Thông tư 46/2015/TT-BNNPTNT chứng nhận hợp quy, công bố hợp quy giống cây trồng

THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

Circular No. 46/2015/TT-BNNPTNT dated December 15, 2015 of the Ministry of Agriculture and Rural Development on certification and announcement of conformity for plant varieties

Pursuant to the Government’s Decree No. 199/2013/NĐ-CP dated 26 November 2013 on regulating the functions, missions, authority and organizational structure of the Ministry of Agriculture and Rural development;

Pursuant to the Law on technical standards and regulations dated 29 June 2006 and Government’s Decree No. 127/2007/NĐ-CP dated 01 August 2007 on regulating the enforcement of certain articles of the Law on technical standards and regulations;

Pursuant to the Law on product and goods quality dated 21 November 2007 and Government’s Decree No. 132/2008/NĐ-CP dated 31 December 2008 on regulating the enforcement of certain articles of the Law on product and goods quality;

Pursuant to the Ordinance on plant varieties dated 05 April 2004;

At the request of the Head of Department of Crop Production;

Minister of Agriculture and Rural development regulates the certification and announcement of conformity for plant varieties as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular regulates the certification and announcement of conformity for plant varieties in the List of 2nd-grouped products and goods as released by Ministry of Agriculture and Rural development.

Article 2. Subject of application

This Circular governs local and foreign entities performing activities related to the certification and announcement of conformity for plant varieties in the List of 2nd-grouped products and goods.

Article 3. Terminology

In this Circular, the following words and phrases are construed as follows:

1.Varietal batch code is affixed to a varietal batch to identify and control quality and trace origin.

2.Pre-control refers to the planting of samples of a varietal batch in a test field to check the trueness of variety and purity prior to the certification or announcement of conformity of that batch.

3.Post-control refers to the planting of samples of a varietal batch certified for conformity in a test field to re-check the trueness of variety and purity.

Article 4. Scheme and method of conformity assessment

1.Scheme of conformity assessment:

a) For plant varieties in 2nd-grouped imports: Conformity is assessed by a certifying organization. A certificate of plant variety import conformity or the report of appraisal, as issued by the certifying organization designated, is the groundwork of customs authorities’ clearance of the variety imports;

b) For plant varieties in 2nd-grouped domestic produce: Conformity is assessed by a certifying organization or by the entities producing such plant varieties.

2.Conformity assessment method for 2nd-grouped plant varieties

a) Subject to method 5: a typical sample is tested and production process is assessed; samples collected from production facilities or markets are tested while the process of domestic plant variety production is assessed fur purpose of supervision;

b) Subject to method 7: imported plant variety batch is tested and assessed.

Article 5: Conformity certifying organizations

1.The designation and management of the activities of organizations certifying 2nd-grouped plant varieties are governed by the Circular No. 55/2012/TT-BNNPTNT dated 31 October 2012 by Ministry of Agriculture and Rural development on the guidelines for the formalities of designating organizations certifying and announcing conformity under the management of the Ministry of Agriculture and Rural development (hereinafter referred to as the Circular No. 55/2012/TT-BNNPTNT).

2.Assessment specialists from plant variety certifying organizations must satisfy requirements in Section 3, Article 6, Circular No. 55/2012/TT-BNNPTNT, and must possess letters of endorsement or training certificates (referred to as certificates) on inspection or sampling of plant varieties according to the Circular No. 17/2011/TT-BNNPTNT dated 06 April 2011 by Ministry of Agriculture and Rural development on redressing and removing certain administrative regulations on the cultivation sector in conformity with the Decree No. 57/NQ-CP dated 15 December 2010.

Chapter II

CERTIFICATION AND SELF-ASSESSMENT OF CONFORMITY FOR PLANT VARIETIES

Article 6. Stages for assessment of conformity for plant varieties domestically produced

1.Field areas for variety production are inspected according to Article 8 of this Circular.

