Circular No. 16/2018/TT-BNNPTNT amends and supplements certain Articles of Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013, issued by the Minister of Agriculture and Rural Development on inspection and certification of food safety for exported aquatic products, and Circular No. 02/2017/TT-BNNPTNT dated February 13, 2017, issued by the Minister of Agriculture and Rural Development to amend and supplement certain Articles of Circular No. 48/2013/TT-BNNPTNT.

CIRCULAR

Amending and supplementing some articles of Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 of the Minister of Agriculture and Rural Development on inspection and certification of food safety for exported aquatic products, and Circular No. 02/2017/TT-BNNPTNT dated February 13, 2017 of the Minister of Agriculture and Rural Development amending and supplementing some articles of Circular No. 48/2013/TT-BNNPTNT

Pursuant to the Food Safety Law dated June 17, 2010;

Pursuant to the Law on Product Quality and Trade Goods dated November 21, 2007;

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product Quality and Trade Goods and Decree No. 74/2018/NĐ-CP dated May 15, 2018 of the Government amending and supplementing some articles of Decree No. 132/2008/NĐ-CP;

Pursuant to Decree No. 15/2018/NĐ-CP dated February 2, 2018, issued by the Government detailing the implementation of certain articles of the Food Safety Law;

Pursuant to Decree No. 15/2017/NĐ-CP dated February 17, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

1. This Circular takes effect from February 3, 2022.

The Minister of Agriculture and Rural Development promulgates this Circular amending and supplementing some articles of Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 of the Minister of Agriculture and Rural Development on inspection and certification of food safety for exported aquatic products, and Circular No. 02/2017/TT-BNNPTNT dated February 13, 2017 of the Minister of Agriculture and Rural Development amending and supplementing some articles of Circular No. 48/2013/TT-BNNPTNT.

Article 1. Amending and supplementing some articles of Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 of the Minister of Agriculture and Rural Development on inspection and certification of food safety for exported aquatic products

1. Amending point a Clause 1 Article 2 as follows:

"a) Establishments exporting to countries and territories that require batches to be certified by the Directorate of Quality Assurance of Forestry, Agricultural and Aquatic Products."

2. Amending point a Clause 3 Article 2 as follows:

"a) Establishments only for domestic consumption; establishments exporting to countries and territories that do not require batches to be certified by the Directorate of Quality Assurance of Forestry, Agricultural and Aquatic Products."

3. Amend Article 5 as follows:

Article 5. Competent Authority

The competent authority for issuing Food Safety Certificates and issuing Certificates: The Directorate of Quality Assurance of Forestry, Agricultural and Aquatic Products (hereinafter referred to as the Competent Authority).

4. Amending the name of Article 6 as follows:

"Article 6. Requirements for Inspectors and Heads of Inspection Teams"

5. Amending the name of Chapter II as follows:

"Chapter II: FOOD SAFETY AUDIT"

"6. Amend Article 10 as follows:"

Article 10. Application Forms and Reports on Information Changes

1. For the issuance of Food Safety Certificates, the application form includes:

a) The application for food safety audit conditions according to Model IIIA attached to this Circular;

b) A report on current status (infrastructure, equipment, food safety assurance system) of the establishment according to Model 1 of Appendix IVA attached to this Circular.

2. For establishments with unsatisfactory audit results for Food Safety Certificates, the application form includes: A report on corrective actions according to Model V attached to this Circular.

3. For periodic audits of food safety conditions as stipulated in point a Clause 2 Article 12 of this Circular, the establishment shall submit reports on information changes according to Model 2 of Appendix IVA attached to this Circular.

4. The establishment shall submit one set of application forms to the Competent Authority via one of the following methods: Direct submission, postal service; fax, email or online registration.

7. Amending Clause 1 Article 18 as follows:

"1. Establishments will have their Food Safety Certificates revoked in cases specified in Clause 2 Article 34 of the Food Safety Law."

8. Amending point c Clause 1 Article 19 as follows:

"c) Establishments requesting changes in the name or address on the Food Safety Certificate."

9. Amending Clause 1 Article 20 as follows:

"1. The program includes activities auditing and issuing Certificates for exported aquatic products to countries and territories where the Competent Authority requires the Directorate of Quality Assurance of Forestry, Agricultural and Aquatic Products to audit and issue Certificates for export batches according to the list of countries and territories specified in Appendix VIIA attached to this Circular."

10. Amending point a Clause 3 Article 20 as follows:

"a) Meeting Vietnam's food safety standards"

11. Amending Article 21 as follows:

"Article 21. Export List

1. According to the regulations of importing countries and territories or agreements with the Competent Authorities of importing countries and territories, the Directorate of Quality Assurance of Forestry, Agricultural and Aquatic Products establishes and updates the Export List for each market for establishments meeting all criteria specified in Clause 3 Article 20 of this Circular.

