 10. Making up inspection and audit team

1. Head of ICB shall decide in writing to make up inspection, audit team (hereinafter called inspection team) for FHS conditions.

2. Such decision includes :

a) Basis for inspection;

b) Scope, items, method and timing of inspection;

c) Name, postal address and approval code (if any) of any establishment to be inspected;

d) Name, positions of leader and members of inspection team;

e) Obligations imposed on establishment and inspection team;

3. Inspectors (including leader of inspection team) shall be officials who are trained, have capability to inspect FHS conditions in the field of fishery.

4. Such decision shall be informed on the spot before starting implementation of inspection activities.

Article 11. Items and method

1. Items to inspect FHS conditions include :

a) FHS conditions of premises, equipments;

b) Hygiene management program;

c) Procedures on traceability

2. Method, items to inspect, evaluation of deficiencies shall be implemented under guidance document given by the National Agro-Forestry-Fisheries Quality Assurance Department.

Article 12. Inspection paper

1. Inspection paper shall include:

a) Sufficient and exact inspection results and be completed on the spot after finishing inspection according to the model given by the National Agro-Forestry-Fisheries Quality Assurance Department;

b) Deficiencies and deadline for corrective actions;

c) General conclusion on FHS conditions and classification of establishment as laid down at the Item 1 and 2 of the Article 13 of the Regulation;

d) Opinions given by competent representative of establishment about inspection results and committment to corrective actions;

đ) Signatures of inspection team leader and competent representative of establishment in closure with seal of such establishment (if any);

e) Two duplicate: one for ICB, one for establishment, it is possible to increase quantity if neccesary.

2. If represenative of establishment does not agree to sign on inspection paper, inspection team shall note the statement ”the representative of establishment did not sign” and reasons but such inspection paper shall be still authentic in case of having signatures of all inspection team members.

Article 13. Classification of establishment

1. Grade ’pass” and grade ”fail” shall be used for establishments mentioned at the Point a, the Item 1, the Article 2 of the Regulation, in details:

a) If any establishment which has eligeble FHS conditions or some deficiencies that are not serious and may be corrected for a short time (no later than 30 days since inspection date), such establishment shall be graded as ”pass”;

b) If any establishment which has ineligeble FHS conditions and correction to deficiencies for a short time is impossible, it shall seriously affect FHS in case of continuing production, such establishment shall be calssified as ”fail”

2. Grade A, B, C, D shall be used for establishments mentioned at the Point b, the Item 1, the Article 2 of the Regulation, in details :

a) Grade A for any establishment which satisfies FHS conditions

b) Grade B for any establishment which basically satisfies FHS conditions but has some deficiencies that affect FHS not much;

c) Grade C for any establishment which does not satisfy FHS conditions but may correct deficiencies for a short time (no later than 30 days since inspection date);

d) Grade D for any establishment which does not satisfy FHS conditions and correction to deficiencies for a short time is impossible, it shall seriously affect FHS in case of continuing production.

3. Only establishments, which are approved as ”Pass”, Grade A or Grade B, shall be certified for FHS conditions.

4. The National Agro-Forestry-Fishries Quality Assurance Department shall develop and promulgate guidance document for classification.

Article 14. Frequency of routine inpsection

1. Frequency of routine inspection applied for establishments shall be as follows:

a) Establishments which manafacture high-risk fishery products: semi-annual;

b) The others: annual;

2. Establishments present in the list of establishments authorized to export to countries, which require frequency higher than that is laid down at the Item 1 of this Article, shall be subject to frequency of those countries.

3. Timing of routine inspection shall be calculated from the latest inspection, randomly carried out on any date of the last month within inspection deadline. For fishing verssels, owners may request local ICB for routine inspection.

