Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Ministry of Labor, War Invalids and Social Affairs prescribing quality management of products and goods likely to become unsafe under the state management by the Ministry of Labor, Invalids and Social Affairs

CIRCULAR

Prescribing quality management of products and goods likely to become unsafe under the state management by the Ministry of Labor, Invalids and Social Affairs^[1]

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

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

Pursuant to the Government’s Decree No. 127/2007/ND-CP of August 1, 2007, detailing a number of articles of the Law on Standards and Technical Regulations;

Pursuant to the Government’s Decree No. 132/2008/ND-CP of December 31, 2008, detailing a number of articles of the Law on Product and Goods Quality;

Pursuant to the Government’s Decree No. 74/2018/ND-CP of May 15, 2018, amending and supplementing a number of articles of Decree No. 132/2008/ND-CP of May 31, 2008, detailing a number of articles of the Law on Product and Goods Quality;

Pursuant to the Government’s Decree No. 78/2018/ND-CP of May 16, 2018, amending and supplementing a number of articles of the Decree No. 127/2007/ND-CP of August 1, 2007, detailing a number of articles of the Law on Standards and Technical Regulations;

Pursuant to the Government’s Decree No. 154/2018/ND-CP of November 9, 2018, amending, supplementing and annulling a number of regulations on investment and business conditions in the fields under the state management by the Ministry of Science and Technology and regulations on specialized inspection;

Pursuant to the Government’s Decree No. 14/2017/ND-CP of February 17, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Labor, Invalids and Social Affairs;

At the proposal of the Director of the Department of Work Safety;

The Minister of Labor, Invalids and Social Affairs promulgates the Circular prescribing quality management of products and goods likely to become unsafe under the state management by the Ministry of Labor, Invalids and Social Affairs,

Chapter 1

GENERAL PROVISIONS

Article 1.Scope of regulation

This Circular prescribes the quality management of products and goods likely to become unsafe (below referred to as group-2 products and goods) under the state management by the Ministry of Labor, War Invalids and Social Affairs.

Article 2.Subjects of application

1. Conformity assessment bodies which have certificates granted or are designated or recognized by the Ministry of Labor, Invalids and Social Affairs in accordance with law.

2. Organizations and individuals producing, trading in, importing or using group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs. The list of products and goods likely to become unsafe under the state management by the Ministry of Labor, Invalids and Social Affairs is prescribed in the Minister of Labor, Invalids and Social Affairs’ Circular No. 22/2018/TT-BLDTBXH of December 6, 2018.

3. Agencies performing the state management of quality of group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs and other related organizations and individuals.

Article 3.State quality inspection of product and goods

1. State quality inspection of group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs in production, importation and market circulation must comply with the Law on Product and Goods Quality, the decrees guiding the implementation of the Law on Product and Goods Quality, guidance of the Ministry of Science and Technology, and this Circular.

2. The Department of Work Safety and provincial-level Labor, Invalids and Social Affairs Departments shall carry out quality inspection of group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs.

Article 4.Conformity assessment of products and goods

1. Organizations conducting conformity assessment of group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs, are those designated or recognized by the Ministry of Labor, Invalids and Social Affairs or having registered conformity assessment activities under the Government’s Decree No. 107/2016/ND-CP of July 1, 2016, prescribing conditions for provision of conformity assessment services.

2. Conformity assessment methods

a/ For group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs, conformity assessment shall be conducted by the methods 5, 7 and 8 prescribed in Article 5 of the Minister of Science and Technology’s Circular No. 28/2012/TT-BKHCN of December 12, 2012, on standard and regulation conformity assessment and conformity assessment methods.

b/ In case national technical regulations on occupational safety applicable to products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs before this Circular takes effect do not provide regulation conformity certification method according to method 5, Point a, Clause 2 of this Article shall apply.

Article 5.Regulation conformity announcement

1. Group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs must be announced as regulation conformable in accordance with relevant national technical regulations.

2. The principles, order and procedures of regulation conformity announcement and responsibilities of conformity announcement bodies must comply with the Minister of Science and Technology’s Circular No. 28/2012/TT-BKHCN of December 12, 2012, on standard and regulation conformity announcement and conformity assessment methods and Circular No. 02/2017/TT-BKHCN of March 31, 2017, amending and supplementing a number of articles of Circular No. 28/2012/TT-BKHCN.

3. Group-2 product and goods producers shall register for regulation conformity announcement at the Department of Work Safety.

4. Group-2 product and goods importers shall carry out regulation conformity announcement through the state quality inspection of imported products and goods.

5. Regulation conformity marks shall be issued by regulation conformity certification bodies for products and goods announced as regulation conformable or stuck by regulation conformity announcement organizations on products and goods announced as regulation conformable after registering for regulation conformity announcement. The shape and size of and information inscribed in regulation conformity marks are prescribed in Appendix I to this Circular.

