Circular 13/tt-Byt/2011: Regulations On The Management Of Chemical Substances, Preparations For Destroying Insects, Bactericide Used In Household And Medical Fields

Original Language Title: Thông tư 29/2011/TT-BYT: Quy định về quản lý hóa chất, chế phẩm diệt côn trùng, diệt khuẩn dùng trong lĩnh vực gia dụng và y tế

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Pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health;

Pursuant to the law on chemicals of 21 November 2007;

Pursuant to the law of product quality, the goods on November 21, 2007;

Commercial Law base on June 14, 2005;

Pursuant to Decree No. 109/2008/ND-CP of June 7, 2008 Government's detailed rules and instructions of some articles of the law on chemicals;

Pursuant to Decree No. 26/2010/ND-CP on April 8, 2012 of the Government revising, supplementing a number of articles of Decree No. 109/2008/ND-CP of June 7, 2008 Government's detailed rules and instructions of some articles of the law on chemicals;

Pursuant to Decree No. 132/2008/ND-CP on December 31, 2008 of the Government detailing and guiding the implementation of the law on product quality, the goods;

Pursuant to Decree No. 12/2006/ND-CP dated 23 January 2006 from the Government detailing the Commercial Law enforcement activities in the international sale of goods and the activities of dealers buying, selling, processing and transiting goods with foreign countries;

Proposal of the Director of environmental management of Health-Ministry of health, chapter I GENERAL PROVISIONS article 1. Scope this circular regulates registration of circulation; tested, assay; export, import and circulation of chemical substances, preparations for destroying insects, bactericide used in household and medical sectors in Vietnam.

Article 2. Explanation of terms In this circular, the terms below are interpreted as follows: 1. active substances are chemicals that kill insects, kill bacteria.

2. chemical insecticides, is bactericidal products containing active substances in the form of techniques used to outsource the processing of finished products or direct use (hereinafter referred to as the chemicals).

3. Preparations for destroying insects, is bactericidal products containing active ingredients and have the trade name, used to use direct (hereinafter referred to as products).

4. Slip the answer results assay is the text of the conclusions of the unit perform assay on the effect and safety of chemical substances, preparations after the implementation of process reviews in accordance by the Ministry of Health issued.

Article 3. Chemical preparations, category 1. Chemical list by the Ministry of Health issued include: a) category chemicals are allowed to register to use;

b) category chemicals are allowed to register but limited use;

c) prohibits the use of chemical categories.

2. Pursuant to the promulgation of the list of chemicals: a) recommended by the World Health Organization;

b) results in scientific research has been approved by the authority;

c) information about chemical substances, preparations of the ministries.

Chapter II REGISTRATION of CHEMICAL CIRCULATION PREPARATIONS, article 4. Trade names of chemical substances, preparations 1. The trade name for the chemical substances, preparations are as defined below: a) Each chemical, the manufacturer of a product register a trade name in Vietnam;

b) do not use a trade name given to two or more chemicals, products of a manufacturer;

c) trade names of chemicals, products are not identical with trade names of chemical substances, preparations have been circulating registration level before it is valid;

d) does not use the active ingredient to name Commerce for chemicals, preparations;

DD) non-trade name for the chemical preparations, with the meaning doesn't fit the effect and safety of chemical substances, preparations for it.

2. The trade name changes are only made in the following cases: a) the export of chemicals, products are manufactured in the Member State of registration valid in circulation;

Records suggest rename sequence and commercial appraisal of records made under the provisions of the law on the certificate of free circulation for products, goods exports and imports;

b) chemicals, preparations containing the registration number issued is valid but has concluded in writing of the authorized State Agency of intellectual property or the Court about trademark infringement.

Article 5. Name registration units in circulation 1. Unit is registered name circulating chemicals, products include: a) individual organizations in Vietnam is the owner (unit production), chemical preparations. The case of the owner is not the units produce chemical, the products must have the documentation to prove ownership.

b) organizations, individuals in Vietnam has the function of production, business, chemical products or the resident representative office of foreign enterprises in Vietnam are authorized by the owner of the chemicals, preparations.

c) resident representative office in Vietnam by foreign units produce chemical products.