4. Any establishment which intends to delay routine inspection shall obligatorily submit a request letter along with explaination. ICB shall respond in a written text that indicates appropriate control measures imposed on such establishment:

a) Strengthening to inspect its final products;

b) Suspending inspection, certification for products placing on the market.

c) Suspending validity of certificate for FHS conditions

Ariticle 15. Procedures on certification

1. If any establishment satisfies requirements laid down at the Item 3 of the Article 13 of the Regulation, within 10 (ten) days since inspection date, ICB shall make decision to certify for FHS conditions, grant approval code and certificate to such establishment

2. Such decision shall include general information on certified establishment such as name, address, approval code.

3. Model of certificate shall be according to the Annex 3 of the Regulation.

Article 16. Unsatisfactory establishments

1. Within 10 (ten) days since inspection date, ICB shall make notification on unsatisfactory establishment. The notification shall be sent to inspected establsihments, the agency reposible for certifying quality of products, the agency responsible for granting business licience.

2. Such notification shall include:

a) Name and code (if any) of establishment;

b) Reasons refered to unsatisfaction;

c) Deficiencies and dealine for corrective actions;

d) Control measures imposed on such establishment as laid down at the Items 3, 4 and 5 of this Article .

3. For C graded establishment as laid down at the Point c, the Item 2, the Article 13 of the Regulation:

a) ICB shall monthly carry out inspection for FHS conditions.

b) Final products shall be subject to higher frequency of inspection as regulated in the Regulation on inspecting, certifying quality of fishery commodities;

c) After 03 consecutive times, if such establishment is not graded as A or B, it shall be subject to the Item 4 of this Regulation.

4. For D graded establishment as laid down at the Point d, the Item 2, the Article 13 of this Regulation:

a) ICB shall request in writting competent authority to suspend validity of business licience until such establishment is certified for FHS condidions;

b) Products manufactured before suspension date shall be subject to higher frequency of inspection as regulated in the Regulation on inspecting, certifying quality of fishery commodities

c) Suspending validity of certificate granted for such establishment.

5. For ”fail” graded establishment as laid down at the Point b, the Item 1, the Article 13 of this Regulation:

a) Any establishment which stores, packages, produces fishery products for domestic consumption shall be subject to regulations laid down at the Item 4 of this Article;

b) Landing site, auction market: ICB shall in writting request its manager to upgrade FHS conditions and inform appropriate control measures applicapble to products which are loaded and placed for sale at these places

c) Fishing verssel; midlemen; preparing establishment; establishment which produce ice-water for fishery preservation and processing shall be subject to regulations laid down at the Point a and c, the Item 4 of this Article.

Article 17. Suspending validity of certificate

1. Validation of certificate for FHS conditions of any establishment shall be suspended if:

a) Inspection results for FHS conditions are unsatisfactory (grade D);

b) Such establishment is graded C in consecutive three times;

c) Establishment refuses inspection as regulated in this Regulations;

d Establishment requests cancelation of inspection in consecutive two times;

đ) Establishment violates regulations on control of foreign bodies;

e) Establishment violates regulations on use of approval code and labeling seriously;

g) Establishment violates regulations on use of additives;

h) Establishment violates regulations on control and use of banned antibiotics, chemicals;

i) Establishment violates regulation according to results of national monitoring progams for fishery quality and FHS;

k) Establishment which has over 2 (two) consignments notified by foreign competent authority within 6 (six) months for same parameter;

2. For any establishment mentioned at the Item 1 of this Article, ICB shall make decision suspending validity of certificate and approval code. Such decision shall be sent to establishment, the agency responsible for certifying quality of products, the agency reponsible for granting business licience and kept at ICB

3. Such decision shall include:

a) Name and approval code of establishment;

b) Reasons for suspension;

c) Deficiencies and dealine for corrective actions

4. For unsatisfactory establishments mentioned at the Article 16 of this Regulation and establishments whose validity of certificates are suspended: After completion of corrective actions, such establishments shall register with ICB for inspection and certification as regulated by the Article 9 of this Regulation.

