Circular No. 29/2011/TT-BYT on the management of chemicals and insecticides, bactericides used in household and medical fields

CIRCULAR

Regulations on the management of chemicals and insecticides, bactericides used in household and medical fields

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Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

The Government issues this Decree amending and supplementing the list of narcotic substances and precursors promulgated together with Decree No. 57/2022/NĐ-CP dated August 25, 2022 of the Government stipulating the lists of narcotic substances and precursors.

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

Pursuant to the Law on Trade dated June 14, 2005;

Pursuant to Decree No. 108/2008/NĐ-CP dated October 7, 2008 of the Government detailing and guiding some provisions of the Chemical Law;

Pursuant to Decree No. 26/2011/NĐ-CP dated April 8, 2011 of the Government amending and supplementing some articles of Decree No. 108/2008/NĐ-CP dated October 7, 2008 of the Government detailing and guiding some provisions of the Chemical Law;

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

Pursuant to Decree No. 12/2006/NĐ-CP dated January 23, 2006 of the Government detailing the implementation of the Trade Law regarding international trade activities and foreign-related agency purchase, sale, processing, and transit goods;

Considering the proposal of the Director of the Medical Environment Management Department under the Ministry of Health,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates registration for circulation; testing, trial use; export, import, and circulation of chemicals and insecticides, bactericides used in household and medical fields in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Chemicals is a substance with insecticidal and bactericidal activity.

2. Insecticide, bactericide chemicals are products containing active ingredients in technical form used for processing into formulations or used directly (hereinafter referred to as chemicals).

3. Insecticide, bactericide formulations are products containing active ingredients and having their own trade name, used for direct application (hereinafter referred to as formulations).

4. Test report on trial use results is the conclusion document of the unit conducting the trial use about the efficacy and safety of chemicals and formulations after implementing the evaluation process according to regulations issued by the Ministry of Health.

Article 3. List of chemicals and formulations

1. The list of chemicals issued by the Ministry of Health includes:

a) List of chemicals permitted for registration for use;

b) List of chemicals permitted for registration but restricted use;

c) List of chemicals prohibited from use.

2. Basis for issuing the List of chemicals:

a) Recommendations of the World Health Organization;

b) Research results approved by competent authorities;

c) Information on chemicals and formulations from ministries and sectors.

Chapter II

REGISTRATION FOR CIRCULATION OF CHEMICALS AND FORMULATIONS

Article 4. Trade Name of Chemicals and Formulations

1. The establishment of trade names for chemicals and formulations must comply with the following provisions:

a) Each chemical or formulation produced by a manufacturer can only be registered with one trade name in Vietnam;

b) A single trade name cannot be used for two or more chemicals or formulations produced by the same manufacturer;

c) The trade name of a chemical or formulation cannot be identical to the trade name of another chemical or formulation that has already been registered and is still valid;

d) Active ingredient names cannot be used as trade names for chemicals or formulations;

e) Trade names for chemicals or formulations cannot be misleading regarding their efficacy and safety.

2. Changing trade names may only be carried out in the following cases:

a) Exporting domestically produced chemicals or formulations with a valid registration number;

The application for changing trade names and the procedures for reviewing the application shall be implemented in accordance with the laws on free circulation certificates for exported and imported products and goods;

b) Chemicals or formulations with a valid registration number but with a written conclusion from a competent state authority regarding intellectual property rights or a court ruling on trademark infringement.

Article 5. Units Entitled to Register for Circulation

1. Units entitled to register for circulation of chemicals and formulations include:

a) Organizations and individuals in Vietnam who are owners (production units) of chemicals and formulations. In cases where the owner is not the production unit of the chemical or formulation, they must provide documentation proving ownership rights.

b) Organizations and individuals in Vietnam with functions of producing and trading in chemicals and formulations, or the permanent representative offices in Vietnam of foreign enterprises authorized by the owners of the chemicals and formulations to register.

c) The permanent representative offices in Vietnam of foreign units that produce chemicals and formulations.

2. Where the owner of the chemical or formulation permits the authorized unit to further authorize another unit to be named on the registration, such permission must be clearly stated in the authorization letter.

3. Where the owner of the chemical or formulation authorizes two or more units in Vietnam to register the same chemical or formulation, the Ministry of Health (Health Environment Management Department) will only accept and process the application of the first unit to submit a complete and valid dossier.