2.Plant varieties are sampled according to Article 9 of this Circular.

3.Samples of plant varieties are tested according to Article 10 of this Circular.

4.Pre-control is carried out according to Article 11 of this Circular.

5.Certifying organizations issue certificates of conformity for varieties and varietal grades according to Article 19 of the Law on product and goods quality.

Article 7. Stages for assessment of conformity for plant variety batches imported

1.The sampling of a varietal batch is carried out, according to Article 9 of this Circular, at ports of entry or warehouses owned or rented by importers.

2.Varietal sample test:

a) In compliance with Article 10 of this Circular;

b) If imported plant variety samples are disqualified, the certifying organization reports and recommends settlement measures, upon the availability of test results, to the Department of Crop Production and customs authorities, at which the companies have import declaration forms registered, according to Section 3, Article 36, Law on product and goods quality.

3.Certifying organizations issue certificates of conformity for varietal batches according to Article 19 of the Law on product and goods quality.

Article 8. Inspection of variety production fields

1.The inspection of variety production fields is conducted by individuals possessing training certificates.

2.The methods for inspection of variety production fields are governed by TCVN 8550:2011 on Crop seed – Field inspection method (referred to as TCVN 8550:2011).

3.The content of a final inspection report is governed by Appendix I of this Circular. Data from previous inspection records bearing inspector’s and field representative’s signatures is recorded.

Article 9. Sampling and storage of samples

1.Sampling

a) Sampling is performed by individuals possessing training certificates;

b) Sampling methods are governed by TCVN 8548:2011 on Crop seed – Testing method (referred to as TCVN 8548:2011) and TCVN 8549:2011 on Tuber seed potato – Testing method (referred to TCVN 8549:2011);

c) Typical case sampling is applied to plant varieties produced domestically. Double sampling: a sample is delivered to a designated laboratory for analysis and the other is stored at the facility producing the varieties. An additional sample is required for pre-control or post-control of varieties in need of such processes;

d) Each imported plant variety batch undergoes double sampling that delivers a sample to a designated laboratory for analysis and stores the other at the importer’s facilities. An additional sample is required for post-control of varieties in need of such process;

dd) The content of the sampling record is governed by Appendix II of this Circular.

2.Storage of varietal samples

Seed samples must be stored in suitable conditions in at least 06 months upon the receipt of samples.

Article 10. Sample test

1.Samples are tested by a designated laboratory.

2.Testing methods are governed by TCVN 8548:2011 for seeds or TCVN 8549:2011 for seed tubers.

3.For imported hybrid rice varieties with colored grains, the following practices apply:

a) Test report does not record norms for distinguishable grains of undesired varieties;

b) Despite the issuance of a certificate of conformity, the owner of the varieties must engage in a written guarantee of varietal trueness;

c) Post-control is required. The certifying organization determines the quantity of samples for post-control of a variety and varietal grade.

Article 11. Pre-control

1.It is applicable to parental hybrid rice varieties or F1 hybrids subject to isolation level, female lines’ self-pollination ratio, off-type plant ratio, distinguishable grains of undesired varieties in the absence of a confirmation of varietal trueness and purity through tests and experiments.

2.Pre-control methods are governed by TCVN 8547:2011 on Crops seed – Method for control plot test (referred to as TCVN 8547:2011).

3.The content of a pre-control report is governed by Appendix III of this Circular.

Article 12. Post-control

1.Certifying organizations post-control process re-checks varietal trueness and purity of imported batches of hybrid rice varieties with colored grains or execute governmental authorities’ requests. If varietal trueness and purity of a variety batch are not qualified, the holders of such variety batch shall be penalized according to the laws.

2.Post-control methods are governed by TCVN 8547:2011.

3.The organization conducting post-control process makes a written record of unqualified varietal samples, if governmental authorities request post-control, with the endorsement by the holders of post-controlled samples.