Article 18. Extension of certificate

1. Extension of certificate shall be carried out as follows:

a) For fishing verssels: Right after completion of routine inspection, head of inspection team or inspector who carried out inspection activities by herself/himself shall sign to extend validity of certificate as regulated;

b) For other establishments: Within 10 (ten) working days since date of routine inspecton, ICB shall extend validity of certificate as regulated.

2. For any fishing verssel inpsected to extend validity of certificate not by local ICB: within 10 (ten) working days since inpsection, the ICB which inpsected and extended for such fishing verssel shall inform results to local ICB.

Article 19. Renewal of certificate

1. Renewal of certificate shall be carried out as follows:

a) If any certificate is out of space for extension, lost, damaged or any establishment changes or supplements its information, such establishment shall request ICB in writing for renewal of certificate.

b) For any fishing vessel granted certificate but its owner is changed or such fishing vessel is removed to another region whereas certificate is still valid, the owner of such fishing vessel shall submit the certificate to ICB in charge to request for renewal.

2. Within 5 (five) working days since reception date of request for renewal of establishments mentioned at the Item 1 of this Article, ICB shall renew certificate for such establishments.

Article 20. Adding to list of establishments authorized to export to countries

1. Any establishment added to list of establishments authorized to export to countries shall meet the following requirements:

a) Registering with ICB for inspection as regulated by the Article 9 of this Regulation;

b) Hygiene management program shall be available and satisfy with requirements of importing countries, production record within at least 30 (thirty) working days since inspection date shall be available;

c) Being certified by ICB for compliance with requirements of importing countries;

2. The National Agro-Forestry-Fisheries Quality Assurance Department shall add to the list of establishments authorized to export to the countries under bilateral agreements in compliance with regulations of importing countries or agreed procedures.

Chapter III

OBLIGATIONS AND RIGHTS

Article 21. Obligations and rights of inspector

1. Obligations:

a) Inspecting, accessing establishments for compliance with requirements, standards and regulations on FHS conditions;

b) Sampling to test for FHS conditions as regulated if necessary

c) Carrying out obligations assigned by head of inspection team or laid down in decision assigning herself/himself to implement;

d) Complying with procedures, method of inspection; respecting objectiveness, exactness, integrity;

đ) Being responsible to head of inspection team; being responsible to leader of ICB and the existing law if carrying out by herself/himself;

e) Reporting inspection results to head of inspection team or leader of ICB if carrying out by herself/himself;

f) Keeping secret information relevant to business of inspected establishment

2. Rights:

a) Accessing to documents, records relevant to FHS management program of establishment, taking photograph, copying and noting information and sampling if necessary;

b) Making an inspection minutes and affixing seals on specimens for a specific time if establishment commits this Regulation and other relevant requirements.

c) Proposing sanctions if establishment commits regulations on FHS conditions;

d) Reporting to leader of ICB if having different opinions from conclusion by head of inspection team.

đ) Extending validity of certificate for fishing vessels in compliance with the regulations laid down at the Point a, the Item 1, the Article 18 of this Regulation.

Article 22. Obligations and rights of head of inspection team

1. Obligations:

Apart from complying with obligations of an inspector, head of inspection team shall be subject to the following obligations:

a) Managing and enforcing member inspectors to comply with provisions laid down in the decision;

b) Reviewing comments, inspection results reported by member inspectors

c) Signing on inspection minutes and inspection paper, being responsible to leader of ICB and the existing law for inspection results.

2. Rights:

Head of inspection team has the same rights of an inspector and the following:

a) On behalf of inspection team, making conclusion on inspection results;

b) Proposing to leader of ICB for supplementing inspector for implementation of inspection;

c) Requesting leader of ICB to grant certificate and approval code to satisfactory establishments.