2. A Facility will be removed from the Export List in the following cases:

a) The Facility submits a written request to withdraw from the Export List;

b) Establishments specified in point b Clause 2 Article 17 of this Circular."

12. Amending point b Clause 1 Article 26 as follows:

"b) Establishments with food safety audit results ranked at level 4."

13. Amending Clause 2 Article 26 as follows:

"2. Establishments mentioned in Clause 1 of this Article continue to be issued Certificates when they meet the following conditions:

a) The establishment has implemented corrective measures as required by the Competent Authority and these measures have been verified and confirmed effective by the Competent Authority;

b) For the facility mentioned in point b of Clause 1 of this Article, it must have passed the food safety assessment meeting the requirements;

c) In addition, the establishment mentioned in point a Clause 1 of this Article must be notified by the Directorate of Quality Assurance of Forestry, Agricultural and Aquatic Products and the Competent Authority of the importing country or territory must lift the temporary import suspension."

14. Amending point b Clause 1 Article 28 as follows:

"b) The consignor sends one set of application forms to the Competent Authority via one of the following methods: Direct submission; postal service; fax, email (followed by submission of original copies) or online registration through the National Single Window mechanism."

15. Amending Clause 3 Article 29 as follows:

"3. The consignor sends one set of application forms for audit to the Competent Authority via one of the following methods: Direct submission, postal service; or fax, email (followed by submission of original copies) or online registration through the National Single Window mechanism."

16. Amending Clause 1 Article 30 as follows:

"1. The Competent Authority assigns inspectors to conduct audits and take samples for testing within two working days from the date the consignor requests or as agreed between the consignor and the Competent Authority."

17. Amending Clause 3 Article 31 as follows:

"3. Within three working days from the date of receipt of the report and explanation from the Facility, the Appraisal Agency shall review the contents of the report and issue a written notification of the review results to the Facility. In cases where on-site verification is necessary, the Appraisal Agency shall conduct such verification and notify the results to the Facility within seven working days from the date of receipt of the report from the Facility."

18. Amend Clause 1 of Article 33 as follows:

"1. When the Certificate is lost or damaged, the Shipper shall submit a written request for reissue of the Certificate stating the reasons to the Appraisal Agency through one of the following methods: direct submission, postal service; or fax, email."

19. Amend Clause 2 of Article 36 as follows:

"2. Within three working days from the date of receipt of the report on the investigation results and measures to address the causes from the Facility, the Appraisal Agency shall review the contents of the report and issue a written notification of the review results to the Facility. In cases where on-site verification is necessary, the Appraisal Agency shall conduct such verification and notify the results to the Facility within seven working days from the date of receipt of the report from the Facility."

19. Amend Point a of Clause 1 of Article 37 as follows:

"a) Register with the Appraisal Agency in accordance with this Circular to be appraised for food safety assurance; comply with the appraisal process as planned by the Appraisal Agency;"

20. Amend Point a of Clause 1 of Article 39 as follows:

"a) Adhere strictly to the procedures, formalities, contents, methods, and bases for appraisal and certification of food safety assurance conditions for the Facility; conduct appraisals and sampling tests of batches of goods in accordance with this Circular;"

21. Amend Article 40 as follows:

"Article 40. Head of the Appraisal Team

1. When performing assigned tasks, the head of the assessment team shall have responsibilities as an inspector as stated in Clause 1 Article 39 of this Circular and other responsibilities as follows:

a) Directing and assigning tasks to members of the assessment team to fully implement the contents specified in the decision to establish the assessment team;

b) Process opinions and appraisal results of members of the appraisal team and draw final conclusions in the appraisal record; c) Review and sign the appraisal record, report on the appraisal results, and bear responsibility before the head of the Appraisal Agency and the law for the results implemented by the appraisal team."

2. Within the scope of the assigned tasks, the head of the inspection team shall have the powers as set forth in Clause 2, Article 39 of this Circular for an inspector, and the following additional powers:

a) Propose to the head of the Inspection Authority to issue a decision adjusting the members of the inspection team to fully implement the contents specified in the decision establishing the inspection team;

b) Draw final conclusions of the appraisal team regarding the appraisal results."