4.The organization handling post-control must deliver, no later than 30 days after such process, the report of post-control, as stipulated by Appendix III of this Circular, to the Department of Crop Production, the governmental authorities requesting post-control, and the owners of varietal batches.

Article 13. Self-assessment of conformity

1.The conformity self-assessment procedure:

a) Field inspection is carried out according to Article 8 of this Circular;

b) Plant varieties are sampled according to point a, b, c and dd, Section 1, Article 9 of this Circular.

c) Samples of plant varieties are tested according to Section 1 and Section 2, Article 10 of this Circular;

d) Pre-control is implemented, if required, prior to the announcement of conformity.

2.Variety producers consider the test results to make evaluation reports on technically suitable varieties and varietal grades according to Appendix IV of this Circular.

3.Conformity is announced according to Section 3, Article 16 of this Circular.

Article 14. Documents on varieties and varietal batches

1.Documents on varieties and varietal batches certified by conformity certifying organizations

a) For varieties produced domestically:

The receipt of the written announcement of past varieties’ and varietal grades’ conformity; test record; sampling record; sample test result sheet; copies of conformity certificates of varieties and varietal grades; pre-control or post-control reports (if any);

b) For import varietal batches: Customs declarations; sampling records; sample test result sheet; copies of conformity certificates of varieties and varietal grades;

c) The documents on varieties and varietal batches are retained by certifying organizations, producers, importers and traders of plant varieties.

2.Documents on varieties certified by producers of such plant varieties

a) Including: the receipt of the written announcement of past varieties and varietal grades’ conformity; test record; sampling record, varietal batch test result sheet; pre-control and post-control reports (if any);

b) The documents on varieties are retained by the producers of such plant varieties.

Chapter III

ANNOUNCEMENT OF CONFORMITY FOR 2ND-GROUPED PLANT VARIETIES

Article 15: Announcement and mark of conformity

1.Announcement of conformity

a) The producers of 2nd-grouped plant varieties announce conformity for each variety by varietal grade at one time. Conformity is re–announced upon changes of at least one of the documents on varieties and varietal grades announced.

b) The documents for announcement of conformity as defined in Article 16 of this Circular;

c) The procedure and time for announcement of conformity as defined in Article 22 and Article 24 of the Circular No. 55/2012/TT-BNNPTNT.

2.Conformity marking is governed by Section 2, Article 4, Circular No. 28/2012/TT-BKHCN dated 12 December 2012 by Ministry of Science and Technology on regulating the announcement of standard compliance and conformity and assessment methods subject to technical standards and regulations.

Article 16. Documents for announcement of conformity

1.The entity announcing conformity executes 02 sets of conformity announcement documents, 01 of which is retained by the announcer of conformity while the other is delivered by hand or by post to a Department of Agriculture and Rural development within the location of the entity s registered main address for production and trading of plant varieties.

2.The documents for conformity announcement through a certifying organization s certification of conformity shall include:

a) The written announcement of conformity according to Appendix V of this Circular;

b) The copy of the certificate of company registration, certificate of business registration, certificate of investment or decision on incorporation;

c) For imported varieties: the copy of the certifying organization’s original conformity certificate for a varietal batch representing a variety by varietal grade;

d) For varieties produced domestically: the copy of the certifying organization’s original conformity certificate for a representative varietal batch by varietal grade.

3.The documents for conformity announcement through the result of self-assessment by the producers of plant varieties include:

a) The written announcement of conformity according to Appendix V of this Circular;

b) The copy of the certificate of company registration, certificate of business registration, certificate of investment or decision on incorporation;

c) The copy of the field inspection record for a varietal field parcel representing a variety by varietal grade;

d) The copy of 01 test result sheet for samples of an original varietal batch representing a variety by varietal grade, within 6 months from the date of a designated laboratory s issuance of the test result sheet to the date of the submission of conformity announcement documents;

dd) If the entity announcing conformity does not obtain an ISO 9001 compliant certificate, the conformity announcement documents shall include the procedures of variety production and the plan of quality control as defined by Appendix 14 of the Circular No. 55/2012/TT-BNNPTNT, and the plan for monitoring management systems;

e) If the entity announcing conformity possesses an ISO 9001 compliant certificate, the conformity announcement documents shall include a copy of ISO 9001 compliant certificate;

g) The report of conformity assessment for a varietal batch representing a variety by varietal grade, within 6 months from its issue date, as stipulated by Appendix IV of this Circular.

