Circular No. 46/2015/TT-BNNPTNT on conformity assessment and declaration of conformity for plant varieties

CIRCULAR

Regulations on conformity assessment and declaration of conformity for plant varieties

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Pursuant to Decree No. 199/2013/NĐ-CP dated November 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006 and Government Decree No. 127/2007 ND-CP dated August 1, 2007/NĐ-CP dated August 1, 2007 of the Government promulgating detailed regulations of the Law on Product QualityuThis Circular stipulates the establishment, management, and operation of the energy information system and the organization, construction, exploitation, and maintenance of the energy database.i tiết thực hiện một sNo. INDUSTRIAL EXPLOSIVES - TNP1 EXPLOSIVESonof the Law on Technical standardsrime Minister cand Regulationsprovision of the Law on Technical Regulations;

Pursuant to the Law on Product Quality and Goods dated November 21, 2007 and Government Decree No. 132/2008/NĐ-CP dated December 31, 2008 providing details on the Law on Product Quality and Goodsi tiết thực hiện một sNo. Banks and Credit Institutionsof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairsgoodsshalla;

Pursuant to the Ordinance on Plant Varieties dated April 5, 2004;

At the proposal of the Director of the Plant Cultivation Department;

The Minister of Agriculture and Rural Development hereby promulgates regulations on conformity assessment and declaration of conformity for plant varieties as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

These Circular stipulates conformity assessment and declaration of conformity for plant varieties listed in the Catalogue of Products and Commodities Group 2 issued by the Ministry of Agriculture and Rural Development.

Article 2. Applicability

These Circular applies to organizations and individuals both within and outside Vietnam involved in conformity assessment and declaration of conformity for plant varieties listed in the Catalogue of Products and Commodities Group 2.

Article 3. Explanation of Terms

In this Circular, the following terms shall be understood as follows:

1. Lot code is the code assigned to a lot of seed for identification, quality control, and traceability.

2. Pre-inspection is the planting of a sample from a lot of seed in a field test plot to check its variety correctness and purity before the lot of seed is issued with a certificate of conformity to technical regulations or before it is declared as conforming.

3. Post-inspection is the planting of a sample from a lot of seed that has been issued with a certificate of conformity in a field test plot to recheck its variety correctness and purity.

Article 4. Forms and methods of conformity assessment

1. Forms of conformity assessment:

b) For domestically produced plant varieties group 2: Conformity assessment is carried out by certification bodies or by the producers themselves.

2. Methods of conformity assessment for plant varieties group 2

a) Method 5: Testing typical samples and assessing production processes; monitoring through sampling at the place of production or on the market combined with assessing production processes for domestically produced plant varieties;

b) Method 7: Testing and assessing seed lots for imported plant varieties.

Article 5. Certification Bodies for Conformity Assessment

1. The designation and management of activities of certification bodies for conformity assessment of plant varieties group 2 are implemented according to the provisions of Circular No. 55/2012/TT-BNNPTNT dated October 31, 2012 of the Ministry of Agriculture and Rural Development guiding procedures for designating certification bodies for conformity assessment and declaration of conformity under the jurisdiction of the Ministry of Agriculture and Rural Development (hereinafter referred to as Circular No. 55/2012/TT-BNNPTNT).

2. For assessors of certification bodies regarding plant varieties: They must meet the requirements stipulated in Clause 3, Article 6 of Circular No. 55/2012/TT-BNNPTNT and have a training certificate or training certificate (hereinafter referred to as training certificate) on seed testing or sampling according to Circular No. 17/2011/TT-BNNPTNT dated April 6, 2011 of the Ministry of Agriculture and Rural Development Amending, Supplementing, and Abolishing Some Provisions on Administrative Procedures in Crop Production Sector pursuant to Resolution No. 57/NQ-CP dated December 15, 2010.

Chapter II

CONFORMITY ASSESSMENT AND SELF-ASSESSMENT OF CONFORMITY FOR PLANT VARIETIES

Article 6. Steps for assessing compliance of domestic crop seed varieties

1. Conduct field seed plot inspection in accordance with Article 8 of this Circular.

2. Collect seed samples in accordance with Article 9 of this Circular.

3. Test seed samples in accordance with Article 10 of this Circular.

4. Pre-inspection shall be carried out in accordance with Article 11 of this Circular.

5. Organize certification to issue Compliance Certificates for seed varieties and seeds in accordance with Article 19 of the Law on Product and Goods Quality.