22. Amend Point b of Clause 1 of Article 41 as follows:

"b) Organize training, instruction, and guidance on professional skills for inspection staff on reviewing documents, appraising Facilities, issuing Food Safety Assurance Certificates; appraising and issuing Certificates for export batches of aquatic products;"

23. Amend certain phrases as follows:

a) Replace the phrase "inspection" with the phrase "appraisal" at the following points, clauses, and articles: Point b of Clause 1, Clause 2, Point c of Clause 3 of Article 2; Clause 3 of Article 3; Point b of Clause 1 of Article 6; Title of Chapter III; Point b of Clause 1 of Article 23; Clause 2 of Article 23; Title of Article 29; Clause 1 of Article 29; Title of Article 30 and Clause 2 of Article 30; Title of Article 31 and Clause 1 of Article 31; Clause 1, Clause 2 of Article 32; Clause 1 of Article 35; Article 38; Point a, c, d, đ, e of Clause 1, Clause 2 of Article 41; Appendix XIII, XV, XVI, XVII; forms 5b-1, 5b-2, 5b-3, 5b-4, 5b-5, 5b-6, 5b-7, 5b-8 promulgated together with Appendix V.

b) Repeal the phrase "inspection" at Article 4; Title of Article 6; Point a of Clause 1, Clause 2 of Article 6; Title of Article 7; Article 13; Article 14; Article 15; Point b, c, đ, e, g of Clause 1 of Article 37; Point d of Clause 1, Point b, d, đ of Clause 2 of Article 39; Appendix V.

c) Replace the phrase "inspection and certification agency" with the phrase "appraisal agency" at the following clauses, points, and articles: Clause 1 of Article 13; Point e of Clause 1 of Article 15; Clause 6 of Article 22; Clause 1, Clause 2 of Article 23; Point c of Clause 3 of Article 24; Article 26; Clause 2, Clause 3 of Article 27; Clause 2 of Article 28; Clause 5 of Article 29; Clause 1 of Article 30; Clause 1, Clause 2 of Article 31; Article 32; Clause 2 of Article 33, Article 34; Article 35; Clause 1 of Article 36; Point đ of Clause 1, Point c of Clause 2 of Article 37; Article 38; Point d of Clause 1, Clause 2 of Article 39; Point c of Clause 2 of Article 41; Article 42; Point c of Clause 1 of Article 43; Appendix VIII, XI, XII, XIII, XV, XVI, XVII.

d) Repeal the phrase "inspection fee" at Point g of Clause 1 of Article 37.

đ) Repeal the phrase "post-certification inspection" at Point a, c of Clause 1 of Article 41.

e) Replace the phrase "guidance, inspection, appraisal, and classification evaluation" with the phrase "guidance on food safety assurance conditions appraisal" at Appendix V, forms 5b-1, 5b-2, 5b-3, 5b-4, 5b-5, 5b-6, 5b-7, 5b-8 promulgated together with Appendix V.

24. Replace Appendix I with Appendix IIIA promulgated together with this Circular; Appendix II with Appendix IVA promulgated together with this Circular; Appendix III with Appendix VA promulgated together with this Circular; Appendix VI with Appendix VIA promulgated together with this Circular; Appendix IX with Appendix VIIA promulgated together with this Circular.

Article 2. Amend and supplement some articles of Circular No. 02/2017/TT-BNNPTNT dated February 13, 2017 issued by the Minister of Agriculture and Rural Development on amending and supplementing some articles of Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 on inspection and certification of food safety for exported aquatic products.

1. Amend Clause 1 of Article 1 as follows:

"1. Amend Article 1 as follows:

1. Documents and procedures for assessing food safety conditions to include production and business establishments of aquatic food products (hereinafter referred to as Establishments) in the Export List for export to countries and territories requiring each shipment to be certified with an aquatic food export certificate issued by the Directorate of Quality Assurance of Forestry, Agriculture and Fisheries Products (hereinafter referred to as the Export List); issuance and revocation of Food Safety Certificate (hereinafter referred to as the Food Safety Certificate) in accordance with the Food Safety Law.

2. Documents and procedures for assessing and issuing export certificates for aquatic food products (hereinafter abbreviated as Certificates) at the request of importing countries and territories."

2. Amend Clause 2 of Article 1 as follows:

"2. Amend Article 9 as follows:

Article 9. Fees

The collection of fees for assessing and issuing Food Safety Certificates for Establishments, fees for periodic assessment of food safety conditions, and fees for assessing export certificates for shipments of exported aquatic products stipulated in this Circular shall be carried out in accordance with the laws on fees and charges."

3. Amend Clause 3 of Article 1 as follows:

"3. Amend Article 11 as follows:

Article 11. Processing of Applications

Within three working days from the date of receipt of the application from the Establishment, the Assessment Authority must verify the validity of the application, guide the Establishment to supplement missing or non-compliant contents.

If the application is valid, within three working days, the Assessment Authority will notify the Establishment of the scheduled date for the on-site assessment but not later than seven working days from the date of receiving the complete and valid application."