2. where the owner of the chemicals, preparations for allowing his unit is authorized to continue to authorize other units be registered name chemicals, preparations must specify the content allowed in the authorization.

3. where the owner of the chemicals, authorized preparations for two or more units in Vietnam registered the same chemicals, preparations, the Ministry of health (environmental health administration) only to receive and settle for the first registration unit is full of valid records.

Article 6. Registration forms in circulation 1. Official circulation registration applies to the following cases: a) chemicals, the new products are produced in the country;

b) chemicals, preparations have been allowed to use abroad but were first imported to use in Vietnam;

c) chemicals, preparations have been circulating registration number level but there is a change in the form of products, solvents, additives or active content;

d) chemicals, preparations have to be registrations certificates circulated but not make registering circulating again within the time limit specified in paragraph 2 to article 9 of this circular.

2. register additional circulation applies to chemical products, have been given the registration number circulating in Vietnam still in force but has one of the following changes: a) the change of packing;

b) change in form or content labels;

c) change production units, address units;

d) change of ownership registration certificates in circulation;

DD) adding new production facilities in addition to production facilities according to official registration;

e) change the location to the bottle, packaging, chemical preparations in the foreign city to bottles, packaged chemicals, preparations in Vietnam;

g) change in work, quality criteria or methods of use.

3. Register the circulation are applicable to the chemicals, preparations have to be registrations certificates in circulation but the registration number circulating about to expire as prescribed in clause 2 article 9 of this circular.

Article 7. Registration documents of official circulation of 1. Registration documents for the official circulation of the chemicals, products are manufactured in the country include the following: a) the suggested text of official circulation registration (form 1 in Appendix 1 attached to this circular);

b) business registration certificate or certificate of investment in Vietnam or the license to establish a representative office in Vietnam of the registered name;

c) authorization to conduct the register floated for cases specified in point b of paragraph 1 article 5 of this circular.

d) test results the composition and concentration of chemical substances, preparations;

DD) assay results answer Votes (to be added to the profile as defined in point b of paragraph 3 article 12 this circular);

e) A commitment to protect the environment or the decision to approve the assessment report on the environmental impact of production units by the competent State agencies;

g) technical documentation of chemicals, suggested products registration (including the content as defined in Appendix 2 attached to this circular);

h) form the label and the official label template content registration proposal circulating in Vietnam.

2. Registration documents for the official circulation of the chemicals imported products, including the following: a) the suggested text of official circulation registration (form 1 in Appendix 1 attached to this circular);

b) in addition to the papers prescribed at points b, c, d, e, g and h of paragraph 1 of this Article, the record of registration for the official circulation of the chemicals, imported products must be more free sale certificate validity of at least one country is allowing the circulation of chemicals recommended products, registered by the competent authority of that country.

Article 8. Registration of additional circulation of 1. Suggested text to register additional circulation of chemicals (in the form of 2 annex 1 attached to this circular).

2. Relevant documents about the problem changes or additions: a) for changing the packing: sample label of chemical preparations, according to packing additional proposal;

b) for changing the form or content of the sample label:-Model label of the chemical product, with new content or form additional proposal;

-Text explanation of reasons please change the content label model;

c) for the case of a change of address, unit production unit registration:-business registration certificate or certificate of investment in Vietnam;

-The model label of the chemical product, the new address of the production units or the new address of the register;

d) for cases of change of ownership registration certificates in circulation: – power of Attorney made the subscription circulation for cases specified in point b of paragraph 1 article 5 this circular;

-The text of the proposal to transfer ownership of the registration number of the unit are in possession of the registration number in circulation;

-The text of the unit please accept the proposal is receiving ownership of registered and committed after receiving the registration number in circulation will continue to ensure the business of chemicals, proper preparations with records were the Ministry of health (environmental health administration) approval;

-License Permanent Representative Office in Vietnam or business registration certificate or certificate of investment in Vietnam of the unit please receive the ownership registration number in circulation;

-The model label of the chemical product, if there is a change in terms of content and form;

DD) for additional cases of new production facilities in addition to production facilities according to official registration Form:-the label of the chemical product, if there is a change in terms of content and form;


-Free sale certificate in at least one country is allowing the circulation of chemicals, products are manufactured at the facility to recommend additional registration by the competent authority of the country which granted (only applicable to imported products, chemicals);