Article 6.Recognition of conformity assessment results

1. In case of conducting regulation conformity announcement using conformity assessment results of a foreign conformity assessment body, such body must have been accredited in accordance with law or provided in relevant national technical regulations.

2. For trials which cannot be conducted at laboratories in Vietnam, designated or accredited conformity assessment bodies may consider recognizing and using test results of overseas laboratories.

3. The recognition and use of test results of overseas laboratories must comply with the law on standards and technical regulations.

4. In case of necessity to test results of overseas laboratories, conformity assessment bodies shall supervise and take the responsibility for their certification and assessment results. When necessary, the Department of Work Safety shall inspect the recognition and use of test results by conformity assessment bodies.

Chapter 2

STATE QUALITY INSPECTION OF PRODUCTS AND GOODS IN PRODUCTION

Article 7.Grounds for quality inspection of products in production by product and goods quality inspection agencies

1. Information and warnings about exports’ failure to meet the conditions prescribed in Article 32 of the Law on Product and Goods Quality.

2. Inspection agencies’ results of survey or quality inspection of goods in market circulation revealing goods’ unconformity with announced applicable standards or relevant technical regulations.

3. Verification information of domestic or foreign organizations and individuals reflecting the quality of products and goods.

4. Annual inspection plans approved by competent agencies.

Article 8.Inspection principles

1. To strictly comply with regulations on product and goods quality; prevent and strictly handle product and goods quality-related violations of producers; to protect lawful rights and interests of producers, traders and consumers.  

2. To ensure transparency, objectiveness and observance of regulations on product and goods quality as well as international agreements and treaties to which Vietnam is a contracting party.

3. To conduct inspection based on national technical regulations, announced applicable standards, regulations on labels and measures for state management of quality of products in production.

4. To conduct inspection under inspection plans approved by competent agencies or unscheduled inspection if having the grounds prescribed in Clauses 1, 2 and 3, Article 7 of this Circular.

5. The quality inspection of products and goods shall be conducted by inspection teams formed under decisions of product and goods quality inspection agencies.

Article 9. Contents of quality inspection of products in production

1. Inspecting the compliance with requirements of relevant national technical regulations concerning conditions of the production process and methods of state management of quality of products in production, including:

a/ Examining regulation conformity certification and announcement dossiers (for products and goods subject to regulation conformity certification and announcement); standard conformity announcement dossiers (for products and goods subject to standard conformity announcement); dossiers of standard conformity certification for quality management systems (for products applying quality management systems); and inspecting the announcement of applicable standards under Article 23 of the Law on Product and Goods Quality;

b/ Inspecting the labeling and contents of warnings (for products and goods subject to regulations on display of warning information); the display of regulation conformity marks (for products and goods subject to regulation conformity certification and announcement) and standard conformity marks (for products and goods certified as standard conformable), and examining documents enclosed with the to-be-inspected products;

c/ Inspecting the implementation of relevant technical regulations’ provisions on conditions of the production process during the process of production, if such provisions exist;

d/ Inspecting the implementation of other measures for state management of quality of products in production prescribed by competent agencies.

2. Inspecting the assessment of conformity of the production process and conformity assessment results.

Inspecting the production facilities’ control of the production process regarding the creation of products and quality maintenance, covering:

a/ Examining products’ technical files (design documents and technical standards of products);

b/ Inspecting of the whole or one of the stages of the production process (from input through intermediary stages until products are created, including also the process of packaging, loading and unloading, warehousing and transportation);

c/ Inspecting quality of raw materials (announced applicable standards, relevant technical regulations, use of forbidden materials, expired raw materials);

d/ Inspecting the compliance with requirements on technological equipment and  measuring, inspection, and testing devices;

e/ Examining professional skills files of workers and technicians;

g/ Inspecting other necessary technical contents.

When necessary, inspection agencies may invite experts to conduct assessment according to requirements of relevant technical regulations. Experts must conduct assessment in an independent and objective manner and shall take responsibility before law for their assessment results.

3. Testing samples to inspect conformity of products with announced applicable standards and relevant technical regulations.

