Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 quality control of potentially dangerous products under management of the Ministry of Labor, War Invalids and Social Affairs

CIRCULAR

QUALITY CONTROL OF POTENTIALLY DANGEROUS PRODUCTS UNDER MANAGEMENT OF THE MINISTRY OF LABOR, WAR INVALIDS AND SOCIAL AFFAIRS

Pursuant to the Law on product quality dated November 21, 2007;

Pursuant to the Law on Technical regulations and standards dated June 29, 2006;

Pursuant to the Government's Decree No. 127/2007/ND-CP dated August 01, 2007 detailing the implementation of a number of articles of the Law on Technical regulations and standards;

Pursuant to the Government's Decree No. 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and goods quality;

Pursuant to the Government's Decree No. 74/2018/ND-CP dated May 15, 2018 on amendments to Decree No. 132/2008/ND-CP;

Pursuant to the Government's Decree No. 78/2018/ND-CP dated May 16, 2018 on amendments to Decree No. 127/2007/ND-CP;

Pursuant to the Government's Decree No. 154/2018/ND-CP dated November 09, 2018 on revision, addition and abrogation of some business conditions under management of the Ministry of Science and Technology and some regulations on specialized inspection;

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

At the request of Director of Occupational Safety Administration;

The Minister of Labor, War Invalids and Social Affairs promulgates a Circular on quality control of potentially dangerous products under management of the Ministry of Labor, War Invalids and Social Affairs,

Chapter 1

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for quality control of potentially dangerous products (also known as Category 2 products) under management of the Ministry of Labor, War Invalids and Social Affairs (MOLISA).

Article 2. Regulated entities

1. Conformity assessment bodies certified, appointed or recognized by MOLISA;

2. Manufactures, sellers, importers and users of Category 2 products under management of MOLISA.The list of potentially dangerous products under management of MOLISA is provided in Circular No. 22/2018/TT-BLDTBXH dated December 06, 2018;

3. Regulatory authorities in charge of quality control of Category 2 products under management of the Ministry of Labor, War Invalids and Social Affairs, relevant organizations and individuals.

Article 3. State inspection of product quality

1. State inspection of quality of Category 2 products under management of the Ministry of Labor, War Invalids and Social Affairs shall be carried out in accordance with the Law on product quality, its guiding Decrees, guidance of the Ministry of Science and Technology and provisions of this Circular.

2. Occupational Safety Administration and Departments of Labor, War Invalids and Social Affairs of central-affiliated cities and provinces (hereinafter referred to as “provinces” shall carry out inspection of quality of Category 2 products under management of the Ministry of Labor, War Invalids and Social Affairs.

Article 4. Product conformity assessment

1. Organizations that carry out conformity assessment of Category 2 products under management ofMOLISA (hereinafter referred to as “conformity assessment bodies”) are organizations that are appointed or recognized by MOLISA or conformity assessment bodies that have been registered in accordance with the Government's Decree No. 107/2016/ND-CP.

2. Conformity assessment methods

a) Conformity assessment of Category 2 products under management of MOLISA shall apply method 5, 7, 8 specified in Article 5 of Circular No. 28/2012/TT-BKHCN.

b) In cases where a National Technical Regulation on occupational safety applied to products under management of MOLISA that is promulgated before the effective date of this Circular does not require the application of method 5, Point a Clause 2 of this Article shall apply.

Article 5. Declaration of conformity

1. Category 2 products under management of MOLISA shall have declaration of conformity according to corresponding National Technical Regulations.

2. Rules and procedures for declaration of conformity, responsibilities of declaring organizations are specified in Circular No. 28/2012/TT-BKHCN and Circular No. 02/2017/TT-BKHCN.

3. Manufacturers of Category 2 products shall register their declaration of conformity at Occupational Safety Administration.

4. Importers of Category 2 products shall register their declaration of conformity during state inspection of quality of imports.

5. The conformity marking shall be granted by the conformity-certifying organization or the declaring organization after the declaration of conformity has been registered. The design, size and information of the conformity marking are specified in Appendix I hereof.

Article 6. Recognition of conformity assessment results

1. If conformity assessment results provided by a foreign conformity assessment body, it must be recognized as per the law or provided for in a National Technical Regulation.

