MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 11/2020/TT-BYT | Hanoi, June 19, 2020 |
CIRCULAR
PROMULGATING LIST OF PROHIBITED AND RESTRICTED ACTIVE INGREDIENTS IN INSECTICIDAL AND MICROBICIDAL PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE
Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, duties, powers and organizational structure of the Ministry of Health;
Pursuant to the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of insecticidal and microbicidal chemicals and preparations for household and medical use;
At the request of the General Director of the Health Environment Management Agency,
The Minister of Health hereby promulgates a Circular promulgating list of prohibited and restricted active ingredients in insecticidal and microbicidal preparations for household and medical use.
Article 1. Scope
This Circular promulgates list of prohibited and restricted active ingredients in insecticidal and microbicidal preparations for household and medical use (hereinafter referred to as “insecticidal and microbicidal preparations for household and medical use”).
Article 2. Regulated entities
This Circular is applicable to regulatory bodies, organizations and individuals involved in trade, manufacturing and marketing authorization of insecticidal and microbicidal preparations for household and medical use in Vietnam and relevant organizations and individuals.
Article 3. List of active ingredients
1. Enclosed with this Circular is Appendix No. 01 containing list of prohibited active ingredients in insecticidal and microbicidal preparations for household and medical use in Vietnam.
2. Enclosed with this Circular is Appendix No. 02 containing list of restricted active ingredients in insecticidal and microbicidal preparations for household and medical use in Vietnam.
Article 4. Effect
1. This Circular takes effect from August 20, 2020.
2. Circular No. 47/2017/TT-BYT dated December 22, 2017 by the Minister of Health promulgating list of prohibited and restricted active ingredients in insecticidal and microbicidal preparations for household and medical use in Vietnam is annulled from the date on which this Circular comes into force.
Article 5. Transitional clauses
1. Insecticidal and microbicidal preparations for household and medical use granted marketing authorization before the effective date of this Circular may continue to be manufactured and imported for a maximum of 1 year and be sold and used for a maximum of 2 years from the date on which this Circular comes into force in the following cases:
a) The insecticidal or microbicidal preparation contains one of the following active ingredients, which are included in Appendix No. 01 enclosed therewith: Chlorpyrifos ethyl, Hexythiazox, Fipronil, Beta-cyfluthrin, Cyfluthrin, Trichlorfon, Diazinon, Acephate, Malathion and Methanol;
b) The insecticidal or microbicidal preparation contains Emamectin benzoate or Spinosad and is not used as regulated in Appendix No. 02 enclosed therewith.
2. From the date on which this Circular comes into force, receipt, processing and appraisal of applications for marketing authorization of insecticidal and microbicidal preparations containing one of the following active ingredients shall cease completely: Chlorpyrifos ethyl, Hexythiazox, Fipronil, Beta-cyfluthrin, Cyfluthrin, Trichlorfon, Diazinon, Acephate, Malathion and Methanol.
3. For insecticidal and microbicidal preparations for household and medical use that contain the active ingredients listed in Appendix No. 02 enclosed therewith and are granted marketing authorization prior to the effective date of this Circular, their advertisements shall provide the exact descriptions of the use(s) written on their marketing authorizations. In case a use besides those prescribed in Appendix No. 02 herein is advertised, revision of the marketing authorization is required as per the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of insecticidal and microbicidal chemicals and preparations for household and medical use and the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health.
Article 6. Implementing responsibilities
1. General Director of the Health Environment Management Agency shall organize implementation of this Circular.
2. Head of Office of the Ministry of Health, chief inspector of the Ministry of Health, heads of affiliates of the Ministry of Health, Office of the Ministry of Health, inspectors of the Ministry of Health, directors of Departments of Health, heads of healthcare units of other ministries and relevant regulatory bodies, organizations and individuals shall implement this Circular.
During the implementation of this Circular, any difficulty arising should be promptly reported to the Ministry of Health for consideration and resolution./.