Article 6. Forms of Registration for Circulation

1. Formal registration for circulation applies in the following cases:

a) New chemicals and formulations produced domestically;

b) Chemicals and formulations already permitted for use abroad but being imported for the first time for use in Vietnam;

c) Chemicals and formulations that have been assigned registration numbers but have undergone changes in product form, solvent, additives, or active ingredient content;

d) Chemicals and formulations that have been issued certificates of registration for circulation but have not renewed their registration within the time limit specified in Clause 2, Article 9 of this Circular.

2. Supplementary registration for circulation applies in the case where chemicals and formulations have been assigned registration numbers in Vietnam which remain valid but undergo one of the following changes:

a) Changes in packaging specifications;

b) Changes in label design or content;

c) Changes in the address of the production unit or the registration unit;

d) Changes in ownership of the certificate of registration for circulation;

đ) Addition of new production facilities outside those registered officially;

e) Changes from bottling or packaging chemicals and formulations abroad to doing so in Vietnam;

g) Changes in function, quality standards, or usage methods.

3. Re-registration for circulation applies to chemicals and formulations that have been issued certificates of registration for circulation but whose registration numbers are nearing expiration according to the provisions of Clause 2, Article 9 of this Circular.

Article 7. Dossier for Formal Registration for Circulation

1. The formal registration dossier for chemicals and formulations produced domestically includes the following documents:

a) A request for formal registration for circulation (Form No. 1 attached as Appendix 1 to this Circular);

b) Business registration certificate or investment certificate in Vietnam or establishment permit for the representative office in Vietnam of the unit named on the registration;

c) Authorization letter for registration for circulation in cases stipulated in Point b, Clause 1, Article 5 of this Circular;

d) Test results for the composition and active ingredient content of the chemical or formulation;

đ) Survey result report (to be added to the dossier as provided in Point b, Clause 3, Article 12 of this Circular);

e) Environmental protection commitment statement or decision approving the environmental impact assessment report of the production unit approved by the competent state authority;

g) Technical documentation of the chemical or formulation proposed for registration (including contents as prescribed in Appendix 2 attached to this Circular);

h) Label sample and label content proposed for registration for circulation in Vietnam.

2. The formal registration dossier for chemicals and formulations imported includes the following documents:

a) A request for formal registration for circulation (Form No. 1 attached as Appendix 1 to this Circular);

b) In addition to the documents specified in Points b, c, d, đ, g, and h, Clause 1 of this Article, the formal registration dossier for imported chemicals and formulations must also include a free sale certificate still valid from at least one country currently allowing the circulation of the proposed chemical or formulation, issued by the competent authority of that country.

Article 8. Documents for supplementary registration for circulation

1. Request document for supplementary registration for circulation of chemicals and formulations (Form No. 2 attached as Appendix 1 to this Circular).

2. Relevant documents regarding changes or supplements:

a) In case of change in packaging format: label sample of chemicals and formulations according to the proposed supplementary packaging format;

b) In case of change in form or content of the label:

- Label sample of chemicals and formulations with new form or content proposed for supplementation;

- Explanation document for reasons requesting change in label content;

c) In case of change in production unit address or registration unit address:

- Business registration certificate or investment certificate in Vietnam;

- Label sample of chemicals and formulations indicating the new address of the production unit or the new address of the registration unit;

d) In case of change in ownership of the circulation registration certificate:

- Power of attorney for registration for circulation in accordance with Point b Clause 1 Article 5 of this Circular;

- Request document for transfer of ownership of the circulation registration number from the current owner of the registration number;

- Document of the entity requesting to accept the transfer of ownership of the circulation registration number and commitment to continue ensuring the business of chemicals and formulations in compliance with the dossier approved by the Ministry of Health (Health Environment Management Department) after accepting the registration number;

- Certificate of establishment of a permanent representative office in Vietnam or business registration certificate or investment certificate in Vietnam of the entity requesting to accept ownership of the registration number;

- Label sample of chemicals and formulations if there is a change in content and form;

đ) In case of adding a new production facility outside the officially registered production facility:

- Label sample of chemicals and formulations if there is a change in content and form;

- Free sale certificate issued by at least one country allowing circulation of chemicals and formulations produced at the proposed supplementary facility by the competent authority of that country (applicable only to imported chemicals and formulations);

- Response form for examination results (to be supplemented into the dossier as stipulated in Point b Clause 3 Article 12 of this Circular);

e) In case of changing the location of bottling and packaging of chemicals and formulations from abroad to Vietnam:

- Business registration certificate or investment certificate in Vietnam of the entity bottling and packaging in Vietnam;

