Circular No. 19/2009/TT-BKHCN stipulates quality management measures for products and goods that need enhanced management before being put into circulation on the market.

 CIRCULAR

Regulations on quality management measures for products and goods that need to be strengthened before being put into circulation on the market

 before being put into circulation on the market

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

Pursuant to Decree No. 28/2008/NĐ-CP dated March 14, 2008, promulgated by the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Product Quality Law;

The Minister of Science and Technology stipulates quality management measures for products and goods that need to be strengthened before being put into circulation on the market as follows:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Circular stipulates quality management measures for products and goods that need to be strengthened before being put into circulation on the market.

2. This Circular applies to organizations and individuals producing and importing products and goods (hereinafter referred to as enterprises) and state agencies managing product and good quality related thereto.

3. This Circular does not apply to products and goods produced and imported for national defense and security purposes of armed forces. Production and importation of such products and goods shall be regulated by the Ministry of National Defense and the Ministry of Public Security.

Article 2. Explanation of terms

Strategic multi-purpose hydropower plant

1. Products and goods with potential to cause safety hazards (hereinafter referred to as group 2 products and goods) are those which, under conditions of transportation, storage, preservation, reasonable and proper use, still pose a risk of harm to people, animals, plants, property, and the environment.

2. Quality management measures (hereinafter referred to as management measures) are technical or non-technical measures aimed at controlling products and goods regarding quality, safety, production conditions, environmental conditions, circulation conditions, and other contents such as labeling and origin.

3. An eco-label (also known as green label or environmental label) is a label providing consumers with information about the environmental friendliness of a product or service compared to similar ones. Eco-labels include three types:

a) Type I label is a certified label issued to products of manufacturing enterprises.

b) Type II label is a self-declared label issued by manufacturing, importing, and distributing enterprises based on their own assessment or third-party assessment results.

c) Type III label is a voluntary label provided by manufacturing enterprises to consumers according to voluntary programs proposed by economic sectors and economic organizations.

4. A chemical safety data sheet is a document established by the chemical supplier or importer, printed in Vietnamese, containing the following information:

a) The accurate name of hazardous industrial chemicals, UN number, and level of hazard of the chemical;

b) Physical and chemical properties;

c) Packaging requirements for transported chemicals;

d) Necessary measures in case of chemical leakage;

đ) Requirements to be implemented during transportation, guidance on handling in case of accidents or incidents;

e) Technical guidance and warnings for storage and preservation;

g) Notes on transportation and disposal;

h) Safety recommendations for workers.

Chapter II
MANAGEMENT MEASURES

Article 3. Compulsory Management Measures

Compulsory management measures applicable to products and goods listed in the Catalogue of Group 2 Products and Goods issued by sectoral ministries include:

1. Management measures (conformity declaration, conformity certification) prescribed in national technical standards, regulatory legal documents for corresponding products and goods issued by sectoral ministries within their assigned areas of responsibility.

Conformity declaration and certification shall be carried out in accordance with the provisions on conformity certification and declaration and conformity declaration and publication accompanying Decision No. 24/2007/QD-BKHCN dated September 28, 2007 of the Ministry of Science and Technology.

2. Publication of applicable standards

Enterprises shall implement the publication of applicable standards for products and goods in accordance with Article 23 of the Law on Product and Good Quality.

3. Implementation of labeling

Enterprises shall carry out product labeling in accordance with Decree No. 89/2006/NĐ-CP dated June 30, 2006 of the Government on product labeling and related guiding documents.

For imported goods, enterprises must also declare the origin of the goods and ensure the truthfulness of the declaration. Determination of the origin of goods shall be carried out in accordance with Decree No. 19/2006/NĐ-CP dated February 20, 2006 of the Government detailing the Law on Trade concerning the origin of goods and related guiding documents.

Article 4. Additional management measures

Based on the actual situation of production, import, circulation in the market, and management needs, the competent ministry or sector shall issue regulations to set criteria and select one or more appropriate additional management measures for each type of product or goods belonging to Group 2 or products or goods not belonging to Group 2 within their assigned scope of management:

1. Conformity certification

Products or goods are certified as conforming to standards by independent certification organizations to affirm that the products or goods meet national standards, foreign standards, or corresponding international standards.

2. Electromagnetic Compatibility (EMC) certification

Products or goods are certified regarding EMC by independent certification organizations to affirm that electrical and electronic equipment systems operate stably, are not interfered with, and do not cause harmful interference to other equipment systems and ensure safety for human health.

3. Energy-saving product certification

Electrical and electronic products are certified for energy savings by independent certification organizations. The product label must include information about energy consumption levels and specific provisions to help consumers choose products with lower energy consumption compared to similar products.

4. Legal Circulation Certificate (Certificate of Free Sale - CFS)

Products are issued a legal circulation certificate by the authorized agency of the exporting country to confirm that the product meets safety, health, and environmental requirements as stipulated.

5. Quality Management System Certification in accordance with TCVN ISO 9001 or ISO 9001 standards

The certification of quality management systems is carried out by independent certification organizations to demonstrate that the enterprise has a quality management system in compliance with TCVN ISO 9001 or ISO 9001 standards.

6. Environmental Management System Certification in accordance with TCVN ISO 14001 or ISO 14001 standards

The certification of environmental management systems is carried out by independent certification organizations to demonstrate that the enterprise has an environmental management system in compliance with TCVN ISO 14001 or ISO 14001 standards.

7. Eco-labeling

Enterprises must affix eco-labels to their products and ensure the authenticity of these labels.

8. Chemical Safety Data Sheet

Enterprises handling chemicals must have a chemical safety data sheet and ensure its authenticity.

9. Other Management System Certification

a) For food and aquatic products, the application of a food safety management system (HACCP, ISO 22000) is required;

b) For textile and garment products, the application of a social responsibility management system (SA 8000) or occupational health and safety management system (ISO 18000/OHSAS 18000) is required;

c) For medical device products, the application of a medical device management system (ISO 13485) is required;

d) For automotive products, the application of an automotive industry management system (ISO/TS 16949) is required;

đ) For agricultural products, the application of Good Agricultural Practices (GlobalGAP) or VietGAP standards is required;

e) For pharmaceutical and cosmetic products, the application of Good Manufacturing Practices (GMP) and Good Hygienic Practices (GHP) standards is required;

g) For veterinary products, the application of Good Veterinary Practices standards is required.

Chapter III
IMPLEMENTATION

Article 5. Effective Date

This Circular takes effect 45 days from the date of issuance.

Article 6. Implementation Organization

During implementation, if there are any difficulties, agencies, organizations, and individuals should promptly report them to the Ministry of Science and Technology (National Standardization, Metrology, and Quality Control Administration) for review and resolution./.