-Assay results answer Votes (added to the profile as defined in point b of paragraph 3 article 12 this circular);

e) for cases to change the venue to the bottle, packaging, chemical preparations in the foreign city to bottles, packaged chemicals, preparations in Vietnam;

-Business registration certificate or certificate of investment in Vietnam of the unit to the bottle, packaged in Vietnam;

-Slip the answer results for chemical assay, after preparations to bottles, packaged in Vietnam (which was added to the profile as defined in point b of paragraph 3 article 12 this circular);

-A commitment to protect the environment or the decision to approve the report of environmental impact assessment of the unit to the bottle, packaged by the competent State agencies;

-The model label of the chemical product, in which the name and address of the unit into the bottle, packaged in Vietnam;

g) for cases of change of work, quality criteria or methods of use;

-Sample label of chemical preparations, including suggested content recording effects, quality criteria or methods of use;

-Reply Vote results for the assay of chemical preparations, after effects changes, quality criteria or methods of use (to be added to the profile as defined in point b of paragraph 3 article 12 of this circular).

Article 9. Registration documents circulated back 1. Registration documents in circulation include the following documents: a) the suggested text circulating back registration of chemicals (in the form of 3 Annex 1 attached to this circular);

b) business registration certificate or certificate of investment in Vietnam, or license the resident representative office in Vietnam;

c) Vote reply assay results for the chemicals, preparations specified in point b of Paragraph 2 of this Article (added to the profile after the unit perform the assay completed the assay and send answer results assay on the Ministry of health);

d) authorization to conduct the register floated for cases specified in point b of paragraph 1 article 5 of this circular.

DD) form the label and the label template content registration proposal circulating in Vietnam;

e) report the process of circulation of products (report template in Appendix 3 attached to this circular).

2. The time limit for filing registration circulation: a) the time limit for filing registration circulation back a minimum of 20 (twenty) working days before the registration number circulating expire for raw material for the production of insecticides, bactericide has been the Ministry of health (medical environment management Bureau) issued the registration number in circulation.

b) for chemical substances, products not subject to the provisions in point a of this Paragraph, the time limit for filing registration circulation back slowly for 14 (fourteen), before the registration number circulating expired;

After the time limit specified in the point a and b of this Paragraph, if want to continue circulating chemicals, preparations, registration unit should conduct registration of official circulation.

Article 10. Requirements for the registration of chemicals in circulation 1. Registration documents circulated officially, register additional registration, circulation circulation again made preparations, chemicals 1.

2. documents in foreign languages must be translated into Vietnamese and accompanied by the original documents in a foreign language. Documents in a foreign language is not English to Vietnamese translation certified by a notary or the translation function units.

3. The documents in the file are printed clearly, arranged in sequence for each registration form specified in articles 7, 8 and 9 of this circular, between sections are separated by coloured paper, have the cover and bibliography.

4. The papers in the registration documents is required to circulate the original: a) the authorization to conduct the register floated for cases specified in point b of paragraph 1 article 5 this circular;

b) assay results answer Votes;

c) test results the composition and concentrations;

5. The papers in the registration documents in circulation does not necessarily have to be original but are required to be certified or authenticated: a) the business registration certificate or certificate of investment in Vietnam or the license to establish a representative office in Vietnam of the registered name;

b) A commitment to protect the environment or the decision to approve the assessment report on the environmental impact of production units by the competent State agencies;

c certificate of free sale) prescribed in clause 2 article 7 of this circular. This certificate must be legalized consular, unless legally exempt under the provisions of the law.

6. The other documents in the registration documents circulated to seal of registered units.

Article 11. Receiving registration documents circulation unit registration proposal floated filed directly records the registration proposal circulating chemicals, preparations at the Ministry of health (environmental health administration) or sent by post.

Article 12. Evaluation of registration documents in circulation 1. For registration documents circulating chemicals, products defined in points a, b, c and d, item 2 article 6 of this circular, in the period of 20 (twenty) working days from the date of the application, the Ministry of health (environmental health administration) have written additional requirements profile , agree or disagree with the content of registration of additional circulation.