- Response form for examination results of chemicals and formulations after bottling and packaging in Vietnam (to be supplemented into the dossier as stipulated in Point b Clause 3 Article 12 of this Circular);

- Environmental protection commitment letter or decision approving environmental impact assessment report of the entity bottling and packaging, approved by the competent state agency;

- Label sample of chemicals and formulations indicating the name and address of the entity bottling and packaging in Vietnam;

g) In case of change in effect, quality criteria or usage method:

- Label sample of chemicals and formulations indicating the proposed supplementary effect, quality criteria or usage method;

- Response form for examination results of chemicals and formulations after changing effect, quality criteria or usage method (to be supplemented into the dossier as stipulated in Point b Clause 3 Article 12 of this Circular).

Article 9. Documents for re-registration

1. The documents for re-registration include the following:

a) A request form for re-registration of chemicals and formulations (Form No. 3 attached as Appendix 1 to this Circular);

b) Business registration certificate or investment certificate in Vietnam or representative office establishment permit in Vietnam;

c) Survey result report for chemicals and formulations specified in Point b Clause 2 of this Article (to be added to the dossier after the survey organization completes the survey and submits the survey result report to the Ministry of Health);

d) Power of attorney for registration for cases specified in Point b Clause 1 of Article 5 of this Circular.

đ) Label samples and label content proposed for registration for circulation in Vietnam;

e) Circulation process report (Report Form at Appendix 3 issued together with this Circular).

2. Time limit for submitting the re-registration dossier:

a) The minimum time limit for submitting the re-registration dossier is 20 (twenty) working days before the registration number expires for raw materials to produce insecticides and bactericides that have been granted a valid registration number by the Ministry of Health (Health Environment Management Department);

b) For chemicals and formulations not covered by Point a of this Clause, the latest time limit for submitting the re-registration dossier is 14 (fourteen) months before the registration number expires;

After the deadlines set out in Points a and b of this Clause, if wishing to continue circulating chemicals and formulations, the registrant must proceed with formal registration.

Article 10. Requirements for chemicals subject to registration for circulation

1. The dossier for formal registration, supplementary registration, and re-registration of chemicals and formulations shall consist of one set.

2. Foreign language documents must be translated into Vietnamese and accompanied by the original foreign language documents. Foreign language documents other than English must be translated into Vietnamese and certified by a notary public or authorized translation agency.

3. Documents in the dossier must be clearly printed and arranged in sequence according to the registration forms prescribed in Articles 7, 8, and 9 of this Circular, with colored paper separating each section, and with a cover page and list of documents.

4. All documents in the registration dossier must be originals:

a) Power of attorney for registration for cases specified in Point b Clause 1 of Article 5 of this Circular;

b) Survey result report;

c) Test results for composition and concentration;

5. Documents in the registration dossier do not necessarily need to be originals but must be notarized or certified:

a) Business registration certificate or investment certificate in Vietnam or representative office establishment permit in Vietnam of the entity named on the registration;

b) Environmental protection commitment letter or environmental impact assessment report approval decision of the production unit approved by the competent state authority;

c) Free sale certificate as stipulated in Clause 2 of Article 7 of this Circular. This certificate must be apostilled, except in cases exempted from apostille under the law.

6. Other documents in the registration dossier must bear the stamp of the registrant.

Article 11. Acceptance of Registration Dossier for Circulation

The entity proposing registration for circulation shall submit directly to the Ministry of Health (Health Environment Management Department) the application dossier for registration of chemicals and formulations, or send it via postal service.

Article 12. Examination of Registration Dossier for Circulation

1. For the registration dossier for circulation of chemicals and formulations specified in Points a, b, c, and d Clause 2 Article 6 of this Circular, within 20 (twenty) working days from the date of receipt of the dossier, the Ministry of Health (Health Environment Management Department) shall issue a document requesting supplementary information, agreeing or disagreeing with the additional content of the registration for circulation.

2. For the registration dossier for circulation of chemicals and formulations specified in Point a Clause 2 Article 9 of this Circular:

a) For incomplete and non-compliant dossiers, within 5 (five) working days, the Ministry of Health (Health Environment Management Department) shall issue a document requesting supplementary information. Within the latest 5 (working) days before the registration number expires, the registering entity must supplement the required documentation; if beyond this period, the submitted dossier will lose its validity and the Ministry of Health (Health Environment Management Department) will not reissue the registration number.

b) For complete and compliant dossiers, within 15 (fifteen) working days, the Ministry of Health (Health Environment Management Department) shall reissue the registration number.