Chapter IV

EFFECT

Article 17: Responsibilities of entities

1.Department of Crop Production is responsible for:

a) Submitting documents to the Ministry for the issuance of legislative documents, national technical regulations and variety production procedures related to the certification of conformity for 2nd-grouped plant varieties;

b) Designating and managing laboratories and plant variety conformity certifying organizations on a nation-wide scale;

c) Inspecting and settling violations, handling complaints and accusations on certification and announcement of plant variety conformity throughout the nation;

d) Making annual reports to the Ministry of Agriculture and Rural development on the activities of plant variety conformity certification.

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

a) Carrying out inspections, handle complaints and accusations on local certification and announcement of plant variety conformity;

b) Receiving the conformity announcement documents and written announcements of conformity from local producers and imports of 2nd-grouped plant varieties and send copies of such to the Department of Crop Production for compilation.

3.Organizations certifying plant variety conformity are responsible for:

a) Certifying plant variety conformity according to the decisions on designation and this Circular;

b) Implementing pre-control and post-control according to Article 11 and Article 12 of this Circular, respectively;

c) Delivering a report compiling conformity certification results, on 6-month basis, to the Department of Crop Production according to Appendix VI of this Circular.

4.Producers and importers of commercial plant varieties are responsible for:

a) Applying for conformity certification by a certifying organization and exercising self-assessment of conformity for plant varieties domestically produced, according to this Circular;

b) Applying for a certifying organization’s certification of imported plant varieties’ conformity according to this Circular;

c) Retaining documents on varieties and varietal batches;

d) Announcing conformity;

dd) Coding varietal batches, managing 2nd-grouped plant varieties by batch and labeling batch codes on the packing.

Article 18. Transitional provisions

1.The entity sampling and inspecting plant varieties, if certified by the Department of Crop Production according to Decision No. 106/2008/QĐ-BNN dated 29 October 2008 and Circular No. 32/2010/TT-BNNPTNT dated 17 June 2010 by Ministry of Agriculture and Rural development on regulating the designation and management of the activities of sampling and inspection entities, laboratories, and organizations certifying variety quality, plants and fertilizers, is permitted to continue its sampling and inspection activities, after the 5-year term expires, by the scope and codes in the existing certificate. Renewal of certificates is not required.

2.The packing, labeled with varietal batch codes according to Circular No. 79/2011/TT-BNNPTNT dated 14 November 2011 by Ministry of Agriculture and Rural development on regulating the certification and announcement of the quality of plant varieties complying with technical regulations (referred to as the Circular No. 79/2011/TT-BNNPTNT), can be used for another 18 months upon the effect of this Circular.

Article 19. Implementation effect

1.This Circular takes January 28, 2016.

2.This Circular replaces the Circular No. 79/2011/TT-BNNPTNT and Circular No. 87/2011/TT-BNNPTNT dated 27 December 2011 on amendments to Article 20 of the Circular No. 79/2011/TT-BNNPTNT dated 14 November 2011 by Ministry of Agriculture and Rural development on regulating the certification and announcement of the quality of plant varieties complying with technical regulations.

3.If standards and legislative documents stated in this Circular are amended, latest amendments shall prevail.

4.Difficulties, arising during the enforcement of this regulation, must be reported to Ministry of Agriculture and Rural development (Department of Crop Production) for prompt solutions.

The Minister

Cao Duc Phat