During the process of inspection at a production facility, if detecting a product showing sign of failing to meet quality requirements, inspection agencies shall take samples of the product for testing. The sampling of a product for quality inspection shall be carried out as follows:

a/ Samples shall be taken by the sampling method prescribed in the relevant standard or technical regulations. In case there is no regulation on sampling method, samples shall be taken randomly provided that such samples represent the product lot. Every sample shall be divided into two units, one for testing and one for storage at the inspection agency. The stored sample shall be liquidated by the inspection agency 3 months after the inspection and handling are completed, provided there is no complaint;

b/ Based on the testing method applicable to the product, the inspection team shall take samples, ensuring sufficient quantity of samples for testing norms according to the announced applicable standard or relevant technical regulation and inspection requirements;

c/ After being taken, samples shall be sealed (seals are made according to Form No. 01 provided in Appendix II to this Circular) and a record thereon shall be made (according to Form No. 02 provided in Appendix II to this Circular) bearing signatures of the sample taker and representative of the facility where samples are taken. In case the representative of the facility where samples are taken refuses to sign the record of sampling and sealing, the inspection team shall state in the record: “the representative of the facility where samples are taken refuses to sign the record of sampling and sealing”. The sampling and sealing record remains legally valid if bearing signatures of the sample taker and the head of the inspection team;

d/ Testing of samples

Within 7 working days from the date of sampling, the inspection team shall send samples to a designated laboratory for testing.

Article 10.Expenses for sample taking and testing

Expenses for sample taking and testing must comply with Joint Circular No. 28/2010/ TTLT-BTC-BKHCN of March 3, 2010, of the Ministry of Finance and Ministry of Science and Technology, guiding the management and use of expenses for state quality inspection of products and goods.

Article 11.Inspection order and procedures

An inspection team shall carry out inspection according to the following order and procedures:

1. To produce an inspection decision.

2. To carry out the inspection according to the contents prescribed in Article 9 of this Circular.

3. To make an inspection record bearing signatures of the representatives of the inspected facility and inspection team. In case the representative of the facility refuses to sign the record, the inspection team shall clearly state in the record that “the representative of the facility refuses to sign the record” and the reason for refusal; the record bearing signatures of the head and members of the inspection team remains valid. When necessary to take samples of goods, the inspection team shall take samples in accordance with Clause 3, Article 9 of this Circular.

4. To report inspection results to the inspection agency and propose the latter to notify testing results of product samples failing to meet quality requirements (according to Form No. 03 provided in Appendix II to this Circular) to the inspected production facility within 5 working days after receiving testing results.

5. Upon detecting a violation, the inspection team and inspection agency shall handle it in accordance with Article 12 of this Circular.

Article 12.Handling of violations in the inspection process

1. In the process of quality inspection of products in production, if detecting a production facility failing to comply with requirements on product labeling and announced applicable standards and relevant technical regulations regarding products and conditions on the production process, an inspection team shall:

a/ Make a record and request the production facility to take remedial measures within the time limit specified in such record. During the period of implementing remedial measures, the production facility may not put unconformable products in market circulation.

The production facility may only put products in market circulation after taking remedial measures at the request of the inspection team and sending a report thereon to the inspection agency;

b/ In case the production facility continues its violation after receiving a request of the inspection team, the inspection agency shall, depending on the nature and extent of the violation and the extent and scale of its impact, within 7 working days (after obtaining conclusion on repeated violation of the production facility) make a public announcement of the name and address of the production facility, name of the unconformable product and the level of product nonconformity in local or central mass media (newspapers, radio and television stations) (such announcement shall be made according to Form No. 04 provided in Appendix II to this Circular);

c/ After the inspection agency makes a public announcement in the mass media, if the production facility still continues its violation, the inspection agency shall, within 5 working days (from the date of making a public announcement of the violation in the mass media), make a record of administrative violation, transfer the dossier under Clause 3 of this Article, and propose a competent state agency to handle the violation in accordance with law.

2. In the process of quality inspection of a product in production, if test results or evidences show that the product is unconformable with the announced applicable standard or relevant technical regulation, threatening the safety of humans, animals, plants, assets and the environment:

a/ The head of the inspection team shall make a record of administrative violation and seal lots of unconformable products at the place of production or warehouse and make a record of sealing (the sealing stamp shall be made according to Form No. 05 provided in Appendix II to this Circular, and the sealing record shall be made according to Form No. 06 provided in Appendix II to this Circular). The inspection agency shall issue a notice of temporary suspension of production and circulation of the unconformable product (according to Form No.  07 provided in Appendix II to this Circular), request the production facility to recall the number of product items already put in market circulation, make a public announcement in the mass media, transfer the dossier under Clause 3 of this Article, and propose a competent state agency to handle the violation in accordance with law;

b/ The production facility may continue manufacturing the product only after it completes remedial measures, obeys the handling and shall, at the same time, report in writing to the inspection agency for the latter to conduct re-inspection and issue a notice allowing the production and circulation of the product (according to Form No. 08 provided in Appendix II to this Circular).