4. Amend Clause 4 of Article 1 as follows:

"4. Amend Article 12 as follows:

Article 12. Forms of Assessment

1. Issuance of Food Safety Certificates and Inclusion in the Export List:

a) Assessment for issuing Food Safety Certificates: applicable to Establishments that do not fall under Clause 1 of Article 12 of Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing implementation of certain provisions of the Food Safety Law without a Food Safety Certificate; have had their Food Safety Certificate revoked; hold a Food Safety Certificate with less than six months remaining validity; change information in the Food Safety Certificate except in cases provided for in Point c Clause 1 of this Circular.

b) Inclusion in the Export List: applicable to establishments not covered by Point a Clause 1 of this provision and not listed in the Export List.

2. Periodic Assessment of Food Safety Conditions: applicable to establishments already listed in the Export List in the following cases:

a) Establishments adding export markets; repairing and upgrading food safety assurance conditions: assessment after the establishment submits the documents as prescribed in Clause 3 of Article 10 of this Circular.

b) Establishments not falling under the category specified in Point a Clause 2 of this Article: unannounced assessment with frequency: Class 1 and Class 2 Establishments: once every eighteen months; Class 3 Establishments: once every twelve months."

5. Amend Clause 6 of Article 1 as follows:

"6. Amend Article 17 as follows:

Article 17. Handling of Assessment Results

Within six working days from the end of the assessment, the Assessment Authority shall review the Assessment Report and proceed as follows:

1. For the issuance of Food Safety Certificates and inclusion in the Export List:

a) For Establishments achieving satisfactory results (Class 1, Class 2, and Class 3): notify the result; assign a code according to Appendix VII attached to this Circular; update the Export List and submit to the Competent Authority of the importing country for inclusion in the list of permitted exporters to the corresponding market; issue a Food Safety Certificate according to the model prescribed in Appendix VIA attached to this Circular for Establishments not exempted from issuance as provided for in Point k Clause 1 of Article 12 of Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing implementation of certain provisions of the Food Safety Law.

b) For Facilities with unsatisfactory results (Class 4): notify the results; require the Facility to implement corrective actions and submit a report on the results of rectifying errors; revoke valid Food Safety Certificates (if any).

2. In cases of periodic assessment of food safety conditions:

a) For Establishments achieving satisfactory results (Class 1, Class 2, and Class 3): notify the result; compile and submit to the Competent Authority of the importing country for updating information;

b) For Establishments failing to achieve satisfactory results (Class 4): notify the result, require the Establishment to implement corrective actions and report the results, revoke any valid Food Safety Certificate. Depending on the severity of the violations, the Assessment Authority may set a deadline for corrective actions not exceeding three months from the date of assessment for a subsequent periodic assessment.

In case the subsequent assessment results still fail (Class 4): notify the result; remove the Establishment from the Export List and request the Competent Authority of the importing country to delete the name of the Establishment from the list of permitted exporters to the corresponding market.

3. In cases where samples are taken for testing to evaluate the effectiveness of hygiene control during production:

Within one working day from the date of non-conformity test results, the Assessment Authority shall notify the Establishment to take corrective actions. Depending on the severity of the violations, the Assessment Authority may set a deadline for corrective actions and organize retesting.

In case the retest results still do not conform, the Assessment Authority may conduct an unscheduled inspection of the food safety assurance conditions of the Establishment."

6. Amend Clause 7 of Article 1 as follows:

"7. Amend Clause 2 of Article 22 as follows:

2. The Directorate of Quality Assurance of Forestry, Agriculture and Fisheries Products shall establish a priority list for Establishments meeting all the following criteria up to the time of consideration:

a) The Facility is listed in the Export List;

b) Establishments exporting shipments and having no shipments found to violate food safety regulations by Vietnamese authorities and importing markets within a minimum period of three months since the Establishment was classified as Class 1 or Class 2."

7. Amend Clause 10 of Article 1 as follows:

"10. Amend Article 32 as follows:"

Article 32. Examination and issuance of certificates

1. Within two working days from the date of export of the consignment, the Shipper must provide in writing all necessary information as specified in the Certificate template at the request of the National Competent Authority of the importing country or territory to the Examination Authority for issuance of the Certificate. Within one working day from receipt of complete information, the Examination Authority shall conduct the examination and issue the Certificate for the exported consignment according to the template of the importing country or territory if the examination and testing results meet the requirements.

2. After ninety days from the inspection date, if the Shipper does not provide complete information to the Examination Authority for examination and issuance of the Certificate, the Shipper must register for examination as prescribed in Article 29 of this Circular.

Article 3. Effectiveness

1. This Circular takes effect from December 13, 2018.

2. During the implementation of this Circular, if there are difficulties or obstacles, it is requested that agencies, organizations, and individuals promptly reflect them to the Ministry of Agriculture and Rural Development for appropriate amendments and supplements./.