2. for registered records released chemicals, preparations specified in point a of Paragraph 2 article 9 of this circular: a) for incomplete records, valid, within 5 (five) working days, the Ministry of health (environmental health administration) have written additional requirements profile. In the slowest time is 5 days (work) before the registration number circulating inactive registration units to supplement the documentation as requested, if the time limit for the submission of record is no longer valid and the Ministry of health (environmental health administration) not to grant registration number back in circulation;

b) for valid, full profile, within 15 (fifteen) working days, the Ministry of health (environmental health administration) must grant leave the registration number.

3. for registration documents circulating chemicals, products not subject to the provisions in clause 1, 2: a) during the 12 months from the date of the application, the Ministry of health (environmental health administration) have text allows for assay. Cases not permit to have assay writing answers and stating the reason;

b) during a maximum of 12 months from the date of the Ministry of health (environmental health administration) have text allows for assay, the unit register must submit to assay results added to the registration documents. After the above mentioned deadline registration unit, additional assay results, profile already filed the registration value no longer in circulation;

c) during the period of 20 (twenty) working days from the date of the vote answered the assay results of registered units to supplement on record, the Ministry of health (environmental health administration) must:-grant or not to grant the registration number. The case of not granting leave the registration number issued to answer in writing and stating the reason for registration documents circulating chemicals, preparations defined in article 6 paragraph 1 and Paragraph 2, point b article 9 of this circular;

-The text to agree or disagree with the content of registration of additional circulation. The case does not agree with the content of registration of additional circulation must reply in writing and stating the reason for the record registered chemical circulation, regulated products at the point of DD, e, and g of Paragraph 2 article 6 of this circular.

Article 13. Number and registration certificates in circulation 1. A chemical preparations, only to be granted a registration number.

2. Registry number circulating chemicals, products are issued by the registration certificate form and force 5 (five) years from the date of issue.

Sample of the certificate of registration issued to follow prescribed in Appendix No. 7 attached to this circular.

Article 14. The case revoked the registration number in circulation 1. Register a fake registration documents.

2. Chemicals, products are circulating on the market are not true to the content of the registration certificate was issued in circulation or not true with registration documents; chemical label content, circulation products on the market are not true to the content label was the Ministry of health (environmental health administration) approval that the register does not fix as required by State administration authorities.

3. the registration unit for rent, borrow the registration certificate of circulation; arbitrarily modify the content of the registration certificate.

4. Register the termination of operations, business, chemical preparations.

5. registration unit is no longer eligible to register patents, chemical circulation.

6. chemical preparations, floated on the market no longer guaranteed safe and effective as the profile is registered with the Ministry of health (environmental health administration).

Article 15. Evaluation fee registration documents in circulation 1. The Organization, the individual proposed register circulation, chemical assay, preparations for implementation of the profile assessment charges filed under the provisions of the law on fees.

2. Fee appraisal records are filed together records of the Ministry of health (environmental health administration).

Chapter III testing, CHEMICAL ASSAY, the TEST category 1 PRODUCTS, CHEMICAL PRODUCTS, article 16. The case is tested 1. Chemical preparations, before signing the official circulation.

2. chemical products, in the process of circulating in Vietnam.

Article 17. Testing content 1. Testing aims to sign up include identification and content of active ingredient in preparations, chemicals.

2. Tested in the process of circulating include testing components and levels of the main active substances, other quality indicators of chemical substances, preparations. The tested chemicals, preparations in the course of circulation are made according to the provisions of the law on quality of goods and products and the other provisions of the law.

Article 18. Perform unit testing 1. The unit was established under the provisions of the law of Vietnam, functional testing of components and concentrations of chemicals, preparations.


2. in case the units tested in Vietnam not tested is and content components of the recommended products, chemical registration, the Ministry of health (environmental health administration) can consider to accept results of testing unit of production or an independent lab and registration unit must be responsible before the law on the legality of the results tested by themselves provide.

Item 2 PREPARATIONS, CHEMICAL ASSAY article 19. The case of the assay 1. Chemical preparations, before signing the official circulation.

2. Chemicals, preparations were the Ministry of health (medical environment management Bureau) issued the registration number circulating current recommendations to register additional circulation of content regulation in the point e e and g of Paragraph 2 article 6 of this circular.

