Circular No. 83/2009/TT-BNNPTNT guiding the activities of conformity assessment and declaration of conformity within the sector under the management of the Ministry of Agriculture and Rural Development.

CIRCULAR

Guidelines on conformity assessment activities and declaration of conformity under

领域 THE HEAD OF THE MINISTRY’S OFFICE, THE HEAD OF THE MINISTRY’S INSPECTION DEPARTMENT, THE HEADS OF THE DEPARTMENTS, THE DIRECTOR OF THE VIETNAM CIVIL AVIATION ADMINISTRATION, THE CHIEF EXECUTIVE OFFICER OF THE VIETNAM AIRPORTS CORPORATION - CPTP, AND THE HEADS OF THE AUTHORITIES, ORGANIZATIONS, AND INDIVIDUALS CONCERNED ARE RESPONSIBLE FOR IMPLEMENTING THIS CIRCULAR./. the Ministry of Agriculture and Rural Development

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Pursuant to Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to Decree No. 75/2009/ND-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Pursuant to Decree No. 127/2007/ND-CP dated August 1, 2007 of the Government detailing the implementation of certain provisions of the Law on Technical Standards and Regulations;

Pursuant to Decree No. 67/2009/ND-CP dated August 3, 2009 of the Government amending certain articles of Decree No. 127/2007/ND-CP dated August 1, 2007 of the Government detailing the implementation of certain provisions of the Law on Technical Standards and Regulations and Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Law on Product Quality;

Pursuant to Decision No. 24/2007/QD-BKHCN dated September 28, 2007 of the Minister of Science and Technology promulgating "regulations on conformity assessment, declaration of conformity";

Pursuant to Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Ministry of Science and Technology guiding requirements, procedures, and formalities for registration of conformity assessment activities;

Pursuant to Circular No. 09/2009/TT-BKHCN dated April 8, 2009 of the Ministry of Science and Technology guiding requirements, procedures, and formalities for designation of conformity assessment organizations;

The Minister of Agriculture and Rural Development hereby issues guidelines on conformity assessment and declaration of conformity as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates conformity assessment and declaration of conformity activities for products and goods that have the potential to cause safety risks under the responsibility of the Ministry of Agriculture and Rural Development (hereinafter referred to as Group 2 Products and Goods), as specified in Circular No. 50/2009/TT-BNNPTNT dated August 18, 2009 of the Ministry of Agriculture and Rural Development; services, processes, and environments (hereinafter referred to as products and goods) under the responsibility of the Ministry of Agriculture and Rural Development.

Article 2. Applicability

This Circular applies to the following entities:

1. Organizations and individuals within and outside Vietnam related to the production and business of Group 2 products and goods, services, processes, and environments;

2. State management agencies related to conformity assessment and declaration of conformity.

Article 3. Nature of Conformity Assessment Certification and Declaration of Conformity

Conformity assessment and declaration of conformity are mandatory activities for organizations and individuals producing and trading in products and goods according to national technical regulations issued by the Ministry of Agriculture and Rural Development.

Article 4. Conformity Mark

1. The Conformity Mark (CR) has the shape and size as prescribed in Appendix 1 of this Circular.

2. The conformity mark shall be displayed directly on the product, commodity, or on its packaging or label attached to the product, commodity at a visible and readable position, and simultaneously printed in accompanying technical documentation.

3. The conformity mark may be enlarged or reduced but must ensure the correct ratio and be recognizable to the naked eye.

4. The conformity mark must be displayed in the same color and be easily distinguishable.

Article 5. Methods of Conformity Assessment

1. The assessment of conformity shall be carried out according to one of the following methods:

a) Method 1: Testing typical samples;

b) Method 2: typical sample testing combined with process production evaluation and market surveillance through sampling.

c) Method 3: Testing typical samples combined with production process evaluation and market surveillance through testing samples taken from the production site combined with production process evaluation;

d) Method 4: Testing typical samples combined with production process evaluation and market surveillance through testing samples taken from the production site and the market combined with production process evaluation;

đ) Method 5: Testing typical samples combined with production process evaluation and market surveillance through testing samples taken from the production site or the market combined with production process evaluation;

e) Method 6: Combined evaluation and system management supervision;

g) Method 7: Testing and evaluating batches of products, commodities;

h) Method 8: Testing or inspecting entire products, commodities.