2. The appointed or certified conformity assessment body may use test results provided by an overseas laboratory if the test cannot be carried out by a laboratory in Vietnam.

3. The recognition or application of test results given by overseas laboratories shall comply with regulations of law on technical standards and regulations.

4. When a test result given by an overseas laboratory has to be recognized or applied, the conformity assessment body shall monitor the process and assume responsibility for its certification.Occupational Safety Administration may inspect the recognition and application of test results by conformity assessment bodies where necessary.

Chapter 2

STATE INSPECTION OF PRODUCT QUALITY DURING MANUFACTURING PROCESS

Article 7. The cases in which an inspection of product quality during the manufacturing process is carried out

1. There is information or warning that the exports fail to fully satisfy the requirements specified in Article 32 of the Law on product quality.

2. The result of survey or quality inspection of goods being sold on the market reveals that the goods quality is not conformable with the applied standards or corresponding technical regulations.

3. There are complaints against the goods quality from domestic or overseas organizations or individuals.

4. The inspection is carried out under the annual inspection plan approved by a competent authority.

Article 8. Inspection rules

1. Comply with regulations of law on goods quality; prevent and take actions against violations against regulations on goods quality; protect the lawful rights and interests of manufacturers, sellers and consumers.

2. Ensure transparency, objectivity and conformity with regulations of law on product quality, and international treaties to which Vietnam is a signatory.

3. The inspection is based upon applied standards or National Technical Regulation, regulations of law on labeling and state management of product quality.

4. The inspection is carried out under an inspection plan approved by a competent authority or on the basis specified in Clause 1, 2, 3 Article 7 of this Circular.

5. The inspection is carried out by an inspectorate established by a product quality inspection authority.

Article 9. Inspection contents

1. Inspection of fulfillment of requirements in corresponding National Technical Regulations relevant to the manufacture process and measures for state management of product quality during manufacture process, including:

a) Documents about the certificate of conformity, declaration of conformity, certificate of standard conformity (if required); certificate of conformity of quality control system (if applied);The inspection of conformity with applied standards is provided for in Article 23 of the Law on product quality.

b) Inspection of labeling and contents of warnings (if required); display of the conformity marking (if the certificate of conformity or declaration of conformity is required), standard conformity marking (if standard conformity certification is available) and documents enclosed with the product inspected;

c) If the applied technical regulation specifies the manufacture requirements, the fulfillment of such requirements during the manufacture process shall also be inspected;

d) Inspection of implementation of other measures for state management of product quality during the manufacture process required by competent authorities.

2. Inspection of the process and result of conformity assessment during the manufacture process.

Inspection of the control of the manufacture process relevant to the creation of products and maintenance of quality assurance, including:

a) Inspection of technical documents of the product (design, specifications);

b) Inspection of the entire or part of the manufacture process (raw materials, intermediate phases and completion of products, including packaging, handling, storage and transport of the products);

c) Inspection of quality of raw materials according to applied standards or technical regulations, use of banned or expired materials);

d) Inspection of adequacy of technological equipment, measurement equipment and testing equipment;

e) Inspection of documents about workers and technicians’ skills;

g) Other necessary technical contents.

The inspecting authority may employ external experts to carry out the assessment according to corresponding technical regulations where necessary.These experts shall work independently and objectively, and take legal responsibility for their performance.

3. Sample testing serving inspection of conformity of the products with applied standards or corresponding technical regulations.

If the products are suspected of having inferior quality during the inspection at the factory, samples shall be taken for testing as follows:

a) The sampling methods specified by the corresponding technical regulations and standards shall be applied. If a sampling method is not specified, samples shall be taken randomly from the batch. Each sample shall be divided into two smaller units, one of which shall be tested and the other stored by the inspecting authority. The latter shall be discarded by the inspecting authority if there is no complaint after 03 months from the completion of the inspection;

b) The quantity of samples shall be suitable for the testing method specified in the applied standards or corresponding technical regulations and the inspection requirements;

c) The samples shall be sealed after taken (the sample seal specimen is provided in Appendix II hereof). The record on the sampling process shall be prepared according to Form No. 02 in Appendix II hereof). The sampling record shall bear the signatures of the sampler and the representative of the inspected facility.If the representative of the inspected facility fails to sign the sampling record and the seal, the inspectorate shall specify that in the record. The record is still legitimate if it has only the signatures of the sampler and the chief of the inspectorate;

d) Sample testing

Within 07 working days from the sampling date, the inspectorate shall send the samples to an appointed laboratory for testing.