Article 23. Obligations and rights of establishment to be inspected

1. Obligations:

a) Registering for inspection as regulated by the Article 9 of this Regulation. Complying with inspection plan made by ICB in spite of not registering for inspection yet;

b) Providing list of competent representative who shall work inspection team in any routine inspection; facilitating inspection activities;

c) Providing all relevant information, documents, records and samples to test if required by inspection team or inspector; being responsible for those information, documents;

d) Maintaining certified FHS conditions;

đ) Carrying out corrective actions required in inspection minutes and ICB notifications;

e) Own-checking FHS conditions as guided and sending results to ICB as regulated if such establishment is subject to relaxed frequency;

f) Developing and implementing trace system with the principle “one step back, one step forward”

g) Signing on inspection minutes.

2. Rights:

a) Giving opinions (agree or disagree) on inspection results;

b) Appealing, in compliance with regulations, against inspection results;

c) Informing leader of ICB about misconducts of inspection team and inspectors

Article 24. Obligations and rights of local ICB assigned by Provincial Department of Agriculture and Rural Development

1. Obligations:

a) Making and informing inspection plan to establishments under control, carrying out inspection and certification as regulated by the Item 1, the Article 5 of this Regulation.

b) Coordinating with local ICBs of other Provincial Departments of Agriculture and Rural Development to routinely inspect, extend certificate for FHS conditions of fishing vessels as regulated by the Item 3, the Article 14 of this Regulation;

c) Keeping records relevant to inspection and certification; providing records, adequately and exactly explaining issues on inspection and certification if required by Provincial Department of Agriculture and Rural Development or the National Agro-Forestry-Fisheries Quality Assurance Department;

d) Keeping secret information relevant to business of inspected establishments;

đ) Quarterly reporting in writing to the Provincial Department of Agriculture and Rural Development and the National Agro-Forestry-Fisheries Quality Assurance Department on inspection results; situation on audit, management, treatment of violations of establishments under control; proposing measures to improve effectiveness of implementation;

e) Annually, coordinating with the National Agro-Forestry-Fisheries Quality Assurance Department to make list of establishments to be inspected by these two bodies; informing list of approved establishments;

g) Proposing demand for training, assign officials to attend training courses, seminars organized by the National Agro-Forestry-Fisheries Quality Assurance Department;

h) Settling appeals from establishments as regulated by the Article 28 of this Regulation.

2. Rights:

a) Requiring establishments under control to register for inspection in compliance with the Article 9 of the Regulation; to carry out corrective actions; to investigate cause of contamination; to set up corrective actions and report results of implementation if any establishment is notified for non-compliance by Vietnamese competent authority;

b) Issuing decision to approve, grant approval code and certificate, suspend, extend and renew validity of certificate, renew certificate for establishments under control;

c) Requesting competent authority to treat violations if any establishment does not satisfy FHS conditions;

Article 25. Obligations and rights of Provincial Department of Agriculture and Rural Development

1. Designating local ICB to inspect establishments under control as regulated by the Item 1, the Article 5 of the Regulation;

2. Managing, guiding and audit enforcement of the Regulation in its locality;

3. Requesting the Ministry of Agriculture and Rural Development, the National Agro-Forestry-Fisheries Quality Assurance Department to revise, supplement technical standards and regulations if necessary.

Article 26. Obligations and rights of the National Agro-Forestry-Fisheries Quality Assurance.

1. Obligations:

a) Unifying management of inspection, certification for FHS conditions nationwide;

b) Presiding and coordinating with relevant Departments of the Ministry to organize implementation of inspection, certification for fishery products of establishments under control of Provincial Department of Agriculture and Rural Development

c) Building up, promulgating and guiding consistent application of documents, forms/models, method, procedures on inspection, norms for classifying establishments and other specific guidance documents to this Regulation;

d) Organizing training courses and seminars to improve profession for inspectors from Provincial Departments of Agriculture and Rural Development and the National Agro-Forestry-Fisheries Quality Assurance Department Branches;