Article 7. Steps for assessing compliance of imported seed lots

1. Collect seed samples from the customs checkpoint or warehouse of the importing organization or individual, or the warehouse rented by the importing organization or individual, in accordance with Article 9 of this Circular.

2. Test seed samples:

a) In accordance with Article 10 of this Circular;

3. The certifying organization shall issue Compliance Certificates for seed lots in accordance with Article 19 of the Law on Product and Goods Quality.

Article 8. Field Seed Plot Inspection

1. Field seed plot inspection shall be conducted by inspectors who have training certificates.

2. The method of field seed plot inspection shall comply with the provisions of National Standard TCVN 8550:2011 "Crop Seeds - Method for Field Seed Plot Inspection" (hereinafter referred to as TCVN 8550:2011).

3. The final inspection record shall be prepared according to the contents in Appendix I attached to this Circular. Data recorded from previous inspections must be signed by the inspector and the representative of the seed plot.

Article 9. Sampling and Storing Seed Samples

1.1. The procedure for sampling cigarette products for quality control inspection is carried out in accordance with the guidance provided in Circular No. 01/2024/TT-BKHCN dated January 18, 2024 issued by the Minister of Science and Technology on state quality control inspections of goods circulating in the market.

a) Sampling shall be performed by individuals with training certificates.

b) The sampling method shall comply with the provisions of National Standards TCVN 8548:2011 "Seed Testing Methods for Crop Seeds" (hereinafter referred to as TCVN 8548:2011) and TCVN 8549:2011 "Testing Methods for Potato Seed Tubers" (hereinafter referred to as TCVN 8549:2011).

c) For domestic crop seed production: Representative sampling shall be conducted. A duplicate sample shall be taken: one sample sent to the designated testing laboratory for analysis, and one sample stored at the production facility that has the seed variety. For seed varieties requiring pre-inspection or post-inspection, an additional sample must be taken for pre-inspection or post-inspection.

d) For imported crop seeds: A duplicate sample shall be taken from each seed lot: one sample sent to the designated testing laboratory for analysis, and one sample stored at the importing facility that has the seed lot. For seed lots requiring post-inspection, an additional sample must be taken for post-inspection.

đ) The sampling record shall be prepared according to the contents in Appendix II attached to this Circular.

2. Storing Seed Samples

Seed samples must be stored under appropriate conditions for at least six months from the date of receipt.

Article 10. Testing Seed Samples

1. Testing of seed samples shall be conducted by designated laboratories.

2. The testing method shall comply with TCVN 8548:2011 for seed grains or TCVN 8549:2011 for seed tubers.

3. For imported hybrid rice seed lots with colored grains, the following procedures shall be implemented:

a) The test result form shall not indicate distinguishable non-hybrid grain characteristics;

b) A Compliance Certificate may be issued but the seed lot owner must provide a written commitment to ensure the correct variety;

c) Post-inspection must be carried out; the number of samples required for post-inspection for a variety and seed lot shall be determined by the certifying organization.

Article 11. Pre-inspection

1. Apply to parent lines of hybrid rice or F1 hybrid lines when relying on isolation levels, self-pollination rates of the female line, and distinguishable proportions of off-type plants and foreign seeds during the inspection and testing process without confirming the accuracy of the variety and purity of the seed lot.

2. The pre-inspection method shall be carried out according to the provisions of the National Standard TCVN 8547:2011 on Seed Varieties - Methods for Checking Variety Accuracy and Purity of Seed Lots (hereinafter referred to as TCVN 8547:2011).

3. Report the results of pre-inspection according to the contents set forth in Appendix III issued together with this Circular.

Article 12. Post-inspection

1. The certification organization conducts post-inspection to recheck the variety accuracy and purity of imported hybrid rice seed lots with colored seeds or upon request of the competent state management agency. If the seed lot does not meet the requirements for variety accuracy and purity, the entity or individual owning that seed lot will be handled according to the law.

2. The post-inspection method shall be carried out according to the provisions of TCVN 8547:2011.

3. In cases where post-inspection is conducted at the request of the competent state management agency, if the post-inspection sample does not meet the requirements, the unit conducting the post-inspection shall prepare a record with confirmation from the entity or individual holding the post-inspection sample.