2. Content, procedure, and principles for using conformity assessment methods prescribed in Appendix 2 of this Circular.

3. Specific conformity assessment methods applicable to each type of product and good are prescribed in corresponding technical regulations.

Article 6. Objects, grounds for certification and announcement of conformity

1. The objects of conformity certification and announcement activities are products and goods specified in national technical regulations issued by the Ministry of Agriculture and Rural Development.

2. The grounds for conformity certification and announcement are specifically stipulated in each national technical regulation issued by the Ministry of Agriculture and Rural Development.

Chapter II

CONFORMITY CERTIFICATION

Article 7. Certification organizations designated

Conformity certification activities are carried out by certification organizations designated by competent state agencies, as provided for in Article 14 of Chapter IV of this Circular. The designated certification organizations include:

1. Public or non-public scientific and technological service units established and registered to operate under the Law on Science and Technology;

2. Enterprises established and registered to operate under the Law on Enterprises;

3. Branches of foreign certification organizations registered to operate under the Investment Law.

Article 8. Requirements for designated organizations

1.1.1. Have registered their scope of certification activities at the Ministry of Science and Technology according to Circular No. 08/2009/TT-BKHCN dated April 8, 2009, issued by the Minister of Science and Technology, guiding on requirements, procedures, and procedures for registering the scope of compliance assessment activities;

1. They have registered their certification activity fields with the Ministry of Science and Technology according to Circular No. 08/2009/TT-BKHCN dated April 8, 2009, guiding requirements, procedures, and registration formalities for conformity assessment activities.

2. They must have at least three full-time staff experts (civil servants or employees with contracts of 12 months or more or indefinite-term contracts) who have graduated from university or higher and have relevant expertise and at least three years of work experience in product and goods certification activities, and have been trained in system management certification.

3. They must have all necessary technical documents, standards, and certification procedures consistent with corresponding national technical regulations.

Article 9. Procedures and formalities for registering and designating conformity certification organizations

1. Conformity certification organizations wishing to participate in specific certification activities must prepare and submit registration files to the specialized management agency assigned in Article 14 of this Circular.

The registration documents include:

a) A conformity certification activity registration form according to the model prescribed in Appendix 3 of this Circular;

b) A copy of the certificate of registration for certification activity fields issued by the Ministry of Science and Technology;

c) A list of evaluation experts meeting the requirements stipulated in Clause 2 of Article 8 of this Circular, according to the model prescribed in Appendix 4 of this Circular, accompanied by copies of corresponding training certificates;

d) A list of technical documents, necessary standards, and certification procedures consistent with corresponding national technical regulations according to the model prescribed in Appendix 5 of this Circular;

đ) Documents proving certification capacity:

- For certification organizations that have been evaluated and certified by legitimate accreditation organizations in Vietnam or international accreditation organizations such as the International Accreditation Forum (IAF) or the Pacific Accreditation Cooperation (PAC): Submit a certified copy of the accreditation certificate along with the scope of accreditation;

- For certification organizations not yet accredited: Submit documents, evaluation procedures, formalities, and other related materials to prove their certification capacity consistent with the requirements of corresponding national technical regulations.

đ) A sample of the Conformity Certificate;

e) Results of conformity certification activities already conducted in the registered field (if any).

2. Within fifteen working days from receiving valid files, the specialized management agency stipulated in Article 14 of this Circular will review the files, conduct practical capability assessments at the premises, and issue a decision to designate conformity certification organizations according to the model prescribed in Appendix 6 of this Circular. The validity period of the designation decision shall not exceed three years.

In case of refusal to designate, the specialized management agency must notify the reasons for refusal in writing to the applying organization.