đ) Making and informing inspection plan to establishments under control as regulated by the Item 1, the Article 8 of this Regulation; inspecting and certifying establishments under control for FHS conditions mentioned at the Item 2, the Article 5 of this Regulation;

e) Keeping records relevant to inspection, certification of establishments under control; providing records, explaining sufficiently and exactly inspection results if required by the Ministry of Agriculture and Rural Development;

g) Keeping secret information relevant to business of establishments.

h) Quarterly reporting in writing to the Ministry of Agriculture and Rural Development on inspection results; situation on audit, management, treatment of violations of establishments nationwide; proposing measures to improve implementation of inspection.

i) Annually, coordinating with Provincial Departments of Agriculture and Rural Development to make list of establishments under control to be inspected by the two bodies; claiming the list of high risk fishery products, the list of approved establishments nationwide;

k) The National Agro-Forestry-Fisheries Quality Assurance Department shall make list of Vietnamese and other countries requirements, technical standards and regulations on fishery product FHS to inform relevant agencies/bodies/organizations for consistent implementation.

l) Settling appeals from establishments as regulated by the Article 28 of this Regulation.

2. Rights:

a) Auditing, supervising inspection, certification for FHS conditions carried out by local ICBs of Provincial Departments of Agriculture and Rural Development;

b) Making decision to approve, grant approval code, certificate, suspend, extend and renew validity of certificate for establishments under control;

c) Requiring establishments under control to register for inspection in compliance with the Article 9 of this Regulation; to carry out corrective actions; to investigate cause of contamination; to set up corrective actions and report results of implementation if any establishment is notified for non-compliance by Vietnamese competent authority;

d) Requiring local ICBs of Provincial Departments of Agriculture and Rural Development to report situation on inspection, certification for FHS conditions of establishments under control;

đ) Suspending exportation to markets under bilateral arrangement if any establishment does not satisfies FHS conditions, is notified for non-compliance by Vietnamese competent authority or importing countries;

e) Requesting the Ministry of Agriculture and Rural Development and competent authorities to treat violations of establishments for unsatisfactory FHS conditions.

Chapter IV

FEE CHARGE

Article 27. Fee charge

1. Collecting fee for certificate issuance shall be carried out in compliance with the existing regulations of the Ministry of Finance and other relevant legal documents;

2. For FHS inspection and certification activities subject to free of charge, ICBs shall make annual plan and estimated costs to submit to competent authorities for approval and organize implementation if approved.

Chương V

COMPLAINT AND DENUNCIATION

Article 28. Complaint, denunciation and settlement

1. Any organziation, individual has right to complain about and denounce violations to this Regulation as regulated by Law on complaints and denunciations and guidance documents thereof.

2. Competent authorities shall be responsible for timely settlement to complaints about inpsection, certification for FHS conditions of establishments as regulated by Law on complaints and denunciations.

Article 29. Sanction

1. Treating violations to this Regulation shall be carried out in compliance with the existing Regulation of the Government on treament of administrative violations commited in fishery sector and other relevant regulations.

2. Any violation which obstruct inspection activities of ICB or causes serious demages shall be criminally prosecuted as regulated.

Chapter VI

EXECUTIVE PROVISIONS

Article 30. Entry into force

1. For establishments mentioned at the Point a, b, the Item 1, the Article 2 of this Regulation: the effective date shall be 15 days after being posted on Official Gazette. For fishing vessels with main engine of at least 50 CV to below 90 CV: the effective shall be since January 1, 2012;

2. For establishmetns mentioned at the Item 2, the Article 7 of this Regulation: the invalid date shall be December 31, 2010. From this time forward, ICB shall inspect, withdraw and re-grant approval code if these establishments upgrade in order to meet requirements of separate fishery processing establishment;

3. Fishing vessels with main engine of at least 50 CV to below 90 CV shall be encouraged to implement this Regulation before the effective date.

Article 31. Modification, supplementation to this Regulation

During implementation of this Regulation, the National Agro-Forestry-Fisheries Quality Assurance Department, Provincial Departments of Agriculture and Rural Development shall be responsible for gathering comments from any organization, individual to submit the Minister of Agriculture and Rural Development for modification, supplementation if necessary.\.