3. Chemicals, preparations were the Ministry of health (medical environment management Bureau) issued the registration number in circulation but the registration number circulating about to expire the registration proposal floated back specified in point b of Paragraph 2 article 9 of this circular.

4. chemical preparations, not containing the registration number circulating Please import in large quantities to kill insects, bactericidal.

Article 20. Assay of content 1. Evaluate the effect of chemical substances, preparations for the destination object by registering suggestions.

2. the safety assessment of chemical substances, preparations: a) for people who directly perform the assay when deploying the assay in the laboratory;

b) for people who directly perform the assay and people living in the area when the assay the assay deployed in the field.

Article 21. The unit perform the assay 1. The unit safety and assay the effect of chemical substances, preparations for destroying insects: a) the Central Institute of hygiene and epidemiology;

b) Ho Chi Minh City Pasteur Institute;

c Nha Trang Pasteur Institute);

d) Institute of hygiene epidemiology Highlands;

DD) Institute of malaria-parasite – insect Central;

e) Institute of malaria-parasite – insect in Ho Chi Minh City;

g) Institute of malaria-parasite – insect Quy Nhon.

2. The unit safety and assay the effect of chemicals, bactericidal products: a) the Central Institute of hygiene and epidemiology;

b) Ho Chi Minh City Pasteur Institute;

c Nha Trang Pasteur Institute);

d) Institute of hygiene epidemiology Highlands;

Labour Medicine) and environmental hygiene;

e) Institute of hygiene and public health.

3. The unit other than the unit named in paragraph 1 and 2 of this Article if requested is specified as the unit performs chemical assay, the Health Ministry will base on the functions, tasks and the ability of the unit to recognize.

4. in case the assay units in Vietnam do not perform the chemical assay, please register the products in circulation, the Ministry of health (environmental health administration) will consider and accept the results of the assay.

Chapter IV export, IMPORT of chemicals, What PREPARATIONS 22. Implementation guidelines for export, import, chemical preparations 1. The export and import of chemicals, products made under the provisions of the law on the export and import of goods.

2. In the case of importing countries have asked to confirm chemicals, preparations have been circulating in Vietnam, the register made under the provisions of the law on the certificate of free circulation for products, goods exports and imports.

3. chemical, imported products have certificates of registration issued by the Ministry of health (environmental health administration) validity level are allowed to import-on-demand, unlimited quantity, value, procedures at customs, not through the Ministry of health for approval. Import unit responsible before the law for his activities.

4. chemical preparations list, import demand is also at least 2/3 (two thirds) use the term since coming to Vietnam.

5. With regard to chemicals, domestic manufacturing products using imported raw materials has not been issued a certificate of registration issued in Vietnam, when the level of registration for circulation of chemical substances, preparations, the Ministry of health (environmental health administration) will confirm in writing the raw materials are imported. Confirmation text effect corresponds to the validity of the registration number in circulation levels for chemicals, preparations.

Article 23. Import licences 1. The chemicals, products must have a permit to import: a) chemicals, preparations have not yet had the registration number in circulation but have had the text allows the assay of the Ministry of health (environmental health administration) to do the assay, testing;

b) chemical preparations, not containing the registration number issued to research; aid; used for other specific purposes (as gifts for gift, or on the market do not have the product and similar methods).

2. Profile, import licensing procedures for chemicals, preparations not already have registered to do importing circulation assay, tested: a) the suggested text import chemicals (annex 4 No. 1 form attached to this circular);

b) within 5 (five) working days from the date of receiving the recommended text import, the Ministry of health (environmental health administration) have written to agree or not agree to allow the import to do testing, assay and stating the reason.