4. Within no more than thirty days after completing the post-inspection, the unit conducting the post-inspection shall submit the report on the post-inspection results according to the contents set forth in Appendix III issued together with this Circular to the Crop Cultivation Department, the state management agency requesting the post-inspection, and the owner of the seed lot.

Article 13. Self-assessment for Compliance

1. Procedure for self-assessment for compliance:

a) Inspect the seed field according to the provisions of Article 8 of this Circular;

b) Take seed samples according to points a, b, c, and d of Clause 1, Article 9 of this Circular;

c) Test the seed samples according to Clauses 1 and 2 of Article 10 of this Circular;

d) Conduct pre-inspection before announcing compliance if necessary.

2. Based on the results of the inspection and testing of the samples, the organization or individual producing the seeds shall prepare a report on seed evaluation and issue seeds in compliance with technical standards according to the contents set forth in Appendix IV issued together with this Circular.

3. Announce compliance according to the provisions of Clause 3, Article 16 of this Circular.

Article 14. Seed and Seed Lot Documentation

1. Seed and seed lot documentation shall be certified by the certification organization issuing the conformity certificate

a) For domestically produced seeds, it includes: Notification of receipt of the announcement of conformity of the seed and previous generation seed; inspection records; sampling records; test result sheets; copies of conformity certificates of the seed and previous generation seed; pre-inspection or post-inspection results (if applicable);

b) For imported seed lots, it includes: Customs declaration form; sampling records; test result sheets; copies of conformity certificates of the seed lot and previous generation seed;

c) Seed and seed lot documentation shall be kept by the certification organization and the entities or individuals producing, importing, and trading in seed varieties.

2. Seed documentation for self-assessment for compliance by organizations or individuals producing seed varieties

a) Documentation includes: Notification of receipt of the announcement of conformity of the seed and previous generation seed; inspection records; sampling records and test result sheets of the seed lot; reports on pre-inspection and post-inspection results (if applicable);

b) Seed documentation shall be kept by the organization or individual producing seed varieties.

Chapter III

ANNOUNCEMENT OF COMPLIANCE FOR SEED VARIETIES GROUP 2

Article 15. Announcement of Compliance and Compliance Mark

1. Declaration of Conformity

a) Organizations and individuals producing or importing Group 2 crop seeds only make a compliance announcement once for each variety according to each seed level. When there is a change in at least one component of the compliance announcement dossier for the announced variety and seed level, a new announcement must be made;

b) The compliance announcement dossier is as prescribed in Article 16 of this Circular;

c) The procedure and time limit for making a compliance announcement are as prescribed in Articles 22 and 24 of Circular No. 55/2012/TT-BNNPTNT.

2. The compliance mark and its usage shall be carried out in accordance with Clause 2, Article 4 of Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Ministry of Science and Technology on the announcement of conformity to standards and technical regulations and methods of conformity assessment.

Article 16. Compliance Announcement Dossier

1. Organizations and individuals making a compliance announcement prepare two sets of compliance announcement dossiers; one set is kept by the organization or individual making the compliance announcement; the other set is directly sent or mailed to the Department of Agriculture and Rural Development where the organization or individual has their main office registered for production and business activities of crop seeds.

2. In cases where the compliance announcement is based on the results of a conformity certification by a certifying organization, the dossier components include:

a) A compliance announcement form in accordance with Appendix V issued together with this Circular;

b) A copy of the enterprise registration certificate or business registration certificate or investment certificate or establishment decision;

c) For imported varieties: A copy from the original conformity certification certificate of a representative batch of a variety according to each seed level issued by the designated certifying organization;

d) For domestically produced varieties: A copy from the original conformity certification certificate of a variety according to each seed level issued by the designated certifying organization.

3. In cases where the compliance announcement is based on the self-assessment results of organizations or individuals producing crop seeds, the dossier components include:

a) A compliance announcement form in accordance with Appendix V issued together with this Circular;

b) A copy of the enterprise registration certificate or business registration certificate or investment certificate or establishment decision;

c) A copy of the field inspection record of a representative batch of a variety according to each seed level;

d) A copy of one test result report from the original of a representative batch of a variety according to each seed level within six months from the date of issuance of the test result report by the designated testing laboratory to the date of submission of the compliance announcement dossier;

đ) In cases where the organization or individual making the compliance announcement has not been certified as ISO 9001 compliant, the compliance announcement dossier includes: Production process and quality control plan established and implemented according to the model prescribed in Appendix 14 of Circular No. 55/2012/TT-BNNPTNT, supervision plan of the management system;

e) In cases where the organization or individual making the compliance announcement has been certified as ISO 9001 compliant, the compliance announcement dossier includes a copy of the ISO 9001 compliance certification certificate;

g) A conformity assessment report of a representative batch of a variety according to each seed level within six months from the date of issuance in accordance with the content of Appendix IV issued together with this Circular.