Article 10. Costs of taking and testing samples

The costs of taking and testing samples are specified in Joint Circular No. 28/2010/TTLT-BTC-BKHCN dated March 03, 2010 of the Ministry of Science and Technology on management and use of funding for state inspection of product quality.

Article 11. Inspection procedures

The inspectorate shall carry out the inspection following these procedures:

1. Present the inspection decision;

2. Carry out the inspection in accordance with Article 9 of this Circular;

3. Prepare the inspection record, which has to bear the signatures of the representatives of the inspected facility and members of the inspectorate.If the representative of the inspected facility fails to sign the record, the inspectorate shall specify that in the record. The record is still legitimate if it has only the signatures of the chief and members of the inspectorate.Samples shall be taken if necessary according to Clause 3 Article 9 of this Circular;

4. Submit a report on the inspection result to the inspecting authority and request the inspecting authority to issue a notice of sample testing result (Form No. 03 in Appendix II hereof) to the inspected facility within 05 working days from the day on which the result is available;

5. Any violations discovered shall be dealt with in accordance with Article 12 of this Circular.

Article 12. Actions against violations

1. During the inspection, ifit is found that the manufacturer fails to comply with regulations on labeling or requirements of the applied standards or corresponding technical regulations and manufacturing process requirements:

a) The inspectorate shall prepare a record, request the manufacturer to implement remedial measures within the time limit specified in the record.While the remedial measures are being implemented, the manufacturer must not sell the non-conformable products on the market.

The manufacturer may only sell the products after remedial measures are implemented as requested by the inspectorate and a report on implementation of remedial measures has been submitted to the inspecting authority;

b) If the manufacturer fails to rectify its violations after being requested to do so by the inspectorate, the inspecting authority shall, depending on the nature and seriousness of the violations, within 07 working days from the day on which the inspecting authority concludes that the manufacturer fails to rectify its violations, and make a press statement through local or central channels (newspaper, radio, television) the manufacturer’s name, address, the non-conformable products and the seriousness of the violations (Form No. 04 in Appendix II hereof);

c) If the manufacturer still fails to rectify its violations after the violations are published, the inspecting authority, within 05 working days from the date of the press statement, shall issue an administrative violation record and transfer the case to a competent authority for handling (hereinafter referred to as “handling authority”) in accordance with Clause 3 of this Article.

2. During the inspection, if there the testing result reveals that or there is evidence that the products are not conformable with applied standards or corresponding technical regulations in a manner that threatens the safety of humans, animals, the environment or property:

a) The chief of the inspectorate shall issue the administrative violation record and seal the non-conformable batch at the factory or warehouse (Form No. 05 and 06 in Appendix II hereof);The inspecting authority shall issue a request for suspension of manufacture and sale of non-conformable products (Form No. 07 in Appendix II hereof), request the manufacturer to recall the non-conformable products that have been sold, make a press statement, and transfer the case and the documents specified in Clause 3 of this Article to the handling authority.

b) The manufacturer may only resume the manufacture after the violations have been rectified; a report shall be submitted to the inspecting authority, which will subsequently carry out a re-inspection and issue a permission to resume the manufacture and sale of products (Form No. 08 in Appendix II hereof).

3. Documents to be transferred to the handling authority include: the inspection decision, inspection record, notice of sample testing result or evidence of non-conformity of products, administrative violation record, sealing record, request for manufacture suspension, the inspecting authority's request for handling of violations.

The handling authority shall handle the case in accordance with law and inform the inspecting authority of the result.