3. For the registration dossier for circulation of chemicals and formulations not covered by Clause 1 and 2 of this Article:

a) Within one month from the date of receipt of the dossier, the Ministry of Health (Health Environment Management Department) shall issue a document permitting testing. In cases where testing is not permitted, a response document with detailed reasons must be issued;

b) Within a maximum of 12 months from the date the Ministry of Health (Health Environment Management Department) issues the document permitting testing, the registering entity must submit the test results to supplement the registration dossier for circulation. Beyond this period, if the registering entity does not supplement the test results, the submitted dossier will lose its validity for registration for circulation;

c) Within 20 (twenty) working days from the date of receipt of the Test Result Reply Form from the registering entity to supplement the dossier, the Ministry of Health (Health Environment Management Department) must:

- Issue or not issue the registration number. If the registration number is not issued, a response document with detailed reasons must be issued for the registration dossier for chemicals and formulations specified in Clause 1 Article 6 and Point b Clause 2 Article 9 of this Circular;

- Issue a document agreeing or disagreeing with the additional content of the registration for circulation. If disagreement with the additional content of the registration for circulation is expressed, a response document with detailed reasons must be issued for the registration dossier for chemicals and formulations specified in Points đ, e, and g Clause 2 Article 6 of this Circular.

Article 13. Registration Number and Certificate of Registration for Circulation

1. A chemical or formulation shall only be granted one registration number.

2. The registration number for chemicals and formulations shall be issued in the form of a certificate of registration for circulation and shall be valid for 05 (five) years from the date of issuance.

The format of the Certificate of Registration for Circulation shall comply with the provisions set out in Appendix No. 7 attached to this Circular.

Article 14. Situations Leading to Revocation of Registration Number

1. The registering entity falsifies the registration dossier.

2. Chemicals and formulations circulating on the market do not conform to the contents of the certificate of registration for circulation issued or do not conform to the registration dossier; the label contents of chemicals and formulations circulating on the market do not conform to the approved label contents by the Ministry of Health (Health Environment Management Department), and the registering entity fails to rectify according to the requirements of the competent state management agency.

3. The registering entity leases or lends the certificate of registration for circulation;擅自修改和补充原文内容是不被允许的。根据规则，翻译必须保持100%的法律意义，不得添加或删除任何信息。因此，我将严格遵循原文内容进行翻译：

4. The registering entity ceases production and business operations of chemicals and formulations.

5. The registering entity no longer meets the conditions for registration for circulation of chemicals and formulations.

6. Chemicals and formulations circulating on the market no longer ensure efficacy and safety as registered with the Ministry of Health (Health Environment Management Department).

Article 15. Registration Filing Review Fees

1. Organizations and individuals proposing to register for circulation, test chemicals, and formulations shall submit registration filing review fees in accordance with the provisions of laws on fees and charges.

2. The registration filing review fee shall be submitted together with the file to the Ministry of Health (Health Environment Management Department).

Chapter III

CHEMICAL TESTING AND FORMULATION TESTING

Section 1

CHEMICAL TESTING AND FORMULATION TESTING

Article 16. Cases Requiring Testing

1. Chemicals and formulations before officially registering for circulation.

2. Chemicals and formulations during circulation in Vietnam.

Article 17. Content of Testing

1. Testing for registration purposes includes determining the active ingredient content and composition in chemicals and formulations.

2. Testing during circulation includes testing the main active ingredient content and other quality indicators of chemicals and formulations. Testing of chemicals and formulations during circulation shall be carried out in accordance with the Product Quality Law and other relevant legal provisions.

Article 18. Units Conducting Testing

1. Units established in accordance with Vietnamese law that have the function of testing the composition and content of chemicals and formulations.

2. In cases where Vietnamese testing units cannot test the content and composition of chemicals and formulations proposed for registration, the Ministry of Health (Health Environment Management Department) may consider accepting the testing results from the manufacturer or an independent laboratory, and the registering entity must bear legal responsibility for the legality of the testing results provided by itself.

Section 2

TESTING OF CHEMICALS AND FORMULATIONS

Article 19. Cases Requiring Testing

1. Chemicals and formulations before officially registering for circulation.

2. Chemicals and formulations that have been issued a circulation registration number by the Ministry of Health (Health Environment Management Department) and are still valid, requesting additional registration content as stipulated in Points d, e, and g Clause 2 Article 6 of this Circular.

3. Chemicals and formulations that have been issued a circulation registration number but whose registration number is about to expire, requesting re-registration as stipulated in Point b Clause 2 Article 9 of this Circular.