Three months before the decision to designate conformity certification organizations expires, if there is a need, the conformity certification organizations must reapply for registration according to Clause 1 of Article 9 of this Circular.

3. When there is a need to change or supplement certification activity fields, designated certification organizations must follow the procedures for changing or supplementing fields and objects of certification as stipulated in Clauses 1 and 2 of this Article. The application for changing or supplementing certification activity fields according to the model prescribed in Appendix 7 of this Circular.

The specialized management agency stipulated in Article 14 of this Circular will organize the examination of files and issue decisions on changes or supplements to certification fields and objects according to the model prescribed in Appendix 8 of this Circular.

Article 10. Rights and obligations of conformity assessment organizations

1. Rights of the Certification Organization:

a) Conduct testing, inspection, examination, and certification of product quality based on contracts signed with organizations or individuals requesting conformity assessment within the fields registered for operation or designated by competent state authorities;

b) Be paid fees according to agreements with production and business organizations or individuals requiring conformity certification or as stipulated by competent state authorities;

c) Provide test results to the corresponding conformity-assessed entities, issue valid conformity certificates for products or goods not exceeding three years if they meet applicable technical standards;

d) To grant and guide the use of the conformity mark to organizations or individuals whose products or goods have been certified for conformity;

đ) Issue new, renew, or expand conformity certifications;

e) Narrow the scope or temporarily suspend, revoke conformity certificates and the right to use conformity marks when organizations or individuals whose products or goods have been certified violate regulations on conformity certification;

g) Refuse to provide information related to test results, inspection, examination, and quality certification of products or goods to third parties except when required by competent state authorities;

h) Be recognized by competent state authorities for the results of conformity assessment in accordance with legal provisions;

2. Obligations of the Certification Organization:

a) Comply with requirements specified in Article 8 of this Circular;

b) Carry out conformity certification activities in the designated fields according to prescribed procedures and formalities. They may not refuse to provide services without justifiable reasons;

c) Ensure the procedures and processes of conformity assessment in accordance with legal provisions on technical standards;

d) Based on the conformity assessment methods prescribed in corresponding technical standards, establish procedures and processes for conformity certification for specific subjects and notify relevant agencies, organizations, and individuals;

đ) To keep confidential information, data, and conformity assessment results of the assessed organization, except when required by the competent state authority;

e) To ensure transparency, independence, objectivity, accuracy, and non-discrimination in the origin of goods and organizations or individuals in conformity certification activities;

g) Monitor entities that have been certified for conformity to ensure continued compliance with relevant technical standards;

h) Promptly report to competent management authorities and widely announce through mass media about issuing new, reissuing, expanding, narrowing the scope, or temporarily suspending, revoking conformity certificates and the right to use conformity marks;

i) To accept inspections and audits by the competent state authority regarding conformity certification activities;

k) To be responsible under the law for the results and activities of conformity certification;

l) Pay fines to organizations or individuals with products or goods assessed in case of providing incorrect conformity certification results. The fine amount is agreed upon by both parties but shall not exceed ten times the evaluation cost; if the parties cannot agree, the fine will be decided by arbitration or court, but shall not exceed ten times the evaluation cost;

m) Compensate for damages arising from providing incorrect results to organizations or individuals requesting conformity certification, in accordance with civil law provisions. Organizations or individuals whose products or goods have been certified must prove the incorrect result and the fault of the conformity certification organization;

n) Notify the specialized management agency that has designated the conformity certification organization of any changes affecting its registered conformity certification capacity within fifteen days from the date of change;

o) Report periodically every six months or at any time upon request, the results of conformity certification activities according to the form prescribed in Appendix 9 of this Circular to the specialized management agency that has designated the conformity certification organization;

Chapter III

DECLARATION OF COMPLIANCE WITH TECHNICAL REGULATIONS

Article 11. Procedures and formalities for announcing conformity

The announcement of compliance shall be carried out as follows:

1. Step 1: Assess the conformity of the subject to be announced with the corresponding technical standard;

a) Conformity assessment may be conducted by a designated conformity certification organization or by the organization or individual announcing conformity;

b) In cases where organizations or individuals conduct their own conformity assessment, they must perform testing at accredited laboratories or those designated by the technical standard issuing authority;

c) The conformity assessment results serve as the basis for organizations or individuals announcing conformity;

2. Step 2: Register the conformity announcement with the Department of Agriculture and Rural Development where the organization or individual registers for production and business operations.