Chapter 3

IMPLEMENTATION ORGANIZATION

Article 13. Responsibilities of Occupational Safety Administration

Occupational Safety Administration shall assist the Minister of Labor, War Invalids and Social Affairs in state management of good quality and has the responsibility to:

1. Receive and manage applications for registration of declarations of conformity; cancel or suspend these applications for registration of declaration of conformity of Category 2 products under the management of MOLISA;Update and publish information about organizations and enterprises that have registered their declarations of conformity;

2. Receive and process applications for inspection of quality of the imports specified in Circular No. 22/2018/TT-BLDTBXH.Keep a log of the receipt of such applications (Form 01 in Appendix III hereof);

3. Cooperate with Departments of Labor, War Invalids and Social Affairs and customs authorities in handling products with inferior quality;

4. Submit annual and irregular reports on state inspection of product quality and receipt of applications for registration of declaration of conformity;

5. Carry out inspections and handle violations against regulations on declaration of conformity and conformity assessment by manufacturers, sellers, importers and conformity assessment bodies relevant to Category 2 products under the management of MOLISA;

6. Estimate the cost of quality inspection for the next year; integrate the cost estimate in the quality inspection plan and submit it to a competent authority for decision.

Article 14. Responsibilities of Departments of Labor, War Invalids and Social Affairs

Departments of Labor, War Invalids and Social Affairs are provincial quality control authorities and have the responsibility to:

1. Receive and process applications for inspection of quality of the imports specified in Circular No. 22/2018/TT-BLDTBXH.Keep a log of the receipt of such applications (Form 01 in Appendix III hereof);

2. Cooperate with Occupational Safety Administration and customs authorities in handling products with inferior quality;

3. Carry out inspections and handle violations against regulations on declaration of conformity and conformity assessment by manufacturers, sellers, importers and conformity assessment bodies relevant to Category 2 products under the management of MOLISA;

4. Submit annual and irregular reports on state inspection of product quality (Form 02 in Appendix III hereof) to Occupational Safety Administration.

Chapter 4

IMPLEMENTATION CLAUSES

Article 15. Entry into force

This Circular comes into force form February 20, 2019 and supersedes Circular No. 35/2012/TT-BLDTBXH dated December 27, 2012 and Circular No. 03/2010/TT-BLDTBXH dated January 19, 2010.

Article 16. Responsibility for implementation

1. Occupational Safety Administration and Departments of Labor, War Invalids and Social Affairs, relevant organizations and individuals are responsible for the implementation of this Circular.

2. In the cases where any of the legislative documents referred to in this Circular is amended or superseded by another legislative document, the latter shall apply.

3. Difficulties that arise during the implementation of this Circular should be reported to MOLISA for consideration./.

APPENDIX I

SPECIMEN OF THE CONFORMITY MARKING
(Promulgated together with Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Minister of Labor, War Invalids and Social Affairs)

1. Conformity marking for products undergoing conformity assessment by registered, appointed or recognized certifying organizations or assessing organizations:

2. Conformity marking for products undergoing internal conformity assessment

3. Dimensions

- H = 1.5 a

- C = 7.5 H

- A= 15 a

- B = 17 a

a (cm): decided by the declaring or certifying organization

4. The size of the conformity may vary as long as the ratio specified in (3) is maintained.

5. The conformity marking may be display directly on the product, package, package insert or label of the product at a noticeable position.

APPENDIX II

(Promulgated together with Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Minister of Labor, War Invalids and Social Affairs)

Form 01: Sample seal;

Form No. 02: Sampling record;

Form No. 03: Notice of sample testing result;

Form No. 04: Notice of non-conformable products;

Form No. 05: Product seal;

Form No. 06: Sealing record;

Form No. 07: Request for suspension of manufacture and sale of products;

Form No. 08: Permission to resume manufacture and sale of products.

Form No. 01

SAMPLE SEAL

(1)

Sample name:

Number:

Sampling date:

(1) Seal of the inspecting authority.

Form No. 02

SAMPLING RECORD

No. ………

1. Inspected facility:

2. Representative of inspected facility: (Full name, position, department)

3. Sample taker: (Full name, position, department)

4. Sampling method: According to TCVN ………… or QCVN …………………… or randomly

5. Status of sample:

- The sample is divided into 02 smaller units, 01 of which will be tested, the other will be stored by the inspecting authority. The sample quantity of each unit must be adequate for testing.

- The sample is sealed in the presence of the inspected facility's representative.

This record has been accepted by both parties and is made into 02 copies with the same value, each of which is held by a party./.