3. A dossier transferred to a competent state agency for handling of a violation must comprise an inspection decision, an inspection record, a notice of test results or evidences affirming the product nonconformity, a record of administrative violation, a recording of sealing, a notice of production suspension, and the inspection agency’s official letter requesting the competent agency to carry out procedures for handling the violation in accordance with law.

State agencies competent to handle violations shall consider and handle them in accordance with law, and notify the inspection agency of handling results for supervision and summarization.

Chapter 3

ORGANIZATION OF IMPLEMENTATION

Article 13.Responsibilities of the Department of Work Safety

The Department of Work Safety shall assist the Minister of Labor, Invalids and Social Affairs in performing the state management of product and goods quality at the central level and has the following responsibilities:

1. To receive regulation conformity announcement registration dossier and manage regulation conformity announcement dossier; to cancel or invalidate results of receipt of regulation conformity announcement dossiers for group-2 products and goods under the Ministry of Labor, Invalids and Social Affairs’ management; to update and publicize information on organizations and enterprises conducting regulation conformity announcement for their products and goods.

2. To receive and process dossiers of registration for quality inspection of imported products and goods, for goods items assigned to it for management under the Minister of Labor, Invalids and Social Affairs’ Circular No. 22/2018/TT-BLDTBXH of December 6, 2018, on the list of products and goods likely to become unsafe under the state management by the Ministry of Labor, Invalids and Social Affairs; to open registers for monitoring the registration of state quality inspection of products and goods according to Form No. 01 provided in Appendix III to this Circular.

3. To coordinate with provincial-level Departments of Labor, Invalids and Social Affairs and customs offices in disposing of inferior quality products and goods.

4. To  summarize and report to the Ministry of Labor, Invalids and Social Affairs on state quality inspection of products and goods and inspection results, and the receipt of regulation conformity announcement dossier on an annual and irregular basis.

5. To examine, inspect and handle violations in standard conformity announcement, regulation conformity announcement and conformity assessment of organizations and individuals producing, trading or importing group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs, and conformity assessment bodies conducting conformity assessment for these products and goods in accordance with law.

6. Based on the situation of quality inspection of goods on the market and quality of products in production, to estimate funds for quality inspection of products in production for the following year for inclusion into the plan on quality inspection of products and goods, and report it to a competent authority for decision.

Article 14.Responsibilities of provincial-level Departments of Labor, Invalids and Social Affairs

Provincial-level Departments of Labor, Invalids and Social Affairs shall perform the state management of quality, products and goods in localities and have the following responsibilities:

1. To receive and process dossiers of registration for quality inspection of imported products and goods, for goods items assigned to them for management under the Minister of Labor, Invalids and Social Affairs’ Circular No. 22/2018/TT-BLDTBXH of December 6, 2018, on the list of products and goods likely to become unsafe under the state management by the Ministry of Labor, Invalids and Social Affairs; open registers for monitoring the registration of state quality inspection of products and goods according to Form No. 01 provided in Appendix III to this Circular.

2. To coordinate with the Department of Work Safety and customs offices in disposing of inferior quality products and goods;

3. To examine, inspect and handle violations in standard conformity announcement, regulation conformity announcement, and conformity assessment by organizations and individuals producing, trading or importing group-2 products and goods under the state management by the Ministry of Labor, Invalids and Social Affairs and conformity assessment bodies conducting conformity assessment for these products and goods in accordance with law.

4. Annually and irregularly, to summarize and report to the Department of Work Safety on the state quality inspection of products and goods and its results  according to Form No. 02 provided in Appendix III to this Circular.

Chapter 4

IMPLEMENTATION PROVISIONS

Article 15.Effect

This Circular takes effect on February 20, 2019, and replaces the Minister of Labor, Invalids and Social Affairs’ Circular No. 35/2012/TT-BLDTBXH of December 27, 2012, prescribing the procedures for designating organizations conducting regulation conformity certification and announcement for products and goods managed by the Ministry of Labor, Invalids and Social Affairs, and Circular No. 03/2010/TT-BLDTBXH of January 19, 2010, promulgating a List of group-2 products and goods, and guiding the order of, procedures for, and contents of, quality inspection of products and goods in production.

Article 16.Implementation responsibility

1. The Department of Work Safety, the Ministry of Labor, Invalids and Social Affairs, provincial-level Departments of Labor, Invalids and Social Affairs, and related agencies, organizations and individuals shall implement this Circular.

2. In case legal documents referred to in this Circular are amended, supplemented or replaced, relevant articles, clauses, points in amending, supplementing or replacing documents shall prevail.

3. Any problems arising in the course of implementation should be reported to the Ministry of Labor, Invalids and Social Affairs for study and settlement.-

For the Minister of Labor, Invalids and Social Affairs
Deputy Minister
LE TAN DUNG

* The appendices to this Circular are not translated.