| P.P. THE MINISTER |
APPENDIX NO. 01
LIST OF PROHIBITED ACTIVE INGREDIENTS IN INSECTICIDAL AND MICROBICIDAL PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE
(Enclosed with Circular No. 11/2020/TT-BYT dated June 19, 2020 by the Minister of Health)
No. | Name of active ingredient | CAS number 1 |
1. | Acephate | 30560-19-1 |
2. | Aldrin | 309-00-2 |
3. | Benzene hexachloride (BHC) | 58-89-9 |
4. | Beta-cyfluthrin | 68359-37-5 |
5. | Chlordance | 57-74-9 |
6. | Chlordecone | 143-50-0 |
7. | Chlorpyrifos ethyl | 2912-88-2 |
8. | Cyfluthrin | 68359-37-5 |
9. | Diazinon | 333-41-5 |
10. | Dichlorodiphenyltrichloroethane (DDT) | 50-29-3 |
11. | Dichlovos | 62-73-7 |
12. | Dieldrin | 60-57-1 |
13. | Endosulfan and isomers thereof |
|
14. | Endrin | 72-20-8 |
15. | Fipronil | 120068-37-3 |
16. | Heptachlor | 76-44-8 |
17. | Hexachlorobenzene | 118-74-1 |
18. | Hexachlorocyclohexane and isomers thereof |
|
19. | Hexythiazox | 78587-05-0 |
20. | Insecticidal and microbicidal biologically-active ingredients (excluding Bacillus thuringiensis israelensis (Bti), strain AM65-52, 266-2) |
|
21. | Cadmium compounds |
|
22. | Lead compounds |
|
23. | Isobenzen | 297-78-9 |
24. | Isodrin | 465-73-6 |
25. | Lindane | 58-89-9 |
26. | Malathion | 121-75-5 |
27. | Methanol (Not registered as a main active ingredient in microbicidal preparations. In a preparation, content of impurities of Methanol shall not exceed 2. 000mg/l). | 67-56-1 |
28. | Methamidophos | 10265-92-6 |
29. | Methyl Parathion | 298-00-0 |
30. | Monocrotophos | 6923-22-4 |
31. | Mirex | 2385-85-5 |
32. | Naphthalene | 91-20-3 |
33. | Paradichlorobenzene (1,4-Dichlorobenzene, p-DCB) | 106-46-7 |
34. | Parathion Ethyl | 56-38-2 |
35. | Pentachlorophenol (PCP) and salts thereof |
|
36. | Perflurooctan sulfonic acid and salts thereof |
|
37. | Phosphamidon | 13171-21-6 |
38. | Polychlorinated Biphenyls (PCB) | 1336-36-3 |
39. | Strobane | 8001-50-1 |
40. | Toxaphen | 8001-35-2 |
41. | Trichlorfon | 52-68-6 |
APPENDIX NO. 02
LIST OF RESTRICTED ACTIVE INGREDIENTS IN INSECTICIDAL AND MICROBICIDAL PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE
(Enclosed with Circular No. 11/2020/TT-BYT dated June 19, 2020 by the Minister of Health)
No. | Name of active ingredient | CAS number 1 | Restriction of use |
1. | AgniqueTM MMF | 52292-17-8 | Only permissible for mosquito larvae control, not permissible for use in drinking and domestic water |
2. | Bacillus thuringiensis israelensis (Bti), strain AM65-52, 266-2 |
| Only permissible for mosquito larvae control, not permissible for use in drinking and domestic water |
3. | Bromchlophos | 53095-31-1 | Only permissible for outdoor ULV spray against flies |
4. | Diethyl toluamid | 134-62-3 | Not permissible for use on children under 4 years of age |
5. | Diflubenzuron | 35367-38-5 | Only permissible for mosquito larvae control, not permissible for use in drinking and domestic water |
6. | Dimethyl phthalate | 131-11-3 | Volume below 30% , not permissible for use on children under 4 years of age |
7. | Emamectin benzoate | 155569-91-8 | Only permissible for use in cockroach bait gel, content below 0,2% |
8. | Fenitrothion | 122-14-5 | Only permissible for outdoor ULV spray against flies, mosquitoes and cockroaches |
9. | Methoprene | 40596-69-8 | Only permissible for mosquito larvae control, not permissible for use in drinking and domestic water |
10. | Novaluron | 116714-46-6 | Only permissible for mosquito larvae control, not permissible for use in drinking and domestic water |
11. | Spinosad | 168316-95-8 | Not permissible for use in drinking and domestic water |
12. | Temephos | 3383-96-8 | Only permissible for mosquito larvae control, not permissible for use in drinking and domestic water |
13. | Pyriproxyfen | 95737-68-1 | Not permissible for use in drinking and domestic water |
1 “CAS” is an acronym for “Chemical Abstracts Service”. CAS numbers are chemical abstracts service registry numbers used to identify chemical elements and compounds.
1 “CAS” is an acronym for “Chemical Abstracts Service”. CAS numbers are chemical abstracts service registry numbers used to identify chemical elements and compounds.
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