3. Profile, import licensing procedures for chemical preparations, not containing the registration number issued to research, aid, used for other specific purposes: a) the suggested profile import chemicals, preparations:-suggested text import (form number 2 Appendix 3 attached to this circular);

-Certified copies of business registration certificate or other documents proving legal personality of the organization recommended import have the Organization's stamp;

-The technical documentation of products, chemicals;

-Research outline (for imported products, chemicals for research) or document explanation of purpose of use of imported products, chemicals (for imported products, chemicals for specific purposes);

-The case of imported chemicals, preparations to aid, used for specific purposes other than total weight once Please import from 50 (fifty) kg or over must have a certificate of GMP, ISO of manufacturing and chemical circulation license, country products or license in some other country that the chemical , that preparations have to be registrations and sales;

-Slip the assay results answer for cases stipulated in article 19 paragraph 4 this circular (to be added to the profile after the unit please enter password get the results answer of the unit perform the assay);

b) within 15 (fifteen) working days from the date of receipt of a valid application, the Ministry of health (environmental health administration) would have written answer allow or not allow imports. Cases not permit to import must have a written reply stating the reason;

c) for cases stipulated in article 19 paragraph 4 this circular:-within 5 (five) working days, the Ministry of health (environmental health administration) have written a request to perform the assay;

-Within 10 working days from the date of the vote answered assay results by importing, please send the unit, Ministry of health (environmental health administration) would have written answer allow or not allow imports. Cases not permit to import must have a written reply stating the reason.

Chapter V CIRCULATION of CHEMICAL SUBSTANCES, PREPARATIONS for article 24. Chemical preparations, label 1. The chemicals, preparations when circulating in Vietnam are labeled by the Vietnamese, the content of the label to the right with the contents stated in the form approved label attach the certificate of registration issued by the Ministry of health (environmental health administration) level and in accordance with the provisions of the law on the labelling of goods circulation in domestic and export goods import.

2. The label must be printed by the minimum font size is 08mm, clear, easy to read, not to be faint or susceptible to torn during the circulation, storage, transportation and use.

3. The label must be attached to or printed on the packaging, chemical preparations.

4. label Background color matches is not used only by toxic chemicals, preparations.

5. the compulsory content of chemical preparations, labels include: a) the trade name of chemical substances, preparations;

b) component, active content;

c) effect;

d) manuals, guidelines for preservation;

DD) information warning of the risk of causing harm to human health and the environment;

e initial emergency measures) when chemical poisoning, preparations;

g) name, address, unit of production;

h) name, address, unit of work, to the bottle, packaging (if any);

I) name, address of the unit responsible for the preparations, chemicals;

k) batch number manufacture;

l) day, month and year of manufacture;

m) expiry date;

n) registered in Vietnam.

6. With regard to the types of chemicals, products are packaged with small packaging, labels are also in the minimum font size is 8 mm and if not in enough of the required information it must have extra label attached to each chemical packaging, products. If chemical packaging, product key label on the side labeled packaging must print the words "read carefully the extra label attached before use".

The content: the trade name; the effect; name of the responsible unit; quantified; date of production; limit the use of chemical substances, preparations must be indicated on the label.

7. With regard to the chemical, toxic products in groups I, II, III and IV according to the classification of the World Health Organization in addition to the information specified in paragraph 5 of this article, on the label must be more iconic expression toxic (as defined in Appendix 6 to this circular) as follows : a toxic only in color) planned the bottom part of the label and of length equal to the length of the label, the height equivalent to 10% of the height of the label:-Red Line: for chemicals, independent group of products Ia, Ib;

-Yellow Line: for chemicals, the independent group II products;

-Blue Line: for chemicals, the independent group III preparations;

-The Green Line: for chemicals, the independent group IV preparations.

b) information about the toxic levels:-"toxic" (the independent groups Ia, Ib) and the iconic symbol toxic skull cross bones is in the square set deflection;

-"Toxic" (the independent group II) and the iconic symbol toxic is a cross in the square set deflection;

-"Dangerous" (the independent group III) and the iconic symbol toxic is the discontinuity in the square set deflection;


-"Careful" (the independent group IV) does not have the iconic symbol toxic;

The iconic expression corresponding to each type's toxicity levels of chemicals, products are placed on the trade name of the product.

Article 25. Packing, chemical preparations 1. Chemical preparations, when circulation in Vietnam must be packed in packaging that meets the following requirements: a) the quality of the packaging need not enough strength to withstand normal shocks and collisions during transport, cargo forwarding between the means and the unloading to the treasure by manual or motorized equipment;

b) packaging must be sealed to ensure enough structure does not make preparations, chemical leak during transport or when shipping with the impacts such as vibration, temperature, humidity and pressure;

c) chemical packaging, products can only be used once. For this type of packaging such as bottles, glass; porcelain, then can be used again after it has processed clean;

d) the outer packaging must ensure clean and do not stick any dangerous chemicals.