ANNEX 1
(promulgated in closure with the Decision No. 117 /2008/QĐ-BNN dated December 11, 2008 of the Minister of Agriculture and Rural Development)

TABLE 1. SYSTEM ON APPROVAL CODES APPLICABLE TO FISHERY TRADERS AND PROCEDURES

TABLE 2. CODES FOR CENTRALLY AFFILIATED PROVINCES/CITIES
(In compliance with the Decision No. 124/2004/QĐ-TTg dated 08/7/2004 of Prime Minister regarding promulgation of the list of codes for Vietnamese administrative units)

TABLE 3. QUALITY CONTROL SYSTEMS FORCED TO APPLY FOR CERTAIN ESTABLISHMENTS

Note:

GMP: Good Manufacturing Practice

SSOP: Sanitation Standard Operating Procedures

HACCP: Hazard Analysis and Critical Control Points

ANNEX 2:

REGISTRATION FORM
(Issued in closure with the Decision No. 117 /2008/QĐ-BNN dated 11 December 2008 of the Minister of Agriculture and Rural Development)

Annex 2a. Used for fishery processing establishments

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
--------------------------------

............., date …month ….year

REGISTRATION TO BE INSPECTED AND CERTIFIED FOR FOOD HYGIENE AND SAFETY OF FISHERY TRADERS AND PRODUCERS (1)

To: ……………………………………………
(Inspecting and certifying body)(2)

Pursuant to the Regulation on inspecting and certifying food hygiene and safety of fishery traders and producers issued in closure with the Decision No. /2008/QĐ-BNN dated / /2008 of the Minister of Agriculture and Rural Development, our establishment:

Name of establishment(3):

Business name: (including abbreviated name if any):

Approval code (if any):

Address:

Tel:                                           Fax:                              Email:

Name of factory (4) requesting to be inspected:

Address:

Tel:                                           Fax:                              Email:

After considering regulations and standards as well as comparing with establishment’s practical conditions, we would request you to inspect our establishment so as to:

- Be certified for food hygiene and safety conditions:                 

- Be approved for domestic consumption:                                  

- Be exported to country: ……………..

Herewith are attached documents:

- Outline of surface construction

- List of the main products and outline of production chain (carried out on above surface).

- Report on current food hygiene and safety conditions (5).

- Report on corrective actions (if any)(6).

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(1): Used for establishments which register for certification

(2): National Agro-Forestry-Fisheries Quality Assurance Department/Provincial Department of Agriculture and Rural Development

(3): Name of establishment printed in License of Business

(4): Full name of factory of registered establishment

(5): According to the Model ĐKKTCNa1.

(6): According to the Model ĐKKTCNa2 .

Model ĐKKTCN a1

REPORT ON CURRENT FOOD HYGIENE AND SAFETY CONDITIONS OF FISHERY TRADERS AND PRODUCERS

I. General Information

1. Name of establishment (factory) requesting to inspected:

2. Address:

3. Tel:                                       Fax:                              Email:

4.Approval code (if any):                                  

5. First year of operation:

6.Date of construction:

7. General description of product :

7.1. Product group:      

7.2.  Product for domestic consumption:

7.3. Product for export:

II.  Factory – Current situation on production conditions

1. Factory

1.1. Surface total for production:                                   m² , among of which:

1.1.1. Raw material reception area:                                m².

1.1.2. Preparation area:                                                 m².

1.1.3. Processing area (sizing, patterning....):                  m².

1.1.4. Freezing area:                                                     m².

1.1.5. Cold store area:                                                  m².

1.1.6.Other production area (....):                                   m².

1.2. Description of current infrastructure conditions of factory and structure:

2. Equipment

2.1. Main equipments:

2.2. Comments on operational situation:

3. Supporting system:

3.1.Water resource reserved for production area:

3.1.1. Water resource:

Tap-water q      Well- water q, quantity: , depth m.