Article 12. Registration for Announcement of Compliance

1. Organizations and individuals announcing compliance shall establish and submit the compliance announcement dossier to the Department of Agriculture and Rural Development at the location where they have registered their production and business activities.

The compliance announcement dossier includes:

a) In cases where the compliance announcement is based on the results of conformity assessment certification issued by a conformity assessment body:

A compliance announcement form according to the model specified in Appendix 10 of this Circular;

A copy of the certificate confirming the product's or commodity's conformity with the corresponding technical regulations issued by the designated conformity assessment body;

A general description of the product or commodity (characteristics, features, functions...).

b) In cases where the compliance announcement is based on self-assessment results conducted by the organization or individual engaged in production and business:

A compliance announcement form according to the model specified in Appendix 10 of this Circular;

A general description of the product or commodity (characteristics, features, functions...);

Test and calibration results (if any) from accredited laboratories;

Production processes and quality control plans established and implemented according to the model specified in Appendix 11 of this Circular or a copy of the ISO 9001 standard certificate if the organization or individual announcing compliance has an ISO 9001 certified quality management system;

Periodic monitoring plan;

A conformity assessment report including the following contents:

- The subject(s) certified for compliance;

- (Number, name) of technical documentation used as the basis for compliance certification;

- Name and address of the organization conducting the conformity assessment;

- Method of conformity assessment used;

- Description of the conformity assessment process (sampling, evaluation, duration of evaluation,...) and necessary explanations (e.g., reasons for selecting sampling methods/evaluation procedures);

- Assessment results (including deviations and acceptance levels);

- Additional information.

Related documents.

2. Within seven working days from the date of receipt of the compliance announcement dossier:

If the dossier meets the requirements stipulated in Clause 1 of this Article, the Department of Agriculture and Rural Development will notify in writing to the organization or individual announcing compliance about the acceptance of the announcement form according to the model specified in Appendix 12 of this Circular;

In case the dossier does not meet the requirements stipulated in Clause 1 of this Article, the Department of Agriculture and Rural Development will notify in writing to the organization or individual announcing compliance about the non-compliant points and contents for improvement and resubmission.

Article 13. Responsibilities of organizations and individuals announcing compliance

1. Shall be responsible for the conformity of products and goods that have been published as conforming; maintain quality control, testing, and regular monitoring at the enterprise.

2. Use the conformity mark for products and goods that have been published as conforming according to the provisions of Article 4 of this Circular before putting them into circulation on the market.

3. When discovering non-conformity of products and goods that have been announced as compliant with technical standards during production, circulation, operation, and use, they must:

a) Timely notify relevant management agencies about the non-conformity;

b) Implement measures to address the non-conformity. If necessary, temporarily halt production and recall non-compliant products and goods currently circulating on the market;

c) Notify relevant management agencies about the results of rectifying non-conformities before continuing to use, circulate, exploit, or trade products and commodities.

4. Retain the announcement of compliance documents as a basis for inspection and supervision by state management agencies.

5. Reannounce when there is any change in the content of the previously registered announcement of compliance.

Chapter IV

IMPLEMENTATION

Article 14. Responsibilities of management agencies

1. General Departments, Bureaus

a) Relevant specialized General Departments and Bureaus under the Ministry of Agriculture and Rural Development are responsible for:

Compiling lists of areas and subjects required to be certified and announced for compliance according to national technical regulations within their management responsibilities and publicizing them through mass media and on the websites of their respective agencies;

Receiving registration dossiers, evaluating, and designating conformity assessment bodies for areas assigned under the Ministry of Agriculture and Rural Development’s management; establishing and publicly announcing on their respective agency websites and appropriate communication channels lists of designated conformity assessment bodies for organizations and individuals to choose from;