4. Chemicals and formulations without a circulation registration number requesting importation in large quantities for insect and bacterial control on aircraft.

Article 20. Content of Testing

1. Evaluation of the effectiveness of chemicals and formulations against target organisms as proposed by the registering entity.

2. Safety evaluation of chemicals and formulations:

a) For persons directly conducting the testing when the testing is implemented in a laboratory;

b) For persons directly conducting the testing and those living in the area where the testing is conducted when the testing is implemented in the field.

Article 21. Units Conducting Testing

1. Units evaluating the safety and efficacy of insecticides:

a) Central Institute of Hygiene and Epidemiology;

b) Ho Chi Minh City Pasteur Institute;

c) Nha Trang Pasteur Institute;

d) West Central Institute of Hygiene and Epidemiology;

đ) Central Institute of Malariology, Parasitology and Entomology;

e) Ho Chi Minh City Institute of Malariology, Parasitology and Entomology;

g) Qui Nhon Institute of Malariology, Parasitology and Entomology.

2. Units evaluating the safety and efficacy of bactericides:

a) Central Institute of Hygiene and Epidemiology;

b) Ho Chi Minh City Pasteur Institute;

c) Nha Trang Pasteur Institute;

d) West Central Institute of Hygiene and Epidemiology;

đ) Institute of Occupational Medicine and Environmental Health;

e) Ho Chi Minh City Institute of Public Health.

3. Other units outside those named in Clauses 1 and 2 of this Article, if they request designation as units conducting chemical and formulation testing, the Ministry of Health will recognize them based on their functions, tasks, and capabilities.

4. In cases where Vietnamese testing units cannot conduct testing of chemicals and formulations proposed for registration, the Ministry of Health (Health Environment Management Department) will consider and accept foreign testing results.

Chapter IV

EXPORT AND IMPORT OF CHEMICALS AND FORMULATIONS

Article 22. Principles for Implementing Chemicals and Formulations Export and Import

1. The export and import of chemicals and formulations shall be carried out in accordance with the provisions of the laws on export and import of goods.

2. In cases where the importing country requires confirmation that the chemicals and formulations have been circulated in Vietnam, the registering entity shall implement in accordance with the provisions of the laws on certificates of free circulation for exported and imported products and goods.

3. Imported chemicals and formulations with registration certificates for circulation issued by the Ministry of Health (Health Environment Management Department) still in effect may be imported according to demand without quantity or value restrictions, procedures handled at Customs, and without approval from the Ministry of Health. The importer shall bear full responsibility under the law for their own activities.

4. Chemicals and formulations included in the list for importation based on demand must still have at least two-thirds of their shelf life remaining from the date they arrived in Vietnam.

5. For domestically produced chemicals and formulations using imported raw materials that have not yet been granted registration certificates for circulation in Vietnam, when issuing registration numbers for circulation for the chemicals and formulations, the Ministry of Health (Health Environment Management Department) will issue a document confirming the permission to import the raw materials. The confirmation document will be valid for the same duration as the registration number issued for the chemicals and formulations.

Article 23. Import Permit

1. Chemicals and formulations must have an import permit:

a) Chemicals and formulations without a registration number but with a document permitting trial testing from the Ministry of Health (Health Environment Management Department) for importation for trial testing and inspection;

b) Chemicals and formulations without a registration number for importation for research; aid; special purposes (as gifts, donations, or where similar products and methods are not available on the market).

2. Documents and procedures for issuing an import permit for chemicals and formulations without a registration number for importation for trial testing and inspection:

a) A document requesting importation of chemicals and formulations (Form No. 1 of Appendix 4 issued together with this Circular);

b) Within five working days from the date of receipt of the import request document, the Ministry of Health (Health Environment Management Department) will issue a document agreeing or disagreeing to permit importation for inspection and trial testing, stating the reasons.