Form No. 03

NOTICE OF SAMPLE TESTING RESULT

Pursuant to the Law on product quality dated November 21, 2007;

Pursuant to the Government's Decree No. 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and goods quality;

Pursuant to Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Minister of Labor, War Invalids and Social Affairs on quality control of potentially dangerous products under management of the Ministry of Labor, War Invalids and Social Affairs;

On the basis of Decision No. … dated … (1);

On the basis inspection record No. … dated … and Sample test result No. … ,

At the request of the chief of the inspectorate,

……………….(2) hereby issues a notice as follows

1. Samples that fail the quality test:

2. Mandatory tasks to be done by the inspected facility:

(specify the remedial measures, time limit for implementation and reporting).

The manufacturer shall comply with the requests in this notice. The chief of the inspectorate shall supervise the manufacturer in doing so.

(1) The decision on functions, tasks, and entitlements of the inspecting authority;

(2) Name of the inspecting authority.

Form No. 04

NOTICE OF NON-CONFORMABLE PRODUCTS

Pursuant to the Law on product quality dated November 21, 2007;

Pursuant to the Government's Decree No. 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and goods quality;

Pursuant to Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Minister of Labor, War Invalids and Social Affairs on quality control of potentially dangerous products under management of the Ministry of Labor, War Invalids and Social Affairs;

On the basis of the testing result notice No. … dated …

(Name of the inspecting authority) hereby issues a notice as follows:

- Product name: …

- Symbol:

- Batch number, batch size, date of manufacture (if any):

- Manufacturer:

- Address:

- Failed criteria:

Form No. 05

BATCH SEAL

(1)

Product name:

Batch number:

Manufacturer

Address

Sealing date:

(1) Seal of the inspecting authority.

Form No. 06

SEALING RECORD

Pursuant to the Law on product quality dated November 21, 2007;

Pursuant to the Government's Decree No. 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and goods quality;

Pursuant to Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Minister of Labor, War Invalids and Social Affairs on quality control of potentially dangerous products under management of the Ministry of Labor, War Invalids and Social Affairs;

On the basis of the Request for manufacture suspension No. …

[hour and date]

The inspectorate

- Chief: …………………

- Member: …………………

Representative of the inspected facility

-Full name: …………. Position: ……………

The batch No. …. with a quantity of … is sealed and stored at …

Status of sealed products:

This record is made into 02 copies with equal value, 01 of which is retained by the inspecting authority, the other by the inspected facility.

Form No. 07

REQUEST FOR SUSPENSION OF MANUFACTURE AND SALE OF PRODUCTS

Pursuant to the Law on product quality dated November 21, 2007;

Pursuant to the Government's Decree No. 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and goods quality;

Pursuant to Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Minister of Labor, War Invalids and Social Affairs on quality control of potentially dangerous products under management of the Ministry of Labor, War Invalids and Social Affairs;

Pursuant to ……… (1)

On the basis of the testing result notice No. … dated …

At the request of the chief of the inspectorate,

The inspecting authority hereby requests that:

1. The manufacture and sale of the following products: (product names, symbols, batch number, batch size, date of manufacture) of (the manufacturer’s name and address of) be suspended.

2. {The manufacturer’s name) shall recall the non-conformable products and rectify the violations within … days and may only resume the manufacture and sale of the products after the rectification is satisfactory and the inspecting authority issues the permission to resume the manufacture and sale of products.

3. (2) has the responsibility to comply with this document. The chief of the inspectorate shall supervise the manufacturer in doing so.

(1) The document specifying the functions, tasks, and entitlements of the inspecting authority;

(2) The manufacturer’s legal representative

Form No. 08

PERMISSION TO RESUME MANUFACTURE AND SALE OF PRODUCTS.

Pursuant to the Law on product quality dated November 21, 2007;

Pursuant to the Government's Decree No. 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and goods quality;

Pursuant to Circular No. 26/2018/TT-BLDTBXH dated December 25, 2018 of the Minister of Labor, War Invalids and Social Affairs on quality control of potentially dangerous products under management of the Ministry of Labor, War Invalids and Social Affairs;

Pursuant to ……… (1);

At the request of (the manufacturer’s name);

On the basis of the testing result notice No. … dated …

At the request of the chief of the inspectorate,

The inspecting authority hereby permits that:

1. (Name and address of the manufacture) may resume the manufacture and sale of the following products: (product names, symbols).

2. (The manufacturer's name) shall comply with the Law on product quality and the applied standards/corresponding technical regulations.

(1) The document specifying the functions, tasks, and entitlements of the inspecting authority;