2. The parts of the packing of the exposure to chemicals, preparations must ensure the following requirements: a) are not affected or impaired the quality due to the impact of chemicals, packaging products inside;

b) does not affect the components, features and effects of chemical substances, preparations.

3. When packing chemicals, liquid preparations must leave the space needed to ensure packaging not be leak or deformed because of the increase in the volume of the liquid when the temperature increases during shipping.

4. The type of packing of the inside in susceptible to rupture or puncture as the type of glass, porcelain or some kind of certain plastic needs to be inserted with the external packaging class with the type of material inserted, cushion shocks.

5. Packing for volatile substances must be sealed to ensure in the course of transport the fluid level not down low under the limit.

6. Packing of the fluid must have the appropriate stamina with the pressure from the inside was born during shipping.

7. Packing used to contain chemicals, liquid preparations must leak test before use.

8. Packaging chemicals, preparations in the form of powder or granules must be sealed to avoid falling finalist or need the enclosed sealing layer.

9. Packaging must have the correct capacity with net weight, the real volume is recorded on the labels of chemical products.

Article 26. Transport of chemical substances, preparations 1. The Organization of personal transport, chemicals, products must comply with the rules on the transport of dangerous law on road traffic, inland waterways, rail, air, sea and other provisions of the relevant laws.

2. in case of incidents occurring during transport of chemicals, who controls the media, owners, media owners must apply timely measures to limit the consequences, troubleshoot, and notify the fire department fire force, the unit concerned, the local authorities nearest to coordinate response and fix the problem.

Article 27. Preserving chemicals, preparations 1. Preservation chemicals, products are guaranteed safe for people, pets and the environment.

2. The store keeper must receive training on occupational safety, fire prevention in the work of preserving chemicals, preparations.

3. In the event of serious chemical incidents, the owner of the chemicals, preparations must promptly implement corrective measures prescribed in clause 2 Article 26 of this circular and the responsibility to coordinate the response to be made according to the provisions in paragraph 3 Article 42 chemical Law, at the same time the owner must bear all costs for the remedial issues.

Article 28. Destruction of chemical substances, preparations 1. The case of destruction: a) chemicals, preparations in the manufacturing business, has expired;

b) tools, chemical packaging, do not continue to use the products; put waste in the production process, product, chemical business.

2. The chemical products, only products for use within households, individuals must be disposed according to the manufacturer's recommendations, the provisions of the law on the protection of the environment, ensuring safety for people and the environment.

3. organizations, individual chemicals, products or packaging of chemicals, forcing the destruction of preparations must bear all costs for the destruction. The case of chemicals, products or packaging of chemicals, forcing the destruction of products which do not identify the owner, the people's Committee of the central cities, where are chemical preparations, management which CITES budget to accomplish the destruction.

4. The collectors, the destruction of chemicals, preparations and packaging of chemical substances, preparations not scattered, dispersed or increases the more hazardous waste into the environment and must be dealt with by appropriate technology as prescribed by the law on the protection of the environment.

Article 29. Chemical products, promotional advertising products, chemical goods made under the provisions of the law on advertising.

Chapter VI article 30 IMPLEMENTATION RESPONSIBILITIES. Environmental Management Bureau of Health-Ministry of health 1. Health Minister help implement state management functionality of chemicals, products within the country.

2. Is the unit of authority, chemical preparations, review.

3. Receiving registration documents circulating, importing, advertising; consider, resolve the granting, withdrawal of the registration number in circulation; chemical records, registration, circulation of products imported, advertised as prescribed in this circular.

4. Authorizations issued the decision to grant registration number circulating in Vietnam for chemicals, preparations.

5. Authorizations issued the decision to withdraw the registration number issued in respect of the production units, business, chemical preparations for violation of the provisions of article 34 of this circular.

6. Every year, if there is a change in the chemical, the chemical products as defined in article 3 of this circular, environmental management Bureau of Health-Ministry of health revised, supplemented and the Minister of health.