3. Documents and procedures for issuing an import permit for chemicals and formulations without a registration number for importation for research, aid, or special purposes:

a) Documents requesting importation of chemicals and formulations:

- An import request document (Form No. 2 of Appendix 4 issued together with this Circular);

- A certified copy of the business registration certificate or other documents proving the legal status of the organization requesting importation stamped by the organization;

- Technical documentation of the chemicals and formulations;

- Research outline (for chemicals and formulations imported for research) or documentation explaining the purpose of using imported chemicals and formulations (for chemicals and formulations imported for special purposes);

- In cases of importing chemicals and formulations for aid or special purposes with a total weight of fifty kilograms or more in a single application, there must be a Good Manufacturing Practice (GMP), ISO certification of the manufacturing plant and a permit for circulating chemicals and formulations in the home country or permits for circulating in several other countries where these chemicals and formulations have been registered and sold;

- A reply sheet of the test results for cases stipulated in Clause 4, Article 19 of this Circular (to be added to the file after the importing entity receives the response from the testing entity);

b) Within fifteen working days from the date of receiving complete and valid documents, the Ministry of Health (Health Environment Management Department) will issue a document approving or disapproving the importation. If importation is not approved, a document must be issued stating the reasons;

c) For cases stipulated in Clause 4, Article 19 of this Circular:

- Within five working days, the Ministry of Health (Health Environment Management Department) will issue a document requiring the performance of testing;

- Within ten working days from the date of receipt of the reply sheet of the test results sent by the importing entity, the Ministry of Health (Health Environment Management Department) will issue a document approving or disapproving the importation. If importation is not approved, a document must be issued stating the reasons.

Chapter V

CIRCULATION OF CHEMICALS AND FORMULATIONS

Article 24. Labeling of Chemicals and Formulations

1. Chemicals and formulations circulating in Vietnam must have labels in Vietnamese, the content of which must be consistent with the approved label model attached to the circulation registration certificate issued by the Ministry of Health (Health Environment Management Department) and comply with the legal provisions on labeling of goods circulating domestically and imported/exported goods.

2. The label must be printed in a minimum font size of 08mm, clearly visible, easy to read, not faded or easily torn during circulation, storage, transportation, and use.

3. The label must be firmly affixed or printed on the packaging of chemicals and formulations.

4. The background of the label shall not use colors that match the color indicating the toxicity level of the chemicals and formulations.

5. The mandatory contents of the label for chemicals and formulations include:

a) The trade name of the chemical or formulation;

b) Composition and active ingredient concentration;

c) Purpose;

d) Usage instructions and storage instructions;

đ) Warning information about health and environmental hazards;

e) Initial first aid measures when exposed to toxic chemicals or formulations;

g) Name and address of the manufacturing unit;

h) Name and address of the processing, bottling, and packaging unit (if applicable);

i) Name and address of the entity responsible for the chemical or formulation;

k) Batch number;

l) Date of production;

m) Expiration date;

n) Registration number for circulation in Vietnam.

6. For chemicals and formulations packaged in small containers, the label must also be printed in a minimum font size of 8mm, and if all required information cannot be included, an additional label must be attached to each package. If the package has an additional label, the main label on the package must print the phrase "Read the accompanying additional label before use."

The contents: trade name; purpose; responsible entity's name; quantity; production date; expiration date of the chemical or formulation must be printed on the main label.

7. For chemicals and formulations classified under toxicity groups I, II, III, and IV according to the World Health Organization classification, in addition to the information specified in Clause 5 of this Article, the label must also include toxicity symbols (as stipulated in Appendix 6 of this Circular) as follows:

a) A colored strip indicating toxicity at the bottom of the label, with a length equal to the width of the label and a height equivalent to 10% of the label's height:

- Red strip: for chemicals and formulations in toxicity group Ia, Ib;

- Yellow strip: for chemicals and formulations in toxicity group II;

- Blue strip: for chemicals and formulations in toxicity group III;

- Green strip: for chemicals and formulations in toxicity group IV.

b) Information on toxicity:

- "Extremely Toxic" (toxicity group Ia, Ib) and the corresponding symbol is a skull and crossbones in a skewed square;

- "Highly Toxic" (toxicity group II) and the corresponding symbol is a cross in a skewed square;

- "Dangerous" (toxicity group III) and the corresponding symbol is a broken line in a skewed square;

- "Caution" (toxicity group IV) without a corresponding symbol;

The toxicity symbols corresponding to each type of chemical or formulation must be placed above the trade name of the product.

Article 25. Packaging of Chemicals and Formulations

1. Chemicals and formulations circulating in Vietnam must be packed in packaging meeting the following requirements:

a) The quality of the packaging must be sufficiently robust to withstand normal impacts and vibrations during transportation, transfer between vehicles, and manual or mechanical handling装卸化学品和制剂的搬运和储存。

b) The packaging must be structurally sealed to ensure that chemicals and formulations do not leak during transportation or when transported with effects such as vibration, temperature increase, humidity, and pressure.

c) Chemical and formulation packaging can only be used once. For types of packaging such as glass bottles or porcelain containers, they may be reused after thorough cleaning.

d) The outer surface of the packaging must be clean and free from any hazardous chemicals.