Chapter IV

IMPLEMENTATION

Article 17. Responsibilities of organizations and individuals

1. The Crop Cultivation Department is responsible for:

a) Submitting to the Ministry for promulgation of regulatory legal documents, national technical standards, and seed production procedures related to the certification of conformity for Group 2 crop seeds;

b) Designating and managing the activities of testing laboratories and organizations certifying conformity for crop seeds nationwide;

c) Inspecting, handling violations, and resolving complaints and denunciations regarding conformity certification and compliance announcements for crop seeds nationwide;

d) Annually reporting to the Ministry of Agriculture and Rural Development on the results of conformity certification activities for crop seeds.

2. Departments of Agriculture and Rural Development are responsible for:

a) Organizing inspections, audits, and resolving complaints and denunciations regarding conformity certification and compliance announcements for crop seeds in their respective areas;

b) Receiving compliance announcement dossiers from organizations and individuals producing or importing Group 2 crop seeds in their respective areas and sending one copy to the Crop Cultivation Department for consolidation;

3. Organizations certifying conformity for crop seeds are responsible for:

a) Implementing conformity certification for crop seeds within the scope of the designation decision and as prescribed in this Circular;

b) Conducting pre-certification inspections as prescribed in Article 11 and post-certification inspections as prescribed in Article 12 of this Circular;

c) Regularly submitting consolidated reports on conformity certification results to the Crop Cultivation Department every six months in accordance with the content of Appendix VI issued together with this Circular.

4. Organizations and individuals producing or importing crop seeds for commercial purposes are responsible for:

a) Registering for conformity certification with a certifying organization or conducting self-assessment for domestically produced crop seeds in accordance with this Circular;

b) Registering for conformity certification with a certifying organization for imported crop seeds in accordance with this Circular;

c) Keeping seed and batch records;

d) Making a compliance announcement;

đ) Specifying batch codes, managing Group 2 crop seeds by batch, and printing batch codes on packaging.

Article 18. Transitional Provisions

1. For seed samplers and inspectors who have been issued certificates by the Crop Cultivation Department in accordance with Decision No. 106/2008/QĐ-BNN dated October 29, 2008 of the Ministry of Agriculture and Rural Development on the designation and management of seed samplers, inspectors, testing laboratories, and quality certification organizations for crop seeds, products, and fertilizers, and Circular No. 32/2010/TT-BNNPTNT dated June 17, 2010 of the Ministry of Agriculture and Rural Development on the designation and management of seed samplers, inspectors, testing laboratories, and quality certification organizations for crop seeds, products, and fertilizers, they may continue to operate within the scope and code number indicated on the Certificate without needing to reissue the certificate after five years.

2. Packaging that has printed batch codes or batch identification marks in accordance with Circular No. 79/2011/TT-BNNPTNT dated November 14, 2011 of the Ministry of Agriculture and Rural Development on the certification and announcement of quality conformity to technical standards for crop seeds (hereinafter referred to as Circular No. 79/2011/TT-BNNPTNT) may continue to be used for eighteen months from the effective date of this Circular.

Article 19. Implementation Provisions

1. This Circular takes effect from January 28, 2016.

2. This Circular replaces Circular No. 79/2011/TT-BNNPTNT and Circular No. 87/2011/TT-BNNPTNT dated December 27, 2011 amending and supplementing Article 20 of Circular No. 79/2011/TT-BNNPTNT dated November 14, 2011 of the Ministry of Agriculture and Rural Development on certification and declaration of quality of plant varieties in accordance with technical standards.

3. In cases where the standards and legal documents referred to in this Circular are amended, supplemented, or replaced, they shall be implemented according to the provisions of the new documents.

4. During the implementation process, if there are difficulties or obstacles, organizations and individuals concerned need to report to the Ministry of Agriculture and Rural Development (Crop Production Department) for prompt resolution./.