3.1.2. Methods to ensure quality of water reserved for production area (including ice-water production area)

- Filtration system : Yes q         No q    Another method q :

- Water container system:                       Capacity total:  m3.

- High pressure cistern system:  Cistern capacity total :  m3.

- Water treatment system: Chlorine quantification q.UV light q. Another q

3.2. Ice-water source:

3.2.1. Produced by establishment: block ice q capacity total: tons/day.

 flake ice q capacity total tons/day.

3.2.2. Bought from other establishments: block ice q quantity :  tons/day.

 flake ice q quantity      tons/day

3.3. Sewage treatment system

3.3.1. Sewage: Short description of sewage treatment and discharge system, evaluation given by relevant body in charge of environment) ….

3.3.2. Solid waste: Chain of custody, transportation, treatment...

3.4. Toilet (reserved for production area)

3.4.1. Quantity:

3.4.2.  Structure:

3.5.  Staff:

3.5.1. Total of staff :                             persons, among of whom:

- Permanent staff:                                 persons.

- Seasonal staff:                                   persons.

3.5.2.  Quantity of staff at the rush time/shift:     persons, among of whom:

- Raw material reception area:    persons

- Preparation area:                      persons

- Processing area:                      persons

- Freezing, packaging area:        persons

- Other areas (....):                     persons

3.6. Systems of insect and pest prevention and elimination

3.6.1. Insect preventive and eliminative methods:

3.6.2. Pest preventive and eliminative methods:

3.7. Industrial hygiene

3.7.1. Frequency of implementation:

3.7.2. Total of staff:                  persons;

3.7.3. Among of whom: Establishment’s staff q employment q

3.8. List of substances, additives, disinfectants

4. Quality Control System:

4.1. Total of quality controllers (QC), among of whom:

4.1.1. Bachelor degree: persons, Immediate degree: persons

4.1.2. HACCP trained QC:                      persons

4.2. Laboratories:

q Establishment’s , parameters capable to analyze:

q Rent

4.3. List of quality management programs applicable to products/group of product and attached file.

DIRECTOR (MANAGER) OF ESTABLISHMENT
(Signature, Seal)

Model ĐKKTCNa2

REPORT ON CORRECTIVE ACTIONS (IF ANY)

I. General Information:

1. Name of establishment:

2. Address:

3. Tel:                                       Fax:                              Email:

II. Summary on corrective results

……, date….. month…..year……
Establishment’s Representative
 (Signature and Seal if any)

Annex 2 b: Used for other establishments

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
------------------------------

................, date         month         year

REGISTRATION TO BE INSPECTED AND CERTIFIED FOR FOOD HYGIENE AND SAFETY OF FISHERY TRADERS AND PRODUCERS (1)

To: ……………………………………………
(Inspecting and certifying body)

Pursuant to the Regulation on inspecting and certifying food hygiene and safety of fishery traders and producers issued in closure with the Decision No. /2008/QĐ-BNN dated / /2008 of the Minister of Agriculture and Rural Development, our establishment:

Name of establishment:

Business name (including abbreviated name if any):

Approval code (if any):

Address:

Tel:                   Fax (if any):                  Email (if any):

After considering regulations and standards as well as comparing with establishment’s practical conditions, we would request you to inspect our establishment so as to:

- Be certified for food hygiene and safety conditions.

- Be exported to country:

- …………………………………………………………………………………

………………………………………………………………………………….

DIRECTOR (MANAGER) OF ESTABLISHMENT
(signature and seal if any)

ANNEX 3:

MODEL OF CERTIFICATE
(Issued in closure with the Decision No. 117 /2008/QĐ-BNN dated 11 December 2008 of the Minister of Agriculture and Rural Development)

Annex 3.a: Used for fishery processing establishments

Annex 3.b: Used for other establishments.