2. Parts of the packaging that come into contact with chemicals and formulations must meet the following requirements:

a) They should not be affected or deteriorate in quality due to the influence of the chemicals or formulations inside.

b) They should not affect the composition, properties, and efficacy of the chemicals or formulations.

3. When packaging liquid chemicals or formulations, sufficient empty space must be left to ensure that the packaging does not leak or deform due to the increased volume of liquids caused by temperature rise during transportation.

4. Inner packaging materials that are prone to breakage or puncture, such as glass, porcelain, or certain types of plastic, must be securely fixed within the outer packaging using appropriate cushioning materials.

5. Packaging for volatile substances must be sufficiently sealed to ensure that the liquid level does not fall below the limit during transportation.

6. Packaging for liquid substances must be able to withstand internal pressure generated during transportation.

7. Packaging used to contain liquid chemicals or formulations must be tested for leakage before use.

8. Packaging for granular or powdered chemicals or formulations must be sufficiently sealed to prevent spillage or require inner lining layers.

9. The packaging capacity must correspond to the net weight or actual volume indicated on the label of the chemical or formulation.

Article 26. Transport of chemicals and formulations

1. Organizations and individuals transporting chemicals and formulations must comply with the regulations on dangerous goods transport under the laws on road traffic, inland waterway traffic, railway, aviation, maritime, and other relevant laws.

2. In case of chemical accidents during transportation, the driver, consignor, and owner of the means of transport must promptly apply measures to limit consequences, rectify the accident, and simultaneously report to firefighting forces, relevant agencies and units, and the nearest local authorities for coordinated response and rectification of the accident.

Article 27. Storage of chemicals and formulations

1. The storage of chemicals and formulations must ensure safety for people, animals, and the environment.

2. Warehouse keepers must be trained in labor safety and fire prevention in the work of storing chemicals and formulations.

3. In case of serious chemical accidents, the owner of the chemicals and formulations must promptly implement the emergency response measures prescribed in Clause 2, Article 26 of this Circular and the responsibility for coordinated response shall be carried out according to the provisions of Clause 3, Article 42 of the Chemicals Law, while the owner must bear all costs for rectifying the consequences of the accident.

Article 28. Disposal of chemicals and formulations

1. Situations requiring disposal:

a) Chemicals and formulations in production and business that have expired;

b) Containers and packaging containing chemicals and formulations that are no longer in use; waste generated during the production and business of chemicals and formulations.

2. Chemical products and formulations intended solely for household and individual use must be disposed of according to the manufacturer's recommendations and environmental protection laws, ensuring safety for people and the environment.

3. Organizations and individuals possessing chemicals, formulations, or their packaging that must be disposed of must bear all costs for disposal. In cases where the owner of the chemicals, formulations, or their packaging cannot be identified, the People's Committee of the province or centrally-administered city where the chemicals and formulations are managed will allocate budget funds to properly dispose of them in accordance with regulations.

4. Collection and disposal of chemicals, formulations, and their packaging must not cause spillage, dispersion, or increase hazardous waste in the environment and must be processed using appropriate technology in accordance with environmental protection laws.

Article 29. Advertising of chemicals and formulations

Advertising of chemicals and formulations shall be conducted in accordance with the laws on advertising.

Chapter VI

RESPONSIBILITIES FOR IMPLEMENTATION

Article 30. Department of Environmental Health Management - Ministry of Health

1. Assist the Minister of Health in performing state management functions over chemicals and formulations nationwide.

2. Serve as the permanent body of the Council for the Appraisal and Approval of Chemicals and Formulations.

3. Receive registration files for circulation, importation, and advertising; examine and resolve applications for issuance and withdrawal of registration numbers; store registration files for circulating, imported, and advertised chemicals and formulations in accordance with the provisions of this Circular.

4. Delegate authority to issue Decisions granting registration numbers for circulation in Vietnam for chemicals and formulations.

5. Delegate authority to issue Decisions withdrawing registration numbers from production and business organizations of chemicals and formulations violating the provisions of Article 34 of this Circular.

6. Annually, if there are changes in chemicals and formulations listed in Article 3 of this Circular, the Department of Environmental Health Management - Ministry of Health shall amend and supplement and submit to the Minister of Health for promulgation.

7. Manage fees for file appraisal in accordance with the law.

8. Take the lead and coordinate with relevant agencies to conduct inspections and checks on chemicals and formulations throughout the country.