Compiling lists of products and commodities that have been announced for compliance and certified for compliance for subjects managed by the Ministry of Agriculture and Rural Development to report to the Ministry and publicize on their respective agency websites;

Directing and managing compliance certification and announcement activities in assigned areas; annually reporting to the Ministry of Agriculture and Rural Development on the status of compliance certification and announcement activities.

b) Allocation of areas and subjects for management of compliance certification by General Departments and Bureaus under the Ministry of Agriculture and Rural Development:

Fisheries General Department: Aquaculture; aquatic seedlings; feed, raw materials for feed production, additives, biological preparations, water quality for aquaculture; aquaculture environment, aquaculture seedling production areas, feed production and trading facilities for aquaculture, biological preparation production facilities for aquaculture, fishing vessels, fish ports, anchorage areas for typhoon shelters, fishing vessel repair facilities; conservation, protection, and development of aquatic resources. Forestry General Department: Forestry plant seeds, forestry processes, forestry services, and forestry environment.

Water Resources General Department, Water Resources Bureau: Water resource exploitation, utilization, and protection, drainage, embankment, flood prevention, and storm mitigation.

Quality Management Bureau for Agricultural, Forestry, and Fishery Products: Conditions ensuring food safety and quality for production facilities of aquatic products, fish ports, fish markets, purchasing, transportation, storage, preliminary processing, processing, wholesale of agricultural, forestry, and fishery products; agricultural, forestry, and fishery products for export and import; food and non-food quality of agricultural, forestry, and fishery products.

Processing and Marketing Bureau for Agricultural, Forestry Products, and Salt Industry: Salt and salt products; machinery and equipment for agriculture.

Crop Production Bureau: Plant seeds, fertilizers, raw materials for fertilizer production, biological preparations for crop cultivation, crop cultivation environment, and food safety and hygiene assurance in crop cultivation.

Plant Protection Bureau: Plant quarantine, plant protection chemicals and raw materials, production, processing, bottling, packaging of plant protection chemicals, preservation of agricultural and forestry products.

Livestock Breeding Bureau: Livestock breeding seeds, livestock feed and raw materials, preservatives used in livestock feed, biological preparations for livestock breeding; livestock breeding production, breeding environment, food safety and hygiene assurance in livestock breeding.

Animal Health Bureau: Animal diseases, veterinary drugs and raw materials, veterinary hygiene conditions.

Construction Project Management Bureau: Water conservancy projects

Department of Construction Management: Waterworks Projects

2. Departments of Agriculture and Rural Development of provinces and centrally governed cities shall be responsible for:

a) Coordinate with the specialized administrations under the Ministry of Agriculture and Rural Development in urging and guiding the implementation of conformity certification and declaration in accordance with this Circular.

b) Receiving registration files, issuing announcements on receiving conformity declarations, maintaining records and managing declaration files according to the provisions of this Circular;

c) Annually, or at any time when requested, compiling and reporting to the Ministry of Agriculture and Rural Development on the situation of conformity declaration activities.

3. The Department of Science, Technology and Environment shall be responsible for assisting the Minister of Agriculture and Rural Development to uniformly manage and guide conformity certification and declaration activities in accordance with this Circular.

Article 15. Inspection, Audit, and Handling of Violations

1. The competent state management agency shall carry out inspection, audit, and handle violations of laws in conformity certification and declaration activities in accordance with Decree No. 54/2009/ND-CP dated June 5, 2009 of the Government on administrative penalties for violations in the field of standards, measurement, and product quality, as well as other current relevant regulations.

2. Organizations and individuals violating the provisions on conformity certification and declaration shall be handled according to the current relevant laws depending on the nature and degree of violation.

Chapter V

IMPLEMENTING PROVISIONS

Article 16. Effective Date

This Circular takes effect forty-five days from the date of signature.

During the implementation of this Circular, if there are any difficulties, individuals and organizations are requested to report to the Ministry of Agriculture and Rural Development for research and amendment./.