7. Manage profile evaluation fee according to the provisions of the law.

8. the Chairman, in collaboration with relevant agencies perform inspections, checking on preparations, chemicals on nationwide.

Article 31. Inspection of the Ministry of health 1. The Ombudsman is responsible for the implementation of this circular on nationwide under the provisions of the law on the Ombudsman.

2. Complaints, accusations and when found to have signs of law violation activities unit in the field of chemicals, preparations on nationwide.

Article 32. The unit performs chemical assay, preparations 1. Perform the assay to sign formal registration, circulation circulation back, sign the additional circulation for the chemicals, preparations had the text allows the assay of the Ministry of health (environmental health administration).

2. Perform the chemical assay, assay process, preparations by the Ministry of Health issued.

3. in case of chemical substances, preparations are allowed but no assay the assay procedure by the Ministry of Health issued, the unit performs the assay is responsible for build process to send the Ministry of health (environmental health administration) to sum up, evaluation and submission to the Minister of health.

4. Be responsible before the law about chemical assay results, preparations.

5. periodic report the implementation of the assay on the 15th of June and December every year to the Ministry of health (environmental health administration). In the case of the actual dosage differences compared with the dosage as recommended by producer indicated on the product label, the assay is responsible to report in writing to the Ministry of health (environmental health administration) to consider and resolve.

6. The case of the unit perform the assay is not done properly the provisions in clause 1, 2, 3, 4, 5 of this, the Ministry of health will review and withdraw from the list of eligible units assay.

Article 33. The Department of health, city in Central 1. Guidelines for the production, trading, use of chemical substances, preparations within the scope of management of locally made under the provisions of this circular and the other provisions of the relevant laws.

2. In coordination with the relevant authorities organize inspections, periodic or irregular inspection and handling administrative violations in the field of production, trading, use of chemicals, products as specified in this circular within the local management.

3. Periodically report in writing to the Ministry of health (environmental health administration) on 15 December, annual or unscheduled reports required by the Ministry of health (model in annex 5 provisions of this circular).

Article 34. Unit of production, business, chemical preparations 1. The correct implementation of the provisions of this circular and the other provisions of the relevant laws.

2. periodic reports in writing on the Health Department of the province or city where the headquarters of the situation produced, preparations, chemical business on 30 November of each year.

3. The notice in writing to the Ministry of health (environmental health administration) when the registration unit or unit of production changed the name due to the split, merger, transformation institutions, do not continue production, the chemical business, products.

4. Be responsible before the law if the production activities, the chemical business, its products bad influence to people, pets and the environment; responsible for the quality of its products when introduced, use.

5. Subject to the inspection, testing and processing the violation under the provisions of the law.

6. the responsible withdrawal, disposal and destruction of the chemicals, when preparations have concluded violated the law by competent authorities.

Article 35. The unit uses chemicals, preparations 1. Only used chemical substances, preparations have been circulating registration number level.

2. for the aid preparations, chemicals or used with specific purposes by the Ministry of health (environmental health administration) allows to import, imported units and institutions, personal use is entirely responsible for the use of chemical substances, imported products.


3. Request the chemical supply unit provides full information about the dangerous properties of chemicals, preparations and requirements ensure effective, safe; provided compensation in the process of using chemicals, preparations by the false information of the vendor under the provisions of the law.

4. Comply with the instructions of use shown on the product label or the directions for use accompanying chemical substances, preparations and totally responsible if used wrong guidelines; ensure safety for themselves, the environment and communities; If the use of chemical substances, preparations for which caused damage to the health, life, property of others to indemnify under the provisions of the law.

Chapter VII ENFORCEMENT PROVISIONS Article 36. Effective enforcement of this circular effect since 01/01/2012.

Decision No. 3490/2001/QD-BYT on 13/8/2001 of the Minister of health on "regulation of chemical management, preparations for destroying insects, bactericide used in household and medical field" and section III provisions on imports of chemicals, insecticides, preparations used in sterilizing household sector and of health circular No. 08/2006/TT-BYT imported vaccine Guide , medical products; chemicals, preparations for destroying insects, bactericide used in household sector and of health and medical equipment from foremost enforceable from the moment this circular effect.

In the process, if there are obstacles, it should reflect timely Health Ministry to consider, resolve./.