Article 31. Inspection by the Ministry of Health

1. Shall be responsible for inspecting the implementation of this Circular throughout the country in accordance with the laws on inspection.

2. Shall handle complaints and denunciations, and investigate any signs of violation of the law by units operating in the chemical and formulation sector throughout the country.

Article 32. Units conducting chemical and formulation testing

1. Shall conduct testing to officially register for circulation, re-register for circulation, and supplementally register for circulation for chemicals and formulations that have been permitted for testing by the Ministry of Health (Health Environment Management Department).

2. Shall carry out chemical and formulation testing according to the Testing Procedures issued by the Ministry of Health.

3. In cases where chemicals and formulations are permitted for testing but do not yet have Testing Procedures issued by the Ministry of Health, the testing unit shall be responsible for developing the procedures and submitting them to the Ministry of Health (Health Environment Management Department) for consolidation, review, and issuance by the Minister of Health.

4. Shall be liable under the law for the results of chemical and formulation testing.

5. Shall report periodically on the implementation of testing on the 15th day of June and December each year to the Ministry of Health (Health Environment Management Department). In case of discovering differences between actual usage doses and recommended usage doses indicated on product labels by manufacturers, the testing unit shall be responsible for reporting in writing to the Ministry of Health (Health Environment Management Department) for consideration and resolution.

6. In case the testing unit fails to comply with the provisions of Clause 1, 2, 3, 4, and 5 of this Article, the Ministry of Health will consider and remove it from the list of qualified testing units.

Article 33. Provincial Departments of Health under Central Cities

1. Shall guide production, trading, and use units of chemicals and formulations within their jurisdiction to implement this Circular and other relevant laws.

2. Shall coordinate with competent agencies to organize regular or spot inspections and handle administrative violations in the production, trading, and use of chemicals and formulations as stipulated in this Circular within their jurisdiction.

3. Shall submit periodic reports in writing to the Ministry of Health (Health Environment Management Department) on the 15th day of December each year or submit ad hoc reports as required by the Ministry of Health (Model at Appendix 5 stipulated in this Circular).

Article 34. Chemical and Formulation Production and Trading Units

1. Shall comply with the provisions of this Circular and other relevant laws.

2. Shall submit periodic written reports to the provincial health department where the headquarters is located on the situation of chemical and formulation production and trading by November 30 each year.

3. Shall notify in writing the Ministry of Health (Health Environment Management Department) when the unit registers or the production unit changes its name due to division, merger, organizational form conversion, or discontinuation of chemical and formulation production and trading.

4. Shall be liable under the law if their chemical and formulation production and trading activities adversely affect people, livestock, and the environment; shall be responsible for the quality of their products when they are put into circulation and use.

5. Shall be subject to inspection, examination, and handling of violations in accordance with the law.

6. Shall be responsible for recalling, processing, and destroying chemicals and formulations based on conclusions of law violations by authorized agencies.

Article 35. Units using chemicals and formulations

1. Shall only use chemicals and formulations that have been granted registration numbers still in effect.

2. For chemicals and formulations provided as aid or used for special purposes permitted by the Ministry of Health (Health Environment Management Department) to import, the importing unit and individuals or organizations using them must fully bear responsibility for the use of the imported chemicals and formulations.

3. Require chemical suppliers to provide complete information on the hazardous characteristics of chemicals and formulations and requirements to ensure effectiveness and safety; be compensated by the supplier for damages during the use of chemicals and formulations due to incorrect information from the supplier according to the provisions of the law.

4. Strictly follow the usage instructions displayed on the product label or accompanying the chemicals and formulations, and shall fully bear responsibility if used incorrectly; ensure safety for oneself, the environment, and the community; if using chemicals and formulations causes damage to the health, life, or property of others, compensation must be provided according to the provisions of the law.

Chapter VII

IMPLEMENTING PROVISIONS

Article 36. Effective Date

This Circular takes effect from January 1, 2012.

Decision No. 3486/2001/QD-BYT dated August 13, 2001 of the Minister of Health on issuing the "Regulations on the Management of Chemicals and Formulations for Insect and Bacterial Control in Household and Medical Fields" and Section III on Importing Chemicals and Formulations for Insect and Bacterial Control in Household and Medical Fields of Circular No. 08/2006/TT-BYT guiding the importation of vaccines, medical products; chemicals and formulations for insect and bacterial control in household and medical fields and medical equipment cease to be effective from the date this Circular takes effect.

During implementation, if there are difficulties, they should be promptly reported to the Ministry of Health for review and resolution./.